TSUNAMI WARNING, EDUCATION, AND RESEARCH ACT OF 2015
(House of Representatives - November 30, 2016)

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[Congressional Record Volume 162, Number 171 (Wednesday, November 30, 2016)]
[Pages H6894-H7006]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          TSUNAMI WARNING, EDUCATION, AND RESEARCH ACT OF 2015

  Mr. UPTON. Mr. Speaker, pursuant to House Resolution 934, I call up 
the bill (H.R. 34) to authorize and strengthen the tsunami detection, 
forecast, warning, research, and mitigation program of the National 
Oceanic and Atmospheric Administration, and for other purposes, with 
the Senate amendment thereto, and ask for its immediate consideration.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore. The Clerk will designate the Senate 
amendment.
  Senate amendment:

In lieu of the matter proposed to be inserted, add the following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Tsunami Warning, Education, 
     and Research Act of 2015''.

     SEC. 2. REFERENCES TO THE TSUNAMI WARNING AND EDUCATION ACT.

       Except as otherwise expressly provided, whenever in this 
     Act an amendment or repeal is expressed in terms of an 
     amendment to, or repeal of, a section or other provision, the 
     reference shall be considered to be made to a section or 
     other provision of the Tsunami Warning and Education Act 
     (Public Law 109-424; 33 U.S.C. 3201 et seq.).

     SEC. 3. EXPANSION OF PURPOSES OF TSUNAMI WARNING AND 
                   EDUCATION ACT.

       Section 3 (33 U.S.C. 3202) is amended--
       (1) in paragraph (1), by inserting ``research,'' after 
     ``warnings,'';
       (2) by amending paragraph (2) to read as follows:
       ``(2) to enhance and modernize the existing United States 
     Tsunami Warning System to increase the accuracy of forecasts 
     and warnings, to ensure full coverage of tsunami threats to 
     the United States with a network of detection assets, and to 
     reduce false alarms;'';
       (3) by amending paragraph (3) to read as follows:
       ``(3) to improve and develop standards and guidelines for 
     mapping, modeling, and assessment efforts to improve tsunami 
     detection, forecasting, warnings, notification, mitigation, 
     resiliency, response, outreach, and recovery;'';
       (4) by redesignating paragraphs (4), (5), and (6) as 
     paragraphs (5), (6), and (8), respectively;
       (5) by inserting after paragraph (3) the following:
       ``(4) to improve research efforts related to improving 
     tsunami detection, forecasting, warnings, notification, 
     mitigation, resiliency, response, outreach, and recovery;'';
       (6) in paragraph (5), as redesignated--
       (A) by striking ``and increase'' and inserting ``, 
     increase, and develop uniform standards and guidelines for''; 
     and
       (B) by inserting ``, including the warning signs of locally 
     generated tsunami'' after ``approaching'';
       (7) in paragraph (6), as redesignated, by striking ``, 
     including the Indian Ocean; and'' and inserting a semicolon; 
     and
       (8) by inserting after paragraph (6), as redesignated, the 
     following:
       ``(7) to foster resilient communities in the face of 
     tsunami and other similar coastal hazards; and''.

     SEC. 4. MODIFICATION OF TSUNAMI FORECASTING AND WARNING 
                   PROGRAM.

       (a) In General.--Subsection (a) of section 4 (33 U.S.C. 
     3203(a)) is amended by striking ``Atlantic Ocean, Caribbean 
     Sea, and Gulf of Mexico region'' and inserting ``Atlantic 
     Ocean region, including the Caribbean Sea and the Gulf of 
     Mexico''.
       (b) Components.--Subsection (b) of section 4 (33 U.S.C. 
     3203(b)) is amended--
       (1) in paragraph (1), by striking ``established'' and 
     inserting ``supported or maintained'';
       (2) by redesignating paragraphs (7) through (9) as 
     paragraphs (8) through (10), respectively;
       (3) by redesignating paragraphs (2) through (6) as 
     paragraphs (3) through (7), respectively;
       (4) by inserting after paragraph (1) the following:
       ``(2) to the degree practicable, maintain not less than 80 
     percent of the Deep-ocean Assessment and Reporting of 
     Tsunamis buoy array at operational capacity to optimize data 
     reliability;''.
       (5) by amending paragraph (5), as redesignated by paragraph 
     (3), to read as follows:
       ``(5) provide tsunami forecasting capability based on 
     models and measurements, including tsunami inundation models 
     and maps for use in increasing the preparedness of 
     communities and safeguarding port and harbor operations, that 
     incorporate inputs, including--
       ``(A) the United States and global ocean and coastal 
     observing system;
       ``(B) the global Earth observing system;
       ``(C) the global seismic network;
       ``(D) the Advanced National Seismic system;
       ``(E) tsunami model validation using historical and 
     paleotsunami data;
       ``(F) digital elevation models and bathymetry;
       ``(G) newly developing tsunami detection methodologies 
     using satellites and airborne remote sensing; and
       ``(H) any other data the Administrator determines is 
     necessary;'';
       (6) by amending paragraph (7), as redesignated by paragraph 
     (3), to read as follows:
       ``(7) include a cooperative effort among the 
     Administration, the United States Geological Survey, and the 
     National Science Foundation under which the Director of the 
     United States Geological Survey and the Director of the 
     National Science Foundation shall--
       ``(A) provide rapid and reliable seismic information to the 
     Administrator from international and domestic seismic 
     networks; and
       ``(B) support seismic stations installed before the date of 
     the enactment of the Tsunami Warning, Education, and Research 
     Act of 2015 to supplement coverage in areas of sparse 
     instrumentation;'';
       (7) in paragraph (8), as redesignated by paragraph (2)--
       (A) by inserting ``, including graphical warning 
     products,'' after ``warnings'';
       (B) by inserting ``, territories,'' after ``States''; and
       (C) by inserting ``and Wireless Emergency Alerts'' after 
     ``Hazards Program''; and
       (8) in paragraph (9), as redesignated by paragraph (2)--
       (A) by inserting ``provide and'' before ``allow''; and
       (B) by inserting ``and commercial and Federal undersea 
     communications cables'' after ``observing technologies''.
       (c) Tsunami Warning System.--Subsection (c) of section 4 
     (33 U.S.C. 3203(c)) is amended to read as follows:
       ``(c) Tsunami Warning System.--The program under this 
     section shall operate a tsunami warning system that--
       ``(1) is capable of forecasting tsunami, including 
     forecasting tsunami arrival time and inundation estimates, 
     anywhere in the Pacific and Arctic Ocean regions and 
     providing adequate warnings;
       ``(2) is capable of forecasting and providing adequate 
     warnings, including tsunami arrival time and inundation 
     models where applicable, in areas of the Atlantic Ocean, 
     including the Caribbean Sea and Gulf of Mexico, that are 
     determined--
       ``(A) to be geologically active, or to have significant 
     potential for geological activity; and
       ``(B) to pose significant risks of tsunami for States along 
     the coastal areas of the Atlantic Ocean, Caribbean Sea, or 
     Gulf of Mexico; and
       ``(3) supports other international tsunami forecasting and 
     warning efforts.''.
       (d) Tsunami Warning Centers.--Subsection (d) of section 4 
     (33 U.S.C. 3203(d)) is amended to read as follows:
       ``(d) Tsunami Warning Centers.--
       ``(1) In general.--The Administrator shall support or 
     maintain centers to support the tsunami warning system 
     required by subsection (c). The Centers shall include--

[[Page H6895]]

       ``(A) the National Tsunami Warning Center, located in 
     Alaska, which is primarily responsible for Alaska and the 
     continental United States;
       ``(B) the Pacific Tsunami Warning Center, located in 
     Hawaii, which is primarily responsible for Hawaii, the 
     Caribbean, and other areas of the Pacific not covered by the 
     National Center; and
       ``(C) any additional forecast and warning centers 
     determined by the National Weather Service to be necessary.
       ``(2) Responsibilities.--The responsibilities of the 
     centers supported or maintained under paragraph (1) shall 
     include the following:
       ``(A) Continuously monitoring data from seismological, deep 
     ocean, coastal sea level, and tidal monitoring stations and 
     other data sources as may be developed and deployed.
       ``(B) Evaluating earthquakes, landslides, and volcanic 
     eruptions that have the potential to generate tsunami.
       ``(C) Evaluating deep ocean buoy data and tidal monitoring 
     stations for indications of tsunami resulting from 
     earthquakes and other sources.
       ``(D) To the extent practicable, utilizing a range of 
     models, including ensemble models, to predict tsunami, 
     including arrival times, flooding estimates, coastal and 
     harbor currents, and duration.
       ``(E) Using data from the Integrated Ocean Observing System 
     of the Administration in coordination with regional 
     associations to calculate new inundation estimates and 
     periodically update existing inundation estimates.
       ``(F) Disseminating forecasts and tsunami warning bulletins 
     to Federal, State, tribal, and local government officials and 
     the public.
       ``(G) Coordinating with the tsunami hazard mitigation 
     program conducted under section 5 to ensure ongoing sharing 
     of information between forecasters and emergency management 
     officials.
       ``(H) In coordination with the Coast Guard, evaluating and 
     recommending procedures for ports and harbors at risk of 
     tsunami inundation, including review of readiness, response, 
     and communication strategies, and data sharing policies.
       ``(I) Making data gathered under this Act and post-warning 
     analyses conducted by the National Weather Service or other 
     relevant Administration offices available to the public.
       ``(J) Integrating and modernizing the program operated 
     under this section with advances in tsunami science to 
     improve performance without compromising service.
       ``(3) Fail-safe warning capability.--The tsunami warning 
     centers supported or maintained under paragraph (1) shall 
     maintain a fail-safe warning capability and perform back-up 
     duties for each other.
       ``(4) Coordination with national weather service.--The 
     Administrator shall coordinate with the forecast offices of 
     the National Weather Service, the centers supported or 
     maintained under paragraph (1), and such program offices of 
     the Administration as the Administrator or the coordinating 
     committee, as established in section 5(d), consider 
     appropriate to ensure that regional and local forecast 
     offices--
       ``(A) have the technical knowledge and capability to 
     disseminate tsunami warnings for the communities they serve;
       ``(B) leverage connections with local emergency management 
     officials for optimally disseminating tsunami warnings and 
     forecasts; and
       ``(C) implement mass communication tools in effect on the 
     day before the date of the enactment of the Tsunami Warning, 
     Education, and Research Act of 2015 used by the National 
     Weather Service on such date and newer mass communication 
     technologies as they are developed as a part of the Weather-
     Ready Nation program of the Administration, or otherwise, for 
     the purpose of timely and effective delivery of tsunami 
     warnings.
       ``(5) Uniform operating procedures.--The Administrator 
     shall--
       ``(A) develop uniform operational procedures for the 
     centers supported or maintained under paragraph (1), 
     including the use of software applications, checklists, 
     decision support tools, and tsunami warning products that 
     have been standardized across the program supported under 
     this section;
       ``(B) ensure that processes and products of the warning 
     system operated under subsection (c)--
       ``(i) reflect industry best practices when practicable;
       ``(ii) conform to the maximum extent practicable with 
     internationally recognized standards for information 
     technology; and
       ``(iii) conform to the maximum extent practicable with 
     other warning products and practices of the National Weather 
     Service;
       ``(C) ensure that future adjustments to operational 
     protocols, processes, and warning products--
       ``(i) are made consistently across the warning system 
     operated under subsection (c); and
       ``(ii) are applied in a uniform manner across such warning 
     system;
       ``(D) establish a systematic method for information 
     technology product development to improve long-term 
     technology planning efforts; and
       ``(E) disseminate guidelines and metrics for evaluating and 
     improving tsunami forecast models.
       ``(6) Available resources.--The Administrator, through the 
     National Weather Service, shall ensure that resources are 
     available to fulfill the obligations of this Act. This 
     includes ensuring supercomputing resources are available to 
     run, as rapidly as possible, such computer models as are 
     needed for purposes of the tsunami warning system operated 
     under subsection (c).''.
       (e) Transfer of Technology; Maintenance and Upgrades.--
     Subsection (e) of section 4 (33 U.S.C. 3203(e)) is amended to 
     read as follows:
       ``(e) Transfer of Technology; Maintenance and Upgrades.--In 
     carrying out this section, the Administrator shall--
       ``(1) develop requirements for the equipment used to 
     forecast tsunami, including--
       ``(A) provisions for multipurpose detection platforms;
       ``(B) reliability and performance metrics; and
       ``(C) to the maximum extent practicable, requirements for 
     the integration of equipment with other United States and 
     global ocean and coastal observation systems, the global 
     Earth observing system of systems, the global seismic 
     networks, and the Advanced National Seismic System;
       ``(2) develop and execute a plan for the transfer of 
     technology from ongoing research conducted as part of the 
     program supported or maintained under section 6 into the 
     program under this section; and
       ``(3) ensure that the Administration's operational tsunami 
     detection equipment is properly maintained.''.
       (f) Federal Cooperation.--Subsection (f) of section 4 (33 
     U.S.C. 3203(f)) is amended to read as follows:
       ``(f) Federal Cooperation.--When deploying and maintaining 
     tsunami detection technologies under the program under this 
     section, the Administrator shall--
       ``(1) identify which assets of other Federal agencies are 
     necessary to support such program; and
       ``(2) work with each agency identified under paragraph 
     (1)--
       ``(A) to acquire the agency's assistance; and
       ``(B) to prioritize the necessary assets in support of the 
     tsunami forecast and warning program.''.
       (g) Unnecessary Provisions.--Section 4 (33 U.S.C. 3203) is 
     further amended--
       (1) by striking subsection (g);
       (2) by striking subsections (i) through (k); and
       (3) by redesignating subsection (h) as subsection (g).
       (h) Congressional Notifications.--Subsection (g) of section 
     4 (33 U.S.C. 3203(g)), as redesignated by subsection (g)(3), 
     is amended--
       (1) in the matter before paragraph (1), by striking ``30'' 
     and inserting ``90'';
       (2) by redesignating paragraphs (1) and (2) as 
     subparagraphs (A) and (B), respectively, and moving such 
     subparagraphs 2 ems to the right;
       (3) in the matter before subparagraph (A), as redesignated 
     by paragraph (2), by striking ``The Administrator'' and 
     inserting the following:
       ``(1) In general.--The Administrator'';
       (4) in paragraph (1), as redesignated by paragraph (3)--
       (A) in subparagraph (A), as redesignated by paragraph (2), 
     by striking ``and'' at the end;
       (B) in subparagraph (B), as redesignated by paragraph (2), 
     by striking the period at the end and inserting ``; and''; 
     and
       (C) by adding at the end the following:
       ``(C) the occurrence of a significant tsunami warning.''; 
     and
       (5) by adding at the end the following:
       ``(2) Contents.--In a case in which notice is submitted 
     under paragraph (1) within 90 days of a significant tsunami 
     warning described in subparagraph (C) of such paragraph, such 
     notice shall include, as appropriate, brief information and 
     analysis of--
       ``(A) the accuracy of the tsunami model used;
       ``(B) the specific deep ocean or other monitoring equipment 
     that detected the incident, as well as the deep ocean or 
     other monitoring equipment that did not detect the incident 
     due to malfunction or other reasons;
       ``(C) the effectiveness of the warning communication, 
     including the dissemination of warnings with State, 
     territory, local, and tribal partners in the affected area 
     under the jurisdiction of the National Weather Service; and
       ``(D) such other findings as the Administrator considers 
     appropriate.''.

     SEC. 5. MODIFICATION OF NATIONAL TSUNAMI HAZARD MITIGATION 
                   PROGRAM.

       (a) In General.--Section 5 (33 U.S.C. 3204) is amended by 
     striking subsections (a) through (d) and inserting the 
     following:
       ``(a) Program Required.--The Administrator, in coordination 
     with the Administrator of the Federal Emergency Management 
     Agency and the heads of such other agencies as the 
     Administrator considers relevant, shall conduct a community-
     based tsunami hazard mitigation program to improve tsunami 
     preparedness and resiliency of at-risk areas in the United 
     States and the territories of the United States.
       ``(b) Program Components.--The Program conducted under 
     subsection (a) shall include the following:
       ``(1) Technical and financial assistance to coastal States, 
     territories, tribes, and local governments to develop and 
     implement activities under this section.
       ``(2) Integration of tsunami preparedness and mitigation 
     programs into ongoing State-based hazard warning, resilience 
     planning, and risk management activities, including 
     predisaster planning, emergency response, evacuation 
     planning, disaster recovery, hazard mitigation, and community 
     development and redevelopment planning programs in affected 
     areas.
       ``(3) Activities to promote the adoption of tsunami 
     resilience, preparedness, warning, and mitigation measures by 
     Federal, State, territorial, tribal, and local governments 
     and nongovernmental entities, including educational and risk 
     communication programs to discourage development in high-risk 
     areas.
       ``(4) Activities to support the development of regional 
     tsunami hazard and risk assessments. Such regional risk 
     assessments may include the following:
       ``(A) The sources, sizes, and other relevant historical 
     data of tsunami in the region, including paleotsunami data.
       ``(B) Inundation models and maps of critical infrastructure 
     and socioeconomic vulnerability in areas subject to tsunami 
     inundation.

[[Page H6896]]

       ``(C) Maps of evacuation areas and evacuation routes, 
     including, when appropriate, traffic studies that evaluate 
     the viability of evacuation routes.
       ``(D) Evaluations of the size of populations that will 
     require evacuation, including populations with special 
     evacuation needs.
       ``(E) Evaluations and technical assistance for vertical 
     evacuation structure planning for communities where models 
     indicate limited or no ability for timely evacuation, 
     especially in areas at risk of near shore generated tsunami.
       ``(F) Evaluation of at-risk ports and harbors.
       ``(G) Evaluation of the effect of tsunami currents on the 
     foundations of closely-spaced, coastal high-rise structures.
       ``(5) Activities to promote preparedness in at-risk ports 
     and harbors, including the following:
       ``(A) Evaluation and recommendation of procedures for ports 
     and harbors in the event of a distant or near-field tsunami.
       ``(B) A review of readiness, response, and communication 
     strategies to ensure coordination and data sharing with the 
     Coast Guard.
       ``(6) Activities to support the development of community-
     based outreach and education programs to ensure community 
     readiness and resilience, including the following:
       ``(A) The development, implementation, and assessment of 
     technical training and public education programs, including 
     education programs that address unique characteristics of 
     distant and near-field tsunami.
       ``(B) The development of decision support tools.
       ``(C) The incorporation of social science research into 
     community readiness and resilience efforts.
       ``(D) The development of evidence-based education 
     guidelines.
       ``(7) Dissemination of guidelines and standards for 
     community planning, education, and training products, 
     programs, and tools, including--
       ``(A) standards for--
       ``(i) mapping products;
       ``(ii) inundation models; and
       ``(iii) effective emergency exercises; and
       ``(B) recommended guidance for at-risk port and harbor 
     tsunami warning, evacuation, and response procedures in 
     coordination with the Coast Guard.
       ``(c) Authorized Activities.--In addition to activities 
     conducted under subsection (b), the program conducted under 
     subsection (a) may include the following:
       ``(1) Multidisciplinary vulnerability assessment research, 
     education, and training to help integrate risk management and 
     resilience objectives with community development planning and 
     policies.
       ``(2) Risk management training for local officials and 
     community organizations to enhance understanding and 
     preparedness.
       ``(3) Interagency, Federal, State, tribal, and territorial 
     intergovernmental tsunami response exercise planning and 
     implementation in high risk areas.
       ``(4) Development of practical applications for existing or 
     emerging technologies, such as modeling, remote sensing, 
     geospatial technology, engineering, and observing systems, 
     including the integration of tsunami sensors into Federal and 
     commercial submarine telecommunication cables if practicable.
       ``(5) Risk management, risk assessment, and resilience data 
     and information services, including--
       ``(A) access to data and products derived from observing 
     and detection systems; and
       ``(B) development and maintenance of new integrated data 
     products to support risk management, risk assessment, and 
     resilience programs.
       ``(6) Risk notification systems that coordinate with and 
     build upon existing systems and actively engage 
     decisionmakers, State, local, tribal, and territorial 
     governments and agencies, business communities, 
     nongovernmental organizations, and the media.
       ``(d) Coordinating Committee.--
       ``(1) In general.--The Administrator shall maintain a 
     coordinating committee to assist the Administrator in the 
     conduct of the program required by subsection (a).
       ``(2) Composition.--The coordinating committee shall be 
     composed of members as follows:
       ``(A) Representatives from each of the States and 
     territories most at risk from tsunami, including Alaska, 
     Washington, Oregon, California, Hawaii, Puerto Rico, Guam, 
     American Samoa, and the Northern Marianas Islands.
       ``(B) Such other members as the Administrator considers 
     appropriate to represent Federal, State, tribal, territorial, 
     and local governments.
       ``(3) Subcommittees.--The Administrator may approve the 
     formation of subcommittees to address specific program 
     components or regional issues.
       ``(4) Responsibilities.--The coordinating committee shall--
       ``(A) provide feedback on how funds should be prioritized 
     to carry out the program required by subsection (a);
       ``(B) ensure that areas described in section 4(c) in the 
     United States and its territories have the opportunity to 
     participate in the program;
       ``(C) provide recommendations to the Administrator on how 
     to improve and continuously advance the TsunamiReady program 
     of the National Weather Service, particularly on ways to make 
     communities more tsunami resilient through the use of 
     inundation maps and models and other hazard mitigation 
     practices;
       ``(D) ensure that all components of the program required by 
     subsection (a) are integrated with ongoing State based hazard 
     warning, risk management, and resilience activities, 
     including--
       ``(i) integrating activities with emergency response plans, 
     disaster recovery, hazard mitigation, and community 
     development programs in affected areas; and
       ``(ii) integrating information to assist in tsunami 
     evacuation route planning.
       ``(5) Exemption from faca.--The provisions of the Federal 
     Advisory Committee Act (5 U.S.C. App.) shall not apply to the 
     committee established and maintained under paragraph (1).
       ``(e) No Preemption With Respect to Designation of At-risk 
     Areas.--The establishment of national standards for 
     inundation models under this section shall not prevent 
     States, territories, tribes, and local governments from 
     designating additional areas as being at risk based on 
     knowledge of local conditions.
       ``(f) No New Regulatory Authority.--Nothing in this Act may 
     be construed as establishing new regulatory authority for any 
     Federal agency.''.
       (b) Report on Accreditation of TsunamiReady Program.--Not 
     later than 180 days after the date of enactment of this Act, 
     the Administrator of the National Oceanic and Atmospheric 
     Administration shall submit to the Committee on Commerce, 
     Science, and Transportation of the Senate and the Committee 
     on Science, Space, and Technology of the House of 
     Representatives a report on which authorities and activities 
     would be needed to have the TsunamiReady program of the 
     National Weather Service accredited by the Emergency 
     Management Accreditation Program.

     SEC. 6. MODIFICATION OF TSUNAMI RESEARCH PROGRAM.

       Section 6 (33 U.S.C. 3205) is amended--
       (1) in the matter before paragraph (1), by striking ``The 
     Administrator shall'' and all that follows through 
     ``establish or maintain'' and inserting the following:
       ``(a) In General.--The Administrator shall, in consultation 
     with such other Federal agencies, State, tribal, and 
     territorial governments, and academic institutions as the 
     Administrator considers appropriate, the coordinating 
     committee under section 5(d), and the panel under section 
     8(a), support or maintain'';
       (2) in subsection (a), as designated by paragraph (1), by 
     striking ``and assessment for tsunami tracking and numerical 
     forecast modeling. Such research program shall--'' and 
     inserting the following: ``assessment for tsunami tracking 
     and numerical forecast modeling, and standards development.
       ``(b) Responsibilities.--The research program supported or 
     maintained under subsection (a) shall--''; and
       (3) in subsection (b), as designated by paragraph (2)--
       (A) by amending paragraph (1) to read as follows:
       ``(1) consider other appropriate and cost effective 
     solutions to mitigate the impact of tsunami, including the 
     improvement of near-field and distant tsunami detection and 
     forecasting capabilities, which may include use of a new 
     generation of the Deep-ocean Assessment and Reporting of 
     Tsunamis array, integration of tsunami sensors into 
     commercial and Federal telecommunications cables, and other 
     real-time tsunami monitoring systems and supercomputer 
     capacity of the Administration to develop a rapid tsunami 
     forecast for all United States coastlines;'';
       (B) in paragraph (3)--
       (i) by striking ``include'' and inserting ``conduct''; and
       (ii) by striking ``and'' at the end;
       (C) by redesignating paragraph (4) as paragraph (5);
       (D) by inserting after paragraph (3) the following:
       ``(4) develop the technical basis for validation of tsunami 
     maps, numerical tsunami models, digital elevation models, and 
     forecasts; and''; and
       (E) in paragraph (5), as redesignated by subparagraph (C), 
     by striking ``to the scientific community'' and inserting 
     ``to the public and the scientific community''.

     SEC. 7. GLOBAL TSUNAMI WARNING AND MITIGATION NETWORK.

       Section 7 (33 U.S.C. 3206) is amended--
       (1) by amending subsection (a) to read as follows:
       ``(a) Support for Development of an International Tsunami 
     Warning System.--The Administrator shall, in coordination 
     with the Secretary of State and in consultation with such 
     other agencies as the Administrator considers relevant, 
     provide technical assistance, operational support, and 
     training to the Intergovernmental Oceanographic Commission of 
     the United Nations Educational, Scientific, and Cultural 
     Organization, the World Meteorological Organization of the 
     United Nations, and such other international entities as the 
     Administrator considers appropriate, as part of the 
     international efforts to develop a fully functional global 
     tsunami forecast and warning system comprised of regional 
     tsunami warning networks.'';
       (2) in subsection (b), by striking ``shall'' each place it 
     appears and inserting ``may''; and
       (3) in subsection (c)--
       (A) in paragraph (1), by striking ``establishing'' and 
     inserting ``supporting''; and
       (B) in paragraph (2)--
       (i) by striking ``establish'' and inserting ``support''; 
     and
       (ii) by striking ``establishing'' and inserting 
     ``supporting''.

     SEC. 8. TSUNAMI SCIENCE AND TECHNOLOGY ADVISORY PANEL.

       (a) In General.--The Act is further amended--
       (1) by redesignating section 8 (33 U.S.C. 3207) as section 
     9; and
       (2) by inserting after section 7 (33 U.S.C. 3206) the 
     following:

     ``SEC. 8. TSUNAMI SCIENCE AND TECHNOLOGY ADVISORY PANEL.

       ``(a) Designation.--The Administrator shall designate an 
     existing working group within the Science Advisory Board of 
     the Administration to manage the Tsunami Science and 
     Technology Advisory Panel to provide advice to the 
     Administrator on matters regarding tsunami science, 
     technology, and regional preparedness.

[[Page H6897]]

       ``(b) Membership.--
       ``(1) Composition.--The Panel shall be composed of no fewer 
     than 7 members selected by the Administrator from among 
     individuals from academia or State agencies who have academic 
     or practical expertise in physical sciences, social sciences, 
     information technology, coastal resilience, emergency 
     management, or such other disciplines as the Administrator 
     considers appropriate.
       ``(2) Federal employment.--No member of the Panel may be a 
     Federal employee.
       ``(c) Responsibilities.--Not less frequently than once 
     every 4 years, the Panel shall--
       ``(1) review the activities of the Administration, and 
     other Federal activities as appropriate, relating to tsunami 
     research, detection, forecasting, warning, mitigation, 
     resiliency, and preparation; and
       ``(2) submit to the Administrator and such others as the 
     Administrator considers appropriate--
       ``(A) the findings of the working group with respect to the 
     most recent review conducted under paragraph (1); and
       ``(B) such recommendations for legislative or 
     administrative action as the working group considers 
     appropriate to improve Federal tsunami research, detection, 
     forecasting, warning, mitigation, resiliency, and 
     preparation.
       ``(d) Reports to Congress.--Not less frequently than once 
     every 4 years, the Administrator shall submit to the 
     Committee on Commerce, Science, and Transportation of the 
     Senate, and the Committee on Science, Space, and Technology 
     of the House of Representatives a report on the findings and 
     recommendations received by the Administrator under 
     subsection (c)(2).''.

     SEC. 9. REPORTS.

       (a) Report on Implementation of Tsunami Warning and 
     Education Act.--
       (1) In general.--Not later than 1 year after the date of 
     the enactment of this Act, the Administrator of the National 
     Oceanic and Atmospheric Administration shall submit to 
     Congress a report on the implementation of the Tsunami 
     Warning and Education Act (33 U.S.C. 3201 et seq.).
       (2) Elements.--The report required by paragraph (1) shall 
     include the following:
       (A) A detailed description of the progress made in 
     implementing sections 4(d)(6), 5(b)(6), and 6(b)(4) of the 
     Tsunami Warning and Education Act.
       (B) A description of the ways that tsunami warnings and 
     warning products issued by the Tsunami Forecasting and 
     Warning Program established under section 4 of the Tsunami 
     Warning and Education Act (33 U.S.C. 3203) can be 
     standardized and streamlined with warnings and warning 
     products for hurricanes, coastal storms, and other coastal 
     flooding events.
       (b) Report on National Efforts That Support Rapid Response 
     Following Near-shore Tsunami Events.--
       (1) In general.--Not later than 1 year after the date of 
     the enactment of this Act, the Administrator and the 
     Secretary of Homeland Security shall jointly, in coordination 
     with the Director of the United States Geological Survey, 
     Administrator of the Federal Emergency Management Agency, the 
     Chief of the National Guard Bureau, and the heads of such 
     other Federal agencies as the Administrator considers 
     appropriate, submit to the appropriate committees of Congress 
     a report on the national efforts in effect on the day before 
     the date of the enactment of this Act that support and 
     facilitate rapid emergency response following a domestic 
     near-shore tsunami event to better understand domestic 
     effects of earthquake derived tsunami on people, 
     infrastructure, and communities in the United States.
       (2) Elements.--The report required by paragraph (1) shall 
     include the following:
       (A) A description of scientific or other measurements 
     collected on the day before the date of the enactment of this 
     Act to quickly identify and quantify lost or degraded 
     infrastructure or terrestrial formations.
       (B) A description of scientific or other measurements that 
     would be necessary to collect to quickly identify and 
     quantify lost or degraded infrastructure or terrestrial 
     formations.
       (C) Identification and evaluation of Federal, State, local, 
     tribal, territorial, and military first responder and search 
     and rescue operation centers, bases, and other facilities as 
     well as other critical response assets and infrastructure, 
     including search and rescue aircraft, located within near-
     shore and distant tsunami inundation areas on the day before 
     the date of the enactment of this Act.
       (D) An evaluation of near-shore tsunami response plans in 
     areas described in subparagraph (C) in effect on the day 
     before the date of the enactment of this Act, and how those 
     response plans would be affected by the loss of search and 
     rescue and first responder infrastructure described in such 
     subparagraph.
       (E) A description of redevelopment plans and reports in 
     effect on the day before the date of the enactment of this 
     Act for communities in areas that are at high-risk for near-
     shore tsunami, as well identification of States or 
     communities that do not have redevelopment plans.
       (F) Recommendations to enhance near-shore tsunami 
     preparedness and response plans, including recommended 
     responder exercises, predisaster planning, and mitigation 
     needs.
       (G) Such other data and analysis information as the 
     Administrator and the Secretary of Homeland Security consider 
     appropriate.
       (3) Appropriate committees of congress.--In this 
     subsection, the term ``appropriate committees of Congress'' 
     means--
       (A) the Committee on Commerce, Science, and Transportation 
     and the Committee on Homeland Security and Governmental 
     Affairs of the Senate; and
       (B) the Committee on Science, Space, and Technology and the 
     Committee on Homeland Security of the House of 
     Representatives.

     SEC. 10. AUTHORIZATION OF APPROPRIATIONS.

       Section 9 of the Act, as redesignated by section 8(a)(1) of 
     this Act, is amended--
       (1) in paragraph (4)(B), by striking ``and'' at the end;
       (2) in paragraph (5)(B), by striking the period at the end 
     and inserting ``; and''; and
       (3) by adding at the end the following:
       ``(6) $27,000,000 for each of fiscal years 2016 through 
     2021, of which--
       ``(A) not less than 27 percent of the amount appropriated 
     for each fiscal year shall be for activities conducted at the 
     State level under the tsunami hazard mitigation program under 
     section 5; and
       ``(B) not less than 8 percent of the amount appropriated 
     shall be for the tsunami research program under section 6.''.

     SEC. 11. OUTREACH RESPONSIBILITIES.

       The Administrator of the National Oceanic and Atmospheric 
     Administration, in coordination with State and local 
     emergency managers, shall develop and carry out formal 
     outreach activities to improve tsunami education and 
     awareness and foster the development of resilient 
     communities. Outreach activities may include--
       (1) the development of outreach plans to ensure the close 
     integration of tsunami warning centers supported or 
     maintained under section 4(d) of the Tsunami Warning and 
     Education Act (33 U.S.C. 3203(d)) with local Weather Forecast 
     Offices of the National Weather Service and emergency 
     managers;
       (2) working with appropriate local Weather Forecast Offices 
     to ensure they have the technical knowledge and capability to 
     disseminate tsunami warnings to the communities they serve; 
     and
       (3) evaluating the effectiveness of warnings and of 
     coordination with local Weather Forecast Offices after 
     significant tsunami events.

     SEC. 12. MODIFICATION OF COASTAL OCEAN PROGRAM.

       Section 201(c) of the National Oceanic and Atmospheric 
     Administration Authorization Act of 1992 (Public Law 102-567; 
     106 Stat. 4280) is amended--
       (1) by inserting ``(1) In general.--'' before ``Of the 
     sums'' and indenting appropriately; and
       (2) by adding at the end the following:
       ``(2) Regional coastal risk management coalitions.--The 
     Administrator of the National Oceanic and Atmospheric 
     Administration may form regional coastal risk management 
     coalitions comprised of representatives of Federal, State, 
     local, and tribal governments, community groups, academic 
     institutions, and nongovernmental groups to advance the goals 
     of this section for communities facing common coastal hazards 
     and risks. Such coalitions may enter into an agreement with 
     an organization described in section 501(c)(3) of the 
     Internal Revenue Code of 1986 to establish a nonprofit 
     foundation in order to accept gifts and donations to support 
     the goals of this subsection.''.

     SEC. 13. REPEAL OF DUPLICATE PROVISIONS OF LAW.

       (a) Repeal.--The Magnuson-Stevens Fishery Conservation and 
     Management Reauthorization Act of 2006 (Public Law 109-479) 
     is amended by striking title VIII (relating to tsunami 
     warning and education).
       (b) Construction.--Nothing in this section shall be 
     construed to repeal, or affect in any way, Public Law 109-
     424.


                      Motion Offered by Mr. Upton

  Mr. UPTON. Mr. Speaker, I have a motion at the desk.
  The SPEAKER pro tempore. The Clerk will designate the motion.
  The text of the motion is as follows:

       Mr. Upton moves that the House concur in the Senate 
     amendment to H.R. 34 with an amendment inserting the text of 
     Rules Committee Print 114-67, modified by the amendment 
     printed in part A of House Report 114-839, in lieu of the 
     matter proposed to be added by the Senate.

  The text of the House amendment to the Senate amendment to the text 
is as follows:

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``21st 
     Century Cures Act''.
       (b) Table of Contents.--The table of contents for this Act 
     is as follows:

Sec. 1. Short title; table of contents.

                     DIVISION A--21ST CENTURY CURES

Sec. 1000. Short title.

    TITLE I--INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID ABUSE

Sec. 1001. NIH innovation projects.
Sec. 1002. FDA innovation projects.
Sec. 1003. Account for the state response to the opioid abuse crisis.
Sec. 1004. Budgetary treatment.

                          TITLE II--DISCOVERY

       Subtitle A--National Institutes of Health Reauthorization

Sec. 2001. National Institutes of Health Reauthorization.
Sec. 2002. EUREKA prize competitions.

                Subtitle B--Advancing Precision Medicine

Sec. 2011. Precision Medicine Initiative.
Sec. 2012. Privacy protection for human research subjects.
Sec. 2013. Protection of identifiable and sensitive information.
Sec. 2014. Data sharing.

            Subtitle C--Supporting Young Emerging Scientists

Sec. 2021. Investing in the next generation of researchers.

[[Page H6898]]

Sec. 2022. Improvement of loan repayment program.

 Subtitle D--National Institutes of Health Planning and Administration

Sec. 2031. National Institutes of Health strategic plan.
Sec. 2032. Triennial reports.
Sec. 2033. Increasing accountability at the National Institutes of 
              Health.
Sec. 2034. Reducing administrative burden for researchers.
Sec. 2035. Exemption for the National Institutes of Health from the 
              Paperwork Reduction Act requirements.
Sec. 2036. High-risk, high-reward research.
Sec. 2037. National Center for Advancing Translational Sciences.
Sec. 2038. Collaboration and coordination to enhance research.
Sec. 2039. Enhancing the rigor and reproducibility of scientific 
              research.
Sec. 2040. Improving medical rehabilitation research at the National 
              Institutes of Health.
Sec. 2041. Task force on research specific to pregnant women and 
              lactating women.
Sec. 2042. Streamlining National Institutes of Health reporting 
              requirements.
Sec. 2043. Reimbursement for research substances and living organisms.
Sec. 2044. Sense of Congress on increased inclusion of underrepresented 
              populations in clinical trials.

 Subtitle E--Advancement of the National Institutes of Health Research 
                            and Data Access

Sec. 2051. Technical updates to clinical trials database.
Sec. 2052. Compliance activities reports.
Sec. 2053. Updates to policies to improve data.
Sec. 2054. Consultation.

            Subtitle F--Facilitating Collaborative Research

Sec. 2061. National neurological conditions surveillance system.
Sec. 2062. Tick-borne diseases.
Sec. 2063. Accessing, sharing, and using health data for research 
              purposes.

                Subtitle G--Promoting Pediatric Research

Sec. 2071. National pediatric research network.
Sec. 2072. Global pediatric clinical study network.

                         TITLE III--DEVELOPMENT

              Subtitle A--Patient-Focused Drug Development

Sec. 3001. Patient experience data.
Sec. 3002. Patient-focused drug development guidance.
Sec. 3003. Streamlining patient input.
Sec. 3004. Report on patient experience drug development.

                Subtitle B--Advancing New Drug Therapies

Sec. 3011. Qualification of drug development tools.
Sec. 3012. Targeted drugs for rare diseases.
Sec. 3013. Reauthorization of program to encourage treatments for rare 
              pediatric diseases.
Sec. 3014. GAO study of priority review voucher programs.
Sec. 3015. Amendments to the Orphan Drug grants.
Sec. 3016. Grants for studying continuous drug manufacturing.

        Subtitle C--Modern Trial Design and Evidence Development

Sec. 3021. Novel clinical trial designs.
Sec. 3022. Real world evidence.
Sec. 3023. Protection of human research subjects.
Sec. 3024. Informed consent waiver or alteration for clinical 
              investigations.

        Subtitle D--Patient Access to Therapies and Information

Sec. 3031. Summary level review.
Sec. 3032. Expanded access policy.
Sec. 3033. Accelerated approval for regenerative advanced therapies.
Sec. 3034. Guidance regarding devices used in the recovery, isolation, 
              or delivery of regenerative advanced therapies.
Sec. 3035. Report on regenerative advanced therapies.
Sec. 3036. Standards for regenerative medicine and regenerative 
              advanced therapies.
Sec. 3037. Health care economic information.
Sec. 3038. Combination product innovation.

          Subtitle E--Antimicrobial Innovation and Stewardship

Sec. 3041. Antimicrobial resistance monitoring.
Sec. 3042. Limited population pathway.
Sec. 3043. Prescribing authority.
Sec. 3044. Susceptibility test interpretive criteria for 
              microorganisms; antimicrobial susceptibility testing 
              devices.

                 Subtitle F--Medical Device Innovations

Sec. 3051. Breakthrough devices.
Sec. 3052. Humanitarian device exemption.
Sec. 3053. Recognition of standards.
Sec. 3054. Certain class I and class II devices.
Sec. 3055. Classification panels.
Sec. 3056. Institutional review board flexibility.
Sec. 3057. CLIA waiver improvements.
Sec. 3058. Least burdensome device review.
Sec. 3059. Cleaning instructions and validation data requirement.
Sec. 3060. Clarifying medical software regulation.

     Subtitle G--Improving Scientific Expertise and Outreach at FDA

Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical 
              Product Assessment Service.
Sec. 3072. Hiring authority for scientific, technical, and professional 
              personnel.
Sec. 3073. Establishment of Food and Drug Administration Intercenter 
              Institutes.
Sec. 3074. Scientific engagement.
Sec. 3075. Drug surveillance.
Sec. 3076. Reagan-Udall Foundation for the Food and Drug 
              Administration.

             Subtitle H--Medical Countermeasures Innovation

Sec. 3081. Medical countermeasure guidelines.
Sec. 3082. Clarifying BARDA contracting authority.
Sec. 3083. Countermeasure budget plan.
Sec. 3084. Medical countermeasures innovation.
Sec. 3085. Streamlining Project BioShield procurement.
Sec. 3086. Encouraging treatments for agents that present a national 
              security threat.
Sec. 3087. Paperwork Reduction Act waiver during a public health 
              emergency.
Sec. 3088. Clarifying Food and Drug Administration emergency use 
              authorization.

         Subtitle I--Vaccine Access, Certainty, and Innovation

Sec. 3091. Predictable review timelines of vaccines by the Advisory 
              Committee on Immunization Practices.
Sec. 3092. Review of processes and consistency of Advisory Committee on 
              Immunization Practices recommendations.
Sec. 3093. Encouraging vaccine innovation.

                   Subtitle J--Technical Corrections

Sec. 3101. Technical corrections.
Sec. 3102. Completed studies.

                           TITLE IV--DELIVERY

Sec. 4001. Assisting doctors and hospitals in improving quality of care 
              for patients.
Sec. 4002. Transparent reporting on usability, security, and 
              functionality.
Sec. 4003. Interoperability.
Sec. 4004. Information blocking.
Sec. 4005. Leveraging electronic health records to improve patient 
              care.
Sec. 4006. Empowering patients and improving patient access to their 
              electronic health information.
Sec. 4007. GAO study on patient matching.
Sec. 4008. GAO study on patient access to health information.
Sec. 4009. Streamlining transfers used for educational purposes.
Sec. 4010. Improving Medicare local coverage determinations.
Sec. 4011. Medicare pharmaceutical and technology ombudsman.
Sec. 4012. Medicare site-of-service price transparency.
Sec. 4013. Telehealth services in Medicare.

                            TITLE V--SAVINGS

Sec. 5001. Savings in the Medicare Improvement Fund.
Sec. 5002. Medicaid reimbursement to States for durable medical 
              equipment.
Sec. 5003. Penalties for violations of grants, contracts, and other 
              agreements.
Sec. 5004. Reducing overpayments of infusion drugs.
Sec. 5005. Increasing oversight of termination of Medicaid providers.
Sec. 5006. Requiring publication of fee-for-service provider directory.
Sec. 5007. Fairness in Medicaid supplemental needs trusts.
Sec. 5008. Eliminating Federal financial participation with respect to 
              expenditures under Medicaid for agents used for cosmetic 
              purposes or hair growth.
Sec. 5009. Amendment to the Prevention and Public Health Fund.
Sec. 5010. Strategic Petroleum Reserve drawdown.
Sec. 5011. Rescission of portion of ACA territory funding.
Sec. 5012. Medicare coverage of home infusion therapy.

          DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS

Sec. 6000. Short title.

         TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY

                         Subtitle A--Leadership

Sec. 6001. Assistant Secretary for Mental Health and Substance Use.
Sec. 6002. Strengthening the leadership of the Substance Abuse and 
              Mental Health Services Administration.
Sec. 6003. Chief Medical Officer.
Sec. 6004. Improving the quality of behavioral health programs.
Sec. 6005. Strategic plan.
Sec. 6006. Biennial report concerning activities and progress.
Sec. 6007. Authorities of centers for mental health services, substance 
              abuse prevention, and substance abuse treatment.
Sec. 6008. Advisory councils.
Sec. 6009. Peer review.

                Subtitle B--Oversight and Accountability

Sec. 6021. Improving oversight of mental and substance use disorders 
              programs through the Assistant Secretary for Planning and 
              Evaluation.
Sec. 6022. Reporting for protection and advocacy organizations.
Sec. 6023. GAO study.

   Subtitle C--Interdepartmental Serious Mental Illness Coordinating 
                               Committee

Sec. 6031. Interdepartmental Serious Mental Illness Coordinating 
              Committee.

[[Page H6899]]

  TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION, 
 TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY

Sec. 7001. Encouraging innovation and evidence-based programs.
Sec. 7002. Promoting access to information on evidence-based programs 
              and practices.
Sec. 7003. Priority mental health needs of regional and national 
              significance.
Sec. 7004. Priority substance use disorder treatment needs of regional 
              and national significance.
Sec. 7005. Priority substance use disorder prevention needs of regional 
              and national significance.

  TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO 
             MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS

Sec. 8001. Community mental health services block grant.
Sec. 8002. Substance abuse prevention and treatment block grant.
Sec. 8003. Additional provisions related to the block grants.
Sec. 8004. Study of distribution of funds under the substance abuse 
              prevention and treatment block grant and the community 
              mental health services block grant.

TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER 
                                  CARE

              Subtitle A--Helping Individuals and Families

Sec. 9001. Grants for treatment and recovery for homeless individuals.
Sec. 9002. Grants for jail diversion programs.
Sec. 9003. Promoting integration of primary and behavioral health care.
Sec. 9004. Projects for assistance in transition from homelessness.
Sec. 9005. National Suicide Prevention Lifeline Program.
Sec. 9006. Connecting individuals and families with care.
Sec. 9007. Strengthening community crisis response systems.
Sec. 9008. Garrett Lee Smith Memorial Act reauthorization.
Sec. 9009. Adult suicide prevention.
Sec. 9010. Mental health awareness training grants.
Sec. 9011. Sense of Congress on prioritizing American Indians and 
              Alaska Native youth within suicide prevention programs.
Sec. 9012. Evidence-based practices for older adults.
Sec. 9013. National violent death reporting system.
Sec. 9014. Assisted outpatient treatment.
Sec. 9015. Assertive community treatment grant program.
Sec. 9016. Sober truth on preventing underage drinking reauthorization.
Sec. 9017. Center and program repeals.

          Subtitle B--Strengthening the Health Care Workforce

Sec. 9021. Mental and behavioral health education and training grants.
Sec. 9022. Strengthening the mental and substance use disorders 
              workforce.
Sec. 9023. Clarification on current eligibility for loan repayment 
              programs.
Sec. 9024. Minority fellowship program.
Sec. 9025. Liability protections for health professional volunteers at 
              community health centers.
Sec. 9026. Reports.

            Subtitle C--Mental Health on Campus Improvement

Sec. 9031. Mental health and substance use disorder services on campus.
Sec. 9032. Interagency Working Group on College Mental Health.
Sec. 9033. Improving mental health on college campuses.

   TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR 
                        CHILDREN AND ADOLESCENTS

Sec. 10001. Programs for children with a serious emotional disturbance.
Sec. 10002. Increasing access to pediatric mental health care.
Sec. 10003. Substance use disorder treatment and early intervention 
              services for children and adolescents.
Sec. 10004. Children's recovery from trauma.
Sec. 10005. Screening and treatment for maternal depression.
Sec. 10006. Infant and early childhood mental health promotion, 
              intervention, and treatment.

             TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA

Sec. 11001. Sense of Congress.
Sec. 11002. Confidentiality of records.
Sec. 11003. Clarification on permitted uses and disclosures of 
              protected health information.
Sec. 11004. Development and dissemination of model training programs.

               TITLE XII--MEDICAID MENTAL HEALTH COVERAGE

Sec. 12001. Rule of construction related to Medicaid coverage of mental 
              health services and primary care services furnished on 
              the same day.
Sec. 12002. Study and report related to Medicaid managed care 
              regulation.
Sec. 12003. Guidance on opportunities for innovation.
Sec. 12004. Study and report on Medicaid emergency psychiatric 
              demonstration project.
Sec. 12005. Providing EPSDT services to children in IMDs.
Sec. 12006. Electronic visit verification system required for personal 
              care services and home health care services under 
              Medicaid.

                    TITLE XIII--MENTAL HEALTH PARITY

Sec. 13001. Enhanced compliance with mental health and substance use 
              disorder coverage requirements.
Sec. 13002. Action plan for enhanced enforcement of mental health and 
              substance use disorder coverage.
Sec. 13003. Report on investigations regarding parity in mental health 
              and substance use disorder benefits.
Sec. 13004. GAO study on parity in mental health and substance use 
              disorder benefits.
Sec. 13005. Information and awareness on eating disorders.
Sec. 13006. Education and training on eating disorders.
Sec. 13007. Clarification of existing parity rules.

             TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES

             Subtitle A--Mental Health and Safe Communities

Sec. 14001. Law enforcement grants for crisis intervention teams, 
              mental health purposes.
Sec. 14002. Assisted outpatient treatment programs.
Sec. 14003. Federal drug and mental health courts.
Sec. 14004. Mental health in the judicial system.
Sec. 14005. Forensic assertive community treatment initiatives.
Sec. 14006. Assistance for individuals transitioning out of systems.
Sec. 14007. Co-occurring substance abuse and mental health challenges 
              in drug courts.
Sec. 14008. Mental health training for Federal uniformed services.
Sec. 14009. Advancing mental health as part of offender reentry.
Sec. 14010. School mental health crisis intervention teams.
Sec. 14011. Active-shooter training for law enforcement.
Sec. 14012. Co-occurring substance abuse and mental health challenges 
              in residential substance abuse treatment programs.
Sec. 14013. Mental health and drug treatment alternatives to 
              incarceration programs.
Sec. 14014. National criminal justice and mental health training and 
              technical assistance.
Sec. 14015. Improving Department of Justice data collection on mental 
              illness involved in crime.
Sec. 14016. Reports on the number of mentally ill offenders in prison.
Sec. 14017. Department of Veterans Affairs patients' rights.
Sec. 14018. Reauthorization of appropriations.

          Subtitle B--Comprehensive Justice and Mental Health

Sec. 14021. Sequential intercept model.
Sec. 14022. Prison and jails.
Sec. 14023. Allowable uses.
Sec. 14024. Law enforcement training.
Sec. 14025. Federal law enforcement training.
Sec. 14026. GAO report.
Sec. 14027. Evidence based practices.
Sec. 14028. Transparency, program accountability, and enhancement of 
              local authority.
Sec. 14029. Grant accountability.

 DIVISION C--INCREASING CHOICE, ACCESS, AND QUALITY IN HEALTH CARE FOR 
                               AMERICANS

Sec. 15000. Short title.

            TITLE XV--PROVISIONS RELATING TO MEDICARE PART A

Sec. 15001. Development of Medicare HCPCS version of MS-DRG codes for 
              similar hospital services.
Sec. 15002. Establishing beneficiary equity in the Medicare hospital 
              readmission program.
Sec. 15003. Five-year extension of the rural community hospital 
              demonstration program.
Sec. 15004. Regulatory relief for LTCHs.
Sec. 15005. Savings from IPPS MACRA pay-for through not applying 
              documentation and coding adjustments.
Sec. 15006. Extension of certain LTCH Medicare payment rules.
Sec. 15007. Application of rules on the calculation of hospital length 
              of stay to all LTCHs.
Sec. 15008. Change in Medicare classification for certain hospitals.
Sec. 15009. Temporary exception to the application of the Medicare LTCH 
              site neutral provisions for certain spinal cord specialty 
              hospitals.
Sec. 15010. Temporary extension to the application of the Medicare LTCH 
              site neutral provisions for certain discharges with 
              severe wounds.

           TITLE XVI--PROVISIONS RELATING TO MEDICARE PART B

Sec. 16001. Continuing Medicare payment under HOPD prospective payment 
              system for services furnished by mid-build off-campus 
              outpatient departments of providers.
Sec. 16002. Treatment of cancer hospitals in off-campus outpatient 
              department of a provider policy.
Sec. 16003. Treatment of eligible professionals in ambulatory surgical 
              centers for meaningful use and MIPS.

[[Page H6900]]

Sec. 16004. Continuing Access to Hospitals Act of 2016.
Sec. 16005. Delay of implementation of Medicare fee schedule 
              adjustments for wheelchair accessories and seating 
              systems when used in conjunction with complex 
              rehabilitation technology (CRT) wheelchairs.
Sec. 16006. Allowing physical therapists to utilize locum tenens 
              arrangements under Medicare.
Sec. 16007. Extension of the transition to new payment rates for 
              durable medical equipment under the Medicare program.
Sec. 16008. Requirements in determining adjustments using information 
              from competitive bidding programs.

                 TITLE XVII--OTHER MEDICARE PROVISIONS

Sec. 17001. Delay in authority to terminate contracts for Medicare 
              Advantage plans failing to achieve minimum quality 
              ratings.
Sec. 17002. Requirement for enrollment data reporting for Medicare.
Sec. 17003. Updating the Welcome to Medicare package.
Sec. 17004. No payment for items and services furnished by newly 
              enrolled providers or suppliers within a temporary 
              moratorium area.
Sec. 17005. Preservation of Medicare beneficiary choice under Medicare 
              Advantage.
Sec. 17006. Allowing end-stage renal disease beneficiaries to choose a 
              Medicare Advantage plan.
Sec. 17007. Improvements to the assignment of beneficiaries under the 
              Medicare Shared Savings Program.

                     TITLE XVIII--OTHER PROVISIONS

Sec. 18001. Exception from group health plan requirements for qualified 
              small employer health reimbursement arrangements.

           DIVISION D--CHILD AND FAMILY SERVICES AND SUPPORT

Sec. 19000. Short title.

         TITLE XIX--INVESTING IN PREVENTION AND FAMILY SERVICES

Sec. 19001. Purpose.

           Subtitle A--Prevention Activities Under Title IV-E

Sec. 19011. Foster care prevention services and programs.
Sec. 19012. Foster care maintenance payments for children with parents 
              in a licensed residential family-based treatment facility 
              for substance abuse.
Sec. 19013. Title IV-E payments for evidence-based kinship navigator 
              programs.

             Subtitle B--Enhanced Support Under Title IV-B

Sec. 19021. Elimination of time limit for family reunification services 
              while in foster care and permitting time-limited family 
              reunification services when a child returns home from 
              foster care.
Sec. 19022. Reducing bureaucracy and unnecessary delays when placing 
              children in homes across State lines.
Sec. 19023. Enhancements to grants to improve well-being of families 
              affected by substance abuse.

                       Subtitle C--Miscellaneous

Sec. 19031. Reviewing and improving licensing standards for placement 
              in a relative foster family home.
Sec. 19032. Development of a statewide plan to prevent child abuse and 
              neglect fatalities.
Sec. 19033. Modernizing the title and purpose of title IV-E.
Sec. 19034. Effective dates.

TITLE XX--ENSURING THE NECESSITY OF A PLACEMENT THAT IS NOT IN A FOSTER 
                              FAMILY HOME

Sec. 20001. Limitation on Federal financial participation for 
              placements that are not in foster family homes.
Sec. 20002. Assessment and documentation of the need for placement in a 
              qualified residential treatment program.
Sec. 20003. Protocols to prevent inappropriate diagnoses.
Sec. 20004. Additional data and reports regarding children placed in a 
              setting that is not a foster family home.
Sec. 20005. Effective dates; application to waivers.

      TITLE XXI--CONTINUING SUPPORT FOR CHILD AND FAMILY SERVICES

Sec. 21001. Supporting and retaining foster families for children.
Sec. 21002. Extension of child and family services programs.
Sec. 21003. Improvements to the John H. Chafee foster care independence 
              program and related provisions.

  TITLE XXII--CONTINUING INCENTIVES TO STATES TO PROMOTE ADOPTION AND 
                           LEGAL GUARDIANSHIP

Sec. 22001. Reauthorizing adoption and legal guardianship incentive 
              programs.

                   TITLE XXIII--TECHNICAL CORRECTIONS

Sec. 23001. Technical corrections to data exchange standards to improve 
              program coordination.
Sec. 23002. Technical corrections to State requirement to address the 
              developmental needs of young children.

TITLE XXIV--ENSURING STATES REINVEST SAVINGS RESULTING FROM INCREASE IN 
                          ADOPTION ASSISTANCE

Sec. 24001. Delay of adoption assistance phase-in.
Sec. 24002. GAO study and report on State reinvestment of savings 
              resulting from increase in adoption assistance.

        TITLE XXV--SOCIAL IMPACT PARTNERSHIPS TO PAY FOR RESULTS

Sec. 25001. Short title.
Sec. 25002. Social Impact Partnerships to Pay for Results.
Sec. 25003. Extension of TANF program.
Sec. 25004. Strengthening welfare research and evaluation and 
              development of a What Works Clearinghouse.
Sec. 25005. Technical corrections to data exchange standards to improve 
              program coordination.

                     DIVISION A--21ST CENTURY CURES

     SEC. 1000. SHORT TITLE.

       This Division may be cited as the ``21st Century Cures 
     Act''.

    TITLE I--INNOVATION PROJECTS AND STATE RESPONSES TO OPIOID ABUSE

     SEC. 1001. NIH INNOVATION PROJECTS.

       (a) In General.--The Director of the National Institutes of 
     Health (referred to in this section as the ``Director of 
     NIH'') shall use any funds appropriated pursuant to the 
     authorization of appropriations in subsection (b)(3) to carry 
     out the National Institutes of Health innovation projects 
     described in subsection (b)(4) (referred to in this section 
     as the ``NIH Innovation Projects'').
       (b) National Institutes of Health Innovation Account.--
       (1) Establishment of nih innovation account.--There is 
     established in the Treasury an account, to be known as the 
     ``NIH Innovation Account'' (referred to in this subsection as 
     the ``Account''), for purposes of carrying out the NIH 
     Innovation Projects described in paragraph (4).
       (2) Transfer of direct spending savings.--
       (A) In general.--The following amounts shall be transferred 
     to the Account from the general fund of the Treasury:
       (i) For fiscal year 2017, $352,000,000.
       (ii) For fiscal year 2018, $496,000,000.
       (iii) For fiscal year 2019, $711,000,000.
       (iv) For fiscal year 2020, $492,000,000.
       (v) For fiscal year 2021, $404,000,000.
       (vi) For fiscal year 2022, $496,000,000.
       (vii) For fiscal year 2023, $1,085,000,000.
       (viii) For fiscal year 2024, $407,000,000.
       (ix) For fiscal year 2025, $127,000,000.
       (x) For fiscal year 2026, $226,000,000.
       (B) Amounts deposited.--Any amounts transferred under 
     subparagraph (A) shall remain unavailable in the Account 
     until such amounts are appropriated pursuant to paragraph 
     (3).
       (3) Appropriations.--
       (A) Authorization of appropriations.--For each of the 
     fiscal years 2017 through 2026, there is authorized to be 
     appropriated from the Account to the Director of NIH, for the 
     purpose of carrying out the NIH Innovation Projects, an 
     amount not to exceed the total amount transferred to the 
     Account under paragraph (2)(A), to remain available until 
     expended.
       (B) Offsetting future appropriations.--For any of fiscal 
     years 2017 through 2026, for any discretionary appropriation 
     under the heading ``NIH Innovation Account'' provided to the 
     Director of NIH pursuant to the authorization of 
     appropriations under subparagraph (A) for the purpose of 
     carrying out the NIH Innovation Projects, the total amount of 
     such appropriations for the applicable fiscal year (not to 
     exceed the total amount remaining in the Account) shall be 
     subtracted from the estimate of discretionary budget 
     authority and the resulting outlays for any estimate under 
     the Congressional Budget and Impoundment Control Act of 1974 
     or the Balanced Budget and Emergency Deficit Control Act of 
     1985, and the amount transferred to the Account shall be 
     reduced by the same amount.
       (4) NIH innovation projects.--NIH Innovation Projects 
     authorized to be funded under this section shall consist of 
     the following and, of the total amounts authorized to be 
     appropriated under paragraph (3), there are authorized to be 
     appropriated to each such project a total amount not to 
     exceed the following, over the period of fiscal years 2017 
     through 2026:
       (A) For the Precision Medicine Initiative, including for 
     the advancement of a cohort of individuals to support the 
     goals of the Precision Medicine Initiative, not to exceed a 
     total of $1,455,000,000, as follows:
       (i) For fiscal year 2017, $40,000,000.
       (ii) For fiscal year 2018, $100,000,000.
       (iii) For fiscal year 2019, $186,000,000.
       (iv) For fiscal year 2020, $149,000,000.
       (v) For fiscal year 2021, $109,000,000.
       (vi) For fiscal year 2022, $150,000,000.
       (vii) For fiscal year 2023, $419,000,000.
       (viii) For fiscal year 2024, $235,000,000.
       (ix) For fiscal year 2025, $36,000,000.
       (x) For fiscal year 2026, $31,000,000.
       (B) For the Brain Research through Advancing Innovative 
     Neurotechnologies Initiative (known as the ``BRAIN 
     Initiative''), not to exceed a total of $1,511,000,000, as 
     follows:
       (i) For fiscal year 2017, $10,000,000.
       (ii) For fiscal year 2018, $86,000,000.
       (iii) For fiscal year 2019, $115,000,000.
       (iv) For fiscal year 2020, $140,000,000.
       (v) For fiscal year 2021, $100,000,000.
       (vi) For fiscal year 2022, $152,000,000.
       (vii) For fiscal year 2023, $450,000,000.
       (viii) For fiscal year 2024, $172,000,000.
       (ix) For fiscal year 2025, $91,000,000.
       (x) For fiscal year 2026, $195,000,000.
       (C) To support cancer research, such as the development of 
     cancer vaccines, the development of more sensitive diagnostic 
     tests for cancer, immunotherapy and the development of

[[Page H6901]]

     combination therapies, and research that has the potential to 
     transform the scientific field, that has inherently higher 
     risk, and that seeks to address major challenges related to 
     cancer, not to exceed a total of $1,800,000,000, as follows:
       (i) For fiscal year 2017, $300,000,000.
       (ii) For fiscal year 2018, $300,000,000.
       (iii) For fiscal year 2019, $400,000,000.
       (iv) For fiscal year 2020, $195,000,000.
       (v) For fiscal year 2021, $195,000,000.
       (vi) For fiscal year 2022, $194,000,000.
       (vii) For fiscal year 2023, $216,000,000.
       (D) For the National Institutes of Health, in coordination 
     with the Food and Drug Administration, to award grants and 
     contracts for clinical research to further the field of 
     regenerative medicine using adult stem cells, including 
     autologous stem cells, for which grants and contracts shall 
     be contingent upon the recipient making available non-Federal 
     contributions toward the costs of such research in an amount 
     not less than $1 for each $1 of Federal funds provided in the 
     award, not to exceed a total of $30,000,000, as follows:
       (i) For fiscal year 2017, $2,000,000.
       (ii) For each of fiscal years 2018 and 2019, $10,000,000.
       (iii) For fiscal year 2020, $8,000,000.
       (iv) For each of fiscal years 2021 through 2026, $0.
       (c) Accountability and Oversight.--
       (1) Work plan.--
       (A) In general.--Not later than 180 days after the date of 
     enactment of this Act, the Director of NIH shall submit to 
     the Committee on Health, Education, Labor, and Pensions and 
     the Committee on Appropriations of the Senate and the 
     Committee on Energy and Commerce and the Committee on 
     Appropriations of the House of Representatives, a work plan 
     including the proposed allocation of funds authorized to be 
     appropriated pursuant to subsection (b)(3) for each of fiscal 
     years 2017 through 2026 for the NIH Innovation Projects and 
     the contents described in subparagraph (B).
       (B) Contents.--The work plan submitted under subparagraph 
     (A) shall include--
       (i) recommendations from the Advisory Committee described 
     in subparagraph (C);
       (ii) the amount of money to be obligated or expended in 
     each fiscal year for each NIH Innovation Project;
       (iii) a description and justification of each such project; 
     and
       (iv) a description of how each such project supports the 
     strategic research priorities identified in the NIH Strategic 
     Plan under subsection (m) of section 402 of the Public Health 
     Service Act (42 U.S.C. 282), as added by section 2031.
       (C) Recommendations.--Prior to submitting the work plan 
     under this paragraph, the Director of NIH shall seek 
     recommendations from the Advisory Committee to the Director 
     of NIH appointed under section 222 of the Public Health 
     Service Act (42 U.S.C. 217a) on--
       (i) the allocations of funds appropriated pursuant to the 
     authorization of appropriations under subsection (b)(3) for 
     each of fiscal years 2017 through 2026; and
       (ii) on the contents of the proposed work plan.
       (2) Reports.--
       (A) Annual reports.--Not later than October 1 of each of 
     fiscal years 2018 through 2027, the Director of NIH shall 
     submit to the Committee on Health, Education, Labor, and 
     Pensions and the Committee on Appropriations of the Senate 
     and the Committee on Energy and Commerce and the Committee on 
     Appropriations of the House of Representatives, a report 
     including--
       (i) the amount of money obligated or expended in the prior 
     fiscal year for each NIH Innovation Project;
       (ii) a description of any such project using funds provided 
     pursuant to the authorization of appropriations under 
     subsection (b)(3); and
       (iii) whether such projects are advancing the strategic 
     research priorities identified in the NIH Strategic Plan 
     under subsection (m) of section 402 of the Public Health 
     Service Act (42 U.S.C. 282), as added by section 2031.
       (B) Additional reports.--At the request of the Committee on 
     Health, Education, Labor, and Pensions or the Committee on 
     Appropriations of the Senate, or the Committee on Energy and 
     Commerce or the Committee on Appropriations of the House of 
     Representatives, the Director of NIH shall provide an update 
     in the form of testimony and any additional reports to the 
     respective congressional committee regarding the allocation 
     of funding under this section or the description of the NIH 
     Innovation Projects.
       (d) Limitations.--Notwithstanding any transfer authority 
     authorized by this Act or any appropriations Act, any funds 
     made available pursuant to the authorization of 
     appropriations under subsection (b)(3) may not be used for 
     any purpose other than a NIH Innovation Project.
       (e) Sunset.--This section shall expire on September 30, 
     2026.

     SEC. 1002. FDA INNOVATION PROJECTS.

       (a) In General.--The Commissioner of Food and Drugs 
     (referred to in this section as the ``Commissioner'') shall 
     use any funds appropriated pursuant to the authorization of 
     appropriations under subsection (b)(3) to carry out the 
     activities described in subsection (b)(4).
       (b) FDA Innovation Account.--
       (1) Establishment of fda innovation account.--There is 
     established in the Treasury an account, to be known as the 
     ``FDA Innovation Account'' (referred to in this subsection as 
     the ``Account''), for purposes of carrying out the activities 
     described in paragraph (4).
       (2) Transfer of direct spending savings.--
       (A) In general.--For each of fiscal years 2017 through 
     2025, the following amounts shall be transferred to the 
     Account from the general fund of the Treasury:
       (i) For fiscal year 2017, $20,000,000.
       (ii) For fiscal year 2018, $60,000,000.
       (iii) For fiscal year 2019, $70,000,000.
       (iv) For fiscal year 2020, $75,000,000.
       (v) For fiscal year 2021, $70,000,000.
       (vi) For fiscal year 2022, $50,000,000.
       (vii) For fiscal year 2023, $50,000,000.
       (viii) For fiscal year 2024, $50,000,000.
       (ix) For fiscal year 2025, $55,000,000.
       (B) Amounts deposited.--Any amounts transferred under 
     subparagraph (A) shall remain unavailable in the Account 
     until such amounts are appropriated pursuant to paragraph 
     (3).
       (3) Appropriations.--
       (A) Authorization of appropriations.--For each of the 
     fiscal years 2017 through 2025, there is authorized to be 
     appropriated from the Account to the Commissioner, for the 
     purpose of carrying out the activities described in paragraph 
     (5), an amount not to exceed the total amount transferred to 
     the Account under paragraph (2)(A), to remain available until 
     expended.
       (B) Offsetting future appropriations.--For any of fiscal 
     years 2017 through 2025, for any discretionary appropriation 
     under the heading ``FDA Innovation Account'' provided to the 
     Commissioner pursuant to the authorization of appropriations 
     under subparagraph (A) for the purpose of carrying out the 
     projects activities described in paragraph (4), the total 
     amount of such appropriations in the applicable fiscal year 
     (not to exceed the total amount remaining in the Account) 
     shall be subtracted from the estimate of discretionary budget 
     authority and the resulting outlays for any estimate under 
     the Congressional Budget and Impoundment Control Act of 1974 
     or the Balanced Budget and Emergency Deficit Control Act of 
     1985, and the amount transferred to the Account shall be 
     reduced by the same amount.
       (4) FDA activities.--The activities authorized to be funded 
     under this section are the activities under subtitles A 
     through F (including the amendments made by such subtitles) 
     of title III of this Act and section 1014 of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 3073 of 
     this Act.
       (c) Accountability and Oversight.--
       (1) Work plan.--
       (A) In general.--Not later than 180 days after the date of 
     enactment of this Act, the Commissioner shall submit to the 
     Committee on Health, Education, Labor, and Pensions and the 
     Committee on Appropriations of the Senate and the Committee 
     on Energy and Commerce and the Committee on Appropriations of 
     the House of Representatives, a work plan including the 
     proposed allocation of funds appropriated pursuant to the 
     authorization of appropriations under subsection (b)(3) for 
     each of fiscal years 2017 through 2025 and the contents 
     described in subparagraph (B).
       (B) Contents.--The work plan submitted under subparagraph 
     (A) shall include--
       (i) recommendations from the Advisory Committee described 
     in subparagraph (C);
       (ii) the amount of money to be obligated or expended in 
     each fiscal year for each activity described in subsection 
     (b)(4); and
       (iii) a description and justification of each such project 
     activity.
       (C) Recommendations.--Prior to submitting the work plan 
     under this paragraph, the Commissioner shall seek 
     recommendations from the Science Board to the Food and Drug 
     Administration, on the proposed allocation of funds 
     appropriated pursuant to the authorization of appropriations 
     under subsection (b)(3) for each of fiscal years 2017 through 
     2025 and on the contents of the proposed work plan.
       (2) Reports.--
       (A) Annual reports.--Not later than October 1 of each of 
     fiscal years 2018 through 2026, the Commissioner shall submit 
     to the Committee on Health, Education, Labor, and Pensions 
     and the Committee on Appropriations of the Senate and the 
     Committee on Energy and Commerce and the Committee on 
     Appropriations of the House of Representatives, a report 
     including--
       (i) the amount of money obligated or expended in the prior 
     fiscal year for each activity described in subsection (b)(4);
       (ii) a description of all such activities using funds 
     provided pursuant to the authorization of appropriations 
     under subsection (b)(3); and
       (iii) how the activities are advancing public health.
       (B) Additional reports.--At the request of the Committee on 
     Health, Education, Labor, and Pensions or the Committee on 
     Appropriations of the Senate, or the Committee on Energy and 
     Commerce or the Committee on Appropriations of the House of 
     Representatives, the Commissioner shall provide an update in 
     the form of testimony and any additional reports to the 
     respective congressional committee regarding the allocation 
     of funding under this section or the description of the 
     activities undertaken with such funding.
       (d) Limitations.--Notwithstanding any transfer authority 
     authorized by this Act or any appropriations Act, any funds 
     made available pursuant to the authorization of 
     appropriations in subsection (b)(3) shall not be used for any 
     purpose other than an activity described in subsection 
     (b)(4).
       (e) Sunset.--This section shall expire on September 30, 
     2025.

     SEC. 1003. ACCOUNT FOR THE STATE RESPONSE TO THE OPIOID ABUSE 
                   CRISIS.

       (a) In General.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall use 
     any funds appropriated pursuant to the authorization of 
     appropriations under subsection (b) to carry out the grant 
     program described in subsection (c) for purposes of 
     addressing the opioid abuse crisis within the States.
       (b) Account for the State Response to the Opioid Abuse 
     Crisis.--
       (1) Establishment.--There is established in the Treasury an 
     account, to be known as the ``Account For the State Response 
     to the Opioid

[[Page H6902]]

     Abuse Crisis'' (referred to in this subsection as the 
     ``Account''), to carry out the opioid grant program described 
     in subsection (c).
       (2) Transfer of direct spending savings.--
       (A) In general.--The following amounts shall be transferred 
     to the Account from the general fund of the Treasury:
       (i) For fiscal year 2017, $500,000,000.
       (ii) For fiscal year 2018, $500,000,000.
       (B) Amounts deposited.--Any amounts transferred under 
     subparagraph (A) shall remain unavailable in the Account 
     until such amounts are appropriated pursuant to paragraph 
     (3).
       (3) Appropriations.--
       (A) Authorization of appropriations.--In each of the fiscal 
     years 2017 and 2018, there is authorized to be appropriated 
     from the Account to the Secretary, for the grant program 
     described in subsection (c), an amount not to exceed the 
     total amount transferred to the Account under paragraph 
     (2)(A), to remain available until expended.
       (B) Offsetting future appropriations.--In each of fiscal 
     years 2017 and 2018, for any discretionary appropriation 
     under the heading ``Account For the State Response to the 
     Opioid Abuse Crisis'' for the grant program described in 
     subsection (c), the total amount of such appropriations in 
     the applicable fiscal year (not to exceed the total amount 
     remaining in the Account) shall be subtracted from the 
     estimate of discretionary budget authority and the resulting 
     outlays for any estimate under the Congressional Budget and 
     Impoundment Control Act of 1974 or the Balanced Budget and 
     Emergency Deficit Control Act of 1985, and the amount 
     transferred to the Account shall be reduced by the same 
     amount.
       (c) Opioid Grant Program.--
       (1) State response to the opioid abuse crisis.--Subject to 
     the availability of appropriations, the Secretary shall award 
     grants to States for the purpose of addressing the opioid 
     abuse crisis within such States, in accordance with 
     subparagraph (B). In awarding such grants, the Secretary 
     shall give preference to States with an incidence or 
     prevalence of opioid use disorders that is substantially 
     higher relative to other States.
       (2) Opioid grants.--Grants awarded to a State under this 
     subsection shall be used for carrying out activities that 
     supplement activities pertaining to opioids undertaken by the 
     State agency responsible for administering the substance 
     abuse prevention and treatment block grant under subpart II 
     of part B of title XIX of the Public Health Service Act (42 
     U.S.C. 300x-21 et seq.), which may include public health-
     related activities such as the following:
       (A) Improving State prescription drug monitoring programs.
       (B) Implementing prevention activities, and evaluating such 
     activities to identify effective strategies to prevent opioid 
     abuse.
       (C) Training for health care practitioners, such as best 
     practices for prescribing opioids, pain management, 
     recognizing potential cases of substance abuse, referral of 
     patients to treatment programs, and overdose prevention.
       (D) Supporting access to health care services, including 
     those services provided by Federally certified opioid 
     treatment programs or other appropriate health care providers 
     to treat substance use disorders.
       (E) Other public health-related activities, as the State 
     determines appropriate, related to addressing the opioid 
     abuse crisis within the State.
       (d) Accountability and Oversight.--A State receiving a 
     grant under subsection (c) shall include in a report related 
     to substance abuse submitted to the Secretary pursuant to 
     section 1942 of the Public Health Service Act (42 U.S.C. 
     300x-52), a description of--
       (1) the purposes for which the grant funds received by the 
     State under such subsection for the preceding fiscal year 
     were expended and a description of the activities of the 
     State under the program; and
       (2) the ultimate recipients of amounts provided to the 
     State in the grant.
       (e) Limitations.--Any funds made available pursuant to the 
     authorization of appropriations under subsection (b)--
       (1) notwithstanding any transfer authority in any 
     appropriations Act, shall not be used for any purpose other 
     than the grant program in subsection (c); and
       (2) shall be subject to the same requirements as substance 
     abuse prevention and treatment programs under titles V and 
     XIX of the Public Health Service Act (42 U.S.C. 290aa et 
     seq., 300w et seq.).
       (f) Sunset.--This section shall expire on September 30, 
     2026.

     SEC. 1004. BUDGETARY TREATMENT.

       (a) Statutory Paygo Scorecards.--The budgetary effects of 
     division A of this Act shall not be entered on either PAYGO 
     scorecard maintained pursuant to section 4(d) of the 
     Statutory Pay-As-You-Go Act of 2010.
       (b) Senate Paygo Scorecards.--The budgetary effects of 
     division A of this Act shall not be entered on any PAYGO 
     scorecard maintained for purposes of section 201 of S. Con. 
     Res. 21 (110th Congress).
       (c) Reservation of Savings.--None of the funds in the NIH 
     Innovation Account, the FDA Innovation Account, or the 
     Account For the State Response to the Opioid Abuse Crisis 
     established by this title shall be made available except to 
     the extent provided in advance in appropriations Acts, and 
     legislation or an Act that rescinds or reduces amounts in 
     such accounts shall not be estimated as a reduction in direct 
     spending under the Congressional Budget and Impoundment 
     Control Act of 1974 or the Balanced Budget and Emergency 
     Deficit Control Act of 1985.

                          TITLE II--DISCOVERY

       Subtitle A--National Institutes of Health Reauthorization

     SEC. 2001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION.

       Section 402A(a)(1) of the Public Health Service Act (42 
     U.S.C. 282a(a)(1)) is amended--
       (1) in subparagraph (B), by striking ``and'' at the end;
       (2) in subparagraph (C), by striking the period at the end 
     and inserting a semicolon; and
       (3) by adding at the end the following new subparagraphs:
       ``(D) $34,851,000,000 for fiscal year 2018;
       ``(E) $35,585,871,000 for fiscal year 2019; and
       ``(F) $36,472,442,775 for fiscal year 2020.''.

     SEC. 2002. EUREKA PRIZE COMPETITIONS.

       (a) In General.--Pursuant to the authorities and processes 
     established under section 24 of the Stevenson-Wydler 
     Technology Innovation Act of 1980 (15 U.S.C. 3719), the 
     Director of the National Institutes of Health shall support 
     prize competitions for one or both of the following goals:
       (1) Identifying and funding areas of biomedical science 
     that could realize significant advancements through a prize 
     competition.
       (2) Improving health outcomes, particularly with respect to 
     human diseases and conditions--
       (A) for which public and private investment in research is 
     disproportionately small relative to Federal Government 
     expenditures on prevention and treatment activities with 
     respect to such diseases and conditions, such that Federal 
     expenditures on health programs would be reduced;
       (B) that are serious and represent a significant disease 
     burden in the United States; or
       (C) for which there is potential for significant return on 
     investment to the United States.
       (b) Tracking; Reporting.--The Director of the National 
     Institutes of Health shall--
       (1) collect information on--
       (A) the effect of innovations funded through the prize 
     competitions under this section in advancing biomedical 
     science or improving health outcomes pursuant to subsection 
     (a); and
       (B) the effect of the innovations on Federal expenditures; 
     and
       (2) include the information collected under paragraph (1) 
     in the triennial report under section 403 of the Public 
     Health Service Act (42 U.S.C. 283) (as amended by section 
     2032).

                Subtitle B--Advancing Precision Medicine

     SEC. 2011. PRECISION MEDICINE INITIATIVE.

       Part H of title IV of the Public Health Service Act (42 
     U.S.C. 289 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 498E. PRECISION MEDICINE INITIATIVE.

       ``(a) In General.--The Secretary is encouraged to establish 
     and carry out an initiative, to be known as the `Precision 
     Medicine Initiative' (in this section referred to as the 
     `Initiative'), to augment efforts to address disease 
     prevention, diagnosis, and treatment.
       ``(b) Components.--The Initiative described under 
     subsection (a) may include--
       ``(1) developing a network of scientists to assist in 
     carrying out the purposes of the Initiative;
       ``(2) developing new approaches for addressing scientific, 
     medical, public health, and regulatory science issues;
       ``(3) applying genomic technologies, such as whole genomic 
     sequencing, to provide data on the molecular basis of 
     disease;
       ``(4) collecting information voluntarily provided by a 
     diverse cohort of individuals that can be used to better 
     understand health and disease; and
       ``(5) other activities to advance the goals of the 
     Initiative, as the Secretary determines appropriate.
       ``(c) Authority of the Secretary.--In carrying out this 
     section, the Secretary may--
       ``(1) coordinate with the Secretary of Energy, private 
     industry, and others, as the Secretary determines 
     appropriate, to identify and address the advanced 
     supercomputing and other advanced technology needs for the 
     Initiative;
       ``(2) develop and utilize public-private partnerships; and
       ``(3) leverage existing data sources.
       ``(d) Requirements.--In the implementation of the 
     Initiative under subsection (a), the Secretary shall--
       ``(1) ensure the collaboration of the National Institutes 
     of Health, the Food and Drug Administration, the Office of 
     the National Coordinator for Health Information Technology, 
     and the Office for Civil Rights of the Department of Health 
     and Human Services;
       ``(2) comply with existing laws and regulations for the 
     protection of human subjects involved in research, including 
     the protection of participant privacy;
       ``(3) implement policies and mechanisms for appropriate 
     secure data sharing across systems that include protections 
     for privacy and security of data;
       ``(4) consider the diversity of the cohort to ensure 
     inclusion of a broad range of participants, including 
     consideration of biological, social, and other determinants 
     of health that contribute to health disparities;
       ``(5) ensure that only authorized individuals may access 
     controlled or sensitive, identifiable biological material and 
     associated information collected or stored in connection with 
     the Initiative; and
       ``(6) on the appropriate Internet website of the Department 
     of Health and Human Services, identify any entities with 
     access to such information and provide information with 
     respect to the purpose of such access, a summary of the 
     research project for which such access is granted, as 
     applicable, and a description of the biological material and 
     associated information to which the entity has access.
       ``(e) Report.--Not later than 1 year after the date of 
     enactment of the 21st Century Cures Act, the Secretary shall 
     submit a report on the relevant data access policies and 
     procedures to the Committee on Health, Education, Labor, and

[[Page H6903]]

     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives. Such report shall 
     include steps the Secretary has taken to consult with experts 
     or other heads of departments or agencies of the Federal 
     Government in the development of such policies.''.

     SEC. 2012. PRIVACY PROTECTION FOR HUMAN RESEARCH SUBJECTS.

       (a) In General.--Subsection (d) of section 301 of the 
     Public Health Service Act (42 U.S.C. 241) is amended to read 
     as follows:
       ``(d)(1)(A) If a person is engaged in biomedical, 
     behavioral, clinical, or other research, in which 
     identifiable, sensitive information is collected (including 
     research on mental health and research on the use and effect 
     of alcohol and other psychoactive drugs), the Secretary, in 
     coordination with other agencies, as applicable--
       ``(i) shall issue to such person a certificate of 
     confidentiality to protect the privacy of individuals who are 
     the subjects of such research if the research is funded 
     wholly or in part by the Federal Government; and
       ``(ii) may, upon application by a person engaged in 
     research, issue to such person a certificate of 
     confidentiality to protect the privacy of such individuals if 
     the research is not so funded.
       ``(B) Except as provided in subparagraph (C), any person to 
     whom a certificate is issued under subparagraph (A) to 
     protect the privacy of individuals described in such 
     subparagraph shall not disclose or provide to any other 
     person not connected with the research the name of such an 
     individual or any information, document, or biospecimen that 
     contains identifiable, sensitive information about such an 
     individual and that was created or compiled for purposes of 
     the research.
       ``(C) The disclosure prohibition in subparagraph (B) shall 
     not apply to disclosure or use that is--
       ``(i) required by Federal, State, or local laws, excluding 
     instances described in subparagraph (D);
       ``(ii) necessary for the medical treatment of the 
     individual to whom the information, document, or biospecimen 
     pertains and made with the consent of such individual;
       ``(iii) made with the consent of the individual to whom the 
     information, document, or biospecimen pertains; or
       ``(iv) made for the purposes of other scientific research 
     that is in compliance with applicable Federal regulations 
     governing the protection of human subjects in research.
       ``(D) Any person to whom a certificate is issued under 
     subparagraph (A) to protect the privacy of an individual 
     described in such subparagraph shall not, in any Federal, 
     State, or local civil, criminal, administrative, legislative, 
     or other proceeding, disclose or provide the name of such 
     individual or any such information, document, or biospecimen 
     that contains identifiable, sensitive information about the 
     individual and that was created or compiled for purposes of 
     the research, except in the circumstance described in 
     subparagraph (C)(iii).
       ``(E) Identifiable, sensitive information protected under 
     subparagraph (A), and all copies thereof, shall be immune 
     from the legal process, and shall not, without the consent of 
     the individual to whom the information pertains, be 
     admissible as evidence or used for any purpose in any action, 
     suit, or other judicial, legislative, or administrative 
     proceeding.
       ``(F) Identifiable, sensitive information collected by a 
     person to whom a certificate has been issued under 
     subparagraph (A), and all copies thereof, shall be subject to 
     the protections afforded by this section for perpetuity.
       ``(G) The Secretary shall take steps to minimize the burden 
     to researchers, streamline the process, and reduce the time 
     it takes to comply with the requirements of this subsection.
       ``(2) The Secretary shall coordinate with the heads of 
     other applicable Federal agencies to ensure that such 
     departments have policies in place with respect to the 
     issuance of a certificate of confidentiality pursuant to 
     paragraph (1) and other requirements of this subsection.
       ``(3) Nothing in this subsection shall be construed to 
     limit the access of an individual who is a subject of 
     research to information about himself or herself collected 
     during such individual's participation in the research.
       ``(4) For purposes of this subsection, the term 
     `identifiable, sensitive information' means information that 
     is about an individual and that is gathered or used during 
     the course of research described in paragraph (1)(A) and--
       ``(A) through which an individual is identified; or
       ``(B) for which there is at least a very small risk, as 
     determined by current scientific practices or statistical 
     methods, that some combination of the information, a request 
     for the information, and other available data sources could 
     be used to deduce the identity of an individual.''.
       (b) Applicability.--Beginning 180 days after the date of 
     enactment of this Act, all persons engaged in research and 
     authorized by the Secretary of Health and Human Services to 
     protect information under section 301(d) of the Public Health 
     Service Act (42 U.S.C. 241(d)) prior to the date of enactment 
     of this Act shall be subject to the requirements of such 
     section (as amended by this Act).

     SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE 
                   INFORMATION.

       Section 301 of the Public Health Service Act (42 U.S.C. 
     241) is amended by adding at the end the following:
       ``(f)(1) The Secretary may exempt from disclosure under 
     section 552(b)(3) of title 5, United States Code, biomedical 
     information that is about an individual and that is gathered 
     or used during the course of biomedical research if--
       ``(A) an individual is identified; or
       ``(B) there is at least a very small risk, as determined by 
     current scientific practices or statistical methods, that 
     some combination of the information, the request, and other 
     available data sources could be used to deduce the identity 
     of an individual.
       ``(2)(A) Each determination of the Secretary under 
     paragraph (1) to exempt information from disclosure shall be 
     made in writing and accompanied by a statement of the basis 
     for the determination.
       ``(B) Each such determination and statement of basis shall 
     be available to the public, upon request, through the Office 
     of the Chief FOIA Officer of the Department of Health and 
     Human Services.
       ``(3) Nothing in this subsection shall be construed to 
     limit a research participant's access to information about 
     such participant collected during the participant's 
     participation in the research.''.

     SEC. 2014. DATA SHARING.

       (a) In General.--Section 402(b) of the Public Health 
     Service Act (42 U.S.C. 282(b)) is amended--
       (1) in paragraph (23), by striking ``and'' at the end;
       (2) in paragraph (24), by striking the period and inserting 
     ``; and''; and
       (3) by inserting after paragraph (24) the following:
       ``(25) may require recipients of National Institutes of 
     Health awards to share scientific data, to the extent 
     feasible, generated from such National Institutes of Health 
     awards in a manner that is consistent with all applicable 
     Federal laws and regulations, including such laws and 
     regulations for the protection of--
       ``(A) human research participants, including with respect 
     to privacy, security, informed consent, and protected health 
     information; and
       ``(B) proprietary interests, confidential commercial 
     information, and the intellectual property rights of the 
     funding recipient.''.
       (b) Confidentiality.--Nothing in the amendments made by 
     subsection (a) authorizes the Secretary of Health and Human 
     Services to disclose any information that is a trade secret, 
     or other privileged or confidential information, described in 
     section 552(b)(4) of title 5, United States Code, or section 
     1905 of title 18, United States Code, or be construed to 
     require recipients of grants or cooperative agreements 
     through the National Institutes of Health to share such 
     information.

            Subtitle C--Supporting Young Emerging Scientists

     SEC. 2021. INVESTING IN THE NEXT GENERATION OF RESEARCHERS.

       (a) In General.--Part A of title IV of the Public Health 
     Service Act (42 U.S.C. 281 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 404M. NEXT GENERATION OF RESEARCHERS.

       ``(a) Next Generation of Researchers Initiative.--There 
     shall be established within the Office of the Director of the 
     National Institutes of Health, the Next Generation of 
     Researchers Initiative (referred to in this section as the 
     `Initiative'), through which the Director shall coordinate 
     all policies and programs within the National Institutes of 
     Health that are focused on promoting and providing 
     opportunities for new researchers and earlier research 
     independence.
       ``(b) Activities.--The Director of the National Institutes 
     of Health, through the Initiative shall--
       ``(1) promote policies and programs within the National 
     Institutes of Health that are focused on improving 
     opportunities for new researchers and promoting earlier 
     research independence, including existing policies and 
     programs, as appropriate;
       ``(2) develop, modify, or prioritize policies, as needed, 
     within the National Institutes of Health to promote 
     opportunities for new researchers and earlier research 
     independence, such as policies to increase opportunities for 
     new researchers to receive funding, enhance training and 
     mentorship programs for researchers, and enhance workforce 
     diversity;
       ``(3) coordinate, as appropriate, with relevant agencies, 
     professional and academic associations, academic 
     institutions, and others, to improve and update existing 
     information on the biomedical research workforce in order to 
     inform programs related to the training, recruitment, and 
     retention of biomedical researchers; and
       ``(4) carry out other activities, including evaluation and 
     oversight of existing programs, as appropriate, to promote 
     the development of the next generation of researchers and 
     earlier research independence.''.
       (b) Consideration of Recommendations.--In carrying out 
     activities under section 404M(b) of the Public Health Service 
     Act, the Director of the National Institutes of Health shall 
     take into consideration the recommendations made by the 
     National Academies of Sciences, Engineering, and Medicine as 
     part of the comprehensive study on policies affecting the 
     next generation of researchers under the Department of Health 
     and Human Services Appropriations Act, 2016 (Public Law 114-
     113), and submit a report to the Committee on Health, 
     Education, Labor, and Pensions and the Committee on 
     Appropriations of the Senate, and the Committee on Energy and 
     Commerce and the Committee on Appropriations of the House of 
     Representatives, with respect to any actions taken by the 
     National Institutes of Health based on the recommendations 
     not later than 2 years after the completion of the study 
     required pursuant to the Department of Health and Human 
     Services Appropriations Act, 2016.

     SEC. 2022. IMPROVEMENT OF LOAN REPAYMENT PROGRAM.

       (a) Intramural Loan Repayment Program.--Section 487A of the 
     Public Health Service Act (42 U.S.C. 288-1) is amended--

[[Page H6904]]

       (1) by amending the section heading to read as follows: 
     ``intramural loan repayment program'';
       (2) in subsection (a)--
       (A) by striking ``The Secretary shall carry out a program'' 
     and inserting ``The Director of the National Institutes of 
     Health shall, as appropriate and based on workforce and 
     scientific priorities, carry out a program through the 
     subcategories listed in subsection (b)(1) (or modified 
     subcategories as provided for in subsection (b)(2))'';
       (B) by striking ``conduct'' and inserting ``conduct 
     research'';
       (C) by striking ``research with respect to acquired immune 
     deficiency syndrome''; and
       (D) by striking ``$35,000'' and inserting ``$50,000'';
       (3) by redesignating subsection (b) as subsection (d);
       (4) by inserting after subsection (a), the following:
       ``(b) Subcategories of Research.--
       ``(1) In general.--In carrying out the program under 
     subsection (a), the Director of the National Institutes of 
     Health--
       ``(A) shall continue to focus on--
       ``(i) general research;
       ``(ii) research on acquired immune deficiency syndrome; and
       ``(iii) clinical research conducted by appropriately 
     qualified health professional who are from disadvantaged 
     backgrounds; and
       ``(B) may focus on an area of emerging scientific or 
     workforce need.
       ``(2) Elimination or establishment of subcategories.--The 
     Director of the National Institutes of Health may eliminate 
     one or more subcategories provided for in paragraph (1) due 
     to changes in workforce or scientific needs related to 
     biomedical research. The Director may establish other 
     subcategory areas based on workforce and scientific 
     priorities if the total number of subcategories does not 
     exceed the number of subcategories listed in paragraph (1).
       ``(c) Limitation.--The Director of the National Institutes 
     of Health may not enter into a contract with a health 
     professional pursuant to subsection (a) unless such 
     professional has a substantial amount of education loans 
     relative to income (as determined pursuant to guidelines 
     issued by the Director).''; and
       (5) by adding at the end the following:
       ``(e) Availability of Appropriations.--Amounts available 
     for carrying out this section shall remain available until 
     the expiration of the second fiscal year beginning after the 
     fiscal year for which such amounts are made available.''.
       (b) Extramural Loan Repayment Program.--Section 487B of the 
     Public Health Service Act (42 U.S.C. 288-2) is amended--
       (1) by amending the section heading to read as follows: 
     ``extramural loan repayment program'';
       (2) in subsection (a)--
       (A) by striking ``The Secretary, in consultation with the 
     Director of the Eunice Kennedy Shriver National Institute of 
     Child Health and Human Development, shall establish a 
     program'' and inserting ``In General.--The Director of the 
     National Institutes of Health shall, as appropriate and based 
     on workforce and scientific priorities, carry out a program 
     through the subcategories listed in subsection (b)(1) (or 
     modified subcategories as provided for in subsection 
     (b)(2)),'';
       (B) by striking ``(including graduate students)'';
       (C) by striking ``with respect to contraception, or with 
     respect to infertility,''; and
       (D) by striking ``service, not more than $35,000'' and 
     inserting ``research, not more than $50,000'';
       (3) by redesignating subsections (b) and (c) as subsections 
     (d) and (e), respectively;
       (4) by inserting after subsection (a), the following:
       ``(b) Subcategories of Research.--
       ``(1) In general.--In carrying out the program under 
     subsection (a), the Director of the National Institutes of 
     Health--
       ``(A) shall continue to focus on--
       ``(i) contraception or infertility research;
       ``(ii) pediatric research, including pediatric 
     pharmacological research;
       ``(iii) minority health disparities research;
       ``(iv) clinical research; and
       ``(v) clinical research conducted by appropriately 
     qualified health professional who are from disadvantaged 
     backgrounds; and
       ``(B) may focus on an area of emerging scientific or 
     workforce need.
       ``(2) Elimination or establishment of subcategories.--The 
     Director of the National Institutes of Health may eliminate 
     one or more subcategories provided for in paragraph (1) due 
     to changes in workforce or scientific needs related to 
     biomedical research. The Director may establish other 
     subcategory areas based on workforce and scientific 
     priorities if the total number of subcategories does not 
     exceed the number of subcategories listed in paragraph (1).
       ``(c) Limitation.--The Director of the National Institutes 
     of Health may not enter into a contract with a health 
     professional pursuant to subsection (a) unless such 
     professional has a substantial amount of education loans 
     relative to income (as determined pursuant to guidelines 
     issued by the Director).'';
       (5) in subsection (d) (as so redesignated), by striking 
     ``The provisions'' and inserting ``Applicability of Certain 
     Provisions Regarding Obligated Service.--The provisions''; 
     and
       (6) in subsection (e) (as so redesignated), by striking 
     ``Amounts'' and inserting ``Availability of Appropriations.--
     Amounts''.
       (c) Technical and Conforming Amendments.--Title IV of the 
     Public Health Service Act is amended--
       (1) by striking section 464z-5 (42 U.S.C. 285t-2);
       (2) by striking section 487C (42 U.S.C. 288-3);
       (3) by striking section 487E (42 U.S.C. 288-5);
       (4) by striking section 487F (42 U.S.C. 288-5a), as added 
     by section 205 of Public Law 106-505, relating to loan 
     repayment for clinical researchers; and
       (5) by striking section 487F (42 U.S.C. 288-6), as added by 
     section 1002(b) of Public Law 106-310 relating to pediatric 
     research loan repayment.
       (d) GAO Report.--Not later than 18 months after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall submit to Congress a report on the efforts of 
     the National Institutes of Health to attract, retain, and 
     develop emerging scientists, including underrepresented 
     individuals in the sciences, such as women, racial and ethnic 
     minorities, and other groups. Such report shall include an 
     analysis of the impact of the additional authority provided 
     to the Secretary of Health and Human Services under this Act 
     to address workforce shortages and gaps in priority research 
     areas, including which centers and research areas offered 
     loan repayment program participants the increased award 
     amount.

 Subtitle D--National Institutes of Health Planning and Administration

     SEC. 2031. NATIONAL INSTITUTES OF HEALTH STRATEGIC PLAN.

       (a) Strategic Plan.--Section 402 of the Public Health 
     Service Act (42 U.S.C. 282) is amended--
       (1) in subsection (b)(5), by inserting before the semicolon 
     the following: ``, and through the development, 
     implementation, and updating of the strategic plan developed 
     under subsection (m)''; and
       (2) by adding at the end the following:
       ``(m) National Institutes of Health Strategic Plan.--
       ``(1) In general.--Not later than 2 years after the date of 
     enactment of the 21st Century Cures Act, and at least every 6 
     years thereafter, the Director of the National Institutes of 
     Health shall develop and submit to the appropriate committees 
     of Congress and post on the Internet website of the National 
     Institutes of Health, a coordinated strategy (to be known as 
     the `National Institutes of Health Strategic Plan') to 
     provide direction to the biomedical research investments made 
     by the National Institutes of Health, to facilitate 
     collaboration across the institutes and centers, to leverage 
     scientific opportunity, and to advance biomedicine.
       ``(2) Requirements.--The strategy under paragraph (1) 
     shall--
       ``(A) identify strategic research priorities and objectives 
     across biomedical research, including--
       ``(i) an assessment of the state of biomedical and 
     behavioral research, including areas of opportunity with 
     respect to basic, clinical, and translational research;
       ``(ii) priorities and objectives to advance the treatment, 
     cure, and prevention of health conditions;
       ``(iii) emerging scientific opportunities, rising public 
     health challenges, and scientific knowledge gaps; and
       ``(iv) the identification of near-, mid-, and long-term 
     scientific needs;
       ``(B) consider, in carrying out subparagraph (A)--
       ``(i) disease burden in the United States and the potential 
     for return on investment to the United States;
       ``(ii) rare diseases and conditions;
       ``(iii) biological, social, and other determinants of 
     health that contribute to health disparities; and
       ``(iv) other factors the Director of National Institutes of 
     Health determines appropriate;
       ``(C) include multi-institute priorities, including 
     coordination of research among institutes and centers;
       ``(D) include strategic priorities for funding research 
     through the Common Fund, in accordance with section 
     402A(c)(1)(C);
       ``(E) address the National Institutes of Health's proposed 
     and ongoing activities related to training and the biomedical 
     workforce; and
       ``(F) describe opportunities for collaboration with other 
     agencies and departments, as appropriate.
       ``(3) Use of plans.--Strategic plans developed and updated 
     by the national research institutes and national centers of 
     the National Institutes of Health shall be prepared regularly 
     and in such a manner that such plans will be informed by the 
     strategic plans developed and updated under this subsection. 
     Such plans developed by and updated by the national research 
     institutes and national centers shall have a common template.
       ``(4) Consultation.--The Director of National Institutes of 
     Health shall develop the strategic plan under paragraph (1) 
     in consultation with the directors of the national research 
     institutes and national centers, researchers, patient 
     advocacy groups, and industry leaders.''.
       (b) Conforming Amendment.--Section 402A(c)(1)(C) of the 
     Public Health Service Act (42 U.S.C. 282a(c)(1)(C)) is 
     amended by striking ``Not later than June 1, 2007, and every 
     2 years thereafter,'' and inserting ``As part of the National 
     Institutes of Health Strategic Plan required under section 
     402(m),''.
       (c) Strategic Plan.--Section 492B(a) of the Public Health 
     Service Act (42 U.S.C. 289a-2(a)) is amended by adding at the 
     end the following:
       ``(3) Strategic planning.--
       ``(A) In general.--The directors of the national institutes 
     and national centers shall consult at least once annually 
     with the Director of the National Institute on Minority 
     Health and Health Disparities and the Director of the Office 
     of Research on Women's Health regarding objectives of the 
     national institutes and national centers to ensure that 
     future activities by such institutes and centers take into 
     account women

[[Page H6905]]

     and minorities and are focused on reducing health 
     disparities.
       ``(B) Strategic plans.--Any strategic plan issued by a 
     national institute or national center shall include details 
     on the objectives described in subparagraph (A).''.

     SEC. 2032. TRIENNIAL REPORTS.

       Section 403 of the Public Health Service Act (42 U.S.C. 
     283) is amended--
       (1) in the section heading, by striking ``biennial'' and 
     inserting ``triennial'' ; and
       (2) in subsection (a)--
       (A) in the matter preceding paragraph (1), by striking 
     ``biennial'' and inserting ``triennial'';
       (B) by amending paragraph (3) to read as follows:
       ``(3) A description of intra-National Institutes of Health 
     activities, including--
       ``(A) identification of the percentage of funds made 
     available by each national research institute and national 
     center with respect to each applicable fiscal year for 
     conducting or supporting research that involves collaboration 
     between the institute or center and 1 or more other national 
     research institutes or national centers; and
       ``(B) recommendations for promoting coordination of 
     information among the centers of excellence.'';
       (C) in paragraph (4)--
       (i) in subparagraph (B), by striking ``demographic 
     variables and other variables'' and inserting ``demographic 
     variables, including biological and social variables and 
     relevant age categories (such as pediatric subgroups), and 
     determinants of health,''; and
       (ii) in subparagraph (C)(v)--

       (I) by striking ``demographic variables and such'' and 
     inserting ``demographic variables, including relevant age 
     categories (such as pediatric subgroups), information 
     submitted by each national research institute and national 
     center to the Director of National Institutes of Health under 
     section 492B(f), and such''; and
       (II) by striking ``(regarding inclusion of women and 
     minorities in clinical research)'' and inserting ``and other 
     applicable requirements regarding inclusion of demographic 
     groups''; and

       (D) in paragraph (6)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``the following:'' and inserting ``the following--'';
       (ii) in subparagraph (A)--

       (I) by striking ``An evaluation'' and inserting ``an 
     evaluation''; and
       (II) by striking the period and inserting ``; and'';

       (iii) by striking subparagraphs (B) and (D);
       (iv) by redesignating subparagraph (C) as subparagraph (B); 
     and
       (v) in subparagraph (B), as redesignated by clause (iv), by 
     striking ``Recommendations'' and inserting 
     ``recommendations''.

     SEC. 2033. INCREASING ACCOUNTABILITY AT THE NATIONAL 
                   INSTITUTES OF HEALTH.

       (a) Appointment and Terms of Directors of National Research 
     Institutes and National Centers.--Subsection (a) of section 
     405 of the Public Health Service Act (42 U.S.C. 284) is 
     amended to read as follows:
       ``(a) Appointment.--
       ``(1) In general.--The Director of the National Cancer 
     Institute shall be appointed by the President, and the 
     Directors of the other national research institutes and 
     national centers shall be appointed by the Secretary, acting 
     through the Director of National Institutes of Health. Each 
     Director of a national research institute or national center 
     shall report directly to the Director of National Institutes 
     of Health.
       ``(2) Appointment.--
       ``(A) Term.--A Director of a national research institute or 
     national center who is appointed by the Secretary, acting 
     through the Director of National Institutes of Health, shall 
     be appointed for 5 years.
       ``(B) Reappointment.--At the end of the term of a Director 
     of a national research institute or national center, the 
     Director may be reappointed in accordance with standards 
     applicable to the relevant appointment mechanism. There shall 
     be no limit on the number of terms that a Director may serve.
       ``(C) Vacancies.--If the office of a Director of a national 
     research institute or national center becomes vacant before 
     the end of such Director's term, the Director appointed to 
     fill the vacancy shall be appointed for a 5-year term 
     starting on the date of such appointment.
       ``(D) Current directors.--Each Director of a national 
     research institute or national center who is serving on the 
     date of enactment of the 21st Century Cures Act shall be 
     deemed to be appointed for a 5-year term under this 
     subsection beginning on such date of enactment.
       ``(E) Rule of construction.--Nothing in this subsection 
     shall be construed to limit the authority of the Secretary or 
     the Director of National Institutes of Health to terminate 
     the appointment of a director referred to in subparagraph (A) 
     before the expiration of such director's 5-year term.
       ``(F) Nature of appointment.--Appointments and 
     reappointments under this subsection shall be made on the 
     basis of ability and experience as it relates to the mission 
     of the National Institutes of Health and its components, 
     including compliance with any legal requirement that the 
     Secretary or Director of National Institutes of Health 
     determines relevant.
       ``(3) Nonapplication of certain provision.--The 
     restrictions contained in section 202 of the Departments of 
     Labor, Health and Human Services, and Education, and Related 
     Agencies Appropriations Act, 1993 (Public Law 102-394; 42 
     U.S.C. 238f note) related to consultants and individual 
     scientists appointed for limited periods of time shall not 
     apply to Directors appointed under this subsection.''.
       (b) Review of Certain Awards by Directors.--Section 405(b) 
     of the Public Health Service Act (42 U.S.C. 284(b)) is 
     amended by adding at the end the following:
       ``(3) Before an award is made by a national research 
     institute or by a national center for a grant for a research 
     program or project (commonly referred to as an `R-series 
     grant'), other than an award constituting a noncompetitive 
     renewal of such a grant, or a noncompetitive administrative 
     supplement to such a grant, the Director of such national 
     research institute or national center shall, consistent with 
     the peer review process--
       ``(A) review and make the final decision with respect to 
     making the award; and
       ``(B) take into consideration, as appropriate--
       ``(i) the mission of the national research institute or 
     national center and the scientific priorities identified in 
     the strategic plan under section 402(m);
       ``(ii) programs or projects funded by other agencies on 
     similar research topics; and
       ``(iii) advice by staff and the advisory council or board 
     of such national research institute or national center.''.
       (c) Report on Duplication in Federal Biomedical Research.--
     The Secretary of Health and Human Services (referred to in 
     this subsection as the ``Secretary''), shall, not later than 
     2 years after the date of enactment of this Act, submit a 
     report to Congress on efforts to prevent and eliminate 
     duplicative biomedical research that is not necessary for 
     scientific purposes. Such report shall--
       (1) describe the procedures in place to identify such 
     duplicative research, including procedures for monitoring 
     research applications and funded research awards to prevent 
     unnecessary duplication;
       (2) describe the steps taken to improve the procedures 
     described in paragraph (1), in response to relevant 
     recommendations made by the Comptroller General of the United 
     States;
       (3) describe how the Secretary operationally distinguishes 
     necessary and appropriate scientific replication from 
     unnecessary duplication; and
       (4) provide examples of instances where the Secretary has 
     identified unnecessarily duplicative research and the steps 
     taken to eliminate the unnecessary duplication.

     SEC. 2034. REDUCING ADMINISTRATIVE BURDEN FOR RESEARCHERS.

       (a) Plan Preparation and Implementation of Measures To 
     Reduce Administrative Burdens.--
       (1) In general.--Not later than 2 years after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall--
       (A) lead a review by research funding agencies of all 
     regulations and policies related to the disclosure of 
     financial conflicts of interest, including the minimum 
     threshold for reporting financial conflicts of interest;
       (B) make revisions, as appropriate, to harmonize existing 
     policies and reduce administrative burden on researchers 
     while maintaining the integrity and credibility of research 
     findings and protections of human participants; and
       (C) confer with the Office of the Inspector General about 
     the activities of such office related to financial conflicts 
     of interest involving research funding agencies.
       (2) Considerations.--In updating policies under paragraph 
     (1)(B), the Secretary shall consider--
       (A) modifying the timelines for the reporting of financial 
     conflicts of interest to just-in-time information by 
     institutions receiving grant or cooperative agreement funding 
     from the National Institutes of Health;
       (B) ensuring that financial interest disclosure reporting 
     requirements are appropriate for, and relevant to, awards 
     that will directly fund research, which may include 
     modification of the definition of the term ``investigator'' 
     for purposes of the regulations and policies described in 
     subparagraphs (A) and (B) of paragraph (1); and
       (C) updating any applicable training modules of the 
     National Institutes of Health related to Federal financial 
     interest disclosure.
       (b) Monitoring of Subrecipients of Funding From the 
     National Institutes of Health.--The Director of the National 
     Institutes of Health (referred to in this section as the 
     ``Director of National Institutes of Health'') shall 
     implement measures to reduce the administrative burdens 
     related to monitoring of subrecipients of grants by primary 
     awardees of funding from the National Institutes of Health, 
     which may incorporate findings and recommendations from 
     existing and ongoing activities. Such measures may include, 
     as appropriate--
       (1) an exemption from subrecipient monitoring requirements, 
     upon request from the primary awardees, provided that--
       (A) the subrecipient is subject to Federal audit 
     requirements pursuant to the Uniform Guidance of the Office 
     of Management and Budget;
       (B) the primary awardee conducts, pursuant to guidance of 
     the National Institutes of Health, a pre-award evaluation of 
     each subrecipient's risk of noncompliance with Federal 
     statutes and regulations, the conditions of the subaward, and 
     any recurring audit findings; and
       (C) such exemption does not absolve the primary awardee of 
     liability for misconduct by subrecipients; and
       (2) the implementation of alternative grant structures that 
     obviate the need for subrecipient monitoring, which may 
     include collaborative grant models allowing for multiple 
     primary awardees.
       (c) Reporting of Financial Expenditures.--The Secretary, in 
     consultation with the Director of National Institutes of 
     Health, shall evaluate financial expenditure reporting 
     procedures and requirements for recipients of funding from 
     the National Institutes of Health and take action, as 
     appropriate, to avoid duplication between department and 
     agency procedures and requirements and minimize burden to 
     funding recipients.

[[Page H6906]]

       (d) Animal Care and Use in Research.--Not later than 2 
     years after the date of enactment of this Act, the Director 
     of National Institutes of Health, in collaboration with the 
     Secretary of Agriculture and the Commissioner of Food and 
     Drugs, shall complete a review of applicable regulations and 
     policies for the care and use of laboratory animals and make 
     revisions, as appropriate, to reduce administrative burden on 
     investigators while maintaining the integrity and credibility 
     of research findings and protection of research animals. In 
     carrying out this effort, the Director of the National 
     Institutes of Health shall seek the input of experts, as 
     appropriate. The Director of the National Institutes of 
     Health shall--
       (1) identify ways to ensure such regulations and policies 
     are not inconsistent, overlapping, or unnecessarily 
     duplicative, including with respect to inspection and review 
     requirements by Federal agencies and accrediting 
     associations;
       (2) take steps to eliminate or reduce identified 
     inconsistencies, overlap, or duplication among such 
     regulations and policies; and
       (3) take other actions, as appropriate, to improve the 
     coordination of regulations and policies with respect to 
     research with laboratory animals.
       (e) Documentation of Personnel Expenses.--The Secretary 
     shall clarify the applicability of the requirements under the 
     Office of Management and Budget Uniform Guidance for 
     management and certification systems adopted by entities 
     receiving Federal research grants through the Department of 
     Health and Human Services regarding documentation of 
     personnel expenses, including clarification of the extent to 
     which any flexibility to such requirements specified in such 
     Uniform Guidance applies to entities receiving grants through 
     the Department of Health and Human Services.
       (f) Research Policy Board.--
       (1) Establishment.--Not later than 1 year after the date of 
     enactment of this Act, the Director of the Office of 
     Management and Budget shall establish an advisory committee, 
     to be known as the ``Research Policy Board'' (referred to in 
     this subsection as the ``Board''), to provide Federal 
     Government officials with information on the effects of 
     regulations related to Federal research requirements.
       (2) Membership.--
       (A) In general.--The Board shall include not more than 10 
     Federal members, including each of the following Federal 
     members or their designees:
       (i) The Administrator of the Office of Information and 
     Regulatory Affairs of the Office of Management and Budget.
       (ii) The Director of the Office of Science and Technology 
     Policy.
       (iii) The Secretary of Health and Human Services.
       (iv) The Director of the National Science Foundation.
       (v) The secretaries and directors of other departments and 
     agencies that support or regulate scientific research, as 
     determined by the Director of the Office of Management and 
     Budget.
       (B) Non-federal members.--The Board shall be comprised of 
     not less than 9 and not more than 12 representatives of 
     academic research institutions, other private, nonprofit 
     research institutions, or other nonprofit organizations with 
     relevant expertise. Such members shall be appointed by a 
     formal process, to be established by the Director of the 
     Office of Management and Budget, in consultation with the 
     Federal membership, and that incorporates--
       (i) nomination by members of the nonprofit scientific 
     research community, including academic research institutions; 
     and
       (ii) procedures to fill membership positions vacated before 
     the end of a member's term.
       (3) Purpose and responsibilities.--The Board shall make 
     recommendations regarding the modification and harmonization 
     of regulations and policies having similar purposes across 
     research funding agencies to ensure that the administrative 
     burden of such research policy and regulation is minimized to 
     the greatest extent possible and consistent with maintaining 
     responsible oversight of federally funded research. 
     Activities of the Board may include--
       (A) providing thorough and informed analysis of regulations 
     and policies;
       (B) identifying negative or adverse consequences of 
     existing policies and making actionable recommendations 
     regarding possible improvement of such policies;
       (C) making recommendations with respect to efforts within 
     the Federal Government to improve coordination of regulation 
     and policy related to research;
       (D) creating a forum for the discussion of research policy 
     or regulatory gaps, challenges, clarification, or 
     harmonization of such policies or regulation, and best 
     practices; and
       (E) conducting ongoing assessment and evaluation of 
     regulatory burden, including development of metrics, periodic 
     measurement, and identification of process improvements and 
     policy changes.
       (4) Expert subcommittees.--The Board may form temporary 
     expert subcommittees, as appropriate, to develop timely 
     analysis on pressing issues and assist the Board in 
     anticipating future regulatory challenges, including 
     challenges emerging from new scientific advances.
       (5) Reporting requirements.--Not later than 2 years after 
     the date of enactment of this Act, and once thereafter, the 
     Board shall submit a report to the Director of the Office of 
     Management and Budget, the Administrator of the Office of 
     Information and Regulatory Affairs of the Office of 
     Management and Budget, the Director of the Office of Science 
     and Technology Policy, the heads of relevant Federal 
     departments and agencies, the Committee on Health, Education, 
     Labor, and Pensions of the Senate, and the Committee on 
     Energy and Commerce of the House of Representatives 
     containing formal recommendations on the conceptualization, 
     development, harmonization, and reconsideration of scientific 
     research policy, including the regulatory benefits and 
     burdens.
       (6) Sunset.--The Board shall terminate on September 30, 
     2021.
       (7) GAO report.--Not later than 4 years after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall conduct an independent evaluation of the 
     activities carried out by the Board pursuant to this 
     subsection and submit to the appropriate committees of 
     Congress a report regarding the results of the independent 
     evaluation. Such report shall review and assess the Board's 
     activities with respect to the responsibilities described in 
     paragraph (3).

     SEC. 2035. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH 
                   FROM THE PAPERWORK REDUCTION ACT REQUIREMENTS.

       Section 301 of the Public Health Service Act (42 U.S.C. 
     241), as amended by section 2013, is further amended by 
     adding at the end the following:
       ``(g) Subchapter I of chapter 35 of title 44, United States 
     Code, shall not apply to the voluntary collection of 
     information during the conduct of research by the National 
     Institutes of Health.''.

     SEC. 2036. HIGH-RISK, HIGH-REWARD RESEARCH.

       (a) In General.--Section 402 of the Public Health Service 
     Act (42 U.S.C. 282), as amended by section 2031, is further 
     amended by adding at the end the following:
       ``(n) Unique Research Initiatives.--
       ``(1) In general.--The Director of NIH may approve, after 
     consideration of a proposal under paragraph (2)(A), requests 
     by the national research institutes and centers, or program 
     officers within the Office of the Director to engage in 
     transactions other than a contract, grant, or cooperative 
     agreement with respect to projects that carry out--
       ``(A) the Precision Medicine Initiative under section 498E; 
     or
       ``(B) section 402(b)(7), except that not more than 50 
     percent of the funds available for a fiscal year through the 
     Common Fund under section 402A(c)(1) for purposes of carrying 
     out such section 402(b)(7) may be used to engage in such 
     other transactions.
       ``(2) Requirements.--The authority provided under this 
     subsection may be used to conduct or support high impact 
     cutting-edge research described in paragraph (1) using the 
     other transactions authority described in such paragraph if 
     the institute, center, or office--
       ``(A) submits a proposal to the Director of NIH for the use 
     of such authority before conducting or supporting the 
     research, including why the use of such authority is 
     essential to promoting the success of the project;
       ``(B) receives approval for the use of such authority from 
     the Director of NIH; and
       ``(C) for each year in which the institute, center, or 
     office has used such authority in accordance with this 
     subsection, submits a report to the Director of NIH on the 
     activities of the institute, center, or office relating to 
     such research.''.
       (b) Report to Congress.--Not later than September 30, 2020, 
     the Secretary of Health and Human Services, acting through 
     the Director of the National Institutes of Health, shall 
     conduct an evaluation of the activities under subsection (n) 
     of section 402 of the Public Health Service Act (42 U.S.C. 
     282), as added by subsection (a), and submit a report to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives on the results of such evaluation.
       (c) Duties of Directors of Institutes.--Section 405(b)(1) 
     of the Public Health Service Act (42 U.S.C. 284(b)(1)) is 
     amended--
       (1) by redesignating subparagraphs (C) through (L) as 
     subparagraphs (D) through (M), respectively; and
       (2) by inserting after subparagraph (B), the following:
       ``(C) shall, as appropriate, conduct and support research 
     that has the potential to transform the scientific field, has 
     inherently higher risk, and that seeks to address major 
     current challenges;''.

     SEC. 2037. NATIONAL CENTER FOR ADVANCING TRANSLATIONAL 
                   SCIENCES.

       (a) In General.--Section 479(b) of the Public Health 
     Service Act (42 U.S.C. 287(b)) is amended--
       (1) in paragraph (1), by striking ``phase IIA'' and 
     inserting ``phase IIB''; and
       (2) in paragraph (2)--
       (A) in the matter preceding subparagraph (A), by striking 
     ``phase IIB'' and inserting ``phase III'';
       (B) in subparagraph (A), by striking ``phase IIB'' and 
     inserting ``phase III'';
       (C) in subparagraph (B), by striking ``phase IIA'' and 
     inserting ``phase IIB''; and
       (D) in subparagraph (C), by striking ``phase IIB'' and 
     inserting ``phase III''.
       (b) Increased Transparency.--Section 479 of the Public 
     Health Service Act (42 U.S.C. 287) is amended--
       (1) in subsection (c)--
       (A) in paragraph (4)(D), by striking ``and'' at the end;
       (B) in paragraph (5), by striking the period and inserting 
     a semicolon; and
       (C) by adding at the end the following:
       ``(6) the methods and tools, if any, that have been 
     developed since the last biennial report was prepared; and
       ``(7) the methods and tools, if any, that have been 
     developed and are being utilized by the Food and Drug 
     Administration to support medical product reviews.''; and
       (2) by adding at the end the following:
       ``(d) Inclusion of List.--The first biennial report 
     submitted under this section after the

[[Page H6907]]

     date of enactment of the 21st Century Cures Act shall include 
     a complete list of all of the methods and tools, if any, 
     which have been developed by research supported by the 
     Center.
       ``(e) Rule of Construction.--Nothing in this section shall 
     be construed as authorizing the Secretary to disclose any 
     information that is a trade secret, or other privileged or 
     confidential information subject to section 552(b)(4) of 
     title 5, United States Code, or section 1905 of title 18, 
     United States Code.''.

     SEC. 2038. COLLABORATION AND COORDINATION TO ENHANCE 
                   RESEARCH.

       (a) Research Priorities; Collaborative Research Projects.--
     Section 402(b) of the Public Health Service Act (42 U.S.C. 
     282(b)) is amended--
       (1) by amending paragraph (4) to read as follows:
       ``(4) shall assemble accurate data to be used to assess 
     research priorities, including--
       ``(A) information to better evaluate scientific 
     opportunity, public health burdens, and progress in reducing 
     health disparities; and
       ``(B) data on study populations of clinical research, 
     funded by or conducted at each national research institute 
     and national center, which--
       ``(i) specifies the inclusion of--

       ``(I) women;
       ``(II) members of minority groups;
       ``(III) relevant age categories, including pediatric 
     subgroups; and
       ``(IV) other demographic variables as the Director of the 
     National Institutes of Health determines appropriate;

       ``(ii) is disaggregated by research area, condition, and 
     disease categories; and
       ``(iii) is to be made publicly available on the Internet 
     website of the National Institutes of Health;''; and
       (2) in paragraph (8)--
       (A) in subparagraph (A), by striking ``and'' at the end; 
     and
       (B) by adding at the end the following:
       ``(C) foster collaboration between clinical research 
     projects funded by the respective national research 
     institutes and national centers that--
       ``(i) conduct research involving human subjects; and
       ``(ii) collect similar data; and
       ``(D) encourage the collaboration described in subparagraph 
     (C) to--
       ``(i) allow for an increase in the number of subjects 
     studied; and
       ``(ii) utilize diverse study populations, with special 
     consideration to biological, social, and other determinants 
     of health that contribute to health disparities;''.
       (b) Reporting.--Section 492B(f) of the Public Health 
     Service Act (42 U.S.C. 289a-2(f)) is amended--
       (1) by striking ``biennial'' each place such term appears 
     and inserting ``triennial'';
       (2) by striking ``The advisory council'' and inserting the 
     following:
       ``(1) In general.--The advisory council''; and
       (3) by adding at the end the following:
       ``(2) Contents.--Each triennial report prepared by an 
     advisory council of each national research institute as 
     described in paragraph (1) shall include each of the 
     following:
       ``(A) The number of women included as subjects, and the 
     proportion of subjects that are women, in any project of 
     clinical research conducted during the applicable reporting 
     period, disaggregated by categories of research area, 
     condition, or disease, and accounting for single-sex studies.
       ``(B) The number of members of minority groups included as 
     subjects, and the proportion of subjects that are members of 
     minority groups, in any project of clinical research 
     conducted during the applicable reporting period, 
     disaggregated by categories of research area, condition, or 
     disease and accounting for single-race and single-ethnicity 
     studies.
       ``(C) For the applicable reporting period, the number of 
     projects of clinical research that include women and members 
     of minority groups and that--
       ``(i) have been completed during such reporting period; and
       ``(ii) are being carried out during such reporting period 
     and have not been completed.
       ``(D) The number of studies completed during the applicable 
     reporting period for which reporting has been submitted in 
     accordance with subsection (c)(2)(A).''.
       (c) Coordination.--Section 486(c)(2) of the Public Health 
     Service Act (42 U.S.C. 287d(c)(2)) is amended by striking 
     ``designees'' and inserting ``senior-level staff designees''.
       (d) In General.--Part A of title IV of the Public Health 
     Service Act (42 U.S.C. 281 et seq.), as amended by section 
     2021, is further amended by adding at the end the following:

     ``SEC. 404N. POPULATION FOCUSED RESEARCH.

       ``The Director of the National Institutes of Health shall, 
     as appropriate, encourage efforts to improve research related 
     to the health of sexual and gender minority populations, 
     including by--
       ``(1) facilitating increased participation of sexual and 
     gender minority populations in clinical research supported by 
     the National Institutes of Health, and reporting on such 
     participation, as applicable;
       ``(2) facilitating the development of valid and reliable 
     methods for research relevant to sexual and gender minority 
     populations; and
       ``(3) addressing methodological challenges.''.
       (e) Reporting.--
       (1) In general.--The Secretary, in collaboration with the 
     Director of the National Institutes of Health, shall as 
     appropriate--
       (A) continue to support research for the development of 
     appropriate measures related to reporting health information 
     about sexual and gender minority populations; and
       (B) not later than 2 years after the date of enactment of 
     this Act, disseminate and make public such measures.
       (2) National academy of medicine recommendations.--In 
     developing the measures described in paragraph (1)(A), the 
     Secretary shall take into account recommendations made by the 
     National Academy of Medicine.
       (f) Improving Coordination Related to Minority Health and 
     Health Disparities.--Section 464z-3 of the Public Health 
     Service Act (42 U.S.C. 285t) is amended--
       (1) by redesignating subsection (h), relating to 
     interagency coordination, that follows subsection (j) as 
     subsection (k); and
       (2) in subsection (k) (as so redesignated)--
       (A) in the subsection heading, by striking ``Interagency'' 
     and inserting ``Intra-National Institutes of Health'';
       (B) by striking ``as the primary Federal officials'' and 
     inserting ``as the primary Federal official'';
       (C) by inserting a comma after ``review'';
       (D) by striking ``Institutes and Centers of the National 
     Institutes of Health'' and inserting ``national research 
     institutes and national centers''; and
       (E) by adding at the end the following: ``The Director of 
     the Institute may foster partnerships between the national 
     research institutes and national centers and may encourage 
     the funding of collaborative research projects to achieve the 
     goals of the National Institutes of Health that are related 
     to minority health and health disparities.''.
       (g) Basic Research.--
       (1) Developing policies.--Not later than 2 years after the 
     date of enactment of this Act, the Director of the National 
     Institutes of Health (referred to in this section as the 
     ``Director of the National Institutes of Health''), taking 
     into consideration the recommendations developed under 
     section 2039, shall develop policies for projects of basic 
     research funded by National Institutes of Health to assess--
       (A) relevant biological variables including sex, as 
     appropriate; and
       (B) how differences between male and female cells, tissues, 
     or animals may be examined and analyzed.
       (2) Revising policies.--The Director of the National 
     Institutes of Health may update or revise the policies 
     developed under paragraph (1) as appropriate.
       (3) Consultation and outreach.--In developing, updating, or 
     revising the policies under this section, the Director of the 
     National Institutes of Health shall--
       (A) consult with--
       (i) the Office of Research on Women's Health;
       (ii) the Office of Laboratory Animal Welfare; and
       (iii) appropriate members of the scientific and academic 
     communities; and
       (B) conduct outreach to solicit feedback from members of 
     the scientific and academic communities on the influence of 
     sex as a variable in basic research, including feedback on 
     when it is appropriate for projects of basic research 
     involving cells, tissues, or animals to include both male and 
     female cells, tissues, or animals.
       (4) Additional requirements.--The Director of the National 
     Institutes of Health shall--
       (A) ensure that projects of basic research funded by the 
     National Institutes of Health are conducted in accordance 
     with the policies developed, updated, or revised under this 
     section, as applicable; and
       (B) encourage that the results of such research, when 
     published or reported, be disaggregated as appropriate with 
     respect to the analysis of any sex differences.
       (h) Clinical Research.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Director of the National 
     Institutes of Health, in consultation with the Director of 
     the Office of Research on Women's Health and the Director of 
     the National Institute on Minority Health and Health 
     Disparities, shall update the guidelines established under 
     section 492B(d) of Public Health Service Act (42 U.S.C. 289a-
     2(d)) in accordance with paragraph (2).
       (2) Requirements.--The updated guidelines described in 
     paragraph (1) shall--
       (A) reflect the science regarding sex differences;
       (B) improve adherence to the requirements under section 
     492B of the Public Health Service Act (42 U.S.C. 289a-2), 
     including the reporting requirements under subsection (f) of 
     such section; and
       (C) clarify the circumstances under which studies should be 
     designed to support the conduct of analyses to detect 
     significant differences in the intervention effect due to 
     demographic factors related to section 492B of the Public 
     Health Service Act, including in the absence of prior studies 
     that demonstrate a difference in study outcomes on the basis 
     of such factors and considering the effects of the absence of 
     such analyses on the availability of data related to 
     demographic differences.
       (i) Appropriate Age Groupings in Clinical Research.--
       (1) Input from experts.--Not later than 180 days after the 
     date of enactment of this Act, the Director of the National 
     Institutes of Health shall convene a workshop of experts on 
     pediatric and older populations to provide input on--
       (A) appropriate age groups to be included in research 
     studies involving human subjects; and
       (B) acceptable justifications for excluding participants 
     from a range of age groups from human subjects research 
     studies.
       (2) Policy updates.--Not later than 180 days after the 
     conclusion of the workshop under paragraph (1), the Director 
     of the National Institutes of Health shall make a 
     determination with respect to whether the policies of the 
     National Institutes of Health on the inclusion of relevant 
     age groups in clinical studies need to be updated, and shall 
     update such policies as appropriate. In making the 
     determination, the Director of the National Institutes of 
     Health shall take into consideration whether such policies--

[[Page H6908]]

       (A) address the consideration of age as an inclusion 
     variable in research involving human subjects; and
       (B) identify the criteria for justification for any age-
     related exclusions in such research.
       (3) Public availability of findings and conclusions.--The 
     Director of the National Institutes of Health shall--
       (A) make the findings and conclusions resulting from the 
     workshop under paragraph (1) and updates to policies in 
     accordance with paragraph (2), as applicable, available to 
     the public on the Internet website of the National Institutes 
     of Health; and
       (B) ensure that age-related data reported in the triennial 
     report under section 403 of the Public Health Service Act (42 
     U.S.C. 283) (as amended by section 2032) are made available 
     to the public on the Internet website of the National 
     Institutes of Health.

     SEC. 2039. ENHANCING THE RIGOR AND REPRODUCIBILITY OF 
                   SCIENTIFIC RESEARCH.

       (a) Establishment.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services, acting through the Director of the National 
     Institutes of Health, shall convene a working group under the 
     Advisory Committee to the Director of the National Institutes 
     of Health (referred to in this section as the ``Advisory 
     Committee''), appointed under section 222 of the Public 
     Health Service Act (42 U.S.C. 217a), to develop and issue 
     recommendations through the Advisory Committee for a formal 
     policy, which may incorporate or be informed by relevant 
     existing and ongoing activities, to enhance rigor and 
     reproducibility of scientific research funded by the National 
     Institutes of Health.
       (b) Considerations.--In developing and issuing 
     recommendations through the Advisory Committee under 
     subsection (a), the working group established under such 
     subsection shall consider, as appropriate--
       (1) preclinical experiment design, including analysis of 
     sex as a biological variable;
       (2) clinical experiment design, including--
       (A) the diversity of populations studied for clinical 
     research, with respect to biological, social, and other 
     determinants of health that contribute to health disparities;
       (B) the circumstances under which summary information 
     regarding biological, social, and other factors that 
     contribute to health disparities should be reported; and
       (C) the circumstances under which clinical studies, 
     including clinical trials, should conduct an analysis of the 
     data collected during the study on the basis of biological, 
     social, and other factors that contribute to health 
     disparities;
       (3) applicable levels of rigor in statistical methods, 
     methodology, and analysis;
       (4) data and information sharing in accordance with 
     applicable privacy laws and regulations; and
       (5) any other matter the working group determines relevant.
       (c) Policies.--Not later than 18 months after the date of 
     enactment of this Act, the Director of the National 
     Institutes of Health shall consider the recommendations 
     developed by the working group and issued by the Advisory 
     Committee under subsection (a) and develop or update policies 
     as appropriate.
       (d) Report.--Not later than 2 years after the date of 
     enactment of this Act, the Director of the National 
     Institutes of Health shall issue a report to the Secretary of 
     Health and Human Services, the Committee on Health, 
     Education, Labor, and Pensions of the Senate, and the 
     Committee on Energy and Commerce of the House of 
     Representatives regarding recommendations developed under 
     subsection (a) and any subsequent policy changes implemented, 
     to enhance rigor and reproducibility in scientific research 
     funded by the National Institutes of Health.
       (e) Confidentiality.--Nothing in this section authorizes 
     the Secretary of Health and Human Services to disclose any 
     information that is a trade secret, or other privileged or 
     confidential information, described in section 552(b)(4) of 
     title 5, United States Code, or section 1905 of title 18, 
     United States Code.

     SEC. 2040. IMPROVING MEDICAL REHABILITATION RESEARCH AT THE 
                   NATIONAL INSTITUTES OF HEALTH.

       (a) In General.--Section 452 of the Public Health Service 
     Act (42 U.S.C. 285g-4) is amended--
       (1) in subsection (b), by striking ``conduct and support'' 
     and inserting ``conduct, support, and coordination'';
       (2) in subsection (c)(1)(C), by striking ``of the Center'' 
     and inserting ``within the Center'';
       (3) in subsection (d)--
       (A) by striking ``(d)(1) In consultation'' and all that 
     follows through the end of paragraph (1) and inserting the 
     following:
       ``(d)(1) The Director of the Center, in consultation with 
     the Director of the Institute, the coordinating committee 
     established under subsection (e), and the advisory board 
     established under subsection (f), shall develop a 
     comprehensive plan (referred to in this section as the 
     `Research Plan') for the conduct, support, and coordination 
     of medical rehabilitation research.'';
       (B) in paragraph (2)--
       (i) in subparagraph (A), by striking ``; and'' and 
     inserting a semicolon;
       (ii) in subparagraph (B), by striking the period and 
     inserting ``; and''; and
       (iii) by adding at the end the following:
       ``(C) include goals and objectives for conducting, 
     supporting, and coordinating medical rehabilitation research, 
     consistent with the purpose described in subsection (b).'';
       (C) by striking paragraph (4) and inserting the following:
       ``(4) The Director of the Center, in consultation with the 
     Director of the Institute, the coordinating committee 
     established under subsection (e), and the advisory board 
     established under subsection (f), shall revise and update the 
     Research Plan periodically, as appropriate, or not less than 
     every 5 years. Not later than 30 days after the Research Plan 
     is so revised and updated, the Director of the Center shall 
     transmit the revised and updated Research Plan to the 
     President, the Committee on Health, Education, Labor, and 
     Pensions of the Senate, and the Committee on Energy and 
     Commerce of the House of Representatives.''; and
       (D) by adding at the end the following:
       ``(5) The Director of the Center, in consultation with the 
     Director of the Institute, shall, prior to revising and 
     updating the Research Plan, prepare a report for the 
     coordinating committee established under subsection (e) and 
     the advisory board established under subsection (f) that 
     describes and analyzes the progress during the preceding 
     fiscal year in achieving the goals and objectives described 
     in paragraph (2)(C) and includes expenditures for 
     rehabilitation research at the National Institutes of Health. 
     The report shall include recommendations for revising and 
     updating the Research Plan, and such initiatives as the 
     Director of the Center and the Director of the Institute 
     determine appropriate. In preparing the report, the Director 
     of the Center and the Director of the Institute shall consult 
     with the Director of the National Institutes of Health.'';
       (4) in subsection (e)--
       (A) in paragraph (2), by inserting ``periodically host a 
     scientific conference or workshop on medical rehabilitation 
     research and'' after ``The Coordinating Committee shall''; 
     and
       (B) in paragraph (3), by inserting ``the Director of the 
     Division of Program Coordination, Planning, and Strategic 
     Initiatives within the Office of the Director of the National 
     Institutes of Health,'' after ``shall be composed of'';
       (5) in subsection (f)(3)(B)--
       (A) by redesignating clauses (ix) through (xi) as clauses 
     (x) through (xii), respectively; and
       (B) by inserting after clause (viii) the following:
       ``(ix) The Director of the Division of Program 
     Coordination, Planning, and Strategic Initiatives.''; and
       (6) by adding at the end the following:
       ``(g)(1) The Secretary and the heads of other Federal 
     agencies shall jointly review the programs carried out (or 
     proposed to be carried out) by each such official with 
     respect to medical rehabilitation research and, as 
     appropriate, enter into agreements preventing duplication 
     among such programs.
       ``(2) The Secretary shall, as appropriate, enter into 
     interagency agreements relating to the coordination of 
     medical rehabilitation research conducted by agencies of the 
     National Institutes of Health and other agencies of the 
     Federal Government.
       ``(h) For purposes of this section, the term `medical 
     rehabilitation research' means the science of mechanisms and 
     interventions that prevent, improve, restore, or replace 
     lost, underdeveloped, or deteriorating function.''.
       (b) Conforming Amendment.--Section 3 of the National 
     Institutes of Health Amendments of 1990 (42 U.S.C. 285g-4 
     note) is amended--
       (1) in subsection (a), by striking ``In General.--''; and
       (2) by striking subsection (b).

     SEC. 2041. TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT WOMEN 
                   AND LACTATING WOMEN.

       (a) Task Force on Research Specific to Pregnant Women and 
     Lactating Women.--
       (1) Establishment.--Not later than 90 days after the date 
     of enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall establish a task force, in accordance with the Federal 
     Advisory Committee Act (5 U.S.C. App.), to be known as the 
     ``Task Force on Research Specific to Pregnant Women and 
     Lactating Women'' (in this section referred to as the ``Task 
     Force'').
       (2) Duties.--The Task Force shall provide advice and 
     guidance to the Secretary regarding Federal activities 
     related to identifying and addressing gaps in knowledge and 
     research regarding safe and effective therapies for pregnant 
     women and lactating women, including the development of such 
     therapies and the collaboration on and coordination of such 
     activities.
       (3) Membership.--
       (A) Federal members.--The Task Force shall be composed of 
     each of the following Federal members, or the designees of 
     such members:
       (i) The Director of the Centers for Disease Control and 
     Prevention.
       (ii) The Director of the National Institutes of Health, the 
     Director of the Eunice Kennedy Shriver National Institute of 
     Child Health and Human Development, and the directors of such 
     other appropriate national research institutes.
       (iii) The Commissioner of Food and Drugs.
       (iv) The Director of the Office on Women's Health.
       (v) The Director of the National Vaccine Program Office.
       (vi) The head of any other research-related agency or 
     department not described in clauses (i) through (v) that the 
     Secretary determines appropriate, which may include the 
     Department of Veterans Affairs and the Department of Defense.
       (B) Non-federal members.--The Task Force shall be composed 
     of each of the following non-Federal members, including--
       (i) representatives from relevant medical societies with 
     subject matter expertise on pregnant women, lactating women, 
     or children;
       (ii) nonprofit organizations with expertise related to the 
     health of women and children;
       (iii) relevant industry representatives; and
       (iv) other representatives, as appropriate.
       (C) Limitations.--The non-Federal members described in 
     subparagraph (B) shall--
       (i) compose not more than one-half, and not less than one-
     third, of the total membership of the Task Force; and

[[Page H6909]]

       (ii) be appointed by the Secretary.
       (4) Termination.--
       (A) In general.--Subject to subparagraph (B), the Task 
     Force shall terminate on the date that is 2 years after the 
     date on which the Task Force is established under paragraph 
     (1).
       (B) Extension.--The Secretary may extend the operation of 
     the Task Force for one additional 2-year period following the 
     2-year period described in subparagraph (A), if the Secretary 
     determines that the extension is appropriate for carrying out 
     the purpose of this section.
       (5) Meetings.--The Task Force shall meet not less than 2 
     times each year and shall convene public meetings, as 
     appropriate, to fulfill its duties under paragraph (2).
       (6) Task force report to congress.--Not later than 18 
     months after the date on which the Task Force is established 
     under paragraph (1), the Task Force shall prepare and submit 
     to the Secretary, the Committee on Health, Education, Labor, 
     and Pensions of the Senate, and the Committee on Energy and 
     Commerce of the House of Representatives a report that 
     includes each of the following:
       (A) A plan to identify and address gaps in knowledge and 
     research regarding safe and effective therapies for pregnant 
     women and lactating women, including the development of such 
     therapies.
       (B) Ethical issues surrounding the inclusion of pregnant 
     women and lactating women in clinical research.
       (C) Effective communication strategies with health care 
     providers and the public on information relevant to pregnant 
     women and lactating women.
       (D) Identification of Federal activities, including--
       (i) the state of research on pregnancy and lactation;
       (ii) recommendations for the coordination of, and 
     collaboration on research related to pregnant women and 
     lactating women;
       (iii) dissemination of research findings and information 
     relevant to pregnant women and lactating women to providers 
     and the public; and
       (iv) existing Federal efforts and programs to improve the 
     scientific understanding of the health impacts on pregnant 
     women, lactating women, and related birth and pediatric 
     outcomes, including with respect to pharmacokinetics, 
     pharmacodynamics, and toxicities.
       (E) Recommendations to improve the development of safe and 
     effective therapies for pregnant women and lactating women.
       (b) Confidentiality.--Nothing in this section shall 
     authorize the Secretary of Health and Human Services to 
     disclose any information that is a trade secret, or other 
     privileged or confidential information, described in section 
     552(b)(4) of title 5, United States Code, or section 1905 of 
     title 18, United States Code.
       (c) Updating Protections for Pregnant Women and Lactating 
     Women in Research.--
       (1) In general.--Not later than 2 years after the date of 
     enactment of this Act, the Secretary, considering any 
     recommendations of the Task Force available at such time and 
     in consultation with the heads of relevant agencies of the 
     Department of Health and Human Services, shall, as 
     appropriate, update regulations and guidance, as applicable, 
     regarding the inclusion of pregnant women and lactating women 
     in clinical research.
       (2) Criteria for excluding pregnant or lactating women.--In 
     updating any regulations or guidance described in paragraph 
     (1), the Secretary shall consider any appropriate criteria to 
     be used by institutional review boards and individuals 
     reviewing grant proposals for excluding pregnant women or 
     lactating women as a study population requiring additional 
     protections from participating in human subject research.

     SEC. 2042. STREAMLINING NATIONAL INSTITUTES OF HEALTH 
                   REPORTING REQUIREMENTS.

       (a) Trans-National Institutes of Health Research 
     Reporting.--Section 402A(c)(2) of the Public Health Service 
     Act (42 U.S.C. 282a(c)(2)) is amended--
       (1) by amending subparagraph (B) to read as follows:
       ``(B) Reporting.--Not later than 2 years after the date of 
     enactment of 21st Century Cures Act, the head of each 
     national research institute or national center shall submit 
     to the Director of the National Institutes of Health a 
     report, to be included in the triennial report under section 
     403, on the amount made available by the institute or center 
     for conducting or supporting research that involves 
     collaboration between the institute or center and 1 or more 
     other national research institutes or national centers.''; 
     and
       (2) in subparagraphs (D) and (E) by striking ``(B)(i)'' 
     each place it appears and inserting ``(B)''.
       (b) Fraud and Abuse Reporting.--Section 403B of the Public 
     Health Service Act (42 U.S.C. 283a-1) is amended--
       (1) by striking subsection (b);
       (2) by redesignating subsection (c) as subsection (b); and
       (3) in subsection (b) (as so redesignated), by striking 
     ``subsections (a) and (b)'' and inserting ``subsection (a)''.
       (c) Doctoral Degrees Reporting.--Section 403C(a)(2) of the 
     Public Health Service Act (42 U.S.C. 283a-2(a)(2)) is amended 
     by striking ``(not including any leaves of absence)''.
       (d) Vaccine Reporting.--Section 404B of the Public Health 
     Service Act (42 U.S.C. 283d) is amended--
       (1) by striking subsection (b); and
       (2) by striking ``(a) Development of New Vaccines.--The 
     Secretary'' and inserting ``The Secretary''.
       (e) National Center for Advancing Translational Sciences.--
     Section 479(c) of the Public Health Service Act (42 U.S.C. 
     287(c)) is amended--
       (1) in the subsection heading, by striking ``Annual'' and 
     inserting ``Biennial''; and
       (2) in the matter preceding paragraph (1), by striking ``an 
     annual report'' and inserting ``a report on a biennial 
     basis''.
       (f) Review of Centers of Excellence.--
       (1) Repeal.--Section 404H of the Public Health Service Act 
     (42 U.S.C. 283j) is repealed.
       (2) Conforming amendment.--Section 399EE(c) of the Public 
     Health Service Act (42 U.S.C. 280-4(c)) is amended by 
     striking ``399CC, 404H,'' and inserting ``399CC''.
       (g) Rapid HIV Test Report.--Section 502(a) of the Ryan 
     White CARE Act Amendments of 2000 (42 U.S.C. 300cc note) is 
     amended--
       (1) by striking paragraph (2); and
       (2) by redesignating paragraph (3) as paragraph (2).
       (h) National Institute of Nursing Research.--
       (1) Repeal.--Section 464Y of the Public Health Service Act 
     (42 U.S.C. 285q-3) is repealed.
       (2) Conforming amendment.--Section 464X(g) of the Public 
     Health Service Act (42 U.S.C. 285q-2(g)) is amended by 
     striking ``biennial report made under section 464Y,'' and 
     inserting ``triennial report made under section 403''.

     SEC. 2043. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING 
                   ORGANISMS.

       Section 301 of the Public Health Service Act (42 U.S.C. 
     241), as amended by section 2035, is further amended--
       (1) in the flush matter at the end of subsection (a)--
       (A) by redesignating such matter as subsection (h)(1); and
       (B) by moving such matter so as to appear at the end of 
     such section; and
       (2) in subsection (h) (as so redesignated), by adding at 
     the end the following:
       ``(2) Where research substances and living organisms are 
     made available under paragraph (1) through contractors, the 
     Secretary may direct such contractors to collect payments on 
     behalf of the Secretary for the costs incurred to make 
     available such substances and organisms and to forward 
     amounts so collected to the Secretary, in the time and manner 
     specified by the Secretary.
       ``(3) Amounts collected under paragraph (2) shall be 
     credited to the appropriations accounts that incurred the 
     costs to make available the research substances and living 
     organisms involved, and shall remain available until expended 
     for carrying out activities under such accounts.''.

     SEC. 2044. SENSE OF CONGRESS ON INCREASED INCLUSION OF 
                   UNDERREPRESENTED POPULATIONS IN CLINICAL 
                   TRIALS.

       It is the sense of Congress that the National Institute on 
     Minority Health and Health Disparities should include within 
     its strategic plan under section 402(m) of the Public Health 
     Service Act (42 U.S.C. 282(m)) ways to increase 
     representation of underrepresented populations in clinical 
     trials.

 Subtitle E--Advancement of the National Institutes of Health Research 
                            and Data Access

     SEC. 2051. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE.

       Section 402(j)(2)(D) of the Public Health Service Act (42 
     U.S.C. 282(j)(2)(D)) is amended--
       (1) in clause (ii)(I), by inserting before the semicolon 
     ``, unless the responsible party affirmatively requests that 
     the Director of the National Institutes of Health publicly 
     post such clinical trial information for an applicable device 
     clinical trial prior to such date of clearance or approval''; 
     and
       (2) by adding at the end the following:
       ``(iii) Option to make certain clinical trial information 
     available earlier.--The Director of the National Institutes 
     of Health shall inform responsible parties of the option to 
     request that clinical trial information for an applicable 
     device clinical trial be publicly posted prior to the date of 
     clearance or approval, in accordance with clause (ii)(I).
       ``(iv) Combination products.--An applicable clinical trial 
     for a product that is a combination of drug, device, or 
     biological product shall be considered--

       ``(I) an applicable drug clinical trial, if the Secretary 
     determines under section 503(g) of the Federal Food, Drug, 
     and Cosmetic Act that the primary mode of action of such 
     product is that of a drug or biological product; or
       ``(II) an applicable device clinical trial, if the 
     Secretary determines under such section that the primary mode 
     of action of such product is that of a device.''.

     SEC. 2052. COMPLIANCE ACTIVITIES REPORTS.

       (a) Definitions.--In this section:
       (1) Applicable clinical trial.--The term ``applicable 
     clinical trial'' has the meaning given the term in section 
     402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
       (2) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.
       (b) Report on Activities To Encourage Compliance.--Not 
     later than 2 years after the date of enactment of this Act, 
     the Secretary, acting through the Director of the National 
     Institutes of Health and in collaboration with the 
     Commissioner of Food and Drugs, shall submit to the Committee 
     on Health, Education, Labor, and Pensions of the Senate and 
     the Committee on Energy and Commerce of the House of 
     Representatives, a report that describes education and 
     outreach, guidance, enforcement, and other activities 
     undertaken to encourage compliance with section 402(j) of the 
     Public Health Service Act (42 U.S.C. 282(j)).
       (c) Reports on Clinical Trials.--
       (1) In general.--Not later than 2 years after the final 
     compliance date under the final rule implementing section 
     402(j) of the Public Health Service Act, and every 2 years 
     thereafter for the next 4 years, the Secretary, acting 
     through the Director of the National Institutes of Health

[[Page H6910]]

     and in collaboration with the Commissioner of Food and Drugs, 
     shall submit to the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives, a report 
     describing--
       (A) the total number of applicable clinical trials with 
     complete data bank registration information registered during 
     the period for which the report is being prepared (broken 
     down by each year of such reporting period);
       (B) the total number of applicable clinical trials 
     registered during the period for which the report is being 
     prepared for which results have been submitted to the data 
     bank (broken down by each year of such reporting period);
       (C) the activities undertaken by the Secretary to educate 
     responsible persons about data bank registration and results 
     submission requirements, including through issuance of 
     guidance documents, informational meetings, and training 
     sessions; and
       (D) the activities described in the report submitted under 
     subsection (b).
       (2) Actions to enforce compliance.--After the Secretary has 
     undertaken the educational activities described in paragraph 
     (1)(C), the Secretary shall include in subsequent reports 
     submitted under paragraph (1) the number of actions taken by 
     the Secretary during the period for which the report is being 
     prepared to enforce compliance with data bank registration 
     and results submission requirements.

     SEC. 2053. UPDATES TO POLICIES TO IMPROVE DATA.

       Section 492B(c) of the Public Health Service Act (42 U.S.C. 
     289a-2(c)) is amended--
       (1) by striking ``In the case'' and inserting the 
     following:
       ``(1) In general.--In the case''; and
       (2) by adding at the end the following:
       ``(2) Reporting requirements.--For any new and competing 
     project of clinical research subject to the requirements 
     under this section that receives a grant award 1 year after 
     the date of enactment of the 21st Century Cures Act, or any 
     date thereafter, for which a valid analysis is provided under 
     paragraph (1)--
       ``(A) and which is an applicable clinical trial as defined 
     in section 402(j), the entity conducting such clinical 
     research shall submit the results of such valid analysis to 
     the clinical trial registry data bank expanded under section 
     402(j)(3), and the Director of the National Institutes of 
     Health shall, as appropriate, consider whether such entity 
     has complied with the reporting requirement described in this 
     subparagraph in awarding any future grant to such entity, 
     including pursuant to section 402(j)(5)(A)(ii) when 
     applicable; and
       ``(B) the Director of the National Institutes of Health 
     shall encourage the reporting of the results of such valid 
     analysis described in paragraph (1) through any additional 
     means determined appropriate by the Director.''.

     SEC. 2054. CONSULTATION.

       Not later than 90 days after the date of enactment of this 
     Act, the Secretary of Health and Human Services shall consult 
     with relevant Federal agencies, including the Food and Drug 
     Administration, the Office of the National Coordinator for 
     Health Information Technology, and the National Institutes of 
     Health, as well as other stakeholders (including patients, 
     researchers, physicians, industry representatives, and 
     developers of health information technology) to receive 
     recommendations with respect to enhancements to the clinical 
     trial registry data bank under section 402(j) of the Public 
     Health Service Act (42 U.S.C. 282(j)), including with respect 
     to usability, functionality, and search capability.

            Subtitle F--Facilitating Collaborative Research

     SEC. 2061. NATIONAL NEUROLOGICAL CONDITIONS SURVEILLANCE 
                   SYSTEM.

       Part P of title III of the Public Health Service Act (42 
     U.S.C. 280g et seq.) is amended by inserting after section 
     399S the following:

     ``SEC. 399S-1. SURVEILLANCE OF NEUROLOGICAL DISEASES.

       ``(a) In General.--The Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention 
     and in coordination with other agencies as the Secretary 
     determines, shall, as appropriate--
       ``(1) enhance and expand infrastructure and activities to 
     track the epidemiology of neurological diseases; and
       ``(2) incorporate information obtained through such 
     activities into an integrated surveillance system, which may 
     consist of or include a registry, to be known as the National 
     Neurological Conditions Surveillance System.
       ``(b) Research.--The Secretary shall ensure that the 
     National Neurological Conditions Surveillance System is 
     designed in a manner that facilitates further research on 
     neurological diseases.
       ``(c) Content.--In carrying out subsection (a), the 
     Secretary--
       ``(1) shall provide for the collection and storage of 
     information on the incidence and prevalence of neurological 
     diseases in the United States;
       ``(2) to the extent practicable, shall provide for the 
     collection and storage of other available information on 
     neurological diseases, including information related to 
     persons living with neurological diseases who choose to 
     participate, such as--
       ``(A) demographics, such as age, race, ethnicity, sex, 
     geographic location, family history, and other information, 
     as appropriate;
       ``(B) risk factors that may be associated with neurological 
     diseases, such as genetic and environmental risk factors and 
     other information, as appropriate; and
       ``(C) diagnosis and progression markers;
       ``(3) may provide for the collection and storage of 
     information relevant to analysis on neurological diseases, 
     such as information concerning--
       ``(A) the natural history of the diseases;
       ``(B) the prevention of the diseases;
       ``(C) the detection, management, and treatment approaches 
     for the diseases; and
       ``(D) the development of outcomes measures;
       ``(4) may address issues identified during the consultation 
     process under subsection (d); and
       ``(5) initially may address a limited number of 
     neurological diseases.
       ``(d) Consultation.--In carrying out this section, the 
     Secretary shall consult with individuals with appropriate 
     expertise, which may include--
       ``(1) epidemiologists with experience in disease 
     surveillance or registries;
       ``(2) representatives of national voluntary health 
     associations that--
       ``(A) focus on neurological diseases; and
       ``(B) have demonstrated experience in research, care, or 
     patient services;
       ``(3) health information technology experts or other 
     information management specialists;
       ``(4) clinicians with expertise in neurological diseases; 
     and
       ``(5) research scientists with experience conducting 
     translational research or utilizing surveillance systems for 
     scientific research purposes.
       ``(e) Grants.--The Secretary may award grants to, or enter 
     into contracts or cooperative agreements with, public or 
     private nonprofit entities to carry out activities under this 
     section.
       ``(f) Coordination With Other Federal, State, and Local 
     Agencies.--Subject to subsection (h), the Secretary shall--
       ``(1) make information and analysis in the National 
     Neurological Conditions Surveillance System available, as 
     appropriate--
       ``(A) to Federal departments and agencies, such as the 
     National Institutes of Health and the Department of Veterans 
     Affairs; and
       ``(B) to State and local agencies; and
       ``(2) identify, build upon, leverage, and coordinate among 
     existing data and surveillance systems, surveys, registries, 
     and other Federal public health infrastructure, wherever 
     practicable.
       ``(g) Public Access.--Subject to subsection (h), the 
     Secretary shall ensure that information and analysis in the 
     National Neurological Conditions Surveillance System are 
     available, as appropriate, to the public, including 
     researchers.
       ``(h) Privacy.--The Secretary shall ensure that information 
     and analysis in the National Neurological Conditions 
     Surveillance System are made available only to the extent 
     permitted by applicable Federal and State law, and in a 
     manner that protects personal privacy, to the extent required 
     by applicable Federal and State privacy law, at a minimum.
       ``(i) Reports.--
       ``(1) Report on information and analyses.--Not later than 1 
     year after the date on which any system is established under 
     this section, the Secretary shall submit an interim report to 
     the Committee on Health, Education, Labor, and Pensions of 
     the Senate and the Committee on Energy and Commerce of the 
     House of Representatives regarding aggregate information 
     collected pursuant to this section and epidemiological 
     analyses, as appropriate. Such report shall be posted on the 
     Internet website of the Department of Health and Human 
     Services and shall be updated biennially.
       ``(2) Implementation report.--Not later than 4 years after 
     the date of the enactment of this section, the Secretary 
     shall submit a report to the Congress concerning the 
     implementation of this section. Such report shall include 
     information on--
       ``(A) the development and maintenance of the National 
     Neurological Conditions Surveillance System;
       ``(B) the type of information collected and stored in the 
     surveillance system;
       ``(C) the use and availability of such information, 
     including guidelines for such use; and
       ``(D) the use and coordination of databases that collect or 
     maintain information on neurological diseases.
       ``(j) Definition.--In this section, the term `national 
     voluntary health association' means a national nonprofit 
     organization with chapters, other affiliated organizations, 
     or networks in States throughout the United States with 
     experience serving the population of individuals with 
     neurological disease and have demonstrated experience in 
     neurological disease research, care, and patient services.
       ``(k) Authorization of Appropriations.--To carry out this 
     section, there is authorized to be appropriated $5,000,000 
     for each of fiscal years 2018 through 2022.''.

     SEC. 2062. TICK-BORNE DISEASES.

       (a) In General.--The Secretary of Health and Human Services 
     (referred to in this section as ``the Secretary'') shall 
     continue to conduct or support epidemiological, basic, 
     translational, and clinical research related to vector-borne 
     diseases, including tick-borne diseases.
       (b) Reports.--The Secretary shall ensure that each 
     triennial report under section 403 of the Public Health 
     Service Act (42 U.S.C. 283) (as amended by section 2032) 
     includes information on actions undertaken by the National 
     Institutes of Health to carry out subsection (a) with respect 
     to tick-borne diseases.
       (c) Tick-borne Diseases Working Group.--
       (1) Establishment.--The Secretary shall establish a working 
     group, to be known as the Tick-Borne Disease Working Group 
     (referred to in this section as the ``Working Group''), 
     comprised of representatives of appropriate Federal agencies 
     and other non-Federal entities, to provide expertise and to 
     review all efforts within the Department of Health and Human 
     Services related to all tick-borne diseases, to help ensure 
     interagency coordination and minimize overlap, and to examine 
     research priorities.
       (2) Responsibilities.--The working group shall--

[[Page H6911]]

       (A) not later than 2 years after the date of enactment of 
     this Act, develop or update a summary of--
       (i) ongoing tick-borne disease research, including research 
     related to causes, prevention, treatment, surveillance, 
     diagnosis, diagnostics, duration of illness, and intervention 
     for individuals with tick-borne diseases;
       (ii) advances made pursuant to such research;
       (iii) Federal activities related to tick-borne diseases, 
     including--

       (I) epidemiological activities related to tick-borne 
     diseases; and
       (II) basic, clinical, and translational tick-borne disease 
     research related to the pathogenesis, prevention, diagnosis, 
     and treatment of tick-borne diseases;

       (iv) gaps in tick-borne disease research described in 
     clause (iii)(II);
       (v) the Working Group's meetings required under paragraph 
     (4); and
       (vi) the comments received by the Working Group;
       (B) make recommendations to the Secretary regarding any 
     appropriate changes or improvements to such activities and 
     research; and
       (C) solicit input from States, localities, and 
     nongovernmental entities, including organizations 
     representing patients, health care providers, researchers, 
     and industry regarding scientific advances, research 
     questions, surveillance activities, and emerging strains in 
     species of pathogenic organisms.
       (3) Membership.--The members of the working group shall 
     represent a diversity of scientific disciplines and views and 
     shall be composed of the following members:
       (A) Federal members.--Seven Federal members, consisting of 
     one of more representatives of each of the following:
       (i) The Office of the Assistant Secretary for Health.
       (ii) The Food and Drug Administration.
       (iii) The Centers for Disease Control and Prevention.
       (iv) The National Institutes of Health.
       (v) Such other agencies and offices of the Department of 
     Health and Human Services as the Secretary determines 
     appropriate.
       (B) Non-Federal public members.--Seven non-Federal public 
     members, consisting of representatives of the following 
     categories:
       (i) Physicians and other medical providers with experience 
     in diagnosing and treating tick-borne diseases.
       (ii) Scientists or researchers with expertise.
       (iii) Patients and their family members.
       (iv) Nonprofit organizations that advocate for patients 
     with respect to tick-borne diseases.
       (v) Other individuals whose expertise is determined by the 
     Secretary to be beneficial to the functioning of the Working 
     Group.
       (4) Meetings.--The Working Group shall meet not less than 
     twice each year.
       (5) Reporting.--Not later than 2 years after the date of 
     enactment of this Act, and every 2 years thereafter until 
     termination of the Working Group pursuant to paragraph (7), 
     the Working Group shall--
       (A) submit a report on its activities under paragraph 
     (2)(A) and any recommendations under paragraph (2)(B) to the 
     Secretary, the Committee on Energy and Commerce of the House 
     of Representatives, and the Committee on Health, Education, 
     Labor, and Pensions of the Senate; and
       (B) make such report publicly available on the Internet 
     website of the Department of Health and Human Services.
       (6) Applicability of faca.--The Working Group shall be 
     treated as an advisory committee subject to the Federal 
     Advisory Committee Act (5 U.S.C. App.).
       (7) Sunset.--The Working Group under this section shall 
     terminate 6 years after the date of enactment of this Act.

     SEC. 2063. ACCESSING, SHARING, AND USING HEALTH DATA FOR 
                   RESEARCH PURPOSES.

       (a) Guidance Related to Remote Access.--Not later than 1 
     year after the date of enactment of this Act, the Secretary 
     of Health and Human Services (referred to in this section as 
     the ``Secretary'') shall issue guidance clarifying that 
     subparagraph (B) of section 164.512(i)(1)(ii) of part 164 of 
     the Rule (prohibiting the removal of protected health 
     information by a researcher) does not prohibit remote access 
     to health information by a researcher for such purposes as 
     described in section 164.512(i)(1)(ii) of part 164 of the 
     Rule so long as--
       (1) at a minimum, security and privacy safeguards, 
     consistent with the requirements of the Rule, are maintained 
     by the covered entity and the researcher; and
       (2) the protected health information is not copied or 
     otherwise retained by the researcher.
       (b) Guidance Related to Streamlining Authorization.--Not 
     later than 1 year after the date of enactment of this Act, 
     the Secretary shall issue guidance on the following:
       (1) Authorization for use and disclosure of health 
     information.--Clarification of the circumstances under which 
     the authorization for the use or disclosure of protected 
     health information, with respect to an individual, for future 
     research purposes contains a sufficient description of the 
     purpose of the use or disclosure, such as if the 
     authorization--
       (A) sufficiently describes the purposes such that it would 
     be reasonable for the individual to expect that the protected 
     health information could be used or disclosed for such future 
     research;
       (B) either--
       (i) states that the authorization will expire on a 
     particular date or on the occurrence of a particular event; 
     or
       (ii) states that the authorization will remain valid unless 
     and until it is revoked by the individual; and
       (C) provides instruction to the individual on how to revoke 
     such authorization at any time.
       (2) Reminder of the right to revoke.--Clarification of the 
     circumstances under which it is appropriate to provide an 
     individual with an annual notice or reminder that the 
     individual has the right to revoke such authorization.
       (3) Revocation of authorization.--Clarification of 
     appropriate mechanisms by which an individual may revoke an 
     authorization for future research purposes, such as described 
     in paragraph (1)(C).
       (c) Working Group on Protected Health Information for 
     Research.--
       (1) Establishment.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary shall convene a working 
     group to study and report on the uses and disclosures of 
     protected health information for research purposes, under the 
     Health Insurance Portability and Accountability Act of 1996 
     (Public Law 104-191).
       (2) Members.--The working group shall include 
     representatives of--
       (A) relevant Federal agencies, including the National 
     Institutes of Health, the Centers for Disease Control and 
     Prevention, the Food and Drug Administration, and the Office 
     for Civil Rights;
       (B) the research community;
       (C) patients;
       (D) experts in civil rights, such as privacy rights;
       (E) developers of health information technology;
       (F) experts in data privacy and security;
       (G) health care providers;
       (H) bioethicists; and
       (I) other experts and entities, as the Secretary determines 
     appropriate.
       (3) Report.--Not later than 1 year after the date on which 
     the working group is convened under paragraph (1), the 
     working group shall conduct a review and submit a report to 
     the Secretary containing recommendations on whether the uses 
     and disclosures of protected health information for research 
     purposes should be modified to allow protected health 
     information to be available, as appropriate, for research 
     purposes, including studies to obtain generalizable 
     knowledge, while protecting individuals' privacy rights. In 
     conducting the review and making recommendations, the working 
     group shall--
       (A) address, at a minimum--
       (i) the appropriate manner and timing of authorization, 
     including whether additional notification to the individual 
     should be required when the individual's protected health 
     information will be used or disclosed for such research;
       (ii) opportunities for individuals to set preferences on 
     the manner in which their protected health information is 
     used in research;
       (iii) opportunities for patients to revoke authorization;
       (iv) notification to individuals of a breach in privacy;
       (v) existing gaps in statute, regulation, or policy related 
     to protecting the privacy of individuals, and
       (vi) existing barriers to research related to the current 
     restrictions on the uses and disclosures of protected health 
     information; and
       (B) consider, at a minimum--
       (i) expectations and preferences on how an individual's 
     protected health information is shared and used;
       (ii) issues related to specific subgroups of people, such 
     as children, incarcerated individuals, and individuals with a 
     cognitive or intellectual disability impacting capacity to 
     consent;
       (iii) relevant Federal and State laws;
       (iv) models of facilitating data access and levels of data 
     access, including data segmentation, where applicable;
       (v) potential impacts of disclosure and non-disclosure of 
     protected health information on access to health care 
     services; and
       (vi) the potential uses of such data.
       (4) Report submission.--The Secretary shall submit the 
     report under paragraph (3) to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives, and shall post such report on the 
     appropriate Internet website of the Department of Health and 
     Human Services.
       (5) Termination.--The working group convened under 
     paragraph (1) shall terminate the day after the report under 
     paragraph (3) is submitted to Congress and made public in 
     accordance with paragraph (4).
       (d) Definitions.--In this section:
       (1) The rule.--References to ``the Rule'' refer to part 160 
     or part 164, as appropriate, of title 45, Code of Federal 
     Regulations (or any successor regulation).
       (2) Part 164.--References to a specified section of ``part 
     164'', refer to such specified section of part 164 of title 
     45, Code of Federal Regulations (or any successor section).

                Subtitle G--Promoting Pediatric Research

     SEC. 2071. NATIONAL PEDIATRIC RESEARCH NETWORK.

       Section 409D(d) of the Public Health Service Act (42 U.S.C. 
     284h(d)) is amended--
       (1) in paragraph (1), by striking ``in consultation with 
     the Director of the Eunice Kennedy Shriver National Institute 
     of Child Health and Human Development and in collaboration 
     with other appropriate national research institutes and 
     national centers that carry out activities involving 
     pediatric research, may provide for the establishment of'' 
     and inserting ``in collaboration with the national research 
     institutes and national centers that carry out activities 
     involving pediatric research, shall support''; and
       (2) in paragraph (2)(A) and the first sentence of paragraph 
     (2)(E), by striking ``may'' each place such term appears and 
     inserting ``shall''.

     SEC. 2072. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK.

       It is the sense of Congress that--
       (1) the National Institutes of Health should encourage a 
     global pediatric clinical study network by providing grants, 
     contracts, or cooperative agreements to support new and early 
     stage

[[Page H6912]]

     investigators who participate in the global pediatric 
     clinical study network;
       (2) the Secretary of Health and Human Services (referred to 
     in this section as the ``Secretary'') should engage with 
     clinical investigators and appropriate authorities outside of 
     the United States, including authorities in the European 
     Union, during the formation of the global pediatric clinical 
     study network to encourage the participation of such 
     investigator and authorities; and
       (3) once a global pediatric clinical study network is 
     established and becomes operational, the Secretary should 
     continue to encourage and facilitate the participation of 
     clinical investigators and appropriate authorities outside of 
     the United States, including in the European Union, to 
     participate in the network with the goal of enhancing the 
     global reach of the network.

                         TITLE III--DEVELOPMENT

              Subtitle A--Patient-Focused Drug Development

     SEC. 3001. PATIENT EXPERIENCE DATA.

       Section 569C of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360bbb-8c) is amended--
       (1) in subsection (a)--
       (A) in the subsection heading, by striking ``In General'' 
     and inserting ``Patient Engagement in Drugs and Devices'';
       (B) by redesignating paragraphs (1) and (2) as 
     subparagraphs (A) and (B), respectively, and moving such 
     subparagraphs 2 ems to the right; and
       (C) by striking ``The Secretary'' and inserting the 
     following:
       ``(1) In general.--The Secretary'';
       (2) by redesignating subsections (b) through (e) as 
     paragraphs (2) through (5), respectively, and moving such 
     paragraphs 2 ems to the right; and
       (3) by adding at the end the following:
       ``(b) Statement of Patient Experience.--
       ``(1) In general.--Following the approval of an application 
     that was submitted under section 505(b) of this Act or 
     section 351(a) of the Public Health Service Act at least 180 
     days after the date of enactment of the 21st Century Cures 
     Act, the Secretary shall make public a brief statement 
     regarding the patient experience data and related 
     information, if any, submitted and reviewed as part of such 
     application.
       ``(2) Data and information.--The data and information 
     referred to in paragraph (1) are--
       ``(A) patient experience data;
       ``(B) information on patient-focused drug development 
     tools; and
       ``(C) other relevant information, as determined by the 
     Secretary.
       ``(c) Patient Experience Data.--For purposes of this 
     section, the term `patient experience data' includes data 
     that--
       ``(1) are collected by any persons (including patients, 
     family members and caregivers of patients, patient advocacy 
     organizations, disease research foundations, researchers, and 
     drug manufacturers); and
       ``(2) are intended to provide information about patients' 
     experiences with a disease or condition, including--
       ``(A) the impact of such disease or condition, or a related 
     therapy, on patients' lives; and
       ``(B) patient preferences with respect to treatment of such 
     disease or condition.''.

     SEC. 3002. PATIENT-FOCUSED DRUG DEVELOPMENT GUIDANCE.

       (a) Publication of Guidance Documents.--Not later than 180 
     days after the date of enactment of this Act, the Secretary 
     of Health and Human Services (referred to in this section as 
     the ``Secretary''), acting through the Commissioner of Food 
     and Drugs, shall develop a plan to issue draft and final 
     versions of one or more guidance documents, over a period of 
     5 years, regarding the collection of patient experience data, 
     and the use of such data and related information in drug 
     development. Not later than 18 months after the date of 
     enactment of this Act, the Secretary shall issue a draft 
     version of at least one such guidance document. Not later 
     than 18 months after the public comment period on the draft 
     guidance ends, the Secretary shall issue a revised draft 
     guidance or final guidance.
       (b) Patient Experience Data.--For purposes of this section, 
     the term ``patient experience data'' has the meaning given 
     such term in section 569C of the Federal Food, Drug, and 
     Cosmetic Act (as added by section 3001).
       (c) Contents.--The guidance documents described in 
     subsection (a) shall address--
       (1) methodological approaches that a person seeking to 
     collect patient experience data for submission to, and 
     proposed use by, the Secretary in regulatory decisionmaking 
     may use, that are relevant and objective and ensure that such 
     data are accurate and representative of the intended 
     population, including methods to collect meaningful patient 
     input throughout the drug development process and 
     methodological considerations for data collection, reporting, 
     management, and analysis;
       (2) methodological approaches that may be used to develop 
     and identify what is most important to patients with respect 
     to burden of disease, burden of treatment, and the benefits 
     and risks in the management of the patient's disease;
       (3) approaches to identifying and developing methods to 
     measure impacts to patients that will help facilitate 
     collection of patient experience data in clinical trials;
       (4) methodologies, standards, and technologies to collect 
     and analyze clinical outcome assessments for purposes of 
     regulatory decisionmaking;
       (5) how a person seeking to develop and submit proposed 
     draft guidance relating to patient experience data for 
     consideration by the Secretary may submit such proposed draft 
     guidance to the Secretary;
       (6) the format and content required for submissions under 
     this section to the Secretary, including with respect to the 
     information described in paragraph (1);
       (7) how the Secretary intends to respond to submissions of 
     information described in paragraph (1), if applicable, 
     including any timeframe for response when such submission is 
     not part of a regulatory application or other submission that 
     has an associated timeframe for response; and
       (8) how the Secretary, if appropriate, anticipates using 
     relevant patient experience data and related information, 
     including with respect to the structured risk-benefit 
     assessment framework described in section 505(d) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)), to 
     inform regulatory decisionmaking.

     SEC. 3003. STREAMLINING PATIENT INPUT.

       Chapter 35 of title 44, United States Code, shall not apply 
     to the collection of information to which a response is 
     voluntary, that is initiated by the Secretary under section 
     569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360bbb-8c) (as amended by section 3001) or section 3002.

     SEC. 3004. REPORT ON PATIENT EXPERIENCE DRUG DEVELOPMENT.

       Not later than June 1 of 2021, 2026, and 2031, the 
     Secretary of Health and Human Services, acting through the 
     Commissioner of Food and Drugs, shall prepare and publish on 
     the Internet website of the Food and Drug Administration a 
     report assessing the use of patient experience data in 
     regulatory decisionmaking, in particular with respect to the 
     review of patient experience data and information on patient-
     focused drug development tools as part of applications 
     approved under section 505(c) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(c)) or section 351(a) of the 
     Public Health Service Act (42 U.S.C. 262(a)).

                Subtitle B--Advancing New Drug Therapies

     SEC. 3011. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 506F the following new section:

     ``SEC. 507. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.

       ``(a) Process for Qualification.--
       ``(1) In general.--The Secretary shall establish a process 
     for the qualification of drug development tools for a 
     proposed context of use under which--
       ``(A)(i) a requestor initiates such process by submitting a 
     letter of intent to the Secretary; and
       ``(ii) the Secretary accepts or declines to accept such 
     letter of intent;
       ``(B)(i) if the Secretary accepts the letter of intent, a 
     requestor submits a qualification plan to the Secretary; and
       ``(ii) the Secretary accepts or declines to accept the 
     qualification plan; and
       ``(C)(i) if the Secretary accepts the qualification plan, 
     the requestor submits to the Secretary a full qualification 
     package;
       ``(ii) the Secretary determines whether to accept such 
     qualification package for review; and
       ``(iii) if the Secretary accepts such qualification package 
     for review, the Secretary conducts such review in accordance 
     with this section.
       ``(2) Acceptance and review of submissions.--
       ``(A) In general.--Subparagraphs (B), (C), and (D) shall 
     apply with respect to the treatment of a letter of intent, a 
     qualification plan, or a full qualification package submitted 
     under paragraph (1) (referred to in this paragraph as 
     `qualification submissions').
       ``(B) Acceptance factors; nonacceptance.--The Secretary 
     shall determine whether to accept a qualification submission 
     based on factors which may include the scientific merit of 
     the qualification submission. A determination not to accept a 
     submission under paragraph (1) shall not be construed as a 
     final determination by the Secretary under this section 
     regarding the qualification of a drug development tool for 
     its proposed context of use.
       ``(C) Prioritization of qualification review.--The 
     Secretary may prioritize the review of a full qualification 
     package submitted under paragraph (1) with respect to a drug 
     development tool, based on factors determined appropriate by 
     the Secretary, including--
       ``(i) as applicable, the severity, rarity, or prevalence of 
     the disease or condition targeted by the drug development 
     tool and the availability or lack of alternative treatments 
     for such disease or condition; and
       ``(ii) the identification, by the Secretary or by 
     biomedical research consortia and other expert stakeholders, 
     of such a drug development tool and its proposed context of 
     use as a public health priority.
       ``(D) Engagement of external experts.--The Secretary may, 
     for purposes of the review of qualification submissions, 
     through the use of cooperative agreements, grants, or other 
     appropriate mechanisms, consult with biomedical research 
     consortia and may consider the recommendations of such 
     consortia with respect to the review of any qualification 
     plan submitted under paragraph (1) or the review of any full 
     qualification package under paragraph (3).
       ``(3) Review of full qualification package.--The Secretary 
     shall--
       ``(A) conduct a comprehensive review of a full 
     qualification package accepted under paragraph (1)(C); and
       ``(B) determine whether the drug development tool at issue 
     is qualified for its proposed context of use.
       ``(4) Qualification.--The Secretary shall determine whether 
     a drug development tool is qualified for a proposed context 
     of use based on

[[Page H6913]]

     the scientific merit of a full qualification package reviewed 
     under paragraph (3).
       ``(b) Effect of Qualification.--
       ``(1) In general.--A drug development tool determined to be 
     qualified under subsection (a)(4) for a proposed context of 
     use specified by the requestor may be used by any person in 
     such context of use for the purposes described in paragraph 
     (2).
       ``(2) Use of a drug development tool.--Subject to paragraph 
     (3), a drug development tool qualified under this section may 
     be used for--
       ``(A) supporting or obtaining approval or licensure (as 
     applicable) of a drug or biological product (including in 
     accordance with section 506(c)) under section 505 of this Act 
     or section 351 of the Public Health Service Act; or
       ``(B) supporting the investigational use of a drug or 
     biological product under section 505(i) of this Act or 
     section 351(a)(3) of the Public Health Service Act.
       ``(3) Rescission or modification.--
       ``(A) In general.--The Secretary may rescind or modify a 
     determination under this section to qualify a drug 
     development tool if the Secretary determines that the drug 
     development tool is not appropriate for the proposed context 
     of use specified by the requestor. Such a determination may 
     be based on new information that calls into question the 
     basis for such qualification.
       ``(B) Meeting for review.--If the Secretary rescinds or 
     modifies under subparagraph (A) a determination to qualify a 
     drug development tool, the requestor involved shall, on 
     request, be granted a meeting with the Secretary to discuss 
     the basis of the Secretary's decision to rescind or modify 
     the determination before the effective date of the rescission 
     or modification.
       ``(c) Transparency.--
       ``(1) In general.--Subject to paragraph (3), the Secretary 
     shall make publicly available, and update on at least a 
     biannual basis, on the Internet website of the Food and Drug 
     Administration the following:
       ``(A) Information with respect to each qualification 
     submission under the qualification process under subsection 
     (a), including--
       ``(i) the stage of the review process applicable to the 
     submission;
       ``(ii) the date of the most recent change in stage status;
       ``(iii) whether external scientific experts were utilized 
     in the development of a qualification plan or the review of a 
     full qualification package; and
       ``(iv) submissions from requestors under the qualification 
     process under subsection (a), including any data and evidence 
     contained in such submissions, and any updates to such 
     submissions.
       ``(B) The Secretary's formal written determinations in 
     response to such qualification submissions.
       ``(C) Any rescissions or modifications under subsection 
     (b)(3) of a determination to qualify a drug development tool.
       ``(D) Summary reviews that document conclusions and 
     recommendations for determinations to qualify drug 
     development tools under subsection (a).
       ``(E) A comprehensive list of--
       ``(i) all drug development tools qualified under subsection 
     (a); and
       ``(ii) all surrogate endpoints which were the basis of 
     approval or licensure (as applicable) of a drug or biological 
     product (including in accordance with section 506(c)) under 
     section 505 of this Act or section 351 of the Public Health 
     Service Act.
       ``(2) Relation to trade secrets act.--Information made 
     publicly available by the Secretary under paragraph (1) shall 
     be considered a disclosure authorized by law for purposes of 
     section 1905 of title 18, United States Code.
       ``(3) Applicability.--Nothing in this section shall be 
     construed as authorizing the Secretary to disclose any 
     information contained in an application submitted under 
     section 505 of this Act or section 351 of the Public Health 
     Service Act that is confidential commercial or trade secret 
     information subject to section 552(b)(4) of title 5, United 
     States Code, or section 1905 of title 18, United States Code.
       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed--
       ``(1) to alter the standards of evidence under subsection 
     (c) or (d) of section 505, including the substantial evidence 
     standard in such subsection (d), or under section 351 of the 
     Public Health Service Act (as applicable); or
       ``(2) to limit the authority of the Secretary to approve or 
     license products under this Act or the Public Health Service 
     Act, as applicable (as in effect before the date of the 
     enactment of the 21st Century Cures Act).
       ``(e) Definitions.--In this section:
       ``(1) Biomarker.--The term `biomarker'--
       ``(A) means a characteristic (such as a physiologic, 
     pathologic, or anatomic characteristic or measurement) that 
     is objectively measured and evaluated as an indicator of 
     normal biologic processes, pathologic processes, or 
     biological responses to a therapeutic intervention; and
       ``(B) includes a surrogate endpoint.
       ``(2) Biomedical research consortia.--The term `biomedical 
     research consortia' means collaborative groups that may take 
     the form of public-private partnerships and may include 
     government agencies, institutions of higher education (as 
     defined in section 101(a) of the Higher Education Act of 
     1965), patient advocacy groups, industry representatives, 
     clinical and scientific experts, and other relevant entities 
     and individuals.
       ``(3) Clinical outcome assessment.--The term `clinical 
     outcome assessment' means--
       ``(A) a measurement of a patient's symptoms, overall mental 
     state, or the effects of a disease or condition on how the 
     patient functions; and
       ``(B) includes a patient-reported outcome.
       ``(4) Context of use.--The term `context of use' means, 
     with respect to a drug development tool, the circumstances 
     under which the drug development tool is to be used in drug 
     development and regulatory review.
       ``(5) Drug development tool.--The term `drug development 
     tool' includes--
       ``(A) a biomarker;
       ``(B) a clinical outcome assessment; and
       ``(C) any other method, material, or measure that the 
     Secretary determines aids drug development and regulatory 
     review for purposes of this section.
       ``(6) Patient-reported outcome.--The term `patient-reported 
     outcome' means a measurement based on a report from a patient 
     regarding the status of the patient's health condition 
     without amendment or interpretation of the patient's report 
     by a clinician or any other person.
       ``(7) Qualification.--The terms `qualification' and 
     `qualified' mean a determination by the Secretary that a drug 
     development tool and its proposed context of use can be 
     relied upon to have a specific interpretation and application 
     in drug development and regulatory review under this Act.
       ``(8) Requestor.--The term `requestor' means an entity or 
     entities, including a drug sponsor or a biomedical research 
     consortia, seeking to qualify a drug development tool for a 
     proposed context of use under this section.
       ``(9) Surrogate endpoint.--The term `surrogate endpoint' 
     means a marker, such as a laboratory measurement, 
     radiographic image, physical sign, or other measure, that is 
     not itself a direct measurement of clinical benefit, and--
       ``(A) is known to predict clinical benefit and could be 
     used to support traditional approval of a drug or biological 
     product; or
       ``(B) is reasonably likely to predict clinical benefit and 
     could be used to support the accelerated approval of a drug 
     or biological product in accordance with section 506(c).''.
       (b) Guidance.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall, in 
     consultation with biomedical research consortia (as defined 
     in subsection (e) of section 507 of the Federal Food, Drug, 
     and Cosmetic Act (as added by subsection (a)) and other 
     interested parties through a collaborative public process, 
     issue guidance to implement such section 507 that--
       (A) provides a conceptual framework describing appropriate 
     standards and scientific approaches to support the 
     development of biomarkers delineated under the taxonomy 
     established under paragraph (3);
       (B) with respect to the qualification process under such 
     section 507--
       (i) describes the requirements that entities seeking to 
     qualify a drug development tool under such section shall 
     observe when engaging in such process;
       (ii) outlines reasonable timeframes for the Secretary's 
     review of letters, qualification plans, or full qualification 
     packages submitted under such process; and
       (iii) establishes a process by which such entities or the 
     Secretary may consult with biomedical research consortia and 
     other individuals and entities with expert knowledge and 
     insights that may assist the Secretary in the review of 
     qualification plans and full qualification submissions under 
     such section; and
       (C) includes such other information as the Secretary 
     determines appropriate.
       (2) Timing.--Not later than 3 years after the date of the 
     enactment of this Act, the Secretary shall issue draft 
     guidance under paragraph (1) on the implementation of section 
     507 of the Federal Food, Drug, and Cosmetic Act (as added by 
     subsection (a)). The Secretary shall issue final guidance on 
     the implementation of such section not later than 6 months 
     after the date on which the comment period for the draft 
     guidance closes.
       (3) Taxonomy.--
       (A) In general.--For purposes of informing guidance under 
     this subsection, the Secretary shall, in consultation with 
     biomedical research consortia and other interested parties 
     through a collaborative public process, establish a taxonomy 
     for the classification of biomarkers (and related scientific 
     concepts) for use in drug development.
       (B) Public availability.--Not later than 2 years after the 
     date of the enactment of this Act, the Secretary shall make 
     such taxonomy publicly available in draft form for public 
     comment. The Secretary shall finalize the taxonomy not later 
     than 1 year after the close of the public comment period.
       (c) Meeting and Report.--
       (1) Meeting.--Not later than 2 years after the date of the 
     enactment of this Act, the Secretary shall convene a public 
     meeting to describe and solicit public input regarding the 
     qualification process under section 507 of the Federal Food, 
     Drug, and Cosmetic Act, as added by subsection (a).
       (2) Report.--Not later than 5 years after the date of the 
     enactment of this Act, the Secretary shall make publicly 
     available on the Internet website of the Food and Drug 
     Administration a report. Such report shall include, with 
     respect to the qualification process under section 507 of the 
     Federal Food, Drug, and Cosmetic Act, as added by subsection 
     (a), information on--
       (A) the number of requests submitted, as a letter of 
     intent, for qualification of a drug development tool (as 
     defined in subsection (e) of such section 507);
       (B) the number of such requests accepted and determined to 
     be eligible for submission of a qualification plan or full 
     qualification package (as such terms are defined in 
     subsection (e) of such section 507), respectively;
       (C) the number of such requests for which external 
     scientific experts were utilized in the development of a 
     qualification plan or review of a full qualification package;
       (D) the number of qualification plans and full 
     qualification packages, respectively, submitted to the 
     Secretary; and

[[Page H6914]]

       (E) the drug development tools qualified through such 
     qualification process, specified by type of tool, such as a 
     biomarker or clinical outcome assessment (as such terms are 
     defined in subsection (e) of such section 507).

     SEC. 3012. TARGETED DRUGS FOR RARE DISEASES.

       Subchapter B of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360aa et seq.) is amended by 
     inserting after section 529 the following:

     ``SEC. 529A. TARGETED DRUGS FOR RARE DISEASES.

       ``(a) Purpose.--The purpose of this section, through the 
     approach provided for in subsection (b), is to--
       ``(1) facilitate the development, review, and approval of 
     genetically targeted drugs and variant protein targeted drugs 
     to address an unmet medical need in one or more patient 
     subgroups, including subgroups of patients with different 
     mutations of a gene, with respect to rare diseases or 
     conditions that are serious or life-threatening; and
       ``(2) maximize the use of scientific tools or methods, 
     including surrogate endpoints and other biomarkers, for such 
     purposes.
       ``(b) Leveraging of Data From Previously Approved Drug 
     Application or Applications.--The Secretary may, consistent 
     with applicable standards for approval under this Act or 
     section 351(a) of the Public Health Service Act, allow the 
     sponsor of an application under section 505(b)(1) of this Act 
     or section 351(a) of the Public Health Service Act for a 
     genetically targeted drug or a variant protein targeted drug 
     to rely upon data and information--
       ``(1) previously developed by the same sponsor (or another 
     sponsor that has provided the sponsor with a contractual 
     right of reference to such data and information); and
       ``(2) submitted by a sponsor described in paragraph (1) in 
     support of one or more previously approved applications that 
     were submitted under section 505(b)(1) of this Act or section 
     351(a) of the Public Health Service Act,

     for a drug that incorporates or utilizes the same or similar 
     genetically targeted technology as the drug or drugs that are 
     the subject of an application or applications described in 
     paragraph (2) or for a variant protein targeted drug that is 
     the same or incorporates or utilizes the same variant protein 
     targeted drug, as the drug or drugs that are the subject of 
     an application or applications described in paragraph (2).
       ``(c) Definitions.--For purposes of this section--
       ``(1) the term `genetically targeted drug' means a drug 
     that--
       ``(A) is the subject of an application under section 
     505(b)(1) of this Act or section 351(a) of the Public Health 
     Service Act for the treatment of a rare disease or condition 
     (as such term is defined in section 526) that is serious or 
     life-threatening;
       ``(B) may result in the modulation (including suppression, 
     up-regulation, or activation) of the function of a gene or 
     its associated gene product; and
       ``(C) incorporates or utilizes a genetically targeted 
     technology;
       ``(2) the term `genetically targeted technology' means a 
     technology comprising non-replicating nucleic acid or 
     analogous compounds with a common or similar chemistry that 
     is intended to treat one or more patient subgroups, including 
     subgroups of patients with different mutations of a gene, 
     with the same disease or condition, including a disease or 
     condition due to other variants in the same gene; and
       ``(3) the term `variant protein targeted drug' means a drug 
     that--
       ``(A) is the subject of an application under section 
     505(b)(1) of this Act or section 351(a) of the Public Health 
     Service Act for the treatment of a rare disease or condition 
     (as such term is defined in section 526) that is serious or 
     life-threatening;
       ``(B) modulates the function of a product of a mutated gene 
     where such mutation is responsible in whole or in part for a 
     given disease or condition; and
       ``(C) is intended to treat one or more patient subgroups, 
     including subgroups of patients with different mutations of a 
     gene, with the same disease or condition.
       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed to--
       ``(1) alter the authority of the Secretary to approve drugs 
     pursuant to this Act or section 351 of the Public Health 
     Service Act (as authorized prior to the date of enactment of 
     the 21st Century Cures Act), including the standards of 
     evidence, and applicable conditions, for approval under such 
     applicable Act; or
       ``(2) confer any new rights, beyond those authorized under 
     this Act or the Public Health Service Act prior to enactment 
     of this section, with respect to the permissibility of a 
     sponsor referencing information contained in another 
     application submitted under section 505(b)(1) of this Act or 
     section 351(a) of the Public Health Service Act.''.

     SEC. 3013. REAUTHORIZATION OF PROGRAM TO ENCOURAGE TREATMENTS 
                   FOR RARE PEDIATRIC DISEASES.

       (a) In General.--Section 529(b) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking 
     paragraph (5) and inserting the following:
       ``(5) Termination of authority.--The Secretary may not 
     award any priority review vouchers under paragraph (1) after 
     September 30, 2020, unless the rare pediatric disease product 
     application--
       ``(A) is for a drug that, not later than September 30, 
     2020, is designated under subsection (d) as a drug for a rare 
     pediatric disease; and
       ``(B) is, not later than September 30, 2022, approved under 
     section 505(b)(1) of this Act or section 351(a) of the Public 
     Health Service Act.''.
       (b) Report.--The Advancing Hope Act of 2016 (Public Law 
     114-229) is amended by striking section 3.

     SEC. 3014. GAO STUDY OF PRIORITY REVIEW VOUCHER PROGRAMS.

       (a) Study.--The Comptroller General of the United States 
     (referred to in this section as the ``Comptroller General'') 
     shall conduct a study addressing the effectiveness and 
     overall impact of the following priority review voucher 
     programs, including any such programs amended or established 
     by this Act:
       (1) The neglected tropical disease priority review voucher 
     program under section 524 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360n).
       (2) The rare pediatric disease priority review voucher 
     program under section 529 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360ff).
       (3) The medical countermeasure priority review voucher 
     program under section 565A of the Federal Food, Drug, and 
     Cosmetic Act, as added by section 3086.
       (b) Issuance of Report.--Not later than January 31, 2020, 
     the Comptroller General shall submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report containing the results of the study 
     under subsection (a).
       (c) Contents of Reports.--The report submitted under 
     subsection (b) shall address--
       (1) for each drug for which a priority review voucher has 
     been awarded as of initiation of the study--
       (A) the indications for which the drug is approved under 
     section 505(c) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(c)), pursuant to an application under section 
     505(b)(1) of such Act, or licensed under section 351(a) of 
     the Public Health Service Act (42 U.S.C. 262(a));
       (B) whether, and to what extent, the voucher impacted the 
     sponsor's decision to develop the drug; and
       (C) whether, and to what extent, the approval or licensure 
     of the drug, as applicable and appropriate--
       (i) addressed a global unmet need related to the treatment 
     or prevention of a neglected tropical disease, including 
     whether the sponsor of a drug coordinated with international 
     development organizations;
       (ii) addressed an unmet need related to the treatment of a 
     rare pediatric disease; or
       (iii) affected the Nation's preparedness against a 
     chemical, biological, radiological, or nuclear threat, 
     including naturally occurring threats;
       (2) for each drug for which a priority review voucher has 
     been used--
       (A) the indications for which such drug is approved under 
     section 505(c) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(c)), pursuant to an application under section 
     505(b)(1) of such Act, or licensed under section 351(a) of 
     the Public Health Service Act (42 U.S.C. 262);
       (B) the value of the voucher, if transferred; and
       (C) the length of time between the date on which the 
     voucher was awarded and the date on which the voucher was 
     used; and
       (3) an analysis of the priority review voucher programs 
     described in subsection (a), including--
       (A) the resources used by the Food and Drug Administration 
     in reviewing drugs for which vouchers were used, including 
     the effect of the programs on the Food and Drug 
     Administration's review of drugs for which priority review 
     vouchers were not awarded or used;
       (B) whether any improvements to such programs are necessary 
     to appropriately target incentives for the development of 
     drugs that would likely not otherwise be developed, or 
     developed in as timely a manner, and, as applicable and 
     appropriate--
       (i) address global unmet needs related to the treatment or 
     prevention of neglected tropical diseases, including in 
     countries in which neglected tropical diseases are endemic; 
     or
       (ii) address unmet needs related to the treatment of rare 
     pediatric diseases; and
       (C) whether the sunset of the rare pediatric disease 
     program and medical countermeasure program has had an impact 
     on the program, including any potential unintended 
     consequences.
       (d) Protection of National Security.--The Comptroller 
     General shall conduct the study and issue reports under this 
     section in a manner that does not compromise national 
     security.

     SEC. 3015. AMENDMENTS TO THE ORPHAN DRUG GRANTS.

       Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is 
     amended--
       (1) in subsection (a), by striking paragraph (1) and 
     inserting the following: ``(1) defraying the costs of 
     developing drugs for rare diseases or conditions, including 
     qualified testing expenses,''; and
       (2) in subsection (b)(1)--
       (A) in subparagraph (A)(ii), by striking ``and'' after the 
     semicolon;
       (B) in subparagraph (B), by striking the period and 
     inserting ``; and''; and
       (C) by adding at the end the following:
       ``(C) prospectively planned and designed observational 
     studies and other analyses conducted to assist in the 
     understanding of the natural history of a rare disease or 
     condition and in the development of a therapy, including 
     studies and analyses to--
       ``(i) develop or validate a drug development tool related 
     to a rare disease or condition; or
       ``(ii) understand the full spectrum of the disease 
     manifestations, including describing genotypic and phenotypic 
     variability and identifying and defining distinct 
     subpopulations affected by a rare disease or condition.''.

[[Page H6915]]

  


     SEC. 3016. GRANTS FOR STUDYING CONTINUOUS DRUG MANUFACTURING.

       (a) In General.--The Secretary of Health and Human Services 
     may award grants to institutions of higher education and 
     nonprofit organizations for the purpose of studying and 
     recommending improvements to the process of continuous 
     manufacturing of drugs and biological products and similar 
     innovative monitoring and control techniques.
       (b) Definitions.--In this section--
       (1) the term ``drug'' has the meaning given such term in 
     section 201 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321);
       (2) the term ``biological product'' has the meaning given 
     such term in section 351(i) of the Public Health Service Act 
     (42 U.S.C. 262(i)); and
       (3) the term ``institution of higher education'' has the 
     meaning given such term in section 101(a) of the Higher 
     Education Act of 1965 (20 U.S.C. 1001(a)).

        Subtitle C--Modern Trial Design and Evidence Development

     SEC. 3021. NOVEL CLINICAL TRIAL DESIGNS.

       (a) Proposals for Use of Novel Clinical Trial Designs for 
     Drugs and Biological Products.--For purposes of assisting 
     sponsors in incorporating complex adaptive and other novel 
     trial designs into proposed clinical protocols and 
     applications for new drugs under section 505 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological 
     products under section 351 of the Public Health Service Act 
     (42 U.S.C. 262), the Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall 
     conduct a public meeting and issue guidance in accordance 
     with subsection (b).
       (b) Guidance Addressing Use of Novel Clinical Trial 
     Designs.--
       (1) In general.--The Secretary, acting through the 
     Commissioner of Food and Drugs, shall update or issue 
     guidance addressing the use of complex adaptive and other 
     novel trial design in the development and regulatory review 
     and approval or licensure for drugs and biological products.
       (2) Contents.--The guidance under paragraph (1) shall 
     address--
       (A) the use of complex adaptive and other novel trial 
     designs, including how such clinical trials proposed or 
     submitted help to satisfy the substantial evidence standard 
     under section 505(d) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(d));
       (B) how sponsors may obtain feedback from the Secretary on 
     technical issues related to modeling and simulations prior 
     to--
       (i) completion of such modeling or simulations; or
       (ii) the submission of resulting information to the 
     Secretary;
       (C) the types of quantitative and qualitative information 
     that should be submitted for review; and
       (D) recommended analysis methodologies.
       (3) Public meeting.--Prior to updating or issuing the 
     guidance required by paragraph (1), the Secretary shall 
     consult with stakeholders, including representatives of 
     regulated industry, academia, patient advocacy organizations, 
     consumer groups, and disease research foundations, through a 
     public meeting to be held not later than 18 months after the 
     date of enactment of this Act.
       (4) Timing.--The Secretary shall update or issue a draft 
     version of the guidance required by paragraph (1) not later 
     than 18 months after the date of the public meeting required 
     by paragraph (3) and finalize such guidance not later than 1 
     year after the date on which the public comment period for 
     the draft guidance closes.

     SEC. 3022. REAL WORLD EVIDENCE.

       Chapter V of the Federal Food, Drug, and Cosmetic Act is 
     amended by inserting after section 505E (21 U.S.C. 355f) the 
     following:

     ``SEC. 505F. UTILIZING REAL WORLD EVIDENCE.

       ``(a) In General.--The Secretary shall establish a program 
     to evaluate the potential use of real world evidence--
       ``(1) to help to support the approval of a new indication 
     for a drug approved under section 505(c); and
       ``(2) to help to support or satisfy postapproval study 
     requirements.
       ``(b) Real World Evidence Defined.--In this section, the 
     term `real world evidence' means data regarding the usage, or 
     the potential benefits or risks, of a drug derived from 
     sources other than randomized clinical trials.
       ``(c) Program Framework.--
       ``(1) In general.--Not later than 2 years after the date of 
     enactment of the 21st Century Cures Act, the Secretary shall 
     establish a draft framework for implementation of the program 
     under this section.
       ``(2) Contents of framework.--The framework shall include 
     information describing--
       ``(A) the sources of real world evidence, including ongoing 
     safety surveillance, observational studies, registries, 
     claims, and patient-centered outcomes research activities;
       ``(B) the gaps in data collection activities;
       ``(C) the standards and methodologies for collection and 
     analysis of real world evidence; and
       ``(D) the priority areas, remaining challenges, and 
     potential pilot opportunities that the program established 
     under this section will address.
       ``(3) Consultation.--
       ``(A) In general.--In developing the program framework 
     under this subsection, the Secretary shall consult with 
     regulated industry, academia, medical professional 
     organizations, representatives of patient advocacy 
     organizations, consumer organizations, disease research 
     foundations, and other interested parties.
       ``(B) Process.--The consultation under subparagraph (A) may 
     be carried out through approaches such as--
       ``(i) a public-private partnership with the entities 
     described in such subparagraph in which the Secretary may 
     participate;
       ``(ii) a contract, grant, or other arrangement, as the 
     Secretary determines appropriate, with such a partnership or 
     an independent research organization; or
       ``(iii) public workshops with the entities described in 
     such subparagraph.
       ``(d) Program Implementation.--The Secretary shall, not 
     later than 2 years after the date of enactment of the 21st 
     Century Cures Act and in accordance with the framework 
     established under subsection (c), implement the program to 
     evaluate the potential use of real world evidence.
       ``(e) Guidance for Industry.--The Secretary shall--
       ``(1) utilize the program established under subsection (a), 
     its activities, and any subsequent pilots or written reports, 
     to inform a guidance for industry on--
       ``(A) the circumstances under which sponsors of drugs and 
     the Secretary may rely on real world evidence for the 
     purposes described in paragraphs (1) and (2) of subsection 
     (a); and
       ``(B) the appropriate standards and methodologies for 
     collection and analysis of real world evidence submitted for 
     such purposes;
       ``(2) not later than 5 years after the date of enactment of 
     the 21st Century Cures Act, issue draft guidance for industry 
     as described in paragraph (1); and
       ``(3) not later than 18 months after the close of the 
     public comment period for the draft guidance described in 
     paragraph (2), issue revised draft guidance or final 
     guidance.
       ``(f) Rule of Construction.--
       ``(1) In general.--Subject to paragraph (2), nothing in 
     this section prohibits the Secretary from using real world 
     evidence for purposes not specified in this section, provided 
     the Secretary determines that sufficient basis exists for any 
     such nonspecified use.
       ``(2) Standards of evidence and secretary's authority.--
     This section shall not be construed to alter--
       ``(A) the standards of evidence under--
       ``(i) subsection (c) or (d) of section 505, including the 
     substantial evidence standard in such subsection (d); or
       ``(ii) section 351(a) of the Public Health Service Act; or
       ``(B) the Secretary's authority to require postapproval 
     studies or clinical trials, or the standards of evidence 
     under which studies or trials are evaluated.''.

     SEC. 3023. PROTECTION OF HUMAN RESEARCH SUBJECTS.

       (a) In General.--In order to simplify and facilitate 
     compliance by researchers with applicable regulations for the 
     protection of human subjects in research, the Secretary of 
     Health and Human Services (referred to in this section as the 
     ``Secretary'') shall, to the extent practicable and 
     consistent with other statutory provisions, harmonize 
     differences between the HHS Human Subject Regulations and the 
     FDA Human Subject Regulations in accordance with subsection 
     (b).
       (b) Avoiding Regulatory Duplication and Unnecessary 
     Delays.--The Secretary shall, as appropriate--
       (1) make such modifications to the provisions of the HHS 
     Human Subject Regulations, the FDA Human Subject Regulations, 
     and the vulnerable populations rules as may be necessary--
       (A) to reduce regulatory duplication and unnecessary 
     delays;
       (B) to modernize such provisions in the context of 
     multisite and cooperative research projects; and
       (C) to protect vulnerable populations, incorporate local 
     considerations, and support community engagement through 
     mechanisms such as consultation with local researchers and 
     human research protection programs, in a manner consistent 
     with subparagraph (B); and
       (2) ensure that human subject research that is subject to 
     the HHS Human Subject Regulations and to the FDA Human 
     Subject Regulations may--
       (A) use joint or shared review;
       (B) rely upon the review of--
       (i) an independent institutional review board; or
       (ii) an institutional review board of an entity other than 
     the sponsor of the research; or
       (C) use similar arrangements to avoid duplication of 
     effort.
       (c) Consultation.--In harmonizing or modifying regulations 
     or guidance under this section, the Secretary shall consult 
     with stakeholders (including researchers, academic 
     organizations, hospitals, institutional research boards, 
     pharmaceutical, biotechnology, and medical device developers, 
     clinical research organizations, patient groups, and others).
       (d) Timing.--The Secretary shall complete the harmonization 
     described in subsection (a) not later than 3 years after the 
     date of enactment of this Act.
       (e) Progress Report.--Not later than 2 years after the date 
     of enactment of this Act, the Secretary shall submit to 
     Congress a report on the progress made toward completing such 
     harmonization.
       (f) Definitions.--
       (1) Human subject regulations.--In this section:
       (A) FDA human subject regulations.--The term ``FDA Human 
     Subject Regulations'' means the provisions of parts 50, 56, 
     312, and 812 of title 21, Code of Federal Regulations (or any 
     successor regulations).
       (B) HHS human subject regulations.--The term ``HHS Human 
     Subject Regulations'' means the provisions of subpart A of 
     part 46 of title 45, Code of Federal Regulations (or any 
     successor regulations).
       (C) Vulnerable population rules.--The term ``vulnerable 
     population rules'' means--
       (i) except in the case of research described in clause 
     (ii), the provisions of subparts B through D of part 46, Code 
     of Federal Regulations (or any successor regulations); and

[[Page H6916]]

       (ii) in the case of research that is subject to FDA Human 
     Subject Regulations, the provisions applicable to vulnerable 
     populations under part 56 of title 21, Code of Federal 
     Regulations (or any successor regulations) and subpart D of 
     part 50 of such title 21 (or any successor regulations).
       (2) Institutional review board defined.--In this section, 
     the term ``institutional review board'' has the meaning that 
     applies to the term ``institutional review board'' under the 
     HHS Human Subject Regulations.
       (B) Lead institutional review board.--The term ``lead 
     institutional review board'' means an institutional review 
     board that otherwise meets the requirements of the HHS Human 
     Subject Regulations and enters into a written agreement with 
     an institution, another institutional review board, a 
     sponsor, or a principal investigator to approve and oversee 
     human subject research that is conducted at multiple 
     locations. References to an institutional review board 
     include an institutional review board that serves a single 
     institution and a lead institutional review board.

     SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL 
                   INVESTIGATIONS.

       (a) Devices.--Section 520(g)(3) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended--
       (1) in subparagraph (D), by striking ``except where subject 
     to such conditions as the Secretary may prescribe, the 
     investigator'' and inserting the following: ``except where, 
     subject to such conditions as the Secretary may prescribe--
       ``(i) the proposed clinical testing poses no more than 
     minimal risk to the human subject and includes appropriate 
     safeguards to protect the rights, safety, and welfare of the 
     human subject; or
       ``(ii) the investigator''; and
       (2) in the matter following subparagraph (D), by striking 
     ``subparagraph (D)'' and inserting ``subparagraph (D)(ii)''.
       (b) Drugs.--Section 505(i)(4) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking 
     ``except where it is not feasible or it is contrary to the 
     best interests of such human beings'' and inserting ``except 
     where it is not feasible, it is contrary to the best 
     interests of such human beings, or the proposed clinical 
     testing poses no more than minimal risk to such human beings 
     and includes appropriate safeguards as prescribed to protect 
     the rights, safety, and welfare of such human beings''.

        Subtitle D--Patient Access to Therapies and Information

     SEC. 3031. SUMMARY LEVEL REVIEW.

       (a) FFDCA.--Section 505(c) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(c)) is amended by adding at the 
     end the following:
       ``(5)(A) The Secretary may rely upon qualified data 
     summaries to support the approval of a supplemental 
     application, with respect to a qualified indication for a 
     drug, submitted under subsection (b), if such supplemental 
     application complies with subparagraph (B).
       ``(B) A supplemental application is eligible for review as 
     described in subparagraph (A) only if--
       ``(i) there is existing data available and acceptable to 
     the Secretary demonstrating the safety of the drug; and
       ``(ii) all data used to develop the qualified data 
     summaries are submitted to the Secretary as part of the 
     supplemental application.
       ``(C) The Secretary shall post on the Internet website of 
     the Food and Drug Administration and update annually--
       ``(i) the number of applications reviewed solely under 
     subparagraph (A) or section 351(a)(2)(E) of the Public Health 
     Service Act;
       ``(ii) the average time for completion of review under 
     subparagraph (A) or section 351(a)(2)(E) of the Public Health 
     Service Act;
       ``(iii) the average time for review of supplemental 
     applications where the Secretary did not use review 
     flexibility under subparagraph (A) or section 351(a)(2)(E) of 
     the Public Health Service Act; and
       ``(iv) the number of applications reviewed under 
     subparagraph (A) or section 351(a)(2)(E) of the Public Health 
     Service Act for which the Secretary made use of full data 
     sets in addition to the qualified data summary.
       ``(D) In this paragraph--
       ``(i) the term `qualified indication' means an indication 
     for a drug that the Secretary determines to be appropriate 
     for summary level review under this paragraph; and
       ``(ii) the term `qualified data summary' means a summary of 
     clinical data that demonstrates the safety and effectiveness 
     of a drug with respect to a qualified indication.''.
       (b) PHSA.--Section 351(a)(2) of the Public Health Service 
     Act (42 U.S.C. 262(a)(2)) is amended by adding at the end the 
     following:
       ``(E)(i) The Secretary may rely upon qualified data 
     summaries to support the approval of a supplemental 
     application, with respect to a qualified indication for a 
     drug, submitted under this subsection, if such supplemental 
     application complies with the requirements of subparagraph 
     (B) of section 505(c)(5) of the Federal Food, Drug, and 
     Cosmetic Act.
       ``(ii) In this subparagraph, the terms `qualified 
     indication' and `qualified data summary' have the meanings 
     given such terms in section 505(c)(5) of the Federal Food, 
     Drug, and Cosmetic Act.''.

     SEC. 3032. EXPANDED ACCESS POLICY.

       Chapter V of the Federal Food, Drug, and Cosmetic Act is 
     amended by inserting after section 561 (21 U.S.C. 360bbb) the 
     following:

     ``SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR 
                   INVESTIGATIONAL DRUGS.

       ``(a) In General.--The manufacturer or distributor of one 
     or more investigational drugs for the diagnosis, monitoring, 
     or treatment of one or more serious diseases or conditions 
     shall make available the policy of the manufacturer or 
     distributor on evaluating and responding to requests 
     submitted under section 561(b) for provision of such a drug.
       ``(b) Public Availability of Expanded Access Policy.--The 
     policies under subsection (a) shall be made public and 
     readily available, such as by posting such policies on a 
     publicly available Internet website. Such policies may be 
     generally applicable to all investigational drugs of such 
     manufacturer or distributor.
       ``(c) Content of Policy.--A policy described in subsection 
     (a) shall include--
       ``(1) contact information for the manufacturer or 
     distributor to facilitate communication about requests 
     described in subsection (a);
       ``(2) procedures for making such requests;
       ``(3) the general criteria the manufacturer or distributor 
     will use to evaluate such requests for individual patients, 
     and for responses to such requests;
       ``(4) the length of time the manufacturer or distributor 
     anticipates will be necessary to acknowledge receipt of such 
     requests; and
       ``(5) a hyperlink or other reference to the clinical trial 
     record containing information about the expanded access for 
     such drug that is required under section 
     402(j)(2)(A)(ii)(II)(gg) of the Public Health Service Act.
       ``(d) No Guarantee of Access.--The posting of policies by 
     manufacturers and distributors under subsection (a) shall not 
     serve as a guarantee of access to any specific 
     investigational drug by any individual patient.
       ``(e) Revised Policy.--Nothing in this section shall 
     prevent a manufacturer or distributor from revising a policy 
     required under this section at any time.
       ``(f) Application.--This section shall apply to a 
     manufacturer or distributor with respect to an 
     investigational drug beginning on the later of--
       ``(1) the date that is 60 calendar days after the date of 
     enactment of the 21st Century Cures Act; or
       ``(2) the first initiation of a phase 2 or phase 3 study 
     (as such terms are defined in section 312.21(b) and (c) of 
     title 21, Code of Federal Regulations (or any successor 
     regulations)) with respect to such investigational drug.''.

     SEC. 3033. ACCELERATED APPROVAL FOR REGENERATIVE ADVANCED 
                   THERAPIES.

       (a) In General.--Section 506 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 356) is amended--
       (1) by transferring subsection (e) (relating to 
     construction) so that it appears before subsection (f) 
     (relating to awareness efforts); and
       (2) by adding at the end the following:
       ``(g) Regenerative Advanced Therapy.--
       ``(1) In general.--The Secretary, at the request of the 
     sponsor of a drug, shall facilitate an efficient development 
     program for, and expedite review of, such drug if the drug 
     qualifies as a regenerative advanced therapy under the 
     criteria described in paragraph (2).
       ``(2) Criteria.--A drug is eligible for designation as a 
     regenerative advanced therapy under this subsection if--
       ``(A) the drug is a regenerative medicine therapy (as 
     defined in paragraph (8));
       ``(B) the drug is intended to treat, modify, reverse, or 
     cure a serious or life-threatening disease or condition; and
       ``(C) preliminary clinical evidence indicates that the drug 
     has the potential to address unmet medical needs for such a 
     disease or condition.
       ``(3) Request for designation.--The sponsor of a drug may 
     request the Secretary to designate the drug as a regenerative 
     advanced therapy concurrently with, or at any time after, 
     submission of an application for the investigation of the 
     drug under section 505(i) of this Act or section 351(a)(3) of 
     the Public Health Service Act.
       ``(4) Designation.--Not later than 60 calendar days after 
     the receipt of a request under paragraph (3), the Secretary 
     shall determine whether the drug that is the subject of the 
     request meets the criteria described in paragraph (2). If the 
     Secretary determines that the drug meets the criteria, the 
     Secretary shall designate the drug as a regenerative advanced 
     therapy and shall take such actions as are appropriate under 
     paragraph (1). If the Secretary determines that a drug does 
     not meet the criteria for such designation, the Secretary 
     shall include with the determination a written description of 
     the rationale for such determination.
       ``(5) Actions.--The sponsor of a regenerative advanced 
     therapy shall be eligible for the actions to expedite 
     development and review of such therapy under subsection 
     (a)(3)(B), including early interactions to discuss any 
     potential surrogate or intermediate endpoint to be used to 
     support the accelerated approval of an application for the 
     product under subsection (c).
       ``(6) Access to expedited approval pathways.--An 
     application for a regenerative advanced therapy under section 
     505(b)(1) of this Act or section 351(a) of the Public Health 
     Service Act may be--
       ``(A) eligible for priority review, as described in the 
     Manual of Policies and Procedures of the Food and Drug 
     Administration and goals identified in the letters described 
     in section 101(b) of the Prescription Drug User Fee 
     Amendments of 2012; and
       ``(B) eligible for accelerated approval under subsection 
     (c), as agreed upon pursuant to subsection (a)(3)(B), 
     through, as appropriate--
       ``(i) surrogate or intermediate endpoints reasonably likely 
     to predict long-term clinical benefit; or
       ``(ii) reliance upon data obtained from a meaningful number 
     of sites, including through expansion to additional sites, as 
     appropriate.
       ``(7) Postapproval requirements.--The sponsor of a 
     regenerative advanced therapy that is granted accelerated 
     approval and is subject to the postapproval requirements 
     under subsection

[[Page H6917]]

     (c) may, as appropriate, fulfill such requirements, as the 
     Secretary may require, through--
       ``(A) the submission of clinical evidence, clinical 
     studies, patient registries, or other sources of real world 
     evidence, such as electronic health records;
       ``(B) the collection of larger confirmatory data sets, as 
     agreed upon pursuant to subsection (a)(3)(B); or
       ``(C) postapproval monitoring of all patients treated with 
     such therapy prior to approval of the therapy.
       ``(8) Definition.--For purposes of this section, the term 
     `regenerative medicine therapy' includes cell therapy, 
     therapeutic tissue engineering products, human cell and 
     tissue products, and combination products using any such 
     therapies or products, except for those regulated solely 
     under section 361 of the Public Health Service Act and part 
     1271 of title 21, Code of Federal Regulations.''.
       (b) Rule of Construction.--Nothing in this section and the 
     amendments made by this section shall be construed to alter 
     the authority of the Secretary of Health and Human Services--
       (1) to approve drugs pursuant to the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 301 et seq.) and section 351 of 
     the Public Health Service Act (42 U.S.C. 262) as authorized 
     prior to the date of enactment of the 21st Century Cures Act, 
     including the standards of evidence, and applicable 
     conditions, for approval under such Acts; or
       (2) to alter the authority of the Secretary to require 
     postapproval studies pursuant to such Acts, as authorized 
     prior to the date of enactment of the 21st Century Cures Act.
       (c) Conforming Amendment.--Section 506(e)(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 356(e)(1)) is amended 
     by inserting ``and the 21st Century Cures Act'' after ``Food 
     and Drug Administration Safety and Innovation Act''.

     SEC. 3034. GUIDANCE REGARDING DEVICES USED IN THE RECOVERY, 
                   ISOLATION, OR DELIVERY OF REGENERATIVE ADVANCED 
                   THERAPIES.

       (a) Draft Guidance.--Not later than 1 year after the date 
     of enactment of the 21st Century Cures Act, the Secretary of 
     Health and Human Services, acting through the Commissioner of 
     Food and Drugs, shall issue draft guidance clarifying how, in 
     the context of regenerative advanced therapies, the Secretary 
     will evaluate devices used in the recovery, isolation, or 
     delivery of regenerative advanced therapies. In doing so, the 
     Secretary shall specifically address--
       (1) how the Food and Drug Administration intends to 
     simplify and streamline regulatory requirements for 
     combination device and cell or tissue products;
       (2) what, if any, intended uses or specific attributes 
     would result in a device used with a regenerative therapy 
     product to be classified as a class III device;
       (3) when the Food and Drug Administration considers it is 
     necessary, if ever, for the intended use of a device to be 
     limited to a specific intended use with only one particular 
     type of cell; and
       (4) application of the least burdensome approach to 
     demonstrate how a device may be used with more than one cell 
     type.
       (b) Final Guidance.--Not later than 12 months after the 
     close of the period for public comment on the draft guidance 
     under subsection (a), the Secretary of Health and Human 
     Services shall finalize such guidance.

     SEC. 3035. REPORT ON REGENERATIVE ADVANCED THERAPIES.

       (a) Report to Congress.--Before March 1 of each calendar 
     year, the Secretary of Health and Human Services shall, with 
     respect to the previous calendar year, submit a report to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives on--
       (1) the number and type of applications for approval of 
     regenerative advanced therapies filed, approved or licensed 
     as applicable, withdrawn, or denied; and
       (2) how many of such applications or therapies, as 
     applicable, were granted accelerated approval or priority 
     review.
       (b) Regenerative Advanced Therapy.--In this section, the 
     term ``regenerative advanced therapy'' has the meaning given 
     such term in section 506(g) of the Federal Food, Drug, and 
     Cosmetic Act, as added by section 3033 of this Act.

     SEC. 3036. STANDARDS FOR REGENERATIVE MEDICINE AND 
                   REGENERATIVE ADVANCED THERAPIES.

       Subchapter A of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 506F the following:

     ``SEC. 506G. STANDARDS FOR REGENERATIVE MEDICINE AND 
                   REGENERATIVE ADVANCED THERAPIES.

       ``(a) In General.--Not later than 2 years after the date of 
     enactment of the 21st Century Cures Act, the Secretary, in 
     consultation with the National Institute of Standards and 
     Technology and stakeholders (including regenerative medicine 
     and advanced therapies manufacturers and clinical trial 
     sponsors, contract manufacturers, academic institutions, 
     practicing clinicians, regenerative medicine and advanced 
     therapies industry organizations, and standard setting 
     organizations), shall facilitate an effort to coordinate and 
     prioritize the development of standards and consensus 
     definition of terms, through a public process, to support, 
     through regulatory predictability, the development, 
     evaluation, and review of regenerative medicine therapies and 
     regenerative advanced therapies, including with respect to 
     the manufacturing processes and controls of such products.
       ``(b) Activities.--
       ``(1) In general.--In carrying out this section, the 
     Secretary shall continue to--
       ``(A) identity opportunities to help advance the 
     development of regenerative medicine therapies and 
     regenerative advanced therapies;
       ``(B) identify opportunities for the development of 
     laboratory regulatory science research and documentary 
     standards that the Secretary determines would help support 
     the development, evaluation, and review of regenerative 
     medicine therapies and regenerative advanced therapies 
     through regulatory predictability; and
       ``(C) work with stakeholders, such as those described in 
     subsection (a), as appropriate, in the development of such 
     standards.
       ``(2) Regulations and guidance.--Not later than 1 year 
     after the development of standards as described in subsection 
     (a), the Secretary shall review relevant regulations and 
     guidance and, through a public process, update such 
     regulations and guidance as the Secretary determines 
     appropriate.
       ``(c) Definitions.--For purposes of this section, the terms 
     `regenerative medicine therapy' and `regenerative advanced 
     therapy' have the meanings given such terms in section 
     506(g).''.

     SEC. 3037. HEALTH CARE ECONOMIC INFORMATION.

       Section 502(a) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 352(a)) is amended--
       (1) by striking ``(a) If its'' and inserting ``(a)(1) If 
     its'';
       (2) by striking ``a formulary committee, or other similar 
     entity, in the course of the committee or the entity carrying 
     out its responsibilities for the selection of drugs for 
     managed care or other similar organizations'' and inserting 
     ``a payor, formulary committee, or other similar entity with 
     knowledge and expertise in the area of health care economic 
     analysis, carrying out its responsibilities for the selection 
     of drugs for coverage or reimbursement'';
       (3) by striking ``directly relates'' and inserting 
     ``relates'';
       (4) by striking ``and is based on competent and reliable 
     scientific evidence. The requirements set forth in section 
     505(a) or in section 351(a) of the Public Health Service Act 
     shall not apply to health care economic information provided 
     to such a committee or entity in accordance with this 
     paragraph'' and inserting ``, is based on competent and 
     reliable scientific evidence, and includes, where applicable, 
     a conspicuous and prominent statement describing any material 
     differences between the health care economic information and 
     the labeling approved for the drug under section 505 or under 
     section 351 of the Public Health Service Act. The 
     requirements set forth in section 505(a) or in subsections 
     (a) and (k) of section 351 of the Public Health Service Act 
     shall not apply to health care economic information provided 
     to such a payor, committee, or entity in accordance with this 
     paragraph''; and
       (5) by striking ``In this paragraph, the term'' and all 
     that follows and inserting the following:
       ``(2)(A) For purposes of this paragraph, the term `health 
     care economic information' means any analysis (including the 
     clinical data, inputs, clinical or other assumptions, 
     methods, results, and other components underlying or 
     comprising the analysis) that identifies, measures, or 
     describes the economic consequences, which may be based on 
     the separate or aggregated clinical consequences of the 
     represented health outcomes, of the use of a drug. Such 
     analysis may be comparative to the use of another drug, to 
     another health care intervention, or to no intervention.
       ``(B) Such term does not include any analysis that relates 
     only to an indication that is not approved under section 505 
     or under section 351 of the Public Health Service Act for 
     such drug.''.

     SEC. 3038. COMBINATION PRODUCT INNOVATION.

       (a) In General.--Section 503(g) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 353(g)) is amended--
       (1) by striking paragraph (3);
       (2) by redesignating paragraph (2) as paragraph (7);
       (3) by redesignating paragraphs (4) and (5) as paragraphs 
     (8) and (9), respectively;
       (4) by striking ``(g)(1)'' and all that follows through the 
     end of paragraph (1) and inserting the following:
       ``(g)(1)(A) The Secretary shall, in accordance with this 
     subsection, assign a primary agency center to regulate 
     products that constitute a combination of a drug, device, or 
     biological product.
       ``(B) The Secretary shall conduct the premarket review of 
     any combination product under a single application, whenever 
     appropriate.
       ``(C) For purposes of this subsection, the term `primary 
     mode of action' means the single mode of action of a 
     combination product expected to make the greatest 
     contribution to the overall intended therapeutic effects of 
     the combination product.
       ``(D) The Secretary shall determine the primary mode of 
     action of the combination product. If the Secretary 
     determines that the primary mode of action is that of--
       ``(i) a drug (other than a biological product), the agency 
     center charged with premarket review of drugs shall have 
     primary jurisdiction;
       ``(ii) a device, the agency center charged with premarket 
     review of devices shall have primary jurisdiction; or
       ``(iii) a biological product, the agency center charged 
     with premarket review of biological products shall have 
     primary jurisdiction.
       ``(E) In determining the primary mode of action of a 
     combination product, the Secretary shall not determine that 
     the primary mode of action is that of a drug or biological 
     product solely because the combination product has any 
     chemical action within or on the human body.
       ``(F) If a sponsor of a combination product disagrees with 
     the determination under subparagraph (D)--
       ``(i) such sponsor may request, and the Secretary shall 
     provide, a substantive rationale to

[[Page H6918]]

     such sponsor that references scientific evidence provided by 
     the sponsor and any other scientific evidence relied upon by 
     the Secretary to support such determination; and
       ``(ii)(I) the sponsor of the combination product may 
     propose one or more studies (which may be nonclinical, 
     clinical, or both) to establish the relevance, if any, of the 
     chemical action in achieving the primary mode of action of 
     such product;
       ``(II) if the sponsor proposes any such studies, the 
     Secretary and the sponsor of such product shall collaborate 
     and seek to reach agreement, within a reasonable time of such 
     proposal, not to exceed 90 calendar days, on the design of 
     such studies; and
       ``(III) if an agreement is reached under subclause (II) and 
     the sponsor conducts one or more of such studies, the 
     Secretary shall consider the data resulting from any such 
     study when reevaluating the determination of the primary mode 
     of action of such product, and unless and until such 
     reevaluation has occurred and the Secretary issues a new 
     determination, the determination of the Secretary under 
     subparagraph (D) shall remain in effect.
       ``(2)(A)(i) To establish clarity and certainty for the 
     sponsor, the sponsor of a combination product may request a 
     meeting on such combination product. If the Secretary 
     concludes that a determination of the primary mode of action 
     pursuant to paragraph (1)(D) is necessary, the sponsor may 
     request such meeting only after the Secretary makes such 
     determination. If the sponsor submits a written meeting 
     request, the Secretary shall, not later than 75 calendar days 
     after receiving such request, meet with the sponsor of such 
     combination product.
       ``(ii) A meeting under clause (i) may--
       ``(I) address the standards and requirements for market 
     approval or clearance of the combination product;
       ``(II) address other issues relevant to such combination 
     product, such as requirements related to postmarket 
     modification of such combination product and good 
     manufacturing practices applicable to such combination 
     product; and
       ``(III) identify elements under subclauses (I) and (II) 
     that may be more appropriate for discussion and agreement 
     with the Secretary at a later date given that scientific or 
     other information is not available, or agreement is otherwise 
     not feasible regarding such elements, at the time a request 
     for such meeting is made.
       ``(iii) Any agreement under this subparagraph shall be in 
     writing and made part of the administrative record by the 
     Secretary.
       ``(iv) Any such agreement shall remain in effect, except--
       ``(I) upon the written agreement of the Secretary and the 
     sponsor or applicant; or
       ``(II) pursuant to a decision by the director of the 
     reviewing division of the primary agency center, or a person 
     more senior than such director, in consultation with 
     consulting centers and the Office, as appropriate, that an 
     issue essential to determining whether the standard for 
     market clearance or other applicable standard under this Act 
     or the Public Health Service Act applicable to the 
     combination product has been identified since the agreement 
     was reached, or that deviating from the agreement is 
     otherwise justifiable based on scientific evidence, for 
     public health reasons.
       ``(3) For purposes of conducting the premarket review of a 
     combination product that contains an approved constituent 
     part described in paragraph (4), the Secretary may require 
     that the sponsor of such combination product submit to the 
     Secretary only data or information that the Secretary 
     determines is necessary to meet the standard for clearance or 
     approval, as applicable, under this Act or the Public Health 
     Service Act, including any incremental risks and benefits 
     posed by such combination product, using a risk-based 
     approach and taking into account any prior finding of safety 
     and effectiveness or substantial equivalence for the approved 
     constituent part relied upon by the applicant in accordance 
     with paragraph (5).
       ``(4) For purposes of paragraph (3), an approved 
     constituent part is--
       ``(A) a drug constituent part of a combination product 
     being reviewed in a single application or request under 
     section 515, 510(k), or 513(f)(2) (submitted in accordance 
     with paragraph (5)), that is an approved drug, provided such 
     application or request complies with paragraph (5);
       ``(B) a device constituent part approved under section 515 
     that is referenced by the sponsor and that is available for 
     use by the Secretary under section 520(h)(4); or
       ``(C) any constituent part that was previously approved, 
     cleared, or classified under section 505, 510(k), 513(f)(2), 
     or 515 of this Act for which the sponsor has a right of 
     reference or any constituent part that is a nonprescription 
     drug, as defined in section 760(a)(2).
       ``(5)(A) If an application is submitted under section 515 
     or 510(k) or a request is submitted under section 513(f)(2), 
     consistent with any determination made under paragraph 
     (1)(D), for a combination product containing as a constituent 
     part an approved drug--
       ``(i) the application or request shall include the 
     certification or statement described in section 505(b)(2); 
     and
       ``(ii) the applicant or requester shall provide notice as 
     described in section 505(b)(3).
       ``(B) For purposes of this paragraph and paragraph (4), the 
     term `approved drug' means an active ingredient--
       ``(i) that was in an application previously approved under 
     section 505(c);
       ``(ii) where such application is relied upon by the 
     applicant submitting the application or request described in 
     subparagraph (A);
       ``(iii) for which full reports of investigations that have 
     been made to show whether such drug is safe for use and 
     whether such drug is effective in use were not conducted by 
     or for the applicant submitting the application or request 
     described in subparagraph (A); and
       ``(iv) for which the applicant submitting the application 
     or request described in subparagraph (A) has not obtained a 
     right of reference or use from the person by or for whom the 
     investigations described in clause (iii) were conducted.
       ``(C) The following provisions shall apply with respect to 
     an application or request described in subparagraph (A) to 
     the same extent and in the same manner as if such application 
     or request were an application described in section 505(b)(2) 
     that referenced the approved drug:
       ``(i) Subparagraphs (A), (B), (C), and (D) of section 
     505(c)(3).
       ``(ii) Clauses (ii), (iii), and (iv) of section 
     505(c)(3)(E).
       ``(iii) Subsections (b) and (c) of section 505A.
       ``(iv) Section 505E(a).
       ``(v) Section 527(a).
       ``(D) Notwithstanding any other provision of this 
     subsection, an application or request for classification for 
     a combination product described in subparagraph (A) shall be 
     considered an application submitted under section 505(b)(2) 
     for purposes of section 271(e)(2)(A) of title 35, United 
     States Code.
       ``(6) Nothing in this subsection shall be construed as 
     prohibiting a sponsor from submitting separate applications 
     for the constituent parts of a combination product, unless 
     the Secretary determines that a single application is 
     necessary.'';
       (5) in paragraph (8) (as redesignated by paragraph (3))--
       (A) in subparagraph (C)--
       (i) by amending clause (i) to read as follows:
       ``(i) In carrying out this subsection, the Office shall 
     help to ensure timely and effective premarket review that 
     involves more than one agency center by coordinating such 
     reviews, overseeing the timeliness of such reviews, and 
     overseeing the alignment of feedback regarding such 
     reviews.'';
       (ii) in clause (ii), by inserting ``and alignment'' after 
     ``the timeliness'' each place it appears; and
       (iii) by adding at the end the following new clauses:
       ``(iii) The Office shall ensure that, with respect to a 
     combination product, a designated person or persons in the 
     primary agency center is the primary point or points of 
     contact for the sponsor of such combination product. The 
     Office shall also coordinate communications to and from any 
     consulting center involved in such premarket review, if 
     requested by such primary agency center or any such 
     consulting center. Agency communications and commitments, to 
     the extent consistent with other provisions of law and the 
     requirements of all affected agency centers, from the primary 
     agency center shall be considered as communication from the 
     Secretary on behalf of all agency centers involved in the 
     review.
       ``(iv) The Office shall, with respect to the premarket 
     review of a combination product--
       ``(I) ensure that any meeting between the Secretary and the 
     sponsor of such product is attended by each agency center 
     involved in the review, as appropriate;
       ``(II) ensure that each consulting agency center has 
     completed its premarket review and provided the results of 
     such review to the primary agency center in a timely manner; 
     and
       ``(III) ensure that each consulting center follows the 
     guidance described in clause (vi) and advises, as 
     appropriate, on other relevant regulations, guidances, and 
     policies.
       ``(v) In seeking agency action with respect to a 
     combination product, the sponsor of such product--
       ``(I) shall identify the product as a combination product; 
     and
       ``(II) may request in writing the participation of 
     representatives of the Office in meetings related to such 
     combination product, or to have the Office otherwise engage 
     on such regulatory matters concerning the combination 
     product.
       ``(vi) Not later than 4 years after the date of enactment 
     of the 21st Century Cures Act, and after a public comment 
     period of not less than 60 calendar days, the Secretary shall 
     issue a final guidance that describes--
       ``(I) the structured process for managing pre-submission 
     interactions with sponsors developing combination products;
       ``(II) the best practices for ensuring that the feedback in 
     such pre-submission interactions represents the Agency's best 
     advice based on the information provided during such pre-
     submission interactions;
       ``(III) the information that is required to be submitted 
     with a meeting request under paragraph (2), how such meetings 
     relate to other types of meetings in the Food and Drug 
     Administration, and the form and content of any agreement 
     reached through a meeting under such paragraph (2);''; and
       (B) in subparagraph (G)--
       (i) in the matter preceding clause (i), by inserting 
     ``(except with respect to clause (iv), beginning not later 
     than one year after the date of the enactment of the 21st 
     Century Cures Act)'' after ``enactment of this paragraph'';
       (ii) in clause (ii), by striking ``and'' at the end;
       (iii) in clause (iii), by striking the period at the end 
     and inserting ``; and''; and
       (iv) by adding at the end the following new clause:
       ``(iv) identifying the percentage of combination products 
     for which a dispute resolution, with respect to premarket 
     review, was requested by the combination product's 
     sponsor.''; and
       (6) in paragraph (9) (as redesignated by paragraph (3))--
       (A) in subparagraph (C)--
       (i) in clause (i), by striking the comma at the end and 
     inserting a semicolon;
       (ii) in clause (ii), by striking ``, and'' at the end and 
     inserting a semicolon;

[[Page H6919]]

       (iii) in clause (iii), by striking the period at the end 
     and inserting ``; and''; and
       (iv) by adding at the end the following:
       ``(iv) de novo classification under section 513(a)(1).''; 
     and
       (B) by adding at the end the following:
       ``(D) The terms `premarket review' and `reviews' include 
     all activities of the Food and Drug Administration conducted 
     prior to approval or clearance of an application, 
     notification, or request for classification submitted under 
     section 505, 510(k), 513(f)(2), 515, or 520 of this Act or 
     under section 351 of the Public Health Service Act, including 
     with respect to investigational use of the product.''.
       (b) Information for Approval of Combination Products.--
     Section 520(h)(4) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360j(h)(4)) is amended--
       (1) in subparagraph (A), by striking ``Any information'' 
     and inserting ``Subject to subparagraph (C), any 
     information''; and
       (2) by adding at the end the following new subparagraph:
       ``(C) No information contained in an application for 
     premarket approval filed with the Secretary pursuant to 
     section 515(c) may be used to approve or clear any 
     application submitted under section 515 or 510(k) or to 
     classify a product under section 513(f)(2) for a combination 
     product containing as a constituent part an approved drug (as 
     defined in section 503(g)(5)(B)) unless--
       ``(i) the application includes the certification or 
     statement referenced in section 503(g)(5)(A);
       ``(ii) the applicant provides notice as described in 
     section 503(g)(5)(A); and
       ``(iii) the Secretary's approval of such application is 
     subject to the provisions in section 503(g)(5)(C).''.
       (c) Variations From CGMP Streamlined Approach.--Not later 
     than 18 months after the date of enactment of this Act, the 
     Secretary of Health and Human Services (referred to in this 
     subsection as the ``Secretary'') shall identify types of 
     combination products and manufacturing processes with respect 
     to which the Secretary proposes that good manufacturing 
     processes may be adopted that vary from the requirements set 
     forth in section 4.4 of title 21, Code of Federal Regulations 
     (or any successor regulations) or that the Secretary proposes 
     can satisfy the requirements in section 4.4 through 
     alternative or streamlined mechanisms. The Secretary shall 
     identify such types, variations from such requirements, and 
     such mechanisms, in a proposed list published in the Federal 
     Register. After a public comment period regarding the 
     appropriate good manufacturing practices for such types, the 
     Secretary shall publish a final list in the Federal Register, 
     notwithstanding section 553 of title 5, United States Code. 
     The Secretary shall evaluate such types, variations, and 
     mechanisms using a risk-based approach. The Secretary shall 
     periodically review such final list.

          Subtitle E--Antimicrobial Innovation and Stewardship

     SEC. 3041. ANTIMICROBIAL RESISTANCE MONITORING.

       (a) In General.--Section 319E of the Public Health Service 
     Act (42 U.S.C. 247d-5) is amended--
       (1) by redesignating subsections (f) and (g) as subsections 
     (l) and (m), respectively; and
       (2) by inserting after subsection (e), the following:
       ``(f) Monitoring at Federal Health Care Facilities.--The 
     Secretary shall encourage reporting on aggregate 
     antimicrobial drug use and antimicrobial resistance to 
     antimicrobial drugs and the implementation of antimicrobial 
     stewardship programs by health care facilities of the 
     Department of Defense, the Department of Veterans Affairs, 
     and the Indian Health Service and shall provide technical 
     assistance to the Secretary of Defense and the Secretary of 
     Veterans Affairs, as appropriate and upon request.
       ``(g) Report on Antimicrobial Resistance in Humans and Use 
     of Antimicrobial Drugs.--Not later than 1 year after the date 
     of enactment of the 21st Century Cures Act, and annually 
     thereafter, the Secretary shall prepare and make publicly 
     available data and information concerning--
       ``(1) aggregate national and regional trends of 
     antimicrobial resistance in humans to antimicrobial drugs, 
     including such drugs approved under section 506(h) of the 
     Federal Food, Drug, and Cosmetic Act;
       ``(2) antimicrobial stewardship, which may include 
     summaries of State efforts to address antimicrobial 
     resistance in humans to antimicrobial drugs and antimicrobial 
     stewardship; and
       ``(3) coordination between the Director of the Centers for 
     Disease Control and Prevention and the Commissioner of Food 
     and Drugs with respect to the monitoring of--
       ``(A) any applicable resistance under paragraph (1); and
       ``(B) drugs approved under section 506(h) of the Federal 
     Food, Drug, and Cosmetic Act.
       ``(h) Information Related to Antimicrobial Stewardship 
     Programs.--The Secretary shall, as appropriate, disseminate 
     guidance, educational materials, or other appropriate 
     materials related to the development and implementation of 
     evidence-based antimicrobial stewardship programs or 
     practices at health care facilities, such as nursing homes 
     and other long-term care facilities, ambulatory surgical 
     centers, dialysis centers, outpatient clinics, and hospitals, 
     including community and rural hospitals.
       ``(i) Supporting State-Based Activities To Combat 
     Antimicrobial Resistance.--The Secretary shall continue to 
     work with State and local public health departments on 
     statewide or regional programs related to antimicrobial 
     resistance. Such efforts may include activities to related 
     to--
       ``(1) identifying patterns of bacterial and fungal 
     resistance in humans to antimicrobial drugs;
       ``(2) preventing the spread of bacterial and fungal 
     infections that are resistant to antimicrobial drugs; and
       ``(3) promoting antimicrobial stewardship.
       ``(j) Antimicrobial Resistance and Stewardship 
     Activities.--
       ``(1) In general.--For the purposes of supporting 
     stewardship activities, examining changes in antimicrobial 
     resistance, and evaluating the effectiveness of section 
     506(h) of the Federal Food, Drug, and Cosmetic Act, the 
     Secretary shall--
       ``(A) provide a mechanism for facilities to report data 
     related to their antimicrobial stewardship activities 
     (including analyzing the outcomes of such activities); and
       ``(B) evaluate--
       ``(i) antimicrobial resistance data using a standardized 
     approach; and
       ``(ii) trends in the utilization of drugs approved under 
     such section 506(h) with respect to patient populations.
       ``(2) Use of systems.--The Secretary shall use available 
     systems, including the National Healthcare Safety Network or 
     other systems identified by the Secretary, to fulfill the 
     requirements or conduct activities under this section.
       ``(k) Antimicrobial.--For purposes of subsections (f) 
     through (j), the term `antimicrobial' includes any 
     antibacterial or antifungal drugs, and may include drugs that 
     eliminate or inhibit the growth of other microorganisms, as 
     appropriate.''.
       (b) Availability of Data.--The Secretary shall make the 
     data collected pursuant to this subsection public. Nothing in 
     this subsection shall be construed as authorizing the 
     Secretary to disclose any information that is a trade secret 
     or confidential information subject to section 552(b)(4) of 
     title 5, United States Code, or section 1905 of title 18, 
     United States Code.

     SEC. 3042. LIMITED POPULATION PATHWAY.

       Section 506 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 356), as amended by section 3033, is further amended 
     by adding at the end the following:
       ``(h) Limited Population Pathway for Antibacterial and 
     Antifungal Drugs.--
       ``(1) In general.--The Secretary may approve an 
     antibacterial or antifungal drug, alone or in combination 
     with one or more other drugs, as a limited population drug 
     pursuant to this subsection only if--
       ``(A) the drug is intended to treat a serious or life-
     threatening infection in a limited population of patients 
     with unmet needs;
       ``(B) the standards for approval under section 505(c) and 
     (d), or the standards for licensure under section 351 of the 
     Public Health Service Act, as applicable, are met; and
       ``(C) the Secretary receives a written request from the 
     sponsor to approve the drug as a limited population drug 
     pursuant to this subsection.
       ``(2) Benefit-risk consideration.--The Secretary's 
     determination of safety and effectiveness of an antibacterial 
     or antifungal drug shall reflect the benefit-risk profile of 
     such drug in the intended limited population, taking into 
     account the severity, rarity, or prevalence of the infection 
     the drug is intended to treat and the availability or lack of 
     alternative treatment in such limited population. Such drug 
     may be approved under this subsection notwithstanding a lack 
     of evidence to fully establish a favorable benefit-risk 
     profile in a population that is broader than the intended 
     limited population.
       ``(3) Additional requirements.--A drug approved under this 
     subsection shall be subject to the following requirements, in 
     addition to any other applicable requirements of this Act:
       ``(A) Labeling.--To indicate that the safety and 
     effectiveness of a drug approved under this subsection has 
     been demonstrated only with respect to a limited population--
       ``(i) all labeling and advertising of an antibacterial or 
     antifungal drug approved under this subsection shall contain 
     the statement `Limited Population' in a prominent manner and 
     adjacent to, and not more prominent than--

       ``(I) the proprietary name of such drug, if any; or
       ``(II) if there is no proprietary name, the established 
     name of the drug, if any, as defined in section 503(e)(3), 
     or, in the case of a drug that is a biological product, the 
     proper name, as defined by regulation; and

       ``(ii) the prescribing information for the drug required by 
     section 201.57 of title 21, Code of Federal Regulations (or 
     any successor regulation) shall also include the following 
     statement: `This drug is indicated for use in a limited and 
     specific population of patients.'.
       ``(B) Promotional material.--The sponsor of an 
     antibacterial or antifungal drug subject to this subsection 
     shall submit to the Secretary copies of all promotional 
     materials related to such drug at least 30 calendar days 
     prior to dissemination of the materials.
       ``(4) Other programs.--A sponsor of a drug that seeks 
     approval of a drug under this subsection may also seek 
     designation or approval, as applicable, of such drug under 
     other applicable sections or subsections of this Act or the 
     Public Health Service Act.
       ``(5) Guidance.--Not later than 18 months after the date of 
     enactment of the 21st Century Cures Act, the Secretary shall 
     issue draft guidance describing criteria, processes, and 
     other general considerations for demonstrating the safety and 
     effectiveness of limited population antibacterial and 
     antifungal drugs. The Secretary shall publish final guidance 
     within 18 months of the close of the public comment period on 
     such draft guidance. The Secretary may approve antibacterial 
     and antifungal drugs under this subsection prior to issuing 
     guidance under this paragraph.
       ``(6) Advice.--The Secretary shall provide prompt advice to 
     the sponsor of a drug for

[[Page H6920]]

     which the sponsor seeks approval under this subsection to 
     enable the sponsor to plan a development program to obtain 
     the necessary data for such approval, and to conduct any 
     additional studies that would be required to gain approval of 
     such drug for use in a broader population.
       ``(7) Termination of limitations.--If, after approval of a 
     drug under this subsection, the Secretary approves a broader 
     indication for such drug under section 505(b) or section 
     351(a) of the Public Health Service Act, the Secretary may 
     remove any postmarketing conditions, including requirements 
     with respect to labeling and review of promotional materials 
     under paragraph (3), applicable to the approval of the drug 
     under this subsection.
       ``(8) Rules of construction.--Nothing in this subsection 
     shall be construed to alter the authority of the Secretary to 
     approve drugs pursuant to this Act or section 351 of the 
     Public Health Service Act, including the standards of 
     evidence and applicable conditions for approval under such 
     Acts, the standards of approval of a drug under such Acts, or 
     to alter the authority of the Secretary to monitor drugs 
     pursuant to such Acts.
       ``(9) Reporting and accountability.--
       ``(A) Biennial reporting.--The Secretary shall report to 
     Congress not less often than once every 2 years on the number 
     of requests for approval, and the number of approvals, of an 
     antibacterial or antifungal drug under this subsection.
       ``(B) GAO report.--Not later than December 2021, the 
     Comptroller General of the United States shall submit to the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, Labor 
     and Pensions of the Senate a report on the coordination of 
     activities required under section 319E of the Public Health 
     Service Act. Such report shall include a review of such 
     activities, and the extent to which the use of the pathway 
     established under this subsection has streamlined premarket 
     approval for antibacterial or antifungal drugs for limited 
     populations, if such pathway has functioned as intended, if 
     such pathway has helped provide for safe and effective 
     treatment for patients, if such premarket approval would be 
     appropriate for other categories of drugs, and if the 
     authorities under this subsection have affected antibacterial 
     or antifungal resistance.''.

     SEC. 3043. PRESCRIBING AUTHORITY.

       Nothing in this subtitle, or an amendment made by this 
     subtitle, shall be construed to restrict the prescribing of 
     antimicrobial drugs or other products, including drugs 
     approved under subsection (h) of section 506 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 356) (as added by 
     section 3042), by health care professionals, or to limit the 
     practice of health care.

     SEC. 3044. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR 
                   MICROORGANISMS; ANTIMICROBIAL SUSCEPTIBILITY 
                   TESTING DEVICES.

       (a) In General.--Subchapter A of chapter V of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is 
     amended by inserting after section 511 the following:

     ``SEC. 511A. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR 
                   MICROORGANISMS.

       ``(a) Purpose; Identification of Criteria.--
       ``(1) Purpose.--The purpose of this section is to clarify 
     the Secretary's authority to--
       ``(A) efficiently update susceptibility test interpretive 
     criteria for antimicrobial drugs when necessary for public 
     health, due to, among other things, the constant evolution of 
     microorganisms that leads to the development of resistance to 
     drugs that have been effective in decreasing morbidity and 
     mortality for patients, which warrants unique management of 
     antimicrobial drugs that is inappropriate for most other 
     drugs in order to delay or prevent the development of further 
     resistance to existing therapies;
       ``(B) provide for public notice of the availability of 
     recognized interpretive criteria and interpretive criteria 
     standards; and
       ``(C) clear under section 510(k), classify under section 
     513(f)(2), or approve under section 515, antimicrobial 
     susceptibility testing devices utilizing updated, recognized 
     susceptibility test interpretive criteria to characterize the 
     in vitro susceptibility of particular bacteria, fungi, or 
     other microorganisms, as applicable, to antimicrobial drugs.
       ``(2) Identification of criteria.--The Secretary shall 
     identify appropriate susceptibility test interpretive 
     criteria with respect to antimicrobial drugs--
       ``(A) if such criteria are available on the date of 
     approval of the drug under section 505 of this Act or 
     licensure of the drug under section 351 of the Public Health 
     Service Act (as applicable), upon such approval or licensure; 
     or
       ``(B) if such criteria are unavailable on such date, on the 
     date on which such criteria are available for such drug.
       ``(3) Bases for initial identification.--The Secretary 
     shall identify appropriate susceptibility test interpretive 
     criteria under paragraph (2), based on the Secretary's review 
     of, to the extent available and relevant--
       ``(A) preclinical and clinical data, including 
     pharmacokinetic, pharmacodynamic, and epidemiological data;
       ``(B) the relationship of susceptibility test interpretive 
     criteria to morbidity and mortality associated with the 
     disease or condition for which such drug is used; and
       ``(C) such other evidence and information as the Secretary 
     considers appropriate.
       ``(b) Susceptibility Test Interpretive Criteria Website.--
       ``(1) In general.--Not later than 1 year after the date of 
     the enactment of the 21st Century Cures Act, the Secretary 
     shall establish, and maintain thereafter, on the website of 
     the Food and Drug Administration, a dedicated website that 
     contains a list of any appropriate new or updated 
     susceptibility test interpretive criteria standards and 
     interpretive criteria in accordance with paragraph (2) 
     (referred to in this section as the `Interpretive Criteria 
     Website').
       ``(2) Listing of susceptibility test interpretive criteria 
     standards and interpretive criteria.--
       ``(A) In general.--The list described in paragraph (1) 
     shall consist of any new or updated susceptibility test 
     interpretive criteria standards that are--
       ``(i) established by a nationally or internationally 
     recognized standard development organization that--

       ``(I) establishes and maintains procedures to address 
     potential conflicts of interest and ensure transparent 
     decisionmaking;
       ``(II) holds open meetings to ensure that there is an 
     opportunity for public input by interested parties, and 
     establishes and maintains processes to ensure that such input 
     is considered in decisionmaking; and
       ``(III) permits its standards to be made publicly 
     available, through the National Library of Medicine or 
     another similar source acceptable to the Secretary; and

       ``(ii) recognized in whole, or in part, by the Secretary 
     under subsection (c).
       ``(B) Other list.--The Interpretive Criteria Website shall, 
     in addition to the list described in subparagraph (A), 
     include a list of interpretive criteria, if any, that the 
     Secretary has determined to be appropriate with respect to 
     legally marketed antimicrobial drugs, where--
       ``(i) the Secretary does not recognize, in whole or in 
     part, an interpretive criteria standard described under 
     subparagraph (A) otherwise applicable to such a drug;
       ``(ii) the Secretary withdraws under subsection (c)(1)(A) 
     recognition of a standard, in whole or in part, otherwise 
     applicable to such a drug;
       ``(iii) the Secretary approves an application under section 
     505 of this Act or section 351 of the Public Health Service 
     Act, as applicable, with respect to marketing of such a drug 
     for which there are no relevant interpretive criteria 
     included in a standard recognized by the Secretary under 
     subsection (c); or
       ``(iv) because the characteristics of such a drug differ 
     from other drugs with the same active ingredient, the 
     interpretive criteria with respect to such drug--

       ``(I) differ from otherwise applicable interpretive 
     criteria included in a standard listed under subparagraph (A) 
     or interpretive criteria otherwise listed under this 
     subparagraph; and
       ``(II) are determined by the Secretary to be appropriate 
     for the drug.

       ``(C) Required statements.--The Interpretive Criteria 
     Website shall include statements conveying--
       ``(i) that the website provides information about the in 
     vitro susceptibility of bacteria, fungi, or other 
     microorganisms, as applicable to a certain drug (or drugs);
       ``(ii) that--

       ``(I) the safety and efficacy of such drugs in treating 
     clinical infections due to such bacteria, fungi, or other 
     microorganisms, as applicable, may or may not have been 
     established in adequate and well-controlled clinical trials 
     in order for the susceptibility information described in 
     clause (i) to be included on the website; and
       ``(II) the clinical significance of such susceptibility 
     information in such instances is unknown;

       ``(iii) that the approved product labeling for specific 
     drugs provides the uses for which the Secretary has approved 
     the product; and
       ``(iv) any other information that the Secretary determines 
     appropriate to adequately convey the meaning of the data 
     supporting the recognition or listing of susceptibility test 
     interpretive criteria standards or susceptibility test 
     interpretive criteria included on the website.
       ``(3) Notice.--Not later than the date on which the 
     Interpretive Criteria Website is established, the Secretary 
     shall publish a notice of that establishment in the Federal 
     Register.
       ``(4) Inapplicability of misbranding provision.--The 
     inclusion in the approved labeling of an antimicrobial drug 
     of a reference or hyperlink to the Interpretive Criteria 
     Website, in and of itself, shall not cause the drug to be 
     misbranded in violation of section 502.
       ``(5) Trade secrets and confidential information.--Nothing 
     in this section shall be construed as authorizing the 
     Secretary to disclose any information that is a trade secret 
     or confidential information subject to section 552(b)(4) of 
     title 5, United States Code.
       ``(c) Recognition of Susceptibility Test Interpretive 
     Criteria.--
       ``(1) Evaluation and publication.--
       ``(A) In general.--Beginning on the date of the 
     establishment of the Interpretive Criteria Website, and at 
     least every 6 months thereafter, the Secretary shall--
       ``(i) evaluate any appropriate new or updated 
     susceptibility test interpretive criteria standards 
     established by a nationally or internationally recognized 
     standard development organization described in subsection 
     (b)(2)(A)(i); and
       ``(ii) publish on the public website of the Food and Drug 
     Administration a notice--

       ``(I) withdrawing recognition of any different 
     susceptibility test interpretive criteria standard, in whole 
     or in part;
       ``(II) recognizing the new or updated standards;
       ``(III) recognizing one or more parts of the new or updated 
     interpretive criteria specified in such a standard and 
     declining to recognize the remainder of such standard; and
       ``(IV) making any necessary updates to the lists under 
     subsection (b)(2).

       ``(B) Upon approval of a drug.--Upon the approval of an 
     initial or supplemental application for an antimicrobial drug 
     under section 505 of this Act or section 351 of the Public 
     Health Service Act, as applicable, where such approval is 
     based on susceptibility test interpretive criteria which 
     differ from those contained in a standard recognized, or from 
     those otherwise

[[Page H6921]]

     listed, by the Secretary pursuant to this subsection, or for 
     which there are no relevant interpretive criteria standards 
     recognized, or interpretive criteria otherwise listed, by the 
     Secretary pursuant to this subsection, the Secretary shall 
     update the lists under subparagraphs (A) and (B) of 
     subsection (b)(2) to include the susceptibility test 
     interpretive criteria upon which such approval was based.
       ``(2) Bases for updating interpretive criteria standards.--
     In evaluating new or updated susceptibility test interpretive 
     criteria standards under paragraph (1)(A), the Secretary may 
     consider--
       ``(A) the Secretary's determination that such a standard is 
     not applicable to a particular drug because the 
     characteristics of the drug differ from other drugs with the 
     same active ingredient;
       ``(B) information provided by interested third parties, 
     including public comment on the annual compilation of notices 
     published under paragraph (3);
       ``(C) any bases used to identify susceptibility test 
     interpretive criteria under subsection (a)(2); and
       ``(D) such other information or factors as the Secretary 
     determines appropriate.
       ``(3) Annual compilation of notices.--Each year, the 
     Secretary shall compile the notices published under paragraph 
     (1)(A) and publish such compilation in the Federal Register 
     and provide for public comment. If the Secretary receives 
     comments, the Secretary shall review such comments and, if 
     the Secretary determines appropriate, update pursuant to this 
     subsection susceptibility test interpretive criteria 
     standards or criteria--
       ``(A) recognized by the Secretary under this subsection; or
       ``(B) otherwise listed on the Interpretive Criteria Website 
     under subsection (b)(2).
       ``(4) Relation to section 514(c).--Any susceptibility test 
     interpretive standard recognized under this subsection or any 
     criteria otherwise listed under subsection (b)(2)(B) shall be 
     deemed to be recognized as a standard by the Secretary under 
     section 514(c)(1).
       ``(5) Voluntary use of interpretive criteria.--Nothing in 
     this section prohibits a person from seeking approval or 
     clearance of a drug or device, or changes to the drug or the 
     device, on the basis of susceptibility test interpretive 
     criteria which differ from those contained in a standard 
     recognized, or from those otherwise listed, by the Secretary 
     pursuant to subsection (b)(2).
       ``(d) Antimicrobial Drug Labeling.--
       ``(1) Drugs marketed prior to establishment of interpretive 
     criteria website.--
       ``(A) In general.--With respect to an antimicrobial drug 
     lawfully introduced or delivered for introduction into 
     interstate commerce for commercial distribution before the 
     establishment of the Interpretive Criteria Website, a holder 
     of an approved application under section 505 of this Act or 
     section 351 of the Public Health Service Act, as applicable, 
     for each such drug, not later than 1 year after establishment 
     of the Interpretive Criteria Website described in subsection 
     (b)(1), shall remove susceptibility test interpretive 
     criteria, if any, and related information from the approved 
     drug labeling and replace it with a reference to the 
     Interpretive Criteria Website.
       ``(B) Labeling changes.--The labeling changes required by 
     this section shall be considered a minor change under section 
     314.70 of title 21, Code of Federal Regulations (or any 
     successor regulations) that may be implemented through 
     documentation in the next applicable annual report.
       ``(2) Drugs marketed subsequent to establishment of 
     interpretive criteria website.--With respect to antimicrobial 
     drugs approved on or after the date of the establishment of 
     the Interpretive Criteria Website described in subsection 
     (b)(1), the labeling for such a drug shall include, in lieu 
     of susceptibility test interpretive criteria and related 
     information, a reference to such Website.
       ``(e) Special Condition for Marketing of Antimicrobial 
     Susceptibility Testing Devices.--
       ``(1) In general.--Notwithstanding sections 501, 502, 505, 
     510, 513, and 515, if the conditions specified in paragraph 
     (2) are met (in addition to other applicable provisions under 
     this chapter) with respect to an antimicrobial susceptibility 
     testing device described in subsection (f)(1), the Secretary 
     may authorize the marketing of such device for a use 
     described in such subsection.
       ``(2) Conditions applicable to antimicrobial susceptibility 
     testing devices.--The conditions specified in this paragraph 
     are the following:
       ``(A) The device is used to make a determination of 
     susceptibility using susceptibility test interpretive 
     criteria that are--
       ``(i) included in a standard recognized by the Secretary 
     under subsection (c); or
       ``(ii) otherwise listed on the Interpretive Criteria 
     Website under subsection (b)(2).
       ``(B) The labeling of such device includes statements 
     conveying--
       ``(i) that the device provides information about the in 
     vitro susceptibility of bacteria, fungi, or other 
     microorganisms, as applicable to antimicrobial drugs;
       ``(ii) that--

       ``(I) the safety and efficacy of such drugs in treating 
     clinical infections due to such bacteria, fungi, or other 
     microorganisms, as applicable, may or may not have been 
     established in adequate and well-controlled clinical trials 
     in order for the device to report the susceptibility of such 
     bacteria, fungi, or other microorganisms, as applicable, to 
     such drugs; and
       ``(II) the clinical significance of such susceptibility 
     information in those instances is unknown;

       ``(iii) that the approved labeling for drugs tested using 
     such a device provides the uses for which the Secretary has 
     approved such drugs; and
       ``(iv) any other information the Secretary determines 
     appropriate to adequately convey the meaning of the data 
     supporting the recognition or listing of susceptibility test 
     interpretive criteria standards or susceptibility test 
     interpretive criteria described in subparagraph (A).
       ``(C) The antimicrobial susceptibility testing device meets 
     all other requirements to be cleared under section 510(k), 
     classified under section 513(f)(2), or approved under section 
     515.
       ``(f) Definitions.--In this section:
       ``(1) The term `antimicrobial susceptibility testing 
     device' means a device that utilizes susceptibility test 
     interpretive criteria to determine and report the in vitro 
     susceptibility of certain microorganisms to a drug (or 
     drugs).
       ``(2) The term `qualified infectious disease product' means 
     a qualified infectious disease product designated under 
     section 505E(d).
       ``(3) The term `susceptibility test interpretive criteria' 
     means--
       ``(A) one or more specific numerical values which 
     characterize the susceptibility of bacteria or other 
     microorganisms to the drug tested; and
       ``(B) related categorizations of such susceptibility, 
     including categorization of the drug as susceptible, 
     intermediate, resistant, or such other term as the Secretary 
     determines appropriate.
       ``(4)(A) The term `antimicrobial drug' means, subject to 
     subparagraph (B), a systemic antibacterial or antifungal drug 
     that--
       ``(i) is intended for human use in the treatment of a 
     disease or condition caused by a bacterium or fungus;
       ``(ii) may include a qualified infectious disease product 
     designated under section 505E(d); and
       ``(iii) is subject to section 503(b)(1).
       ``(B) If provided by the Secretary through regulations, 
     such term may include--
       ``(i) drugs other than systemic antibacterial and 
     antifungal drugs; and
       ``(ii) biological products (as such term is defined in 
     section 351 of the Public Health Service Act) to the extent 
     such products exhibit antimicrobial activity. 
       ``(5) The term `interpretive criteria standard' means a 
     compilation of susceptibility test interpretive criteria 
     developed by a standard development organization that meets 
     the criteria set forth in subsection (b)(2)(A)(i).
       ``(g) Rule of Construction.--Nothing in this section shall 
     be construed to--
       ``(1) alter the standards of evidence under subsection (c) 
     or (d) of section 505 (including the substantial evidence 
     standard under section 505(d)) or under section 351 of the 
     Public Health Service Act (as applicable); or
       ``(2) with respect to clearing devices under section 
     510(k), classifying devices under section 513(f)(2), or 
     approving devices under section 515--
       ``(A) apply with respect to any drug, device, or biological 
     product, in any context other than an antimicrobial drug and 
     an antimicrobial susceptibility testing device that uses 
     susceptibility test interpretive criteria to characterize and 
     report the susceptibility of certain bacteria, fungi, or 
     other microorganisms, as applicable, to such drug to reflect 
     patient morbidity and mortality in accordance with this 
     section; or
       ``(B) unless specifically stated, have any effect on 
     authorities provided under other sections of this Act, 
     including any regulations issued under such sections.''.
       (b) Conforming Amendments.--
       (1) Repeal of prior related authority.--Section 1111 of the 
     Food and Drug Administration Amendments Act of 2007 (42 
     U.S.C. 247d-5a), relating to identification of clinically 
     susceptible concentrations of antimicrobials, is repealed.
       (2) Addition to categories of misbranded drugs.--Section 
     502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     352) is amended by adding at the end the following:
       ``(dd) If it is an antimicrobial drug, as defined in 
     section 511A(f), and its labeling fails to conform with the 
     requirements under section 511A(d).''.
       (3) Recognition of interpretive criteria standard as device 
     standard.--Section 514(c)(1)(A) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by 
     inserting after ``the Secretary shall, by publication in the 
     Federal Register'' the following: ``(or, with respect to a 
     susceptibility test interpretive criteria standard under 
     section 511A, by posting on the Interpretive Criteria Website 
     in accordance with such section)''.
       (c) Report to Congress.--Not later than 2 years after the 
     date of enactment of this Act, the Secretary of Health and 
     Human Services shall submit to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report on the progress made in implementing 
     section 511A of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360a), as added by subsection (a).
       (d) Requests for Updates to Interpretive Criteria 
     Website.--Chapter 35 of title 44, United States Code, shall 
     not apply to the collection of information from interested 
     parties regarding updating the lists established under 
     section 511A(b) of the Federal Food, Drug, and Cosmetic Act 
     and posted on the Interpretive Criteria Website established 
     under section 511A(c) of such Act.

                 Subtitle F--Medical Device Innovations

     SEC. 3051. BREAKTHROUGH DEVICES.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 515B, as added by section 3034(b), the 
     following:

[[Page H6922]]

  


     ``SEC. 515C. BREAKTHROUGH DEVICES.

       ``(a) Purpose.--The purpose of this section is to encourage 
     the Secretary, and provide the Secretary with sufficient 
     authority, to apply efficient and flexible approaches to 
     expedite the development of, and prioritize the Food and Drug 
     Administration's review of, devices that represent 
     breakthrough technologies.
       ``(b) Establishment of Program.--The Secretary shall 
     establish a program to expedite the development of, and 
     provide for the priority review for, devices, as determined 
     by the Secretary--
       ``(1) that provide for more effective treatment or 
     diagnosis of life-threatening or irreversibly debilitating 
     human disease or conditions; and
       ``(2)(A) that represent breakthrough technologies;
       ``(B) for which no approved or cleared alternatives exist;
       ``(C) that offer significant advantages over existing 
     approved or cleared alternatives, including the potential, 
     compared to existing approved alternatives, to reduce or 
     eliminate the need for hospitalization, improve patient 
     quality of life, facilitate patients' ability to manage their 
     own care (such as through self-directed personal assistance), 
     or establish long-term clinical efficiencies; or
       ``(D) the availability of which is in the best interest of 
     patients.
       ``(c) Request for Designation.--A sponsor of a device may 
     request that the Secretary designate such device for 
     expedited development and priority review under this section. 
     Any such request for designation may be made at any time 
     prior to the submission of an application under section 
     515(c), a notification under section 510(k), or a petition 
     for classification under section 513(f)(2).
       ``(d) Designation Process.--
       ``(1) In general.--Not later than 60 calendar days after 
     the receipt of a request under subsection (c), the Secretary 
     shall determine whether the device that is the subject of the 
     request meets the criteria described in subsection (b). If 
     the Secretary determines that the device meets the criteria, 
     the Secretary shall designate the device for expedited 
     development and priority review.
       ``(2) Review.--Review of a request under subsection (c) 
     shall be undertaken by a team that is composed of experienced 
     staff and senior managers of the Food and Drug 
     Administration.
       ``(3) Withdrawal.--The Secretary may not withdraw a 
     designation granted under this section on the basis of the 
     criteria under subsection (b) no longer applying because of 
     the subsequent clearance or approval of another device that--
       ``(A) was designated under this section; or
       ``(B) was given priority review under section 515(d)(5), as 
     in effect prior to the date of enactment of the 21st Century 
     Cures Act.
       ``(e) Expedited Development and Priority Review.--
       ``(1) Actions.--For purposes of expediting the development 
     and review of devices designated under subsection (d) the 
     Secretary shall--
       ``(A) assign a team of staff, including a team leader with 
     appropriate subject matter expertise and experience, for each 
     device for which a request is submitted under subsection (c);
       ``(B) provide for oversight of the team by senior agency 
     personnel to facilitate the efficient development of the 
     device and the efficient review of any submission described 
     in subsection (c) for the device;
       ``(C) adopt an efficient process for timely dispute 
     resolution;
       ``(D) provide for interactive and timely communication with 
     the sponsor of the device during the development program and 
     review process;
       ``(E) expedite the Secretary's review of manufacturing and 
     quality systems compliance, as applicable;
       ``(F) disclose to the sponsor, not less than 5 business 
     days in advance, the topics of any consultation the Secretary 
     intends to undertake with external experts or an advisory 
     committee concerning the sponsor's device and provide the 
     sponsor the opportunity to recommend such external experts;
       ``(G) provide for advisory committee input, as the 
     Secretary determines appropriate (including in response to 
     the request of the sponsor) for applications submitted under 
     section 515(c); and
       ``(H) assign staff to be available within a reasonable time 
     to address questions by institutional review committees 
     concerning the conditions and clinical testing requirements 
     applicable to the investigational use of the device pursuant 
     to an exemption under section 520(g).
       ``(2) Additional actions.--In addition to the actions 
     described in paragraph (1), for purposes of expediting the 
     development and review of devices designated under subsection 
     (d), the Secretary, in collaboration with the device sponsor, 
     may, as appropriate--
       ``(A) coordinate with the sponsor regarding early agreement 
     on a data development plan;
       ``(B) take steps to ensure that the design of clinical 
     trials is as efficient and flexible as practicable, when 
     scientifically appropriate;
       ``(C) facilitate, when scientifically appropriate, 
     expedited and efficient development and review of the device 
     through utilization of timely postmarket data collection with 
     regard to application for approval under section 515(c); and
       ``(D) agree in writing to clinical protocols that the 
     Secretary will consider binding on the Secretary and the 
     sponsor, subject to--
       ``(i) changes to such protocols agreed to in writing by the 
     sponsor and the Secretary; or
       ``(ii) a decision, made by the director of the office 
     responsible for reviewing the device submission, that a 
     substantial scientific issue essential to determining the 
     safety or effectiveness of such device exists, provided that 
     such decision is in writing, and is made only after the 
     Secretary provides to the device sponsor or applicant an 
     opportunity for a meeting at which the director and the 
     sponsor or applicant are present and at which the director 
     documents the substantial scientific issue.
       ``(f) Priority Review Guidance.--
       ``(1) Content.--Not later than 1 year after the date of 
     enactment of the 21st Century Cures Act, the Secretary shall 
     issue guidance on the implementation of this section. Such 
     guidance shall--
       ``(A) set forth the process by which a person may seek a 
     designation under subsection (d);
       ``(B) provide a template for requests under subsection (c);
       ``(C) identify the criteria the Secretary will use in 
     evaluating a request for designation under this section; and
       ``(D) identify the criteria and processes the Secretary 
     will use to assign a team of staff, including team leaders, 
     to review devices designated for expedited development and 
     priority review, including any training required for such 
     personnel to ensure effective and efficient review.
       ``(2) Process.--Prior to finalizing the guidance under 
     paragraph (1), the Secretary shall seek public comment on a 
     proposed guidance.
       ``(g) Rule of Construction.--Nothing in this section shall 
     be construed to affect--
       ``(1) the criteria and standards for evaluating an 
     application pursuant to section 515(c), a report and request 
     for classification under section 513(f)(2), or a report under 
     section 510(k), including the recognition of valid scientific 
     evidence as described in section 513(a)(3)(B) and 
     consideration and application of the least burdensome means 
     of evaluating device effectiveness or demonstrating 
     substantial equivalence between devices with differing 
     technological characteristics, as applicable;
       ``(2) the authority of the Secretary with respect to 
     clinical holds under section 520(g)(8)(A);
       ``(3) the authority of the Secretary to act on an 
     application pursuant to section 515(d) before completion of 
     an establishment inspection, as the Secretary determines 
     appropriate; or
       ``(4) the authority of the Secretary with respect to 
     postmarket surveillance under sections 519(h) and 522.''.
       (b) Documentation and Review of Significant Decisions.--
     Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 360g-1(a)(1)) is amended by inserting ``a 
     request for designation under section 515C,'' after 
     ``application under section 515,''.
       (c) Termination of Previous Program.--
       (1) In general.--Section 515(d) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360e(d)) is amended--
       (A) by striking paragraph (5); and
       (B) by redesignating paragraph (6) as paragraph (5).
       (2) Conforming amendment.--Section 737(5) of the Federal 
     Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is amended 
     by striking ``515(d)(6)'' and inserting ``515(d)(5)''.
       (d) Report.--On January 1, 2019, the Secretary of Health 
     and Human Services shall issue a report to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives--
       (1) on the program under section 515C of the Federal Food, 
     Drug, and Cosmetic Act, as added by subsection (a), in 
     bringing safe and effective devices included in such program 
     to patients as soon as possible; and
       (2) that includes recommendations, if any, to strengthen 
     the program to better meet patient device needs in a manner 
     as timely as possible.

     SEC. 3052. HUMANITARIAN DEVICE EXEMPTION.

       (a) In General.--Section 520(m) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360j) is amended--
       (1) in paragraph (1) by striking ``fewer than 4,000'' and 
     inserting ``not more than 8,000'';
       (2) in paragraph (2)(A) by striking ``fewer than 4,000'' 
     and inserting ``not more than 8,000''; and
       (3) in paragraph (6)(A)(ii), by striking ``4,000'' and 
     inserting ``8,000''.
       (b) Guidance Document on Probable Benefit.--Not later than 
     18 months after the date of enactment of this Act, the 
     Secretary of Health and Human Services, acting through the 
     Commissioner of Food and Drugs, shall publish a draft 
     guidance that defines the criteria for establishing 
     ``probable benefit'' as that term is used in section 
     520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360j(m)(2)(C)).

     SEC. 3053. RECOGNITION OF STANDARDS.

       (a) In General.--Section 514(c) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360d(c)) is amended--
       (1) in paragraph (1), by inserting after subparagraph (B) 
     the following new subparagraphs:
       ``(C)(i) Any person may submit a request for recognition 
     under subparagraph (A) of all or part of an appropriate 
     standard established by a nationally or internationally 
     recognized standard organization.
       ``(ii) Not later than 60 calendar days after the Secretary 
     receives such a request, the Secretary shall--
       ``(I) make a determination to recognize all, part, or none 
     of the standard that is the subject of the request; and
       ``(II) issue to the person who submitted such request a 
     response in writing that states the Secretary's rationale for 
     that determination, including the scientific, technical, 
     regulatory, or other basis for such determination.
       ``(iii) The Secretary shall make a response issued under 
     clause (ii)(II) publicly available, in such a manner as the 
     Secretary determines appropriate.
       ``(iv) The Secretary shall take such actions as may be 
     necessary to implement all or part of a standard recognized 
     under clause (ii)(I), in accordance with subparagraph (A).
       ``(D) The Secretary shall make publicly available, in such 
     manner as the Secretary determines appropriate, the rationale 
     for recognition

[[Page H6923]]

     under subparagraph (A) of all, part, or none of a standard, 
     including the scientific, technical, regulatory, or other 
     basis for the decision regarding such recognition.''; and
       (2) by adding at the end the following:
       ``(4) The Secretary shall provide to all employees of the 
     Food and Drug Administration who review premarket submissions 
     for devices periodic training on the concept and use of 
     recognized standards for purposes of meeting a premarket 
     submission requirement or other applicable requirement under 
     this Act, including standards relevant to an employee's area 
     of device review.''.
       (b) Guidance.--The Secretary of Health and Human Services, 
     acting through the Commissioner of Food and Drugs, shall 
     review and update, if necessary, previously published 
     guidance and standard operating procedures identifying the 
     principles for recognizing standards, and for withdrawing the 
     recognition of standards, under section 514(c) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)), taking into 
     account the experience with and reliance on a standard by 
     foreign regulatory authorities and the device industry, and 
     whether recognition of a standard will promote harmonization 
     among regulatory authorities in the regulation of devices.

     SEC. 3054. CERTAIN CLASS I AND CLASS II DEVICES.

       (a) Class I Devices.--Section 510(l) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amended--
       (1) by striking ``A report under subsection (k)'' and 
     inserting ``(1) A report under subsection (k)''; and
       (2) by adding at the end the following new paragraph:
       ``(2) Not later than 120 calendar days after the date of 
     enactment of the 21st Century Cures Act and at least once 
     every 5 years thereafter, as the Secretary determines 
     appropriate, the Secretary shall identify, through 
     publication in the Federal Register, any type of class I 
     device that the Secretary determines no longer requires a 
     report under subsection (k) to provide reasonable assurance 
     of safety and effectiveness. Upon such publication--
       ``(A) each type of class I device so identified shall be 
     exempt from the requirement for a report under subsection 
     (k); and
       ``(B) the classification regulation applicable to each such 
     type of device shall be deemed amended to incorporate such 
     exemption.''.
       (b) Class II Devices.--Section 510(m) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360(m)) is amended--
       (1) by striking ``(m)(1)'' and all that follows through 
     ``by the Secretary.'' and inserting the following:
       ``(m)(1) The Secretary shall--
       ``(A) not later than 90 days after the date of enactment of 
     the 21st Century Cures Act and at least once every 5 years 
     thereafter, as the Secretary determines appropriate--
       ``(i) publish in the Federal Register a notice that 
     contains a list of each type of class II device that the 
     Secretary determines no longer requires a report under 
     subsection (k) to provide reasonable assurance of safety and 
     effectiveness; and
       ``(ii) provide for a period of not less than 60 calendar 
     days for public comment beginning on the date of the 
     publication of such notice; and
       ``(B) not later than 210 calendar days after the date of 
     enactment of the 21st Century Cures Act, publish in the 
     Federal Register a list representing the Secretary's final 
     determination with respect to the devices contained in the 
     list published under subparagraph (A).''; and
       (2) in paragraph (2)--
       (A) by striking ``1 day after the date of publication of a 
     list under this subsection,'' and inserting ``1 calendar day 
     after the date of publication of the final list under 
     paragraph (1)(B),''; and
       (B) by striking ``30-day period'' and inserting ``60-
     calendar-day period''; and
       (C) by adding at the end the following new paragraph:
       ``(3) Upon the publication of the final list under 
     paragraph (1)(B)--
       ``(A) each type of class II device so listed shall be 
     exempt from the requirement for a report under subsection 
     (k); and
       ``(B) the classification regulation applicable to each such 
     type of device shall be deemed amended to incorporate such 
     exemption.''.

     SEC. 3055. CLASSIFICATION PANELS.

       (a) Classification Panels.--Paragraph (5) of section 513(b) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360c(b)) is amended--
       (1) by striking ``(5)'' and inserting ``(5)(A)''; and
       (2) by adding at the end the following:
       ``(B) When a device is specifically the subject of review 
     by a classification panel, the Secretary shall--
       ``(i) ensure that adequate expertise is represented on the 
     classification panel to assess--
       ``(I) the disease or condition which the device is intended 
     to cure, treat, mitigate, prevent, or diagnose; and
       ``(II) the technology of the device; and
       ``(ii) provide an opportunity for the person whose device 
     is specifically the subject of panel review to provide 
     recommendations on the expertise needed among the voting 
     members of the panel.
       ``(C) For purposes of subparagraph (B)(i), the term 
     `adequate expertise' means that the membership of the 
     classification panel includes--
       ``(i) two or more voting members, with a specialty or other 
     expertise clinically relevant to the device under review; and
       ``(ii) at least one voting member who is knowledgeable 
     about the technology of the device.
       ``(D) The Secretary shall provide an annual opportunity for 
     patients, representatives of patients, and sponsors of 
     medical device submissions to provide recommendations for 
     individuals with appropriate expertise to fill voting member 
     positions on classification panels.''.
       (b) Panel Review Process.--Section 513(b)(6) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is 
     amended--
       (1) in subparagraph (A)(iii), by inserting before the 
     period at the end ``, including, subject to the discretion of 
     the panel chairperson, by designating a representative who 
     will be provided a time during the panel meeting to address 
     the panel for the purpose of correcting misstatements of fact 
     or providing clarifying information, and permitting the 
     person or representative to call on experts within the 
     person's organization to address such specific issues in the 
     time provided''; and
       (2) by striking subparagraph (B) and inserting the 
     following new subparagraph:
       ``(B)(i) Any meeting of a classification panel with respect 
     to the review of a device shall--
       ``(I) provide adequate time for initial presentations by 
     the person whose device is specifically the subject of such 
     review and by the Secretary; and
       ``(II) encourage free and open participation by all 
     interested persons.
       ``(ii) Following the initial presentations described in 
     clause (i), the panel may--
       ``(I) pose questions to a designated representative 
     described in subparagraph (A)(iii); and
       ``(II) consider the responses to such questions in the 
     panel's review of the device.''.

     SEC. 3056. INSTITUTIONAL REVIEW BOARD FLEXIBILITY.

       Section 520 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360j) is amended--
       (1) in subsection (g)(3)--
       (A) in subparagraph (A)(i)--
       (i) by striking ``local''; and
       (ii) by striking ``which has been''; and
       (B) in subparagraph (B), by striking ``a local 
     institutional'' and inserting ``an institutional''; and
       (2) in subsection (m)(4)--
       (A) by striking subparagraph (A) and inserting the 
     following:
       ``(A) in facilities in which clinical testing of devices is 
     supervised by an institutional review committee established 
     in accordance with the regulations of the Secretary; and'';
       (B) in subparagraph (B), by striking ``a local 
     institutional'' and inserting ``an institutional''; and
       (C) in the matter following subparagraph (B), by striking 
     ``local''.

     SEC. 3057. CLIA WAIVER IMPROVEMENTS.

       (a) Draft Revised Guidance.--Not later than 1 year after 
     the date of the enactment of this Act, the Secretary of 
     Health and Human Services, acting through the Commissioner of 
     Food and Drugs, shall publish a draft guidance that--
       (1) revises ``Section V. Demonstrating Insignificant Risk 
     of an Erroneous Result - Accuracy'' of the guidance entitled 
     ``Recommendations for Clinical Laboratory Improvement 
     Amendments of 1988 (CLIA) Waiver Applications for 
     Manufacturers of In Vitro Diagnostic Devices'' and dated 
     January 30, 2008; and
       (2) includes the appropriate use of comparable performance 
     between a waived user and a moderately complex laboratory 
     user to demonstrate accuracy.
       (b) Final Revised Guidance.--The Secretary of Health and 
     Human Services, acting through the Commissioner of Food and 
     Drugs, shall finalize the draft guidance published under 
     subsection (a) not later than 1 year after the comment period 
     for such draft guidance closes.

     SEC. 3058. LEAST BURDENSOME DEVICE REVIEW.

       (a) In General.--Section 513 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end 
     the following:
       ``(j) Training and Oversight of Least Burdensome 
     Requirements.--
       ``(1) The Secretary shall--
       ``(A) ensure that each employee of the Food and Drug 
     Administration who is involved in the review of premarket 
     submissions, including supervisors, receives training 
     regarding the meaning and implementation of the least 
     burdensome requirements under subsections (a)(3)(D) and 
     (i)(1)(D) of this section and section 515(c)(5); and
       ``(B) periodically assess the implementation of the least 
     burdensome requirements, including the employee training 
     under subparagraph (A), to ensure that the least burdensome 
     requirements are fully and consistently applied.
       ``(2) Not later than 18 months after the date of enactment 
     of the 21st Century Cures Act, the ombudsman for any 
     organizational unit of the Food and Drug Administration 
     responsible for the premarket review of devices shall--
       ``(A) conduct an audit of the training described in 
     paragraph (1)(A), including the effectiveness of such 
     training in implementing the least burdensome requirements;
       ``(B) include in such audit interviews of persons who are 
     representatives of the device industry regarding their 
     experiences in the device premarket review process, including 
     with respect to the application of least burdensome concepts 
     to premarket review and decisionmaking;
       ``(C) include in such audit a list of the measurement tools 
     the Secretary uses to assess the implementation of the least 
     burdensome requirements, including under paragraph (1)(B) and 
     section 517A(a)(3), and may also provide feedback on the 
     effectiveness of such tools in the implementation of the 
     least burdensome requirements;
       ``(D) summarize the findings of such audit in a final audit 
     report; and
       ``(E) within 30 calendar days of completion of such final 
     audit report, make such final audit report available--
       ``(i) to the Committee on Health, Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives; and

[[Page H6924]]

       ``(ii) on the Internet website of the Food and Drug 
     Administration.''.
       (b) Premarket Applications.--Section 515(c) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended 
     by adding at the end the following:
       ``(5)(A) In requesting additional information with respect 
     to an application under this section, the Secretary shall 
     consider the least burdensome appropriate means necessary to 
     demonstrate a reasonable assurance of device safety and 
     effectiveness.
       ``(B) For purposes of subparagraph (A), the term 
     `necessary' means the minimum required information that would 
     support a determination by the Secretary that an application 
     provides a reasonable assurance of the safety and 
     effectiveness of the device.
       ``(C) For purposes of this paragraph, the Secretary shall 
     consider the role of postmarket information in determining 
     the least burdensome means of demonstrating a reasonable 
     assurance of device safety and effectiveness.
       ``(D) Nothing in this paragraph alters the standards for 
     premarket approval of a device.''.
       (c) Rationale for Significant Decisions Regarding 
     Devices.--Section 517A(a) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360g-1(a)) is amended by adding at 
     the end the following:
       ``(3) Application of least burdensome requirements.--The 
     substantive summary required under this subsection shall 
     include a brief statement regarding how the least burdensome 
     requirements were considered and applied consistent with 
     section 513(i)(1)(D), section 513(a)(3)(D), and section 
     515(c)(5), as applicable.''.

     SEC. 3059. CLEANING INSTRUCTIONS AND VALIDATION DATA 
                   REQUIREMENT.

       (a) In General.--Section 510 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360) is amended by adding at the end 
     the following:
       ``(q) Reusable Medical Devices.--
       ``(1) In general.--Not later than 180 days after the date 
     of enactment of the 21st Century Cures Act, the Secretary 
     shall identify and publish a list of reusable device types 
     for which reports under subsection (k) are required to 
     include--
       ``(A) instructions for use, which have been validated in a 
     manner specified by the Secretary; and
       ``(B) validation data, the types of which shall be 
     specified by the Secretary;
     regarding cleaning, disinfection, and sterilization, and for 
     which a substantial equivalence determination may be based.
       ``(2) Revision of list.--The Secretary shall revise the 
     list under paragraph (2), as the Secretary determines 
     appropriate, with notice in the Federal Register.
       ``(3) Content of reports.--Reports under subsection (k) 
     that are submitted after the publication of the list 
     described in paragraph (1), for devices or types of devices 
     included on such list, shall include such instructions for 
     use and validation data.''.
       (b) Device Modifications.--The Secretary of Health and 
     Human Services, acting through the Commissioner of Food and 
     Drugs, shall issue final guidance regarding when a premarket 
     notification under section 510(k) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360(k)) is required to be 
     submitted for a modification or change to a legally marketed 
     device. Such final guidance shall be issued not later than 1 
     year after the date on which the comment period closes for 
     the draft guidance on such subject.

     SEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATION.

       (a) In General.--Section 520 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360j) is amended by adding at the end 
     the following:
       ``(o) Regulation of Medical and Certain Decisions Support 
     Software.--
       ``(1) The term device, as defined in section 201(h), shall 
     not include a software function that is intended--
       ``(A) for administrative support of a health care facility, 
     including the processing and maintenance of financial 
     records, claims or billing information, appointment 
     schedules, business analytics, information about patient 
     populations, admissions, practice and inventory management, 
     analysis of historical claims data to predict future 
     utilization or cost-effectiveness, determination of health 
     benefit eligibility, population health management, and 
     laboratory workflow;
       ``(B) for maintaining or encouraging a healthy lifestyle 
     and is unrelated to the diagnosis, cure, mitigation, 
     prevention, or treatment of a disease or condition;
       ``(C) to serve as electronic patient records, including 
     patient-provided information, to the extent that such records 
     are intended to transfer, store, convert formats, or display 
     the equivalent of a paper medical chart, so long as--
       ``(i) such records were created, stored, transferred, or 
     reviewed by health care professionals, or by individuals 
     working under supervision of such professionals;
       ``(ii) such records are part of health information 
     technology that is certified under section 3001(c)(5) of the 
     Public Health Service Act; and
       ``(iii) such function is not intended to interpret or 
     analyze patient records, including medical image data, for 
     the purpose of the diagnosis, cure, mitigation, prevention, 
     or treatment of a disease or condition;
       ``(D) for transferring, storing, converting formats, or 
     displaying clinical laboratory test or other device data and 
     results, findings by a health care professional with respect 
     to such data and results, general information about such 
     findings, and general background information about such 
     laboratory test or other device, unless such function is 
     intended to interpret or analyze clinical laboratory test or 
     other device data, results, and findings; or
       ``(E) unless the function is intended to acquire, process, 
     or analyze a medical image or a signal from an in vitro 
     diagnostic device or a pattern or signal from a signal 
     acquisition system, for the purpose of--
       ``(i) displaying, analyzing, or printing medical 
     information about a patient or other medical information 
     (such as peer-reviewed clinical studies and clinical practice 
     guidelines);
       ``(ii) supporting or providing recommendations to a health 
     care professional about prevention, diagnosis, or treatment 
     of a disease or condition; and
       ``(iii) enabling such health care professional to 
     independently review the basis for such recommendations that 
     such software presents so that it is not the intent that such 
     health care professional rely primarily on any of such 
     recommendations to make a clinical diagnosis or treatment 
     decision regarding an individual patient.
       ``(2) In the case of a product with multiple functions that 
     contains--
       ``(A) at least one software function that meets the 
     criteria under paragraph (1) or that otherwise does not meet 
     the definition of device under section 201(h); and
       ``(B) at least one function that does not meet the criteria 
     under paragraph (1) and that otherwise meets the definition 
     of a device under section 201(h),

     the Secretary shall not regulate the software function of 
     such product described in subparagraph (A) as a device. 
     Notwithstanding the preceding sentence, when assessing the 
     safety and effectiveness of the device function or functions 
     of such product described in subparagraph (B), the Secretary 
     may assess the impact that the software function or functions 
     described in subparagraph (A) have on such device function or 
     functions.
       ``(3)(A) Notwithstanding paragraph (1), a software function 
     described in subparagraph (C), (D), or (E) of paragraph (1) 
     shall not be excluded from the definition of device under 
     section 201(h) if--
       ``(i) the Secretary makes a finding that use of such 
     software function would be reasonably likely to have serious 
     adverse health consequences; and
       ``(ii) the software function has been identified in a final 
     order issued by the Secretary under subparagraph (B).
       ``(B) Subparagraph (A) shall apply only if the Secretary--
       ``(i) publishes a notification and proposed order in the 
     Federal Register;
       ``(ii) includes in such notification the Secretary's 
     finding, including the rationale and identification of the 
     evidence on which such finding was based, as described in 
     subparagraph (A)(i); and
       ``(iii) provides for a period of not less than 30 calendar 
     days for public comment before issuing a final order or 
     withdrawing such proposed order.
       ``(C) In making a finding under subparagraph (A)(i) with 
     respect to a software function, the Secretary shall 
     consider--
       ``(i) the likelihood and severity of patient harm if the 
     software function were to not perform as intended;
       ``(ii) the extent to which the software function is 
     intended to support the clinical judgment of a health care 
     professional;
       ``(iii) whether there is a reasonable opportunity for a 
     health care professional to review the basis of the 
     information or treatment recommendation provided by the 
     software function; and
       ``(iv) the intended user and user environment, such as 
     whether a health care professional will use a software 
     function of a type described in subparagraph (E) of paragraph 
     (1).
       ``(4) Nothing in this subsection shall be construed as 
     limiting the authority of the Secretary to--
       ``(A) exercise enforcement discretion as to any device 
     subject to regulation under this Act;
       ``(B) regulate software used in the manufacture and 
     transfusion of blood and blood components to assist in the 
     prevention of disease in humans; or
       ``(C) regulate software as a device under this Act if such 
     software meets the criteria under section 513(a)(1)(C).''.
       (b) Reports.--The Secretary of Health and Human Services 
     (referred to in this subsection as the ``Secretary''), after 
     consultation with agencies and offices of the Department of 
     Health and Human Services involved in health information 
     technology, shall publish a report, not later than 2 years 
     after the date of enactment of this Act and every 2 years 
     thereafter, that--
       (1) includes input from outside experts, such as 
     representatives of patients, consumers, health care 
     providers, startup companies, health plans or other third-
     party payers, venture capital investors, information 
     technology vendors, health information technology vendors, 
     small businesses, purchasers, employers, and other 
     stakeholders with relevant expertise, as determined by the 
     Secretary;
       (2) examines information available to the Secretary on any 
     risks and benefits to health associated with software 
     functions described in section 520(o)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360j) (as amended by 
     subsection (a)); and
       (3) summarizes findings regarding the impact of such 
     software functions on patient safety, including best 
     practices to promote safety, education, and competency 
     related to such functions.
       (c) Classification of Accessories.--Section 513(b) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is 
     amended by adding at the end the following:
       ``(9) The Secretary shall classify an accessory under this 
     section based on the intended use of the accessory, 
     notwithstanding the classification of any other device with 
     which such accessory is intended to be used.''.

[[Page H6925]]

       (d) Conforming Amendment.--Section 201(h) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) is amended by 
     adding at the end the following: ``The term `device' does not 
     include software functions excluded pursuant to section 
     520(o).''.

     Subtitle G--Improving Scientific Expertise and Outreach at FDA

     SEC. 3071. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND 
                   BIOMEDICAL PRODUCT ASSESSMENT SERVICE.

       (a) Hiring and Retention Authority.--Section 228 of the 
     Public Health Service Act (42 U.S.C. 237) is amended--
       (1) in the section heading, by inserting ``and biomedical 
     product assessment'' after ``research'';
       (2) in subsection (a)--
       (A) in paragraph (1), by striking ``Silvio O. Conte Senior 
     Biomedical Research Service, not to exceed 500 members'' and 
     inserting ``Silvio O. Conte Senior Biomedical Research and 
     Biomedical Product Assessment Service (in this section 
     referred to as the `Service'), not to exceed 2,000 members, 
     the purpose of which is to recruit and retain outstanding and 
     qualified scientific and technical experts in the fields of 
     biomedical research, clinical research evaluation, and 
     biomedical product assessment'';
       (B) by amending paragraph (2) to read as follows:
       ``(2) The authority established in paragraph (1) may not be 
     construed to require the Secretary to reduce the number of 
     employees serving under any other employment system in order 
     to offset the number of members serving in the Service.''; 
     and
       (C) by adding at the end the following:
       ``(3) The Secretary shall assign experts under this section 
     to agencies within the Department of Health and Human 
     Services taking into account the need for the expertise of 
     such expert.'';
       (3) in subsection (b)--
       (A) in the matter preceding paragraph (1), by striking ``or 
     clinical research evaluation'' and inserting ``, clinical 
     research evaluation, or biomedical product assessment''; and
       (B) in paragraph (1), by inserting ``or a doctoral or 
     master's level degree in engineering, bioinformatics, or a 
     related or emerging field,'' after the comma;
       (4) in subsection (d)(2), by striking ``and shall not 
     exceed the rate payable for level I of the Executive Schedule 
     unless approved by the President under section 5377(d)(2) of 
     title 5, United States Code'' and inserting ``and shall not 
     exceed the amount of annual compensation (excluding expenses) 
     specified in section 102 of title 3, United States Code'';
       (5) by striking subsection (e); and
       (6) by redesignating subsections (f) and (g) as subsections 
     (e) and (f), respectively.
       (b) GAO Study.--
       (1) In general.--The Comptroller General of the United 
     States shall conduct a study of the effectiveness of the 
     amendments to section 228 of the Public Health Service Act 
     (42 U.S.C. 237) made by subsection (a) and the impact of such 
     amendments, if any, on all agencies or departments of the 
     Department of Health and Human Services, and, not later than 
     4 years after the date of enactment of this Act, shall submit 
     a report based on such study to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives.
       (2) Content of study and report.--The study and report 
     under paragraph (1) shall include an examination of the 
     extent to which recruitment and retention of outstanding and 
     qualified scientific, medical, or technical experts in the 
     fields of biomedical research, clinical research evaluation, 
     and biomedical product assessment have improved or otherwise 
     have been affected by the amendments to section 228 of the 
     Public Health Service Act (42 U.S.C. 237) made by subsection 
     (a), including by determining, during the period between the 
     date of enactment of this Act and the completion of the 
     study--
       (A) the total number of members recruited and retained 
     under the Senior Biomedical Research and Biomedical Product 
     Assessment Service under such section 228, and the effect of 
     increasing the number of members eligible for such Service;
       (B) the number of members of such Senior Biomedical 
     Research and Biomedical Product Assessment Service hired with 
     a doctoral level degree in biomedicine or a related field, 
     and the number of such members hired with a doctoral or 
     master's level degree in engineering, bioinformatics, or a 
     related or emerging field; and
       (C) the number of Senior Biomedical Research and Biomedical 
     Product Assessment Service members that have been hired by 
     each agency or department of the Department of Health and 
     Human Services, and how such Department assigns such members 
     to each agency or department.

     SEC. 3072. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND 
                   PROFESSIONAL PERSONNEL.

       (a) In General.--The Federal Food, Drug, and Cosmetic Act 
     is amended by inserting after section 714 (21 U.S.C. 379d-3) 
     the following:

     ``SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND 
                   PROFESSIONAL PERSONNEL.

       ``(a) In General.--The Secretary may, notwithstanding title 
     5, United States Code, governing appointments in the 
     competitive service, appoint outstanding and qualified 
     candidates to scientific, technical, or professional 
     positions that support the development, review, and 
     regulation of medical products. Such positions shall be 
     within the competitive service.
       ``(b) Compensation.--
       ``(1) In general.--Notwithstanding any other provision of 
     law, including any requirement with respect to General 
     Schedule pay rates under subchapter III of chapter 53 of 
     title 5, United States Code, and consistent with the 
     requirements of paragraph (2), the Commissioner of Food and 
     Drugs may determine and set--
       ``(A) the annual rate of pay of any individual appointed 
     under subsection (a); and
       ``(B) for purposes of retaining qualified employees, the 
     annual rate of pay for any qualified scientific, technical, 
     or professional personnel appointed to a position described 
     in subsection (a) before the date of enactment of the 21st 
     Century Cures Act.
       ``(2) Limitation.--The annual rate of pay established 
     pursuant to paragraph (1) may not exceed the amount of annual 
     compensation (excluding expenses) specified in section 102 of 
     title 3, United States Code.
       ``(3) Public availability.--The annual rate of pay provided 
     to an individual in accordance with this section shall be 
     publicly available information.
       ``(c) Rule of Construction.--The authorities under this 
     section shall not be construed to affect the authority 
     provided under section 714.
       ``(d) Report on Workforce Planning.--
       ``(1) In general.--Not later than 18 months after the date 
     of enactment of the 21st Century Cures Act, the Secretary 
     shall submit a report on workforce planning to the Committee 
     on Health, Education, Labor, and Pensions of the Senate and 
     the Committee on Energy and Commerce of the House of 
     Representatives that examines the extent to which the Food 
     and Drug Administration has a critical need for qualified 
     individuals for scientific, technical, or professional 
     positions, including--
       ``(A) an analysis of the workforce needs at the Food and 
     Drug Administration and the Secretary's strategic plan for 
     addressing such needs, including through use of the authority 
     under this section; and
       ``(B) a recruitment and retention plan for hiring qualified 
     scientific, technical, and professional candidates, which may 
     include the use of--
       ``(i) recruitment through nongovernmental recruitment or 
     placement agencies;
       ``(ii) recruitment through academic institutions;
       ``(iii) recruitment or hiring bonuses, if applicable;
       ``(iv) recruitment using targeted direct hiring 
     authorities; and
       ``(v) retention of qualified scientific, technical, and 
     professional employees using the authority under this 
     section, or other applicable authorities of the Secretary.
       ``(2) Recommendations.--The report under paragraph (1) may 
     include the recommendations of the Commissioner of Food and 
     Drugs that would help the Food and Drug Administration to 
     better recruit and retain qualified individuals for 
     scientific, technical, or professional positions at the 
     agency.''.
       (b) GAO Study and Report.--
       (1) In general.--The Comptroller General of the United 
     States shall conduct a study of the ability of the Food and 
     Drug Administration to hire, train, and retain qualified 
     scientific, technical, and professional staff, not including 
     contractors, necessary to fulfill the mission of the Food and 
     Drug Administration to protect and promote public health. Not 
     later than January 1, 2022, the Comptroller General shall 
     submit a report on such study to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives.
       (2) Contents of study.--The Comptroller General shall 
     include in the study and report under paragraph (1)--
       (A) information about the progress of the Food and Drug 
     Administration in recruiting and retaining qualified 
     scientific, technical, and professional staff outstanding in 
     the field of biomedical research, clinical research 
     evaluation, and biomedical product assessment;
       (B) the extent to which critical staffing needs exist at 
     the Food and Drug Administration, and barriers to hiring, 
     training, and retaining qualified staff, if any;
       (C) an examination of the recruitment and retention 
     strategies of the Food and Drug Administration, including 
     examining any strategic workforce plan, focused on improving 
     scientific, technical, and professional staff recruitment and 
     retention; and
       (D) recommendations for potential improvements that would 
     address staffing needs of the Food and Drug Administration.

     SEC. 3073. ESTABLISHMENT OF FOOD AND DRUG ADMINISTRATION 
                   INTERCENTER INSTITUTES.

       (a) In General.--Chapter X of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 1014. FOOD AND DRUG ADMINISTRATION INTERCENTER 
                   INSTITUTES.

       ``(a) In General.--The Secretary shall establish one or 
     more Intercenter Institutes within the Food and Drug 
     Administration (referred to in this section as an 
     `Institute') for a major disease area or areas. With respect 
     to the major disease area of focus of an Institute, such 
     Institute shall develop and implement processes for 
     coordination of activities, as applicable to such major 
     disease area or areas, among the Center for Drug Evaluation 
     and Research, the Center for Biologics Evaluation and 
     Research, and the Center for Devices and Radiological Health 
     (for the purposes of this section, referred to as the 
     `Centers'). Such activities may include--
       ``(1) coordination of staff from the Centers with diverse 
     product expertise in the diagnosis, cure, mitigation, 
     treatment, or prevention of the specific diseases relevant to 
     the major disease area of focus of the Institute;
       ``(2) streamlining, where appropriate, the review of 
     medical products to diagnose, cure, mitigate, treat, or 
     prevent the specific diseases relevant to the major disease 
     area of focus of the

[[Page H6926]]

     Institute, applying relevant standards under sections 505, 
     510(k), 513(f)(2), and 515 of this Act and section 351 of the 
     Public Health Service Act, and other applicable authorities;
       ``(3) promotion of scientific programs within the Centers 
     related to the major disease area of focus of the Institute;
       ``(4) development of programs and enhancement of strategies 
     to recruit, train, and provide continuing education 
     opportunities for the personnel of the Centers with expertise 
     related to the major disease area of focus of the Institute;
       ``(5) enhancement of the interactions of the Centers with 
     patients, sponsors, and the external biomedical community 
     regarding the major disease area of focus of the Institute; 
     and
       ``(6) facilitation of the collaborative relationships of 
     the Centers with other agencies within the Department of 
     Health and Human Services regarding the major disease area of 
     focus of the Institute.
       ``(b) Public Process.--The Secretary shall provide a period 
     for public comment during the time that each Institute is 
     being implemented.
       ``(c) Timing.--The Secretary shall establish at least one 
     Institute under subsection (a) before the date that is 1 year 
     after the date of enactment of the 21st Century Cures Act.
       ``(d) Termination of Institutes.--The Secretary may 
     terminate any Institute established pursuant to this section 
     if the Secretary determines such Institute is no longer 
     benefitting the public health. Not less than 60 days prior to 
     so terminating an Institute, the Secretary shall provide 
     public notice, including the rationale for such 
     termination.''.
       (b) Technical Amendments.--Chapter X of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended--
       (1) by redesignating section 1012 as section 1013; and
       (2) by redesignating the second section 1011 (with respect 
     to improving the training of State, local, territorial, and 
     tribal food safety officials), as added by section 209(a) of 
     the FDA Food Safety Modernization Act (Public Law 111-353), 
     as section 1012.

     SEC. 3074. SCIENTIFIC ENGAGEMENT.

       (a) In General.--Scientific meetings that are attended by 
     scientific or medical personnel, or other professionals, of 
     the Department of Health and Human Services for whom 
     attendance at such meeting is directly related to their 
     professional duties and the mission of the Department--
       (1) shall not be considered conferences for the purposes of 
     complying with Federal reporting requirements contained in 
     annual appropriations Acts or in this section; and
       (2) shall not be considered conferences for purposes of a 
     restriction contained in an annual appropriations Act, based 
     on Office of Management and Budget Memorandum M-12-12 or any 
     other regulation restricting travel to such meeting.
       (b) Limitation.--Nothing in this section shall be construed 
     to exempt travel for scientific meetings from Federal 
     regulations relating to travel.
       (c) Reports.--Not later than 90 days after the end of the 
     fiscal year, each operating division of the Department of 
     Health and Human Services shall prepare, and post on an 
     Internet website of the operating division, an annual report 
     on scientific meeting attendance and related travel spending 
     for each fiscal year. Such report shall include--
       (1) general information concerning the scientific meeting 
     activities involved;
       (2) information concerning the total amount expended for 
     such meetings;
       (3) a description of all such meetings that were attended 
     by scientific or medical personnel, or other professionals, 
     of each such operating division where the total amount 
     expended by the operating division associated with each such 
     meeting were in excess of $30,000, including--
       (A) the total amount of meeting expenses incurred by the 
     operating division for such meeting;
       (B) the location of such meeting;
       (C) the date of such meeting;
       (D) a brief explanation on how such meeting advanced the 
     mission of the operating division; and
       (E) the total number of individuals whose travel expenses 
     or other scientific meeting expenses were paid by the 
     operating division; and
       (4) with respect to any such meeting where the total 
     expenses to the operating division exceeded $150,000, a 
     description of the exceptional circumstances that 
     necessitated the expenditure of such amounts.

     SEC. 3075. DRUG SURVEILLANCE.

       (a) New Drugs.--Section 505(k)(5) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 355(k)(5)), as amended by 
     section 2074, is further amended--
       (1) in subparagraph (A), by striking ``, bi-weekly 
     screening'' and inserting ``screenings'';
       (2) in subparagraph (B), as redesignated by section 
     2074(1)(C), by striking the period at the end and inserting 
     ``; and''; and
       (3) by adding at the end the following:
       ``(C) make available on the Internet website of the Food 
     and Drug Administration--
       ``(i) guidelines, developed with input from experts 
     qualified by scientific training and experience to evaluate 
     the safety and effectiveness of drugs, that detail best 
     practices for drug safety surveillance using the Adverse 
     Event Reporting System; and
       ``(ii) criteria for public posting of adverse event 
     signals.''.
       (b) FAERS Revision.--Section 505(r)(2)(D) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(r)(2)(D)) is 
     amended by striking ``, by 18 months'' and all that follows 
     through the semicolon at the end of the subparagraph and 
     inserting ``and making publicly available on the Internet 
     website established under paragraph (1) best practices for 
     drug safety surveillance activities for drugs approved under 
     this section or section 351 of the Public Health Service 
     Act;''.
       (c) Risk Evaluation and Mitigation Strategies.--Section 
     505-1(f)(5) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355-1(f)(5)) is amended--
       (1) in the matter preceding subparagraph (A), by inserting 
     ``or other advisory committee'' after ``(or successor 
     committee)''; and
       (2) in subparagraph (B), by striking ``at least annually,'' 
     and inserting ``periodically''.

     SEC. 3076. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
                   ADMINISTRATION.

       (a) Board of Directors.--
       (1) Composition and size.--Section 770(d)(1)(C) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379dd(d)(1)(C)) is amended--
       (A) by redesignating clause (ii) as clause (iii);
       (B) by inserting after clause (i) the following:
       ``(ii) Additional members.--The Board, through amendments 
     to the bylaws of the Foundation, may provide that the number 
     of voting members of the Board shall be a number (to be 
     specified in such amendment) greater than 14. Any Board 
     positions that are established by any such amendment shall be 
     appointed (by majority vote) by the individuals who, as of 
     the date of such amendment, are voting members of the Board 
     and persons so appointed may represent any of the categories 
     specified in subclauses (I) through (V) of clause (i), so 
     long as no more than 30 percent of the total voting members 
     of the Board (including members whose positions are 
     established by such amendment) are representatives of the 
     general pharmaceutical, device, food, cosmetic, and 
     biotechnology industries.''; and
       (C) in clause (iii)(I), as redesignated by subparagraph 
     (A), by striking ``The ex officio members shall ensure'' and 
     inserting ``The ex officio members, acting pursuant to clause 
     (i), and the Board, acting pursuant to clause (ii), shall 
     ensure''.
       (2) Federal employees allowed to serve on board.--Clause 
     (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated 
     by paragraph (1)(A), is amended by adding at the end the 
     following: ``For purposes of this section, the term `employee 
     of the Federal Government' does not include a special 
     Government employee, as that term is defined in section 
     202(a) of title 18, United States Code.''.
       (3) Staggered terms.--Subparagraph (A) of section 770(d)(3) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379dd(d)(3)) is amended to read as follows:
       ``(A) Term.--The term of office of each member of the Board 
     appointed under paragraph (1)(C)(i), and the term of office 
     of any member of the Board whose position is established 
     pursuant to paragraph (1)(C)(ii), shall be 4 years, except 
     that--
       ``(i) the terms of offices for the members of the Board 
     initially appointed under paragraph (1)(C)(i) shall expire on 
     a staggered basis as determined by the ex officio members; 
     and
       ``(ii) the terms of office for the persons initially 
     appointed to positions established pursuant to paragraph 
     (1)(C)(ii) may be made to expire on a staggered basis, as 
     determined by the individuals who, as of the date of the 
     amendment establishing such positions, are members of the 
     Board.''.
       (b) Executive Director Compensation.--Section 770(g)(2) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379dd(g)(2)) is amended by striking ``but shall not be 
     greater than the compensation of the Commissioner''.
       (c) Separation of Funds.--Section 770(m) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(m)) is amended 
     by striking ``are held in separate accounts from funds 
     received from entities under subsection (i)'' and inserting 
     ``are managed as individual programmatic funds under 
     subsection (i), according to best accounting practices''.

             Subtitle H--Medical Countermeasures Innovation

     SEC. 3081. MEDICAL COUNTERMEASURE GUIDELINES.

       Section 319F-2 of the Public Health Service Act (42 U.S.C. 
     247d-6b) is amended--
       (1) in subsection (a), by adding at the end the following:
       ``(3) Utilization guidelines.--The Secretary shall ensure 
     timely and accurate recommended utilization guidelines for 
     qualified countermeasures (as defined in section 319F-1), 
     qualified pandemic and epidemic products (as defined in 
     section 319F-3), and security countermeasures (as defined in 
     subsection (c)), including for such products in the 
     stockpile.''; and
       (2) in subsection (g)--
       (A) by amending paragraph (4) to read as follows:
       ``(4) Report on security countermeasure procurement.--Not 
     later than March 1 of each year in which the Secretary 
     determines that the amount of funds available for procurement 
     of security countermeasures is less than $1,500,000,000, the 
     Secretary shall submit to the Committee on Appropriations and 
     the Committee on Health, Education, Labor, and Pensions of 
     the Senate and the Committee on Appropriations and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report detailing the amount of such funds 
     available for procurement and the impact such amount of 
     funding will have--
       ``(A) in meeting the security countermeasure needs 
     identified under this section; and
       ``(B) on the annual Public Health Emergency Medical 
     Countermeasures Enterprise and Strategy Implementation Plan 
     (pursuant to section 2811(d)).''.

     SEC. 3082. CLARIFYING BARDA CONTRACTING AUTHORITY.

       (a) In General.--Section 319F-2(g) of the Public Health 
     Service Act (42 U.S.C. 247d-6b(g)) is amended by adding at 
     the end the following:
       ``(5) Clarification on contracting authority.--The 
     Secretary, acting through the Director of the Biomedical 
     Advanced Research and

[[Page H6927]]

     Development Authority, shall carry out the programs funded by 
     the special reserve fund (for the procurement of security 
     countermeasures under subsection (c) and for carrying out 
     section 319L), including the execution of procurement 
     contracts, grants, and cooperative agreements pursuant to 
     this section and section 319L.''.
       (b) BARDA Contracting Authority.--Section 319L(c)(3) of the 
     Public Health Service Act (42 U.S.C. 247d-7c) is amended by 
     inserting ``, including the execution of procurement 
     contracts, grants, and cooperative agreements pursuant to 
     this section'' before the period.

     SEC. 3083. COUNTERMEASURE BUDGET PLAN.

       Section 2811(b)(7) of the Public Health Service Act (42 
     U.S.C. 300hh-10(b)(7)) is amended--
       (1) in the matter preceding subparagraph (A), by striking 
     the first sentence and inserting ``Develop, and update not 
     later than March 1 of each year, a coordinated 5-year budget 
     plan based on the medical countermeasure priorities described 
     in subsection (d), including with respect to chemical, 
     biological, radiological, and nuclear agent or agents that 
     may present a threat to the Nation, including such agents 
     that are novel or emerging infectious diseases, and the 
     corresponding efforts to develop qualified countermeasures 
     (as defined in section 319F-1), security countermeasures (as 
     defined in section 319F-2), and qualified pandemic or 
     epidemic products (as defined in section 319F-3) for each 
     such threat.'';
       (2) in subparagraph (C), by striking ``; and'' and 
     inserting a semicolon;
       (3) in subparagraph (D), by striking ``to the appropriate 
     committees of Congress upon request.'' and inserting ``, not 
     later than March 15 of each year, to the Committee on 
     Appropriations and the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Committee on 
     Appropriations and the Committee on Energy and Commerce of 
     the House of Representatives; and''; and
       (4) by adding at the end the following:
       ``(E) not later than March 15 of each year, be made 
     publicly available in a manner that does not compromise 
     national security.''.

     SEC. 3084. MEDICAL COUNTERMEASURES INNOVATION.

       Section 319L(c)(4) of the Public Health Service Act (42 
     U.S.C. 247d-7e(c)(4)) is amended by adding at the end the 
     following:
       ``(E) Medical countermeasures innovation partner.--
       ``(i) In general.--To support the purposes described in 
     paragraph (2), the Secretary, acting through the Director of 
     BARDA, may enter into an agreement (including through the use 
     of grants, contracts, cooperative agreements, or other 
     transactions as described in paragraph (5)) with an 
     independent, nonprofit entity to--

       ``(I) foster and accelerate the development and innovation 
     of medical countermeasures and technologies that may assist 
     advanced research and the development of qualified 
     countermeasures and qualified pandemic or epidemic products, 
     including through the use of strategic venture capital 
     practices and methods;
       ``(II) promote the development of new and promising 
     technologies that address urgent medical countermeasure 
     needs, as identified by the Secretary;
       ``(III) address unmet public health needs that are directly 
     related to medical countermeasure requirements, such as novel 
     antimicrobials for multidrug resistant organisms and multiuse 
     platform technologies for diagnostics, prophylaxis, vaccines, 
     and therapeutics; and
       ``(IV) provide expert consultation and advice to foster 
     viable medical countermeasure innovators, including helping 
     qualified countermeasure innovators navigate unique industry 
     challenges with respect to developing chemical, biological, 
     radiological, and nuclear countermeasure products.

       ``(ii) Eligibility.--

       ``(I) In general.--To be eligible to enter into an 
     agreement under clause (i) an entity shall--

       ``(aa) be an independent, nonprofit entity;
       ``(bb) have a demonstrated record of being able to create 
     linkages between innovators and investors and leverage such 
     partnerships and resources for the purpose of addressing 
     identified strategic needs of the Federal Government;
       ``(cc) have experience in promoting novel technology 
     innovation;
       ``(dd) be problem-driven and solution-focused based on the 
     needs, requirements, and problems identified by the Secretary 
     under clause (iv);
       ``(ee) demonstrate the ability, or the potential ability, 
     to promote the development of medical countermeasure 
     products;
       ``(ff) demonstrate expertise, or the capacity to develop or 
     acquire expertise, related to technical and regulatory 
     considerations with respect to medical countermeasures; and
       ``(gg) not be within the Department of Health and Human 
     Services.

       ``(II) Partnering experience.--In selecting an entity with 
     which to enter into an agreement under clause (i), the 
     Secretary shall place a high value on the demonstrated 
     experience of the entity in partnering with the Federal 
     Government to meet identified strategic needs.

       ``(iii) Not agency.--An entity that enters into an 
     agreement under clause (i) shall not be deemed to be a 
     Federal agency for any purpose, including for any purpose 
     under title 5, United States Code.
       ``(iv) Direction.--Pursuant to an agreement entered into 
     under this subparagraph, the Secretary, acting through the 
     Director of BARDA, shall provide direction to the entity that 
     enters into an agreement under clause (i). As part of this 
     agreement the Director of BARDA shall--

       ``(I) communicate the medical countermeasure needs, 
     requirements, and problems to be addressed by the entity 
     under the agreement;
       ``(II) develop a description of work to be performed by the 
     entity under the agreement;
       ``(III) provide technical feedback and appropriate 
     oversight over work carried out by the entity under the 
     agreement, including subsequent development and partnerships 
     consistent with the needs and requirements set forth in this 
     subparagraph;
       ``(IV) ensure fair consideration of products developed 
     under the agreement in order to maintain competition to the 
     maximum practical extent, as applicable and appropriate under 
     applicable provisions of this section; and
       ``(V) ensure, as a condition of the agreement that the 
     entity--

       ``(aa) has in place a comprehensive set of policies that 
     demonstrate a commitment to transparency and accountability;
       ``(bb) protects against conflicts of interest through a 
     comprehensive set of policies that address potential 
     conflicts of interest, ethics, disclosure, and reporting 
     requirements;
       ``(cc) provides monthly accounting on the use of funds 
     provided under such agreement; and
       ``(dd) provides on a quarterly basis, reports regarding the 
     progress made toward meeting the identified needs set forth 
     in the agreement.
       ``(v) Supplement not supplant.--Activities carried out 
     under this subparagraph shall supplement, and not supplant, 
     other activities carried out under this section.
       ``(vi) No establishment of entity.--To prevent unnecessary 
     duplication and target resources effectively, nothing in this 
     subparagraph shall be construed to authorize the Secretary to 
     establish within the Department of Health and Human Services 
     an entity for the purposes of carrying out this subparagraph.
       ``(vii) Transparency and oversight.--Upon request, the 
     Secretary shall provide to Congress the information provided 
     to the Secretary under clause (iv)(V)(dd).
       ``(viii) Independent evaluation.--Not later than 4 years 
     after the date of enactment of the 21st Century Cures Act, 
     the Comptroller General of the United States shall conduct an 
     independent evaluation, and submit to the Secretary and the 
     appropriate committees of Congress a report, concerning the 
     activities conducted under this subparagraph. Such report 
     shall include recommendations with respect to any agreement 
     or activities carried out pursuant to this subparagraph.
       ``(ix) Sunset.--This subparagraph shall have no force or 
     effect after September 30, 2022.''.

     SEC. 3085. STREAMLINING PROJECT BIOSHIELD PROCUREMENT.

       Section 319F-2(c) of the Public Health Service Act (42 
     U.S.C. 247d-6b(c)) is amended--
       (1) in paragraph (4)(A)(ii), by striking ``make a 
     recommendation under paragraph (6) that the special reserve 
     fund as defined in subsection (h) be made available for the 
     procurement of such countermeasure'' and inserting ``and 
     subject to the availability of appropriations, make available 
     the special reserve fund as defined in subsection (h) for 
     procurement of such countermeasure, as applicable'';
       (2) in paragraph (6)--
       (A) by striking subparagraphs (A), (B), and (E);
       (B) by redesignating subparagraphs (C) and (D) as 
     subparagraphs (A) and (B), respectively;
       (C) by amending subparagraph (A), as so redesignated, to 
     read as follows:
       ``(A) Notice to appropriate congressional committees.--The 
     Secretary shall notify the Committee on Appropriations and 
     the Committee on Health, Education, Labor, and Pensions of 
     the Senate and the Committee on Appropriations and the 
     Committee on Energy and Commerce of the House of 
     Representatives of each decision to make available the 
     special reserve fund as defined in subsection (h) for 
     procurement of a security countermeasure, including, where 
     available, the number of, the nature of, and other 
     information concerning potential suppliers of such 
     countermeasure, and whether other potential suppliers of the 
     same or similar countermeasures were considered and rejected 
     for procurement under this section and the reasons for each 
     such rejection.''; and
       (D) in the heading, by striking ``Recommendation for 
     president's approval'' and inserting ``Recommendations for 
     procurement''; and
       (3) in paragraph (7)--
       (A) by striking subparagraphs (A) and (B) and inserting the 
     following:
       ``(A) Payments from special reserve fund.--The special 
     reserve fund as defined in subsection (h) shall be available 
     for payments made by the Secretary to a vendor for 
     procurement of a security countermeasure in accordance with 
     the provisions of this paragraph.''; and
       (B) by redesignating subparagraph (C) as subparagraph (B).

     SEC. 3086. ENCOURAGING TREATMENTS FOR AGENTS THAT PRESENT A 
                   NATIONAL SECURITY THREAT.

       Subchapter E of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by 
     inserting after section 565 the following:

     ``SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR 
                   AGENTS THAT PRESENT NATIONAL SECURITY THREATS.

       ``(a) Definitions.--In this section:
       ``(1) Human drug application.--The term `human drug 
     application' has the meaning given such term in section 
     735(1).
       ``(2) Priority review.--The term `priority review', with 
     respect to a human drug application, means review and action 
     by the Secretary on such application not later than 6 months 
     after receipt by the Secretary of such application, as 
     described in the Manual of Policies and Procedures in the 
     Food and Drug Administration and goals identified in the 
     letters described in section 101(b) of the Food and Drug 
     Administration Safety and Innovation Act.
       ``(3) Priority review voucher.--The term `priority review 
     voucher' means a voucher

[[Page H6928]]

     issued by the Secretary to the sponsor of a material threat 
     medical countermeasure application that entitles the holder 
     of such voucher to priority review of a single human drug 
     application submitted under section 505(b)(1) or section 
     351(a) of the Public Health Service Act after the date of 
     approval of the material threat medical countermeasure 
     application.
       ``(4) Material threat medical countermeasure application.--
     The term `material threat medical countermeasure application' 
     means an application that--
       ``(A) is a human drug application for a drug intended for 
     use--
       ``(i) to prevent, or treat harm from a biological, 
     chemical, radiological, or nuclear agent identified as a 
     material threat under section 319F-2(c)(2)(A)(ii) of the 
     Public Health Service Act; or
       ``(ii) to mitigate, prevent, or treat harm from a condition 
     that may result in adverse health consequences or death and 
     may be caused by administering a drug, or biological product 
     against such agent; and
       ``(B) the Secretary determines eligible for priority 
     review;
       ``(C) is approved after the date of enactment of the 21st 
     Century Cures Act; and
       ``(D) is for a human drug, no active ingredient (including 
     any ester or salt of the active ingredient) of which has been 
     approved in any other application under section 505(b)(1) or 
     section 351(a) of the Public Health Service Act.
       ``(b) Priority Review Voucher.--
       ``(1) In general.--The Secretary shall award a priority 
     review voucher to the sponsor of a material threat medical 
     countermeasure application upon approval by the Secretary of 
     such material threat medical countermeasure application.
       ``(2) Transferability.--The sponsor of a material threat 
     medical countermeasure application that receives a priority 
     review voucher under this section may transfer (including by 
     sale) the entitlement to such voucher to a sponsor of a human 
     drug for which an application under section 505(b)(1) or 
     section 351(a) of the Public Health Service Act will be 
     submitted after the date of the approval of the material 
     threat medical countermeasure application. There is no limit 
     on the number of times a priority review voucher may be 
     transferred before such voucher is used.
       ``(3) Notification.--
       ``(A) In general.--The sponsor of a human drug application 
     shall notify the Secretary not later than 90 calendar days 
     prior to submission of the human drug application that is the 
     subject of a priority review voucher of an intent to submit 
     the human drug application, including the date on which the 
     sponsor intends to submit the application. Such notification 
     shall be a legally binding commitment to pay for the user fee 
     to be assessed in accordance with this section.
       ``(B) Transfer after notice.--The sponsor of a human drug 
     application that provides notification of the intent of such 
     sponsor to use the voucher for the human drug application 
     under subparagraph (A) may transfer the voucher after such 
     notification is provided, if such sponsor has not yet 
     submitted the human drug application described in the 
     notification.
       ``(c) Priority Review User Fee.--
       ``(1) In general.--The Secretary shall establish a user fee 
     program under which a sponsor of a human drug application 
     that is the subject of a priority review voucher shall pay to 
     the Secretary a fee determined under paragraph (2). Such fee 
     shall be in addition to any fee required to be submitted by 
     the sponsor under chapter VII.
       ``(2) Fee amount.--The amount of the priority review user 
     fee shall be determined each fiscal year by the Secretary and 
     based on the average cost incurred by the agency in the 
     review of a human drug application subject to priority review 
     in the previous fiscal year.
       ``(3) Annual fee setting.--The Secretary shall establish, 
     before the beginning of each fiscal year beginning after 
     September 30, 2016, for that fiscal year, the amount of the 
     priority review user fee.
       ``(4) Payment.--
       ``(A) In general.--The priority review user fee required by 
     this subsection shall be due upon the submission of a human 
     drug application under section 505(b)(1) or section 351(a) of 
     the Public Health Service Act for which the priority review 
     voucher is used.
       ``(B) Complete application.--An application described under 
     subparagraph (A) for which the sponsor requests the use of a 
     priority review voucher shall be considered incomplete if the 
     fee required by this subsection and all other applicable user 
     fees are not paid in accordance with the Secretary's 
     procedures for paying such fees.
       ``(C) No waivers, exemptions, reductions, or refunds.--The 
     Secretary may not grant a waiver, exemption, reduction, or 
     refund of any fees due and payable under this section.
       ``(5) Offsetting collections.--Fees collected pursuant to 
     this subsection for any fiscal year--
       ``(A) shall be deposited and credited as offsetting 
     collections to the account providing appropriations to the 
     Food and Drug Administration; and
       ``(6) shall not be collected for any fiscal year except to 
     the extent provided in advance in appropriation Acts.
       ``(d) Notice of Issuance of Voucher and Approval of 
     Products Under Voucher.--The Secretary shall publish a notice 
     in the Federal Register and on the Internet website of the 
     Food and Drug Administration not later than 30 calendar days 
     after the occurrence of each of the following:
       ``(1) The Secretary issues a priority review voucher under 
     this section.
       ``(2) The Secretary approves a drug pursuant to an 
     application submitted under section 505(b) of this Act or 
     section 351(a) of the Public Health Service Act for which the 
     sponsor of the application used a priority review voucher 
     issued under this section.
       ``(e) Eligibility for Other Programs.--Nothing in this 
     section precludes a sponsor who seeks a priority review 
     voucher under this section from participating in any other 
     incentive program, including under this Act, except that no 
     sponsor of a material threat medical countermeasure 
     application may receive more than one priority review voucher 
     issued under any section of this Act with respect to such 
     drug.
       ``(f) Relation to Other Provisions.--The provisions of this 
     section shall supplement, not supplant, any other provisions 
     of this Act or the Public Health Service Act that encourage 
     the development of medical countermeasures.
       ``(g) Sunset.--The Secretary may not award any priority 
     review vouchers under subsection (b) after October 1, 
     2023.''.

     SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC 
                   HEALTH EMERGENCY.

       Section 319 of the Public Health Service Act (42 U.S.C. 
     247d) is amended by adding at the end the following:
       ``(f) Determination With Respect to Paperwork Reduction Act 
     Waiver During a Public Health Emergency.--
       ``(1) Determination.--If the Secretary determines, after 
     consultation with such public health officials as may be 
     necessary, that--
       ``(A)(i) the criteria set forth for a public health 
     emergency under paragraph (1) or (2) of subsection (a) has 
     been met; or
       ``(ii) a disease or disorder, including a novel and 
     emerging public health threat, is significantly likely to 
     become a public health emergency; and
       ``(B) the circumstances of such public health emergency, or 
     potential for such significantly likely public health 
     emergency, including the specific preparation for and 
     response to such public health emergency or threat, 
     necessitate a waiver from the requirements of subchapter I of 
     chapter 35 of title 44, United States Code (commonly referred 
     to as the Paperwork Reduction Act),

     then the requirements of such subchapter I with respect to 
     voluntary collection of information shall not be applicable 
     during the immediate investigation of, and response to, such 
     public health emergency during the period of such public 
     health emergency or the period of time necessary to determine 
     if a disease or disorder, including a novel and emerging 
     public health threat, will become a public health emergency 
     as provided for in this paragraph. The requirements of such 
     subchapter I with respect to voluntary collection of 
     information shall not be applicable during the immediate 
     postresponse review regarding such public health emergency if 
     such immediate postresponse review does not exceed a 
     reasonable length of time.
       ``(2) Transparency.--If the Secretary determines that a 
     waiver is necessary under paragraph (1), the Secretary shall 
     promptly post on the Internet website of the Department of 
     Health and Human Services a brief justification for such 
     waiver, the anticipated period of time such waiver will be in 
     effect, and the agencies and offices within the Department of 
     Health and Human Services to which such waiver shall apply, 
     and update such information posted on the Internet website of 
     the Department of Health and Human Services, as applicable.
       ``(3) Effectiveness of waiver.--Any waiver under this 
     subsection shall take effect on the date on which the 
     Secretary posts information on the Internet website as 
     provided for in this subsection.
       ``(4) Termination of waiver.--Upon determining that the 
     circumstances necessitating a waiver under paragraph (1) no 
     longer exist, the Secretary shall promptly update the 
     Internet website of the Department of Health and Human 
     Services to reflect the termination of such waiver.
       ``(5) Limitations.--
       ``(A) Period of waiver.--The period of a waiver under 
     paragraph (1) shall not exceed the period of time for the 
     related public health emergency, including a public health 
     emergency declared pursuant to subsection (a), and any 
     immediate postresponse review regarding the public health 
     emergency consistent with the requirements of this 
     subsection.
       ``(B) Subsequent compliance.--An initiative subject to a 
     waiver under paragraph (1) that is ongoing after the date on 
     which the waiver expires, shall be subject to the 
     requirements of subchapter I of chapter 35 of title 44, 
     United States Code, and the Secretary shall ensure that 
     compliance with such requirements occurs in as timely a 
     manner as possible based on the applicable circumstances, but 
     not to exceed 30 calendar days after the expiration of the 
     applicable waiver.''.

     SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION EMERGENCY 
                   USE AUTHORIZATION.

       (a) Authorization for Medical Products for Use in 
     Emergencies.--Section 564 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb-3) is amended--
       (1) in subsection (a)(2)--
       (A) in subparagraph (A)--
       (i) by striking ``or 515'' and inserting ``512, or 515''; 
     and
       (ii) by inserting ``or conditionally approved under section 
     571 of this Act'' after ``Public Health Service Act''; and
       (B) in subparagraph (B), by inserting ``conditionally 
     approved under section 571,'' after ``approved,'' each place 
     the term appears;
       (2) in subsection (b)(4), by striking the second comma 
     after ``determination'';
       (3) in subsection (e)(3)(B), by striking ``section 503(b)'' 
     and inserting ``subsection (b) or (f) of section 503 or under 
     section 504'';
       (4) in subsection (f)(2)--
       (A) by inserting ``, or an animal to which,'' after ``to a 
     patient to whom''; and

[[Page H6929]]

       (B) by inserting ``or by the veterinarian caring for such 
     animal, as applicable'' after ``attending physician'';
       (5) in subsection (g)(1), by inserting ``conditional 
     approval under section 571,'' after ``approval,'';
       (6) in subsection (h)(1), by striking ``or section 
     520(g)''and inserting ``512(j), or 520(g)''; and
       (7) in subsection (k), by striking ``section 520(g),''and 
     inserting ``512(j), or 520(g)''.
       (b) New Animal Drugs.--Section 512(a)(1) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360b(a)(1)) is 
     amended--
       (1) in subparagraph (B), by striking ``or'' at the end;
       (2) in subparagraph (C), by striking the period and 
     inserting ``; or''; and
       (3) by inserting after subparagraph (C) the following:
       ``(D) there is in effect an authorization pursuant to 
     section 564 with respect to such use or intended use of such 
     drug, and such drug, its labeling, and such use conform to 
     any conditions of such authorization.''.
       (c) Emergency Use of Medical Products.--Section 564A of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a) is 
     amended--
       (1) in subsection (a)(1)(A), by inserting ``, conditionally 
     approved under section 571,'' after ``chapter''; and
       (2) in subsection (d), by striking ``sections 503(b) and 
     520(e)'' and inserting ``subsections (b) and (f) of section 
     503, section 504, and section 520(e)''.
       (d) Products Held for Emergency Use.--Section 564B(2) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-
     3b(2)) is amended--
       (1) in subparagraph (A)--
       (A) by inserting ``or conditionally approved under section 
     571 of this Act'' after ``Public Health Service Act''; and
       (B) by striking ``or 515'' and inserting ``512, or 515''; 
     and
       (2) in subparagraph (B), by striking ``or 520'' and 
     inserting ``512, or 520''.

         Subtitle I--Vaccine Access, Certainty, and Innovation

     SEC. 3091. PREDICTABLE REVIEW TIMELINES OF VACCINES BY THE 
                   ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES.

       (a) Consideration of New Vaccines.--Upon the licensure of 
     any vaccine or any new indication for a vaccine, the Advisory 
     Committee on Immunization Practices (in this section referred 
     to as the ``Advisory Committee'') shall, as appropriate, 
     consider the use of the vaccine at its next regularly 
     scheduled meeting.
       (b) Additional Information.--If the Advisory Committee does 
     not make a recommendation with respect to the use of a 
     vaccine at the Advisory Committee's first regularly scheduled 
     meeting after the licensure of the vaccine or any new 
     indication for the vaccine, the Advisory Committee shall 
     provide an update on the status of such committee's review.
       (c) Consideration for Breakthrough Therapies and for 
     Potential Use During Public Health Emergency.--The Advisory 
     Committee shall make recommendations with respect to the use 
     of certain vaccines in a timely manner, as appropriate, 
     including vaccines that--
       (1) are designated as a breakthrough therapy under section 
     506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     356) and licensed under section 351 of the Public Health 
     Service Act (42 U.S.C. 262); or
       (2) could be used in a public health emergency.
       (d) Definition.--In this section, the terms ``Advisory 
     Committee on Immunization Practices'' and ``Advisory 
     Committee'' mean the Advisory Committee on Immunization 
     Practices established by the Secretary pursuant to section 
     222 of the Public Health Service Act (42 U.S.C. 217a), acting 
     through the Director of the Centers for Disease Control and 
     Prevention.''.

     SEC. 3092. REVIEW OF PROCESSES AND CONSISTENCY OF ADVISORY 
                   COMMITTEE ON IMMUNIZATION PRACTICES 
                   RECOMMENDATIONS.

       (a) Review.--The Director of the Centers for Disease 
     Control and Prevention shall conduct a review of the 
     processes used by the Advisory Committee on Immunization 
     Practices in formulating and issuing recommendations 
     pertaining to vaccines, including with respect to 
     consistency.
       (b) Considerations.--The review under subsection (a) shall 
     include an assessment of--
       (1) the criteria used to evaluate new and existing 
     vaccines, including the identification of any areas for which 
     flexibility in evaluating such criteria is necessary and the 
     reason for such flexibility;
       (2) the Grading of Recommendations, Assessment, 
     Development, and Evaluation (GRADE) approach to the review 
     and analysis of scientific and economic data, including the 
     scientific basis for such approach; and
       (3) the extent to which the processes used by the work 
     groups of the Advisory Committee on Immunization Practices 
     are consistent among such groups, including the 
     identification of reasons for any variation.
       (c) Stakeholders.--In carrying out the review under 
     subsection (a), the Director of the Centers for Disease 
     Control and Prevention shall solicit input from vaccine 
     stakeholders.
       (d) Report.--Not later than 18 months after the date of 
     enactment of this Act, the Director of the Centers for 
     Disease Control and Prevention shall submit to the 
     appropriate committees of the Congress, and make publicly 
     available, a report on the results of the review under 
     subsection (a), including any recommendations on improving 
     the consistency of the processes described in such 
     subsection.
       (e) Definition.--In this section, the term ``Advisory 
     Committee on Immunization Practices'' means the Advisory 
     Committee on Immunization Practices established by the 
     Secretary of Health and Human Services pursuant to section 
     222 of the Public Health Service Act (42 U.S.C. 217a), acting 
     through the Director of the Centers for Disease Control and 
     Prevention.

     SEC. 3093. ENCOURAGING VACCINE INNOVATION.

       (a) Vaccine Meetings.--The Director of the Centers for 
     Disease Control and Prevention shall ensure that appropriate 
     staff within the relevant centers and divisions of the Office 
     of Infectious Diseases, and others, as appropriate, 
     coordinate with respect to the public health needs, 
     epidemiology, and program planning and implementation 
     considerations related to immunization, including with regard 
     to meetings with stakeholders related to such topics.
       (b) Report on Vaccine Innovation.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary''), 
     in collaboration with appropriate agencies or offices within 
     the Department of Health and Human Services, including the 
     National Institutes of Health, the Centers for Disease 
     Control and Prevention, the Food and Drug Administration, and 
     the Biomedical Advanced Research and Development Authority, 
     shall submit to the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives, and post publicly 
     on the Internet website of the Department of Health and Human 
     Services, a report on ways to promote innovation in the 
     development of vaccines that minimize the burden of 
     infectious disease.
       (2) Contents.--The report described in paragraph (1) shall 
     review the current status of vaccine development and, as 
     appropriate--
       (A) consider the optimal process to determine which 
     vaccines would be beneficial to public health and how 
     information on such vaccines is disseminated to key 
     stakeholders;
       (B) examine and identify whether obstacles exist that 
     inhibit the development of beneficial vaccines; and
       (C) make recommendations about how best to remove any 
     obstacles identified under subparagraph (B) in order to 
     promote and incentivize vaccine innovation and development.
       (3) Consultation.--In preparing the report under this 
     subsection, the Secretary may consult with--
       (A) representatives of relevant Federal agencies and 
     departments, including the Department of Defense and the 
     Department of Veterans Affairs;
       (B) academic researchers;
       (C) developers and manufacturers of vaccines;
       (D) medical and public health practitioners;
       (E) representatives of patient, policy, and advocacy 
     organizations; and
       (F) representatives of other entities, as the Secretary 
     determines appropriate.
       (c) Updates Related to Maternal Immunization.--
       (1) Additional vaccines.--Section 2114(e) of the Public 
     Health Service Act (42 U.S.C. 300aa-14(e)) is amended by 
     adding at the end the following:
       ``(3) Vaccines recommended for use in pregnant women.--The 
     Secretary shall revise the Vaccine Injury Table included in 
     subsection (a), through the process described in subsection 
     (c), to include vaccines recommended by the Centers for 
     Disease Control and Prevention for routine administration in 
     pregnant women and the information described in subparagraphs 
     (B) and (C) of paragraph (2) with respect to such 
     vaccines.''.
       (2) Petition content.--Section 2111 of the Public Health 
     Service Act (42 U.S.C. 300aa-11) is amended by adding at the 
     end the following:
       ``(f) Maternal Immunization.--
       ``(1) In general.--Notwithstanding any other provision of 
     law, for purposes of this subtitle, both a woman who received 
     a covered vaccine while pregnant and any child who was in 
     utero at the time such woman received the vaccine shall be 
     considered persons to whom the covered vaccine was 
     administered and persons who received the covered vaccine.
       ``(2) Definition.--As used in this subsection, the term 
     `child' shall have the meaning given that term by subsections 
     (a) and (b) of section 8 of title 1, United States Code, 
     except that, for purposes of this subsection, such section 8 
     shall be applied as if the term `include' in subsection (a) 
     of such section were replaced with the term `mean'.''.
       (3) Petitioners.--Section 2111(b)(2) of the Public Health 
     Service Act (42 U.S.C. 300aa-11(b)(2)) is amended by adding 
     ``A covered vaccine administered to a pregnant woman shall 
     constitute more than one administration, one to the mother 
     and one to each child (as such term is defined in subsection 
     (f)(2)) who was in utero at the time such woman was 
     administered the vaccine.'' at the end.

                   Subtitle J--Technical Corrections

     SEC. 3101. TECHNICAL CORRECTIONS.

       (a) FFDCA.--
       (1) References.--Except as otherwise expressly provided, 
     whenever in this subsection an amendment is expressed in 
     terms of an amendment to a section or other provision, the 
     reference shall be considered to be made to that section or 
     other provision of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 301 et seq.).
       (2) Amendments.--
       (A) Prohibited acts.--Section 301(r) (21 U.S.C. 331(r)) is 
     amended by inserting ``, drug,'' after ``device'' each place 
     the term appears.
       (B) New drugs.--Section 505 (21 U.S.C. 355) is amended--
       (i) in subsection (d), in the last sentence, by striking 
     ``premarket approval'' and inserting ``marketing approval''; 
     and
       (ii) in subsection (q)(5)(A), by striking ``subsection 
     (b)(2) or (j) of the Act or 351(k)'' and inserting 
     ``subsection (b)(2) or (j) of this section or section 
     351(k)''.

[[Page H6930]]

       (C) Risk evaluation and mitigation strategies.--Section 
     505-1(h)(21 U.S.C. 355-1(h)) is amended--
       (i) in paragraph (2)(A)(iii)--

       (I) in the clause heading, by striking ``label'' and 
     inserting ``labeling'';
       (II) by striking ``label'' each place the term appears and 
     inserting ``labeling''; and
       (III) by striking ``sponsor'' and inserting ``responsible 
     person''; and

       (ii) in paragraph (8), by striking ``and (7).'' and 
     inserting ``and (7)''.
       (D) Pediatric study plans.--Section 505B (21 U.S.C. 355c) 
     is amended--
       (i) in subsection (e)--

       (I) in paragraph (2)--

       (aa) in subparagraph (A), by inserting ``study'' after 
     ``initial pediatric'' each place the term appears; and
       (bb) in subparagraph (B), in the subparagraph heading, by 
     striking ``initial plan'' and inserting ``initial pediatric 
     study plan'';

       (II) in paragraph (5), in the paragraph heading, by 
     inserting ``agreed initial pediatric study'' before ``plan''; 
     and
       (III) in paragraph (6), by striking ``agreed initial 
     pediatric plan'' and inserting ``agreed initial pediatric 
     study plan''; and

       (ii) in subsection (f)(1), by inserting ``and any 
     significant amendments to such plans,'' after ``agreed 
     initial pediatric study plans,''.
       (E) Discontinuance or interruption in the production of 
     live-saving drugs.--Section 506C (21 U.S.C. 356c) is 
     amended--
       (i) in subsection (c), by striking ``discontinuation'' and 
     inserting ``discontinuance''; and
       (ii) in subsection (g)(1), by striking ``section 505(j) 
     that could help'' and inserting ``section 505(j), that could 
     help''.
       (F) Annual reporting on drug shortages.--Section 506C-1(a) 
     (21 U.S.C. 331(a)) is amended, in the matter before paragraph 
     (1)--
       (i) by striking ``Not later than the end of calendar year 
     2013, and not later than the end of each calendar year 
     thereafter,'' and inserting ``Not later than March 31 of each 
     calendar year,''; and
       (ii) by inserting ``, with respect to the preceding 
     calendar year,'' after ``a report''.
       (G) Drug shortage list.--Section 506E(b)(3)(E) (21 U.S.C. 
     356e(b)(3)(E)) is amended by striking ``discontinuation'' and 
     inserting ``discontinuance''.
       (H) Inspections of establishments.--Section 510(h) (21 
     U.S.C. 360(h)) is amended--
       (i) in paragraph (4), in the matter preceding subparagraph 
     (A), by striking ``establishing the risk-based scheduled'' 
     and inserting ``establishing a risk-based schedule''; and
       (ii) in paragraph (6)--

       (I) in subparagraph (A), by striking ``fiscal'' and 
     inserting ``calendar'' each place the term appears; and
       (II) in subparagraph (B), by striking ``an active 
     ingredient of a drug, a finished drug product, or an 
     excipient of a drug'' and inserting ``an active ingredient of 
     a drug or a finished drug product''.

       (I) Classification of devices intended for human use.--
     Section 513(f)(2)(A) (21 U.S.C. 360c(f)(2)(A)) is amended--
       (i) in clause (i), by striking ``within 30 days''; and
       (ii) in clause (iv), by striking ``low-moderate'' and 
     inserting ``low to moderate''.
       (J) Premarket approval.--Section 515(a)(1) (21 U.S.C. 
     360e(a)(1)) is amended by striking ``subject to a an order'' 
     and inserting ``subject to an order''.
       (K) Program to improve the device recall system.--Section 
     518A (21 U.S.C. 360h-1) is amended--
       (i) by striking subsection (c); and
       (ii) by redesignating subsection (d) as subsection (c).
       (L) Unique device identifier.--Section 519(f) (21 U.S.C. 
     360i(f)) is amended by striking ``and life sustaining'' and 
     inserting ``or life sustaining''.
       (M) Priority review to encourage treatments for tropical 
     diseases.--Section 524(c)(4)(A) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360n(c)(4)(A)) is amended by 
     striking ``Services Act'' and inserting ``Service Act''.
       (N) Priority review for qualified infectious disease 
     products.--Section 524A (21 U.S.C. 360n-1) is amended--
       (i) by striking ``If the Secretary'' and inserting the 
     following:
       ``(a) In General.--If the Secretary'';
       (ii) by striking ``any'' and inserting ``the first''; and
       (iii) by adding at the end the following:
       ``(b) Construction.--Nothing in this section shall prohibit 
     the Secretary from giving priority review to a human drug 
     application or efficacy supplement submitted for approval 
     under section 505(b) that otherwise meets the criteria for 
     the Secretary to grant priority review.''.
       (O) Consultation with external experts on rare diseases, 
     targeted therapies, and genetic targeting of treatments.--
     Section 569(a)(2)(A) (21 U.S.C. 360bbb-8(a)(2)(A)) is 
     amended, in the first sentence, by striking ``subsection 
     (c)'' and inserting ``subsection (b)''.
       (P) Optimizing global clinical trials.--Section 569A(c) (21 
     U.S.C. 360bbb-8a(c)) is amended by inserting ``or under the 
     Public Health Service Act'' after ``this Act''.
       (Q) Use of clinical investigation data from outside the 
     united states.--Section 569B (21 U.S.C. 360bbb-8b) is amended 
     by striking ``drug or device'' and inserting ``drug, 
     biological product, or device'' each place the term appears.
       (R) Medical gases definitions.--Section 575(1)(H) (21 
     U.S.C. 360ddd(1)(H)) is amended--
       (i) by inserting ``for a new drug'' after ``any period of 
     exclusivity''; and
       (ii) by inserting ``or any period of exclusivity for a new 
     animal drug under section 512(c)(2)(F),'' after ``section 
     505A,''.
       (S) Regulation of medical gases.--Section 576(a) (21 U.S.C. 
     360ddd-1(a)) is amended--
       (i) in the matter preceding subparagraph (A) of paragraph 
     (1), by inserting ``who seeks to initially introduce or 
     deliver for introduction a designated medical gas into 
     interstate commerce'' after ``any person''; and
       (ii) in paragraph (3)--

       (I) in subparagraph (A)--

       (aa) in clause (i)(VIII), by inserting ``for a new drug'' 
     after ``any period of exclusivity''; and
       (bb) in clause (ii), in the matter preceding subclause (I), 
     by inserting ``the'' before ``final use''; and

       (II) in subparagraph (B)--

       (aa) in clause (i), by inserting ``for a new drug'' after 
     ``any period of exclusivity''; and
       (bb) in clause (ii), by inserting a comma after ``drug 
     product''.
       (T) Inapplicability of drug fees to designated medical 
     gases.--Section 577 (21 U.S.C. 360ddd-2) is amended by 
     inserting ``or 740(a)'' after ``section 736(a)''.
       (U) Conflicts of interest.--Section 712(e)(1)(B) (21 U.S.C. 
     379d-1(e)(1)(B)) is amended by striking ``services'' and 
     inserting ``service''.
       (V) Authority to assess and use biosimilar biological 
     product fees.--Section 744H(a) (21 U.S.C. 379j-52(a)) is 
     amended--
       (i) in paragraph (1)(A)(v), by striking ``Biosimilars User 
     Fee Act of 2012'' and inserting ``Biosimilar User Fee Act of 
     2012''; and
       (ii) in paragraph (2)(B), by striking ``Biosimilars User 
     Fee Act of 2012'' and inserting ``Biosimilar User Fee Act of 
     2012''.
       (W) Registration of commercial importers.--
       (i) Amendment.--Section 801(s)(2) (21 U.S.C. 381(s)(2)) is 
     amended by adding at the end the following:
       ``(D) Effective date.--In establishing the effective date 
     of the regulations under subparagraph (A), the Secretary 
     shall, in consultation with the Secretary of Homeland 
     Security acting through U.S. Customs and Border Protection, 
     as determined appropriate by the Secretary of Health and 
     Human Services, provide a reasonable period of time for an 
     importer of a drug to comply with good importer practices, 
     taking into account differences among importers and types of 
     imports, including based on the level of risk posed by the 
     imported product.''.
       (ii) Conforming amendment.--Section 714 of the Food and 
     Drug Administration Safety and Innovation Act (Public Law 
     112-144; 126 Stat. 1074) is amended by striking subsection 
     (d).
       (X) Recognition of foreign government inspections.--Section 
     809(a)(2) (21 U.S.C. 384e(a)(2)) is amended by striking 
     ``conduction'' and inserting ``conducting''.
       (b) FDASIA.--
       (1) Findings relating to drug approval.--Section 
     901(a)(1)(A) of the Food and Drug Administration Safety and 
     Innovation Act (Public Law 112-144; 21 U.S.C. 356 note) is 
     amended by striking ``serious and life-threatening diseases'' 
     and inserting ``serious or life-threatening diseases''.
       (2) Reporting of inclusion of demographic subgroups.--
     Section 907 of the Food and Drug Administration Safety and 
     Innovation Act (Public Law 112-144; 126 Stat. 1092, 1093) is 
     amended--
       (A) in the section heading, by striking ``biologics'' in 
     the heading and inserting ``biological products''; and
       (B) in subsection (a)(2)(B), by striking ``applications for 
     new drug applications'' and inserting ``new drug 
     applications''.
       (3) Combating prescription drug abuse.--Section 1122 of the 
     Food and Drug Administration Safety and Innovation Act 
     (Public Law 112-144; 126 Stat. 1112, 1113) is amended--
       (A) in subsection (a)(2), by striking ``dependance'' and 
     inserting ``dependence''; and
       (B) in subsection (c), by striking ``promulgate'' and 
     inserting ``issue''.

     SEC. 3102. COMPLETED STUDIES.

       The Federal Food, Drug, and Cosmetic Act is amended--
       (1) in section 505(k)(5) (21 U.S.C. 355(k)(5))--
       (A) in subparagraph (A), by inserting ``and'' after the 
     semicolon;
       (B) by striking subparagraph (B); and
       (C) by redesignating subparagraph (C) as subparagraph (B);
       (2) in section 505A (21 U.S.C. 355a), by striking 
     subsection (p);
       (3) in section 505B (21 U.S.C. 355c)--
       (A) by striking subsection (l); and
       (B) by redesignating subsection (m) as subsection (l); and
       (4) in section 523 (21 U.S.C. 360m), by striking subsection 
     (d).

                           TITLE IV--DELIVERY

     SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING 
                   QUALITY OF CARE FOR PATIENTS.

       (a) In General.--The Health Information Technology for 
     Economic and Clinical Health Act (title XIII of division A of 
     Public Law 111-5) is amended--
       (1) by adding at the end of part 1 of subtitle A the 
     following:

     ``SEC. 13103. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING 
                   QUALITY OF CARE FOR PATIENTS.

       ``(a) Reduction in Burdens Goal.--The Secretary of Health 
     and Human Services (referred to in this section as the 
     `Secretary'), in consultation with providers of health 
     services, health care suppliers of services, health care 
     payers, health professional societies, health information 
     technology developers, health care quality organizations, 
     health care accreditation organizations, public health 
     entities, States, and other appropriate entities, shall, in 
     accordance with subsection (b)--
       ``(1) establish a goal with respect to the reduction of 
     regulatory or administrative burdens

[[Page H6931]]

     (such as documentation requirements) relating to the use of 
     electronic health records;
       ``(2) develop a strategy for meeting the goal established 
     under paragraph (1); and
       ``(3) develop recommendations for meeting the goal 
     established under paragraph (1).
       ``(b) Strategy and Recommendations.--
       ``(1) In general.--To achieve the goal established under 
     subsection (a)(1), the Secretary, in consultation with the 
     entities described in such subsection, shall, not later than 
     1 year after the date of enactment of the 21st Century Cures 
     Act, develop a strategy and recommendations to meet the goal 
     in accordance with this subsection.
       ``(2) Strategy.--The strategy developed under paragraph (1) 
     shall address the regulatory and administrative burdens (such 
     as documentation requirements) relating to the use of 
     electronic health records. Such strategy shall include broad 
     public comment and shall prioritize--
       ``(A)(i) incentives for meaningful use of certified EHR 
     technology for eligible professionals and hospitals under 
     sections 1848(a)(7) and 1886(b)(3)(B)(ix), respectively, of 
     the Social Security Act (42 U.S.C. 1395w-4(a)(7), 
     1395ww(b)(3)(B)(ix));
       ``(ii) the program for making payments under section 
     1903(a)(3)(F) of the Social Security Act (42 U.S.C. 
     1396b(a)(3)(F)) to encourage the adoption and use of 
     certified EHR technology by Medicaid providers;
       ``(iii) the Merit-based Incentive Payment System under 
     section 1848(q) of the Social Security Act (42 U.S.C. 1395w-
     4(q));
       ``(iv) alternative payment models (as defined in section 
     1833(z)(3)(C) of the Social Security Act (42 U.S.C. 
     1395l(z)(3)(C));
       ``(v) the Hospital Value-Based Purchasing Program under 
     section 1886(o) of the Social Security Act (42 U.S.C. 
     1395ww(o)); and
       ``(vi) other value-based payment programs, as the Secretary 
     determines appropriate;
       ``(B) health information technology certification;
       ``(C) standards and implementation specifications, as 
     appropriate;
       ``(D) activities that provide individuals access to their 
     electronic health information;
       ``(E) activities related to protecting the privacy of 
     electronic health information;
       ``(F) activities related to protecting the security of 
     electronic health information;
       ``(G) activities related to facilitating health and 
     clinical research;
       ``(H) activities related to public health;
       ``(I) activities related to aligning and simplifying 
     quality measures across Federal programs and other payers;
       ``(J) activities related to reporting clinical data for 
     administrative purposes; and
       ``(K) other areas, as the Secretary determines appropriate.
       ``(3) Recommendations.--The recommendations developed under 
     paragraph (1) shall address--
       ``(A) actions that improve the clinical documentation 
     experience;
       ``(B) actions that improve patient care;
       ``(C) actions to be taken by the Secretary and by other 
     entities; and
       ``(D) other areas, as the Secretary determines appropriate, 
     to reduce the reporting burden required of health care 
     providers.
       ``(4) FACA.--The Federal Advisory Committee Act (5 U.S.C. 
     App.) shall not apply to the development of the goal, 
     strategies, or recommendations described in this section.
       ``(c) Application of Certain Regulatory Requirements.--A 
     physician (as defined in section 1861(r)(1) of the Social 
     Security Act), to the extent consistent with applicable State 
     law, may delegate electronic medical record documentation 
     requirements specified in regulations promulgated by the 
     Centers for Medicare & Medicaid Services to a person 
     performing a scribe function who is not such physician if 
     such physician has signed and verified the documentation.''; 
     and
       (2) in the table of contents in section 13001(b), by 
     inserting after the item relating to section 13102 the 
     following:

``13103. Assisting doctors and hospitals in improving the quality and 
              care for patients.''.
       (b) Certification of Health Information Technology for 
     Medical Specialties and Sites of Service.--Section 3001(c)(5) 
     of the Public Health Service Act (42 U.S.C. 300jj-11(c)(5)) 
     is amended by adding at the end the following:
       ``(C) Health information technology for medical specialties 
     and sites of service.--
       ``(i) In general.--The National Coordinator shall 
     encourage, keep, or recognize, through existing authorities, 
     the voluntary certification of health information technology 
     under the program developed under subparagraph (A) for use in 
     medical specialties and sites of service for which no such 
     technology is available or where more technological 
     advancement or integration is needed.
       ``(ii) Specific medical specialties.--The Secretary shall 
     accept public comment on specific medical specialties and 
     sites of service, in addition to those described in clause 
     (i), for the purpose of selecting additional specialties and 
     sites of service as necessary.
       ``(iii) Health information technology for pediatrics.--Not 
     later than 18 months after the date of enactment of the 21st 
     Century Cures Act, the Secretary, in consultation with 
     relevant stakeholders, shall make recommendations for the 
     voluntary certification of health information technology for 
     use by pediatric health providers to support the health care 
     of children. Not later than 2 years after the date of 
     enactment of the 21st Century Cures Act, the Secretary shall 
     adopt certification criteria under section 3004 to support 
     the voluntary certification of health information technology 
     for use by pediatric health providers to support the health 
     care of children.''.
       (c) Meaningful Use Statistics.--
       (1) In general.--Not later than 6 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall submit to the HIT Advisory Committee of the 
     Office of the National Coordinator for Health Information 
     Technology, a report concerning attestation statistics for 
     the Medicare and Medicaid EHR Meaningful Use Incentive 
     programs to assist in informing standards adoption and 
     related practices. Such statistics shall include attestation 
     information delineated by State, including, to the extent 
     practicable, the number of providers who did not meet the 
     minimum criteria necessary to attest for the Medicare and 
     Medicaid EHR Meaningful Use Incentive programs for a calendar 
     year, and shall be made publicly available on the Internet 
     website of the Secretary on at least a quarterly basis.
       (2) Authority to alter format.--The Secretary of Health and 
     Human Services may alter the format of the reports on the 
     attestation of eligible health care professionals following 
     the first performance year of the Merit-based Incentive 
     Payment System to account for changes arising from the 
     implementation of such payment system.

     SEC. 4002. TRANSPARENT REPORTING ON USABILITY, SECURITY, AND 
                   FUNCTIONALITY.

       (a) Enhancements to Certification.--Section 3001(c)(5) of 
     the Public Health Service Act (42 U.S.C. 300jj-11), as 
     amended by section 4001(b), is further amended by adding at 
     the end the following:
       ``(D) Conditions of certification.--Not later than 1 year 
     after the date of enactment of the 21st Century Cures Act, 
     the Secretary, through notice and comment rulemaking, shall 
     require, as a condition of certification and maintenance of 
     certification for programs maintained or recognized under 
     this paragraph, consistent with other conditions and 
     requirements under this title, that the health information 
     technology developer or entity--
       ``(i) does not take any action that constitutes information 
     blocking as defined in section 3022(a);
       ``(ii) provides assurances satisfactory to the Secretary 
     that such developer or entity, unless for legitimate purposes 
     specified by the Secretary, will not take any action 
     described in clause (i) or any other action that may inhibit 
     the appropriate exchange, access, and use of electronic 
     health information;
       ``(iii) does not prohibit or restrict communication 
     regarding--

       ``(I) the usability of the health information technology;
       ``(II) the interoperability of the health information 
     technology;
       ``(III) the security of the health information technology;
       ``(IV) relevant information regarding users' experiences 
     when using the health information technology;
       ``(V) the business practices of developers of health 
     information technology related to exchanging electronic 
     health information; and
       ``(VI) the manner in which a user of the health information 
     technology has used such technology;

       ``(iv) has published application programming interfaces and 
     allows health information from such technology to be 
     accessed, exchanged, and used without special effort through 
     the use of application programming interfaces or successor 
     technology or standards, as provided for under applicable 
     law, including providing access to all data elements of a 
     patient's electronic health record to the extent permissible 
     under applicable privacy laws;
       ``(v) has successfully tested the real world use of the 
     technology for interoperability (as defined in section 3000) 
     in the type of setting in which such technology would be 
     marketed;
       ``(vi) provides to the Secretary an attestation that the 
     developer or entity--

       ``(I) has not engaged in any of the conduct described in 
     clause (i);
       ``(II) has provided assurances satisfactory to the 
     Secretary in accordance with clause (ii);
       ``(III) does not prohibit or restrict communication as 
     described in clause (iii);
       ``(IV) has published information in accordance with clause 
     (iv);
       ``(V) ensures that its technology allows for health 
     information to be exchanged, accessed, and used, in the 
     manner described in clause (iv); and
       ``(VI) has undertaken real world testing as described in 
     clause (v); and

       ``(vii) submits reporting criteria in accordance with 
     section 3009A(b).''.
       ``(E) Compliance with conditions of certification.--The 
     Secretary may encourage compliance with the conditions of 
     certification described in subparagraph (D) and take action 
     to discourage noncompliance, as appropriate.''.
       (b) EHR Significant Hardship Exception.--
       (1) Application to eligible professionals.--
       (A) In case of decertification.--Section 1848(a)(7)(B) of 
     the Social Security Act (42 U.S.C. 1395w-4(a)(7)(B)) is 
     amended by inserting after the first sentence the following 
     new sentence: ``The Secretary shall exempt an eligible 
     professional from the application of the payment adjustment 
     under subparagraph (A) with respect to a year, subject to 
     annual renewal, if the Secretary determines that compliance 
     with the requirement for being a meaningful EHR user is not 
     possible because the certified EHR technology used by such 
     professional has been decertified under a program kept or 
     recognized pursuant to section 3001(c)(5) of the Public 
     Health Service Act.''.
       (B) Continued application under mips.--Section 
     1848(o)(2)(D) of the Social Security Act (42 U.S.C. 1395w-
     4(o)(2)(D)) is amended by adding at the end the following new 
     sentence: ``The

[[Page H6932]]

     provisions of subparagraphs (B) and (D) of subsection (a)(7), 
     shall apply to assessments of MIPS eligible professionals 
     under subsection (q) with respect to the performance category 
     described in subsection (q)(2)(A)(iv) in an appropriate 
     manner which may be similar to the manner in which such 
     provisions apply with respect to payment adjustments made 
     under subsection (a)(7)(A).''.
       (2) Application to eligible hospitals.--Section 
     1886(b)(3)(B)(ix)(II) of the Social Security Act (42 U.S.C. 
     1395ww(b)(3)(B)(ix)(II)) is amended by inserting after the 
     first sentence the following new sentence: ``The Secretary 
     shall exempt an eligible hospital from the application of the 
     payment adjustment under subclause (I) with respect to a 
     fiscal year, subject to annual renewal, if the Secretary 
     determines that compliance with the requirement for being a 
     meaningful EHR user is not possible because the certified EHR 
     technology used by such hospital is decertified under a 
     program kept or recognized pursuant to section 3001(c)(5) of 
     the Public Health Service Act.''.
       (c) Electronic Health Record Reporting Program.--Subtitle A 
     of title XXX of the Public Health Service Act (42 U.S.C. 
     300jj-11 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 3009A. ELECTRONIC HEALTH RECORD REPORTING PROGRAM.

       ``(a) Reporting Criteria.--
       ``(1) Convening of stakeholders.--Not later than 1 year 
     after the date of enactment of the 21st Century Cures Act, 
     the Secretary shall convene stakeholders, as described in 
     paragraph (2), for the purpose of developing the reporting 
     criteria in accordance with paragraph (3).
       ``(2) Development of reporting criteria.--The reporting 
     criteria under this subsection shall be developed through a 
     public, transparent process that reflects input from relevant 
     stakeholders, including--
       ``(A) health care providers, including primary care and 
     specialty care health care professionals;
       ``(B) hospitals and hospital systems;
       ``(C) health information technology developers;
       ``(D) patients, consumers, and their advocates;
       ``(E) data sharing networks, such as health information 
     exchanges;
       ``(F) authorized certification bodies and testing 
     laboratories;
       ``(G) security experts;
       ``(H) relevant manufacturers of medical devices;
       ``(I) experts in health information technology market 
     economics;
       ``(J) public and private entities engaged in the evaluation 
     of health information technology performance;
       ``(K) quality organizations, including the consensus based 
     entity described in section 1890 of the Social Security Act;
       ``(L) experts in human factors engineering and the 
     measurement of user-centered design; and
       ``(M) other entities or individuals, as the Secretary 
     determines appropriate.
       ``(3) Considerations for reporting criteria.--The reporting 
     criteria developed under this subsection--
       ``(A) shall include measures that reflect categories 
     including--
       ``(i) security;
       ``(ii) usability and user-centered design;
       ``(iii) interoperability;
       ``(iv) conformance to certification testing; and
       ``(v) other categories, as appropriate to measure the 
     performance of electronic health record technology;
       ``(B) may include categories such as--
       ``(i) enabling the user to order and view the results of 
     laboratory tests, imaging tests, and other diagnostic tests;
       ``(ii) submitting, editing, and retrieving data from 
     registries such as clinician-led clinical data registries;
       ``(iii) accessing and exchanging information and data from 
     and through health information exchanges;
       ``(iv) accessing and exchanging information and data from 
     medical devices;
       ``(v) accessing and exchanging information and data held by 
     Federal, State, and local agencies and other applicable 
     entities useful to a health care provider or other applicable 
     user in the furtherance of patient care;
       ``(vi) accessing and exchanging information from other 
     health care providers or applicable users;
       ``(vii) accessing and exchanging patient generated 
     information;
       ``(viii) providing the patient or an authorized designee 
     with a complete copy of their health information from an 
     electronic record in a computable format;
       ``(ix) providing accurate patient information for the 
     correct patient, including exchanging such information, and 
     avoiding the duplication of patients records; and
       ``(x) other categories regarding performance, 
     accessibility, as the Secretary determines appropriate; and
       ``(C) shall be designed to ensure that small and startup 
     health information technology developers are not unduly 
     disadvantaged by the reporting criteria.
       ``(4) Modifications.--After the reporting criteria have 
     been developed under paragraph (3), the Secretary may convene 
     stakeholders and conduct a public comment period for the 
     purpose of modifying the reporting criteria developed under 
     such paragraph.
       ``(b) Participation.--As a condition of maintaining 
     certification under section 3001(c)(5)(D), a developer of 
     certified electronic health records shall submit to an 
     appropriate recipient of a grant, contract, or agreement 
     under subsection (c)(1) responses to the criteria developed 
     under subsection (a), with respect to all certified 
     technology offered by such developer.
       ``(c) Reporting Program.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of the 21st Century Cures Act, the Secretary shall 
     award grants, contracts, or agreements to independent 
     entities on a competitive basis to support the convening of 
     stakeholders as described in subsection (a)(2), collect the 
     information required to be reported in accordance with the 
     criteria established as described subsection (a)(3), and 
     develop and implement a process in accordance with paragraph 
     (5) and report such information to the Secretary.
       ``(2) Applications.--An independent entity that seeks a 
     grant, contract, or agreement under this subsection shall 
     submit an application to the Secretary at such time, in such 
     manner, and containing such information as the Secretary may 
     reasonably require, including a description of--
       ``(A) the proposed method for reviewing and summarizing 
     information gathered based on reporting criteria established 
     under subsection (a);
       ``(B) if applicable, the intended focus on a specific 
     subset of certified electronic health record technology 
     users, such as health care providers, including primary care, 
     specialty care, and care provided in rural settings; 
     hospitals and hospital systems; and patients, consumers, and 
     patients and consumer advocates;
       ``(C) the plan for widely distributing reports described in 
     paragraph (6);
       ``(D) the period for which the grant, contract, or 
     agreement is requested, which may be up to 2 years; and
       ``(E) the budget for reporting program participation, and 
     whether the eligible independent entity intends to continue 
     participation after the period of the grant, contract, or 
     agreement.
       ``(3) Considerations for independent entities.--In awarding 
     grants, contracts, and agreements under paragraph (1), the 
     Secretary shall give priority to independent entities with 
     appropriate expertise in health information technology 
     usability, interoperability, and security (especially 
     entities with such expertise in electronic health records) 
     with respect to--
       ``(A) health care providers, including primary care, 
     specialty care, and care provided in rural settings;
       ``(B) hospitals and hospital systems; and
       ``(C) patients, consumers, and patient and consumer 
     advocates.
       ``(4) Limitations.--
       ``(A) Assessment and redetermination.--Not later than 4 
     years after the date of enactment of the 21st Century Cures 
     Act and every 2 years thereafter, the Secretary, in 
     consultation with stakeholders, shall--
       ``(i) assess performance of the recipients of the grants, 
     contracts, and agreements under paragraph (1) based on 
     quality and usability of reports described in paragraph (6); 
     and
       ``(ii) re-determine grants, contracts, and agreements as 
     necessary.
       ``(B) Prohibitions on participation.--The Secretary may not 
     award a grant, contract, or cooperative agreement under 
     paragraph (1) to--
       ``(i) a proprietor of certified health information 
     technology or a business affiliate of such a proprietor;
       ``(ii) a developer of certified health information 
     technology; or
       ``(iii) a State or local government agency.
       ``(5) Feedback.--Based on reporting criteria established 
     under subsection (a), the recipients of grants, contracts, 
     and agreements under paragraph (1) shall develop and 
     implement a process to collect and verify confidential 
     feedback on such criteria from--
       ``(A) health care providers, patients, and other users of 
     certified electronic health record technology; and
       ``(B) developers of certified electronic health record 
     technology.
       ``(6) Reports.--
       ``(A) Development of reports.--Each recipient of a grant, 
     contract, or agreement under paragraph (1) shall report on 
     the information reported to such recipient pursuant to 
     subsection (a) and the user feedback collected under 
     paragraph (5) by preparing summary reports and detailed 
     reports of such information.
       ``(B) Distribution of reports.--Each recipient of a grant, 
     contract, or agreement under paragraph (1) shall submit the 
     reports prepared under subparagraph (A) to the Secretary for 
     public distribution in accordance with subsection (d).
       ``(d) Publication.--The Secretary shall distribute widely, 
     as appropriate, and publish, on the Internet website of the 
     Office of the National Coordinator--
       ``(1) the reporting criteria developed under subsection 
     (a); and
       ``(2) the summary and detailed reports under subsection 
     (c)(6).
       ``(e) Review.--Each recipient of a grant, contract, or 
     agreement under paragraph (1) shall develop and implement a 
     process through which participating electronic health record 
     technology developers may review and recommend changes to the 
     reports created under subsection (c)(6) for products 
     developed by such developer prior to the publication of such 
     report under subsection (d).
       ``(f) Additional Resources.--The Secretary may provide 
     additional resources on the Internet website of the Office of 
     the National Coordinator to better inform consumers of health 
     information technology. Such reports may be carried out 
     through partnerships with private organizations with 
     appropriate expertise.''.
       (d) Authorization of Appropriations.--There is authorized 
     to be appropriated $15,000,000 for purposes of carrying out 
     subparagraph (D) of section 3001(c)(5) of the Public Health 
     Service Act (42 U.S.C. 300jj-11) (as added by subsection (a)) 
     and section 3009A of the Public Health Service Act (as added 
     by subsection (b)), including for purposes of administering 
     any contracts, grants, or agreements, to remain available 
     until expended.

[[Page H6933]]

  


     SEC. 4003. INTEROPERABILITY.

       (a) Definition.--Section 3000 of the Public Health Service 
     Act (42 U.S.C. 300jj) is amended--
       (1) by redesignating paragraphs (10) through (14), as 
     paragraphs (11) through (15), respectively; and
       (2) by inserting after paragraph (9) the following:
       ``(10) Interoperability.--The term `interoperability', with 
     respect to health information technology, means such health 
     information technology that--
       ``(A) enables the secure exchange of electronic health 
     information with, and use of electronic health information 
     from, other health information technology without special 
     effort on the part of the user;
       ``(B) allows for complete access, exchange, and use of all 
     electronically accessible health information for authorized 
     use under applicable State or Federal law; and
       ``(C) does not constitute information blocking as defined 
     in section 3022(a).''.
       (b) Support for Interoperable Network Exchange.--Section 
     3001(c) of the Public Health Service Act (42 U.S.C. 300jj-
     11(c)) is amended by adding at the end the following:
       ``(9) Support for interoperable networks exchange.--
       ``(A) In general.--The National Coordinator shall, in 
     collaboration with the National Institute of Standards and 
     Technology and other relevant agencies within the Department 
     of Health and Human Services, for the purpose of ensuring 
     full network-to-network exchange of health information, 
     convene public-private and public-public partnerships to 
     build consensus and develop or support a trusted exchange 
     framework, including a common agreement among health 
     information networks nationally. Such convention may occur at 
     a frequency determined appropriate by the Secretary.
       ``(B) Establishing a trusted exchange framework.--
       ``(i) In general.--Not later than 6 months after the date 
     of enactment of the 21st Century Cures Act, the National 
     Coordinator shall convene appropriate public and private 
     stakeholders to develop or support a trusted exchange 
     framework for trust policies and practices and for a common 
     agreement for exchange between health information networks. 
     The common agreement may include--

       ``(I) a common method for authenticating trusted health 
     information network participants;
       ``(II) a common set of rules for trusted exchange;
       ``(III) organizational and operational policies to enable 
     the exchange of health information among networks, including 
     minimum conditions for such exchange to occur; and
       ``(IV) a process for filing and adjudicating noncompliance 
     with the terms of the common agreement.

       ``(ii) Technical assistance.--The National Coordinator, in 
     collaboration with the National Institute of Standards and 
     Technology, shall provide technical assistance on how to 
     implement the trusted exchange framework and common agreement 
     under this paragraph.
       ``(iii) Pilot testing.--The National Coordinator, in 
     consultation with the National Institute of Standards and 
     Technology, shall provide for the pilot testing of the 
     trusted exchange framework and common agreement established 
     or supported under this subsection (as authorized under 
     section 13201 of the Health Information Technology for 
     Economic and Clinical Health Act). The National Coordinator, 
     in consultation with the National Institute of Standards and 
     Technology, may delegate pilot testing activities under this 
     clause to independent entities with appropriate expertise.
       ``(C) Publication of a trusted exchange framework and 
     common agreement.--Not later than 1 year after convening 
     stakeholders under subparagraph (A), the National Coordinator 
     shall publish on its public Internet website, and in the 
     Federal register, the trusted exchange framework and common 
     agreement developed or supported under subparagraph (B). Such 
     trusted exchange framework and common agreement shall be 
     published in a manner that protects proprietary and security 
     information, including trade secrets and any other protected 
     intellectual property.
       ``(D) Directory of participating health information 
     networks.--
       ``(i) In general.--Not later than 2 years after convening 
     stakeholders under subparagraph (A), and annually thereafter, 
     the National Coordinator shall publish on its public Internet 
     website a list of the health information networks that have 
     adopted the common agreement and are capable of trusted 
     exchange pursuant to the common agreement developed or 
     supported under paragraph (B).
       ``(ii) Process.--The Secretary shall, through notice and 
     comment rulemaking, establish a process for health 
     information networks that voluntarily elect to adopt the 
     trusted exchange framework and common agreement to attest to 
     such adoption of the framework and agreement.
       ``(E) Application of the trusted exchange framework and 
     common agreement.--As appropriate, Federal agencies 
     contracting or entering into agreements with health 
     information exchange networks may require that as each such 
     network upgrades health information technology or trust and 
     operational practices, such network may adopt, where 
     available, the trusted exchange framework and common 
     agreement published under subparagraph (C).
       ``(F) Rule of construction.--
       ``(i) General adoption.--Nothing in this paragraph shall be 
     construed to require a health information network to adopt 
     the trusted exchange framework or common agreement.
       ``(ii) Adoption when exchange of information is within 
     network.--Nothing in this paragraph shall be construed to 
     require a health information network to adopt the trusted 
     exchange framework or common agreement for the exchange of 
     electronic health information between participants of the 
     same network.
       ``(iii) Existing frameworks and agreements.--The trusted 
     exchange framework and common agreement published under 
     subparagraph (C) shall take into account existing trusted 
     exchange frameworks and agreements used by health information 
     networks to avoid the disruption of existing exchanges 
     between participants of health information networks.
       ``(iv) Application by federal agencies.--Notwithstanding 
     clauses (i), (ii), and (iii), Federal agencies may require 
     the adoption of the trusted exchange framework and common 
     agreement published under subparagraph (C) for health 
     information exchanges contracting with or entering into 
     agreements pursuant to subparagraph (E).
       ``(v) Consideration of ongoing work.--In carrying out this 
     paragraph, the Secretary shall ensure the consideration of 
     activities carried out by public and private organizations 
     related to exchange between health information exchanges to 
     avoid duplication of efforts.''.
       (c) Provider Digital Contact Information Index.--
       (1) In general.--Not later than 3 years after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this subsection as the 
     ``Secretary'') shall, directly or through a partnership with 
     a private entity, establish a provider digital contact 
     information index to provide digital contact information for 
     health professionals and health facilities.
       (2) Use of existing index.--In establishing the initial 
     index under paragraph (1), the Secretary may utilize an 
     existing provider directory to make such digital contact 
     information available.
       (3) Contact information.--An index established under this 
     subsection shall ensure that contact information is available 
     at the individual health care provider level and at the 
     health facility or practice level.
       (4) Rule of construction.--
       (A) In general.--The purpose of this subsection is to 
     encourage the exchange of electronic health information by 
     providing the most useful, reliable, and comprehensive index 
     of providers possible. In furthering such purpose, the 
     Secretary shall include all health professionals and health 
     facilities applicable to provide a useful, reliable, and 
     comprehensive index for use in the exchange of health 
     information.
       (B) Limitation.--In no case shall exclusion from the index 
     of providers be used as a measure to achieve objectives other 
     the objectives described in subparagraph (A).
       (d) Standards Development Organizations.--Section 3004 of 
     the Public Health Service Act (42 U.S.C. 300jj-14) is amended 
     by adding at the end the following:
       ``(c) Deference to Standards Development Organizations.--In 
     adopting and implementing standards under this section, the 
     Secretary shall give deference to standards published by 
     standards development organizations and voluntary consensus-
     based standards bodies.''.
       (e) Health Information Technology Advisory Committee.--
       (1) In general.--Title XXX of the Public Health Service Act 
     (42 U.S.C. 300jj et seq.) is amended by striking sections 
     3002 (42 U.S.C. 300jj-12) and 3003 (42 U.S.C. 300jj-13) and 
     inserting the following:

     ``SEC. 3002. HEALTH INFORMATION TECHNOLOGY ADVISORY 
                   COMMITTEE.

       ``(a) Establishment.--There is established a Health 
     Information Technology Advisory Committee (referred to in 
     this section as the `HIT Advisory Committee') to recommend to 
     the National Coordinator, consistent with the implementation 
     of the strategic plan described in section 3001(c)(3), 
     policies, and, for purposes of adoption under section 3004, 
     standards, implementation specifications, and certification 
     criteria, relating to the implementation of a health 
     information technology infrastructure, nationally and 
     locally, that advances the electronic access, exchange, and 
     use of health information. Such Committee shall serve to 
     unify the roles of, and replace, the HIT Policy Committee and 
     the HIT Standards Committee, as in existence before the date 
     of the enactment of the 21st Century Cures Act.
       ``(b) Duties.--
       ``(1) Recommendations on policy framework to advance an 
     interoperable health information technology infrastructure.--
       ``(A) In general.--The HIT Advisory Committee shall 
     recommend to the National Coordinator a policy framework for 
     adoption by the Secretary consistent with the strategic plan 
     under section 3001(c)(3) for advancing the target areas 
     described in this subsection. Such policy framework shall 
     seek to prioritize achieving advancements in the target areas 
     specified in subparagraph (B) of paragraph (2) and may, to 
     the extent consistent with this section, incorporate policy 
     recommendations made by the HIT Policy Committee, as in 
     existence before the date of the enactment of the 21st 
     Century Cures Act.
       ``(B) Updates.--The HIT Advisory Committee shall propose 
     updates to such recommendations to the policy framework and 
     make new recommendations, as appropriate.
       ``(2) General duties and target areas.--
       ``(A) In general.--The HIT Advisory Committee shall 
     recommend to the National Coordinator for purposes of 
     adoption under section 3004, standards, implementation 
     specifications, and certification criteria and an order of 
     priority for the development, harmonization, and recognition 
     of such standards, specifications, and certification 
     criteria. Such recommendations shall include recommended 
     standards, architectures, and software schemes for access to 
     electronic individually identifiable health information 
     across disparate systems including user

[[Page H6934]]

     vetting, authentication, privilege management, and access 
     control.
       ``(B) Priority target areas.--For purposes of this section, 
     the HIT Advisory Committee shall make recommendations under 
     subparagraph (A) with respect to at least each of the 
     following target areas:
       ``(i) Achieving a health information technology 
     infrastructure, nationally and locally, that allows for the 
     electronic access, exchange, and use of health information, 
     including through technology that provides accurate patient 
     information for the correct patient, including exchanging 
     such information, and avoids the duplication of patient 
     records.
       ``(ii) The promotion and protection of privacy and security 
     of health information in health information technology, 
     including technologies that allow for an accounting of 
     disclosures and protections against disclosures of 
     individually identifiable health information made by a 
     covered entity for purposes of treatment, payment, and health 
     care operations (as such terms are defined for purposes of 
     the regulation promulgated under section 264(c) of the Health 
     Insurance Portability and Accountability Act of 1996), 
     including for the segmentation and protection from disclosure 
     of specific and sensitive individually identifiable health 
     information with the goal of minimizing the reluctance of 
     patients to seek care.
       ``(iii) The facilitation of secure access by an individual 
     to such individual's protected health information and access 
     to such information by a family member, caregiver, or 
     guardian acting on behalf of a patient, including due to age-
     related and other disability, cognitive impairment, or 
     dementia.
       ``(iv) Subject to subparagraph (D), any other target area 
     that the HIT Advisory Committee identifies as an appropriate 
     target area to be considered under this subparagraph.
       ``(C) Additional target areas.--For purposes of this 
     section, the HIT Advisory Committee may make recommendations 
     under subparagraph (A), in addition to areas described in 
     subparagraph (B), with respect to any of the following areas:
       ``(i) The use of health information technology to improve 
     the quality of health care, such as by promoting the 
     coordination of health care and improving continuity of 
     health care among health care providers, reducing medical 
     errors, improving population health, reducing chronic 
     disease, and advancing research and education.
       ``(ii) The use of technologies that address the needs of 
     children and other vulnerable populations.
       ``(iii) The use of electronic systems to ensure the 
     comprehensive collection of patient demographic data, 
     including at a minimum, race, ethnicity, primary language, 
     and gender information.
       ``(iv) The use of self-service, telemedicine, home health 
     care, and remote monitoring technologies.
       ``(v) The use of technologies that meet the needs of 
     diverse populations.
       ``(vi) The use of technologies that support--

       ``(I) data for use in quality and public reporting 
     programs;
       ``(II) public health; or
       ``(III) drug safety.

       ``(vii) The use of technologies that allow individually 
     identifiable health information to be rendered unusable, 
     unreadable, or indecipherable to unauthorized individuals 
     when such information is transmitted in a health information 
     network or transported outside of the secure facilities or 
     systems where the disclosing covered entity is responsible 
     for security conditions.
       ``(viii) The use of a certified health information 
     technology for each individual in the United States.
       ``(D) Authority for temporary additional priority target 
     areas.--For purposes of subparagraph (B)(iv), the HIT 
     Advisory Committee may identify an area to be considered for 
     purposes of recommendations under this subsection as a target 
     area described in subparagraph (B) if--
       ``(i) the area is so identified for purposes of responding 
     to new circumstances that have arisen in the health 
     information technology community that affect the 
     interoperability, privacy, or security of health information, 
     or affect patient safety; and
       ``(ii) at least 30 days prior to treating such area as if 
     it were a target area described in subparagraph (B), the 
     National Coordinator provides adequate notice to Congress of 
     the intent to treat such area as so described.
       ``(E) Focus of committee work.--It is the sense of Congress 
     that the HIT Advisory Committee shall focus its work on the 
     priority areas described in subparagraph (B) before 
     proceeding to other work under subparagraph (C).
       ``(3) Rules relating to recommendations for standards, 
     implementation specifications, and certification criteria.--
       ``(A) In general.--The HIT Advisory Committee shall 
     recommend to the National Coordinator standards, 
     implementation specifications, and certification criteria 
     described in subsection (a), which may include standards, 
     implementation specifications, and certification criteria 
     that have been developed, harmonized, or recognized by the 
     HIT Advisory Committee or predecessor committee. The HIT 
     Advisory Committee shall update such recommendations and make 
     new recommendations as appropriate, including in response to 
     a notification sent under section 3004(a)(2)(B). Such 
     recommendations shall be consistent with the latest 
     recommendations made by the Committee.
       ``(B) Harmonization.--The HIT Advisory Committee may 
     recognize harmonized or updated standards from an entity or 
     entities for the purpose of harmonizing or updating standards 
     and implementation specifications in order to achieve uniform 
     and consistent implementation of the standards and 
     implementation specification.
       ``(C) Pilot testing of standards and implementation 
     specifications.--In the development, harmonization, or 
     recognition of standards and implementation specifications, 
     the HIT Advisory Committee for purposes of recommendations 
     under paragraph (2)(B), shall, as appropriate, provide for 
     the testing of such standards and specifications by the 
     National Institute for Standards and Technology under section 
     13201(a) of the Health Information Technology for Economic 
     and Clinical Health Act.
       ``(D) Consistency.--The standards, implementation 
     specifications, and certification criteria recommended under 
     paragraph (2)(B) shall be consistent with the standards for 
     information transactions and data elements adopted pursuant 
     to section 1173 of the Social Security Act.
       ``(E) Special rule related to interoperability.--Any 
     recommendation made by the HIT Advisory Committee after the 
     date of the enactment of this subparagraph with respect to 
     interoperability of health information technology shall be 
     consistent with interoperability as described in section 
     3000.
       ``(4) Forum.--The HIT Advisory Committee shall serve as a 
     forum for the participation of a broad range of stakeholders 
     with specific expertise in policies, including technical 
     expertise, relating to the matters described in paragraphs 
     (1), (2), and (3) to provide input on the development, 
     harmonization, and recognition of standards, implementation 
     specifications, and certification criteria necessary for the 
     development and adoption of health information technology 
     infrastructure nationally and locally that allows for the 
     electronic access, exchange, and use of health information.
       ``(5) Schedule.--Not later than 30 days after the date on 
     which the HIT Advisory Committee first meets, such HIT 
     Advisory Committee shall develop a schedule for the 
     assessment of policy recommendations developed under 
     paragraph (1). The HIT Advisory Committee shall update such 
     schedule annually. The Secretary shall publish such schedule 
     in the Federal Register.
       ``(6) Public input.--The HIT Advisory Committee shall 
     conduct open public meetings and develop a process to allow 
     for public comment on the schedule described in paragraph (5) 
     and recommendations described in this subsection. Under such 
     process comments shall be submitted in a timely manner after 
     the date of publication of a recommendation under this 
     subsection.
       ``(c) Measured Progress in Advancing Priority Areas.--
       ``(1) In general.--For purposes of this section, the 
     National Coordinator, in collaboration with the Secretary, 
     shall establish, and update as appropriate, objectives and 
     benchmarks for advancing and measuring the advancement of the 
     priority target areas described in subsection (b)(2)(B).
       ``(2) Annual progress reports on advancing 
     interoperability.--
       ``(A) In general.--The HIT Advisory Committee, in 
     consultation with the National Coordinator, shall annually 
     submit to the Secretary and Congress a report on the progress 
     made during the preceding fiscal year in--
       ``(i) achieving a health information technology 
     infrastructure, nationally and locally, that allows for the 
     electronic access, exchange, and use of health information; 
     and
       ``(ii) meeting the objectives and benchmarks described in 
     paragraph (1).
       ``(B) Content.--Each such report shall include, for a 
     fiscal year--
       ``(i) a description of the work conducted by the HIT 
     Advisory Committee during the preceding fiscal year with 
     respect to the areas described in subsection (b)(2)(B);
       ``(ii) an assessment of the status of the infrastructure 
     described in subparagraph (A), including the extent to which 
     electronic health information is appropriately and readily 
     available to enhance the access, exchange, and the use of 
     electronic health information between users and across 
     technology offered by different developers;
       ``(iii) the extent to which advancements have been achieved 
     with respect to areas described in subsection (b)(2)(B);
       ``(iv) an analysis identifying existing gaps in policies 
     and resources for--

       ``(I) achieving the objectives and benchmarks established 
     under paragraph (1); and
       ``(II) furthering interoperability throughout the health 
     information technology infrastructure;

       ``(v) recommendations for addressing the gaps identified in 
     clause (iii); and
       ``(vi) a description of additional initiatives as the HIT 
     Advisory Committee and National Coordinator determine 
     appropriate.
       ``(3) Significant advancement determination.--The Secretary 
     shall periodically, based on the reports submitted under this 
     subsection, review the target areas described in subsection 
     (b)(2)(B), and, based on the objectives and benchmarks 
     established under paragraph (1), the Secretary shall 
     determine if significant advancement has been achieved with 
     respect to such an area. Such determination shall be taken 
     into consideration by the HIT Advisory Committee when 
     determining to what extent the Committee makes 
     recommendations for an area other than an area described in 
     subsection (b)(2)(B).
       ``(d) Membership and Operations.--
       ``(1) In general.--The National Coordinator shall take a 
     leading position in the establishment and operations of the 
     HIT Advisory Committee.
       ``(2) Membership.--The membership of the HIT Advisory 
     Committee shall--
       ``(A) include at least 25 members, of which--
       ``(i) no fewer than 2 members are advocates for patients or 
     consumers of health information technology;
       ``(ii) 3 members are appointed by the Secretary, 1 of whom 
     shall be appointed to represent the Department of Health and 
     Human

[[Page H6935]]

     Services and 1 of whom shall be a public health official;
       ``(iii) 2 members are appointed by the majority leader of 
     the Senate;
       ``(iv) 2 members are appointed by the minority leader of 
     the Senate;
       ``(v) 2 members are appointed by the Speaker of the House 
     of Representatives;
       ``(vi) 2 members are appointed by the minority leader of 
     the House of Representatives; and
       ``(vii) such other members are appointed by the Comptroller 
     General of the United States; and
       ``(B) at least reflect providers, ancillary health care 
     workers, consumers, purchasers, health plans, health 
     information technology developers, researchers, patients, 
     relevant Federal agencies, and individuals with technical 
     expertise on health care quality, system functions, privacy, 
     security, and on the electronic exchange and use of health 
     information, including the use standards for such activity.
       ``(3) Participation.--The members of the HIT Advisory 
     Committee shall represent a balance among various sectors of 
     the health care system so that no single sector unduly 
     influences the recommendations of the Committee.
       ``(4) Terms.--
       ``(A) In general.--The terms of the members of the HIT 
     Advisory Committee shall be for 3 years, except that the 
     Secretary shall designate staggered terms of the members 
     first appointed.
       ``(B) Vacancies.--Any member appointed to fill a vacancy in 
     the membership of the HIT Advisory Committee that occurs 
     prior to the expiration of the term for which the member's 
     predecessor was appointed shall be appointed only for the 
     remainder of that term. A member may serve after the 
     expiration of that member's term until a successor has been 
     appointed. A vacancy in the HIT Advisory Committee shall be 
     filled in the manner in which the original appointment was 
     made.
       ``(C) Limits.--Members of the HIT Advisory Committee shall 
     be limited to two 3-year terms, for a total of not to exceed 
     6 years of service on the Committee.
       ``(5) Outside involvement.--The HIT Advisory Committee 
     shall ensure an opportunity for the participation in 
     activities of the Committee of outside advisors, including 
     individuals with expertise in the development of policies and 
     standards for the electronic exchange and use of health 
     information, including in the areas of health information 
     privacy and security.
       ``(6) Quorum.--A majority of the members of the HIT 
     Advisory Committee shall constitute a quorum for purposes of 
     voting, but a lesser number of members may meet and hold 
     hearings.
       ``(7) Consideration.--The National Coordinator shall ensure 
     that the relevant and available recommendations and comments 
     from the National Committee on Vital and Health Statistics 
     are considered in the development of policies.
       ``(8) Assistance.--For the purposes of carrying out this 
     section, the Secretary may provide or ensure that financial 
     assistance is provided by the HIT Advisory Committee to 
     defray in whole or in part any membership fees or dues 
     charged by such Committee to those consumer advocacy groups 
     and not-for-profit entities that work in the public interest 
     as a party of their mission.
       ``(e) Application of FACA.--The Federal Advisory Committee 
     Act (5 U.S.C. App.), other than section 14 of such Act, shall 
     apply to the HIT Advisory Committee.
       ``(f) Publication.--The Secretary shall provide for 
     publication in the Federal Register and the posting on the 
     Internet website of the Office of the National Coordinator 
     for Health Information Technology of all policy 
     recommendations made by the HIT Advisory Committee under this 
     section.''.
       (2) Technical and conforming amendments.--Title XXX of the 
     Public Health Service Act (42 U.S.C. 300jj et seq.) is 
     amended--
       (A) by striking--
       (i) ``HIT Policy Committee'' and ``HIT Standards 
     Committee'' each place that such terms appear (other than 
     within the term ``HIT Policy Committee and the HIT Standards 
     Committee'' or within the term ``HIT Policy Committee or the 
     HIT Standards Committee'') and inserting ``HIT Advisory 
     Committee'';
       (ii) ``HIT Policy Committee and the HIT Standards 
     Committee'' each place that such term appears and inserting 
     ``HIT Advisory Committee''; and
       (iii) ``HIT Policy Committee or the HIT Standards 
     Committee'' each place that such term appears and inserting 
     ``HIT Advisory Committee'';
       (B) in section 3000 (42 U.S.C. 300jj)--
       (i) by striking paragraphs (7) and (8) and redesignating 
     paragraphs (9) through (14) as paragraphs (8) through (13), 
     respectively; and
       (ii) by inserting after paragraph (6) the following 
     paragraph:
       ``(7) Hit advisory committee.--The term `HIT Advisory 
     Committee' means such Committee established under section 
     3002(a).'';
       (C) in section 3001(c) (42 U.S.C. 300jj-11(c))--
       (i) in paragraph (1)(A), by striking ``under section 3003'' 
     and inserting ``under section 3002'';
       (ii) in paragraph (2), by striking subparagraph (B) and 
     inserting the following:
       ``(B) Hit advisory committee.--The National Coordinator 
     shall be a leading member in the establishment and operations 
     of the HIT Advisory Committee and shall serve as a liaison 
     between that Committee and the Federal Government.'';
       (D) in section 3004(b)(3) (42 U.S.C. 300jj-14(b)(3)), by 
     striking ``3003(b)(2)'' and inserting ``3002(b)(4)'';
       (E) in section 3007(b) (42 U.S.C. 300jj-17(b)), by striking 
     ``3003(a)'' and inserting ``3002(a)(2)''; and
       (F) in section 3008 (42 U.S.C. 300jj-18)--
       (i) in subsection (b), by striking ``or 3003''; and
       (ii) in subsection (c), by striking ``3003(b)(1)(A)'' and 
     inserting ``3002(b)(2)''.
       (3) Transition to the hit advisory committee.--The 
     Secretary of Health and Human Services shall provide for an 
     orderly and timely transition to the HIT Advisory Committee 
     established under amendments made by this section.
       (f) Priorities for Adoption of Standards, Implementation 
     Specifications, and Certification Criteria.--Title XXX of the 
     Public Health Service Act (42 U.S.C. 300jj et seq.), as 
     amended by subsection (e), is further amended by inserting 
     after section 3002 the following:

     ``SEC. 3003. SETTING PRIORITIES FOR STANDARDS ADOPTION.

       ``(a) Identifying Priorities.--
       ``(1) In general.--Not later than 6 months after the date 
     on which the HIT Advisory Committee first meets, the National 
     Coordinator shall periodically convene the HIT Advisory 
     Committee to--
       ``(A) identify priority uses of health information 
     technology, focusing on priorities--
       ``(i) arising from the implementation of the incentive 
     programs for the meaningful use of certified EHR technology, 
     the Merit-based Incentive Payment System, Alternative Payment 
     Models, the Hospital Value-Based Purchasing Program, and any 
     other value-based payment program determined appropriate by 
     the Secretary;
       ``(ii) related to the quality of patient care;
       ``(iii) related to public health;
       ``(iv) related to clinical research;
       ``(v) related to the privacy and security of electronic 
     health information;
       ``(vi) related to innovation in the field of health 
     information technology;
       ``(vii) related to patient safety;
       ``(viii) related to the usability of health information 
     technology;
       ``(ix) related to individuals' access to electronic health 
     information; and
       ``(x) other priorities determined appropriate by the 
     Secretary;
       ``(B) identify existing standards and implementation 
     specifications that support the use and exchange of 
     electronic health information needed to meet the priorities 
     identified in subparagraph (A); and
       ``(C) publish a report summarizing the findings of the 
     analysis conducted under subparagraphs (A) and (B) and make 
     appropriate recommendations.
       ``(2) Prioritization.--In identifying such standards and 
     implementation specifications under paragraph (1)(B), the HIT 
     Advisory Committee shall prioritize standards and 
     implementation specifications developed by consensus-based 
     standards development organizations.
       ``(3) Guidelines for review of existing standards and 
     specifications.--In consultation with the consensus-based 
     entity described in section 1890 of the Social Security Act 
     and other appropriate Federal agencies, the analysis of 
     existing standards under paragraph (1)(B) shall include an 
     evaluation of the need for a core set of common data elements 
     and associated value sets to enhance the ability of certified 
     health information technology to capture, use, and exchange 
     structured electronic health information.
       ``(b) Review of Adopted Standards.--
       ``(1) In general.--Beginning 5 years after the date of 
     enactment of the 21st Century Cures Act and every 3 years 
     thereafter, the National Coordinator shall convene 
     stakeholders to review the existing set of adopted standards 
     and implementation specifications and make recommendations 
     with respect to whether to--
       ``(A) maintain the use of such standards and implementation 
     specifications; or
       ``(B) phase out such standards and implementation 
     specifications.
       ``(2) Priorities.--The HIT Advisory Committee, in 
     collaboration with the National Institute for Standards and 
     Technology, shall annually and through the use of public 
     input, review and publish priorities for the use of health 
     information technology, standards, and implementation 
     specifications to support those priorities.
       ``(c) Rule of Construction.--Nothing in this section shall 
     be construed to prevent the use or adoption of novel 
     standards that improve upon the existing health information 
     technology infrastructure and facilitate the secure exchange 
     of health information.''.

     SEC. 4004. INFORMATION BLOCKING.

       Subtitle C of title XXX of the Public Health Service Act 
     (42 U.S.C. 300jj-51 et seq.) is amended by adding at the end 
     the following:

     ``SEC. 3022. INFORMATION BLOCKING.

       ``(a) Definition.--
       ``(1) In general.--In this section, the term `information 
     blocking' means a practice that--
       ``(A) except as required by law or specified by the 
     Secretary pursuant to rulemaking under paragraph (3), is 
     likely to interfere with, prevent, or materially discourage 
     access, exchange, or use of electronic health information; 
     and
       ``(B)(i) if conducted by a health information technology 
     developer, exchange, or network, such developer, exchange, or 
     network knows, or should know, that such practice is likely 
     to interfere with, prevent, or materially discourage the 
     access, exchange, or use of electronic health information; or
       ``(ii) if conducted by a health care provider, such 
     provider knows that such practice is unreasonable and is 
     likely to interfere with, prevent, or materially discourage 
     access, exchange, or use of electronic health information.
       ``(2) Practices described.--The information blocking 
     practices described in paragraph (1) may include--
       ``(A) practices that restrict authorized access, exchange, 
     or use under applicable State or Federal law of such 
     information for treatment and other permitted purposes under 
     such applicable law, including transitions between certified 
     health information technologies;
       ``(B) implementing health information technology in 
     nonstandard ways that are likely to

[[Page H6936]]

     substantially increase the complexity or burden of accessing, 
     exchanging, or using electronic health information; and
       ``(C) implementing health information technology in ways 
     that are likely to--
       ``(i) restrict the access, exchange, or use of electronic 
     health information with respect to exporting complete 
     information sets or in transitioning between health 
     information technology systems; or
       ``(ii) lead to fraud, waste, or abuse, or impede 
     innovations and advancements in health information access, 
     exchange, and use, including care delivery enabled by health 
     information technology.
       ``(3) Rulemaking.--The Secretary, through rulemaking, shall 
     identify reasonable and necessary activities that do not 
     constitute information blocking for purposes of paragraph 
     (1).
       ``(4) No enforcement before exception identified.--The term 
     `information blocking' does not include any practice or 
     conduct occurring prior to the date that is 30 days after the 
     date of enactment of the 21st Century Cures Act.
       ``(5) Consultation.--The Secretary may consult with the 
     Federal Trade Commission in promulgating regulations under 
     this subsection, to the extent that such regulations define 
     practices that are necessary to promote competition and 
     consumer welfare.
       ``(6) Application.--The term `information blocking', with 
     respect to an individual or entity, shall not include an act 
     or practice other than an act or practice committed by such 
     individual or entity.
       ``(7) Clarification.--In carrying out this section, the 
     Secretary shall ensure that health care providers are not 
     penalized for the failure of developers of health information 
     technology or other entities offering health information 
     technology to such providers to ensure that such technology 
     meets the requirements to be certified under this title.
       ``(b) Inspector General Authority.--
       ``(1) In general.--The inspector general of the Department 
     of Health and Human Services (referred to in this section as 
     the `Inspector General') may investigate any claim that--
       ``(A) a health information technology developer of 
     certified health information technology or other entity 
     offering certified health information technology--
       ``(i) submitted a false attestation under section 
     3001(c)(5)(D)(vii); or
       ``(ii) engaged in information blocking;
       ``(B) a health care provider engaged in information 
     blocking; or
       ``(C) a health information exchange or network engaged in 
     information blocking.
       ``(2) Penalties.--
       ``(A) Developers, networks, and exchanges.--Any individual 
     or entity described in subparagraph (A) or (C) of paragraph 
     (1) that the Inspector General, following an investigation 
     conducted under this subsection, determines to have committed 
     information blocking shall be subject to a civil monetary 
     penalty determined by the Secretary for all such violations 
     identified through such investigation, which may not exceed 
     $1,000,000 per violation. Such determination shall take into 
     account factors such as the nature and extent of the 
     information blocking and harm resulting from such information 
     blocking, including, where applicable, the number of patients 
     affected, the number of providers affected, and the number of 
     days the information blocking persisted.
       ``(B) Providers.--Any individual or entity described in 
     subparagraph (B) of paragraph (1) determined by the Inspector 
     General to have committed information blocking shall be 
     referred to the appropriate agency to be subject to 
     appropriate disincentives using authorities under applicable 
     Federal law, as the Secretary sets forth through notice and 
     comment rulemaking.
       ``(C) Procedure.--The provisions of section 1128A of the 
     Social Security Act (other than subsections (a) and (b) of 
     such section) shall apply to a civil money penalty applied 
     under this paragraph in the same manner as such provisions 
     apply to a civil money penalty or proceeding under such 
     section 1128A(a).
       ``(D) Recovered penalty funds.--The amounts recovered under 
     this paragraph shall be allocated as follows:
       ``(i) Annual operating expenses.--Each year following the 
     establishment of the authority under this subsection, the 
     Office of the Inspector General shall provide to the 
     Secretary an estimate of the costs to carry out 
     investigations under this section. Such estimate may include 
     reasonable reserves to account for variance in annual amounts 
     recovered under this paragraph. There is authorized to be 
     appropriated for purposes of carrying out this section an 
     amount equal to the amount specified in such estimate for the 
     fiscal year.
       ``(ii) Application to other programs.--The amounts 
     recovered under this paragraph and remaining after amounts 
     are made available under clause (i) shall be transferred to 
     the Federal Hospital Insurance Trust Fund under section 1817 
     of the Social Security Act and the Federal Supplementary 
     Medical Insurance Trust Fund under section 1841 of such Act, 
     in such proportion as the Secretary determines appropriate.
       ``(E) Authorization of appropriations.--There is authorized 
     to be appropriated to the Office of the Inspector General to 
     carry out this section $10,000,000, to remain available until 
     expended.
       ``(3) Resolution of claims.--
       ``(A) In general.--The Office of the Inspector General, if 
     such Office determines that a consultation regarding the 
     health privacy and security rules promulgated under section 
     264(c) of the Health Insurance Portability and Accountability 
     Act of 1996 (42 U.S.C. 1320d-2 note) will resolve an 
     information blocking claim, may refer such instances of 
     information blocking to the Office for Civil Rights of the 
     Department of Health and Human Services for resolution.
       ``(B) Limitation on liability.--If a health care provider 
     or health information technology developer makes information 
     available based on a good faith reliance on consultations 
     with the Office for Civil Rights of the Department of Health 
     and Human Services pursuant to a referral under subparagraph 
     (A), with respect to such information, the health care 
     provider or developer shall not be liable for such disclosure 
     or disclosures made pursuant to subparagraph (A).
       ``(c) Identifying Barriers To Exchange of Certified Health 
     Information Technology.--
       ``(1) Trusted exchange defined.--In this section, the term 
     `trusted exchange' with respect to certified electronic 
     health records means that the certified electronic health 
     record technology has the technical capability to enable 
     secure health information exchange between users and multiple 
     certified electronic health record technology systems.
       ``(2) Guidance.--The National Coordinator, in consultation 
     with the Office for Civil Rights of the Department of Health 
     and Human Services, shall issue guidance on common legal, 
     governance, and security barriers that prevent the trusted 
     exchange of electronic health information.
       ``(3) Referral.--The National Coordinator and the Office 
     for Civil Rights of the Department of Health and Human 
     Services may refer to the Inspector General instances or 
     patterns of refusal to exchange health information with an 
     individual or entity using certified electronic health record 
     technology that is technically capable of trusted exchange 
     and under conditions when exchange is legally permissible.
       ``(d) Additional Provisions.--
       ``(1) Information sharing provisions.--The National 
     Coordinator may serve as a technical consultant to the 
     Inspector General and the Federal Trade Commission for 
     purposes of carrying out this section. The National 
     Coordinator may, notwithstanding any other provision of law, 
     share information related to claims or investigations under 
     subsection (b) with the Federal Trade Commission for purposes 
     of such investigations and shall share information with the 
     Inspector General, as required by law.
       ``(2) Protection from disclosure of information.--Any 
     information that is received by the National Coordinator in 
     connection with a claim or suggestion of possible information 
     blocking and that could reasonably be expected to facilitate 
     identification of the source of the information--
       ``(A) shall not be disclosed by the National Coordinator 
     except as may be necessary to carry out the purpose of this 
     section;
       ``(B) shall be exempt from mandatory disclosure under 
     section 552 of title 5, United States Code, as provided by 
     subsection (b)(3) of such section; and
       ``(C) may be used by the Inspector General or Federal Trade 
     Commission for reporting purposes to the extent that such 
     information could not reasonably be expected to facilitate 
     identification of the source of such information.
       ``(3) Standardized process.--
       ``(A) In general.--The National Coordinator shall implement 
     a standardized process for the public to submit reports on 
     claims of--
       ``(i) health information technology products or developers 
     of such products (or other entities offering such products to 
     health care providers) not being interoperable or resulting 
     in information blocking;
       ``(ii) actions described in subsection (b)(1) that result 
     in information blocking as described in subsection (a); and
       ``(iii) any other act described in subsection (a).
       ``(B) Collection of information.--The standardized process 
     implemented under subparagraph (A) shall provide for the 
     collection of such information as the originating 
     institution, location, type of transaction, system and 
     version, timestamp, terminating institution, locations, 
     system and version, failure notice, and other related 
     information.
       ``(4) Nonduplication of penalty structures.--In carrying 
     out this subsection, the Secretary shall, to the extent 
     possible, ensure that penalties do not duplicate penalty 
     structures that would otherwise apply with respect to 
     information blocking and the type of individual or entity 
     involved as of the day before the date of the enactment of 
     this section.''.

     SEC. 4005. LEVERAGING ELECTRONIC HEALTH RECORDS TO IMPROVE 
                   PATIENT CARE.

       (a) Requirement Relating to Registries.--
       (1) In general.--To be certified in accordance with title 
     XXX of the Public Health Service Act (42 U.S.C. 300jj et 
     seq.), electronic health records shall be capable of 
     transmitting to, and where applicable, receiving and 
     accepting data from, registries in accordance with standards 
     recognized by the Office of the National Coordinator for 
     Health Information Technology, including clinician-led 
     clinical data registries, that are also certified to be 
     technically capable of receiving and accepting from, and 
     where applicable, transmitting data to certified electronic 
     health record technology in accordance with such standards.
       (2) Rule of construction.--Nothing in this subsection shall 
     be construed to require the certification of registries 
     beyond the technical capability to exchange data in 
     accordance with applicable recognized standards.
       (b) Definition.--For purposes of this Act, the term 
     ``clinician-led clinical data registry'' means a clinical 
     data repository--
       (1) that is established and operated by a clinician-led or 
     controlled, tax-exempt (pursuant to section 501(c) of the 
     Internal Revenue Code of 1986), professional society or other 
     similar clinician-led or -controlled organization, or such 
     organization's controlled affiliate, devoted to the

[[Page H6937]]

     care of a population defined by a particular disease, 
     condition, exposure or therapy;
       (2) that is designed to collect detailed, standardized data 
     on an ongoing basis for medical procedures, services, or 
     therapies for particular diseases, conditions, or exposures;
       (3) that provides feedback to participants who submit 
     reports to the repository;
       (4) that meets standards for data quality including--
       (A) systematically collecting clinical and other health 
     care data, using standardized data elements and having 
     procedures in place to verify the completeness and validity 
     of those data; and
       (B) being subject to regular data checks or audits to 
     verify completeness and validity; and
       (5) that provides ongoing participant training and support.
       (c) Treatment of Health Information Technology Developers 
     With Respect to Patient Safety Organizations.--
       (1) In general.--In applying part C of title IX of the 
     Public Health Service Act (42 U.S.C. 299b-21 et seq.), a 
     health information technology developer shall be treated as a 
     provider (as defined in section 921 of such Act) for purposes 
     of reporting and conducting patient safety activities 
     concerning improving clinical care through the use of health 
     information technology that could result in improved patient 
     safety, health care quality, or health care outcomes.
       (2) Report.--Not later than 4 years after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall submit to the Committee on Health, Education, 
     Labor, and Pensions of the Senate and the Committee on Energy 
     and Commerce of the House of Representatives, a report 
     concerning best practices and current trends voluntarily 
     provided, without identifying individual providers or 
     disclosing or using protected health information or 
     individually identifiable information, by patient safety 
     organizations to improve the integration of health 
     information technology into clinical practice.

     SEC. 4006. EMPOWERING PATIENTS AND IMPROVING PATIENT ACCESS 
                   TO THEIR ELECTRONIC HEALTH INFORMATION.

       (a) Use of Health Information Exchanges for Patient 
     Access.--Section 3009 of the Public Health Service Act (42 
     U.S.C. 300jj-19) is amended by adding at the end the 
     following:
       ``(c) Promoting Patient Access to Electronic Health 
     Information Through Health Information Exchanges .--
       ``(1) In general.--The Secretary shall use existing 
     authorities to encourage partnerships between health 
     information exchange organizations and networks and health 
     care providers, health plans, and other appropriate entities 
     with the goal of offering patients access to their electronic 
     health information in a single, longitudinal format that is 
     easy to understand, secure, and may be updated automatically.
       ``(2) Education of providers.--The Secretary, in 
     coordination with the Office for Civil Rights of the 
     Department of Health and Human Services, shall--
       ``(A) educate health care providers on ways of leveraging 
     the capabilities of health information exchanges (or other 
     relevant platforms) to provide patients with access to their 
     electronic health information;
       ``(B) clarify misunderstandings by health care providers 
     about using health information exchanges (or other relevant 
     platforms) for patient access to electronic health 
     information; and
       ``(C) to the extent practicable, educate providers about 
     health information exchanges (or other relevant platforms) 
     that employ some or all of the capabilities described in 
     paragraph (1).
       ``(3) Requirements.--In carrying out paragraph (1), the 
     Secretary, in coordination with the Office for Civil Rights, 
     shall issue guidance to health information exchanges related 
     to best practices to ensure that the electronic health 
     information provided to patients is--
       ``(A) private and secure;
       ``(B) accurate;
       ``(C) verifiable; and
       ``(D) where a patient's authorization to exchange 
     information is required by law, easily exchanged pursuant to 
     such authorization.
       ``(4) Rule of construction.--Nothing in this subsection 
     shall be construed to preempt State laws applicable to 
     patient consent for the access of information through a 
     health information exchange (or other relevant platform) that 
     provide protections to patients that are greater than the 
     protections otherwise provided for under applicable Federal 
     law.
       ``(d) Efforts To Promote Access to Health Information.--The 
     National Coordinator and the Office for Civil Rights of the 
     Department of Health and Human Services shall jointly promote 
     patient access to health information in a manner that would 
     ensure that such information is available in a form 
     convenient for the patient, in a reasonable manner, without 
     burdening the health care provider involved.
       ``(e) Accessibility of Patient Records.--
       ``(1) Accessibility and updating of information.--
       ``(A) In general.--The Secretary, in consultation with the 
     National Coordinator, shall promote policies that ensure that 
     a patient's electronic health information is accessible to 
     that patient and the patient's designees, in a manner that 
     facilitates communication with the patient's health care 
     providers and other individuals, including researchers, 
     consistent with such patient's consent.
       ``(B) Updating education on accessing and exchanging 
     personal health information.--To promote awareness that an 
     individual has a right of access to inspect, obtain a copy 
     of, and transmit to a third party a copy of such individual's 
     protected health information pursuant to the Health 
     Information Portability and Accountability Act, Privacy Rule 
     (subpart E of part 164 of title 45, Code of Federal 
     Regulations), the Director of the Office for Civil Rights, in 
     consultation with the National Coordinator, shall assist 
     individuals and health care providers in understanding a 
     patient's rights to access and protect personal health 
     information under the Health Insurance Portability and 
     Accountability Act of 1996 (Public Law 104-191), including 
     providing best practices for requesting personal health 
     information in a computable format, including using patient 
     portals or third-party applications and common cases when a 
     provider is permitted to exchange and provide access to 
     health information.''.
       ``(2) Certifying usability for patients.--In carrying out 
     certification programs under section 3001(c)(5), the National 
     Coordinator may require that--
       ``(A) the certification criteria support--
       ``(i) patient access to their electronic health 
     information, including in a single longitudinal format that 
     is easy to understand, secure, and may be updated 
     automatically;
       ``(ii) the patient's ability to electronically communicate 
     patient-reported information (such as family history and 
     medical history); and
       ``(iii) patient access to their personal electronic health 
     information for research at the option of the patient; and
       ``(B) the HIT Advisory Committee develop and prioritize 
     standards, implementation specifications, and certification 
     criteria required to help support patient access to 
     electronic health information, patient usability, and support 
     for technologies that offer patients access to their 
     electronic health information in a single, longitudinal 
     format that is easy to understand, secure, and may be updated 
     automatically.''.
       (b) Access to Information in an Electronic Format.--Section 
     13405(e) of the Health Information Technology for Economic 
     and Clinical Health Act (42 U.S.C. 17935) is amended--
       (1) in paragraph (1), by striking ``and'' at the end;
       (2) by redesignating paragraph (2) as paragraph (3); and
       (3) by inserting after paragraph (1), the following:
       ``(2) if the individual makes a request to a business 
     associate for access to, or a copy of, protected health 
     information about the individual, or if an individual makes a 
     request to a business associate to grant such access to, or 
     transmit such copy directly to, a person or entity designated 
     by the individual, a business associate may provide the 
     individual with such access or copy, which may be in an 
     electronic form, or grant or transmit such access or copy to 
     such person or entity designated by the individual; and''.

     SEC. 4007. GAO STUDY ON PATIENT MATCHING.

       (a) In General.--Not later than 1 year after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall conduct a study to--
       (1) review the policies and activities of the Office of the 
     National Coordinator for Health Information Technology and 
     other relevant stakeholders, which may include standards 
     development organizations, experts in the technical aspects 
     of health information technology, health information 
     technology developers, providers of health services, health 
     care suppliers, health care payers, health care quality 
     organizations, States, health information technology policy 
     experts, and other appropriate entities, to ensure 
     appropriate patient matching to protect patient privacy and 
     security with respect to electronic health records and the 
     exchange of electronic health information; and
       (2) survey ongoing efforts related to the policies and 
     activities described in paragraph (1) and the effectiveness 
     of such efforts occurring in the private sector.
       (b) Areas of Concentration.--In conducting the study under 
     subsection (a), the Comptroller General shall--
       (1) evaluate current methods used in certified electronic 
     health records for patient matching based on performance 
     related to factors such as--
       (A) the privacy of patient information;
       (B) the security of patient information;
       (C) improving matching rates;
       (D) reducing matching errors; and
       (E) reducing duplicate records; and
       (2) determine whether the Office of the National 
     Coordinator for Health Information Technology could improve 
     patient matching by taking steps including--
       (A) defining additional data elements to assist in patient 
     data matching;
       (B) agreeing on a required minimum set of elements that 
     need to be collected and exchanged;
       (C) requiring electronic health records to have the ability 
     to make certain fields required and use specific standards; 
     and
       (D) other options recommended by the relevant stakeholders 
     consulted pursuant to subsection (a).
       (c) Report.--Not later than 2 years after the date of 
     enactment of this Act, the Comptroller General shall submit 
     to the appropriate committees of Congress a report concerning 
     the findings of the study conducted under subsection (a).

     SEC. 4008. GAO STUDY ON PATIENT ACCESS TO HEALTH INFORMATION.

       (a) Study.--
       (1) In general.--The Comptroller General of the United 
     States (referred to in this section as the ``Comptroller 
     General'') shall build on prior Government Accountability 
     Office studies and other literature review and conduct a 
     study to review patient access to their own protected health 
     information, including barriers to such patient access and 
     complications or difficulties providers experience in 
     providing access to patients. In conducting such study, the 
     Comptroller General shall consider the increase in adoption 
     of health information technology and the increasing 
     prevalence of protected health information that is maintained 
     electronically.

[[Page H6938]]

       (2) Areas of concentration.--In conducting the review under 
     paragraph (1), the Comptroller General shall consider--
       (A) instances when covered entities charge individuals, 
     including patients, third parties, and health care providers, 
     for record requests, including records that are requested in 
     an electronic format;
       (B) examples of the amounts and types of fees charged to 
     individuals for record requests, including instances when the 
     record is requested to be transmitted to a third party;
       (C) the extent to which covered entities are unable to 
     provide the access requested by individuals in the form and 
     format requested by the individual, including examples of 
     such instances;
       (D) instances in which third parties may request protected 
     health information through patients' individual right of 
     access, including instances where such requests may be used 
     to circumvent appropriate fees that may be charged to third 
     parties;
       (E) opportunities that permit covered entities to charge 
     appropriate fees to third parties for patient records while 
     providing patients with access to their protected health 
     information at low or no cost;
       (F) the ability of providers to distinguish between 
     requests originating from an individual that require 
     limitation to a cost-based fee and requests originating from 
     third parties that may not be limited to cost-based fees; and
       (G) other circumstances that may inhibit the ability of 
     providers to provide patients with access to their records, 
     and the ability of patients to gain access to their records.
       (b) Report.--Not later than 18 months after the date of 
     enactment of this Act, the Comptroller General shall submit a 
     report to Congress on the findings of the study conducted 
     under subsection (a).

     SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DETERMINATIONS.

       (a) In General.--Section 1862(l)(5) of the Social Security 
     Act (42 U.S.C. 1395y(l)(5)) is amended by adding at the end 
     the following new subparagraph:
       ``(D) Local coverage determinations.--The Secretary shall 
     require each Medicare administrative contractor that develops 
     a local coverage determination to make available on the 
     Internet website of such contractor and on the Medicare 
     Internet website, at least 45 days before the effective date 
     of such determination, the following information:
       ``(i) Such determination in its entirety.
       ``(ii) Where and when the proposed determination was first 
     made public.
       ``(iii) Hyperlinks to the proposed determination and a 
     response to comments submitted to the contractor with respect 
     to such proposed determination.
       ``(iv) A summary of evidence that was considered by the 
     contractor during the development of such determination and a 
     list of the sources of such evidence.
       ``(v) An explanation of the rationale that supports such 
     determination.''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply with respect to local coverage determinations 
     that are proposed or revised on or after the date that is 180 
     days after the date of enactment of this Act.

     SEC. 4010. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.

       Section 1808 of the Social Security Act (42 U.S.C. 1395b-9) 
     is amended by adding at the end the following new subsection:
       ``(d) Pharmaceutical and Technology Ombudsman.--
       ``(1) In general.--Not later than 12 months after the date 
     of enactment of this paragraph, the Secretary shall provide 
     for a pharmaceutical and technology ombudsman within the 
     Centers for Medicare & Medicaid Services who shall receive 
     and respond to complaints, grievances, and requests that--
       ``(A) are from entities that manufacture pharmaceutical, 
     biotechnology, medical device, or diagnostic products that 
     are covered or for which coverage is being sought under this 
     title; and
       ``(B) are with respect to coverage, coding, or payment 
     under this title for such products.
       ``(2) Application.--The second sentence of subsection 
     (c)(2) shall apply to the ombudsman under subparagraph (A) in 
     the same manner as such sentence applies to the Medicare 
     Beneficiary Ombudsman under subsection (c).''.

     SEC. 4011. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY.

       Section 1834 of the Social Security Act (42 U.S.C. 1395m) 
     is amended by adding at the end the following new subsection:
       ``(t) Site-of-Service Price Transparency.--
       ``(1) In general.--In order to facilitate price 
     transparency with respect to items and services for which 
     payment may be made either to a hospital outpatient 
     department or to an ambulatory surgical center under this 
     title, the Secretary shall, for 2018 and each year 
     thereafter, make available to the public via a searchable 
     Internet website, with respect to an appropriate number of 
     such items and services--
       ``(A) the estimated payment amount for the item or service 
     under the outpatient department fee schedule under subsection 
     (t) of section 1833 and the ambulatory surgical center 
     payment system under subsection (i) of such section; and
       ``(B) the estimated amount of beneficiary liability 
     applicable to the item or service.
       ``(2) Calculation of estimated beneficiary liability.--For 
     purposes of paragraph (1)(B), the estimated amount of 
     beneficiary liability, with respect to an item or service, is 
     the amount for such item or service for which an individual 
     who does not have coverage under a Medicare supplemental 
     policy certified under section 1882 or any other supplemental 
     insurance coverage is responsible.
       ``(3) Implementation.--In carrying out this subsection, the 
     Secretary--
       ``(A) shall include in the notice described in section 
     1804(a) a notification of the availability of the estimated 
     amounts made available under paragraph (1); and
       ``(B) may utilize mechanisms in existence on the date of 
     enactment of this subsection, such as the portion of the 
     Internet website of the Centers for Medicare & Medicaid 
     Services on which information comparing physician performance 
     is posted (commonly referred to as the Physician Compare 
     Internet website), to make available such estimated amounts 
     under such paragraph.
       ``(4) Funding.--For purposes of implementing this 
     subsection, the Secretary shall provide for the transfer, 
     from the Federal Supplementary Medical Insurance Trust Fund 
     under section 1841 to the Centers for Medicare & Medicaid 
     Services Program Management Account, of $6,000,000 for fiscal 
     year 2017, to remain available until expended.''.

     SEC. 4012. TELEHEALTH SERVICES IN MEDICARE.

       (a) Provision of Information by Centers for Medicare & 
     Medicaid Services.--Not later than 1 year after the date of 
     enactment of this Act, the Administrator of the Centers for 
     Medicare & Medicaid Services shall provide to the committees 
     of jurisdiction of the House of Representatives and the 
     Senate information on the following:
       (1) The populations of Medicare beneficiaries, such as 
     those who are dually eligible for the Medicare program under 
     title XVIII of the Social Security Act (42 U.S.C. 1395 et 
     seq.) and the Medicaid program under title XIX of such Act 
     (42 U.S.C. 1396 et seq.) and those with chronic conditions, 
     whose care may be improved most in terms of quality and 
     efficiency by the expansion, in a manner that meets or 
     exceeds the existing in-person standard of care under the 
     Medicare program under such title XVIII, of telehealth 
     services under section 1834(m)(4) of such Act (42 U.S.C. 
     1395m(m)(4)).
       (2) Activities by the Center for Medicare and Medicaid 
     Innovation which examine the use of telehealth services in 
     models, projects, or initiatives funded through section 1115A 
     of such Act (42 U.S.C. 1315a).
       (3) The types of high-volume services (and related 
     diagnoses) under such title XVIII which might be suitable to 
     be furnished using telehealth.
       (4) Barriers that might prevent the expansion of telehealth 
     services under section 1834(m)(4) of the Social Security Act 
     (42 U.S.C. 1395m(m)(4)) beyond such services that are in 
     effect as of the date of enactment of this Act.
       (b) Provision of Information by MedPAC.--Not later than 
     March 15, 2018, the Medicare Payment Advisory Commission 
     established under section 1805 of the Social Security Act (42 
     U.S.C. 1395b-6) shall, using quantitative and qualitative 
     research methods, provide information to the committees of 
     jurisdiction of the House of Representatives and the Senate 
     that identifies--
       (1) the telehealth services for which payment can be made, 
     as of the date of enactment of this Act, under the fee-for-
     service program under parts A and B of title XVIII of such 
     Act;
       (2) the telehealth services for which payment can be made, 
     as of such date, under private health insurance plans; and
       (3) with respect to services identified under paragraph (2) 
     but not under paragraph (1), ways in which payment for such 
     services might be incorporated into such fee-for-service 
     program (including any recommendations for ways to accomplish 
     this incorporation).
       (c) Sense of Congress.--It is the sense of Congress that--
       (1) eligible originating sites should be expanded beyond 
     those originating sites described in section 1834(m)(4)(C) of 
     the Social Security Act (42 U.S.C. 1395m(m)(4)(C)); and
       (2) any expansion of telehealth services under the Medicare 
     program under title XVIII of such Act should--
       (A) recognize that telemedicine is the delivery of safe, 
     effective, quality health care services, by a health care 
     provider, using technology as the mode of care delivery;
       (B) meet or exceed the conditions of coverage and payment 
     with respect to the Medicare program if the service was 
     furnished in person, including standards of care, unless 
     specifically addressed in subsequent legislation; and
       (C) involve clinically appropriate means to furnish such 
     services.

                            TITLE V--SAVINGS

     SEC. 5001. SAVINGS IN THE MEDICARE IMPROVEMENT FUND.

       Section 1898(b)(1) of the Social Security Act (42 U.S.C. 
     1395iii(b)(1)), as amended by section 704(h) of the 
     Comprehensive Addiction and Recovery Act of 2016, is amended 
     by striking ``$140,000,000'' and inserting ``$270,000,000''.

     SEC. 5002. MEDICAID REIMBURSEMENT TO STATES FOR DURABLE 
                   MEDICAL EQUIPMENT.

       Section 1903(i)(27) of the Social Security Act (42 U.S.C. 
     1396b(i)(27)) is amended by striking ``January 1, 2019'' and 
     inserting ``January 1, 2018''.

     SEC. 5003. PENALTIES FOR VIOLATIONS OF GRANTS, CONTRACTS, AND 
                   OTHER AGREEMENTS.

       (a) In General.--Section 1128A of the Social Security Act 
     (42 U.S.C. 1320a-7a) is amended by adding at the end the 
     following new subsections:
       ``(o) Any person (including an organization, agency, or 
     other entity, but excluding a program beneficiary, as defined 
     in subsection (q)(4)) that, with respect to a grant, 
     contract, or other agreement for which the Secretary provides 
     funding--
       ``(1) knowingly presents or causes to be presented a 
     specified claim (as defined in subsection (r)) under such 
     grant, contract, or other agreement that the person knows or 
     should know is false or fraudulent;
       ``(2) knowingly makes, uses, or causes to be made or used 
     any false statement, omission, or

[[Page H6939]]

     misrepresentation of a material fact in any application, 
     proposal, bid, progress report, or other document that is 
     required to be submitted in order to directly or indirectly 
     receive or retain funds provided in whole or in part by such 
     Secretary pursuant to such grant, contract, or other 
     agreement;
       ``(3) knowingly makes, uses, or causes to be made or used, 
     a false record or statement material to a false or fraudulent 
     specified claim under such grant, contract, or other 
     agreement;
       ``(4) knowingly makes, uses, or causes to be made or used, 
     a false record or statement material to an obligation (as 
     defined in subsection (s)) to pay or transmit funds or 
     property to such Secretary with respect to such grant, 
     contract, or other agreement, or knowingly conceals or 
     knowingly and improperly avoids or decreases an obligation to 
     pay or transmit funds or property to such Secretary with 
     respect to such grant, contract, or other agreement; or
       ``(5) fails to grant timely access, upon reasonable request 
     (as defined by such Secretary in regulations), to the 
     Inspector General of the Department, for the purpose of 
     audits, investigations, evaluations, or other statutory 
     functions of such Inspector General in matters involving such 
     grants, contracts, or other agreements;
     shall be subject, in addition to any other penalties that may 
     be prescribed by law, to a civil money penalty in cases under 
     paragraph (1), of not more than $10,000 for each specified 
     claim; in cases under paragraph (2), not more than $50,000 
     for each false statement, omission, or misrepresentation of a 
     material fact; in cases under paragraph (3), not more than 
     $50,000 for each false record or statement; in cases under 
     paragraph (4), not more than $50,000 for each false record or 
     statement or $10,000 for each day that the person knowingly 
     conceals or knowingly and improperly avoids or decreases an 
     obligation to pay; or in cases under paragraph (5), not more 
     than $15,000 for each day of the failure described in such 
     paragraph. In addition, in cases under paragraphs (1) and 
     (3), such a person shall be subject to an assessment of not 
     more than 3 times the amount claimed in the specified claim 
     described in such paragraph in lieu of damages sustained by 
     the United States or a specified State agency because of such 
     specified claim, and in cases under paragraphs (2) and (4), 
     such a person shall be subject to an assessment of not more 
     than 3 times the total amount of the funds described in 
     paragraph (2) or (4), respectively (or, in the case of an 
     obligation to transmit property to the Secretary described in 
     paragraph (4), of the value of the property described in such 
     paragraph) in lieu of damages sustained by the United States 
     or a specified State agency because of such case. In 
     addition, the Secretary may make a determination in the same 
     proceeding to exclude the person from participation in the 
     Federal health care programs (as defined in section 
     1128B(f)(1)) and to direct the appropriate State agency to 
     exclude the person from participation in any State health 
     care program.
       ``(p) The provisions of subsections (c), (d), (g), and (h) 
     shall apply to a civil money penalty or assessment under 
     subsection (o) in the same manner as such provisions apply to 
     a penalty, assessment, or proceeding under subsection (a). In 
     applying subsection (d), each reference to a claim under such 
     subsection shall be treated as including a reference to a 
     specified claim (as defined in subsection (r)).
       ``(q) For purposes of this subsection and subsections (o) 
     and (p):
       ``(1) The term `Department' means the Department of Health 
     and Human Services.
       ``(2) The term `material' means having a natural tendency 
     to influence, or be capable of influencing, the payment or 
     receipt of money or property.
       ``(3) The term `other agreement' includes a cooperative 
     agreement, scholarship, fellowship, loan, subsidy, payment 
     for a specified use, donation agreement, award, or subaward 
     (regardless of whether one or more of the persons entering 
     into the agreement is a contractor or subcontractor).
       ``(4) The term `program beneficiary' means, in the case of 
     a grant, contract, or other agreement designed to accomplish 
     the objective of awarding or otherwise furnishing benefits or 
     assistance to individuals and for which the Secretary 
     provides funding, an individual who applies for, or who 
     receives, such benefits or assistance from such grant, 
     contract, or other agreement. Such term does not include, 
     with respect to such grant, contract, or other agreement, an 
     officer, employee, or agent of a person or entity that 
     receives such grant or that enters into such contract or 
     other agreement.
       ``(5) The term `recipient' includes a subrecipient or 
     subcontractor.
       ``(6) The term `specified State agency' means an agency of 
     a State government established or designated to administer or 
     supervise the administration of a grant, contract, or other 
     agreement funded in whole or in part by the Secretary.
       ``(r) For purposes of this section, the term `specified 
     claim' means any application, request, or demand under a 
     grant, contract, or other agreement for money or property, 
     whether or not the United States or a specified State agency 
     has title to the money or property, that is not a claim (as 
     defined in subsection (i)(2)) and that--
       ``(1) is presented or caused to be presented to an officer, 
     employee, or agent of the Department or agency thereof, or of 
     any specified State agency; or
       ``(2) is made to a contractor, grantee, or any other 
     recipient if the money or property is to be spent or used on 
     the Department's behalf or to advance a Department program or 
     interest, and if the Department--
       ``(A) provides or has provided any portion of the money or 
     property requested or demanded; or
       ``(B) will reimburse such contractor, grantee, or other 
     recipient for any portion of the money or property which is 
     requested or demanded.
       ``(s) For purposes of subsection (o), the term `obligation' 
     means an established duty, whether or not fixed, arising from 
     an express or implied contractual, grantor-grantee, or 
     licensor-licensee relationship, for a fee-based or similar 
     relationship, from statute or regulation, or from the 
     retention of any overpayment.''.
       (b) Conforming Amendments.--Section 1128A of the Social 
     Security Act (42 U.S.C. 1320a-7a) is amended--
       (1) in subsection (e), by inserting ``or specified claim'' 
     after ``claim'' in the first sentence; and
       (2) in subsection (f)--
       (A) in the matter preceding paragraph (1)--
       (i) by inserting ``or specified claim (as defined in 
     subsection (r))'' after ``district where the claim''; and
       (ii) by inserting ``(or, with respect to a person described 
     in subsection (o), the person)'' after ``claimant''; and
       (B) in the matter following paragraph (4), by inserting 
     ``(or, in the case of a penalty or assessment under 
     subsection (o), by a specified State agency (as defined in 
     subsection (q)(6)),'' after ``or a State agency''.

     SEC. 5004. REDUCING OVERPAYMENTS OF INFUSION DRUGS.

       (a) Treatment of Infusion Drugs Furnished Through Durable 
     Medical Equipment.--Section 1842(o)(1) of the Social Security 
     Act (42 U.S.C. 1395u(o)(1)) is amended--
       (1) in subparagraph (C), by inserting ``(and including a 
     drug or biological described in subparagraph (D)(i) furnished 
     on or after January 1, 2017)'' after ``2005''; and
       (2) in subparagraph (D)--
       (A) by striking ``infusion drugs'' and inserting ``infusion 
     drugs or biologicals'' each place it appears; and
       (B) in clause (i)--
       (i) by striking ``2004'' and inserting ``2004, and before 
     January 1, 2017''; and
       (ii) by striking ``for such drug''.
       (b) Noninclusion of DME Infusion Drugs Under DME 
     Competitive Acquisition Programs.--
       (1) In general.--Section 1847(a)(2)(A) of the Social 
     Security Act (42 U.S.C. 1395w-3(a)(2)(A)) is amended--
       (A) by striking ``and excluding'' and inserting ``, 
     excluding''; and
       (B) by inserting before the period at the end the 
     following: ``, and excluding drugs and biologicals described 
     in section 1842(o)(1)(D)''.
       (2) Conforming amendment.--Section 1842(o)(1)(D)(ii) of the 
     Social Security Act (42 U.S.C. 1395u(o)(1)(D)(ii)) is amended 
     by striking ``2007'' and inserting ``2007, and before the 
     date of the enactment of the 21st Century Cures Act.''.

     SEC. 5005. INCREASING OVERSIGHT OF TERMINATION OF MEDICAID 
                   PROVIDERS.

       (a) Increased Oversight and Reporting.--
       (1) State reporting requirements.--Section 1902(kk) of the 
     Social Security Act (42 U.S.C. 1396a(kk)) is amended--
       (A) by redesignating paragraph (8) as paragraph (9); and
       (B) by inserting after paragraph (7) the following new 
     paragraph:
       ``(8) Provider terminations.--
       ``(A) In general.--Beginning on July 1, 2018, in the case 
     of a notification under subsection (a)(41) with respect to a 
     termination for a reason specified in section 455.101 of 
     title 42, Code of Federal Regulations (as in effect on 
     November 1, 2015) or for any other reason specified by the 
     Secretary, of the participation of a provider of services or 
     any other person under the State plan (or under a waiver of 
     the plan), the State, not later than 30 days after the 
     effective date of such termination submits to the Secretary 
     with respect to any such provider or person, as appropriate--
       ``(i) the name of such provider or person;
       ``(ii) the provider type of such provider or person;
       ``(iii) the specialty of such provider's or person's 
     practice;
       ``(iv) the date of birth, Social Security number, national 
     provider identifier (if applicable), Federal taxpayer 
     identification number, and the State license or certification 
     number of such provider or person (if applicable);
       ``(v) the reason for the termination;
       ``(vi) a copy of the notice of termination sent to the 
     provider or person;
       ``(vii) the date on which such termination is effective, as 
     specified in the notice; and
       ``(viii) any other information required by the Secretary.
       ``(B) Effective date defined.--For purposes of this 
     paragraph, the term `effective date' means, with respect to a 
     termination described in subparagraph (A), the later of--
       ``(i) the date on which such termination is effective, as 
     specified in the notice of such termination; or
       ``(ii) the date on which all appeal rights applicable to 
     such termination have been exhausted or the timeline for any 
     such appeal has expired.''.
       (2) Contract requirement for managed care entities.--
     Section 1932(d) of the Social Security Act (42 U.S.C. 1396u-
     2(d)) is amended by adding at the end the following new 
     paragraph:
       ``(5) Contract requirement for managed care entities.--With 
     respect to any contract with a managed care entity under 
     section 1903(m) or 1905(t)(3) (as applicable), no later than 
     July 1, 2018, such contract shall include a provision that 
     providers of services or persons terminated (as described in 
     section 1902(kk)(8)) from participation under this title, 
     title XVIII, or title XXI shall be terminated from 
     participating under this title as a provider in any network 
     of such entity that serves individuals eligible to receive 
     medical assistance under this title.''.
       (3) Termination notification database.--Section 1902 of the 
     Social Security Act (42 U.S.C.

[[Page H6940]]

     1396a) is amended by adding at the end the following new 
     subsection:
       ``(ll) Termination Notification Database.--In the case of a 
     provider of services or any other person whose participation 
     under this title or title XXI is terminated (as described in 
     subsection (kk)(8)), the Secretary shall, not later than 30 
     days after the date on which the Secretary is notified of 
     such termination under subsection (a)(41) (as applicable), 
     review such termination and, if the Secretary determines 
     appropriate, include such termination in any database or 
     similar system developed pursuant to section 6401(b)(2) of 
     the Patient Protection and Affordable Care Act (42 U.S.C. 
     1395cc note; Public Law 111-148).''.
       (4) No federal funds for items and services furnished by 
     terminated providers.--Section 1903 of the Social Security 
     Act (42 U.S.C. 1396b) is amended--
       (A) in subsection (i)(2)--
       (i) in subparagraph (A), by striking the comma at the end 
     and inserting a semicolon;
       (ii) in subparagraph (B), by striking ``or'' at the end; 
     and
       (iii) by adding at the end the following new subparagraph:
       ``(D) beginning on July 1, 2018, under the plan by any 
     provider of services or person whose participation in the 
     State plan is terminated (as described in section 
     1902(kk)(8)) after the date that is 60 days after the date on 
     which such termination is included in the database or other 
     system under section 1902(ll); or''; and
       (B) in subsection (m), by inserting after paragraph (2) the 
     following new paragraph:
       ``(3) No payment shall be made under this title to a State 
     with respect to expenditures incurred by the State for 
     payment for services provided by a managed care entity (as 
     defined under section 1932(a)(1)) under the State plan under 
     this title (or under a waiver of the plan) unless the State--
       ``(A) beginning on July 1, 2018, has a contract with such 
     entity that complies with the requirement specified in 
     section 1932(d)(5); and
       ``(B) beginning on January 1, 2018, complies with the 
     requirement specified in section 1932(d)(6)(A).''.
       (5) Development of uniform terminology for reasons for 
     provider termination.--Not later than July 1, 2017, the 
     Secretary of Health and Human Services shall, in consultation 
     with the heads of State agencies administering State Medicaid 
     plans (or waivers of such plans), issue regulations 
     establishing uniform terminology to be used with respect to 
     specifying reasons under subparagraph (A)(v) of paragraph (8) 
     of section 1902(kk) of the Social Security Act (42 U.S.C. 
     1396a(kk)), as added by paragraph (1), for the termination 
     (as described in such paragraph (8)) of the participation of 
     certain providers in the Medicaid program under title XIX of 
     such Act or the Children's Health Insurance Program under 
     title XXI of such Act.
       (6) Conforming amendment.--Section 1902(a)(41) of the 
     Social Security Act (42 U.S.C. 1396a(a)(41)) is amended by 
     striking ``provide that whenever'' and inserting ``provide, 
     in accordance with subsection (kk)(8) (as applicable), that 
     whenever''.
       (b) Increasing Availability of Medicaid Provider 
     Information.--
       (1) FFS provider enrollment.--Section 1902(a) of the Social 
     Security Act (42 U.S.C. 1396a(a)) is amended by inserting 
     after paragraph (77) the following new paragraph:
       ``(78) provide that, not later than January 1, 2017, in the 
     case of a State that pursuant to its State plan or waiver of 
     the plan for medical assistance pays for medical assistance 
     on a fee-for-service basis, the State shall require each 
     provider furnishing items and services to, or ordering, 
     prescribing, referring, or certifying eligibility for, 
     services for individuals eligible to receive medical 
     assistance under such plan to enroll with the State agency 
     and provide to the State agency the provider's identifying 
     information, including the name, specialty, date of birth, 
     Social Security number, national provider identifier (if 
     applicable), Federal taxpayer identification number, and the 
     State license or certification number of the provider (if 
     applicable);''.
       (2) Managed care provider enrollment.--Section 1932(d) of 
     the Social Security Act (42 U.S.C. 1396u-2(d)), as amended by 
     subsection (a)(2), is amended by adding at the end the 
     following new paragraph:
       ``(6) Enrollment of participating providers.--
       ``(A) In general.--Beginning not later than January 1, 
     2018, a State shall require that, in order to participate as 
     a provider in the network of a managed care entity that 
     provides services to, or orders, prescribes, refers, or 
     certifies eligibility for services for, individuals who are 
     eligible for medical assistance under the State plan under 
     this title (or under a waiver of the plan) and who are 
     enrolled with the entity, the provider is enrolled consistent 
     with section 1902(kk) with the State agency administering the 
     State plan under this title. Such enrollment shall include 
     providing to the State agency the provider's identifying 
     information, including the name, specialty, date of birth, 
     Social Security number, national provider identifier, Federal 
     taxpayer identification number, and the State license or 
     certification number of the provider.
       ``(B) Rule of construction.--Nothing in subparagraph (A) 
     shall be construed as requiring a provider described in such 
     subparagraph to provide services to individuals who are not 
     enrolled with a managed care entity under this title.''.
       (c) Coordination With CHIP.--
       (1) In general.--Section 2107(e)(1) of the Social Security 
     Act (42 U.S.C. 1397gg(e)(1)) is amended--
       (A) by redesignating subparagraphs (B), (C), (D), (E), (F), 
     (G), (H), (I), (J), (K), (L), (M), (N), and (O) as 
     subparagraphs (D), (E), (F), (G), (H), (I), (J), (K), (M), 
     (N), (O), (P), (Q), and (R), respectively;
       (B) by inserting after subparagraph (A) the following new 
     subparagraphs:
       ``(B) Section 1902(a)(39) (relating to termination of 
     participation of certain providers).
       ``(C) Section 1902(a)(78) (relating to enrollment of 
     providers participating in State plans providing medical 
     assistance on a fee-for-service basis).'';
       (C) by inserting after subparagraph (K) (as redesignated by 
     subparagraph (A)) the following new subparagraph:
       ``(L) Section 1903(m)(3) (relating to limitation on payment 
     with respect to managed care).''; and
       (D) in subparagraph (P) (as redesignated by subparagraph 
     (A)), by striking ``(a)(2)(C) and (h)'' and inserting 
     ``(a)(2)(C) (relating to Indian enrollment), (d)(5) (relating 
     to contract requirement for managed care entities), (d)(6) 
     (relating to enrollment of providers participating with a 
     managed care entity), and (h) (relating to special rules with 
     respect to Indian enrollees, Indian health care providers, 
     and Indian managed care entities)''.
       (2) Excluding from medicaid providers excluded from chip.--
     Section 1902(a)(39) of the Social Security Act (42 U.S.C. 
     1396a(a)(39)) is amended by striking ``title XVIII or any 
     other State plan under this title'' and inserting ``title 
     XVIII, any other State plan under this title (or waiver of 
     the plan), or any State child health plan under title XXI (or 
     waiver of the plan) and such termination is included by the 
     Secretary in any database or similar system developed 
     pursuant to section 6401(b)(2) of the Patient Protection and 
     Affordable Care Act''.
       (d) Rule of Construction.--Nothing in this section shall be 
     construed as changing or limiting the appeal rights of 
     providers or the process for appeals of States under the 
     Social Security Act.
       (e) OIG Report.--Not later than March 31, 2020, the 
     Inspector General of the Department of Health and Human 
     Services shall submit to Congress a report on the 
     implementation of the amendments made by this section. Such 
     report shall include the following:
       (1) An assessment of the extent to which providers who are 
     included under subsection (ll) of section 1902 of the Social 
     Security Act (42 U.S.C. 1396a) (as added by subsection 
     (a)(3)) in the database or similar system referred to in such 
     subsection are terminated (as described in paragraph (8) of 
     subsection (kk) of such section, as added by subsection 
     (a)(1)) from participation in all State plans under title XIX 
     of such Act (or waivers of such plans).
       (2) Information on the amount of Federal financial 
     participation paid to States under section 1903 of such Act 
     in violation of the limitation on such payment specified in 
     subparagraph (D) of subsection (i)(2) of such section and 
     paragraph (3) of subsection (m) of such section, as added by 
     subsection (a)(4).
       (3) An assessment of the extent to which contracts with 
     managed care entities under title XIX of such Act comply with 
     the requirement specified in paragraph (5) of section 1932(d) 
     of such Act, as added by subsection (a)(2).
       (4) An assessment of the extent to which providers have 
     been enrolled under section 1902(a)(78) or 1932(d)(6)(A) of 
     such Act (42 U.S.C. 1396a(a)(78), 1396u-2(d)(6)(A)) with 
     State agencies administering State plans under title XIX of 
     such Act (or waivers of such plans).

     SEC. 5006. REQUIRING PUBLICATION OF FEE-FOR-SERVICE PROVIDER 
                   DIRECTORY.

       (a) In General.--Section 1902(a) of the Social Security Act 
     (42 U.S.C. 1396a(a)) is amended--
       (1) in paragraph (81), by striking ``and'' at the end;
       (2) in paragraph (82), by striking the period at the end 
     and inserting ``; and''; and
       (3) by inserting after paragraph (82) the following new 
     paragraph:
       ``(83) provide that, not later than January 1, 2017, in the 
     case of a State plan (or waiver of the plan) that provides 
     medical assistance on a fee-for-service basis or through a 
     primary care case-management system described in section 
     1915(b)(1) (other than a primary care case management entity 
     (as defined by the Secretary)), the State shall publish (and 
     update on at least an annual basis) on the public website of 
     the State agency administering the State plan, a directory of 
     the physicians described in subsection (mm) and, at State 
     option, other providers described in such subsection that--
       ``(A) includes--
       ``(i) with respect to each such physician or provider--

       ``(I) the name of the physician or provider;
       ``(II) the specialty of the physician or provider;
       ``(III) the address at which the physician or provider 
     provides services; and
       ``(IV) the telephone number of the physician or provider; 
     and

       ``(ii) with respect to any such physician or provider 
     participating in such a primary care case-management system, 
     information regarding--

       ``(I) whether the physician or provider is accepting as new 
     patients individuals who receive medical assistance under 
     this title; and
       ``(II) the physician's or provider's cultural and 
     linguistic capabilities, including the languages spoken by 
     the physician or provider or by the skilled medical 
     interpreter providing interpretation services at the 
     physician's or provider's office; and

       ``(B) may include, at State option, with respect to each 
     such physician or provider--
       ``(i) the Internet website of such physician or provider; 
     or
       ``(ii) whether the physician or provider is accepting as 
     new patients individuals who receive medical assistance under 
     this title.''.
       (b) Directory Physician or Provider Described.--Section 
     1902 of the Social Security Act (42 U.S.C. 1396a), as amended 
     by section

[[Page H6941]]

     5005(a)(3), is further amended by adding at the end the 
     following new subsection:
       ``(mm) Directory Physician or Provider Described.--A 
     physician or provider described in this subsection is--
       ``(1) in the case of a physician or provider of a provider 
     type for which the State agency, as a condition on receiving 
     payment for items and services furnished by the physician or 
     provider to individuals eligible to receive medical 
     assistance under the State plan, requires the enrollment of 
     the physician or provider with the State agency, a physician 
     or a provider that--
       ``(A) is enrolled with the agency as of the date on which 
     the directory is published or updated (as applicable) under 
     subsection (a)(83); and
       ``(B) received payment under the State plan in the 12-month 
     period preceding such date; and
       ``(2) in the case of a physician or provider of a provider 
     type for which the State agency does not require such 
     enrollment, a physician or provider that received payment 
     under the State plan (or a waiver of the plan) in the 12-
     month period preceding the date on which the directory is 
     published or updated (as applicable) under subsection 
     (a)(83).''.
       (c) Rule of Construction.--
       (1) In general.--The amendment made by subsection (a) shall 
     not be construed to apply in the case of a State (as defined 
     for purposes of title XIX of the Social Security Act) in 
     which all the individuals enrolled in the State plan under 
     such title (or under a waiver of such plan), other than 
     individuals described in paragraph (2), are enrolled with a 
     medicaid managed care organization (as defined in section 
     1903(m)(1)(A) of such Act (42 U.S.C. 1396b(m)(1)(A))), 
     including prepaid inpatient health plans and prepaid 
     ambulatory health plans (as defined by the Secretary of 
     Health and Human Services).
       (2) Individuals described.--An individual described in this 
     paragraph is an individual who is an Indian (as defined in 
     section 4 of the Indian Health Care Improvement Act (25 
     U.S.C. 1603)) or an Alaska Native.
       (d) Exception for State Legislation.--In the case of a 
     State plan under title XIX of the Social Security Act (42 
     U.S.C. 1396 et seq.), which the Secretary of Health and Human 
     Services determines requires State legislation in order for 
     the respective plan to meet one or more additional 
     requirements imposed by amendments made by this section, the 
     respective plan shall not be regarded as failing to comply 
     with the requirements of such title solely on the basis of 
     its failure to meet such an additional requirement before the 
     first day of the first calendar quarter beginning after the 
     close of the first regular session of the State legislature 
     that begins after the date of enactment of this Act. For 
     purposes of the previous sentence, in the case of a State 
     that has a 2-year legislative session, each year of the 
     session shall be considered to be a separate regular session 
     of the State legislature.

     SEC. 5007. FAIRNESS IN MEDICAID SUPPLEMENTAL NEEDS TRUSTS.

       (a) In General.--Section 1917(d)(4)(A) of the Social 
     Security Act (42 U.S.C. 1396p(d)(4)(A)) is amended by 
     inserting ``the individual,'' after ``for the benefit of such 
     individual by''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply to trusts established on or after the date of the 
     enactment of this Act.

     SEC. 5008. ELIMINATING FEDERAL FINANCIAL PARTICIPATION WITH 
                   RESPECT TO EXPENDITURES UNDER MEDICAID FOR 
                   AGENTS USED FOR COSMETIC PURPOSES OR HAIR 
                   GROWTH.

       (a) In General.--Section 1903(i)(21) of the Social Security 
     Act (42 U.S.C. 1396b(i)(21)) is amended by inserting 
     ``section 1927(d)(2)(C) (relating to drugs when used for 
     cosmetic purposes or hair growth), except where medically 
     necessary, and'' after ``drugs described in''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall apply with respect to calendar quarters beginning on or 
     after the date of the enactment of this Act.

     SEC. 5009. AMENDMENT TO THE PREVENTION AND PUBLIC HEALTH 
                   FUND.

       Section 4002(b) of the Patient Protection and Affordable 
     Care Act (42 U.S.C. 300u-11(b)) is amended--
       (1) in paragraph (3), by striking ``$1,250,000,000'' and 
     inserting ``$900,000,000'';
       (2) in paragraph (4), by striking ``$1,500,000,000'' and 
     inserting ``$1,000,000,000''; and
       (3) by striking paragraph (5) and inserting the following:
       ``(5) for fiscal year 2022, $1,500,000,000;
       ``(6) for fiscal year 2023, $1,000,000,000;
       ``(7) for fiscal year 2024, $1,700,000,000; and
       ``(8) for fiscal year 2025 and each fiscal year thereafter, 
     $2,000,000,000.''.

     SEC. 5010. STRATEGIC PETROLEUM RESERVE DRAWDOWN.

       (a) Drawdown and Sale.--
       (1) In general.--Notwithstanding section 161 of the Energy 
     Policy and Conservation Act (42 U.S.C. 6241), except as 
     provided in subsections (b) and (c), the Secretary of Energy 
     shall drawdown and sell from the Strategic Petroleum 
     Reserve--
       (A) 10,000,000 barrels of crude oil during fiscal year 
     2017;
       (B) 9,000,000 barrels of crude oil during fiscal year 2018; 
     and
       (C) 6,000,000 barrels of crude oil during fiscal year 2019.
       (2) Deposit of amounts received from sale.--Amounts 
     received from a sale under paragraph (1) shall be deposited 
     in the general fund of the Treasury during the fiscal year in 
     which the sale occurs.
       (b) Emergency Protection.--The Secretary shall not draw 
     down and sell crude oil under this section in quantities that 
     would limit the authority to sell petroleum products under 
     section 161(h) of the Energy Policy and Conservation Act (42 
     U.S.C. 6241(h)) in the full quantity authorized by that 
     subsection.
       (c) Strategic Petroleum Drawdown Limitations.--
     Subparagraphs (C) and (D) of section 161(h)(2) of the Energy 
     Policy and Conservation Act (42 U.S.C. 6241(h)(2)(C) and (D)) 
     are both amended by striking ``500,000,000'' and inserting 
     ``450,000,000''.

     SEC. 5011. RESCISSION OF PORTION OF ACA TERRITORY FUNDING.

       Of the unobligated amounts available under section 
     1323(c)(1) of the Patient Protection and Affordable Care Act 
     (42 U.S.C. 18043(c)(1)), $464,000,000 is rescinded 
     immediately upon the date of the enactment of this Act.

     SEC. 5012. MEDICARE COVERAGE OF HOME INFUSION THERAPY.

       (a) In General.--Section 1861 of the Social Security Act 
     (42 U.S.C. 1395x) is amended--
       (1) in subsection (s)(2)--
       (A) by striking ``and'' at the end of subparagraph (EE);
       (B) by inserting ``and'' at the end of subparagraph (FF); 
     and
       (C) by inserting at the end the following new subparagraph:
       ``(GG) home infusion therapy (as defined in subsection 
     (iii)(1));''; and
       (2) by adding at the end the following new subsection:
       ``(iii) Home Infusion Therapy.--(1) The term `home infusion 
     therapy' means the items and services described in paragraph 
     (2) furnished by a qualified home infusion therapy supplier 
     (as defined in paragraph (3)(D)) which are furnished in the 
     individual's home (as defined in paragraph (3)(B)) to an 
     individual--
       ``(A) who is under the care of an applicable provider (as 
     defined in paragraph (3)(A)); and
       ``(B) with respect to whom a plan prescribing the type, 
     amount, and duration of infusion therapy services that are to 
     be furnished such individual has been established by a 
     physician (as defined in subsection (r)(1)) and is 
     periodically reviewed by a physician (as so defined) in 
     coordination with the furnishing of home infusion drugs (as 
     defined in paragraph (3)(C)) under part B.
       ``(2) The items and services described in this paragraph 
     are the following:
       ``(A) Professional services, including nursing services, 
     furnished in accordance with the plan.
       ``(B) Training and education (not otherwise paid for as 
     durable medical equipment (as defined in subsection (n)), 
     remote monitoring, and monitoring services for the provision 
     of home infusion therapy and home infusion drugs furnished by 
     a qualified home infusion therapy supplier.
       ``(3) For purposes of this subsection:
       ``(A) The term `applicable provider' means--
       ``(i) a physician;
       ``(ii) a nurse practitioner; and
       ``(iii) a physician assistant.
       ``(B) The term `home' means a place of residence used as 
     the home of an individual (as defined for purposes of 
     subsection (n)).
       ``(C) The term `home infusion drug' means a parenteral drug 
     or biological administered intravenously, or subcutaneously 
     for an administration period of 15 minutes or more, in the 
     home of an individual through a pump that is an item of 
     durable medical equipment (as defined in subsection (n)). 
     Such term does not include the following:
       ``(i) Insulin pump systems.
       ``(ii) A self-administered drug or biological on a self-
     administered drug exclusion list.
       ``(D)(i) The term `qualified home infusion therapy 
     supplier' means a pharmacy, physician, or other provider of 
     services or supplier licensed by the State in which the 
     pharmacy, physician, or provider or services or supplier 
     furnishes items or services and that--
       ``(I) furnishes infusion therapy to individuals with acute 
     or chronic conditions requiring administration of home 
     infusion drugs;
       ``(II) ensures the safe and effective provision and 
     administration of home infusion therapy on a 7-day-a-week, 
     24-hour-a-day basis;
       ``(III) is accredited by an organization designated by the 
     Secretary pursuant to section 1834(u)(5); and
       ``(IV) meets such other requirements as the Secretary 
     determines appropriate, taking into account the standards of 
     care for home infusion therapy established by Medicare 
     Advantage plans under part C and in the private sector.
       ``(ii) A qualified home infusion therapy supplier may 
     subcontract with a pharmacy, physician, provider of services, 
     or supplier to meet the requirements of this subparagraph.''.
       (b) Payment and Related Requirements for Home Infusion 
     Therapy.--Section 1834 of the Social Security Act (42 U.S.C. 
     1395m), as amended by section 4011, is further amended by 
     adding at the end the following new subsection:
       ``(u) Payment and Related Requirements for Home Infusion 
     Therapy.--
       ``(1) Payment.--
       ``(A) Single payment.--
       ``(i) In general.--Subject to clause (iii) and 
     subparagraphs (B) and (C), the Secretary shall implement a 
     payment system under which a single payment is made under 
     this title to a qualified home infusion therapy supplier for 
     items and services described in subparagraphs (A) and (B) of 
     section 1861(iii)(2)) furnished by a qualified home infusion 
     therapy supplier (as defined in section 1861(iii)(3)(D)) in 
     coordination with the furnishing of home infusion drugs (as 
     defined in section 1861(iii)(3)(C)) under this part.
       ``(ii) Unit of single payment.--A unit of single payment 
     under the payment system implemented under this subparagraph 
     is for each infusion drug administration calendar day in the 
     individual's home. The Secretary shall, as appropriate, 
     establish single payment amounts for types of infusion 
     therapy, including to take into account variation in 
     utilization of nursing services by therapy type.
       ``(iii) Limitation.--The single payment amount determined 
     under this subparagraph

[[Page H6942]]

     after application of subparagraph (B) and paragraph (3) shall 
     not exceed the amount determined under the fee schedule under 
     section 1848 for infusion therapy services furnished in a 
     calendar day if furnished in a physician office setting, 
     except such single payment shall not reflect more than 5 
     hours of infusion for a particular therapy in a calendar day.
       ``(B) Required adjustments.--The Secretary shall adjust the 
     single payment amount determined under subparagraph (A) for 
     home infusion therapy services under section 1861(iii)(1) to 
     reflect other factors such as--
       ``(i) a geographic wage index and other costs that may vary 
     by region; and
       ``(ii) patient acuity and complexity of drug 
     administration.
       ``(C) Discretionary adjustments.--
       ``(i) In general.--Subject to clause (ii), the Secretary 
     may adjust the single payment amount determined under 
     subparagraph (A) (after application of subparagraph (B)) to 
     reflect outlier situations and other factors as the Secretary 
     determines appropriate.
       ``(ii) Requirement of budget neutrality.--Any adjustment 
     under this subparagraph shall be made in a budget neutral 
     manner.
       ``(2) Considerations.--In developing the payment system 
     under this subsection, the Secretary may consider the costs 
     of furnishing infusion therapy in the home, consult with home 
     infusion therapy suppliers, consider payment amounts for 
     similar items and services under this part and part A, and 
     consider payment amounts established by Medicare Advantage 
     plans under part C and in the private insurance market for 
     home infusion therapy (including average per treatment day 
     payment amounts by type of home infusion therapy).
       ``(3) Annual updates.--
       ``(A) In general.--Subject to subparagraph (B), the 
     Secretary shall update the single payment amount under this 
     subsection from year to year beginning in 2022 by increasing 
     the single payment amount from the prior year by the 
     percentage increase in the Consumer Price Index for all urban 
     consumers (United States city average) for the 12-month 
     period ending with June of the preceding year.
       ``(B) Adjustment.--For each year, the Secretary shall 
     reduce the percentage increase described in subparagraph (A) 
     by the productivity adjustment described in section 
     1886(b)(3)(B)(xi)(II). The application of the preceding 
     sentence may result in a percentage being less than 0.0 for a 
     year, and may result in payment being less than such payment 
     rates for the preceding year.
       ``(4) Authority to apply prior authorization.--The 
     Secretary may, as determined appropriate by the Secretary, 
     apply prior authorization for home infusion therapy services 
     under section 1861(iii)(1).
       ``(5) Accreditation of qualified home infusion therapy 
     suppliers.--
       ``(A) Factors for designation of accreditation 
     organizations.--The Secretary shall consider the following 
     factors in designating accreditation organizations under 
     subparagraph (B) and in reviewing and modifying the list of 
     accreditation organizations designated pursuant to 
     subparagraph (C):
       ``(i) The ability of the organization to conduct timely 
     reviews of accreditation applications.
       ``(ii) The ability of the organization to take into account 
     the capacities of suppliers located in a rural area (as 
     defined in section 1886(d)(2)(D)).
       ``(iii) Whether the organization has established reasonable 
     fees to be charged to suppliers applying for accreditation.
       ``(iv) Such other factors as the Secretary determines 
     appropriate.
       ``(B) Designation.--Not later than January 1, 2021, the 
     Secretary shall designate organizations to accredit suppliers 
     furnishing home infusion therapy. The list of accreditation 
     organizations so designated may be modified pursuant to 
     subparagraph (C).
       ``(C) Review and modification of list of accreditation 
     organizations.--
       ``(i) In general.--The Secretary shall review the list of 
     accreditation organizations designated under subparagraph (B) 
     taking into account the factors under subparagraph (A). 
     Taking into account the results of such review, the Secretary 
     may, by regulation, modify the list of accreditation 
     organizations designated under subparagraph (B).
       ``(ii) Special rule for accreditations done prior to 
     removal from list of designated accreditation 
     organizations.--In the case where the Secretary removes an 
     organization from the list of accreditation organizations 
     designated under subparagraph (B), any supplier that is 
     accredited by the organization during the period beginning on 
     the date on which the organization is designated as an 
     accreditation organization under subparagraph (B) and ending 
     on the date on which the organization is removed from such 
     list shall be considered to have been accredited by an 
     organization designated by the Secretary under subparagraph 
     (B) for the remaining period such accreditation is in effect.
       ``(D) Rule for accreditations made prior to designation.--
     In the case of a supplier that is accredited before January 
     1, 2021, by an accreditation organization designated by the 
     Secretary under subparagraph (B) as of January 1, 2019, such 
     supplier shall be considered to have been accredited by an 
     organization designated by the Secretary under such paragraph 
     as of January 1, 2023, for the remaining period such 
     accreditation is in effect.
       ``(6) Notification of infusion therapy options available 
     prior to furnishing home infusion therapy.--Prior to the 
     furnishing of home infusion therapy to an individual, the 
     physician who establishes the plan described in section 
     1861(iii)(1) for the individual shall provide notification 
     (in a form, manner, and frequency determined appropriate by 
     the Secretary) of the options available (such as home, 
     physician's office, hospital outpatient department) for the 
     furnishing of infusion therapy under this part.''.
       (c) Conforming Amendments.--
       (1) Payment reference.--Section 1833(a)(1) of the Social 
     Security Act (42 U.S.C. 1395l(a)(1)) is amended--
       (A) by striking ``and'' before ``(AA)''; and
       (B) by inserting before the semicolon at the end the 
     following: ``, and (BB) with respect to home infusion 
     therapy, the amount paid shall be an amount equal to 80 
     percent of the lesser of the actual charge for the services 
     or the amount determined under section 1834(u)''.
       (2) Direct payment.--The first sentence of section 
     1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6)) 
     is amended--
       (A) by striking ``and'' before ``(H)''; and
       (B) by inserting before the period at the end the 
     following: ``, and (I) in the case of home infusion therapy, 
     payment shall be made to the qualified home infusion therapy 
     supplier''.
       (3) Exclusion from home health services.--Section 1861(m) 
     of the Social Security Act (42 U.S.C. 1395x(m)) is amended, 
     in the first sentence, by inserting the following before the 
     period at the end: ``and home infusion therapy (as defined in 
     subsection (iii)(i))''.
       (d) Effective Date.--The amendments made by this section 
     shall apply to items and services furnished on or after 
     January 1, 2021.

          DIVISION B--HELPING FAMILIES IN MENTAL HEALTH CRISIS

     SEC. 6000. SHORT TITLE.

       This division may be cited as the ``Helping Families in 
     Mental Health Crisis Reform Act of 2016''.

         TITLE VI--STRENGTHENING LEADERSHIP AND ACCOUNTABILITY

                         Subtitle A--Leadership

     SEC. 6001. ASSISTANT SECRETARY FOR MENTAL HEALTH AND 
                   SUBSTANCE USE.

       (a) Assistant Secretary.--Section 501(c) of the Public 
     Health Service Act (42 U.S.C. 290aa(c)) is amended to read as 
     follows:
       ``(c) Assistant Secretary and Deputy Assistant Secretary.--
       ``(1) Assistant secretary.--The Administration shall be 
     headed by an official to be known as the Assistant Secretary 
     for Mental Health and Substance Use (hereinafter in this 
     title referred to as the `Assistant Secretary') who shall be 
     appointed by the President, by and with the advice and 
     consent of the Senate.
       ``(2) Deputy assistant secretary.--The Assistant Secretary, 
     with the approval of the Secretary, may appoint a Deputy 
     Assistant Secretary and may employ and prescribe the 
     functions of such officers and employees, including 
     attorneys, as are necessary to administer the activities to 
     be carried out through the Administration.''.
       (b) Transfer of Authorities.--The Secretary of Health and 
     Human Services shall delegate to the Assistant Secretary for 
     Mental Health and Substance Use all duties and authorities 
     that--
       (1) as of the day before the date of enactment of this Act, 
     were vested in the Administrator of the Substance Abuse and 
     Mental Health Services Administration; and
       (2) are not terminated by this Act.
       (c) Conforming Amendments.--Title V of the Public Health 
     Service Act (42 U.S.C. 290aa et seq.), as amended by the 
     previous provisions of this section, is further amended--
       (1) by striking ``Administrator of the Substance Abuse and 
     Mental Health Services Administration'' each place it appears 
     and inserting ``Assistant Secretary for Mental Health and 
     Substance Use''; and
       (2) by striking ``Administrator'' or ``Administrator'' each 
     place it appears (including in any headings) and inserting 
     ``Assistant Secretary'' or ``Assistant Secretary'', 
     respectively, except where the term ``Administrator'' 
     appears--
       (A) in each of subsections (e) and (f) of section 501 of 
     such Act (42 U.S.C. 290aa), including the headings of such 
     subsections, within the term ``Associate Administrator'';
       (B) in section 507(b)(6) of such Act (42 U.S.C. 
     290bb(b)(6)), within the term ``Administrator of the Health 
     Resources and Services Administration'';
       (C) in section 507(b)(6) of such Act (42 U.S.C. 
     290bb(b)(6)), within the term ``Administrator of the Centers 
     for Medicare & Medicaid Services'';
       (D) in section 519B(c)(1)(B) of such Act (42 U.S.C. 290bb-
     25b(c)(1)(B)), within the term ``Administrator of the 
     National Highway Traffic Safety Administration''; or
       (E) in each of sections 519B(c)(1)(B), 520C(a), and 520D(a) 
     of such Act (42 U.S.C. 290bb-25b(c)(1)(B), 290bb-34(a), 
     290bb-35(a)), within the term ``Administrator of the Office 
     of Juvenile Justice and Delinquency Prevention''.
       (d) References.--After executing subsections (a), (b), and 
     (c), any reference in statute, regulation, or guidance to the 
     Administrator of the Substance Abuse and Mental Health 
     Services Administration shall be construed to be a reference 
     to the Assistant Secretary for Mental Health and Substance 
     Use.

     SEC. 6002. STRENGTHENING THE LEADERSHIP OF THE SUBSTANCE 
                   ABUSE AND MENTAL HEALTH SERVICES 
                   ADMINISTRATION.

       Section 501 of the Public Health Service Act (42 U.S.C. 
     290aa), as amended by section 6001, is further amended--
       (1) in subsection (b)--
       (A) in the subsection heading, by striking ``Agencies'' and 
     inserting ``Centers''; and

[[Page H6943]]

       (B) in the matter preceding paragraph (1), by striking 
     ``entities'' and inserting ``Centers'';
       (2) in subsection (d)--
       (A) in paragraph (1)--
       (i) by striking ``agencies'' each place the term appears 
     and inserting ``Centers''; and
       (ii) by striking ``such agency'' and inserting ``such 
     Center'';
       (B) in paragraph (2)--
       (i) by striking ``agencies'' and inserting ``Centers'';
       (ii) by striking ``with respect to substance abuse'' and 
     inserting ``with respect to substance use disorders''; and
       (iii) by striking ``and individuals who are substance 
     abusers'' and inserting ``and individuals with substance use 
     disorders'';
       (C) in paragraph (5), by striking ``substance abuse'' and 
     inserting ``substance use disorder'';
       (D) in paragraph (6)--
       (i) by striking ``the Centers for Disease Control'' and 
     inserting ``the Centers for Disease Control and 
     Prevention,'';
       (ii) by striking ``Administration develop'' and inserting 
     ``Administration, develop'';
       (iii) by striking ``HIV or tuberculosis among substance 
     abusers and individuals with mental illness'' and inserting 
     ``HIV, hepatitis, tuberculosis, and other communicable 
     diseases among individuals with mental or substance use 
     disorders,''; and
       (iv) by striking ``illnesses'' at the end and inserting 
     ``diseases or disorders'';
       (E) in paragraph (7), by striking ``abuse utilizing anti-
     addiction medications, including methadone'' and inserting 
     ``use disorders, including services that utilize drugs or 
     devices approved or cleared by the Food and Drug 
     Administration for the treatment of substance use 
     disorders'';
       (F) in paragraph (8)--
       (i) by striking ``Agency for Health Care Policy Research'' 
     and inserting ``Agency for Healthcare Research and Quality''; 
     and
       (ii) by striking ``treatment and prevention'' and inserting 
     ``prevention and treatment'';
       (G) in paragraph (9)--
       (i) by inserting ``and maintenance'' after ``development'';
       (ii) by striking ``Agency for Health Care Policy Research'' 
     and inserting ``Agency for Healthcare Research and Quality''; 
     and
       (iii) by striking ``treatment and prevention services'' and 
     inserting ``prevention, treatment, and recovery support 
     services and are appropriately incorporated into programs 
     carried out by the Administration'';
       (H) in paragraph (10), by striking ``abuse'' and inserting 
     ``use disorder'';
       (I) by striking paragraph (11) and inserting the following:
       ``(11) work with relevant agencies of the Department of 
     Health and Human Services on integrating mental health 
     promotion and substance use disorder prevention with general 
     health promotion and disease prevention and integrating 
     mental and substance use disorders treatment services with 
     physical health treatment services;'';
       (J) in paragraph (13)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``this title, assure that'' and inserting ``this title or 
     part B of title XIX, or grant programs otherwise funded by 
     the Administration'';
       (ii) in subparagraph (A)--

       (I) by inserting ``require that'' before ``all grants''; 
     and
       (II) by striking ``and'' at the end;

       (iii) by redesignating subparagraph (B) as subparagraph 
     (C);
       (iv) by inserting after subparagraph (A) the following:
       ``(B) ensure that the director of each Center of the 
     Administration consistently documents the application of 
     criteria when awarding grants and the ongoing oversight of 
     grantees after such grants are awarded;'';
       (v) in subparagraph (C), as so redesignated--

       (I) by inserting ``require that'' before ``all grants''; 
     and
       (II) in clause (ii), by inserting ``and'' after the 
     semicolon at the end; and

       (vi) by adding at the end the following:
       ``(D) inform a State when any funds are awarded through 
     such a grant to any entity within such State;'';
       (K) in paragraph (16), by striking ``abuse and mental 
     health information'' and inserting ``use disorder 
     information, including evidence-based and promising best 
     practices for prevention, treatment, and recovery support 
     services for individuals with mental and substance use 
     disorders,'';
       (L) in paragraph (17)--
       (i) by striking ``substance abuse'' and inserting 
     ``substance use disorder''; and
       (ii) by striking ``and'' at the end;
       (M) in paragraph (18), by striking the period and inserting 
     a semicolon; and
       (N) by adding at the end the following:
       ``(19) consult with State, local, and tribal governments, 
     nongovernmental entities, and individuals with mental 
     illness, particularly adults with a serious mental illness, 
     children with a serious emotional disturbance, and the family 
     members of such adults and children, with respect to 
     improving community-based and other mental health services;
       ``(20) collaborate with the Secretary of Defense and the 
     Secretary of Veterans Affairs to improve the provision of 
     mental and substance use disorder services provided by the 
     Department of Defense and the Department of Veterans Affairs 
     to members of the Armed Forces, veterans, and the family 
     members of such members and veterans, including through the 
     provision of services using the telehealth capabilities of 
     the Department of Defense and the Department of Veterans 
     Affairs;
       ``(21) collaborate with the heads of relevant Federal 
     agencies and departments, States, communities, and 
     nongovernmental experts to improve mental and substance use 
     disorders services for chronically homeless individuals, 
     including by designing strategies to provide such services in 
     supportive housing;
       ``(22) work with States and other stakeholders to develop 
     and support activities to recruit and retain a workforce 
     addressing mental and substance use disorders;
       ``(23) collaborate with the Attorney General and 
     representatives of the criminal justice system to improve 
     mental and substance use disorders services for individuals 
     who have been arrested or incarcerated;
       ``(24) after providing an opportunity for public input, set 
     standards for grant programs under this title for mental and 
     substance use disorders services and prevention programs, 
     which standards may address--
       ``(A) the capacity of the grantee to implement the award;
       ``(B) requirements for the description of the program 
     implementation approach;
       ``(C) the extent to which the grant plan submitted by the 
     grantee as part of its application must explain how the 
     grantee will reach the population of focus and provide a 
     statement of need, which may include information on how the 
     grantee will increase access to services and a description of 
     measurable objectives for improving outcomes;
       ``(D) the extent to which the grantee must collect and 
     report on required performance measures; and
       ``(E) the extent to which the grantee is proposing to use 
     evidence-based practices; and
       ``(25) advance, through existing programs, the use of 
     performance metrics, including those based on the 
     recommendations on performance metrics from the Assistant 
     Secretary for Planning and Evaluation under section 6021(d) 
     of the Helping Families in Mental Health Crisis Reform Act of 
     2016.''; and
       (3) in subsection (m), by adding at the end the following:
       ``(4) Emergency response.--Amounts made available for 
     carrying out this subsection shall remain available through 
     the end of the fiscal year following the fiscal year for 
     which such amounts are appropriated.''.

     SEC. 6003. CHIEF MEDICAL OFFICER.

       Section 501 of the Public Health Service Act (42 U.S.C. 
     290aa), as amended by sections 6001 and 6002, is further 
     amended--
       (1) by redesignating subsections (g) through (j) and 
     subsections (k) through (o) as subsections (h) through (k) 
     and subsections (m) through (q), respectively;
       (2) in subsection (e)(3)(C), by striking ``subsection (k)'' 
     and inserting ``subsection (m)'';
       (3) in subsection (f)(2)(C)(iii), by striking ``subsection 
     (k)'' and inserting ``subsection (m)''; and
       (4) by inserting after subsection (f) the following:
       ``(g) Chief Medical Officer.--
       ``(1) In general.--The Assistant Secretary, with the 
     approval of the Secretary, shall appoint a Chief Medical 
     Officer to serve within the Administration.
       ``(2) Eligible candidates.--The Assistant Secretary shall 
     select the Chief Medical Officer from among individuals who--
       ``(A) have a doctoral degree in medicine or osteopathic 
     medicine;
       ``(B) have experience in the provision of mental or 
     substance use disorder services;
       ``(C) have experience working with mental or substance use 
     disorder programs;
       ``(D) have an understanding of biological, psychosocial, 
     and pharmaceutical treatments of mental or substance use 
     disorders; and
       ``(E) are licensed to practice medicine in one or more 
     States.
       ``(3) Duties.--The Chief Medical Officer shall--
       ``(A) serve as a liaison between the Administration and 
     providers of mental and substance use disorders prevention, 
     treatment, and recovery services;
       ``(B) assist the Assistant Secretary in the evaluation, 
     organization, integration, and coordination of programs 
     operated by the Administration;
       ``(C) promote evidence-based and promising best practices, 
     including culturally and linguistically appropriate 
     practices, as appropriate, for the prevention and treatment 
     of, and recovery from, mental and substance use disorders, 
     including serious mental illness and serious emotional 
     disturbances;
       ``(D) participate in regular strategic planning with the 
     Administration;
       ``(E) coordinate with the Assistant Secretary for Planning 
     and Evaluation to assess the use of performance metrics to 
     evaluate activities within the Administration related to 
     mental and substance use disorders; and
       ``(F) coordinate with the Assistant Secretary to ensure 
     mental and substance use disorders grant programs within the 
     Administration consistently utilize appropriate performance 
     metrics and evaluation designs.''.

     SEC. 6004. IMPROVING THE QUALITY OF BEHAVIORAL HEALTH 
                   PROGRAMS.

       Section 505 of the Public Health Service Act (42 U.S.C. 
     290aa-4), as amended by section 6001(c), is amended--
       (1) by striking the section designation and heading and 
     inserting the following:

     ``SEC. 505. CENTER FOR BEHAVIORAL HEALTH STATISTICS AND 
                   QUALITY.'';

       (2) by redesignating subsections (a) through (d) as 
     subsections (b) through (e), respectively;
       (3) before subsection (b), as redesignated by paragraph 
     (2), by inserting the following:
       ``(a) In General.--The Assistant Secretary shall maintain 
     within the Administration a Center for Behavioral Health 
     Statistics and Quality (in this section referred to as the 
     `Center'). The Center shall be headed by a Director (in this 
     section referred to as the `Director') appointed

[[Page H6944]]

     by the Secretary from among individuals with extensive 
     experience and academic qualifications in research and 
     analysis in behavioral health care or related fields.'';
       (4) in subsection (b), as redesignated by paragraph (2)--
       (A) by redesignating paragraphs (1) and (2) as 
     subparagraphs (A) and (B), respectively;
       (B) by striking ``The Secretary, acting'' and all that 
     follows through ``year on--'' and inserting ``The Director 
     shall--
       ``(1) coordinate the Administration's integrated data 
     strategy, including by collecting data each year on--'';
       (C) in the subparagraph (B), as redesignated by 
     subparagraph (A), by striking ``Assistant Secretary'' and 
     inserting ``Director''; and
       (D) by adding at the end the following new paragraphs:
       ``(2) provide statistical and analytical support for 
     activities of the Administration;
       ``(3) recommend a core set of performance metrics to 
     evaluate activities supported by the Administration; and
       ``(4) coordinate with the Assistant Secretary, the 
     Assistant Secretary for Planning and Evaluation, and the 
     Chief Medical Officer appointed under section 501(g), as 
     appropriate, to improve the quality of services provided by 
     programs of the Administration and the evaluation of 
     activities carried out by the Administration.''.
       (5) in subsection (c), as so redesignated--
       (A) by striking ``With respect to the activities'' and 
     inserting ``Mental Health.--With respect to the activities'';
       (B) by striking ``Assistant Secretary'' each place it 
     appears and inserting ``Director''; and
       (C) by striking ``subsection (a)'' and inserting 
     ``subsection (b)(1)'';
       (6) in subsection (d), as so redesignated--
       (A) by striking the subsection designation and all that 
     follows through ``With respect to the activities'' and 
     inserting the following:
       ``(d) Substance Abuse.--
       ``(1) In general.--With respect to the activities'';
       (B) in paragraph (1)--
       (i) in the matter before subparagraph (A)--

       (I) by striking ``subsection (a)'' and inserting 
     ``subsection (b)(1)''; and
       (II) by striking ``Assistant Secretary'' each place it 
     appears and inserting ``Director''; and

       (ii) in subparagraph (B), by inserting ``in coordination 
     with the Centers for Disease Control and Prevention'' before 
     the semicolon at the end; and
       (C) in paragraph (2), by striking ``Annual surveys'' and 
     inserting ``Annual surveys; public availability of data.--
     Annual surveys''; and
       (7) in subsection (e), as so redesignated--
       (A) by striking ``After consultation'' and inserting 
     ``Consultation.--After consultation''; and
       (B) by striking ``Assistant Secretary shall develop'' and 
     inserting ``Assistant Secretary shall use existing standards 
     and best practices to develop''.

     SEC. 6005. STRATEGIC PLAN.

       Section 501 of the Public Health Service Act (42 U.S.C. 
     290aa), as amended by sections 6001 through 6003, is further 
     amended by inserting after subsection (k), as redesignated by 
     section 6003, the following:
       ``(l) Strategic Plan.--
       ``(1) In general.--Not later than September 30, 2018, and 
     every 4 years thereafter, the Assistant Secretary shall 
     develop and carry out a strategic plan in accordance with 
     this subsection for the planning and operation of activities 
     carried out by the Administration, including evidence-based 
     programs.
       ``(2) Coordination.--In developing and carrying out the 
     strategic plan under this subsection, the Assistant Secretary 
     shall take into consideration the findings and 
     recommendations of the Assistant Secretary for Planning and 
     Evaluation under section 6021(d) of the Helping Families in 
     Mental Health Crisis Reform Act of 2016 and the report of the 
     Interdepartmental Serious Mental Illness Coordinating 
     Committee under section 6031 of such Act.
       ``(3) Publication of plan.--Not later than September 30, 
     2018, and every 4 years thereafter, the Assistant Secretary 
     shall--
       ``(A) submit the strategic plan developed under paragraph 
     (1) to the Committee on Energy and Commerce and the Committee 
     on Appropriations of the House of Representatives and the 
     Committee on Health, Education, Labor, and Pensions and the 
     Committee on Appropriations of the Senate; and
       ``(B) post such plan on the Internet website of the 
     Administration.
       ``(4) Contents.--The strategic plan developed under 
     paragraph (1) shall--
       ``(A) identify strategic priorities, goals, and measurable 
     objectives for mental and substance use disorders activities 
     and programs operated and supported by the Administration, 
     including priorities to prevent or eliminate the burden of 
     mental and substance use disorders;
       ``(B) identify ways to improve the quality of services for 
     individuals with mental and substance use disorders, and to 
     reduce homelessness, arrest, incarceration, violence, 
     including self-directed violence, and unnecessary 
     hospitalization of individuals with a mental or substance use 
     disorder, including adults with a serious mental illness or 
     children with a serious emotional disturbance;
       ``(C) ensure that programs provide, as appropriate, access 
     to effective and evidence-based prevention, diagnosis, 
     intervention, treatment, and recovery services, including 
     culturally and linguistically appropriate services, as 
     appropriate, for individuals with a mental or substance use 
     disorder;
       ``(D) identify opportunities to collaborate with the Health 
     Resources and Services Administration to develop or improve--
       ``(i) initiatives to encourage individuals to pursue 
     careers (especially in rural and underserved areas and with 
     rural and underserved populations) as psychiatrists, 
     including child and adolescent psychiatrists, psychologists, 
     psychiatric nurse practitioners, physician assistants, 
     clinical social workers, certified peer support specialists, 
     licensed professional counselors, or other licensed or 
     certified mental health or substance use disorder 
     professionals, including such professionals specializing in 
     the diagnosis, evaluation, or treatment of adults with a 
     serious mental illness or children with a serious emotional 
     disturbance; and
       ``(ii) a strategy to improve the recruitment, training, and 
     retention of a workforce for the treatment of individuals 
     with mental or substance use disorders, or co-occurring 
     disorders;
       ``(E) identify opportunities to improve collaboration with 
     States, local governments, communities, and Indian tribes and 
     tribal organizations (as such terms are defined in section 4 
     of the Indian Self-Determination and Education Assistance 
     Act); and
       ``(F) specify a strategy to disseminate evidence-based and 
     promising best practices related to prevention, diagnosis, 
     early intervention, treatment, and recovery services related 
     to mental illness, particularly for adults with a serious 
     mental illness and children with a serious emotional 
     disturbance, and for individuals with a substance use 
     disorder.''.

     SEC. 6006. BIENNIAL REPORT CONCERNING ACTIVITIES AND 
                   PROGRESS.

       (a) In General.--Section 501 of the Public Health Service 
     Act (42 U.S.C. 290aa), as so amended, is further amended by 
     amending subsection (m), as redesignated by section 6003, to 
     read as follows:
       ``(m) Biennial Report Concerning Activities and Progress.--
     Not later than September 30, 2020, and every 2 years 
     thereafter, the Assistant Secretary shall prepare and submit 
     to the Committee on Energy and Commerce and the Committee on 
     Appropriations of the House of Representatives and the 
     Committee on Health, Education, Labor, and Pensions and the 
     Committee on Appropriations of the Senate, and post on the 
     Internet website of the Administration, a report containing 
     at a minimum--
       ``(1) a review of activities conducted or supported by the 
     Administration, including progress toward strategic 
     priorities, goals, and objectives identified in the strategic 
     plan developed under subsection (l);
       ``(2) an assessment of programs and activities carried out 
     by the Assistant Secretary, including the extent to which 
     programs and activities under this title and part B of title 
     XIX meet identified goals and performance measures developed 
     for the respective programs and activities;
       ``(3) a description of the progress made in addressing gaps 
     in mental and substance use disorders prevention, treatment, 
     and recovery services and improving outcomes by the 
     Administration, including with respect to serious mental 
     illnesses, serious emotional disturbances, and co-occurring 
     disorders;
       ``(4) a description of the manner in which the 
     Administration coordinates and partners with other Federal 
     agencies and departments related to mental and substance use 
     disorders, including activities related to--
       ``(A) the implementation and dissemination of research 
     findings into improved programs, including with respect to 
     how advances in serious mental illness and serious emotional 
     disturbance research have been incorporated into programs;
       ``(B) the recruitment, training, and retention of a mental 
     and substance use disorders workforce;
       ``(C) the integration of mental disorder services, 
     substance use disorder services, and physical health 
     services;
       ``(D) homelessness; and
       ``(E) veterans;
       ``(5) a description of the manner in which the 
     Administration promotes coordination by grantees under this 
     title, and part B of title XIX, with State or local agencies; 
     and
       ``(6) a description of the activities carried out under 
     section 501A(e), with respect to mental and substance use 
     disorders, including--
       ``(A) the number and a description of grants awarded;
       ``(B) the total amount of funding for grants awarded;
       ``(C) a description of the activities supported through 
     such grants, including outcomes of programs supported; and
       ``(D) information on how the National Mental Health and 
     Substance Use Policy Laboratory is consulting with the 
     Assistant Secretary for Planning and Evaluation and 
     collaborating with the Center for Substance Abuse Treatment, 
     the Center for Substance Abuse Prevention, the Center for 
     Behavioral Health Statistics and Quality, and the Center for 
     Mental Health Services to carry out such activities; and
       ``(7) recommendations made by the Assistant Secretary for 
     Planning and Evaluation under section 6021 of the Helping 
     Families in Mental Health Crisis Reform Act of 2016 to 
     improve programs within the Administration, and actions taken 
     in response to such recommendations to improve programs 
     within the Administration.
     The Assistant Secretary may meet reporting requirements 
     established under this title by providing the contents of 
     such reports as an addendum to the biennial report 
     established under this subsection, notwithstanding the 
     timeline of other reporting requirements in this title. 
     Nothing in this subsection shall be construed to alter the 
     content requirements of such reports or authorize the 
     Assistant Secretary to alter the timeline of any such reports 
     to be less frequent than biennially, unless as specified in 
     this title.''.
       (b) Conforming Amendment.--Section 508(p) of the Public 
     Health Service Act (42 U.S.C. 290bb-1(p)) is amended by 
     striking ``section 501(k)'' and inserting ``section 501(m)''.

[[Page H6945]]

  


     SEC. 6007. AUTHORITIES OF CENTERS FOR MENTAL HEALTH SERVICES, 
                   SUBSTANCE ABUSE PREVENTION, AND SUBSTANCE ABUSE 
                   TREATMENT.

       (a) Center for Mental Health Services.--Section 520(b) of 
     the Public Health Service Act (42 U.S.C. 290bb-31(b)) is 
     amended--
       (1) by redesignating paragraphs (3) through (15) as 
     paragraphs (4) through (16), respectively;
       (2) by inserting after paragraph (2) the following:
       ``(3) collaborate with the Director of the National 
     Institute of Mental Health and the Chief Medical Officer, 
     appointed under section 501(g), to ensure that, as 
     appropriate, programs related to the prevention and treatment 
     of mental illness and the promotion of mental health and 
     recovery support are carried out in a manner that reflects 
     the best available science and evidence-based practices, 
     including culturally and linguistically appropriate services, 
     as appropriate;'';
       (3) in paragraph (5), as so redesignated, by inserting ``, 
     including through programs that reduce risk and promote 
     resiliency'' before the semicolon;
       (4) in paragraph (6), as so redesignated, by inserting ``in 
     collaboration with the Director of the National Institute of 
     Mental Health,'' before ``develop'';
       (5) in paragraph (8), as so redesignated, by inserting ``, 
     increase meaningful participation of individuals with mental 
     illness in programs and activities of the Administration,'' 
     before ``and protect the legal'';
       (6) in paragraph (10), as so redesignated, by striking 
     ``professional and paraprofessional personnel pursuant to 
     section 303'' and inserting ``health paraprofessional 
     personnel and health professionals'';
       (7) in paragraph (11), as so redesignated, by inserting 
     ``and tele-mental health'' after ``rural mental health'';
       (8) in paragraph (12), as so redesignated, by striking 
     ``establish a clearinghouse for mental health information to 
     assure the widespread dissemination of such information'' and 
     inserting ``disseminate mental health information, including 
     evidence-based practices,'';
       (9) in paragraph (15), as so redesignated, by striking 
     ``and'' at the end;
       (10) in paragraph (16), as so redesignated, by striking the 
     period and inserting ``; and''; and
       (11) by adding at the end the following:
       ``(17) ensure the consistent documentation of the 
     application of criteria when awarding grants and the ongoing 
     oversight of grantees after such grants are awarded.''.
       (b) Director of the Center for Substance Abuse 
     Prevention.--Section 515 of the Public Health Service Act (42 
     U.S.C. 290bb-21) is amended--
       (1) in the section heading, by striking ``office'' and 
     inserting ``center'';
       (2) in subsection (a)--
       (A) by striking ``an Office'' and inserting ``a Center''; 
     and
       (B) by striking ``The Office'' and inserting ``The 
     Prevention Center''; and
       (3) in subsection (b)--
       (A) in paragraph (1), by inserting ``through the reduction 
     of risk and the promotion of resiliency'' before the 
     semicolon;
       (B) by redesignating paragraphs (3) through (11) as 
     paragraphs (4) through (12), respectively;
       (C) by inserting after paragraph (2) the following:
       ``(3) collaborate with the Director of the National 
     Institute on Drug Abuse, the Director of the National 
     Institute on Alcohol Abuse and Alcoholism, and States to 
     promote the study of substance abuse prevention and the 
     dissemination and implementation of research findings that 
     will improve the delivery and effectiveness of substance 
     abuse prevention activities;'';
       (D) in paragraph (4), as so redesignated, by striking 
     ``literature on the adverse effects of cocaine free base 
     (known as crack)'' and inserting ``educational information on 
     the effects of drugs abused by individuals, including drugs 
     that are emerging as abused drugs'';
       (E) in paragraph (6), as so redesignated--
       (i) by striking ``substance abuse counselors'' and 
     inserting ``health professionals who provide substance use 
     and misuse prevention and treatment services''; and
       (ii) by striking ``drug abuse education, prevention,'' and 
     inserting ``illicit drug use education and prevention'';
       (F) by amending paragraph (7), as so redesignated, to read 
     as follows:
       ``(7) in cooperation with the Director of the Centers for 
     Disease Control and Prevention, develop and disseminate 
     educational materials to increase awareness for individuals 
     at greatest risk for substance use disorders to prevent the 
     transmission of communicable diseases, such as HIV, 
     hepatitis, tuberculosis, and other communicable diseases;'';
       (G) in paragraph (9), as so redesignated--
       (i) by striking ``to discourage'' and inserting ``that 
     reduce the risk of''; and
       (ii) by inserting before the semicolon ``and promote 
     resiliency'';
       (H) in paragraph (11), as so redesignated, by striking 
     ``and'' after the semicolon;
       (I) in paragraph (12), as so redesignated, by striking the 
     period and inserting a semicolon; and
       (J) by adding at the end the following:
       ``(13) ensure the consistent documentation of the 
     application of criteria when awarding grants and the ongoing 
     oversight of grantees after such grants are awarded; and
       ``(14) assist and support States in preventing illicit drug 
     use, including emerging illicit drug use issues.''.
       (c) Director of the Center for Substance Abuse Treatment.--
     Section 507 of the Public Health Service Act (42 U.S.C. 
     290bb) is amended--
       (1) in subsection (a)--
       (A) by striking ``treatment of substance abuse'' and 
     inserting ``treatment of substance use disorders''; and
       (B) by striking ``abuse treatment systems'' and inserting 
     ``use disorder treatment systems''; and
       (2) in subsection (b)--
       (A) in paragraph (1), by striking ``abuse'' and inserting 
     ``use disorder'';
       (B) in paragraph (3), by striking ``abuse'' and inserting 
     ``use disorder'';
       (C) in paragraph (4), by striking ``individuals who abuse 
     drugs'' and inserting ``individuals who illicitly use 
     drugs'';
       (D) in paragraph (9), by striking ``carried out by the 
     Director'';
       (E) by striking paragraph (10);
       (F) by redesignating paragraphs (11) through (14) as 
     paragraphs (10) through (13), respectively;
       (G) in paragraph (12), as so redesignated, by striking ``; 
     and'' and inserting a semicolon; and
       (H) by striking paragraph (13), as so redesignated, and 
     inserting the following:
       ``(13) ensure the consistent documentation of the 
     application of criteria when awarding grants and the ongoing 
     oversight of grantees after such grants are awarded; and
       ``(14) work with States, providers, and individuals in 
     recovery, and their families, to promote the expansion of 
     recovery support services and systems of care oriented toward 
     recovery.''.

     SEC. 6008. ADVISORY COUNCILS.

       Section 502(b) of the Public Health Service Act (42 U.S.C. 
     290aa-1(b)) is amended--
       (1) in paragraph (2)--
       (A) in subparagraph (E), by striking ``and'' after the 
     semicolon;
       (B) by redesignating subparagraph (F) as subparagraph (J); 
     and
       (C) by inserting after subparagraph (E), the following:
       ``(F) the Chief Medical Officer, appointed under section 
     501(g);
       ``(G) the Director of the National Institute of Mental 
     Health for the advisory councils appointed under subsections 
     (a)(1)(A) and (a)(1)(D);
       ``(H) the Director of the National Institute on Drug Abuse 
     for the advisory councils appointed under subsections 
     (a)(1)(A), (a)(1)(B), and (a)(1)(C);
       ``(I) the Director of the National Institute on Alcohol 
     Abuse and Alcoholism for the advisory councils appointed 
     under subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C); and''; 
     and
       (2) in paragraph (3), by adding at the end the following:
       ``(C) Not less than half of the members of the advisory 
     council appointed under subsection (a)(1)(D)--
       ``(i) shall--

       ``(I) have a medical degree;
       ``(II) have a doctoral degree in psychology; or
       ``(III) have an advanced degree in nursing or social work 
     from an accredited graduate school or be a certified 
     physician assistant; and

       ``(ii) shall specialize in the mental health field.
       ``(D) Not less than half of the members of the advisory 
     councils appointed under subsections (a)(1)(B) and 
     (a)(1)(C)--
       ``(i) shall--

       ``(I) have a medical degree;
       ``(II) have a doctoral degree; or
       ``(III) have an advanced degree in nursing, public health, 
     behavioral or social sciences, or social work from an 
     accredited graduate school or be a certified physician 
     assistant; and

       ``(ii) shall have experience in the provision of substance 
     use disorder services or the development and implementation 
     of programs to prevent substance misuse.''.

     SEC. 6009. PEER REVIEW.

       Section 504(b) of the Public Health Service Act (42 U.S.C. 
     290aa-3(b)) is amended by adding at the end the following: 
     ``In the case of any such peer review group that is reviewing 
     a grant, cooperative agreement, or contract related to mental 
     illness treatment, not less than half of the members of such 
     peer review group shall be licensed and experienced 
     professionals in the prevention, diagnosis, or treatment of, 
     or recovery from, mental illness or co-occurring mental 
     illness and substance use disorders and have a medical 
     degree, a doctoral degree in psychology, or an advanced 
     degree in nursing or social work from an accredited program, 
     and the Secretary, in consultation with the Assistant 
     Secretary, shall, to the extent possible, ensure such peer 
     review groups include broad geographic representation, 
     including both urban and rural representatives.''.

                Subtitle B--Oversight and Accountability

     SEC. 6021. IMPROVING OVERSIGHT OF MENTAL AND SUBSTANCE USE 
                   DISORDERS PROGRAMS THROUGH THE ASSISTANT 
                   SECRETARY FOR PLANNING AND EVALUATION.

       (a) In General.--The Secretary of Health and Human 
     Services, acting through the Assistant Secretary for Planning 
     and Evaluation, shall ensure efficient and effective planning 
     and evaluation of mental and substance use disorders 
     prevention and treatment programs and related activities.
       (b) Evaluation Strategy.--In carrying out subsection (a), 
     the Assistant Secretary for Planning and Evaluation shall, 
     not later than 180 days after the date of enactment of this 
     Act, develop a strategy for conducting ongoing evaluations 
     that identifies priority programs to be evaluated by the 
     Assistant Secretary for Planning and Evaluation and priority 
     programs to be evaluated by other relevant offices and 
     agencies within the Department of Health and Human Services. 
     The strategy shall--
       (1) include a plan for evaluating programs related to 
     mental and substance use disorders, including co-occurring 
     disorders, across agencies, as appropriate, including 
     programs related to--

[[Page H6946]]

       (A) prevention, intervention, treatment, and recovery 
     support services, including such services for adults with a 
     serious mental illness or children with a serious emotional 
     disturbance;
       (B) the reduction of homelessness and incarceration among 
     individuals with a mental or substance use disorder; and
       (C) public health and health services; and
       (2) include a plan for assessing the use of performance 
     metrics to evaluate activities carried out by entities 
     receiving grants, contracts, or cooperative agreements 
     related to mental and substance use disorders prevention and 
     treatment services under title V or title XIX of the Public 
     Health Service Act (42 U.S.C. 290aa et seq.; 42 U.S.C. 300w 
     et seq.).
       (c) Consultation.--In carrying out this section, the 
     Assistant Secretary for Planning and Evaluation shall 
     consult, as appropriate, with the Assistant Secretary for 
     Mental Health and Substance Use, the Chief Medical Officer of 
     the Substance Abuse and Mental Health Services Administration 
     appointed under section 501(g) of the Public Health Service 
     Act (42 U.S.C. 290aa(g)), as amended by section 6003, the 
     Behavioral Health Coordinating Council of the Department of 
     Health and Human Services, other agencies within the 
     Department of Health and Human Services, and other relevant 
     Federal departments and agencies.
       (d) Recommendations.--In carrying out this section, the 
     Assistant Secretary for Planning and Evaluation shall provide 
     recommendations to the Secretary of Health and Human 
     Services, the Assistant Secretary for Mental Health and 
     Substance Use, and the Congress on improving the quality of 
     prevention and treatment programs and activities related to 
     mental and substance use disorders, including recommendations 
     for the use of performance metrics. The Assistant Secretary 
     for Mental Health and Substance Use shall include such 
     recommendations in the biennial report required by subsection 
     501(m) of the Public Health Service Act, as redesignated by 
     section 6003 of this Act.

     SEC. 6022. REPORTING FOR PROTECTION AND ADVOCACY 
                   ORGANIZATIONS.

       (a) Public Availability of Reports.--Section 105(a)(7) of 
     the Protection and Advocacy for Individuals with Mental 
     Illness Act (42 U.S.C. 10805(a)(7)) is amended by striking 
     ``is located a report'' and inserting ``is located, and make 
     publicly available, a report''.
       (b) Detailed Accounting.--Section 114(a) of the Protection 
     and Advocacy for Individuals with Mental Illness Act (42 
     U.S.C. 10824(a)) is amended--
       (1) in paragraph (3), by striking ``and'' at the end;
       (2) in paragraph (4), by striking the period at the end and 
     inserting ``; and''; and
       (3) by adding at the end the following:
       ``(5) using data from the existing required annual program 
     progress reports submitted by each system funded under this 
     title, a detailed accounting for each such system of how 
     funds are spent, disaggregated according to whether the funds 
     were received from the Federal Government, the State 
     government, a local government, or a private entity.''.

     SEC. 6023. GAO STUDY.

       (a) In General.--Not later than 18 months after the date of 
     enactment of this Act, the Comptroller General of the United 
     States, in consultation with the Secretary of Health and 
     Human Services and the Assistant Secretary for Mental Health 
     and Substance Use, shall conduct an independent evaluation, 
     and submit a report, to the Committee on Health, Education, 
     Labor, and Pensions of the Senate and the Committee on Energy 
     and Commerce of the House of Representatives, on programs 
     funded by allotments made under title I of the Protection and 
     Advocacy for Individuals with Mental Illness Act (42 U.S.C. 
     10801 et seq.).
       (b) Contents.--The report and evaluation required under 
     subsection (a) shall include--
       (1) a review of the programs described in such subsection 
     that are carried out by State agencies and such programs that 
     are carried out by private, nonprofit organizations; and
       (2) a review of the compliance of the programs described in 
     subsection (a) with statutory and regulatory 
     responsibilities, such as--
       (A) responsibilities relating to family engagement;
       (B) responsibilities relating to the grievance procedure 
     for clients or prospective clients of the system to assure 
     that individuals with mental illness have full access to the 
     services of the system, for individuals who have received or 
     are receiving mental health services, and for family members 
     of such individuals with mental illness, or representatives 
     of such individuals or family members, to assure that the 
     eligible system is operating in compliance with the 
     provisions of the Protection and Advocacy for Individuals 
     with Mental Illness Act, as required to be established by 
     section 105(a)(9) of such Act (42 U.S.C. 10805(a)(9));
       (C) investigation of alleged abuse and neglect of persons 
     with mental illness;
       (D) availability of adequate medical and behavioral health 
     treatment;
       (E) denial of rights for persons with mental illness; and
       (F) compliance with the Federal prohibition on lobbying.

   Subtitle C--Interdepartmental Serious Mental Illness Coordinating 
                               Committee

     SEC. 6031. INTERDEPARTMENTAL SERIOUS MENTAL ILLNESS 
                   COORDINATING COMMITTEE.

       (a) Establishment.--
       (1) In general.--Not later than 3 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services, or the designee of the Secretary, shall establish a 
     committee to be known as the Interdepartmental Serious Mental 
     Illness Coordinating Committee (in this section referred to 
     as the ``Committee'').
       (2) Federal advisory committee act.--Except as provided in 
     this section, the provisions of the Federal Advisory 
     Committee Act (5 U.S.C. App.) shall apply to the Committee.
       (b) Meetings.--The Committee shall meet not fewer than 2 
     times each year.
       (c) Responsibilities.--Not later than 1 year after the date 
     of enactment of this Act, and 5 years after such date of 
     enactment, the Committee shall submit to Congress and any 
     other relevant Federal department or agency a report 
     including--
       (1) a summary of advances in serious mental illness and 
     serious emotional disturbance research related to the 
     prevention of, diagnosis of, intervention in, and treatment 
     and recovery of serious mental illnesses, serious emotional 
     disturbances, and advances in access to services and support 
     for adults with a serious mental illness or children with a 
     serious emotional disturbance;
       (2) an evaluation of the effect Federal programs related to 
     serious mental illness have on public health, including 
     public health outcomes such as--
       (A) rates of suicide, suicide attempts, incidence and 
     prevalence of serious mental illnesses, serious emotional 
     disturbances, and substance use disorders, overdose, overdose 
     deaths, emergency hospitalizations, emergency room boarding, 
     preventable emergency room visits, interaction with the 
     criminal justice system, homelessness, and unemployment;
       (B) increased rates of employment and enrollment in 
     educational and vocational programs;
       (C) quality of mental and substance use disorders treatment 
     services; or
       (D) any other criteria as may be determined by the 
     Secretary; and
       (3) specific recommendations for actions that agencies can 
     take to better coordinate the administration of mental health 
     services for adults with a serious mental illness or children 
     with a serious emotional disturbance.
       (d) Committee Extension.--Upon the submission of the second 
     report under subsection (c), the Secretary shall submit a 
     recommendation to Congress on whether to extend the operation 
     of the Committee.
       (e) Membership.--
       (1) Federal members.--The Committee shall be composed of 
     the following Federal representatives, or the designees of 
     such representatives--
       (A) the Secretary of Health and Human Services, who shall 
     serve as the Chair of the Committee;
       (B) the Assistant Secretary for Mental Health and Substance 
     Use;
       (C) the Attorney General;
       (D) the Secretary of Veterans Affairs;
       (E) the Secretary of Defense;
       (F) the Secretary of Housing and Urban Development;
       (G) the Secretary of Education;
       (H) the Secretary of Labor;
       (I) the Administrator of the Centers for Medicare & 
     Medicaid Services; and
       (J) the Commissioner of Social Security.
       (2) Non-federal members.--The Committee shall also include 
     not less than 14 non-Federal public members appointed by the 
     Secretary of Health and Human Services, of which--
       (A) at least 2 members shall be an individual who has 
     received treatment for a diagnosis of a serious mental 
     illness;
       (B) at least 1 member shall be a parent or legal guardian 
     of an adult with a history of a serious mental illness or a 
     child with a history of a serious emotional disturbance;
       (C) at least 1 member shall be a representative of a 
     leading research, advocacy, or service organization for 
     adults with a serious mental illness;
       (D) at least 2 members shall be--
       (i) a licensed psychiatrist with experience in treating 
     serious mental illnesses;
       (ii) a licensed psychologist with experience in treating 
     serious mental illnesses or serious emotional disturbances;
       (iii) a licensed clinical social worker with experience 
     treating serious mental illnesses or serious emotional 
     disturbances; or
       (iv) a licensed psychiatric nurse, nurse practitioner, or 
     physician assistant with experience in treating serious 
     mental illnesses or serious emotional disturbances;
       (E) at least 1 member shall be a licensed mental health 
     professional with a specialty in treating children and 
     adolescents with a serious emotional disturbance;
       (F) at least 1 member shall be a mental health professional 
     who has research or clinical mental health experience in 
     working with minorities;
       (G) at least 1 member shall be a mental health professional 
     who has research or clinical mental health experience in 
     working with medically underserved populations;
       (H) at least 1 member shall be a State certified mental 
     health peer support specialist;
       (I) at least 1 member shall be a judge with experience in 
     adjudicating cases related to criminal justice or serious 
     mental illness;
       (J) at least 1 member shall be a law enforcement officer or 
     corrections officer with extensive experience in interfacing 
     with adults with a serious mental illness, children with a 
     serious emotional disturbance, or individuals in a mental 
     health crisis; and
       (K) at least 1 member shall have experience providing 
     services for homeless individuals and working with adults 
     with a serious mental illness, children with a serious 
     emotional disturbance, or individuals in a mental health 
     crisis.
       (3) Terms.--A member of the Committee appointed under 
     subsection (e)(2) shall serve for a term of 3 years, and may 
     be reappointed for 1 or more additional 3-year terms. Any 
     member appointed to fill a vacancy for an unexpired term 
     shall be appointed for the remainder of such term. A member 
     may serve after the expiration of the member's term until a 
     successor has been appointed.
       (f) Working Groups.--In carrying out its functions, the 
     Committee may establish working

[[Page H6947]]

     groups. Such working groups shall be composed of Committee 
     members, or their designees, and may hold such meetings as 
     are necessary.
       (g) Sunset.--The Committee shall terminate on the date that 
     is 6 years after the date on which the Committee is 
     established under subsection (a)(1).

  TITLE VII--ENSURING MENTAL AND SUBSTANCE USE DISORDERS PREVENTION, 
 TREATMENT, AND RECOVERY PROGRAMS KEEP PACE WITH SCIENCE AND TECHNOLOGY

     SEC. 7001. ENCOURAGING INNOVATION AND EVIDENCE-BASED 
                   PROGRAMS.

       Title V of the Public Health Service Act (42 U.S.C. 290aa 
     et seq.) is amended by inserting after section 501 (42 U.S.C. 
     290aa) the following:

     ``SEC. 501A. NATIONAL MENTAL HEALTH AND SUBSTANCE USE POLICY 
                   LABORATORY.

       ``(a) In General.--There shall be established within the 
     Administration a National Mental Health and Substance Use 
     Policy Laboratory (referred to in this section as the 
     `Laboratory').
       ``(b) Responsibilities.--The Laboratory shall--
       ``(1) continue to carry out the authorities and activities 
     that were in effect for the Office of Policy, Planning, and 
     Innovation as such Office existed prior to the date of 
     enactment of the Helping Families in Mental Health Crisis 
     Reform Act of 2016;
       ``(2) identify, coordinate, and facilitate the 
     implementation of policy changes likely to have a significant 
     effect on mental health, mental illness, recovery supports, 
     and the prevention and treatment of substance use disorder 
     services;
       ``(3) work with the Center for Behavioral Health Statistics 
     and Quality to collect, as appropriate, information from 
     grantees under programs operated by the Administration in 
     order to evaluate and disseminate information on evidence-
     based practices, including culturally and linguistically 
     appropriate services, as appropriate, and service delivery 
     models;
       ``(4) provide leadership in identifying and coordinating 
     policies and programs, including evidence-based programs, 
     related to mental and substance use disorders;
       ``(5) periodically review programs and activities operated 
     by the Administration relating to the diagnosis or prevention 
     of, treatment for, and recovery from, mental and substance 
     use disorders to--
       ``(A) identify any such programs or activities that are 
     duplicative;
       ``(B) identify any such programs or activities that are not 
     evidence-based, effective, or efficient; and
       ``(C) formulate recommendations for coordinating, 
     eliminating, or improving programs or activities identified 
     under subparagraph (A) or (B) and merging such programs or 
     activities into other successful programs or activities; and
       ``(6) carry out other activities as deemed necessary to 
     continue to encourage innovation and disseminate evidence-
     based programs and practices.
       ``(c) Evidence-Based Practices and Service Delivery 
     Models.--
       ``(1) In general.--In carrying out subsection (b)(3), the 
     Laboratory--
       ``(A) may give preference to models that improve--
       ``(i) the coordination between mental health and physical 
     health providers;
       ``(ii) the coordination among such providers and the 
     justice and corrections system; and
       ``(iii) the cost effectiveness, quality, effectiveness, and 
     efficiency of health care services furnished to adults with a 
     serious mental illness, children with a serious emotional 
     disturbance, or individuals in a mental health crisis; and
       ``(B) may include clinical protocols and practices that 
     address the needs of individuals with early serious mental 
     illness.
       ``(2) Consultation.--In carrying out this section, the 
     Laboratory shall consult with--
       ``(A) the Chief Medical Officer appointed under section 
     501(g);
       ``(B) representatives of the National Institute of Mental 
     Health, the National Institute on Drug Abuse, and the 
     National Institute on Alcohol Abuse and Alcoholism, on an 
     ongoing basis;
       ``(C) other appropriate Federal agencies;
       ``(D) clinical and analytical experts with expertise in 
     psychiatric medical care and clinical psychological care, 
     health care management, education, corrections health care, 
     and mental health court systems, as appropriate; and
       ``(E) other individuals and agencies as determined 
     appropriate by the Assistant Secretary.
       ``(d) Deadline for Beginning Implementation.--The 
     Laboratory shall begin implementation of this section not 
     later than January 1, 2018.
       ``(e) Promoting Innovation.--
       ``(1) In general.--The Assistant Secretary, in coordination 
     with the Laboratory, may award grants to States, local 
     governments, Indian tribes or tribal organizations (as such 
     terms are defined in section 4 of the Indian Self-
     Determination and Education Assistance Act), educational 
     institutions, and nonprofit organizations to develop 
     evidence-based interventions, including culturally and 
     linguistically appropriate services, as appropriate, for--
       ``(A) evaluating a model that has been scientifically 
     demonstrated to show promise, but would benefit from further 
     applied development, for--
       ``(i) enhancing the prevention, diagnosis, intervention, 
     and treatment of, and recovery from, mental illness, serious 
     emotional disturbances, substance use disorders, and co-
     occurring illness or disorders; or
       ``(ii) integrating or coordinating physical health services 
     and mental and substance use disorders services; and
       ``(B) expanding, replicating, or scaling evidence-based 
     programs across a wider area to enhance effective screening, 
     early diagnosis, intervention, and treatment with respect to 
     mental illness, serious mental illness, serious emotional 
     disturbances, and substance use disorders, primarily by--
       ``(i) applying such evidence-based programs to the delivery 
     of care, including by training staff in effective evidence-
     based treatments; or
       ``(ii) integrating such evidence-based programs into models 
     of care across specialties and jurisdictions.
       ``(2) Consultation.--In awarding grants under this 
     subsection, the Assistant Secretary shall, as appropriate, 
     consult with the Chief Medical Officer, appointed under 
     section 501(g), the advisory councils described in section 
     502, the National Institute of Mental Health, the National 
     Institute on Drug Abuse, and the National Institute on 
     Alcohol Abuse and Alcoholism, as appropriate.
       ``(3) Authorization of appropriations.--There are 
     authorized to be appropriated--
       ``(A) to carry out paragraph (1)(A), $7,000,000 for the 
     period of fiscal years 2018 through 2020; and
       ``(B) to carry out paragraph (1)(B), $7,000,000 for the 
     period of fiscal years 2018 through 2020.''.

     SEC. 7002. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-BASED 
                   PROGRAMS AND PRACTICES.

       Part D of title V of the Public Health Service Act (42 
     U.S.C. 290dd et seq.) is amended by inserting after section 
     543 of such Act (42 U.S.C. 290dd-2) the following:

     ``SEC. 543A. PROMOTING ACCESS TO INFORMATION ON EVIDENCE-
                   BASED PROGRAMS AND PRACTICES.

       ``(a) In General.--The Assistant Secretary shall, as 
     appropriate, improve access to reliable and valid information 
     on evidence-based programs and practices, including 
     information on the strength of evidence associated with such 
     programs and practices, related to mental and substance use 
     disorders for States, local communities, nonprofit entities, 
     and other stakeholders, by posting on the Internet website of 
     the Administration information on evidence-based programs and 
     practices that have been reviewed by the Assistant Secretary 
     in accordance with the requirements of this section.
       ``(b) Applications.--
       ``(1) Application period.--In carrying out subsection (a), 
     the Assistant Secretary may establish a period for the 
     submission of applications for evidence-based programs and 
     practices to be posted publicly in accordance with subsection 
     (a).
       ``(2) Notice.--In establishing the application period under 
     paragraph (1), the Assistant Secretary shall provide for the 
     public notice of such application period in the Federal 
     Register. Such notice may solicit applications for evidence-
     based programs and practices to address gaps in information 
     identified by the Assistant Secretary, the National Mental 
     Health and Substance Use Policy Laboratory established under 
     section 501A, or the Assistant Secretary for Planning and 
     Evaluation, including pursuant to the evaluation and 
     recommendations under section 6021 of the Helping Families in 
     Mental Health Crisis Reform Act of 2016 or priorities 
     identified in the strategic plan under section 501(l).
       ``(c) Requirements.--The Assistant Secretary may establish 
     minimum requirements for the applications submitted under 
     subsection (b), including applications related to the 
     submission of research and evaluation.
       ``(d) Review and Rating.--
       ``(1) In general.--The Assistant Secretary shall review 
     applications prior to public posting in accordance with 
     subsection (a), and may prioritize the review of applications 
     for evidence-based programs and practices that are related to 
     topics included in the notice provided under subsection 
     (b)(2).
       ``(2) System.--In carrying out paragraph (1), the Assistant 
     Secretary may utilize a rating and review system, which may 
     include information on the strength of evidence associated 
     with the evidence-based programs and practices and a rating 
     of the methodological rigor of the research supporting the 
     applications.
       ``(3) Public access to metrics and rating.--The Assistant 
     Secretary shall make the metrics used to evaluate 
     applications under this section, and any resulting ratings of 
     such applications, publicly available.''.

     SEC. 7003. PRIORITY MENTAL HEALTH NEEDS OF REGIONAL AND 
                   NATIONAL SIGNIFICANCE.

       Section 520A of the Public Health Service Act (42 U.S.C. 
     290bb-32) is amended--
       (1) in subsection (a)--
       (A) in paragraph (4), by inserting before the period ``, 
     which may include technical assistance centers''; and
       (B) in the flush sentence following paragraph (4)--
       (i) by inserting ``, contracts,'' before ``or cooperative 
     agreements''; and
       (ii) by striking ``Indian tribes and tribal organizations'' 
     and inserting ``Indian tribes or tribal organizations (as 
     such terms are defined in section 4 of the Indian Self-
     Determination and Education Assistance Act), health 
     facilities, or programs operated by or in accordance with a 
     contract or grant with the Indian Health Service, or''; and
       (2) by amending subsection (f) to read as follows:
       ``(f) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section 
     $394,550,000 for each of fiscal years 2018 through 2022.''.

     SEC. 7004. PRIORITY SUBSTANCE USE DISORDER TREATMENT NEEDS OF 
                   REGIONAL AND NATIONAL SIGNIFICANCE.

       Section 509 of the Public Health Service Act (42 U.S.C. 
     290bb-2) is amended--
       (1) in subsection (a)--
       (A) in the matter preceding paragraph (1), by striking 
     ``abuse'' and inserting ``use disorder'';

[[Page H6948]]

       (B) in paragraph (3), by inserting before the period ``that 
     permit States, local governments, communities, and Indian 
     tribes and tribal organizations (as the terms `Indian tribes' 
     and `tribal organizations' are defined in section 4 of the 
     Indian Self-Determination and Education Assistance Act) to 
     focus on emerging trends in substance abuse and co-occurrence 
     of substance use disorders with mental illness or other 
     conditions''; and
       (C) in the flush sentence following paragraph (3)--
       (i) by inserting ``, contracts,'' before ``or cooperative 
     agreements''; and
       (ii) by striking ``Indian tribes and tribal 
     organizations,'' and inserting ``Indian tribes or tribal 
     organizations (as such terms are defined in section 4 of the 
     Indian Self-Determination and Education Assistance Act), 
     health facilities, or programs operated by or in accordance 
     with a contract or grant with the Indian Health Service, 
     or'';
       (2) in subsection (b)--
       (A) in paragraph (1), by striking ``abuse'' and inserting 
     ``use disorder''; and
       (B) in paragraph (2), by striking ``abuse'' and inserting 
     ``use disorder'';
       (3) in subsection (e), by striking ``abuse'' and inserting 
     ``use disorder''; and
       (4) in subsection (f), by striking ``$300,000,000'' and all 
     that follows through the period and inserting ``$333,806,000 
     for each of fiscal years 2018 through 2022.''.

     SEC. 7005. PRIORITY SUBSTANCE USE DISORDER PREVENTION NEEDS 
                   OF REGIONAL AND NATIONAL SIGNIFICANCE.

       Section 516 of the Public Health Service Act (42 U.S.C. 
     290bb-22) is amended--
       (1) in the section heading, by striking ``abuse'' and 
     inserting ``use disorder'';
       (2) in subsection (a)--
       (A) in the matter preceding paragraph (1), by striking 
     ``abuse'' and inserting ``use disorder'';
       (B) in paragraph (3), by inserting before the period ``, 
     including such programs that focus on emerging drug abuse 
     issues''; and
       (C) in the flush sentence following paragraph (3)--
       (i) by inserting ``, contracts,'' before ``or cooperative 
     agreements''; and
       (ii) by striking ``Indian tribes and tribal 
     organizations,'' and inserting ``Indian tribes or tribal 
     organizations (as such terms are defined in section 4 of the 
     Indian Self-Determination and Education Assistance Act), 
     health facilities, or programs operated by or in accordance 
     with a contract or grant with the Indian Health Service,'';
       (3) in subsection (b)--
       (A) in paragraph (1), by striking ``abuse'' and inserting 
     ``use disorder''; and
       (B) in paragraph (2)--
       (i) in subparagraph (A), by striking ``; and'' at the end 
     and inserting ``;'';
       (ii) in subparagraph (B)--

       (I) by striking ``abuse'' and inserting ``use disorder''; 
     and
       (II) by striking the period and inserting ``; and''; and

       (iii) by adding at the end the following:
       ``(C) substance use disorder prevention among high-risk 
     groups.'';
       (4) in subsection (e), by striking ``abuse'' and inserting 
     ``use disorder''; and
       (5) in subsection (f), by striking ``$300,000,000'' and all 
     that follows through the period and inserting ``$211,148,000 
     for each of fiscal years 2018 through 2022.''.

  TITLE VIII--SUPPORTING STATE PREVENTION ACTIVITIES AND RESPONSES TO 
             MENTAL HEALTH AND SUBSTANCE USE DISORDER NEEDS

     SEC. 8001. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT.

       (a) Formula Grants.--Section 1911(b) of the Public Health 
     Service Act (42 U.S.C. 300x(b)) is amended--
       (1) by redesignating paragraphs (1) through (3) as 
     paragraphs (2) through (4), respectively; and
       (2) by inserting before paragraph (2) (as so redesignated) 
     the following:
       ``(1) providing community mental health services for adults 
     with a serious mental illness and children with a serious 
     emotional disturbance as defined in accordance with section 
     1912(c);''.
       (b) State Plan.--Section 1912(b) of the Public Health 
     Service Act (42 U.S.C. 300x-1(b)) is amended--
       (1) in paragraph (3), by redesignating subparagraphs (A) 
     through (C) as clauses (i) through (iii), respectively, and 
     realigning the margins accordingly;
       (2) by redesignating paragraphs (1) through (5) as 
     subparagraphs (A) through (E), respectively, and realigning 
     the margins accordingly;
       (3) in the matter preceding subparagraph (A) (as so 
     redesignated), by striking ``With respect to'' and all that 
     follows through ``are as follows:'' and inserting ``In 
     accordance with subsection (a), a State shall submit to the 
     Secretary a plan every two years that, at a minimum, includes 
     each of the following:'';
       (4) by inserting before subparagraph (A) (as so 
     redesignated) the following:
       ``(1) System of care.--A description of the State's system 
     of care that contains the following:'';
       (5) by striking subparagraph (A) (as so redesignated) and 
     inserting the following:
       ``(A) Comprehensive community-based health systems.--The 
     plan shall--
       ``(i) identify the single State agency to be responsible 
     for the administration of the program under the grant, 
     including any third party who administers mental health 
     services and is responsible for complying with the 
     requirements of this part with respect to the grant;
       ``(ii) provide for an organized community-based system of 
     care for individuals with mental illness, and describe 
     available services and resources in a comprehensive system of 
     care, including services for individuals with co-occurring 
     disorders;
       ``(iii) include a description of the manner in which the 
     State and local entities will coordinate services to maximize 
     the efficiency, effectiveness, quality, and cost-
     effectiveness of services and programs to produce the best 
     possible outcomes (including health services, rehabilitation 
     services, employment services, housing services, educational 
     services, substance use disorder services, legal services, 
     law enforcement services, social services, child welfare 
     services, medical and dental care services, and other support 
     services to be provided with Federal, State, and local public 
     and private resources) with other agencies to enable 
     individuals receiving services to function outside of 
     inpatient or residential institutions, to the maximum extent 
     of their capabilities, including services to be provided by 
     local school systems under the Individuals with Disabilities 
     Education Act;
       ``(iv) include a description of how the State promotes 
     evidence-based practices, including those evidence-based 
     programs that address the needs of individuals with early 
     serious mental illness regardless of the age of the 
     individual at onset, provide comprehensive individualized 
     treatment, or integrate mental and physical health services;
       ``(v) include a description of case management services;
       ``(vi) include a description of activities that seek to 
     engage adults with a serious mental illness or children with 
     a serious emotional disturbance and their caregivers where 
     appropriate in making health care decisions, including 
     activities that enhance communication among individuals, 
     families, caregivers, and treatment providers; and
       ``(vii) as appropriate to, and reflective of, the uses the 
     State proposes for the block grant funds, include--

       ``(I) a description of the activities intended to reduce 
     hospitalizations and hospital stays using the block grant 
     funds;
       ``(II) a description of the activities intended to reduce 
     incidents of suicide using the block grant funds;
       ``(III) a description of how the State integrates mental 
     health and primary care using the block grant funds, which 
     may include providing, in the case of individuals with co-
     occurring mental and substance use disorders, both mental and 
     substance use disorders services in primary care settings or 
     arrangements to provide primary and specialty care services 
     in community-based mental and substance use disorders 
     settings; and
       ``(IV) a description of recovery and recovery support 
     services for adults with a serious mental illness and 
     children with a serious emotional disturbance.'';

       (6) in subparagraph (B) (as so redesignated)--
       (A) by striking ``The plan contains'' and inserting ``The 
     plan shall contain''; and
       (B) by striking ``presents quantitative targets to be 
     achieved in the implementation of the system described in 
     paragraph (1)'' and inserting ``present quantitative targets 
     and outcome measures for programs and services provided under 
     this subpart'';
       (7) in subparagraph (C) (as so redesignated)--
       (A) by striking ``serious emotional disturbance'' in the 
     matter preceding clause (i) (as so redesignated) and all that 
     follows through ``substance abuse services'' in clause (i) 
     (as so redesignated) and inserting the following: ``a serious 
     emotional disturbance (as defined pursuant to subsection 
     (c)), the plan shall provide for a system of integrated 
     social services, educational services, child welfare 
     services, juvenile justice services, law enforcement 
     services, and substance use disorder services'';
       (B) by striking ``Education Act);'' and inserting 
     ``Education Act).''; and
       (C) by striking clauses (ii) and (iii) (as so 
     redesignated);
       (8) in subparagraph (D) (as so redesignated), by striking 
     ``plan describes'' and inserting ``plan shall describe'';
       (9) in subparagraph (E) (as so redesignated)--
       (A) in the subparagraph heading by striking ``systems'' and 
     inserting ``services'';
       (B) in the first sentence, by striking ``plan describes'' 
     and all that follows through ``and provides for'' and 
     inserting ``plan shall describe the financial resources 
     available, the existing mental health workforce, and the 
     workforce trained in treating individuals with co-occurring 
     mental and substance use disorders, and shall provide for''; 
     and
       (C) in the second sentence--
       (i) by striking ``further describes'' and inserting ``shall 
     further describe''; and
       (ii) by striking ``involved.'' and inserting ``involved, 
     and the manner in which the State intends to comply with each 
     of the funding agreements in this subpart and subpart III.'';
       (10) by striking the flush matter at the end; and
       (11) by adding at the end the following:
       ``(2) Goals and objectives.--The establishment of goals and 
     objectives for the period of the plan, including targets and 
     milestones that are intended to be met, and the activities 
     that will be undertaken to achieve those targets.''.
       (c) Early Serious Mental Illness.--Section 1920 of the 
     Public Health Service Act (42 U.S.C. 300x-9) is amended by 
     adding at the end the following:
       ``(c) Early Serious Mental Illness.--
       ``(1) In general.--Except as provided in paragraph (2), a 
     State shall expend not less than 10 percent of the amount the 
     State receives for carrying out this section for each fiscal 
     year to support evidence-based programs that address the 
     needs of individuals with early serious mental illness, 
     including psychotic disorders, regardless of the age of the 
     individual at onset.
       ``(2) State flexibility.--In lieu of expending 10 percent 
     of the amount the State receives

[[Page H6949]]

     under this section for a fiscal year as required under 
     paragraph (1), a State may elect to expend not less than 20 
     percent of such amount by the end of such succeeding fiscal 
     year.''.
       (d) Additional Provisions.--Section 1915(b) of the Public 
     Health Service Act (42 U.S.C. 300x-4(b)) is amended--
       (1) in paragraph (3)--
       (A) by striking ``The Secretary'' and inserting the 
     following:
       ``(A) In general.--The Secretary'';
       (B) by striking ``paragraph (1) if'' and inserting 
     ``paragraph (1) in whole or in part if'';
       (C) by striking ``State justify the waiver.'' and inserting 
     ``State in the fiscal year involved or in the previous fiscal 
     year justify the waiver''; and
       (D) by adding at the end the following:
       ``(B) Date certain for action upon request.--The Secretary 
     shall approve or deny a request for a waiver under this 
     paragraph not later than 120 days after the date on which the 
     request is made.
       ``(C) Applicability of waiver.--A waiver provided by the 
     Secretary under this paragraph shall be applicable only to 
     the fiscal year involved.''; and
       (2) in paragraph (4)--
       (A) in subparagraph (A)--
       (i) by inserting after the subparagraph designation the 
     following: ``In general.--'';
       (ii) by striking ``In making a grant'' and inserting the 
     following:
       ``(i) Determination.--In making a grant''; and
       (iii) by inserting at the end the following:
       ``(ii) Alternative.--A State that has failed to comply with 
     paragraph (1) and would otherwise be subject to a reduction 
     in the State's allotment under section 1911 may, upon request 
     by the State, in lieu of having the amount of the allotment 
     under section 1911 for the State reduced for the fiscal year 
     of the grant, agree to comply with a negotiated agreement 
     that is approved by the Secretary and carried out in 
     accordance with guidelines issued by the Secretary. If a 
     State fails to enter into or comply with a negotiated 
     agreement, the Secretary may take action under this paragraph 
     or the terms of the negotiated agreement.''; and
       (B) in subparagraph (B)--
       (i) by inserting after the subparagraph designation the 
     following: ``Submission of information to the secretary.--''; 
     and
       (ii) by striking ``subparagraph (A)'' and inserting 
     ``subparagraph (A)(i)''.
       (e) Application for Grant.--Section 1917(a) of the Public 
     Health Service Act (42 U.S.C. 300x-6(a)) is amended--
       (1) in paragraph (1), by striking ``1941'' and inserting 
     ``1942(a)''; and
       (2) in paragraph (5), by striking ``1915(b)(3)(B)'' and 
     inserting ``1915(b)''.
       (f) Funding.--Section 1920 of the Public Health Service Act 
     (42 U.S.C. 300x-9) is amended--
       (1) in subsection (a)--
       (A) by striking ``section 505'' and inserting ``section 
     505(c)''; and
       (B) by striking ``$450,000,000'' and all that follows 
     through the period and inserting ``$532,571,000 for each of 
     fiscal years 2018 through 2022.''; and
       (2) in subsection (b)(2) by striking ``sections 505 and'' 
     and inserting ``sections 505(c) and''.

     SEC. 8002. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK 
                   GRANT.

       (a) Formula Grants.--Section 1921(b) of the Public Health 
     Service Act (42 U.S.C. 300x-21(b)) is amended--
       (1) by inserting ``carrying out the plan developed in 
     accordance with section 1932(b) and for'' after ``for the 
     purpose of''; and
       (2) by striking ``abuse'' and inserting ``use disorders''.
       (b) Outreach to Persons Who Inject Drugs.--Section 1923(b) 
     of the Public Health Service Act (42 U.S.C. 300x-23(b)) is 
     amended--
       (1) in the subsection heading, by striking ``Regarding 
     Intravenous Substance Abuse'' and inserting ``to Persons Who 
     Inject Drugs''; and
       (2) by striking ``for intravenous drug abuse'' and 
     inserting ``for persons who inject drugs''.
       (c) Requirements Regarding Tuberculosis and Human 
     Immunodeficiency Virus.--Section 1924 of the Public Health 
     Service Act (42 U.S.C. 300x-24) is amended--
       (1) in subsection (a)(1)--
       (A) in the matter preceding subparagraph (A), by striking 
     ``substance abuse'' and inserting ``substance use 
     disorders''; and
       (B) in subparagraph (A), by striking ``such abuse'' and 
     inserting ``such disorders'';
       (2) in subsection (b)--
       (A) in paragraph (1)(A), by striking ``substance abuse'' 
     and inserting ``substance use disorders'';
       (B) in paragraph (2), by inserting ``and Prevention'' after 
     ``Disease Control'';
       (C) in paragraph (3)--
       (i) in the paragraph heading, by striking ``abuse'' and 
     inserting ``use disorders''; and
       (ii) by striking ``substance abuse'' and inserting 
     ``substance use disorders''; and
       (D) in paragraph (6)(B), by striking ``substance abuse'' 
     and inserting ``substance use disorders'';
       (3) by striking subsection (d); and
       (4) by redesignating subsection (e) as subsection (d).
       (d) Group Homes.--Section 1925 of the Public Health Service 
     Act (42 U.S.C. 300x-25) is amended--
       (1) in the section heading, by striking ``recovering 
     substance abusers'' and inserting ``persons in recovery from 
     substance use disorders''; and
       (2) in subsection (a), in the matter preceding paragraph 
     (1), by striking ``recovering substance abusers'' and 
     inserting ``persons in recovery from substance use 
     disorders''.
       (e) Additional Agreements.--Section 1928 of the Public 
     Health Service Act (42 U.S.C. 300x-28) is amended--
       (1) in subsection (a), by striking ``(relative to fiscal 
     year 1992)'';
       (2) by striking subsection (b) and inserting the following:
       ``(b) Professional Development.--A funding agreement for a 
     grant under section 1921 is that the State involved will 
     ensure that prevention, treatment, and recovery personnel 
     operating in the State's substance use disorder prevention, 
     treatment, and recovery systems have an opportunity to 
     receive training, on an ongoing basis, concerning--
       ``(1) recent trends in substance use disorders in the 
     State;
       ``(2) improved methods and evidence-based practices for 
     providing substance use disorder prevention and treatment 
     services;
       ``(3) performance-based accountability;
       ``(4) data collection and reporting requirements; and
       ``(5) any other matters that would serve to further improve 
     the delivery of substance use disorder prevention and 
     treatment services within the State.''; and
       (3) in subsection (d)(1), by striking ``substance abuse'' 
     and inserting ``substance use disorders''.
       (f) Repeal.--Section 1929 of the Public Health Service Act 
     (42 U.S.C. 300x-29) is repealed.
       (g) Maintenance of Effort.--Section 1930 of the Public 
     Health Service Act (42 U.S.C. 300x-30) is amended--
       (1) in subsection (c)(1), by striking ``in the State 
     justify the waiver'' and inserting ``exist in the State, or 
     any part of the State, to justify the waiver''; and
       (2) in subsection (d), by inserting at the end the 
     following:
       ``(3) Alternative.--A State that has failed to comply with 
     this section and would otherwise be subject to a reduction in 
     the State's allotment under section 1921, may, upon request 
     by the State, in lieu of having the State's allotment under 
     section 1921 reduced, agree to comply with a negotiated 
     agreement that is approved by the Secretary and carried out 
     in accordance with guidelines issued by the Secretary. If a 
     State fails to enter into or comply with a negotiated 
     agreement, the Secretary may take action under this paragraph 
     or the terms of the negotiated agreement.''.
       (h) Restrictions on Expenditures.--Section 1931(b)(1) of 
     the Public Health Service Act (42 U.S.C. 300x-31(b)(1)) is 
     amended by striking ``substance abuse'' and inserting 
     ``substance use disorders''.
       (i) Application.--Section 1932 of the Public Health Service 
     Act (42 U.S.C. 300x-32) is amended--
       (1) in subsection (a)--
       (A) in the matter preceding paragraph (1), by striking 
     ``subsections (c) and (d)(2)'' and inserting ``subsection 
     (c)''; and
       (B) in paragraph (5), by striking ``the information 
     required in section 1929, the information required in section 
     1930(c)(2), and'';
       (2) in subsection (b)--
       (A) by striking paragraph (1) and inserting the following:
       ``(1) In general.--In order for a State to be in compliance 
     with subsection (a)(6), the State shall submit to the 
     Secretary a plan that, at a minimum, includes the following:
       ``(A) A description of the State's system of care that--
       ``(i) identifies the single State agency responsible for 
     the administration of the program, including any third party 
     who administers substance use disorder services and is 
     responsible for complying with the requirements of the grant;
       ``(ii) provides information on the need for substance use 
     disorder prevention and treatment services in the State, 
     including estimates on the number of individuals who need 
     treatment, who are pregnant women, women with dependent 
     children, individuals with a co-occurring mental health and 
     substance use disorder, persons who inject drugs, and persons 
     who are experiencing homelessness;
       ``(iii) provides aggregate information on the number of 
     individuals in treatment within the State, including the 
     number of such individuals who are pregnant women, women with 
     dependent children, individuals with a co-occurring mental 
     health and substance use disorder, persons who inject drugs, 
     and persons who are experiencing homelessness;
       ``(iv) provides a description of the system that is 
     available to provide services by modality, including the 
     provision of recovery support services;
       ``(v) provides a description of the State's comprehensive 
     statewide prevention efforts, including the number of 
     individuals being served in the system, target populations, 
     and priority needs, and provides a description of the amount 
     of funds from the prevention set-aside expended on primary 
     prevention;
       ``(vi) provides a description of the financial resources 
     available;
       ``(vii) describes the existing substance use disorders 
     workforce and workforce trained in treating co-occurring 
     substance use and mental disorders;
       ``(viii) includes a description of how the State promotes 
     evidence-based practices; and
       ``(ix) describes how the State integrates substance use 
     disorder services and primary health care, which in the case 
     of those individuals with co-occurring mental health and 
     substance use disorders may include providing both mental 
     health and substance use disorder services in primary care 
     settings or providing primary and specialty care services in 
     community-based mental health and substance use disorder 
     service settings.
       ``(B) The establishment of goals and objectives for the 
     period of the plan, including targets and milestones that are 
     intended to be met, and the activities that will be 
     undertaken to achieve those targets.

[[Page H6950]]

       ``(C) A description of how the State will comply with each 
     funding agreement for a grant under section 1921 that is 
     applicable to the State, including a description of the 
     manner in which the State intends to expend grant funds.''; 
     and
       (B) in paragraph (2)--
       (i) in the paragraph heading, by striking ``authority of 
     secretary regarding modifications'' and inserting 
     ``modifications'';
       (ii) by striking ``As a condition'' and inserting the 
     following:
       ``(A) Authority of secretary.--As a condition;''; and
       (iii) by adding at the end the following:
       ``(B) State request for modification.--If the State 
     determines that a modification to such plan is necessary, the 
     State may request the Secretary to approve the modification. 
     Any such modification shall be in accordance with paragraph 
     (1) and section 1941.''; and
       (C) in paragraph (3), by inserting, ``, including any 
     modification under paragraph (2)'' after ``subsection 
     (a)(6)''; and
       (3) in subsection (e)(2), by striking ``section 1922(c)'' 
     and inserting ``section 1922(b)''.
       (j) Definitions.--Section 1934 of the Public Health Service 
     Act (42 U.S.C. 300x-34) is amended--
       (1) in paragraph (3), by striking ``substance abuse'' and 
     inserting ``substance use disorders''; and
       (2) in paragraph (7), by striking ``substance abuse'' and 
     inserting ``substance use disorders''.
       (k) Funding.--Section 1935 of the Public Health Service Act 
     (42 U.S.C. 300x-35) is amended--
       (1) in subsection (a)--
       (A) by striking ``section 505'' and inserting ``section 
     505(d)''; and
       (B) by striking ``$2,000,000,000 for fiscal year 2001, and 
     such sums as may be necessary for each of the fiscal years 
     2002 and 2003'' and inserting ``$1,858,079,000 for each of 
     fiscal years 2018 through 2022.''; and
       (2) in subsection (b)(1)(B) by striking ``sections 505 
     and'' and inserting ``sections 505(d) and''.

     SEC. 8003. ADDITIONAL PROVISIONS RELATED TO THE BLOCK GRANTS.

       Subpart III of part B of title XIX of the Public Health 
     Service Act (42 U.S.C. 300x-51 et seq.) is amended--
       (1) in section 1943(a)(3) (42 U.S.C. 300x-53(a)(3)), by 
     striking ``section 505'' and inserting ``subsections (c) and 
     (d) of section 505'';
       (2) in section 1953(b) (42 U.S.C. 300x-63(b)), by striking 
     ``substance abuse'' and inserting ``substance use disorder''; 
     and
       (3) by adding at the end the following:

     ``SEC. 1957. PUBLIC HEALTH EMERGENCIES.

       ``In the case of a public health emergency (as determined 
     under section 319), the Secretary, on a State by State basis, 
     may, as the circumstances of the emergency reasonably require 
     and for the period of the emergency, grant an extension, or 
     waive application deadlines or compliance with any other 
     requirement, of a grant authorized under section 521, 1911, 
     or 1921 or an allotment authorized under Public Law 99-319 
     (42 U.S.C. 10801 et seq.).

     ``SEC. 1958. JOINT APPLICATIONS.

       ``The Secretary, acting through the Assistant Secretary for 
     Mental Health and Substance Use, shall permit a joint 
     application to be submitted for grants under subpart I and 
     subpart II upon the request of a State. Such application may 
     be jointly reviewed and approved by the Secretary with 
     respect to such subparts, consistent with the purposes and 
     authorized activities of each such grant program. A State 
     submitting such a joint application shall otherwise meet the 
     requirements with respect to each such subpart.''.

     SEC. 8004. STUDY OF DISTRIBUTION OF FUNDS UNDER THE SUBSTANCE 
                   ABUSE PREVENTION AND TREATMENT BLOCK GRANT AND 
                   THE COMMUNITY MENTAL HEALTH SERVICES BLOCK 
                   GRANT.

       (a) In General.--The Secretary of Health and Human 
     Services, acting through the Assistant Secretary for Mental 
     Health and Substance Use, shall through a grant or contract, 
     or through an agreement with a third party, conduct a study 
     on the formulas for distribution of funds under the substance 
     abuse prevention and treatment block grant, and the community 
     mental health services block grant, under part B of title XIX 
     of the Public Health Service Act (42 U.S.C. 300x et seq.) and 
     recommend changes if necessary. Such study shall include--
       (1) an analysis of whether the distributions under such 
     block grants accurately reflect the need for the services 
     under the grants in the States;
       (2) an examination of whether the indices used under the 
     formulas for distribution of funds under such block grants 
     are appropriate, and if not, alternatives recommended by the 
     Secretary;
       (3) where recommendations are included under paragraph (2) 
     for the use of different indices, a description of the 
     variables and data sources that should be used to determine 
     the indices;
       (4) an evaluation of the variables and data sources that 
     are being used for each of the indices involved, and whether 
     such variables and data sources accurately represent the need 
     for services, the cost of providing services, and the ability 
     of the States to pay for such services;
       (5) the effect that the minimum allotment requirements for 
     each such block grant have on each State's final allotment 
     and the effect of such requirements, if any, on each State's 
     formula-based allotment;
       (6) recommendations for modifications to the minimum 
     allotment provisions to ensure an appropriate distribution of 
     funds; and
       (7) any other information that the Secretary determines 
     appropriate.
       (b) Report.--Not later than 2 years after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall submit to the Committee on Health, Education, 
     Labor, and Pensions of the Senate and the Committee on Energy 
     and Commerce of the House of Representatives, a report 
     containing the findings and recommendations of the study 
     conducted under subsection (a) and the study conducted under 
     section 9004(g).

TITLE IX--PROMOTING ACCESS TO MENTAL HEALTH AND SUBSTANCE USE DISORDER 
                                  CARE

              Subtitle A--Helping Individuals and Families

     SEC. 9001. GRANTS FOR TREATMENT AND RECOVERY FOR HOMELESS 
                   INDIVIDUALS.

       Section 506 of the Public Health Service Act (42 U.S.C. 
     290aa-5) is amended--
       (1) in subsection (a), by striking ``substance abuse'' and 
     inserting ``substance use disorder'';
       (2) in subsection (b)--
       (A) in paragraphs (1) and (3), by striking ``substance 
     abuse'' each place the term appears and inserting ``substance 
     use disorder''; and
       (B) in paragraph (4), by striking ``substance abuse'' and 
     inserting ``a substance use disorder'';
       (3) in subsection (c)--
       (A) in paragraph (1), by striking ``substance abuse 
     disorder'' and inserting ``substance use disorder''; and
       (B) in paragraph (2)--
       (i) in subparagraph (A), by striking ``substance abuse'' 
     and inserting ``a substance use disorder''; and
       (ii) in subparagraph (B), by striking ``substance abuse'' 
     and inserting ``substance use disorder''; and
       (4) in subsection (e), by striking ``, $50,000,000 for 
     fiscal year 2001, and such sums as may be necessary for each 
     of the fiscal years 2002 and 2003'' and inserting 
     ``$41,304,000 for each of fiscal years 2018 through 2022''.

     SEC. 9002. GRANTS FOR JAIL DIVERSION PROGRAMS.

       Section 520G of the Public Health Service Act (42 U.S.C. 
     290bb-38) is amended--
       (1) by striking ``substance abuse'' each place such term 
     appears and inserting ``substance use disorder'';
       (2) in subsection (a)--
       (A) by striking ``Indian tribes, and tribal organizations'' 
     and inserting ``and Indian tribes and tribal organizations 
     (as the terms `Indian tribes' and `tribal organizations' are 
     defined in section 4 of the Indian Self-Determination and 
     Education Assistance Act)''; and
       (B) by inserting ``or a health facility or program operated 
     by or in accordance with a contract or grant with the Indian 
     Health Service,'' after ``entities,'';
       (3) in subsection (c)(2)(A)(i), by striking ``the best 
     known'' and inserting ``evidence-based'';
       (4) by redesignating subsections (d) through (i) as 
     subsections (e) through (j), respectively;
       (5) by inserting after subsection (c) the following:
       ``(d) Special Consideration Regarding Veterans.--In 
     awarding grants under subsection (a), the Secretary shall, as 
     appropriate, give special consideration to entities proposing 
     to use grant funding to support jail diversion services for 
     veterans.'';
       (6) in subsection (e), as so redesignated--
       (A) in paragraph (3), by striking ``; and'' and inserting a 
     semicolon;
       (B) in paragraph (4), by striking the period and inserting 
     ``; and''; and
       (C) by adding at the end the following:
       ``(5) develop programs to divert individuals prior to 
     booking or arrest.''; and
       (7) in subsection (j), as so redesignated, by striking 
     ``$10,000,000 for fiscal year 2001, and such sums as may be 
     necessary for fiscal years 2002 through 2003'' and inserting 
     ``$4,269,000 for each of fiscal years 2018 through 2022''.

     SEC. 9003. PROMOTING INTEGRATION OF PRIMARY AND BEHAVIORAL 
                   HEALTH CARE.

       Section 520K of the Public Health Service Act (42 U.S.C. 
     290bb-42) is amended to read as follows:

     ``SEC. 520K. INTEGRATION INCENTIVE GRANTS AND COOPERATIVE 
                   AGREEMENTS.

       ``(a) Definitions.--In this section:
       ``(1) Eligible entity.--The term `eligible entity' means a 
     State, or other appropriate State agency, in collaboration 
     with 1 or more qualified community programs as described in 
     section 1913(b)(1) or 1 or more community health centers as 
     described in section 330.
       ``(2) Integrated care.--The term `integrated care' means 
     collaborative models or practices offering mental and 
     physical health services, which may include practices that 
     share the same space in the same facility.
       ``(3) Special population.--The term `special population' 
     means--
       ``(A) adults with a mental illness who have co-occurring 
     physical health conditions or chronic diseases;
       ``(B) adults with a serious mental illness who have co-
     occurring physical health conditions or chronic diseases;
       ``(C) children and adolescents with a serious emotional 
     disturbance with co-occurring physical health conditions or 
     chronic diseases; or
       ``(D) individuals with a substance use disorder.
       ``(b) Grants and Cooperative Agreements.--
       ``(1) In general.--The Secretary may award grants and 
     cooperative agreements to eligible entities to support the 
     improvement of integrated care for primary care and 
     behavioral health care in accordance with paragraph (2).
       ``(2) Purposes.--A grant or cooperative agreement awarded 
     under this section shall be designed to--

[[Page H6951]]

       ``(A) promote full integration and collaboration in 
     clinical practices between primary and behavioral health 
     care;
       ``(B) support the improvement of integrated care models for 
     primary care and behavioral health care to improve the 
     overall wellness and physical health status of adults with a 
     serious mental illness or children with a serious emotional 
     disturbance; and
       ``(C) promote integrated care services related to 
     screening, diagnosis, prevention, and treatment of mental and 
     substance use disorders, and co-occurring physical health 
     conditions and chronic diseases.
       ``(c) Applications.--
       ``(1) In general.--An eligible entity seeking a grant or 
     cooperative agreement under this section shall submit an 
     application to the Secretary at such time, in such manner, 
     and accompanied by such information as the Secretary may 
     require, including the contents described in paragraph (2).
       ``(2) Contents.--The contents described in this paragraph 
     are--
       ``(A) a description of a plan to achieve fully 
     collaborative agreements to provide services to special 
     populations;
       ``(B) a document that summarizes the policies, if any, that 
     serve as barriers to the provision of integrated care, and 
     the specific steps, if applicable, that will be taken to 
     address such barriers;
       ``(C) a description of partnerships or other arrangements 
     with local health care providers to provide services to 
     special populations;
       ``(D) an agreement and plan to report to the Secretary 
     performance measures necessary to evaluate patient outcomes 
     and facilitate evaluations across participating projects; and
       ``(E) a plan for sustainability beyond the grant or 
     cooperative agreement period under subsection (e).
       ``(d) Grant and Cooperative Agreement Amounts.--
       ``(1) Target amount.--The target amount that an eligible 
     entity may receive for a year through a grant or cooperative 
     agreement under this section shall be $2,000,000.
       ``(2) Adjustment permitted.--The Secretary, taking into 
     consideration the quality of the application and the number 
     of eligible entities that received grants under this section 
     prior to the date of enactment of the Helping Families in 
     Mental Health Crisis Reform Act of 2016, may adjust the 
     target amount that an eligible entity may receive for a year 
     through a grant or cooperative agreement under this section.
       ``(3) Limitation.--An eligible entity receiving funding 
     under this section may not allocate more than 10 percent of 
     funds awarded under this section to administrative functions, 
     and the remaining amounts shall be allocated to health 
     facilities that provide integrated care.
       ``(e) Duration.--A grant or cooperative agreement under 
     this section shall be for a period not to exceed 5 years.
       ``(f) Report on Program Outcomes.--An eligible entity 
     receiving a grant or cooperative agreement under this section 
     shall submit an annual report to the Secretary that 
     includes--
       ``(1) the progress made to reduce barriers to integrated 
     care as described in the entity's application under 
     subsection (c); and
       ``(2) a description of functional outcomes of special 
     populations, including--
       ``(A) with respect to adults with a serious mental illness, 
     participation in supportive housing or independent living 
     programs, attendance in social and rehabilitative programs, 
     participation in job training opportunities, satisfactory 
     performance in work settings, attendance at scheduled medical 
     and mental health appointments, and compliance with 
     prescribed medication regimes;
       ``(B) with respect to individuals with co-occurring mental 
     illness and physical health conditions and chronic diseases, 
     attendance at scheduled medical and mental health 
     appointments, compliance with prescribed medication regimes, 
     and participation in learning opportunities related to 
     improved health and lifestyle practices; and
       ``(C) with respect to children and adolescents with a 
     serious emotional disturbance who have co-occurring physical 
     health conditions and chronic diseases, attendance at 
     scheduled medical and mental health appointments, compliance 
     with prescribed medication regimes, and participation in 
     learning opportunities at school and extracurricular 
     activities.
       ``(g) Technical Assistance for Primary-Behavioral Health 
     Care Integration.--
       ``(1) In general.--The Secretary may provide appropriate 
     information, training, and technical assistance to eligible 
     entities that receive a grant or cooperative agreement under 
     this section, in order to help such entities meet the 
     requirements of this section, including assistance with--
       ``(A) development and selection of integrated care models;
       ``(B) dissemination of evidence-based interventions in 
     integrated care;
       ``(C) establishment of organizational practices to support 
     operational and administrative success; and
       ``(D) other activities, as the Secretary determines 
     appropriate.
       ``(2) Additional dissemination of technical information.--
     The information and resources provided by the Secretary under 
     paragraph (1) shall, as appropriate, be made available to 
     States, political subdivisions of States, Indian tribes or 
     tribal organizations (as defined in section 4 of the Indian 
     Self-Determination and Education Assistance Act), outpatient 
     mental health and addiction treatment centers, community 
     mental health centers that meet the criteria under section 
     1913(c), certified community behavioral health clinics 
     described in section 223 of the Protecting Access to Medicare 
     Act of 2014, primary care organizations such as Federally 
     qualified health centers or rural health clinics as defined 
     in section 1861(aa) of the Social Security Act, other 
     community-based organizations, or other entities engaging in 
     integrated care activities, as the Secretary determines 
     appropriate.
       ``(h) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated $51,878,000 
     for each of fiscal years 2018 through 2022.''.

     SEC. 9004. PROJECTS FOR ASSISTANCE IN TRANSITION FROM 
                   HOMELESSNESS.

       (a) Formula Grants to States.--Section 521 of the Public 
     Health Service Act (42 U.S.C. 290cc-21) is amended by 
     striking ``1991 through 1994'' and inserting ``2018 through 
     2022''.
       (b) Purpose of Grants.--Section 522 of the Public Health 
     Service Act (42 U.S.C. 290cc-22) is amended--
       (1) in subsection (a)(1)(B), by striking ``substance 
     abuse'' and inserting ``a substance use disorder'';
       (2) in subsection (b)(6), by striking ``substance abuse'' 
     and inserting ``substance use disorder'';
       (3) in subsection (c), by striking ``substance abuse'' and 
     inserting ``a substance use disorder'';
       (4) in subsection (e)--
       (A) in paragraph (1), by striking ``substance abuse'' and 
     inserting ``a substance use disorder''; and
       (B) in paragraph (2), by striking ``substance abuse'' and 
     inserting ``substance use disorder'';
       (5) by striking subsection (g) and redesignating 
     subsections (h) and (i) as (g) and (h), accordingly; and
       (6) in subsection (g), as redesignated by paragraph (5), by 
     striking ``substance abuse'' each place such term appears and 
     inserting ``substance use disorder''.
       (c) Description of Intended Expenditures of Grant.--Section 
     527 of the Public Health Service Act (42 U.S.C. 290cc-27) is 
     amended by striking ``substance abuse'' each place such term 
     appears and inserting ``substance use disorder''.
       (d) Technical Assistance.--Section 530 of the Public Health 
     Service Act (42 U.S.C. 290cc-30) is amended by striking 
     ``through the National Institute of Mental Health, the 
     National Institute of Alcohol Abuse and Alcoholism, and the 
     National Institute on Drug Abuse'' and inserting ``acting 
     through the Assistant Secretary''.
       (e) Definitions.--Section 534(4) of the Public Health 
     Service Act (42 U.S.C. 290cc-34(4)) is amended to read as 
     follows:
       ``(4) Substance use disorder services.--The term `substance 
     use disorder services' has the meaning given the term 
     `substance abuse services' in section 330(h)(5)(C).''.
       (f) Funding.--Section 535(a) of the Public Health Service 
     Act (42 U.S.C. 290cc-35(a)) is amended by striking 
     ``$75,000,000 for each of the fiscal years 2001 through 
     2003'' and inserting ``$64,635,000 for each of fiscal years 
     2018 through 2022''.
       (g) Study Concerning Formula.--
       (1) In general.--Not later than 2 years after the date of 
     enactment of this Act, the Assistant Secretary for Mental 
     Health and Substance Use (referred to in this section as the 
     ``Assistant Secretary'') shall conduct a study concerning the 
     formula used under section 524 of the Public Health Service 
     Act (42 U.S.C. 290cc-24) for making allotments to States 
     under section 521 of such Act (42 U.S.C. 290cc-21). Such 
     study shall include an evaluation of quality indicators of 
     need for purposes of revising the formula for determining the 
     amount of each allotment for the fiscal years following the 
     submission of the study.
       (2) Report.--In accordance with section 8004(b), the 
     Assistant Secretary shall submit to the committees of 
     Congress described in such section a report concerning the 
     results of the study conducted under paragraph (1).

     SEC. 9005. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.

       Subpart 3 of part B of title V of the Public Health Service 
     Act (42 U.S.C. 290bb-31 et seq.) is amended by inserting 
     after section 520E-2 (42 U.S.C. 290bb-36b) the following:

     ``SEC. 520E-3. NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.

       ``(a) In General.--The Secretary, acting through the 
     Assistant Secretary, shall maintain the National Suicide 
     Prevention Lifeline program (referred to in this section as 
     the `program'), authorized under section 520A and in effect 
     prior to the date of enactment of the Helping Families in 
     Mental Health Crisis Reform Act of 2016.
       ``(b) Activities.--In maintaining the program, the 
     activities of the Secretary shall include--
       ``(1) coordinating a network of crisis centers across the 
     United States for providing suicide prevention and crisis 
     intervention services to individuals seeking help at any 
     time, day or night;
       ``(2) maintaining a suicide prevention hotline to link 
     callers to local emergency, mental health, and social 
     services resources; and
       ``(3) consulting with the Secretary of Veterans Affairs to 
     ensure that veterans calling the suicide prevention hotline 
     have access to a specialized veterans' suicide prevention 
     hotline.
       ``(c) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated $7,198,000 
     for each of fiscal years 2018 through 2022.''.

     SEC. 9006. CONNECTING INDIVIDUALS AND FAMILIES WITH CARE.

       Subpart 3 of part B of title V of the Public Health Service 
     Act (42 U.S.C. 290bb-31 et seq.), as amended by section 9005, 
     is further amended by inserting after section 520E-3 the 
     following:

     ``SEC. 520E-4. TREATMENT REFERRAL ROUTING SERVICE.

       ``(a) In General.--The Secretary, acting through the 
     Assistant Secretary, shall maintain the National Treatment 
     Referral Routing Service (referred to in this section as the 
     `Routing Service') to assist individuals and families in 
     locating mental and substance use disorders treatment 
     providers.

[[Page H6952]]

       ``(b) Activities of the Secretary.--To maintain the Routing 
     Service, the activities of the Assistant Secretary shall 
     include administering--
       ``(1) a nationwide, telephone number providing year-round 
     access to information that is updated on a regular basis 
     regarding local behavioral health providers and community-
     based organizations in a manner that is confidential, without 
     requiring individuals to identify themselves, is in languages 
     that include at least English and Spanish, and is at no cost 
     to the individual using the Routing Service; and
       ``(2) an Internet website to provide a searchable, online 
     treatment services locator of behavioral health treatment 
     providers and community-based organizations, which shall 
     include information on the name, location, contact 
     information, and basic services provided by such providers 
     and organizations.
       ``(c) Removing Practitioner Contact Information.--In the 
     event that the Internet website described in subsection 
     (b)(2) contains information on any qualified practitioner 
     that is certified to prescribe medication for opioid 
     dependency under section 303(g)(2)(B) of the Controlled 
     Substances Act, the Assistant Secretary--
       ``(1) shall provide an opportunity to such practitioner to 
     have the contact information of the practitioner removed from 
     the website at the request of the practitioner; and
       ``(2) may evaluate other methods to periodically update the 
     information displayed on such website.
       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed to prevent the Assistant Secretary from using 
     any unobligated amounts otherwise made available to the 
     Administration to maintain the Routing Service.''.

     SEC. 9007. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.

       Section 520F of the Public Health Service Act (42 U.S.C. 
     290bb-37) is amended to read as follows:

     ``SEC. 520F. STRENGTHENING COMMUNITY CRISIS RESPONSE SYSTEMS.

       ``(a) In General.--The Secretary shall award competitive 
     grants to--
       ``(1) State and local governments and Indian tribes and 
     tribal organizations, to enhance community-based crisis 
     response systems; or
       ``(2) States to develop, maintain, or enhance a database of 
     beds at inpatient psychiatric facilities, crisis 
     stabilization units, and residential community mental health 
     and residential substance use disorder treatment facilities, 
     for adults with a serious mental illness, children with a 
     serious emotional disturbance, or individuals with a 
     substance use disorder.
       ``(b) Applications.--
       ``(1) In general.--To receive a grant under subsection (a), 
     an entity shall submit to the Secretary an application, at 
     such time, in such manner, and containing such information as 
     the Secretary may require.
       ``(2) Community-based crisis response plan.--An application 
     for a grant under subsection (a)(1) shall include a plan 
     for--
       ``(A) promoting integration and coordination between local 
     public and private entities engaged in crisis response, 
     including first responders, emergency health care providers, 
     primary care providers, law enforcement, court systems, 
     health care payers, social service providers, and behavioral 
     health providers;
       ``(B) developing memoranda of understanding with public and 
     private entities to implement crisis response services;
       ``(C) addressing gaps in community resources for crisis 
     intervention and prevention; and
       ``(D) developing models for minimizing hospital 
     readmissions, including through appropriate discharge 
     planning.
       ``(3) Beds database plan.--An application for a grant under 
     subsection (a)(2) shall include a plan for developing, 
     maintaining, or enhancing a real-time, Internet-based bed 
     database to collect, aggregate, and display information about 
     beds in inpatient psychiatric facilities and crisis 
     stabilization units, and residential community mental health 
     and residential substance use disorder treatment facilities 
     to facilitate the identification and designation of 
     facilities for the temporary treatment of individuals in 
     mental or substance use disorder crisis.
       ``(c) Database Requirements.--A bed database described in 
     this section is a database that--
       ``(1) includes information on inpatient psychiatric 
     facilities, crisis stabilization units, and residential 
     community mental health and residential substance use 
     disorder facilities in the State involved, including contact 
     information for the facility or unit;
       ``(2) provides real-time information about the number of 
     beds available at each facility or unit and, for each 
     available bed, the type of patient that may be admitted, the 
     level of security provided, and any other information that 
     may be necessary to allow for the proper identification of 
     appropriate facilities for treatment of individuals in mental 
     or substance use disorder crisis; and
       ``(3) enables searches of the database to identify 
     available beds that are appropriate for the treatment of 
     individuals in mental or substance use disorder crisis.
       ``(d) Evaluation.--An entity receiving a grant under 
     subsection (a)(1) shall submit to the Secretary, at such 
     time, in such manner, and containing such information as the 
     Secretary may reasonably require, a report, including an 
     evaluation of the effect of such grant on--
       ``(1) local crisis response services and measures for 
     individuals receiving crisis planning and early intervention 
     supports;
       ``(2) individuals reporting improved functional outcomes; 
     and
       ``(3) individuals receiving regular followup care following 
     a crisis.
       ``(e) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section, 
     $12,500,000 for the period of fiscal years 2018 through 
     2022.''.

     SEC. 9008. GARRETT LEE SMITH MEMORIAL ACT REAUTHORIZATION.

       (a) Suicide Prevention Technical Assistance Center.--
     Section 520C of the Public Health Service Act (42 U.S.C. 
     290bb-34), as amended by section 6001, is further amended--
       (1) in the section heading, by striking ``youth interagency 
     research, training, and technical assistance centers'' and 
     inserting ``suicide prevention technical assistance center'';
       (2) in subsection (a), by striking ``acting through the 
     Assistant Secretary for Mental Health and Substance Use'' and 
     all that follows through the period at the end of paragraph 
     (2) and inserting ``acting through the Assistant Secretary, 
     shall establish a research, training, and technical 
     assistance resource center to provide appropriate 
     information, training, and technical assistance to States, 
     political subdivisions of States, federally recognized Indian 
     tribes, tribal organizations, institutions of higher 
     education, public organizations, or private nonprofit 
     organizations regarding the prevention of suicide among all 
     ages, particularly among groups that are at a high risk for 
     suicide.'';
       (3) by striking subsections (b) and (c);
       (4) by redesignating subsection (d) as subsection (b);
       (5) in subsection (b), as so redesignated--
       (A) in the subsection heading, by striking ``Additional 
     Center'' and inserting ``Responsibilities of the Center'';
       (B) in the matter preceding paragraph (1), by striking 
     ``The additional research'' and all that follows through 
     ``nonprofit organizations for'' and inserting ``The center 
     established under subsection (a) shall conduct activities for 
     the purpose of'';
       (C) by striking ``youth suicide'' each place such term 
     appears and inserting ``suicide'';
       (D) in paragraph (1)--
       (i) by striking ``the development or continuation of'' and 
     inserting ``developing and continuing''; and
       (ii) by inserting ``for all ages, particularly among groups 
     that are at a high risk for suicide'' before the semicolon at 
     the end;
       (E) in paragraph (2), by inserting ``for all ages, 
     particularly among groups that are at a high risk for 
     suicide'' before the semicolon at the end;
       (F) in paragraph (3), by inserting ``and tribal'' after 
     ``statewide'';
       (G) in paragraph (5), by inserting ``and prevention'' after 
     ``intervention'';
       (H) in paragraph (8), by striking ``in youth'';
       (I) in paragraph (9), by striking ``and behavioral health'' 
     and inserting ``health and substance use disorder''; and
       (J) in paragraph (10), by inserting ``conducting'' before 
     ``other''; and
       (6) by striking subsection (e) and inserting the following:
       ``(c) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated $5,988,000 for each of fiscal years 2018 through 
     2022.
       ``(d) Annual Report.--Not later than 2 years after the date 
     of enactment of this subsection, the Secretary shall submit 
     to Congress a report on the activities carried out by the 
     center established under subsection (a) during the year 
     involved, including the potential effects of such activities, 
     and the States, organizations, and institutions that have 
     worked with the center.''.
       (b) Youth Suicide Early Intervention and Prevention 
     Strategies.--Section 520E of the Public Health Service Act 
     (42 U.S.C. 290bb-36) is amended--
       (1) in paragraph (1) of subsection (a) and in subsection 
     (c), by striking ``substance abuse'' each place such term 
     appears and inserting ``substance use disorder'';
       (2) in subsection (b)--
       (A) in paragraph (2)--
       (i) by striking ``ensure that each State is awarded only 1 
     grant or cooperative agreement under this section'' and 
     inserting ``ensure that a State does not receive more than 1 
     grant or cooperative agreement under this section at any 1 
     time''; and
       (ii) by striking ``been awarded'' and inserting 
     ``received''; and
       (B) by adding after paragraph (2) the following:
       ``(3) Consideration.--In awarding grants under this 
     section, the Secretary shall take into consideration the 
     extent of the need of the applicant, including the incidence 
     and prevalence of suicide in the State and among the 
     populations of focus, including rates of suicide determined 
     by the Centers for Disease Control and Prevention for the 
     State or population of focus.'';
       (3) in subsection (g)(2), by striking ``2 years after the 
     date of enactment of this section,'' and insert ``2 years 
     after the date of enactment of Helping Families in Mental 
     Health Crisis Reform Act of 2016,''; and
       (4) by striking subsection (m) and inserting the following:
       ``(m) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated $30,000,000 for each of fiscal years 2018 
     through 2022.''.

     SEC. 9009. ADULT SUICIDE PREVENTION.

       Subpart 3 of part B of title V of the Public Health Service 
     Act (42 U.S.C. 290bb-31 et seq.) is amended by adding at the 
     end the following:

     ``SEC. 520L. ADULT SUICIDE PREVENTION.

       ``(a) Grants.--
       ``(1) In general.--The Assistant Secretary shall award 
     grants to eligible entities described in paragraph (2) to 
     implement suicide prevention and intervention programs, for 
     individuals

[[Page H6953]]

     who are 25 years of age or older, that are designed to raise 
     awareness of suicide, establish referral processes, and 
     improve care and outcomes for such individuals who are at 
     risk of suicide.
       ``(2) Eligible entities.--To be eligible to receive a grant 
     under this section, an entity shall be a community-based 
     primary care or behavioral health care setting, an emergency 
     department, a State mental health agency (or State health 
     agency with mental or behavioral health functions), public 
     health agency, a territory of the United States, or an Indian 
     tribe or tribal organization (as the terms `Indian tribe' and 
     `tribal organization' are defined in section 4 of the Indian 
     Self-Determination and Education Assistance Act).
       ``(3) Use of funds.--The grants awarded under paragraph (1) 
     shall be used to implement programs, in accordance with such 
     paragraph, that include one or more of the following 
     components:
       ``(A) Screening for suicide risk, suicide intervention 
     services, and services for referral for treatment for 
     individuals at risk for suicide.
       ``(B) Implementing evidence-based practices to provide 
     treatment for individuals at risk for suicide, including 
     appropriate followup services.
       ``(C) Raising awareness and reducing stigma of suicide.
       ``(b) Evaluations and Technical Assistance.--The Assistant 
     Secretary shall--
       ``(1) evaluate the activities supported by grants awarded 
     under subsection (a), and disseminate, as appropriate, the 
     findings from the evaluation; and
       ``(2) provide appropriate information, training, and 
     technical assistance, as appropriate, to eligible entities 
     that receive a grant under this section, in order to help 
     such entities to meet the requirements of this section, 
     including assistance with selection and implementation of 
     evidence-based interventions and frameworks to prevent 
     suicide.
       ``(c) Duration.--A grant under this section shall be for a 
     period of not more than 5 years.
       ``(d) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section 
     $30,000,000 for the period of fiscal years 2018 through 
     2022.''.

     SEC. 9010. MENTAL HEALTH AWARENESS TRAINING GRANTS.

       Section 520J of the Public Health Service Act (42 U.S.C. 
     290bb-41) is amended--
       (1) in the section heading, by inserting ``mental health 
     awareness'' before ``training''; and
       (2) in subsection (b)--
       (A) in the subsection heading, by striking ``Illness'' and 
     inserting ``Health'';
       (B) in paragraph (1), by inserting ``veterans, law 
     enforcement, and other categories of individuals, as 
     determined by the Secretary,'' after ``emergency services 
     personnel'';
       (C) in paragraph (5)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``to'' and inserting ``for evidence-based programs that 
     provide training and education in accordance with paragraph 
     (1) on matters including''; and
       (ii) by striking subparagraphs (A) through (C) and 
     inserting the following:
       ``(A) recognizing the signs and symptoms of mental illness; 
     and
       ``(B)(i) resources available in the community for 
     individuals with a mental illness and other relevant 
     resources; or
       ``(ii) safely de-escalating crisis situations involving 
     individuals with a mental illness.''; and
       (D) in paragraph (7), by striking ``, $25,000,000'' and all 
     that follows through the period at the end and inserting 
     ``$14,693,000 for each of fiscal years 2018 through 2022.''.

     SEC. 9011. SENSE OF CONGRESS ON PRIORITIZING AMERICAN INDIANS 
                   AND ALASKA NATIVE YOUTH WITHIN SUICIDE 
                   PREVENTION PROGRAMS.

       (a) Findings.--The Congress finds as follows:
       (1) Suicide is the eighth leading cause of death among 
     American Indians and Alaska Natives across all ages.
       (2) Among American Indians and Alaska Natives who are 10 to 
     34 years of age, suicide is the second leading cause of 
     death.
       (3) The suicide rate among American Indian and Alaska 
     Native adolescents and young adults ages 15 to 34 (17.9 per 
     100,000) is approximately 1.3 times higher than the national 
     average for that age group (13.3 per 100,000).
       (b) Sense of Congress.--It is the sense of Congress that 
     the Secretary of Health and Human Services, in carrying out 
     suicide prevention and intervention programs, should 
     prioritize programs and activities for populations with 
     disproportionately high rates of suicide, such as American 
     Indians and Alaska Natives.

     SEC. 9012. EVIDENCE-BASED PRACTICES FOR OLDER ADULTS.

       Section 520A(e) of the Public Health Service Act (42 U.S.C. 
     290bb-32(e)) is amended by adding at the end the following:
       ``(3) Geriatric mental disorders.--The Secretary shall, as 
     appropriate, provide technical assistance to grantees 
     regarding evidence-based practices for the prevention and 
     treatment of geriatric mental disorders and co-occurring 
     mental health and substance use disorders among geriatric 
     populations, as well as disseminate information about such 
     evidence-based practices to States and nongrantees throughout 
     the United States.''.

     SEC. 9013. NATIONAL VIOLENT DEATH REPORTING SYSTEM.

       The Secretary of Health and Human Services, acting through 
     the Director of the Centers for Disease Control and 
     Prevention, is encouraged to improve, particularly through 
     the inclusion of additional States, the National Violent 
     Death Reporting System as authorized by title III of the 
     Public Health Service Act (42 U.S.C. 241 et seq.). 
     Participation in the system by the States shall be voluntary.

     SEC. 9014. ASSISTED OUTPATIENT TREATMENT.

       Section 224 of the Protecting Access to Medicare Act of 
     2014 (42 U.S.C. 290aa note) is amended--
       (1) in subsection (e), by striking ``and 2018,'' and 
     inserting ``2018, 2019, 2020, 2021, and 2022,''; and
       (2) in subsection (g)--
       (A) in paragraph (1), by striking ``2018'' and inserting 
     ``2022''; and
       (B) in paragraph (2), by striking ``is authorized to be 
     appropriated to carry out this section $15,000,000 for each 
     of fiscal years 2015 through 2018'' and inserting ``are 
     authorized to be appropriated to carry out this section 
     $15,000,000 for each of fiscal years 2015 through 2017, 
     $20,000,000 for fiscal year 2018, $19,000,000 for each of 
     fiscal years 2019 and 2020, and $18,000,000 for each of 
     fiscal years 2021 and 2022''.

     SEC. 9015. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.

       Part B of title V of the Public Health Service Act (42 
     U.S.C. 290bb et seq.), as amended by section 9009, is further 
     amended by adding at the end the following:

     ``SEC. 520M. ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.

       ``(a) In General.--The Assistant Secretary shall award 
     grants to eligible entities--
       ``(1) to establish assertive community treatment programs 
     for adults with a serious mental illness; or
       ``(2) to maintain or expand such programs.
       ``(b) Eligible Entities.--To be eligible to receive a grant 
     under this section, an entity shall be a State, political 
     subdivision of a State, Indian tribe or tribal organization 
     (as such terms are defined in section 4 of the Indian Self-
     Determination and Education Assistance Act), mental health 
     system, health care facility, or any other entity the 
     Assistant Secretary deems appropriate.
       ``(c) Special Consideration.--In selecting among applicants 
     for a grant under this section, the Assistant Secretary may 
     give special consideration to the potential of the 
     applicant's program to reduce hospitalization, homelessness, 
     and involvement with the criminal justice system while 
     improving the health and social outcomes of the patient.
       ``(d) Additional Activities.--The Assistant Secretary 
     shall--
       ``(1) not later than the end of fiscal year 2021, submit a 
     report to the appropriate congressional committees on the 
     grant program under this section, including an evaluation 
     of--
       ``(A) any cost savings and public health outcomes such as 
     mortality, suicide, substance use disorders, hospitalization, 
     and use of services;
       ``(B) rates of involvement with the criminal justice system 
     of patients;
       ``(C) rates of homelessness among patients; and
       ``(D) patient and family satisfaction with program 
     participation; and
       ``(2) provide appropriate information, training, and 
     technical assistance to grant recipients under this section 
     to help such recipients to establish, maintain, or expand 
     their assertive community treatment programs.
       ``(e) Authorization of Appropriations.--
       ``(1) In general.--To carry out this section, there is 
     authorized to be appropriated $5,000,000 for the period of 
     fiscal years 2018 through 2022.
       ``(2) Use of certain funds.--Of the funds appropriated to 
     carry out this section in any fiscal year, not more than 5 
     percent shall be available to the Assistant Secretary for 
     carrying out subsection (d).''.

     SEC. 9016. SOBER TRUTH ON PREVENTING UNDERAGE DRINKING 
                   REAUTHORIZATION.

       Section 519B of the Public Health Service Act (42 U.S.C. 
     290bb-25b) is amended--
       (1) in subsection (c)(3), by striking ``fiscal year 2007'' 
     and all that follows through the period at the end and 
     inserting ``each of the fiscal years 2018 through 2022.'';
       (2) in subsection (d)(4), by striking ``fiscal year 2007'' 
     and all that follows through the period at the end and 
     inserting ``each of the fiscal years 2018 through 2022.'';
       (3) in subsection (e)(1)(I), by striking ``fiscal year 
     2007'' and all that follows through the period at the end and 
     inserting ``each of the fiscal years 2018 through 2022.'';
       (4) in subsection (f)(2), by striking ``$6,000,000 for 
     fiscal year 2007'' and all that follows through the period at 
     the end and inserting ``$3,000,000 for each of the fiscal 
     years 2018 through 2022''; and
       (5) by adding at the end the following new subsection:
       ``(g) Reducing Underage Drinking Through Screening and 
     Brief Intervention.--
       ``(1) Grants to pediatric health care providers to reduce 
     underage drinking.--The Assistant Secretary may make grants 
     to eligible entities to increase implementation of practices 
     for reducing the prevalence of alcohol use among individuals 
     under the age of 21, including college students.
       ``(2) Purposes.--Grants under this subsection shall be made 
     to improve--
       ``(A) screening children and adolescents for alcohol use;
       ``(B) offering brief interventions to children and 
     adolescents to discourage such use;
       ``(C) educating parents about the dangers of, and methods 
     of discouraging, such use;
       ``(D) diagnosing and treating alcohol use disorders; and
       ``(E) referring patients, when necessary, to other 
     appropriate care.
       ``(3) Use of funds.--An entity receiving a grant under this 
     subsection may use such funding for the purposes identified 
     in paragraph (2) by--
       ``(A) providing training to health care providers;

[[Page H6954]]

       ``(B) disseminating best practices, including culturally 
     and linguistically appropriate best practices, as 
     appropriate, and developing and distributing materials; and
       ``(C) supporting other activities, as determined 
     appropriate by the Assistant Secretary.
       ``(4) Application.--To be eligible to receive a grant under 
     this subsection, an entity shall submit an application to the 
     Assistant Secretary at such time, and in such manner, and 
     accompanied by such information as the Assistant Secretary 
     may require. Each application shall include--
       ``(A) a description of the entity;
       ``(B) a description of activities to be completed;
       ``(C) a description of how the services specified in 
     paragraphs (2) and (3) will be carried out and the 
     qualifications for providing such services; and
       ``(D) a timeline for the completion of such activities.
       ``(5) Definitions.--For the purpose of this subsection:
       ``(A) Brief intervention.--The term `brief intervention' 
     means, after screening a patient, providing the patient with 
     brief advice and other brief motivational enhancement 
     techniques designed to increase the insight of the patient 
     regarding the patient's alcohol use, and any realized or 
     potential consequences of such use, to effect the desired 
     related behavioral change.
       ``(B) Children and adolescents.--The term `children and 
     adolescents' means any person under 21 years of age.
       ``(C) Eligible entity.--The term `eligible entity' means an 
     entity consisting of pediatric health care providers and that 
     is qualified to support or provide the activities identified 
     in paragraph (2).
       ``(D) Pediatric health care provider.--The term `pediatric 
     health care provider' means a provider of primary health care 
     to individuals under the age of 21 years.
       ``(E) Screening.--The term `screening' means using 
     validated patient interview techniques to identify and assess 
     the existence and extent of alcohol use in a patient.''.

     SEC. 9017. CENTER AND PROGRAM REPEALS.

       Part B of title V of the Public Health Service Act (42 
     U.S.C. 290bb et seq.) is amended by striking section 506B (42 
     U.S.C. 290aa-5b), the second section 514 (42 U.S.C. 290bb-9) 
     relating to methamphetamine and amphetamine treatment 
     initiatives, and each of sections 514A, 517, 519A, 519C, 
     519E, 520B, 520D, and 520H (42 U.S.C. 290bb-8, 290bb-23, 
     290bb-25a, 290bb-25c, 290bb-25e, 290bb-33, 290bb-35, and 
     290bb-39).

          Subtitle B--Strengthening the Health Care Workforce

     SEC. 9021. MENTAL AND BEHAVIORAL HEALTH EDUCATION AND 
                   TRAINING GRANTS.

       Section 756 of the Public Health Service Act (42 U.S.C. 
     294e-1) is amended--
       (1) in subsection (a)--
       (A) in the matter preceding paragraph (1), by striking ``of 
     higher education''; and
       (B) by striking paragraphs (1) through (4) and inserting 
     the following:
       ``(1) accredited institutions of higher education or 
     accredited professional training programs that are 
     establishing or expanding internships or other field 
     placement programs in mental health in psychiatry, 
     psychology, school psychology, behavioral pediatrics, 
     psychiatric nursing (which may include master's and doctoral 
     level programs), social work, school social work, substance 
     use disorder prevention and treatment, marriage and family 
     therapy, occupational therapy, school counseling, or 
     professional counseling, including such programs with a focus 
     on child and adolescent mental health and transitional-age 
     youth;
       ``(2) accredited doctoral, internship, and post-doctoral 
     residency programs of health service psychology (including 
     clinical psychology, counseling, and school psychology) for 
     the development and implementation of interdisciplinary 
     training of psychology graduate students for providing 
     behavioral health services, including substance use disorder 
     prevention and treatment services, as well as the development 
     of faculty in health service psychology;
       ``(3) accredited master's and doctoral degree programs of 
     social work for the development and implementation of 
     interdisciplinary training of social work graduate students 
     for providing behavioral health services, including substance 
     use disorder prevention and treatment services, and the 
     development of faculty in social work; and
       ``(4) State-licensed mental health nonprofit and for-profit 
     organizations to enable such organizations to pay for 
     programs for preservice or in-service training in a 
     behavioral health-related paraprofessional field with 
     preference for preservice or in-service training of 
     paraprofessional child and adolescent mental health 
     workers.'';
       (2) in subsection (b)--
       (A) by striking paragraph (5);
       (B) by redesignating paragraphs (1) through (4) as 
     paragraphs (2) through (5), respectively;
       (C) by inserting before paragraph (2), as so redesignated, 
     the following:
       ``(1) an ability to recruit and place the students 
     described in subsection (a) in areas with a high need and 
     high demand population;'';
       (D) in paragraph (3), as so redesignated, by striking 
     ``subsection (a)'' and inserting ``paragraph (2), especially 
     individuals with mental disorder symptoms or diagnoses, 
     particularly children and adolescents, and transitional-age 
     youth'';
       (E) in paragraph (4), as so redesignated, by striking ``;'' 
     and inserting ``; and''; and
       (F) in paragraph (5), as so redesignated, by striking ``; 
     and'' and inserting a period;
       (3) in subsection (c), by striking ``authorized under 
     subsection (a)(1)'' and inserting ``awarded under paragraphs 
     (2) and (3) of subsection (a)'';
       (4) by amending subsection (d) to read as follows:
       ``(d) Priority.--In selecting grant recipients under this 
     section, the Secretary shall give priority to--
       ``(1) programs that have demonstrated the ability to train 
     psychology, psychiatry, and social work professionals to work 
     in integrated care settings for purposes of recipients under 
     paragraphs (1), (2), and (3) of subsection (a); and
       ``(2) programs for paraprofessionals that emphasize the 
     role of the family and the lived experience of the consumer 
     and family-paraprofessional partnerships for purposes of 
     recipients under subsection (a)(4).''; and
       (5) by striking subsection (e) and inserting the following:
       ``(e) Report to Congress.--Not later than 4 years after the 
     date of enactment of the Helping Families in Mental Health 
     Crisis Reform Act of 2016, the Secretary shall include in the 
     biennial report submitted to Congress under section 501(m) an 
     assessment on the effectiveness of the grants under this 
     section in--
       ``(1) providing graduate students support for experiential 
     training (internship or field placement);
       ``(2) recruiting students interested in behavioral health 
     practice;
       ``(3) recruiting students in accordance with subsection 
     (b)(1);
       ``(4) developing and implementing interprofessional 
     training and integration within primary care;
       ``(5) developing and implementing accredited field 
     placements and internships; and
       ``(6) collecting data on the number of students trained in 
     behavioral health care and the number of available accredited 
     internships and field placements.
       ``(f) Authorization of Appropriations.--For each of fiscal 
     years 2018 through 2022, there are authorized to be 
     appropriated to carry out this section $50,000,000, to be 
     allocated as follows:
       ``(1) For grants described in subsection (a)(1), 
     $15,000,000.
       ``(2) For grants described in subsection (a)(2), 
     $15,000,000.
       ``(3) For grants described in subsection (a)(3), 
     $10,000,000.
       ``(4) For grants described in subsection (a)(4), 
     $10,000,000.''.

     SEC. 9022. STRENGTHENING THE MENTAL AND SUBSTANCE USE 
                   DISORDERS WORKFORCE.

       Part D of title VII of the Public Health Service Act (42 
     U.S.C. 294 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 760. TRAINING DEMONSTRATION PROGRAM.

       ``(a) In General.--The Secretary shall establish a training 
     demonstration program to award grants to eligible entities to 
     support--
       ``(1) training for medical residents and fellows to 
     practice psychiatry and addiction medicine in underserved, 
     community-based settings that integrate primary care with 
     mental and substance use disorders prevention and treatment 
     services;
       ``(2) training for nurse practitioners, physician 
     assistants, health service psychologists, and social workers 
     to provide mental and substance use disorders services in 
     underserved community-based settings that integrate primary 
     care and mental and substance use disorders services; and
       ``(3) establishing, maintaining, or improving academic 
     units or programs that--
       ``(A) provide training for students or faculty, including 
     through clinical experiences and research, to improve the 
     ability to be able to recognize, diagnose, and treat mental 
     and substance use disorders, with a special focus on 
     addiction; or
       ``(B) develop evidence-based practices or recommendations 
     for the design of the units or programs described in 
     subparagraph (A), including curriculum content standards.
       ``(b) Activities.--
       ``(1) Training for residents and fellows.--A recipient of a 
     grant under subsection (a)(1)--
       ``(A) shall use the grant funds--
       ``(i)(I) to plan, develop, and operate a training program 
     for medical psychiatry residents and fellows in addiction 
     medicine practicing in eligible entities described in 
     subsection (c)(1); or
       ``(II) to train new psychiatric residents and fellows in 
     addiction medicine to provide and expand access to integrated 
     mental and substance use disorders services; and
       ``(ii) to provide at least 1 training track that is--

       ``(I) a virtual training track that includes an in-person 
     rotation at a teaching health center or in a community-based 
     setting, followed by a virtual rotation in which the resident 
     or fellow continues to support the care of patients at the 
     teaching health center or in the community-based setting 
     through the use of health information technology and, as 
     appropriate, telehealth services;
       ``(II) an in-person training track that includes a 
     rotation, during which the resident or fellow practices at a 
     teaching health center or in a community-based setting; or
       ``(III) an in-person training track that includes a 
     rotation during which the resident practices in a community-
     based setting that specializes in the treatment of infants, 
     children, adolescents, or pregnant or postpartum women; and

       ``(B) may use the grant funds to provide additional support 
     for the administration of the program or to meet the costs of 
     projects to establish, maintain, or improve faculty 
     development, or departments, divisions, or other units 
     necessary to implement such training.
       ``(2) Training for other providers.--A recipient of a grant 
     under subsection (a)(2)--
       ``(A) shall use the grant funds to plan, develop, or 
     operate a training program to provide

[[Page H6955]]

     mental and substance use disorders services in underserved, 
     community-based settings, as appropriate, that integrate 
     primary care and mental and substance use disorders 
     prevention and treatment services; and
       ``(B) may use the grant funds to provide additional support 
     for the administration of the program or to meet the costs of 
     projects to establish, maintain, or improve faculty 
     development, or departments, divisions, or other units 
     necessary to implement such program.
       ``(3) Academic units or programs.--A recipient of a grant 
     under subsection (a)(3) shall enter into a partnership with 
     organizations such as an education accrediting organization 
     (such as the Liaison Committee on Medical Education, the 
     Accreditation Council for Graduate Medical Education, the 
     Commission on Osteopathic College Accreditation, the 
     Accreditation Commission for Education in Nursing, the 
     Commission on Collegiate Nursing Education, the Accreditation 
     Council for Pharmacy Education, the Council on Social Work 
     Education, American Psychological Association Commission on 
     Accreditation, or the Accreditation Review Commission on 
     Education for the Physician Assistant) to carry out 
     activities under subsection (a)(3).
       ``(c) Eligible Entities.--
       ``(1) Training for residents and fellows.--To be eligible 
     to receive a grant under subsection (a)(1), an entity shall--
       ``(A) be a consortium consisting of--
       ``(i) at least one teaching health center; and
       ``(ii) the sponsoring institution (or parent institution of 
     the sponsoring institution) of--

       ``(I) a psychiatry residency program that is accredited by 
     the Accreditation Council of Graduate Medical Education (or 
     the parent institution of such a program); or
       ``(II) a fellowship in addiction medicine, as determined 
     appropriate by the Secretary; or

       ``(B) be an entity described in subparagraph (A)(ii) that 
     provides opportunities for residents or fellows to train in 
     community-based settings that integrate primary care with 
     mental and substance use disorders prevention and treatment 
     services.
       ``(2) Training for other providers.--To be eligible to 
     receive a grant under subsection (a)(2), an entity shall be--
       ``(A) a teaching health center (as defined in section 
     749A(f));
       ``(B) a Federally qualified health center (as defined in 
     section 1905(l)(2)(B) of the Social Security Act);
       ``(C) a community mental health center (as defined in 
     section 1861(ff)(3)(B) of the Social Security Act);
       ``(D) a rural health clinic (as defined in section 1861(aa) 
     of the Social Security Act);
       ``(E) a health center operated by the Indian Health 
     Service, an Indian tribe, a tribal organization, or an urban 
     Indian organization (as defined in section 4 of the Indian 
     Health Care Improvement Act); or
       ``(F) an entity with a demonstrated record of success in 
     providing training for nurse practitioners, physician 
     assistants, health service psychologists, and social workers.
       ``(3) Academic units or programs.--To be eligible to 
     receive a grant under subsection (a)(3), an entity shall be a 
     school of medicine or osteopathic medicine, a nursing school, 
     a physician assistant training program, a school of pharmacy, 
     a school of social work, an accredited public or nonprofit 
     private hospital, an accredited medical residency program, or 
     a public or private nonprofit entity which the Secretary has 
     determined is capable of carrying out such grant.
       ``(d) Priority.--
       ``(1) In general.--In awarding grants under subsection 
     (a)(1) or (a)(2), the Secretary shall give priority to 
     eligible entities that--
       ``(A) demonstrate sufficient size, scope, and capacity to 
     undertake the requisite training of an appropriate number of 
     psychiatric residents, fellows, nurse practitioners, 
     physician assistants, or social workers in addiction medicine 
     per year to meet the needs of the area served;
       ``(B) demonstrate experience in training providers to 
     practice team-based care that integrates mental and substance 
     use disorder prevention and treatment services with primary 
     care in community-based settings;
       ``(C) demonstrate experience in using health information 
     technology and, as appropriate, telehealth to support--
       ``(i) the delivery of mental and substance use disorders 
     services at the eligible entities described in subsections 
     (c)(1) and (c)(2); and
       ``(ii) community health centers in integrating primary care 
     and mental and substance use disorders treatment; or
       ``(D) have the capacity to expand access to mental and 
     substance use disorders services in areas with demonstrated 
     need, as determined by the Secretary, such as tribal, rural, 
     or other underserved communities.
       ``(2) Academic units or programs.--In awarding grants under 
     subsection (a)(3), the Secretary shall give priority to 
     eligible entities that--
       ``(A) have a record of training the greatest percentage of 
     mental and substance use disorders providers who enter and 
     remain in these fields or who enter and remain in settings 
     with integrated primary care and mental and substance use 
     disorder prevention and treatment services;
       ``(B) have a record of training individuals who are from 
     underrepresented minority groups, including native 
     populations, or from a rural or disadvantaged background;
       ``(C) provide training in the care of vulnerable 
     populations such as infants, children, adolescents, pregnant 
     and postpartum women, older adults, homeless individuals, 
     victims of abuse or trauma, individuals with disabilities, 
     and other groups as defined by the Secretary;
       ``(D) teach trainees the skills to provide 
     interprofessional, integrated care through collaboration 
     among health professionals; or
       ``(E) provide training in cultural competency and health 
     literacy.
       ``(e) Duration.--Grants awarded under this section shall be 
     for a minimum of 5 years.
       ``(f) Study and Report.--
       ``(1) Study.--
       ``(A) In general.--The Secretary, acting through the 
     Administrator of the Health Resources and Services 
     Administration, shall conduct a study on the results of the 
     demonstration program under this section.
       ``(B) Data submission.--Not later than 90 days after the 
     completion of the first year of the training program and each 
     subsequent year that the program is in effect, each recipient 
     of a grant under subsection (a) shall submit to the Secretary 
     such data as the Secretary may require for analysis for the 
     report described in paragraph (2).
       ``(2) Report to congress.--Not later than 1 year after 
     receipt of the data described in paragraph (1)(B), the 
     Secretary shall submit to Congress a report that includes--
       ``(A) an analysis of the effect of the demonstration 
     program under this section on the quality, quantity, and 
     distribution of mental and substance use disorders services;
       ``(B) an analysis of the effect of the demonstration 
     program on the prevalence of untreated mental and substance 
     use disorders in the surrounding communities of health 
     centers participating in the demonstration; and
       ``(C) recommendations on whether the demonstration program 
     should be expanded.
       ``(g) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section 
     $10,000,000 for each of fiscal years 2018 through 2022.''.

     SEC. 9023. CLARIFICATION ON CURRENT ELIGIBILITY FOR LOAN 
                   REPAYMENT PROGRAMS.

       The Administrator of the Health Resources and Services 
     Administration shall clarify the eligibility pursuant to 
     section 338B(b)(1)(B) of the Public Health Service Act (42 
     U.S.C. 254l-1(b)(1)(B)) of child and adolescent psychiatrists 
     for the National Health Service Corps Loan Repayment Program 
     under subpart III of part D of title III of such Act (42 
     U.S.C. 254l et seq.).

     SEC. 9024. MINORITY FELLOWSHIP PROGRAM.

       Title V of the Public Health Service Act (42 U.S.C. 290aa 
     et seq.) is amended by adding at the end the following:

                 ``PART K--MINORITY FELLOWSHIP PROGRAM

     ``SEC. 597. FELLOWSHIPS.

       ``(a) In General.--The Secretary shall maintain a program, 
     to be known as the Minority Fellowship Program, under which 
     the Secretary shall award fellowships, which may include 
     stipends, for the purposes of--
       ``(1) increasing the knowledge of mental and substance use 
     disorders practitioners on issues related to prevention, 
     treatment, and recovery support for individuals who are from 
     racial and ethnic minority populations and who have a mental 
     or substance use disorder;
       ``(2) improving the quality of mental and substance use 
     disorder prevention and treatment services delivered to 
     racial and ethnic minority populations; and
       ``(3) increasing the number of culturally competent mental 
     and substance use disorders professionals who teach, 
     administer services, conduct research, and provide direct 
     mental or substance use disorder services to racial and 
     ethnic minority populations.
       ``(b) Training Covered.--The fellowships awarded under 
     subsection (a) shall be for postbaccalaureate training 
     (including for master's and doctoral degrees) for mental and 
     substance use disorder treatment professionals, including in 
     the fields of psychiatry, nursing, social work, psychology, 
     marriage and family therapy, mental health counseling, and 
     substance use disorder and addiction counseling.
       ``(c) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated $12,669,000 
     for each of fiscal years 2018 through 2022.''.

     SEC. 9025. LIABILITY PROTECTIONS FOR HEALTH PROFESSIONAL 
                   VOLUNTEERS AT COMMUNITY HEALTH CENTERS.

       Section 224 of the Public Health Service Act (42 U.S.C. 
     233) is amended by adding at the end the following:
       ``(q)(1) For purposes of this section, a health 
     professional volunteer at a deemed entity described in 
     subsection (g)(4) shall, in providing a health professional 
     service eligible for funding under section 330 to an 
     individual, be deemed to be an employee of the Public Health 
     Service for a calendar year that begins during a fiscal year 
     for which a transfer was made under paragraph (4)(C). The 
     preceding sentence is subject to the provisions of this 
     subsection.
       ``(2) In providing a health service to an individual, a 
     health care practitioner shall for purposes of this 
     subsection be considered to be a health professional 
     volunteer at an entity described in subsection (g)(4) if the 
     following conditions are met:
       ``(A) The service is provided to the individual at the 
     facilities of an entity described in subsection (g)(4), or 
     through offsite programs or events carried out by the entity.
       ``(B) The entity is sponsoring the health care practitioner 
     pursuant to paragraph (3)(B).
       ``(C) The health care practitioner does not receive any 
     compensation for the service from the individual, the entity 
     described in subsection (g)(4), or any third-party payer 
     (including reimbursement under any insurance policy or health 
     plan, or under any Federal or State health benefits program), 
     except that the health care practitioner may receive 
     repayment from the entity described in subsection (g)(4) for 
     reasonable expenses incurred by the health care practitioner 
     in the provision of the service to the individual, which may 
     include travel expenses to or from the site of services.

[[Page H6956]]

       ``(D) Before the service is provided, the health care 
     practitioner or the entity described in subsection (g)(4) 
     posts a clear and conspicuous notice at the site where the 
     service is provided of the extent to which the legal 
     liability of the health care practitioner is limited pursuant 
     to this subsection.
       ``(E) At the time the service is provided, the health care 
     practitioner is licensed or certified in accordance with 
     applicable Federal and State laws regarding the provision of 
     the service.
       ``(F) At the time the service is provided, the entity 
     described in subsection (g)(4) maintains relevant 
     documentation certifying that the health care practitioner 
     meets the requirements of this subsection.
       ``(3) Subsection (g) (other than paragraphs (3) and (5)) 
     and subsections (h), (i), and (l) apply to a health care 
     practitioner for purposes of this subsection to the same 
     extent and in the same manner as such subsections apply to an 
     officer, governing board member, employee, or contractor of 
     an entity described in subsection (g)(4), subject to 
     paragraph (4), and subject to the following:
       ``(A) The first sentence of paragraph (1) applies in lieu 
     of the first sentence of subsection (g)(1)(A).
       ``(B) With respect to an entity described in subsection 
     (g)(4), a health care practitioner is not a health 
     professional volunteer at such entity unless the entity 
     sponsors the health care practitioner. For purposes of this 
     subsection, the entity shall be considered to be sponsoring 
     the health care practitioner if--
       ``(i) with respect to the health care practitioner, the 
     entity submits to the Secretary an application meeting the 
     requirements of subsection (g)(1)(D); and
       ``(ii) the Secretary, pursuant to subsection (g)(1)(E), 
     determines that the health care practitioner is deemed to be 
     an employee of the Public Health Service.
       ``(C) In the case of a health care practitioner who is 
     determined by the Secretary pursuant to subsection (g)(1)(E) 
     to be a health professional volunteer at such entity, this 
     subsection applies to the health care practitioner (with 
     respect to services performed on behalf of the entity 
     sponsoring the health care practitioner pursuant to 
     subparagraph (B)) for any cause of action arising from an act 
     or omission of the health care practitioner occurring on or 
     after the date on which the Secretary makes such 
     determination.
       ``(D) Subsection (g)(1)(F) applies to a health care 
     practitioner for purposes of this subsection only to the 
     extent that, in providing health services to an individual, 
     each of the conditions specified in paragraph (2) is met.
       ``(4)(A) Amounts in the fund established under subsection 
     (k)(2) shall be available for transfer under subparagraph (C) 
     for purposes of carrying out this subsection.
       ``(B)(i) Not later than May 1 of each fiscal year, the 
     Attorney General, in consultation with the Secretary, shall 
     submit to the Congress a report providing an estimate of the 
     amount of claims (together with related fees and expenses of 
     witnesses) that, by reason of the acts or omissions of health 
     professional volunteers, will be paid pursuant to this 
     section during the calendar year that begins in the following 
     fiscal year.
       ``(ii) Subsection (k)(1)(B) applies to the estimate under 
     clause (i) regarding health professional volunteers to the 
     same extent and in the same manner as such subsection applies 
     to the estimate under such subsection regarding officers, 
     governing board members, employees, and contractors of 
     entities described in subsection (g)(4).
       ``(iii) The report shall include a summary of the data 
     relied upon for the estimate in clause (i), including the 
     number of claims filed and paid from the previous calendar 
     year.
       ``(C) Not later than December 31 of each fiscal year, the 
     Secretary shall transfer from the fund under subsection 
     (k)(2) to the appropriate accounts in the Treasury an amount 
     equal to the estimate made under subparagraph (B) for the 
     calendar year beginning in such fiscal year, subject to the 
     extent of amounts in the fund.
       ``(5)(A) This subsection shall take effect on October 1, 
     2017, except as provided in subparagraph (B) and paragraph 
     (6).
       ``(B) Effective on the date of the enactment of this 
     subsection--
       ``(i) the Secretary may issue regulations for carrying out 
     this subsection, and the Secretary may accept and consider 
     applications submitted pursuant to paragraph (3)(B); and
       ``(ii) reports under paragraph (4)(B) may be submitted to 
     Congress.
       ``(6) Beginning on October 1, 2022, this subsection shall 
     cease to have any force or effect.''.

     SEC. 9026. REPORTS.

       (a) Workforce Development Report.--
       (1) In general.--Not later than 2 years after the date of 
     enactment of this Act, the Administrator of the Health 
     Resources and Services Administration, in consultation with 
     the Assistant Secretary for Mental Health and Substance Use, 
     shall conduct a study and publicly post on the appropriate 
     Internet website of the Department of Health and Human 
     Services a report on the adult and pediatric mental health 
     and substance use disorder workforce in order to inform 
     Federal, State, and local efforts related to workforce 
     enhancement.
       (2) Contents.--The report under this subsection shall 
     contain--
       (A) national and State-level projections of the supply and 
     demand of the mental health and substance use disorder health 
     workforce, disaggregated by profession;
       (B) an assessment of the mental health and substance use 
     disorder workforce capacity, strengths, and weaknesses as of 
     the date of the report, including the extent to which primary 
     care providers are preventing, screening, or referring for 
     mental and substance use disorder services;
       (C) information on trends within the mental health and 
     substance use disorder provider workforce, including the 
     number of individuals expected to enter the mental health 
     workforce over the next 5 years; and
       (D) any additional information determined by the 
     Administrator of the Health Resources and Services 
     Administration, in consultation with the Assistant Secretary 
     for Mental Health and Substance Use, to be relevant to the 
     mental health and substance use disorder provider workforce.
       (b) Peer-Support Specialist Programs.--
       (1) In general.--The Comptroller General of the United 
     States shall conduct a study on peer-support specialist 
     programs in up to 10 States that receive funding from the 
     Substance Abuse and Mental Health Services Administration.
       (2) Contents of study.--In conducting the study under 
     paragraph (1), the Comptroller General of the United States 
     shall examine and identify best practices, in the States 
     selected pursuant to such paragraph, related to training and 
     credential requirements for peer-support specialist programs, 
     such as--
       (A) hours of formal work or volunteer experience related to 
     mental and substance use disorders conducted through such 
     programs;
       (B) types of peer-support specialist exams required for 
     such programs in the selected States;
       (C) codes of ethics used by such programs in the selected 
     States;
       (D) required or recommended skill sets for such programs in 
     the selected States; and
       (E) requirements for continuing education.
       (3) Report.--Not later than 2 years after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall submit to the Committee on Health, Education, 
     Labor, and Pensions of the Senate and the Committee on Energy 
     and Commerce of the House of Representatives a report on the 
     study conducted under paragraph (1).

            Subtitle C--Mental Health on Campus Improvement

     SEC. 9031. MENTAL HEALTH AND SUBSTANCE USE DISORDER SERVICES 
                   ON CAMPUS.

       Section 520E-2 of the Public Health Service Act (42 U.S.C. 
     290bb-36b) is amended--
       (1) in the section heading, by striking ``and behavioral 
     health'' and inserting ``health and substance use disorder'';
       (2) in subsection (a)--
       (A) by striking ``Services,'' and inserting ``Services 
     and'';
       (B) by striking ``and behavioral health problems'' and 
     inserting ``health or substance use disorders'';
       (C) by striking ``substance abuse'' and inserting 
     ``substance use disorders''; and
       (D) by adding after, ``suicide attempts,'' the following: 
     ``prevent mental and substance use disorders, reduce stigma, 
     and improve the identification and treatment for students at 
     risk,'';
       (3) in subsection (b)--
       (A) in the matter preceding paragraph (1), by striking 
     ``for--'' and inserting ``for one or more of the 
     following:''; and
       (B) by striking paragraphs (1) through (6) and inserting 
     the following:
       ``(1) Educating students, families, faculty, and staff to 
     increase awareness of mental and substance use disorders.
       ``(2) The operation of hotlines.
       ``(3) Preparing informational material.
       ``(4) Providing outreach services to notify students about 
     available mental and substance use disorder services.
       ``(5) Administering voluntary mental and substance use 
     disorder screenings and assessments.
       ``(6) Supporting the training of students, faculty, and 
     staff to respond effectively to students with mental and 
     substance use disorders.
       ``(7) Creating a network infrastructure to link 
     institutions of higher education with health care providers 
     who treat mental and substance use disorders.
       ``(8) Providing mental and substance use disorders 
     prevention and treatment services to students, which may 
     include recovery support services and programming and early 
     intervention, treatment, and management, including through 
     the use of telehealth services.
       ``(9) Conducting research through a counseling or health 
     center at the institution of higher education involved 
     regarding improving the behavioral health of students through 
     clinical services, outreach, prevention, or academic success, 
     in a manner that is in compliance with all applicable 
     personal privacy laws.
       ``(10) Supporting student groups on campus, including 
     athletic teams, that engage in activities to educate 
     students, including activities to reduce stigma surrounding 
     mental and behavioral disorders, and promote mental health.
       ``(11) Employing appropriately trained staff.
       ``(12) Developing and supporting evidence-based and 
     emerging best practices, including a focus on culturally and 
     linguistically appropriate best practices.'';
       (4) in subsection (c)(5), by striking ``substance abuse'' 
     and inserting ``substance use disorder'';
       (5) in subsection (d)--
       (A) in the matter preceding paragraph (1), by striking ``An 
     institution of higher education desiring a grant under this 
     section'' and inserting ``To be eligible to receive a grant 
     under this section, an institution of higher education'';
       (B) by striking paragraph (1) and inserting--
       ``(1) A description of the population to be targeted by the 
     program carried out under the grant, including veterans 
     whenever possible and appropriate, and of identified mental 
     and substance use disorder needs of students at the 
     institution of higher education.'';
       (C) in paragraph (2), by inserting ``, which may include, 
     as appropriate and in accordance with subsection (b)(7), a 
     plan to seek input from relevant stakeholders in the 
     community, including appropriate public and private entities, 
     in

[[Page H6957]]

     order to carry out the program under the grant'' before the 
     period at the end; and
       (D) by adding after paragraph (5) the following new 
     paragraphs:
       ``(6) An outline of the objectives of the program carried 
     out under the grant.
       ``(7) For an institution of higher education proposing to 
     use the grant for an activity described in paragraph (8) or 
     (9) of subsection (b), a description of the policies and 
     procedures of the institution of higher education that are 
     related to applicable laws regarding access to, and sharing 
     of, treatment records of students at any campus-based mental 
     health center or partner organization, including the policies 
     and State laws governing when such records can be accessed 
     and shared for non-treatment purposes and a description of 
     the process used by the institution of higher education to 
     notify students of these policies and procedures, including 
     the extent to which written consent is required.
       ``(8) An assurance that grant funds will be used to 
     supplement and not supplant any other Federal, State, or 
     local funds available to carry out activities of the type 
     carried out under the grant.'';
       (6) in subsection (e)(1), by striking ``and behavioral 
     health problems'' and inserting ``health and substance use 
     disorders'';
       (7) in subsection (f)(2)--
       (A) by striking ``and behavioral health'' and inserting 
     ``health and substance use disorder''; and
       (B) by striking ``suicide and substance abuse'' and 
     inserting ``suicide and substance use disorders'';
       (8) by redesignating subsection (h) as subsection (i);
       (9) by inserting after subsection (g) the following new 
     subsection:
       ``(h) Technical Assistance.--The Secretary may provide 
     technical assistance to grantees in carrying out this 
     section.''; and
       (10) in subsection (i), as redesignated by paragraph (8), 
     by striking ``$5,000,000 for fiscal year 2005'' and all that 
     follows through the period at the end and inserting 
     ``$7,000,000 for each of fiscal years 2018 through 2022.''.

     SEC. 9032. INTERAGENCY WORKING GROUP ON COLLEGE MENTAL 
                   HEALTH.

       (a) Purpose.--It is the purpose of this section to provide 
     for the establishment of a College Campus Task Force to 
     discuss mental and behavioral health concerns on campuses of 
     institutions of higher education.
       (b) Establishment.--The Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall establish a College Campus Task Force (referred to in 
     this section as the ``Task Force'') to discuss mental and 
     behavioral health concerns on campuses of institutions of 
     higher education.
       (c) Membership.--The Task Force shall be composed of a 
     representative from each Federal agency (as appointed by the 
     head of the agency) that has jurisdiction over, or is 
     affected by, mental health and education policies and 
     projects, including--
       (1) the Department of Education;
       (2) the Department of Health and Human Services;
       (3) the Department of Veterans Affairs; and
       (4) such other Federal agencies as the Assistant Secretary 
     for Mental Health and Substance Use, in consultation with the 
     Secretary, determines to be appropriate.
       (d) Duties.--The Task Force shall--
       (1) serve as a centralized mechanism to coordinate a 
     national effort to--
       (A) discuss and evaluate evidence and knowledge on mental 
     and behavioral health services available to, and the 
     prevalence of mental illness among, the age population of 
     students attending institutions of higher education in the 
     United States;
       (B) determine the range of effective, feasible, and 
     comprehensive actions to improve mental and behavioral health 
     on campuses of institutions of higher education;
       (C) examine and better address the needs of the age 
     population of students attending institutions of higher 
     education dealing with mental illness;
       (D) survey Federal agencies to determine which policies are 
     effective in encouraging, and how best to facilitate outreach 
     without duplicating, efforts relating to mental and 
     behavioral health promotion;
       (E) establish specific goals within and across Federal 
     agencies for mental health promotion, including 
     determinations of accountability for reaching those goals;
       (F) develop a strategy for allocating responsibilities and 
     ensuring participation in mental and behavioral health 
     promotion, particularly in the case of competing agency 
     priorities;
       (G) coordinate plans to communicate research results 
     relating to mental and behavioral health amongst the age 
     population of students attending institutions of higher 
     education to enable reporting and outreach activities to 
     produce more useful and timely information;
       (H) provide a description of evidence-based practices, 
     model programs, effective guidelines, and other strategies 
     for promoting mental and behavioral health on campuses of 
     institutions of higher education;
       (I) make recommendations to improve Federal efforts 
     relating to mental and behavioral health promotion on 
     campuses of institutions of higher education and to ensure 
     Federal efforts are consistent with available standards, 
     evidence, and other programs in existence as of the date of 
     enactment of this Act;
       (J) monitor Federal progress in meeting specific mental and 
     behavioral health promotion goals as they relate to settings 
     of institutions of higher education; and
       (K) examine and disseminate best practices related to 
     intracampus sharing of treatment records;
       (2) consult with national organizations with expertise in 
     mental and behavioral health, especially those organizations 
     working with the age population of students attending 
     institutions of higher education; and
       (3) consult with and seek input from mental health 
     professionals working on campuses of institutions of higher 
     education as appropriate.
       (e) Meetings.--
       (1) In general.--The Task Force shall meet not fewer than 
     three times each year.
       (2) Annual conference.--The Secretary shall sponsor an 
     annual conference on mental and behavioral health in settings 
     of institutions of higher education to enhance coordination, 
     build partnerships, and share best practices in mental and 
     behavioral health promotion, data collection, analysis, and 
     services.
       (f) Definition.--In this section, the term ``institution of 
     higher education'' has the meaning given such term in section 
     101 of the Higher Education Act of 1965 (20 U.S.C. 1001).
       (g) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated $1,000,000 
     for the period of fiscal years 2018 through 2022.

     SEC. 9033. IMPROVING MENTAL HEALTH ON COLLEGE CAMPUSES.

       Part D of title V of the Public Health Service Act (42 
     U.S.C. 290dd et seq.) is amended by adding at the end the 
     following:

     ``SEC. 549. MENTAL AND BEHAVIORAL HEALTH OUTREACH AND 
                   EDUCATION ON COLLEGE CAMPUSES.

       ``(a) Purpose.--It is the purpose of this section to 
     increase access to, and reduce the stigma associated with, 
     mental health services to ensure that students at 
     institutions of higher education have the support necessary 
     to successfully complete their studies.
       ``(b) National Public Education Campaign.--The Secretary, 
     acting through the Assistant Secretary and in collaboration 
     with the Director of the Centers for Disease Control and 
     Prevention, shall convene an interagency, public-private 
     sector working group to plan, establish, and begin 
     coordinating and evaluating a targeted public education 
     campaign that is designed to focus on mental and behavioral 
     health on the campuses of institutions of higher education. 
     Such campaign shall be designed to--
       ``(1) improve the general understanding of mental health 
     and mental disorders;
       ``(2) encourage help-seeking behaviors relating to the 
     promotion of mental health, prevention of mental disorders, 
     and treatment of such disorders;
       ``(3) make the connection between mental and behavioral 
     health and academic success; and
       ``(4) assist the general public in identifying the early 
     warning signs and reducing the stigma of mental illness.
       ``(c) Composition.--The working group convened under 
     subsection (b) shall include--
       ``(1) mental health consumers, including students and 
     family members;
       ``(2) representatives of institutions of higher education;
       ``(3) representatives of national mental and behavioral 
     health associations and associations of institutions of 
     higher education;
       ``(4) representatives of health promotion and prevention 
     organizations at institutions of higher education;
       ``(5) representatives of mental health providers, including 
     community mental health centers; and
       ``(6) representatives of private-sector and public-sector 
     groups with experience in the development of effective public 
     health education campaigns.
       ``(d) Plan.--The working group under subsection (b) shall 
     develop a plan that--
       ``(1) targets promotional and educational efforts to the 
     age population of students at institutions of higher 
     education and individuals who are employed in settings of 
     institutions of higher education, including through the use 
     of roundtables;
       ``(2) develops and proposes the implementation of research-
     based public health messages and activities;
       ``(3) provides support for local efforts to reduce stigma 
     by using the National Health Information Center as a primary 
     point of contact for information, publications, and service 
     program referrals; and
       ``(4) develops and proposes the implementation of a social 
     marketing campaign that is targeted at the population of 
     students attending institutions of higher education and 
     individuals who are employed in settings of institutions of 
     higher education.
       ``(e) Definition.--In this section, the term `institution 
     of higher education' has the meaning given such term in 
     section 101 of the Higher Education Act of 1965 (20 U.S.C. 
     1001).
       ``(f) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated $1,000,000 
     for the period of fiscal years 2018 through 2022.''.

   TITLE X--STRENGTHENING MENTAL AND SUBSTANCE USE DISORDER CARE FOR 
                        CHILDREN AND ADOLESCENTS

     SEC. 10001. PROGRAMS FOR CHILDREN WITH A SERIOUS EMOTIONAL 
                   DISTURBANCE.

       (a) Comprehensive Community Mental Health Services for 
     Children With a Serious Emotional Disturbance.--Section 
     561(a)(1) of the Public Health Service Act (42 U.S.C. 
     290ff(a)(1)) is amended by inserting ``, which may include 
     efforts to identify and serve children at risk'' before the 
     period.
       (b) Requirements With Respect to Carrying Out Purpose of 
     Grants.--Section 562(b) of the Public Health Service Act (42 
     U.S.C. 290ff-1(b)) is amended by striking ``will not provide 
     an individual with access to the system if the individual is 
     more than 21 years of age'' and inserting ``will provide an 
     individual with access to the system through the age of 21 
     years''.
       (c) Additional Provisions.--Section 564(f) of the Public 
     Health Service Act (42 U.S.C. 290ff-

[[Page H6958]]

     3(f)) is amended by inserting ``(and provide a copy to the 
     State involved)'' after ``to the Secretary''.
       (d) General Provisions.--Section 565 of the Public Health 
     Service Act (42 U.S.C. 290ff-4) is amended--
       (1) in subsection (b)(1)--
       (A) in the matter preceding subparagraph (A), by striking 
     ``receiving a grant under section 561(a)'' and inserting ``, 
     regardless of whether such public entity is receiving a grant 
     under section 561(a)''; and
       (B) in subparagraph (B), by striking ``pursuant to'' and 
     inserting ``described in'';
       (2) in subsection (d)(1), by striking ``not more than 21 
     years of age'' and inserting ``through the age of 21 years''; 
     and
       (3) in subsection (f)(1), by striking ``$100,000,000 for 
     fiscal year 2001, and such sums as may be necessary for each 
     of the fiscal years 2002 and 2003'' and inserting 
     ``$119,026,000 for each of fiscal years 2018 through 2022''.

     SEC. 10002. INCREASING ACCESS TO PEDIATRIC MENTAL HEALTH 
                   CARE.

       Title III of the Public Health Service Act is amended by 
     inserting after section 330L of such Act (42 U.S.C. 254c-18) 
     the following new section:

     ``SEC. 330M PEDIATRIC MENTAL HEALTH CARE ACCESS GRANTS.

       ``(a) In General.--The Secretary, acting through the 
     Administrator of the Health Resources and Services 
     Administration and in coordination with other relevant 
     Federal agencies, shall award grants to States, political 
     subdivisions of States, and Indian tribes and tribal 
     organizations (for purposes of this section, as such terms 
     are defined in section 4 of the Indian Self-Determination and 
     Education Assistance Act (25 U.S.C. 450b)) to promote 
     behavioral health integration in pediatric primary care by--
       ``(1) supporting the development of statewide or regional 
     pediatric mental health care telehealth access programs; and
       ``(2) supporting the improvement of existing statewide or 
     regional pediatric mental health care telehealth access 
     programs.
       ``(b) Program Requirements.--
       ``(1) In general.--A pediatric mental health care 
     telehealth access program referred to in subsection (a), with 
     respect to which a grant under such subsection may be used, 
     shall--
       ``(A) be a statewide or regional network of pediatric 
     mental health teams that provide support to pediatric primary 
     care sites as an integrated team;
       ``(B) support and further develop organized State or 
     regional networks of pediatric mental health teams to provide 
     consultative support to pediatric primary care sites;
       ``(C) conduct an assessment of critical behavioral 
     consultation needs among pediatric providers and such 
     providers' preferred mechanisms for receiving consultation, 
     training, and technical assistance;
       ``(D) develop an online database and communication 
     mechanisms, including telehealth, to facilitate consultation 
     support to pediatric practices;
       ``(E) provide rapid statewide or regional clinical 
     telephone or telehealth consultations when requested between 
     the pediatric mental health teams and pediatric primary care 
     providers;
       ``(F) conduct training and provide technical assistance to 
     pediatric primary care providers to support the early 
     identification, diagnosis, treatment, and referral of 
     children with behavioral health conditions;
       ``(G) provide information to pediatric providers about, and 
     assist pediatric providers in accessing, pediatric mental 
     health care providers, including child and adolescent 
     psychiatrists, and licensed mental health professionals, such 
     as psychologists, social workers, or mental health counselors 
     and in scheduling and conducting technical assistance;
       ``(H) assist with referrals to specialty care and community 
     or behavioral health resources; and
       ``(I) establish mechanisms for measuring and monitoring 
     increased access to pediatric mental health care services by 
     pediatric primary care providers and expanded capacity of 
     pediatric primary care providers to identify, treat, and 
     refer children with mental health problems.
       ``(2) Pediatric mental health teams.--In this subsection, 
     the term `pediatric mental health team' means a team 
     consisting of at least one case coordinator, at least one 
     child and adolescent psychiatrist, and at least one licensed 
     clinical mental health professional, such as a psychologist, 
     social worker, or mental health counselor. Such a team may be 
     regionally based.
       ``(c) Application.--A State, political subdivision of a 
     State, Indian tribe, or tribal organization seeking a grant 
     under this section shall submit an application to the 
     Secretary at such time, in such manner, and containing such 
     information as the Secretary may require, including a plan 
     for the comprehensive evaluation of activities that are 
     carried out with funds received under such grant.
       ``(d) Evaluation.--A State, political subdivision of a 
     State, Indian tribe, or tribal organization that receives a 
     grant under this section shall prepare and submit an 
     evaluation of activities that are carried out with funds 
     received under such grant to the Secretary at such time, in 
     such manner, and containing such information as the Secretary 
     may reasonably require, including a process and outcome 
     evaluation.
       ``(e) Access to Broadband.--In administering grants under 
     this section, the Secretary may coordinate with other 
     agencies to ensure that funding opportunities are available 
     to support access to reliable, high-speed Internet for 
     providers.
       ``(f) Matching Requirement.--The Secretary may not award a 
     grant under this section unless the State, political 
     subdivision of a State, Indian tribe, or tribal organization 
     involved agrees, with respect to the costs to be incurred by 
     the State, political subdivision of a State, Indian tribe, or 
     tribal organization in carrying out the purpose described in 
     this section, to make available non-Federal contributions (in 
     cash or in kind) toward such costs in an amount that is not 
     less than 20 percent of Federal funds provided in the grant.
       ``(g) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated, $9,000,000 
     for the period of fiscal years 2018 through 2022.''.

     SEC. 10003. SUBSTANCE USE DISORDER TREATMENT AND EARLY 
                   INTERVENTION SERVICES FOR CHILDREN AND 
                   ADOLESCENTS.

       The first section 514 of the Public Health Service Act (42 
     U.S.C. 290bb-7), relating to substance abuse treatment 
     services for children and adolescents, is amended--
       (1) in the section heading, by striking ``abuse treatment'' 
     and inserting ``use disorder treatment and early 
     intervention'';
       (2) by striking subsection (a) and inserting the following:
       ``(a) In General.--The Secretary shall award grants, 
     contracts, or cooperative agreements to public and private 
     nonprofit entities, including Indian tribes or tribal 
     organizations (as such terms are defined in section 4 of the 
     Indian Self-Determination and Education Assistance Act), or 
     health facilities or programs operated by or in accordance 
     with a contract or grant with the Indian Health Service, for 
     the purpose of--
       ``(1) providing early identification and services to meet 
     the needs of children and adolescents who are at risk of 
     substance use disorders;
       ``(2) providing substance use disorder treatment services 
     for children, including children and adolescents with co-
     occurring mental illness and substance use disorders; and
       ``(3) providing assistance to pregnant women, and parenting 
     women, with substance use disorders, in obtaining treatment 
     services, linking mothers to community resources to support 
     independent family lives, and staying in recovery so that 
     children are in safe, stable home environments and receive 
     appropriate health care services.'';
       (3) in subsection (b)--
       (A) by striking paragraph (1) and inserting the following:
       ``(1) apply evidence-based and cost-effective methods;'';
       (B) in paragraph (2)--
       (i) by striking ``treatment''; and
       (ii) by inserting ``substance abuse,'' after ``child 
     welfare,'';
       (C) in paragraph (3), by striking ``substance abuse 
     disorders'' and inserting ``substance use disorders, 
     including children and adolescents with co-occurring mental 
     illness and substance use disorders,'';
       (D) in paragraph (5), by striking ``treatment;'' and 
     inserting ``services; and'';
       (E) in paragraph (6), by striking ``substance abuse 
     treatment; and'' and inserting ``treatment.''; and
       (F) by striking paragraph (7); and
       (4) in subsection (f), by striking ``$40,000,000'' and all 
     that follows through the period and inserting ``$29,605,000 
     for each of fiscal years 2018 through 2022.''.

     SEC. 10004. CHILDREN'S RECOVERY FROM TRAUMA.

       The first section 582 of the Public Health Service Act (42 
     U.S.C. 290hh-1; relating to grants to address the problems of 
     persons who experience violence related stress) is amended--
       (1) in subsection (a), by striking ``developing programs'' 
     and all that follows through the period at the end and 
     inserting the following: ``developing and maintaining 
     programs that provide for--
       ``(1) the continued operation of the National Child 
     Traumatic Stress Initiative (referred to in this section as 
     the `NCTSI'), which includes a cooperative agreement with a 
     coordinating center, that focuses on the mental, behavioral, 
     and biological aspects of psychological trauma response, 
     prevention of the long-term consequences of child trauma, and 
     early intervention services and treatment to address the 
     long-term consequences of child trauma; and
       ``(2) the development of knowledge with regard to evidence-
     based practices for identifying and treating mental, 
     behavioral, and biological disorders of children and youth 
     resulting from witnessing or experiencing a traumatic 
     event.'';
       (2) in subsection (b)--
       (A) by striking ``subsection (a) related'' and inserting 
     ``subsection (a)(2) (related'';
       (B) by striking ``treating disorders associated with 
     psychological trauma'' and inserting ``treating mental, 
     behavioral, and biological disorders associated with 
     psychological trauma)''; and
       (C) by striking ``mental health agencies and programs that 
     have established clinical and basic research'' and inserting 
     ``universities, hospitals, mental health agencies, and other 
     programs that have established clinical expertise and 
     research'';
       (3) by redesignating subsections (c) through (g) as 
     subsections (g) through (k), respectively;
       (4) by inserting after subsection (b), the following:
       ``(c) Child Outcome Data.--The NCTSI coordinating center 
     described in subsection (a)(1) shall collect, analyze, 
     report, and make publicly available, as appropriate, NCTSI-
     wide child treatment process and outcome data regarding the 
     early identification and delivery of evidence-based treatment 
     and services for children and families served by the NCTSI 
     grantees.
       ``(d) Training.--The NCTSI coordinating center shall 
     facilitate the coordination of training initiatives in 
     evidence-based and trauma-informed treatments, interventions, 
     and practices offered to NCTSI grantees, providers, and 
     partners.
       ``(e) Dissemination and Collaboration.--The NCTSI 
     coordinating center shall, as appropriate, collaborate with--

[[Page H6959]]

       ``(1) the Secretary, in the dissemination of evidence-based 
     and trauma-informed interventions, treatments, products, and 
     other resources to appropriate stakeholders; and
       ``(2) appropriate agencies that conduct or fund research 
     within the Department of Health and Human Services, for 
     purposes of sharing NCTSI expertise, evaluation data, and 
     other activities, as appropriate.
       ``(f) Review.--The Secretary shall, consistent with the 
     peer-review process, ensure that NCTSI applications are 
     reviewed by appropriate experts in the field as part of a 
     consensus-review process. The Secretary shall include review 
     criteria related to expertise and experience in child trauma 
     and evidence-based practices.'';
       (5) in subsection (g) (as so redesignated), by striking 
     ``with respect to centers of excellence are distributed 
     equitably among the regions of the country'' and inserting 
     ``are distributed equitably among the regions of the United 
     States'';
       (6) in subsection (i) (as so redesignated), by striking 
     ``recipient may not exceed 5 years'' and inserting 
     ``recipient shall not be less than 4 years, but shall not 
     exceed 5 years''; and
       (7) in subsection (j) (as so redesignated), by striking 
     ``$50,000,000'' and all that follows through ``2006'' and 
     inserting ``$46,887,000 for each of fiscal years 2018 through 
     2022''.

     SEC. 10005. SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.

       Part B of title III of the Public Health Service Act (42 
     U.S.C. 243 et seq.) is amended by inserting after section 
     317L (42 U.S.C. 247b-13) the following:

     ``SEC. 317L-1. SCREENING AND TREATMENT FOR MATERNAL 
                   DEPRESSION.

       ``(a) Grants.--The Secretary shall make grants to States to 
     establish, improve, or maintain programs for screening, 
     assessment, and treatment services, including culturally and 
     linguistically appropriate services, as appropriate, for 
     women who are pregnant, or who have given birth within the 
     preceding 12 months, for maternal depression.
       ``(b) Application.--To seek a grant under this section, a 
     State shall submit an application to the Secretary at such 
     time, in such manner, and containing such information as the 
     Secretary may require. At a minimum, any such application 
     shall include explanations of--
       ``(1) how a program, or programs, will increase the 
     percentage of women screened and treated, as appropriate, for 
     maternal depression in 1 or more communities; and
       ``(2) how a program, or programs, if expanded, would 
     increase access to screening and treatment services for 
     maternal depression.
       ``(c) Priority.--In awarding grants under this section, the 
     Secretary may give priority to States proposing to improve or 
     enhance access to screening services for maternal depression 
     in primary care settings.
       ``(d) Use of Funds.--The activities eligible for funding 
     through a grant under subsection (a)--
       ``(1) shall include--
       ``(A) providing appropriate training to health care 
     providers; and
       ``(B) providing information to health care providers, 
     including information on maternal depression screening, 
     treatment, and followup support services, and linkages to 
     community-based resources; and
       ``(2) may include--
       ``(A) enabling health care providers (including 
     obstetrician-gynecologists, pediatricians, psychiatrists, 
     mental health care providers, and adult primary care 
     clinicians) to provide or receive real-time psychiatric 
     consultation (in-person or remotely) to aid in the treatment 
     of pregnant and parenting women;
       ``(B) establishing linkages with and among community-based 
     resources, including mental health resources, primary care 
     resources, and support groups; and
       ``(C) utilizing telehealth services for rural areas and 
     medically underserved areas (as defined in section 330I(a)).
       ``(e) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated $5,000,000 
     for each of fiscal years 2018 through 2022.''.

     SEC. 10006. INFANT AND EARLY CHILDHOOD MENTAL HEALTH 
                   PROMOTION, INTERVENTION, AND TREATMENT.

       Part Q of title III of the Public Health Service Act (42 
     U.S.C. 280h et seq.) is amended by adding at the end the 
     following:

     ``SEC. 399Z-2. INFANT AND EARLY CHILDHOOD MENTAL HEALTH 
                   PROMOTION, INTERVENTION, AND TREATMENT.

       ``(a) Grants.--The Secretary shall--
       ``(1) award grants to eligible entities to develop, 
     maintain, or enhance infant and early childhood mental health 
     promotion, intervention, and treatment programs, including--
       ``(A) programs for infants and children at significant risk 
     of developing, showing early signs of, or having been 
     diagnosed with mental illness, including a serious emotional 
     disturbance; and
       ``(B) multigenerational therapy and other services that 
     support the caregiving relationship; and
       ``(2) ensure that programs funded through grants under this 
     section are evidence-informed or evidence-based models, 
     practices, and methods that are, as appropriate, culturally 
     and linguistically appropriate, and can be replicated in 
     other appropriate settings.
       ``(b) Eligible Children and Entities.--In this section:
       ``(1) Eligible child.--The term `eligible child' means a 
     child from birth to not more than 12 years of age who--
       ``(A) is at risk for, shows early signs of, or has been 
     diagnosed with a mental illness, including a serious 
     emotional disturbance; and
       ``(B) may benefit from infant and early childhood 
     intervention or treatment programs or specialized preschool 
     or elementary school programs that are evidence-based or that 
     have been scientifically demonstrated to show promise but 
     would benefit from further applied development.
       ``(2) Eligible entity.--The term `eligible entity' means a 
     human services agency or nonprofit institution that--
       ``(A) employs licensed mental health professionals who have 
     specialized training and experience in infant and early 
     childhood mental health assessment, diagnosis, and treatment, 
     or is accredited or approved by the appropriate State agency, 
     as applicable, to provide for children from infancy to 12 
     years of age mental health promotion, intervention, or 
     treatment services; and
       ``(B) provides services or programs described in subsection 
     (a) that are evidence-based or that have been scientifically 
     demonstrated to show promise but would benefit from further 
     applied development.
       ``(c) Application.--An eligible entity seeking a grant 
     under subsection (a) shall submit to the Secretary an 
     application at such time, in such manner, and containing such 
     information as the Secretary may require.
       ``(d) Use of Funds for Early Intervention and Treatment 
     Programs.--An eligible entity may use amounts awarded under a 
     grant under subsection (a)(1) to carry out the following:
       ``(1) Provide age-appropriate mental health promotion and 
     early intervention services or mental illness treatment 
     services, which may include specialized programs, for 
     eligible children at significant risk of developing, showing 
     early signs of, or having been diagnosed with a mental 
     illness, including a serious emotional disturbance. Such 
     services may include social and behavioral services as well 
     as multigenerational therapy and other services that support 
     the caregiving relationship.
       ``(2) Provide training for health care professionals with 
     expertise in infant and early childhood mental health care 
     with respect to appropriate and relevant integration with 
     other disciplines such as primary care clinicians, early 
     intervention specialists, child welfare staff, home visitors, 
     early care and education providers, and others who work with 
     young children and families.
       ``(3) Provide mental health consultation to personnel of 
     early care and education programs (including licensed or 
     regulated center-based and home-based child care, home 
     visiting, preschool special education, and early intervention 
     programs) who work with children and families.
       ``(4) Provide training for mental health clinicians in 
     infant and early childhood in promising and evidence-based 
     practices and models for infant and early childhood mental 
     health treatment and early intervention, including with 
     regard to practices for identifying and treating mental 
     illness and behavioral disorders of infants and children 
     resulting from exposure or repeated exposure to adverse 
     childhood experiences or childhood trauma.
       ``(5) Provide age-appropriate assessment, diagnostic, and 
     intervention services for eligible children, including early 
     mental health promotion, intervention, and treatment 
     services.
       ``(e) Matching Funds.--The Secretary may not award a grant 
     under this section to an eligible entity unless the eligible 
     entity agrees, with respect to the costs to be incurred by 
     the eligible entity in carrying out the activities described 
     in subsection (d), to make available non-Federal 
     contributions (in cash or in kind) toward such costs in an 
     amount that is not less than 10 percent of the total amount 
     of Federal funds provided in the grant.
       ``(f) Authorization of Appropriations.--To carry out this 
     section, there are authorized to be appropriated $20,000,000 
     for the period of fiscal years 2018 through 2022.''.

             TITLE XI--COMPASSIONATE COMMUNICATION ON HIPAA

     SEC. 11001. SENSE OF CONGRESS.

       (a) Findings.--Congress finds the following:
       (1) According to the National Survey on Drug Use and 
     Health, in 2015, there were approximately 9,800,000 adults in 
     the United States with serious mental illness.
       (2) The Substance Abuse and Mental Health Services 
     Administration defines the term ``serious mental illness'' as 
     an illness affecting individuals 18 years of age or older as 
     having, at any time in the past year, a diagnosable mental, 
     behavioral, or emotional disorder that results in serious 
     functional impairment and substantially interferes with or 
     limits one or more major life activities.
       (3) In reporting on the incidence of serious mental 
     illness, the Substance Abuse and Mental Health Services 
     Administration includes major depression, schizophrenia, 
     bipolar disorder, and other mental disorders that cause 
     serious impairment.
       (4) Adults with a serious mental illness are at a higher 
     risk for chronic physical illnesses and premature death.
       (5) According to the World Health Organization, adults with 
     a serious mental illness have lifespans that are 10 to 25 
     years shorter than those without serious mental illness. The 
     vast majority of these deaths are due to chronic physical 
     medical conditions, such as cardiovascular, respiratory, and 
     infectious diseases, as well as diabetes and hypertension.
       (6) According to the World Health Organization, the 
     majority of deaths of adults with a serious mental illness 
     that are due to physical medical conditions are preventable.
       (7) Supported decision making can facilitate care decisions 
     in areas where serious mental illness may impact the capacity 
     of an individual to determine a course of treatment while 
     still allowing the individual to make decisions 
     independently.
       (8) Help should be provided to adults with a serious mental 
     illness to address their acute or chronic physical illnesses, 
     make informed choices about treatment, and understand and 
     follow through with appropriate treatment.

[[Page H6960]]

       (9) There is confusion in the health care community 
     regarding permissible practices under the regulations 
     promulgated under the Health Insurance Portability and 
     Accountability Act of 1996 (commonly known as ``HIPAA''). 
     This confusion may hinder appropriate communication of health 
     care information or treatment preferences with appropriate 
     caregivers.
       (b) Sense of Congress.--It is the sense of Congress that 
     clarification is needed regarding the privacy rule 
     promulgated under section 264(c) of the Health Insurance 
     Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 
     note) regarding existing permitted uses and disclosures of 
     health information by health care professionals to 
     communicate with caregivers of adults with a serious mental 
     illness to facilitate treatment.

     SEC. 11002. CONFIDENTIALITY OF RECORDS.

       Not later than 1 year after the date on which the Secretary 
     of Health and Human Services (in this title referred to as 
     the ``Secretary'') first finalizes regulations updating part 
     2 of title 42, Code of Federal Regulations, relating to 
     confidentiality of alcohol and drug abuse patient records, 
     after the date of enactment of this Act, the Secretary shall 
     convene relevant stakeholders to determine the effect of such 
     regulations on patient care, health outcomes, and patient 
     privacy.

     SEC. 11003. CLARIFICATION ON PERMITTED USES AND DISCLOSURES 
                   OF PROTECTED HEALTH INFORMATION.

       (a) In General.--The Secretary, acting through the Director 
     of the Office for Civil Rights, shall ensure that health care 
     providers, professionals, patients and their families, and 
     others involved in mental or substance use disorder treatment 
     have adequate, accessible, and easily comprehensible 
     resources relating to appropriate uses and disclosures of 
     protected health information under the regulations 
     promulgated under section 264(c) of the Health Insurance 
     Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 
     note).
       (b) Guidance.--
       (1) Issuance.--In carrying out subsection (a), not later 
     than 1 year after the date of enactment of this section, the 
     Secretary shall issue guidance clarifying the circumstances 
     under which, consistent with regulations promulgated under 
     section 264(c) of the Health Insurance Portability and 
     Accountability Act of 1996, a health care provider or covered 
     entity may use or disclose protected health information.
       (2) Circumstances addressed.--The guidance issued under 
     this section shall address circumstances including those 
     that--
       (A) require the consent of the patient;
       (B) require providing the patient with an opportunity to 
     object;
       (C) are based on the exercise of professional judgment 
     regarding whether the patient would object when the 
     opportunity to object cannot practicably be provided because 
     of the incapacity of the patient or an emergency treatment 
     circumstance; and
       (D) are determined, based on the exercise of professional 
     judgment, to be in the best interest of the patient when the 
     patient is not present or otherwise incapacitated.
       (3) Communication with family members and caregivers.--In 
     addressing the circumstances described in paragraph (2), the 
     guidance issued under this section shall clarify permitted 
     uses or disclosures of protected health information for 
     purposes of--
       (A) communicating with a family member of the patient, 
     caregiver of the patient, or other individual, to the extent 
     that such family member, caregiver, or individual is involved 
     in the care of the patient;
       (B) in the case that the patient is an adult, communicating 
     with a family member of the patient, caregiver of the 
     patient, or other individual involved in the care of the 
     patient;
       (C) in the case that the patient is a minor, communicating 
     with the parent or caregiver of the patient;
       (D) involving the family members or caregivers of the 
     patient, or others involved in the patient's care or care 
     plan, including facilitating treatment and medication 
     adherence;
       (E) listening to the patient, or receiving information with 
     respect to the patient from the family or caregiver of the 
     patient;
       (F) communicating with family members of the patient, 
     caregivers of the patient, law enforcement, or others when 
     the patient presents a serious and imminent threat of harm to 
     self or others; and
       (G) communicating to law enforcement and family members or 
     caregivers of the patient about the admission of the patient 
     to receive care at, or the release of a patient from, a 
     facility for an emergency psychiatric hold or involuntary 
     treatment.

     SEC. 11004. DEVELOPMENT AND DISSEMINATION OF MODEL TRAINING 
                   PROGRAMS.

       (a) Initial Programs and Materials.--Not later than 1 year 
     after the date of the enactment of this Act, the Secretary, 
     in consultation with appropriate experts, shall identify the 
     following model programs and materials, or (in the case that 
     no such programs or materials exist) recognize private or 
     public entities to develop and disseminate each of the 
     following:
       (1) Model programs and materials for training health care 
     providers (including physicians, emergency medical personnel, 
     psychiatrists, including child and adolescent psychiatrists, 
     psychologists, counselors, therapists, nurse practitioners, 
     physician assistants, behavioral health facilities and 
     clinics, care managers, and hospitals, including individuals 
     such as general counsels or regulatory compliance staff who 
     are responsible for establishing provider privacy policies) 
     regarding the permitted uses and disclosures, consistent with 
     the standards governing the privacy and security of 
     individually identifiable health information promulgated by 
     the Secretary under part C of title XI of the Social Security 
     Act (42 U.S.C. 1320d et seq.) and regulations promulgated 
     under section 264(c) of the Health Insurance Portability and 
     Accountability Act of 1996 (42 U.S.C. 1320d-2 note) and such 
     part C, of the protected health information of patients 
     seeking or undergoing mental or substance use disorder 
     treatment.
       (2) A model program and materials for training patients and 
     their families regarding their rights to protect and obtain 
     information under the standards and regulations specified in 
     paragraph (1).
       (b) Periodic Updates.--The Secretary shall--
       (1) periodically review and update the model programs and 
     materials identified or developed under subsection (a); and
       (2) disseminate the updated model programs and materials to 
     the individuals described in subsection (a).
       (c) Coordination.--The Secretary shall carry out this 
     section in coordination with the Director of the Office for 
     Civil Rights within the Department of Health and Human 
     Services, the Assistant Secretary for Mental Health and 
     Substance Use, the Administrator of the Health Resources and 
     Services Administration, and the heads of other relevant 
     agencies within the Department of Health and Human Services.
       (d) Input of Certain Entities.--In identifying, reviewing, 
     or updating the model programs and materials under 
     subsections (a) and (b), the Secretary shall solicit the 
     input of relevant national, State, and local associations; 
     medical societies; licensing boards; providers of mental and 
     substance use disorder treatment; organizations with 
     expertise on domestic violence, sexual assault, elder abuse, 
     and child abuse; and organizations representing patients and 
     consumers and the families of patients and consumers.
       (e) Funding.--There are authorized to be appropriated to 
     carry out this section--
       (1) $4,000,000 for fiscal year 2018;
       (2) $2,000,000 for each of fiscal years 2019 and 2020; and
       (3) $1,000,000 for each of fiscal years 2021 and 2022.

               TITLE XII--MEDICAID MENTAL HEALTH COVERAGE

     SEC. 12001. RULE OF CONSTRUCTION RELATED TO MEDICAID COVERAGE 
                   OF MENTAL HEALTH SERVICES AND PRIMARY CARE 
                   SERVICES FURNISHED ON THE SAME DAY.

       Nothing in title XIX of the Social Security Act (42 U.S.C. 
     1396 et seq.) shall be construed as prohibiting separate 
     payment under the State plan under such title (or under a 
     waiver of the plan) for the provision of a mental health 
     service or primary care service under such plan, with respect 
     to an individual, because such service is--
       (1) a primary care service furnished to the individual by a 
     provider at a facility on the same day a mental health 
     service is furnished to such individual by such provider (or 
     another provider) at the facility; or
       (2) a mental health service furnished to the individual by 
     a provider at a facility on the same day a primary care 
     service is furnished to such individual by such provider (or 
     another provider) at the facility.

     SEC. 12002. STUDY AND REPORT RELATED TO MEDICAID MANAGED CARE 
                   REGULATION.

       (a) Study.--The Secretary of Health and Human Services, 
     acting through the Administrator of the Centers for Medicare 
     & Medicaid Services, shall conduct a study on coverage under 
     the Medicaid program under title XIX of the Social Security 
     Act (42 U.S.C. 1396 et seq.) of services provided through a 
     medicaid managed care organization (as defined in section 
     1903(m) of such Act (42 U.S.C. 1396b(m)) or a prepaid 
     inpatient health plan (as defined in section 438.2 of title 
     42, Code of Federal Regulations (or any successor 
     regulation)) with respect to individuals over the age of 21 
     and under the age of 65 for the treatment of a mental health 
     disorder in institutions for mental diseases (as defined in 
     section 1905(i) of such Act (42 U.S.C. 1396d(i))). Such study 
     shall include information on the following:
       (1) The extent to which States, including the District of 
     Columbia and each territory or possession of the United 
     States, are providing capitated payments to such 
     organizations or plans for enrollees who are receiving 
     services in institutions for mental diseases.
       (2) The number of individuals receiving medical assistance 
     under a State plan under such title XIX, or a waiver of such 
     plan, who receive services in institutions for mental 
     diseases through such organizations and plans.
       (3) The range of and average number of months, and the 
     length of stay during such months, that such individuals are 
     receiving such services in such institutions.
       (4) How such organizations or plans determine when to 
     provide for the furnishing of such services through an 
     institution for mental diseases in lieu of other benefits 
     (including the full range of community-based services) under 
     their contract with the State agency administering the State 
     plan under such title XIX, or a waiver of such plan, to 
     address psychiatric or substance use disorder treatment.
       (5) The extent to which the provision of services within 
     such institutions has affected the capitated payments for 
     such organizations or plans.
       (b) Report.--Not later than 3 years after the date of the 
     enactment of this Act, the Secretary shall submit to Congress 
     a report on the study conducted under subsection (a).

     SEC. 12003. GUIDANCE ON OPPORTUNITIES FOR INNOVATION.

       Not later than 1 year after the date of the enactment of 
     this Act, the Administrator of the Centers for Medicare & 
     Medicaid Services shall issue a State Medicaid Director 
     letter regarding opportunities to design innovative service 
     delivery systems, including systems for providing

[[Page H6961]]

     community-based services, for adults with a serious mental 
     illness or children with a serious emotional disturbance who 
     are receiving medical assistance under title XIX of the 
     Social Security Act (42 U.S.C. 1396 et seq.). The letter 
     shall include opportunities for demonstration projects under 
     section 1115 of such Act (42 U.S.C. 1315) to improve care for 
     such adults and children.

     SEC. 12004. STUDY AND REPORT ON MEDICAID EMERGENCY 
                   PSYCHIATRIC DEMONSTRATION PROJECT.

       (a) Collection of Information.--The Secretary of Health and 
     Human Services, acting through the Administrator of the 
     Centers for Medicare & Medicaid Services, shall, to the 
     extent practical and data is available, with respect to each 
     State that has participated in the demonstration project 
     established under section 2707 of the Patient Protection and 
     Affordable Care Act (42 U.S.C. 1396a note), collect from each 
     such State information on the following:
       (1) The number of institutions for mental diseases (as 
     defined in section 1905(i) of the Social Security Act (42 
     U.S.C. 1396d(i))) and beds in such institutions that received 
     payment for the provision of services to individuals who 
     receive medical assistance under a State plan under the 
     Medicaid program under title XIX of the Social Security Act 
     (42 U.S.C. 1396 et seq.) (or under a waiver of such plan) 
     through the demonstration project in each such State as 
     compared to the total number of institutions for mental 
     diseases and beds in the State.
       (2) The extent to which there is a reduction in 
     expenditures under the Medicaid program under title XIX of 
     the Social Security Act (42 U.S.C. 1396 et seq.) or other 
     spending on the full continuum of physical or mental health 
     care for individuals who receive treatment in an institution 
     for mental diseases under the demonstration project, 
     including outpatient, inpatient, emergency, and ambulatory 
     care, that is attributable to such individuals receiving 
     treatment in institutions for mental diseases under the 
     demonstration project.
       (3) The number of forensic psychiatric hospitals, the 
     number of beds in such hospitals, and the number of forensic 
     psychiatric beds in other hospitals in such State, based on 
     the most recent data available, to the extent practical, as 
     determined by such Administrator.
       (4) The amount of any disproportionate share hospital 
     payments under section 1923 of the Social Security Act (42 
     U.S.C. 1396r-4) that institutions for mental diseases in the 
     State received during the period beginning on July 1, 2012, 
     and ending on June 30, 2015, and the extent to which the 
     demonstration project reduced the amount of such payments.
       (5) The most recent data regarding all facilities or sites 
     in the State in which any adults with a serious mental 
     illness who are receiving medical assistance under a State 
     plan under the Medicaid program under title XIX of the Social 
     Security Act (42 U.S.C. 1396 et seq.) (or under a waiver of 
     such plan) are treated during the period referred to in 
     paragraph (4), to the extent practical, as determined by the 
     Administrator, including--
       (A) the types of such facilities or sites (such as an 
     institution for mental diseases, a hospital emergency 
     department, or other inpatient hospital);
       (B) the average length of stay in such a facility or site 
     by such an individual, disaggregated by facility type; and
       (C) the payment rate under the State plan (or a waivers of 
     such plan) for services furnished to such an individual for 
     that treatment, disaggregated by facility type, during the 
     period in which the demonstration project is in operation.
       (6) The extent to which the utilization of hospital 
     emergency departments during the period in which the 
     demonstration project was is in operation differed, with 
     respect to individuals who are receiving medical assistance 
     under a State plan under the Medicaid program under title XIX 
     of the Social Security Act (42 U.S.C. 1396 et seq.) (or under 
     a waiver of such plan), between--
       (A) those individuals who received treatment in an 
     institution for mental diseases under the demonstration 
     project;
       (B) those individuals who met the eligibility requirements 
     for the demonstration project but who did not receive 
     treatment in an institution for mental diseases under the 
     demonstration project; and
       (C) those adults with a serious mental illness who did not 
     meet such eligibility requirements and did not receive 
     treatment for such illness in an institution for mental 
     diseases.
       (b) Report.--Not later than 2 years after the date of the 
     enactment of this Act, the Secretary of Health and Human 
     Services shall submit to Congress a report that summarizes 
     and analyzes the information collected under subsection (a). 
     Such report may be submitted as part of the report required 
     under section 2707(f) of the Patient Protection and 
     Affordable Care Act (42 U.S.C. 1396a note) or separately.

     SEC. 12005. PROVIDING EPSDT SERVICES TO CHILDREN IN IMDS.

       (a) In General.--Section 1905(a)(16) of the Social Security 
     Act (42 U.S.C. 1396d(a)(16)) is amended--
       (1) by striking ``effective January 1, 1973'' and inserting 
     ``(A) effective January 1, 1973''; and
       (2) by inserting before the semicolon at the end the 
     following: ``, and, (B) for individuals receiving services 
     described in subparagraph (A), early and periodic screening, 
     diagnostic, and treatment services (as defined in subsection 
     (r)), whether or not such screening, diagnostic, and 
     treatment services are furnished by the provider of the 
     services described in such subparagraph''.
       (b) Effective Date.--The amendments made by subsection (a) 
     shall apply with respect to items and services furnished in 
     calendar quarters beginning on or after January 1, 2019.

     SEC. 12006. ELECTRONIC VISIT VERIFICATION SYSTEM REQUIRED FOR 
                   PERSONAL CARE SERVICES AND HOME HEALTH CARE 
                   SERVICES UNDER MEDICAID.

       (a) In General.--Section 1903 of the Social Security Act 
     (42 U.S.C. 1396b) is amended by inserting after subsection 
     (k) the following new subsection:
       ``(l)(1) Subject to paragraphs (3) and (4), with respect to 
     any amount expended for personal care services or home health 
     care services requiring an in-home visit by a provider that 
     are provided under a State plan under this title (or under a 
     waiver of the plan) and furnished in a calendar quarter 
     beginning on or after January 1, 2019 (or, in the case of 
     home health care services, on or after January 1, 2023), 
     unless a State requires the use of an electronic visit 
     verification system for such services furnished in such 
     quarter under the plan or such waiver, the Federal medical 
     assistance percentage shall be reduced--
       ``(A) in the case of personal care services--
       ``(i) for calendar quarters in 2019 and 2020, by .25 
     percentage points;
       ``(ii) for calendar quarters in 2021, by .5 percentage 
     points;
       ``(iii) for calendar quarters in 2022, by .75 percentage 
     points; and
       ``(iv) for calendar quarters in 2023 and each year 
     thereafter, by 1 percentage point; and
       ``(B) in the case of home health care services--
       ``(i) for calendar quarters in 2023 and 2024, by .25 
     percentage points;
       ``(ii) for calendar quarters in 2025, by .5 percentage 
     points;
       ``(iii) for calendar quarters in 2026, by .75 percentage 
     points; and
       ``(iv) for calendar quarters in 2027 and each year 
     thereafter, by 1 percentage point.
       ``(2) Subject to paragraphs (3) and (4), in implementing 
     the requirement for the use of an electronic visit 
     verification system under paragraph (1), a State shall--
       ``(A) consult with agencies and entities that provide 
     personal care services, home health care services, or both 
     under the State plan (or under a waiver of the plan) to 
     ensure that such system--
       ``(i) is minimally burdensome;
       ``(ii) takes into account existing best practices and 
     electronic visit verification systems in use in the State; 
     and
       ``(iii) is conducted in accordance with the requirements of 
     HIPAA privacy and security law (as defined in section 3009 of 
     the Public Health Service Act);
       ``(B) take into account a stakeholder process that includes 
     input from beneficiaries, family caregivers, individuals who 
     furnish personal care services or home health care services, 
     and other stakeholders, as determined by the State in 
     accordance with guidance from the Secretary; and
       ``(C) ensure that individuals who furnish personal care 
     services, home health care services, or both under the State 
     plan (or under a waiver of the plan) are provided the 
     opportunity for training on the use of such system.
       ``(3) Paragraphs (1) and (2) shall not apply in the case of 
     a State that, as of the date of the enactment of this 
     subsection, requires the use of any system for the electronic 
     verification of visits conducted as part of both personal 
     care services and home health care services, so long as the 
     State continues to require the use of such system with 
     respect to the electronic verification of such visits.
       ``(4)(A) In the case of a State described in subparagraph 
     (B), the reduction under paragraph (1) shall not apply--
       ``(i) in the case of personal care services, for calendar 
     quarters in 2019; and
       ``(ii) in the case of home health care services, for 
     calendar quarters in 2023.
       ``(B) For purposes of subparagraph (A), a State described 
     in this subparagraph is a State that demonstrates to the 
     Secretary that the State--
       ``(i) has made a good faith effort to comply with the 
     requirements of paragraphs (1) and (2) (including by taking 
     steps to adopt the technology used for an electronic visit 
     verification system); and
       ``(ii) in implementing such a system, has encountered 
     unavoidable system delays.
       ``(5) In this subsection:
       ``(A) The term `electronic visit verification system' 
     means, with respect to personal care services or home health 
     care services, a system under which visits conducted as part 
     of such services are electronically verified with respect 
     to--
       ``(i) the type of service performed;
       ``(ii) the individual receiving the service;
       ``(iii) the date of the service;
       ``(iv) the location of service delivery;
       ``(v) the individual providing the service; and
       ``(vi) the time the service begins and ends.
       ``(B) The term `home health care services' means services 
     described in section 1905(a)(7) provided under a State plan 
     under this title (or under a waiver of the plan).
       ``(C) The term `personal care services' means personal care 
     services provided under a State plan under this title (or 
     under a waiver of the plan), including services provided 
     under section 1905(a)(24), 1915(c), 1915(i), 1915(j), or 
     1915(k) or under a wavier under section 1115.
       ``(6)(A) In the case in which a State requires personal 
     care service and home health care service providers to 
     utilize an electronic visit verification system operated by 
     the State or a contractor on behalf of the State, the 
     Secretary shall pay to the State, for each quarter, an amount 
     equal to 90 per centum of so much of the sums expended during 
     such quarter as are attributable to the design, development, 
     or installation of such system, and 75 per centum of so much 
     of the sums for the operation and maintenance of such system.
       ``(B) Subparagraph (A) shall not apply in the case in which 
     a State requires personal care service and home health care 
     service providers

[[Page H6962]]

     to utilize an electronic visit verification system that is 
     not operated by the State or a contractor on behalf of the 
     State.''.
       (b) Collection and Dissemination of Best Practices.--Not 
     later than January 1, 2018, the Secretary of Health and Human 
     Services shall, with respect to electronic visit verification 
     systems (as defined in subsection (l)(5) of section 1903 of 
     the Social Security Act (42 U.S.C. 1396b), as inserted by 
     subsection (a)), collect and disseminate best practices to 
     State Medicaid Directors with respect to--
       (1) training individuals who furnish personal care 
     services, home health care services, or both under the State 
     plan under title XIX of such Act (or under a waiver of the 
     plan) on such systems and the operation of such systems and 
     the prevention of fraud with respect to the provision of 
     personal care services or home health care services (as 
     defined in such subsection (l)(5)); and
       (2) the provision of notice and educational materials to 
     family caregivers and beneficiaries with respect to the use 
     of such electronic visit verification systems and other means 
     to prevent such fraud.
       (c) Rules of Construction.--
       (1) No employer-employee relationship established.--Nothing 
     in the amendment made by this section may be construed as 
     establishing an employer-employee relationship between the 
     agency or entity that provides for personal care services or 
     home health care services and the individuals who, under a 
     contract with such an agency or entity, furnish such services 
     for purposes of part 552 of title 29, Code of Federal 
     Regulations (or any successor regulations).
       (2) No particular or uniform electronic visit verification 
     system required.--Nothing in the amendment made by this 
     section shall be construed to require the use of a particular 
     or uniform electronic visit verification system (as defined 
     in subsection (l)(5) of section 1903 of the Social Security 
     Act (42 U.S.C. 1396b), as inserted by subsection (a)) by all 
     agencies or entities that provide personal care services or 
     home health care under a State plan under title XIX of the 
     Social Security Act (or under a waiver of the plan) (42 
     U.S.C. 1396 et seq.).
       (3) No limits on provision of care.--Nothing in the 
     amendment made by this section may be construed to limit, 
     with respect to personal care services or home health care 
     services provided under a State plan under title XIX of the 
     Social Security Act (or under a waiver of the plan) (42 
     U.S.C. 1396 et seq.), provider selection, constrain 
     beneficiaries' selection of a caregiver, or impede the manner 
     in which care is delivered.
       (4) No prohibition on state quality measures 
     requirements.--Nothing in the amendment made by this section 
     shall be construed as prohibiting a State, in implementing an 
     electronic visit verification system (as defined in 
     subsection (l)(5) of section 1903 of the Social Security Act 
     (42 U.S.C. 1396b), as inserted by subsection (a)), from 
     establishing requirements related to quality measures for 
     such system.

                    TITLE XIII--MENTAL HEALTH PARITY

     SEC. 13001. ENHANCED COMPLIANCE WITH MENTAL HEALTH AND 
                   SUBSTANCE USE DISORDER COVERAGE REQUIREMENTS.

       (a) Compliance Program Guidance Document.--Section 2726(a) 
     of the Public Health Service Act (42 U.S.C. 300gg-26(a)) is 
     amended by adding at the end the following:
       ``(6) Compliance program guidance document.--
       ``(A) In general.--Not later than 12 months after the date 
     of enactment of the Helping Families in Mental Health Crisis 
     Reform Act of 2016, the Secretary, the Secretary of Labor, 
     and the Secretary of the Treasury, in consultation with the 
     Inspector General of the Department of Health and Human 
     Services, the Inspector General of the Department of Labor, 
     and the Inspector General of the Department of the Treasury, 
     shall issue a compliance program guidance document to help 
     improve compliance with this section, section 712 of the 
     Employee Retirement Income Security Act of 1974, and section 
     9812 of the Internal Revenue Code of 1986, as applicable. In 
     carrying out this paragraph, the Secretaries may take into 
     consideration the 2016 publication of the Department of 
     Health and Human Services and the Department of Labor, 
     entitled `Warning Signs - Plan or Policy Non-Quantitative 
     Treatment Limitations (NQTLs) that Require Additional 
     Analysis to Determine Mental Health Parity Compliance'.
       ``(B) Examples illustrating compliance and noncompliance.--
       ``(i) In general.--The compliance program guidance document 
     required under this paragraph shall provide illustrative, de-
     identified examples (that do not disclose any protected 
     health information or individually identifiable information) 
     of previous findings of compliance and noncompliance with 
     this section, section 712 of the Employee Retirement Income 
     Security Act of 1974, or section 9812 of the Internal Revenue 
     Code of 1986, as applicable, based on investigations of 
     violations of such sections, including--

       ``(I) examples illustrating requirements for information 
     disclosures and nonquantitative treatment limitations; and
       ``(II) descriptions of the violations uncovered during the 
     course of such investigations.

       ``(ii) Nonquantitative treatment limitations.--To the 
     extent that any example described in clause (i) involves a 
     finding of compliance or noncompliance with regard to any 
     requirement for nonquantitative treatment limitations, the 
     example shall provide sufficient detail to fully explain such 
     finding, including a full description of the criteria 
     involved for approving medical and surgical benefits and the 
     criteria involved for approving mental health and substance 
     use disorder benefits.
       ``(iii) Access to additional information regarding 
     compliance.--In developing and issuing the compliance program 
     guidance document required under this paragraph, the 
     Secretaries specified in subparagraph (A)--

       ``(I) shall enter into interagency agreements with the 
     Inspector General of the Department of Health and Human 
     Services, the Inspector General of the Department of Labor, 
     and the Inspector General of the Department of the Treasury 
     to share findings of compliance and noncompliance with this 
     section, section 712 of the Employee Retirement Income 
     Security Act of 1974, or section 9812 of the Internal Revenue 
     Code of 1986, as applicable; and
       ``(II) shall seek to enter into an agreement with a State 
     to share information on findings of compliance and 
     noncompliance with this section, section 712 of the Employee 
     Retirement Income Security Act of 1974, or section 9812 of 
     the Internal Revenue Code of 1986, as applicable.

       ``(C) Recommendations.--The compliance program guidance 
     document shall include recommendations to advance compliance 
     with this section, section 712 of the Employee Retirement 
     Income Security Act of 1974, or section 9812 of the Internal 
     Revenue Code of 1986, as applicable, and encourage the 
     development and use of internal controls to monitor adherence 
     to applicable statutes, regulations, and program 
     requirements. Such internal controls may include illustrative 
     examples of nonquantitative treatment limitations on mental 
     health and substance use disorder benefits, which may fail to 
     comply with this section, section 712 of the Employee 
     Retirement Income Security Act of 1974, or section 9812 of 
     the Internal Revenue Code of 1986, as applicable, in relation 
     to nonquantitative treatment limitations on medical and 
     surgical benefits.
       ``(D) Updating the compliance program guidance document.--
     The Secretary, the Secretary of Labor, and the Secretary of 
     the Treasury, in consultation with the Inspector General of 
     the Department of Health and Human Services, the Inspector 
     General of the Department of Labor, and the Inspector General 
     of the Department of the Treasury, shall update the 
     compliance program guidance document every 2 years to include 
     illustrative, de-identified examples (that do not disclose 
     any protected health information or individually identifiable 
     information) of previous findings of compliance and 
     noncompliance with this section, section 712 of the Employee 
     Retirement Income Security Act of 1974, or section 9812 of 
     the Internal Revenue Code of 1986, as applicable.''.
       (b) Additional Guidance.--Section 2726(a) of the Public 
     Health Service Act (42 U.S.C. 300gg-26(a)), as amended by 
     subsection (a), is further amended by adding at the end the 
     following:
       ``(7) Additional guidance.--
       ``(A) In general.--Not later than 12 months after the date 
     of enactment of the Helping Families in Mental Health Crisis 
     Reform Act of 2016, the Secretary, the Secretary of Labor, 
     and the Secretary of the Treasury shall issue guidance to 
     group health plans and health insurance issuers offering 
     group or individual health insurance coverage to assist such 
     plans and issuers in satisfying the requirements of this 
     section, section 712 of the Employee Retirement Income 
     Security Act of 1974, or section 9812 of the Internal Revenue 
     Code of 1986, as applicable.
       ``(B) Disclosure.--
       ``(i) Guidance for plans and issuers.--The guidance issued 
     under this paragraph shall include clarifying information and 
     illustrative examples of methods that group health plans and 
     health insurance issuers offering group or individual health 
     insurance coverage may use for disclosing information to 
     ensure compliance with the requirements under this section, 
     section 712 of the Employee Retirement Income Security Act of 
     1974, or section 9812 of the Internal Revenue Code of 1986, 
     as applicable, (and any regulations promulgated pursuant to 
     such sections, as applicable).
       ``(ii) Documents for participants, beneficiaries, 
     contracting providers, or authorized representatives.--The 
     guidance issued under this paragraph shall include clarifying 
     information and illustrative examples of methods that group 
     health plans and health insurance issuers offering group or 
     individual health insurance coverage may use to provide any 
     participant, beneficiary, contracting provider, or authorized 
     representative, as applicable, with documents containing 
     information that the health plans or issuers are required to 
     disclose to participants, beneficiaries, contracting 
     providers, or authorized representatives to ensure compliance 
     with this section, section 712 of the Employee Retirement 
     Income Security Act of 1974, or section 9812 of the Internal 
     Revenue Code of 1986, as applicable, compliance with any 
     regulation issued pursuant to such respective section, or 
     compliance with any other applicable law or regulation. Such 
     guidance shall include information that is comparative in 
     nature with respect to--

       ``(I) nonquantitative treatment limitations for both 
     medical and surgical benefits and mental health and substance 
     use disorder benefits;
       ``(II) the processes, strategies, evidentiary standards, 
     and other factors used to apply the limitations described in 
     subclause (I); and
       ``(III) the application of the limitations described in 
     subclause (I) to ensure that such limitations are applied in 
     parity with respect to both medical and surgical benefits and 
     mental health and substance use disorder benefits.

       ``(C) Nonquantitative treatment limitations.--The guidance 
     issued under this paragraph shall include clarifying 
     information and illustrative examples of methods, processes, 
     strategies, evidentiary standards, and other factors that 
     group health plans and health insurance issuers offering 
     group or individual health insurance coverage may use 
     regarding the development and application of nonquantitative 
     treatment limitations to ensure compliance with this section, 
     section 712 of the Employee Retirement Income Security Act of 
     1974, or section 9812

[[Page H6963]]

     of the Internal Revenue Code of 1986, as applicable, (and any 
     regulations promulgated pursuant to such respective section), 
     including--
       ``(i) examples of methods of determining appropriate types 
     of nonquantitative treatment limitations with respect to both 
     medical and surgical benefits and mental health and substance 
     use disorder benefits, including nonquantitative treatment 
     limitations pertaining to--

       ``(I) medical management standards based on medical 
     necessity or appropriateness, or whether a treatment is 
     experimental or investigative;
       ``(II) limitations with respect to prescription drug 
     formulary design; and
       ``(III) use of fail-first or step therapy protocols;

       ``(ii) examples of methods of determining--

       ``(I) network admission standards (such as credentialing); 
     and
       ``(II) factors used in provider reimbursement methodologies 
     (such as service type, geographic market, demand for 
     services, and provider supply, practice size, training, 
     experience, and licensure) as such factors apply to network 
     adequacy;

       ``(iii) examples of sources of information that may serve 
     as evidentiary standards for the purposes of making 
     determinations regarding the development and application of 
     nonquantitative treatment limitations;
       ``(iv) examples of specific factors, and the evidentiary 
     standards used to evaluate such factors, used by such plans 
     or issuers in performing a nonquantitative treatment 
     limitation analysis;
       ``(v) examples of how specific evidentiary standards may be 
     used to determine whether treatments are considered 
     experimental or investigative;
       ``(vi) examples of how specific evidentiary standards may 
     be applied to each service category or classification of 
     benefits;
       ``(vii) examples of methods of reaching appropriate 
     coverage determinations for new mental health or substance 
     use disorder treatments, such as evidence-based early 
     intervention programs for individuals with a serious mental 
     illness and types of medical management techniques;
       ``(viii) examples of methods of reaching appropriate 
     coverage determinations for which there is an indirect 
     relationship between the covered mental health or substance 
     use disorder benefit and a traditional covered medical and 
     surgical benefit, such as residential treatment or 
     hospitalizations involving voluntary or involuntary 
     commitment; and
       ``(ix) additional illustrative examples of methods, 
     processes, strategies, evidentiary standards, and other 
     factors for which the Secretary determines that additional 
     guidance is necessary to improve compliance with this 
     section, section 712 of the Employee Retirement Income 
     Security Act of 1974, or section 9812 of the Internal Revenue 
     Code of 1986, as applicable.
       ``(D) Public comment.--Prior to issuing any final guidance 
     under this paragraph, the Secretary shall provide a public 
     comment period of not less than 60 days during which any 
     member of the public may provide comments on a draft of the 
     guidance.''.
       (c) Availability of Plan Information.--
       (1) Solicitation of public feedback.--Not later than 6 
     months after the date of enactment of this Act, the Secretary 
     of Health and Human Services, the Secretary of Labor, and the 
     Secretary of the Treasury shall solicit feedback from the 
     public on how the disclosure request process for documents 
     containing information that health plans or health insurance 
     issuers are required under Federal or State law to disclose 
     to participants, beneficiaries, contracting providers, or 
     authorized representatives to ensure compliance with existing 
     mental health parity and addiction equity requirements can be 
     improved while continuing to ensure consumers' rights to 
     access all information required by Federal or State law to be 
     disclosed.
       (2) Public availability.--Not later than 12 months after 
     the date of the enactment of this Act, the Secretary of 
     Health and Human Services, the Secretary of Labor, and the 
     Secretary of the Treasury shall make such feedback publicly 
     available.
       (3) NAIC.--The Secretary of Health and Human Services, the 
     Secretary of Labor, and the Secretary of the Treasury shall 
     share feedback obtained pursuant to paragraph (1) directly 
     with the National Association of Insurance Commissioners to 
     the extent such feedback includes recommendations for the 
     development of simplified information disclosure tools to 
     provide consistent information for consumers. Such feedback 
     may be taken into consideration by the National Association 
     of Insurance Commissioners and other appropriate entities for 
     the voluntary development and voluntary use of common 
     templates and other sample standardized forms to improve 
     consumer access to plan information.
       (d) Improving Compliance.--
       (1) In general.--In the case that the Secretary of Health 
     and Human Services, the Secretary of Labor, or the Secretary 
     of the Treasury determines that a group health plan or health 
     insurance issuer offering group or individual health 
     insurance coverage has violated, at least 5 times, section 
     2726 of the Public Health Service Act (42 U.S.C. 300gg-26), 
     section 712 of the Employee Retirement Income Security Act of 
     1974 (29 U.S.C. 1185a), or section 9812 of the Internal 
     Revenue Code of 1986, respectively, the appropriate Secretary 
     shall audit plan documents for such health plan or issuer in 
     the plan year following the Secretary's determination in 
     order to help improve compliance with such section.
       (2) Rule of construction.--Nothing in this subsection shall 
     be construed to limit the authority, as in effect on the day 
     before the date of enactment of this Act, of the Secretary of 
     Health and Human Services, the Secretary of Labor, or the 
     Secretary of the Treasury to audit documents of health plans 
     or health insurance issuers.

     SEC. 13002. ACTION PLAN FOR ENHANCED ENFORCEMENT OF MENTAL 
                   HEALTH AND SUBSTANCE USE DISORDER COVERAGE.

       (a) Public Meeting.--
       (1) In general.--Not later than 6 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall convene a public meeting of stakeholders 
     described in paragraph (2) to produce an action plan for 
     improved Federal and State coordination related to the 
     enforcement of section 2726 of the Public Health Service Act 
     (42 U.S.C. 300gg-26), section 712 of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1185a), and section 
     9812 of the Internal Revenue Code of 1986, and any comparable 
     provisions of State law (in this section such sections and 
     provisions are collectively referred to as ``mental health 
     parity and addiction equity requirements'').
       (2) Stakeholders.--The stakeholders described in this 
     paragraph shall include each of the following:
       (A) The Federal Government, including representatives 
     from--
       (i) the Department of Health and Human Services;
       (ii) the Department of the Treasury;
       (iii) the Department of Labor; and
       (iv) the Department of Justice.
       (B) State governments, including--
       (i) State health insurance commissioners;
       (ii) appropriate State agencies, including agencies on 
     public health or mental health; and
       (iii) State attorneys general or other representatives of 
     State entities involved in the enforcement of mental health 
     parity and addiction equity requirements.
       (C) Representatives from key stakeholder groups, 
     including--
       (i) the National Association of Insurance Commissioners;
       (ii) health insurance issuers;
       (iii) providers of mental health and substance use disorder 
     treatment;
       (iv) employers; and
       (v) patients or their advocates.
       (b) Action Plan.--Not later than 6 months after the 
     conclusion of the public meeting under subsection (a), the 
     Secretary of Health and Human Services shall finalize the 
     action plan described in such subsection and make it plainly 
     available on the Internet website of the Department of Health 
     and Human Services.
       (c) Content.--The action plan under this section shall--
       (1) take into consideration the recommendations of the 
     Mental Health and Substance Use Disorder Parity Task Force in 
     its final report issued in October of 2016, and any 
     subsequent Federal and State actions in relation to such 
     recommendations;
       (2) reflect the input of the stakeholders participating in 
     the public meeting under subsection (a);
       (3) identify specific strategic objectives regarding how 
     the various Federal and State agencies charged with 
     enforcement of mental health parity and addiction equity 
     requirements will collaborate to improve enforcement of such 
     requirements;
       (4) provide a timeline for implementing the action plan; 
     and
       (5) provide specific examples of how such objectives may be 
     met, which may include--
       (A) providing common educational information and documents, 
     such as the Consumer Guide to Disclosure Rights, to patients 
     about their rights under mental health parity and addiction 
     equity requirements;
       (B) facilitating the centralized collection of, monitoring 
     of, and response to patient complaints or inquiries relating 
     to mental health parity and addiction equity requirements, 
     which may be through the development and administration of--
       (i) a single, toll-free telephone number; and
       (ii) a new parity website--

       (I) to help consumers find the appropriate Federal or State 
     agency to assist with their parity complaints, appeals, and 
     other actions; and
       (II) that takes into consideration, but is not duplicative 
     of, the parity beta site being tested, and released for 
     public comment, by the Department of Health and Human 
     Services as of the date of the enactment of this Act;

       (C) Federal and State law enforcement agencies entering 
     into memoranda of understanding to better coordinate 
     enforcement responsibilities and information sharing--
       (i) including whether such agencies should make the results 
     of enforcement actions related to mental health parity and 
     addiction equity requirements publicly available; and
       (ii) which may include State Policy Academies on Parity 
     Implementation for State Officials and other forums to bring 
     together national experts to provide technical assistance to 
     teams of State officials on strategies to advance compliance 
     with mental health parity and addiction equity requirements 
     in both the commercial market, and in the Medicaid program 
     under title XIX of the Social Security Act and the State 
     Children's Health Insurance Program under title XXI of such 
     Act; and
       (D) recommendations to the Congress regarding the need for 
     additional legal authority to improve enforcement of mental 
     health parity and addiction equity requirements, including 
     the need for additional legal authority to ensure that 
     nonquantitative treatment limitations are applied, and the 
     extent and frequency of the applications of such limitations, 
     both to medical and surgical benefits and to mental health 
     and substance use disorder benefits in a comparable manner.

     SEC. 13003. REPORT ON INVESTIGATIONS REGARDING PARITY IN 
                   MENTAL HEALTH AND SUBSTANCE USE DISORDER 
                   BENEFITS.

       (a) In General.--Not later than 1 year after the date of 
     enactment of this Act, and annually

[[Page H6964]]

     thereafter for the subsequent 5 years, the Assistant 
     Secretary of Labor of the Employee Benefits Security 
     Administration, in collaboration with the Administrator of 
     the Centers for Medicare & Medicaid Services and the 
     Secretary of the Treasury, shall submit to the Committee on 
     Energy and Commerce of the House of Representatives and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate a report summarizing the results of all closed Federal 
     investigations completed during the preceding 12-month period 
     with findings of any serious violation regarding compliance 
     with mental health and substance use disorder coverage 
     requirements under section 2726 of the Public Health Service 
     Act (42 U.S.C. 300gg-26), section 712 of the Employee 
     Retirement Income Security Act of 1974 (29 U.S.C. 1185a), and 
     section 9812 of the Internal Revenue Code of 1986.
       (b) Contents.--Subject to subsection (c), a report under 
     subsection (a) shall, with respect to investigations 
     described in such subsection, include each of the following:
       (1) The number of closed Federal investigations conducted 
     during the covered reporting period.
       (2) Each benefit classification examined by any such 
     investigation conducted during the covered reporting period.
       (3) Each subject matter, including compliance with 
     requirements for quantitative and nonquantitative treatment 
     limitations, of any such investigation conducted during the 
     covered reporting period.
       (4) A summary of the basis of the final decision rendered 
     for each closed investigation conducted during the covered 
     reporting period that resulted in a finding of a serious 
     violation.
       (c) Limitation.--Any individually identifiable information 
     shall be excluded from reports under subsection (a) 
     consistent with protections under the health privacy and 
     security rules promulgated under section 264(c) of the Health 
     Insurance Portability and Accountability Act of 1996 (42 
     U.S.C. 1320d-2 note).

     SEC. 13004. GAO STUDY ON PARITY IN MENTAL HEALTH AND 
                   SUBSTANCE USE DISORDER BENEFITS.

       Not later than 3 years after the date of enactment of this 
     Act, the Comptroller General of the United States, in 
     consultation with the Secretary of Health and Human Services, 
     the Secretary of Labor, and the Secretary of the Treasury, 
     shall submit to the Committee on Energy and Commerce of the 
     House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate a report 
     detailing the extent to which group health plans or health 
     insurance issuers offering group or individual health 
     insurance coverage that provides both medical and surgical 
     benefits and mental health or substance use disorder 
     benefits, medicaid managed care organizations with a contract 
     under section 1903(m) of the Social Security Act (42 U.S.C. 
     1396b(m)), and health plans provided under the State 
     Children's Health Insurance Program under title XXI of the 
     Social Security Act (42 U.S.C. 1397aa et seq.) comply with 
     section 2726 of the Public Health Service Act (42 U.S.C. 
     300gg-26), section 712 of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1185a), and section 9812 of 
     the Internal Revenue Code of 1986, including--
       (1) how nonquantitative treatment limitations, including 
     medical necessity criteria, of such plans or issuers comply 
     with such sections;
       (2) how the responsible Federal departments and agencies 
     ensure that such plans or issuers comply with such sections, 
     including an assessment of how the Secretary of Health and 
     Human Services has used its authority to conduct audits of 
     such plans to ensure compliance;
       (3) a review of how the various Federal and State agencies 
     responsible for enforcing mental health parity requirements 
     have improved enforcement of such requirements in accordance 
     with the objectives and timeline described in the action plan 
     under section 13002; and
       (4) recommendations for how additional enforcement, 
     education, and coordination activities by responsible Federal 
     and State departments and agencies could better ensure 
     compliance with such sections, including recommendations 
     regarding the need for additional legal authority.

     SEC. 13005. INFORMATION AND AWARENESS ON EATING DISORDERS.

       (a) Information.--The Secretary of Health and Human 
     Services, acting through the Director of the Office on 
     Women's Health, may--
       (1) update information, related fact sheets, and resource 
     lists related to eating disorders that are available on the 
     public Internet website of the National Women's Health 
     Information Center sponsored by the Office on Women's Health, 
     to include--
       (A) updated findings and current research related to eating 
     disorders, as appropriate; and
       (B) information about eating disorders, including 
     information related to males and females;
       (2) incorporate, as appropriate, and in coordination with 
     the Secretary of Education, information from publicly 
     available resources into appropriate obesity prevention 
     programs developed by the Office on Women's Health; and
       (3) make publicly available (through a public Internet 
     website or other method) information, related fact sheets, 
     and resource lists, as updated under paragraph (1), and the 
     information incorporated into appropriate obesity prevention 
     programs under paragraph (2).
       (b) Awareness.--The Secretary of Health and Human Services 
     may advance public awareness on--
       (1) the types of eating disorders;
       (2) the seriousness of eating disorders, including 
     prevalence, comorbidities, and physical and mental health 
     consequences;
       (3) methods to identify, intervene, refer for treatment, 
     and prevent behaviors that may lead to the development of 
     eating disorders;
       (4) discrimination and bullying based on body size;
       (5) the effects of media on self-esteem and body image; and
       (6) the signs and symptoms of eating disorders.

     SEC. 13006. EDUCATION AND TRAINING ON EATING DISORDERS.

       The Secretary of Health and Human Services may facilitate 
     the identification of model programs and materials for 
     educating and training health professionals in effective 
     strategies to--
       (1) identify individuals with eating disorders;
       (2) provide early intervention services for individuals 
     with eating disorders;
       (3) refer patients with eating disorders for appropriate 
     treatment;
       (4) prevent the development of eating disorders; and
       (5) provide appropriate treatment services for individuals 
     with eating disorders.

     SEC. 13007. CLARIFICATION OF EXISTING PARITY RULES.

       If a group health plan or a health insurance issuer 
     offering group or individual health insurance coverage 
     provides coverage for eating disorder benefits, including 
     residential treatment, such group health plan or health 
     insurance issuer shall provide such benefits consistent with 
     the requirements of section 2726 of the Public Health Service 
     Act (42 U.S.C. 300gg-26), section 712 of the Employee 
     Retirement Income Security Act of 1974 (29 U.S.C. 1185a), and 
     section 9812 of the Internal Revenue Code of 1986.

             TITLE XIV--MENTAL HEALTH AND SAFE COMMUNITIES

             Subtitle A--Mental Health and Safe Communities

     SEC. 14001. LAW ENFORCEMENT GRANTS FOR CRISIS INTERVENTION 
                   TEAMS, MENTAL HEALTH PURPOSES.

       (a) Edward Byrne Memorial Justice Assistance Grant 
     Program.--Section 501(a)(1) of title I of the Omnibus Crime 
     Control and Safe Streets Act of 1968 (42 U.S.C. 3751(a)(1)) 
     is amended by adding at the end the following:
       ``(H) Mental health programs and related law enforcement 
     and corrections programs, including behavioral programs and 
     crisis intervention teams.''.
       (b) Community Oriented Policing Services Program.--Section 
     1701(b) of title I of the Omnibus Crime Control and Safe 
     Streets Act of 1968 (42 U.S.C. 3796dd(b)) is amended--
       (1) in paragraph (17), by striking ``and'' at the end;
       (2) by redesignating paragraph (18) as paragraph (22);
       (3) by inserting after paragraph (17) the following:
       ``(18) to provide specialized training to law enforcement 
     officers to--
       ``(A) recognize individuals who have a mental illness; and
       ``(B) properly interact with individuals who have a mental 
     illness, including strategies for verbal de-escalation of 
     crises;
       ``(19) to establish collaborative programs that enhance the 
     ability of law enforcement agencies to address the mental 
     health, behavioral, and substance abuse problems of 
     individuals encountered by law enforcement officers in the 
     line of duty;
       ``(20) to provide specialized training to corrections 
     officers to recognize individuals who have a mental illness;
       ``(21) to enhance the ability of corrections officers to 
     address the mental health of individuals under the care and 
     custody of jails and prisons, including specialized training 
     and strategies for verbal de-escalation of crises; and''; and
       (4) in paragraph (22), as redesignated, by striking 
     ``through (17)'' and inserting ``through (21)''.
       (c) Modifications to the Staffing for Adequate Fire and 
     Emergency Response Grants.--Section 34(a)(1)(B) of the 
     Federal Fire Prevention and Control Act of 1974 (15 U.S.C. 
     2229a(a)(1)(B)) is amended by inserting before the period at 
     the end the following: ``and to provide specialized training 
     to paramedics, emergency medical services workers, and other 
     first responders to recognize individuals who have mental 
     illness and how to properly intervene with individuals with 
     mental illness, including strategies for verbal de-escalation 
     of crises''.

     SEC. 14002. ASSISTED OUTPATIENT TREATMENT PROGRAMS.

       (a) In General.--Section 2201 of title I of the Omnibus 
     Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796ii) 
     is amended in paragraph (2)(B), by inserting before the 
     semicolon the following: ``, or court-ordered assisted 
     outpatient treatment when the court has determined such 
     treatment to be necessary''.
       (b) Definitions.--Section 2202 of title I of the Omnibus 
     Crime Control and Safe Streets Act of 1968 (42 U.S.C. 
     3796ii--1) is amended--
       (1) in paragraph (1), by striking ``and'' at the end;
       (2) in paragraph (2), by striking the period at the end and 
     inserting a semicolon; and
       (3) by adding at the end the following:
       ``(3) the term `court-ordered assisted outpatient 
     treatment' means a program through which a court may order a 
     treatment plan for an eligible patient that--
       ``(A) requires such patient to obtain outpatient mental 
     health treatment while the patient is not currently residing 
     in a correctional facility or inpatient treatment facility; 
     and
       ``(B) is designed to improve access and adherence by such 
     patient to intensive behavioral health services in order to--
       ``(i) avert relapse, repeated hospitalizations, arrest, 
     incarceration, suicide, property destruction, and violent 
     behavior; and
       ``(ii) provide such patient with the opportunity to live in 
     a less restrictive alternative to incarceration or 
     involuntary hospitalization; and

[[Page H6965]]

       ``(4) the term `eligible patient' means an adult, mentally 
     ill person who, as determined by a court--
       ``(A) has a history of violence, incarceration, or 
     medically unnecessary hospitalizations;
       ``(B) without supervision and treatment, may be a danger to 
     self or others in the community;
       ``(C) is substantially unlikely to voluntarily participate 
     in treatment;
       ``(D) may be unable, for reasons other than indigence, to 
     provide for any of his or her basic needs, such as food, 
     clothing, shelter, health, or safety;
       ``(E) has a history of mental illness or a condition that 
     is likely to substantially deteriorate if the person is not 
     provided with timely treatment; or
       ``(F) due to mental illness, lacks capacity to fully 
     understand or lacks judgment to make informed decisions 
     regarding his or her need for treatment, care, or 
     supervision.''.

     SEC. 14003. FEDERAL DRUG AND MENTAL HEALTH COURTS.

       (a) Definitions.--In this section--
       (1) the term ``eligible offender'' means a person who--
       (A)(i) previously or currently has been diagnosed by a 
     qualified mental health professional as having a mental 
     illness, mental retardation, or co-occurring mental illness 
     and substance abuse disorders; or
       (ii) manifests obvious signs of mental illness, mental 
     retardation, or co-occurring mental illness and substance 
     abuse disorders during arrest or confinement or before any 
     court;
       (B) comes into contact with the criminal justice system or 
     is arrested or charged with an offense that is not--
       (i) a crime of violence, as defined under applicable State 
     law or in section 3156 of title 18, United States Code; or
       (ii) a serious drug offense, as defined in section 
     924(e)(2)(A) of title 18, United States Code; and
       (C) is determined by a judge to be eligible; and
       (2) the term ``mental illness'' means a diagnosable mental, 
     behavioral, or emotional disorder--
       (A) of sufficient duration to meet diagnostic criteria 
     within the most recent edition of the Diagnostic and 
     Statistical Manual of Mental Disorders published by the 
     American Psychiatric Association; and
       (B) that has resulted in functional impairment that 
     substantially interferes with or limits 1 or more major life 
     activities.
       (b) Establishment of Program.--Not later than 1 year after 
     the date of enactment of this Act, the Attorney General shall 
     establish a pilot program to determine the effectiveness of 
     diverting eligible offenders from Federal prosecution, 
     Federal probation, or a Bureau of Prisons facility, and 
     placing such eligible offenders in drug or mental health 
     courts.
       (c) Program Specifications.--The pilot program established 
     under subsection (b) shall involve--
       (1) continuing judicial supervision, including periodic 
     review, of program participants who have a substance abuse 
     problem or mental illness; and
       (2) the integrated administration of services and 
     sanctions, which shall include--
       (A) mandatory periodic testing, as appropriate, for the use 
     of controlled substances or other addictive substances during 
     any period of supervised release or probation for each 
     program participant;
       (B) substance abuse treatment for each program participant 
     who requires such services;
       (C) diversion, probation, or other supervised release with 
     the possibility of prosecution, confinement, or incarceration 
     based on noncompliance with program requirements or failure 
     to show satisfactory progress toward completing program 
     requirements;
       (D) programmatic offender management, including case 
     management, and aftercare services, such as relapse 
     prevention, health care, education, vocational training, job 
     placement, housing placement, and child care or other family 
     support services for each program participant who requires 
     such services;
       (E) outpatient or inpatient mental health treatment, as 
     ordered by the court, that carries with it the possibility of 
     dismissal of charges or reduced sentencing upon successful 
     completion of such treatment;
       (F) centralized case management, including--
       (i) the consolidation of all cases, including violations of 
     probations, of the program participant; and
       (ii) coordination of all mental health treatment plans and 
     social services, including life skills and vocational 
     training, housing and job placement, education, health care, 
     and relapse prevention for each program participant who 
     requires such services; and
       (G) continuing supervision of treatment plan compliance by 
     the program participant for a term not to exceed the maximum 
     allowable sentence or probation period for the charged or 
     relevant offense and, to the extent practicable, continuity 
     of psychiatric care at the end of the supervised period.
       (d) Implementation; Duration.--The pilot program 
     established under subsection (b) shall be conducted--
       (1) in not less than 1 United States judicial district, 
     designated by the Attorney General in consultation with the 
     Director of the Administrative Office of the United States 
     Courts, as appropriate for the pilot program; and
       (2) during fiscal year 2017 through fiscal year 2021.
       (e) Criteria for Designation.--Before making a designation 
     under subsection (d)(1), the Attorney General shall--
       (1) obtain the approval, in writing, of the United States 
     Attorney for the United States judicial district being 
     designated;
       (2) obtain the approval, in writing, of the chief judge for 
     the United States judicial district being designated; and
       (3) determine that the United States judicial district 
     being designated has adequate behavioral health systems for 
     treatment, including substance abuse and mental health 
     treatment.
       (f) Assistance From Other Federal Entities.--The 
     Administrative Office of the United States Courts and the 
     United States Probation Offices shall provide such assistance 
     and carry out such functions as the Attorney General may 
     request in monitoring, supervising, providing services to, 
     and evaluating eligible offenders placed in a drug or mental 
     health court under this section.
       (g) Reports.--The Attorney General, in consultation with 
     the Director of the Administrative Office of the United 
     States Courts, shall monitor the drug and mental health 
     courts under this section, and shall submit a report to 
     Congress on the outcomes of the program at the end of the 
     period described in subsection (d)(2).

     SEC. 14004. MENTAL HEALTH IN THE JUDICIAL SYSTEM.

       Part V of title I of the Omnibus Crime Control and Safe 
     Streets Act of 1968 (42 U.S.C. 3796ii et seq.) is amended by 
     inserting at the end the following:

     ``SEC. 2209. MENTAL HEALTH RESPONSES IN THE JUDICIAL SYSTEM.

       ``(a) Pretrial Screening and Supervision.--
       ``(1) In general.--The Attorney General may award grants to 
     States, units of local government, territories, Indian 
     Tribes, nonprofit agencies, or any combination thereof, to 
     develop, implement, or expand pretrial services programs to 
     improve the identification and outcomes of individuals with 
     mental illness.
       ``(2) Allowable uses.--Grants awarded under this subsection 
     may be may be used for--
       ``(A) behavioral health needs and risk screening of 
     defendants, including verification of interview information, 
     mental health evaluation, and criminal history screening;
       ``(B) assessment of risk of pretrial misconduct through 
     objective, statistically validated means, and presentation to 
     the court of recommendations based on such assessment, 
     including services that will reduce the risk of pre-trial 
     misconduct;
       ``(C) followup review of defendants unable to meet the 
     conditions of pretrial release;
       ``(D) evaluation of process and results of pre-trial 
     service programs;
       ``(E) supervision of defendants who are on pretrial 
     release, including reminders to defendants of scheduled court 
     dates;
       ``(F) reporting on process and results of pretrial services 
     programs to relevant public and private mental health 
     stakeholders; and
       ``(G) data collection and analysis necessary to make 
     available information required for assessment of risk.
       ``(b) Behavioral Health Assessments and Intervention.--
       ``(1) In general.--The Attorney General may award grants to 
     States, units of local government, territories, Indian 
     Tribes, nonprofit agencies, or any combination thereof, to 
     develop, implement, or expand a behavioral health screening 
     and assessment program framework for State or local criminal 
     justice systems.
       ``(2) Allowable uses.--Grants awarded under this subsection 
     may be used for--
       ``(A) promotion of the use of validated assessment tools to 
     gauge the criminogenic risk, substance abuse needs, and 
     mental health needs of individuals;
       ``(B) initiatives to match the risk factors and needs of 
     individuals to programs and practices associated with 
     research-based, positive outcomes;
       ``(C) implementing methods for identifying and treating 
     individuals who are most likely to benefit from coordinated 
     supervision and treatment strategies, and identifying 
     individuals who can do well with fewer interventions; and
       ``(D) collaborative decision-making among the heads of 
     criminal justice agencies, mental health systems, judicial 
     systems, substance abuse systems, and other relevant systems 
     or agencies for determining how treatment and intensive 
     supervision services should be allocated in order to maximize 
     benefits, and developing and utilizing capacity accordingly.
       ``(c) Use of Grant Funds.--A State, unit of local 
     government, territory, Indian Tribe, o