[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6 Referred in Senate (RFS)]
114th CONGRESS
1st Session
H. R. 6
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 13, 2015
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
AN ACT
To accelerate the discovery, development, and delivery of 21st century
cures, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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.
Sec. 2. NIH and Cures Innovation Fund.
TITLE I--DISCOVERY
Subtitle A--National Institutes of Health Funding
Sec. 1001. National Institutes of Health reauthorization.
Sec. 1002. Prize competitions.
Subtitle B--National Institutes of Health Planning and Administration
Sec. 1021. NIH research strategic plan.
Sec. 1022. Increasing accountability at the National Institutes of
Health.
Sec. 1023. Reducing administrative burdens of researchers.
Sec. 1024. Exemption for the National Institutes of Health from the
Paperwork Reduction Act requirements.
Sec. 1025. NIH travel.
Sec. 1026. Other transactions authority.
Sec. 1027. NCATS phase IIB restriction.
Sec. 1028. High-risk, high-reward research.
Sec. 1029. Sense of Congress on increased inclusion of underrepresented
communities in clinical trials.
Subtitle C--Supporting Young Emerging Scientists
Sec. 1041. Improvement of loan repayment programs of the National
Institutes of Health.
Sec. 1042. Report.
Subtitle D--Capstone Grant Program
Sec. 1061. Capstone award.
Subtitle E--Promoting Pediatric Research Through the National
Institutes of Health
Sec. 1081. National pediatric research network.
Sec. 1082. Global pediatric clinical study network sense of Congress.
Sec. 1083. Appropriate age groupings in clinical research.
Subtitle F--Advancement of the National Institutes of Health Research
and Data Access
Sec. 1101. Standardization of data in Clinical Trial Registry Data Bank
on eligibility for clinical trials.
Subtitle G--Facilitating Collaborative Research
Sec. 1121. Clinical trial data system.
Sec. 1122. National neurological diseases surveillance system.
Sec. 1123. Data on natural history of diseases.
Sec. 1124. Accessing, sharing, and using health data for research
purposes.
Subtitle H--Council for 21st Century Cures
Sec. 1141. Council for 21st Century Cures.
TITLE II--DEVELOPMENT
Subtitle A--Patient-Focused Drug Development
Sec. 2001. Development and use of patient experience data to enhance
structured risk-benefit assessment
framework.
Subtitle B--Qualification and Use of Drug Development Tools
Sec. 2021. Qualification of drug development tools.
Sec. 2022. Accelerated approval development plan.
Subtitle C--FDA Advancement of Precision Medicine
Sec. 2041. Precision medicine guidance and other programs of Food and
Drug Administration.
Subtitle D--Modern Trial Design and Evidence Development
Sec. 2061. Broader application of Bayesian statistics and adaptive
trial designs.
Sec. 2062. Utilizing evidence from clinical experience.
Sec. 2063. Streamlined data review program.
Subtitle E--Expediting Patient Access
Sec. 2081. Sense of Congress.
Sec. 2082. Expanded access policy.
Sec. 2083. Finalizing draft guidance on expanded access.
Subtitle F--Facilitating Responsible Manufacturer Communications
Sec. 2101. Facilitating dissemination of health care economic
information.
Sec. 2102. Facilitating responsible communication of scientific and
medical developments.
Subtitle G--Antibiotic Drug Development
Sec. 2121. Approval of certain drugs for use in a limited population of
patients.
Sec. 2122. Susceptibility test interpretive criteria for
microorganisms.
Sec. 2123. Encouraging the development and use of DISARM drugs.
Subtitle H--Vaccine Access, Certainty, and Innovation
Sec. 2141. Timely review of vaccines by the Advisory Committee on
Immunization Practices.
Sec. 2142. Review of processes and consistency of ACIP recommendations.
Sec. 2143. Meetings between CDC and vaccine developers.
Subtitle I--Orphan Product Extensions Now; Incentives for Certain
Products for Limited Populations
Sec. 2151. Extension of exclusivity periods for a drug approved for a
new indication for a rare disease or
condition.
Sec. 2152. Reauthorization of rare pediatric disease priority review
voucher incentive program.
Subtitle J--Domestic Manufacturing and Export Efficiencies
Sec. 2161. Grants for studying the process of continuous drug
manufacturing.
Sec. 2162. Re-exportation among members of the European Economic Area.
Subtitle K--Enhancing Combination Products Review
Sec. 2181. Enhancing combination products review.
Subtitle L--Priority Review for Breakthrough Devices
Sec. 2201. Priority review for breakthrough devices.
Subtitle M--Medical Device Regulatory Process Improvements
Sec. 2221. Third-party quality system assessment.
Sec. 2222. Valid scientific evidence.
Sec. 2223. Training and oversight in least burdensome appropriate means
concept.
Sec. 2224. Recognition of standards.
Sec. 2225. Easing regulatory burden with respect to certain class I and
class II devices.
Sec. 2226. Advisory committee process.
Sec. 2227. Humanitarian device exemption application.
Sec. 2228. CLIA waiver study design guidance for in vitro diagnostics.
Subtitle N--Sensible Oversight for Technology Which Advances Regulatory
Efficiency
Sec. 2241. Health software.
Sec. 2242. Applicability and inapplicability of regulation.
Sec. 2243. Exclusion from definition of device.
Subtitle O--Streamlining Clinical Trials
Sec. 2261. Protection of human subjects in research; applicability of
rules.
Sec. 2262. Use of non-local institutional review boards for review of
investigational device exemptions and human
device exemptions.
Sec. 2263. Alteration or waiver of informed consent for clinical
investigations.
Subtitle P--Improving Scientific Expertise and Outreach at FDA
Sec. 2281. Silvio O. Conte Senior Biomedical Research Service.
Sec. 2282. Enabling FDA scientific engagement.
Sec. 2283. Reagan-Udall Foundation for the Food and Drug
Administration.
Sec. 2284. Collection of certain voluntary information exempted from
Paperwork Reduction Act.
Sec. 2285. Hiring authority for scientific, technical, and professional
personnel.
Subtitle Q--Exempting From Sequestration Certain User Fees
Sec. 2301. Exempting from sequestration certain user fees of Food and
Drug Administration.
Subtitle R--Other Provisions
Sec. 2321. Sense of Congress.
TITLE III--DELIVERY
Subtitle A--Interoperability
Sec. 3001. Ensuring interoperability of health information technology.
Subtitle B--Telehealth
Sec. 3021. Telehealth services under the Medicare Program.
Subtitle C--Encouraging Continuing Medical Education for Physicians
Sec. 3041. Exempting from manufacturer transparency reporting certain
transfers used for educational purposes.
Subtitle D--Disposable Medical Technologies
Sec. 3061. Treatment of certain items and devices.
Subtitle E--Local Coverage Decision Reforms
Sec. 3081. Improvements in the Medicare local coverage determination
(LCD) process.
Subtitle F--Medicare Pharmaceutical and Technology Ombudsman
Sec. 3101. Medicare pharmaceutical and technology ombudsman.
Subtitle G--Medicare Site-of-Service Price Transparency
Sec. 3121. Medicare site-of-Service price transparency.
Subtitle H--Medicare Part D Patient Safety and Drug Abuse Prevention
Sec. 3141. Programs to prevent prescription drug abuse under Medicare
parts C and D.
TITLE IV--MEDICAID, MEDICARE, AND OTHER REFORMS
Subtitle A--Medicaid and Medicare Reforms
Sec. 4001. Limiting Federal Medicaid reimbursement to States for
durable medical equipment (DME) to Medicare
payment rates.
Sec. 4002. Excluding authorized generics from calculation of average
manufacturer price.
Sec. 4003. Medicare payment incentive for the transition from
traditional x-ray imaging to digital
radiography and other Medicare imaging
payment provision.
Sec. 4004. Treatment of infusion drugs furnished through durable
medical equipment.
Sec. 4005. Extension and expansion of prior authorization for power
mobility devices (PMDs) and accessories and
prior authorization audit limitations.
Sec. 4006. Civil monetary penalties for violations related to grants,
contracts, and other agreements.
Subtitle B--Other Reforms
Sec. 4041. SPR drawdown.
Subtitle C--Miscellaneous
Sec. 4061. Lyme disease and other tick-borne diseases.
Sec. 4062. Outreach to historically black colleges and universities.
SEC. 2. NIH AND CURES INNOVATION FUND.
(a) Establishment.--There is hereby established in the Treasury of
the United States a fund to be known as the NIH and Cures Innovation
Fund.
(b) Amounts Made Available to Fund.--
(1) In general.--There is authorized to be appropriated,
and appropriated, to the NIH and Cures Innovation Fund, out of
any funds in the Treasury not otherwise appropriated,
$1,860,000,000 for each of fiscal years 2016 through 2020. The
amounts appropriated to the NIH and Cures Innovation Fund by
the preceding sentence shall be in addition to any amounts
otherwise made available to the Department of Health and Human
Services.
(2) Allocation of amounts.--Of the amounts made available
from the NIH and Cures Innovation Fund for a fiscal year--
(A) $1,750,000,000 shall be for biomedical research
of the National Institutes of Health under subsection
(c)(1), of which--
(i) not less than $500,000,000 shall be for
the Accelerating Advancement Program under
subsection (d)(2);
(ii) not less than 35 percent of such
amounts remaining after subtracting the
allocation for the Accelerating Advancement
Program shall be for early stage investigators
as defined in subsection (g);
(iii) not less than 20 percent of such
amounts remaining after subtracting the
allocation for the Accelerating Advancement
Program shall be for high-risk, high-reward
research under section 409L of the Public
Health Service Act, as added by section 1028;
and
(iv) not more than 10 percent of such
amounts (without subtracting the allocation for
the Accelerating Advancement Program) shall be
for intramural research; and
(B) $110,000,000 shall be for carrying out the
provisions listed in subsection (c)(2).
(3) Inapplicability of certain provisions.--Amounts in the
NIH and Cures Innovation Fund (including amounts made available
to the National Institutes of Health) shall not be subject to--
(A) any transfer authority of the Secretary of
Health and Human Services or the Director of the
National Institutes of Health under sections 241,
402A(c), or 402A(d) of the Public Health Service Act
(42 U.S.C. 238j, 282a(c) and (d)) or any other
provision of law (other than this section); or
(B) the Nonrecurring expenses fund under section
223 of division G of the Consolidated Appropriations
Act, 2008 (42 U.S.C. 3514a).
(c) Authorized Uses.--
(1) NIH biomedical research.--Amounts in the NIH and Cures
Innovation Fund that are allocated pursuant to subsection
(b)(2)(A) may only be used for the purpose of conducting or
supporting biomedical research (including basic, translational,
and clinical research) through the following:
(A) Research in which--
(i) a principal investigator has a specific
project or specific objectives; and
(ii) funding is tied to pursuit of such
project or objectives.
(B) Research in which--
(i) a principal investigator has shown
promise in biomedical research; and
(ii) funding is not tied to a specific
project or specific objectives.
(C) Research to be carried out by an early stage
investigator (as defined in subsection (g)).
(D) Research to be carried out by a small business
concern (as defined in section 3 of the Small Business
Act).
(E) The Accelerating Advancement Program under
subsection (d)(2).
(F) Development and implementation of the strategic
plan under subsection (d)(3).
(2) Cures development.--Amounts in the NIH and Cures
Innovation Fund that are allocated pursuant to subsection
(b)(2)(B) may only be used for the purpose of carrying out the
following provisions:
(A) Section 229A of the Public Health Service Act,
as added by section 1123 (relating to data on natural
history of diseases).
(B) Section 2001 and the amendments made by such
section (relating to development and use of patient
experience data to enhance structured risk-benefit
assessment framework).
(C) Section 2021 and the amendments made by such
section (relating to qualification of drug development
tools).
(D) Section 2062 and the amendments made by such
section (relating to utilizing evidence from clinical
experience).
(E) Section 2161 (relating to grants for studying
the process of continuous drug manufacturing).
(F) Section 2201 and the amendments made by such
section (relating to priority review for breakthrough
devices).
(G) Section 2221 and the amendments made by such
section (relating to third-party quality system
assessments).
(H) Sections 2241, 2242, and 2243 and the
amendments made by such sections (relating to health
software).
(I) Section 513(j) of the Federal Food, Drug, and
Cosmetic Act, as added by section 2223 (relating to
training and oversight in least burdensome appropriate
means concept).
(d) NIH Innovation Fund.--
(1) Coordination.--In conducting or supporting biomedical
research pursuant to funds allocated pursuant to subsection
(b)(2)(A), the Secretary of Health and Human Services, acting
through the Director of the National Institutes of Health,
shall--
(A) ensure coordination among the national research
institutes, the national centers, and other
departments, agencies, and offices of the Federal
Government; and
(B) minimize unnecessary duplication.
(2) Accelerating advancement program.--The Director of the
National Institutes of Health shall establish a program, to be
known as the Accelerating Advancement Program, under which--
(A) the Director partners with national research
institutes and national centers to accomplish important
biomedical research objectives; and
(B) for every $1 made available by the Director to
a national research institute or national center for a
research project, the institute or center makes $1
available for such project from funds that are not
derived from the NIH and Cures Innovation Fund.
(3) Strategic plan.--
(A) In general.--The Director of the National
Institutes of Health shall ensure that scientifically
based strategic planning is implemented in support of
research priorities, including through development,
use, and updating of a research strategic plan that--
(i) is designed to increase the efficient
and effective focus of biomedical research in a
manner that leverages the best scientific
opportunities through a deliberative planning
process;
(ii) identifies areas, to be known as
strategic focus areas, in which the resources
of the NIH and Cures Innovation Fund can
contribute to the goals of expanding knowledge
to address, and find more effective treatments
for, unmet medical needs in the United States,
including the areas of--
(I) biomarkers;
(II) precision medicine;
(III) infectious diseases,
including pathogens listed as a
qualifying pathogen under section
505E(f) of the Federal Food, Drug, and
Cosmetic Act or listed or designated as
a tropical disease under section 524 of
such Act; and
(IV) antibiotics;
(iii) includes objectives for each such
strategic focus area; and
(iv) ensures that basic research remains a
priority.
(B) Updates and reviews.--The Director of the
National Institutes of Health shall review and, as
appropriate, update the research strategic plan under
subparagraph (A) not less than every 18 months.
(e) Transfer Authority.--The Committee on Appropriations of the
Senate and the Committee on Appropriations of the House of
Representatives may provide for the transfer of funds in the NIH and
Cures Innovation Fund for the purposes specified in subsection (c).
(f) Supplement, Not Supplant; Limitations.--Funds appropriated by
subsection (b)--
(1) shall be used to supplement, not supplant, amounts
otherwise made available to the Department of Health and Human
Services;
(2) are subject to the requirements and limitations of the
most recently enacted regular or full-year continuing
appropriation Act or resolution (as of the date of obligation)
for programs of the National Institutes of Health or the Food
and Drug Administration, as applicable; and
(3) notwithstanding any transfer authority in any
appropriation Act, shall not be used for any purpose other than
the purposes specified in subsection (c).
(g) Definition.--In this subsection:
(1) The term ``early stage investigator'' means an
investigator who--
(A) will be the principal investigator or the
program director of the proposed research;
(B) has never been awarded, or has been awarded
only once, a substantial, competing grant by the
National Institutes of Health for independent research;
and
(C) is within 10 years of having completed--
(i) the investigator's terminal degree; or
(ii) a medical residency (or the
equivalent).
(2) The terms ``national center'' and ``national research
institute'' have the meanings given to those terms in section
401(g) of the Public Health Service Act (42 U.S.C. 281(g)).
TITLE I--DISCOVERY
Subtitle A--National Institutes of Health Funding
SEC. 1001. 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 at the end ``and'';
(2) in subparagraph (C), by striking at the end the period
and inserting a semicolon; and
(3) by adding at the end the following new subparagraphs:
``(D) $31,811,000,000 for fiscal year 2016;
``(E) $33,331,000,000 for fiscal year 2017; and
``(F) $34,851,000,000 for fiscal year 2018.''.
SEC. 1002. PRIZE COMPETITIONS.
Part B of title IV of the Public Health Service Act (42 U.S.C. 284
et seq.) is amended by adding at the end the following:
``SEC. 409K. PRIZE COMPETITIONS FOR IMPROVING HEALTH OUTCOMES AND
REDUCING FEDERAL EXPENDITURES.
``(a) Establishment; Goals.--The Director of NIH shall establish
and implement an Innovation Prizes Program for one or both of the
following goals:
``(1) Identifying and funding areas of biomedical science
that could realize significant advancements through the
creation of a prize competition.
``(2) Improving health outcomes, particularly with respect
to human diseases and conditions for which public and private
investment in research is disproportionately small relative to
Federal Government expenditures on prevention and treatment
activities, thereby reducing Federal expenditures on health
programs.
``(b) Design of Prize Competitions.--Not later than 6 months after
the date of enactment of this section, the Director of NIH shall--
``(1) design prize competitions--
``(A) to cooperate with competitors to realize
innovations to identify and address areas of biomedical
science that could realize significant advancements
through the creation of a prize competition; and
``(B) to award one or more prizes--
``(i) if appropriate, at the beginning of
or during the competitions, to the competitors
whose innovations are most promising or
demonstrate progress; and
``(ii) at the end of the competitions, to
the competitors whose innovations prove to be
the best solutions;
``(2) ensure that the design of such competitions--
``(A) is realistic, given the amount of funds to be
awarded as prizes;
``(B) does not reflect any bias concerning the type
of innovations which will prove to be the best
solutions; and
``(C) allows any person to participate as a
competitor without regard to the person's place of
incorporation, primary place of business, citizenship,
and residency, as applicable; and
``(3) submit to the Congress a report on the design of such
competitions.
``(c) Innovation Prizes Advisory Board.--
``(1) Establishment.--The Director of NIH shall establish
and maintain a board, to be known as the I-Prize Board, to
advise and assist the Director of NIH in carrying out this
section.
``(2) Composition; terms.--
``(A) Composition.--The I-Prize Board shall be
composed of nine voting members as follows:
``(i) The Director of NIH (or the
Director's designee).
``(ii) Four members appointed by the
Director of NIH.
``(iii) One member appointed by the Speaker
of the House of Representatives.
``(iv) One member appointed by the majority
leader of the Senate.
``(v) One member appointed by the minority
leader of the House of Representatives.
``(vi) One member appointed by the minority
leader in the Senate.
``(B) Inclusion of certain experts.--The members of
the I-Prize Board appointed under clauses (ii) through
(vi) of subparagraph (A) shall, collectively, include
medical, economic, budgetary, innovation, or venture
capital experts from for-profit and not-for-profit
private sector entities with experience in awarding
prizes similar to the prizes under this section.
``(C) Terms.--The appointed members of the I-Prize
Board shall each be appointed for a term of 5 years.
``(D) Appointment of initial members.--The initial
appointed members of the I-Prize Board shall be
appointed not later than 120 days after the date of
enactment of this section.
``(3) Responsibilities.--The I-Prize Board shall be
responsible for advising the Director of NIH by--
``(A) identifying areas of biomedical science that
could realize significant advancements through the
creation of a prize competition;
``(B) making recommendations on establishing the
criteria for prize competitions under this section;
``(C) making recommendations on which business
organizations or other entities have successfully met
the criteria established for the prize competition; and
``(D) gaining insight from researchers, health
economists, academia, and industry on how to conduct
prize competitions.
``(d) Restrictions.--
``(1) No financial conflicts of interest.--Any member of
the I-Prize Board, and any officer or employee of the National
Institutes of Health responsible for carrying out this section,
may not personally or substantially participate in the
consideration or determination by the I-Prize Board of any
matter that would directly or predictably effect any financial
interest of--
``(A) the individual or a relative (as such term is
defined in section 109(16) of the Ethics in Government
Act of 1978) of the individual; or
``(B) of any business organization or other
entity--
``(i) of which the individual is an officer
or employee;
``(ii) with respect to which the individual
is negotiating for employment; or
``(iii) in which the individual has any
other financial interest.
``(2) No awards to competitors likely to reap financial
benefit from innovation.--The Director of NIH may not, with
respect to an innovation, award a prize under this section to
any individual or entity that has a vested financial interest
in any product or procedure that is likely to be developed or
marketed because of such innovation.
``(e) Process of Award.--The full monetary amount of any prize
awarded under this section shall be made available to the prize winner
not later than 90 days after the date of such award.
``(f) Simulation.--The Director of NIH may--
``(1) award one or more contracts--
``(A) to perform a simulation of the prize
competitions to be conducted under this section, based
on the designs developed under subsection (b); and
``(B) to use the simulation to assess the
effectiveness of the design; and
``(2) not later than 4 months after awarding such one or
more contracts, submit to the Congress a report on the results
of the simulation and assessment.
``(g) Implementation of Prize Competitions.--
``(1) In general.--The Director of NIH may enter into an
agreement with one or more entities described in section
501(c), and exempt from tax under section 501(a), of the
Internal Revenue Code of 1986 to implement prize competitions
based on the designs developed under subsection (b).
``(2) Minimum percentage for prizes.--If the Director of
NIH enters into an agreement under paragraph (1) to provide
funds or other assistance (including in-kind contributions and
testing or other technical support) to an entity to implement a
prize competition under this section--
``(A) not more than 15 percent of such assistance
shall be for administration of the prize competition;
and
``(B) not less than 85 percent of such assistance
shall be for activities in direct support of
competitors such as demonstration, testing, education,
and prize awards.
``(h) Tracking; Reporting.--The Director of NIH shall--
``(1) collect information on--
``(A) the medical efficacy of innovations funded
through the prize competitions under this section; and
``(B) the actual and potential effect of the
innovations on Federal expenditures; and
``(2) not later than 1 year after the conclusion of the
prize competitions under this section, and not later than the
end of each of the 4 succeeding years, submit to the Congress a
report on the information collected under paragraph (1).
``(i) Intellectual Property.--
``(1) Prohibition on the government acquiring intellectual
property rights.--The Federal Government may not gain an
interest in intellectual property developed by a participant in
a prize competition under this section without the written
consent of the participant.
``(2) Licenses.--The Federal Government may negotiate a
license for the use of intellectual property developed by a
participant in a prize competition under this section.''.
Subtitle B--National Institutes of Health Planning and Administration
SEC. 1021. NIH RESEARCH STRATEGIC PLAN.
Section 402 of the Public Health Service Act (42 U.S.C. 282) is
amended--
(1) in subsection (b), by amending paragraph (5) to read as
follows:
``(5) shall ensure that scientifically based strategic
planning is implemented in support of research priorities as
determined by the agencies of the National Institutes of
Health, including through development, use, and updating of the
research strategic plan under subsection (m);''; and
(2) by adding at the end the following:
``(m) Research Strategic Plan.--
``(1) Five-year plans for biomedical research strategy.--
``(A) In general.--For each successive 5-year
period beginning with the period of fiscal years 2016
through 2020, the Director of NIH, in consultation with
the entities described in subparagraph (B), shall
develop and maintain a biomedical research strategic
plan that--
``(i) is designed to increase the efficient
and effective focus of biomedical research in a
manner that leverages the best scientific
opportunities through a deliberative planning
process;
``(ii) identifies areas, to be known as
strategic focus areas, in which the resources
of the National Institutes of Health can best
contribute to the goal of expanding knowledge
on human health in the United States through
biomedical research; and
``(iii) includes objectives for each such
strategic focus area.
``(B) Entities described.--The entities described
in this subparagraph are the directors of the national
research institutes and national centers, researchers,
patient advocacy groups, and industry leaders.
``(2) Use of plan.--The Director of NIH and the directors
of the national research institutes and national centers shall
use the strategic plan--
``(A) to identify research opportunities; and
``(B) to develop individual strategic plans for the
research activities of each of the national research
institutes and national centers that--
``(i) have a common template; and
``(ii) identify strategic focus areas in
which the resources of the national research
institutes and national centers can best
contribute to the goal of expanding knowledge
on human health in the United States through
biomedical research.
``(3) Contents of plans.--
``(A) Strategic focus areas.--The strategic focus
areas identified pursuant to paragraph (1)(A)(ii)
shall--
``(i) be identified in a manner that--
``(I) considers the return on
investment to the United States public
through the investments of the National
Institutes of Health in biomedical
research; and
``(II) contributes to expanding
knowledge to improve the United States
public's health through biomedical
research; and
``(ii) include overarching and trans-
National Institutes of Health strategic focus
areas, to be known as Mission Priority Focus
Areas, which best serve the goals of preventing
or eliminating the burden of a disease or
condition and scientifically merit enhanced and
focused research over the next 5 years.
``(B) Rare and pediatric diseases and conditions.--
In developing and maintaining a strategic plan under
this subsection, the Director of NIH shall ensure that
rare and pediatric diseases and conditions remain a
priority.
``(C) Workforce.--In developing and maintaining a
strategic plan under this subsection, the Director of
NIH shall ensure that maintaining the biomedical
workforce of the future, including the participation by
scientists from groups traditionally underrepresented
in the scientific workforce, remains a priority.
``(4) Initial plan.--Not later than 270 days after the date
of enactment of this subsection, the Director of NIH and the
directors of the national research institutes and national
centers shall--
``(A) complete the initial strategic plan required
by paragraphs (1) and (2); and
``(B) make such initial strategic plan publicly
available on the website of the National Institutes of
Health.
``(5) Review; updates.--
``(A) Progress reviews.--Not less than annually,
the Director of NIH, in consultation with the directors
of the national research institutes and national
centers, shall conduct progress reviews for each
strategic focus area identified under paragraph
(1)(A)(ii).
``(B) Updates.--Not later than the end of the 5-
year period covered by the initial strategic plan under
this subsection, and every 5 years thereafter, the
Director of NIH, in consultation with the directors of
the national research institutes and national centers,
stakeholders in the scientific field, advocates, and
the public at large, shall--
``(i) conduct a review of the plan,
including each strategic focus area identified
under paragraph (2)(B); and
``(ii) update such plan in accordance with
this section.''.
SEC. 1022. 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; Terms.--
``(1) Appointment.--The Director of the National Cancer
Institute shall be appointed by the President and the directors
of the other national research institutes, as well as the
directors of the national centers, shall be appointed by the
Director of NIH. The directors of the national research
institutes, as well as national centers, shall report directly
to the Director of NIH.
``(2) Terms.--
``(A) In general.--The term of office of a director
of a national research institute or national center
shall be 5 years.
``(B) Removal.--The director of a national research
institute or national center may be removed from office
by the Director of NIH prior to the expiration of such
director's 5-year term.
``(C) Reappointment.--At the end of the term of a
director of a national research institute or national
center, the director may be reappointed. There is no
limit on the number of terms a director may serve.
``(D) 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.
``(E) Transitional provision.--Each director of a
national research institute or national center serving
on the date of enactment of the 21st Century Cures Act
is deemed to be appointed for a 5-year term under this
subsection starting on such date of enactment.''.
(b) Compensation to Consultants or Individual Scientists.--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) is amended by striking ``portable
structures;'' and all that follows and inserting ``portable
structures.''.
(c) 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 noncompeting renewal of such grant, or a noncompeting
administrative supplement to such grant, the director of such national
research institute or national center--
``(A) shall review and approve the award; and
``(B) shall take into consideration--
``(i) the mission of the national research
institute or national center and the scientific
priorities identified in the strategic plan under
section 402(m); and
``(ii) whether other agencies are funding programs
or projects to accomplish the same goal.''.
(d) IOM Study on Duplication in Federal Biomedical Research.--The
Secretary of Health and Human Services shall enter into an arrangement
with the Institute of Medicine of the National Academies (or, if the
Institute declines, another appropriate entity) under which the
Institute (or other appropriate entity) not later than 2 years after
the date of enactment of this Act will--
(1) complete a study on the extent to which biomedical
research conducted or supported by Federal agencies is
duplicative; and
(2) submit a report to the Congress on the results of such
study, including recommendations on how to prevent such
duplication.
SEC. 1023. REDUCING ADMINISTRATIVE BURDENS OF RESEARCHERS.
(a) Plan Preparation and Implementation of Measures To Reduce
Administrative Burdens.--The Director of the National Institutes of
Health shall prepare a plan, including time frames, and implement
measures to reduce the administrative burdens of researchers funded by
the National Institutes of Health, taking into account the
recommendations, evaluations, and plans researched by the following
entities:
(1) The Scientific Management Review Board.
(2) The National Academy of Sciences.
(3) The 2007 and 2012 Faculty Burden Survey conducted by
The Federal Demonstration Partnership.
(4) Relevant recommendations from the Research Business
Models Working Group.
(b) Report.--Not later than 2 years after the date of enactment of
this Act, the Director of the National Institutes of Health shall
submit to Congress a report on the extent to which the Director has
implemented measures pursuant to subsection (a).
SEC. 1024. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH FROM THE
PAPERWORK REDUCTION ACT REQUIREMENTS.
Section 3518(c)(1) of title 44, United States Code, is amended--
(1) in subparagraph (C), by striking ``; or'' and inserting
a semicolon;
(2) in subparagraph (D), by striking the period at the end
and inserting ``; or''; and
(3) by inserting at the end the following new subparagraph:
``(E) during the conduct of research by the National
Institutes of Health.''.
SEC. 1025. NIH TRAVEL.
It is the sense of Congress that participation in or sponsorship of
scientific conferences and meetings is essential to the mission of the
National Institutes of Health.
SEC. 1026. OTHER TRANSACTIONS AUTHORITY.
Section 480 of the Public Health Service Act (42 U.S.C. 287a) is
amended--
(1) in subsection (b), by striking ``the appropriation of
funds as described in subsection (g)'' and inserting ``the
availability of funds as described in subsection (f)'';
(2) in subsection (e)(3), by amending subparagraph (C) to
read as follows:
``(C) Other transactions authority.--The Director
of the Center shall have other transactions authority
in entering into transactions to fund projects in
accordance with the terms and conditions of this
section.'';
(3) by striking subsection (f); and
(4) by redesignating subsection (g) as subsection (f).
SEC. 1027. NCATS PHASE IIB RESTRICTION.
Section 479 of the Public Health Service Act (42 U.S.C. 287) is
amended--
(1) prior to making the amendments under paragraph (2), by
striking ``IIB'' each place it appears and inserting ``III'';
and
(2) by striking ``IIA'' each place it appears and inserting
``IIB''.
SEC. 1028. HIGH-RISK, HIGH-REWARD RESEARCH.
Part B of title IV of the Public Health Service Act (42 U.S.C. 284
et seq.), as amended by section 1002 of this Act, is amended by adding
at the end the following:
``SEC. 409L. HIGH-RISK, HIGH-REWARD RESEARCH PROGRAM.
``The director of each national research institute shall, as
appropriate--
``(1) establish programs to conduct or support research
projects that pursue innovative approaches to major
contemporary challenges in biomedical research that involve
inherent high risk, but have the potential to lead to
breakthroughs; and
``(2) set aside a specific percentage of funding, to be
determined by the Director of NIH for each national research
institute, for such projects.''.
SEC. 1029. SENSE OF CONGRESS ON INCREASED INCLUSION OF UNDERREPRESENTED
COMMUNITIES IN CLINICAL TRIALS.
It is the sense of Congress that the National Institute on Minority
Health and Health Disparities (NIMHD) should include within its
strategic plan ways to increase representation of underrepresented
communities in clinical trials.
Subtitle C--Supporting Young Emerging Scientists
SEC. 1041. IMPROVEMENT OF LOAN REPAYMENT PROGRAMS OF THE NATIONAL
INSTITUTES OF HEALTH.
(a) In General.--Part G of title IV of the Public Health Service
Act (42 U.S.C. 288 et seq.) is amended--
(1) by redesignating the second section 487F (42 U.S.C.
288-6; relating to pediatric research loan repayment program)
as section 487G; and
(2) by inserting after section 487G, as so redesignated,
the following:
``SEC. 487H. LOAN REPAYMENT PROGRAM.
``(a) In General.--The Secretary shall establish a program, based
on workforce and scientific needs, of entering into contracts with
qualified health professionals under which such health professionals
agree to engage in research in consideration of the Federal Government
agreeing to pay, for each year of engaging in such research, not more
than $50,000 of the principal and interest of the educational loans of
such health professionals.
``(b) Adjustment for Inflation.--Beginning with respect to fiscal
year 2017, the Secretary may increase the maximum amount specified in
subsection (a) by an amount that is determined by the Secretary, on an
annual basis, to reflect inflation.
``(c) Limitation.--The Secretary may not enter into a contract with
a health professional pursuant to subsection (a) unless such
professional has a substantial amount of educational loans relative to
income.
``(d) Applicability of Certain Provisions Regarding Obligated
Service.--Except to the extent inconsistent with this section, the
provisions of sections 338B, 338C, and 338E shall apply to the program
established under this section to the same extent and in the same
manner as such provisions apply to the National Health Service Corps
Loan Repayment Program established under section 338B.
``(e) Availability of Appropriations.--Amounts appropriated for a
fiscal year for contracts under subsection (a) are authorized to remain
available until the expiration of the second fiscal year beginning
after the fiscal year for which the amounts were appropriated.''.
(b) Update of Other Loan Repayment Programs.--
(1) Section 464z-5(a) of the Public Health Service Act (42
U.S.C.285t-2(a)) is amended--
(A) by striking ``$35,000'' and inserting
``$50,000''; and
(B) by adding at the end the following new
sentence: ``Subsection (b) of section 487H shall apply
with respect to the maximum amount specified in this
subsection in the same manner as it applies to the
maximum amount specified in subsection (a) of such
section.''.
(2) Section 487A(a) of such Act (42 U.S.C. 288-1(a)) is
amended--
(A) by striking ``$35,000'' and inserting
``$50,000''; and
(B) by adding at the end the following new
sentence: ``Subsection (b) of section 487H shall apply
with respect to the maximum amount specified in this
subsection in the same manner as it applies to the
maximum amount specified in subsection (a) of such
section.''.
(3) Section 487B(a) of such Act (42 U.S.C. 288-2(a)) is
amended--
(A) by striking ``$35,000'' and inserting
``$50,000''; and
(B) by adding at the end the following new
sentence: ``Subsection (b) of section 487H shall apply
with respect to the maximum amount specified in this
subsection in the same manner as it applies to the
maximum amount specified in such subsection (a) of such
section.''.
(4) Section 487C(a)(1) of such Act (42 U.S.C. 288-3(a)(1))
is amended--
(A) by striking ``$35,000'' and inserting
``$50,000''; and
(B) by adding at the end the following new
sentence: ``Subsection (b) of section 487H shall apply
with respect to the maximum amount specified in this
paragraph in the same manner as it applies to the
maximum amount specified in such subsection (a) of such
section.''.
(5) Section 487E(a)(1) of such Act (42 U.S.C. 288-5(a)(1))
is amended--
(A) by striking ``$35,000'' and inserting
``$50,000''; and
(B) by adding at the end the following new
sentence: ``Subsection (b) of section 487H shall apply
with respect to the maximum amount specified in this
paragraph in the same manner as it applies to the
maximum amount specified in such subsection (a) of such
section.''.
(6) Section 487F(a) of such Act (42 U.S.C. 288-5a(a)), as
added by section 205 of Public Law 106-505, is amended--
(A) by striking ``$35,000'' and inserting
``$50,000''; and
(B) by adding at the end the following new
sentence: ``Subsection (b) of section 487H shall apply
with respect to the maximum amount specified in this
subsection in the same manner as it applies to the
maximum amount specified in such subsection (a) of such
section.''.
(7) Section 487G of such Act (42 U.S.C. 288-6, as
redesignated by subsection (a)(1)), is further amended--
(A) in subsection (a)(1), by striking ``$35,000''
and inserting ``$50,000''; and
(B) in subsection (b), by adding at the end the
following new sentence: ``Subsection (b) of section
487H shall apply with respect to the maximum amount
specified in subsection (a)(1) in the same manner as it
applies to the maximum amount specified in such
subsection (a) of such section.''.
SEC. 1042. REPORT.
Not later than 18 months after the date of the enactment of this
Act, the Director of the National Institutes of Health shall submit to
Congress a report on efforts of the National Institutes of Health to
attract, retain, and develop emerging scientists, including
underrepresented individuals in the sciences, such as women and other
minorities.
Subtitle D--Capstone Grant Program
SEC. 1061. CAPSTONE AWARD.
Part G of title IV of the Public Health Service Act (42 U.S.C. 288
et seq.) is amended by adding at the end the following:
``SEC. 490. CAPSTONE AWARD.
``(a) In General.--The Secretary may make awards (each of which,
hereafter in this section, referred to as a `Capstone Award') to
support outstanding scientists who have been funded by the National
Institutes of Health.
``(b) Purpose.--Capstone Awards shall be made to facilitate the
successful transition or conclusion of research programs, or for other
purposes, as determined by the Director of NIH, in consultation with
the directors of the national research institutes and national centers.
``(c) Duration and Amount.--The duration and amount of each
Capstone Award shall be determined by the Director of NIH in
consultation with the directors of the national research institutes and
national centers.
``(d) Limitation.--Individuals who have received a Capstone Award
shall not be eligible to have principle investigator status on
subsequent awards from the National Institutes of Health.''.
Subtitle E--Promoting Pediatric Research Through the National
Institutes of Health
SEC. 1081. 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)--
(A) 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'' and inserting ``in collaboration
with the national research institutes and national
centers that carry out activities involving pediatric
research'';
(B) by striking subparagraph (B);
(C) by striking ``may be comprised of, as
appropriate'' and all that follows through ``the
pediatric research consortia'' and inserting ``may be
comprised of, as appropriate, the pediatric research
consortia''; and
(D) by striking ``; or'' at the end and inserting a
period; and
(2) in paragraph (1), paragraph (2)(A), the first sentence
of paragraph (2)(E), and paragraph (4), by striking ``may''
each place it appears and inserting ``shall''.
SEC. 1082. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK SENSE OF CONGRESS.
It is the sense of Congress that--
(1) the National Institutes of Health should encourage a
global pediatric clinical study network through the allocation
of grants, contracts, or cooperative agreements to supplement
the salaries of new and early investigators who participate in
the global pediatric clinical study network;
(2) National Institutes of Health grants, contracts, or
cooperative agreements should be awarded, solely for the
purpose of supplementing the salaries of new and early
investigators, to entities that participate in the global
pediatric clinical study network;
(3) the Food and Drug Administration should engage the
European Medicines Agency and other foreign regulatory entities
during the formation of the global pediatric clinical study
network to encourage their participation; and
(4) once a global pediatric clinical study network is
established and becomes operational, the Food and Drug
Administration should continue to engage the European Medicines
Agency and other foreign regulatory entities to encourage and
facilitate their participation in the network with the goal of
enhancing the global reach of the network.
SEC. 1083. APPROPRIATE AGE GROUPINGS IN CLINICAL RESEARCH.
(a) 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 pediatrics and experts on
geriatrics to provide input on--
(1) appropriate age groupings to be included in research
studies involving human subjects; and
(2) acceptable scientific justifications for excluding
participants from a range of age groups from human subjects
research studies.
(b) Guidelines.--Not later than 180 days after the conclusion of
the workshop under subsection (a), the Director of the National
Institutes of Health shall publish guidelines--
(1) addressing the consideration of age as an inclusion
variable in research involving human subjects; and
(2) identifying criteria for justifications for any age-
related exclusions in such research.
(c) Public Availability of Findings and Conclusions.--The Director
of the National Institutes of Health shall--
(1) make the findings and conclusions resulting from the
workshop under subsection (a) available to the public on the
website of the National Institutes of Health; and
(2) not less than biennially, disclose to the public on
such website the number of children included in research that
is conducted or supported by the National Institutes of Health,
disaggregated by developmentally appropriate age group, race,
and gender.
Subtitle F--Advancement of the National Institutes of Health Research
and Data Access
SEC. 1101. STANDARDIZATION OF DATA IN CLINICAL TRIAL REGISTRY DATA BANK
ON ELIGIBILITY FOR CLINICAL TRIALS.
(a) Standardization.--
(1) In general.--Section 402(j) of the Public Health
Service Act (42 U.S.C. 282(j)) is amended--
(A) by redesignating paragraph (7) as paragraph
(8); and
(B) by inserting after paragraph (6) the following:
``(7) Standardization.--The Director of NIH shall--
``(A) ensure that the registry and results data
bank is easily used by the public;
``(B) ensure that entries in the registry and
results data bank are easily compared;
``(C) ensure that information required to be
submitted to the registry and results data bank,
including recruitment information under paragraph
(2)(A)(ii)(II), is submitted by persons and posted by
the Director of NIH in a standardized format and
includes at least--
``(i) the disease or indication being
studied;
``(ii) inclusion criteria such as age,
gender, diagnosis or diagnoses, laboratory
values, or imaging results; and
``(iii) exclusion criteria such as specific
diagnosis or diagnoses, laboratory values, or
prohibited medications; and
``(D) to the extent possible, in carrying out this
paragraph, make use of standard health care
terminologies, such as the International Classification
of Diseases or the Current Procedural Terminology, that
facilitate electronic matching to data in electronic
health records or other relevant health information
technologies.''.
(2) Conforming amendment.--Clause (iv) of section
402(j)(2)(B) of the Public Health Service Act (42 U.S.C.
282(j)(2)(B)) is hereby stricken.
(b) Consultation.--Not later than 90 days after the date of
enactment of this Act, the Secretary of Health and Human Services shall
consult with stakeholders (including patients, researchers, physicians,
industry representatives, health information technology providers, the
Food and Drug Administration, and standard setting organizations such
as CDISC that have experience working with Federal agencies to
standardize health data submissions) to receive advice on 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 enhancements to
usability, functionality, and search capability) that are necessary to
implement paragraph (7) of section 402(j) of such Act, as added by
subsection (a).
(c) Applicability.--Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human Services shall
begin implementation of paragraph (7) of section 402(j) of the Public
Health Service Act, as added by subsection (a).
Subtitle G--Facilitating Collaborative Research
SEC. 1121. CLINICAL TRIAL DATA SYSTEM.
(a) Establishment.--The Secretary, acting through the Commissioner
of Food and Drugs and the Director of the National Institutes of
Health, shall enter into a cooperative agreement, contract, or grant
for a period of 7 years, to be known as the Clinical Trial Data System
Agreement, with one or more eligible entities to implement a pilot
program with respect to all clinical trial data obtained from qualified
clinical trials for purposes of registered users conducting further
research on such data.
(b) Application.--Eligible entities seeking to enter into a
cooperative agreement, contract, or grant with the Secretary under this
section shall submit to the Secretary an application in such time and
manner, and containing such information, as the Secretary may require
in accordance with this section. The Secretary shall not enter into a
cooperative agreement, contract, or grant under this section with an
eligible entity unless such entity submits an application including the
following:
(1) A certification that the eligible entity is not
currently and does not plan to be involved in sponsoring,
operating, or participating in a clinical trial nor
collaborating with another entity for the purposes of
sponsoring, operating, or participating in a clinical trial.
(2) Information demonstrating that the eligible entity can
compile clinical trial data in standardized formats using
terminologies and standards that have been developed by
recognized standards developing organizations with input from
diverse stakeholder groups, and information demonstrating that
the eligible entity can de-identify clinical trial data
consistent with the requirements of section 164.514 of title
45, Code of Federal Regulations (or successor regulations).
(3) A description of the system the eligible entity will
use to store and maintain such data, and information
demonstrating that this system will comply with applicable
standards and requirements for ensuring the security of the
clinical trial data.
(4) A certification that the eligible entity will allow
only registered users to access and use de-identified clinical
trial data, gathered from qualified clinical trials, and that
the eligible entity will allow each registered user to access
and use such data only after such registered user agrees in
writing to the terms described in (e)(4)(B), and such other
carefully controlled contractual terms as may be defined by the
Secretary.
(5) Evidence demonstrating the ability of the eligible
entity to ensure that registered users disseminate the results
of the research conducted in accordance with this section to
interested parties to serve as a guide to future medical
product development or scientific research.
(6) The plan of the eligible entity for securing funding
for the activities it would conduct under the clinical trial
data system agreement from governmental sources and private
foundations, entities, and individuals.
(7) Evidence demonstrating a proven track record of--
(A) being a neutral third party in working with
medical product manufacturers, academic institutions,
and the Food and Drug Administration; and
(B) having the ability to protect confidential
data.
(8) An agreement that the eligible entity will work with
the Comptroller General of the United States for purposes of
the study and report under subsection (d).
(c) Extension, Expansion, Termination.--The Secretary, acting
through the Commissioner of Food and Drugs and the Director of the
National Institutes of Health, upon the expiration of the 7-year period
referred to in subsection (a), may extend (including permanently),
expand, or terminate the pilot program established under such
subsection, in whole or in part.
(d) Study and Report.--
(1) In general.--The Comptroller General of the United
States shall conduct a study and issue a report to the Congress
and the Secretary with respect to the pilot program established
under subsection (a), not later than 6 years after the date on
which the pilot program is established under subsection (a).
(2) Study.--The study under paragraph (1) shall--
(A) review the effectiveness of the pilot program
established under subsection (a); and
(B) be designed to formulate recommendations on
improvements to the program.
(3) Report.--The report under paragraph (1) shall contain
at least the following information:
(A) The new discoveries, research inquiries, or
clinical trials that have resulted from accessing
clinical trial data under the pilot program established
under subsection (a).
(B) The number of times scientists have accessed
such data, disaggregated by research area and clinical
trial phase.
(C) An analysis of whether the program has helped
to reduce adverse events in clinical trials.
(D) An analysis of whether scientists have raised
any concerns about the burden of having to share data
with the system established under the program and, if
so, a description of such concerns.
(E) An analysis of privacy and data integrity
practices used in the program.
(e) Definitions.--In this section:
(1) The term ``eligible entity'' means an entity that has
experienced personnel with clinical and other technical
expertise in the biomedical sciences and biomedical ethics and
that is--
(A) an institution of higher education (as such
term is defined in section 1001 of the Higher Education
Act of 1965 (20 U.S.C. 1001)) or a consortium of such
institutions; or
(B) an organization described in section 501(c)(3)
of title 26 of the Internal Revenue Code of 1986 and
exempt from tax under section 501(a) of such title.
(2) The term ``medical product'' means a drug (as defined
in section 201(g) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(g))), a device (as defined in section 201(h) of
such Act (21 U.S.C. 331(h)), a biological product (as defined
in section 351 of the Public Health Service Act (42 U.S.C.
262)), or any combination thereof.
(3) The term ``qualified clinical trial'' means a clinical
trial sponsored solely by an agency of the Department of Health
and Human Services with respect to a medical product--
(A) that--
(i) was approved or cleared under section
505, 510(k), or 515, or has an exemption for
investigational use in effect under section 505
or 520(m), of the Federal Food, Drug, and
Cosmetic Act (42 U.S.C. 301 et seq.); or
(ii) was licensed under section 351 of the
Public Health Service Act (42 U.S.C. 262) or
has an exemption for investigational use in
effect under such section 351; or
(B) that is an investigational product for which
the original development was discontinued and with
respect to which--
(i) no additional work to support approval,
licensure, or clearance of such medical product
is being or is planned to be undertaken by the
sponsor of the original development program,
its successors, assigns, or collaborators; and
(ii) the sponsor of the original
investigational development program has
provided its consent to the Secretary for
inclusion of data regarding such product in the
system established under this section.
(4) The term ``registered user'' means a scientific or
medical researcher who has--
(A) a legitimate biomedical research purpose for
accessing information from the clinical trials data
system and has appropriate qualifications to conduct
such research; and
(B) agreed in writing not to transfer to any other
person that is not a registered user de-identified
clinical trial data from qualified clinical trials
accessed through an eligible entity, use such data for
reasons not specified in the research proposal, or seek
to re-identify qualified clinical trial participants.
(5) The term ``Secretary'' means the Secretary of Health
and Human Services.
SEC. 1122. NATIONAL NEUROLOGICAL DISEASES SURVEILLANCE SYSTEM.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following:
``SEC. 399V-6 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 determined appropriate by the Secretary, shall--
``(1) enhance and expand infrastructure and activities to
track the epidemiology of neurological diseases, including
multiple sclerosis and Parkinson's disease; and
``(2) incorporate information obtained through such
activities into a statistically sound, scientifically credible,
integrated surveillance system, to be known as the National
Neurological Diseases Surveillance System.
``(b) Research.--The Secretary shall ensure that the National
Neurological Diseases 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, such as information concerning--
``(A) demographics and other information associated
or possibly associated with neurological diseases, such
as age, race, ethnicity, sex, geographic location, and
family history;
``(B) risk factors associated or possibly
associated with neurological diseases, including
genetic and environmental risk factors; 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 epidemiology of the diseases;
``(B) the natural history of the diseases;
``(C) the prevention of the diseases;
``(D) the detection, management, and treatment
approaches for the diseases; and
``(E) the development of outcomes measures; and
``(4) may address issues identified during the consultation
process under subsection (d).
``(d) Consultation.--In carrying out this section, the Secretary
shall consult with individuals with appropriate expertise, including--
``(1) epidemiologists with experience in disease
surveillance or registries;
``(2) representatives of national voluntary health
associations that--
``(A) focus on neurological diseases, including
multiple sclerosis and Parkinson's disease; 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 make information and
analysis in the National Neurological Diseases Surveillance System
available, as appropriate--
``(1) to Federal departments and agencies, such as the
National Institutes of Health, the Food and Drug
Administration, the Centers for Medicare & Medicaid Services,
the Agency for Healthcare Research and Quality, the Department
of Veterans Affairs, and the Department of Defense; and
``(2) to State and local agencies.
``(g) Public Access.--Subject to subsection (h), the Secretary
shall make information and analysis in the National Neurological
Diseases Surveillance System available, as appropriate, to the public,
including researchers.
``(h) Privacy.--The Secretary shall ensure that privacy and
security protections applicable to the National Neurological Diseases
Surveillance System are at least as stringent as the privacy and
security protections under HIPAA privacy and security law (as defined
in section 3009(a)(2)).
``(i) 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--
``(1) the development and maintenance of the National
Neurological Diseases Surveillance System;
``(2) the type of information collected and stored in the
System;
``(3) the use and availability of such information,
including guidelines for such use; and
``(4) 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.
``(k) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $5,000,000 for each of fiscal
years 2016 through 2020.''.
SEC. 1123. DATA ON NATURAL HISTORY OF DISEASES.
(a) Sense of Congress.--It is the sense of the Congress that
studies on the natural history of diseases can help to facilitate and
expedite the development of medical products for such diseases.
(b) Authority.--Part A of title II of the Public Health Service Act
(42 U.S.C. 202 et seq.) is amended by adding at the end the following:
``SEC. 229A. DATA ON NATURAL HISTORY OF DISEASES.
``(a) In General.--The Secretary, acting through the Commissioner
of Food and Drugs, may, for the purposes described in subsection (b)--
``(1) participate in public-private partnerships engaged in
one or more activities specified in subsection (c); and
``(2) award grants to patient advocacy groups or other
organizations determined appropriate by the Secretary.
``(b) Purposes Described.--The purposes described in this
subsection are to establish or facilitate the collection, maintenance,
analysis, and interpretation of data regarding the natural history of
diseases, with a particular focus on rare diseases.
``(c) Activities of Public-Private Partnerships.--The activities of
public-private partnerships in which the Secretary may participate for
purposes of this section include--
``(1) cooperating with other entities that sponsor or
maintain disease registries, including disease registries and
disease registry platforms for rare diseases;
``(2) developing or enhancing a secure information
technology system that--
``(A) has the capacity to support data needs across
a wide range of disease studies;
``(B) is easily modified as knowledge is gained
during such studies; and
``(C) is capable of handling increasing amounts of
data as more studies are carried out; and
``(3) providing advice to clinical researchers, patient
advocacy groups, and other entities with respect to--
``(A) the design and conduct of disease studies;
``(B) the modification of any such ongoing studies;
and
``(C) addressing associated patient privacy issues.
``(d) Availability of Data on Natural History of Diseases.--Data
relating to the natural history of diseases obtained, aggregated, or
otherwise maintained by a public-private partnership in which the
Secretary participates under subsection (a) shall be made available,
consistent with otherwise applicable Federal and State privacy laws, to
the public (including patient advocacy groups, researchers, and drug
developers) to help to facilitate and expedite medical product
development programs.
``(e) Confidentiality.--Notwithstanding subsection (d), nothing in
this section authorizes the disclosure of any information that is a
trade secret or commercial or financial information that is privileged
or confidential and subject to section 552(b)(4) of title 5, United
States Code, or section 1905 of title 18, United States Code.
``(f) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $5,000,000 for each of fiscal
years 2016 through 2020.''.
SEC. 1124. ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH
PURPOSES.
(a) In General.--(1) The HITECH Act (title XIII of division A of
Public Law 111-5) is amended by adding at the end of subtitle D of such
Act (42 U.S.C. 17921 et seq.) the following:
``PART 4--ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH
PURPOSES
``SEC. 13441. REFERENCES.
``In this part:
``(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).
``SEC. 13442. DEFINING HEALTH DATA RESEARCH AS PART OF HEALTH CARE
OPERATIONS.
``(a) In General.--Subject to subsection (b), the Secretary shall
revise or clarify the Rule to allow the use and disclosure of protected
health information by a covered entity for research purposes, including
studies whose purpose is to obtain generalizable knowledge, to be
treated as the use and disclosure of such information for health care
operations described in subparagraph (1) of the definition of health
care operations in section 164.501 of part 164.
``(b) Modifications to Rules for Disclosures for Health Care
Operations.--In applying section 164.506 of part 164 to the disclosure
of protected health information described in subsection (a)--
``(1) the Secretary shall revise or clarify the Rule so
that the disclosure may be made by the covered entity to only--
``(A) another covered entity for health care
operations (as defined in section 164.501 of part 164);
``(B) a business associate that has entered into a
contract under section 164.504(e) of part 164 with a
disclosing covered entity to perform health care
operations; or
``(C) a business associate that has entered into a
contract under section 164.504(e) of part 164 for the
purpose of data aggregation (as defined in section
164.501 of part 164); and
``(2) the Secretary shall further revise or clarify the
Rule so that the limitation specified by section 164.506(c)(4)
of part 164 does not apply to disclosures that are described by
subsection (a).
``(c) Rule of Construction.--This section shall not be construed as
prohibiting or restricting a use or disclosure of protected health
information for research purposes that is otherwise permitted under
part 164.
``SEC. 13443. TREATING DISCLOSURES OF PROTECTED HEALTH INFORMATION FOR
RESEARCH SIMILARLY TO DISCLOSURES OF SUCH INFORMATION FOR
PUBLIC HEALTH PURPOSES.
``(a) Remuneration.--The Secretary shall revise or clarify the Rule
so that disclosures of protected health information for research
purposes are not subject to the limitation on remuneration described in
section 164.502(a)(5)(ii)(B)(2)(ii) of part 164.
``(b) Permitted Uses and Disclosures.--The Secretary shall revise
or clarify the Rule so that research activities, including comparative
research activities, related to the quality, safety, or effectiveness
of a product or activity that is regulated by the Food and Drug
Administration are included as public health activities for purposes of
which a covered entity may disclose protected health information to a
person described in section 164.512(b)(1)(iii) of part 164.
``SEC. 13444. PERMITTING REMOTE ACCESS TO PROTECTED HEALTH INFORMATION
BY RESEARCHERS.
``The Secretary shall revise or clarify the Rule so that
subparagraph (B) of section 164.512(i)(1)(ii) of part 164 (prohibiting
the removal of protected health information by a researcher) does not
prohibit remote access to health information by a researcher so long
as--
``(1) appropriate security and privacy safeguards are
maintained by the covered entity and the researcher; and
``(2) the protected health information is not copied or
otherwise retained by the researcher.
``SEC. 13445. ALLOWING ONE-TIME AUTHORIZATION OF USE AND DISCLOSURE OF
PROTECTED HEALTH INFORMATION FOR RESEARCH PURPOSES.
``(a) In General.--The Secretary shall revise or clarify the Rule
to specify that an authorization for the use or disclosure of protected
health information, with respect to an individual, for future research
purposes shall be deemed to contain a sufficient description of the
purpose of the use or disclosure if the authorization--
``(1) 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;
``(2) either--
``(A) states that the authorization will expire on
a particular date or on the occurrence of a particular
event; or
``(B) states that the authorization will remain
valid unless and until it is revoked by the individual;
and
``(3) provides instruction to the individual on how to
revoke such authorization at any time.
``(b) Revocation of Authorization.--The Secretary shall revise or
clarify the Rule to specify that, if an individual revokes an
authorization for future research purposes such as is described by
subsection (a), the covered entity may not make any further uses or
disclosures based on that authorization, except, as provided in
paragraph (b)(5) of section 164.508 of part 164, to the extent that the
covered entity has taken action in reliance on the authorization.''.
(2) The table of sections in section 13001(b) of such Act is
amended by adding at the end of the items relating to subtitle D the
following new items:
``Part 4--Accessing, Sharing, and Using Health Data for Research
Purposes
``Sec. 13441. References.
``Sec. 13442. Defining health data research as part of health care
operations.
``Sec. 13443. Treating disclosures of protected health information for
research similarly to disclosures of such
information for public health purposes.
``Sec. 13444. Permitting remote access to protected health information
by researchers.
``Sec. 13445. Allowing one-time authorization of use and disclosure of
protected health information for research
purposes.''.
(b) Revision of Regulations.--Not later than 12 months after the
date of the enactment of this Act, the Secretary of Health and Human
Services shall revise and clarify the provisions of title 45, Code of
Federal Regulations, for consistency with part 4 of subtitle D of the
HITECH Act, as added by subsection (a).
Subtitle H--Council for 21st Century Cures
SEC. 1141. COUNCIL FOR 21ST CENTURY CURES.
Title II of the Public Health Service Act (42 U.S.C. 202 et seq.)
is amended by adding at the end the following:
``PART E--COUNCIL FOR 21ST CENTURY CURES
``SEC. 281. ESTABLISHMENT.
``A nonprofit corporation to be known as the Council for 21st
Century Cures (referred to in this part as the `Council') shall be
established in accordance with this section. The Council shall be a
public-private partnership headed by an Executive Director (referred to
in this part as the `Executive Director'), appointed by the members of
the Board of Directors. The Council shall not be an agency or
instrumentality of the United States Government.
``SEC. 281A. PURPOSE.
``The purpose of the Council is to accelerate the discovery,
development, and delivery in the United States of innovative cures,
treatments, and preventive measures for patients.
``SEC. 281B. DUTIES.
``For the purpose described in section 281A, the Council shall--
``(1) foster collaboration and coordination among the
entities that comprise the Council, including academia,
government agencies, industry, health care payors and
providers, patient advocates, and others engaged in the cycle
of discovery, development, and delivery of life-saving and
health-enhancing innovative interventions;
``(2) undertake communication and dissemination activities;
``(3) publish information on the activities funded under
section 281D;
``(4) establish a strategic agenda for accelerating the
discovery, development, and delivery in the United States of
innovative cures, treatments, and preventive measures for
patients;
``(5) identify gaps and opportunities within and across the
discovery, development, and delivery cycle;
``(6) develop and propose recommendations based on the gaps
and opportunities so identified;
``(7) facilitate the interoperability of the components of
the discovery, development, and delivery cycle;
``(8) propose recommendations that will facilitate
precompetitive collaboration;
``(9) identify opportunities to work with, but not
duplicate the efforts of, nonprofit organizations and other
public-private partnerships; and
``(10) identify opportunities for collaboration with
organizations operating outside of the United States, such as
the Innovative Medicines Initiative of the European Union.
``SEC. 281C. ORGANIZATION; ADMINISTRATION.
``(a) Board of Directors.--
``(1) Establishment.--
``(A) In general.--The Council shall have a Board
of Directors (in this part referred to as the `Board of
Directors'), which shall be composed of the ex officio
members under subparagraph (B) and the appointed
members under subparagraph (C). All members of the
Board shall be voting members.
``(B) Ex officio members.--The ex officio members
of the Board shall be the following individuals or
their designees:
``(i) The Director of the National
Institutes of Health.
``(ii) The Commissioner of Food and Drugs.
``(iii) The Administrator of the Centers
for Medicare & Medicaid Services.
``(iv) The heads of five other Federal
agencies deemed by the Secretary to be engaged
in biomedical research and development.
``(C) Appointed members.--The appointed members of
the Board shall consist of 17 individuals, of whom--
``(i) eight shall be appointed by the
Comptroller General of the United States from a
list of nominations submitted by leading trade
associations--
``(I) four of whom shall be
representatives of the
biopharmaceutical industry;
``(II) two of whom shall be
representatives of the medical device
industry; and
``(III) two of whom shall be
representatives of the information and
digital technology industry; and
``(ii) nine shall be appointed by the
Comptroller General of the United States, after
soliciting nominations--
``(I) two of whom shall be
representatives of academic
researchers;
``(II) three of whom shall be
representatives of patients;
``(III) two of whom shall be
representatives of health care
providers; and
``(IV) two of whom shall be
representatives of health care plans
and insurers.
``(D) Chair.--The Chair of the Board shall be
selected by the members of the Board by majority vote
from among the members of the Board.
``(2) Terms and vacancies.--
``(A) In general.--The term of office of each
member of the Board appointed under paragraph (1)(C)
shall be 5 years.
``(B) Vacancy.--Any vacancy in the membership of
the Board--
``(i) shall not affect the power of the
remaining members to execute the duties of the
Board; and
``(ii) shall be filled by appointment by
the appointed members described in paragraph
(1)(C) by majority vote.
``(C) Partial term.--If a member of the Board does
not serve the full term applicable under subparagraph
(A), the individual appointed under subparagraph (B) to
fill the resulting vacancy shall be appointed for the
remainder of the term of the predecessor of the
individual.
``(3) Responsibilities.--Not later than 90 days after the
date on which the Council is incorporated and its Board of
Directors is fully constituted, the Board of Directors shall
establish bylaws and policies for the Council that--
``(A) are published in the Federal Register and
available for public comment;
``(B) establish policies for the selection and, as
applicable, appointment of--
``(i) the officers, employees, agents, and
contractors of the Council; and
``(ii) the members of any committees of the
Council;
``(C) establish policies, including ethical
standards, for the conduct of programs and other
activities under section 281D; and
``(D) establish specific duties of the Executive
Director.
``(4) Meetings.--
``(A) In general.--The Board of Directors shall--
``(i) meet on a quarterly basis; and
``(ii) submit to Congress, and make
publicly available, the minutes of such
meetings.
``(B) Agenda.--The Board of Directors shall, not
later than 3 months after the incorporation of the
Council--
``(i) issue an agenda (in this part
referred to as the `agenda') outlining how the
Council will achieve the purpose described in
section 281A; and
``(ii) annually thereafter, in consultation
with the Executive Director, review and update
such agenda.
``(b) Appointment and Incorporation.--Not later than 6 months after
the date of enactment of the 21st Century Cures Act--
``(1) the Comptroller General of the United States shall
appoint the appointed members of the Board of Directors under
subsection (a)(1)(C); and
``(2) the ex officio members of the Board of Directors
under subsection (a)(1)(B) shall serve as incorporators and
shall take whatever actions are necessary to incorporate the
Council.
``(c) Nonprofit Status.--In carrying out this part, the Board of
Directors shall establish such policies and bylaws, and the Executive
Director shall carry out such activities, as may be necessary to ensure
that the Council maintains status as an organization that--
``(1) is described in subsection (c)(3) of section 501 of
the Internal Revenue Code of 1986; and
``(2) is, under subsection (a) of such section, exempt from
taxation.
``(d) Executive Director.--The Executive Director shall--
``(1) be the chief executive officer of the Council; and
``(2) subject to the oversight of the Board of Directors,
be responsible for the day-to-day management of the Council.
``SEC. 281D. OPERATIONAL ACTIVITIES AND ASSISTANCE.
``(a) In General.--The Council shall establish a sufficient
operational infrastructure to fulfill the duties specified in section
281B.
``(b) Private Sector Matching Funds.--The Council may accept
financial or in-kind support from participating entities or private
foundations or organizations when such support is deemed appropriate.
``SEC. 281E. TERMINATION; REPORT.
``(a) In General.--The Council shall terminate on September 30,
2023.
``(b) Report.--Not later than 1 year after the date on which the
Council is established and each year thereafter, the Executive Director
shall submit to the appropriate congressional committees a report on
the performance of the Council. In preparing such report, the Council
shall consult with a nongovernmental consultant with appropriate
expertise.
``SEC. 281F. FUNDING.
``For the each of fiscal years 2016 through 2023, there is
authorized to be appropriated $10,000,000 to the Council for purposes
of carrying out the duties of the Council under this part.''.
TITLE II--DEVELOPMENT
Subtitle A--Patient-Focused Drug Development
SEC. 2001. DEVELOPMENT AND USE OF PATIENT EXPERIENCE DATA TO ENHANCE
STRUCTURED RISK-BENEFIT ASSESSMENT FRAMEWORK.
(a) In General.--Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) is amended--
(1) in subsection (d), by striking ``The Secretary shall
implement'' and all that follows through ``premarket approval
of a drug.''; and
(2) by adding at the end the following new subsections:
``(x) Structured Risk-Benefit Assessment Framework.--
``(1) In general.--The Secretary shall implement a
structured risk-benefit assessment framework in the new drug
approval process--
``(A) to facilitate the balanced consideration of
benefits and risks; and
``(B) to develop and implement a consistent and
systematic approach to the discussion of, regulatory
decisionmaking with respect to, and the communication
of, the benefits and risks of new drugs.
``(2) Rule of construction.--Nothing in paragraph (1) shall
alter the criteria for evaluating an application for premarket
approval of a drug.
``(y) Development and Use of Patient Experience Data To Enhance
Structured Risk-Benefit Assessment Framework.--
``(1) In general.--Not later than 2 years after the date of
the enactment of this subsection, the Secretary shall establish
and implement processes under which--
``(A) an entity seeking to develop patient
experience data may submit to the Secretary--
``(i) initial research concepts for
feedback from the Secretary; and
``(ii) with respect to patient experience
data collected by the entity, draft guidance
documents, completed data, and summaries and
analyses of such data;
``(B) the Secretary may request such an entity to
submit such documents, data, and summaries and
analyses; and
``(C) patient experience data may be developed and
used to enhance the structured risk-benefit assessment
framework under subsection (x).
``(2) Patient experience data.--In this subsection, the
term `patient experience data' means data collected by
patients, parents, caregivers, patient advocacy organizations,
disease research foundations, medical researchers, research
sponsors, or other parties determined appropriate by the
Secretary that is intended to facilitate or enhance the
Secretary's risk-benefit assessments, including information
about the impact of a disease or a therapy on patients'
lives.''.
(b) Guidance.--
(1) In general.--The Secretary of Health and Human Services
shall publish guidance on the implementation of subsection (y)
of section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as added by subsection (a). Such guidance shall
include--
(A) with respect to draft guidance documents, data,
or summaries and analyses submitted to the Secretary
under paragraph (1)(A) of such subsection, guidance--
(i) specifying the timelines for the review
of such documents, data, or summaries and
analyses by the Secretary; and
(ii) on how the Secretary will use such
documents, data, or summaries and analyses to
update any guidance documents published under
this subsection or publish new guidance;
(B) with respect to the collection and analysis of
patient experience data (as defined in paragraph (2) of
such subsection (y)), guidance on--
(i) methodological considerations for the
collection of patient experience data, which
may include structured approaches to gathering
information on--
(I) the experience of a patient
living with a particular disease;
(II) the burden of living with or
managing the disease;
(III) the impact of the disease on
daily life and long-term functioning;
and
(IV) the effect of current
therapeutic options on different
aspects of the disease; and
(ii) the establishment and maintenance of
registries designed to increase understanding
of the natural history of a disease;
(C) methodological approaches that may be used to
assess patients' beliefs with respect to the benefits
and risks in the management of the patient's disease;
and
(D) methodologies, standards, and potential
experimental designs for patient-reported outcomes.
(2) Timing.--Not later than 3 years after the date of the
enactment of this Act, the Secretary of Health and Human
Services shall issue draft guidance on the implementation of
subsection (y) of section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), as added by subsection (a). The
Secretary shall issue final guidance on the implementation of
such subsection not later than 1 year after the date on which
the comment period for the draft guidance closes.
(3) Workshops.--
(A) In general.--Not later than 6 months after the
date of the enactment of this Act and once every 6
months during the following 12-month period, the
Secretary of Health and Human Services shall convene a
workshop to obtain input regarding methodologies for
developing the guidance under paragraph (1), including
the collection of patient experience data.
(B) Attendees.--A workshop convened under this
paragraph shall include--
(i) patients;
(ii) representatives from patient advocacy
organizations, biopharmaceutical companies, and
disease research foundations;
(iii) representatives of the reviewing
divisions of the Food and Drug Administration;
and
(iv) methodological experts with
significant expertise in patient experience
data.
(4) Public meeting.--Not later than 90 days after the date
on which the draft guidance is published under this subsection,
the Secretary of Health and Human Services shall convene a
public meeting to solicit input on the guidance.
Subtitle B--Qualification and Use of Drug Development Tools
SEC. 2021. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
(a) Findings.--Congress finds the following:
(1) Development of new drugs has become increasingly
challenging and resource intensive.
(2) Development of drug development tools can benefit the
availability of new medical therapies by helping to translate
scientific discoveries into clinical applications.
(3) Biomedical research consortia (as defined in section
507(f) of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (c)) can play a valuable role in helping to develop
and qualify drug development tools.
(b) Sense of Congress.--It is the sense of Congress that--
(1) Congress should promote and facilitate a collaborative
effort among the biomedical research consortia described in
subsection (a)(3)--
(A) to develop, through a transparent public
process, data standards and scientific approaches to
data collection accepted by the medical and clinical
research community for purposes of qualifying drug
development tools;
(B) to coordinate efforts toward developing and
qualifying drug development tools in key therapeutic
areas; and
(C) to encourage the development of accessible
databases for collecting relevant drug development tool
data for such purposes; and
(2) an entity seeking to qualify a drug development tool
should be encouraged, in addition to consultation with the
Secretary, to consult with biomedical research consortia and
other individuals and entities with expert knowledge and
insights that may assist the requestor and benefit the process
for such qualification.
(c) Qualification of Drug Development Tools.--Chapter V of the
Federal Food, Drug, and Cosmetic Act 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.--The succeeding provisions of
this paragraph 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 submission and the
available resources of the Food and Drug Administration
to review 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 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 the 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.--(A) The term `biomarker' 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) such term 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.--(A) The term `clinical
outcome assessment' means 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) such term 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).
``(f) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $10,000,000 for each of fiscal
years 2016 through 2020.''.
(d) Guidance.--
(1) In general.--The Secretary of Health and Human Services
shall, in consultation with biomedical research consortia (as
defined in subsection (f) of section 507 the Federal Food,
Drug, and Cosmetic Act (as added by subsection (c))) 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) makes recommendations for demonstrating that a
surrogate endpoint is reasonably likely to predict
clinical benefit for the purpose of supporting the
accelerated approval of a drug under section 506(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356(c));
(C) 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
(D) includes such other information as the
Secretary determines appropriate.
(2) Timing.--Not later than 24 months after the date of the
enactment of this Act, the Secretary of Health and Human
Services 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 (c)). 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 of Health and
Human Services 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 12 months
after the date of the enactment of this Act, the
Secretary of Health and Human Services shall make such
taxonomy publicly available in draft form for public
comment. The Secretary shall finalize the taxonomy not
later than 12 months after the close of the public
comment period.
(e) Meeting and Report.--
(1) Meeting.--Not later than 12 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services 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 (c).
(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
(c), information on--
(A) the number of requests submitted, as a letter
of intent, for qualification of a drug development tool
(as defined in subsection (f) of such section);
(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 such subsection),
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
(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 (f) of such
section 507).
SEC. 2022. ACCELERATED APPROVAL DEVELOPMENT PLAN.
(a) In General.--Section 506 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356) is amended by adding the following
subsection:
``(g) Accelerated Approval Development Plan.--
``(1) In general.--In the case of a drug that the Secretary
determines may be eligible for accelerated approval in
accordance with subsection (c), the sponsor of such drug may
request, at any time after the 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, that the
Secretary agree to an accelerated approval development plan
described in paragraph (2).
``(2) Plan described.--A plan described in this paragraph,
with respect to a drug described in paragraph (1), is an
accelerated approval development plan, which shall include
agreement on--
``(A) the surrogate endpoint to be assessed under
such plan;
``(B) the design of the study that will utilize the
surrogate endpoint; and
``(C) the magnitude of the effect of the drug on
the surrogate endpoint that is the subject of the
agreement that would be sufficient to form the primary
basis of a claim that the drug is effective.
``(3) Modification; termination.--The Secretary may require
the sponsor of a drug that is the subject of an accelerated
approval development plan to modify or terminate the plan if
additional data or information indicates that--
``(A) the plan as originally agreed upon is no
longer sufficient to demonstrate the safety and
effectiveness of the drug involved; or
``(B) the drug is no longer eligible for
accelerated approval under subsection (c).
``(4) Sponsor consultation.--If the Secretary requires the
modification or termination of an accelerated approval
development plan under paragraph (3), the sponsor shall be
granted a request for a meeting to discuss the basis of the
Secretary's decision before the effective date of the
modification or termination.
``(5) Definition.--In this section, the term `accelerated
approval development plan' means a development plan agreed upon
by the Secretary and the sponsor submitting the plan that
contains study parameters for the use of a surrogate endpoint
that--
``(A) is reasonably likely to predict clinical
benefit; and
``(B) is intended to be the basis of the
accelerated approval of a drug in accordance with
subsection (c).''.
(b) Technical Amendments.--Section 506 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356) is amended--
(1) by striking ``(f) Awareness Efforts'' and inserting
``(e) Awareness Efforts''; and
(2) by striking ``(e) Construction'' and inserting ``(f)
Construction''.
Subtitle C--FDA Advancement of Precision Medicine
SEC. 2041. PRECISION MEDICINE GUIDANCE AND OTHER PROGRAMS OF FOOD AND
DRUG ADMINISTRATION.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.) is amended by adding at the end the following:
``Subchapter J--Precision Medicine
``SEC. 591. GENERAL AGENCY GUIDANCE ON PRECISION MEDICINE.
``(a) In General.--The Secretary shall issue and periodically
update guidance to assist sponsors in the development of a precision
drug or biological product. Such guidance shall--
``(1) define the term `precision drug or biological
product'; and
``(2) address the topics described in subsection (b).
``(b) Certain Issues.--The topics to be addressed by guidance under
subsection (a) are--
``(1) the evidence needed to support the use of biomarkers
(as defined in section 507(e)) that identify subsets of
patients as likely responders to therapies in order to
streamline the conduct of clinical trials;
``(2) recommendations for the design of studies to
demonstrate the validity of a biomarker as a predictor of drug
or biological product response;
``(3) the manner and extent to which a benefit-risk
assessment may be affected when clinical trials are limited to
patient population subsets that are identified using
biomarkers;
``(4) the development of companion diagnostics in the
context of a drug development program; and
``(5) considerations for developing biomarkers that inform
prescribing decisions for a drug or biological product, and
when information regarding a biomarker may be included in the
approved prescription labeling for a precision drug or
biological product.
``(c) Date Certain for Initial Guidance.--The Secretary shall issue
guidance under subsection (a) not later than 18 months after the date
of the enactment of the 21st Century Cures Act.
``SEC. 592. PRECISION MEDICINE REGARDING ORPHAN-DRUG AND EXPEDITED-
APPROVAL PROGRAMS.
``(a) In General.--In the case of a precision drug or biological
product that is the subject of an application submitted under section
505(b)(1), or section 351(a) of the Public Health Service Act, for the
treatment of a serious or life-threatening disease or condition and has
been designated under section 526 as a drug for a rare disease or
condition, the Secretary may--
``(1) consistent with applicable standards for approval,
rely upon data or information previously submitted by the
sponsor of the precision drug or biological product, or another
sponsor, provided that the sponsor of the precision drug or
biological product has obtained a contractual right of
reference to such other sponsor's data and information, in an
application approved under section 505(c) or licensed under
section 351(a) of the Public Health Service Act, as
applicable--
``(A) for a different drug or biological product;
or
``(B) for a different indication for such precision
drug or biological product,
in order to expedite clinical development for a precision drug
or biological product that is using the same or similar
approach as that used to support approval of the prior approved
application or license, as appropriate; and
``(2) as appropriate, consider the application for approval
of such precision drug or biological product to be eligible for
expedited review and approval programs described in section
506, including accelerated approval in accordance with
subsection (c) of such section.
``(b) Rule of Construction.--Nothing in this section shall be
construed to--
``(1) limit the authority of the Secretary to approve
products pursuant to this Act and the Public Health Service Act
as authorized prior to the date of enactment of this section;
or
``(2) confer any new rights, beyond those authorized under
this Act prior to enactment of this section, with respect to a
sponsor's ability to reference information contained in another
application submitted under section 505(b)(1) of this Act or
section 351(a) of the Public Health Service Act.''.
Subtitle D--Modern Trial Design and Evidence Development
SEC. 2061. BROADER APPLICATION OF BAYESIAN STATISTICS AND ADAPTIVE
TRIAL DESIGNS.
(a) Proposals for Use of Innovative Statistical Methods in Clinical
Protocols for Drugs and Biological Products.--For purposes of assisting
sponsors in incorporating adaptive trial design and Bayesian methods
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 shall conduct a public meeting and
issue guidance in accordance with subsection (b).
(b) Guidance Addressing Use of Adaptive Trial Designs and Bayesian
Methods.--
(1) In general.--The Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs (in
this subsection referred to as the ``Secretary''), shall--
(A) update and finalize the draft guidance
addressing the use of adaptive trial design for drugs
and biological products; and
(B) issue draft guidance on the use of Bayesian
methods in the development and regulatory review and
approval or licensure of drugs and biological products.
(2) Contents.--The guidances under paragraph (1) shall
address--
(A) the use of adaptive trial designs and Bayesian
methods in clinical trials, including clinical trials
proposed or submitted to 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 developing the
guidances required by paragraph (1), the Secretary shall
consult with stakeholders, including representatives of
regulated industry, academia, patient advocacy organizations,
and disease research foundations, through a public meeting to
be held not later than 1 year after the date of enactment of
this Act.
(4) Schedule.--The Secretary shall publish--
(A) the final guidance required by paragraph (1)(A)
not later than 18 months after the date of the public
meeting required by paragraph (3); and
(B) the guidance required by paragraph (1)(B) not
later than 48 months after the date of the public
meeting required by paragraph (3).
SEC. 2062. UTILIZING EVIDENCE FROM CLINICAL EXPERIENCE.
Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by
inserting after section 505E of such Act (21 U.S.C. 355f) the
following:
``SEC. 505F. UTILIZING EVIDENCE FROM CLINICAL EXPERIENCE.
``(a) In General.--The Secretary shall establish a program to
evaluate the potential use of evidence from clinical experience--
``(1) to help to support the approval of a new indication
for a drug approved under section 505(b); and
``(2) to help to support or satisfy postapproval study
requirements.
``(b) Evidence From Clinical Experience Defined.--In this section,
the term `evidence from clinical experience' means data regarding the
usage, or the potential benefits or risks, of a drug derived from
sources other than randomized clinical trials, including from
observational studies, registries, and therapeutic use.
``(c) Program Framework.--
``(1) In general.--Not later than 18 months after the date
of enactment of this section, 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 current sources of data developed through
clinical experience, including ongoing safety
surveillance, registry, claims, and patient-centered
outcomes research activities;
``(B) the gaps in current data collection
activities;
``(C) the current standards and methodologies for
collection and analysis of data generated through
clinical experience; 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, 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; or
``(ii) a contract, grant, or other
arrangement, as determined appropriate by the
Secretary with such a partnership or an
independent research organization.
``(d) Program Implementation.--The Secretary shall, not later than
24 months after the date of enactment of this section and in accordance
with the framework established under subsection (c), implement the
program to evaluate the potential use of evidence from clinical
experience.
``(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 evidence from
clinical experience for the purposes described in
subsection (a)(1) or (a)(2); and
``(B) the appropriate standards and methodologies
for collection and analysis of evidence from clinical
experience submitted for such purposes;
``(2) not later than 36 months after the date of enactment
of this section, issue draft guidance for industry as described
in paragraph (1); and
``(3) not later than 48 months after the date of enactment
of this section, after providing an opportunity for public
comment on the draft guidance, issue final guidance.
``(f) Rule of Construction.--
``(1) Subject to paragraph (2), nothing in this section
prohibits the Secretary from using evidence from clinical
experience for purposes not specified in this section, provided
the Secretary determines that sufficient basis exists for any
such nonspecified use.
``(2) 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. 505G. COLLECTING EVIDENCE FROM CLINICAL EXPERIENCE THROUGH
TARGETED EXTENSIONS OF THE SENTINEL SYSTEM.
``(a) In General.--The Secretary shall, in parallel to implementing
the program established under section 505F and in order to build
capacity for utilizing the evidence from clinical experience described
in that section, identify and execute pilot demonstrations to extend
existing use of the Sentinel System surveillance infrastructure
authorized under section 505(k).
``(b) Pilot Demonstrations.--
``(1) In general.--The Secretary--
``(A) shall design and implement pilot
demonstrations to utilize data captured through the
Sentinel System surveillance infrastructure authorized
under section 505(k) for purposes of, as appropriate--
``(i) generating evidence from clinical
experience to improve characterization or
assessment of risks or benefits of a drug
approved under section 505(c);
``(ii) protecting the public health; or
``(iii) advancing patient-centered care;
and
``(B) may make strategic linkages with sources of
complementary public health data and infrastructure the
Secretary determines appropriate and necessary.
``(2) Consultation.--In developing the pilot demonstrations
under this subsection, the Secretary shall--
``(A) consult with regulated industry, academia,
medical professional organizations, representatives of
patient advocacy organizations, disease research
foundations, and other interested parties through a
public process; and
``(B) develop a framework to promote appropriate
transparency and dialogue about research conducted
under these pilot demonstrations, including by--
``(i) providing adequate notice to a
sponsor of a drug approved under section 505 or
section 351 of the Public Health Service Act of
the Secretary's intent to conduct analyses of
such sponsor's drug or drugs under these pilot
demonstrations;
``(ii) providing adequate notice of the
findings related to analyses described in
clause (i) and an opportunity for the sponsor
of such drug or drugs to comment on such
findings; and
``(iii) ensuring the protection from public
disclosure of 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.
``(3) HIPAA privacy rule; human subject research
regulation.--The Secretary may deem such pilot demonstrations--
``(A) public health activities, for purposes of
which a use or disclosure of protected health
information would be permitted as described in section
164.512(b)(1) of title 45, Code of Federal Regulations
(or any successor regulation); and
``(B) outside the scope of `research' as defined in
section 46.102(d) of title 45, Code of Federal
Regulations (or any successor regulation).
``(c) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $3,000,000 for each of fiscal
years 2016 through 2020.''.
SEC. 2063. STREAMLINED DATA REVIEW PROGRAM.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act, as amended by section 2062, is further amended by inserting after
section 505G of such Act the following:
``SEC. 505H. STREAMLINED DATA REVIEW PROGRAM.
``(a) In General.--The Secretary shall establish a streamlined data
review program under which a holder of an approved application
submitted under section 505(b)(1) or under section 351(a) of the Public
Health Service Act may, to support the approval or licensure (as
applicable) of the use of the drug that is the subject of such approved
application for a new qualified indication, submit qualified data
summaries.
``(b) Eligibility.--In carrying out the streamlined data review
program under subsection (a), the Secretary may authorize the holder of
the approved application to include one or more qualified data
summaries described in subsection (a) in a supplemental application
if--
``(1) the drug has been approved under section 505(c) of
this Act or licensed under section 351(a) of the Public Health
Service Act for one or more indications, and such approval or
licensure remains in effect;
``(2) the supplemental application is for approval or
licensure (as applicable) under such section 505(c) or 351(a)
of the use of the drug for a new qualified indication under
such section 505(c) or 351(a);
``(3) there is an existing database acceptable to the
Secretary regarding the safety of the drug developed for one or
more indications of the drug approved under such section 505(c)
or licensed under such section 351(a);
``(4) the supplemental application incorporates or
supplements the data submitted in the application for approval
or licensure referred to in paragraph (1); and
``(5) the full data sets used to develop the qualified data
summaries are submitted, unless the Secretary determines that
the full data sets are not required.
``(c) Public Availability of Information on Program.--The Secretary
shall post on the public website of the Food and Drug Administration
and update annually--
``(1) the number of applications reviewed under the
streamlined data review program;
``(2) the average time for completion of review under the
streamlined data review program versus other review of
applications for new indications; and
``(3) the number of applications reviewed under the
streamlined data review program for which the Food and Drug
Administration made use of full data sets in addition to the
qualified data summary.
``(d) Definitions.--In this section:
``(1) The term `qualified indication' means--
``(A) an indication for the treatment of cancer, as
determined appropriate by the Secretary; or
``(B) such other types of indications as the
Secretary determines to be subject to the streamlined
data review program under this section.
``(2) The term `qualified data summary' means a summary of
clinical data intended to demonstrate safety and effectiveness
with respect to a qualified indication for use of a drug.''.
(b) Sense of Congress.--It is the sense of Congress that the
streamlined data review program under section 505H of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a), should enable the
Food and Drug Administration to make approval decisions for certain
supplemental applications based on qualified data summaries (as defined
in such section 505H).
(c) Guidance; Regulations.--The Commissioner of Food and Drugs--
(1) shall--
(A) issue final guidance for implementation of the
streamlined data review program established under
section 505H of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (a), not later than 24
months after the date of enactment of this Act; and
(B) include in such guidance the process for
expanding the types of indications to be subject to the
streamlined data review program, as authorized by
section 505H(c)(1)(B) of such Act; and
(2) in addition to issuing guidance under paragraph (1),
may issue such regulations as may be necessary for
implementation of the program.
Subtitle E--Expediting Patient Access
SEC. 2081. SENSE OF CONGRESS.
It is the sense of Congress that the Food and Drug Administration
should continue to expedite the approval of drugs designated as
breakthrough therapies pursuant to section 506(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356(a)) by approving drugs so
designated as early as possible in the clinical development process,
regardless of the phase of development, provided that the Secretary of
Health and Human Services determines that an application for such a
drug meets the standards of evidence of safety and effectiveness under
section 505 of such Act (21 U.S.C. 355), including the substantial
evidence standard under subsection (d) of such section or under section
351(a) of the Public Health Service Act (42 U.S.C. 262(a)).
SEC. 2082. 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 publicly
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. A manufacturer or distributor may satisfy the
requirement of the preceding sentence by posting such policy as
generally applicable to all of such manufacturer's or distributor's
investigational drugs.
``(b) Content of Policy.--A policy described in subsection (a)
shall include making publicly available--
``(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 consider or use to approve such requests; and
``(4) the length of time the manufacturer or distributor
anticipates will be necessary to acknowledge receipt of such
requests.
``(c) 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.
``(d) Revised Policy.--A manufacturer or distributor that has made
a policy publicly available as required by this section may revise the
policy at any time.
``(e) 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 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 new drug.''.
SEC. 2083. FINALIZING DRAFT GUIDANCE ON EXPANDED ACCESS.
(a) In General.--Not later than 12 months after the date of
enactment of this Act, the Secretary of Health and Human Services shall
finalize the draft guidance entitled ``Expanded Access to
Investigational Drugs for Treatment Use--Qs & As'' and dated May 2013.
(b) Contents.--The final guidance referred to in subsection (a)
shall clearly define how the Secretary of Health and Human Services
interprets and uses adverse drug event data reported by investigators
in the case of data reported from use under a request submitted under
section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb(b)).
Subtitle F--Facilitating Responsible Manufacturer Communications
SEC. 2101. FACILITATING DISSEMINATION OF 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. 2102. FACILITATING RESPONSIBLE COMMUNICATION OF SCIENTIFIC AND
MEDICAL DEVELOPMENTS.
(a) Guidance.--Not later than 18 months after the date of enactment
of this Act, the Secretary of Health and Human Services shall issue
draft guidance on facilitating the responsible dissemination of
truthful and nonmisleading scientific and medical information not
included in the approved labeling of drugs and devices.
(b) Definition.--In this section, the terms ``drug'' and ``device''
have the meaning given to such terms in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321).
Subtitle G--Antibiotic Drug Development
SEC. 2121. APPROVAL OF CERTAIN DRUGS FOR USE IN A LIMITED POPULATION OF
PATIENTS.
(a) Purpose.--The purpose of this section is to help to expedite
the development and availability of treatments for serious or life-
threatening bacterial or fungal infections in patients with unmet
needs, while maintaining safety and effectiveness standards for such
treatments, taking into account the severity of the infection and the
availability or lack of alternative treatments.
(b) Approval of Certain Antibacterial and Antifungal Drugs.--
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), as amended by section 2001, is further amended by adding at the
end the following new subsection:
``(z) Approval of Certain Antibacterial and Antifungal Drugs for
Use in a Limited Population of Patients.--
``(1) Process.--At the request of the sponsor of an
antibacterial or antifungal drug that is intended to treat a
serious or life-threatening infection, the Secretary--
``(A) may execute a written agreement with the
sponsor on the process for developing data to support
an application for approval of such drug, for use in a
limited population of patients in accordance with this
subsection;
``(B) shall proceed in accordance with this
subsection only if a written agreement is reached under
subparagraph (A);
``(C) shall provide the sponsor with an opportunity
to request meetings under paragraph (2);
``(D) if a written agreement is reached under
subparagraph (A), may approve the drug under this
subsection for such use--
``(i) in a limited population of patients
for which there is an unmet medical need;
``(ii) based on a streamlined development
program; and
``(iii) only if the standards for approval
under subsections (c) and (d) of this section
or licensure under section 351 of the Public
Health Service Act, as applicable, are met; and
``(E) in approving a drug in accordance with this
subsection, subject to subparagraph (D)(iii), may rely
upon--
``(i) traditional endpoints, alternate
endpoints, or a combination of traditional and
alternate endpoints, and, as appropriate, data
sets of a limited size; and
``(ii)(I) additional data, including
preclinical, pharmacologic, or pathophysiologic
evidence;
``(II) nonclinical susceptibility and
pharmacokinetic data;
``(III) data from phase 2 clinical trials;
and
``(IV) such other confirmatory evidence as
the Secretary determines appropriate to approve
the drug.
``(2) Formal meetings.--
``(A) In general.--To help to expedite and
facilitate the development and review of a drug for
which a sponsor intends to request approval in
accordance with this subsection, the Secretary may, at
the request of the sponsor, conduct meetings that
provide early consultation, timely advice, and
sufficient opportunities to develop an agreement
described in paragraph (1)(A) and help the sponsor
design and conduct a drug development program as
efficiently as possible, including the following types
of meetings:
``(i) An early consultation meeting.
``(ii) An assessment meeting.
``(iii) A postapproval meeting.
``(B) No altering of goals.--Nothing in this
paragraph shall be construed to alter agreed-upon goals
and procedures identified in the letters described in
section 101(b) of the Prescription Drug User Fee
Amendments of 2012.
``(C) Breakthrough therapies.--In the case of a
drug designated as a breakthrough therapy under section
506(a), the sponsor of such drug may elect to utilize
meetings provided under such section with respect to
such drug in lieu of meetings described in subparagraph
(A).
``(3) Labeling requirement.--The labeling of an
antibacterial or antifungal drug approved in accordance with
this subsection shall contain the statement `Limited
Population' in a prominent manner and adjacent to, and not more
prominent than, the brand name of the product. The prescribing
information for such antibacterial or antifungal 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.'.
``(4) Promotional materials.--The provisions of section
506(c)(2)(B) shall apply with respect to approval in accordance
with this subsection to the same extent and in the same manner
as such provisions apply with respect to accelerated approval
in accordance with section 506(c)(1).
``(5) Termination of requirements or conditions.--If a drug
is approved in accordance with this subsection for an
indication in a limited population of patients and is
subsequently approved or licensed under this section or section
351 of the Public Health Service Act, other than in accordance
with this subsection, for--
``(A) the same indication and the same conditions
of use, the Secretary shall remove any labeling
requirements or postmarketing conditions that were made
applicable to the drug under this subsection; or
``(B) a different indication or condition of use,
the Secretary shall not apply the labeling requirements
and postmarketing conditions that were made applicable
to the drug under this subsection to the subsequent
approval of the drug for such different indication or
condition of use.
``(6) Relation to other provisions.--Nothing in this
subsection shall be construed to prohibit the approval of a
drug for use in a limited population of patients in accordance
with this subsection, in combination with--
``(A) an agreement on the design and size of a
clinical trial pursuant to subparagraphs (B) and (C) of
subsection (b)(5);
``(B) designation and treatment of the drug as a
breakthrough therapy under section 506(a);
``(C) designation and treatment of the drug as a
fast track product under section 506(b); or
``(D) accelerated approval of the drug in
accordance with section 506(c).
``(7) Rule of construction.--Nothing in this subsection
shall be construed--
``(A) to alter the standards of evidence under
subsection (c) or (d) (including the substantial
evidence standard in subsection (d));
``(B) to waive or otherwise preclude the
application of requirements under subsection (o);
``(C) to otherwise, in any way, limit the authority
of the Secretary to approve products pursuant to this
Act and the Public Health Service Act as authorized
prior to the date of enactment of this subsection; or
``(D) to restrict in any manner, the prescribing of
antibiotics or other products by health care providers,
or to otherwise limit or restrict the practice of
health care.
``(8) Effective immediately.--The Secretary shall have the
authorities vested in the Secretary by this subsection
beginning on the date of enactment of this subsection,
irrespective of when and whether the Secretary promulgates
final regulations or guidance.
``(9) Definitions.--In this subsection:
``(A) Early consultation meeting.--The term `early
consultation meeting' means a pre-investigational new
drug meeting or an end-of-phase-1 meeting that--
``(i) is conducted to review and reach a
written agreement--
``(I) on the scope of the
streamlined development plan for a drug
for which a sponsor intends to request
approval in accordance with this
subsection; and
``(II) which, as appropriate, may
include agreement on the design and
size of necessary preclinical and
clinical studies early in the
development process, including clinical
trials whose data are intended to form
the primary basis for an effectiveness
claim; and
``(ii) provides an opportunity to discuss
expectations of the Secretary regarding studies
or other information that the Secretary deems
appropriate for purposes of applying paragraph
(5), relating to the termination of labeling
requirements or postmarketing conditions.
``(B) Assessment meeting.--The term `assessment
meeting' means an end-of-phase-2 meeting, pre-new drug
application meeting, or pre-biologics license
application meeting conducted to resolve questions and
issues raised during the course of clinical
investigations, and details addressed in the written
agreement regarding postapproval commitments or
expansion of approved uses.
``(C) Postapproval meeting.--The term `postapproval
meeting' means a meeting following initial approval or
licensure of the drug for use in a limited population,
to discuss any issues identified by the Secretary or
the sponsor regarding postapproval commitments or
expansion of approved uses.''.
(c) Guidance.--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 issue draft guidance
describing criteria, process, and other general considerations for
demonstrating the safety and effectiveness of antibacterial and
antifungal drugs to be approved for use in a limited population in
accordance with section 505(z) of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (b).
(d) Conforming Amendments.--
(1) Licensure of certain biological products.--Section
351(j) of the Public Health Service Act (42 U.S.C. 262(j)) is
amended--
(A) by striking ``(j)'' and inserting ``(j)(1)'';
(B) by inserting ``505(z),'' after ``505(p),''; and
(C) by adding at the end the following new
paragraph:
``(2) In applying section 505(z) of the Federal Food, Drug, and
Cosmetic Act to the licensure of biological products under this
section--
``(A) references to an antibacterial or antifungal drug
that is intended to treat a serious or life-threatening
infection shall be construed to refer to a biological product
intended to treat a serious or life-threatening bacterial or
fungal infection; and
``(B) references to approval of a drug under section 505(c)
of such Act shall be construed to refer to a licensure of a
biological product under subsection (a) of this section.''.
(2) Misbranding.--Section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352) is amended by adding at the
end the following new subsection:
``(dd) If it is a drug approved in accordance with section 505(z)
and its labeling does not meet the requirements under paragraph (3) of
such subsection, subject to paragraph (5) of such subsection.''.
(e) Evaluation.--
(1) Assessment.--Not later than 48 months after the date of
enactment of this Act, the Secretary of Health and Human
Services shall publish for public comment an assessment of the
program established under section 505(z) of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (b). Such
assessment shall determine if the limited-use pathway
established under such section 505(z) has improved or is likely
to improve patient access to novel antibacterial or antifungal
treatments and assess how the pathway could be expanded to
cover products for serious or life-threatening diseases or
conditions beyond bacterial and fungal infections.
(2) Meeting.--Not later than 90 days after the date of the
publication of such assessment, the Secretary, acting through
the Commissioner of Food and Drugs, shall hold a public meeting
to discuss the findings of the assessment, during which public
stakeholders may present their views on the success of the
program established under section 505(z) of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (b), and the
appropriateness of expanding such program.
(f) Expansion of Program.--If the Secretary of Health and Human
Services determines, based on the assessment under subsection (e)(1),
evaluation of the assessment, and any other relevant information, that
the public health would benefit from expansion of the limited-use
pathway established under section 505(z) of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (b)) beyond the drugs approved in
accordance with such section, the Secretary may expand such limited-use
pathway in accordance with such a determination. The approval of any
drugs under any such expansion shall be subject to the considerations
and requirements described in such section 505(z) for purposes of
expansion to other serious or life-threatening diseases or conditions.
(g) Monitoring.--The Public Health Service Act is amended by
inserting after section 317T (42 U.S.C. 247b-22) the following:
``SEC. 317U. MONITORING ANTIBACTERIAL AND ANTIFUNGAL DRUG USE AND
RESISTANCE.
``(a) Monitoring.--The Secretary shall use an appropriate
monitoring system to monitor--
``(1) the use of antibacterial and antifungal drugs,
including those receiving approval or licensure for a limited
population pursuant to section 505(z) of the Federal Food,
Drug, and Cosmetic Act; and
``(2) changes in bacterial and fungal resistance to drugs.
``(b) Public Availability of Data.--The Secretary shall make
summaries of the data derived from monitoring under this section
publicly available for the purposes of--
``(1) improving the monitoring of important trends in
antibacterial and antifungal resistance; and
``(2) ensuring appropriate stewardship of antibacterial and
antifungal drugs, including those receiving approval or
licensure for a limited population pursuant to section 505(z)
of the Federal Food, Drug, and Cosmetic Act.''.
SEC. 2122. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR
MICROORGANISMS.
(a) In General.--Section 511 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360a) is amended to read as follows:
``SEC. 511. IDENTIFYING AND UPDATING SUSCEPTIBILITY TEST INTERPRETIVE
CRITERIA FOR MICROORGANISMS.
``(a) Purpose; Identification of Criteria.--
``(1) Purpose.--The purpose of this section is to provide
the Secretary with an expedited, flexible method for--
``(A) clearance or premarket approval of
antimicrobial susceptibility testing devices utilizing
updated, recognized susceptibility test interpretive
criteria to characterize the in vitro susceptibility of
particular bacteria, fungi, or other microorganisms to
antimicrobial drugs; and
``(B) providing public notice of the availability
of recognized interpretive criteria to meet premarket
submission requirements or other requirements under
this Act for antimicrobial susceptibility testing
devices.
``(2) In general.--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) Bayesian and pharmacometric statistical
methodologies; 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 in accordance with paragraph
(2) (referred to in this section as the `Interpretive Criteria
Website').
``(2) Listing of susceptibility test interpretive criteria
standards.--
``(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)(B) 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 of limitations of
information.--The Interpretive Criteria Website shall
include the following:
``(i) A statement that--
``(I) the website provides
information about the susceptibility of
bacteria, fungi, or other
microorganisms to a certain drug (or
drugs); and
``(II) the safety and efficacy of
the drug in treating clinical
infections due to such bacteria, fungi,
or other microorganisms may not have
been established in adequate and well-
controlled clinical trials and the
clinical significance of such
susceptibility information in such
trials is unknown.
``(ii) A statement that directs health care
practitioners to consult the approved product
labeling for specific drugs to determine the
uses for which the Food and Drug Administration
has approved the product.
``(iii) Any other statement that the
Secretary determines appropriate to adequately
convey the limitations of the data supporting
susceptibility test interpretive criteria
standard listed 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, or the regulations promulgated
thereunder.
``(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 From
Standard Development Organizations.--
``(1) In general.--Beginning on the date of the
establishment of the Interpretive Criteria Website, and at
least every 6 months thereafter, the Secretary shall--
``(A) 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
``(B) 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).
``(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)(B) 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--
``(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 standards which differ from those recognized pursuant
to paragraph (1).
``(d) Antimicrobial Drug Labeling.--
``(1) Drugs marketed prior to establishment of interpretive
criteria website.--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--
``(A) not later than 1 year after establishment of
the Interpretive Criteria Website, shall submit to the
Secretary a supplemental application for purposes of
changing the drug's labeling to substitute a reference
or hyperlink to such Website for any susceptibility
test interpretive criteria and related information; and
``(B) may begin distribution of the drug involved
upon receipt by the Secretary of the supplemental
application for such change.
``(2) Drugs marketed subsequent to establishment of
interpretive criteria website.--With respect to antimicrobial
drugs lawfully introduced or delivered for introduction into
interstate commerce for commercial distribution on or after the
date of the establishment of the Interpretive Criteria Website,
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, 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 prominently and
conspicuously--
``(i) includes a statement that--
``(I) the device provides
information about the susceptibility of
bacteria and fungi to certain drugs;
and
``(II) the safety and efficacy of
such drugs in treating clinical
infections due to such bacteria or
fungi may not have been established in
adequate and well-controlled clinical
trials and the clinical significance of
such susceptibility information in
those instances is unknown;
``(ii) includes a statement directing
health care practitioners to consult the
approved labeling for drugs tested using such a
device, to determine the uses for which the
Food and Drug Administration has approved such
drugs; and
``(iii) includes any other statement the
Secretary determines appropriate to adequately
convey the limitations of the data supporting
the interpretive criteria described in
subparagraph (A).
``(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.
``(g) Rule of Construction.--Nothing in this section shall be
construed--
``(1) to alter the standards of evidence--
``(A) under subsection (c) or (d) of section 505,
including the substantial evidence standard in section
505(d), or under section 351 of the Public Health
Service Act (as applicable); or
``(B) with respect to marketing authorization for
devices, under section 510, 513, or 515;
``(2) to apply with respect to any drug, device, or
biological product, in any context other than--
``(A) an antimicrobial drug; or
``(B) an antimicrobial susceptibility testing
device that uses susceptibility test interpretive
criteria to characterize and report the in vitro
susceptibility of certain bacteria, fungi, or other
microorganisms to antimicrobial drugs in accordance
with this section; or
``(3) unless specifically stated, to 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 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) Clerical amendment.--The table of contents in section 2
of the Food and Drug Administration Amendments Act of 2007 is
amended by striking the item relating to section 1111.
(3) Misbranding.--Section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352), as amended by section 2121,
is further amended by adding at the end the following:
``(ee) If it is an antimicrobial drug and its labeling fails to
conform with the requirements under section 511(d).''.
(4) Recognition of interpretive criteria 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 susceptibility
test interpretive criteria or standards recognized or otherwise
listed under section 511, 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 Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on the progress made in implementing
section 511 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360a), as amended by this section.
(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 the updating of lists
under paragraph (2) of subsection (b) section 511 of the Federal Food,
Drug, and Cosmetic Act (as amended by subsection (a)) and posted on the
Interpretive Criteria Website established under paragraph (1) of such
subsection (b).
(e) No Effect on Health Care Practice.--Nothing in this subtitle
(including the amendments made by this subtitle) shall be construed to
restrict, in any manner, the prescribing or administering of
antibiotics or other products by health care practitioners, or to limit
the practice of health care.
SEC. 2123. ENCOURAGING THE DEVELOPMENT AND USE OF DISARM DRUGS.
(a) Additional Payment for DISARM Drugs Under Medicare.--
(1) In general.--Section 1886(d)(5) of the Social Security
Act (42 U.S.C. 1395ww(d)(5)) is amended by adding at the end
the following new subparagraph:
``(M)(i) As part of the annual rulemaking conducted with respect to
payment for subsection (d) hospitals for each fiscal year beginning
with fiscal year 2018, the Secretary shall--
``(I) include a list of the DISARM drugs for such fiscal
year; and
``(II) with respect to discharges by eligible hospitals
that involve a drug so listed, provide for an additional
payment to be made under this subsection in accordance with the
provisions of this subparagraph.
``(ii) Additional payments may not be made for a drug under this
subparagraph--
``(I) other than during the 5-fiscal-year period beginning
with the fiscal year for which the drug is first included in
the list described in clause (i)(I); and
``(II) with respect to which payment has ever been made
pursuant to subparagraph (K).
``(iii) For purposes of this subparagraph, the term `DISARM drug'
means a product that is approved for use, or a product for which an
indication is first approved for use, by the Food and Drug
Administration on or after December 1, 2014, and that the Food and Drug
Administration determines is an antimicrobial product (as defined in
clause (iv)) and is intended to treat an infection--
``(I) for which there is an unmet medical need; and
``(II) which is associated with high rates of mortality or
significant patient morbidity, as determined in consultation
with the Director of the Centers for Disease Control and
Prevention and the infectious disease professional community.
``(iv) For purposes of clause (iii), the term `antimicrobial
product' means a product that either--
``(I) is intended to treat an infection caused by, or
likely to be caused by, a qualifying pathogen (as defined under
section 505E(f) of the Federal Food, Drug, and Cosmetic Act);
or
``(II) meets the definition of a qualified infectious
disease product under section 505E(g) of the Federal Food,
Drug, and Cosmetic Act.
Such determination may be revoked only upon a finding
that the request for such determination contained an
untrue statement of material fact.
``(v) For purposes of this subparagraph, the term `eligible
hospital' means a subsection (d) hospital that participates in the
National Healthcare Safety Network of the Centers for Disease Control
and Prevention (or, to the extent a similar surveillance system that
includes reporting about antimicrobial drugs is determined by the
Secretary to be available to such hospitals, such similar surveillance
system as the Secretary may specify).
``(vi) Subject to the succeeding provisions of this subparagraph,
the additional payment under this subparagraph, with respect to a drug,
shall be in the amount provided for such drug under section 1847A.
``(vii) As part of the rulemaking referred to in clause (i) for
each fiscal year, the Secretary shall estimate--
``(I) total add-on payments (as defined in subclause (I) of
clause (ix)); and
``(II) total hospital payments (as defined in subclause
(II) of such clause).
``(viii) If the total add-on payments estimated pursuant to clause
(vii)(I) for a fiscal year exceed 0.02 percent of the total hospital
payments estimated pursuant to clause (vii)(II) for such fiscal year,
the Secretary shall reduce in a pro rata manner the amount of each
additional payment under this subsection pursuant to this subparagraph
for such fiscal year in order to ensure that the total add-on payments
estimated for such fiscal year do not exceed 0.02 percent of the total
hospital payments estimated for such fiscal year.
``(ix) In this subparagraph:
``(I) The term `total add-on payments' means, with respect
to a fiscal year, the total amount of the additional payments
under this subsection pursuant to this subparagraph for
discharges in such fiscal year without regard to the
application of clause (viii).
``(II) The term `total hospital payments' means, with
respect to a fiscal year, the total amount of payments made
under this subsection for all discharges in such fiscal
year.''.
(2) Conforming amendments.--
(A) No duplicative ntap payments.--Section
1886(d)(5)(K)(vi) of the Social Security Act (42 U.S.C.
1395ww(d)(5)(K)(vi)) is amended by inserting ``and if
additional payment has never been made under this
subsection pursuant to subparagraph (M) with respect to
the service or technology'' before the period at the
end.
(B) Access to price information.--Section
1927(b)(3)(A) of the Social Security Act (42 U.S.C.
1396r-8(b)(3)(A)) is amended--
(i) in clause (ii)--
(I) by striking ``for each'' and
inserting ``, for each''; and
(II) by striking ``and'' at the
end;
(ii) in clause (iii)--
(I) in subclause (II), by inserting
``or under section 1886(d) pursuant to
paragraph (5)(M) of such section,''
after ``1847A,'';
(II) in the matter following
subclause (III), by striking ``or
1881(b)(13)(A)(ii)'' and inserting ``,
section 1881(b)(13)(A)(ii), or section
1886(d)(5)(M)''; and
(III) by striking the period at the
end and inserting ``; and''; and
(iii) in clause (iv), by striking the
semicolon at the end and inserting a period.
(b) Study and Report on Removing Barriers to Development of DISARM
Drugs.--
(1) Study.--The Comptroller General of the United States
shall, in consultation with the Director of the National
Institutes of Health, the Commissioner of Food and Drugs, and
the Director of the Centers for Disease Control and Prevention,
conduct a study to--
(A) identify and examine the barriers that prevent
the development of DISARM drugs, as defined in section
1886(d)(5)(M)(iii) of the Social Security Act (42
U.S.C. 1395ww(d)(5)(M)(iii)), as added by subsection
(a)(1); and
(B) develop recommendations for actions to be taken
in order to overcome any barriers identified under
subparagraph (A).
(2) Report.--Not later than 1 year after the date of the
enactment of this Act, the Comptroller General shall submit to
Congress a report on the study conducted under paragraph (1).
(c) Study and Report on the Impact of Additional Medicare Payment
for DISARM Drugs on Usage Practices and Development of Resistance.--
(1) Study.--The Director of the Centers for Disease Control
and Prevention shall conduct a study to examine the effects of
the additional payment for DISARM drugs under the Medicare
Program provided under subparagraph (M) of section 1886(d)(5)
of the Social Security Act (42 U.S.C. 1395ww(d)(5)), as added
by subsection (a), on--
(A) the usage of DISARM drugs (as defined by clause
(iii) of such subparagraph) by subsection (d) hospitals
(as defined in section 1886(d)(1)(B) of such Act); and
(B) the development of resistance by individuals to
such DISARM drugs.
(2) Report.--Not later than 3 years after the date of the
enactment of this Act, such Director shall submit to Congress a
report on the study conducted under paragraph (1).
Subtitle H--Vaccine Access, Certainty, and Innovation
SEC. 2141. TIMELY REVIEW OF VACCINES BY THE ADVISORY COMMITTEE ON
IMMUNIZATION PRACTICES.
Section 2102(a) of the Public Health Service Act (42 U.S.C. 300aa-
2(a)) is amended by adding at the end the following:
``(10) Advisory committee on immunization practices.--
``(A) Standard periods of time for making
recommendations.--Upon the licensure of any vaccine or
any new indication for a vaccine, the Director of the
Program shall direct the Advisory Committee on
Immunization Practices, at its next regularly scheduled
meeting, to consider the use of the vaccine.
``(B) Expedited review pursuant to request by
sponsor or manufacturer.--If the Advisory Committee
does not make recommendations 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, at the request of the sponsor of
the vaccine, shall make such recommendations on an
expedited basis.
``(C) Expedited review for breakthrough therapies
and for use during public health emergencies.--If a
vaccine is designated as a breakthrough therapy under
section 506 of the Federal Food, Drug, and Cosmetic
Act, and is licensed under section 351 of this Act, the
Advisory Committee shall make recommendations with
respect to the use of the vaccine on an expedited
basis.
``(D) Definition.--In this paragraph, 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, acting through the Director of
the Centers for Disease Control and Prevention.''.
SEC. 2142. REVIEW OF PROCESSES AND CONSISTENCY OF ACIP RECOMMENDATIONS.
(a) Review.--The Director of the Centers for Disease Control and
Prevention shall conduct a review of the process used by the Advisory
Committee on Immunization Practices to evaluate consistency in
formulating and issuing recommendations pertaining to vaccines.
(b) Considerations.--The review under subsection (a) shall include
assessment of--
(1) the criteria used to evaluate new and existing
vaccines;
(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 working
groups of the Advisory Committee on Immunization Practices are
consistent among groups.
(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 recommendations on improving the consistency
of the process 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. 2143. MEETINGS BETWEEN CDC AND VACCINE DEVELOPERS.
Section 310 of the Public Health Service Act (42 U.S.C. 242o) is
amended by adding at the end the following:
``(c)(1) In this subsection, the term `vaccine developer' means a
nongovernmental entity engaged in--
``(A)(i) the development of a vaccine with the intent to
pursue licensing of the vaccine by the Food and Drug
Administration; or
``(ii) the production of a vaccine licensed by the Food and
Drug Administration; and
``(B) vaccine research.
``(2)(A) Upon the submission of a written request for a meeting by
a vaccine developer, that includes a valid justification for the
meeting, the Secretary, acting through the Director of the Centers for
Disease Control and Prevention, shall convene a meeting of
representatives of the vaccine developer and experts from the Centers
for Disease Control and Prevention in immunization programs,
epidemiology, and other relevant areas at which the Director (or the
Director's designee), for the purpose of informing the vaccine
developer's understanding of public health needs and priorities, shall
provide the perspectives of the Centers for Disease Control and
Prevention and other relevant Federal agencies regarding--
``(i) public health needs, epidemiology, and implementation
considerations with regard to a vaccine developer's potential
vaccine profile; and
``(ii) potential implications of such perspectives for the
vaccine developer's vaccine research and development planning.
``(B) In addition to the representatives specified in subparagraph
(A), the Secretary may, with the agreement of the vaccine developer
requesting a meeting under such subparagraph, include in such meeting
representatives of--
``(i) the Food and Drug Administration; and
``(ii) the National Vaccine Program.
``(C) The Secretary shall convene a meeting requested with a valid
justification under subparagraph (A) not later than 120 days after
receipt of the request for the meeting.
``(3)(A) Upon the submission of a written request by a vaccine
developer, the Secretary, acting through the Director of the Centers
for Disease Control and Prevention, shall provide to the vaccine
developer any age-based or other demographically assessed disease
epidemiological analyses or data that--
``(i) are specified in the request;
``(ii) have been published;
``(iii) have been performed by or are in the possession of
the Centers;
``(iv) are not a trade secret or commercial or financial
information that is privileged or confidential and subject to
section 552(b)(4) of title 5, United States Code, or section
1905 of title 18, United States Code; and
``(v) do not contain individually identifiable information.
``(B) The Secretary shall provide analyses requested by a vaccine
manufacturer under subparagraph (A) not later than 120 calendar days
after receipt of the request for the analyses.
``(4) The Secretary shall promptly notify a vaccine developer if--
``(A) the Secretary becomes aware of any significant change
to information that was--
``(i) shared by the Secretary with the vaccine
developer during a meeting under paragraph (2); or
``(ii) provided by the Secretary to the vaccine
developer in one or more analyses under paragraph (3);
and
``(B) the change to such information may have implications
for the vaccine developer's vaccine research and
development.''.
Subtitle I--Orphan Product Extensions Now; Incentives for Certain
Products for Limited Populations
SEC. 2151. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG APPROVED FOR A
NEW INDICATION FOR A RARE DISEASE OR CONDITION.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act, as amended by sections 2062 and 2063, is further amended by
inserting after section 505H of such Act the following:
``SEC. 505I. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG APPROVED FOR A
NEW INDICATION FOR A RARE DISEASE OR CONDITION.
``(a) Designation.--
``(1) In general.--The Secretary shall designate a drug as
a drug approved for a new indication to prevent, diagnose, or
treat a rare disease or condition for purposes of granting the
extensions under subsection (b) if--
``(A) prior to approval of an application or
supplemental application for the new indication, the
drug was approved or licensed for marketing under
section 505(c) of this Act or section 351(a) of the
Public Health Service Act but was not so approved or
licensed for the new indication;
``(B)(i) the sponsor of the approved or licensed
drug files an application or a supplemental application
for approval of the new indication for use of the drug
to prevent, diagnose, or treat the rare disease or
condition; and
``(ii) the Secretary approves the application or
supplemental application; and
``(C) the application or supplemental application
for the new indication contains the consent of the
applicant to notice being given by the Secretary under
paragraph (4) respecting the designation of the drug.
``(2) Revocation of designation.--
``(A) In general.--Except as provided in
subparagraph (B), a designation under paragraph (1)
shall not be revoked for any reason.
``(B) Exception.--The Secretary may revoke a
designation of a drug under paragraph (1) if the
Secretary finds that the application or supplemental
application resulting in such designation contained an
untrue statement of material fact.
``(3) Notification prior to discontinuance of production
for solely commercial reasons.--A designation of a drug under
paragraph (1) shall be subject to the condition that the
sponsor of the drug will notify the Secretary of any
discontinuance of the production of the drug for solely
commercial reasons at least 1 year before such discontinuance.
``(4) Notice to public.--Notice respecting the designation
of a drug under paragraph (1) shall be made available to the
public.
``(b) Extension.--If the Secretary designates a drug as a drug
approved for a new indication for a rare disease or condition, as
described in subsection (a)(1)--
``(1)(A) the 4-, 5-, and 7\1/2\-year periods described in
subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the
3-year periods described in clauses (iii) and (iv) of
subsection (c)(3)(E) and clauses (iii) and (iv) of subsection
(j)(5)(F) of section 505, and the 7-year period described in
section 527, as applicable, shall be extended by 6 months; or
``(B) the 4- and 12-year periods described in subparagraphs
(A) and (B) of section 351(k)(7) of the Public Health Service
Act and the 7-year period described in section 527, as
applicable, shall be extended by 6 months; and
``(2)(A) if the drug is the subject of a listed patent for
which a certification has been submitted under subsection
(b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 or a listed
patent for which a certification has been submitted under
subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section
505, the period during which an application may not be approved
under section 505(c)(3) or section 505(j)(5)(B) shall be
extended by a period of 6 months after the date the patent
expires (including any patent extensions); or
``(B) if the drug is the subject of a listed patent for
which a certification has been submitted under subsection
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the
patent infringement litigation resulting from the certification
the court determines that the patent is valid and would be
infringed, the period during which an application may not be
approved under section 505(c)(3) or section 505(j)(5)(B) shall
be extended by a period of 6 months after the date the patent
expires (including any patent extensions).
``(c) Relation to Pediatric and Qualified Infectious Disease
Product Exclusivity.--Any extension under subsection (b) of a period
shall be in addition to any extension of the periods under sections
505A and 505E of this Act and section 351(m) of the Public Health
Service Act, as applicable, with respect to the drug.
``(d) Limitations.--The extension described in subsection (b) shall
not apply if the drug designated under subsection (a)(1) has previously
received an extension by operation of subsection (b).
``(e) Definition.--In this section, the term `rare disease or
condition' has the meaning given to such term in section 526(a)(2).''.
(b) Application.--Section 505G of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), applies only with respect to
a drug for which an application or supplemental application described
in subsection (a)(1)(B)(i) of such section 505G is first approved under
section 505(c) of such Act (21 U.S.C. 355(c)) or section 351(a) of the
Public Health Service Act (42 U.S.C. 262(a)) on or after the date of
the enactment of this Act.
(c) Conforming Amendments.--
(1) Relation to pediatric exclusivity for drugs.--Section
505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a) is amended--
(A) in subsection (b), by adding at the end the
following:
``(3) Relation to exclusivity for a drug approved for a new
indication for a rare disease or condition.--Notwithstanding
the references in paragraph (1) to the lengths of the
exclusivity periods after application of pediatric exclusivity,
the 6-month extensions described in paragraph (1) shall be in
addition to any extensions under section 505G.''; and
(B) in subsection (c), by adding at the end the
following:
``(3) Relation to exclusivity for a drug approved for a new
indication for a rare disease or condition.--Notwithstanding
the references in paragraph (1) to the lengths of the
exclusivity periods after application of pediatric exclusivity,
the 6-month extensions described in paragraph (1) shall be in
addition to any extensions under section 505G.''.
(2) Relation to exclusivity for new qualified infectious
disease products that are drugs.--Subsection (b) of section
505E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355f) is amended--
(A) by amending the subsection heading to read as
follows: ``Relation to Pediatric Exclusivity and
Exclusivity for a Drug Approved for a New Indication
for a Rare Disease or Condition.--''; and
(B) by striking ``any extension of the period under
section 505A'' and inserting ``any extension of the
periods under sections 505A and 505G, as applicable,''.
(3) Relation to pediatric exclusivity for biological
products.--Section 351(m) of the Public Health Service Act (42
U.S.C. 262(m)) is amended by adding at the end the following:
``(5) Relation to exclusivity for a biological product
approved for a new indication for a rare disease or
condition.--Notwithstanding the references in paragraphs
(2)(A), (2)(B), (3)(A), and (3)(B) to the lengths of the
exclusivity periods after application of pediatric exclusivity,
the 6-month extensions described in such paragraphs shall be in
addition to any extensions under section 505G.''.
SEC. 2152. REAUTHORIZATION OF RARE PEDIATRIC DISEASE PRIORITY REVIEW
VOUCHER INCENTIVE PROGRAM.
(a) In General.--Section 529 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360ff) is amended--
(1) in subsection (a)--
(A) in paragraph (3), by amending subparagraph (A)
to read as follows:
``(A) The disease is a serious or life-threatening
disease in which the serious or life-threatening
manifestations primarily affect individuals aged from
birth to 18 years, including age groups often called
neonates, infants, children, and adolescents.''; and
(B) in paragraph (4)--
(i) in subparagraph (E), by striking
``and'' at the end;
(ii) in subparagraph (F), by striking the
period at the end and inserting ``; and''; and
(iii) by adding at the end the following:
``(G) is for a drug or biological product for which
a priority review voucher has not been issued under
section 524 (relating to tropical disease products).'';
and
(2) in subsection (b), by striking paragraph (5) and
inserting the following:
``(5) Termination of authority.--
``(A) In general.--The Secretary may not award any
priority review vouchers under paragraph (1) after
December 31, 2018.
``(B) Exception.--Notwithstanding subparagraph (A),
the sponsor of a drug that is designated under
subsection (d) as a drug for a rare pediatric disease
and that is the subject of a rare pediatric disease
product application that is submitted during the period
beginning on the date of enactment of the 21st Century
Cures Act and ending the date specified in subparagraph
(A) shall remain eligible to receive a priority review
voucher under paragraph (1) irrespective of whether the
rare pediatric disease product application with respect
to such drug is approved after the end of such
period.''.
(b) GAO Study and Report.--
(1) Study.--The Comptroller General of the United States
shall conduct a study on the effectiveness of awarding priority
review vouchers under section 529 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360ff) in providing incentives for
the development of drugs that treat or prevent rare pediatric
diseases (as defined in subsection (a)(3) of such section) that
would not otherwise have been developed. In conducting such
study, the Comptroller General shall examine the following:
(A) The indications for which each drug for which a
priority review voucher was awarded under such section
529 was approved under section 505 of such Act (21
U.S.C. 355) or section 351 of the Public Health Service
Act (42 U.S.C. 262).
(B) Whether the priority review voucher impacted a
sponsor's decision to invest in developing a drug to
treat or prevent a rare pediatric disease.
(C) An analysis of the drugs that utilized such
priority review vouchers, which shall include--
(i) the indications for which such drugs
were approved under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
section 351 of the Public Health Service Act
(42 U.S.C. 262);
(ii) whether unmet medical needs were
addressed through the approval of such drugs,
including, for each such drug--
(I) if an alternative therapy was
previously available to treat the
indication; and
(II) the benefit or advantage the
drug provided over another available
therapy;
(iii) the number of patients potentially
treated by such drugs;
(iv) the value of the priority review
voucher if transferred; and
(v) the length of time between the date on
which a priority review voucher was awarded and
the date on which it was used.
(D) With respect to the priority review voucher
program under section 529 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360ff)--
(i) the resources used by, and burden
placed on, the Food and Drug Administration in
implementing such program, including the effect
of such program on the Food and Drug
Administration's review of drugs for which a
priority review voucher was not awarded or
used;
(ii) the impact of the program on the
public health as a result of the expedited
review of applications for drugs that treat or
prevent non-serious indications that are
generally used by the broader public; and
(iii) alternative approaches to improving
such program so that the program is
appropriately targeted toward providing
incentives for the development of clinically
important drugs that--
(I) prevent or treat rare pediatric
diseases; and
(II) would likely not otherwise
have been developed to prevent or treat
such diseases.
(2) Report.--Not later than December 31, 2017, 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 containing the results of
the study of conducted under paragraph (1).
Subtitle J--Domestic Manufacturing and Export Efficiencies
SEC. 2161. GRANTS FOR STUDYING THE PROCESS OF CONTINUOUS DRUG
MANUFACTURING.
(a) In General.--The Commissioner of Food and Drugs 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 to 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
to such term in section 351(i) of the Public Health Service Act
(42 U.S.C. 262(i)).
(3) The term ``institution of higher education'' has the
meaning given to such term in section 101 of the Higher
Education Act of 1965 (20 U.S.C. 1001).
(c) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $5,000,000 for each of fiscal
years 2016 through 2020.
SEC. 2162. RE-EXPORTATION AMONG MEMBERS OF THE EUROPEAN ECONOMIC AREA.
Section 1003 of the Controlled Substances Import and Export Act (21
U.S.C. 953) is amended--
(1) in subsection (f)--
(A) in paragraph (5)--
(i) by striking ``(5)'' and inserting
``(5)(A)'';
(ii) by inserting ``, except that the
controlled substance may be exported from the
second country to another country that is a
member of the European Economic Area'' before
the period at the end; and
(iii) by adding at the end the following:
``(B) Subsequent to any re-exportation described in
subparagraph (A), a controlled substance may continue to be
exported from any country that is a member of the European
Economic Area to any other such country, provided that--
``(i) the conditions applicable with respect to the
first country under paragraphs (1), (2), (3), (4), (6),
and (7) are met by each subsequent country from which
the controlled substance is exported pursuant to this
paragraph; and
``(ii) the conditions applicable with respect to
the second country under such paragraphs are met by
each subsequent country to which the controlled
substance is exported pursuant to this paragraph.'';
and
(B) in paragraph (6)--
(i) by striking ``(6)'' and inserting
``(6)(A)''; and
(ii) by adding at the end the following:
``(B) In the case of re-exportation among members of the
European Economic Area, within 30 days after each re-
exportation, the person who exported the controlled substance
from the United States delivers to the Attorney General--
``(i) documentation certifying that such re-
exportation has occurred; and
``(ii) information concerning the consignee,
country, and product.''; and
(2) by adding at the end the following:
``(g) Limitation.--Subject to paragraphs (5) and (6) of subsection
(f) in the case of any controlled substance in schedule I or II or any
narcotic drug in schedule III or IV, the Attorney General shall not
promulgate nor enforce any regulation, subregulatory guidance, or
enforcement policy which impedes re-exportation of any controlled
substance among European Economic Area countries, including by
promulgating or enforcing any requirement that--
``(1) re-exportation from the first country to the second
country or re-exportation from the second country to another
country occur within a specified period of time; or
``(2) information concerning the consignee, country, and
product be provided prior to exportation of the controlled
substance from the United States or prior to each re-
exportation among members of the European Economic Area.''.
Subtitle K--Enhancing Combination Products Review
SEC. 2181. ENHANCING COMBINATION PRODUCTS REVIEW.
Section 503(g)(4)(C) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(g)(4)(C)) is amended by adding at the end the following
new clause:
``(iii) Not later than 18 months after the date of the enactment of
the 21st Century Cures Act, the Secretary shall issue final guidance
that describes the responsibilities of each agency center regarding its
review of combination products. The Secretary shall, after soliciting
public comment, review and update the guidance periodically.''.
Subtitle L--Priority Review for Breakthrough Devices
SEC. 2201. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act is amended--
(1) in section 515(d)--
(A) by striking paragraph (5); and
(B) by redesignating paragraph (6) as paragraph
(5); and
(2) by inserting after section 515A (21 U.S.C. 360e-1) the
following:
``SEC. 515B. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.
``(a) In General.--In order to provide for more effective treatment
or diagnosis of life-threatening or irreversibly debilitating human
diseases or conditions, the Secretary shall establish a program to
provide priority review for devices--
``(1) representing breakthrough technologies;
``(2) for which no approved alternatives exist;
``(3) offering significant advantages over existing
approved or cleared alternatives, including the potential to,
compared to existing approved or cleared alternatives, 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
``(4) the availability of which is in the best interest of
patients.
``(b) Request for Designation.--A sponsor of a device may request
that the Secretary designate the device for 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 petition
for classification under section 513(f)(2), or a notification under
section 510(k).
``(c) Designation Process.--
``(1) In general.--Not later than 60 calendar days after
the receipt of a request under subsection (b), the Secretary
shall determine whether the device that is the subject of the
request meets the criteria described in subsection (a). If the
Secretary determines that the device meets the criteria, the
Secretary shall designate the device for priority review.
``(2) Review.--Review of a request under subsection (b)
shall be undertaken by a team that is composed of experienced
staff and managers of the Food and Drug Administration and is
chaired by a senior manager.
``(3) Designation determination.--A determination approving
or denying a request under subsection (b) shall be considered a
significant decision under section 517A and the Secretary shall
provide a written, substantive summary of the basis for the
determination in accordance with section 517A(a).
``(4) Reconsideration.--
``(A) Request for reconsideration.--Any person
whose request under subsection (b) is denied may,
within 30 days of the denial, request reconsideration
of the denial in accordance with section 517A(b)--
``(i) based upon the submission of
documents by such person; or
``(ii) based upon such documents and a
meeting or teleconference.
``(B) Response.--Reconsideration of a designation
determination under this paragraph shall be conducted
in accordance with section 517A(b).
``(5) Withdrawal.--If the Secretary approves a priority
review designation for a device under this section, the
Secretary may not withdraw the designation based on the fact
that the criteria specified in subsection (a) are no longer met
because of the subsequent clearance or approval of another
device that was designated under--
``(A) this section; or
``(B) section 515(d)(5) (as in effect immediately
prior to the enactment of the 21st Century Cures Act).
``(d) Priority Review.--
``(1) Actions.--For purposes of expediting the development
and review of devices designated under subsection (c), 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 (b);
``(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 (b) for the
device;
``(C) adopt an efficient process for timely dispute
resolution;
``(D) provide for interactive communication with
the sponsor of the device during the review process;
``(E) expedite the Secretary's review of
manufacturing and quality systems compliance, as
applicable;
``(F) disclose to the sponsor in advance the topics
of any consultation concerning the sponsor's device
that the Secretary intends to undertake with external
experts or an advisory committee and provide the
sponsor an opportunity to recommend such external
experts;
``(G) for applications submitted under section
515(c), provide for advisory committee input, as the
Secretary determines appropriate (including in response
to the request of the sponsor); and
``(H) assign staff to be available within a
reasonable time to address questions posed 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
(c), 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 as practicable, such as
through adoption of shorter or smaller clinical trials,
application of surrogate endpoints, and use of adaptive
trial designs and Bayesian statistics, to the extent
scientifically appropriate;
``(C) facilitate, to the extent scientifically
appropriate, expedited and efficient development and
review of the device through utilization of timely
postmarket data collection, with regard to applications
for approval under section 515(c); and
``(D) agree to clinical protocols that the
Secretary will consider binding on the Secretary and
the sponsor, subject to--
``(i) changes agreed to by the sponsor and
the Secretary;
``(ii) changes that the Secretary
determines are required to prevent an
unreasonable risk to the public health; or
``(iii) the identification of a substantial
scientific issue determined by the Secretary to
be essential to the safety or effectiveness of
the device involved.
``(e) Priority Review Guidance.--
``(1) Content.--The Secretary shall issue guidance on the
implementation of this section. Such guidance shall include the
following:
``(A) The process for a person to seek a priority
review designation.
``(B) A template for requests under subsection (b).
``(C) The criteria the Secretary will use in
evaluating a request for priority review.
``(D) The standards the Secretary will use in
assigning a team of staff, including team leaders, to
review devices designated for priority review,
including any training required for such personnel on
effective and efficient review.
``(2) Process.--Prior to finalizing the guidance under
paragraph (1), the Secretary shall propose such guidance for
public comment.
``(f) Construction.--
``(1) Purpose.--This section is intended to encourage the
Secretary and provide the Secretary sufficient authorities to
apply efficient and flexible approaches to expedite the
development of, and prioritize the agency's review of, devices
that represent breakthrough technologies.
``(2) Construction.--Nothing in this section shall be
construed to alter 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 of the least burdensome means of evaluating
device effectiveness or demonstrating substantial equivalence
between devices with differing technological characteristics,
as applicable. Nothing in this section alters the authority of
the Secretary to act on an application pursuant to section
515(d) before completion of an establishment inspection, as the
Secretary deems appropriate.''.
(b) Conforming Amendment Related to Designation Determinations.--
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 515B,'' after ``an application under section
515,''.
Subtitle M--Medical Device Regulatory Process Improvements
SEC. 2221. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.
(a) Establishment of Third-Party Quality System Assessment
Program.--Chapter V of the Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 524A (21 U.S.C. 360n-1) the
following new section:
``SEC. 524B. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.
``(a) Accreditation and Assessment.--
``(1) In general; certification of device quality system.--
The Secretary shall, in accordance with this section, establish
a third-party quality system assessment program--
``(A) to accredit persons to assess whether a
requestor's quality system, including its design
controls, can reasonably assure the safety and
effectiveness of in-scope devices subject to device-
related changes;
``(B) under which accredited persons shall (as
applicable) certify that a requestor's quality system
meets the criteria included in the guidance issued
under paragraph (5) with respect to the in-scope
devices at issue; and
``(C) under which the Secretary shall rely on such
certifications for purposes of determining the safety
and effectiveness (or as applicable, substantial
equivalence) of in-scope devices subject to the device-
related changes involved, in lieu of compliance with
the following submission requirements:
``(i) A premarket notification.
``(ii) A 30-day notice.
``(iii) A Special PMA supplement.
``(2) Definitions.--For purposes of this sectionU
``(A) the term `device-related changes' means
changes made by a requestor with respect to in-scope
devices, which are--
``(i) changes to a device found to be
substantially equivalent under sections 513(i)
and 510(k) to a predicate device, that--
``(I) would otherwise be subject to
a premarket notification; and
``(II) do not alter--
``(aa) the intended use of
the changed device; or
``(bb) the fundamental
scientific technology of such
device;
``(ii) manufacturing changes subject to a
30-day notice;
``(iii) changes that qualify for a Special
PMA Supplement; and
``(iv) such other changes relating to the
devices or the device manufacturing process as
the Secretary determines appropriate;
``(B) the term `in-scope device' means a device
within the scope of devices agreed to by the requestor
and the accredited person for purposes of a request for
certification under this section;
``(C) the term `premarket notification' means a
premarket notification under section 510(k);
``(D) the term `quality system' means the methods
used in, and the facilities and controls used for, the
design, manufacture, packaging, labeling, storage,
installation, and servicing of devices, as described in
section 520(f);
``(E) the term `requestor' means a device
manufacturer that is seeking certification under this
section of a quality system used by such manufacturer;
``(F) the term `Special PMA' means a Special PMA
supplement under section 814.39(d) of title 21, Code of
Federal Regulations (or any successor regulations); and
``(G) the term `30-day notice' means a notice
described in section 515(d)(6).
``(3) Accreditation process; accreditation renewal.--Except
as inconsistent with this section, the process and
qualifications for accreditation of persons and renewal of such
accreditation under section 704(g) shall apply with respect to
accreditation of persons and renewal of such accreditation
under this section.
``(4) Use of accredited parties to conduct assessments.--
``(A) Initiation of assessment services.--
``(i) Date assessments authorized.--
Beginning after the date on which the final
guidance is issued under paragraph (5), an
accredited person may conduct an assessment
under this section.
``(ii) Initiation of assessments.--Use of
one or more accredited persons to assess a
requestor's quality system under this section
with respect to in-scope devices shall be at
the initiation of the person who registers and
lists the devices at issue under section 510.
``(B) Compensation.--Compensation for such
accredited persons shall--
``(i) be determined by agreement between
the accredited person and the person who
engages the services of the accredited person;
and
``(ii) be paid by the person who engages
such services.
``(C) Accredited person selection.--Each person who
chooses to use an accredited person to assess a
requestor's quality system, as described in this
section, shall select the accredited person from a list
of such persons published by the Secretary in
accordance with section 704(g)(4).
``(5) Guidance; criteria for certification.--
``(A) In general.--The criteria for certification
of a quality system under this section shall be as
specified by the Secretary in guidance issued under
this paragraph.
``(B) Contents; criteria.--The guidance under this
paragraph shall include specification of--
``(i) evaluative criteria to be used by an
accredited person to assess and, as applicable,
certify a requestor's quality system under this
section with respect to in-scope devices; and
``(ii) criteria for accredited persons to
apply for a waiver of, and exemptions from, the
criteria under clause (i).
``(C) Timeframe for issuing guidance.--The
Secretary shall issue under this paragraph--
``(i) draft guidance not later than 12
months after the enactment of the 21st Century
Cures Act; and
``(ii) final guidance not later than 12
months after issuance of the draft guidance
under clause (i).
``(b) Use of Third-Party Assessment.--
``(1) Assessment summary; certification.--
``(A) Submission of assessment to secretary.--An
accredited person who assesses a requestor's quality
system under subsection (a) shall submit to the
Secretary a summary of the assessment--
``(i) within 30 days of the assessment; and
``(ii) which shall include (as
applicable)--
``(I) the accredited person's
certification that the requestor has
satisfied the criteria specified in the
guidance issued under subsection (a)(5)
for quality system certification with
respect to the in-scope devices at
issue; and
``(II) any waivers or exemptions
from such criteria applied by the
accredited person.
``(B) Treatment of assessments.--Subject to action
by the Secretary under subparagraph (C), with respect
to assessments which include a certification under this
section--
``(i) the Secretary's review of the
assessment summary shall be deemed complete on
the day that is 30 days after the date on which
the Secretary receives the summary under
subparagraph (A); and
``(ii) the assessment summary and
certification of the quality system of a
requestor shall be deemed accepted by the
Secretary on such 30th day.
``(C) Actions by secretary.--
``(i) In general.--Within 30 days of
receiving an assessment summary and
certification under subparagraph (A), the
Secretary may, by written notice to the
accredited person submitting such assessment
certification, deem any such certification to
be provisional beyond such 30-day period,
suspended pending further review by the
Secretary, or otherwise qualified or cancelled,
based on the Secretary's determination that (as
applicable)--
``(I) additional information is
needed to support such certification;
``(II) such assessment or
certification is unwarranted; or
``(III) such action with regard to
the certification is otherwise
justified according to such factors and
criteria as the Secretary finds
appropriate.
``(ii) Acceptance of certification.--If
following action by the Secretary under clause
(i) with respect to a certification, the
Secretary determines that such certification is
acceptable, the Secretary shall issue written
notice to the applicable accredited person
indicating such acceptance.
``(2) Notifications to secretary by certified requestors or
accredited persons for program evaluation purposes.--
``(A) Annual summary report for device-related
changes otherwise subject to premarket notification.--A
requestor whose quality system is certified under this
section that effectuates device-related changes with
respect to in-scope devices, without prior submission
of a premarket notification, shall ensure that an
annual summary report is submitted to the Secretary by
the accredited person which--
``(i) describes the changes made to the in-
scope device; and
``(ii) indicates the effective dates of
such changes.
``(B) Periodic notification for manufacturing
changes otherwise subject to 30-day notice.--A
requestor whose quality system is certified under this
section that effectuates device-related changes with
respect to in-scope devices, without prior submission
of a 30-day notice, shall provide notification to the
Secretary of such changes in the requestor's next
periodic report under section 814.84(b) of title 21,
Code of Federal Regulations (or any successor
regulation). Such notification shall--
``(i) describe the changes made; and
``(ii) indicate the effective dates of such
changes.
``(C) Periodic notification for device-related
changes otherwise subject to special pma supplement.--A
requestor whose quality system is certified under this
section that effectuates device-related changes with
respect to in-scope devices, without prior submission
of a Special PMA Supplement, shall provide notification
to the Secretary of such changes in the requestor's
next periodic report under section 814.84(b) of title
21, Code of Federal Regulations (or any successor
regulation). Such notification shall--
``(i) describe the changes made, including
a full explanation of the basis for the
changes; and
``(ii) indicate the effective dates of such
changes.
``(D) Use of notifications for program evaluation
purposes.--Information submitted to the Secretary under
subparagraphs (A) through (C) shall be used by the
Secretary for purposes of the program evaluation under
subsection (d).
``(c) Duration and Effect of Certification.--A certification under
this section--
``(1) shall remain in effect for a period of 2 years from
the date such certification is accepted by the Secretary,
subject to paragraph (6);
``(2) may be renewed through the process described in
subsection (a)(3);
``(3) shall continue to apply with respect to device-
related changes made during such 2-year period, provided the
certification remains in effect, irrespective of whether such
certification is renewed after such 2-year period;
``(4) shall have no effect on the need to comply with
applicable submission requirements specified in subsection
(a)(1)(C) with respect to any change pertaining to in-scope
devices which is not a device-related change under subsection
(a)(2);
``(5) shall have no effect on the authority of the
Secretary to conduct an inspection or otherwise determine
whether the requestor has complied with the applicable
requirements of this Act; and
``(6) may be revoked by the Secretary upon a determination
that the requestor's quality system no longer meets the
criteria specified in the guidance issued under subsection
(a)(5) with respect to the in-scope devices at issue.
``(d) Notice of Revocation.--The Secretary shall provide written
notification to the requestor of a revocation pursuant to subsection
(c)(6) not later than 10 business days after the determination
described in such subsection. Upon receipt of the written notification,
the requestor shall satisfy the applicable submission requirements
specified in subsection (a)(1)(C) for any device-related changes
effectuated after the date of such determination. After such
revocation, such requestor is eligible to seek re-certification under
this section of its quality system.
``(e) Program Evaluation; Sunset.--
``(1) Program evaluation and report.--
``(A) Evaluation.--The Secretary shall complete an
evaluation of the third-party quality system assessment
program under this section no later than January 31,
2021, based on--
``(i) analysis of information from a
representative group of device manufacturers
obtained from notifications provided by
certified requestors or accredited persons
under subsection (b)(2); and
``(ii) such other available information and
data as the Secretary determines appropriate.
``(B) Report.--No later than 1 year after
completing the evaluation under subparagraph (A), the
Secretary shall issue a report of the evaluation's
findings on the website of the Food and Drug
Administration, which shall include the Secretary's
recommendations with respect to continuation and as
applicable expansion of the program under this section
to encompass--
``(i) device submissions beyond those
identified in subsection (a)(1)(C); and
``(ii) device changes beyond those
described in subsection (a)(2)(A).
``(2) Sunset.--This section shall cease to be effective
October 1, 2022.
``(f) Rule of Construction.--Nothing in this section shall be
construed to limit the authority of the Secretary to request and review
the complete assessment of a certified requestor under this section on
a for-cause basis.''.
(b) Conforming Amendments.--
(1) Requirements for premarket approval supplements.--
Section 515(d)(5)(A)(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e(d)(5)(A)(i)), as redesignated by section
2201, is further amended by inserting ``, subject to section
524B'' after ``that affects safety or effectiveness''.
(2) Requirements for 30-day notice.--Section
515(d)(5)(A)(ii) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e(d)(5)(A)(ii)), as redesignated by section 2201,
is further amended by inserting ``, subject to section 524B''
after ``the date on which the Secretary receives the notice''.
(3) Requirements for premarket notification; technical
correction to reference to section 510(k).--Section 510(l) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is
amended by striking ``of this subsection under subsection (m)''
and inserting ``of subsection (k) under subsection (m) or
section 524B''.
(4) Misbranded devices.--Section 502(t) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 352(t)) is amended by
inserting ``or 524B'' after ``section 519''.
SEC. 2222. VALID SCIENTIFIC EVIDENCE.
Section 513(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360c(a)(3)(B)) is amended--
(1) by redesignating clauses (i) and (ii) as subclauses (I)
and (II), respectively;
(2) by striking ``(B) If the Secretary'' and inserting
``(B)(i) If the Secretary''; and
(3) by adding at the end the following:
``(ii) For purposes of clause (i), valid scientific evidence may
include--
``(I) evidence described in well-documented case histories,
including registry data, that are collected and monitored under
a protocol determined to be acceptable by the Secretary;
``(II) studies published in peer-reviewed journals; and
``(III) data collected in countries other than the United
States so long as such data otherwise meet the criteria
specified in this subparagraph.
``(iii) In the case of a study published in a peer-reviewed journal
that is offered as valid scientific evidence for purposes of clause
(i), the Secretary may request data underlying the study if--
``(I) the Secretary, in making such request, complies with
the requirement of subparagraph (D)(ii) to consider the least
burdensome appropriate means of evaluating device effectiveness
or subsection (i)(1)(D) to consider the least burdensome means
of determining substantial equivalence, as applicable;
``(II) the Secretary furnishes a written rationale for so
requesting the underlying data together with such request; and
``(III) if the requested underlying data for such a study
are unavailable, the Secretary shall consider such study to be
part of the totality of the evidence with respect to the
device, as the Secretary determines appropriate.''.
SEC. 2223. TRAINING AND OVERSIGHT IN LEAST BURDENSOME APPROPRIATE MEANS
CONCEPT.
(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 in Least Burdensome Appropriate Means
Concept.--
``(1) Training.--Each employee of the Food and Drug
Administration who is involved in the review of premarket
submissions under section 515 or section 510(k), including
supervisors, shall receive training regarding the meaning and
implementation of the least burdensome appropriate means
concept in the context of the use of that term in subsections
(a)(3)(D) and (i)(1)(D) of this section and in section
515(c)(5).
``(2) Guidance documents.--
``(A) Draft updated guidance.--Not later than 12
months after the date of enactment of the 21st Century
Cures Act, the Secretary shall issue a draft guidance
document updating the October 4, 2002, guidance
document entitled `The Least Burdensome Provision of
the FDA Modernization Act of 1997: Concept and
Principles; Final Guidance for FDA and Industry'.
``(B) Meeting of stakeholders.--In developing such
draft guidance document, the Secretary shall convene a
meeting of stakeholders to ensure a full record to
support the publication of such document.
``(3) Ombudsman audit.--Not later than 18 months after the
date of issuance of final version of the draft guidance under
paragraph (2), the ombudsman for the organizational unit of the
Food and Drug Administration responsible for the premarket
review of devices shall--
``(A) conduct, or have conducted, an audit of the
training described in paragraph (1); and
``(B) include in such audit interviews with a
representative sample of persons from industry
regarding their experience in the device premarket
review process.''.
(b) Additional Information Regarding Premarket Applications.--
Subsection (c) of section 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e) is amended by adding at the end the following:
``(5)(A) Whenever the Secretary requests additional information
from an applicant regarding an application under paragraph (1), the
Secretary shall consider the least burdensome appropriate means
necessary to demonstrate device safety and effectiveness, and request
information accordingly.
``(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) Nothing in this paragraph alters the standards for premarket
approval of a device.''.
SEC. 2224. RECOGNITION OF STANDARDS.
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 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 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 (i)(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
under subparagraph (A) of part of a standard, including the scientific,
technical, regulatory, or other basis for such recognition.''; and
(2) by adding at the end the following new paragraphs:
``(4) Training on use of standards.--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.
``(5) Guidance.--
``(A) Draft guidance.--The Secretary shall publish
guidance identifying the principles for recognizing
standards under this section. In publishing such
guidance, the Secretary shall consider--
``(i) the experience with, and reliance on,
a standard by other Federal regulatory
authorities and the device industry; and
``(ii) whether recognition of a standard
will promote harmonization among regulatory
authorities in the regulation of devices.
``(B) Timing.--The Secretary shall publish--
``(i) draft guidance under subparagraph (A)
not later than 12 months after the date of the
enactment of the 21st Century Cures Act; and
``(ii) final guidance not later than 12
months after the close of the public comment
period for the draft guidance under clause
(i).''.
SEC. 2225. EASING REGULATORY BURDEN WITH RESPECT TO 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 days after the date of the enactment of
the 21st Century Cures Act, 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 paragraph (1) and inserting the following
new paragraph: `` (1) The Secretary shall--
``(A) not later than 60 days after the date of the
enactment of the 21st Century Cures Act--
``(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
days for public comment beginning on the date of the
publication of such notice; and
``(B) not later than 180 days after the date of the
enactment of 21st Century Cures Act, publish in the Federal
Register a list representing the Secretary's final
determination with respect to the devices included in the list
published under subparagraph (A).'';
(2) in paragraph (2)--
(A) by striking ``1 day after the date of the
publication of a list under this subsection,'' and
inserting ``1 day after the date of publication of the
final list under paragraph (1)(B),''; and
(B) by striking ``30-day period'' and inserting
``60-day period''; and
(3) 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. 2226. ADVISORY COMMITTEE PROCESS.
(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) as part of the process to ensure adequate expertise
under clause (i), give due consideration to the recommendations
of the person whose premarket submission is subject to panel
review on the expertise needed among the voting members of the
panel.
``(C) For purposes of subparagraph (B)(ii), the term `adequate
expertise' means, with respect to the membership of the classification
panel reviewing a premarket submission, that such membership 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.''.
(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 by designating a representative
who will be provided a time during the panel meeting to address
the panel individually (or accompanied by experts selected by
such representative) for the purpose of correcting
misstatements of fact or providing clarifying information,
subject to the discretion of the panel chairperson''; and
(2) by striking subparagraph (B) and inserting the
following new subparagraph:
``(B)(i) Any meeting of a classification panel for a device that is
specifically the subject of review shall--
``(I) provide adequate time for initial presentations by
the person whose device is specifically the subject of a
classification panel 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 that is specifically the subject
of review by the panel.''.
SEC. 2227. HUMANITARIAN DEVICE EXEMPTION APPLICATION.
(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 document 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. 2228. CLIA WAIVER STUDY DESIGN GUIDANCE FOR IN VITRO DIAGNOSTICS.
(a) Draft Revised Guidance.--Not later than 12 months after the
date of the enactment of this Act, the Secretary of Health and Human
Services 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 guidance on 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 shall finalize the draft guidance published under subsection
(a) not later than 12 months after the comment period for such draft
guidance closes.
Subtitle N--Sensible Oversight for Technology Which Advances Regulatory
Efficiency
SEC. 2241. HEALTH SOFTWARE.
Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321) is amended by adding at the end the following:
``(ss)(1) The term `health software' means software that does not,
through use of an in vitro diagnostic device or signal acquisition
system, acquire, process, or analyze an image or physiological signal,
is not an accessory, is not an integral part of a device necessary to
support the use of the device, is not used in the manufacture and
transfusion of blood and blood components to assist in the prevention
of disease in humans, and--
``(A) is intended for use for administrative or operational
support or the processing and maintenance of financial records;
``(B) is intended for use in clinical, laboratory, or
administrative workflow and related recordkeeping;
``(C)(i) is intended for use solely in the transfer,
aggregation, conversion (in accordance with a present
specification), storage, management, retrieval, or transmission
of data or information;
``(ii) utilizes a connectivity software platform,
electronic or electrical hardware, or a physical communications
infrastructure; and
``(iii) is not intended for use--
``(I) in active patient monitoring; or
``(II) in controlling or altering the functions or
parameters of a device that is connected to such
software;
``(D) is intended for use to organize and present
information for health or wellness education or for use in
maintaining a healthy lifestyle, including medication adherence
and health management tools;
``(E) is intended for use to analyze information to provide
general health information that does not include patient-
specific recommended options to consider in the prevention,
diagnosis, treatment, cure, or mitigation of a particular
disease or condition; or
``(F) is intended for use to analyze information to provide
patient-specific recommended options to consider in the
prevention, diagnosis, treatment, cure, or mitigation of a
particular disease or condition.
``(2) The term `accessory' means a product that--
``(A) is intended for use with one or more parent devices;
``(B) is intended to support, supplement, or augment the
performance of one or more parent devices; and
``(C) shall be classified by the Secretary--
``(i) according to its intended use; and
``(ii) independently of any classification of any
parent device with which it is used.''.
SEC. 2242. APPLICABILITY AND INAPPLICABILITY OF REGULATION.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.), as amended by section 2221(a), is further
amended by adding at the end the following:
``SEC. 524C. HEALTH SOFTWARE.
``(a) Inapplicability of Regulation to Health Software.--Except as
provided in subsection (b), health software shall not be subject to
regulation under this Act.
``(b) Exception.--
``(1) In general.--Subsection (a) shall not apply with
respect to a software product--
``(A) of a type described in subparagraph (F) of
section 201(ss)(1); and
``(B) that the Secretary determines poses a
significant risk to patient safety.
``(2) Considerations.--In making a determination under
subparagraph (B) of paragraph (1) with respect to a product to
which such paragraph applies, the Secretary shall consider the
following:
``(A) The likelihood and severity of patient harm
if the product were to not perform as intended.
``(B) The extent to which the product is intended
to support the clinical judgment of a medical
professional.
``(C) Whether there is a reasonable opportunity for
a medical professional to review the basis of the
information or treatment recommendation provided by the
product.
``(D) The intended user and user environment, such
as whether a medical professional will use a software
product of a type described in subparagraph (F) of
section 201(ss)(1).
``(c) Delegation.--The Secretary shall delegate primary
jurisdiction for regulating a software product determined under
subsection (b) to be subject to regulation under this Act to the center
at the Food and Drug Administration charged with regulating devices.
``(d) Regulation of Software.--
``(1) In general.--The Secretary shall review existing
regulations and guidance regarding the regulation of software
under this Act. The Secretary may implement a new framework for
the regulation of software and shall, as appropriate, modify
such regulations and guidance or issue new regulations or
guidance.
``(2) Issuance by order.--Notwithstanding subchapter II of
chapter 5 of title 5, United States Code, the Secretary may
modify or issue regulations for the regulation of software
under this Act by administrative order published in the Federal
Register following the publication of a proposed order.
``(3) Areas under review.--The review of existing
regulations and guidance under paragraph (1) may include review
of the following areas:
``(A) Classification of software.
``(B) Standards for development of software.
``(C) Standards for validation and verification of
software.
``(D) Review of software.
``(E) Modifications to software.
``(F) Manufacturing of software.
``(G) Quality systems for software.
``(H) Labeling requirements for software.
``(I) Postmarketing requirements for reporting of
adverse events.
``(4) Process for issuing proposed regulations,
administrative order, and guidance.--Not later than 18 months
after the date of enactment of this section, the Secretary
shall consult with external stakeholders (including patients,
industry, health care providers, academia, and government) to
gather input before issuing regulations, an administrative
order, and guidance under this subsection.
``(e) Rule of Construction.--Nothing in this section shall be
construed as providing the Secretary with the authority to regulate
under this Act any health software product of the type described in
subparagraph (F) of section 201(ss)(1) unless and until the Secretary
has made a determination described in subsection (b)(1)(B) with respect
to such product.''.
SEC. 2243. EXCLUSION FROM DEFINITION OF DEVICE.
Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321) is amended--
(1) in subparagraph (2), by striking ``or'' after ``or
other animals,'';
(2) in subparagraph (3), by striking ``and'' and inserting
``or''; and
(3) by inserting after subparagraph (3) the following:
``(4) not health software (other than software determined
to be a risk to patient safety under section 524B(b)), and''.
Subtitle O--Streamlining Clinical Trials
SEC. 2261. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; APPLICABILITY OF
RULES.
(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 shall,
to the extent possible 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.--
(1) In general.--The Secretary shall--
(A) 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--
(i) to reduce regulatory duplication and
unnecessary delays;
(ii) to modernize such provisions in the
context of multisite and cooperative research
projects; and
(iii) to incorporate local considerations,
community values, and mechanisms to protect
vulnerable populations; and
(B) ensure that human subject research that is
subject to the HHS Human Subject Regulations or to the
FDA Human Subject Regulations may--
(i) use joint or shared review;
(ii) 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
(iii) use similar arrangements to avoid
duplication of effort.
(2) Regulations and guidance.--Not later than 36 months
after the date of enactment of this Act, the Secretary, acting
through the relevant agencies and offices of the Department of
Health and Human Services, including the Office for Human
Research Protections and relevant agencies and offices of the
Food and Drug Administration, shall issue such regulations and
guidance and take such other actions as may be necessary to
implement this section and help to facilitate the broader use
of single, central, or lead institutional review boards. Such
regulations and guidance shall clarify the requirements and
policies relating to the following:
(A) Arrangements to avoid duplication described in
paragraph (1)(A)(i), including--
(i) delineating the roles of institutional
review boards in multisite or cooperative,
multisite studies where one or more local
institutional review boards are relied upon, or
similar arrangements are used;
(ii) the risks and benefits to human
subjects;
(iii) standardizing the informed consent
and other processes and legal documents; and
(iv) incorporating community values through
the use of local institutional review boards
while continuing to use central or lead
institutional review boards.
(B) Concerns about regulatory and legal liability
contributing to decisions by the sponsors of research
to rely on local institutional review boards for
multisite research.
(3) Consultation.--In issuing regulations or guidance under
paragraph (2), 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).
(c) Timing.--The Secretary shall complete the harmonization
described in subsection (a) not later than 36 months after the date of
enactment of this Act.
(d) Progress Report.--Not later than 24 months after the date of
enactment of this Act, the Secretary shall submit to Congress a report
on the progress made toward completing such harmonization.
(e) Draft NIH Policy.--Not later than 12 months after the date of
enactment of this Act, the Secretary, acting through the Director of
the National Institutes of Health, shall finalize the draft policy
entitled ``Draft NIH Policy on Use of a Single Institutional Review
Board for Multi-Site Research''.
(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-populations rules.--The term
``vulnerable-populations rules''--
(i) subject to clause (ii), means the
provisions of subparts B through D of such part
46 (or any successor regulations); or
(ii) as applicable to research that is
subject to the FDA Human Subject Regulations,
means the provisions applicable to vulnerable
populations under part 56 of such title 21 (or
any successor regulations) and subpart D of
part 50 of such title 21 (or any successor
regulations).
(2) Other definitions.--In this section:
(A) Institutional review board.--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 as well as a lead institutional
review board.
SEC. 2262. USE OF NON-LOCAL INSTITUTIONAL REVIEW BOARDS FOR REVIEW OF
INVESTIGATIONAL DEVICE EXEMPTIONS AND HUMAN DEVICE
EXEMPTIONS.
(a) In General.--Section 520 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(j)) is amended--
(1) in subsection (g)(3)--
(A) by striking ``local'' each place it appears;
and
(B) in subparagraph (A)(i), by striking ``which has
been''; and
(2) in subsection (m)(4)--
(A) by striking ``local'' each place it appears;
and
(B) by striking subparagraph (A) and inserting the
following new subparagraph:
``(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) Regulations.--Not later than 12 months after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
revise or issue such regulations or guidance as may be necessary to
carry out the amendments made by subsection (a).
SEC. 2263. ALTERATION OR WAIVER OF INFORMED CONSENT 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 P--Improving Scientific Expertise and Outreach at FDA
SEC. 2281. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH 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)(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'), the purpose of which is to recruit and
retain competitive and qualified scientific and technical
experts outstanding in the field of biomedical research,
clinical research evaluation, and biomedical product
assessment'';
(3) by amending subsection (a)(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.'';
(4) 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 master's
level degree in engineering, bioinformatics, or a
related or emerging field,'' after the comma;
(5) 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 rate payable for the President'';
(6) by striking subsection (e); and
(7) by redesignating subsections (f) and (g) as subsections
(e) and (f), respectively.
(b) Report.--Not later than 3 years after the date of the enactment
of this Act, the Secretary of Health and Human Services shall submit,
and publish on the website of the Department of Health and Human
Services a report on the implementation of the amendments made by
subsection (a), including whether the amendments have improved the
ability of the Food and Drug Administration to hire and retain
qualified experts to fulfill obligations specified under user fee
agreements.
SEC. 2282. ENABLING FDA SCIENTIFIC ENGAGEMENT.
It is the sense of Congress that the participation in, or
sponsorship of, scientific conferences and meetings is essential to the
mission of the Food and Drug Administration.
SEC. 2283. 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''.
SEC. 2284. COLLECTION OF CERTAIN VOLUNTARY INFORMATION EXEMPTED FROM
PAPERWORK REDUCTION ACT.
Chapter VII of the Federal Food, Drug, and Cosmetic Act is amended
by inserting after section 708 of such Act (21 U.S.C. 379) the
following:
``SEC. 708A. COLLECTION OF CERTAIN VOLUNTARY INFORMATION EXEMPTED FROM
PAPERWORK REDUCTION ACT.
``Chapter 35 of title 44, United States Code, shall not apply to
the collection from patients, industry, academia, and other
stakeholders, of voluntary information such as through voluntary
surveys or questionnaires, initiated by the Secretary.''.
SEC. 2285. 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. ADDITIONAL HIRING AUTHORITY.
``(a) In General.--The Secretary may, without regard to the
provisions of title 5, United States Code, governing appointments in
the competitive service, appoint qualified candidates to scientific,
technical, or professional positions within the following centers of
the Food and Drug Administration:
``(1) The Center for Drug Evaluation and Research.
``(2) The Center for Biologics Evaluation and Research.
``(3) The Center for Devices and Radiological Health.
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 Secretary may determine and fix--
``(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 highly
qualified scientific, technical, or professional
personnel appointed to a position at any of the centers
listed under subsection (a) before the date of
enactment of this section.
``(2) Limitation.--The annual rate of pay established
pursuant to paragraph (1) may not exceed the annual rate of pay
of the President.
``(c) Report.--
``(1) In general.--Not later than September 30, 2021, the
Secretary shall submit a report to Congress that examines the
extent to which the authority to appoint and retain personnel
under this section enhanced the Food and Drug Administration's
ability to meet the agency's critical need for highly qualified
individuals for scientific, technical, or professional
positions.
``(2) Recommendations.--The report under paragraph (1)
shall include the recommendations of the Secretary on--
``(A) whether the authority to appoint personnel
under this section should be reauthorized; and
``(B) other personnel authorities that would help
the Food and Drug Administration to better recruit and
retain highly qualified individuals for scientific,
technical, or professional positions in the agency's
medical product centers.''.
(b) Rule of Construction.--The authority provided by section 714A
of the Federal Food, Drug, and Cosmetic Act (as added by subsection
(a)) shall not be construed to affect the authority provided under
section 714 of such Act.
Subtitle Q--Exempting From Sequestration Certain User Fees
SEC. 2301. EXEMPTING FROM SEQUESTRATION CERTAIN USER FEES OF FOOD AND
DRUG ADMINISTRATION.
The Balanced Budget and Emergency Deficit Control Act of 1985 is
amended--
(1) in section 255(g)(1)(A) (2 U.S.C. 905(g)(1)(A)), by
inserting after the item relating to ``Financial Agent
Services'' the following new item:
``Food and Drug Administration, Salaries and
Expenses, but only the portion of appropriations under
such account corresponding to fees collected under
sections 736, 738, 740, 741, 744B, and 744H of the
Federal Food, Drug, and Cosmetic Act (75-9911-0-1-
554).''; and
(2) in section 256(h) (2 U.S.C. 906(h)), by adding at the
end the following new paragraph:
``(5) Notwithstanding any other provision of law, this
subsection shall not apply with respect to the portion of
administrative expenses incurred by the Food and Drug
Administration that are funded through fees collected under
sections 736, 738, 740, 741, 744B, and 744H of the Federal
Food, Drug, and Cosmetic Act.''.
Subtitle R--Other Provisions
SEC. 2321. SENSE OF CONGRESS.
It is the sense of the Congress that recording unique device
identifiers at the point-of-care in electronic health record systems
could significantly enhance the availability of medical device data for
postmarket surveillance purposes.
TITLE III--DELIVERY
Subtitle A--Interoperability
SEC. 3001. ENSURING INTEROPERABILITY OF HEALTH INFORMATION TECHNOLOGY.
(a) Interoperability Standards.--
(1) In general.--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 new section:
``SEC. 3010. ENSURING INTEROPERABILITY OF HEALTH INFORMATION
TECHNOLOGY.
``(a) Interoperability.--In order for health information technology
to be considered interoperable, such technology must satisfy the
following criteria:
``(1) Secure transfer.--The technology allows the secure
transfer of all electronically accessible health information to
and from any and all health information technology for
authorized use under applicable State or Federal law.
``(2) Complete access to health information.--The
technology allows for complete access, exchange, and use of all
electronically accessible health information for authorized use
under applicable State or Federal law without special effort by
the requestor of such health information.
``(3) No information blocking.--The technology is not
configured, set up, or implemented to information block, as
defined in section 3010A(d).
``(b) Categories for Interoperability Standards.--The categories
described in this subsection, with respect to standards and the
corresponding implementation specifications for determining if health
information technology is interoperable, consistent with the criteria
described in subsection (a), include at least categories of standards
and implementation specifications with respect to the following:
``(1) Vocabulary and terminology.
``(2) Content and structure.
``(3) Transport.
``(4) Security.
``(5) Services.
``(6) Querying and requesting health information for
access, exchange, and use.
``(c) Allowing for Flexibility.--A standard and implementation
specification, with respect to such standard, that is determined under
section 3001(c)(5)(D) to be compatible with baseline standards and
implementation specifications (as defined in clause (ii) of such
section) shall be treated as in compliance with this section.''.
(2) Guidance.--Not later than January 1, 2017, the
Secretary of Health and Human Services, in consultation with
the National Coordinator of the Office of the National
Coordinator for Health Information Technology, shall issue
guidance with respect to the implementation of section 3010 of
the Public Health Service Act, as added by paragraph (1),
including with respect to defining and providing examples of
authorized use under applicable State or Federal law of health
information.
(b) Improvements to Recommendation Process.--
(1) HIT policy committee to incorporate policies for
updates to interoperability standards.--Section 3002 of the
Public Health Service Act (42 U.S.C. 300jj-12) is amended--
(A) in subsection (a)--
(i) by striking ``National Coordinator''
and inserting ``Secretary, in consultation with
the National Coordinator,''; and
(ii) by adding at the end the following new
sentence: ``The HIT Policy Committee is
authorized only to provide policy and priority
recommendations to the Secretary and not
authorized to otherwise affect the development
or modification of any standard, implementation
specification, or certification criterion under
this title.''; and
(B) in subsection (b)(2)--
(i) in subparagraph (A), in the first
sentence--
(I) by striking ``The HIT Policy
Committee'' and inserting ``Subject to
subparagraph (D), the HIT Policy
Committee''; and
(II) by inserting ``(including the
areas in which modifications and
additions to interoperability standards
and implementation specifications, with
respect to such interoperability
standards, under section 3010 are
needed for the electronic access,
exchange, and use of health information
for purposes of adoption of such
modifications and additions under
section 3004)'' after ``section 3004''.
(ii) by adding at the end the following new
subparagraph:
``(D) Special rule related to interoperability.--
Any recommendation made by the HIT Policy Committee on
or after the date of the enactment of this subparagraph
with respect to interoperability of health information
technology shall be consistent with the criteria
described in subsection (a) of section 3010.''.
(2) Sunset of hit standards committee.--Section 3003 of the
Public Health Service Act (42 U.S.C. 300jj-13) is amended by
adding at the end the following new subsection:
``(f) Termination.--The HIT Standards Committee shall terminate on
the date that is 90 days after the date of the enactment of this
subsection.''.
(3) Standards development organizations.--Title XXX of the
Public Health Service Act is amended by inserting after section
3003 the following new section:
``SEC. 3003A. RECOMMENDATIONS FOR STANDARDS THROUGH CONTRACTS WITH
STANDARDS DEVELOPMENT ORGANIZATIONS.
``(a) Contracts.--
``(1) In general.--For purposes of activities conducted
under this title, the Secretary shall enter into one or more
contracts with health care standards development organizations
accredited by the American National Standards Institute (or
with the American National Standards Institute) to carry out,
directly or through contracts with subcontractors, the duties
described in subsection (b), as applicable.
``(2) Timing for first contract.--As soon as practicable
after the date of the enactment of this section, the Secretary
shall enter into the first contracts under paragraph (1).
``(3) Period of contract.--Each contract under paragraph
(1) shall be for a period determined necessary by the
Secretary, in consultation with the National Coordinator, to
carry out the applicable duties described in subsection (b).
``(4) Appropriate entities.--The Secretary shall ensure the
most appropriate entities described in paragraph (1) are
selected for each contract under such paragraph.
``(b) Duties.--
``(1) Initial contract.--The Secretary shall initially
enter into one or more contracts under subsection (a)(1) with
entities described in such subsection, under which the
entities--
``(A) shall recommend to the Secretary--
``(i) for adoption under section 3004, an
initial set of interoperability standards and
implementation specifications, with respect to
such standards, identified or, as appropriate,
developed by such entities that are consistent
with the criteria described in subsection (a)
of section 3010, and with respect to the
categories described in subsection (b) of such
section; and
``(ii) as applicable, for purposes of
section 3001(c)(5)(D), methods to test if
health information technology is compatible
with health information technology that applies
baseline standards and implementation
specifications (as defined in clause (ii) of
such section); and
``(B) may provide to the Secretary recommendations
described in paragraph (2).
``(2) Subsequent contracts.--Under each subsequent contract
entered into under this section with entities described in
subsection (a)(1) pursuant to subsection (c), the entities
shall recommend to the Secretary--
``(A) for adoption under section 3004 any standards
(including interoperability standards), implementation
specifications, and, to the extent necessary,
certification criteria (and modifications, including
additions, to such standards, specifications, and, to
the extent necessary, criteria), which are in
accordance with the criteria described in section 3010;
and
``(B) as applicable, for purposes of section
3001(c)(5)(D), methods to test if health information
technology is compatible with baseline standards and
implementation specifications (as defined in clause
(ii) of such section).
``(3) Submission to nist.--Under each contract with an
entity under this section, the entity shall submit to the
Director of the National Institute of Standards and Technology
each recommendation submitted to the Secretary by such entity
under this section.
``(4) Consultation.--For the purposes of developing methods
to test interoperability standards and implementation
specifications with respect to such standards, the entities
with a contract under this section may consult with the
Director of the National Institute of Standards and Technology.
``(c) Modifications and Subsequent Contracts.--
``(1) In general.--The Secretary, in consultation with the
National Coordinator, shall periodically conduct hearings to
evaluate and review the standards, implementation
specifications, and certification criteria adopted under
section 3004 for purposes of determining if modifications,
including any additions, are needed with respect to such
standards, specifications, and criteria.
``(2) Contract trigger.--Based on the needs for standards,
implementation specifications, and certification criteria (and
modifications, including additions, to such standards,
specifications, and criteria) under this title, as determined
by the Secretary, with due consideration to section 3010(b) and
in consultation with the National Coordinator, the Secretary
shall, as needed, enter into contracts under subsection (a) to
carry out the duties described in subsection (b)(2) in addition
to any contract entered into to carry out the duties described
in subsection (b)(1).
``(d) Authorization of Appropriations.--There is authorized to be
appropriated $10,000,000 for contracts under subsection (a), to remain
available until expended.''.
(4) Modifications to role of the national coordinator.--
Section 3001(c)(1)(A) of the Public Health Service Act (42
U.S.C. 300jj-11(c)(1)(A)) is amended by inserting ``for
recommendations made before the date of the enactment of the
21st Century Cures Act,'' before ``review and determine''.
(c) Adoption.--Section 3004 of the Public Health Service Act (42
U.S.C. 300jj-14) is amended--
(1) in subsection (a)--
(A) in paragraph (1), by inserting after ``section
3001(c)'' the following: ``(or, subject to subsection
(c), in the case of a standard, implementation
specification, or criterion recommended on or after the
date of the enactment of the 21st Century Cures Act,
after the date of submission of the recommendation to
the Secretary under section 3003A)''; and
(B) in paragraph (2)(B), by striking ``and the HIT
Standards Committee'';
(2) in subsection (b)--
(A) in paragraph (3), by striking ``with the
schedule published under section 3003(b)(2)'' and
inserting ``with subsection (d)''; and
(B) by adding at the end the following new
paragraph:
``(4) Limitation.--The Secretary may not adopt any
policies, priorities, standards, implementation specifications,
or certification criteria under this subsection or subsection
(a) that are inconsistent with or duplicative of an
interoperability standard or implementation specification with
respect to such standard adopted under this section, in
accordance with subsections (c) and (d). In the case of a
standard, specification, or criterion that has been adopted
under this section and is inconsistent or duplicative of such
an interoperability standard or specification that is
subsequently adopted under this section, such interoperability
standard or specification shall supercede such other standard,
specification, or criterion and such other standard,
specification, or criterion shall no longer be considered
adopted under this section beginning on the date that such
interoperability standard or specification becomes
effective.''; and
(3) by adding at the end the following new subsections:
``(c) Adoption of Initial Interoperability Standards and
Implementation Specifications.--Notwithstanding the previous
subsections of this section, the following shall apply in the case of
the initial set of interoperability standards and implementation
specifications with respect to such standards recommended under section
3003A:
``(1) Review of standards.--Not later than 90 days after
the date of receipt of recommendations for such
interoperability standards and implementation specifications,
the Secretary, in consultation with the National Coordinator
and representatives of other relevant Federal agencies, such as
the National Institute of Standards and Technology, shall
jointly review such standards and implementation specifications
and shall determine whether or not to propose adoption of such
standards and implementation specifications.
``(2) Determination to adopt.--If, subject to subsection
(d)(3), the Secretary determines--
``(A) to propose adoption of such standards and
implementation specifications, the Secretary shall, by
regulation under section 553 of title 5, United States
Code, determine whether or not to adopt such standards
and implementation specifications; or
``(B) not to propose adoption of such standards and
implementation specifications, the Secretary shall
notify the applicable entity with a contract under
section 3003A in writing of such determination and the
reasons for not proposing the adoption of the
recommendation for such standards and implementation
specifications.
``(3) Publication.--The Secretary shall provide for
publication in the Federal Register of all determinations made
by the Secretary under paragraph (1).
``(d) Rules for Adoption.--In the case of a standard (including
interoperability standard), implementation specification, or
certification criterion adopted under this section on or after the date
of the enactment of the 21st Century Cures Act, the following shall
apply:
``(1) In general.--Except as provided in paragraphs (2) and
(3), any such standard (including interoperability standard),
implementation specification, or certification criterion shall
be a standard, specification, or criterion that has been
recommended by the entities with which the Secretary has
entered into a contract under section 3003A.
``(2) Special rule if no standard, specification, or
criterion recommended.--If no standard, implementation
specification, or, to the extent necessary, certification
criterion is recommended under paragraph (1)--
``(A) in the case of interoperability standards and
implementation specifications with respect to such
standards, relating to a category described in section
3010(b)--
``(i) paragraph (1) shall not apply; and
``(ii) paragraph (4) shall apply; or
``(B) in the case of any other standard,
implementation specification, or, to the extent
necessary, certification criterion, relating to a
policy or priority to carry out this title, as
determined by the Secretary, in consultation with the
National Coordinator--
``(i) paragraph (1) shall not apply; and
``(ii) paragraph (4) shall apply.
``(3) Authority to modify implementation specifications.--
If, following public comment pursuant to subsection (c), the
Secretary would propose adoption of interoperability standards
recommended under section 3003A but for the implementation
specifications, with respect to such standards, so recommended,
the Secretary may modify such implementation specifications and
adopt such standards and specifications in accordance with
subsection (c)(2).
``(4) Effective date.--In the case of a standard,
implementation specification, or certification criterion for
which there is a determination to adopt such standard,
implementation specification, or certification criterion, such
standard, implementation specification, or certification
criterion shall be considered adopted under this section and
shall be effective beginning on the date that is 12 months
after the date of publication of the final rule to adopt such
standard, implementation specification, or certification
criterion.
``(5) Assistance to the secretary.--In complying with the
requirements of this subsection, the Secretary shall give due
consideration to any recommendations of the National Committee
on Vital and Health Statistics established under section
306(k), and shall consult with appropriate Federal and State
agencies and private organizations. The Secretary shall publish
in the Federal Register any recommendation of the National
Committee on Vital and Health Statistics regarding the adoption
of a standard, implementation specification, or certification
criterion under this section. Any standard, implementation
specification, or certification criterion adopted pursuant to
this paragraph shall be promulgated in accordance with the
rulemaking procedures of subchapter III of chapter 5 of title
5, United States Code.
``(e) Allowing for Flexibility Through Compatibility With Baseline
Standards and Implementation Specifications.--For purposes of this
title, title XVIII of the Social Security Act, title XIX of such Act,
and any other provision of law, a standard and implementation
specification, with respect to such standard, that is determined under
section 3001(c)(5)(D) to be compatible with baseline standards and
implementation specifications (as defined in clause (ii) of such
section) shall be treated as if such standard and specification were an
interoperability standard and implementation specification, with
respect to such interoperability standard, adopted under this
section.''.
(d) Reports and Notifications.--Section 3010 of the Public Health
Service Act, as added by subsection (a), is amended by adding at the
end the following new subsection:
``(c) Dissemination of Information.--
``(1) Initial summary report.--Not later than July 1, 2017,
the Secretary, after consultation with relevant stakeholders,
shall submit to Congress and 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 a report on the following:
``(A) The initial set of interoperability standards
and implementation specifications adopted under section
3004(c).
``(B) The strategies for achieving widespread
interoperability.
``(C) Any barriers that are preventing widespread
interoperability.
``(D) The plan and milestones, including specific
steps, to achieve widespread interoperability.
``(2) Ongoing publication of recommendations.--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 recommendations made under this section.''.
(e) Certification and Other Enforcement Provisions.--
(1) Certification of qualified electronic health records.--
(A) In general.--Section 3007(b) of the Public
Health Service Act (42 U.S.C. 300jj-17(b)) is amended
by striking ``under section 3001(c)(3) to be in
compliance with'' and all that follows through the
period at the end and inserting ``under section
3001(c)(3)--
``(1) for certifications made before January 1, 2018, to be
in compliance with applicable standards adopted under
subsections (a) and (b) of section 3004; and
``(2) for certifications made on or after January 1, 2018,
to be in compliance with applicable standards adopted under
subsections (a) and (b) of section 3004 and to be interoperable
in accordance with section 3010 and in compliance with
interoperability standards adopted under section 3004.''.
(B) Requirements of secretary.--Section 3001(c)(5)
of the Public Health Service Act (42 U.S.C. 300jj-
11(c)(5)) is amended--
(i) in subparagraph (B), by inserting
before the period at the end the following:
``and, for certifications made on or after
January 1, 2018, with respect to health
information technology, additional criteria to
establish that the technology is interoperable,
in accordance with section 3010, and in
compliance with interoperability standards and
implementation specifications, with respect to
such standards, adopted under section 3004'';
and
(ii) by adding at the end the following new
subparagraphs:
``(C) Enforcement; decertifications.--
``(i) Requirements.--Under any program kept
or recognized under subparagraph (A), the
Secretary shall ensure that any vendor of or
other entity offering to health care providers
(as defined in section 3010A(g)) qualified
electronic health records seeking a
certification of such records under such
program on or after January 1, 2018, shall, as
a condition of certification (and maintenance
of certification) of such a record under such
program--
``(I) provide to the Secretary an
attestation--
``(aa) the entity has
implemented interoperability
standards and implementation
specifications, with respect to
such standards, adopted under
section 3004 (including through
application of subsection (e)
of such section);
``(bb) that the entity,
unless for a legitimate purpose
specified by the Secretary, has
not taken and will not take any
action that constitutes
information blocking (as
defined in section 3010A(d)),
with respect to such qualified
electronic health records;
``(cc) that includes the
pricing information described
in clause (iii) for purposes of
inclusion under subsection (f)
of such information on the
Internet website of the
Department of Health and Human
Services; that such information
will be available on a public
Internet website of such
entity; and that the entity
will voluntarily provide such
information to customers prior
to offering any qualified
electronic health records or
related product or service
(including subsequent updates,
add-ons, or additional products
or services to be provided
during the course of an on-
going contract), prospective
customers (such as persons who
request or receive a quotation
or estimate), and other persons
who request such information;
``(dd) that the technology
with respect to such records
has published application
programming interfaces, with
respect to health information
within such records, for search
and indexing, semantic
harmonization and vocabulary
translation, and user interface
applications;
``(ee) that the entity has
successfully and rigorously
tested the real world use of
the record in the type of
setting in which it would be
marketed; and
``(ff) that the entity has
in place data sharing programs
or capabilities based on common
data elements through such
mechanisms as application
programming interfaces without
the requirement for vendor-
specific interfaces;
``(II) publish application
programming interfaces and associated
documentation, with respect to health
information within such records, for
search and indexing, semantic
harmonization and vocabulary
translation, and user interface
applications; and
``(III) demonstrate to the
satisfaction of the Secretary that
health information from such records
are able to be exchanged, accessed, and
used through the use of application
programming interfaces without special
effort, as authorized under applicable
law.
``(ii) Decertification.--Under any program
kept or recognized under subparagraph (A), the
Secretary shall ensure that beginning January
1, 2019, any qualified electronic health
records that do not satisfy the certification
criteria described in subparagraph (B) or with
respect to which the vendor or other entity
described in clause (i) does not satisfy the
requirements under such clause (or is
determined to be in violation of the terms of
the attestation or other requirements under
such clause) shall no longer be considered as
certified under such program.
``(iii) Pricing information.--For purposes
of clause (i)(I)(cc), the pricing information
described in this clause, with respect to a
vendor of or other entity offering a qualified
electronic health record, is the following:
``(I) Additional types of costs or
fees (whether fixed, recurring,
transaction based, or otherwise)
imposed by the entity (or any third-
party from whom the entity purchases,
licenses, or obtains any technology,
products, or services in connection
with the qualified electronic health
record) to purchase, license,
implement, maintain, upgrade, use, or
otherwise enable and support the use of
capabilities to which such record is to
be certified under this section; or in
connection with any health information
generated in the course of using any
capability to which the record is to be
so certified.
``(II) Limitations, whether by
contract or otherwise, on the use of
any capability to which the record is
to be certified under this section for
any purpose within the scope of the
record's certification; or in
connection with any health information
generated in the course of using any
capability to which the record is to be
certified under this section.
``(III) Limitations, including
technical or practical limitations of
technology or its capabilities, that
could prevent or impair the successful
implementation, configuration,
customization, maintenance, support, or
use of any capabilities to which the
record is to be certified under this
section; or that could prevent or limit
the access, use, exchange, or
portability of any health information
generated in the course of using any
capability to which the record is to be
so certified.
``(D) Flexibility through compatibility.--
``(i) In general.--Under any program kept
or recognized under subparagraph (A), the
Secretary shall provide for a method and
process by which a vendor of or other entity
offering to health care providers (as defined
in section 3010A(g)) qualified electronic
health records seeking a certification of such
records under such program on or after January
1, 2018, may demonstrate, using such mechanisms
as a reference implementation model or other
means, that the standards and implementation
specifications applied by such entity with
respect to such records are compatible with
baseline standards and implementation
specifications, including by demonstrating such
records are able to transmit information that
is compatible with qualified electronic health
records that would receive such information and
that apply the baseline standards and
implementation specifications. Such a method
and process shall ensure that any such entity
using a standard or implementation
specification other than a baseline standard or
implementation specification demonstrates,
through testing, compatibility with the
baseline standard and implementation
specification with respect to receiving
information.
``(ii) Baseline standards and
implementation specifications.--For purposes of
clause (i), the term `baseline standards and
implementation specifications' means the
interoperability standards and implementation
specifications, with respect to such standards,
adopted under section 3004 (without application
of subsection (e) of such section).''.
(2) Additional enforcement provisions under the public
health service act.--Subtitle A of title XXX of the Public
Health Service Act (42 U.S.C. 300jj-11 et seq.), as amended by
subsections (a)(1) and (d), is further amended by adding at the
end the following new section:
``SEC. 3010A. ENFORCEMENT MECHANISMS.
``(a) Inspector General Authority.--The Inspector General of the
Department of Health and Human Services shall have the authority to
investigate claims of--
``(1)(A) vendors of, or other entities offering to health
care providers (as defined in subsection (g)), qualified
electronic health records (as defined in section 3000(13))
being in violation of an attestation (whether providing false
information at the time of such attestation or by act or
practice conducted after such attestation) made under section
3001(c)(5)(C)(i)(I), with respect to the use of such records by
a health care provider with respect to items and services
furnished under the Medicare Program under title XVIII of the
Social Security Act or Medicaid program under title XIX of such
Act; and
``(B) vendors of, or other entities offering to health care
providers (as defined in subsection (g)), health information
technology having engaged in information blocking (as defined
in subsection (d)), unless for a legitimate purpose specified
by the Secretary, with respect to the use of such technology by
a health care provider with respect to items and services
furnished under such a program;
``(2) health care providers having engaged in information
blocking (as so defined), with respect to the use of health
information technology with respect to items and services
furnished under such a program, unless for a legitimate purpose
specified by the Secretary; and
``(3) health information system providers (such as
operators of health information exchanges, clinical data
registries, and other systems that facilitate the exchange of
information) having engaged in information blocking (as so
defined), unless for a legitimate purpose specified by the
Secretary, with respect to the use of health information
technology with respect to items and services furnished under
such a program.
``(b) Information Sharing Provisions.--
``(1) In general.--The National Coordinator may serve as a
technical consultant to the Inspector General of the Department
of Health and Human Services and the Federal Trade Commission
for purposes of carrying out this section. As such technical
consultant, the National Coordinator may, notwithstanding any
other provision of law, share information related to claims or
investigations under subsection (a) 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; and
``(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.
Such information may be used by the Inspector General of the
Department of Health and Human Services 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) Non-application of paperwork reduction act.--Chapter
35 of title 44, United States Code (commonly referred to as the
Paperwork Reduction Act of 1995) shall not apply to the
National Coordinator or to the Office of the National
Coordinator for Health Information Technology with respect to
the collection of complaints relating to claims described in
subsection (a).
``(4) Standardized process.--The National Coordinator shall
implement a standardized process for the public to submit
reports on claims of--
``(A) health information technology products of
vendors (or other entities offering such products to
health care providers (as defined in subsection (g)))
not being interoperable or resulting in information
blocking; or
``(B) actions by such entities, health care
providers, or health information system providers that
result in such technology not being interoperable or in
information blocking with respect to such technology;
and
``(C) any other act described in subsection (a).
The standardized process 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.
``(c) Penalty.--
``(1) In general.--Any person or entity described in
paragraph (1), (2), or (3) of subsection (a) determined to have
committed on or after January 1, 2018, an act described in such
respective paragraph with respect to the use of a qualified
electronic health record or health information technology, as
applicable under such respective paragraph, with respect to
items and services furnished under the Medicare Program under
title XVIII of the Social Security Act or the Medicaid program
under title XIX of such Act, shall be subject to a civil
monetary penalty in such amount as determined appropriate by
the Secretary through rulemaking.
``(2) Application.--Subject to paragraph (3), the
provisions of section 1128A (other than subsections (a) and
(b)) of such Act (42 U.S.C. 1320a-7a) shall apply to a civil
money penalty applied under this subsection in the same manner
as they apply to a civil money penalty or proceeding under
subsection (a) of such section 1128A.
``(3) Recovery of funds.--Notwithstanding section 3302 of
title 31, United States Code, or any other provision of law
affecting the crediting of collections, the Inspector General
of the Department of Health and Human Services may receive and
retain for current use any amounts recovered under this
subsection. In addition to amounts otherwise available to the
Inspector General, funds received by the Inspector General
under this paragraph shall be deposited, as an offsetting
collection, to the credit of any appropriation available for
purposes of carrying out this subsection and subsection (a) and
shall be available without fiscal year limitation and without
further appropriation.
``(d) Information Blocking.--
``(1) In general.--For purposes of this section and section
3010, subject to paragraph (3), the term `information blocking'
means, with respect to the access, use, and exchange of
qualified electronic health records and other health
information technology, business, technical, and organizational
practices, including practices described in paragraph (2),
that--
``(A) prevent or materially discourage the access,
exchange, or use of electronic health information; and
``(B) the actor knows or should know (as defined in
section 1128A(i)(7) of the Social Security Act) are
likely to interfere with the access, exchange, or use
of electronic health information.
``(2) Practices described.--For purposes of paragraph (1),
the practices described in this paragraph shall include the
following:
``(A) Contract terms, policies, or business or
organizational practices that restrict authorized use
under applicable State or Federal law of electronic
health information or restrict the authorized exchange
under applicable State or Federal law of such
information for treatment and other permitted purposes
under such applicable law, including transitions
between certified EHR technologies.
``(B) Charging unreasonable prices or fees (such as
for health information exchange, portability,
interfaces, and full export of health information) that
make accessing, exchanging, or using electronic health
information cost prohibitive.
``(C) Developing or implementing health information
technology in nonstandard ways that are likely to
substantially increase the costs, complexity, or burden
of sharing electronic health information, especially in
cases in which relevant interoperability standards or
methods to measure interoperability have been adopted
by the Secretary.
``(D) Developing or implementing health information
technology in ways that are likely to lock in users or
electronic health information, such as not allowing for
the full export of health information; lead to fraud,
waste, or abuse; or impede innovations and advancements
in health information access, exchange, and use,
including health information technology-enabled care
delivery.
``(3) Exceptions.--
``(A) In general.--The term `information blocking'
shall not include practices that--
``(i) are required by applicable law; or
``(ii) that the Secretary, through
regulation, identifies as necessary to protect
patient safety, to maintain the privacy or
security of individuals' health information, or
to promote competition and consumer welfare.
``(B) Process.--For purposes of subparagraph
(A)(ii), not later than 12 months after the date of the
enactment of this section, the Secretary shall issue
regulations following the notice and comment procedures
of section 553 of title 5, United States Code, except
that the Secretary may issue the first such regulation
as an interim final regulation.
``(C) No enforcement before exceptions
identified.--The term `information blocking' shall not
include any practice or conduct occurring before the
date that is 30 days after the date on which the first
regulation (as described in subparagraph (B)) is issued
under such subparagraph.
``(D) Consultation.--To the extent that regulations
issued under this paragraph define practices that are
necessary to promote competition and consumer welfare,
the Secretary may consult with the Federal Trade
Commission in issuing such regulations.
``(E) 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.
``(e) Treatment of Vendors With Respect to Patient Safety
Organizations.--In applying part C of title IX--
``(1) vendors shall be treated as a provider (as defined in
section 921) for purposes of reporting requirements under such
part, to the extent that such reports are related to
attestation requirements under section 3001(c)(5)(C)(i)(I);
``(2) claims of information blocking described in
subsection (a) shall be treated as a patient safety activity
under such part for purposes of reporting requirements under
such part; and
``(3) health care providers that are not members of patient
safety organizations shall be treated in the same manner as
health care providers that are such members for purposes of
such reporting requirements with respect to claims of
information blocking described in subsection (a).
``(f) Rulemaking and Guidance.--
``(1) In general.--Not later than 12 months after the date
of the enactment of this section, the Secretary, in
consultation with the National Coordinator and the Inspector
General of the Department of Health and Human Services, shall,
through rulemaking, implement the provisions of section 3001 of
the 21st Century Cures Act, including amendments made by such
section, relating to information blocking.
``(2) Non-duplication of penalty structures.--In carrying
out paragraph (1), in determining the scope of penalties,
assessments, or exclusions under such section 3001, including
amendments made by such section, relating to information
blocking, the Secretary shall ensure to the extent possible
that such penalties, assessments, and exclusions do not
duplicate penalty, assessment, and exclusion 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.
``(3) Clarification.--In carrying out paragraph (1), the
Secretary shall ensure that health care providers are not
penalized for actions of vendor of, and other entities offering
to such providers, health information technology for the
failure of such technology to meet requirements for such
technology to be certified under this title.
``(4) Guidance relating to hipaa.--Not later than January
1, 2017, the National Coordinator shall publish guidance to
clarify the relationship of the provisions of the HIPAA privacy
and security law, as defined in section 3009(a)(2) to
information blocking, including--
``(A) examples of how such provisions may result in
information blocking; and
``(B) clarifying that a health care provider (as
defined in subsection (g)) who discloses health
information as allowed under applicable State and
Federal law is not liable for unlawful actions,
including breaches that occur in the custody of the
recipient unless the disclosure proximately cause the
breach.
``(g) Health Care Provider Defined.--For purposes of this section,
the term `health care provider' means a provider of services under
subsection (u) of section 1861 of the Social Security Act and a
supplier under subsection (d) of such section.
``(h) Authorization of Appropriations.--In addition to amounts made
available under subsection (c)(3), there is authorized to be
appropriated $10,000,000 for fiscal year 2017 to carry out subsection
(a), to remain available until expended.''.
(3) Postings relating to enforcement on hhs internet
website.--Section 3001 of the Public Health Service Act (42
U.S.C. 300jj-11) is amended by adding at the end the following
new subsection:
``(f) Enforcement Information Posted on HHS Internet Website.--
``(1) Pricing information.--Not later than January 1, 2019,
the National Coordinator shall post the information described
in subsection (c)(5)(C)(I)(i)(cc) on the public Internet
website of the Office of the National Coordinator for Health
Information Technology in a manner that allows for comparison
of functionality, price information, and other features among
health information technology products that aids in making
informed decisions for purchasing such a product.
``(2) Annual posting.--For 2019 and each subsequent year,
the Secretary shall post on the public Internet website of the
Department of Health and Human Services a list of any qualified
electronic health records with respect to which certification
has been withdrawn under subsection (c)(5)(C)(ii) during such
year and the vendor of or other entity offering to health care
providers (as defined in section 3010A(g)) such qualified
electronic health records.
``(3) Periodic review.--The Secretary shall periodically
review and confirm that vendors of and other entities offering
to health care providers (as defined in section 3010A(g))
qualified electronic health records have publicly published
application programming interfaces and associated documentation
as required by subsection (c)(5)(C)(i)(II) for purposes of
certification and maintaining certification under any program
kept or recognized under subsection (c)(5)(A).''.
(4) Demonstration required for meaningful ehr use under
medicare.--
(A) Eligible professionals.--
(i) In general.--Section 1848(o)(2)(A) of
the Social Security Act (42 U.S.C. 1395w-
4(o)(2)(A)) is amended by inserting after
clause (iii) the following new clause:
``(iv) Interoperability.--With respect to
EHR reporting periods for payment years
beginning with 2020, the eligible professional
demonstrates to the satisfaction of the
Secretary, in accordance with subparagraph
(C)(i), that during such period the
professional has not taken any action described
in subsection (a)(2) of section 3010A of the
Public Health Service Act, with respect to the
use of any certified EHR technology.''.
(ii) Hardship exemption in case of
decertified ehr.--Subparagraph (B) of section
1848(a)(7) of the Social Security Act (42
U.S.C. 1395w-4(a)(7)) is amended to read as
follows:
``(B) Significant hardship exception.--
``(i) In general.--The Secretary may, on a
case-by-case basis, exempt an eligible
professional from the application of the
payment adjustment under subparagraph (A) if
the Secretary determines, subject to annual
renewal, that compliance with the requirement
for being a meaningful EHR user would result in
a significant hardship, such as in the case of
an eligible professional who practices in a
rural area without sufficient Internet access.
``(ii) Decertification.--The Secretary
shall exempt an eligible professional from the
application of the payment adjustment under
subparagraph (A) if the Secretary determines
that such professional was determined to not be
a meaningful EHR user because the certified EHR
technology used by such professional is
decertified under section 3001(c)(5)(C) of the
Public Health Service Act. An exemption under
the previous sentence may be applied to an
eligible professional only, subject to clause
(iii), during the first payment year with
respect to the first EHR reporting period to
which such decertification applies.
``(iii) Duration of decertification.--
``(I) In general.--Notwithstanding
clause (iv)(I), in no case shall an
exemption by reason of clause (ii) be
for a period of less than 12 months.
``(II) Extension.--An exemption
under clause (ii) may be extended, on a
case-by-case basis, for a period of an
additional 12 months subject to the
limitation described in clause (iv)(I).
``(iv) Limitation.--
``(I) In general.--Subject to
subclause (II), in no case may an
eligible professional be granted an
exemption under this subparagraph for
more than 5 years.
``(II) Exception.--Subclause (I)
shall not apply to an exemption by
reason of clause (ii) to the extent
necessary to satisfy clause
(iii)(I).''.
(iii) Further application.--Section
1848(o)(2) of the Social Security Act (42
U.S.C. 1395w-4(o)(2)) is amended by adding at
the end the following new subparagraph:
``(E) Hardship exemption in case of decertified
ehr.--In the case of certified EHR technology used by
an eligible professional that is decertified under
section 3001(c)(5)(C), during the first payment year
with respect to the first EHR reporting period to which
such decertification applies, the Secretary shall not
treat the professional as not being a meaningful EHR
user solely because the technology used by such
professional was so decertified. The treatment of a
professional under the previous sentence shall be for a
period of at least 12 months and may, on a case-by-case
basis, be for a period of an additional 12 months.''.
(B) Eligible hospitals.--
(i) In general.--Section 1886(n)(3)(A) of
the Social Security Act (42 U.S.C.
1395ww(n)(3)(A)) is amended by inserting after
clause (iii) the following new clause:
``(iv) Interoperability.--With respect to
EHR reporting periods for payment years
beginning with 2020, the hospital demonstrates
to the satisfaction of the Secretary, in
accordance with subparagraph (C)(i), that
during such period the hospital has not taken
any action described in subsection (a)(2) of
section 3010A of the Public Health Service Act,
with respect to the use of any certified EHR
technology.''.
(ii) Hardship exemption in case of
decertified ehr.--Subclause (II) of section
1886(b)(3)(B)(ix) of the Social Security Act
(42 U.S.C. 1395ww(b)(3)(B)(ix)) is amended to
read as follows:
``(II)(aa) The Secretary may, on a case-by-
case basis, exempt a subsection (d) hospital
from the application of subclause (I) with
respect to a fiscal year if the Secretary
determines, subject to annual renewal, that
requiring such hospital to be a meaningful EHR
user during such fiscal year would result in a
significant hardship, such as in the case of a
hospital in a rural area without sufficient
Internet access.
``(bb) The Secretary shall exempt a
subsection (d) hospital from the application of
subclause (I) with respect to a fiscal year if
the Secretary determines that such hospital was
determined to not be a meaningful EHR user
because the certified EHR technology used by
such hospital is decertified under section
3001(c)(5)(C) of the Public Health Service Act.
An exemption under the previous sentence may be
applied to a subsection (d) hospital only,
subject to items (cc) and (dd), during the
first payment year with respect to the first
EHR reporting period to which such
decertification applies.
``(cc) Notwithstanding item (ee), in no
case shall an exemption by reason of item (bb)
be for a period of less than 12 months.
``(dd) An exemption under item (bb) may, on
a case-by-case basis, be extended for a period
of an additional 12 months subject to the
limitation described in item (ee).
``(ee) Subject to item (ff), in no case may
a hospital be granted an exemption under this
subclause for more than 5 years.
``(ff) Item (ee) shall not apply to an
exemption by reason of item (bb) to the extent
necessary to satisfy item (cc).''.
(C) Demonstration required for meaningful ehr use
under medicaid.--Section 1903(t)(2) of the Social
Security Act (42 U.S.C. 1396b(t)(2)) is amended by
adding at the end the following: ``An eligible
professional shall not qualify as a Medicaid provider
under this subsection, with respect to a year beginning
with 2020, unless such provider demonstrates to the
Secretary, through means such as an attestation, that
the provider has not taken any action described in
subsection (a)(2) of section 3010A of the Public Health
Service Act, with respect to the use of any certified
EHR technology.''.
(5) Guidance.--Not later than January 1, 2018, the
Secretary of Health and Human Services shall issue guidance to
further the voluntary transition of health care providers
between different certified EHR technology (as defined in
section 3000(1) of the Public Health Service Act (42 U.S.C.
300jj(1)) by removing disincentives to such transition, which
may include applying to instances of such a transition the
hardship exemption authority under section 1848(a)(7) of the
Social Security Act (42 U.S.C. 1395w-4(a)(7)), section
1886(b)(3)(B)(ix) of such Act (42 U.S.C. 1395ww(b)(3)(B)(ix)),
and other provisions of law in existence as of the date of the
enactment of this Act. In developing such guidance, the
Secretary may consult with the relevant Federal agencies.
(f) Definitions.--
(1) Certified ehr technology.--Paragraph (1) of section
3000 of the Public Health Service Act (42 U.S.C. 300jj) is
amended to read as follows:
``(1) Certified ehr technology.--The term `certified EHR
technology' means a qualified electronic health record that is
certified pursuant to section 3001(c)(5) as meeting the
certification criteria defined in subparagraph (B) of such
section that are applicable to the type of record involved (as
determined by the Secretary, such as an ambulatory electronic
health record for office-based physicians or an inpatient
hospital electronic health record for hospitals) including,
beginning January 1, 2018, with respect to which the vendor or
other entity offering such technology is in compliance with the
requirements under section 3001(c)(5)(C)(i).''.
(2) Widespread interoperability.--Section 3000 of the
Public Health Service Act (42 U.S.C. 300jj) is amended by
adding at the end the following new paragraph:
``(15) Widespread interoperability.--The term `widespread
interoperability' means that, on a nationwide basis--
``(A) health information technology is
interoperable, in accordance with section 3010; and
``(B) such technology is employed by meaningful EHR
users under the Medicare Program under title XVIII of
the Social Security Act and the Medicaid program under
title XIX of such Act and by other clinicians and
health care providers.''.
(g) Conforming Amendments.--
(1) Voluntary use of standards.--Section 3006 of the Public
Health Service Act (42 U.S.C. 300jj-16) is amended--
(A) in subsection (a)(1), by inserting ``,
including an interoperability standard or
implementation specification, with respect to such
interoperability standard, adopted under such section''
after ``section 3004''.
(B) in subsection (b), by inserting ``, including
the interoperability standards and implementation
specifications, with respect to such interoperability
standards, adopted under such section'' after ``section
3004''.
(2) HIPAA privacy and security law definition correction.--
Section 3009(a)(2)(A) of the Public Health Service Act (42
U.S.C. 300jj-19(a)(2)(A)) is amended by striking ``title IV''
and inserting ``title XIII''.
(3) Coordination of federal activities.--Section 13111 of
the HITECH Act is amended--
(A) in subsection (a), by inserting before the
period at the end the following: ``(and, beginning on
January 1, 2018, that are also interoperable under
section 3010 of such Act and in compliance with
interoperability standards and implementation
specifications, with respect to such interoperability
standards, adopted under section 3004 of such Act )'';
and
(B) in subsection (b), by inserting ``(and,
beginning on January 1, 2018, including an
interoperability standard or implementation
specification, with respect to such interoperability
standard, adopted under section 3004 of such Act)''
before ``the President''.
(4) Application to private entities.--Section 13112 of the
HITECH Act is amended by inserting before the period at the end
the following: ``(and, beginning on January 1, 2018, that are
also interoperable under section 3010 of such Act and in
compliance with interoperability standards and implementation
specifications, with respect to such interoperability
standards, adopted under section 3004 of such Act)''.
(5) NIST testing.--Section 13201 of the HITECH Act (42
U.S.C. 17911) is amended--
(A) in subsection (a), by inserting ``(or,
beginning January 1, 2018, in coordination with the
entities with contracts under section 3003A, with
respect to standards, and implementation specifications
under section 3004)'' before ``, the Director'';
(B) in subsection (b), by inserting ``(or,
beginning January 1, 2018, in coordination with the
entities with contracts under section 3003A, with
respect to standards and implementation specifications
under section 3004)'' before ``, the Director''; and
(C) by adding at the end the following new
subsection:
``(c) Funding.--For purposes of carrying out this section, in
addition to any other funds made available to carry out this section,
there is authorized to be appropriated $15,000,000, to remain available
until expended.''.
(6) Coordination with recommendations for achieving
widespread ehr interoperability.--Section 106 of the Medicare
Access and CHIP Reauthorization Act of 2015 (Public Law 114-10)
is amended by striking subsection (b).
(h) Patient Engagement and Empowerment.--It is the sense of
Congress that--
(1) if the strategic goals that Congress set forth in the
HITECH Act are to be achieved, interoperability is best
achieved with individuals and authorized representatives having
equal access to the health information of such individuals in
electronic format;
(2) patients have the right to the entirety of the health
information of such individuals, including such information
contained in an electronic health record of such individuals;
(3) such right extends to both structured and unstructured
data;
(4) such right extends to authorized representatives of the
individual involved, such as caretakers of such individual,
family members of such individual, and guardians of such
individual; and
(5) to further facilitate access of an individual to health
information of such individual--
(A) health care providers should not have the
ability to deny a request of the individual for access
to the entirety of such health information of such
individual;
(B) health care providers do not need the consent
of individuals to share personal health information of
such individuals with other covered entities, in
compliance with the HIPAA privacy regulations
promulgated pursuant to section 264(c) of the Health
Insurance Portability and Accountability Act of 1996
for the purposes of supporting patient care, except in
situations where consent is specifically required under
such regulations, such as in cases related to the
psychiatric records of the individual involved;
(C) mechanisms should be utilized that allow for
the bidirectional exchange of information through such
mechanisms as web portals, appointments, and
prescription refills, for the purpose of patients
partnering with providers to assist in managing health
and care;
(D) mechanisms described in subparagraph (C) should
allow for connecting individuals across the continuum
of care;
(E) an individual has the right to access the
health information of the individual without cost to
the individual;
(F) mechanisms described in subparagraph (C) should
allow for data of an individual generated by the
individual to be integrated into such platforms as
electronic health records;
(G) such access should be timely, in accordance
with the HIPAA privacy regulations described in
subparagraph (B), and take into account communications
preferences of the individual involved;
(H) an individual should have the right to be
confident that the data in the electronic health record
of the individual pertains to such individual; and
(I) the right described in subparagraph (H) will
promote safety and care coordination for individuals.
Subtitle B--Telehealth
SEC. 3021. TELEHEALTH SERVICES UNDER THE MEDICARE PROGRAM.
(a) Provision of Information by Centers for Medicare & Medicaid
Services.--Not later than 1 year after the date of the 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 title
XVIII of such Act, 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 the Social Security 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
the furnishing of services via 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 the enactment of this Act.
(b) Provision of Information by MedPAC.--Not later than March 15,
2017, 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 the 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;
(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 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 under
title XVIII unless specifically address in subsequent
statute, of such Act if the service were furnished in
person, including standards of care; and
(C) involve clinically appropriate means to furnish
such services.
Subtitle C--Encouraging Continuing Medical Education for Physicians
SEC. 3041. EXEMPTING FROM MANUFACTURER TRANSPARENCY REPORTING CERTAIN
TRANSFERS USED FOR EDUCATIONAL PURPOSES.
(a) In General.--Section 1128G(e)(10)(B) of the Social Security Act
(42 U.S.C. 1320a-7h(e)(10)(B)) is amended--
(1) in clause (iii), by inserting ``, including peer-
reviewed journals, journal reprints, journal supplements,
medical conference reports, and medical textbooks'' after
``patient use''; and
(2) by adding at the end the following new clause:
``(xiii) In the case of a covered recipient
who is a physician, an indirect payment or
transfer of value to the covered recipient--
``(I) for speaking at, or preparing
educational materials for, an
educational event for physicians or
other health care professionals that
does not commercially promote a covered
drug, device, biological, or medical
supply; or
``(II) that serves the sole purpose
of providing the covered recipient with
medical education, such as by providing
the covered recipient with the tuition
required to attend an educational event
or with materials provided to
physicians at an educational event.''.
(b) Effective Date.--The amendments made by this section shall
apply with respect to transfers of value made on or after the date of
the enactment of this Act.
Subtitle D--Disposable Medical Technologies
SEC. 3061. TREATMENT OF CERTAIN ITEMS AND DEVICES.
(a) In General.--Section 1834 of the Social Security Act (42 U.S.C.
1395m) is amended by adding at the end the following new subsection:
``(r) Payment for Certain Disposable Devices.--
``(1) In general.--The Secretary shall make separate
payment in the amount established under paragraph (3) to a home
health agency for a device described in paragraph (2) when
furnished to an individual who receives home health services
for which payment is made under section 1895(b).
``(2) Device described.--For purposes of paragraph (1), a
device described in this paragraph is a disposable device for
which, as of January 1, 2015, there is--
``(A) a Level I Healthcare Common Procedure Coding
System (HCPCS) code for which the description for a
professional service includes the furnishing of such
device; and
``(B) a separate Level I HCPCS code for a
professional service that uses durable medical
equipment instead of such device.
``(3) Payment amount.--The Secretary shall establish the
separate payment amount for such a device such that such amount
does not exceed the payment that would be made for the HCPCS
code described in paragraph (2)(A) under section 1833(t)
(relating to payment for covered OPD services).''.
(b) Conforming Amendment.--Section 1861(m)(5) of the Social
Security Act (42 U.S.C. 1395x(m)(5)) is amended by inserting ``and
devices described in section 1834(r)(2)'' after ``durable medical
equipment''.
(c) Effective Date.--The amendments made by this section shall
apply to devices furnished on or after January 1, 2017.
Subtitle E--Local Coverage Decision Reforms
SEC. 3081. IMPROVEMENTS IN THE MEDICARE LOCAL COVERAGE DETERMINATION
(LCD) PROCESS.
(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 website of such contractor and on the
Medicare 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 the
enactment of this Act.
Subtitle F--Medicare Pharmaceutical and Technology Ombudsman
SEC. 3101. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.
Section 1808(c) of the Social Security Act (42 U.S.C. 1395b-9(c))
is amended by adding at the end the following new paragraph:
``(4) Pharmaceutical and technology ombudsman.--Not later
than 12 months after the date of the 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.
The second sentence of paragraph (2) shall apply to this
paragraph in the same manner as such sentence applies to
paragraph (2).''.
Subtitle G--Medicare Site-of-Service Price Transparency
SEC. 3121. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY.
Section 1834 of the Social Security Act (42 U.S.C. 1395m), as
amended by section 3061, is further amended by adding at the end the
following new subsection:
``(s) 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 2017 and each year thereafter, make
available to the public via a searchable 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 the enactment of this subsection, such as the
portion of the website of the Centers for Medicare &
Medicaid Services on which information comparing
physician performance is posted (commonly referred to
as the Physician Compare 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 Supplemental Medical Insurance Trust Fund under section
1841 to the Centers for Medicare & Medicaid Services Program
Management Account, of $6,000,000 for fiscal year 2015, to
remain available until expended.''.
Subtitle H--Medicare Part D Patient Safety and Drug Abuse Prevention
SEC. 3141. PROGRAMS TO PREVENT PRESCRIPTION DRUG ABUSE UNDER MEDICARE
PARTS C AND D.
(a) Drug Management Program for At-Risk Beneficiaries.--
(1) In general.--Section 1860D-4(c) of the Social Security
Act (42 U.S.C. 1395w-10(c)) is amended by adding at the end the
following:
``(5) Drug management program for at-risk beneficiaries.--
``(A) Authority to establish.--A PDP sponsor may
establish a drug management program for at-risk
beneficiaries under which, subject to subparagraph (B),
the PDP sponsor may, in the case of an at-risk
beneficiary for prescription drug abuse who is an
enrollee in a prescription drug plan of such PDP
sponsor, limit such beneficiary's access to coverage
for frequently abused drugs under such plan to
frequently abused drugs that are prescribed for such
beneficiary by one or more prescribers selected under
subparagraph (D), and dispensed for such beneficiary by
one or more pharmacies selected under such
subparagraph.
``(B) Requirement for notices.--
``(i) In general.--A PDP sponsor may not
limit the access of an at-risk beneficiary for
prescription drug abuse to coverage for
frequently abused drugs under a prescription
drug plan until such sponsor--
``(I) provides to the beneficiary
an initial notice described in clause
(ii) and a second notice described in
clause (iii); and
``(II) verifies with the providers
of the beneficiary that the beneficiary
is an at-risk beneficiary for
prescription drug abuse.
``(ii) Initial notice.--An initial notice
described in this clause is a notice that
provides to the beneficiary--
``(I) notice that the PDP sponsor
has identified the beneficiary as
potentially being an at-risk
beneficiary for prescription drug
abuse;
``(II) information describing all
State and Federal public health
resources that are designed to address
prescription drug abuse to which the
beneficiary has access, including
mental health services and other
counseling services;
``(III) notice of, and information
about, the right of the beneficiary to
appeal such identification under
subsection (h) and the option of an
automatic escalation to external
review;
``(IV) a request for the
beneficiary to submit to the PDP
sponsor preferences for which
prescribers and pharmacies the
beneficiary would prefer the PDP
sponsor to select under subparagraph
(D) in the case that the beneficiary is
identified as an at-risk beneficiary
for prescription drug abuse as
described in clause (iii)(I);
``(V) an explanation of the meaning
and consequences of the identification
of the beneficiary as potentially being
an at-risk beneficiary for prescription
drug abuse, including an explanation of
the drug management program established
by the PDP sponsor pursuant to
subparagraph (A);
``(VI) clear instructions that
explain how the beneficiary can contact
the PDP sponsor in order to submit to
the PDP sponsor the preferences
described in subclause (IV) and any
other communications relating to the
drug management program for at-risk
beneficiaries established by the PDP
sponsor; and
``(VII) contact information for
other organizations that can provide
the beneficiary with assistance
regarding such drug management program
(similar to the information provided by
the Secretary in other standardized
notices provided to part D eligible
individuals enrolled in prescription
drug plans under this part).
``(iii) Second notice.--A second notice
described in this clause is a notice that
provides to the beneficiary notice--
``(I) that the PDP sponsor has
identified the beneficiary as an at-
risk beneficiary for prescription drug
abuse;
``(II) that such beneficiary is
subject to the requirements of the drug
management program for at-risk
beneficiaries established by such PDP
sponsor for such plan;
``(III) of the prescriber (or
prescribers) and pharmacy (or
pharmacies) selected for such
individual under subparagraph (D);
``(IV) of, and information about,
the beneficiary's right to appeal such
identification under subsection (h) and
the option of an automatic escalation
to external review;
``(V) that the beneficiary can, in
the case that the beneficiary has not
previously submitted to the PDP sponsor
preferences for which prescribers and
pharmacies the beneficiary would prefer
the PDP sponsor select under
subparagraph (D), submit such
preferences to the PDP sponsor; and
``(VI) that includes clear
instructions that explain how the
beneficiary can contact the PDP
sponsor.
``(iv) Timing of notices.--
``(I) In general.--Subject to
subclause (II), a second notice
described in clause (iii) shall be
provided to the beneficiary on a date
that is not less than 60 days after an
initial notice described in clause (ii)
is provided to the beneficiary.
``(II) Exception.--In the case that
the PDP sponsor, in conjunction with
the Secretary, determines that concerns
identified through rulemaking by the
Secretary regarding the health or
safety of the beneficiary or regarding
significant drug diversion activities
require the PDP sponsor to provide a
second notice described in clause (iii)
to the beneficiary on a date that is
earlier than the date described in
subclause (I), the PDP sponsor may
provide such second notice on such
earlier date.
``(C) At-risk beneficiary for prescription drug
abuse.--
``(i) In general.--For purposes of this
paragraph, the term `at-risk beneficiary for
prescription drug abuse' means a part D
eligible individual who is not an exempted
individual described in clause (ii) and--
``(I) who is identified as such an
at-risk beneficiary through the use of
clinical guidelines developed by the
Secretary in consultation with PDP
sponsors and other stakeholders
described in section 3141(f)(2)(A) of
the 21st Century Cures Act; or
``(II) with respect to whom the PDP
sponsor of a prescription drug plan,
upon enrolling such individual in such
plan, received notice from the
Secretary that such individual was
identified under this paragraph to be
an at-risk beneficiary for prescription
drug abuse under the prescription drug
plan in which such individual was most
recently previously enrolled and such
identification has not been terminated
under subparagraph (F).
``(ii) Exempted individual described.--An
exempted individual described in this clause is
an individual who--
``(I) receives hospice care under
this title;
``(II) is a resident of a long-term
care facility, of an intermediate care
facility for the mentally retarded, or
of another facility for which
frequently abused drugs are dispensed
for residents through a contract with a
single pharmacy; or
``(III) the Secretary elects to
treat as an exempted individual for
purposes of clause (i).
``(D) Selection of prescribers and pharmacies.--
``(i) In general.--With respect to each at-
risk beneficiary for prescription drug abuse
enrolled in a prescription drug plan offered by
such sponsor, a PDP sponsor shall, based on the
preferences submitted to the PDP sponsor by the
beneficiary pursuant to clauses (ii)(IV) and
(iii)(V) of subparagraph (B) (except as
otherwise provided in this subparagraph),
select--
``(I) one or more individuals who
are authorized to prescribe frequently
abused drugs (referred to in this
paragraph as `prescribers') who may
write prescriptions for such drugs for
such beneficiary; and
``(II) one or more pharmacies that
may dispense such drugs to such
beneficiary.
``(ii) Reasonable access.--In making the
selections under this subparagraph--
``(I) a PDP sponsor shall ensure
that the beneficiary continues to have
reasonable access to frequently abused
drugs (as defined in subparagraph (G)),
taking into account geographic
location, beneficiary preference,
impact on costsharing, and reasonable
travel time; and
``(II) a PDP sponsor shall ensure
such access (including access to
prescribers and pharmacies with respect
to frequently abused drugs) in the case
of individuals with multiple residences
and in the case of natural disasters
and similar emergency situations.
``(iii) Beneficiary preferences.--If an at-
risk beneficiary for prescription drug abuse
submits preferences for which in-network
prescribers and pharmacies the beneficiary
would prefer the PDP sponsor select in response
to a notice under subparagraph (B), the PDP
sponsor shall--
``(I) review such preferences;
``(II) select or change the
selection of prescribers and pharmacies
for the beneficiary based on such
preferences; and
``(III) inform the beneficiary of
such selection or change of selection.
``(iv) Exception regarding beneficiary
preferences.--In the case that the PDP sponsor
determines that a change to the selection of
prescriber or pharmacy under clause (iii)(II)
by the PDP sponsor is contributing or would
contribute to prescription drug abuse or drug
diversion by the beneficiary, the PDP sponsor
may change the selection of prescriber or
pharmacy for the beneficiary without regard to
the preferences of the beneficiary described in
clause (iii).
``(v) Confirmation.--Before selecting a
prescriber (or prescribers) or pharmacy (or
pharmacies) under this subparagraph, a PDP
sponsor must request and receive confirmation
from such a prescriber or pharmacy
acknowledging and accepting that the
beneficiary involved is in the drug management
program for at-risk beneficiaries.
``(E) Terminations and appeals.--The identification
of an individual as an at-risk beneficiary for
prescription drug abuse under this paragraph, a
coverage determination made under a drug management
program for at-risk beneficiaries, and the selection of
prescriber or pharmacy under subparagraph (D) with
respect to such individual shall be subject to
reconsideration and appeal under subsection (h) and the
option of an automatic escalation to external review to
the extent provided by the Secretary.
``(F) Termination of identification.--
``(i) In general.--The Secretary shall
develop standards for the termination of
identification of an individual as an at-risk
beneficiary for prescription drug abuse under
this paragraph. Under such standards such
identification shall terminate as of the
earlier of--
``(I) the date the individual
demonstrates that the individual is no
longer likely, in the absence of the
restrictions under this paragraph, to
be an at-risk beneficiary for
prescription drug abuse described in
subparagraph (C)(i); and
``(II) the end of such maximum
period of identification as the
Secretary may specify.
``(ii) Rule of construction.--Nothing in
clause (i) shall be construed as preventing a
plan from identifying an individual as an at-
risk beneficiary for prescription drug abuse
under subparagraph (C)(i) after such
termination on the basis of additional
information on drug use occurring after the
date of notice of such termination.
``(G) Frequently abused drug.--For purposes of this
subsection, the term `frequently abused drug' means a
drug that is a controlled substance that the Secretary
determines to be frequently abused or diverted.
``(H) Data disclosure.--In the case of an at-risk
beneficiary for prescription drug abuse whose access to
coverage for frequently abused drugs under a
prescription drug plan has been limited by a PDP
sponsor under this paragraph, such PDP sponsor shall
disclose data, including any necessary individually
identifiable health information, in a form and manner
specified by the Secretary, about the decision to
impose such limitations and the limitations imposed by
the sponsor under this part to other PDP sponsors that
request such data.
``(I) Education.--The Secretary shall provide
education to enrollees in prescription drug plans of
PDP sponsors and providers regarding the drug
management program for at-risk beneficiaries described
in this paragraph, including education--
``(i) provided by Medicare administrative
contractors through the improper payment
outreach and education program described in
section 1874A(h); and
``(ii) through current education efforts
(such as State health insurance assistance
programs described in subsection (a)(1)(A) of
section 119 of the Medicare Improvements for
Patients and Providers Act of 2008 (42 U.S.C.
1395b-3 note)) and materials directed toward
such enrollees.
``(J) Application under ma-pd plans.--Pursuant to
section 1860D-21(c)(1), the provisions of this
paragraph apply under part D to MA organizations
offering MA-PD plans to MA eligible individuals in the
same manner as such provisions apply under this part to
a PDP sponsor offering a prescription drug plan to a
part D eligible individual.''.
(2) Information for consumers.--Section 1860D-4(a)(1)(B) of
the Social Security Act (42 U.S.C. 1395w-104(a)(1)(B)) is
amended by adding at the end the following:
``(v) The drug management program for at-
risk beneficiaries under subsection (c)(5).''.
(b) Utilization Management Programs.--Section 1860D-4(c) of the
Social Security Act (42 U.S.C. 1395w-104(c)), as amended by subsection
(a)(1), is further amended--
(1) in paragraph (1), by inserting after subparagraph (D)
the following new subparagraph:
``(E) A utilization management tool to prevent drug
abuse (as described in paragraph (6)(A)).''; and
(2) by adding at the end the following new paragraph:
``(6) Utilization management tool to prevent drug abuse.--
``(A) In general.--A tool described in this
paragraph is any of the following:
``(i) A utilization tool designed to
prevent the abuse of frequently abused drugs by
individuals and to prevent the diversion of
such drugs at pharmacies.
``(ii) Retrospective utilization review to
identify--
``(I) individuals that receive
frequently abused drugs at a frequency
or in amounts that are not clinically
appropriate; and
``(II) providers of services or
suppliers that may facilitate the abuse
or diversion of frequently abused drugs
by beneficiaries.
``(iii) Consultation with the contractor
described in subparagraph (B) to verify if an
individual enrolling in a prescription drug
plan offered by a PDP sponsor has been
previously identified by another PDP sponsor as
an individual described in clause (ii)(I).
``(B) Reporting.--A PDP sponsor offering a
prescription drug plan (and an MA organization offering
an MA-PD plan) in a State shall submit to the Secretary
and the Medicare drug integrity contractor with which
the Secretary has entered into a contract under section
1893 with respect to such State a report, on a monthly
basis, containing information on--
``(i) any provider of services or supplier
described in subparagraph (A)(ii)(II) that is
identified by such plan sponsor (or
organization) during the 30-day period before
such report is submitted; and
``(ii) the name and prescription records of
individuals described in paragraph (5)(C).''.
(c) Expanding Activities of Medicare Drug Integrity Contractors
(MEDICs).--
(1) In general.--Section 1893 of the Social Security Act
(42 U.S.C. 1395ddd) is amended by adding at the end the
following new subsection:
``(j) Expanding Activities of Medicare Drug Integrity Contractors
(MEDICs).--
``(1) Access to information.--Under contracts entered into
under this section with Medicare drug integrity contractors
(including any successor entity to a Medicare drug integrity
contractor), the Secretary shall authorize such contractors to
directly accept prescription and necessary medical records from
entities such as pharmacies, prescription drug plans, MA-PD
plans, and physicians with respect to an individual in order
for such contractors to provide information relevant to the
determination of whether such individual is an at-risk
beneficiary for prescription drug abuse, as defined in section
1860D-4(c)(5)(C).
``(2) Requirement for acknowledgment of referrals.--If a
PDP sponsor or MA organization refers information to a
contractor described in paragraph (1) in order for such
contractor to assist in the determination described in such
paragraph, the contractor shall--
``(A) acknowledge to the sponsor or organization
receipt of the referral; and
``(B) in the case that any PDP sponsor or MA
organization contacts the contractor requesting to know
the determination by the contractor of whether or not
an individual has been determined to be an individual
described such paragraph, shall inform such sponsor or
organization of such determination on a date that is
not later than 15 days after the date on which the
sponsor or organization contacts the contractor.
``(3) Making data available to other entities.--
``(A) In general.--For purposes of carrying out
this subsection, subject to subparagraph (B), the
Secretary shall authorize MEDICs to respond to requests
for information from PDP sponsors and MA organizations,
State prescription drug monitoring programs, and other
entities delegated by such sponsors or organizations
using available programs and systems in the effort to
prevent fraud, waste, and abuse.
``(B) HIPAA compliant information only.--
Information may only be disclosed by a MEDIC under
subparagraph (A) if the disclosure of such information
is permitted under the Federal regulations (concerning
the privacy of individually identifiable health
information) promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of
1996 (42 U.S.C. 1320d-2 note).''.
(2) OIG study and report on effectiveness of medics.--
(A) Study.--The Inspector General of the Department
of Health and Human Services shall conduct a study on
the effectiveness of Medicare drug integrity
contractors with which the Secretary of Health and
Human Services has entered into a contract under
section 1893 of the Social Security Act (42 U.S.C.
1395ddd) in identifying, combating, and preventing
fraud under the Medicare Program, including under the
authority provided under section 1893(j) of the Social
Security Act, added by paragraph (1).
(B) Report.--Not later than 1 year after the date
of the enactment of this Act, the Inspector General
shall submit to Congress a report on the study
conducted under subparagraph (A). Such report shall
include such recommendations for improvements in the
effectiveness of such contractors as the Inspector
General determines appropriate.
(d) Treatment of Certain Complaints for Purposes of Quality or
Performance Assessment.--Section 1860D-42 of the Social Security Act
(42 U.S.C. 1395w-152) is amended by adding at the end the following new
subsection:
``(d) Treatment of Certain Complaints for Purposes of Quality or
Performance Assessment.--In conducting a quality or performance
assessment of a PDP sponsor, the Secretary shall develop or utilize
existing screening methods for reviewing and considering complaints
that are received from enrollees in a prescription drug plan offered by
such PDP sponsor and that are complaints regarding the lack of access
by the individual to prescription drugs due to a drug management
program for at-risk beneficiaries.''.
(e) Sense of Congress Regarding Use of Technology Tools To Combat
Fraud.--It is the sense of Congress that MA organizations and PDP
sponsors should consider using e-prescribing and other health
information technology tools to support combating fraud under MA-PD
plans and prescription drug plans under parts C and D of the Medicare
Program.
(f) Effective Date.--
(1) In general.--The amendments made by this section shall
apply to prescription drug plans (and MA-PD plans) for plan
years beginning more than 1 year after the date of the
enactment of this Act.
(2) Stakeholder meetings prior to effective date.--
(A) In general.--Not later than January 1, 2016,
the Secretary of Health and Human Services shall
convene stakeholders, including individuals entitled to
benefits under part A of title XVIII of the Social
Security Act or enrolled under part B of such title of
such Act, advocacy groups representing such
individuals, physicians, pharmacists, and other
clinicians, retail pharmacies, plan sponsors, entities
delegated by plan sponsors, and biopharmaceutical
manufacturers for input regarding the topics described
in subparagraph (B).
(B) Topics described.--The topics described in this
subparagraph are the topics of--
(i) the anticipated impact of drug
management programs for at-risk beneficiaries
under paragraph (5) of section 1860D-4(c) of
the Social Security Act (42 U.S.C. 1395w-
104(c)) on cost-sharing and ensuring
accessibility to prescription drugs for
enrollees in prescription drug plans of PDP
sponsors, and enrollees in MA-PD plans, who are
at-risk beneficiaries for prescription drug
abuse (as defined in subparagraph (C) of such
paragraph);
(ii) the use of an expedited appeals
process under which such an enrollee may appeal
an identification of such enrollee as an at-
risk beneficiary for prescription drug abuse
under such paragraph (similar to the processes
established under the Medicare Advantage
program under part C of title XVIII of the
Social Security Act that allow an automatic
escalation to external review of claims
submitted under such part);
(iii) the types of enrollees that should be
treated as exempted individuals, as described
in subparagraph (C)(ii) of such paragraph;
(iv) the manner in which terms and
definitions in such paragraph should be
applied, such as the use of clinical
appropriateness in determining whether an
enrollee is an at-risk beneficiary for
prescription drug abuse as defined in
subparagraph (C) of such paragraph;
(v) the information to be included in the
notices described in subparagraph (B) of such
paragraph and the standardization of such
notices; and
(vi) with respect to a PDP sponsor (or
Medicare Advantage organization) that
establishes a drug management program for at-
risk beneficiaries under such paragraph, the
responsibilities of such PDP sponsor (or
organization) with respect to the
implementation of such program.
(g) Rulemaking.--The Secretary of Health and Human Services shall
promulgate regulations based on the input gathered pursuant to
subsection (f)(2)(A).
TITLE IV--MEDICAID, MEDICARE, AND OTHER REFORMS
Subtitle A--Medicaid and Medicare Reforms
SEC. 4001. LIMITING FEDERAL MEDICAID REIMBURSEMENT TO STATES FOR
DURABLE MEDICAL EQUIPMENT (DME) TO MEDICARE PAYMENT
RATES.
(a) Medicaid Reimbursement.--
(1) In general.--Section 1903(i) of the Social Security Act
(42 U.S.C. 1396b(i)) is amended--
(A) in paragraph (25), by striking ``or'' at the
end;
(B) in paragraph (26), by striking the period at
the end and inserting ``; or''; and
(C) by inserting after paragraph (26) the following
new paragraph:
``(27) with respect to any amounts expended by the State on
the basis of a fee schedule for items described in section
1861(n), as determined in the aggregate with respect to each
class of such items as defined by the Secretary, in excess of
the aggregate amount, if any, that would be paid for such items
within such class on a fee-for-service basis under the program
under part B of title XVIII, including, as applicable, under a
competitive acquisition program under section 1847 in an area
of the State.''.
(2) Effective date.--The amendments made by this subsection
shall be effective with respect to payments for items furnished
on or after January 1, 2020.
(b) Medicare Ombudsman.--Section 1808(c) of the Social Security Act
(42 U.S.C. 1395b(c)), as amended by section 3101, is further amended by
adding at the end the following new paragraph:
``(5) Monitoring dme reimbursement under medicaid.--The
ombudsmen under each of paragraphs (1) and (4) shall evaluate
the impact of the competitive acquisition program under section
1847, including as applied under section 1903(i)(27), on
beneficiary health status and health outcomes.''.
SEC. 4002. EXCLUDING AUTHORIZED GENERICS FROM CALCULATION OF AVERAGE
MANUFACTURER PRICE.
(a) In General.--Subparagraph (C) of section 1927(k)(1) of the
Social Security Act (42 U.S.C. 1396r-8(k)(1)) is amended--
(1) in the subparagraph heading, by striking ``Inclusion''
and inserting ``Exclusion'';
(2) by striking ``a new drug application'' and inserting
``the manufacturer's new drug application''; and
(3) by striking ``inclusive'' and inserting ``exclusive''.
(b) Effective Date.--The amendments made by this section take
effect on October 1, 2015.
SEC. 4003. MEDICARE PAYMENT INCENTIVE FOR THE TRANSITION FROM
TRADITIONAL X-RAY IMAGING TO DIGITAL RADIOGRAPHY AND
OTHER MEDICARE IMAGING PAYMENT PROVISION.
(a) Physician Fee Schedule.--
(1) Payment incentive for transition.--
(A) In general.--Section 1848(b) of the Social
Security Act (42 U.S.C. 1395w-4(b)) is amended by
adding at the end the following new paragraph:
``(9) Special rule to incentivize transition from
traditional x-ray imaging to digital radiography.--
``(A) Limitation on payment for film x-ray imaging
services.--In the case of an imaging service (including
the imaging portion of a service) that is an X-ray
taken using film and that is furnished during 2017 or a
subsequent year, the payment amount for the technical
component (including the technical component portion of
a global service) of such service that would otherwise
be determined under this section (without application
of this paragraph and before application of any other
adjustment under this section) for such year shall be
reduced by 20 percent.
``(B) Phased-in limitation on payment for computed
radiography imaging services.--In the case of an
imaging service (including the imaging portion of a
service) that is an X-ray taken using computed
radiography technology--
``(i) in the case of such a service
furnished during 2018, 2019, 2020, 2021, or
2022, the payment amount for the technical
component (including the technical component
portion of a global service) of such service
that would otherwise be determined under this
section (without application of this paragraph
and before application of any other adjustment
under this section) for such year shall be
reduced by 7 percent; and
``(ii) in the case of such a service
furnished during 2023 or a subsequent year, the
payment amount for the technical component
(including the technical component portion of a
global service) of such service that would
otherwise be determined under this section
(without application of this paragraph and
before application of any other adjustment
under this section) for such year shall be
reduced by 10 percent.
``(C) Computed radiography technology defined.--For
purposes of this paragraph, the term `computed
radiography technology' means cassette-based imaging
which utilizes an imaging plate to create the image
involved.
``(D) Implementation.--In order to implement this
paragraph, the Secretary shall adopt appropriate
mechanisms which may include use of modifiers.''.
(B) Exemption from budget neutrality.--Section
1848(c)(2)(B)(v) of the Social Security Act (42 U.S.C.
1395w-4(c)(2)(B)(v)) is amended by adding at the end
the following new subclause:
``(X) Reduced expenditures
attributable to incentives to
transition to digital radiography.--
Effective for fee schedules established
beginning with 2017, reduced
expenditures attributable to
subparagraph (A) of subsection (b)(9)
and effective for fee schedules
established beginning with 2018,
reduced expenditures attributable to
subparagraph (B) of such subsection.''.
(2) Elimination of application of multiple procedure
payment reduction.--
(A) In general.--Section 1848(b)(4) of the Social
Security Act (42 U.S.C. 1395w-4(b)(4)) is amended by
adding at the end the following new subparagraph:
``(E) Elimination of application of multiple
procedure payment reduction.--
``(i) In general.--For services furnished
on or after January 1, 2017, the Secretary
shall not apply a multiple procedure payment
reduction to the professional component of
imaging services unless the Secretary has
published as part of a Medicare Physician Fee
Schedule Proposed Rule the empirical analysis
described in clause (ii) with tables made
available on the website of the Centers for
Medicare & Medicaid Services.
``(ii) Empirical analysis described.--The
empirical analysis described in this clause is
an analysis of the Resource-Based Relative
Value Scale Data Manager information or other
information that is used to determine what, if
any, efficiencies exist within the professional
component of imaging services when two or more
studies are furnished to the same individual on
the same day. Such empirical analysis shall
include--
``(I) information detailing which
physician work activities overlap and
the reductions applicable to such
overlap;
``(II) a discussion of the clinical
aspects that informed the assignment of
the reduction percentages described in
subclause (I);
``(III) to the extent that such
reductions are used for proposed
payment reductions, an explanation of
how the percentage reductions for pre-
service, intra-service, and post-
service work were determined and
calculated;
``(IV) other data used to determine
a reduction; and
``(V) a demonstration that the
Secretary has consulted with practicing
radiologists to gain knowledge of how
radiologists interpret studies of
multiple body parts on the same
individual on the same day.''.
(B) Conforming amendment.--Section 220(i) of the
Protecting Access to Medicare Act of 2014 (42 U.S.C.
1395w-4 note) is repealed.
(b) Payment Incentive for Transition Under Hospital Outpatient
Prospective Payment System.--Section 1833(t)(16) of the Social Security
Act (42 U.S.C. 1395(t)(16)) is amended by adding at the end the
following new subparagraph:
``(F) Payment incentive for the transition from
traditional x-ray imaging to digital radiography.--
Notwithstanding the previous provisions of this
subsection:
``(i) Limitation on payment for film x-ray
imaging services.--In the case of an imaging
service that is an X-ray taken using film and
that is furnished during 2017 or a subsequent
year, the payment amount for such service
(including the X-ray component of a packaged
service) that would otherwise be determined
under this section (without application of this
paragraph and before application of any other
adjustment under this subsection) for such year
shall be reduced by 20 percent.
``(ii) Phased-in limitation on payment for
computed radiography imaging services.--In the
case of an imaging service that is an X-ray
taken using computed radiography technology (as
defined in section 1848(b)(9)(C))--
``(I) in the case of such a service
furnished during 2018, 2019, 2020,
2021, or 2022, the payment amount for
such service (including the X-ray
component of a packaged service) that
would otherwise be determined under
this section (without application of
this paragraph and before application
of any other adjustment under this
subsection) for such year shall be
reduced by 7 percent; and
``(II) in the case of such a
service furnished during 2023 or a
subsequent year, the payment amount for
such service (including the X-ray
component of a packaged service) that
would otherwise be determined under
this section (without application of
this paragraph and before application
of any other adjustment under this
subsection) for such year shall be
reduced by 10 percent.
``(iii) Application without regard to
budget neutrality.--The reductions made under
this paragraph--
``(I) shall not be considered an
adjustment under paragraph (2)(E); and
``(II) shall not be implemented in
a budget neutral manner.
``(iv) Implementation.--In order to
implement this subparagraph, the Secretary
shall adopt appropriate mechanisms which may
include use of modifiers.''.
SEC. 4004. 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''.
SEC. 4005. EXTENSION AND EXPANSION OF PRIOR AUTHORIZATION FOR POWER
MOBILITY DEVICES (PMDS) AND ACCESSORIES AND PRIOR
AUTHORIZATION AUDIT LIMITATIONS.
Section 1834(a) of the Social Security Act (42 U.S.C. 1395m(a)) is
amended--
(1) in paragraph (15), by adding at the end the following
new subparagraph:
``(D) Limitation on audits after advance
determination.--A claim for an item that has received a
provisional affirmation under an advance determination
under this paragraph or a prior authorization under
paragraph (23) shall not be subject to review under
section 1893(h) but may be subject to audits for
potential fraud, inappropriate utilization, changes in
billing patterns, or information that could not have
been considered during the advance determination (such
as proof of item delivery).''; and
(2) by adding at the end the following new paragraph:
``(23) Prior authorization for power mobility devices
(pmds) and accessories.--Not later than 90 days after the date
of the enactment of this paragraph, the Secretary shall, using
funds provided under paragraph (2) of section 402(a) of the
Social Security Amendments of 1967 and other funds available to
the Secretary--
``(A) extend at least through August 31, 2018, the
PMD Prior Authorization Demonstration (being conducted
under paragraph (1)(J) of such section);
``(B) begin to expand, as appropriate, such
demonstration to include additional power mobility
devices and accessories as part of initial claims for
payment under this part for such devices; and
``(C) begin to expand such demonstration to such
additional States or geographic areas as may be
appropriate.''.
SEC. 4006. CIVIL MONETARY PENALTIES FOR VIOLATIONS RELATED TO 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
subsection:
``(o) Any person (including an organization, agency, or other
entity, but excluding a program beneficiary, as defined in subsection
(r)(4)) that, with respect to a grant, contract, or other agreement for
which the Secretary of Health and Human Services provides funding--
``(1) knowingly presents or causes to be presented a
specified claim (as defined in subsection (r)(6)) 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 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 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 Health and Human Services 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 of Health and Human
Services 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), and (g) 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).
``(q) With respect to a penalty or assessment under subsection (o),
the Inspector General of the Department is authorized to receive, and
to retain for current use, such amounts of such penalty or assessment
as are necessary to provide reimbursement for the costs of conducting
investigations and audits with respect to such subsection and for
monitoring compliance plans with respect to such subsection when such
penalty or assessment is ordered by a court, voluntarily agreed to by
the payor, or otherwise. Funds received by such Inspector General as
reimbursement under the preceding sentence shall be deposited to the
credit of the appropriations from which initially paid, or to
appropriations for similar purposes currently available at the time of
deposit, and shall remain available for obligation for 1 year from the
date of the deposit of such funds.
``(r) For purposes of this subsection and subsections (o), (p), and
(q):
``(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 sub-award
(regardless of whether one or more of the persons entering into
the agreement is a contractor or sub-contractor).
``(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 of Health
and Human Services 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 sub-recipient or
subcontractor.
``(6) 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--
``(A) 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
``(B) 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--
``(i) provides or has provided any portion
of the money or property requested or demanded;
or
``(ii) will reimburse such contractor,
grantee or other recipient for any portion of
the money or property which is requested or
demanded.
``(7) 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 of Health
and Human Services.
``(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 (d)--
(A) in paragraph (1), by inserting ``or specified
claims'' after ``claims''; and
(B) in paragraph (2), by inserting ``or specified
claims'' after ``claims'';
(2) in subsection (e), by inserting ``or specified claim''
after ``claim''; and
(3) in subsection (f)--
(A) by inserting ``or specified claim (as defined
in subsection (r)(6))'' after ``district where the
claim'';
(B) by inserting ``(or, with respect to a person
described in subsection (o), the person)'' after
``claimant'';
(C) by inserting ``that are not received by the
Inspector General of the Department of Health and Human
Services under subsection (q) as reimbursement'' after
``amounts recovered''; and
(D) by inserting ``(or, in the case of a penalty or
assessment under subsection (o), by a specified State
agency (as defined in subsection (r)(7))'' after ``or a
State agency''.
Subtitle B--Other Reforms
SEC. 4041. SPR DRAWDOWN.
(a) Drawdown and Sale.--Notwithstanding section 161 of the Energy
Policy and Conservation Act (42 U.S.C. 6241), except as provided in
subsection (b) the Secretary of Energy shall draw down and sell--
(1) 4 million barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2018;
(2) 5 million barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2019;
(3) 8 million barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2020;
(4) 8 million barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2021;
(5) 10 million barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2022;
(6) 15 million barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2023;
(7) 15 million barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2024; and
(8) 15 million barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2025.
Amounts received for a sale under this subsection 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 amounts that would result in a
Strategic Petroleum Reserve that contains an inventory of petroleum
products representing less than 90 days of emergency reserves, based on
the average daily level of net imports of crude oil and petroleum
products in the previous calendar year.
(c) Proceeds.--Proceeds from a sale under this section shall be
deposited into the general fund of the Treasury of the United States.
Subtitle C--Miscellaneous
SEC. 4061. LYME DISEASE AND OTHER TICK-BORNE DISEASES.
(a) In General.--Title III of the Public Health Service Act (42
U.S.C. 241 et seq.) is amended by adding at the end the following new
part:
``PART W--LYME DISEASE AND OTHER TICK-BORNE DISEASES
``SEC. 399OO. RESEARCH.
``(a) In General.--The Secretary shall conduct or support
epidemiological, basic, translational, and clinical research regarding
Lyme disease and other tick-borne diseases.
``(b) Biennial Reports.--The Secretary shall ensure that each
biennial report under section 403 includes information on actions
undertaken by the National Institutes of Health to carry out subsection
(a) with respect to Lyme disease and other tick-borne diseases,
including an assessment of the progress made in improving the outcomes
of Lyme disease and such other tick-borne diseases.
``SEC. 399OO-1. WORKING GROUP.
``(a) Establishment.--The Secretary shall establish a permanent
working group, to be known as the Interagency Lyme and Tick-Borne
Disease Working Group (in this section and section 399OO-2 referred to
as the `Working Group'), to review all efforts within the Department of
Health and Human Services concerning Lyme disease and other tick-borne
diseases to ensure interagency coordination, minimize overlap, and
examine research priorities.
``(b) Responsibilities.--The Working Group shall--
``(1) not later than 24 months after the date of enactment
of this part, and every 24 months thereafter, develop or update
a summary of--
``(A) ongoing Lyme disease and other tick-borne
disease research related to causes, prevention,
treatment, surveillance, diagnosis, diagnostics,
duration of illness, intervention, and access to
services and supports for individuals with Lyme disease
or other tick-borne diseases;
``(B) advances made pursuant to such research;
``(C) the engagement of the Department of Health
and Human Services with persons that participate at the
public meetings required by paragraph (5); and
``(D) the comments received by the Working Group at
such public meetings and the Secretary's response to
such comments;
``(2) ensure that a broad spectrum of scientific viewpoints
is represented in each such summary;
``(3) monitor Federal activities with respect to Lyme
disease and other tick-borne diseases;
``(4) make recommendations to the Secretary regarding any
appropriate changes to such activities; and
``(5) ensure public input by holding annual public meetings
that address scientific advances, research questions,
surveillance activities, and emerging strains in species of
pathogenic organisms.
``(c) Membership.--
``(1) In general.--The Working Group shall be composed of a
total of 14 members as follows:
``(A) Federal members.--Seven Federal members,
consisting of one or more representatives of each of--
``(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;
and
``(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 Lyme disease and other 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 Lyme
disease and other tick-borne diseases.
``(v) Other individuals whose expertise is
determined by the Secretary to be beneficial to
the functioning of the Working Group.
``(2) Appointment.--The members of the Working Group shall
be appointed by the Secretary, except that of the non-Federal
public members under paragraph (1)(B)--
``(A) one shall be appointed by the Speaker of the
House of Representatives; and
``(B) one shall be appointed by the majority leader
of the Senate.
``(3) Diversity of scientific perspectives.--In making
appointments under paragraph (2), the Secretary, the Speaker of
the House of Representatives, and the majority leader of the
Senate shall ensure that the non-Federal public members of the
Working Group represent a diversity of scientific perspectives.
``(4) Terms.--The non-Federal public members of the Working
Group shall each be appointed to serve a 4-year term and may be
reappointed at the end of such term.
``(d) Meetings.--The Working Group shall meet as often as
necessary, as determined by the Secretary, but not less than twice each
year.
``(e) Applicability of FACA.--The Working Group shall be treated as
an advisory committee subject to the Federal Advisory Committee Act.
``(f) Reporting.--Not later than 24 months after the date of
enactment of this part, and every 24 months thereafter, the Working
Group--
``(1) shall submit a report on its activities, including an
up-to-date summary under subsection (b)(1) and any
recommendations under subsection (b)(4), 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;
``(2) shall make each such report publicly available on the
website of the Department of Health and Human Services; and
``(3) shall allow any member of the Working Group to
include in any such report minority views.
``SEC. 399OO-2. STRATEGIC PLAN.
``Not later than 3 years after the date of enactment of this
section, and every 5 years thereafter, the Secretary shall submit to
the Congress a strategic plan, informed by the most recent summary
under section 399OO-1(b)(1), for the conduct and support of Lyme
disease and tick-borne disease research, including--
``(1) proposed budgetary requirements;
``(2) a plan for improving outcomes of Lyme disease and
other tick-borne diseases, including progress related to
chronic or persistent symptoms and chronic or persistent
infection and co-infections;
``(3) a plan for improving diagnosis, treatment, and
prevention;
``(4) appropriate benchmarks to measure progress on
achieving the improvements described in paragraphs (2) and (3);
and
``(5) a plan to disseminate each summary under section
399OO-1(b)(1) and other relevant information developed by the
Working Group to the public, including health care providers,
public health departments, and other relevant medical
groups.''.
(b) No Additional Authorization of Appropriations.--No additional
funds are authorized to be appropriated for the purpose of carrying out
this section and the amendment made by this section, and this section
and such amendment shall be carried out using amounts otherwise
available for such purpose.
SEC. 4062. OUTREACH TO HISTORICALLY BLACK COLLEGES AND UNIVERSITIES.
The Secretary of Health and Human Services shall conduct outreach
to historically Black colleges and universities, Hispanic-serving
institutions, Native American colleges, and rural colleges to ensure
that health
professionals from underrepresented populations are aware of research
opportunities under this Act.
Passed the House of Representatives July 10, 2015.
Attest:
KAREN L. HAAS,
Clerk.