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114th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 114-669
======================================================================
COMPREHENSIVE ADDICTION AND RECOVERY ACT OF 2016
_______
July 6, 2016.--Ordered to be printed
_______
Mr. Upton, from the committee of conference, submitted the following
CONFERENCE REPORT
[To accompany S. 524]
The committee of conference on the disagreeing votes of
the two Houses on the amendments of the House do the bill (S.
524), to authorize the Attorney General to award grants to
address the national epidemics of prescription opioid abuse and
heroin use, having met, after full and free conference, have
agreed to recommend and do recommend to their respective Houses
as follows:
That the Senate recede from its disagreement to the
amendment of the House to the text of the bill and agree to the
same with an amendment as follows:
In lieu of the matter proposed to be inserted by the
House amendment, insert the following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the
``Comprehensive Addiction and Recovery Act of 2016''.
(b) Table of Contents.--The table of contents for this Act
is as follows:
Sec. 1. Short title; table of contents.
TITLE I--PREVENTION AND EDUCATION
Sec. 101. Task force on pain management.
Sec. 102. Awareness campaigns.
Sec. 103. Community-based coalition enhancement grants to address local
drug crises.
Sec. 104. Information materials and resources to prevent addiction
related to youth sports injuries.
Sec. 105. Assisting veterans with military emergency medical training to
meet requirement for becoming civilian health care
professionals.
Sec. 106. FDA opioid action plan.
Sec. 107. Improving access to overdose treatment.
Sec. 108. NIH opioid research.
Sec. 109. National All Schedules Prescription Electronic Reporting
Reauthorization.
Sec. 110. Opioid overdose reversal medication access and education grant
programs.
TITLE II--LAW ENFORCEMENT AND TREATMENT
Sec. 201. Comprehensive Opioid Abuse Grant Program.
Sec. 202. First responder training.
Sec. 203. Prescription drug take back expansion.
TITLE III--TREATMENT AND RECOVERY
Sec. 301. Evidence-based prescription opioid and heroin treatment and
interventions demonstration.
Sec. 302. Building communities of recovery.
Sec. 303. Medication-assisted treatment for recovery from addiction.
TITLE IV--ADDRESSING COLLATERAL CONSEQUENCES
Sec. 401. GAO report on recovery and collateral consequences.
TITLE V--ADDICTION AND TREATMENT SERVICES FOR WOMEN, FAMILIES, AND
VETERANS
Sec. 501. Improving treatment for pregnant and postpartum women.
Sec. 502. Veterans treatment courts.
Sec. 503. Infant plan of safe care.
Sec. 504. GAO report on neonatal abstinence syndrome (NAS).
TITLE VI--INCENTIVIZING STATE COMPREHENSIVE INITIATIVES TO ADDRESS
PRESCRIPTION OPIOID ABUSE
Sec. 601. State demonstration grants for comprehensive opioid abuse
response.
TITLE VII--MISCELLANEOUS
Sec. 701. Grant accountability and evaluations.
Sec. 702. Partial fills of schedule II controlled substances.
Sec. 703. Good samaritan assessment.
Sec. 704. Programs to prevent prescription drug abuse under Medicare
parts C and D.
Sec. 705. Excluding abuse-deterrent formulations of prescription drugs
from the Medicaid additional rebate requirement for new
formulations of prescription drugs.
Sec. 706. Limiting disclosure of predictive modeling and other analytics
technologies to identify and prevent waste, fraud, and abuse.
Sec. 707. Medicaid Improvement Fund.
Sec. 708. Sense of the Congress regarding treatment of substance abuse
epidemics.
TITLE VIII--KINGPIN DESIGNATION IMPROVEMENT
Sec. 801. Protection of classified information in Federal court
challenges relating to designations under the Narcotics
Kingpin Designation Act.
TITLE IX--DEPARTMENT OF VETERANS AFFAIRS
Sec. 901. Short title.
Sec. 902. Definitions.
Subtitle A--Opioid Therapy and Pain Management
Sec. 911. Improvement of opioid safety measures by Department of
Veterans Affairs.
Sec. 912. Strengthening of joint working group on pain management of the
Department of Veterans Affairs and the Department of Defense.
Sec. 913. Review, investigation, and report on use of opioids in
treatment by Department of Veterans Affairs.
Sec. 914. Mandatory disclosure of certain veteran information to State
controlled substance monitoring programs.
Sec. 915. Elimination of copayment requirement for veterans receiving
opioid antagonists or education on use of opioid antagonists.
Subtitle B--Patient Advocacy
Sec. 921. Community meetings on improving care furnished by Department
of Veterans Affairs.
Sec. 922. Improvement of awareness of patient advocacy program and
patient bill of rights of Department of Veterans Affairs.
Sec. 923. Comptroller General report on patient advocacy program of
Department of Veterans Affairs.
Sec. 924. Establishment of Office of Patient Advocacy of the Department
of Veterans Affairs.
Subtitle C--Complementary and Integrative Health
Sec. 931. Expansion of research and education on and delivery of
complementary and integrative health to veterans.
Sec. 932. Expansion of research and education on and delivery of
complementary and integrative health to veterans.
Sec. 933. Pilot program on integration of complementary and integrative
health and related issues for veterans and family members of
veterans.
Subtitle D--Fitness of Health Care Providers
Sec. 941. Additional requirements for hiring of health care providers by
Department of Veterans Affairs.
Sec. 942. Provision of information on health care providers of
Department of Veterans Affairs to State medical boards.
Sec. 943. Report on compliance by Department of Veterans Affairs with
reviews of health care providers leaving the Department or
transferring to other facilities.
Subtitle E--Other Matters
Sec. 951. Modification to limitation on awards and bonuses.
TITLE I--PREVENTION AND EDUCATION
SEC. 101. TASK FORCE ON PAIN MANAGEMENT.
(a) Definitions.--In this section:
(1) Secretary.--The term ``Secretary'' means the
Secretary of Health and Human Services.
(2) Task force.--The term ``task force'' means the
Pain Management Best Practices Inter-Agency Task Force
convened under subsection (b).
(b) Inter-Agency Task Force.--Not later than 2 years after
the date of enactment of this Act, the Secretary, in
cooperation with the Secretary of Veterans Affairs and the
Secretary of Defense, shall convene a Pain Management Best
Practices Inter-Agency Task Force.
(c) Membership.--The task force shall be comprised of--
(1) representatives of--
(A) the Department of Health and Human
Services and relevant agencies within the
Department of Health and Human Services;
(B) the Department of Veterans Affairs;
(C) the Department of Defense; and
(D) the Office of National Drug Control
Policy;
(2) currently licensed and practicing physicians,
dentists, and nonphysician prescribers;
(3) currently licensed and practicing pharmacists
and pharmacies;
(4) experts in the fields of pain research and
addiction research, including adolescent and young
adult addiction research;
(5) representatives of--
(A) pain management professional
organizations;
(B) the mental health treatment community;
(C) the addiction treatment community,
including individuals in recovery from
substance use disorder;
(D) pain advocacy groups, including
patients;
(E) veteran service organizations;
(F) groups with expertise on overdose
reversal, including first responders;
(G) State medical boards; and
(H) hospitals;
(6) experts on the health of, and prescription
opioid use disorders in, members of the Armed Forces
and veterans; and
(7) experts in the field of minority health.
(d) Representation.--The Secretary shall ensure that the
membership of the task force includes individuals representing
rural and underserved areas.
(e) Duties.--The task force shall--
(1) identify, review, and, as appropriate,
determine whether there are gaps in or inconsistencies
between best practices for pain management (including
chronic and acute pain) developed or adopted by Federal
agencies;
(2) not later than 1 year after the date on which
the task force is convened under subsection (b),
propose updates to best practices and recommendations
on addressing gaps or inconsistencies identified under
paragraph (1), as appropriate, and submit to relevant
Federal agencies and the general public such proposed
updates and recommendations, taking into
consideration--
(A) existing pain management research and
other relevant research;
(B) recommendations from relevant
conferences and existing relevant evidence-
based guidelines;
(C) ongoing efforts at the State and local
levels and by medical professional
organizations to develop improved pain
management strategies, including consideration
of differences within and between classes of
opioids, the availability of opioids with abuse
deterrent technology, and pharmacological,
nonpharmacological, and medical device
alternatives to opioids to reduce opioid
monotherapy in appropriate cases;
(D) the management of high-risk populations
who receive opioids in the course of medical
care, other than for pain management;
(E) the 2016 Guideline for Prescribing
Opioids for Chronic Pain issued by the Centers
for Disease Control and Prevention; and
(F) private sector, State, and local
government efforts related to pain management
and prescribing pain medication;
(3) provide the public with at least 90 days to
submit comments on any proposed updates and
recommendations under paragraph (2); and
(4) develop a strategy for disseminating
information about best practices for pain management
(including chronic and acute pain) to stakeholders, if
appropriate.
(f) Limitation.--The task force shall not have rulemaking
authority.
(g) Sunset.--The task force under this section shall sunset
after 3 years.
SEC. 102. AWARENESS CAMPAIGNS.
(a) In General.--The Secretary of Health and Human
Services, in coordination with the heads of other departments
and agencies, shall, as appropriate, through existing programs
and activities, advance the education and awareness of the
public (including providers, patients, and consumers) and other
appropriate entities regarding the risk of abuse of
prescription opioids if such drugs are not taken as prescribed.
(b) Topics.--The education and awareness campaigns under
subsection (a) shall address--
(1) the dangers of opioid abuse;
(2) the prevention of opioid abuse, including
through safe disposal of prescription medications and
other safety precautions; and
(3) the detection of early warning signs of
addiction.
(c) Other Requirements.--The education and awareness
campaigns under subsection (a) shall, as appropriate--
(1) take into account any association between
prescription opioid abuse and heroin use;
(2) emphasize--
(A) the similarities between heroin and
prescription opioids; and
(B) the effects of heroin and prescription
opioids on the human body; and
(3) bring greater public awareness to the dangerous
effects of fentanyl when mixed with heroin or abused in
a similar manner.
SEC. 103. COMMUNITY-BASED COALITION ENHANCEMENT GRANTS TO ADDRESS LOCAL
DRUG CRISES.
(a) Definitions.--In this section:
(1) Administrator.--The term ``Administrator''
means the Administrator of the Substance Abuse and
Mental Health Services Administration.
(2) Director.--The term ``Director'' means the
Director of the Office of National Drug Control Policy.
(3) Drug-free communities act of 1997.--The term
``Drug-Free Communities Act of 1997'' means chapter 2
of the National Narcotics Leadership Act of 1988 (21
U.S.C. 1521 et seq.).
(4) Eligible entity.--The term ``eligible entity''
means an organization that--
(A) on or before the date of submitting an
application for a grant under this section,
receives or has received a grant under the
Drug-Free Communities Act of 1997; and
(B) has documented, using local data, rates
of abuse of opioids or methamphetamines at
levels that are--
(i) significantly higher than the
national average as determined by the
Secretary (including appropriate
consideration of the results of the
Monitoring the Future Survey published
by the National Institute on Drug Abuse
and the National Survey on Drug Use and
Health published by the Substance Abuse
and Mental Health Services
Administration); or
(ii) higher than the national
average, as determined by the Secretary
(including appropriate consideration of
the results of the surveys described in
clause (i)), over a sustained period of
time.
(5) Emerging drug abuse issue.--The term ``emerging
drug abuse issue'' means a substance use disorder
within an area involving--
(A) a sudden increase in demand for
particular drug abuse treatment services
relative to previous demand; and
(B) a lack of resources in the area to
address the emerging problem.
(6) Local drug crisis.--The term ``local drug
crisis'' means, with respect to the area served by an
eligible entity--
(A) a sudden increase in the abuse of
opioids or methamphetamines, as documented by
local data;
(B) the abuse of prescription medications,
specifically opioids or methamphetamines, that
is significantly higher than the national
average, over a sustained period of time, as
documented by local data; or
(C) a sudden increase in opioid-related
deaths, as documented by local data.
(7) Opioid.--The term ``opioid'' means any drug
having an addiction-forming or addiction-sustaining
liability similar to morphine or being capable of
conversion into a drug having such addiction-forming or
addiction-sustaining liability.
(b) Program Authorized.--The Director, in coordination with
the Administrator, may make grants to eligible entities to
implement comprehensive community-wide strategies that address
local drug crises and emerging drug abuse issues within the
area served by the eligible entity.
(c) Application.--
(1) In general.--An eligible entity seeking a grant
under this section shall submit an application to the
Director at such time, in such manner, and accompanied
by such information as the Director may require.
(2) Criteria.--As part of an application for a
grant under this section, the Director shall require an
eligible entity to submit a detailed, comprehensive,
multisector plan for addressing the local drug crisis
or emerging drug abuse issue within the area served by
the eligible entity.
(d) Use of Funds.--An eligible entity shall use a grant
received under this section--
(1) for programs designed to implement
comprehensive community-wide prevention strategies to
address the local drug crisis in the area served by the
eligible entity, in accordance with the plan submitted
under subsection (c)(2);
(2) to obtain specialized training and technical
assistance from the organization funded under section 4
of Public Law 107-82 (21 U.S.C. 1521 note); and
(3) for programs designed to implement
comprehensive community-wide strategies to address
emerging drug abuse issues in the community.
(e) Supplement Not Supplant.--An eligible entity shall use
Federal funds received under this section only to supplement
the funds that would, in the absence of those Federal funds, be
made available from other Federal and non-Federal sources for
the activities described in this section, and not to supplant
those funds.
(f) Evaluation.--A grant under this section shall be
subject to the same evaluation requirements and procedures as
the evaluation requirements and procedures imposed on the
recipient of a grant under the Drug-Free Communities Act of
1997, and may also include an evaluation of the effectiveness
at reducing abuse of opioids or methamphetamines.
(g) Limitation on Administrative Expenses.--Not more than 8
percent of the amounts made available to carry out this section
for a fiscal year may be used to pay for administrative
expenses.
(h) Delegation Authority.--The Director may enter into an
interagency agreement with the Administrator to delegate
authority for the execution of grants and for such other
activities as may be necessary to carry out this section.
(i) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $5,000,000 for each of fiscal years 2017 through
2021.
SEC. 104. INFORMATION MATERIALS AND RESOURCES TO PREVENT ADDICTION
RELATED TO YOUTH SPORTS INJURIES.
(a) Report.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall, not
later than 24 months after the date of the enactment of this
section, make publicly available on the appropriate website of
the Department of Health and Human Services a report
determining the extent to which informational materials and
resources described in subsection (c) are available to
teenagers and adolescents who play youth sports, families of
such teenagers and adolescents, nurses, youth sports groups,
and relevant health care provider groups.
(b) Development of Informational Materials and Resources.--
The Secretary may, for purposes of preventing substance use
disorder in teenagers and adolescents who are injured playing
youth sports and are subsequently prescribed an opioid, not
later than 12 months after the report is made publicly
available under subsection (a), and taking into consideration
the findings of such report and in coordination with relevant
health care provider groups, facilitate the development of
informational materials and resources described in subsection
(c) for teenagers and adolescents who play youth sports,
families of such teenagers and adolescents, nurses, youth
sports groups, and relevant health care provider groups.
(c) Materials and Resources Described.--For purposes of
this section, the informational materials and resources
described in this subsection are informational materials and
resources with respect to youth sports injuries for which
opioids are potentially prescribed, including materials and
resources focused on the risks associated with opioid use and
misuse, treatment options for such injuries that do not involve
the use of opioids, and how to seek treatment for addiction.
(d) No Additional Funds.--No additional funds are
authorized to be appropriated for the purpose of carrying out
this section. This section shall be carried out using amounts
otherwise available for such purpose.
SEC. 105. ASSISTING VETERANS WITH MILITARY EMERGENCY MEDICAL TRAINING
TO MEET REQUIREMENT FOR BECOMING CIVILIAN HEALTH
CARE PROFESSIONALS.
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq.) is amended by inserting after section 314
the following:
``SEC. 315. ASSISTING VETERANS WITH MILITARY EMERGENCY MEDICAL TRAINING
TO MEET REQUIREMENTS FOR BECOMING CIVILIAN HEALTH
CARE PROFESSIONALS.
``(a) Program.--
``(1) In general.--The Secretary may establish a
program, in consultation with the Secretary of Labor,
consisting of awarding demonstration grants to States
to streamline State requirements and procedures in
order to assist veterans who held certain military
occupational specialties related to medical care or who
have completed certain medical training while serving
in the Armed Forces of the United States to meet
certification, licensure, and other requirements
applicable to civilian health care professions (such as
emergency medical technician, paramedic, licensed
practical nurse, registered nurse, physical therapy
assistant, or physician assistant professions) in the
State.
``(2) Consultation and collaboration.--In
determining the eligible military occupational
specialties or training courses and the assistance
required as described in paragraph (1), the Secretary
shall consult with the Secretary of Defense, the
Secretary of Veterans Affairs, and the Assistant
Secretary of Labor for Veterans' Employment and
Training, and shall collaborate with the initiatives
carried out under section 4114 of title 38, United
States Code, and sections 1142 through 1144 of title
10, United States Code.
``(b) Use of Funds.--Amounts received as a demonstration
grant under this section shall be used to--
``(1) prepare and implement a plan to streamline
State requirements and procedures as described in
subsection (a), including by--
``(A) determining the extent to which the
requirements for the education, training, and
skill level of civilian health care professions
(such as emergency medical technicians,
paramedics, licensed practical nurses,
registered nurses, physical therapy assistants,
or physician assistants) in the State are
equivalent to requirements for the education,
training, and skill level of veterans who
served in medical related fields while a member
of the Armed Forces of the United States; and
``(B) identifying methods, such as waivers,
for veterans who served in medical related
fields while a member of the Armed Forces of
the United States to forgo or meet any such
equivalent State requirements; and
``(2) if necessary to meet workforce shortages or
address gaps in education, training, or skill level to
meet certification, licensure or other requirements
applicable to becoming a civilian health care
professional (such as an emergency medical technician,
paramedic, licensed practical nurse, registered nurse,
physical therapy assistant, or physician assistant
professions) in the State, develop or expand career
pathways at institutions of higher education to support
veterans in meeting such requirements.
``(c) Report.--Upon the completion of the demonstration
program under this section, the Secretary shall submit to
Congress a report on the program.
``(d) Funding.--No additional funds are authorized to be
appropriated for the purpose of carrying out this section. This
section shall be carried out using amounts otherwise available
for such purpose.
``(e) Sunset.--The demonstration program under this section
shall not exceed 5 years.''.
SEC. 106. FDA OPIOID ACTION PLAN.
(a) In General.--
(1) New drug application.--
(A) In general.--Subject to subparagraph
(B), prior to the approval pursuant to an
application submitted under section 505(b) of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(b)) of a new drug that is an opioid,
the Secretary of Health and Human Services
(referred to in this section as the
``Secretary'') shall refer the application to
an advisory committee of the Food and Drug
Administration to seek recommendations from
such advisory committee.
(B) Public health exemption.--A referral to
an advisory committee under subparagraph (A) is
not required with respect to a new opioid drug
or drugs if the Secretary--
(i) finds that such a referral is
not in the interest of protecting and
promoting public health;
(ii) finds that such a referral is
not necessary based on a review of the
relevant scientific information; and
(iii) submits a notice containing
the rationale for such findings to the
Committee on Health, Education, Labor,
and Pensions of the Senate and the
Committee on Energy and Commerce of the
House of Representatives.
(2) Pediatric opioid labeling.--The Secretary shall
convene the Pediatric Advisory Committee of the Food
and Drug Administration to seek recommendations from
such Committee regarding a framework for the inclusion
of information in the labeling of drugs that are
opioids relating to the use of such drugs in pediatric
populations before the Secretary approves any labeling
or change to labeling for any drug that is an opioid
intended for use in a pediatric population.
(3) Sunset.--The requirements of paragraphs (1) and
(2) shall cease to be effective on October 1, 2022.
(b) Prescriber Education.--Not later than 1 year after the
date of the enactment of this Act, the Secretary, acting
through the Commissioner of Food and Drugs, as part of the Food
and Drug Administration's evaluation of the Extended-Release/
Long-Acting Opioid Analgesics Risk Evaluation and Mitigation
Strategy, and in consultation with relevant stakeholders, shall
develop recommendations regarding education programs for
prescribers of opioids pursuant to section 505-1 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), including
recommendations on--
(1) which prescribers should participate in such
programs; and
(2) how often participation in such programs is
necessary.
(c) Guidance on Evaluating the Abuse Deterrence of Generic
Solid Oral Opioid Drug Products.--Not later than 18 months
after the end of the period for public comment on the draft
guidance entitled ``General Principles for Evaluating the Abuse
Deterrence of Generic Solid Oral Opioid Drug Products'' issued
by the Center for Drug Evaluation and Research of the Food and
Drug Administration in March 2016, the Commissioner of Food and
Drugs shall publish in the Federal Register a final version of
such guidance.
SEC. 107. IMPROVING ACCESS TO OVERDOSE TREATMENT.
(a) Grants for Reducing Overdose Deaths.--Part D of title V
of the Public Health Service Act (42 U.S.C. 290dd et seq.) is
amended by adding at the end the following:
``SEC. 544. GRANTS FOR REDUCING OVERDOSE DEATHS.
``(a) Establishment.--
``(1) In general.--The Secretary shall award grants
to eligible entities to expand access to drugs or
devices approved or cleared under the Federal Food,
Drug, and Cosmetic Act for emergency treatment of known
or suspected opioid overdose.
``(2) Maximum grant amount.--A grant awarded under
this section may not be for more than $200,000 per
grant year.
``(3) Eligible entity.--For purposes of this
section, the term `eligible entity' means a Federally
qualified health center (as defined in section 1861(aa)
of the Social Security Act), an opioid treatment
program under part 8 of title 42, Code of Federal
Regulations, any practitioner dispensing narcotic drugs
pursuant to section 303(g) of the Controlled Substances
Act, or any other entity that the Secretary deems
appropriate.
``(4) Prescribing.--For purposes of this section,
the term `prescribing' means, with respect to a drug or
device approved or cleared under the Federal Food,
Drug, and Cosmetic Act for emergency treatment of known
or suspected opioid overdose, the practice of
prescribing such drug or device--
``(A) in conjunction with an opioid
prescription for patients at an elevated risk
of overdose;
``(B) in conjunction with an opioid agonist
approved under section 505 of the Federal Food,
Drug, and Cosmetic Act for the treatment of
opioid use disorder;
``(C) to the caregiver or a close relative
of patients at an elevated risk of overdose
from opioids; or
``(D) in other circumstances in which a
provider identifies a patient is at an elevated
risk for an intentional or unintentional drug
overdose from heroin or prescription opioid
therapies.
``(b) Application.--To be eligible to receive a grant under
this section, an eligible entity shall submit to the Secretary,
in such form and manner as specified by the Secretary, an
application that describes--
``(1) the extent to which the area to which the
entity will furnish services through use of the grant
is experiencing significant morbidity and mortality
caused by opioid abuse;
``(2) the criteria that will be used to identify
eligible patients to participate in such program; and
``(3) a plan for sustaining the program after
Federal support for the program has ended.
``(c) Use of Funds.--An eligible entity receiving a grant
under this section may use amounts under the grant for any of
the following activities, but may use not more than 20 percent
of the grant funds for activities described in paragraphs (3)
and (4):
``(1) To establish a program for prescribing a drug
or device approved or cleared under the Federal Food,
Drug, and Cosmetic Act for emergency treatment of known
or suspected opioid overdose.
``(2) To train and provide resources for health
care providers and pharmacists on the prescribing of
drugs or devices approved or cleared under the Federal
Food, Drug, and Cosmetic Act for emergency treatment of
known or suspected opioid overdose.
``(3) To purchase drugs or devices approved or
cleared under the Federal Food, Drug, and Cosmetic Act
for emergency treatment of known or suspected opioid
overdose, for distribution under the program described
in paragraph (1).
``(4) To offset the co-payments and other cost
sharing associated with drugs or devices approved or
cleared under the Federal Food, Drug, and Cosmetic Act
for emergency treatment of known or suspected opioid
overdose.
``(5) To establish protocols to connect patients
who have experienced a drug overdose with appropriate
treatment, including medication-assisted treatment and
appropriate counseling and behavioral therapies.
``(d) Evaluations by Recipients.--As a condition of receipt
of a grant under this section, an eligible entity shall, for
each year for which the grant is received, submit to the
Secretary an evaluation of activities funded by the grant which
contains such information as the Secretary may reasonably
require.
``(e) Reports by the Secretary.--Not later than 5 years
after the date on which the first grant under this section is
awarded, the Secretary shall submit to the appropriate
committees of the House of Representatives and of the Senate a
report aggregating the information received from the grant
recipients for such year under subsection (d) and evaluating
the outcomes achieved by the programs funded by grants awarded
under this section.
``(f) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $5,000,000 for
the period of fiscal years 2017 through 2021.''.
(b) Improving Access to Overdose Treatment.--
(1) Information on best practices.--Not later than
180 days after the date of enactment of this Act:
(A) The Secretary of Health and Human
Services may provide information to prescribers
within Federally qualified health centers (as
defined in paragraph (4) of section 1861(aa) of
the Social Security Act (42 U.S.C. 1395x(aa))),
and the health care facilities of the Indian
Health Service, on best practices for
prescribing or co-prescribing a drug or device
approved or cleared under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
for emergency treatment of known or suspected
opioid overdose, including for patients
receiving chronic opioid therapy and patients
being treated for opioid use disorders.
(B) The Secretary of Defense may provide
information to prescribers within Department of
Defense medical facilities on best practices
for prescribing or co-prescribing a drug or
device approved or cleared under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.) for emergency treatment of known or
suspected opioid overdose, including for
patients receiving chronic opioid therapy and
patients being treated for opioid use
disorders.
(C) The Secretary of Veterans Affairs may
provide information to prescribers within
Department of Veterans Affairs medical
facilities on best practices for prescribing or
co-prescribing a drug or device approved or
cleared under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) for
emergency treatment of known or suspected
opioid overdose, including for patients
receiving chronic opioid therapy and patients
being treated for opioid use disorders.
(2) Rule of construction.--Nothing in this
subsection should be construed to establish or
contribute to a medical standard of care.
SEC. 108. NIH OPIOID RESEARCH.
(a) In General.--The Director of the National Institutes of
Health (referred to in this section as the ``NIH'') may
intensify and coordinate fundamental, translational, and
clinical research of the NIH with respect to--
(1) the understanding of pain;
(2) the discovery and development of therapies for
chronic pain; and
(3) the development of alternatives to opioids for
effective pain treatments.
(b) Priority and Direction.--The prioritization and
direction of the Federally funded portfolio of pain research
studies shall consider recommendations made by the Interagency
Pain Research Coordinating Committee in concert with the Pain
Management Best Practices Inter-Agency Task Force, and in
accordance with the National Pain Strategy, the Federal Pain
Research Strategy, and the NIH-Wide Strategic Plan for Fiscal
Years 2016-2020, the latter of which calls for the relative
burdens of individual diseases and medical disorders to be
regarded as crucial considerations in balancing the priorities
of the Federal research portfolio.
SEC. 109. NATIONAL ALL SCHEDULES PRESCRIPTION ELECTRONIC REPORTING
REAUTHORIZATION.
(a) Amendment to Purpose.--Paragraph (1) of section 2 of
the National All Schedules Prescription Electronic Reporting
Act of 2005 (Public Law 109-60) is amended to read as follows:
``(1) foster the establishment of State-
administered controlled substance monitoring systems in
order to ensure that health care providers have access
to the accurate, timely prescription history
information that they may use as a tool for the early
identification of patients at risk for addiction in
order to initiate appropriate medical interventions and
avert the tragic personal, family, and community
consequences of untreated addiction; and''.
(b) Amendments to Controlled Substance Monitoring
Program.--Section 399O of the Public Health Service Act (42
U.S.C. 280g-3) is amended--
(1) in subsection (a)(1)--
(A) in the matter preceding subparagraph
(A), by inserting ``, in consultation with the
Administrator of the Substance Abuse and Mental
Health Services Administration and Director of
the Centers for Disease Control and
Prevention,'' after ``the Secretary'';
(B) in subparagraph (A), by striking
``or'';
(C) in subparagraph (B), by striking the
period at the end and inserting ``; or''; and
(D) by adding at the end the following:
``(C) to maintain an existing State-
controlled substance monitoring program.'';
(2) by amending subsection (b) to read as follows:
``(b) Minimum Requirements.--The Secretary shall maintain
and, as appropriate, supplement or revise (after publishing
proposed additions and revisions in the Federal Register and
receiving public comments thereon) minimum requirements for
criteria to be used by States for purposes of clauses (ii),
(v), (vi), and (vii) of subsection (c)(1)(A).'';
(3) in subsection (c)--
(A) in paragraph (1)(B)--
(i) in the matter preceding clause
(i), by striking ``(a)(1)(B)'' and
inserting ``(a)(1)(B) or (a)(1)(C)'';
(ii) in clause (i), by striking
``program to be improved'' and
inserting ``program to be improved or
maintained'';
(iii) by redesignating clauses
(iii) and (iv) as clauses (iv) and (v),
respectively;
(iv) by inserting after clause
(ii), the following:
``(iii) a plan to apply the latest
advances in health information
technology, to the extent practicable,
in order to incorporate prescription
drug monitoring program data directly
into the workflow of prescribers and
dispensers to ensure timely access to
patients' controlled prescription drug
history;'';
(v) in clause (iv) (as so
redesignated), by striking ``; and''
and inserting the following: ``and at
least one health information technology
system such as electronic health
records, health information exchanges,
or e-prescribing systems;'';
(vi) in clause (v) (as so
redesignated)--
(I) by striking ``public
health'' and inserting ``public
health or safety''; and
(II) by striking the period
and inserting ``; and''; and
(vii) by adding at the end the
following:
``(vi) information, where
applicable, on how the controlled
substance monitoring program jointly
works with the applicant's respective
State substance abuse agency to ensure
information collected and maintained by
the controlled substance monitoring
program is used to inform the provision
of clinically appropriate substance use
disorder services to individuals in
need.'';
(B) in paragraph (3)--
(i) by striking ``If a State that
submits'' and inserting the following:
``(A) In general.--If a State that
submits'';
(ii) by inserting before the period
at the end ``and include timelines for
full implementation of such
interoperability. The State shall also
describe the manner in which it will
achieve interoperability between its
monitoring program and health
information technology systems, as
allowable under State law, and include
timelines for the implementation of
such interoperability''; and
(iii) by adding at the end the
following:
``(B) Monitoring of efforts.--The Secretary
shall monitor State efforts to achieve
interoperability, as described in subparagraph
(A).''; and
(C) in paragraph (5)--
(i) by striking ``implement or
improve'' and inserting ``establish,
improve, or maintain''; and
(ii) by adding at the end the
following: ``The Secretary shall
redistribute any funds that are so
returned among the remaining grantees
under this section in accordance with
the formula described in subsection
(a)(2)(B).'';
(4) in subsection (d)--
(A) in the matter preceding paragraph (1)--
(i) by striking ``In implementing
or improving'' and all that follows
through ``(a)(1)(B)'' and inserting
``In establishing, improving, or
maintaining a controlled substance
monitoring program under this section,
a State shall comply, or with respect
to a State that applies for a grant
under subparagraph (B) or (C) of
subsection (a)(1)''; and
(ii) by striking ``public health''
and inserting ``public health or
safety''; and
(B) by adding at the end the following:
``(5) The State shall report on interoperability
with the controlled substance monitoring program of
Federal agencies, where appropriate, interoperability
with health information technology systems such as
electronic health records, health information
exchanges, and e-prescribing, where appropriate, and
whether or not the State provides automatic, up-to-
date, or daily information about a patient when a
practitioner (or the designee of a practitioner, where
permitted) requests information about such patient.'';
(5) in subsections (e), (f)(1), and (g), by
striking ``implementing or improving'' each place it
appears and inserting ``establishing, improving, or
maintaining'';
(6) in subsection (f)--
(A) in paragraph (1)--
(i) in subparagraph (B), by
striking ``misuse of a schedule II,
III, or IV substance'' and inserting
``misuse of a controlled substance
included in schedule II, III, or IV of
section 202(c) of the Controlled
Substances Act''; and
(ii) in subparagraph (D)--
(I) by inserting ``a State
substance abuse agency,'' after
``State health department,'';
and
(II) by striking ``such
department, program, or
administration'' each place it
appears and inserting ``such
department, program, agency, or
administration'' in each such
place; and
(B) by adding at the end the following:
``(3) Evaluation and reporting.--Subject to
subsection (g), a State receiving a grant under
subsection (a) shall provide the Secretary with
aggregate data to enable the Secretary--
``(A) to evaluate the success of the
State's program in achieving its purposes; or
``(B) to prepare and submit the report to
Congress required by subsection (k)(2).
``(4) Research by other entities.--A department,
program, agency, or administration receiving
nonidentifiable information under paragraph (1)(D) may
make such information available to other entities for
research purposes.'';
(7) by striking subsection (k);
(8) by redesignating subsections (h) through (j) as
subsections (i) through (k), respectively;
(9) in subsections (c)(1)(A)(iv) and (d)(4), by
striking ``subsection (h)'' each place it appears and
inserting ``subsection (i)'';
(10) by inserting after subsection (g) the
following:
``(h) Education and Access to the Monitoring System.--A
State receiving a grant under subsection (a) shall take steps
to--
``(1) facilitate prescriber and dispenser use of
the State's controlled substance monitoring system, to
the extent practicable; and
``(2) educate prescribers and dispensers on the
benefits of the system.'';
(11) in subsection (k)(2)(A), as so redesignated--
(A) in clause (ii), by striking ``or
affected'' and inserting ``, established or
strengthened initiatives to ensure linkages to
substance use disorder services, or affected'';
and
(B) in clause (iii), by striking
``including an assessment'' and inserting ``and
between controlled substance monitoring
programs and health information technology
systems, including an assessment'';
(12) in subsection (l)(1), by striking
``establishment, implementation, or improvement'' and
inserting ``establishment, improvement, or
maintenance'';
(13) in subsection (m)(8), by striking ``and the
District of Columbia'' and inserting ``, the District
of Columbia, and any commonwealth or territory of the
United States''; and
(14) by amending subsection (n) to read as follows:
``(n) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated, $10,000,000
for each of fiscal years 2017 through 2021.''.
SEC. 110. OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND EDUCATION
GRANT PROGRAMS.
(a) In General.--Part D of title V of the Public Health
Service Act (42 U.S.C. 290dd et seq.), as amended by section
107, is further amended by adding at the end the following:
``SEC. 545. OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND EDUCATION
GRANT PROGRAMS.
``(a) Grants to States.--The Secretary shall make grants to
States to--
``(1) implement strategies for pharmacists to
dispense a drug or device approved or cleared under the
Federal Food, Drug, and Cosmetic Act for emergency
treatment of known or suspected opioid overdose, as
appropriate, pursuant to a standing order;
``(2) encourage pharmacies to dispense opioid
overdose reversal medication pursuant to a standing
order;
``(3) develop or provide training materials that
persons authorized to prescribe or dispense a drug or
device approved or cleared under the Federal Food,
Drug, and Cosmetic Act for emergency treatment of known
or suspected opioid overdose may use to educate the
public concerning--
``(A) when and how to safely administer
such drug or device; and
``(B) steps to be taken after administering
such drug or device; and
``(4) educate the public concerning the
availability of drugs or devices approved or cleared
under the Federal Food, Drug, and Cosmetic Act for
emergency treatment of known or suspected opioid
overdose without a person-specific prescription.
``(b) Certain Requirement.--A grant may be made under this
section only if the State involved has authorized standing
orders to be issued for drugs or devices approved or cleared
under the Federal Food, Drug, and Cosmetic Act for emergency
treatment of known or suspected opioid overdose.
``(c) Preference in Making Grants.--In making grants under
this section, the Secretary may give preference to States that
have a significantly higher rate of opioid overdoses than the
national average, and that--
``(1) have not implemented standing orders
regarding drugs or devices approved or cleared under
the Federal Food, Drug, and Cosmetic Act for emergency
treatment of known or suspected opioid overdose;
``(2) authorize standing orders to be issued that
permit community-based organizations, substance abuse
programs, or other nonprofit entities to acquire,
dispense, or administer drugs or devices approved or
cleared under the Federal Food, Drug, and Cosmetic Act
for emergency treatment of known or suspected opioid
overdose; or
``(3) authorize standing orders to be issued that
permit police, fire, or emergency medical services
agencies to acquire and administer drugs or devices
approved or cleared under the Federal Food, Drug, and
Cosmetic Act for emergency treatment of known or
suspected opioid overdose.
``(d) Grant Terms.--
``(1) Number.--A State may not receive more than
one grant under this section at a time.
``(2) Period.--A grant under this section shall be
for a period of 3 years.
``(3) Limitation.--A State may use not more than 20
percent of a grant under this section for educating the
public pursuant to subsection (a)(4).
``(e) Applications.--To be eligible to receive a grant
under this section, a State shall submit an application to the
Secretary in such form and manner and containing such
information as the Secretary may reasonably require, including
detailed proposed expenditures of grant funds.
``(f) Reporting.--A State that receives a grant under this
section shall, at least annually for the duration of the grant,
submit a report to the Secretary evaluating the progress of the
activities supported through the grant. Such reports shall
include information on the number of pharmacies in the State
that dispense a drug or device approved or cleared under the
Federal Food, Drug, and Cosmetic Act for emergency treatment of
known or suspected opioid overdose under a standing order, and
other information as the Secretary determines appropriate to
evaluate the use of grant funds.
``(g) Definitions.--In this section the term `standing
order' means a document prepared by a person authorized to
prescribe medication that permits another person to acquire,
dispense, or administer medication without a person-specific
prescription.
``(h) Authorization of Appropriations.--
``(1) In general.--To carry out this section, there
are authorized to be appropriated $5,000,000 for the
period of fiscal years 2017 through 2019.
``(2) Administrative costs.--Not more than 3
percent of the amounts made available to carry out this
section may be used by the Secretary for administrative
expenses of carrying out this section.''.
(b) Technical Clarification.--Effective as if included in
the enactment of the Children's Health Act of 2000 (Public Law
106-310), section 3405(a) of such Act (114 Stat. 1221) is
amended by striking ``Part E of title III'' and inserting
``Part E of title III of the Public Health Service Act''.
TITLE II--LAW ENFORCEMENT AND TREATMENT
SEC. 201. COMPREHENSIVE OPIOID ABUSE GRANT PROGRAM.
(a) Comprehensive Opioid Abuse Grant Program.--
(1) In general.--Title I of the Omnibus Crime
Control and Safe Streets Act of 1968 (42 U.S.C. 3711 et
seq.) is amended by adding at the end the following:
``PART LL--COMPREHENSIVE OPIOID ABUSE GRANT PROGRAM
``SEC. 3021. DESCRIPTION.
``(a) Grants Authorized.--From amounts made available to
carry out this part, the Attorney General may make grants to
States, units of local government, and Indian tribes, for use
by the State, unit of local government, or Indian tribe to
provide services primarily relating to opioid abuse, including
for any one or more of the following:
``(1) Developing, implementing, or expanding a
treatment alternative to incarceration program, which
may include--
``(A) prebooking or postbooking components,
which may include the activities described in
part DD or HH of this title;
``(B) training for criminal justice agency
personnel on substance use disorders and co-
occurring mental illness and substance use
disorders;
``(C) a mental health court, including the
activities described in part V of this title;
``(D) a drug court, including the
activities described in part EE of this title;
``(E) a veterans treatment court program,
including the activities described in
subsection (i) of section 2991 of this title;
``(F) a focus on parents whose
incarceration could result in their children
entering the child welfare system; and
``(G) a community-based substance use
diversion program sponsored by a law
enforcement agency.
``(2) In the case of a State, facilitating or
enhancing planning and collaboration between State
criminal justice agencies and State substance abuse
agencies in order to more efficiently and effectively
carry out activities or services described in any
paragraph of this subsection that address problems
related to opioid abuse.
``(3) Providing training and resources for first
responders on carrying and administering an opioid
overdose reversal drug or device approved or cleared by
the Food and Drug Administration, and purchasing such a
drug or device for first responders who have received
such training to so carry and administer.
``(4) Locating or investigating illicit activities
related to the unlawful distribution of opioids.
``(5) Developing, implementing, or expanding a
medication-assisted treatment program used or operated
by a criminal justice agency, which may include
training criminal justice agency personnel on
medication-assisted treatment, and carrying out the
activities described in part S of this title.
``(6) In the case of a State, developing,
implementing, or expanding a prescription drug
monitoring program to collect and analyze data related
to the prescribing of schedules II, III, and IV
controlled substances through a centralized database
administered by an authorized State agency, which
includes tracking the dispensation of such substances,
and providing for interoperability and data sharing
with each other such program in each other State, and
with any interstate entity that shares information
between such programs.
``(7) Developing, implementing, or expanding a
program to prevent and address opioid abuse by
juveniles.
``(8) Developing, implementing, or expanding a
program (which may include demonstration projects) to
utilize technology that provides a secure container for
prescription drugs that would prevent or deter
individuals, particularly adolescents, from gaining
access to opioid medications that are lawfully
prescribed for other individuals.
``(9) Developing, implementing, or expanding a
prescription drug take-back program.
``(10) Developing, implementing, or expanding an
integrated and comprehensive opioid abuse response
program.
``(b) Contracts and Subawards.--A State, unit of local
government, or Indian tribe may, in using a grant under this
part for purposes authorized by subsection (a), use all or a
portion of that grant to contract with, or make one or more
subawards to, one or more--
``(1) local or regional organizations that are
private and nonprofit, including faith-based
organizations;
``(2) units of local government; or
``(3) tribal organizations.
``(c) Program Assessment Component; Waiver.--
``(1) Program assessment component.--Each program
funded under this part shall contain a program
assessment component, developed pursuant to guidelines
established by the Attorney General, in coordination
with the National Institute of Justice.
``(2) Waiver.--The Attorney General may waive the
requirement of paragraph (1) with respect to a program
if, in the opinion of the Attorney General, the program
is not of sufficient size to justify a full program
assessment.
``(d) Administrative Costs.--Not more than 10 percent of a
grant made under this part may be used for costs incurred to
administer such grant.
``(e) Period.--The period of a grant made under this part
may not be longer than 4 years, except that renewals and
extensions beyond that period may be granted at the discretion
of the Attorney General.
``SEC. 3022. APPLICATIONS.
``To request a grant under this part, the chief executive
officer of a State, unit of local government, or Indian tribe
shall submit an application to the Attorney General at such
time and in such form as the Attorney General may require. Such
application shall include the following:
``(1) A certification that Federal funds made
available under this part will not be used to supplant
State, local, or tribal funds, but will be used to
increase the amounts of such funds that would, in the
absence of Federal funds, be made available for the
activities described in section 3021(a).
``(2) An assurance that, for each fiscal year
covered by an application, the applicant shall maintain
and report such data, records, and information
(programmatic and financial) as the Attorney General
may reasonably require.
``(3) A certification, made in a form acceptable to
the Attorney General and executed by the chief
executive officer of the applicant (or by another
officer of the applicant, if qualified under
regulations promulgated by the Attorney General),
that--
``(A) the activities or services to be
funded by the grant meet all the requirements
of this part;
``(B) all the information contained in the
application is correct;
``(C) there has been appropriate
coordination with affected agencies; and
``(D) the applicant will comply with all
provisions of this part and all other
applicable Federal laws.
``(4) An assurance that the applicant will work
with the Drug Enforcement Administration to develop an
integrated and comprehensive strategy to address opioid
abuse.
``SEC. 3023. REVIEW OF APPLICATIONS.
``The Attorney General shall not finally disapprove any
application (or any amendment to that application) submitted
under this part without first affording the applicant
reasonable notice of any deficiencies in the application and an
opportunity for correction of any such deficiencies and
reconsideration.
``SEC. 3024. EQUITABLE DISTRIBUTION OF FUNDS.
``In awarding grants under this part, the Attorney General
shall distribute funds in a manner that--
``(1) equitably addresses the needs of underserved
populations, including rural and tribal communities;
and
``(2) focuses on communities that have been
disproportionately impacted by opioid abuse as
evidenced in part by--
``(A) high rates of primary treatment
admissions for heroin and other opioids;
``(B) high rates of drug poisoning deaths
from heroin and other opioids; and
``(C) a lack of accessibility to treatment
providers and facilities and to emergency
medical services.
``SEC. 3025. DEFINITIONS.
``In this part:
``(1) The term `first responder' includes a
firefighter, law enforcement officer, paramedic,
emergency medical technician, or other individual
(including an employee of a legally organized and
recognized volunteer organization, whether compensated
or not), who, in the course of his or her professional
duties, responds to fire, medical, hazardous material,
or other similar emergencies.
``(2) The term `medication-assisted treatment'
means the use of medications approved by the Food and
Drug Administration for the treatment of opioid abuse.
``(3) The term `opioid' means any drug, including
heroin, having an addiction-forming or addiction-
sustaining liability similar to morphine or being
capable of conversion into a drug having such
addiction-forming or addiction-sustaining liability.
``(4) The term `schedule II, III, or IV controlled
substance' means a controlled substance that is listed
on schedule II, schedule III, or schedule IV of section
202(c) of the Controlled Substances Act (21 U.S.C.
812(c)).
``(5) The terms `drug' and `device' have the
meanings given those terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
``(6) The term `criminal justice agency' means a
State, local, or tribal--
``(A) court;
``(B) prison;
``(C) jail;
``(D) law enforcement agency; or
``(E) other agency that performs the
administration of criminal justice, including
prosecution, pretrial services, and community
supervision.
``(7) The term `tribal organization' has the
meaning given that term in section 4 of the Indian
Self-Determination and Education Assistance Act (25
U.S.C. 450b).
``(8) The term `State substance abuse agency' has
the meaning given that term in section 508(r)(6) of the
Public Health Service Act (42 U.S.C. 290bb-1).''.
(2) Authorization of appropriations.--Section
1001(a) of title I of the Omnibus Crime Control and
Safe Streets Act of 1968 (42 U.S.C. 3793(a)) is amended
by inserting after paragraph (26) the following:
``(27) There are authorized to be appropriated to
carry out part LL $103,000,000 for each of fiscal years
2017 through 2021.''.
(b) Emergency Federal Law Enforcement Assistance.--Section
609Y(a) of the Justice Assistance Act of 1984 (42 U.S.C.
10513(a)) is amended by striking ``September 30, 1984'' and
inserting ``September 30, 2021''.
(c) Inclusion of Services for Pregnant Women Under Family-
Based Substance Abuse Grants.--Part DD of title I of the
Omnibus Crime Control and Safe Streets Act (42 U.S.C. 3797s et
seq.) is amended--
(1) in section 2921(2), by inserting before the
period at the end ``or pregnant women''; and
(2) in section 2927--
(A) in paragraph (1)(A), by inserting
``pregnant or'' before ``a parent''; and
(B) in paragraph (3), by inserting ``or
pregnant women'' after ``incarcerated
parents''.
(d) GAO Study and Report on Federal Agency Programs and
Research Relative to Substance Use and Substance Use Disorders
Among Adolescents and Young Adults.--
(1) Study.--The Comptroller General of the United
States shall conduct a study on how Federal agencies,
through grant programs, are addressing prevention of,
treatment for, and recovery from, substance use by, and
substance use disorders among, adolescents and young
adults. Such study shall include an analysis of each of
the following:
(A) The research that has been, and is
being, conducted or supported pursuant to grant
programs operated by Federal agencies on
prevention of, treatment for, and recovery from
substance use by and substance use disorders
among adolescents and young adults, including
an assessment of--
(i) such research relative to any
unique circumstances (including social
and biological circumstances) of
adolescents and young adults that may
make adolescent-specific and young
adult-specific treatment protocols
necessary, including any effects that
substance use and substance use
disorders may have on brain development
and the implications for treatment and
recovery; and
(ii) areas of such research in
which greater investment or focus is
necessary relative to other areas of
such research.
(B) Federal agency nonresearch programs and
activities that address prevention of,
treatment for, and recovery from substance use
by and substance use disorders among
adolescents and young adults, including an
assessment of the effectiveness of such
programs and activities in preventing substance
use by and substance use disorders among
adolescents and young adults, treating such
adolescents and young adults in a way that
accounts for any unique circumstances faced by
adolescents and young adults, and supports
long-term recovery among adolescents and young
adults.
(C) Gaps that have been identified by
officials of Federal agencies or experts in the
efforts supported by grant programs operated by
Federal agencies relating to prevention of,
treatment for, and recovery from substance use
by and substance use disorders among
adolescents and young adults, including gaps in
research, data collection, and measures to
evaluate the effectiveness of such efforts, and
the reasons for such gaps.
(2) Report.--Not later than 2 years after the date
of enactment of this Act, the Comptroller General shall
submit to the appropriate committees of the Congress a
report containing the results of the study conducted
under paragraph (1), including--
(A) a summary of the findings of the study;
and
(B) recommendations based on the results of
the study, including recommendations for such
areas of research and legislative and
administrative action as the Comptroller
General determines appropriate.
SEC. 202. FIRST RESPONDER TRAINING.
Part D of title V of the Public Health Service Act (42
U.S.C. 290dd et seq.), as amended by section 110, is further
amended by adding at the end the following:
``SEC. 546. FIRST RESPONDER TRAINING.
``(a) Program Authorized.--The Secretary shall make grants
to States, local governmental entities, and Indian tribes and
tribal organizations (as defined in section 4 of the Indian
Self-Determination and Education Assistance Act) to allow first
responders and members of other key community sectors to
administer a drug or device approved or cleared under the
Federal Food, Drug, and Cosmetic Act for emergency treatment of
known or suspected opioid overdose.
``(b) Application.--
``(1) In general.--An entity seeking a grant under
this section shall submit an application to the
Secretary--
``(A) that meets the criteria under
paragraph (2); and
``(B) at such time, in such manner, and
accompanied by such information as the
Secretary may require.
``(2) Criteria.--An entity, in submitting an
application under paragraph (1), shall--
``(A) describe the evidence-based
methodology and outcome measurements that will
be used to evaluate the program funded with a
grant under this section, and specifically
explain how such measurements will provide
valid measures of the impact of the program;
``(B) describe how the program could be
broadly replicated if demonstrated to be
effective;
``(C) identify the governmental and
community agencies with which the entity will
coordinate to implement the program; and
``(D) describe how the entity will ensure
that law enforcement agencies will coordinate
with their corresponding State substance abuse
and mental health agencies to identify
protocols and resources that are available to
overdose victims and families, including
information on treatment and recovery
resources.
``(c) Use of Funds.--An entity shall use a grant received
under this section to--
``(1) make a drug or device approved or cleared
under the Federal Food, Drug, and Cosmetic Act for
emergency treatment of known or suspected opioid
overdose available to be carried and administered by
first responders and members of other key community
sectors;
``(2) train and provide resources for first
responders and members of other key community sectors
on carrying and administering a drug or device approved
or cleared under the Federal Food, Drug, and Cosmetic
Act for emergency treatment of known or suspected
opioid overdose; and
``(3) establish processes, protocols, and
mechanisms for referral to appropriate treatment, which
may include an outreach coordinator or team to connect
individuals receiving opioid overdose reversal drugs to
followup services.
``(d) Technical Assistance Grants.--The Secretary shall
make a grant for the purpose of providing technical assistance
and training on the use of a drug or device approved or cleared
under the Federal Food, Drug, and Cosmetic Act for emergency
treatment of known or suspected opioid overdose, and mechanisms
for referral to appropriate treatment for an entity receiving a
grant under this section.
``(e) Geographic Distribution.--In making grants under this
section, the Secretary shall ensure that not less than 20
percent of grant funds are awarded to eligible entities that
are not located in metropolitan statistical areas (as defined
by the Office of Management and Budget). The Secretary shall
take into account the unique needs of rural communities,
including communities with an incidence of individuals with
opioid use disorder that is above the national average and
communities with a shortage of prevention and treatment
services.
``(f) Evaluation.--The Secretary shall conduct an
evaluation of grants made under this section to determine--
``(1) the number of first responders and members of
other key community sectors equipped with a drug or
device approved or cleared under the Federal Food,
Drug, and Cosmetic Act for emergency treatment of known
or suspected opioid overdose;
``(2) the number of opioid and heroin overdoses
reversed by first responders and members of other key
community sectors receiving training and supplies of a
drug or device approved or cleared under the Federal
Food, Drug, and Cosmetic Act for emergency treatment of
known or suspected opioid overdose, through a grant
received under this section;
``(3) the number of responses to requests for
services by the entity or subgrantee, to opioid and
heroin overdose; and
``(4) the extent to which overdose victims and
families receive information about treatment services
and available data describing treatment admissions.
``(g) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $12,000,000
for each of fiscal years 2017 through 2021.''.
SEC. 203. PRESCRIPTION DRUG TAKE BACK EXPANSION.
(a) Definition of Covered Entity.--In this section, the
term ``covered entity'' means--
(1) a State, local, or tribal law enforcement
agency;
(2) a manufacturer, distributor, or reverse
distributor of prescription medications;
(3) a retail pharmacy;
(4) a registered narcotic treatment program;
(5) a hospital or clinic with an onsite pharmacy;
(6) an eligible long-term care facility; or
(7) any other entity authorized by the Drug
Enforcement Administration to dispose of prescription
medications.
(b) Program Authorized.--The Attorney General, in
coordination with the Administrator of the Drug Enforcement
Administration, the Secretary of Health and Human Services, and
the Director of the Office of National Drug Control Policy,
shall coordinate with covered entities in expanding or making
available disposal sites for unwanted prescription medications.
TITLE III--TREATMENT AND RECOVERY
SEC. 301. EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN TREATMENT AND
INTERVENTIONS DEMONSTRATION.
Subpart 1 of part B of title V of the Public Health Service
Act (42 U.S.C. 290bb et seq.) is amended by adding at the end
the following:
``SEC. 514B. EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN TREATMENT
AND INTERVENTIONS DEMONSTRATION.
``(a) Grants To Expand Access.--
``(1) Authority to award grants.--The Secretary
shall award grants, contracts, or cooperative
agreements to State substance abuse agencies, units of
local government, nonprofit organizations, and Indian
tribes and tribal organizations (as defined in section
4 of the Indian Self-Determination and Education
Assistance Act) that have a high rate, or have had a
rapid increase, in the use of heroin or other opioids,
in order to permit such entities to expand activities,
including an expansion in the availability of evidence-
based medication-assisted treatment and other
clinically appropriate services, with respect to the
treatment of addiction in the specific geographical
areas of such entities where there is a high rate or
rapid increase in the use of heroin or other opioids,
such as in rural areas.
``(2) Nature of activities.--Funds awarded under
paragraph (1) shall be used for activities that are
based on reliable scientific evidence of efficacy in
the treatment of problems related to heroin or other
opioids.
``(b) Application.--To be eligible for a grant, contract,
or cooperative agreement under subsection (a), an entity shall
submit an application to the Secretary at such time, in such
manner, and accompanied by such information as the Secretary
may reasonably require.
``(c) Evaluation.--An entity that receives a grant,
contract, or cooperative agreement under subsection (a) shall
submit, in the application for such grant, contract, or
agreement a plan for the evaluation of any project undertaken
with funds provided under this section. Such entity shall
provide the Secretary with periodic evaluations of the progress
of such project and an evaluation at the completion of such
project as the Secretary determines to be appropriate.
``(d) Geographic Distribution.--In awarding grants,
contracts, and cooperative agreements under this section, the
Secretary shall ensure that not less than 15 percent of funds
are awarded to eligible entities that are not located in
metropolitan statistical areas (as defined by the Office of
Management and Budget). The Secretary shall take into account
the unique needs of rural communities, including communities
with an incidence of individuals with opioid use disorder that
is above the national average and communities with a shortage
of prevention and treatment services.
``(e) Additional Activities.--In administering grants,
contracts, and cooperative agreements under subsection (a), the
Secretary shall--
``(1) evaluate the activities supported under such
subsection;
``(2) disseminate information, as appropriate,
derived from evaluations as the Secretary considers
appropriate;
``(3) provide States, Indian tribes and tribal
organizations, and providers with technical assistance
in connection with the provision of treatment of
problems related to heroin and other opioids; and
``(4) fund only those applications that
specifically support recovery services as a critical
component of the program involved.
``(f) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $25,000,000
for each of fiscal years 2017 through 2021.''.
SEC. 302. BUILDING COMMUNITIES OF RECOVERY.
Part D of title V of the Public Health Service Act (42
U.S.C. 290dd et seq.), as amended by section 202, is further
amended by adding at the end the following:
``SEC. 547. BUILDING COMMUNITIES OF RECOVERY.
``(a) Definition.--In this section, the term `recovery
community organization' means an independent nonprofit
organization that--
``(1) mobilizes resources within and outside of the
recovery community to increase the prevalence and
quality of long-term recovery from substance use
disorders; and
``(2) is wholly or principally governed by people
in recovery for substance use disorders who reflect the
community served.
``(b) Grants Authorized.--The Secretary shall award grants
to recovery community organizations to enable such
organizations to develop, expand, and enhance recovery
services.
``(c) Federal Share.--The Federal share of the costs of a
program funded by a grant under this section may not exceed 50
percent.
``(d) Use of Funds.--Grants awarded under subsection (b)--
``(1) shall be used to develop, expand, and enhance
community and statewide recovery support services; and
``(2) may be used to--
``(A) build connections between recovery
networks, between recovery community
organizations, and with other recovery support
services, including--
``(i) behavioral health providers;
``(ii) primary care providers and
physicians;
``(iii) the criminal justice
system;
``(iv) employers;
``(v) housing services;
``(vi) child welfare agencies; and
``(vii) other recovery support
services that facilitate recovery from
substance use disorders;
``(B) reduce the stigma associated with
substance use disorders; and
``(C) conduct outreach on issues relating
to substance use disorders and recovery,
including--
``(i) identifying the signs of
addiction;
``(ii) the resources available to
individuals struggling with addiction
and to families with a family member
struggling with, or being treated for,
addiction, including programs that
mentor and provide support services to
children;
``(iii) the resources available to
help support individuals in recovery;
and
``(iv) related medical outcomes of
substance use disorders, the potential
of acquiring an infectious disease from
intravenous drug use, and neonatal
abstinence syndrome among infants
exposed to opioids during pregnancy.
``(e) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section
$1,000,000 for each of fiscal years 2017 through 2021.''.
SEC. 303. MEDICATION-ASSISTED TREATMENT FOR RECOVERY FROM ADDICTION.
(a) In General.--
(1) In general.--Section 303(g)(2) of the
Controlled Substances Act (21 U.S.C. 823(g)(2)) is
amended--
(A) in subparagraph (B), by striking
clauses (i), (ii), and (iii) and inserting the
following:
``(i) The practitioner is a qualifying practitioner
(as defined in subparagraph (G)).
``(ii) With respect to patients to whom the
practitioner will provide such drugs or combinations of
drugs, the practitioner has the capacity to provide
directly, by referral, or in such other manner as
determined by the Secretary--
``(I) all drugs approved by the Food and
Drug Administration for the treatment of opioid
use disorder, including for maintenance,
detoxification, overdose reversal, and relapse
prevention; and
``(II) appropriate counseling and other
appropriate ancillary services.
``(iii)(I) The total number of such patients of the
practitioner at any one time will not exceed the
applicable number. Except as provided in subclause
(II), the applicable number is 30.
``(II) The applicable number is 100 if, not sooner
than 1 year after the date on which the practitioner
submitted the initial notification, the practitioner
submits a second notification to the Secretary of the
need and intent of the practitioner to treat up to 100
patients.
``(III) The Secretary may by regulation change such
applicable number.
``(IV) The Secretary may exclude from the
applicable number patients to whom such drugs or
combinations of drugs are directly administered by the
qualifying practitioner in the office setting.'';
(B) in subparagraph (D)--
(i) in clause (ii), by striking
``Upon receiving a notification under
subparagraph (B)'' and inserting ``Upon
receiving a determination from the
Secretary under clause (iii) finding
that a practitioner meets all
requirements for a waiver under
subparagraph (B)''; and
(ii) in clause (iii)--
(I) by inserting ``and
shall forward such
determination to the Attorney
General'' before the period at
the end of the first sentence;
and
(II) by striking
``physician'' and inserting
``practitioner'';
(C) in subparagraph (G)--
(i) by amending clause (ii)(I) to
read as follows:
``(I) The physician holds a
board certification in
addiction psychiatry or
addiction medicine from the
American Board of Medical
Specialties.'';
(ii) by amending clause (ii)(II) to
read as follows:
``(II) The physician holds
an addiction certification or
board certification from the
American Society of Addiction
Medicine or the American Board
of Addiction Medicine.'';
(iii) in clause (ii)(III), by
striking ``subspecialty'';
(iv) by amending clause (ii)(IV) to
read as follows:
``(IV) The physician has, with respect to
the treatment and management of opiate-
dependent patients, completed not less than 8
hours of training (through classroom
situations, seminars at professional society
meetings, electronic communications, or
otherwise) that is provided by the American
Society of Addiction Medicine, the American
Academy of Addiction Psychiatry, the American
Medical Association, the American Osteopathic
Association, the American Psychiatric
Association, or any other organization that the
Secretary determines is appropriate for
purposes of this subclause. Such training shall
include--
``(aa) opioid maintenance and
detoxification;
``(bb) appropriate clinical use of
all drugs approved by the Food and Drug
Administration for the treatment of
opioid use disorder;
``(cc) initial and periodic patient
assessments (including substance use
monitoring);
``(dd) individualized treatment
planning, overdose reversal, and
relapse prevention;
``(ee) counseling and recovery
support services;
``(ff) staffing roles and
considerations;
``(gg) diversion control; and
``(hh) other best practices, as
identified by the Secretary.''; and
(v) by adding at the end the
following:
``(iii) The term `qualifying practitioner' means--
``(I) a qualifying physician, as defined in
clause (ii); or
``(II) during the period beginning on the
date of enactment of the Comprehensive
Addiction and Recovery Act of 2016 and ending
on October 1, 2021, a qualifying other
practitioner, as defined in clause (iv).
``(iv) The term `qualifying other practitioner'
means a nurse practitioner or physician assistant who
satisfies each of the following:
``(I) The nurse practitioner or physician
assistant is licensed under State law to
prescribe schedule III, IV, or V medications
for the treatment of pain.
``(II) The nurse practitioner or physician
assistant has--
``(aa) completed not fewer than 24
hours of initial training addressing
each of the topics listed in clause
(ii)(IV) (through classroom situations,
seminars at professional society
meetings, electronic communications, or
otherwise) provided by the American
Society of Addiction Medicine, the
American Academy of Addiction
Psychiatry, the American Medical
Association, the American Osteopathic
Association, the American Nurses
Credentialing Center, the American
Psychiatric Association, the American
Association of Nurse Practitioners, the
American Academy of Physician
Assistants, or any other organization
that the Secretary determines is
appropriate for purposes of this
subclause; or
``(bb) has such other training or
experience as the Secretary determines
will demonstrate the ability of the
nurse practitioner or physician
assistant to treat and manage opiate-
dependent patients.
``(III) The nurse practitioner or physician
assistant is supervised by, or works in
collaboration with, a qualifying physician, if
the nurse practitioner or physician assistant
is required by State law to prescribe
medications for the treatment of opioid use
disorder in collaboration with or under the
supervision of a physician.
The Secretary may, by regulation, revise the
requirements for being a qualifying other practitioner
under this clause.''; and
(D) in subparagraph (H)--
(i) in clause (i), by inserting
after subclause (II) the following:
``(III) Such other elements of the requirements
under this paragraph as the Secretary determines
necessary for purposes of implementing such
requirements.''; and
(ii) by amending clause (ii) to
read as follows:
``(ii) Not later than 18 months after the date of enactment
of the Opioid Use Disorder Treatment Expansion and
Modernization Act, the Secretary shall update the treatment
improvement protocol containing best practice guidelines for
the treatment of opioid-dependent patients in office-based
settings. The Secretary shall update such protocol in
consultation with experts in opioid use disorder research and
treatment.''.
(2) Opioid defined.--Section 102(18) of the
Controlled Substances Act (21 U.S.C. 802(18)) is
amended by inserting ``or `opioid''' after ``The term
`opiate'''.
(3) Reports to congress.--
(A) In general.--Not later than 3 years
after the date of enactment of this Act and not
later than 3 years thereafter, the Secretary of
Health and Human Services, in consultation with
the Drug Enforcement Administration and experts
in opioid use disorder research and treatment,
shall--
(i) perform a thorough review of
the provision of opioid use disorder
treatment services in the United
States, including services provided in
opioid treatment programs and other
specialty and nonspecialty settings;
and
(ii) submit a report to the
Congress on the findings and
conclusions of such review.
(B) Contents.--Each report under
subparagraph (A) shall include an assessment
of--
(i) compliance with the
requirements of section 303(g)(2) of
the Controlled Substances Act (21
U.S.C. 823(g)(2)), as amended by this
section;
(ii) the measures taken by the
Secretary of Health and Human Services
to ensure such compliance;
(iii) whether there is further need
to increase or decrease the number of
patients a practitioner, pursuant to a
waiver under section 303(g)(2) of the
Controlled Substances Act (21 U.S.C.
823(g)(2)), is permitted to treat;
(iv) the extent to which, and
proportions with which, the full range
of Food and Drug Administration-
approved treatments for opioid use
disorder are used in routine health
care settings and specialty substance
use disorder treatment settings;
(v) access to, and use of,
counseling and recovery support
services, including the percentage of
patients receiving such services;
(vi) changes in State or local
policies and legislation relating to
opioid use disorder treatment;
(vii) the use of prescription drug
monitoring programs by practitioners
who are permitted to dispense narcotic
drugs to individuals pursuant to a
waiver described in clause (iii);
(viii) the findings resulting from
inspections by the Drug Enforcement
Administration of practitioners
described in clause (vii); and
(ix) the effectiveness of cross-
agency collaboration between Department
of Health and Human Services and the
Drug Enforcement Administration for
expanding effective opioid use disorder
treatment.
(b) State Flexibility.--Section 303(g)(2) of the Controlled
Substances Act (21 U.S.C. 823(g)(2)) is amended by striking
subparagraphs (I) and (J), and inserting the following:
``(I) Notwithstanding section 708, nothing in this
paragraph shall be construed to preempt any State law that--
``(i) permits a qualifying practitioner to dispense
narcotic drugs in schedule III, IV, or V, or
combinations of such drugs, for maintenance or
detoxification treatment in accordance with this
paragraph to a total number of patients that is more
than 30 or less than the total number applicable to the
qualifying practitioner under subparagraph (B)(iii)(II)
if a State enacts a law modifying such total number and
the Attorney General is notified by the State of such
modification; or
``(ii) requires a qualifying practitioner to comply
with additional requirements relating to the dispensing
of narcotic drugs in schedule III, IV, or V, or
combinations of such drugs, including requirements
relating to the practice setting in which the
qualifying practitioner practices and education,
training, and reporting requirements.''.
(c) Update Regulations.--Not later than 18 months after the
date of enactment of this Act, the Attorney General and the
Secretary of Health and Human Services, as appropriate, shall
update regulations regarding practitioners described in
subsection (a)(3)(B)(vii) (as amended by this section) to
include nurse practitioners and physician assistants to ensure
the quality of patient care and prevent diversion.
TITLE IV--ADDRESSING COLLATERAL CONSEQUENCES
SEC. 401. GAO REPORT ON RECOVERY AND COLLATERAL CONSEQUENCES.
(a) Report Required.--Not later than 1 year after the date
of enactment of this Act, the Comptroller General of the United
States shall submit to the Committee on the Judiciary of the
Senate and the Committee on the Judiciary of the House of
Representatives a report that--
(1) describes the collateral consequences for
individuals with convictions for nonviolent drug-
related offenses;
(2) describes the effect of the collateral
consequences described in paragraph (1) on individuals
in resuming their personal and professional activities,
especially, to the extent data are available, the
effect on individuals who are participating in or have
completed a recovery program for a substance use
disorder;
(3) discusses policy bases and justifications for
imposing collateral consequences on individuals
convicted of nonviolent drug-related offenses
identified under paragraph (1); and
(4) provides perspectives on the potential for
mitigating the effect of the collateral consequences
described in paragraph (1) on individuals who are
participating in or have completed a recovery program,
while also taking into account the policy interests
described in paragraph (3).
(b) Definition.--In this section, the term ``collateral
consequence''--
(1) means a penalty, disability, or disadvantage
imposed upon an individual as a result of a criminal
conviction for a drug-related offense--
(A) automatically by operation of law; or
(B) by authorized action of an
administrative agency or court on a case-by-
case basis; and
(2) does not include a direct consequence imposed
as part of the judgment of a court at sentencing,
including a term of imprisonment or community
supervision, or a fine.
TITLE V--ADDICTION AND TREATMENT SERVICES FOR WOMEN, FAMILIES, AND
VETERANS
SEC. 501. IMPROVING TREATMENT FOR PREGNANT AND POSTPARTUM WOMEN.
(a) General Amendments to the Residential Treatment Program
for Pregnant and Postpartum Women.--Section 508 of the Public
Health Service Act (42 U.S.C. 290bb-1) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1)--
(i) by inserting ``(referred to in
this section as the `Director')'' after
``Substance Abuse Treatment'';
(ii) by striking ``grants,
cooperative agreement,'' and inserting
``grants, including the grants under
subsection (r), cooperative
agreements''; and
(iii) by striking ``for substance
abuse'' and inserting ``for substance
use disorders''; and
(B) in paragraph (1), by inserting ``or
receive outpatient treatment services from''
after ``reside in'';
(2) in subsection (b)(2), by inserting ``and her
children'' before the period at the end;
(3) in subsection (c)--
(A) in paragraph (1), by striking ``to the
woman of the services'' and inserting ``of
services for the woman and her children''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by
striking ``substance abuse'' and
inserting ``substance use disorders'';
and
(ii) in subparagraph (B), by
striking ``such abuse'' and inserting
``such a disorder'';
(4) in subsection (d)--
(A) in paragraph (3)(A), by striking
``maternal substance abuse'' and inserting ``a
maternal substance use disorder'';
(B) by amending paragraph (4) to read as
follows:
``(4) Providing therapeutic, comprehensive child
care for children during the periods in which the woman
is engaged in therapy or in other necessary health and
rehabilitative activities.'';
(C) in paragraphs (9), (10), and (11), by
striking ``women'' each place such term appears
and inserting ``woman'';
(D) in paragraph (9), by striking ``units''
and inserting ``unit''; and
(E) in paragraph (11)--
(i) in subparagraph (A), by
striking ``their children'' and
inserting ``any child of such woman'';
(ii) in subparagraph (B), by
striking ``; and'' and inserting a
semicolon;
(iii) in subparagraph (C), by
striking the period and inserting ``;
and''; and
(iv) by adding at the end the
following:
``(D) family reunification with children in
kinship or foster care arrangements, where safe
and appropriate.'';
(5) in subsection (e)--
(A) in paragraph (1)--
(i) in the matter preceding
subparagraph (A), by striking
``substance abuse'' and inserting
``substance use disorders''; and
(ii) in subparagraph (B), by
striking ``substance abuse'' and
inserting ``substance use disorders'';
and
(B) in paragraph (2)--
(i) by striking ``(A) Subject'' and
inserting the following:
``(A) In general.--Subject'';
(ii) in subparagraph (B)--
(I) by striking ``(B)(i) In
the case'' and inserting the
following:
``(B) Waiver of participation agreements.--
``(i) In general.--In the case'';
and
(II) by striking ``(ii) A
determination'' and inserting
the following:
``(ii) Donations.--A
determination''; and
(iii) by striking ``(C) With
respect'' and inserting the following:
``(C) Nonapplication of certain
requirements.--With respect'';
(6) in subsection (g)--
(A) by striking ``who are engaging in
substance abuse'' and inserting ``who have a
substance use disorder''; and
(B) by striking ``such abuse'' and
inserting ``such disorder'';
(7) in subsection (j)--
(A) in the matter preceding paragraph (1),
by striking ``to on'' and inserting ``to or
on''; and
(B) in paragraph (3), by striking ``Office
for'' and inserting ``Office of'';
(8) by amending subsection (m) to read as follows:
``(m) Allocation of Awards.--In making awards under
subsection (a), the Director shall give priority to an
applicant that agrees to use the award for a program serving an
area that is a rural area, an area designated under section 332
by the Secretary as a health professional shortage area, or an
area determined by the Director to have a shortage of family-
based substance use disorder treatment options.''; and
(9) in subsection (q)--
(A) in paragraph (3), by striking ``funding
agreement under subsection (a)'' and inserting
``funding agreement''; and
(B) in paragraph (4), by striking
``substance abuse'' and inserting ``a substance
use disorder''.
(b) Reauthorization of Program.--Section 508 of the Public
Health Service Act (42 U.S.C. 290bb-1), as amended by
subsection (a), is further amended--
(1) in subsection (p), in the first sentence, by
inserting ``(other than subsection (r))'' after
``section''; and
(2) in subsection (r), by striking ``such sums''
and all that follows through ``2003'' and inserting
``$16,900,000 for each of fiscal years 2017 through
2021''.
(c) Pilot Program Grants for State Substance Abuse
Agencies.--
(1) In general.--Section 508 of the Public Health
Service Act (42 U.S.C. 290bb-1), as amended by
subsections (a) and (b), is further amended--
(A) by redesignating subsection (r), as
amended by subsection (b), as subsection (s);
and
(B) by inserting after subsection (q) the
following new subsection:
``(r) Pilot Program for State Substance Abuse Agencies.--
``(1) In general.--From amounts made available
under subsection (s), the Director of the Center for
Substance Abuse Treatment shall carry out a pilot
program under which competitive grants are made by the
Director to State substance abuse agencies--
``(A) to enhance flexibility in the use of
funds designed to support family-based services
for pregnant and postpartum women with a
primary diagnosis of a substance use disorder,
including opioid use disorders;
``(B) to help State substance abuse
agencies address identified gaps in services
furnished to such women along the continuum of
care, including services provided to women in
nonresidential-based settings; and
``(C) to promote a coordinated, effective,
and efficient State system managed by State
substance abuse agencies by encouraging new
approaches and models of service delivery.
``(2) Requirements.--In carrying out the pilot
program under this subsection, the Director shall--
``(A) require State substance abuse
agencies to submit to the Director
applications, in such form and manner and
containing such information as specified by the
Director, to be eligible to receive a grant
under the program;
``(B) identify, based on such submitted
applications, State substance abuse agencies
that are eligible for such grants;
``(C) require services proposed to be
furnished through such a grant to support
family-based treatment and other services for
pregnant and postpartum women with a primary
diagnosis of a substance use disorder,
including opioid use disorders;
``(D) not require that services furnished
through such a grant be provided solely to
women that reside in facilities;
``(E) not require that grant recipients
under the program make available through use of
the grant all the services described in
subsection (d); and
``(F) consider not applying the
requirements described in paragraphs (1) and
(2) of subsection (f) to an applicant,
depending on the circumstances of the
applicant.
``(3) Required services.--
``(A) In general.--The Director shall
specify a minimum set of services required to
be made available to eligible women through a
grant awarded under the pilot program under
this subsection. Such minimum set of services--
``(i) shall include the services
requirements described in subsection
(c) and be based on the recommendations
submitted under subparagraph (B); and
``(ii) may be selected from among
the services described in subsection
(d) and include other services as
appropriate.
``(B) Stakeholder input.--The Director
shall convene and solicit recommendations from
stakeholders, including State substance abuse
agencies, health care providers, persons in
recovery from substance abuse, and other
appropriate individuals, for the minimum set of
services described in subparagraph (A).
``(4) Duration.--The pilot program under this
subsection shall not exceed 5 years.
``(5) Evaluation and report to congress.--
``(A) In general.--The Director of the
Center for Behavioral Health Statistics and
Quality shall evaluate the pilot program at the
conclusion of the first grant cycle funded by
the pilot program.
``(B) Report.--The Director of the Center
for Behavioral Health Statistics and Quality,
in coordination with the Director of the Center
for Substance Abuse Treatment shall submit to
the relevant committees of jurisdiction of the
House of Representatives and the Senate a
report on the evaluation under subparagraph
(A). The report shall include, at a minimum--
``(i) outcomes information from the
pilot program, including any resulting
reductions in the use of alcohol and
other drugs;
``(ii) engagement in treatment
services;
``(iii) retention in the
appropriate level and duration of
services;
``(iv) increased access to the use
of medications approved by the Food and
Drug Administration for the treatment
of substance use disorders in
combination with counseling; and
``(v) other appropriate measures.
``(C) Recommendation.--The report under
subparagraph (B) shall include a recommendation
by the Director of the Center for Substance
Abuse Treatment as to whether the pilot program
under this subsection should be extended.
``(6) State substance abuse agencies defined.--For
purposes of this subsection, the term `State substance
abuse agency' means, with respect to a State, the
agency in such State that manages the Substance Abuse
Prevention and Treatment Block Grant under part B of
title XIX.''.
(2) Funding.--Subsection (s) of section 508 of the
Public Health Service Act (42 U.S.C. 290bb-1), as
amended by subsection (a) and redesignated by paragraph
(1), is further amended by adding at the end the
following new sentences: ``Of the amounts made
available for a year pursuant to the previous sentence
to carry out this section, not more than 25 percent of
such amounts shall be made available for such year to
carry out subsection (r), other than paragraph (5) of
such subsection. Notwithstanding the preceding
sentence, no funds shall be made available to carry out
subsection (r) for a fiscal year unless the amount made
available to carry out this section for such fiscal
year is more than the amount made available to carry
out this section for fiscal year 2016.''.
SEC. 502. VETERANS TREATMENT COURTS.
Section 2991 of the Omnibus Crime Control and Safe Streets
Act of 1968 (42 U.S.C. 3797aa) is amended--
(1) by redesignating subsection (i) as subsection
(j); and
(2) by inserting after subsection (h) the
following:
``(i) Assisting Veterans.--
``(1) Definitions.--In this subsection:
``(A) Peer-to-peer services or programs.--
The term `peer-to-peer services or programs'
means services or programs that connect
qualified veterans with other veterans for the
purpose of providing support and mentorship to
assist qualified veterans in obtaining
treatment, recovery, stabilization, or
rehabilitation.
``(B) Qualified veteran.--The term
`qualified veteran' means a preliminarily
qualified offender who--
``(i) served on active duty in any
branch of the Armed Forces, including
the National Guard or Reserves; and
``(ii) was discharged or released
from such service under conditions
other than dishonorable, unless the
reason for the dishonorable discharge
was attributable to a substance abuse
disorder.
``(C) Veterans treatment court program.--
The term `veterans treatment court program'
means a court program involving collaboration
among criminal justice, veterans, and mental
health and substance abuse agencies that
provides qualified veterans with--
``(i) intensive judicial
supervision and case management, which
may include random and frequent drug
testing where appropriate;
``(ii) a full continuum of
treatment services, including mental
health services, substance abuse
services, medical services, and
services to address trauma;
``(iii) alternatives to
incarceration; or
``(iv) other appropriate services,
including housing, transportation,
mentoring, employment, job training,
education, or assistance in applying
for and obtaining available benefits.
``(2) Veterans assistance program.--
``(A) In general.--The Attorney General, in
consultation with the Secretary of Veterans
Affairs, may award grants under this subsection
to applicants to establish or expand--
``(i) veterans treatment court
programs;
``(ii) peer-to-peer services or
programs for qualified veterans;
``(iii) practices that identify and
provide treatment, rehabilitation,
legal, transitional, and other
appropriate services to qualified
veterans who have been incarcerated; or
``(iv) training programs to teach
criminal justice, law enforcement,
corrections, mental health, and
substance abuse personnel how to
identify and appropriately respond to
incidents involving qualified veterans.
``(B) Priority.--In awarding grants under
this subsection, the Attorney General shall
give priority to applications that--
``(i) demonstrate collaboration
between and joint investments by
criminal justice, mental health,
substance abuse, and veterans service
agencies;
``(ii) promote effective strategies
to identify and reduce the risk of harm
to qualified veterans and public
safety; and
``(iii) propose interventions with
empirical support to improve outcomes
for qualified veterans.''.
SEC. 503. INFANT PLAN OF SAFE CARE.
(a) Best Practices for Development of Plans of Safe Care.--
Section 103(b) of the Child Abuse Prevention and Treatment Act
(42 U.S.C. 5104(b)) is amended--
(1) by redesignating paragraphs (5) through (8) as
paragraphs (6) through (9), respectively; and
(2) by inserting after paragraph (4) the following:
``(5) maintain and disseminate information about
the requirements of section 106(b)(2)(B)(iii) and best
practices relating to the development of plans of safe
care as described in such section for infants born and
identified as being affected by substance abuse or
withdrawal symptoms, or a Fetal Alcohol Spectrum
Disorder;''.
(b) State Plans.--Section 106(b)(2)(B) of the Child Abuse
Prevention and Treatment Act (42 U.S.C. 5106a(b)(2)(B)) is
amended--
(1) in clause (ii), by striking ``illegal substance
abuse'' and inserting ``substance abuse''; and
(2) in clause (iii)--
(A) by striking ``illegal substance abuse''
and inserting ``substance abuse''; and
(B) by inserting before the semicolon at
the end the following: ``to ensure the safety
and well-being of such infant following release
from the care of health care providers,
including through--
``(I) addressing the health and
substance use disorder treatment needs
of the infant and affected family or
caregiver; and
``(II) the development and
implementation by the State of
monitoring systems regarding the
implementation of such plans to
determine whether and in what manner
local entities are providing, in
accordance with State requirements,
referrals to and delivery of
appropriate services for the infant and
affected family or caregiver''.
(c) Data Reports.--
(1) In general.--Section 106(d) of the Child Abuse
Prevention and Treatment Act (42 U.S.C. 5106a(d)) is
amended by adding at the end of the following:
``(17) The number of infants--
``(A) identified under subsection
(b)(2)(B)(ii);
``(B) for whom a plan of safe care was
developed under subsection (b)(2)(B)(iii); and
``(C) for whom a referral was made for
appropriate services, including services for
the affected family or caregiver, under
subsection (b)(2)(B)(iii).''.
(2) Redesignation.--Effective on May 29, 2017,
section 106(d) of the Child Abuse Prevention and
Treatment Act (42 U.S.C. 5106a(d)) is amended by
redesignating paragraph (17) (as added by paragraph
(1)) as paragraph (18).
(d) Monitoring and Oversight.--
(1) Amendment.--Title I of the Child Abuse
Prevention and Treatment Act (42 U.S.C. 5101 et seq.)
is amended by adding at the end the following:
``SEC. 114. MONITORING AND OVERSIGHT.
``The Secretary shall conduct monitoring to ensure that
each State that receives a grant under section 106 is in
compliance with the requirements of section 106(b), which--
``(1) shall--
``(A) be in addition to the review of the
State plan upon its submission under section
106(b)(1)(A); and
``(B) include monitoring of State policies
and procedures required under clauses (ii) and
(iii) of section 106(b)(2)(B); and
``(2) may include--
``(A) a comparison of activities carried
out by the State to comply with the
requirements of section 106(b) with the State
plan most recently approved under section 432
of the Social Security Act;
``(B) a review of information available on
the website of the State relating to its
compliance with the requirements of section
106(b);
``(C) site visits, as may be necessary to
carry out such monitoring; and
``(D) a review of information available in
the State's Annual Progress and Services Report
most recently submitted under section 1357.16
of title 45, Code of Federal Regulations (or
successor regulations).''.
(2) Table of contents.--The table of contents in
section 1(b) of the Child Abuse Prevention and
Treatment Act (42 U.S.C. 5101 note) is amended by
inserting after the item relating to section 113, the
following:
``Sec. 114. Monitoring and oversight.''.
(e) Rule of Construction.--Nothing in this section, or the
amendments made by this section, shall be construed to
authorize the Secretary of Health and Human Services or any
other officer of the Federal Government to add new requirements
to section 106(b) of the Child Abuse Prevention and Treatment
Act (42 U.S.C. 5106a(b)), as amended by this section.
SEC. 504. GAO REPORT ON NEONATAL ABSTINENCE SYNDROME (NAS).
(a) In General.--Not later than 1 year after the date of
the enactment of this Act, 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
Finance and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on neonatal abstinence syndrome
(in this section referred to as ``NAS'') in the United States.
(b) Information To Be Included in Report.--Such report
shall include information on the following:
(1) The prevalence of NAS in the United States,
including the proportion of children born in the United
States with NAS who are eligible for medical assistance
under State Medicaid programs under title XIX of the
Social Security Act (42 U.S.C. 1396 et seq.) at birth,
and the costs associated with coverage under such
programs for treatment of infants with NAS.
(2) The services for which coverage is available
under State Medicaid programs for treatment of infants
with NAS.
(3) The settings (including inpatient, outpatient,
hospital-based, and other settings) for the treatment
of infants with NAS and the reimbursement methodologies
and costs associated with such treatment in such
settings.
(4) The prevalence of utilization of various care
settings under State Medicaid programs for treatment of
infants with NAS and any Federal barriers to treating
such infants under such programs, particularly in non-
hospital-based settings.
(5) What is known about best practices for treating
infants with NAS.
(c) Recommendations.--Such report also shall include such
recommendations as the Comptroller General determines
appropriate for improvements that will ensure access to
treatment for infants with NAS under State Medicaid programs.
TITLE VI--INCENTIVIZING STATE COMPREHENSIVE INITIATIVES TO ADDRESS
PRESCRIPTION OPIOID ABUSE
SEC. 601. STATE DEMONSTRATION GRANTS FOR COMPREHENSIVE OPIOID ABUSE
RESPONSE.
Part D of title V of the Public Health Service Act (42
U.S.C. 290dd et seq.), as amended by section 302, is further
amended by adding at the end the following:
``SEC. 548. STATE DEMONSTRATION GRANTS FOR COMPREHENSIVE OPIOID ABUSE
RESPONSE.
``(a) Definitions.--In this section:
``(1) Dispenser.--The term `dispenser' has the
meaning given the term in section 102 of the Controlled
Substances Act (21 U.S.C. 802).
``(2) Prescriber.--The term `prescriber' means a
dispenser who prescribes a controlled substance, or the
agent of such a dispenser.
``(3) Prescriber of a schedule ii, iii, or iv
controlled substance.--The term `prescriber of a
schedule II, III, or IV controlled substance' does not
include a prescriber of a schedule II, III, or IV
controlled substance that dispenses the substance--
``(A) for use on the premises on which the
substance is dispensed;
``(B) in a hospital emergency room, when
the substance is in short supply;
``(C) for a certified opioid treatment
program; or
``(D) in other situations as the Secretary
may reasonably determine.
``(4) Schedule ii, iii, or iv controlled
substance.--The term `schedule II, III, or IV
controlled substance' means a controlled substance that
is listed on schedule II, schedule III, or schedule IV
of section 202(c) of the Controlled Substances Act.
``(b) Grants for Comprehensive Opioid Abuse Response.--
``(1) In general.--The Secretary shall award grants
to States, and combinations of States, to implement an
integrated opioid abuse response initiative.
``(2) Purposes.--A State receiving a grant under
this section shall establish a comprehensive response
plan to opioid abuse, which may include--
``(A) education efforts around opioid use,
treatment, and addiction recovery, including
education of residents, medical students, and
physicians and other prescribers of schedule
II, III, or IV controlled substances on
relevant prescribing guidelines, the
prescription drug monitoring program of the
State described in subparagraph (B), and
overdose prevention methods;
``(B) establishing, maintaining, or
improving a comprehensive prescription drug
monitoring program to track dispensing of
schedule II, III, or IV controlled substances,
which may--
``(i) provide for data sharing with
other States; and
``(ii) allow all individuals
authorized by the State to write
prescriptions for schedule II, III, or
IV controlled substances to access the
prescription drug monitoring program of
the State;
``(C) developing, implementing, or
expanding prescription drug and opioid
addiction treatment programs by--
``(i) expanding the availability of
treatment for prescription drug and
opioid addiction, including medication-
assisted treatment and behavioral
health therapy, as appropriate;
``(ii) developing, implementing, or
expanding screening for individuals in
treatment for prescription drug and
opioid addiction for hepatitis C and
HIV, and treating or referring those
individuals if clinically appropriate;
or
``(iii) developing, implementing,
or expanding recovery support services
and programs at high schools or
institutions of higher education;
``(D) developing, implementing, and
expanding efforts to prevent overdose death
from opioid abuse or addiction to prescription
medications and opioids; and
``(E) advancing the education and awareness
of the public, providers, patients, consumers,
and other appropriate entities regarding the
dangers of opioid abuse, safe disposal of
prescription medications, and detection of
early warning signs of opioid use disorders.
``(3) Application.--A State seeking a grant under
this section shall submit to the Secretary an
application in such form, and containing such
information, as the Secretary may reasonably require.
``(4) Use of funds.--A State that receives a grant
under this section shall use the grant for the cost,
including the cost for technical assistance, training,
and administration expenses, of carrying out an
integrated opioid abuse response initiative as outlined
by the State's comprehensive response plan to opioid
abuse established under paragraph (2).
``(5) Priority considerations.--In awarding grants
under this section, the Secretary shall, as
appropriate, give priority to a State that--
``(A)(i) provides civil liability
protection for first responders, health
professionals, and family members who have
received appropriate training in administering
a drug or device approved or cleared under the
Federal Food, Drug, and Cosmetic Act for
emergency treatment of known or suspected
opioid overdose; and
``(ii) submits to the Secretary a
certification by the attorney general of the
State that the attorney general has--
``(I) reviewed any applicable civil
liability protection law to determine
the applicability of the law with
respect to first responders, health
care professionals, family members, and
other individuals who--
``(aa) have received
appropriate training in
administering a drug or device
approved or cleared under the
Federal Food, Drug, and
Cosmetic Act for emergency
treatment of known or suspected
opioid overdose; and
``(bb) may administer a
drug or device approved or
cleared under the Federal Food,
Drug, and Cosmetic Act for
emergency treatment of known or
suspected opioid overdose; and
``(II) concluded that the law
described in subclause (I) provides
adequate civil liability protection
applicable to such persons;
``(B) has a process for enrollment in
services and benefits necessary by criminal
justice agencies to initiate or continue
treatment in the community, under which an
individual who is incarcerated may, while
incarcerated, enroll in services and benefits
that are necessary for the individual to
continue treatment upon release from
incarceration;
``(C) ensures the capability of data
sharing with other States, where applicable,
such as by making data available to a
prescription monitoring hub;
``(D) ensures that data recorded in the
prescription drug monitoring program database
of the State are regularly updated, to the
extent possible;
``(E) ensures that the prescription drug
monitoring program of the State notifies
prescribers and dispensers of schedule II, III,
or IV controlled substances when overuse or
misuse of such controlled substances by
patients is suspected; and
``(F) has in effect one or more statutes or
implements policies that maximize use of
prescription drug monitoring programs by
individuals authorized by the State to
prescribe schedule II, III, or IV controlled
substances.
``(6) Evaluation.--In conducting an evaluation of
the program under this section pursuant to section 701
of the Comprehensive Addiction and Recovery Act of
2016, with respect to a State, the Secretary shall
report on State legislation or policies related to
maximizing the use of prescription drug monitoring
programs and the incidence of opioid use disorders and
overdose deaths in such State.
``(7) States with local prescription drug
monitoring programs.--
``(A) In general.--In the case of a State
that does not have a prescription drug
monitoring program, a county or other unit of
local government within the State that has a
prescription drug monitoring program shall be
treated as a State for purposes of this
section, including for purposes of eligibility
for grants under paragraph (1).
``(B) Plan for interoperability.--In
submitting an application to the Secretary
under paragraph (3), a county or other unit of
local government shall submit a plan outlining
the methods such county or unit of local
government shall use to ensure the capability
of data sharing with other counties and units
of local government within the state and with
other States, as applicable.
``(c) Authorization of Funding.--For the purpose of
carrying out this section, there are authorized to be
appropriated $5,000,000 for each of fiscal years 2017 through
2021.''.
TITLE VII--MISCELLANEOUS
SEC. 701. GRANT ACCOUNTABILITY AND EVALUATIONS.
(a) Department of Justice Grant Accountability.--Part LL of
title I of the Omnibus Crime Control and Safe Streets Act of
1968 (42 U.S.C. 3711 et seq.), as added by section 201, is
amended by adding at the end the following:
``SEC. 3026. GRANT ACCOUNTABILITY.
``(a) Definition of Applicable Committees.--In this
section, the term `applicable committees' means--
``(1) the Committee on the Judiciary of the Senate;
and
``(2) the Committee on the Judiciary of the House
of Representatives.
``(b) Accountability.--All grants awarded by the Attorney
General under this part shall be subject to the following
accountability provisions:
``(1) Audit requirement.--
``(A) Definition.--In this paragraph, the
term `unresolved audit finding' means a finding
in the final audit report of the Inspector
General of the Department of Justice that the
audited grantee has utilized grant funds for an
unauthorized expenditure or otherwise
unallowable cost that is not closed or resolved
within 12 months after the date on which the
final audit report is issued.
``(B) Audit.--Beginning in the first fiscal
year beginning after the date of enactment of
this section, and in each fiscal year
thereafter, the Inspector General of the
Department of Justice shall conduct audits of
recipients of grants awarded by the Attorney
General under this part to prevent waste,
fraud, and abuse of funds by grantees. The
Inspector General shall determine the
appropriate number of grantees to be audited
each year.
``(C) Mandatory exclusion.--A recipient of
grant funds under this part that is found to
have an unresolved audit finding shall not be
eligible to receive grant funds under this part
during the first 2 fiscal years beginning after
the end of the 12-month period described in
subparagraph (A).
``(D) Priority.--In awarding grants under
this part, the Attorney General shall give
priority to eligible applicants that did not
have an unresolved audit finding during the 3
fiscal years before submitting an application
for a grant under this part.
``(E) Reimbursement.--If an entity is
awarded grant funds under this part during the
2-fiscal-year period during which the entity is
barred from receiving grants under subparagraph
(C), the Attorney General shall--
``(i) deposit an amount equal to
the amount of the grant funds that were
improperly awarded to the grantee into
the General Fund of the Treasury; and
``(ii) seek to recoup the costs of
the repayment to the fund from the
grant recipient that was erroneously
awarded grant funds.
``(2) Nonprofit organization requirements.--
``(A) Definition.--For purposes of this
paragraph and the grant programs under this
part, the term `nonprofit organization' means
an organization that is described in section
501(c)(3) of the Internal Revenue Code of 1986
and is exempt from taxation under section
501(a) of such Code.
``(B) Prohibition.--A nonprofit
organization that holds money in offshore
accounts for the purpose of avoiding paying the
tax described in section 511(a) of the Internal
Revenue Code of 1986 may not--
``(i) be party to a contract
entered into under section 3021(b); or
``(ii) receive a subaward under
section 3021(b).
``(C) Disclosure.--Each nonprofit
organization that receives a subaward or is
party to a contract entered into under section
3021(b) and uses the procedures prescribed in
regulations to create a rebuttable presumption
of reasonableness for the compensation of its
officers, directors, trustees, and key
employees, shall disclose, in the application
for such contract or subaward, the process for
determining such compensation, including the
independent persons involved in reviewing and
approving such compensation, the comparability
data used, and contemporaneous substantiation
of the deliberation and decision. Upon request,
the Attorney General shall make the information
disclosed under this subparagraph available for
public inspection.
``(3) Conference expenditures.--
``(A) Limitation.--No amounts made
available to the Attorney General under this
part may be used by the Attorney General, or by
any State, unit of local government, or entity
awarded a grant, subaward, or contract under
this part, to host or support any expenditure
for conferences that uses more than $20,000 in
funds made available by the Attorney General,
unless the head of the relevant agency, bureau,
or program office provides prior written
authorization that the funds may be expended to
host or support the conference.
``(B) Written authorization.--Written
authorization under subparagraph (A) shall
include a written estimate of all costs
associated with the conference, including the
cost of all food, beverages, audio-visual
equipment, honoraria for speakers, and
entertainment.
``(C) Report.--The Deputy Attorney General
shall submit to the applicable committees an
annual report on all conference expenditures
approved by the Attorney General under this
paragraph.
``(4) Annual certification.--Beginning in the first
fiscal year beginning after the date of enactment of
this section, the Attorney General shall submit to the
applicable committees an annual certification--
``(A) indicating whether--
``(i) all audits issued by the
Inspector General of the Department of
Justice under paragraph (1) have been
completed and reviewed by the
appropriate Assistant Attorney General
or Director;
``(ii) all mandatory exclusions
required under paragraph (1)(C) have
been issued; and
``(iii) all reimbursements required
under paragraph (1)(E) have been made;
and
``(B) that includes a list of any grant
recipients excluded under paragraph (1) from
the previous year.
``(c) Preventing Duplicative Grants.--
``(1) In general.--Before the Attorney General
awards a grant to an applicant under this part, the
Attorney General shall compare potential grant awards
with other grants awarded under this part by the
Attorney General to determine if duplicate grant awards
are awarded for the same purpose.
``(2) Report.--If the Attorney General awards
duplicate grants under this part to the same applicant
for the same purpose, the Attorney General shall submit
to the applicable committees a report that includes--
``(A) a list of all duplicate grants
awarded under this part, including the total
dollar amount of any duplicate grants awarded;
and
``(B) the reason the Attorney General
awarded the duplicate grants.''.
(b) Evaluation of Performance of Department of Justice
Programs.--
(1) Evaluation of justice department comprehensive
opioid abuse grant program.--Not later than 5 years
after the date of enactment of this Act, the Attorney
General shall complete an evaluation of the
effectiveness of the Comprehensive Opioid Abuse Grant
Program under part LL of title I of the Omnibus Crime
Control and Safe Streets Act of 1968, as added by
section 201, administered by the Department of Justice
based upon the information reported under paragraph
(4).
(2) Interim evaluation.--Not later than 3 years
after the date of enactment of this Act, the Attorney
General shall complete an interim evaluation assessing
the nature and extent of the incidence of opioid abuse
and illegal opioid distribution in the United States.
(3) Metrics and outcomes for evaluation.--Not later
than 180 days after the date of enactment of this Act,
the Attorney General shall identify outcomes that are
to be achieved by activities funded by the
Comprehensive Opioid Abuse Grant Program and the
metrics by which the achievement of such outcomes shall
be determined.
(4) Metrics data collection.--The Attorney General
shall require grantees under the Comprehensive Opioid
Abuse Grant Program (and those receiving subawards
under section 3021(b) of part LL of title I of the
Omnibus Crime Control and Safe Streets Act of 1968, as
added by section 201) to collect and annually report to
the Department of Justice data based upon the metrics
identified under paragraph (3).
(5) Publication of data and findings.--
(A) Publication of outcomes and metrics.--
The Attorney General shall, not later than 30
days after completion of the requirement under
paragraph (3), publish the outcomes and metrics
identified under that paragraph.
(B) Publication of evaluation.--In the case
of the interim evaluation under paragraph (2),
and the final evaluation under paragraph (1),
the entity conducting the evaluation shall, not
later than 90 days after such an evaluation is
completed, publish the results of such
evaluation and issue a report on such
evaluation to the Committee on the Judiciary of
the House of Representatives and the Committee
on the Judiciary of the Senate. Such report
shall also be published along with the data
used to make such evaluation.
(6) Independent evaluation.--For purposes of
paragraphs (1), (2), and (3), the Attorney General
shall--
(A) enter into an arrangement with the
National Academy of Sciences; or
(B) enter into a contract or cooperative
agreement with an entity that is not an agency
of the Federal Government, and is qualified to
conduct and evaluate research pertaining to
opioid use and abuse, and draw conclusions
about overall opioid use and abuse on the basis
of that research.
(c) Department of Health and Human Services Grant
Accountability.--
(1) Definitions.--In this subsection:
(A) Applicable committees.--The term
``applicable committees'' means--
(i) the Committee on Health,
Education, Labor and Pensions of the
Senate; and
(ii) the Committee on Energy and
Commerce of the House of
Representatives.
(B) Covered grant.--The term ``covered
grant'' means a grant awarded by the Secretary
under a program established under this Act (or
an amendment made by this Act, other than
sections 703 through 707), including any grant
administered by the Administrator of the
Substance Abuse and Mental Health Services
Administration under section 103.
(C) Grantee.--The term ``grantee'' means
the recipient of a covered grant.
(D) Secretary.--The term ``Secretary''
means the Secretary of Health and Human
Services.
(2) Accountability measures.--Each covered grant
shall be subject to the following accountability
requirements:
(A) Effectiveness report.--The Secretary
shall require grantees to report on the
effectiveness of the activities carried out
with amounts made available to carry out the
program under which the covered grant is
awarded, including the number of persons served
by such grant, if applicable, the number of
persons seeking services who could not be
served by such grant, and such other
information as the Secretary may prescribe.
(B) Report on prevention of fraud, waste,
and abuse.--
(i) In general.--Not later than 1
year after the date of the enactment of
this Act, the Secretary, in
coordination with the Inspector General
of the Department of Health and Human
Services, shall submit to the
applicable committees a report on the
policies and procedures the Department
has in place to prevent waste, fraud,
and abuse in the administration of
covered grants.
(ii) Contents.--The policies and
procedures referred to in clause (i)
shall include policies and procedures
that are designed to--
(I) prevent grantees from
utilizing funds awarded through
a covered grant for
unauthorized expenditures or
otherwise unallowable costs;
and
(II) ensure grantees will
not receive unwarranted
duplicate grants for the same
purpose.
(C) Conference expenditures.--
(i) In general.--No amounts made
available to the Secretary under this
Act (or in a provision of law amended
by this Act, other than sections 703
through 707) may be used by the
Secretary, or by any individual or
entity awarded discretionary funds
through a cooperative agreement under a
program established under this Act (or
in a provision of law amended by this
Act), to host or support any
expenditure for conferences that uses
more than $20,000 in funds made
available by the Secretary, unless the
head of the relevant operating division
or program office provides prior
written authorization that the funds
may be expended to host or support the
conference. Such written authorization
shall include a written estimate of all
costs associated with the conference,
including the cost of all food,
beverages, audio-visual equipment,
honoraria for speakers, and
entertainment.
(ii) Report.--The Secretary (or the
Secretary's designee) shall submit to
the applicable committees an annual
report on all conference expenditures
approved by the Secretary under this
subparagraph.
(d) Evaluation of Performance of Department of Health and
Human Services Programs.--
(1) Evaluations.--
(A) In general.--Not later than 5 years
after the date of enactment of this Act, except
as otherwise provided in this section, the
Secretary of Health and Human Services (in this
subsection referred to as the ``Secretary'')
shall complete an evaluation of any program
administered by the Secretary included in this
Act (or an amendment made by this Act,
excluding sections 703 through 707), including
any grant administered by the Administrator of
the Substance Abuse and Mental Health Services
Administration under section 103, that provides
grants for the primary purpose of providing
assistance in addressing problems pertaining to
opioid abuse based upon the outcomes and
metrics identified under paragraph (2).
(B) Publication.--With respect to each
evaluation completed under subparagraph (A),
the Secretary shall, not later than 90 days
after the date on which such evaluation is
completed, publish the results of such
evaluation and issue a report on such
evaluation to the appropriate committees. Such
report shall also be published along with the
data used to make such evaluation.
(2) Metrics and outcomes.--
(A) In general.--Not later than 180 days
after the date of enactment of this Act, the
Secretary shall identify--
(i) outcomes that are to be
achieved by activities funded by the
programs described in paragraph (1)(A);
and
(ii) the metrics by which the
achievement of such outcomes shall be
determined.
(B) Publication.--The Secretary shall, not
later than 30 days after completion of the
requirement under subparagraph (A), publish the
outcomes and metrics identified under such
subparagraph.
(3) Metrics data collection.--The Secretary shall
require grantees under the programs described in
paragraph (1)(A) to collect, and annually report to the
Secretary, data based upon the metrics identified under
paragraph (2)(A).
(4) Independent evaluation.--For purposes of
paragraph (1), the Secretary shall--
(A) enter into an arrangement with the
National Academy of Sciences; or
(B) enter into a contract or cooperative
agreement with an entity that--
(i) is not an agency of the Federal
Government; and
(ii) is qualified to conduct and
evaluate research pertaining to opioid
use and abuse and draw conclusions
about overall opioid use and abuse on
the basis of that research.
(5) Exception.--If a program described in paragraph
(1)(A) is subject to an evaluation similar to the
evaluation required under such paragraph pursuant to
another provision of Federal law, the Secretary may opt
not to conduct an evaluation under such paragraph with
respect to such program.
(e) Additional Report.--In the case of a report submitted
under subsection (c) to the applicable committees, if such
report pertains to a grant under section 103, that report shall
also be submitted, in the same manner and at the same time, to
the Committee on Oversight and Government Reform of the House
of Representatives and to the Committee on the Judiciary of the
Senate.
(f) No Additional Funds Authorized.--No additional funds
are authorized to be appropriated to carry out this section.
SEC. 702. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES.
(a) In General.--Section 309 of the Controlled Substances
Act (21 U.S.C. 829) is amended by adding at the end the
following:
``(f) Partial Fills of Schedule II Controlled Substances.--
``(1) Partial fills.--A prescription for a
controlled substance in schedule II may be partially
filled if--
``(A) it is not prohibited by State law;
``(B) the prescription is written and
filled in accordance with this title,
regulations prescribed by the Attorney General,
and State law;
``(C) the partial fill is requested by the
patient or the practitioner that wrote the
prescription; and
``(D) the total quantity dispensed in all
partial fillings does not exceed the total
quantity prescribed.
``(2) Remaining portions.--
``(A) In general.--Except as provided in
subparagraph (B), remaining portions of a
partially filled prescription for a controlled
substance in schedule II--
``(i) may be filled; and
``(ii) shall be filled not later
than 30 days after the date on which
the prescription is written.
``(B) Emergency situations.--In emergency
situations, as described in subsection (a), the
remaining portions of a partially filled
prescription for a controlled substance in
schedule II--
``(i) may be filled; and
``(ii) shall be filled not later
than 72 hours after the prescription is
issued.
``(3) Currently lawful partial fills.--
Notwithstanding paragraph (1) or (2), in any
circumstance in which, as of the day before the date of
enactment of this subsection, a prescription for a
controlled substance in schedule II may be lawfully
partially filled, the Attorney General may allow such a
prescription to be partially filled.''.
(b) Rule of Construction.--Nothing in this section shall be
construed to affect the authority of the Attorney General to
allow a prescription for a controlled substance in schedule
III, IV, or V of section 202(c) of the Controlled Substances
Act (21 U.S.C. 812(c)) to be partially filled.
SEC. 703. GOOD SAMARITAN ASSESSMENT.
(a) Finding.--The Congress finds that the executive branch,
including the Office of National Drug Control Policy, has a
policy focus on preventing and addressing prescription drug
misuse and heroin use, and has worked with States and
municipalities to enact Good Samaritan laws that would protect
caregivers, law enforcement personnel, and first responders who
administer opioid overdose reversal drugs or devices.
(b) GAO Study on Good Samaritan Laws Pertaining to
Treatment of Opioid Overdoses.--The Comptroller General of the
United States shall submit to the Committee on the Judiciary of
the House of Representatives, the Committee on Oversight and
Government Reform of the House of Representatives, the
Committee on the Judiciary of the Senate, and the Committee on
Homeland Security and Governmental Affairs of the Senate a
report on--
(1) the extent to which the Director of National
Drug Control Policy has reviewed Good Samaritan laws,
and any findings from such a review, including findings
related to the potential effects of such laws, if
available;
(2) efforts by the Director to encourage the
enactment of Good Samaritan laws; and
(3) a compilation of Good Samaritan laws in effect
in the States, the territories, and the District of
Columbia.
(c) Definitions.--In this section--
(1) the term ``Good Samaritan law'' means a law of
a State or unit of local government that exempts from
criminal or civil liability any individual who
administers an opioid overdose reversal drug or device,
or who contacts emergency services providers in
response to an overdose; and
(2) the term ``opioid'' means any drug, including
heroin, having an addiction-forming or addiction-
sustaining liability similar to morphine or being
capable of conversion into a drug having such
addiction-forming or addiction-sustaining liability.
SEC. 704. 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 30 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 that indicate misuse
or abuse of prescription drugs
described in subparagraph (G)
and that are developed by the
Secretary in consultation with
PDP sponsors and other
stakeholders, including
individuals entitled to
benefits under part A or
enrolled under part B, advocacy
groups representing such
individuals, physicians,
pharmacists, and other
clinicians, retail pharmacies,
plan sponsors, entities
delegated by plan sponsors, and
biopharmaceutical
manufacturers; 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 a
facility described in section
1905(d), 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).
``(iii) Program size.--The
Secretary shall establish policies,
including the guidelines developed
under clause (i)(I) and the exemptions
under clause (ii)(III), to ensure that
the population of enrollees in a drug
management program for at-risk
beneficiaries operated by a
prescription drug plan can be
effectively managed by such plans.
``(iv) Clinical contact.--With
respect to each at-risk beneficiary for
prescription drug abuse enrolled in a
prescription drug plan offered by a PDP
sponsor, the PDP sponsor shall contact
the beneficiary's providers who have
prescribed frequently abused drugs
regarding whether prescribed
medications are appropriate for such
beneficiary's medical conditions.
``(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, if the PDP
sponsor reasonably determines
it necessary to provide the
beneficiary with reasonable
access under clause (ii), more
than one, individual who is
authorized to prescribe
frequently abused drugs
(referred to in this paragraph
as a `prescriber') who may
write prescriptions for such
drugs for such beneficiary; and
``(II) one, or, if the PDP
sponsor reasonably determines
it necessary to provide the
beneficiary with reasonable
access under clause (ii), more
than one, pharmacy that may
dispense such drugs to such
beneficiary.
For purposes of subclause (II), in the
case of a pharmacy that has multiple
locations that share real-time
electronic data, all such locations of
the pharmacy shall collectively be
treated as one pharmacy.
``(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, in the
case of natural disasters and
similar situations, and in the
case of the provision of
emergency services.
``(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). If the PDP
sponsor changes the selection pursuant
to the preceding sentence, the PDP
sponsor shall provide the beneficiary
with--
``(I) at least 30 days
written notice of the change of
selection; and
``(II) a rationale for the
change.
``(v) Confirmation.--Before
selecting a prescriber or pharmacy
under this subparagraph, a PDP sponsor
must notify the prescriber and pharmacy
that the beneficiary involved has been
identified for inclusion in the drug
management program for at-risk
beneficiaries and that the prescriber
and pharmacy has been selected as the
beneficiary's designated prescriber and
pharmacy.
``(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, the selection of prescriber or
pharmacy under subparagraph (D), and
information to be shared under subparagraph
(I), 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.--
``(i) Data on decision to impose
limitation.--In the case of an at-risk
beneficiary for prescription drug abuse
(or an individual who is a potentially
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,
the Secretary shall establish rules and
procedures to require the PDP sponsor
to 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.
``(ii) Data to reduce fraud, abuse,
and waste.--The Secretary shall
establish rules and procedures to
require PDP sponsors operating a drug
management program for at-risk
beneficiaries under this paragraph to
provide the Secretary with such data as
the Secretary determines appropriate
for purposes of identifying patterns of
prescription drug utilization for plan
enrollees that are outside normal
patterns and that may indicate
fraudulent, medically unnecessary, or
unsafe use.
``(I) Sharing of information for subsequent
plan enrollments.--The Secretary shall
establish procedures under which PDP sponsors
who offer prescription drug plans shall share
information with respect to individuals who are
at-risk beneficiaries for prescription drug
abuse (or individuals who are potentially at-
risk beneficiaries for prescription drug abuse)
and enrolled in a prescription drug plan and
who subsequently disenroll from such plan and
enroll in another prescription drug plan
offered by another PDP sponsor.
``(J) Privacy issues.--Prior to the
implementation of the rules and procedures
under this paragraph, the Secretary shall
clarify privacy requirements, including
requirements under the regulations promulgated
pursuant to section 264(c) of the Health
Insurance Portability and Accountability Act of
1996 (42 U.S.C. 1320d-2 note), related to the
sharing of data under subparagraphs (H) and (I)
by PDP sponsors. Such clarification shall
provide that the sharing of such data shall be
considered to be protected health information
in accordance with the requirements of the
regulations promulgated pursuant to such
section 264(c).
``(K) 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.
``(L) 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.
``(M) CMS compliance review.--The Secretary
shall ensure that existing plan sponsor
compliance reviews and audit processes include
the drug management programs for at-risk
beneficiaries under this paragraph, including
appeals processes under such programs.''.
(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).''.
(3) Dual eligibles.--Section 1860D-1(b)(3)(D) of
the Social Security Act (42 U.S.C. 1395w-101(b)(3)(D))
is amended by inserting ``, subject to such limits as
the Secretary may establish for individuals identified
pursuant to section 1860D-4(c)(5)'' after ``the
Secretary''.
(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) CMS compliance review.--The Secretary
shall ensure that plan sponsor compliance
reviews and program audits biennially include a
certification that utilization management tools
under this paragraph are in compliance with the
requirements for such tools.''.
(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
in 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 24 months 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) Reports.--
(1) Report by secretary on appeals process.--
(A) In general.--Not later than 12 months
after the date of the enactment of this Act,
the Secretary of Health and Human Services
shall submit to the appropriate committees of
jurisdiction of Congress a report on ways to
improve upon the appeals process for Medicare
beneficiaries with respect to prescription drug
coverage under part D of title XVIII of the
Social Security Act. Such report shall include
an analysis comparing appeals processes under
parts C and D of such title XVIII.
(B) Feedback.--In development of the report
described in subparagraph (A), the Secretary of
Health and Human Services shall solicit
feedback on the current appeals process from
stakeholders, such as beneficiaries, consumer
advocates, plan sponsors, pharmacy benefit
managers, pharmacists, providers, independent
review entity evaluators, and pharmaceutical
manufacturers.
(2) GAO study and report.--
(A) Study.--The Comptroller General of the
United States shall conduct a study on the
implementation of the amendments made by this
section, including the effectiveness of the at-
risk beneficiaries for prescription drug abuse
drug management programs authorized by section
1860D-4(c)(5) of the Social Security Act (42
U.S.C. 1395w-10(c)(5)), as added by subsection
(a)(1). Such study shall include an analysis
of--
(i) the impediments, if any, that
impair the ability of individuals
described in subparagraph (C) of such
section 1860D-4(c)(5) to access
clinically appropriate levels of
prescription drugs;
(ii) the effectiveness of the
reasonable access protections under
subparagraph (D)(ii) of such section
1860D-4(c)(5), including the impact on
beneficiary access and health;
(iii) the types of--
(I) individuals who, in the
implementation of such section,
are determined to be
individuals described in such
subparagraph (C); and
(II) prescribers and
pharmacies that are selected
under subparagraph (D) of such
section; and
(iv) other areas determined
appropriate by the Comptroller General.
(B) Report.--Not later than July 1, 2019,
the Comptroller General of the United States
shall submit to the appropriate committees of
jurisdiction of Congress a report on the study
conducted under subparagraph (A), together with
recommendations for such legislation and
administrative action as the Comptroller
General determines to be appropriate.
(g) Effective Date; Rulemaking.--
(1) In general.--The amendments made by this
section shall apply to prescription drug plans (and MA-
PD plans) for plan years beginning on or after January
1, 2019.
(2) Stakeholder meetings prior to effective date.--
(A) In general.--Not later than January 1,
2017, 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, 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). The input described in the preceding
sentence shall be provided to the Secretary in
sufficient time in order for the Secretary to
take such input into account in promulgating
the regulations pursuant to paragraph (3).
(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;
(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;
(vii) notices for plan enrollees at
the point of sale that would explain
why an at-risk beneficiary has been
prohibited from receiving a
prescription at a location outside of
the designated pharmacy;
(viii) evidence-based prescribing
guidelines for opiates; and
(ix) the sharing of claims data
under parts A and B of title XVIII of
the Social Security Act with PDP
sponsors.
(3) Rulemaking.--Not later than one year after the
date of the enactment of this Act, the Secretary of
Health and Human Services shall, taking into account
the input gathered pursuant to paragraph (2)(A) and
after providing notice and an opportunity to comment,
promulgate regulations to carry out the provisions of,
and amendments made by this section.
(h) Deposit of Savings Into Medicare Improvement Fund.--
Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)) is amended by striking ``during and after fiscal
year 2020, $0'' and inserting ``during and after fiscal year
2021, $140,000,000''.
SEC. 705. EXCLUDING ABUSE-DETERRENT FORMULATIONS OF PRESCRIPTION DRUGS
FROM THE MEDICAID ADDITIONAL REBATE REQUIREMENT FOR
NEW FORMULATIONS OF PRESCRIPTION DRUGS.
(a) In General.--The last sentence of section 1927(c)(2)(C)
of the Social Security Act (42 U.S.C. 1396r-8(c)(2)(C)) is
amended by inserting before the period at the end the
following: ``, but does not include an abuse-deterrent
formulation of the drug (as determined by the Secretary),
regardless of whether such abuse-deterrent formulation is an
extended release formulation''.
(b) Effective Date.--The amendment made by subsection (a)
shall apply to drugs that are paid for by a State in calendar
quarters beginning on or after the date of the enactment of
this Act.
SEC. 706. LIMITING DISCLOSURE OF PREDICTIVE MODELING AND OTHER
ANALYTICS TECHNOLOGIES TO IDENTIFY AND PREVENT
WASTE, FRAUD, AND ABUSE.
(a) In General.--Title XI of the Social Security Act is
amended by inserting after section 1128J (42 U.S.C. 1320a-7k)
the following new section:
``SEC. 1128K. DISCLOSURE OF PREDICTIVE MODELING AND OTHER ANALYTICS
TECHNOLOGIES TO IDENTIFY AND PREVENT WASTE, FRAUD,
AND ABUSE.
``(a) Reference to Predictive Modeling Technologies
Requirements.--For provisions relating to the use of predictive
modeling and other analytics technologies to identify and
prevent waste, fraud, and abuse with respect to the Medicare
program under title XVIII, the Medicaid program under title
XIX, and the Children's Health Insurance Program under title
XXI, see section 4241 of the Small Business Jobs Act of 2010
(42 U.S.C. 1320a-7m).
``(b) Limiting Disclosure of Predictive Modeling
Technologies.--In implementing such provisions under such
section 4241 with respect to covered algorithms (as defined in
subsection (c)), the following shall apply:
``(1) Nonapplication of foia.--The covered
algorithms used or developed for purposes of such
section 4241 (including by the Secretary or a State (or
an entity operating under a contract with a State))
shall be exempt from disclosure under section 552(b)(3)
of title 5, United States Code.
``(2) Limitation with respect to use and disclosure
of information by state agencies.--
``(A) In general.--A State agency may not
use or disclose covered algorithms used or
developed for purposes of such section 4241
except for purposes of administering the State
plan (or a waiver of the plan) under the
Medicaid program under title XIX or the State
child health plan (or a waiver of the plan)
under the Children's Health Insurance Program
under title XXI, including by enabling an
entity operating under a contract with a State
to assist the State to identify or prevent
waste, fraud, and abuse with respect to such
programs.
``(B) Information security.--A State agency
shall have in effect data security and control
policies that the Secretary finds adequate to
ensure the security of covered algorithms used
or developed for purposes of such section 4241
and to ensure that access to such information
is restricted to authorized persons for
purposes of authorized uses and disclosures
described in subparagraph (A).
``(C) Procedural requirements.--State
agencies to which information is disclosed
pursuant to such section 4241 shall adhere to
uniform procedures established by the
Secretary.
``(c) Covered Algorithm Defined.--In this section, the term
`covered algorithm'--
``(1) means a predictive modeling or other
analytics technology, as used for purposes of section
4241(a) of the Small Business Jobs Act of 2010 (42
U.S.C. 1320a-7m(a)) to identify and prevent waste,
fraud, and abuse with respect to the Medicare program
under title XVIII, the Medicaid program under title
XIX, and the Children's Health Insurance Program under
title XXI; and
``(2) includes the mathematical expressions
utilized in the application of such technology and the
means by which such technology is developed.''.
(b) Conforming Amendments.--
(1) Medicaid state plan requirement.--Section
1902(a) of the Social Security Act (42 U.S.C. 1396a(a))
is amended--
(A) in paragraph (80), by striking ``and''
at the end;
(B) in paragraph (81), by striking the
period at the end and inserting ``; and''; and
(C) by inserting after paragraph (81) the
following new paragraph:
``(82) provide that the State agency responsible
for administering the State plan under this title
provides assurances to the Secretary that the State
agency is in compliance with subparagraphs (A), (B),
and (C) of section 1128K(b)(2).''.
(2) State child health plan requirement.--Section
2102(a)(7) of the Social Security Act (42 U.S.C.
1397bb(a)(7)) is amended--
(A) in subparagraph (A), by striking ``,
and'' at the end and inserting a semicolon;
(B) in subparagraph (B), by striking the
period at the end and inserting ``; and''; and
(C) by adding at the end the following new
subparagraph:
``(C) to ensure that the State agency
involved is in compliance with subparagraphs
(A), (B), and (C) of section 1128K(b)(2).''.
SEC. 707. MEDICAID IMPROVEMENT FUND.
Section 1941(b)(1) of the Social Security Act (42 U.S.C.
1396w-1(b)(1)) is amended to read as follows:
``(1) In general.--There shall be available to the
Fund, for expenditures from the Fund for fiscal year
2021 and thereafter, $5,000,000.''.
SEC. 708. SENSE OF THE CONGRESS REGARDING TREATMENT OF SUBSTANCE ABUSE
EPIDEMICS.
It is the sense of the Congress that decades of experience
and research have demonstrated that a fiscally responsible
approach to addressing the opioid abuse epidemic and other
substance abuse epidemics requires treating such epidemics as a
public health emergency emphasizing prevention, treatment, and
recovery.
TITLE VIII--KINGPIN DESIGNATION IMPROVEMENT
SEC. 801. PROTECTION OF CLASSIFIED INFORMATION IN FEDERAL COURT
CHALLENGES RELATING TO DESIGNATIONS UNDER THE
NARCOTICS KINGPIN DESIGNATION ACT.
Section 804 of the Foreign Narcotics Kingpin Designation
Act (21 U.S.C. 1903) is amended by adding at the end the
following:
``(i) Protection of Classified Information in Federal Court
Challenges Relating to Designations.--In any judicial review of
a determination made under this section, if the determination
was based on classified information (as defined in section 1(a)
of the Classified Information Procedures Act) such information
may be submitted to the reviewing court ex parte and in camera.
This subsection does not confer or imply any right to judicial
review.''.
TITLE IX--DEPARTMENT OF VETERANS AFFAIRS
SEC. 901. SHORT TITLE.
This title may be cited as the ``Jason Simcakoski Memorial
and Promise Act''.
SEC. 902. DEFINITIONS.
In this title:
(1) The term ``controlled substance'' has the
meaning given that term in section 102 of the
Controlled Substances Act (21 U.S.C. 802).
(2) The term ``State'' means each of the several
States, territories, and possessions of the United
States, the District of Columbia, and the Commonwealth
of Puerto Rico.
(3) The term ``complementary and integrative
health'' has the meaning given that term, or any
successor term, by the National Institutes of Health.
(4) The term ``opioid receptor antagonist'' means a
drug or device approved or cleared under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
for emergency treatment of known or suspected opioid
overdose.
Subtitle A--Opioid Therapy and Pain Management
SEC. 911. IMPROVEMENT OF OPIOID SAFETY MEASURES BY DEPARTMENT OF
VETERANS AFFAIRS.
(a) Expansion of Opioid Safety Initiative.--
(1) Inclusion of all medical facilities.--Not later
than 180 days after the date of the enactment of this
Act, the Secretary of Veterans Affairs shall expand the
Opioid Safety Initiative of the Department of Veterans
Affairs to include all medical facilities of the
Department.
(2) Guidance.--The Secretary shall establish
guidance that each health care provider of the
Department of Veterans Affairs, before initiating
opioid therapy to treat a patient as part of the
comprehensive assessment conducted by the health care
provider, use the Opioid Therapy Risk Report tool of
the Department of Veterans Affairs (or any subsequent
tool), which shall include information from the
prescription drug monitoring program of each
participating State as applicable, that includes the
most recent information to date relating to the patient
that accessed such program to assess the risk for
adverse outcomes of opioid therapy for the patient,
including the concurrent use of controlled substances
such as benzodiazepines, as part of the comprehensive
assessment conducted by the health care provider.
(3) Enhanced standards.--The Secretary shall
establish enhanced standards with respect to the use of
routine and random urine drug tests for all patients
before and during opioid therapy to help prevent
substance abuse, dependence, and diversion, including--
(A) that such tests occur not less
frequently than once each year or as otherwise
determined according to treatment protocols;
and
(B) that health care providers
appropriately order, interpret and respond to
the results from such tests to tailor pain
therapy, safeguards, and risk management
strategies to each patient.
(b) Pain Management Education and Training.--
(1) In general.--In carrying out the Opioid Safety
Initiative of the Department, the Secretary shall
require all employees of the Department responsible for
prescribing opioids to receive education and training
described in paragraph (2).
(2) Education and training.--Education and training
described in this paragraph is education and training
on pain management and safe opioid prescribing
practices for purposes of safely and effectively
managing patients with chronic pain, including
education and training on the following:
(A) The implementation of and full
compliance with the VA/DOD Clinical Practice
Guideline for Management of Opioid Therapy for
Chronic Pain, including any update to such
guideline.
(B) The use of evidence-based pain
management therapies and complementary and
integrative health services, including
cognitive-behavioral therapy, non-opioid
alternatives, and non-drug methods and
procedures to managing pain and related health
conditions including, to the extent
practicable, medical devices approved or
cleared by the Food and Drug Administration for
the treatment of patients with chronic pain and
related health conditions.
(C) Screening and identification of
patients with substance use disorder, including
drug-seeking behavior, before prescribing
opioids, assessment of risk potential for
patients developing an addiction, and referral
of patients to appropriate addiction treatment
professionals if addiction is identified or
strongly suspected.
(D) Communication with patients on the
potential harm associated with the use of
opioids and other controlled substances,
including the need to safely store and dispose
of supplies relating to the use of opioids and
other controlled substances.
(E) Such other education and training as
the Secretary considers appropriate to ensure
that veterans receive safe and high-quality
pain management care from the Department.
(3) Use of existing program.--In providing
education and training described in paragraph (2), the
Secretary shall use the Interdisciplinary Chronic Pain
Management Training Team Program of the Department (or
successor program).
(c) Pain Management Teams.--
(1) In general.--In carrying out the Opioid Safety
Initiative of the Department, the director of each
medical facility of the Department shall identify and
designate a pain management team of health care
professionals, which may include board certified pain
medicine specialists, responsible for coordinating and
overseeing pain management therapy at such facility for
patients experiencing acute and chronic pain that is
non-cancer related.
(2) Establishment of protocols.--
(A) In general.--In consultation with the
Directors of each Veterans Integrated Service
Network, the Secretary shall establish standard
protocols for the designation of pain
management teams at each medical facility
within the Department.
(B) Consultation on prescription of
opioids.--Each protocol established under
subparagraph (A) shall ensure that any health
care provider without expertise in prescribing
analgesics or who has not completed the
education and training under subsection (b),
including a mental health care provider, does
not prescribe opioids to a patient unless that
health care provider--
(i) consults with a health care
provider with pain management expertise
or who is on the pain management team
of the medical facility; and
(ii) refers the patient to the pain
management team for any subsequent
prescriptions and related therapy.
(3) Report.--
(A) In general.--Not later than one year
after the date of enactment of this Act, the
director of each medical facility of the
Department shall submit to the Under Secretary
for Health and the director of the Veterans
Integrated Service Network in which the medical
facility is located a report identifying the
health care professionals that have been
designated as members of the pain management
team at the medical facility pursuant to
paragraph (1).
(B) Elements.--Each report submitted under
subparagraph (A) with respect to a medical
facility of the Department shall include--
(i) a certification as to whether
all members of the pain management team
at the medical facility have completed
the education and training required
under subsection (b);
(ii) a plan for the management and
referral of patients to such pain
management team if health care
providers without expertise in
prescribing analgesics prescribe opioid
medications to treat acute and chronic
pain that is non-cancer related; and
(iii) a certification as to whether
the medical facility--
(I) fully complies with the
stepped-care model, or
successor models, of pain
management and other pain
management policies of the
Department; or
(II) does not fully comply
with such stepped-care model,
or successor models, of pain
management and other pain
management policies but is
carrying out a corrective plan
of action to ensure such full
compliance.
(d) Tracking and Monitoring of Opioid Use.--
(1) Prescription drug monitoring programs of
states.--In carrying out the Opioid Safety Initiative
and the Opioid Therapy Risk Report tool of the
Department, the Secretary shall--
(A) ensure access by health care providers
of the Department to information on controlled
substances, including opioids and
benzodiazepines, prescribed to veterans who
receive care outside the Department through the
prescription drug monitoring program of each
State with such a program, including by seeking
to enter into memoranda of understanding with
States to allow shared access of such
information between States and the Department;
(B) include such information in the Opioid
Therapy Risk Report tool; and
(C) require health care providers of the
Department to submit to the prescription drug
monitoring program of each State with such a
program information on prescriptions of
controlled substances received by veterans in
that State under the laws administered by the
Secretary.
(2) Report on tracking of data on opioid use.--Not
later than 18 months after the date of the enactment of
this Act, the Secretary shall submit to the Committee
on Veterans' Affairs of the Senate and the Committee on
Veterans' Affairs of the House of Representatives a
report on the feasibility and advisability of improving
the Opioid Therapy Risk Report tool of the Department
to allow for more advanced real-time tracking of and
access to data on--
(A) the key clinical indicators with
respect to the totality of opioid use by
veterans;
(B) concurrent prescribing by health care
providers of the Department of opioids in
different health care settings, including data
on concurrent prescribing of opioids to treat
mental health disorders other than opioid use
disorder; and
(C) mail-order prescriptions of opioids
prescribed to veterans under the laws
administered by the Secretary.
(e) Availability of Opioid Receptor Antagonists.--
(1) Increased availability and use.--
(A) In general.--The Secretary shall
maximize the availability of opioid receptor
antagonists, including naloxone, to veterans.
(B) Availability, training, and
distributing.--In carrying out subparagraph
(A), not later than 90 days after the date of
the enactment of this Act, the Secretary
shall--
(i) equip each pharmacy of the
Department with opioid receptor
antagonists to be dispensed to
outpatients as needed; and
(ii) expand the Overdose Education
and Naloxone Distribution program of
the Department to ensure that all
veterans in receipt of health care
under laws administered by the
Secretary who are at risk of opioid
overdose may access such opioid
receptor antagonists and training on
the proper administration of such
opioid receptor antagonists.
(C) Veterans who are at risk.--For purposes
of subparagraph (B), veterans who are at risk
of opioid overdose include--
(i) veterans receiving long-term
opioid therapy;
(ii) veterans receiving opioid
therapy who have a history of substance
use disorder or prior instances of
overdose; and
(iii) veterans who are at risk as
determined by a health care provider
who is treating the veteran.
(2) Report.--Not later than 120 days after the date
of the enactment of this Act, the Secretary shall
submit to the Committee on Veterans' Affairs of the
Senate and the Committee on Veterans' Affairs of the
House of Representatives a report on carrying out
paragraph (1), including an assessment of any remaining
steps to be carried out by the Secretary to carry out
such paragraph.
(f) Inclusion of Certain Information and Capabilities in
Opioid Therapy Risk Report Tool of the Department.--
(1) Information.--The Secretary shall include in
the Opioid Therapy Risk Report tool of the Department--
(A) information on the most recent time the
tool was accessed by a health care provider of
the Department with respect to each veteran;
and
(B) information on the results of the most
recent urine drug test for each veteran.
(2) Capabilities.--The Secretary shall include in
the Opioid Therapy Risk Report tool the ability of the
health care providers of the Department to determine
whether a health care provider of the Department
prescribed opioids to a veteran without checking the
information in the tool with respect to the veteran.
(g) Notifications of Risk in Computerized Health Record.--
The Secretary shall modify the computerized patient record
system of the Department to ensure that any health care
provider that accesses the record of a veteran, regardless of
the reason the veteran seeks care from the health care
provider, will be immediately notified whether the veteran--
(1) is receiving opioid therapy and has a history
of substance use disorder or prior instances of
overdose;
(2) has a history of opioid abuse; or
(3) is at risk of developing an opioid use
disorder, as determined by a health care provider who
is treating the veteran.
SEC. 912. STRENGTHENING OF JOINT WORKING GROUP ON PAIN MANAGEMENT OF
THE DEPARTMENT OF VETERANS AFFAIRS AND THE
DEPARTMENT OF DEFENSE.
(a) In General.--Not later than 90 days after the date of
enactment of this Act, the Secretary of Veterans Affairs and
the Secretary of Defense shall ensure that the Pain Management
Working Group of the Health Executive Committee of the
Department of Veterans Affairs-Department of Defense Joint
Executive Committee (Pain Management Working Group) established
under section 320 of title 38, United States Code, includes a
focus on the following:
(1) The opioid prescribing practices of health care
providers of each Department.
(2) The ability of each Department to manage acute
and chronic pain among individuals receiving health
care from the Department, including training health
care providers with respect to pain management.
(3) The use by each Department of complementary and
integrative health in treating such individuals.
(4) The concurrent use and practice by health care
providers of each Department of opioids and
prescription drugs to treat mental health disorders,
including benzodiazepines.
(5) The use of care transition plans by health care
providers of each Department to address case management
issues for patients receiving opioid therapy who
transition between inpatient and outpatient care.
(6) The coordination in coverage of and consistent
access to medications prescribed for patients
transitioning from receiving health care from the
Department of Defense to receiving health care from the
Department of Veterans Affairs.
(7) The ability of each Department to properly
screen, identify, refer, and treat patients with
substance use disorders who are seeking treatment for
acute and chronic pain management conditions.
(b) Coordination and Consultation.--The Secretary of
Veterans Affairs and the Secretary of Defense shall ensure that
the working group described in subsection (a)--
(1) coordinates the activities of the working group
with other relevant working groups established under
section 320 of title 38, United States Code;
(2) consults with other relevant Federal agencies,
including the Centers for Disease Control and
Prevention, with respect to the activities of the
working group; and
(3) consults with the Department of Veterans
Affairs and the Department of Defense with respect to
the VA/DOD Clinical Practice Guideline for Management
of Opioid Therapy for Chronic Pain, or any successor
guideline, and reviews and provides comments before any
update to the guideline is released.
(c) Clinical Practice Guidelines.--
(1) In general.--Not later than 180 days after the
date of the enactment of this Act, the Secretary of
Veterans Affairs and the Secretary of Defense shall
issue an update to the VA/DOD Clinical Practice
Guideline for Management of Opioid Therapy for Chronic
Pain.
(2) Matters included.--In conducting the update
under paragraph (1), the Pain Management Working Group,
in coordination with the Clinical Practice Guideline
VA/DoD Management of Opioid Therapy for Chronic Pain
Working Group, shall work to ensure that the Clinical
Practical Guideline includes the following:
(A) Enhanced guidance with respect to--
(i) the co-administration of an
opioid and other drugs, including
benzodiazepines, that may result in
life-limiting drug interactions;
(ii) the treatment of patients with
current acute psychiatric instability
or substance use disorder or patients
at risk of suicide; and
(iii) the use of opioid therapy to
treat mental health disorders other
than opioid use disorder.
(B) Enhanced guidance with respect to the
treatment of patients with behaviors or
comorbidities, such as post-traumatic stress
disorder or other psychiatric disorders, or a
history of substance abuse or addiction, that
requires a consultation or co-management of
opioid therapy with one or more specialists in
pain management, mental health, or addictions.
(C) Enhanced guidance with respect to
health care providers--
(i) conducting an effective
assessment for patients beginning or
continuing opioid therapy, including
understanding and setting realistic
goals with respect to achieving and
maintaining an expected level of pain
relief, improved function, or a
clinically appropriate combination of
both; and
(ii) effectively assessing whether
opioid therapy is achieving or
maintaining the established treatment
goals of the patient or whether the
patient and health care provider should
discuss adjusting, augmenting, or
discontinuing the opioid therapy.
(D) Guidelines to inform the methodologies
used by health care providers of the Department
of Veterans Affairs and the Department of
Defense to safely taper opioid therapy when
adjusting or discontinuing the use of opioid
therapy, including--
(i) prescription of the lowest
effective dose based on patient need;
(ii) use of opioids only for a
limited time; and
(iii) augmentation of opioid
therapy with other pain management
therapies and modalities.
(E) Guidelines with respect to appropriate
case management for patients receiving opioid
therapy who transition between inpatient and
outpatient health care settings, which may
include the use of care transition plans.
(F) Guidelines with respect to appropriate
case management for patients receiving opioid
therapy who transition from receiving care
during active duty to post-military health care
networks.
(G) Guidelines with respect to providing
options, before initiating opioid therapy, for
pain management therapies without the use of
opioids and options to augment opioid therapy
with other clinical and complementary and
integrative health services to minimize opioid
dependence.
(H) Guidelines with respect to the
provision of evidence-based non-opioid
treatments within the Department of Veterans
Affairs and the Department of Defense,
including medical devices and other therapies
approved or cleared by the Food and Drug
Administration for the treatment of chronic
pain as an alternative to or to augment opioid
therapy.
(I) Guidelines developed by the Centers for
Disease Control and Prevention for safely
prescribing opioids for the treatment of
chronic, non-cancer related pain in outpatient
settings.
(3) Rule of construction.--Nothing in this
subsection shall be construed to prevent the Secretary
of Veterans Affairs and the Secretary of Defense from
considering all relevant evidence, as appropriate, in
updating the VA/DOD Clinical Practice Guideline for
Management of Opioid Therapy for Chronic Pain, as
required under paragraph (1), or from ensuring that the
final clinical practice guideline updated under such
paragraph remains applicable to the patient populations
of the Department of Veterans Affairs and the
Department of Defense.
SEC. 913. REVIEW, INVESTIGATION, AND REPORT ON USE OF OPIOIDS IN
TREATMENT BY DEPARTMENT OF VETERANS AFFAIRS.
(a) Comptroller General Report.--
(1) In general.--Not later than two years after the
date of the enactment of this Act, the Comptroller
General of the United States shall submit to the
Committee on Veterans' Affairs of the Senate and the
Committee on Veterans' Affairs of the House of
Representatives a report on the Opioid Safety
Initiative of the Department of Veterans Affairs and
the opioid prescribing practices of health care
providers of the Department.
(2) Elements.--The report submitted under paragraph
(1) shall include the following:
(A) An assessment of the implementation and
monitoring by the Veterans Health
Administration of the Opioid Safety Initiative
of the Department, including examining, as
appropriate, the following:
(i) How the Department monitors the
key clinical outcomes of such safety
initiative (for example, the percentage
of unique veterans visiting each
medical center of the Department that
are prescribed an opioid or an opioid
and benzodiazepine concurrently) and
how the Department uses that
information--
(I) to improve prescribing
practices; and
(II) to identify high
prescribing or otherwise
inappropriate prescribing
practices by health care
providers.
(ii) How the Department monitors
the use of the Opioid Therapy Risk
Report tool of the Department (as
developed through such safety
initiative) and compliance with such
tool by medical facilities and health
care providers of the Department,
including any findings by the
Department of prescription rates or
prescription practices by medical
facilities or health care providers
that are inappropriate.
(iii) The implementation of
academic detailing programs within the
Veterans Integrated Service Networks of
the Department and how such programs
are being used to improve opioid
prescribing practices.
(iv) Recommendations on such
improvements to the Opioid Safety
Initiative of the Department as the
Comptroller General considers
appropriate.
(B) Information made available under the
Opioid Therapy Risk Report tool with respect
to--
(i) deaths resulting from sentinel
events involving veterans prescribed
opioids by a health care provider;
(ii) overall prescription rates
and, if applicable, indications used by
health care providers for prescribing
chronic opioid therapy to treat non-
cancer, non-palliative, and non-hospice
care patients;
(iii) the prescription rates and
indications used by health care
providers for prescribing
benzodiazepines and opioids
concomitantly;
(iv) the practice by health care
providers of prescribing opioids to
treat patients without any pain,
including to treat patients with mental
health disorders other than opioid use
disorder; and
(v) the effectiveness of opioid
therapy for patients receiving such
therapy, including the effectiveness of
long-term opioid therapy.
(C) An evaluation of processes of the
Department in place to oversee opioid use among
veterans, including procedures to identify and
remedy potential over-prescribing of opioids by
health care providers of the Department.
(D) An assessment of the implementation by
the Secretary of Veterans Affairs of the VA/DOD
Clinical Practice Guideline for Management of
Opioid Therapy for Chronic Pain, including any
figures or approaches used by the Department to
assess compliance with such guidelines by
medical centers of the Department and identify
any medical centers of the Department operating
action plans to improve compliance with such
guidelines.
(E) An assessment of the data that the
Department has developed to review the opioid
prescribing practices of health care providers
of the Department, as required by this
subtitle, including a review of how the
Department identifies the practices of
individual health care providers that warrant
further review based on prescribing levels,
health conditions for which the health care
provider is prescribing opioids or opioids and
benzodiazepines concurrently, or other
practices of the health care provider.
(b) Semi-annual Progress Report on Implementation of
Comptroller General Recommendations.--Not later than 180 days
after the date of the submittal of the report required under
subsection (a), and not less frequently than annually
thereafter until the Comptroller General of the United States
determines that all recommended actions are closed, the
Secretary of Veterans Affairs shall submit to the Committee on
Veterans' Affairs of the Senate and the Committee on Veterans'
Affairs of the House of Representatives a progress report
detailing the actions by the Secretary to address any
outstanding findings and recommendations by the Comptroller
General of the United States under subsection (a) with respect
to the Veterans Health Administration.
(c) Annual Report on Opioid Therapy and Prescription
Rates.--Not later than one year after the date of the enactment
of this Act, and not less frequently than annually for the
following five years, the Secretary shall submit to the
Committee on Veterans' Affairs of the Senate and the Committee
on Veterans' Affairs of the House of Representatives a report
on opioid therapy and prescription rates for the one-year
period preceding the date of the submission of the report. Each
such report shall include each of the following:
(1) The number of patients and the percentage of
the patient population of the Department who were
prescribed benzodiazepines and opioids concurrently by
a health care provider of the Department.
(2) The number of patients and the percentage of
the patient population of the Department without any
pain who were prescribed opioids by a health care
provider of the Department, including those who were
prescribed benzodiazepines and opioids concurrently.
(3) The number of non-cancer, non-palliative, and
non-hospice care patients and the percentage of such
patients who were treated with opioids by a health care
provider of the Department on an inpatient-basis and
who also received prescription opioids by mail from the
Department while being treated on an inpatient-basis.
(4) The number of non-cancer, non-palliative, and
non-hospice care patients and the percentage of such
patients who were prescribed opioids concurrently by a
health care provider of the Department and a health
care provider that is not a health care provider of the
Department.
(5) With respect to each medical facility of the
Department, the collected and reviewed information on
opioids prescribed by health care providers at the
facility to treat non-cancer, non-palliative, and non-
hospice care patients, including--
(A) the prescription rate at which each
health care provider at the facility prescribed
benzodiazepines and opioids concurrently to
such patients and the aggregate of such
prescription rate for all health care providers
at the facility;
(B) the prescription rate at which each
health care provider at the facility prescribed
benzodiazepines or opioids to such patients to
treat conditions for which benzodiazepines or
opioids are not approved treatment and the
aggregate of such prescription rate for all
health care providers at the facility;
(C) the prescription rate at which each
health care provider at the facility prescribed
or dispensed mail-order prescriptions of
opioids to such patients while such patients
were being treated with opioids on an
inpatient-basis and the aggregate of such
prescription rate for all health care providers
at the facility; and
(D) the prescription rate at which each
health care provider at the facility prescribed
opioids to such patients who were also
concurrently prescribed opioids by a health
care provider that is not a health care
provider of the Department and the aggregate of
such prescription rates for all health care
providers at the facility.
(6) With respect to each medical facility of the
Department, the number of times a pharmacist at the
facility overrode a critical drug interaction warning
with respect to an interaction between opioids and
another medication before dispensing such medication to
a veteran.
(d) Investigation of Prescription Rates.--If the Secretary
determines that a prescription rate with respect to a health
care provider or medical facility of the Department conflicts
with or is otherwise inconsistent with the standards of
appropriate and safe care, the Secretary shall--
(1) immediately notify the Committee on Veterans'
Affairs of the Senate and the Committee on Veterans'
Affairs of the House of Representatives of such
determination, including information relating to such
determination, prescription rate, and health care
provider or medical facility, as the case may be; and
(2) through the Office of the Medical Inspector of
the Veterans Health Administration, conduct a full
investigation of the health care provider or medical
facility, as the case may be.
(e) Prescription Rate Defined.--In this section, the term
``prescription rate'' means, with respect to a health care
provider or medical facility of the Department, each of the
following:
(1) The number of patients treated with opioids by
the health care provider or at the medical facility, as
the case may be, divided by the total number of
pharmacy users of that health care provider or medical
facility.
(2) The average number of morphine equivalents per
day prescribed by the health care provider or at the
medical facility, as the case may be, to patients being
treated with opioids.
(3) Of the patients being treated with opioids by
the health care provider or at the medical facility, as
the case may be, the average number of prescriptions of
opioids per patient.
SEC. 914. MANDATORY DISCLOSURE OF CERTAIN VETERAN INFORMATION TO STATE
CONTROLLED SUBSTANCE MONITORING PROGRAMS.
Section 5701(l) of title 38, United States Code, is amended
by striking ``may'' and inserting ``shall''.
SEC. 915. ELIMINATION OF COPAYMENT REQUIREMENT FOR VETERANS RECEIVING
OPIOID ANTAGONISTS OR EDUCATION ON USE OF OPIOID
ANTAGONISTS.
(a) Copayment for Opioid Antagonists.--Section 1722A(a) of
title 38, United States Code, is amended by adding at the end
the following new paragraph:
``(4) Paragraph (1) does not apply to opioid antagonists
furnished under this chapter to a veteran who is at high risk
for overdose of a specific medication or substance in order to
reverse the effect of such an overdose.''.
(b) Copayment for Education on Use of Opioid Antagonists.--
Section 1710(g)(3) of such title is amended--
(1) by striking ``with respect to home health
services'' and inserting ``with respect to the
following:''
``(A) Home health services''; and
(2) by adding at the end the following
subparagraph:
``(B) Education on the use of opioid antagonists to
reverse the effects of overdoses of specific
medications or substances.''.
Subtitle B--Patient Advocacy
SEC. 921. COMMUNITY MEETINGS ON IMPROVING CARE FURNISHED BY DEPARTMENT
OF VETERANS AFFAIRS.
(a) Community Meetings.--
(1) Medical centers.--Not later than 90 days after
the date of the enactment of this Act, and not less
frequently than once every 90 days thereafter, the
Secretary shall ensure that each medical facility of
the Department of Veterans Affairs hosts a community
meeting open to the public on improving health care
furnished by the Secretary.
(2) Community-based outpatient clinics.--Not later
than one year after the date of the enactment of this
Act, and not less frequently than annually thereafter,
the Secretary shall ensure that each community-based
outpatient clinic of the Department hosts a community
meeting open to the public on improving health care
furnished by the Secretary.
(b) Attendance by Director of Veterans Integrated Service
Network or Designee.--
(1) In general.--Each community meeting hosted by a
medical facility or community-based outpatient clinic
under subsection (a) shall be attended by the Director
of the Veterans Integrated Service Network in which the
medical facility or community-based outpatient clinic,
as the case may be, is located. Subject to paragraph
(2), the Director may delegate such attendance only to
an employee who works in the Office of the Director.
(2) Attendance by director.--Each Director of a
Veterans Integrated Service Network shall personally
attend not less than one community meeting under
subsection (a) hosted by each medical facility located
in the Veterans Integrated Service Network each year.
(c) Notice.--The Secretary shall notify the Committee on
Veterans' Affairs of the Senate, the Committee on Veterans'
Affairs of the House of Representatives, and each Member of
Congress (as defined in section 902) who represents the area in
which the medical facility is located of a community meeting
under subsection (a) by not later than 10 days before such
community meeting occurs.
SEC. 922. IMPROVEMENT OF AWARENESS OF PATIENT ADVOCACY PROGRAM AND
PATIENT BILL OF RIGHTS OF DEPARTMENT OF VETERANS
AFFAIRS.
Not later than 90 days after the date of the enactment of
this Act, the Secretary of Veterans Affairs shall, in as many
prominent locations as the Secretary determines appropriate to
be seen by the largest percentage of patients and family
members of patients at each medical facility of the Department
of Veterans Affairs--
(1) display the purposes of the Patient Advocacy
Program of the Department and the contact information
for the patient advocate at such medical facility; and
(2) display the rights and responsibilities of--
(A) patients and family members of patients
at such medical facility; and
(B) with respect to community living
centers and other residential facilities of the
Department, residents and family members of
residents at such medical facility.
SEC. 923. COMPTROLLER GENERAL REPORT ON PATIENT ADVOCACY PROGRAM OF
DEPARTMENT OF VETERANS AFFAIRS.
(a) In General.--Not later than two years after the date of
the enactment of this Act, the Comptroller General of the
United States shall submit to the Committee on Veterans'
Affairs of the Senate and the Committee on Veterans' Affairs of
the House of Representatives a report on the Patient Advocacy
Program of the Department of Veterans Affairs (in this section
referred to as the ``Program'').
(b) Elements.--The report required by subsection (a) shall
include the following:
(1) A description of the Program, including--
(A) the purpose of the Program;
(B) the activities carried out under the
Program; and
(C) the sufficiency of the Program in
achieving the purpose of the Program.
(2) An assessment of the sufficiency of staffing of
employees of the Department responsible for carrying
out the Program.
(3) An assessment of the sufficiency of the
training of such employees.
(4) An assessment of--
(A) the awareness of the Program among
veterans and family members of veterans; and
(B) the use of the Program by veterans and
family members of veterans.
(5) Such recommendations and proposals for
improving or modifying the Program as the Comptroller
General considers appropriate.
(6) Such other information with respect to the
Program as the Comptroller General considers
appropriate.
SEC. 924. ESTABLISHMENT OF OFFICE OF PATIENT ADVOCACY OF THE DEPARTMENT
OF VETERANS AFFAIRS.
(a) In General.--Subchapter I of chapter 73 of title 38,
United States Code, is amended by adding at the end the
following new section:
``Sec. 7309A. Office of Patient Advocacy
``(a) Establishment.--There is established in the
Department within the Office of the Under Secretary for Health
an office to be known as the `Office of Patient Advocacy' (in
this section referred to as the `Office').
``(b) Head.--(1) The Director of the Office of Patient
Advocacy shall be the head of the Office.
``(2) The Director of the Office of Patient Advocacy shall
be appointed by the Under Secretary for Health from among
individuals qualified to perform the duties of the position and
shall report directly to the Under Secretary for Health.
``(c) Function.--(1) The function of the Office is to carry
out the Patient Advocacy Program of the Department.
``(2) In carrying out the Patient Advocacy Program of the
Department, the Director shall ensure that patient advocates of
the Department--
``(A) advocate on behalf of veterans with respect
to health care received and sought by veterans under
the laws administered by the Secretary;
``(B) carry out the responsibilities specified in
subsection (d); and
``(C) receive training in patient advocacy.
``(d) Patient Advocacy Responsibilities.--The
responsibilities of each patient advocate at a medical facility
of the Department are the following:
``(1) To resolve complaints by veterans with
respect to health care furnished under the laws
administered by the Secretary that cannot be resolved
at the point of service or at a higher level easily
accessible to the veteran.
``(2) To present at various meetings and to various
committees the issues experienced by veterans in
receiving such health care at such medical facility.
``(3) To express to veterans their rights and
responsibilities as patients in receiving such health
care.
``(4) To manage the Patient Advocate Tracking
System of the Department at such medical facility.
``(5) To compile data at such medical facility of
complaints made by veterans with respect to the receipt
of such health care at such medical facility and the
satisfaction of veterans with such health care at such
medical facility to determine whether there are trends
in such data.
``(6) To ensure that a process is in place for the
distribution of the data compiled under paragraph (5)
to appropriate leaders, committees, services, and staff
of the Department.
``(7) To identify, not less frequently than
quarterly, opportunities for improvements in the
furnishing of such health care to veterans at such
medical facility based on complaints by veterans.
``(8) To ensure that any significant complaint by a
veteran with respect to such health care is brought to
the attention of appropriate staff of the Department to
trigger an assessment of whether there needs to be a
further analysis of the problem at the facility-wide
level.
``(9) To support any patient advocacy programs
carried out by the Department.
``(10) To ensure that all appeals and final
decisions with respect to the receipt of such health
care are entered into the Patient Advocate Tracking
System of the Department.
``(11) To understand all laws, directives, and
other rules with respect to the rights and
responsibilities of veterans in receiving such health
care, including the appeals processes available to
veterans.
``(12) To ensure that veterans receiving mental
health care, or the surrogate decision-makers for such
veterans, are aware of the rights of veterans to seek
representation from systems established under section
103 of the Protection and Advocacy for Mentally Ill
Individuals Act of 1986 (42 U.S.C. 10803) to protect
and advocate the rights of individuals with mental
illness and to investigate incidents of abuse and
neglect of such individuals.
``(13) To fulfill requirements established by the
Secretary with respect to the inspection of controlled
substances.
``(14) To document potentially threatening behavior
and report such behavior to appropriate authorities.
``(e) Training.--In providing training to patient advocates
under subsection (c)(2)(C), the Director shall ensure that such
training is consistent throughout the Department.
``(f) Controlled Substance Defined.--In this section, the
term `controlled substance' has the meaning given that term in
section 102 of the Controlled Substances Act (21 U.S.C.
802).''.
(b) Clerical Amendment.--The table of sections at the
beginning of chapter 73 of such title is amended by inserting
after the item relating to section 7309 the following new item:
``7309A. Office of Patient Advocacy.''.
(c) Date Fully Operational.--The Secretary of Veterans
Affairs shall ensure that the Office of Patient Advocacy
established under section 7309A of title 38, United States
Code, as added by subsection (a), is fully operational not
later than the date that is one year after the date of the
enactment of this Act.
Subtitle C--Complementary and Integrative Health
SEC. 931. EXPANSION OF RESEARCH AND EDUCATION ON AND DELIVERY OF
COMPLEMENTARY AND INTEGRATIVE HEALTH TO VETERANS.
(a) Establishment.--There is established a commission to be
known as the ``Creating Options for Veterans' Expedited
Recovery'' or the ``COVER Commission'' (in this section
referred to as the ``Commission''). The Commission shall
examine the evidence-based therapy treatment model used by the
Secretary of Veterans Affairs for treating mental health
conditions of veterans and the potential benefits of
incorporating complementary and integrative health treatments
available in non-Department facilities (as defined in section
1701 of title 38, United States Code).
(b) Duties.--The Commission shall perform the following
duties:
(1) Examine the efficacy of the evidence-based
therapy model used by the Secretary for treating mental
health illnesses of veterans and identify areas to
improve wellness-based outcomes.
(2) Conduct a patient-centered survey within each
of the Veterans Integrated Service Networks to
examine--
(A) the experience of veterans with the
Department of Veterans Affairs when seeking
medical assistance for mental health issues
through the health care system of the
Department;
(B) the experience of veterans with non-
Department facilities and health professionals
for treating mental health issues;
(C) the preference of veterans regarding
available treatment for mental health issues
and which methods the veterans believe to be
most effective;
(D) the experience, if any, of veterans
with respect to the complementary and
integrative health treatment therapies
described in paragraph (3);
(E) the prevalence of prescribing
prescription medication among veterans seeking
treatment through the health care system of the
Department as remedies for addressing mental
health issues; and
(F) the outreach efforts of the Secretary
regarding the availability of benefits and
treatments for veterans for addressing mental
health issues, including by identifying ways to
reduce barriers to gaps in such benefits and
treatments.
(3) Examine available research on complementary and
integrative health treatment therapies for mental
health issues and identify what benefits could be made
with the inclusion of such treatments for veterans,
including with respect to--
(A) music therapy;
(B) equine therapy;
(C) training and caring for service dogs;
(D) yoga therapy;
(E) acupuncture therapy;
(F) meditation therapy;
(G) outdoor sports therapy;
(H) hyperbaric oxygen therapy;
(I) accelerated resolution therapy;
(J) art therapy;
(K) magnetic resonance therapy; and
(L) other therapies the Commission
determines appropriate.
(4) Study the sufficiency of the resources of the
Department to ensure the delivery of quality health
care for mental health issues among veterans seeking
treatment within the Department.
(5) Study the current treatments and resources
available within the Department and assess--
(A) the effectiveness of such treatments
and resources in decreasing the number of
suicides per day by veterans;
(B) the number of veterans who have been
diagnosed with mental health issues;
(C) the percentage of veterans using the
resources of the Department who have been
diagnosed with mental health issues;
(D) the percentage of veterans who have
completed counseling sessions offered by the
Department; and
(E) the efforts of the Department to expand
complementary and integrative health treatments
viable to the recovery of veterans with mental
health issues as determined by the Secretary to
improve the effectiveness of treatments offered
by the Department.
(c) Membership.--
(1) In general.--The Commission shall be composed
of 10 members, appointed as follows:
(A) Two members appointed by the Speaker of
the House of Representatives, at least one of
whom shall be a veteran.
(B) Two members appointed by the minority
leader of the House of Representatives, at
least one of whom shall be a veteran.
(C) Two members appointed by the majority
leader of the Senate, at least one of whom
shall be a veteran.
(D) Two members appointed by the minority
leader of the Senate, at least one of whom
shall be a veteran.
(E) Two members appointed by the President,
at least one of whom shall be a veteran.
(2) Qualifications.--Members of the Commission
shall be individuals who--
(A) are of recognized standing and
distinction within the medical community with a
background in treating mental health;
(B) have experience working with the
military and veteran population; and
(C) do not have a financial interest in any
of the complementary and integrative health
treatments reviewed by the Commission.
(3) Chairman.--The President shall designate a
member of the Commission to be the Chairman.
(4) Period of appointment.--Members of the
Commission shall be appointed for the life of the
Commission.
(5) Vacancy.--A vacancy in the Commission shall be
filled in the manner in which the original appointment
was made.
(6) Appointment deadline.--The appointment of
members of the Commission in this section shall be made
not later than 90 days after the date of the enactment
of this Act.
(d) Powers of Commission.--
(1) Meetings.--
(A) Initial meeting.--The Commission shall
hold its first meeting not later than 30 days
after a majority of members are appointed to
the Commission.
(B) Meeting.--The Commission shall
regularly meet at the call of the Chairman.
Such meetings may be carried out through the
use of telephonic or other appropriate
telecommunication technology if the Commission
determines that such technology will allow the
members to communicate simultaneously.
(2) Hearings.--The Commission may hold such
hearings, sit and act at such times and places, take
such testimony, and receive evidence as the Commission
considers advisable to carry out the responsibilities
of the Commission.
(3) Information from federal agencies.--The
Commission may secure directly from any department or
agency of the Federal Government such information as
the Commission considers necessary to carry out the
duties of the Commission.
(4) Information from nongovernmental
organizations.--In carrying out its duties, the
Commission may seek guidance through consultation with
foundations, veteran service organizations, nonprofit
groups, faith-based organizations, private and public
institutions of higher education, and other
organizations as the Commission determines appropriate.
(5) Commission records.--The Commission shall keep
an accurate and complete record of the actions and
meetings of the Commission. Such record shall be made
available for public inspection and the Comptroller
General of the United States may audit and examine such
record.
(6) Personnel records.--The Commission shall keep
an accurate and complete record of the actions and
meetings of the Commission. Such record shall be made
available for public inspection and the Comptroller
General of the United States may audit and examine such
records.
(7) Compensation of members; travel expenses.--Each
member shall serve without pay but shall receive travel
expenses to perform the duties of the Commission,
including per diem in lieu of substances, at rates
authorized under subchapter I of chapter 57 of title 5,
United States Code.
(8) Staff.--The Chairman, in accordance with rules
agreed upon the Commission, may appoint and fix the
compensation of a staff director and such other
personnel as may be necessary to enable the Commission
to carry out its functions, without regard to the
provisions of title 5, United States Code, governing
appointments in the competitive service, without regard
to the provision of chapter 51 and subchapter III of
chapter 53 of such title relating to classification and
General Schedule pay rates, except that no rate of pay
fixed under this paragraph may exceed the equivalent of
that payable for a position at level IV of the
Executive Schedule under section 5315 of title 5,
United States Code.
(9) Personnel as federal employees.--
(A) In general.--The executive director and
any personnel of the Commission are employees
under section 2105 of title 5, United States
Code, for purpose of chapters 63, 81, 83, 84,
85, 87, 89, and 90 of such title.
(B) Members of the commission.--
Subparagraph (A) shall not be construed to
apply to members of the Commission.
(10) Contracting.--The Commission may, to such
extent and in such amounts as are provided in
appropriations Acts, enter into contracts to enable the
Commission to discharge the duties of the Commission
under this Act.
(11) Expert and consultant service.--The Commission
may procure the services of experts and consultants in
accordance with section 3109 of title 5, United States
Code, at rates not to exceed the daily rate paid to a
person occupying a position at level IV of the
Executive Schedule under section 5315 of title 5,
United States Code.
(12) Postal service.--The Commission may use the
United States mails in the same manner and under the
same conditions as departments and agencies of the
United States.
(13) Physical facilities and equipment.--Upon the
request of the Commission, the Administrator of General
Services shall provide to the Commission, on a
reimbursable basis, the administrative support services
necessary for the Commission to carry out its
responsibilities under this Act. These administrative
services may include human resource management, budget,
leasing accounting, and payroll services.
(e) Report.--
(1) Interim reports.--
(A) In general.--Not later than 60 days
after the date on which the Commission first
meets, and each 30-day period thereafter ending
on the date on which the Commission submits the
final report under paragraph (2), the
Commission shall submit to the Committees on
Veterans' Affairs of the House of
Representatives and the Senate and the
President a report detailing the level of
cooperation the Secretary of Veterans Affairs
(and the heads of other departments or agencies
of the Federal Government) has provided to the
Commission.
(B) Other reports.--In carrying out its
duties, at times that the Commission determines
appropriate, the Commission shall submit to the
Committees on Veterans' Affairs of the House of
Representatives and the Senate and any other
appropriate entities an interim report with
respect to the findings identified by the
Commission.
(2) Final report.--Not later than 18 months after
the first meeting of the Commission, the Commission
shall submit to the Committee on Veterans' Affairs of
the House of Representatives and the Senate, the
President, and the Secretary of Veterans Affairs a
final report on the findings of the Commission. Such
report shall include the following:
(A) Recommendations to implement in a
feasible, timely, and cost-efficient manner the
solutions and remedies identified within the
findings of the Commission pursuant to
subsection (b).
(B) An analysis of the evidence-based
therapy model used by the Secretary of Veterans
Affairs for treating veterans with mental
health care issues, and an examination of the
prevalence and efficacy of prescription drugs
as a means for treatment.
(C) The findings of the patient-centered
survey conducted within each of the Veterans
Integrated Service Networks pursuant to
subsection (b)(2).
(D) An examination of complementary and
integrative health treatments described in
subsection (b)(3) and the potential benefits of
incorporating such treatments in the therapy
models used by the Secretary for treating
veterans with mental health issues.
(3) Plan.--Not later than 90 days after the date on
which the Commission submits the final report under
paragraph (2), the Secretary of Veterans Affairs shall
submit to the Committees on Veterans' Affairs of the
House of Representatives and the Senate a report on the
following:
(A) An action plan for implementing the
recommendations established by the Commission
on such solutions and remedies for improving
wellness-based outcomes for veterans with
mental health care issues.
(B) A feasible timeframe on when the
complementary and integrative health treatments
described in subsection (b)(3) can be
implemented Department-wide.
(C) With respect to each recommendation
established by the Commission, including any
complementary and integrative health treatment,
that the Secretary determines is not
appropriate or feasible to implement, a
justification for such determination and an
alternative solution to improve the efficacy of
the therapy models used by the Secretary for
treating veterans with mental health issues.
(f) Termination of Commission.--The Commission shall
terminate 30 days after the Commission submits the final report
under subsection (e)(2).
SEC. 932. EXPANSION OF RESEARCH AND EDUCATION ON AND DELIVERY OF
COMPLEMENTARY AND INTEGRATIVE HEALTH TO VETERANS.
(a) Development of Plan To Expand Research, Education, and
Delivery.--Not later than 180 days after the date of the
enactment of this Act, the Secretary of Veterans Affairs shall
develop a plan to expand materially and substantially the scope
of the effectiveness of research and education on, and delivery
and integration of, complementary and integrative health
services into the health care services provided to veterans.
(b) Elements.--The plan required by subsection (a) shall
provide for the following:
(1) Research on the following:
(A) The effectiveness of various
complementary and integrative health services,
including the effectiveness of such services
integrated with clinical services.
(B) Approaches to integrating complementary
and integrative health services into other
health care services provided by the Department
of Veterans Affairs.
(2) Education and training for health care
professionals of the Department on the following:
(A) Complementary and integrative health
services selected by the Secretary for purposes
of the plan.
(B) Appropriate uses of such services.
(C) Integration of such services into the
delivery of health care to veterans.
(3) Research, education, and clinical activities on
complementary and integrative health at centers of
innovation at medical centers of the Department.
(4) Identification or development of metrics and
outcome measures to evaluate the effectiveness of the
provision and integration of complementary and
integrative health services into the delivery of health
care to veterans.
(5) Integration and delivery of complementary and
integrative health services with other health care
services provided by the Department.
(c) Consultation.--
(1) In general.--In carrying out subsection (a),
the Secretary shall consult with the following:
(A) The Director of the National Center for
Complementary and Integrative Health of the
National Institutes of Health.
(B) The Commissioner of Food and Drugs.
(C) Institutions of higher education,
private research institutes, and individual
researchers with extensive experience in
complementary and integrative health and the
integration of complementary and integrative
health practices into the delivery of health
care.
(D) Nationally recognized providers of
complementary and integrative health.
(E) Such other officials, entities, and
individuals with expertise on complementary and
integrative health as the Secretary considers
appropriate.
(2) Scope of consultation.--The Secretary shall
undertake consultation under paragraph (1) in carrying
out subsection (a) with respect to the following:
(A) To develop the plan.
(B) To identify specific complementary and
integrative health practices that, on the basis
of research findings or promising clinical
interventions, are appropriate to include as
services to veterans.
(C) To identify barriers to the effective
provision and integration of complementary and
integrative health services into the delivery
of health care to veterans, and to identify
mechanisms for overcoming such barriers.
SEC. 933. PILOT PROGRAM ON INTEGRATION OF COMPLEMENTARY AND INTEGRATIVE
HEALTH AND RELATED ISSUES FOR VETERANS AND FAMILY
MEMBERS OF VETERANS.
(a) Pilot Program.--
(1) In general.--Not later than 180 days after the
date on which the Secretary of Veterans Affairs
receives the final report under section 931(e)(2), the
Secretary shall commence a pilot program to assess the
feasibility and advisability of using complementary and
integrative health and wellness-based programs (as
defined by the Secretary) to complement the provision
of pain management and related health care services,
including mental health care services, to veterans.
(2) Matters addressed.--In carrying out the pilot
program, the Secretary shall assess the following:
(A) Means of improving coordination between
Federal, State, local, and community providers
of health care in the provision of pain
management and related health care services to
veterans.
(B) Means of enhancing outreach, and
coordination of outreach, by and among
providers of health care referred to in
subparagraph (A) on the pain management and
related health care services available to
veterans.
(C) Means of using complementary and
integrative health and wellness-based programs
of providers of health care referred to in
subparagraph (A) as complements to the
provision by the Department of Veterans Affairs
of pain management and related health care
services to veterans.
(D) Whether complementary and integrative
health and wellness-based programs described in
subparagraph (C)--
(i) are effective in enhancing the
quality of life and well-being of
veterans;
(ii) are effective in increasing
the adherence of veterans to the
primary pain management and related
health care services provided such
veterans by the Department;
(iii) have an effect on the sense
of well-being of veterans who receive
primary pain management and related
health care services from the
Department; and
(iv) are effective in encouraging
veterans receiving health care from the
Department to adopt a more healthy
lifestyle.
(b) Duration.--The Secretary shall carry out the pilot
program under subsection (a)(1) for a period of three years.
(c) Locations.--
(1) Facilities.--The Secretary shall carry out the
pilot program under subsection (a)(1) at facilities of
the Department providing pain management and related
health care services, including mental health care
services, to veterans. In selecting such facilities to
carry out the pilot program, the Secretary shall select
not fewer than 15 geographically diverse medical
centers of the Department, of which not fewer than two
shall be polytrauma rehabilitation centers of the
Department.
(2) Medical centers with prescription rates of
opioids that conflict with care standards.--In
selecting the medical centers under paragraph (1), the
Secretary shall give priority to medical centers of the
Department at which there is a prescription rate of
opioids that conflicts with or is otherwise
inconsistent with the standards of appropriate and safe
care.
(d) Provision of Services.--Under the pilot program under
subsection (a)(1), the Secretary shall provide covered services
to covered veterans by integrating complementary and
integrative health services with other services provided by the
Department at the medical centers selected under subsection
(c).
(e) Covered Veterans.--For purposes of the pilot program
under subsection (a)(1), a covered veteran is any veteran who--
(1) has a mental health condition diagnosed by a
clinician of the Department;
(2) experiences chronic pain;
(3) has a chronic condition being treated by a
clinician of the Department; or
(4) is not described in paragraph (1), (2), or (3)
and requests to participate in the pilot program or is
referred by a clinician of the Department who is
treating the veteran.
(f) Covered Services.--
(1) In general.--For purposes of the pilot program,
covered services are services consisting of
complementary and integrative health services as
selected by the Secretary.
(2) Administration of services.--Covered services
shall be administered under the pilot program as
follows:
(A) Covered services shall be administered
by professionals or other instructors with
appropriate training and expertise in
complementary and integrative health services
who are employees of the Department or with
whom the Department enters into an agreement to
provide such services.
(B) Covered services shall be included as
part of the Patient Aligned Care Teams
initiative of the Office of Patient Care
Services, Primary Care Program Office, in
coordination with the Office of Patient
Centered Care and Cultural Transformation.
(C) Covered services shall be made
available to--
(i) covered veterans who have
received conventional treatments from
the Department for the conditions for
which the covered veteran seeks
complementary and integrative health
services under the pilot program; and
(ii) covered veterans who have not
received conventional treatments from
the Department for such conditions.
(g) Reports.--
(1) In general.--Not later than 30 months after the
date on which the Secretary commences the pilot program
under subsection (a)(1), the Secretary shall submit to
the Committee on Veterans' Affairs of the Senate and
the Committee on Veterans' Affairs of the House of
Representatives a report on the pilot program.
(2) Elements.--The report under paragraph (1) shall
include the following:
(A) The findings and conclusions of the
Secretary with respect to the pilot program
under subsection (a)(1), including with respect
to--
(i) the use and efficacy of the
complementary and integrative health
services established under the pilot
program;
(ii) the outreach conducted by the
Secretary to inform veterans and
community organizations about the pilot
program; and
(iii) an assessment of the benefit
of the pilot program to covered
veterans in mental health diagnoses,
pain management, and treatment of
chronic illness.
(B) Identification of any unresolved
barriers that impede the ability of the
Secretary to incorporate complementary and
integrative health services with other health
care services provided by the Department.
(C) Such recommendations for the
continuation or expansion of the pilot program
as the Secretary considers appropriate.
Subtitle D--Fitness of Health Care Providers
SEC. 941. ADDITIONAL REQUIREMENTS FOR HIRING OF HEALTH CARE PROVIDERS
BY DEPARTMENT OF VETERANS AFFAIRS.
As part of the hiring process for each health care provider
considered for a position at the Department of Veterans Affairs
after the date of the enactment of the Act, the Secretary of
Veterans Affairs shall require from the medical board of each
State in which the health care provider has or had a medical
license--
(1) information on any violation of the
requirements of the medical license of the health care
provider during the 20-year period preceding the
consideration of the health care provider by the
Department; and
(2) information on whether the health care provider
has entered into any settlement agreement for a
disciplinary charge relating to the practice of
medicine by the health care provider.
SEC. 942. PROVISION OF INFORMATION ON HEALTH CARE PROVIDERS OF
DEPARTMENT OF VETERANS AFFAIRS TO STATE MEDICAL
BOARDS.
Notwithstanding section 552a of title 5, United States
Code, with respect to each health care provider of the
Department of Veterans Affairs who has violated a requirement
of the medical license of the health care provider, the
Secretary of Veterans Affairs shall provide to the medical
board of each State in which the health care provider is
licensed detailed information with respect to such violation,
regardless of whether such board has formally requested such
information.
SEC. 943. REPORT ON COMPLIANCE BY DEPARTMENT OF VETERANS AFFAIRS WITH
REVIEWS OF HEALTH CARE PROVIDERS LEAVING THE
DEPARTMENT OR TRANSFERRING TO OTHER FACILITIES.
Not later than 180 days after the date of the enactment of
this Act, the Secretary of Veterans Affairs shall submit to the
Committee on Veterans' Affairs of the Senate and the Committee
on Veterans' Affairs of the House of Representatives a report
on the compliance by the Department of Veterans Affairs with
the policy of the Department--
(1) to conduct a review of each health care
provider of the Department who transfers to another
medical facility of the Department, resigns, retires,
or is terminated to determine whether there are any
concerns, complaints, or allegations of violations
relating to the medical practice of the health care
provider; and
(2) to take appropriate action with respect to any
such concern, complaint, or allegation.
Subtitle E--Other Matters
SEC. 951. MODIFICATION TO LIMITATION ON AWARDS AND BONUSES.
Section 705 of the Veterans Access, Choice, and
Accountability Act of 2014 (Public Law 113-146; 38 U.S.C. 703
note) is amended to read as follows:
``SEC. 705. LIMITATION ON AWARDS AND BONUSES PAID TO EMPLOYEES OF
DEPARTMENT OF VETERANS AFFAIRS.
``(a) Limitation.--The Secretary of Veterans Affairs shall
ensure that the aggregate amount of awards and bonuses paid by
the Secretary in a fiscal year under chapter 45 or 53 of title
5, United States Code, or any other awards or bonuses
authorized under such title or title 38, United States Code,
does not exceed the following amounts:
``(1) With respect to each of fiscal years 2017
through 2018, $230,000,000.
``(2) With respect to each of fiscal years 2019
through 2021, $225,000,000.
``(3) With respect to each of fiscal years 2022
through 2024, $360,000,000.
``(b) Sense of Congress.--It is the sense of Congress that
the limitation under subsection (a) should not
disproportionately impact lower-wage employees and that the
Department of Veterans Affairs is encouraged to use bonuses to
incentivize high-performing employees in areas in which
retention is challenging.''.
And the House agree to the same.
That the Senate recede from its disagreement to the
amendment of the House to the title of the bill and agree to
the same with an amendment as follows:
In lieu of the matter proposed to be inserted by the
House amendment to the title of the bill, insert the following:
``An Act to authorize the Attorney General and Secretary of
Health and Human Services to award grants to address the
prescription opioid abuse and heroin use crisis, and for other
purposes.''.
And the House agree to the same.
For consideration of the Senate bill and the
House amendments, and modifications committed
to conference:
Fred Upton,
Joseph R. Pitts,
Leonard Lance,
Brett Guthrie,
Adam Kinzinger,
Larry Bucshon,
Susan W. Brooks,
Bob Goodlatte,
F. James Sensenbrenner, Jr.,
Lamar Smith,
Tom Marino,
Doug Collins,
David A. Trott,
Mike Bishop,
Kevin McCarthy,
From the Committee on Education and the
Workforce, for consideration of title VII of
the House amendment, and modifications
committed to conference:
Lou Barletta,
Earl L. ``Buddy'' Carter,
From the Committee on Veterans' Affairs, for
consideration of title III of the House
amendment, and modifications committed to
conference:
Gus M. Bilirakis,
Jackie Walorski,
From the Committee on Ways and Means, for
consideration of sec. 705 of the Senate bill,
and sec. 804 of the House amendment, and
modifications committed to conference:
Patrick Meehan,
Robert J. Dold,
Managers on the Part of the House.
Chuck Grassley,
Lamar Alexander,
Orrin G. Hatch,
Jeff Sessions,
Managers on the Part of the Senate.
JOINT EXPLANATORY STATEMENT OF THE COMMITTEE OF CONFERENCE
The managers on the part of the House and the Senate at
the conference on the disagreeing votes of the two Houses on
the amendments of the House to the bill (S. 524), to authorize
the Attorney General to award grants to address the national
epidemics of prescription opioid abuse and heroin use, submit
the following joint statement to the House and the Senate in
explanation of the effect of the action agreed upon by the
managers and recommended in the accompanying conference report:
The House amendment to the text of the bill struck all of
the Senate bill after the enacting clause and inserted a
substitute text.
The Senate recedes from its disagreement to the amendment
of the House with an amendment that is a substitute for the
Senate bill and the House amendment. The differences between
the Senate bill, the House amendment, and the substitute agreed
to in conference are noted below, except for clerical
corrections, conforming changes made necessary by agreements
reached by the conferees, and minor drafting and clarifying
changes.
S. 524, the Comprehensive Addiction and Recovery Act
(CARA), authorizes the Attorney General and the Secretary of
Health and Human Services to award grants to address the
national epidemics of addiction to heroin and prescription
opioids, and makes various other changes to Federal law to
combat opioid addiction and abuse.
TITLE I--PREVENTION AND EDUCATION
Section 101--Task force on pain management
S. 524 included a task force to review best practices for
chronic and acute pain management and prescribing pain
medication. It was unclear which best practices the task force
would review, modify, and update. The task force would have
been required to convene not later than December 14, 2018, and
within 180 days, modify and update such best practices, as
appropriate, and amend them further, if appropriate, after
soliciting and taking into consideration public comment. Not
later than 90 days after that, the task force would have been
required to submit a report to Congress, including a strategy
for disseminating best practices as reviewed, modified, or
updated.
The House amendment included the same timeframes and
underlying activities but added a number of participants to the
task force. The House amendment also added considerations that
the task force would have been required to take into account
while reviewing, modifying, and updating best practices,
several of which extended beyond the scope of chronic and acute
pain management.
Section 101 of the conference report requires the
Secretary of Health and Human Services (HHS), within two years
of enactment, to convene a task force comprised of federal
agencies and non-governmental stakeholders to identify, review,
and as appropriate, determine whether there are gaps or
inconsistencies between best practices for chronic and acute
pain management that have been developed or adopted by Federal
agencies. The task force is required to consider a number of
factors, existing research, and related efforts, and, within
one year of convening, propose any updates to such best
practices and recommendations on addressing gaps or
inconsistencies after providing the public with at least 90
days to submit comments. The task force would also develop a
strategy for disseminating information about best practices
prior to disbanding three years after enactment.
Section 102--Awareness campaigns
Section 102 requires that the Secretary of HHS, as
appropriate, to advance education and awareness of issues
related to opioid abuse. The Secretary is directed to carry out
these activities through existing programs and activities. The
awareness campaigns should address information on prevention
and detection of opioid abuse. Section 102 of S. 524 included a
similar provision.
Section 103--Community-based coalition enhancement grants to address
local drug crises
Section 103 authorizes the Office of National Drug
Control Policy (ONDCP) to award grants to implement community-
wide prevention strategies for addressing the local drug crisis
or emerging drug abuse issue in areas with high rates of opioid
or methamphetamine abuse. The section authorizes the
appropriation of $5 million for each of fiscal years 2017
through 2021, and allows ONDCP to delegate authority for
carrying out the grant program. Section 103 of S. 524 included
a similar provision.
Section 104--Information materials and resources to prevent addiction
related to youth sports injuries
Section 104 directs the Secretary of HHS to make
publically available a report determining the extent to which
informational materials and resources are available with
respect to youth sports injuries for which opioids are
potentially prescribed. The Secretary may then facilitate the
development of materials if gaps are found in resources that
are currently available. Teenage athletes who are prescribed an
opioid are uniquely susceptible to opioid addiction. The House
amendment included similar language.
Section 105--Assisting veterans with military emergency medical
training to meet requirements for becoming civilian health care
professionals
Section 105 would award demonstration grants to states to
streamline the licensure requirements for veterans who held
military occupational specialties related to medical care or
who completed certain military medical training to more easily
meet civilian health care licensure requirements. The House
amendment included similar language that applied only to
military emergency medical technicians.
Section 106--FDA opioid action plan
Section 106 requires that the Food and Drug
Administration (FDA) consult with advisory committees prior to
approval or labeling of certain new opioids in pediatric
populations. FDA must also issue final guidance for generic
drugs that claim abuse deterrence within 18 months of the date
of enactment, and develop recommendations regarding educational
programs for prescribers of opioids. The House amendment
included similar language.
Section 107--Improving access to overdose treatment
Currently, there are questions as to when co-prescribing
or prescribing of opioid reversal drugs approved by the Federal
Food, Drug and Cosmetic Act for emergency treatment of known or
suspected opioid overdose is appropriate. Section 107 would
allow the Secretary of HHS, the Secretary of Veterans Affairs
(VA), and the Secretary of Defense, 180 days after enactment,
to provide information to prescribers on co-prescribing or
prescribing a drug or device for emergency treatment of known
or suspected opioid overdose. It explicitly states that the
best practices in this section are not to be construed as or to
establish a medical standard of care. This section also
establishes a grant program to increase access to opioid
overdose treatment. The House amendment included similar
language.
Section 108--NIH opioid research
Section 108 allows the National Institutes of Health
(NIH) to intensify and coordinate fundamental, translational,
and clinical research with respect to the understanding of
pain, the discovery and development of therapies for chronic
pain, and the development of alternatives to opioids for
effective pain treatments in order to advance the discovery and
development of novel, safe, non-addictive, effective, and
affordable pharmaceuticals and other therapies for chronic
pain.
Section 109--National All Schedules Prescription Electronic Reporting
reauthorization
Section 109 reauthorizes the National All Schedules
Prescription Electronic Reporting (NASPER) Act within HHS to
provide grants to states to establish, implement, and improve
state-based prescription drug monitoring programs (PDMPs).
NASPER first became law in 2005 but expired in 2010. CARA will
extend funding for NASPER for five years at $10 million a year
for FY 2017 through FY 2021. The House amendment included
similar language.
Section 110--Opioid overdose reversal medication access and education
grant programs
Section 110 would allow the Secretary of HHS to make
grants available for states to implement standing orders for
opioid reversal drugs approved by the Federal Food, Drug and
Cosmetic Act for emergency treatment of known or suspected
opioid overdose. These grants may target states that have a
significantly higher per-capita rate of opioid overdoses than
the national average. Each state that is awarded a grant under
this program must submit a report to the Secretary of HHS
evaluating the grant and the services that were provided. The
House amendment included similar language.
TITLE II--LAW ENFORCEMENT AND TREATMENT
Section 201--Comprehensive opioid abuse grant program
Section 201 includes the provisions of Title II of the
House amendment to S. 524. It creates a comprehensive grant
program at the Department of Justice (DOJ) to address the
problems of opioid addiction and abuse. Though there is no
corresponding provision in S. 524 as passed by the Senate, the
program created by this section includes several ``allowable
uses'' that are similar to provisions in that bill. Minor
changes have been made to the conference provisions for
clarity. The allowable uses of grant funds include:
(1) Alternatives to incarceration programs, which
replaces Section 201 of the Senate bill. The list of
allowable alternatives to incarceration programs is
very similar to the programs in the Senate bill,
including pre- and post-booking treatment programs such
as drug courts and veterans treatment courts, and
criminal justice training programs.
(2) Collaboration between criminal justice agencies
and substance abuse systems, which is nearly identical
to Section 201 of the Senate bill;
(3) Training for first responders in carrying and
administering opioid overdose reversal drugs and
purchasing such drugs for first responders who have
received training;
(4) Investigative purposes related to the unlawful
distribution of opioids;
(5) Medication-assisted treatment by criminal
justice agencies, which is highlighted in Section 302
of the Senate bill;
(6) Prescription drug monitoring programs
administered by states;
(7) Programs that address juvenile opioid abuse,
which does not have a Senate companion;
(8) Initiatives to prevent pilfering of
prescription opioids, which does not have a Senate
companion;
(9) Prescription drug take-back programs; and
(10) Development of a jurisdiction's own
comprehensive opioid abuse reduction program.
$103,000,000 is authorized to be appropriated for each of
fiscal years 2017 through 2021 to carry out this grant program.
This discretionary authorization is fully offset in accordance
with the House's CUTGO protocol.
This section also allows grantees to make subawards to
local or regional nonprofit organizations, including faith-
based organizations, units of local government, and tribal
organizations. This section would permit organizations that are
private and nonprofit to receive subawards, including
organizations that provide alternative complementary mental
health services.
This section requires that the Attorney General ensure
equitable distribution of funds, taking into consideration the
needs of underserved populations such as rural and tribal
communities, and the prevalence of opioid abuse in a community.
It also ensures that entities that provide services to pregnant
women are eligible for grants under the Family-Based Substance
Abuse Grant Program.
Finally, this section directs the Government
Accountability Office (GAO) to study and report on how federal
agencies, including ONDCP, through grant programs, are
addressing prevention, treatment, and recovery from substance
abuse disorders on the part of adolescents and young adults.
Section 202--First responder training
Section 201 of the conference report codifies an existing
grant program at the Substance Abuse and Mental Health Services
Administration (SAMSHA) to expand access to life-saving opioid
overdose reversal drugs by supporting the purchase and
distribution of opioid overdose reversal drugs and training for
first responders and other key community sectors. S. 524
included similar language.
Section 203--Prescription drug take-back expansion
This section, identical to Section 203 of the Senate
bill, authorizes the Attorney General, in coordination with the
Administrator of the Drug Enforcement Administration (DEA), the
Secretary of HHS, and the Director of ONDCP, to coordinate with
certain entities in expanding or making available disposal
sites for unwanted prescription medications. These entities
include state and local law enforcement agencies, manufacturers
and distributors of prescription medications, retail
pharmacies, narcotic treatment programs, hospitals with on-site
pharmacies, and long-term care facilities.
TITLE III--TREATMENT AND RECOVERY
Section 301--Evidence-based prescription opioid and heroin treatment
and interventions demonstration
Section 301 of the conference report codifies an existing
grant program at SAMHSA to support states in expanding access
to addiction treatment services for individuals with an opioid
use disorder, including evidence-based medication assisted
treatment. This program is targeted toward areas where there is
a high rate or a rapid increase in the use of heroin or other
opioids, including rural areas. S. 524 included this language.
Section 302--Building communities of recovery
Section 302 of the conference report allows HHS to
provide grants to community organizations to develop, expand,
and enhance recovery services and build connections between
recovery networks, including physicians, the criminal justice
system, employers, and other recovery support systems. Recovery
services help individuals with a substance use disorder get and
stay well and increase long-term recovery from substance use
disorders. S. 524 included this language.
Section 303--Medication-assisted treatment for recovery from addiction
The House amendment included provisions amending the
Controlled Substances Act to permit nurse practitioners and
physician assistants (NPs and PAs) who meet certain criteria to
receive a waiver from SAMHSA to dispense certain drugs for
maintenance or detoxification treatment in an office-based
setting to up to 30 patients in the first year and up to 100
patients after the first year and going forward. In states
where NPs and PAs are required to practice in collaboration
with, or under the supervision of a physician, such physician
would also need to be a qualifying practitioner (i.e., have
their own waiver from SAMHSA). This new authority for NPs and
PAs would sunset three years after the date of enactment.
Section 303 of the conference report includes similar
operative language to the House amendment, though it requires
the implementing regulations to be updated no later than 18
months after the date of enactment and the new authority for
NPs and PAs expires October 1, 2021. Further, this section
would not preempt any state law that establishes a lower limit
on the number of patients a qualifying practitioner can treat
at any given time or requires a qualifying practitioner to
comply with additional requirements relating to the dispensing
of such drugs.
TITLE IV--ADDRESING COLLATORAL CONSEQUENCES
Section 401--GAO report on recovery and collateral consequences
This section directs GAO to submit a report to the Senate
and House Judiciary Committees on recovery and the collateral
consequences of drug-related criminal convictions within one
year of the date of the Act's enactment. The report will study
the collateral consequences for individuals with convictions
for non-violent drug-related offenses and the effects of these
collateral consequences on individuals in recovery on their
ability to resume their personal and professional activities.
The report will also discuss the policy bases and
justifications for imposing these collateral consequences and
provide perspectives on the potential for mitigating the effect
of these collateral consequences on individuals in recovery.
TITLE V--ADDICTION AND TREATMENT SERVICES FOR WOMEN, FAMILIES, AND
VETERANS
Section 501--Improving treatment for pregnant and postpartum women
Section 501 reauthorizes a grant program for residential
treatment for pregnant and postpartum women who have an opioid
use disorder. This program also provides services for the
children of such women, including those who may be born with
neonatal abstinence syndrome. It creates a new pilot program to
enhance the flexibility of the funds so states can more broadly
support family-based services for pregnant and postpartum women
and their children. S. 524 included language to reauthorize
this program and create a pilot program but at a lower
authorized level than the language included in the House
amendment.
Section 502--Veterans treatment courts
The language in this section is drawn from the House
amendment to S. 524, and replaces the language from Section 503
of the Senate bill. However, consistent with the Senate bill,
this section defines ``qualified veterans'' for purposes of the
DOJ grant program as those who have served on active duty in
any branch of the Armed Services and have been discharged under
conditions other than dishonorable, unless the reason for the
dishonorable discharge was attributable to a substance abuse
disorder.
Additionally, this section provides a definitional
framework for ``peer-to peer'' programs, ``veterans treatment
court'' programs, and ``veterans assistance'' programs that are
eligible under this section. This section is cross-referenced
in the ``alternatives to incarceration'' piece of section 201
of the conference report, and should provide guidance on how
grantees are to use grant funds received for veterans courts.
Section 503--Infant plan of safe care
Section 503 incorporates text originally passed as part
of the House amendment to S. 524 and responds to concerns about
the increased number of infants born suffering from opioid
withdrawal symptoms and ensures states are in compliance with
the Child Abuse Prevention and Treatment Act (CAPTA). No
corresponding provision was included in S. 524. This section
requires the Department of HHS to review and confirm states
have CAPTA policies in place as required under the law,
strengthens protections for infants born with substance
exposure by clarifying the intent of safe care plans, and
requires the HHS Secretary to share best practices for
developing plans to keep infants and their caregivers safe and
healthy. It also improves accountability related to the care of
infants and their families by requiring additional information
be shared on incidents of infants exposed and their subsequent
care. Additionally, it encourages the use of information made
available through other child welfare laws in verifying CAPTA
compliance. Finally, section 503 prevents HHS from adding new
requirements to state assurances and plans.
Section 504--GAO report on Neonatal Abstinence Syndrome (NAS)
Section 504 requires the Comptroller General of the
United States to, one year after enactment, issue a report on
neonatal abstinence syndrome (NAS), including information on
the treatment for infants with NAS under Medicaid.
Specifically, the report will examine what is known about the
prevalence of NAS in the country; the Medicaid-reimbursable
services available to treat NAS; the types of, and
reimbursement for care settings in which infants with NAS
receive care; and any federal policy barriers for treating
infants with NAS and what is known about best practices for
caring for infants with NAS. Similar language was included in
the House amendment.
TITLE VI--INCENTIVIZING STATE COMPREHENSIVE INITIATIVES TO ADDRESS
PRESCRIPTION OPIOID ABUSE
Section 601--State demonstration grants for comprehensive opioid abuse
response
Section 601 of the conference report supports State
efforts to combat opioid abuse by authorizing HHS to award
grants to States and combinations of States to carry out a
comprehensive opioid abuse response, including education,
treatment, and recovery efforts, maintaining prescription drug
monitoring programs, and efforts to prevent overdose deaths. S.
524 included this language; there was no corresponding
legislation in the House amendment.
TITLE VII--MISCELLANEOUS
Section 701--Grant accountability and evaluations
This section combines language that originated in both
the House and Senate on grant oversight. It requires the DOJ
Inspector General, at his or her discretion, to conduct audits
of covered grantees to prevent waste, fraud, and abuse of
funds. This section prohibits grantees with unresolved audit
findings from receiving grants in the following fiscal year,
and prioritizes grantees that do not have unresolved audit
findings. If a grantee nevertheless receives funds
inappropriately, this section also compels DOJ to reimburse the
Department of the Treasury for the amount awarded, and to seek
to recoup the funds from the grantee.
With respect to nonprofit organizations, this section
prohibits nonprofits that hold money in offshore accounts for
the purpose of avoiding certain federal taxes from receiving
subawards from grant recipients. It also requires nonprofit
organizations to disclose, in a grant application, the
compensation of its board of directors. Finally, this section
limits the use of grant funds for conference expenditures, and
prevents the awarding of duplicative grants.
This section also contains the provisions applicable to
DOJ from Title VI of the House amendment to S. 524, the Opioid
Program Evaluation (OPEN) Act, which did not have a Senate
companion. It requires the Attorney General to complete an
evaluation of the effectiveness of the Comprehensive Opioid
Abuse Grant Program based upon the information reported by
grantees not later than 5 years after the enactment of the Act.
It requires the Attorney General to identify outcomes to be
achieved under the Comprehensive Opioid Grant Abuse Program,
and the metrics by which the achievement of such outcomes shall
be determined, not later than 180 days after the enactment of
the Act.
This section provides that the Attorney General must
require grantees and those receiving subawards to collect and
annually report data on the activities conducted using their
grant funding. It requires that the Attorney General publish
the outcomes and metrics to be used to evaluate the program not
later than 30 days after identifying such outcomes and metrics,
and that the entity conducting the evaluation publish the
results and issue a report to the House and Senate Judiciary
Committees not later than 90 days after completion of the
evaluation. It further requires the data collected from
grantees to be published along with the report.
Finally, this section requires that the Attorney General
enter into an arrangement with the National Academy of
Sciences--or another non-government entity with expertise in
conducting and evaluating research pertaining to opioid use and
abuse and drawing conclusions about overall opioid use and
abuse on the basis of that research--to identify the outcomes
to be achieved, the metrics by which performance will be
evaluated, and the evaluation of the Comprehensive Opioid Abuse
Grant Program.
Section 701 also authorizes HHS to evaluate grants
authorized within the Comprehensive Addiction Recovery Act and
identify outcomes to be achieved by the programs, and metrics
by which to measure those outcomes.
This section also places restrictions on conference
expenditures using funding under a grant program in this Act.
Section 702--Partial fill of Schedule II controlled substances
Section 702 clarifies that if a doctor or patient
requests a prescription for a Schedule II substance (such as an
opioid) not be filled in its entirety, in accordance with state
law; pharmacists are permitted to dispense only part of the
prescription. This change could lead to fewer opioids being
dispensed. The House amendment to CARA permitted more
flexibility in filling Schedule II prescriptions such as
opioids.
Section 703--Good Samaritan Assessment
This section includes the provisions of Title V of the
House amendment to S. 524, the Good Samaritan Assessment Act,
which did not have a Senate companion. It directs the GAO to
issue a report to the House and Senate Judiciary Committees,
the House Oversight and Government Reform Committee, and the
Senate Homeland Security and Governmental Affairs Committee, on
the extent to which ONDCP has reviewed Good Samaritan laws and
the findings from such a review; efforts by the ONDCP Director
to encourage the enactment of Good Samaritan laws; and a
compilation of Good Samaritan laws in effect in the States, the
territories, and the District of Columbia.
Currently, more than half the states and the District of
Columbia have some form of Good Samaritan law on the books, to
protect citizens who render help to someone in need--or, in the
context of opioids, to exempt from criminal or civil liability
someone who administers an opioid overdose reversal drug or
device, such as naloxone, or who calls 911 to report an
overdose.
Given the widespread activity in state legislatures on
this issue, and the differences between individual state
statutes, this section directs GAO to study and report to
Congress on the effects of the various Good Samaritan laws at
the state level, and efforts by ONDCP to address the issue.
Section 704--Programs to prevent prescription drug abuse under Medicare
Parts C and D
Section 704 would allow prescription drug plans in
Medicare, including Medicare Part D plans as well as standalone
Medicare Advantage Prescription Drug Plans, to develop a safe
prescribing and dispensing program for beneficiaries that are
at risk of abuse or diversion of drugs that are frequently
abused or diverted. The provision allows the Secretary of HHS
to work with private drug plan sponsors to facilitate the
creation and management of ``lock-in'' programs to curb
identified fraud, abuse, and misuse of prescribed medications
while at the same time ensuring that legitimate beneficiary
access to needed medications is not impeded.
Such controls would prevent doctor/pharmacy shopping as
well as duplicative and inappropriate drug therapies that can
lead to prescription drug abuse. The conference report gives
the Secretary responsibility to define an at-risk beneficiary
using clinical guidelines developed in consultation with
stakeholders. Plans would be able to identify enrolled Medicare
beneficiaries deemed at high risk of abusing prescription
drugs, and to limit such beneficiaries' choice of prescribers
or pharmacies in order to better monitor their use of these
medications. For example, restrictions might be placed on
beneficiaries suspected of abusing or reselling certain
controlled substances, but not placed on beneficiaries with
cancer or other conditions for which those drugs are considered
appropriate. Plan sponsors, under the conference report, would
have to take into consideration where an at-risk beneficiary
lives and works, as well as other relevant factors when
assigning providers and pharmacies and would also consider the
beneficiary's preferences unless it is deemed the cause of
potential abuse. Plan sponsors also will have to comply with a
number of beneficiary protections including ensuring access,
notifications and disclosure requirements, as well as appeal
rights. S. 524 included similar language.
Sections 705-707--Exempting abuse-deterrent formulations of
prescription drugs from the Medicaid additional rebate
requirement for new formulations of prescription drugs;
limiting disclosure of predictive modeling and other analytics
technologies to identify and prevent fraud, waste, and abuse;
and Medicaid improvement fund
Sections 705-707 would exempt abuse deterrent
formulations of opioid drugs (ADFs) from the definition of
``line extension'' for the purpose of calculating Medicaid
rebates. In its Opioids Action Plan, FDA said its goal is to
``expand access to abuse deterrent formulations to discourage
abuse.'' And in its ADF guidance to manufacturers, the agency
has said it ``considers the development of these products a
high public health priority.'' This policy was also included in
the President's FY 2017 Budget, which noted that this statutory
change would ``incentivize continued development of abuse
deterrent formulations.''
The budgetary impact of the ADF policy is being offset by
a policy from the President's budget that prevents the public
disclosure of program integrity algorithms used to identify and
predict waste, fraud, and abuse in Medicare, Medicaid, and the
Children's Health Insurance Program (CHIP) and places the
remaining savings in a Medicaid Improvement Fund. The
mathematical algorithms and predictive technologies the Centers
for Medicare and Medicaid Services (CMS) uses in Medicare,
Medicaid, and CHIP are vital to uncovering fraud, waste, and
abuse. However, if various aspects of these algorithms were to
become publicly known, fraudsters could utilize the information
to re-direct their schemes to other areas of the Medicare,
Medicaid, and CHIP programs or adjust their schemes to avoid
detection. This policy would simply prevent the disclosure of
these anti-fraud tools through FOIA-related laws while still
allowing CMS and state Medicaid and CHIP programs to freely
share algorithms and other predictive analytical tools.
The conference provision is the same as the provision
included in the House amendment.
Section 708--Sense of Congress regarding treatment of substance abuse
epidemics
This section includes a Sense of Congress that decades of
experience and research have demonstrated that a fiscally
responsible approach to addressing the opioid abuse epidemic
and other substance abuse epidemics requires treating such
epidemics as a public health emergency emphasizing prevention,
treatment, and recovery.
TITLE VIII--KINGPIN DESIGNATION IMPROVEMENT
Section 801--Protection of classified information
This section incorporates the provisions of Title IV of
the House amendment to S. 524, which passed the House on May
10, 2016, and its Senate companion, S. 2914, the ``Kingpin
Designation Improvement Act.'' The section amends Section 804
of the Foreign Narcotics Kingpin Designation Act to include
language to protect classified information from disclosure
during a federal court challenge by a designee.
Under current law, the Treasury Department's Office of
Foreign Assets Control (OFAC) uses the International Emergency
Economic Powers Act (IEEPA) and the Foreign Narcotics Kingpin
Designation Act (the ``Kingpin Act'') to target and apply
sanctions to international narcotics traffickers and their
organizations. The Kingpin Act is the principal mechanism by
which OFAC sanctions foreign persons tied to global narcotics
trafficking.
OFAC's designations are often based upon classified
information. Unlike in a related federal statute, the Kingpin
Act does not contain such a mechanism to protect classified
information from release during a ``de-listing'' process. That
means OFAC may lose the opportunity to designate a high-level
drug kingpin because it cannot risk the disclosure of
classified information.
This section clarifies that OFAC can submit classified
information to defend its designations ex parte and in camera
in the relevant U.S. district court, thereby ensuring
classified information can be protected from disclosure.
TITLE IX--DEPARTMENT OF VETERANS AFFAIRS
Section 901--Short title
Includes the title ``Jason Simcakoski Memorial and
Promise Act.''
Section 902--Definitions
This section includes various definitions of terms used
throughout Title IX.
Section 911--Improvement of opioid safety measures by the Department of
Veterans Affairs
This provision requires the Secretary to expand the
Opioid Safety Initiative to include all VA medical facilities
within 180 days of enactment of this act, and would require
that all VA employees who prescribe opioids receive education
and training on pain management and safe opioid prescribing
practices. The Secretary would also be required to establish
enhanced standards with respect to the use of routine and
random drug tests for all patients before and during opioid
therapy. Directors of each medical facility will be required to
designate a pain management team of health care professionals
responsible for coordinating and overseeing pain management
therapy and will provide an annual report identifying the
members of the facility's pain management team, certification
as to education and training, and compliance with the stepped-
care model or other pain management policies. This provision
also requires participation in state prescription drug
monitoring programs; a report on the feasibility and
advisability of advanced real-time tracking of opioid use data
in the Opioid Therapy Risk Report tool; an increase in the
availability of opioid receptor antagonists such as naloxone
and a report on compliance; inclusion in the Opioid Therapy
Risk Report tool of information identifying when health care
providers access the tool and the most recent urine drug test
for each veteran; and notification of opioid abuse risk in the
computerized patient record system.
Both H.R. 4063 and S. 2921, as reported, included similar
language.
Section 912--Strengthening of joint working group on pain management of
the Department of Veterans Affairs and the Department of
Defense
H.R. 4063 and S. 2921, as reported, require that VA and
the Department of Defense (DOD) ensure that the Health
Executive Committee's Pain Management Working Group (PMWG)
includes a focus on the opioid prescribing practices of health
care providers of each Department; the ability of each
Department to manage acute and chronic pain, including training
health care providers with respect to pain management; the use
by each Department of complementary and integrative health; the
concurrent use by health care providers of each Department of
opioids and prescription drugs to treat mental health
disorders, including benzodiazepines; the use of care
transition plans by health care providers of each Department to
address case management issues for patients receiving opioid
therapy who transition between inpatient and outpatient
settings; coordination in coverage of and consistent access to
medications prescribed for patients transitioning from
receiving health care from DOD to VA; and the ability of each
Department to screen, identify, and treat patients with
substance use disorders who are seeking treatment for acute and
chronic pain.
This provision also ensures the PMWG coordinates its
activities with other relevant working groups; consults with
other relevant federal agencies, including the Centers for
Disease Control and Prevention; consults with the VA and DOD
with respect to the VA/DOD Clinical Practice Guideline for
Management of Opioid Therapy for Chronic Pain; and reviews and
comments on the guideline before any update to such guideline
is released.
This provision requires VA and DOD to jointly update the
VA/DOD Clinical Practice Guideline for Management of Opioid
Therapy for Chronic Pain within 180 days of enactment. This
provision requires that the PMWG, in coordination with the
Clinical Practice Guideline VA/DOD Management of Opioid Therapy
for Chronic Pain Working Group, examine whether the guidelines
should include numerous elements. The elements to be considered
include, but are not limited to, enhanced guidance with respect
to: opioid and other drug prescription practices; treatment of
patients with behaviors or comorbidities that require co-
management of opioid therapy; patient status assessments
conducted by providers; governance of the methodologies used by
VA and DOD providers to taper opioid therapy; appropriate case
management for opioid patients transitioning from an inpatient
setting to an outpatient setting; appropriate case management
for opioid patients transitioning from active duty to post-
military health care networks; how providers should discuss
with patients options for pain management therapies before
initiating opioid therapy; provision of evidence-based non-
opioid treatments within VA and DOD; and consideration of
guidelines developed by CDC for safely prescribing opioids.
Section 913--Review, investigation, and report on use of opioids in
treatment by Department of Veterans Affairs
This provision requires GAO, not later than 2 years after
enactment, to submit a report on the Opioid Safety Initiative
and the opioid prescribing practices of VA health care
providers. This provision also requires semi-annual progress
reports on the implementation of any GAO recommendations
generated by this report. The Secretary must also review and
report annually on the patient population receiving opioid
therapy and the prescription rates of each medical facility and
conduct investigations, through the Office of the Medical
Inspector, on prescription rates that conflict with or are
otherwise inconsistent with the standards of appropriate and
safe care.
Both H.R. 4063 and S. 2921, as reported, included similar
language.
Section 914--Mandatory disclosure of certain veteran information to
state controlled substance monitoring programs
This provision includes the H.R. 4063, as reported,
language requiring that VA providers shall disclose certain
veteran information to state controlled substance monitoring
programs.
Section 915--Elimination of copayment requirement for veterans
receiving opioid antagonists or education on use of opioid
antagonists
This provision includes the S. 2921, as reported,
language that would eliminate the copayment requirement for
veterans receiving opioid antagonists or education on the use
of opioid antagonists.
Section 921--Community meetings on improving care furnished by
Department of Veterans Affairs
This provision requires that, within 90 days of the
enactment of this act, and quarterly thereafter, each VA
medical facility hosts a public community meeting on improving
VA health care; and within one year of the enactment of this
act, and at least annually thereafter, that each community-
based outpatient clinic (CBOC) hosts such a community meeting.
These meetings will require regular senior leadership
attendance and notice will be given to the Committees on
Veterans' Affairs of the House and of the Senate and the
Members of Congress who represent the area in which the
facility is located at least ten days in advance.
Both H.R. 4063 and S. 2921, as reported, included similar
language.
Section 922--Improvement of awareness of Patient Advocacy Program and
Patient Bill of Rights of Department of Veterans Affairs
This provision would require, within 90 days of the
enactment of this act, the display of, in as many prominent
locations as the Secretary determines appropriate to be seen by
the largest percentage of patients at each VA medical facility:
(1) the purposes of the VA Patient Advocacy Program and the
contact information for the patient advocate at each medical
facility; and (2) the rights and responsibilities of patients
and family members and, with respect to community living
centers and other VA residential facilities.
Both H.R. 4063 and S. 2921, as reported, included similar
language.
Section 923--Comptroller General report on Patient Advocacy Programs of
Department of Veterans Affairs
Both H.R. 4063 and S. 2921 require that, within two years
of the enactment of this act, GAO submit a report on the VA
Patient Advocacy Program to the Committees on Veterans' Affairs
of the House and of the Senate. The report will include: (1) a
description of the Program, including the Program's purpose,
activities, and sufficiency in achieving its purpose; (2) an
assessment of the sufficiency of the Program's staffing; (3) an
assessment of the Program's employee training; (4) an
assessment of veterans' and family members' awareness of and
utilization of the Program; (5) recommendations for improving
the Program; and (6) any other information the GAO considers
appropriate.
Both H.R. 4063 and S. 2921, as reported, included similar
language.
Section 924--Establishment of office of patient advocacy of the
Department of Veterans Affairs
This section establishes an office of patient advocacy
within the Office of the Undersecretary for Health of the
Department of Veterans Affairs. This office will ensure patient
advocates appropriately advocate for veteran patients and are
trained in their responsibilities.
Section 931--Expansion of research and education on and delivery of
complementary and integrative health to veterans
H.R. 4063, as reported, establishes a Commission to
examine the evidence-based therapy treatment model used by VA
for treating mental health conditions of veterans and the
potential benefits of incorporating complementary and
integrative health as standard practice throughout the
Department. The Commission would: (1) examine the efficacy of
the evidence-based therapy model used by VA to treat mental
health illnesses and identify areas of improvement; (2) conduct
a patient-centered survey within each VISN to examine: the
experiences of veterans with VA facilities regarding mental
health care, the experiences of veterans with non-VA facilities
regarding mental health care, the preferences of veterans
regarding available treatment for mental health issues and
which methods the veterans believe to be most effective, the
experience, if any, of veterans with respect to the
complementary and integrative health treatment therapies, the
prevalence of prescribing medication to veterans seeking
treatment for mental health disorders through VA, and the
outreach efforts of VA regarding the availability of benefits
and treatments for veterans for addressing mental health
issues; (3) examine available research on complementary and
integrative health for mental health disorders in areas of
therapy including: music therapy, equine therapy, training and
caring for service dogs, yoga therapy, acupuncture therapy,
meditation therapy, outdoor sports therapy, hyperbaric oxygen
therapy, accelerated resolution therapy, art therapy, magnetic
resonance therapy, and others; (4) study the sufficiency of VA
resources to deliver quality mental health care; and (5) study
the current treatments and resources available within VA and
assess: the effectiveness of such treatments and resources in
decreasing the number of suicides per day by veterans, the
number of veterans who have been diagnosed with mental health
issues, the percentage of veterans who have completed VA
counseling sessions, and the efforts of VA to expand
complementary and integrative health treatments viable to the
recovery of veterans with mental health issues as determined by
the Secretary to improve the effectiveness of treatments
offered by VA.
Section 932--Pilot program on integration of complementary and
integrative health and related issues for veterans and family
members of veterans
The provision requires that the Secretary, informed by
the Commission's findings, commence a pilot program to assess
the feasibility and advisability of using wellness-based
programs to complement pain management and related health care
services. The pilot program would last for three years and be
carried out at no fewer than 15 VA facilities providing pain
management, two of which must be polytrauma centers. The
Secretary should prioritize medical centers at which there is a
prescription rate that is inconsistent with the standards of
appropriate care when selecting medical centers for the pilot.
The Secretary will report on findings and conclusions regarding
the use and efficacy of complementary and integrative health
services established under the pilot program, the outreach
conducted by VA about the pilot, and an assessment of the
benefit of the pilot program to covered veterans, as well as
identify any unresolved barriers to VA's use of complementary
and integrative medicine, and make recommendations for the
continuation or expansion of the pilot program.
Both H.R. 4063 and S. 2921, as reported, included similar
language.
Section 941--Additional requirements for hiring of health care
providers by Department of Veterans Affairs
This provision would require that, as part of the hiring
process for all heath care providers considered for a position
after the date of the enactment of this act, that the Secretary
require from the medical board of the State in which the
applicant is licensed: (1) information on any violations of the
requirements of medical license over the previous 20 years; and
(2) information on whether the provider has entered into any
settlement agreements for disciplinary charges related to the
practice of medicine.
Both H.R. 4063 and S. 2921, as reported, included similar
language.
Section 942--Provision of information on health care providers of
Department of Veterans Affairs to state medical boards
This provision would require that VA provide to the
medical board of each State in which the provider is licensed
information regarding violations, regardless of whether the
board has requested such information.
Both H.R. 4063 and S. 2921, as reported, included similar
language.
Section 943--Report on compliance by Department of Veterans Affairs
with reviews of health care providers leaving the department or
transferring to other facilities
This provision would require that, within 180 days of the
enactment of this act, that the Secretary submit to the
Committees on Veterans' Affairs of the House and of the Senate
a report on VA's compliance with VA policy to conduct a review
of each provider who transfers from another VA medical
facility, retires, or is terminated, and to take appropriate
actions with respect to any concerns, complaints, or
allegations against the provider.
Both H.R. 4063 and S. 2921, as reported, included similar
language.
Section 951--Modification to limitation on bonus and awards
This provision limits the amounts of funds available for
payment as bonuses and awards and directs those amounts now
available within the budget toward the payment for the programs
and services directed in this title.
This section also includes a Sense of Congress that
states the limitation under this subsection should not
disproportionately impact lower-wage employees within the VA.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
In compliance with clause 9(e), 9(f), and 9(g) of Rule
XXI of the Rules of the House of Representatives, the
conference report and joint explanatory statement contain no
earmarks, limited tax benefits, or limited tariff benefits.
Constitutional Statement of Authority
Congress has the power to enact this legislation pursuant
to the following: Article I, Section 8, Clause 3 of the United
States Constitution.
For consideration of the Senate bill and the
House amendments, and modifications committed
to conference:
Fred Upton,
Joseph R. Pitts,
Leonard Lance,
Brett Guthrie,
Adam Kinzinger,
Larry Bucshon,
Susan W. Brooks,
Bob Goodlatte,
F. James Sensenbrenner, Jr.,
Lamar Smith,
Tom Marino,
Doug Collins,
David A. Trott,
Mike Bishop,
Kevin McCarthy,
From the Committee on Education and the
Workforce, for consideration of title VII of
the House amendment, and modifications
committed to conference:
Lou Barletta,
Earl L. ``Buddy'' Carter,
From the Committee on Veterans' Affairs, for
consideration of title III of the House
amendment, and modifications committed to
conference:
Gus M. Bilirakis,
Jackie Walorski,
From the Committee on Ways and Means, for
consideration of sec. 705 of the Senate bill,
and sec. 804 of the House amendment, and
modifications committed to conference:
Patrick Meehan,
Robert J. Dold,
Managers on the Part of the House.
Chuck Grassley,
Lamar Alexander,
Orrin G. Hatch,
Jeff Sessions,
Managers on the Part of the Senate.
[all]
