[United States Statutes at Large, Volume 130, 114th Congress, 2nd Session]
[From the U.S. Government Publishing Office, www.gpo.gov]
Public Law 114-198
114th Congress
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. <>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <>
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``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).
[[Page 696]]
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.
[[Page 697]]
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
[[Page 698]]
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
[[Page 699]]
(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.
[[Page 700]]
(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
[[Page 701]]
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
[[Page 702]]
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;
[[Page 703]]
(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
[[Page 704]]
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
[[Page 705]]
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.
[[Page 706]]
(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:
[[Page 707]]
``(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
[[Page 708]]
(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--
[[Page 709]]
(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--
[[Page 710]]
``(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''.
[[Page 711]]
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
[[Page 712]]
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:
[[Page 713]]
``(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.
[[Page 714]]
``(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
[[Page 715]]
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
[[Page 716]]
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
[[Page 717]]
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.--
[[Page 718]]
``(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.''.
[[Page 719]]
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.''.
[[Page 720]]
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'';
[[Page 721]]
(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
[[Page 722]]
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
[[Page 723]]
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--
[[Page 724]]
(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)--
[[Page 725]]
(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)--
[[Page 726]]
(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
[[Page 727]]
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;
[[Page 728]]
``(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--
[[Page 729]]
``(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--
[[Page 730]]
(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);
[[Page 731]]
``(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.
[[Page 732]]
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--
[[Page 733]]
``(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
[[Page 734]]
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.''.
[[Page 735]]
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.--
[[Page 736]]
``(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;
[[Page 737]]
``(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
[[Page 738]]
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.
[[Page 739]]
(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--
[[Page 740]]
(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.--
[[Page 741]]
``(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
[[Page 742]]
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);
[[Page 743]]
``(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
[[Page 744]]
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
[[Page 745]]
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
[[Page 746]]
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
[[Page 747]]
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.
[[Page 748]]
``(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--
[[Page 749]]
``(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
[[Page 750]]
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,
[[Page 751]]
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--
[[Page 752]]
(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''.
[[Page 753]]
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
[[Page 754]]
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
[[Page 755]]
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
[[Page 756]]
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.
[[Page 757]]
(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
[[Page 758]]
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.--
[[Page 759]]
(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;
[[Page 760]]
(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
[[Page 761]]
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
[[Page 762]]
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
[[Page 763]]
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
[[Page 764]]
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
[[Page 765]]
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
[[Page 766]]
(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--
[[Page 767]]
(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.
[[Page 768]]
``(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.
[[Page 769]]
``(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;
[[Page 770]]
(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.
[[Page 771]]
(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
[[Page 772]]
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
[[Page 773]]
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.
[[Page 774]]
(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.
[[Page 775]]
(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.
[[Page 776]]
(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
[[Page 777]]
(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
[[Page 778]]
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
[[Page 779]]
Affairs is encouraged to use bonuses to incentivize high-performing
employees in areas in which retention is challenging.''.
Approved July 22, 2016.
LEGISLATIVE HISTORY--S. 524 (H.R. 1725) (H.R. 1818) (H.R. 3680) (H.R.
3691) (H.R. 4063) (H.R. 4586) (H.R. 4599) (H.R. 4641)
(H.R. 4843) (H.R. 4892) (H.R. 4969) (H.R. 4976)
(H.R. 4978) (H.R. 4981) (H.R. 4982) (H.R. 4985)
(H.R. 5046) (H.R. 5048) (H.R. 5052):
---------------------------------------------------------------------------
HOUSE REPORTS: Nos. 114-669 (Comm. of Conference), 114-245 (Comm. on
Energy and Commerce) accompanying H.R. 1725, 114-552 (Comm. on Energy
and Commerce) accompanying H.R. 1818, 114-553 (Comm. on Energy and
Commerce) accompanying
H.R. 3680, 114-554 (Comm. on Energy and Commerce) accompanying H.R.
3691, 114-546, Pt. 1 (Comm. on Veterans' Affairs) accompanying H.R.
4063, 114-555 (Comm. on Energy and Commerce) accompanying H.R. 4586,
114-556 (Comm. on Energy and Commerce) accompanying H.R. 4599, 114-536
(Comm. on Energy and Commerce) accompanying H.R. 4641, 114-548 (Comm. on
Education and the Workforce) accompanying H.R. 4843, 114-558 (Comm. on
Energy and Commerce) accompanying H.R. 4969, 114-557 (Comm. on Energy
and Commerce) accompanying H.R. 4976, 114-559 (Comm. on Energy and
Commerce) accompanying H.R. 4978, 114-561, Pt. 1 (Comm. on Energy and
Commerce) accompanying H.R. 4981, 114-560 (Comm. on Energy and Commerce)
accompanying
H.R. 4982, 114-547, Pt. 1 (Comm. on the Judiciary) accompany-
ing H.R. 4985, 114-539 (Comm. on the Judiciary) accompanying H.R. 5046,
114-540 (Comm. on the Judiciary) accompanying H.R. 5048, and 114-541,
Pt. 1 (Comm. on the Judiciary) accompanying H.R. 5052.
CONGRESSIONAL RECORD, Vol. 162 (2016):
Mar. 2, 3, 7-10, considered and passed Senate.
May 13, considered and passed House, amended.
July 8, House agreed to conference report.
July 11-13, Senate considered and agreed to conference
report.
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2016):
July 22, Presidential statement.