Cara

PUBLIC LAW 114–198—JULY 22, 2016

130 STAT. 695

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:

July 22, 2016
[S. 524]

Comprehensive
Addiction and
Recovery Act
of 2016.
42 USC 201 note.

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.

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TITLE V—ADDICTION AND TREATMENT SERVICES FOR WOMEN, FAMILIES,
AND VETERANS
Sec.
Sec.
Sec.
Sec.

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501.
502.
503.
504.

Improving treatment for pregnant and postpartum women.
Veterans treatment courts.
Infant plan of safe care.
GAO report on neonatal abstinence syndrome (NAS).

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130 STAT. 696

PUBLIC LAW 114–198—JULY 22, 2016
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.
Sec.
Sec.
Sec.

701.
702.
703.
704.

Sec. 705.
Sec. 706.
Sec. 707.
Sec. 708.

Grant accountability and evaluations.
Partial fills of schedule II controlled substances.
Good samaritan assessment.
Programs to prevent prescription drug abuse under Medicare parts C and
D.
Excluding abuse-deterrent formulations of prescription drugs from the
Medicaid additional rebate requirement for new formulations of prescription drugs.
Limiting disclosure of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse.
Medicaid Improvement Fund.
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

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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.

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PUBLIC LAW 114–198—JULY 22, 2016

130 STAT. 697

TITLE I—PREVENTION AND EDUCATION

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SEC. 101. TASK FORCE ON PAIN MANAGEMENT.

Establishment.

(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

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Deadline.
Recommendations.
Public
information.

PUBL198

130 STAT. 698

Public
information.
Time period.

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42 USC
290bb–25g.
Coordination.

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PUBLIC LAW 114–198—JULY 22, 2016

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

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PUBLIC LAW 114–198—JULY 22, 2016

130 STAT. 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.

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SEC. 103. COMMUNITY-BASED COALITION ENHANCEMENT GRANTS TO
ADDRESS LOCAL DRUG CRISES.

21 USC 1536.

(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 ‘‘DrugFree 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.

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130 STAT. 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.

Coordination.

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Contracts.

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PUBLIC LAW 114–198—JULY 22, 2016

42 USC
290bb–25g note.

SEC. 104. INFORMATION MATERIALS AND RESOURCES TO PREVENT
ADDICTION RELATED TO YOUTH SPORTS INJURIES.

Public
information.
Web posting.

(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

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PUBLIC LAW 114–198—JULY 22, 2016

130 STAT. 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.

Deadline.

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:

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‘‘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

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42 USC 247.

Consultation.

PUBL198

130 STAT. 702

Plan.

Determination.

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21 USC 355 note.

PUBLIC LAW 114–198—JULY 22, 2016

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;

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PUBLIC LAW 114–198—JULY 22, 2016

130 STAT. 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/LongActing 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.

Notice.

Recommendations.

Deadline.
Consultation.
Recommendations.
21 USC 355–1
note.

Deadline.
Time period.
Federal Register,
publication.
21 USC 355 note.

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:

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‘‘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

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42 USC 290dd–3.

Definition.

PUBL198

130 STAT. 704

Definition.

Criteria.

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Plan.

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PUBLIC LAW 114–198—JULY 22, 2016

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

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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.

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SEC. 108. NIH OPIOID RESEARCH.

Deadline.

42 USC 284q–1.

(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.

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PUBLIC LAW 114–198—JULY 22, 2016

(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.

42 USC 280g–3
note.

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Federal Register,
publication.
Public
information.

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(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:

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PUBLIC LAW 114–198—JULY 22, 2016

130 STAT. 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

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Reports.

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PUBLIC LAW 114–198—JULY 22, 2016

(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—

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(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:

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‘‘SEC. 545. OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND
EDUCATION GRANT PROGRAMS.

42 USC 290ee.

‘‘(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—

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Effective date.
42 USC 257 note.

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‘‘(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’’.

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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

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‘‘SEC. 3021. DESCRIPTION.

42 USC 3797ff.

‘‘(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 medicationassisted treatment program used or operated by a criminal
justice agency, which may include training criminal justice

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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.

Coordination.

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42 USC 3797ff–1.

Certification.

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‘‘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:

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‘‘(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.

Notice.
42 USC 3797ff–2.

42 USC 3797ff–3.

‘‘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.

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‘‘SEC. 3025. DEFINITIONS.

42 USC 3797ff–4.

‘‘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.

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42 USC 3797s.

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42 USC 3797s–6.

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‘‘(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

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130 STAT. 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.

Summary.
Recommendations.

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:
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‘‘SEC. 546. FIRST RESPONDER TRAINING.

42 USC 290ee–1.

‘‘(a) PROGRAM AUTHORIZED.—The Secretary shall make grants
to States, local governmental entities, and Indian tribes and tribal

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130 STAT. 716

PUBLIC LAW 114–198—JULY 22, 2016

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

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130 STAT. 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.

Determination.

21 USC 822a.

Coordination.

TITLE III—TREATMENT AND RECOVERY
SEC. 301. EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN
TREATMENT AND INTERVENTIONS DEMONSTRATION.

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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.

42 USC
290bb–10.

‘‘(a) GRANTS TO EXPAND ACCESS.—

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Contracts.

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Evaluation.

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‘‘(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 medicationassisted 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.’’.

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130 STAT. 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:

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‘‘SEC. 547. BUILDING COMMUNITIES OF RECOVERY.

42 USC 290ee–2.

‘‘(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 longterm 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.’’.

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PUBLIC LAW 114–198—JULY 22, 2016

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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’’;

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130 STAT. 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

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Definition.

Time period.

Definition.

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Deadline.

Consultation.

21 USC 823 note.
Consultation.

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Assessment.

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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 opioiddependent 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 Administrationapproved treatments for opioid use disorder are used

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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.

Deadline.
21 USC 823 note.

TITLE IV—ADDRESSING COLLATERAL
CONSEQUENCES

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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—

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(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

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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)—

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130 STAT. 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)—

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130 STAT. 726

PUBLIC LAW 114–198—JULY 22, 2016

(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

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PUBLIC LAW 114–198—JULY 22, 2016

130 STAT. 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;

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PUBLIC LAW 114–198—JULY 22, 2016
‘‘(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.’’.

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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—

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130 STAT. 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.’’.

Consultation.

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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—

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130 STAT. 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:

Effective date.
42 USC 5106a
note.

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42 USC 5108.

PUBLIC LAW 114–198—JULY 22, 2016

‘‘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);

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130 STAT. 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.

42 USC 5106a
note.

SEC. 504. GAO REPORT ON NEONATAL ABSTINENCE SYNDROME (NAS).

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(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, hospitalbased, 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.

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PUBLIC LAW 114–198—JULY 22, 2016

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:
42 USC 290ee–3.

‘‘SEC. 548. STATE DEMONSTRATION GRANTS FOR COMPREHENSIVE
OPIOID ABUSE RESPONSE.

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‘‘(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—

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‘‘(i) provide for data sharing with other States;

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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

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Certification.

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Records.

Notification.

Reports.

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Records.

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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.’’.

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130 STAT. 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:

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‘‘SEC. 3026. GRANT ACCOUNTABILITY.

42 USC 3797ff–5.

‘‘(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.—

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Effective date.

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Contracts.

Public
information.

Cost estimate.

Effective date.

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‘‘(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;

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130 STAT. 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

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List.

Determination.

List.

Deadlines.
42 USC 3797ff–6.

Assessment.

Determination.

Reports.

Reports.

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Contracts.

42 USC
290aa–15.

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Coordination.

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PUBLIC LAW 114–198—JULY 22, 2016

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.

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130 STAT. 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—

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Deadlines.
42 USC
290aa–16.

PUBL198

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Determination.

Reports.

Contracts.

42 USC
290aa–15 note.

PUBLIC LAW 114–198—JULY 22, 2016

(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.

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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.—

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130 STAT. 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.

Deadline.

Deadline.

21 USC 829 note.

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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

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PUBLIC LAW 114–198—JULY 22, 2016
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);

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‘‘(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

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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 atrisk 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

Definition.

Guidelines.
Consultation.

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Guidelines.

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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

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Determination.

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130 STAT. 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

Time period.
Notice.
Notification.

Standards.

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Definition.

Regulations.
Procedures.

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130 STAT. 747

drug abuse (or an individual who is a potentially atrisk 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.

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Procedures.

Clarification.

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130 STAT. 748

Audits.

Consultation.
Verification.

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Contracts.

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PUBLIC LAW 114–198—JULY 22, 2016

‘‘(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—

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130 STAT. 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

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Time period.

Audits.
Deadline.
Certification.

Records.
Determination.

Determination.
Deadline.

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130 STAT. 750

Recommendations.

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Analysis.

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PUBLIC LAW 114–198—JULY 22, 2016

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,

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130 STAT. 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—

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Analysis.

Recommendations.

42 USC
1395w–101 note.
Applicability.

Deadline.

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Determination.

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Deadline.
Notice.

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PUBLIC LAW 114–198—JULY 22, 2016

(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’’.

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PUBLIC LAW 114–198—JULY 22, 2016
SEC.

705.

130 STAT. 753

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 abusedeterrent 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.

Determination.

Applicability.
42 USC 1396r–8
note.

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:

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‘‘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

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42 USC
1320a–7n.

Applicability.

Contracts.

Contracts.

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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.’’.

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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

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130 STAT. 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.

Review.
Determination.

Jason
Simcakoski
Memorial and
Promise Act.
38 USC 1701
note.

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

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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

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note.
Deadline.

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PUBLIC LAW 114–198—JULY 22, 2016
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.

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130 STAT. 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

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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 steppedcare 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.—

Plan.

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Certification.

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130 STAT. 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;

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Assessment.

Determination.

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(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.
38 USC 1701
note.

SEC. 912. STRENGTHENING OF JOINT WORKING GROUP ON PAIN
MANAGEMENT OF THE DEPARTMENT OF VETERANS
AFFAIRS AND THE DEPARTMENT OF DEFENSE.

Deadline.

(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

Deadline.

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130 STAT. 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 posttraumatic 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 postmilitary health care networks.
(G) Guidelines with respect to providing options, before
initiating opioid therapy, for pain management therapies

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PUBLIC LAW 114–198—JULY 22, 2016
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.

38 USC 1701
note.

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

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130 STAT. 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

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Evaluation.
Procedures.

Review.

Determination.

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130 STAT. 764

PUBLIC LAW 114–198—JULY 22, 2016

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 nonhospice 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 nonhospice 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

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130 STAT. 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.

Determination.

Notification.

38 USC 1701
note.

Section 5701(l) of title 38, United States Code, is amended
by striking ‘‘may’’ and inserting ‘‘shall’’.

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SEC. 915. ELIMINATION OF COPAYMENT REQUIREMENT FOR VETERANS RECEIVING OPIOID ANTAGONISTS OR EDUCATION
ON USE OF OPIOID ANTAGONISTS.

38 USC 1701
note.

(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

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PUBLIC LAW 114–198—JULY 22, 2016
(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
38 USC 1701
note.

SEC. 921. COMMUNITY MEETINGS ON IMPROVING CARE FURNISHED
BY DEPARTMENT OF VETERANS AFFAIRS.

Deadline.

(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.

Deadline.

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Deadline.
38 USC 1701
note.

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—

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130 STAT. 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.

38 USC 1701
note.

Assessments.

Recommendations.

38 USC 1701
note.

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(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:
‘‘§ 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.

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38 USC 7309A.

Appointment.

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PUBLIC LAW 114–198—JULY 22, 2016

‘‘(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.

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130 STAT. 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:

38 USC
prec. 7301.

‘‘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.

38 USC 7309A
note.

Subtitle C—Complementary and
Integrative Health

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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;

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38 USC 1701
note.

Examination.

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PUBLIC LAW 114–198—JULY 22, 2016
(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.

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130 STAT. 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

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President.

President.

Deadline.

Determination.

Public
information.

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130 STAT. 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 30day period thereafter ending on the date on which the

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Public
information.

Time period.

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130 STAT. 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.

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Analysis.

Examination.

Timeframe.

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(f) TERMINATION OF COMMISSION.—The Commission shall terminate 30 days after the Commission submits the final report under
subsection (e)(2).
38 USC 1701
note.

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Deadline.

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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,
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.
AND

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(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.

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SEC. 933. PILOT PROGRAM ON INTEGRATION OF COMPLEMENTARY
AND INTEGRATIVE HEALTH AND RELATED ISSUES FOR
VETERANS AND FAMILY MEMBERS OF VETERANS.

38 USC 1701
note.

(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 wellnessbased 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.

Assessments.
Deadline.

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130 STAT. 776

PUBLIC LAW 114–198—JULY 22, 2016

(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

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(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.

Assessment.

Recommendations.

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.

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SEC. 942. PROVISION OF INFORMATION ON HEALTH CARE PROVIDERS
OF DEPARTMENT OF VETERANS AFFAIRS TO STATE MEDICAL BOARDS.

38 USC 1701
note.

Time period.

38 USC 1701
note.

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

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PUBLIC LAW 114–198—JULY 22, 2016

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.
38 USC 1701
note.

Review.

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
38 USC 1701
note.

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
EMPLOYEES OF DEPARTMENT OF VETERANS AFFAIRS.

TO

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‘‘(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

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Affairs is encouraged to use bonuses to incentivize high-performing
employees in areas in which retention is challenging.’’.

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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, 114–646 (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 the Workforce) accompanying H.R. 4976, 114–559 (Comm. on Energy
and Commerce) accompanying H.R. 4978, 114–561 (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) accompanying
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.

Æ

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