Comprehensive Addiction and Recovery Act of 2016
PL 114-198 (S.524), enacted 07/22/2016

130 STAT. 695 
PUBLIC LAW 114–198—JULY 22, 2016 
Public Law 114–198 
114th Congress 
An Act 
To authorize the Attorney General and Secretary of Health and Human Services 
to award grants to address the prescription opioid abuse and heroin use crisis, 
and for other purposes. 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the ‘‘Comprehensive 
Addiction and Recovery Act of 2016’’. 
(b) TABLE OF CONTENTS.—The table of contents for this Act 
is as follows: 
Sec. 1. Short title; table of contents. 
TITLE I—PREVENTION AND EDUCATION 
Sec. 101. Task force on pain management. 
Sec. 102. Awareness campaigns. 
Sec. 103. Community-based coalition enhancement grants to address local drug cri-
ses. 
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 re-
quirement 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 pro-
grams. 
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 interven-
tions demonstration. 
Sec. 302. Building communities of recovery. 
Sec. 303. Medication-assisted treatment for recovery from addiction. 
TITLE IV—ADDRESSING COLLATERAL CONSEQUENCES 
Sec. 401. GAO report on recovery and collateral consequences. 
TITLE V—ADDICTION AND TREATMENT SERVICES FOR WOMEN, FAMILIES, 
AND VETERANS 
Sec. 501. Improving treatment for pregnant and postpartum women. 
Sec. 502. Veterans treatment courts. 
Sec. 503. Infant plan of safe care. 
Sec. 504. GAO report on neonatal abstinence syndrome (NAS). 
Comprehensive 
Addiction and 
Recovery Act 
of 2016. 
42 USC 201 note. 
July 22, 2016 
[S. 524] 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00693
Fmt 6580
Sfmt 6582
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
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. 701. Grant accountability and evaluations. 
Sec. 702. Partial fills of schedule II controlled substances. 
Sec. 703. Good samaritan assessment. 
Sec. 704. Programs to prevent prescription drug abuse under Medicare parts C and 
D. 
Sec. 705. Excluding abuse-deterrent formulations of prescription drugs from the 
Medicaid additional rebate requirement for new formulations of pre-
scription drugs. 
Sec. 706. Limiting disclosure of predictive modeling and other analytics tech-
nologies to identify and prevent waste, fraud, and abuse. 
Sec. 707. Medicaid Improvement Fund. 
Sec. 708. Sense of the Congress regarding treatment of substance abuse epidemics. 
TITLE VIII—KINGPIN DESIGNATION IMPROVEMENT 
Sec. 801. Protection of classified information in Federal court challenges relating to 
designations under the Narcotics Kingpin Designation Act. 
TITLE IX—DEPARTMENT OF VETERANS AFFAIRS 
Sec. 901. Short title. 
Sec. 902. Definitions. 
Subtitle A—Opioid Therapy and Pain Management 
Sec. 911. Improvement of opioid safety measures by Department of Veterans Af-
fairs. 
Sec. 912. Strengthening of joint working group on pain management of the Depart-
ment of Veterans Affairs and the Department of Defense. 
Sec. 913. Review, investigation, and report on use of opioids in treatment by De-
partment 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 an-
tagonists or education on use of opioid antagonists. 
Subtitle B—Patient Advocacy 
Sec. 921. Community meetings on improving care furnished by Department of Vet-
erans 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 Vet-
erans Affairs. 
Subtitle C—Complementary and Integrative Health 
Sec. 931. Expansion of research and education on and delivery of complementary 
and integrative health to veterans. 
Sec. 932. Expansion of research and education on and delivery of complementary 
and integrative health to veterans. 
Sec. 933. Pilot program on integration of complementary and integrative health 
and related issues for veterans and family members of veterans. 
Subtitle D—Fitness of Health Care Providers 
Sec. 941. Additional requirements for hiring of health care providers by Depart-
ment of Veterans Affairs. 
Sec. 942. Provision of information on health care providers of Department of Vet-
erans 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. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00694
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 697 
PUBLIC LAW 114–198—JULY 22, 2016 
TITLE I—PREVENTION AND EDUCATION 
SEC. 101. TASK FORCE ON PAIN MANAGEMENT. 
(a) DEFINITIONS.—In this section: 
(1) SECRETARY.—The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
(2) TASK FORCE.—The term ‘‘task force’’ means the Pain 
Management Best Practices Inter-Agency Task Force convened 
under subsection (b). 
(b) INTER-AGENCY TASK FORCE.—Not later than 2 years after 
the date of enactment of this Act, the Secretary, in cooperation 
with the Secretary of Veterans Affairs and the Secretary of Defense, 
shall convene a Pain Management Best Practices Inter-Agency Task 
Force. 
(c) MEMBERSHIP.—The task force shall be comprised of— 
(1) representatives of— 
(A) the Department of Health and Human Services 
and relevant agencies within the Department of Health 
and Human Services; 
(B) the Department of Veterans Affairs; 
(C) the Department of Defense; and 
(D) the Office of National Drug Control Policy; 
(2) currently licensed and practicing physicians, dentists, 
and nonphysician prescribers; 
(3) currently licensed and practicing pharmacists and phar-
macies; 
(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) devel-
oped 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 
Deadline. 
Recommenda- 
tions. 
Public 
information. 
Establishment. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00695
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 698 
PUBLIC LAW 114–198—JULY 22, 2016 
such proposed updates and recommendations, taking into 
consideration— 
(A) existing pain management research and other rel-
evant 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 dif-
ferences within and between classes of opioids, the avail-
ability 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 medica-
tion; 
(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 pro-
viders, 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 pre-
cautions; and 
(3) the detection of early warning signs of addiction. 
(c) OTHER REQUIREMENTS.—The education and awareness cam-
paigns 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 
42 USC 
290bb–25g. 
Coordination. 
Public 
information. 
Time period. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00696
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 699 
PUBLIC LAW 114–198—JULY 22, 2016 
(B) the effects of heroin and prescription opioids on 
the human body; and 
(3) bring greater public awareness to the dangerous effects 
of fentanyl when mixed with heroin or abused in a similar 
manner. 
SEC. 103. COMMUNITY-BASED COALITION ENHANCEMENT GRANTS TO 
ADDRESS LOCAL DRUG CRISES. 
(a) DEFINITIONS.—In this section: 
(1) ADMINISTRATOR.—The term ‘‘Administrator’’ means the 
Administrator of the Substance Abuse and Mental Health Serv-
ices Administration. 
(2) DIRECTOR.—The term ‘‘Director’’ means the Director 
of the Office of National Drug Control Policy. 
(3) DRUG-FREE COMMUNITIES ACT OF 1997.—The term ‘‘Drug- 
Free Communities Act of 1997’’ means chapter 2 of the National 
Narcotics Leadership Act of 1988 (21 U.S.C. 1521 et seq.). 
(4) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means an 
organization that— 
(A) on or before the date of submitting an application 
for a grant under this section, receives or has received 
a grant under the Drug-Free Communities Act of 1997; 
and 
(B) has documented, using local data, rates of abuse 
of opioids or methamphetamines at levels that are— 
(i) significantly higher than the national average 
as determined by the Secretary (including appropriate 
consideration of the results of the Monitoring the 
Future Survey published by the National Institute on 
Drug Abuse and the National Survey on Drug Use 
and Health published by the Substance Abuse and 
Mental Health Services Administration); or 
(ii) higher than the national average, as deter-
mined by the Secretary (including appropriate consid-
eration 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 docu-
mented 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. 
21 USC 1536. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00697
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 700 
PUBLIC LAW 114–198—JULY 22, 2016 
(b) PROGRAM AUTHORIZED.—The Director, in coordination with 
the Administrator, may make grants to eligible entities to imple-
ment 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 informa-
tion 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 activi-
ties 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 evalua-
tion requirements and procedures imposed on the recipient of a 
grant under the Drug-Free Communities Act of 1997, and may 
also include an evaluation of the effectiveness at reducing abuse 
of opioids or methamphetamines. 
(g) LIMITATION ON ADMINISTRATIVE EXPENSES.—Not more than 
8 percent of the amounts made available to carry out this section 
for a fiscal year may be used to pay for administrative expenses. 
(h) DELEGATION AUTHORITY.—The Director may enter into an 
interagency agreement with the Administrator to delegate authority 
for the execution of grants and for such other activities as may 
be necessary to carry out this section. 
(i) AUTHORIZATION
OF APPROPRIATIONS.—For the purpose of 
carrying out this section, there are authorized to be appropriated 
$5,000,000 for each of fiscal years 2017 through 2021. 
SEC. 104. INFORMATION MATERIALS AND RESOURCES TO PREVENT 
ADDICTION RELATED TO YOUTH SPORTS INJURIES. 
(a) REPORT.—The Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’) shall, not later 
than 24 months after the date of the enactment of this section, 
make publicly available on the appropriate website of the Depart-
ment of Health and Human Services a report determining the 
extent to which informational materials and resources described 
Public 
information. 
Web posting. 
42 USC 
290bb–25g note. 
Contracts. 
Coordination. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00698
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 701 
PUBLIC LAW 114–198—JULY 22, 2016 
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 sub-
stance use disorder in teenagers and adolescents who are injured 
playing youth sports and are subsequently prescribed an opioid, 
not later than 12 months after the report is made publicly available 
under subsection (a), and taking into consideration the findings 
of such report and in coordination with relevant health care provider 
groups, facilitate the development of informational materials and 
resources described in subsection (c) for teenagers and adolescents 
who play youth sports, families of such teenagers and adolescents, 
nurses, youth sports groups, and relevant health care provider 
groups. 
(c) MATERIALS AND RESOURCES DESCRIBED.—For purposes of 
this section, the informational materials and resources described 
in this subsection are informational materials and resources with 
respect to youth sports injuries for which opioids are potentially 
prescribed, including materials and resources focused on the risks 
associated with opioid use and misuse, treatment options for such 
injuries that do not involve the use of opioids, and how to seek 
treatment for addiction. 
(d) NO ADDITIONAL FUNDS.—No additional funds are authorized 
to be appropriated for the purpose of carrying out this section. 
This section shall be carried out using amounts otherwise available 
for such purpose. 
SEC. 105. ASSISTING VETERANS WITH MILITARY EMERGENCY MEDICAL 
TRAINING 
TO 
MEET 
REQUIREMENT 
FOR 
BECOMING 
CIVILIAN HEALTH CARE PROFESSIONALS. 
Part B of title III of the Public Health Service Act (42 U.S.C. 
243 et seq.) is amended by inserting after section 314 the following: 
‘‘SEC. 315. ASSISTING VETERANS WITH MILITARY EMERGENCY MED-
ICAL 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 profes-
sions) 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 
Consultation. 
42 USC 247. 
Deadline. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00699
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 702 
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 profes-
sions) 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 pro-
gram under this section, the Secretary shall submit to Congress 
a report on the program. 
‘‘(d) FUNDING.—No additional funds are authorized to be appro-
priated 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 Administra-
tion to seek recommendations from such advisory com-
mittee. 
(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 Sec-
retary— 
(i) finds that such a referral is not in the interest 
of protecting and promoting public health; 
21 USC 355 note. 
Determination. 
Plan. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00700
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 703 
PUBLIC LAW 114–198—JULY 22, 2016 
(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 Representa-
tives. 
(2) PEDIATRIC OPIOID LABELING.—The Secretary shall con-
vene the Pediatric Advisory Committee of the Food and Drug 
Administration to seek recommendations from such Committee 
regarding a framework for the inclusion of information in the 
labeling of drugs that are opioids relating to the use of such 
drugs in pediatric populations before the Secretary approves 
any labeling or change to labeling for any drug that is an 
opioid intended for use in a pediatric population. 
(3) SUNSET.—The requirements of paragraphs (1) and (2) 
shall cease to be effective on October 1, 2022. 
(b) PRESCRIBER EDUCATION.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary, acting through 
the Commissioner of Food and Drugs, as part of the Food and 
Drug Administration’s evaluation of the Extended-Release/Long- 
Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, 
and in consultation with relevant stakeholders, shall develop rec-
ommendations regarding education programs for prescribers of 
opioids pursuant to section 505–1 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1), including recommendations on— 
(1) which prescribers should participate in such programs; 
and 
(2) how often participation in such programs is necessary. 
(c) GUIDANCE
ON EVALUATING
THE ABUSE DETERRENCE
OF 
GENERIC SOLID ORAL OPIOID DRUG PRODUCTS.—Not later than 
18 months after the end of the period for public comment on 
the draft guidance entitled ‘‘General Principles for Evaluating the 
Abuse Deterrence of Generic Solid Oral Opioid Drug Products’’ 
issued by the Center for Drug Evaluation and Research of the 
Food and Drug Administration in March 2016, the Commissioner 
of Food and Drugs shall publish in the Federal Register a final 
version of such guidance. 
SEC. 107. IMPROVING ACCESS TO OVERDOSE TREATMENT. 
(a) GRANTS FOR REDUCING OVERDOSE DEATHS.—Part D of title 
V of the Public Health Service Act (42 U.S.C. 290dd et seq.) is 
amended by adding at the end the following: 
‘‘SEC. 544. GRANTS FOR REDUCING OVERDOSE DEATHS. 
‘‘(a) ESTABLISHMENT.— 
‘‘(1) IN
GENERAL.—The Secretary shall award grants to 
eligible entities to expand access to drugs or devices approved 
or cleared under the Federal Food, Drug, and Cosmetic Act 
for emergency treatment of known or suspected opioid overdose. 
‘‘(2) MAXIMUM GRANT AMOUNT.—A grant awarded under 
this section may not be for more than $200,000 per grant 
year. 
‘‘(3) ELIGIBLE ENTITY.—For purposes of this section, the 
term ‘eligible entity’ means a Federally qualified health center 
(as defined in section 1861(aa) of the Social Security Act), 
an opioid treatment program under part 8 of title 42, Code 
Definition. 
42 USC 290dd–3. 
Deadline. 
Time period. 
Federal Register, 
publication. 
21 USC 355 note. 
Deadline. 
Consultation. 
Recommenda- 
tions. 
21 USC 355–1 
note. 
Recommenda- 
tions. 
Notice. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00701
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 704 
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 identi-
fies 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 signifi-
cant 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 Cos-
metic 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 treat-
ment 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 associ-
ated with drugs or devices approved or cleared under the Fed-
eral 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 coun-
seling 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 
Plan. 
Criteria. 
Definition. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00702
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 705 
PUBLIC LAW 114–198—JULY 22, 2016 
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 quali-
fied 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 emer-
gency 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 facili-
ties 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 emer-
gency treatment of known or suspected opioid overdose, 
including for patients receiving chronic opioid therapy and 
patients being treated for opioid use disorders. 
(C) The Secretary of Veterans Affairs may provide 
information to prescribers within Department of Veterans 
Affairs medical facilities on best practices for prescribing 
or co-prescribing a drug or device approved or cleared under 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.) for emergency treatment of known or suspected 
opioid overdose, including for patients receiving chronic 
opioid therapy and patients being treated for opioid use 
disorders. 
(2) RULE OF CONSTRUCTION.—Nothing in this subsection 
should be construed to establish or contribute to a medical 
standard of care. 
SEC. 108. NIH OPIOID RESEARCH. 
(a) IN GENERAL.—The Director of the National Institutes of 
Health (referred to in this section as the ‘‘NIH’’) may intensify 
and coordinate fundamental, translational, and clinical research 
of the NIH with respect to— 
(1) the understanding of pain; 
(2) the discovery and development of therapies for chronic 
pain; and 
(3) the development of alternatives to opioids for effective 
pain treatments. 
42 USC 284q–1. 
Deadline. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00703
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 706 
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. 
(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 con-
trolled 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 PRO-
GRAM.—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 Administra-
tion 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: 
Federal Register, 
publication. 
Public 
information. 
42 USC 280g–3 
note. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00704
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 707 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(iii) a plan to apply the latest advances in health 
information technology, to the extent practicable, in 
order to incorporate prescription drug monitoring pro-
gram 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 elec-
tronic 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 sub-
stance 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 inter-
operability. 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 interoper-
ability’’; 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 Sec-
retary 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 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00705
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 708 
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 ‘‘imple-
menting 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 Sub-
stances 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, pro-
gram, 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 sub-
sections (i) through (k), respectively; 
(9) in subsections (c)(1)(A)(iv) and (d)(4), by striking ‘‘sub-
section (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 prac-
ticable; and 
‘‘(2) educate prescribers and dispensers on the benefits 
of the system.’’; 
(11) in subsection (k)(2)(A), as so redesignated— 
Reports. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00706
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 709 
PUBLIC LAW 114–198—JULY 22, 2016 
(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 moni-
toring programs and health information technology sys-
tems, including an assessment’’; 
(12) in subsection (l)(1), by striking ‘‘establishment, 
implementation, or improvement’’ and inserting ‘‘establishment, 
improvement, or maintenance’’; 
(13) in subsection (m)(8), by striking ‘‘and the District 
of Columbia’’ and inserting ‘‘, the District of Columbia, and 
any commonwealth or territory of the United States’’; and 
(14) by amending subsection (n) to read as follows: 
‘‘(n) AUTHORIZATION
OF APPROPRIATIONS.—To carry out this 
section, there are authorized to be appropriated, $10,000,000 for 
each of fiscal years 2017 through 2021.’’. 
SEC. 110. OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND 
EDUCATION GRANT PROGRAMS. 
(a) IN GENERAL.—Part D of title V of the Public Health Service 
Act (42 U.S.C. 290dd et seq.), as amended by section 107, is further 
amended by adding at the end the following: 
‘‘SEC. 545. OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND 
EDUCATION GRANT PROGRAMS. 
‘‘(a) GRANTS TO STATES.—The Secretary shall make grants to 
States to— 
‘‘(1) implement strategies for pharmacists to dispense a 
drug or device approved or cleared under the Federal Food, 
Drug, and Cosmetic Act for emergency treatment of known 
or suspected opioid overdose, as appropriate, pursuant to a 
standing order; 
‘‘(2) encourage pharmacies to dispense opioid overdose 
reversal medication pursuant to a standing order; 
‘‘(3) develop or provide training materials that persons 
authorized to prescribe or dispense a drug or device approved 
or cleared under the Federal Food, Drug, and Cosmetic Act 
for emergency treatment of known or suspected opioid overdose 
may use to educate the public concerning— 
‘‘(A) when and how to safely administer such drug 
or device; and 
‘‘(B) steps to be taken after administering such drug 
or device; and 
‘‘(4) educate the public concerning the availability of drugs 
or devices approved or cleared under the Federal Food, Drug, 
and Cosmetic Act for emergency treatment of known or sus-
pected 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— 
42 USC 290ee. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00707
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 710 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(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 sus-
pected 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 treat-
ment 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 per-
cent 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 sec-
tion 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’’. 
Effective date. 
42 USC 257 note. 
Evaluation. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00708
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 711 
PUBLIC LAW 114–198—JULY 22, 2016 
TITLE II—LAW ENFORCEMENT AND 
TREATMENT 
SEC. 201. COMPREHENSIVE OPIOID ABUSE GRANT PROGRAM. 
(a) COMPREHENSIVE OPIOID ABUSE GRANT PROGRAM.— 
(1) IN GENERAL.—Title I of the Omnibus Crime Control 
and Safe Streets Act of 1968 (42 U.S.C. 3711 et seq.) is amended 
by adding at the end the following: 
‘‘PART LL—COMPREHENSIVE OPIOID ABUSE 
GRANT PROGRAM 
‘‘SEC. 3021. DESCRIPTION. 
‘‘(a) GRANTS AUTHORIZED.—From amounts made available to 
carry out this part, the Attorney General may make grants to 
States, units of local government, and Indian tribes, for use by 
the State, unit of local government, or Indian tribe to provide 
services primarily relating to opioid abuse, including for any one 
or more of the following: 
‘‘(1) Developing, implementing, or expanding a treatment 
alternative to incarceration program, which may include— 
‘‘(A) prebooking or postbooking components, which may 
include the activities described in part DD or HH of this 
title; 
‘‘(B) training for criminal justice agency personnel on 
substance use disorders and co-occurring mental illness 
and substance use disorders; 
‘‘(C) a mental health court, including the activities 
described in part V of this title; 
‘‘(D) a drug court, including the activities described 
in part EE of this title; 
‘‘(E) a veterans treatment court program, including 
the activities described in subsection (i) of section 2991 
of this title; 
‘‘(F) a focus on parents whose incarceration could result 
in their children entering the child welfare system; and 
‘‘(G) a community-based substance use diversion pro-
gram sponsored by a law enforcement agency. 
‘‘(2) In the case of a State, facilitating or enhancing plan-
ning 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 Administra-
tion, and purchasing such a drug or device for first responders 
who have received such training to so carry and administer. 
‘‘(4) Locating or investigating illicit activities related to 
the unlawful distribution of opioids. 
‘‘(5) Developing, implementing, or expanding a medication- 
assisted treatment program used or operated by a criminal 
justice agency, which may include training criminal justice 
42 USC 3797ff. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00709
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 712 
PUBLIC LAW 114–198—JULY 22, 2016 
agency personnel on medication-assisted treatment, and car-
rying 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 tech-
nology that provides a secure container for prescription drugs 
that would prevent or deter individuals, particularly adoles-
cents, from gaining access to opioid medications that are law-
fully 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 govern-
ment, or Indian tribe may, in using a grant under this part for 
purposes authorized by subsection (a), use all or a portion of that 
grant to contract with, or make one or more subawards to, one 
or more— 
‘‘(1) local or regional organizations that are private and 
nonprofit, including faith-based organizations; 
‘‘(2) units of local government; or 
‘‘(3) tribal organizations. 
‘‘(c) PROGRAM ASSESSMENT COMPONENT; WAIVER.— 
‘‘(1) PROGRAM
ASSESSMENT
COMPONENT.—Each program 
funded under this part shall contain a program assessment 
component, developed pursuant to guidelines established by 
the Attorney General, in coordination with the National 
Institute of Justice. 
‘‘(2) WAIVER.—The Attorney General may waive the 
requirement of paragraph (1) with respect to a program if, 
in the opinion of the Attorney General, the program is not 
of sufficient size to justify a full program assessment. 
‘‘(d) ADMINISTRATIVE COSTS.—Not more than 10 percent of a 
grant made under this part may be used for costs incurred to 
administer such grant. 
‘‘(e) PERIOD.—The period of a grant made under this part may 
not be longer than 4 years, except that renewals and extensions 
beyond that period may be granted at the discretion of the Attorney 
General. 
‘‘SEC. 3022. APPLICATIONS. 
‘‘To request a grant under this part, the chief executive officer 
of a State, unit of local government, or Indian tribe shall submit 
an application to the Attorney General at such time and in such 
form as the Attorney General may require. Such application shall 
include the following: 
Certification. 
42 USC 3797ff–1. 
Coordination. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00710
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 713 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(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 quali-
fied 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 applica-
tion (or any amendment to that application) submitted under this 
part without first affording the applicant reasonable notice of any 
deficiencies in the application and an opportunity for correction 
of any such deficiencies and reconsideration. 
‘‘SEC. 3024. EQUITABLE DISTRIBUTION OF FUNDS. 
‘‘In awarding grants under this part, the Attorney General 
shall distribute funds in a manner that— 
‘‘(1) equitably addresses the needs of underserved popu-
lations, including rural and tribal communities; and 
‘‘(2) focuses on communities that have been disproportion-
ately impacted by opioid abuse as evidenced in part by— 
‘‘(A) high rates of primary treatment admissions for 
heroin and other opioids; 
‘‘(B) high rates of drug poisoning deaths from heroin 
and other opioids; and 
‘‘(C) a lack of accessibility to treatment providers and 
facilities and to emergency medical services. 
‘‘SEC. 3025. DEFINITIONS. 
‘‘In this part: 
‘‘(1) The term ‘first responder’ includes a firefighter, law 
enforcement officer, paramedic, emergency medical technician, 
or other individual (including an employee of a legally organized 
and recognized volunteer organization, whether compensated 
or not), who, in the course of his or her professional duties, 
responds to fire, medical, hazardous material, or other similar 
emergencies. 
42 USC 3797ff–4. 
42 USC 3797ff–3. 
Notice. 
42 USC 3797ff–2. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00711
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 714 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(2) The term ‘medication-assisted treatment’ means the 
use of medications approved by the Food and Drug Administra-
tion 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 para-
graph (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 
42 USC 3797s–6. 
42 USC 3797s. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00712
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 715 
PUBLIC LAW 114–198—JULY 22, 2016 
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 Fed-
eral 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 cir-
cumstances 
(including 
social 
and 
biological 
cir-
cumstances) of adolescents and young adults that may 
make adolescent-specific and young adult-specific treat-
ment protocols necessary, including any effects that 
substance use and substance use disorders may have 
on brain development and the implications for treat-
ment and recovery; and 
(ii) areas of such research in which greater invest-
ment or focus is necessary relative to other areas of 
such research. 
(B) Federal agency nonresearch programs and activi-
ties 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 pre-
venting substance use by and substance use disorders 
among adolescents and young adults, treating such adoles-
cents 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 Fed-
eral agencies or experts in the efforts supported by grant 
programs operated by Federal agencies relating to preven-
tion 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 enact-
ment of this Act, the Comptroller General shall submit to 
the appropriate committees of the Congress a report containing 
the results of the study conducted under paragraph (1), 
including— 
(A) a summary of the findings of the study; and 
(B) recommendations based on the results of the study, 
including recommendations for such areas of research and 
legislative and administrative action as the Comptroller 
General determines appropriate. 
SEC. 202. FIRST RESPONDER TRAINING. 
Part D of title V of the Public Health Service Act (42 U.S.C. 
290dd et seq.), as amended by section 110, is further amended 
by adding at the end the following: 
‘‘SEC. 546. FIRST RESPONDER TRAINING. 
‘‘(a) PROGRAM AUTHORIZED.—The Secretary shall make grants 
to States, local governmental entities, and Indian tribes and tribal 
42 USC 290ee–1. 
Recommenda- 
tions. 
Summary. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00713
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 716 
PUBLIC LAW 114–198—JULY 22, 2016 
organizations (as defined in section 4 of the Indian Self-Determina-
tion 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 out-
come measurements that will be used to evaluate the pro-
gram funded with a grant under this section, and specifi-
cally explain how such measurements will provide valid 
measures of the impact of the program; 
‘‘(B) describe how the program could be broadly rep-
licated 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 cor-
responding State substance abuse and mental health agen-
cies 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 treat-
ment 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 out-
reach 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 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00714
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 717 
PUBLIC LAW 114–198—JULY 22, 2016 
in metropolitan statistical areas (as defined by the Office of Manage-
ment 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 sec-
tors 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 coordina-
tion with the Administrator of the Drug Enforcement Administra-
tion, the Secretary of Health and Human Services, and the Director 
of the Office of National Drug Control Policy, shall coordinate 
with covered entities in expanding or making available disposal 
sites for unwanted prescription medications. 
TITLE III—TREATMENT AND RECOVERY 
SEC. 301. EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN 
TREATMENT AND INTERVENTIONS DEMONSTRATION. 
Subpart 1 of part B of title V of the Public Health Service 
Act (42 U.S.C. 290bb et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 514B. EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN 
TREATMENT AND INTERVENTIONS DEMONSTRATION. 
‘‘(a) GRANTS TO EXPAND ACCESS.— 
42 USC 
290bb–10. 
Coordination. 
21 USC 822a. 
Determination. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00715
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 718 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(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 Edu-
cation Assistance Act) that have a high rate, or have had 
a rapid increase, in the use of heroin or other opioids, in 
order to permit such entities to expand activities, including 
an expansion in the availability of evidence-based medication- 
assisted treatment and other clinically appropriate services, 
with respect to the treatment of addiction in the specific geo-
graphical 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 para-
graph (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 reason-
ably 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 commu-
nities, including communities with an incidence of individuals with 
opioid use disorder that is above the national average and commu-
nities with a shortage of prevention and treatment services. 
‘‘(e) ADDITIONAL ACTIVITIES.—In administering grants, con-
tracts, and cooperative agreements under subsection (a), the Sec-
retary shall— 
‘‘(1) evaluate the activities supported under such sub-
section; 
‘‘(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 sec-
tion, there are authorized to be appropriated $25,000,000 for each 
of fiscal years 2017 through 2021.’’. 
Evaluation. 
Contracts. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00716
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 719 
PUBLIC LAW 114–198—JULY 22, 2016 
SEC. 302. BUILDING COMMUNITIES OF RECOVERY. 
Part D of title V of the Public Health Service Act (42 U.S.C. 
290dd et seq.), as amended by section 202, is further amended 
by adding at the end the following: 
‘‘SEC. 547. BUILDING COMMUNITIES OF RECOVERY. 
‘‘(a) DEFINITION.—In this section, the term ‘recovery community 
organization’ means an independent nonprofit organization that— 
‘‘(1) mobilizes resources within and outside of the recovery 
community to increase the prevalence and quality of long- 
term recovery from substance use disorders; and 
‘‘(2) is wholly or principally governed by people in recovery 
for substance use disorders who reflect the community served. 
‘‘(b) GRANTS AUTHORIZED.—The Secretary shall award grants 
to recovery community organizations to enable such organizations 
to develop, expand, and enhance recovery services. 
‘‘(c) FEDERAL SHARE.—The Federal share of the costs of a pro-
gram 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 commu-
nity 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 strug-
gling 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 dis-
ease 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.’’. 
42 USC 290ee–2. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00717
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 720 
PUBLIC LAW 114–198—JULY 22, 2016 
SEC. 303. MEDICATION-ASSISTED TREATMENT FOR RECOVERY FROM 
ADDICTION. 
(a) IN GENERAL.— 
(1) IN GENERAL.—Section 303(g)(2) of the Controlled Sub-
stances 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 practi-
tioner 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 Adminis-
tration 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 deter-
mination 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 certifi-
cation 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’’; 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00718
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 721 
PUBLIC LAW 114–198—JULY 22, 2016 
(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 situa-
tions, 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 Sec-
retary.’’; 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 enact-
ment 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 communica-
tions, or otherwise) provided by the American Society 
of Addiction Medicine, the American Academy of Addic-
tion Psychiatry, the American Medical Association, the 
American Osteopathic Association, the American 
Nurses Credentialing Center, the American Psychiatric 
Association, the American Association of Nurse Practi-
tioners, the American Academy of Physician Assist-
ants, or any other organization that the Secretary 
determines is appropriate for purposes of this sub-
clause; or 
‘‘(bb) has such other training or experience as the 
Secretary determines will demonstrate the ability of 
Definition. 
Time period. 
Definition. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00719
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 722 
PUBLIC LAW 114–198—JULY 22, 2016 
the nurse practitioner or physician assistant to treat 
and manage opiate-dependent patients. 
‘‘(III) The nurse practitioner or physician assistant is 
supervised by, or works in collaboration with, a qualifying 
physician, if the nurse practitioner or physician assistant 
is required by State law to prescribe medications for the 
treatment of opioid use disorder in collaboration with or 
under the supervision of a physician. 
The Secretary may, by regulation, revise the requirements for 
being a qualifying other practitioner under this clause.’’; and 
(D) in subparagraph (H)— 
(i) in clause (i), by inserting after subclause (II) 
the following: 
‘‘(III) Such other elements of the requirements under this 
paragraph as the Secretary determines necessary for purposes 
of implementing such requirements.’’; and 
(ii) by amending clause (ii) to read as follows: 
‘‘(ii) Not later than 18 months after the date of enactment 
of the Opioid Use Disorder Treatment Expansion and Modernization 
Act, the Secretary shall update the treatment improvement protocol 
containing best practice guidelines for the treatment of opioid- 
dependent patients in office-based settings. The Secretary shall 
update such protocol in consultation with experts in opioid use 
disorder research and treatment.’’. 
(2) OPIOID DEFINED.—Section 102(18) of the Controlled Sub-
stances 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 set-
tings; 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, pursu-
ant to a waiver under section 303(g)(2) of the Con-
trolled Substances Act (21 U.S.C. 823(g)(2)), is per-
mitted to treat; 
(iv) the extent to which, and proportions with 
which, the full range of Food and Drug Administration- 
approved treatments for opioid use disorder are used 
Assessment. 
Consultation. 
21 USC 823 note. 
Consultation. 
Deadline. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00720
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 723 
PUBLIC LAW 114–198—JULY 22, 2016 
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 legisla-
tion relating to opioid use disorder treatment; 
(vii) the use of prescription drug monitoring pro-
grams 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 Sub-
stances Act (21 U.S.C. 823(g)(2)) is amended by striking subpara-
graphs (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 quali-
fying 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 addi-
tional 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 practi-
tioners and physician assistants to ensure the quality of patient 
care and prevent diversion. 
TITLE IV—ADDRESSING COLLATERAL 
CONSEQUENCES 
SEC. 401. GAO REPORT ON RECOVERY AND COLLATERAL CON-
SEQUENCES. 
(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— 
Deadline. 
21 USC 823 note. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00721
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 724 
PUBLIC LAW 114–198—JULY 22, 2016 
(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 partici-
pating 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 con-
sequence’’— 
(1) means a penalty, disability, or disadvantage imposed 
upon an individual as a result of a criminal conviction for 
a drug-related offense— 
(A) automatically by operation of law; or 
(B) by authorized action of an administrative agency 
or court on a case-by-case basis; and 
(2) does not include a direct consequence imposed as part 
of the judgment of a court at sentencing, including a term 
of imprisonment or community supervision, or a fine. 
TITLE V—ADDICTION AND TREATMENT 
SERVICES 
FOR 
WOMEN, 
FAMILIES, 
AND VETERANS 
SEC. 501. IMPROVING TREATMENT FOR PREGNANT AND POSTPARTUM 
WOMEN. 
(a) GENERAL AMENDMENTS TO THE RESIDENTIAL TREATMENT 
PROGRAM FOR PREGNANT AND POSTPARTUM WOMEN.—Section 508 
of the Public Health Service Act (42 U.S.C. 290bb–1) is amended— 
(1) in subsection (a)— 
(A) in the matter preceding paragraph (1)— 
(i) by inserting ‘‘(referred to in this section as 
the ‘Director’)’’ after ‘‘Substance Abuse Treatment’’; 
(ii) by striking ‘‘grants, cooperative agreement,’’ 
and inserting ‘‘grants, including the grants under sub-
section (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)— 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00722
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 725 
PUBLIC LAW 114–198—JULY 22, 2016 
(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 sub-
stance 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 activi-
ties.’’; 
(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 fol-
lowing: 
‘‘(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 dis-
order’’; 
(7) in subsection (j)— 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00723
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
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 sub-
section (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 competi-
tive 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 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00724
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 727 
PUBLIC LAW 114–198—JULY 22, 2016 
and containing such information as specified by the 
Director, to be eligible to receive a grant under the pro-
gram; 
‘‘(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 pri-
mary 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 pro-
gram 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 min-
imum 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 serv-
ices— 
‘‘(i) 
shall 
include 
the 
services 
requirements 
described in subsection (c) and be based on the rec-
ommendations 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, per-
sons in recovery from substance abuse, and other appro-
priate 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 Behav-
ioral 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 dura-
tion of services; 
Coordination. 
Recommenda- 
tions. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00725
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 728 
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 combina-
tion with counseling; and 
‘‘(v) other appropriate measures. 
‘‘(C) RECOMMENDATION.—The report under subpara-
graph (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 pur-
poses 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 sub-
section (a) and redesignated by paragraph (1), is further 
amended by adding at the end the following new sentences: 
‘‘Of the amounts made available for a year pursuant to the 
previous sentence to carry out this section, not more than 
25 percent of such amounts shall be made available for such 
year to carry out subsection (r), other than paragraph (5) of 
such subsection. Notwithstanding the preceding sentence, no 
funds shall be made available to carry out subsection (r) for 
a fiscal year unless the amount made available to carry out 
this section for such fiscal year is more than the amount made 
available to carry out this section for fiscal year 2016.’’. 
SEC. 502. VETERANS TREATMENT COURTS. 
Section 2991 of the Omnibus Crime Control and Safe Streets 
Act of 1968 (42 U.S.C. 3797aa) is amended— 
(1) by redesignating subsection (i) as subsection (j); and 
(2) by inserting after subsection (h) the following: 
‘‘(i) ASSISTING VETERANS.— 
‘‘(1) DEFINITIONS.—In this subsection: 
‘‘(A) PEER-TO-PEER SERVICES OR PROGRAMS.—The term 
‘peer-to-peer services or programs’ means services or pro-
grams 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 pro-
vides qualified veterans with— 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00726
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 729 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(i) intensive judicial supervision and case manage-
ment, which may include random and frequent drug 
testing where appropriate; 
‘‘(ii) a full continuum of treatment services, 
including mental health services, substance abuse serv-
ices, 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 consulta-
tion 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 appro-
priate services to qualified veterans who have been 
incarcerated; or 
‘‘(iv) training programs to teach criminal justice, 
law enforcement, corrections, mental health, and sub-
stance abuse personnel how to identify and appro-
priately respond to incidents involving qualified vet-
erans. 
‘‘(B) PRIORITY.—In awarding grants under this sub-
section, the Attorney General shall give priority to applica-
tions that— 
‘‘(i) demonstrate collaboration between and joint 
investments by criminal justice, mental health, sub-
stance abuse, and veterans service agencies; 
‘‘(ii) promote effective strategies to identify and 
reduce the risk of harm to qualified veterans and public 
safety; and 
‘‘(iii) propose interventions with empirical support 
to improve outcomes for qualified veterans.’’. 
SEC. 503. INFANT PLAN OF SAFE CARE. 
(a) BEST PRACTICES
FOR DEVELOPMENT
OF PLANS
OF SAFE 
CARE.—Section 103(b) of the Child Abuse Prevention and Treatment 
Act (42 U.S.C. 5104(b)) is amended— 
(1) by redesignating paragraphs (5) through (8) as para-
graphs (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— 
Consultation. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00727
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 730 
PUBLIC LAW 114–198—JULY 22, 2016 
(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 pro-
viders, including through— 
‘‘(I) addressing the health and substance use dis-
order treatment needs of the infant and affected family 
or caregiver; and 
‘‘(II) the development and implementation by the 
State of monitoring systems regarding the implementa-
tion of such plans to determine whether and in what 
manner local entities are providing, in accordance with 
State requirements, referrals to and delivery of appro-
priate services for the infant and affected family or 
caregiver’’. 
(c) DATA REPORTS.— 
(1) IN GENERAL.—Section 106(d) of the Child Abuse Preven-
tion 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 care-
giver, under subsection (b)(2)(B)(iii).’’. 
(2) REDESIGNATION.—Effective on May 29, 2017, section 
106(d) of the Child Abuse Prevention and Treatment Act (42 
U.S.C. 5106a(d)) is amended by redesignating paragraph (17) 
(as added by paragraph (1)) as paragraph (18). 
(d) MONITORING AND OVERSIGHT.— 
(1) AMENDMENT.—Title I of the Child Abuse Prevention 
and Treatment Act (42 U.S.C. 5101 et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 114. MONITORING AND OVERSIGHT. 
‘‘The Secretary shall conduct monitoring to ensure that each 
State that receives a grant under section 106 is in compliance 
with the requirements of section 106(b), which— 
‘‘(1) shall— 
‘‘(A) be in addition to the review of the State plan 
upon its submission under section 106(b)(1)(A); and 
‘‘(B) include monitoring of State policies and procedures 
required under clauses (ii) and (iii) of section 106(b)(2)(B); 
and 
‘‘(2) may include— 
‘‘(A) a comparison of activities carried out by the State 
to comply with the requirements of section 106(b) with 
the State plan most recently approved under section 432 
of the Social Security Act; 
‘‘(B) a review of information available on the website 
of the State relating to its compliance with the require-
ments of section 106(b); 
42 USC 5108. 
Effective date. 
42 USC 5106a 
note. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00728
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 731 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(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 sub-
mitted under section 1357.16 of title 45, Code of Federal 
Regulations (or successor regulations).’’. 
(2) TABLE OF CONTENTS.—The table of contents in section 
1(b) of the Child Abuse Prevention and Treatment Act (42 
U.S.C. 5101 note) is amended by inserting after the item 
relating to section 113, the following: 
‘‘Sec. 114. Monitoring and oversight.’’. 
(e) RULE OF CONSTRUCTION.—Nothing in this section, or the 
amendments made by this section, shall be construed to authorize 
the Secretary of Health and Human Services or any other officer 
of the Federal Government to add new requirements to section 
106(b) of the Child Abuse Prevention and Treatment Act (42 U.S.C. 
5106a(b)), as amended by this section. 
SEC. 504. GAO REPORT ON NEONATAL ABSTINENCE SYNDROME (NAS). 
(a) IN GENERAL.—Not later than 1 year after the date of the 
enactment of this Act, the Comptroller General of the United States 
shall submit to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on Finance and the 
Committee on Health, Education, Labor, and Pensions of the Senate 
a report on neonatal abstinence syndrome (in this section referred 
to as ‘‘NAS’’) in the United States. 
(b) INFORMATION TO BE INCLUDED IN REPORT.—Such report 
shall include information on the following: 
(1) The prevalence of NAS in the United States, including 
the proportion of children born in the United States with NAS 
who are eligible for medical assistance under State Medicaid 
programs under title XIX of the Social Security Act (42 U.S.C. 
1396 et seq.) at birth, and the costs associated with coverage 
under such programs for treatment of infants with NAS. 
(2) The services for which coverage is available under State 
Medicaid programs for treatment of infants with NAS. 
(3) The settings (including inpatient, outpatient, hospital- 
based, and other settings) for the treatment of infants with 
NAS and the reimbursement methodologies and costs associated 
with such treatment in such settings. 
(4) The prevalence of utilization of various care settings 
under State Medicaid programs for treatment of infants with 
NAS and any Federal barriers to treating such infants under 
such programs, particularly in non-hospital-based settings. 
(5) What is known about best practices for treating infants 
with NAS. 
(c) RECOMMENDATIONS.—Such report also shall include such 
recommendations as the Comptroller General determines appro-
priate for improvements that will ensure access to treatment for 
infants with NAS under State Medicaid programs. 
42 USC 5106a 
note. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00729
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 732 
PUBLIC LAW 114–198—JULY 22, 2016 
TITLE VI—INCENTIVIZING STATE COM-
PREHENSIVE 
INITIATIVES 
TO 
AD-
DRESS PRESCRIPTION OPIOID ABUSE 
SEC. 601. STATE DEMONSTRATION GRANTS FOR COMPREHENSIVE 
OPIOID ABUSE RESPONSE. 
Part D of title V of the Public Health Service Act (42 U.S.C. 
290dd et seq.), as amended by section 302, is further amended 
by adding at the end the following: 
‘‘SEC. 548. STATE DEMONSTRATION GRANTS FOR COMPREHENSIVE 
OPIOID ABUSE RESPONSE. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) DISPENSER.—The term ‘dispenser’ has the meaning 
given the term in section 102 of the Controlled Substances 
Act (21 U.S.C. 802). 
‘‘(2) PRESCRIBER.—The term ‘prescriber’ means a dispenser 
who prescribes a controlled substance, or the agent of such 
a dispenser. 
‘‘(3) PRESCRIBER OF A SCHEDULE II, III, OR IV CONTROLLED 
SUBSTANCE.—The term ‘prescriber of a schedule II, III, or IV 
controlled substance’ does not include a prescriber of a schedule 
II, III, or IV controlled substance that dispenses the sub-
stance— 
‘‘(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 reason-
ably 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 sec-
tion 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 com-
prehensive prescription drug monitoring program to track 
dispensing of schedule II, III, or IV controlled substances, 
which may— 
Response plan. 
42 USC 290ee–3. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00730
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 733 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(i) provide for data sharing with other States; 
and 
‘‘(ii) allow all individuals authorized by the State 
to write prescriptions for schedule II, III, or IV con-
trolled substances to access the prescription drug moni-
toring program of the State; 
‘‘(C) developing, implementing, or expanding prescrip-
tion drug and opioid addiction treatment programs by— 
‘‘(i) expanding the availability of treatment for 
prescription drug and opioid addiction, including medi-
cation-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 appro-
priate 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 sec-
tion shall submit to the Secretary an application in such form, 
and containing such information, as the Secretary may reason-
ably 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 protec-
tion 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 
Certification. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00731
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 734 
PUBLIC LAW 114–198—JULY 22, 2016 
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 bene-
fits 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 incar-
ceration; 
‘‘(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 regu-
larly updated, to the extent possible; 
‘‘(E) ensures that the prescription drug monitoring pro-
gram 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 sus-
pected; 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 pre-
scribe schedule II, III, or IV controlled substances. 
‘‘(6) EVALUATION.—In conducting an evaluation of the pro-
gram under this section pursuant to section 701 of the Com-
prehensive 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 govern-
ment 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.’’. 
Records. 
Reports. 
Notification. 
Records. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00732
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 735 
PUBLIC LAW 114–198—JULY 22, 2016 
TITLE VII—MISCELLANEOUS 
SEC. 701. GRANT ACCOUNTABILITY AND EVALUATIONS. 
(a) DEPARTMENT OF JUSTICE GRANT ACCOUNTABILITY.—Part LL 
of title I of the Omnibus Crime Control and Safe Streets Act 
of 1968 (42 U.S.C. 3711 et seq.), as added by section 201, is amended 
by adding at the end the following: 
‘‘SEC. 3026. GRANT ACCOUNTABILITY. 
‘‘(a) DEFINITION OF APPLICABLE COMMITTEES.—In this section, 
the term ‘applicable committees’ means— 
‘‘(1) the Committee on the Judiciary of the Senate; and 
‘‘(2) the Committee on the Judiciary of the House of Rep-
resentatives. 
‘‘(b) ACCOUNTABILITY.—All grants awarded by the Attorney 
General under this part shall be subject to the following account-
ability provisions: 
‘‘(1) AUDIT REQUIREMENT.— 
‘‘(A) DEFINITION.—In this paragraph, the term ‘unre-
solved 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 begin-
ning 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 appro-
priate 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 subpara-
graph (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 erro-
neously awarded grant funds. 
‘‘(2) NONPROFIT ORGANIZATION REQUIREMENTS.— 
Effective date. 
Time periods. 
42 USC 3797ff–5. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00733
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 736 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(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 sec-
tion 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 reason-
ableness for the compensation of its officers, directors, 
trustees, and key employees, shall disclose, in the applica-
tion for such contract or subaward, the process for deter-
mining such compensation, including the independent per-
sons involved in reviewing and approving such compensa-
tion, 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, hono-
raria 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 Gen-
eral 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; 
Audits. 
Effective date. 
Cost estimate. 
Public 
information. 
Contracts. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00734
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 737 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(ii) all mandatory exclusions required under para-
graph (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 Comprehen-
sive 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 achieve-
ment 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 comple-
tion 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 
Reports. 
Reports. 
Determination. 
Assessment. 
Deadlines. 
42 USC 3797ff–6. 
List. 
Determination. 
List. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00735
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 738 
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 evalua-
tion 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 estab-
lished 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 Sec-
retary 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 activi-
ties 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 informa-
tion 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 Depart-
ment 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 cov-
ered grants. 
Coordination. 
42 USC 
290aa–15. 
Contracts. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00736
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 739 
PUBLIC LAW 114–198—JULY 22, 2016 
(ii) 
CONTENTS.—The 
policies 
and 
procedures 
referred to in clause (i) shall include policies and proce-
dures 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 pur-
pose. 
(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 expendi-
ture 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 esti-
mate 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 des-
ignee) 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 Sub-
stance 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 evalua-
tion 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— 
Deadlines. 
42 USC 
290aa–16. 
Cost estimate. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00737
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 740 
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 subpara-
graph (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 conclu-
sions about overall opioid use and abuse on the basis 
of that research. 
(5) EXCEPTION.—If a program described in paragraph (1)(A) 
is subject to an evaluation similar to the evaluation required 
under such paragraph pursuant to another provision of Federal 
law, the Secretary may opt not to conduct an evaluation under 
such paragraph with respect to such program. 
(e) ADDITIONAL REPORT.—In the case of a report submitted 
under subsection (c) to the applicable committees, if such report 
pertains to a grant under section 103, that report shall also be 
submitted, in the same manner and at the same time, to the 
Committee on Oversight and Government Reform of the House 
of Representatives and to the Committee on the Judiciary of the 
Senate. 
(f) NO ADDITIONAL FUNDS AUTHORIZED.—No additional funds 
are authorized to be appropriated to carry out this section. 
SEC. 702. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES. 
(a) IN GENERAL.—Section 309 of the Controlled Substances 
Act (21 U.S.C. 829) is amended by adding at the end the following: 
‘‘(f) PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES.— 
‘‘(1) PARTIAL FILLS.—A prescription for a controlled sub-
stance 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 Gen-
eral, 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.— 
42 USC 
290aa–15 note. 
Contracts. 
Reports. 
Determination. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00738
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 741 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(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 situa-
tions, 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 prescrip-
tion for a controlled substance in schedule II may be lawfully 
partially filled, the Attorney General may allow such a prescrip-
tion to be partially filled.’’. 
(b) RULE OF CONSTRUCTION.—Nothing in this section shall be 
construed to affect the authority of the Attorney General to allow 
a prescription for a controlled substance in schedule III, IV, or 
V of section 202(c) of the Controlled Substances Act (21 U.S.C. 
812(c)) to be partially filled. 
SEC. 703. GOOD SAMARITAN ASSESSMENT. 
(a) FINDING.—The Congress finds that the executive branch, 
including the Office of National Drug Control Policy, has a policy 
focus on preventing and addressing prescription drug misuse and 
heroin use, and has worked with States and municipalities to enact 
Good Samaritan laws that would protect caregivers, law enforce-
ment personnel, and first responders who administer opioid over-
dose 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 over-
dose 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 
Reports. 
21 USC 829 note. 
Deadline. 
Deadline. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00739
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 742 
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
BENE-
FICIARIES.— 
(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
BENE-
FICIARIES.— 
‘‘(A) AUTHORITY TO ESTABLISH.—A PDP sponsor may 
establish a drug management program for at-risk bene-
ficiaries 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 prescrip-
tion 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 bene-
ficiary 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 bene-
ficiary— 
‘‘(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 Fed-
eral public health resources that are designed to 
address prescription drug abuse to which the bene-
ficiary has access, including mental health services 
and other counseling services; 
‘‘(III) notice of, and information about, the 
right of the beneficiary to appeal such identifica-
tion 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 pre-
scribers and pharmacies the beneficiary would 
prefer the PDP sponsor to select under subpara-
graph (D) in the case that the beneficiary is identi-
fied as an at-risk beneficiary for prescription drug 
abuse as described in clause (iii)(I); 
Verification. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00740
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 743 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(V) an explanation of the meaning and con-
sequences 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 commu-
nications relating to the drug management pro-
gram for at-risk beneficiaries established by the 
PDP sponsor; and 
‘‘(VII) contact information for other organiza-
tions that can provide the beneficiary with assist-
ance regarding such drug management program 
(similar to the information provided by the Sec-
retary 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 prescrip-
tion 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 indi-
vidual under subparagraph (D); 
‘‘(IV) of, and information about, the bene-
ficiary’s right to appeal such identification under 
subsection (h) and the option of an automatic esca-
lation 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, deter-
mines that concerns identified through rulemaking 
by the Secretary regarding the health or safety 
of the beneficiary or regarding significant drug 
Determination. 
Regulations. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00741
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 744 
PUBLIC LAW 114–198—JULY 22, 2016 
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 bene-
ficiary through the use of clinical guidelines that 
indicate misuse or abuse of prescription drugs 
described in subparagraph (G) and that are devel-
oped by the Secretary in consultation with PDP 
sponsors and other stakeholders, including individ-
uals 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, enti-
ties delegated by plan sponsors, and biopharma-
ceutical 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 indi-
vidual who— 
‘‘(I) receives hospice care under this title; 
‘‘(II) is a resident of a long-term care facility, 
of a facility described in section 1905(d), or of 
another facility for which frequently abused drugs 
are dispensed for residents through a contract with 
a single pharmacy; or 
‘‘(III) the Secretary elects to treat as an 
exempted individual for purposes of clause (i). 
‘‘(iii) PROGRAM SIZE.—The Secretary shall establish 
policies, including the guidelines developed under 
clause (i)(I) and the exemptions under clause (ii)(III), 
to ensure that the population of enrollees in a drug 
management program for at-risk beneficiaries operated 
by a prescription drug plan can be effectively managed 
by such plans. 
‘‘(iv) CLINICAL CONTACT.—With respect to each at- 
risk beneficiary for prescription drug abuse enrolled 
in a prescription drug plan offered by a PDP sponsor, 
the PDP sponsor shall contact the beneficiary’s pro-
viders who have prescribed frequently abused drugs 
Guidelines. 
Guidelines. 
Consultation. 
Definition. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00742
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 745 
PUBLIC LAW 114–198—JULY 22, 2016 
regarding whether prescribed medications are appro-
priate 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 other-
wise 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 fre-
quently abused drugs (referred to in this para-
graph as a ‘prescriber’) who may write prescrip-
tions 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 phar-
macy 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 selec-
tions under this subparagraph— 
‘‘(I) a PDP sponsor shall ensure that the bene-
ficiary continues to have reasonable access to fre-
quently abused drugs (as defined in subparagraph 
(G)), taking into account geographic location, bene-
ficiary 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 serv-
ices. 
‘‘(iii) BENEFICIARY
PREFERENCES.—If an at-risk 
beneficiary for prescription drug abuse submits pref-
erences for which in-network prescribers and phar-
macies 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 pre-
scribers 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
PREF-
ERENCES.—In the case that the PDP sponsor deter-
mines that a change to the selection of prescriber or 
pharmacy under clause (iii)(II) by the PDP sponsor 
Determination. 
Review. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00743
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 746 
PUBLIC LAW 114–198—JULY 22, 2016 
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 phar-
macy for the beneficiary without regard to the pref-
erences 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 bene-
ficiary 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 bene-
ficiaries, 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 stand-
ards 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 identi-
fication as the Secretary may specify. 
‘‘(ii) RULE OF CONSTRUCTION.—Nothing in clause 
(i) shall be construed as preventing a plan from identi-
fying 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 
Regulations. 
Procedures. 
Definition. 
Standards. 
Notification. 
Time period. 
Notice. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00744
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 747 
PUBLIC LAW 114–198—JULY 22, 2016 
drug abuse (or an individual who is a potentially at- 
risk beneficiary for prescription drug abuse) whose 
access to coverage for frequently abused drugs under 
a prescription drug plan has been limited by a PDP 
sponsor under this paragraph, the Secretary shall 
establish rules and procedures to require the PDP 
sponsor to disclose data, including any necessary 
individually identifiable health information, in a form 
and manner specified by the Secretary, about the deci-
sion 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 Sec-
retary determines appropriate for purposes of identi-
fying 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 Sec-
retary shall clarify privacy requirements, including require-
ments under the regulations promulgated pursuant to sec-
tion 264(c) of the Health Insurance Portability and Account-
ability 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 edu-
cation to enrollees in prescription drug plans of PDP spon-
sors and providers regarding the drug management pro-
gram for at-risk beneficiaries described in this paragraph, 
including education— 
‘‘(i) provided by Medicare administrative contrac-
tors through the improper payment outreach and edu-
cation 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. 
Clarification. 
Procedures. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00745
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 748 
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 indi-
vidual. 
‘‘(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 pre-
vent 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 prescrip-
tion 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 Sec-
retary has entered into a contract under section 1893 with 
respect to such State a report, on a monthly basis, con-
taining information on— 
Contracts. 
Consultation. 
Verification. 
Audits. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00746
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 749 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(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 individ-
uals 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 CON-
TRACTORS (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 CON-
TRACTORS (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 bene-
ficiary 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 con-
tractor to assist in the determination described in such para-
graph, 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 organiza-
tion contacts the contractor requesting to know the deter-
mination 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 prescrip-
tion drug monitoring programs, and other entities dele-
gated by such sponsors or organizations using available 
programs and systems in the effort to prevent fraud, waste, 
and abuse. 
‘‘(B) HIPAA COMPLIANT INFORMATION ONLY.—Informa-
tion may only be disclosed by a MEDIC under subpara-
graph (A) if the disclosure of such information is permitted 
under the Federal regulations (concerning the privacy of 
Determination. 
Deadline. 
Records. 
Determination. 
Audits. 
Deadline. 
Certification. 
Time period. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00747
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 750 
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 rec-
ommendations 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 prescrip-
tion drugs due to a drug management program for at-risk bene-
ficiaries.’’. 
(e) SENSE OF CONGRESS REGARDING USE OF TECHNOLOGY TOOLS 
TO COMBAT FRAUD.—It is the sense of Congress that MA organiza-
tions 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 bene-
ficiaries 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 proc-
esses 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, 
Analysis. 
Recommenda- 
tions. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00748
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 751 
PUBLIC LAW 114–198—JULY 22, 2016 
pharmacists, providers, independent review entity eval-
uators, 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 sec-
tion 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 Comp-
troller 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 administra-
tive 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 manu-
facturers 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 para-
graph (3). 
(B) TOPICS DESCRIBED.—The topics described in this 
subparagraph are the topics of— 
Deadline. 
42 USC 
1395w–101 note. 
Applicability. 
Recommenda- 
tions. 
Analysis. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00749
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 752 
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 prescrip-
tion drug abuse under such paragraph (similar to the 
processes established under the Medicare Advantage 
program under part C of title XVIII of the Social Secu-
rity 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 para-
graph; 
(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 opi-
ates; 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’’. 
Deadline. 
Notice. 
Determination. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00750
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 753 
PUBLIC LAW 114–198—JULY 22, 2016 
SEC. 
705. 
EXCLUDING 
ABUSE-DETERRENT 
FORMULATIONS 
OF 
PRESCRIPTION DRUGS FROM THE MEDICAID ADDITIONAL 
REBATE REQUIREMENT FOR NEW FORMULATIONS OF 
PRESCRIPTION DRUGS. 
(a) IN GENERAL.—The last sentence of section 1927(c)(2)(C) 
of the Social Security Act (42 U.S.C. 1396r–8(c)(2)(C)) is amended 
by inserting before the period at the end the following: ‘‘, but 
does not include an abuse-deterrent formulation of the drug (as 
determined by the Secretary), regardless of whether such abuse- 
deterrent formulation is an extended release formulation’’. 
(b) EFFECTIVE DATE.—The amendment made by subsection (a) 
shall apply to drugs that are paid for by a State in calendar 
quarters beginning on or after the date of the enactment of this 
Act. 
SEC. 706. LIMITING DISCLOSURE OF PREDICTIVE MODELING AND 
OTHER ANALYTICS TECHNOLOGIES TO IDENTIFY AND PRE-
VENT WASTE, FRAUD, AND ABUSE. 
(a) IN GENERAL.—Title XI of the Social Security Act is amended 
by inserting after section 1128J (42 U.S.C. 1320a–7k) the following 
new section: 
‘‘SEC. 1128K. DISCLOSURE OF PREDICTIVE MODELING AND OTHER 
ANALYTICS TECHNOLOGIES TO IDENTIFY AND PREVENT 
WASTE, FRAUD, AND ABUSE. 
‘‘(a) REFERENCE
TO
PREDICTIVE
MODELING
TECHNOLOGIES 
REQUIREMENTS.—For provisions relating to the use of predictive 
modeling and other analytics technologies to identify and prevent 
waste, fraud, and abuse with respect to the Medicare program 
under title XVIII, the Medicaid program under title XIX, and the 
Children’s Health Insurance Program under title XXI, see section 
4241 of the Small Business Jobs Act of 2010 (42 U.S.C. 1320a– 
7m). 
‘‘(b) LIMITING DISCLOSURE
OF PREDICTIVE MODELING TECH-
NOLOGIES.—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 
Contracts. 
Contracts. 
Applicability. 
42 USC 
1320a–7n. 
Applicability. 
42 USC 1396r–8 
note. 
Determination. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00751
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 754 
PUBLIC LAW 114–198—JULY 22, 2016 
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 tech-
nology, 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 Medi-
care 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 admin-
istering 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 subpara-
graph: 
‘‘(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 there-
after, $5,000,000.’’. 
SEC. 708. SENSE OF THE CONGRESS REGARDING TREATMENT OF SUB-
STANCE 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 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00752
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 755 
PUBLIC LAW 114–198—JULY 22, 2016 
epidemics requires treating such epidemics as a public health emer-
gency 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 determina-
tion was based on classified information (as defined in section 
1(a) of the Classified Information Procedures Act) such information 
may be submitted to the reviewing court ex parte and in camera. 
This subsection does not confer or imply any right to judicial 
review.’’. 
TITLE IX—DEPARTMENT OF VETERANS 
AFFAIRS 
SEC. 901. SHORT TITLE. 
This title may be cited as the ‘‘Jason Simcakoski Memorial 
and Promise Act’’. 
SEC. 902. DEFINITIONS. 
In this title: 
(1) The term ‘‘controlled substance’’ has the meaning given 
that term in section 102 of the Controlled Substances Act 
(21 U.S.C. 802). 
(2) The term ‘‘State’’ means each of the several States, 
territories, and possessions of the United States, the District 
of Columbia, and the Commonwealth of Puerto Rico. 
(3) The term ‘‘complementary and integrative health’’ has 
the meaning given that term, or any successor term, by the 
National Institutes of Health. 
(4) The term ‘‘opioid receptor antagonist’’ means a drug 
or device approved or cleared under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) for emergency treat-
ment of known or suspected opioid overdose. 
Subtitle A—Opioid Therapy and Pain 
Management 
SEC. 911. IMPROVEMENT OF OPIOID SAFETY MEASURES BY DEPART-
MENT 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 
Deadline. 
38 USC 1701 
note. 
Jason 
Simcakoski 
Memorial and 
Promise Act. 
38 USC 1701 
note. 
Review. 
Determination. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00753
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 756 
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 con-
ducted 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 treat-
ment 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 Initia-
tive 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 thera-
pies and complementary and integrative health services, 
including cognitive-behavioral therapy, non-opioid alter-
natives, 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 sub-
stance use disorder, including drug-seeking behavior, before 
prescribing opioids, assessment of risk potential for patients 
developing an addiction, and referral of patients to appro-
priate addiction treatment professionals if addiction is 
identified or strongly suspected. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00754
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 757 
PUBLIC LAW 114–198—JULY 22, 2016 
(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 con-
trolled 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 Depart-
ment. 
(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 Initia-
tive of the Department, the director of each medical facility 
of the Department shall identify and designate a pain manage-
ment team of health care professionals, which may include 
board certified pain medicine specialists, responsible for coordi-
nating 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 pre-
scribing 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 manage-
ment 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 Sec-
retary 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 manage-
ment team at the medical facility pursuant to paragraph 
(1). 
(B) ELEMENTS.—Each report submitted under subpara-
graph (A) with respect to a medical facility of the Depart-
ment shall include— 
(i) a certification as to whether all members of 
the pain management team at the medical facility have 
Certification. 
Consultation. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00755
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 758 
PUBLIC LAW 114–198—JULY 22, 2016 
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 Depart-
ment; or 
(II) does not fully comply with such stepped- 
care model, or successor models, of pain manage-
ment 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 Sec-
retary shall— 
(A) ensure access by health care providers of the 
Department to information on controlled substances, 
including opioids and benzodiazepines, prescribed to vet-
erans 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 Depart-
ment; 
(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 prescrip-
tions 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 set-
tings, 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.— 
Certification. 
Plan. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00756
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 759 
PUBLIC LAW 114–198—JULY 22, 2016 
(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 out-
patients 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 over-
dose 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 Com-
mittee 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 sub-
stance use disorder or prior instances of overdose; 
Determination. 
Assessment. 
Deadline. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00757
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 760 
PUBLIC LAW 114–198—JULY 22, 2016 
(2) has a history of opioid abuse; or 
(3) is at risk of developing an opioid use disorder, as deter-
mined by a health care provider who is treating the veteran. 
SEC. 912. STRENGTHENING OF JOINT WORKING GROUP ON PAIN 
MANAGEMENT 
OF 
THE 
DEPARTMENT 
OF 
VETERANS 
AFFAIRS AND THE DEPARTMENT OF DEFENSE. 
(a) IN GENERAL.—Not later than 90 days after the date of 
enactment of this Act, the Secretary of Veterans Affairs and the 
Secretary of Defense shall ensure that the Pain Management 
Working Group of the Health Executive Committee of the Depart-
ment 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 pro-
viders 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 manage-
ment conditions. 
(b) COORDINATION AND CONSULTATION.—The Secretary of Vet-
erans 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. 
Deadline. 
38 USC 1701 
note. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00758
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 761 
PUBLIC LAW 114–198—JULY 22, 2016 
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 Guide-
line includes the following: 
(A) Enhanced guidance with respect to— 
(i) the co-administration of an opioid and other 
drugs, including benzodiazepines, that may result in 
life-limiting drug interactions; 
(ii) the treatment of patients with current acute 
psychiatric instability or substance use disorder or 
patients at risk of suicide; and 
(iii) the use of opioid therapy to treat mental health 
disorders other than opioid use disorder. 
(B) Enhanced guidance with respect to the treatment 
of patients with behaviors or comorbidities, such as post- 
traumatic stress disorder or other psychiatric disorders, 
or a history of substance abuse or addiction, that requires 
a consultation or co-management of opioid therapy with 
one or more specialists in pain management, mental health, 
or addictions. 
(C) Enhanced guidance with respect to health care 
providers— 
(i) conducting an effective assessment for patients 
beginning or continuing opioid therapy, including 
understanding and setting realistic goals with respect 
to achieving and maintaining an expected level of pain 
relief, improved function, or a clinically appropriate 
combination of both; and 
(ii) effectively assessing whether opioid therapy 
is achieving or maintaining the established treatment 
goals of the patient or whether the patient and health 
care provider should discuss adjusting, augmenting, 
or discontinuing the opioid therapy. 
(D) Guidelines to inform the methodologies used by 
health care providers of the Department of Veterans Affairs 
and the Department of Defense to safely taper opioid 
therapy when adjusting or discontinuing the use of opioid 
therapy, including— 
(i) prescription of the lowest effective dose based 
on patient need; 
(ii) use of opioids only for a limited time; and 
(iii) augmentation of opioid therapy with other 
pain management therapies and modalities. 
(E) Guidelines with respect to appropriate case 
management for patients receiving opioid therapy who 
transition between inpatient and outpatient health care 
settings, which may include the use of care transition plans. 
(F) Guidelines with respect to appropriate case 
management for patients receiving opioid therapy who 
transition from receiving care during active duty to post- 
military health care networks. 
(G) Guidelines with respect to providing options, before 
initiating opioid therapy, for pain management therapies 
Assessments. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00759
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 762 
PUBLIC LAW 114–198—JULY 22, 2016 
without the use of opioids and options to augment opioid 
therapy with other clinical and complementary and integra-
tive health services to minimize opioid dependence. 
(H) Guidelines with respect to the provision of evi-
dence-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 out-
patient settings. 
(3) RULE OF CONSTRUCTION.—Nothing in this subsection 
shall be construed to prevent the Secretary of Veterans Affairs 
and the Secretary of Defense from considering all relevant 
evidence, as appropriate, in updating the VA/DOD Clinical 
Practice Guideline for Management of Opioid Therapy for 
Chronic Pain, as required under paragraph (1), or from ensuring 
that the final clinical practice guideline updated under such 
paragraph remains applicable to the patient populations of 
the Department of Veterans Affairs and the Department of 
Defense. 
SEC. 913. REVIEW, INVESTIGATION, AND REPORT ON USE OF OPIOIDS 
IN TREATMENT BY DEPARTMENT OF VETERANS AFFAIRS. 
(a) COMPTROLLER GENERAL REPORT.— 
(1) IN GENERAL.—Not later than two years after the date 
of the enactment of this Act, the Comptroller General of the 
United States shall submit to the Committee on Veterans’ 
Affairs of the Senate and the Committee on Veterans’ Affairs 
of the House of Representatives a report on the Opioid Safety 
Initiative of the Department of Veterans Affairs and the opioid 
prescribing practices of health care providers of the Depart-
ment. 
(2) ELEMENTS.—The report submitted under paragraph (1) 
shall include the following: 
(A) An assessment of the implementation and moni-
toring 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 
Assessments. 
38 USC 1701 
note. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00760
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 763 
PUBLIC LAW 114–198—JULY 22, 2016 
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 pro-
grams within the Veterans Integrated Service Net-
works 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 pre-
scribing 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 pre-
scribing opioids to treat patients without any pain, 
including to treat patients with mental health dis-
orders 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 proce-
dures to identify and remedy potential over-prescribing 
of opioids by health care providers of the Department. 
(D) An assessment of the implementation by the Sec-
retary 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 concur-
rently, 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 
Determination. 
Review. 
Evaluation. 
Procedures. 
Recommenda- 
tions. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00761
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 764 
PUBLIC LAW 114–198—JULY 22, 2016 
Representatives a progress report detailing the actions by the Sec-
retary 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 pro-
vider 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 Depart-
ment, including those who were prescribed benzodiazepines 
and opioids concurrently. 
(3) The number of non-cancer, non-palliative, and non- 
hospice care patients and the percentage of such patients who 
were treated with opioids by a health care provider of the 
Department on an inpatient-basis and who also received 
prescription opioids by mail from the Department while being 
treated on an inpatient-basis. 
(4) The number of non-cancer, non-palliative, and non- 
hospice care patients and the percentage of such patients who 
were prescribed opioids concurrently by a health care provider 
of the Department and a health care provider that is not 
a health care provider of the Department. 
(5) With respect to each medical facility of the Department, 
the collected and reviewed information on opioids prescribed 
by health care providers at the facility to treat non-cancer, 
non-palliative, and non-hospice care patients, including— 
(A) the prescription rate at which each health care 
provider at the facility prescribed benzodiazepines and 
opioids concurrently to such patients and the aggregate 
of such prescription rate for all health care providers at 
the facility; 
(B) the prescription rate at which each health care 
provider at the facility prescribed benzodiazepines or 
opioids to such patients to treat conditions for which 
benzodiazepines or opioids are not approved treatment and 
the aggregate of such prescription rate for all health care 
providers at the facility; 
(C) the prescription rate at which each health care 
provider at the facility prescribed or dispensed mail-order 
prescriptions of opioids to such patients while such patients 
were being treated with opioids on an inpatient-basis and 
the aggregate of such prescription rate for all health care 
providers at the facility; and 
(D) the prescription rate at which each health care 
provider at the facility prescribed opioids to such patients 
who were also concurrently prescribed opioids by a health 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00762
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 765 
PUBLIC LAW 114–198—JULY 22, 2016 
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 inter-
action between opioids and another medication before dis-
pensing 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 Vet-
erans 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 INFORMA-
TION TO STATE CONTROLLED SUBSTANCE MONITORING 
PROGRAMS. 
Section 5701(l) of title 38, United States Code, is amended 
by striking ‘‘may’’ and inserting ‘‘shall’’. 
SEC. 915. ELIMINATION OF COPAYMENT REQUIREMENT FOR VET-
ERANS RECEIVING OPIOID ANTAGONISTS OR EDUCATION 
ON USE OF OPIOID ANTAGONISTS. 
(a) COPAYMENT FOR OPIOID ANTAGONISTS.—Section 1722A(a) 
of title 38, United States Code, is amended by adding at the end 
the following new paragraph: 
‘‘(4) Paragraph (1) does not apply to opioid antagonists fur-
nished 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 ANTAGO-
NISTS.—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 
38 USC 1701 
note. 
38 USC 1701 
note. 
Notification. 
Determination. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00763
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 766 
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 
SEC. 921. COMMUNITY MEETINGS ON IMPROVING CARE FURNISHED 
BY DEPARTMENT OF VETERANS AFFAIRS. 
(a) COMMUNITY MEETINGS.— 
(1) MEDICAL CENTERS.—Not later than 90 days after the 
date of the enactment of this Act, and not less frequently 
than once every 90 days thereafter, the Secretary shall ensure 
that each medical facility of the Department of Veterans Affairs 
hosts a community meeting open to the public on improving 
health care furnished by the Secretary. 
(2) COMMUNITY-BASED OUTPATIENT CLINICS.—Not later than 
one year after the date of the enactment of this Act, and 
not less frequently than annually thereafter, the Secretary 
shall ensure that each community-based outpatient clinic of 
the Department hosts a community meeting open to the public 
on improving health care furnished by the Secretary. 
(b) ATTENDANCE
BY
DIRECTOR
OF
VETERANS
INTEGRATED 
SERVICE NETWORK OR DESIGNEE.— 
(1) IN GENERAL.—Each community meeting hosted by a 
medical facility or community-based outpatient clinic under 
subsection (a) shall be attended by the Director of the Veterans 
Integrated Service Network in which the medical facility or 
community-based outpatient clinic, as the case may be, is 
located. Subject to paragraph (2), the Director may delegate 
such attendance only to an employee who works in the Office 
of the Director. 
(2) ATTENDANCE BY DIRECTOR.—Each Director of a Veterans 
Integrated Service Network shall personally attend not less 
than one community meeting under subsection (a) hosted by 
each medical facility located in the Veterans Integrated Service 
Network each year. 
(c) NOTICE.—The Secretary shall notify the Committee on Vet-
erans’ Affairs of the Senate, the Committee on Veterans’ Affairs 
of the House of Representatives, and each Member of Congress 
(as defined in section 902) who represents the area in which the 
medical facility is located of a community meeting under subsection 
(a) by not later than 10 days before such community meeting 
occurs. 
SEC. 922. IMPROVEMENT OF AWARENESS OF PATIENT ADVOCACY PRO-
GRAM 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 promi-
nent 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— 
Deadline. 
38 USC 1701 
note. 
Deadline. 
Deadline. 
38 USC 1701 
note. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00764
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 767 
PUBLIC LAW 114–198—JULY 22, 2016 
(A) patients and family members of patients at such 
medical facility; and 
(B) with respect to community living centers and other 
residential facilities of the Department, residents and 
family members of residents at such medical facility. 
SEC. 923. COMPTROLLER GENERAL REPORT ON PATIENT ADVOCACY 
PROGRAM OF DEPARTMENT OF VETERANS AFFAIRS. 
(a) IN GENERAL.—Not later than two years after the date of 
the enactment of this Act, the Comptroller General of the United 
States shall submit to the Committee on Veterans’ Affairs of the 
Senate and the Committee on Veterans’ Affairs of the House of 
Representatives a report on the Patient Advocacy Program of the 
Department of Veterans Affairs (in this section referred to as the 
‘‘Program’’). 
(b) ELEMENTS.—The report required by subsection (a) shall 
include the following: 
(1) A description of the Program, including— 
(A) the purpose of the Program; 
(B) the activities carried out under the Program; and 
(C) the sufficiency of the Program in achieving the 
purpose of the Program. 
(2) An assessment of the sufficiency of staffing of employees 
of the Department responsible for carrying out the Program. 
(3) An assessment of the sufficiency of the training of 
such employees. 
(4) An assessment of— 
(A) the awareness of the Program among veterans 
and family members of veterans; and 
(B) the use of the Program by veterans and family 
members of veterans. 
(5) Such recommendations and proposals for improving or 
modifying the Program as the Comptroller General considers 
appropriate. 
(6) Such other information with respect to the Program 
as the Comptroller General considers appropriate. 
SEC. 924. ESTABLISHMENT OF OFFICE OF PATIENT ADVOCACY OF THE 
DEPARTMENT OF VETERANS AFFAIRS. 
(a) IN GENERAL.—Subchapter I of chapter 73 of title 38, United 
States Code, is amended by adding at the end the following new 
section: 
‘‘§ 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 individ-
uals 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. 
Appointment. 
38 USC 7309A. 
38 USC 1701 
note. 
Recommenda- 
tions. 
Assessments. 
38 USC 1701 
note. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00765
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 768 
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 adminis-
tered 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 Sec-
retary 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 commit-
tees 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. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00766
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 769 
PUBLIC LAW 114–198—JULY 22, 2016 
‘‘(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 begin-
ning of chapter 73 of such title is amended by inserting after 
the item relating to section 7309 the following new item: 
‘‘7309A. Office of Patient Advocacy.’’. 
(c) DATE FULLY OPERATIONAL.—The Secretary of Veterans 
Affairs shall ensure that the Office of Patient Advocacy established 
under section 7309A of title 38, United States Code, as added 
by subsection (a), is fully operational not later than the date that 
is one year after the date of the enactment of this Act. 
Subtitle C—Complementary and 
Integrative Health 
SEC. 931. EXPANSION OF RESEARCH AND EDUCATION ON AND 
DELIVERY 
OF 
COMPLEMENTARY 
AND 
INTEGRATIVE 
HEALTH TO VETERANS. 
(a) ESTABLISHMENT.—There is established a commission to be 
known as the ‘‘Creating Options for Veterans’ Expedited Recovery’’ 
or the ‘‘COVER Commission’’ (in this section referred to as the 
‘‘Commission’’). The Commission shall examine the evidence-based 
therapy treatment model used by the Secretary of Veterans Affairs 
for treating mental health conditions of veterans and the potential 
benefits of incorporating complementary and integrative health 
treatments available in non-Department facilities (as defined in 
section 1701 of title 38, United States Code). 
(b) DUTIES.—The Commission shall perform the following 
duties: 
(1) Examine the efficacy of the evidence-based therapy 
model used by the Secretary for treating mental health illnesses 
of veterans and identify areas to improve wellness-based out-
comes. 
(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; 
Examination. 
38 USC 1701 
note. 
38 USC 7309A 
note. 
38 USC 
prec. 7301. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00767
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 770 
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 medica-
tion 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 treat-
ments. 
(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 appro-
priate. 
(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 Depart-
ment. 
(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 complemen-
tary and integrative health treatments viable to the 
recovery of veterans with mental health issues as deter-
mined 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. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00768
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 771 
PUBLIC LAW 114–198—JULY 22, 2016 
(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 deter-
mines 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 Commis-
sion 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
ORGANIZA-
TIONS.—In carrying out its duties, the Commission may seek 
guidance through consultation with foundations, veteran service 
organizations, nonprofit groups, faith-based organizations, pri-
vate 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 
Public 
information. 
Determination. 
Deadline. 
President. 
President. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00769
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 772 
PUBLIC LAW 114–198—JULY 22, 2016 
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 sub-
chapter 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 per-
sonnel 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 Commis-
sion. 
(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 accord-
ance 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 Serv-
ices shall provide to the Commission, on a reimbursable basis, 
the administrative support services necessary for the Commis-
sion to carry out its responsibilities under this Act. These 
administrative services may include human resource manage-
ment, budget, leasing accounting, and payroll services. 
(e) REPORT.— 
(1) INTERIM REPORTS.— 
(A) IN GENERAL.—Not later than 60 days after the 
date on which the Commission first meets, and each 30- 
day period thereafter ending on the date on which the 
Time period. 
Public 
information. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00770
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 773 
PUBLIC LAW 114–198—JULY 22, 2016 
Commission submits the final report under paragraph (2), 
the Commission shall submit to the Committees on Vet-
erans’ 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 Rep-
resentatives and the Senate, the President, and the Secretary 
of Veterans Affairs a final report on the findings of the Commis-
sion. Such report shall include the following: 
(A) Recommendations to implement in a feasible, 
timely, and cost-efficient manner the solutions and rem-
edies 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 vet-
erans 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 con-
ducted within each of the Veterans Integrated Service Net-
works 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 Commit-
tees on Veterans’ Affairs of the House of Representatives and 
the Senate a report on the following: 
(A) An action plan for implementing the recommenda-
tions 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. 
Timeframe. 
Examination. 
Analysis. 
Recommenda- 
tions. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00771
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 774 
PUBLIC LAW 114–198—JULY 22, 2016 
(f) TERMINATION OF COMMISSION.—The Commission shall termi-
nate 30 days after the Commission submits the final report under 
subsection (e)(2). 
SEC. 932. EXPANSION OF RESEARCH AND EDUCATION ON AND 
DELIVERY 
OF 
COMPLEMENTARY 
AND 
INTEGRATIVE 
HEALTH TO VETERANS. 
(a) DEVELOPMENT OF PLAN TO EXPAND RESEARCH, EDUCATION, 
AND DELIVERY.—Not later than 180 days after the date of the 
enactment of this Act, the Secretary of Veterans Affairs shall 
develop a plan to expand materially and substantially the scope 
of the effectiveness of research and education on, and delivery 
and integration of, complementary and integrative health services 
into the health care services provided to veterans. 
(b) ELEMENTS.—The plan required by subsection (a) shall pro-
vide 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 com-
plementary 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 integra-
tive health services with other health care services provided 
by the Department. 
(c) CONSULTATION.— 
(1) IN GENERAL.—In carrying out subsection (a), the Sec-
retary shall consult with the following: 
(A) The Director of the National Center for Com-
plementary 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. 
Deadline. 
38 USC 1701 
note. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00772
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 775 
PUBLIC LAW 114–198—JULY 22, 2016 
(2) SCOPE OF CONSULTATION.—The Secretary shall under-
take consultation under paragraph (1) in carrying out sub-
section (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 serv-
ices into the delivery of health care to veterans, and to 
identify mechanisms for overcoming such barriers. 
SEC. 933. PILOT PROGRAM ON INTEGRATION OF COMPLEMENTARY 
AND INTEGRATIVE HEALTH AND RELATED ISSUES FOR 
VETERANS AND FAMILY MEMBERS OF VETERANS. 
(a) PILOT PROGRAM.— 
(1) IN GENERAL.—Not later than 180 days after the date 
on which the Secretary of Veterans Affairs receives the final 
report under section 931(e)(2), the Secretary shall commence 
a pilot program to assess the feasibility and advisability of 
using complementary and integrative health and wellness- 
based programs (as defined by the Secretary) to complement 
the provision of pain management and related health care 
services, including mental health care services, to veterans. 
(2) MATTERS ADDRESSED.—In carrying out the pilot pro-
gram, 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 vet-
erans. 
(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. 
Deadline. 
Assessments. 
38 USC 1701 
note. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00773
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
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 med-
ical centers under paragraph (1), the Secretary shall give pri-
ority to medical centers of the Department at which there 
is a prescription rate of opioids that conflicts with or is other-
wise 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 integra-
tive 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 profes-
sionals 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 serv-
ices. 
(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 conven-
tional treatments from the Department for the condi-
tions for which the covered veteran seeks complemen-
tary and integrative health services under the pilot 
program; and 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00774
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 777 
PUBLIC LAW 114–198—JULY 22, 2016 
(ii) covered veterans who have not received conven-
tional treatments from the Department for such condi-
tions. 
(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 Vet-
erans’ 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 pro-
gram 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 com-
plementary and integrative health services with other 
health care services provided by the Department. 
(C) Such recommendations for the continuation or 
expansion of the pilot program as the Secretary considers 
appropriate. 
Subtitle D—Fitness of Health Care 
Providers 
SEC. 941. ADDITIONAL REQUIREMENTS FOR HIRING OF HEALTH CARE 
PROVIDERS BY DEPARTMENT OF VETERANS AFFAIRS. 
As part of the hiring process for each health care provider 
considered for a position at the Department of Veterans Affairs 
after the date of the enactment of the Act, the Secretary of Veterans 
Affairs shall require from the medical board of each State in which 
the health care provider has or had a medical license— 
(1) information on any violation of the requirements of 
the medical license of the health care provider during the 
20-year period preceding the consideration of the health care 
provider by the Department; and 
(2) information on whether the health care provider has 
entered into any settlement agreement for a disciplinary charge 
relating to the practice of medicine by the health care provider. 
SEC. 942. PROVISION OF INFORMATION ON HEALTH CARE PROVIDERS 
OF DEPARTMENT OF VETERANS AFFAIRS TO STATE MED-
ICAL BOARDS. 
Notwithstanding section 552a of title 5, United States Code, 
with respect to each health care provider of the Department of 
Veterans Affairs who has violated a requirement of the medical 
38 USC 1701 
note. 
Time period. 
38 USC 1701 
note. 
Recommenda- 
tions. 
Assessment. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00775
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 778 
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. 
SEC. 943. REPORT ON COMPLIANCE BY DEPARTMENT OF VETERANS 
AFFAIRS WITH REVIEWS OF HEALTH CARE PROVIDERS 
LEAVING 
THE 
DEPARTMENT 
OR 
TRANSFERRING 
TO 
OTHER FACILITIES. 
Not later than 180 days after the date of the enactment of 
this Act, the Secretary of Veterans Affairs shall submit to the 
Committee on Veterans’ Affairs of the Senate and the Committee 
on Veterans’ Affairs of the House of Representatives a report on 
the compliance by the Department of Veterans Affairs with the 
policy of the Department— 
(1) to conduct a review of each health care provider of 
the Department who transfers to another medical facility of 
the Department, resigns, retires, or is terminated to determine 
whether there are any concerns, complaints, or allegations of 
violations relating to the medical practice of the health care 
provider; and 
(2) to take appropriate action with respect to any such 
concern, complaint, or allegation. 
Subtitle E—Other Matters 
SEC. 951. MODIFICATION TO LIMITATION ON AWARDS AND BONUSES. 
Section 705 of the Veterans Access, Choice, and Accountability 
Act of 2014 (Public Law 113–146; 38 U.S.C. 703 note) is amended 
to read as follows: 
‘‘SEC. 
705. 
LIMITATION 
ON 
AWARDS 
AND 
BONUSES 
PAID 
TO 
EMPLOYEES OF DEPARTMENT OF VETERANS AFFAIRS. 
‘‘(a) LIMITATION.—The Secretary of Veterans Affairs shall 
ensure that the aggregate amount of awards and bonuses paid 
by the Secretary in a fiscal year under chapter 45 or 53 of title 
5, United States Code, or any other awards or bonuses authorized 
under such title or title 38, United States Code, does not exceed 
the following amounts: 
‘‘(1) With respect to each of fiscal years 2017 through 
2018, $230,000,000. 
‘‘(2) With respect to each of fiscal years 2019 through 
2021, $225,000,000. 
‘‘(3) With respect to each of fiscal years 2022 through 
2024, $360,000,000. 
‘‘(b) SENSE OF CONGRESS.—It is the sense of Congress that 
the limitation under subsection (a) should not disproportionately 
impact lower-wage employees and that the Department of Veterans 
38 USC 1701 
note. 
Review. 
38 USC 1701 
note. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00776
Fmt 6580
Sfmt 6581
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)
130 STAT. 779 
PUBLIC LAW 114–198—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 En-
ergy 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) accom-
panying H.R. 3691, 114–546, Pt. 1 (Comm. on Veterans’ Af-
fairs) 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) accom-
panying H.R. 4843, 114–558 (Comm. on Energy and Commerce) 
accompanying H.R. 4969, 114–557 (Comm. on Energy and 
Commerce) accompanying H.R. 4976, 114–559 (Comm. on En-
ergy and Commerce) accompanying H.R. 4978, 114–561, Pt. 1 
(Comm. on Energy and Commerce) accompanying H.R. 4981, 
114–560 (Comm. on Energy and Commerce) accompanying 
H.R. 4982, 114–547, Pt. 1 (Comm. on the Judiciary) accompany- 
ing H.R. 4985, 114–539 (Comm. on the Judiciary) accompanying 
H.R. 5046, 114–540 (Comm. on the Judiciary) accompanying 
H.R. 5048, and 114–541, Pt. 1 (Comm. on the Judiciary) accom-
panying 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. 
Affairs is encouraged to use bonuses to incentivize high-performing 
employees in areas in which retention is challenging.’’. 
Approved July 22, 2016. 
VerDate Sep 11 2014 
06:31 Jul 18, 2022
Jkt 059194
PO 00001
Frm 00777
Fmt 6580
Sfmt 6580
G:\STATUTES\2016\PT1\59194PT1.001
59194PT1
dkrause on LAP5T8D0R2PROD with DISTILLER (1)