PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 695 

Public Law 114–198 

114th Congress 

An Act 

To authorize the Attorney General and Secretary of Health and Human Services 

to award grants to address the prescription opioid abuse and heroin use crisis, 

and for other purposes. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

(a) SHORT TITLE.—This Act may be cited as the ‘‘Comprehensive 

Addiction and Recovery Act of 2016’’. 

(b) TABLE OF CONTENTS.—The table of contents for this Act 

is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—PREVENTION AND EDUCATION 

Sec. 101. Task force on pain management. 

Sec. 102. Awareness campaigns. 

Sec. 103. Community-based coalition enhancement grants to address local drug crises. 

Sec. 104. Information materials and resources to prevent addiction related to youth 

sports injuries. 

Sec. 105. Assisting veterans with military emergency medical training to meet requirement for becoming civilian health care professionals. 

Sec. 106. FDA opioid action plan. 

Sec. 107. Improving access to overdose treatment. 

Sec. 108. NIH opioid research. 

Sec. 109. National All Schedules Prescription Electronic Reporting Reauthorization. 

Sec. 110. Opioid overdose reversal medication access and education grant programs. 

TITLE II—LAW ENFORCEMENT AND TREATMENT 

Sec. 201. Comprehensive Opioid Abuse Grant Program. 

Sec. 202. First responder training. 

Sec. 203. Prescription drug take back expansion. 

TITLE III—TREATMENT AND RECOVERY 

Sec. 301. Evidence-based prescription opioid and heroin treatment and interventions demonstration. 

Sec. 302. Building communities of recovery. 

Sec. 303. Medication-assisted treatment for recovery from addiction. 

TITLE IV—ADDRESSING COLLATERAL CONSEQUENCES 

Sec. 401. GAO report on recovery and collateral consequences. 

TITLE V—ADDICTION AND TREATMENT SERVICES FOR WOMEN, FAMILIES, 

AND VETERANS 

Sec. 501. Improving treatment for pregnant and postpartum women. 

Sec. 502. Veterans treatment courts. 

Sec. 503. Infant plan of safe care. 

Sec. 504. GAO report on neonatal abstinence syndrome (NAS). 

Comprehensive 

Addiction and 

Recovery Act 

of 2016. 

42 USC 201 note. 

July 22, 2016 

[S. 524] 


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130 STAT. 696 PUBLIC LAW 114–198—JULY 22, 2016 

TITLE VI—INCENTIVIZING STATE COMPREHENSIVE INITIATIVES TO 

ADDRESS PRESCRIPTION OPIOID ABUSE 

Sec. 601. State demonstration grants for comprehensive opioid abuse response. 

TITLE VII—MISCELLANEOUS 

Sec. 701. Grant accountability and evaluations. 

Sec. 702. Partial fills of schedule II controlled substances. 

Sec. 703. Good samaritan assessment. 

Sec. 704. Programs to prevent prescription drug abuse under Medicare parts C and 

D. 

Sec. 705. Excluding abuse-deterrent formulations of prescription drugs from the 

Medicaid additional rebate requirement for new formulations of prescription drugs. 

Sec. 706. Limiting disclosure of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse. 

Sec. 707. Medicaid Improvement Fund. 

Sec. 708. Sense of the Congress regarding treatment of substance abuse epidemics. 

TITLE VIII—KINGPIN DESIGNATION IMPROVEMENT 

Sec. 801. Protection of classified information in Federal court challenges relating to 

designations under the Narcotics Kingpin Designation Act. 

TITLE IX—DEPARTMENT OF VETERANS AFFAIRS 

Sec. 901. Short title. 

Sec. 902. Definitions. 

Subtitle A—Opioid Therapy and Pain Management 

Sec. 911. Improvement of opioid safety measures by Department of Veterans Affairs. 

Sec. 912. Strengthening of joint working group on pain management of the Department of Veterans Affairs and the Department of Defense. 

Sec. 913. Review, investigation, and report on use of opioids in treatment by Department of Veterans Affairs. 

Sec. 914. Mandatory disclosure of certain veteran information to State controlled 

substance monitoring programs. 

Sec. 915. Elimination of copayment requirement for veterans receiving opioid antagonists or education on use of opioid antagonists. 

Subtitle B—Patient Advocacy 

Sec. 921. Community meetings on improving care furnished by Department of Veterans Affairs. 

Sec. 922. Improvement of awareness of patient advocacy program and patient bill 

of rights of Department of Veterans Affairs. 

Sec. 923. Comptroller General report on patient advocacy program of Department 

of Veterans Affairs. 

Sec. 924. Establishment of Office of Patient Advocacy of the Department of Veterans Affairs. 

Subtitle C—Complementary and Integrative Health 

Sec. 931. Expansion of research and education on and delivery of complementary 

and integrative health to veterans. 

Sec. 932. Expansion of research and education on and delivery of complementary 

and integrative health to veterans. 

Sec. 933. Pilot program on integration of complementary and integrative health 

and related issues for veterans and family members of veterans. 

Subtitle D—Fitness of Health Care Providers 

Sec. 941. Additional requirements for hiring of health care providers by Department of Veterans Affairs. 

Sec. 942. Provision of information on health care providers of Department of Veterans Affairs to State medical boards. 

Sec. 943. Report on compliance by Department of Veterans Affairs with reviews of 

health care providers leaving the Department or transferring to other 

facilities. 

Subtitle E—Other Matters 

Sec. 951. Modification to limitation on awards and bonuses. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 697 

TITLE I—PREVENTION AND EDUCATION 

SEC. 101. TASK FORCE ON PAIN MANAGEMENT. 

(a) DEFINITIONS.—In this section: 

(1) SECRETARY.—The term ‘‘Secretary’’ means the Secretary 

of Health and Human Services. 

(2) TASK FORCE.—The term ‘‘task force’’ means the Pain 

Management Best Practices Inter-Agency Task Force convened 

under subsection (b). 

(b) INTER-AGENCY TASK FORCE.—Not later than 2 years after 

the date of enactment of this Act, the Secretary, in cooperation 

with the Secretary of Veterans Affairs and the Secretary of Defense, 

shall convene a Pain Management Best Practices Inter-Agency Task 

Force. 

(c) MEMBERSHIP.—The task force shall be comprised of— 

(1) representatives of— 

(A) the Department of Health and Human Services 

and relevant agencies within the Department of Health 

and Human Services; 

(B) the Department of Veterans Affairs; 

(C) the Department of Defense; and 

(D) the Office of National Drug Control Policy; 

(2) currently licensed and practicing physicians, dentists, 

and nonphysician prescribers; 

(3) currently licensed and practicing pharmacists and pharmacies; 

(4) experts in the fields of pain research and addiction 

research, including adolescent and young adult addiction 

research; 

(5) representatives of— 

(A) pain management professional organizations; 

(B) the mental health treatment community; 

(C) the addiction treatment community, including 

individuals in recovery from substance use disorder; 

(D) pain advocacy groups, including patients; 

(E) veteran service organizations; 

(F) groups with expertise on overdose reversal, 

including first responders; 

(G) State medical boards; and 

(H) hospitals; 

(6) experts on the health of, and prescription opioid use 

disorders in, members of the Armed Forces and veterans; and 

(7) experts in the field of minority health. 

(d) REPRESENTATION.—The Secretary shall ensure that the 

membership of the task force includes individuals representing 

rural and underserved areas. 

(e) DUTIES.—The task force shall— 

(1) identify, review, and, as appropriate, determine whether 

there are gaps in or inconsistencies between best practices 

for pain management (including chronic and acute pain) developed or adopted by Federal agencies; 

(2) not later than 1 year after the date on which the 

task force is convened under subsection (b), propose updates 

to best practices and recommendations on addressing gaps or 

inconsistencies identified under paragraph (1), as appropriate, 

and submit to relevant Federal agencies and the general public 

Deadline. 

Recommendations. 

Public 

information. 

Establishment. 


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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 relevant research; 

(B) recommendations from relevant conferences and 

existing relevant evidence-based guidelines; 

(C) ongoing efforts at the State and local levels and 

by medical professional organizations to develop improved 

pain management strategies, including consideration of differences within and between classes of opioids, the availability of opioids with abuse deterrent technology, and 

pharmacological, nonpharmacological, and medical device 

alternatives to opioids to reduce opioid monotherapy in 

appropriate cases; 

(D) the management of high-risk populations who 

receive opioids in the course of medical care, other than 

for pain management; 

(E) the 2016 Guideline for Prescribing Opioids for 

Chronic Pain issued by the Centers for Disease Control 

and Prevention; and 

(F) private sector, State, and local government efforts 

related to pain management and prescribing pain medication; 

(3) provide the public with at least 90 days to submit 

comments on any proposed updates and recommendations 

under paragraph (2); and 

(4) develop a strategy for disseminating information about 

best practices for pain management (including chronic and 

acute pain) to stakeholders, if appropriate. 

(f) LIMITATION.—The task force shall not have rulemaking 

authority. 

(g) SUNSET.—The task force under this section shall sunset 

after 3 years. 

SEC. 102. AWARENESS CAMPAIGNS. 

(a) IN GENERAL.—The Secretary of Health and Human Services, 

in coordination with the heads of other departments and agencies, 

shall, as appropriate, through existing programs and activities, 

advance the education and awareness of the public (including providers, patients, and consumers) and other appropriate entities 

regarding the risk of abuse of prescription opioids if such drugs 

are not taken as prescribed. 

(b) TOPICS.—The education and awareness campaigns under 

subsection (a) shall address— 

(1) the dangers of opioid abuse; 

(2) the prevention of opioid abuse, including through safe 

disposal of prescription medications and other safety precautions; and 

(3) the detection of early warning signs of addiction. 

(c) OTHER REQUIREMENTS.—The education and awareness campaigns under subsection (a) shall, as appropriate— 

(1) take into account any association between prescription 

opioid abuse and heroin use; 

(2) emphasize— 

(A) the similarities between heroin and prescription 

opioids; and 

42 USC 

290bb–25g. 

Coordination. 

Public 

information. 

Time period. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 699 

(B) the effects of heroin and prescription opioids on 

the human body; and 

(3) bring greater public awareness to the dangerous effects 

of fentanyl when mixed with heroin or abused in a similar 

manner. 

SEC. 103. COMMUNITY-BASED COALITION ENHANCEMENT GRANTS TO 

ADDRESS LOCAL DRUG CRISES. 

(a) DEFINITIONS.—In this section: 

(1) ADMINISTRATOR.—The term ‘‘Administrator’’ means the 

Administrator of the Substance Abuse and Mental Health Services Administration. 

(2) DIRECTOR.—The term ‘‘Director’’ means the Director 

of the Office of National Drug Control Policy. 

(3) DRUG-FREE COMMUNITIES ACT OF 1997.—The term ‘‘DrugFree Communities Act of 1997’’ means chapter 2 of the National 

Narcotics Leadership Act of 1988 (21 U.S.C. 1521 et seq.). 

(4) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means an 

organization that— 

(A) on or before the date of submitting an application 

for a grant under this section, receives or has received 

a grant under the Drug-Free Communities Act of 1997; 

and 

(B) has documented, using local data, rates of abuse 

of opioids or methamphetamines at levels that are— 

(i) significantly higher than the national average 

as determined by the Secretary (including appropriate 

consideration of the results of the Monitoring the 

Future Survey published by the National Institute on 

Drug Abuse and the National Survey on Drug Use 

and Health published by the Substance Abuse and 

Mental Health Services Administration); or 

(ii) higher than the national average, as determined by the Secretary (including appropriate consideration of the results of the surveys described in clause 

(i)), over a sustained period of time. 

(5) EMERGING DRUG ABUSE ISSUE.—The term ‘‘emerging 

drug abuse issue’’ means a substance use disorder within an 

area involving— 

(A) a sudden increase in demand for particular drug 

abuse treatment services relative to previous demand; and 

(B) a lack of resources in the area to address the 

emerging problem. 

(6) LOCAL DRUG CRISIS.—The term ‘‘local drug crisis’’ 

means, with respect to the area served by an eligible entity— 

(A) a sudden increase in the abuse of opioids or 

methamphetamines, as documented by local data; 

(B) the abuse of prescription medications, specifically 

opioids or methamphetamines, that is significantly higher 

than the national average, over a sustained period of time, 

as documented by local data; or 

(C) a sudden increase in opioid-related deaths, as documented by local data. 

(7) OPIOID.—The term ‘‘opioid’’ means any drug having 

an addiction-forming or addiction-sustaining liability similar 

to morphine or being capable of conversion into a drug having 

such addiction-forming or addiction-sustaining liability. 

21 USC 1536. 


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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 implement comprehensive community-wide strategies that address local 

drug crises and emerging drug abuse issues within the area served 

by the eligible entity. 

(c) APPLICATION.— (1) IN GENERAL.—An eligible entity seeking a grant under 

this section shall submit an application to the Director at 

such time, in such manner, and accompanied by such information as the Director may require. 

(2) CRITERIA.—As part of an application for a grant under 

this section, the Director shall require an eligible entity to 

submit a detailed, comprehensive, multisector plan for 

addressing the local drug crisis or emerging drug abuse issue 

within the area served by the eligible entity. 

(d) USE OF FUNDS.—An eligible entity shall use a grant received 

under this section— 

(1) for programs designed to implement comprehensive 

community-wide prevention strategies to address the local drug 

crisis in the area served by the eligible entity, in accordance 

with the plan submitted under subsection (c)(2); 

(2) to obtain specialized training and technical assistance 

from the organization funded under section 4 of Public Law 

107–82 (21 U.S.C. 1521 note); and 

(3) for programs designed to implement comprehensive 

community-wide strategies to address emerging drug abuse 

issues in the community. 

(e) SUPPLEMENT NOT SUPPLANT.—An eligible entity shall use 

Federal funds received under this section only to supplement the 

funds that would, in the absence of those Federal funds, be made 

available from other Federal and non-Federal sources for the activities described in this section, and not to supplant those funds. 

(f) EVALUATION.—A grant under this section shall be subject 

to the same evaluation requirements and procedures as the evaluation requirements and procedures imposed on the recipient of a 

grant under the Drug-Free Communities Act of 1997, and may 

also include an evaluation of the effectiveness at reducing abuse 

of opioids or methamphetamines. 

(g) LIMITATION ON ADMINISTRATIVE EXPENSES.—Not more than 

8 percent of the amounts made available to carry out this section 

for a fiscal year may be used to pay for administrative expenses. 

(h) DELEGATION AUTHORITY.—The Director may enter into an 

interagency agreement with the Administrator to delegate authority 

for the execution of grants and for such other activities as may 

be necessary to carry out this section. 

(i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 

carrying out this section, there are authorized to be appropriated 

$5,000,000 for each of fiscal years 2017 through 2021. 

SEC. 104. INFORMATION MATERIALS AND RESOURCES TO PREVENT 

ADDICTION RELATED TO YOUTH SPORTS INJURIES. 

(a) REPORT.—The Secretary of Health and Human Services 

(referred to in this section as the ‘‘Secretary’’) shall, not later 

than 24 months after the date of the enactment of this section, 

make publicly available on the appropriate website of the Department of Health and Human Services a report determining the 

extent to which informational materials and resources described 

Public 

information. 

Web posting. 

42 USC 

290bb–25g note. 

Contracts. 

Coordination. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 701 

in subsection (c) are available to teenagers and adolescents who 

play youth sports, families of such teenagers and adolescents, 

nurses, youth sports groups, and relevant health care provider 

groups. 

(b) DEVELOPMENT OF INFORMATIONAL MATERIALS AND

RESOURCES.—The Secretary may, for purposes of preventing substance use disorder in teenagers and adolescents who are injured 

playing youth sports and are subsequently prescribed an opioid, 

not later than 12 months after the report is made publicly available 

under subsection (a), and taking into consideration the findings 

of such report and in coordination with relevant health care provider 

groups, facilitate the development of informational materials and 

resources described in subsection (c) for teenagers and adolescents 

who play youth sports, families of such teenagers and adolescents, 

nurses, youth sports groups, and relevant health care provider 

groups. 

(c) MATERIALS AND RESOURCES DESCRIBED.—For purposes of 

this section, the informational materials and resources described 

in this subsection are informational materials and resources with 

respect to youth sports injuries for which opioids are potentially 

prescribed, including materials and resources focused on the risks 

associated with opioid use and misuse, treatment options for such 

injuries that do not involve the use of opioids, and how to seek 

treatment for addiction. 

(d) NO ADDITIONAL FUNDS.—No additional funds are authorized 

to be appropriated for the purpose of carrying out this section. 

This section shall be carried out using amounts otherwise available 

for such purpose. 

SEC. 105. ASSISTING VETERANS WITH MILITARY EMERGENCY MEDICAL 

TRAINING TO MEET REQUIREMENT FOR BECOMING 

CIVILIAN HEALTH CARE PROFESSIONALS. 

Part B of title III of the Public Health Service Act (42 U.S.C. 

243 et seq.) is amended by inserting after section 314 the following: 

‘‘SEC. 315. ASSISTING VETERANS WITH MILITARY EMERGENCY MEDICAL TRAINING TO MEET REQUIREMENTS FOR BECOMING 

CIVILIAN HEALTH CARE PROFESSIONALS. 

‘‘(a) PROGRAM.— ‘‘(1) IN GENERAL.—The Secretary may establish a program, 

in consultation with the Secretary of Labor, consisting of 

awarding demonstration grants to States to streamline State 

requirements and procedures in order to assist veterans who 

held certain military occupational specialties related to medical 

care or who have completed certain medical training while 

serving in the Armed Forces of the United States to meet 

certification, licensure, and other requirements applicable to 

civilian health care professions (such as emergency medical 

technician, paramedic, licensed practical nurse, registered 

nurse, physical therapy assistant, or physician assistant professions) in the State. 

‘‘(2) CONSULTATION AND COLLABORATION.—In determining 

the eligible military occupational specialties or training courses 

and the assistance required as described in paragraph (1), 

the Secretary shall consult with the Secretary of Defense, the 

Secretary of Veterans Affairs, and the Assistant Secretary of 

Labor for Veterans’ Employment and Training, and shall 

collaborate with the initiatives carried out under section 4114 

Consultation. 

42 USC 247. 

Deadline. 


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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 professions) in the State, develop or expand career pathways at 

institutions of higher education to support veterans in meeting 

such requirements. 

‘‘(c) REPORT.—Upon the completion of the demonstration program under this section, the Secretary shall submit to Congress 

a report on the program. 

‘‘(d) FUNDING.—No additional funds are authorized to be appropriated for the purpose of carrying out this section. This section 

shall be carried out using amounts otherwise available for such 

purpose. 

‘‘(e) SUNSET.—The demonstration program under this section 

shall not exceed 5 years.’’. 

SEC. 106. FDA OPIOID ACTION PLAN. 

(a) IN GENERAL.— 

(1) NEW DRUG APPLICATION.— 

(A) IN GENERAL.—Subject to subparagraph (B), prior 

to the approval pursuant to an application submitted under 

section 505(b) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355(b)) of a new drug that is an opioid, 

the Secretary of Health and Human Services (referred to 

in this section as the ‘‘Secretary’’) shall refer the application 

to an advisory committee of the Food and Drug Administration to seek recommendations from such advisory committee. 

(B) PUBLIC HEALTH EXEMPTION.—A referral to an 

advisory committee under subparagraph (A) is not required 

with respect to a new opioid drug or drugs if the Secretary— 

(i) finds that such a referral is not in the interest 

of protecting and promoting public health; 

21 USC 355 note. 

Determination. 

Plan. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 703 

(ii) finds that such a referral is not necessary 

based on a review of the relevant scientific information; 

and 

(iii) submits a notice containing the rationale for 

such findings to the Committee on Health, Education, 

Labor, and Pensions of the Senate and the Committee 

on Energy and Commerce of the House of Representatives. 

(2) PEDIATRIC OPIOID LABELING.—The Secretary shall convene the Pediatric Advisory Committee of the Food and Drug 

Administration to seek recommendations from such Committee 

regarding a framework for the inclusion of information in the 

labeling of drugs that are opioids relating to the use of such 

drugs in pediatric populations before the Secretary approves 

any labeling or change to labeling for any drug that is an 

opioid intended for use in a pediatric population. 

(3) SUNSET.—The requirements of paragraphs (1) and (2) 

shall cease to be effective on October 1, 2022. 

(b) PRESCRIBER EDUCATION.—Not later than 1 year after the 

date of the enactment of this Act, the Secretary, acting through 

the Commissioner of Food and Drugs, as part of the Food and 

Drug Administration’s evaluation of the Extended-Release/LongActing Opioid Analgesics Risk Evaluation and Mitigation Strategy, 

and in consultation with relevant stakeholders, shall develop recommendations regarding education programs for prescribers of 

opioids pursuant to section 505–1 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355–1), including recommendations on— 

(1) which prescribers should participate in such programs; 

and 

(2) how often participation in such programs is necessary. 

(c) GUIDANCE ON EVALUATING THE ABUSE DETERRENCE OF

GENERIC SOLID ORAL OPIOID DRUG PRODUCTS.—Not later than 

18 months after the end of the period for public comment on 

the draft guidance entitled ‘‘General Principles for Evaluating the 

Abuse Deterrence of Generic Solid Oral Opioid Drug Products’’ 

issued by the Center for Drug Evaluation and Research of the 

Food and Drug Administration in March 2016, the Commissioner 

of Food and Drugs shall publish in the Federal Register a final 

version of such guidance. 

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. 

Recommendations. 

21 USC 355–1 

note. 

Recommendations. 

Notice. 


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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 identifies a patient is at an elevated risk for an intentional 

or unintentional drug overdose from heroin or prescription 

opioid therapies. 

‘‘(b) APPLICATION.—To be eligible to receive a grant under this 

section, an eligible entity shall submit to the Secretary, in such 

form and manner as specified by the Secretary, an application 

that describes— 

‘‘(1) the extent to which the area to which the entity will 

furnish services through use of the grant is experiencing significant morbidity and mortality caused by opioid abuse; 

‘‘(2) the criteria that will be used to identify eligible patients 

to participate in such program; and 

‘‘(3) a plan for sustaining the program after Federal support 

for the program has ended. 

‘‘(c) USE OF FUNDS.—An eligible entity receiving a grant under 

this section may use amounts under the grant for any of the 

following activities, but may use not more than 20 percent of 

the grant funds for activities described in paragraphs (3) and (4): 

‘‘(1) To establish a program for prescribing a drug or device 

approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid 

overdose. 

‘‘(2) To train and provide resources for health care providers 

and pharmacists on the prescribing of drugs or devices approved 

or cleared under the Federal Food, Drug, and Cosmetic Act 

for emergency treatment of known or suspected opioid overdose. 

‘‘(3) To purchase drugs or devices approved or cleared under 

the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, for distribution 

under the program described in paragraph (1). 

‘‘(4) To offset the co-payments and other cost sharing associated with drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment 

of known or suspected opioid overdose. 

‘‘(5) To establish protocols to connect patients who have 

experienced a drug overdose with appropriate treatment, 

including medication-assisted treatment and appropriate counseling and behavioral therapies. 

‘‘(d) EVALUATIONS BY RECIPIENTS.—As a condition of receipt 

of a grant under this section, an eligible entity shall, for each 

year for which the grant is received, submit to the Secretary an 

Plan. 

Criteria. 

Definition. 


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evaluation of activities funded by the grant which contains such 

information as the Secretary may reasonably require. 

‘‘(e) REPORTS BY THE SECRETARY.—Not later than 5 years after 

the date on which the first grant under this section is awarded, 

the Secretary shall submit to the appropriate committees of the 

House of Representatives and of the Senate a report aggregating 

the information received from the grant recipients for such year 

under subsection (d) and evaluating the outcomes achieved by the 

programs funded by grants awarded under this section. 

‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized 

to be appropriated to carry out this section, $5,000,000 for the 

period of fiscal years 2017 through 2021.’’. 

(b) IMPROVING ACCESS TO OVERDOSE TREATMENT.— (1) INFORMATION ON BEST PRACTICES.—Not later than 180 

days after the date of enactment of this Act: 

(A) The Secretary of Health and Human Services may 

provide information to prescribers within Federally qualified health centers (as defined in paragraph (4) of section 

1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa))), 

and the health care facilities of the Indian Health Service, 

on best practices for prescribing or co-prescribing a drug 

or device approved or cleared under the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) for emergency treatment of known or suspected opioid overdose, 

including for patients receiving chronic opioid therapy and 

patients being treated for opioid use disorders. 

(B) The Secretary of Defense may provide information 

to prescribers within Department of Defense medical facilities on best practices for prescribing or co-prescribing a 

drug or device approved or cleared under the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) for emergency treatment of known or suspected opioid overdose, 

including for patients receiving chronic opioid therapy and 

patients being treated for opioid use disorders. 

(C) The Secretary of Veterans Affairs may provide 

information to prescribers within Department of Veterans 

Affairs medical facilities on best practices for prescribing 

or co-prescribing a drug or device approved or cleared under 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 

et seq.) for emergency treatment of known or suspected 

opioid overdose, including for patients receiving chronic 

opioid therapy and patients being treated for opioid use 

disorders. 

(2) RULE OF CONSTRUCTION.—Nothing in this subsection 

should be construed to establish or contribute to a medical 

standard of care. 

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. 


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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 controlled substance monitoring systems in order to ensure that 

health care providers have access to the accurate, timely 

prescription history information that they may use as a tool 

for the early identification of patients at risk for addiction 

in order to initiate appropriate medical interventions and avert 

the tragic personal, family, and community consequences of 

untreated addiction; and’’. 

(b) AMENDMENTS TO CONTROLLED SUBSTANCE MONITORING PROGRAM.—Section 399O of the Public Health Service Act (42 U.S.C. 

280g–3) is amended— 

(1) in subsection (a)(1)— 

(A) in the matter preceding subparagraph (A), by 

inserting ‘‘, in consultation with the Administrator of the 

Substance Abuse and Mental Health Services Administration and Director of the Centers for Disease Control and 

Prevention,’’ after ‘‘the Secretary’’; 

(B) in subparagraph (A), by striking ‘‘or’’; 

(C) in subparagraph (B), by striking the period at 

the end and inserting ‘‘; or’’; and 

(D) by adding at the end the following: 

‘‘(C) to maintain an existing State-controlled substance 

monitoring program.’’; 

(2) by amending subsection (b) to read as follows: 

‘‘(b) MINIMUM REQUIREMENTS.—The Secretary shall maintain 

and, as appropriate, supplement or revise (after publishing proposed 

additions and revisions in the Federal Register and receiving public 

comments thereon) minimum requirements for criteria to be used 

by States for purposes of clauses (ii), (v), (vi), and (vii) of subsection 

(c)(1)(A).’’; 

(3) in subsection (c)— 

(A) in paragraph (1)(B)— 

(i) in the matter preceding clause (i), by striking 

‘‘(a)(1)(B)’’ and inserting ‘‘(a)(1)(B) or (a)(1)(C)’’; 

(ii) in clause (i), by striking ‘‘program to be 

improved’’ and inserting ‘‘program to be improved or 

maintained’’; 

(iii) by redesignating clauses (iii) and (iv) as 

clauses (iv) and (v), respectively; 

(iv) by inserting after clause (ii), the following: 

Federal Register, 

publication. 

Public 

information. 

42 USC 280g–3 

note. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 707 

‘‘(iii) a plan to apply the latest advances in health 

information technology, to the extent practicable, in 

order to incorporate prescription drug monitoring program data directly into the workflow of prescribers 

and dispensers to ensure timely access to patients’ 

controlled prescription drug history;’’; 

(v) in clause (iv) (as so redesignated), by striking 

‘‘; and’’ and inserting the following: ‘‘and at least one 

health information technology system such as electronic health records, health information exchanges, 

or e-prescribing systems;’’; 

(vi) in clause (v) (as so redesignated)— 

(I) by striking ‘‘public health’’ and inserting 

‘‘public health or safety’’; and 

(II) by striking the period and inserting ‘‘; 

and’’; and 

(vii) by adding at the end the following: 

‘‘(vi) information, where applicable, on how the 

controlled substance monitoring program jointly works 

with the applicant’s respective State substance abuse 

agency to ensure information collected and maintained 

by the controlled substance monitoring program is used 

to inform the provision of clinically appropriate substance use disorder services to individuals in need.’’; 

(B) in paragraph (3)— 

(i) by striking ‘‘If a State that submits’’ and 

inserting the following: 

‘‘(A) IN GENERAL.—If a State that submits’’; 

(ii) by inserting before the period at the end ‘‘and 

include timelines for full implementation of such interoperability. The State shall also describe the manner 

in which it will achieve interoperability between its 

monitoring program and health information technology 

systems, as allowable under State law, and include 

timelines for the implementation of such interoperability’’; and 

(iii) by adding at the end the following: 

‘‘(B) MONITORING OF EFFORTS.—The Secretary shall 

monitor State efforts to achieve interoperability, as 

described in subparagraph (A).’’; and 

(C) in paragraph (5)— 

(i) by striking ‘‘implement or improve’’ and 

inserting ‘‘establish, improve, or maintain’’; and 

(ii) by adding at the end the following: ‘‘The Secretary shall redistribute any funds that are so returned 

among the remaining grantees under this section in 

accordance with the formula described in subsection 

(a)(2)(B).’’; 

(4) in subsection (d)— 

(A) in the matter preceding paragraph (1)— 

(i) by striking ‘‘In implementing or improving’’ and 

all that follows through ‘‘(a)(1)(B)’’ and inserting ‘‘In 

establishing, improving, or maintaining a controlled 

substance monitoring program under this section, a 

State shall comply, or with respect to a State that 

applies for a grant under subparagraph (B) or (C) 

of subsection (a)(1)’’; and 


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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 ‘‘implementing or improving’’ each place it appears and inserting 

‘‘establishing, improving, or maintaining’’; 

(6) in subsection (f)— 

(A) in paragraph (1)— 

(i) in subparagraph (B), by striking ‘‘misuse of 

a schedule II, III, or IV substance’’ and inserting 

‘‘misuse of a controlled substance included in schedule 

II, III, or IV of section 202(c) of the Controlled Substances Act’’; and 

(ii) in subparagraph (D)— 

(I) by inserting ‘‘a State substance abuse 

agency,’’ after ‘‘State health department,’’; and 

(II) by striking ‘‘such department, program, 

or administration’’ each place it appears and 

inserting ‘‘such department, program, agency, or 

administration’’ in each such place; and 

(B) by adding at the end the following: 

‘‘(3) EVALUATION AND REPORTING.—Subject to subsection 

(g), a State receiving a grant under subsection (a) shall provide 

the Secretary with aggregate data to enable the Secretary— 

‘‘(A) to evaluate the success of the State’s program 

in achieving its purposes; or 

‘‘(B) to prepare and submit the report to Congress 

required by subsection (k)(2). 

‘‘(4) RESEARCH BY OTHER ENTITIES.—A department, program, agency, or administration receiving nonidentifiable 

information under paragraph (1)(D) may make such information 

available to other entities for research purposes.’’; 

(7) by striking subsection (k); 

(8) by redesignating subsections (h) through (j) as subsections (i) through (k), respectively; 

(9) in subsections (c)(1)(A)(iv) and (d)(4), by striking ‘‘subsection (h)’’ each place it appears and inserting ‘‘subsection 

(i)’’; 

(10) by inserting after subsection (g) the following: 

‘‘(h) EDUCATION AND ACCESS TO THE MONITORING SYSTEM.— 

A State receiving a grant under subsection (a) shall take steps 

to— 

‘‘(1) facilitate prescriber and dispenser use of the State’s 

controlled substance monitoring system, to the extent practicable; and 

‘‘(2) educate prescribers and dispensers on the benefits 

of the system.’’; 

(11) in subsection (k)(2)(A), as so redesignated— 

Reports. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 709 

(A) in clause (ii), by striking ‘‘or affected’’ and inserting 

‘‘, established or strengthened initiatives to ensure linkages 

to substance use disorder services, or affected’’; and 

(B) in clause (iii), by striking ‘‘including an assessment’’ 

and inserting ‘‘and between controlled substance monitoring programs and health information technology systems, including an assessment’’; 

(12) in subsection (l)(1), by striking ‘‘establishment, 

implementation, or improvement’’ and inserting ‘‘establishment, 

improvement, or maintenance’’; 

(13) in subsection (m)(8), by striking ‘‘and the District 

of Columbia’’ and inserting ‘‘, the District of Columbia, and 

any commonwealth or territory of the United States’’; and 

(14) by amending subsection (n) to read as follows: 

‘‘(n) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated, $10,000,000 for 

each of fiscal years 2017 through 2021.’’. 

SEC. 110. OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND 

EDUCATION GRANT PROGRAMS. 

(a) IN GENERAL.—Part D of title V of the Public Health Service 

Act (42 U.S.C. 290dd et seq.), as amended by section 107, is further 

amended by adding at the end the following: 

‘‘SEC. 545. OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND 

EDUCATION GRANT PROGRAMS. 

‘‘(a) GRANTS TO STATES.—The Secretary shall make grants to 

States to— 

‘‘(1) implement strategies for pharmacists to dispense a 

drug or device approved or cleared under the Federal Food, 

Drug, and Cosmetic Act for emergency treatment of known 

or suspected opioid overdose, as appropriate, pursuant to a 

standing order; 

‘‘(2) encourage pharmacies to dispense opioid overdose 

reversal medication pursuant to a standing order; 

‘‘(3) develop or provide training materials that persons 

authorized to prescribe or dispense a drug or device approved 

or cleared under the Federal Food, Drug, and Cosmetic Act 

for emergency treatment of known or suspected opioid overdose 

may use to educate the public concerning— 

‘‘(A) when and how to safely administer such drug 

or device; and 

‘‘(B) steps to be taken after administering such drug 

or device; and 

‘‘(4) educate the public concerning the availability of drugs 

or devices approved or cleared under the Federal Food, Drug, 

and Cosmetic Act for emergency treatment of known or suspected opioid overdose without a person-specific prescription. 

‘‘(b) CERTAIN REQUIREMENT.—A grant may be made under this 

section only if the State involved has authorized standing orders 

to be issued for drugs or devices approved or cleared under the 

Federal Food, Drug, and Cosmetic Act for emergency treatment 

of known or suspected opioid overdose. 

‘‘(c) PREFERENCE IN MAKING GRANTS.—In making grants under 

this section, the Secretary may give preference to States that have 

a significantly higher rate of opioid overdoses than the national 

average, and that— 

42 USC 290ee. 


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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 suspected opioid overdose; 

‘‘(2) authorize standing orders to be issued that permit 

community-based organizations, substance abuse programs, or 

other nonprofit entities to acquire, dispense, or administer 

drugs or devices approved or cleared under the Federal Food, 

Drug, and Cosmetic Act for emergency treatment of known 

or suspected opioid overdose; or 

‘‘(3) authorize standing orders to be issued that permit 

police, fire, or emergency medical services agencies to acquire 

and administer drugs or devices approved or cleared under 

the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose. 

‘‘(d) GRANT TERMS.— 

‘‘(1) NUMBER.—A State may not receive more than one 

grant under this section at a time. 

‘‘(2) PERIOD.—A grant under this section shall be for a 

period of 3 years. 

‘‘(3) LIMITATION.—A State may use not more than 20 percent of a grant under this section for educating the public 

pursuant to subsection (a)(4). 

‘‘(e) APPLICATIONS.—To be eligible to receive a grant under 

this section, a State shall submit an application to the Secretary 

in such form and manner and containing such information as the 

Secretary may reasonably require, including detailed proposed 

expenditures of grant funds. 

‘‘(f) REPORTING.—A State that receives a grant under this section shall, at least annually for the duration of the grant, submit 

a report to the Secretary evaluating the progress of the activities 

supported through the grant. Such reports shall include information 

on the number of pharmacies in the State that dispense a drug 

or device approved or cleared under the Federal Food, Drug, and 

Cosmetic Act for emergency treatment of known or suspected opioid 

overdose under a standing order, and other information as the 

Secretary determines appropriate to evaluate the use of grant funds. 

‘‘(g) DEFINITIONS.—In this section the term ‘standing order’ 

means a document prepared by a person authorized to prescribe 

medication that permits another person to acquire, dispense, or 

administer medication without a person-specific prescription. 

‘‘(h) AUTHORIZATION OF APPROPRIATIONS.— 

‘‘(1) IN GENERAL.—To carry out this section, there are 

authorized to be appropriated $5,000,000 for the period of fiscal 

years 2017 through 2019. 

‘‘(2) ADMINISTRATIVE COSTS.—Not more than 3 percent of 

the amounts made available to carry out this section may 

be used by the Secretary for administrative expenses of carrying 

out this section.’’. 

(b) TECHNICAL CLARIFICATION.—Effective as if included in the 

enactment of the Children’s Health Act of 2000 (Public Law 106– 

310), section 3405(a) of such Act (114 Stat. 1221) is amended 

by striking ‘‘Part E of title III’’ and inserting ‘‘Part E of title 

III of the Public Health Service Act’’. 

Effective date. 

42 USC 257 note. 

Evaluation. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 711 

TITLE II—LAW ENFORCEMENT AND 

TREATMENT 

SEC. 201. COMPREHENSIVE OPIOID ABUSE GRANT PROGRAM. 

(a) COMPREHENSIVE OPIOID ABUSE GRANT PROGRAM.— 

(1) IN GENERAL.—Title I of the Omnibus Crime Control 

and Safe Streets Act of 1968 (42 U.S.C. 3711 et seq.) is amended 

by adding at the end the following: 

‘‘PART LL—COMPREHENSIVE OPIOID ABUSE 

GRANT PROGRAM 

‘‘SEC. 3021. DESCRIPTION. 

‘‘(a) GRANTS AUTHORIZED.—From amounts made available to 

carry out this part, the Attorney General may make grants to 

States, units of local government, and Indian tribes, for use by 

the State, unit of local government, or Indian tribe to provide 

services primarily relating to opioid abuse, including for any one 

or more of the following: 

‘‘(1) Developing, implementing, or expanding a treatment 

alternative to incarceration program, which may include— 

‘‘(A) prebooking or postbooking components, which may 

include the activities described in part DD or HH of this 

title; 

‘‘(B) training for criminal justice agency personnel on 

substance use disorders and co-occurring mental illness 

and substance use disorders; 

‘‘(C) a mental health court, including the activities 

described in part V of this title; 

‘‘(D) a drug court, including the activities described 

in part EE of this title; 

‘‘(E) a veterans treatment court program, including 

the activities described in subsection (i) of section 2991 

of this title; 

‘‘(F) a focus on parents whose incarceration could result 

in their children entering the child welfare system; and 

‘‘(G) a community-based substance use diversion program sponsored by a law enforcement agency. 

‘‘(2) In the case of a State, facilitating or enhancing planning and collaboration between State criminal justice agencies 

and State substance abuse agencies in order to more efficiently 

and effectively carry out activities or services described in any 

paragraph of this subsection that address problems related 

to opioid abuse. 

‘‘(3) Providing training and resources for first responders 

on carrying and administering an opioid overdose reversal drug 

or device approved or cleared by the Food and Drug Administration, and purchasing such a drug or device for first responders 

who have received such training to so carry and administer. 

‘‘(4) Locating or investigating illicit activities related to 

the unlawful distribution of opioids. 

‘‘(5) Developing, implementing, or expanding a medicationassisted treatment program used or operated by a criminal 

justice agency, which may include training criminal justice 

42 USC 3797ff. 


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130 STAT. 712 PUBLIC LAW 114–198—JULY 22, 2016 

agency personnel on medication-assisted treatment, and carrying out the activities described in part S of this title. 

‘‘(6) In the case of a State, developing, implementing, or 

expanding a prescription drug monitoring program to collect 

and analyze data related to the prescribing of schedules II, 

III, and IV controlled substances through a centralized database 

administered by an authorized State agency, which includes 

tracking the dispensation of such substances, and providing 

for interoperability and data sharing with each other such 

program in each other State, and with any interstate entity 

that shares information between such programs. 

‘‘(7) Developing, implementing, or expanding a program 

to prevent and address opioid abuse by juveniles. 

‘‘(8) Developing, implementing, or expanding a program 

(which may include demonstration projects) to utilize technology that provides a secure container for prescription drugs 

that would prevent or deter individuals, particularly adolescents, from gaining access to opioid medications that are lawfully prescribed for other individuals. 

‘‘(9) Developing, implementing, or expanding a prescription 

drug take-back program. 

‘‘(10) Developing, implementing, or expanding an integrated 

and comprehensive opioid abuse response program. 

‘‘(b) CONTRACTS AND SUBAWARDS.—A State, unit of local government, or Indian tribe may, in using a grant under this part for 

purposes authorized by subsection (a), use all or a portion of that 

grant to contract with, or make one or more subawards to, one 

or more— 

‘‘(1) local or regional organizations that are private and 

nonprofit, including faith-based organizations; 

‘‘(2) units of local government; or 

‘‘(3) tribal organizations. 

‘‘(c) PROGRAM ASSESSMENT COMPONENT; WAIVER.— 

‘‘(1) PROGRAM ASSESSMENT COMPONENT.—Each program 

funded under this part shall contain a program assessment 

component, developed pursuant to guidelines established by 

the Attorney General, in coordination with the National 

Institute of Justice. 

‘‘(2) WAIVER.—The Attorney General may waive the 

requirement of paragraph (1) with respect to a program if, 

in the opinion of the Attorney General, the program is not 

of sufficient size to justify a full program assessment. 

‘‘(d) ADMINISTRATIVE COSTS.—Not more than 10 percent of a 

grant made under this part may be used for costs incurred to 

administer such grant. 

‘‘(e) PERIOD.—The period of a grant made under this part may 

not be longer than 4 years, except that renewals and extensions 

beyond that period may be granted at the discretion of the Attorney 

General. 

‘‘SEC. 3022. APPLICATIONS. 

‘‘To request a grant under this part, the chief executive officer 

of a State, unit of local government, or Indian tribe shall submit 

an application to the Attorney General at such time and in such 

form as the Attorney General may require. Such application shall 

include the following: 

Certification. 

42 USC 3797ff–1. 

Coordination. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 713 

‘‘(1) A certification that Federal funds made available under 

this part will not be used to supplant State, local, or tribal 

funds, but will be used to increase the amounts of such funds 

that would, in the absence of Federal funds, be made available 

for the activities described in section 3021(a). 

‘‘(2) An assurance that, for each fiscal year covered by 

an application, the applicant shall maintain and report such 

data, records, and information (programmatic and financial) 

as the Attorney General may reasonably require. 

‘‘(3) A certification, made in a form acceptable to the 

Attorney General and executed by the chief executive officer 

of the applicant (or by another officer of the applicant, if qualified under regulations promulgated by the Attorney General), 

that— 

‘‘(A) the activities or services to be funded by the 

grant meet all the requirements of this part; 

‘‘(B) all the information contained in the application 

is correct; 

‘‘(C) there has been appropriate coordination with 

affected agencies; and 

‘‘(D) the applicant will comply with all provisions of 

this part and all other applicable Federal laws. 

‘‘(4) An assurance that the applicant will work with the 

Drug Enforcement Administration to develop an integrated and 

comprehensive strategy to address opioid abuse. 

‘‘SEC. 3023. REVIEW OF APPLICATIONS. 

‘‘The Attorney General shall not finally disapprove any application (or any amendment to that application) submitted under this 

part without first affording the applicant reasonable notice of any 

deficiencies in the application and an opportunity for correction 

of any such deficiencies and reconsideration. 

‘‘SEC. 3024. EQUITABLE DISTRIBUTION OF FUNDS. 

‘‘In awarding grants under this part, the Attorney General 

shall distribute funds in a manner that— 

‘‘(1) equitably addresses the needs of underserved populations, including rural and tribal communities; and 

‘‘(2) focuses on communities that have been disproportionately impacted by opioid abuse as evidenced in part by— 

‘‘(A) high rates of primary treatment admissions for 

heroin and other opioids; 

‘‘(B) high rates of drug poisoning deaths from heroin 

and other opioids; and 

‘‘(C) a lack of accessibility to treatment providers and 

facilities and to emergency medical services. 

‘‘SEC. 3025. DEFINITIONS. 

‘‘In this part: 

‘‘(1) The term ‘first responder’ includes a firefighter, law 

enforcement officer, paramedic, emergency medical technician, 

or other individual (including an employee of a legally organized 

and recognized volunteer organization, whether compensated 

or not), who, in the course of his or her professional duties, 

responds to fire, medical, hazardous material, or other similar 

emergencies. 

42 USC 3797ff–4. 

42 USC 3797ff–3. 

Notice. 

42 USC 3797ff–2. 


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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 Administration for the treatment of opioid abuse. 

‘‘(3) The term ‘opioid’ means any drug, including heroin, 

having an addiction-forming or addiction-sustaining liability 

similar to morphine or being capable of conversion into a drug 

having such addiction-forming or addiction-sustaining liability. 

‘‘(4) The term ‘schedule II, III, or IV controlled substance’ 

means a controlled substance that is listed on schedule II, 

schedule III, or schedule IV of section 202(c) of the Controlled 

Substances Act (21 U.S.C. 812(c)). 

‘‘(5) The terms ‘drug’ and ‘device’ have the meanings given 

those terms in section 201 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 321). 

‘‘(6) The term ‘criminal justice agency’ means a State, local, 

or tribal— 

‘‘(A) court; 

‘‘(B) prison; 

‘‘(C) jail; 

‘‘(D) law enforcement agency; or 

‘‘(E) other agency that performs the administration 

of criminal justice, including prosecution, pretrial services, 

and community supervision. 

‘‘(7) The term ‘tribal organization’ has the meaning given 

that term in section 4 of the Indian Self-Determination and 

Education Assistance Act (25 U.S.C. 450b). 

‘‘(8) The term ‘State substance abuse agency’ has the 

meaning given that term in section 508(r)(6) of the Public 

Health Service Act (42 U.S.C. 290bb–1).’’. 

(2) AUTHORIZATION OF APPROPRIATIONS.—Section 1001(a) 

of title I of the Omnibus Crime Control and Safe Streets Act 

of 1968 (42 U.S.C. 3793(a)) is amended by inserting after paragraph (26) the following: 

‘‘(27) There are authorized to be appropriated to carry 

out part LL $103,000,000 for each of fiscal years 2017 through 

2021.’’. 

(b) EMERGENCY FEDERAL LAW ENFORCEMENT ASSISTANCE.— 

Section 609Y(a) of the Justice Assistance Act of 1984 (42 U.S.C. 

10513(a)) is amended by striking ‘‘September 30, 1984’’ and 

inserting ‘‘September 30, 2021’’. 

(c) INCLUSION OF SERVICES FOR PREGNANT WOMEN UNDER

FAMILY-BASED SUBSTANCE ABUSE GRANTS.—Part DD of title I of 

the Omnibus Crime Control and Safe Streets Act (42 U.S.C. 3797s 

et seq.) is amended— 

(1) in section 2921(2), by inserting before the period at 

the end ‘‘or pregnant women’’; and 

(2) in section 2927— 

(A) in paragraph (1)(A), by inserting ‘‘pregnant or’’ 

before ‘‘a parent’’; and 

(B) in paragraph (3), by inserting ‘‘or pregnant women’’ 

after ‘‘incarcerated parents’’. 

(d) GAO STUDY AND REPORT ON FEDERAL AGENCY PROGRAMS

AND RESEARCH RELATIVE TO SUBSTANCE USE AND SUBSTANCE USE

DISORDERS AMONG ADOLESCENTS AND YOUNG ADULTS.— 

(1) STUDY.—The Comptroller General of the United States 

shall conduct a study on how Federal agencies, through grant 

programs, are addressing prevention of, treatment for, and 

42 USC 3797s–6. 

42 USC 3797s. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 715 

recovery from, substance use by, and substance use disorders 

among, adolescents and young adults. Such study shall include 

an analysis of each of the following: 

(A) The research that has been, and is being, conducted 

or supported pursuant to grant programs operated by Federal agencies on prevention of, treatment for, and recovery 

from substance use by and substance use disorders among 

adolescents and young adults, including an assessment of— 

(i) such research relative to any unique circumstances (including social and biological circumstances) of adolescents and young adults that may 

make adolescent-specific and young adult-specific treatment protocols necessary, including any effects that 

substance use and substance use disorders may have 

on brain development and the implications for treatment and recovery; and 

(ii) areas of such research in which greater investment or focus is necessary relative to other areas of 

such research. 

(B) Federal agency nonresearch programs and activities that address prevention of, treatment for, and recovery 

from substance use by and substance use disorders among 

adolescents and young adults, including an assessment of 

the effectiveness of such programs and activities in preventing substance use by and substance use disorders 

among adolescents and young adults, treating such adolescents and young adults in a way that accounts for any 

unique circumstances faced by adolescents and young 

adults, and supports long-term recovery among adolescents 

and young adults. 

(C) Gaps that have been identified by officials of Federal agencies or experts in the efforts supported by grant 

programs operated by Federal agencies relating to prevention of, treatment for, and recovery from substance use 

by and substance use disorders among adolescents and 

young adults, including gaps in research, data collection, 

and measures to evaluate the effectiveness of such efforts, 

and the reasons for such gaps. 

(2) REPORT.—Not later than 2 years after the date of enactment of this Act, the Comptroller General shall submit to 

the appropriate committees of the Congress a report containing 

the results of the study conducted under paragraph (1), 

including— 

(A) a summary of the findings of the study; and 

(B) recommendations based on the results of the study, 

including recommendations for such areas of research and 

legislative and administrative action as the Comptroller 

General determines appropriate. 

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. 

Recommendations. 

Summary. 


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130 STAT. 716 PUBLIC LAW 114–198—JULY 22, 2016 

organizations (as defined in section 4 of the Indian Self-Determination and Education Assistance Act) to allow first responders and 

members of other key community sectors to administer a drug 

or device approved or cleared under the Federal Food, Drug, and 

Cosmetic Act for emergency treatment of known or suspected opioid 

overdose. 

‘‘(b) APPLICATION.— 

‘‘(1) IN GENERAL.—An entity seeking a grant under this 

section shall submit an application to the Secretary— 

‘‘(A) that meets the criteria under paragraph (2); and 

‘‘(B) at such time, in such manner, and accompanied 

by such information as the Secretary may require. 

‘‘(2) CRITERIA.—An entity, in submitting an application 

under paragraph (1), shall— 

‘‘(A) describe the evidence-based methodology and outcome measurements that will be used to evaluate the program funded with a grant under this section, and specifically explain how such measurements will provide valid 

measures of the impact of the program; 

‘‘(B) describe how the program could be broadly replicated if demonstrated to be effective; 

‘‘(C) identify the governmental and community agencies 

with which the entity will coordinate to implement the 

program; and 

‘‘(D) describe how the entity will ensure that law 

enforcement agencies will coordinate with their corresponding State substance abuse and mental health agencies to identify protocols and resources that are available 

to overdose victims and families, including information on 

treatment and recovery resources. 

‘‘(c) USE OF FUNDS.—An entity shall use a grant received under 

this section to— 

‘‘(1) make a drug or device approved or cleared under 

the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose available to be 

carried and administered by first responders and members 

of other key community sectors; 

‘‘(2) train and provide resources for first responders and 

members of other key community sectors on carrying and 

administering a drug or device approved or cleared under the 

Federal Food, Drug, and Cosmetic Act for emergency treatment 

of known or suspected opioid overdose; and 

‘‘(3) establish processes, protocols, and mechanisms for 

referral to appropriate treatment, which may include an outreach coordinator or team to connect individuals receiving 

opioid overdose reversal drugs to followup services. 

‘‘(d) TECHNICAL ASSISTANCE GRANTS.—The Secretary shall 

make a grant for the purpose of providing technical assistance 

and training on the use of a drug or device approved or cleared 

under the Federal Food, Drug, and Cosmetic Act for emergency 

treatment of known or suspected opioid overdose, and mechanisms 

for referral to appropriate treatment for an entity receiving a grant 

under this section. 

‘‘(e) GEOGRAPHIC DISTRIBUTION.—In making grants under this 

section, the Secretary shall ensure that not less than 20 percent 

of grant funds are awarded to eligible entities that are not located 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 717 

in metropolitan statistical areas (as defined by the Office of Management and Budget). The Secretary shall take into account the unique 

needs of rural communities, including communities with an 

incidence of individuals with opioid use disorder that is above 

the national average and communities with a shortage of prevention 

and treatment services. 

‘‘(f) EVALUATION.—The Secretary shall conduct an evaluation 

of grants made under this section to determine— 

‘‘(1) the number of first responders and members of other 

key community sectors equipped with a drug or device approved 

or cleared under the Federal Food, Drug, and Cosmetic Act 

for emergency treatment of known or suspected opioid overdose; 

‘‘(2) the number of opioid and heroin overdoses reversed 

by first responders and members of other key community sectors receiving training and supplies of a drug or device approved 

or cleared under the Federal Food, Drug, and Cosmetic Act 

for emergency treatment of known or suspected opioid overdose, 

through a grant received under this section; 

‘‘(3) the number of responses to requests for services by 

the entity or subgrantee, to opioid and heroin overdose; and 

‘‘(4) the extent to which overdose victims and families 

receive information about treatment services and available data 

describing treatment admissions. 

‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated $12,000,000 for 

each of fiscal years 2017 through 2021.’’. 

SEC. 203. PRESCRIPTION DRUG TAKE BACK EXPANSION. 

(a) DEFINITION OF COVERED ENTITY.—In this section, the term 

‘‘covered entity’’ means— 

(1) a State, local, or tribal law enforcement agency; 

(2) a manufacturer, distributor, or reverse distributor of 

prescription medications; 

(3) a retail pharmacy; 

(4) a registered narcotic treatment program; 

(5) a hospital or clinic with an onsite pharmacy; 

(6) an eligible long-term care facility; or 

(7) any other entity authorized by the Drug Enforcement 

Administration to dispose of prescription medications. 

(b) PROGRAM AUTHORIZED.—The Attorney General, in coordination with the Administrator of the Drug Enforcement Administration, the Secretary of Health and Human Services, and the Director 

of the Office of National Drug Control Policy, shall coordinate 

with covered entities in expanding or making available disposal 

sites for unwanted prescription medications. 

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. 


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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 Education Assistance Act) that have a high rate, or have had 

a rapid increase, in the use of heroin or other opioids, in 

order to permit such entities to expand activities, including 

an expansion in the availability of evidence-based medicationassisted treatment and other clinically appropriate services, 

with respect to the treatment of addiction in the specific geographical areas of such entities where there is a high rate 

or rapid increase in the use of heroin or other opioids, such 

as in rural areas. 

‘‘(2) NATURE OF ACTIVITIES.—Funds awarded under paragraph (1) shall be used for activities that are based on reliable 

scientific evidence of efficacy in the treatment of problems 

related to heroin or other opioids. 

‘‘(b) APPLICATION.—To be eligible for a grant, contract, or 

cooperative agreement under subsection (a), an entity shall submit 

an application to the Secretary at such time, in such manner, 

and accompanied by such information as the Secretary may reasonably require. 

‘‘(c) EVALUATION.—An entity that receives a grant, contract, 

or cooperative agreement under subsection (a) shall submit, in 

the application for such grant, contract, or agreement a plan for 

the evaluation of any project undertaken with funds provided under 

this section. Such entity shall provide the Secretary with periodic 

evaluations of the progress of such project and an evaluation at 

the completion of such project as the Secretary determines to be 

appropriate. 

‘‘(d) GEOGRAPHIC DISTRIBUTION.—In awarding grants, contracts, 

and cooperative agreements under this section, the Secretary shall 

ensure that not less than 15 percent of funds are awarded to 

eligible entities that are not located in metropolitan statistical 

areas (as defined by the Office of Management and Budget). The 

Secretary shall take into account the unique needs of rural communities, including communities with an incidence of individuals with 

opioid use disorder that is above the national average and communities with a shortage of prevention and treatment services. 

‘‘(e) ADDITIONAL ACTIVITIES.—In administering grants, contracts, and cooperative agreements under subsection (a), the Secretary shall— 

‘‘(1) evaluate the activities supported under such subsection; 

‘‘(2) disseminate information, as appropriate, derived from 

evaluations as the Secretary considers appropriate; 

‘‘(3) provide States, Indian tribes and tribal organizations, 

and providers with technical assistance in connection with the 

provision of treatment of problems related to heroin and other 

opioids; and 

‘‘(4) fund only those applications that specifically support 

recovery services as a critical component of the program 

involved. 

‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $25,000,000 for each 

of fiscal years 2017 through 2021.’’. 

Evaluation. 

Contracts. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 719 

SEC. 302. BUILDING COMMUNITIES OF RECOVERY. 

Part D of title V of the Public Health Service Act (42 U.S.C. 

290dd et seq.), as amended by section 202, is further amended 

by adding at the end the following: 

‘‘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 longterm recovery from substance use disorders; and 

‘‘(2) is wholly or principally governed by people in recovery 

for substance use disorders who reflect the community served. 

‘‘(b) GRANTS AUTHORIZED.—The Secretary shall award grants 

to recovery community organizations to enable such organizations 

to develop, expand, and enhance recovery services. 

‘‘(c) FEDERAL SHARE.—The Federal share of the costs of a program funded by a grant under this section may not exceed 50 

percent. 

‘‘(d) USE OF FUNDS.—Grants awarded under subsection (b)— 

‘‘(1) shall be used to develop, expand, and enhance community and statewide recovery support services; and 

‘‘(2) may be used to— 

‘‘(A) build connections between recovery networks, 

between recovery community organizations, and with other 

recovery support services, including— 

‘‘(i) behavioral health providers; 

‘‘(ii) primary care providers and physicians; 

‘‘(iii) the criminal justice system; 

‘‘(iv) employers; 

‘‘(v) housing services; 

‘‘(vi) child welfare agencies; and 

‘‘(vii) other recovery support services that facilitate 

recovery from substance use disorders; 

‘‘(B) reduce the stigma associated with substance use 

disorders; and 

‘‘(C) conduct outreach on issues relating to substance 

use disorders and recovery, including— 

‘‘(i) identifying the signs of addiction; 

‘‘(ii) the resources available to individuals struggling with addiction and to families with a family 

member struggling with, or being treated for, addiction, 

including programs that mentor and provide support 

services to children; 

‘‘(iii) the resources available to help support 

individuals in recovery; and 

‘‘(iv) related medical outcomes of substance use 

disorders, the potential of acquiring an infectious disease from intravenous drug use, and neonatal 

abstinence syndrome among infants exposed to opioids 

during pregnancy. 

‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 

to be appropriated to carry out this section $1,000,000 for each 

of fiscal years 2017 through 2021.’’. 

42 USC 290ee–2. 


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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 Substances Act (21 U.S.C. 823(g)(2)) is amended— 

(A) in subparagraph (B), by striking clauses (i), (ii), 

and (iii) and inserting the following: 

‘‘(i) The practitioner is a qualifying practitioner (as defined 

in subparagraph (G)). 

‘‘(ii) With respect to patients to whom the practitioner 

will provide such drugs or combinations of drugs, the practitioner has the capacity to provide directly, by referral, or in 

such other manner as determined by the Secretary— 

‘‘(I) all drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including 

for maintenance, detoxification, overdose reversal, and 

relapse prevention; and 

‘‘(II) appropriate counseling and other appropriate 

ancillary services. 

‘‘(iii)(I) The total number of such patients of the practitioner 

at any one time will not exceed the applicable number. Except 

as provided in subclause (II), the applicable number is 30. 

‘‘(II) The applicable number is 100 if, not sooner than 

1 year after the date on which the practitioner submitted 

the initial notification, the practitioner submits a second 

notification to the Secretary of the need and intent of the 

practitioner to treat up to 100 patients. 

‘‘(III) The Secretary may by regulation change such 

applicable number. 

‘‘(IV) The Secretary may exclude from the applicable 

number patients to whom such drugs or combinations of drugs 

are directly administered by the qualifying practitioner in the 

office setting.’’; 

(B) in subparagraph (D)— 

(i) in clause (ii), by striking ‘‘Upon receiving a 

notification under subparagraph (B)’’ and inserting 

‘‘Upon receiving a determination from the Secretary 

under clause (iii) finding that a practitioner meets 

all requirements for a waiver under subparagraph (B)’’; 

and 

(ii) in clause (iii)— 

(I) by inserting ‘‘and shall forward such determination to the Attorney General’’ before the 

period at the end of the first sentence; and 

(II) by striking ‘‘physician’’ and inserting 

‘‘practitioner’’; 

(C) in subparagraph (G)— 

(i) by amending clause (ii)(I) to read as follows: 

‘‘(I) The physician holds a board certification 

in addiction psychiatry or addiction medicine from 

the American Board of Medical Specialties.’’; 

(ii) by amending clause (ii)(II) to read as follows: 

‘‘(II) The physician holds an addiction certification or board certification from the American 

Society of Addiction Medicine or the American 

Board of Addiction Medicine.’’; 

(iii) in clause (ii)(III), by striking ‘‘subspecialty’’; 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 721 

(iv) by amending clause (ii)(IV) to read as follows: 

‘‘(IV) The physician has, with respect to the treatment 

and management of opiate-dependent patients, completed 

not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic 

communications, or otherwise) that is provided by the 

American Society of Addiction Medicine, the American 

Academy of Addiction Psychiatry, the American Medical 

Association, the American Osteopathic Association, the 

American Psychiatric Association, or any other organization 

that the Secretary determines is appropriate for purposes 

of this subclause. Such training shall include— 

‘‘(aa) opioid maintenance and detoxification; 

‘‘(bb) appropriate clinical use of all drugs approved 

by the Food and Drug Administration for the treatment 

of opioid use disorder; 

‘‘(cc) initial and periodic patient assessments 

(including substance use monitoring); 

‘‘(dd) individualized treatment planning, overdose 

reversal, and relapse prevention; 

‘‘(ee) counseling and recovery support services; 

‘‘(ff) staffing roles and considerations; 

‘‘(gg) diversion control; and 

‘‘(hh) other best practices, as identified by the Secretary.’’; and 

(v) by adding at the end the following: 

‘‘(iii) The term ‘qualifying practitioner’ means— 

‘‘(I) a qualifying physician, as defined in clause (ii); 

or 

‘‘(II) during the period beginning on the date of enactment of the Comprehensive Addiction and Recovery Act 

of 2016 and ending on October 1, 2021, a qualifying other 

practitioner, as defined in clause (iv). 

‘‘(iv) The term ‘qualifying other practitioner’ means a nurse 

practitioner or physician assistant who satisfies each of the 

following: 

‘‘(I) The nurse practitioner or physician assistant is 

licensed under State law to prescribe schedule III, IV, 

or V medications for the treatment of pain. 

‘‘(II) The nurse practitioner or physician assistant 

has— 

‘‘(aa) completed not fewer than 24 hours of initial 

training addressing each of the topics listed in clause 

(ii)(IV) (through classroom situations, seminars at 

professional society meetings, electronic communications, or otherwise) provided by the American Society 

of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the 

American Osteopathic Association, the American 

Nurses Credentialing Center, the American Psychiatric 

Association, the American Association of Nurse Practitioners, the American Academy of Physician Assistants, or any other organization that the Secretary 

determines is appropriate for purposes of this subclause; or 

‘‘(bb) has such other training or experience as the 

Secretary determines will demonstrate the ability of 

Definition. 

Time period. 

Definition. 


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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 opioiddependent patients in office-based settings. The Secretary shall 

update such protocol in consultation with experts in opioid use 

disorder research and treatment.’’. 

(2) OPIOID DEFINED.—Section 102(18) of the Controlled Substances Act (21 U.S.C. 802(18)) is amended by inserting ‘‘or 

‘opioid’ ’’ after ‘‘The term ‘opiate’ ’’. 

(3) REPORTS TO CONGRESS.— 

(A) IN GENERAL.—Not later than 3 years after the 

date of enactment of this Act and not later than 3 years 

thereafter, the Secretary of Health and Human Services, 

in consultation with the Drug Enforcement Administration 

and experts in opioid use disorder research and treatment, 

shall— 

(i) perform a thorough review of the provision of 

opioid use disorder treatment services in the United 

States, including services provided in opioid treatment 

programs and other specialty and nonspecialty settings; and 

(ii) submit a report to the Congress on the findings 

and conclusions of such review. 

(B) CONTENTS.—Each report under subparagraph (A) 

shall include an assessment of— 

(i) compliance with the requirements of section 

303(g)(2) of the Controlled Substances Act (21 U.S.C. 

823(g)(2)), as amended by this section; 

(ii) the measures taken by the Secretary of Health 

and Human Services to ensure such compliance; 

(iii) whether there is further need to increase or 

decrease the number of patients a practitioner, pursuant to a waiver under section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)), is permitted to treat; 

(iv) the extent to which, and proportions with 

which, the full range of Food and Drug Administrationapproved treatments for opioid use disorder are used 

Assessment. 

Consultation. 

21 USC 823 note. 

Consultation. 

Deadline. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 723 

in routine health care settings and specialty substance 

use disorder treatment settings; 

(v) access to, and use of, counseling and recovery 

support services, including the percentage of patients 

receiving such services; 

(vi) changes in State or local policies and legislation relating to opioid use disorder treatment; 

(vii) the use of prescription drug monitoring programs by practitioners who are permitted to dispense 

narcotic drugs to individuals pursuant to a waiver 

described in clause (iii); 

(viii) the findings resulting from inspections by 

the Drug Enforcement Administration of practitioners 

described in clause (vii); and 

(ix) the effectiveness of cross-agency collaboration 

between Department of Health and Human Services 

and the Drug Enforcement Administration for 

expanding effective opioid use disorder treatment. 

(b) STATE FLEXIBILITY.—Section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) is amended by striking subparagraphs (I) and (J), and inserting the following: 

‘‘(I) Notwithstanding section 708, nothing in this paragraph 

shall be construed to preempt any State law that— 

‘‘(i) permits a qualifying practitioner to dispense narcotic 

drugs in schedule III, IV, or V, or combinations of such drugs, 

for maintenance or detoxification treatment in accordance with 

this paragraph to a total number of patients that is more 

than 30 or less than the total number applicable to the qualifying practitioner under subparagraph (B)(iii)(II) if a State 

enacts a law modifying such total number and the Attorney 

General is notified by the State of such modification; or 

‘‘(ii) requires a qualifying practitioner to comply with additional requirements relating to the dispensing of narcotic drugs 

in schedule III, IV, or V, or combinations of such drugs, 

including requirements relating to the practice setting in which 

the qualifying practitioner practices and education, training, 

and reporting requirements.’’. 

(c) UPDATE REGULATIONS.—Not later than 18 months after 

the date of enactment of this Act, the Attorney General and the 

Secretary of Health and Human Services, as appropriate, shall 

update regulations regarding practitioners described in subsection 

(a)(3)(B)(vii) (as amended by this section) to include nurse practitioners and physician assistants to ensure the quality of patient 

care and prevent diversion. 

TITLE IV—ADDRESSING COLLATERAL 

CONSEQUENCES 

SEC. 401. GAO REPORT ON RECOVERY AND COLLATERAL CONSEQUENCES. 

(a) REPORT REQUIRED.—Not later than 1 year after the date 

of enactment of this Act, the Comptroller General of the United 

States shall submit to the Committee on the Judiciary of the Senate 

and the Committee on the Judiciary of the House of Representatives 

a report that— 

Deadline. 

21 USC 823 note. 


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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 participating in or have completed a recovery program for a substance 

use disorder; 

(3) discusses policy bases and justifications for imposing 

collateral consequences on individuals convicted of nonviolent 

drug-related offenses identified under paragraph (1); and 

(4) provides perspectives on the potential for mitigating 

the effect of the collateral consequences described in paragraph 

(1) on individuals who are participating in or have completed 

a recovery program, while also taking into account the policy 

interests described in paragraph (3). 

(b) DEFINITION.—In this section, the term ‘‘collateral consequence’’— 

(1) means a penalty, disability, or disadvantage imposed 

upon an individual as a result of a criminal conviction for 

a drug-related offense— 

(A) automatically by operation of law; or 

(B) by authorized action of an administrative agency 

or court on a case-by-case basis; and 

(2) does not include a direct consequence imposed as part 

of the judgment of a court at sentencing, including a term 

of imprisonment or community supervision, or a fine. 

TITLE V—ADDICTION AND TREATMENT 

SERVICES FOR WOMEN, FAMILIES, 

AND VETERANS 

SEC. 501. IMPROVING TREATMENT FOR PREGNANT AND POSTPARTUM 

WOMEN. 

(a) GENERAL AMENDMENTS TO THE RESIDENTIAL TREATMENT

PROGRAM FOR PREGNANT AND POSTPARTUM WOMEN.—Section 508 

of the Public Health Service Act (42 U.S.C. 290bb–1) is amended— 

(1) in subsection (a)— 

(A) in the matter preceding paragraph (1)— 

(i) by inserting ‘‘(referred to in this section as 

the ‘Director’)’’ after ‘‘Substance Abuse Treatment’’; 

(ii) by striking ‘‘grants, cooperative agreement,’’ 

and inserting ‘‘grants, including the grants under subsection (r), cooperative agreements’’; and 

(iii) by striking ‘‘for substance abuse’’ and inserting 

‘‘for substance use disorders’’; and 

(B) in paragraph (1), by inserting ‘‘or receive outpatient 

treatment services from’’ after ‘‘reside in’’; 

(2) in subsection (b)(2), by inserting ‘‘and her children’’ 

before the period at the end; 

(3) in subsection (c)— 

(A) in paragraph (1), by striking ‘‘to the woman of 

the services’’ and inserting ‘‘of services for the woman and 

her children’’; and 

(B) in paragraph (2)— 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 725 

(i) in subparagraph (A), by striking ‘‘substance 

abuse’’ and inserting ‘‘substance use disorders’’; and 

(ii) in subparagraph (B), by striking ‘‘such abuse’’ 

and inserting ‘‘such a disorder’’; 

(4) in subsection (d)— 

(A) in paragraph (3)(A), by striking ‘‘maternal substance abuse’’ and inserting ‘‘a maternal substance use 

disorder’’; 

(B) by amending paragraph (4) to read as follows: 

‘‘(4) Providing therapeutic, comprehensive child care for 

children during the periods in which the woman is engaged 

in therapy or in other necessary health and rehabilitative activities.’’; 

(C) in paragraphs (9), (10), and (11), by striking 

‘‘women’’ each place such term appears and inserting 

‘‘woman’’; 

(D) in paragraph (9), by striking ‘‘units’’ and inserting 

‘‘unit’’; and 

(E) in paragraph (11)— 

(i) in subparagraph (A), by striking ‘‘their children’’ 

and inserting ‘‘any child of such woman’’; 

(ii) in subparagraph (B), by striking ‘‘; and’’ and 

inserting a semicolon; 

(iii) in subparagraph (C), by striking the period 

and inserting ‘‘; and’’; and 

(iv) by adding at the end the following: 

‘‘(D) family reunification with children in kinship or 

foster care arrangements, where safe and appropriate.’’; 

(5) in subsection (e)— 

(A) in paragraph (1)— 

(i) in the matter preceding subparagraph (A), by 

striking ‘‘substance abuse’’ and inserting ‘‘substance 

use disorders’’; and 

(ii) in subparagraph (B), by striking ‘‘substance 

abuse’’ and inserting ‘‘substance use disorders’’; and 

(B) in paragraph (2)— 

(i) by striking ‘‘(A) Subject’’ and inserting the following: 

‘‘(A) IN GENERAL.—Subject’’; 

(ii) in subparagraph (B)— 

(I) by striking ‘‘(B)(i) In the case’’ and inserting 

the following: 

‘‘(B) WAIVER OF PARTICIPATION AGREEMENTS.— 

‘‘(i) IN GENERAL.—In the case’’; and 

(II) by striking ‘‘(ii) A determination’’ and 

inserting the following: 

‘‘(ii) DONATIONS.—A determination’’; and 

(iii) by striking ‘‘(C) With respect’’ and inserting 

the following: 

‘‘(C) NONAPPLICATION OF CERTAIN REQUIREMENTS.— 

With respect’’; 

(6) in subsection (g)— 

(A) by striking ‘‘who are engaging in substance abuse’’ 

and inserting ‘‘who have a substance use disorder’’; and 

(B) by striking ‘‘such abuse’’ and inserting ‘‘such disorder’’; 

(7) in subsection (j)— 


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130 STAT. 726 PUBLIC LAW 114–198—JULY 22, 2016 

(A) in the matter preceding paragraph (1), by striking 

‘‘to on’’ and inserting ‘‘to or on’’; and 

(B) in paragraph (3), by striking ‘‘Office for’’ and 

inserting ‘‘Office of’’; 

(8) by amending subsection (m) to read as follows: 

‘‘(m) ALLOCATION OF AWARDS.—In making awards under subsection (a), the Director shall give priority to an applicant that 

agrees to use the award for a program serving an area that is 

a rural area, an area designated under section 332 by the Secretary 

as a health professional shortage area, or an area determined 

by the Director to have a shortage of family-based substance use 

disorder treatment options.’’; and 

(9) in subsection (q)— 

(A) in paragraph (3), by striking ‘‘funding agreement 

under subsection (a)’’ and inserting ‘‘funding agreement’’; 

and 

(B) in paragraph (4), by striking ‘‘substance abuse’’ 

and inserting ‘‘a substance use disorder’’. 

(b) REAUTHORIZATION OF PROGRAM.—Section 508 of the Public 

Health Service Act (42 U.S.C. 290bb–1), as amended by subsection 

(a), is further amended— 

(1) in subsection (p), in the first sentence, by inserting 

‘‘(other than subsection (r))’’ after ‘‘section’’; and 

(2) in subsection (r), by striking ‘‘such sums’’ and all that 

follows through ‘‘2003’’ and inserting ‘‘$16,900,000 for each 

of fiscal years 2017 through 2021’’. 

(c) PILOT PROGRAM GRANTS FOR STATE SUBSTANCE ABUSE

AGENCIES.— 

(1) IN GENERAL.—Section 508 of the Public Health Service 

Act (42 U.S.C. 290bb–1), as amended by subsections (a) and 

(b), is further amended— 

(A) by redesignating subsection (r), as amended by 

subsection (b), as subsection (s); and 

(B) by inserting after subsection (q) the following new 

subsection: 

‘‘(r) PILOT PROGRAM FOR STATE SUBSTANCE ABUSE AGENCIES.— 

‘‘(1) IN GENERAL.—From amounts made available under 

subsection (s), the Director of the Center for Substance Abuse 

Treatment shall carry out a pilot program under which competitive grants are made by the Director to State substance abuse 

agencies— 

‘‘(A) to enhance flexibility in the use of funds designed 

to support family-based services for pregnant and 

postpartum women with a primary diagnosis of a substance 

use disorder, including opioid use disorders; 

‘‘(B) to help State substance abuse agencies address 

identified gaps in services furnished to such women along 

the continuum of care, including services provided to 

women in nonresidential-based settings; and 

‘‘(C) to promote a coordinated, effective, and efficient 

State system managed by State substance abuse agencies 

by encouraging new approaches and models of service 

delivery. 

‘‘(2) REQUIREMENTS.—In carrying out the pilot program 

under this subsection, the Director shall— 

‘‘(A) require State substance abuse agencies to submit 

to the Director applications, in such form and manner 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 727 

and containing such information as specified by the 

Director, to be eligible to receive a grant under the program; 

‘‘(B) identify, based on such submitted applications, 

State substance abuse agencies that are eligible for such 

grants; 

‘‘(C) require services proposed to be furnished through 

such a grant to support family-based treatment and other 

services for pregnant and postpartum women with a primary diagnosis of a substance use disorder, including opioid 

use disorders; 

‘‘(D) not require that services furnished through such 

a grant be provided solely to women that reside in facilities; 

‘‘(E) not require that grant recipients under the program make available through use of the grant all the 

services described in subsection (d); and 

‘‘(F) consider not applying the requirements described 

in paragraphs (1) and (2) of subsection (f) to an applicant, 

depending on the circumstances of the applicant. 

‘‘(3) REQUIRED SERVICES.— 

‘‘(A) IN GENERAL.—The Director shall specify a minimum set of services required to be made available to 

eligible women through a grant awarded under the pilot 

program under this subsection. Such minimum set of services— 

‘‘(i) shall include the services requirements 

described in subsection (c) and be based on the recommendations submitted under subparagraph (B); and 

‘‘(ii) may be selected from among the services 

described in subsection (d) and include other services 

as appropriate. 

‘‘(B) STAKEHOLDER INPUT.—The Director shall convene 

and solicit recommendations from stakeholders, including 

State substance abuse agencies, health care providers, persons in recovery from substance abuse, and other appropriate individuals, for the minimum set of services 

described in subparagraph (A). 

‘‘(4) DURATION.—The pilot program under this subsection 

shall not exceed 5 years. 

‘‘(5) EVALUATION AND REPORT TO CONGRESS.— 

‘‘(A) IN GENERAL.—The Director of the Center for 

Behavioral Health Statistics and Quality shall evaluate 

the pilot program at the conclusion of the first grant cycle 

funded by the pilot program. 

‘‘(B) REPORT.—The Director of the Center for Behavioral Health Statistics and Quality, in coordination with 

the Director of the Center for Substance Abuse Treatment 

shall submit to the relevant committees of jurisdiction of 

the House of Representatives and the Senate a report 

on the evaluation under subparagraph (A). The report shall 

include, at a minimum— 

‘‘(i) outcomes information from the pilot program, 

including any resulting reductions in the use of alcohol 

and other drugs; 

‘‘(ii) engagement in treatment services; 

‘‘(iii) retention in the appropriate level and duration of services; 

Coordination. 

Recommendations. 


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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 combination with counseling; and 

‘‘(v) other appropriate measures. 

‘‘(C) RECOMMENDATION.—The report under subparagraph (B) shall include a recommendation by the Director 

of the Center for Substance Abuse Treatment as to whether 

the pilot program under this subsection should be extended. 

‘‘(6) STATE SUBSTANCE ABUSE AGENCIES DEFINED.—For purposes of this subsection, the term ‘State substance abuse agency’ 

means, with respect to a State, the agency in such State that 

manages the Substance Abuse Prevention and Treatment Block 

Grant under part B of title XIX.’’. 

(2) FUNDING.—Subsection (s) of section 508 of the Public 

Health Service Act (42 U.S.C. 290bb–1), as amended by subsection (a) and redesignated by paragraph (1), is further 

amended by adding at the end the following new sentences: 

‘‘Of the amounts made available for a year pursuant to the 

previous sentence to carry out this section, not more than 

25 percent of such amounts shall be made available for such 

year to carry out subsection (r), other than paragraph (5) of 

such subsection. Notwithstanding the preceding sentence, no 

funds shall be made available to carry out subsection (r) for 

a fiscal year unless the amount made available to carry out 

this section for such fiscal year is more than the amount made 

available to carry out this section for fiscal year 2016.’’. 

SEC. 502. VETERANS TREATMENT COURTS. 

Section 2991 of the Omnibus Crime Control and Safe Streets 

Act of 1968 (42 U.S.C. 3797aa) is amended— 

(1) by redesignating subsection (i) as subsection (j); and 

(2) by inserting after subsection (h) the following: 

‘‘(i) ASSISTING VETERANS.— 

‘‘(1) DEFINITIONS.—In this subsection: 

‘‘(A) PEER-TO-PEER SERVICES OR PROGRAMS.—The term 

‘peer-to-peer services or programs’ means services or programs that connect qualified veterans with other veterans 

for the purpose of providing support and mentorship to 

assist qualified veterans in obtaining treatment, recovery, 

stabilization, or rehabilitation. 

‘‘(B) QUALIFIED VETERAN.—The term ‘qualified veteran’ 

means a preliminarily qualified offender who— 

‘‘(i) served on active duty in any branch of the 

Armed Forces, including the National Guard or 

Reserves; and 

‘‘(ii) was discharged or released from such service 

under conditions other than dishonorable, unless the 

reason for the dishonorable discharge was attributable 

to a substance abuse disorder. 

‘‘(C) VETERANS TREATMENT COURT PROGRAM.—The term 

‘veterans treatment court program’ means a court program 

involving collaboration among criminal justice, veterans, 

and mental health and substance abuse agencies that provides qualified veterans with— 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 729 

‘‘(i) intensive judicial supervision and case management, which may include random and frequent drug 

testing where appropriate; 

‘‘(ii) a full continuum of treatment services, 

including mental health services, substance abuse services, medical services, and services to address trauma; 

‘‘(iii) alternatives to incarceration; or 

‘‘(iv) other appropriate services, including housing, 

transportation, mentoring, employment, job training, 

education, or assistance in applying for and obtaining 

available benefits. 

‘‘(2) VETERANS ASSISTANCE PROGRAM.— 

‘‘(A) IN GENERAL.—The Attorney General, in consultation with the Secretary of Veterans Affairs, may award 

grants under this subsection to applicants to establish or 

expand— 

‘‘(i) veterans treatment court programs; 

‘‘(ii) peer-to-peer services or programs for qualified 

veterans; 

‘‘(iii) practices that identify and provide treatment, 

rehabilitation, legal, transitional, and other appropriate services to qualified veterans who have been 

incarcerated; or 

‘‘(iv) training programs to teach criminal justice, 

law enforcement, corrections, mental health, and substance abuse personnel how to identify and appropriately respond to incidents involving qualified veterans. 

‘‘(B) PRIORITY.—In awarding grants under this subsection, the Attorney General shall give priority to applications that— 

‘‘(i) demonstrate collaboration between and joint 

investments by criminal justice, mental health, substance abuse, and veterans service agencies; 

‘‘(ii) promote effective strategies to identify and 

reduce the risk of harm to qualified veterans and public 

safety; and 

‘‘(iii) propose interventions with empirical support 

to improve outcomes for qualified veterans.’’. 

SEC. 503. INFANT PLAN OF SAFE CARE. 

(a) BEST PRACTICES FOR DEVELOPMENT OF PLANS OF SAFE

CARE.—Section 103(b) of the Child Abuse Prevention and Treatment 

Act (42 U.S.C. 5104(b)) is amended— 

(1) by redesignating paragraphs (5) through (8) as paragraphs (6) through (9), respectively; and 

(2) by inserting after paragraph (4) the following: 

‘‘(5) maintain and disseminate information about the 

requirements of section 106(b)(2)(B)(iii) and best practices 

relating to the development of plans of safe care as described 

in such section for infants born and identified as being affected 

by substance abuse or withdrawal symptoms, or a Fetal Alcohol 

Spectrum Disorder;’’. 

(b) STATE PLANS.—Section 106(b)(2)(B) of the Child Abuse 

Prevention and Treatment Act (42 U.S.C. 5106a(b)(2)(B)) is 

amended— 

Consultation. 


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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 providers, including through— 

‘‘(I) addressing the health and substance use disorder treatment needs of the infant and affected family 

or caregiver; and 

‘‘(II) the development and implementation by the 

State of monitoring systems regarding the implementation of such plans to determine whether and in what 

manner local entities are providing, in accordance with 

State requirements, referrals to and delivery of appropriate services for the infant and affected family or 

caregiver’’. 

(c) DATA REPORTS.— 

(1) IN GENERAL.—Section 106(d) of the Child Abuse Prevention and Treatment Act (42 U.S.C. 5106a(d)) is amended by 

adding at the end of the following: 

‘‘(17) The number of infants— 

‘‘(A) identified under subsection (b)(2)(B)(ii); 

‘‘(B) for whom a plan of safe care was developed under 

subsection (b)(2)(B)(iii); and 

‘‘(C) for whom a referral was made for appropriate 

services, including services for the affected family or caregiver, under subsection (b)(2)(B)(iii).’’. 

(2) REDESIGNATION.—Effective on May 29, 2017, section 

106(d) of the Child Abuse Prevention and Treatment Act (42 

U.S.C. 5106a(d)) is amended by redesignating paragraph (17) 

(as added by paragraph (1)) as paragraph (18). 

(d) MONITORING AND OVERSIGHT.— (1) AMENDMENT.—Title I of the Child Abuse Prevention 

and Treatment Act (42 U.S.C. 5101 et seq.) is amended by 

adding at the end the following: 

‘‘SEC. 114. MONITORING AND OVERSIGHT. 

‘‘The Secretary shall conduct monitoring to ensure that each 

State that receives a grant under section 106 is in compliance 

with the requirements of section 106(b), which— 

‘‘(1) shall— 

‘‘(A) be in addition to the review of the State plan 

upon its submission under section 106(b)(1)(A); and 

‘‘(B) include monitoring of State policies and procedures 

required under clauses (ii) and (iii) of section 106(b)(2)(B); 

and 

‘‘(2) may include— 

‘‘(A) a comparison of activities carried out by the State 

to comply with the requirements of section 106(b) with 

the State plan most recently approved under section 432 

of the Social Security Act; 

‘‘(B) a review of information available on the website 

of the State relating to its compliance with the requirements of section 106(b); 

42 USC 5108. 

Effective date. 

42 USC 5106a 

note. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 731 

‘‘(C) site visits, as may be necessary to carry out such 

monitoring; and 

‘‘(D) a review of information available in the State’s 

Annual Progress and Services Report most recently submitted under section 1357.16 of title 45, Code of Federal 

Regulations (or successor regulations).’’. 

(2) TABLE OF CONTENTS.—The table of contents in section 

1(b) of the Child Abuse Prevention and Treatment Act (42 

U.S.C. 5101 note) is amended by inserting after the item 

relating to section 113, the following: 

‘‘Sec. 114. Monitoring and oversight.’’. 

(e) RULE OF CONSTRUCTION.—Nothing in this section, or the 

amendments made by this section, shall be construed to authorize 

the Secretary of Health and Human Services or any other officer 

of the Federal Government to add new requirements to section 

106(b) of the Child Abuse Prevention and Treatment Act (42 U.S.C. 

5106a(b)), as amended by this section. 

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, hospitalbased, and other settings) for the treatment of infants with 

NAS and the reimbursement methodologies and costs associated 

with such treatment in such settings. 

(4) The prevalence of utilization of various care settings 

under State Medicaid programs for treatment of infants with 

NAS and any Federal barriers to treating such infants under 

such programs, particularly in non-hospital-based settings. 

(5) What is known about best practices for treating infants 

with NAS. 

(c) RECOMMENDATIONS.—Such report also shall include such 

recommendations as the Comptroller General determines appropriate for improvements that will ensure access to treatment for 

infants with NAS under State Medicaid programs. 

42 USC 5106a 

note. 


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130 STAT. 732 PUBLIC LAW 114–198—JULY 22, 2016 

TITLE VI—INCENTIVIZING STATE COMPREHENSIVE INITIATIVES TO ADDRESS PRESCRIPTION OPIOID ABUSE 

SEC. 601. STATE DEMONSTRATION GRANTS FOR COMPREHENSIVE 

OPIOID ABUSE RESPONSE. 

Part D of title V of the Public Health Service Act (42 U.S.C. 

290dd et seq.), as amended by section 302, is further amended 

by adding at the end the following: 

‘‘SEC. 548. STATE DEMONSTRATION GRANTS FOR COMPREHENSIVE 

OPIOID ABUSE RESPONSE. 

‘‘(a) DEFINITIONS.—In this section: 

‘‘(1) DISPENSER.—The term ‘dispenser’ has the meaning 

given the term in section 102 of the Controlled Substances 

Act (21 U.S.C. 802). 

‘‘(2) PRESCRIBER.—The term ‘prescriber’ means a dispenser 

who prescribes a controlled substance, or the agent of such 

a dispenser. 

‘‘(3) PRESCRIBER OF A SCHEDULE II, III, OR IV CONTROLLED

SUBSTANCE.—The term ‘prescriber of a schedule II, III, or IV 

controlled substance’ does not include a prescriber of a schedule 

II, III, or IV controlled substance that dispenses the substance— 

‘‘(A) for use on the premises on which the substance 

is dispensed; 

‘‘(B) in a hospital emergency room, when the substance 

is in short supply; 

‘‘(C) for a certified opioid treatment program; or 

‘‘(D) in other situations as the Secretary may reasonably determine. 

‘‘(4) SCHEDULE II, III, OR IV CONTROLLED SUBSTANCE.—The 

term ‘schedule II, III, or IV controlled substance’ means a 

controlled substance that is listed on schedule II, schedule 

III, or schedule IV of section 202(c) of the Controlled Substances 

Act. 

‘‘(b) GRANTS FOR COMPREHENSIVE OPIOID ABUSE RESPONSE.— 

‘‘(1) IN GENERAL.—The Secretary shall award grants to 

States, and combinations of States, to implement an integrated 

opioid abuse response initiative. 

‘‘(2) PURPOSES.—A State receiving a grant under this section shall establish a comprehensive response plan to opioid 

abuse, which may include— 

‘‘(A) education efforts around opioid use, treatment, 

and addiction recovery, including education of residents, 

medical students, and physicians and other prescribers of 

schedule II, III, or IV controlled substances on relevant 

prescribing guidelines, the prescription drug monitoring 

program of the State described in subparagraph (B), and 

overdose prevention methods; 

‘‘(B) establishing, maintaining, or improving a comprehensive prescription drug monitoring program to track 

dispensing of schedule II, III, or IV controlled substances, 

which may— 

Response plan. 

42 USC 290ee–3. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 733 

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

and 

‘‘(ii) allow all individuals authorized by the State 

to write prescriptions for schedule II, III, or IV controlled substances to access the prescription drug monitoring program of the State; 

‘‘(C) developing, implementing, or expanding prescription drug and opioid addiction treatment programs by— 

‘‘(i) expanding the availability of treatment for 

prescription drug and opioid addiction, including medication-assisted treatment and behavioral health 

therapy, as appropriate; 

‘‘(ii) developing, implementing, or expanding 

screening for individuals in treatment for prescription 

drug and opioid addiction for hepatitis C and HIV, 

and treating or referring those individuals if clinically 

appropriate; or 

‘‘(iii) developing, implementing, or expanding 

recovery support services and programs at high schools 

or institutions of higher education; 

‘‘(D) developing, implementing, and expanding efforts 

to prevent overdose death from opioid abuse or addiction 

to prescription medications and opioids; and 

‘‘(E) advancing the education and awareness of the 

public, providers, patients, consumers, and other appropriate entities regarding the dangers of opioid abuse, safe 

disposal of prescription medications, and detection of early 

warning signs of opioid use disorders. 

‘‘(3) APPLICATION.—A State seeking a grant under this section shall submit to the Secretary an application in such form, 

and containing such information, as the Secretary may reasonably require. 

‘‘(4) USE OF FUNDS.—A State that receives a grant under 

this section shall use the grant for the cost, including the 

cost for technical assistance, training, and administration 

expenses, of carrying out an integrated opioid abuse response 

initiative as outlined by the State’s comprehensive response 

plan to opioid abuse established under paragraph (2). 

‘‘(5) PRIORITY CONSIDERATIONS.—In awarding grants under 

this section, the Secretary shall, as appropriate, give priority 

to a State that— 

‘‘(A)(i) provides civil liability protection for first 

responders, health professionals, and family members who 

have received appropriate training in administering a drug 

or device approved or cleared under the Federal Food, 

Drug, and Cosmetic Act for emergency treatment of known 

or suspected opioid overdose; and 

‘‘(ii) submits to the Secretary a certification by the 

attorney general of the State that the attorney general 

has— 

‘‘(I) reviewed any applicable civil liability protection law to determine the applicability of the law with 

respect to first responders, health care professionals, 

family members, and other individuals who— 

‘‘(aa) have received appropriate training in 

administering a drug or device approved or cleared 

under the Federal Food, Drug, and Cosmetic Act 

Certification. 


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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 benefits necessary by criminal justice agencies to initiate or 

continue treatment in the community, under which an 

individual who is incarcerated may, while incarcerated, 

enroll in services and benefits that are necessary for the 

individual to continue treatment upon release from incarceration; 

‘‘(C) ensures the capability of data sharing with other 

States, where applicable, such as by making data available 

to a prescription monitoring hub; 

‘‘(D) ensures that data recorded in the prescription 

drug monitoring program database of the State are regularly updated, to the extent possible; 

‘‘(E) ensures that the prescription drug monitoring program of the State notifies prescribers and dispensers of 

schedule II, III, or IV controlled substances when overuse 

or misuse of such controlled substances by patients is suspected; and 

‘‘(F) has in effect one or more statutes or implements 

policies that maximize use of prescription drug monitoring 

programs by individuals authorized by the State to prescribe schedule II, III, or IV controlled substances. 

‘‘(6) EVALUATION.—In conducting an evaluation of the program under this section pursuant to section 701 of the Comprehensive Addiction and Recovery Act of 2016, with respect 

to a State, the Secretary shall report on State legislation or 

policies related to maximizing the use of prescription drug 

monitoring programs and the incidence of opioid use disorders 

and overdose deaths in such State. 

‘‘(7) STATES WITH LOCAL PRESCRIPTION DRUG MONITORING

PROGRAMS.— 

‘‘(A) IN GENERAL.—In the case of a State that does 

not have a prescription drug monitoring program, a county 

or other unit of local government within the State that 

has a prescription drug monitoring program shall be 

treated as a State for purposes of this section, including 

for purposes of eligibility for grants under paragraph (1). 

‘‘(B) PLAN FOR INTEROPERABILITY.—In submitting an 

application to the Secretary under paragraph (3), a county 

or other unit of local government shall submit a plan 

outlining the methods such county or unit of local government shall use to ensure the capability of data sharing 

with other counties and units of local government within 

the state and with other States, as applicable. 

‘‘(c) AUTHORIZATION OF FUNDING.—For the purpose of carrying 

out this section, there are authorized to be appropriated $5,000,000 

for each of fiscal years 2017 through 2021.’’. 

Records. 

Reports. 

Notification. 

Records. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 735 

TITLE VII—MISCELLANEOUS 

SEC. 701. GRANT ACCOUNTABILITY AND EVALUATIONS. 

(a) DEPARTMENT OF JUSTICE GRANT ACCOUNTABILITY.—Part LL 

of title I of the Omnibus Crime Control and Safe Streets Act 

of 1968 (42 U.S.C. 3711 et seq.), as added by section 201, is amended 

by adding at the end the following: 

‘‘SEC. 3026. GRANT ACCOUNTABILITY. 

‘‘(a) DEFINITION OF APPLICABLE COMMITTEES.—In this section, 

the term ‘applicable committees’ means— 

‘‘(1) the Committee on the Judiciary of the Senate; and 

‘‘(2) the Committee on the Judiciary of the House of Representatives. 

‘‘(b) ACCOUNTABILITY.—All grants awarded by the Attorney 

General under this part shall be subject to the following accountability provisions: 

‘‘(1) AUDIT REQUIREMENT.— 

‘‘(A) DEFINITION.—In this paragraph, the term ‘unresolved audit finding’ means a finding in the final audit 

report of the Inspector General of the Department of Justice 

that the audited grantee has utilized grant funds for an 

unauthorized expenditure or otherwise unallowable cost 

that is not closed or resolved within 12 months after the 

date on which the final audit report is issued. 

‘‘(B) AUDIT.—Beginning in the first fiscal year beginning after the date of enactment of this section, and in 

each fiscal year thereafter, the Inspector General of the 

Department of Justice shall conduct audits of recipients 

of grants awarded by the Attorney General under this 

part to prevent waste, fraud, and abuse of funds by 

grantees. The Inspector General shall determine the appropriate number of grantees to be audited each year. 

‘‘(C) MANDATORY EXCLUSION.—A recipient of grant 

funds under this part that is found to have an unresolved 

audit finding shall not be eligible to receive grant funds 

under this part during the first 2 fiscal years beginning 

after the end of the 12-month period described in subparagraph (A). 

‘‘(D) PRIORITY.—In awarding grants under this part, 

the Attorney General shall give priority to eligible 

applicants that did not have an unresolved audit finding 

during the 3 fiscal years before submitting an application 

for a grant under this part. 

‘‘(E) REIMBURSEMENT.—If an entity is awarded grant 

funds under this part during the 2-fiscal-year period during 

which the entity is barred from receiving grants under 

subparagraph (C), the Attorney General shall— 

‘‘(i) deposit an amount equal to the amount of 

the grant funds that were improperly awarded to the 

grantee into the General Fund of the Treasury; and 

‘‘(ii) seek to recoup the costs of the repayment 

to the fund from the grant recipient that was erroneously awarded grant funds. 

‘‘(2) NONPROFIT ORGANIZATION REQUIREMENTS.— 

Effective date. 

Time periods. 

42 USC 3797ff–5. 


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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 section 3021(b); or 

‘‘(ii) receive a subaward under section 3021(b). 

‘‘(C) DISCLOSURE.—Each nonprofit organization that 

receives a subaward or is party to a contract entered into 

under section 3021(b) and uses the procedures prescribed 

in regulations to create a rebuttable presumption of reasonableness for the compensation of its officers, directors, 

trustees, and key employees, shall disclose, in the application for such contract or subaward, the process for determining such compensation, including the independent persons involved in reviewing and approving such compensation, the comparability data used, and contemporaneous 

substantiation of the deliberation and decision. Upon 

request, the Attorney General shall make the information 

disclosed under this subparagraph available for public 

inspection. 

‘‘(3) CONFERENCE EXPENDITURES.— 

‘‘(A) LIMITATION.—No amounts made available to the 

Attorney General under this part may be used by the 

Attorney General, or by any State, unit of local government, 

or entity awarded a grant, subaward, or contract under 

this part, to host or support any expenditure for conferences 

that uses more than $20,000 in funds made available by 

the Attorney General, unless the head of the relevant 

agency, bureau, or program office provides prior written 

authorization that the funds may be expended to host 

or support the conference. 

‘‘(B) WRITTEN AUTHORIZATION.—Written authorization 

under subparagraph (A) shall include a written estimate 

of all costs associated with the conference, including the 

cost of all food, beverages, audio-visual equipment, honoraria for speakers, and entertainment. 

‘‘(C) REPORT.—The Deputy Attorney General shall 

submit to the applicable committees an annual report on 

all conference expenditures approved by the Attorney General under this paragraph. 

‘‘(4) ANNUAL CERTIFICATION.—Beginning in the first fiscal 

year beginning after the date of enactment of this section, 

the Attorney General shall submit to the applicable committees 

an annual certification— 

‘‘(A) indicating whether— 

‘‘(i) all audits issued by the Inspector General of 

the Department of Justice under paragraph (1) have 

been completed and reviewed by the appropriate 

Assistant Attorney General or Director; 

Audits. 

Effective date. 

Cost estimate. 

Public 

information. 

Contracts. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 737 

‘‘(ii) all mandatory exclusions required under paragraph (1)(C) have been issued; and 

‘‘(iii) all reimbursements required under paragraph 

(1)(E) have been made; and 

‘‘(B) that includes a list of any grant recipients excluded 

under paragraph (1) from the previous year. 

‘‘(c) PREVENTING DUPLICATIVE GRANTS.— ‘‘(1) IN GENERAL.—Before the Attorney General awards a 

grant to an applicant under this part, the Attorney General 

shall compare potential grant awards with other grants 

awarded under this part by the Attorney General to determine 

if duplicate grant awards are awarded for the same purpose. 

‘‘(2) REPORT.—If the Attorney General awards duplicate 

grants under this part to the same applicant for the same 

purpose, the Attorney General shall submit to the applicable 

committees a report that includes— 

‘‘(A) a list of all duplicate grants awarded under this 

part, including the total dollar amount of any duplicate 

grants awarded; and 

‘‘(B) the reason the Attorney General awarded the 

duplicate grants.’’. 

(b) EVALUATION OF PERFORMANCE OF DEPARTMENT OF JUSTICE

PROGRAMS.— 

(1) EVALUATION OF JUSTICE DEPARTMENT COMPREHENSIVE

OPIOID ABUSE GRANT PROGRAM.—Not later than 5 years after 

the date of enactment of this Act, the Attorney General shall 

complete an evaluation of the effectiveness of the Comprehensive Opioid Abuse Grant Program under part LL of title I 

of the Omnibus Crime Control and Safe Streets Act of 1968, 

as added by section 201, administered by the Department of 

Justice based upon the information reported under paragraph 

(4). 

(2) INTERIM EVALUATION.—Not later than 3 years after 

the date of enactment of this Act, the Attorney General shall 

complete an interim evaluation assessing the nature and extent 

of the incidence of opioid abuse and illegal opioid distribution 

in the United States. 

(3) METRICS AND OUTCOMES FOR EVALUATION.—Not later 

than 180 days after the date of enactment of this Act, the 

Attorney General shall identify outcomes that are to be 

achieved by activities funded by the Comprehensive Opioid 

Abuse Grant Program and the metrics by which the achievement of such outcomes shall be determined. 

(4) METRICS DATA COLLECTION.—The Attorney General 

shall require grantees under the Comprehensive Opioid Abuse 

Grant Program (and those receiving subawards under section 

3021(b) of part LL of title I of the Omnibus Crime Control 

and Safe Streets Act of 1968, as added by section 201) to 

collect and annually report to the Department of Justice data 

based upon the metrics identified under paragraph (3). 

(5) PUBLICATION OF DATA AND FINDINGS.— (A) PUBLICATION OF OUTCOMES AND METRICS.—The 

Attorney General shall, not later than 30 days after completion of the requirement under paragraph (3), publish the 

outcomes and metrics identified under that paragraph. 

(B) PUBLICATION OF EVALUATION.—In the case of the 

interim evaluation under paragraph (2), and the final 

Reports. 

Reports. 

Determination. 

Assessment. 

Deadlines. 

42 USC 3797ff–6. 

List. 

Determination. 

List. 


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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 evaluation and issue a report on such evaluation to the Committee 

on the Judiciary of the House of Representatives and the 

Committee on the Judiciary of the Senate. Such report 

shall also be published along with the data used to make 

such evaluation. 

(6) INDEPENDENT EVALUATION.—For purposes of paragraphs 

(1), (2), and (3), the Attorney General shall— 

(A) enter into an arrangement with the National 

Academy of Sciences; or 

(B) enter into a contract or cooperative agreement with 

an entity that is not an agency of the Federal Government, 

and is qualified to conduct and evaluate research pertaining 

to opioid use and abuse, and draw conclusions about overall 

opioid use and abuse on the basis of that research. 

(c) DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANT

ACCOUNTABILITY.— 

(1) DEFINITIONS.—In this subsection: 

(A) APPLICABLE COMMITTEES.—The term ‘‘applicable 

committees’’ means— 

(i) the Committee on Health, Education, Labor 

and Pensions of the Senate; and 

(ii) the Committee on Energy and Commerce of 

the House of Representatives. 

(B) COVERED GRANT.—The term ‘‘covered grant’’ means 

a grant awarded by the Secretary under a program established under this Act (or an amendment made by this 

Act, other than sections 703 through 707), including any 

grant administered by the Administrator of the Substance 

Abuse and Mental Health Services Administration under 

section 103. 

(C) GRANTEE.—The term ‘‘grantee’’ means the recipient 

of a covered grant. 

(D) SECRETARY.—The term ‘‘Secretary’’ means the Secretary of Health and Human Services. 

(2) ACCOUNTABILITY MEASURES.—Each covered grant shall 

be subject to the following accountability requirements: 

(A) EFFECTIVENESS REPORT.—The Secretary shall 

require grantees to report on the effectiveness of the activities carried out with amounts made available to carry 

out the program under which the covered grant is awarded, 

including the number of persons served by such grant, 

if applicable, the number of persons seeking services who 

could not be served by such grant, and such other information as the Secretary may prescribe. 

(B) REPORT ON PREVENTION OF FRAUD, WASTE, AND

ABUSE.— 

(i) IN GENERAL.—Not later than 1 year after the 

date of the enactment of this Act, the Secretary, in 

coordination with the Inspector General of the Department of Health and Human Services, shall submit 

to the applicable committees a report on the policies 

and procedures the Department has in place to prevent 

waste, fraud, and abuse in the administration of covered grants. 

Coordination. 

42 USC 

290aa–15. 

Contracts. 


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(ii) CONTENTS.—The policies and procedures 

referred to in clause (i) shall include policies and procedures that are designed to— 

(I) prevent grantees from utilizing funds 

awarded through a covered grant for unauthorized 

expenditures or otherwise unallowable costs; and 

(II) ensure grantees will not receive 

unwarranted duplicate grants for the same purpose. 

(C) CONFERENCE EXPENDITURES.— (i) IN GENERAL.—No amounts made available to 

the Secretary under this Act (or in a provision of 

law amended by this Act, other than sections 703 

through 707) may be used by the Secretary, or by 

any individual or entity awarded discretionary funds 

through a cooperative agreement under a program 

established under this Act (or in a provision of law 

amended by this Act), to host or support any expenditure for conferences that uses more than $20,000 in 

funds made available by the Secretary, unless the head 

of the relevant operating division or program office 

provides prior written authorization that the funds 

may be expended to host or support the conference. 

Such written authorization shall include a written estimate of all costs associated with the conference, 

including the cost of all food, beverages, audio-visual 

equipment, honoraria for speakers, and entertainment. 

(ii) REPORT.—The Secretary (or the Secretary’s designee) shall submit to the applicable committees an 

annual report on all conference expenditures approved 

by the Secretary under this subparagraph. 

(d) EVALUATION OF PERFORMANCE OF DEPARTMENT OF HEALTH

AND HUMAN SERVICES PROGRAMS.— 

(1) EVALUATIONS.— 

(A) IN GENERAL.—Not later than 5 years after the 

date of enactment of this Act, except as otherwise provided 

in this section, the Secretary of Health and Human Services 

(in this subsection referred to as the ‘‘Secretary’’) shall 

complete an evaluation of any program administered by 

the Secretary included in this Act (or an amendment made 

by this Act, excluding sections 703 through 707), including 

any grant administered by the Administrator of the Substance Abuse and Mental Health Services Administration 

under section 103, that provides grants for the primary 

purpose of providing assistance in addressing problems 

pertaining to opioid abuse based upon the outcomes and 

metrics identified under paragraph (2). 

(B) PUBLICATION.—With respect to each evaluation 

completed under subparagraph (A), the Secretary shall, 

not later than 90 days after the date on which such evaluation is completed, publish the results of such evaluation 

and issue a report on such evaluation to the appropriate 

committees. Such report shall also be published along with 

the data used to make such evaluation. 

(2) METRICS AND OUTCOMES.— (A) IN GENERAL.—Not later than 180 days after the 

date of enactment of this Act, the Secretary shall identify— 

Deadlines. 

42 USC 

290aa–16. 

Cost estimate. 


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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 subparagraph (A), publish the outcomes and metrics identified 

under such subparagraph. 

(3) METRICS DATA COLLECTION.—The Secretary shall 

require grantees under the programs described in paragraph 

(1)(A) to collect, and annually report to the Secretary, data 

based upon the metrics identified under paragraph (2)(A). 

(4) INDEPENDENT EVALUATION.—For purposes of paragraph 

(1), the Secretary shall— 

(A) enter into an arrangement with the National 

Academy of Sciences; or 

(B) enter into a contract or cooperative agreement with 

an entity that— 

(i) is not an agency of the Federal Government; 

and 

(ii) is qualified to conduct and evaluate research 

pertaining to opioid use and abuse and draw conclusions about overall opioid use and abuse on the basis 

of that research. 

(5) EXCEPTION.—If a program described in paragraph (1)(A) 

is subject to an evaluation similar to the evaluation required 

under such paragraph pursuant to another provision of Federal 

law, the Secretary may opt not to conduct an evaluation under 

such paragraph with respect to such program. 

(e) ADDITIONAL REPORT.—In the case of a report submitted 

under subsection (c) to the applicable committees, if such report 

pertains to a grant under section 103, that report shall also be 

submitted, in the same manner and at the same time, to the 

Committee on Oversight and Government Reform of the House 

of Representatives and to the Committee on the Judiciary of the 

Senate. 

(f) NO ADDITIONAL FUNDS AUTHORIZED.—No additional funds 

are authorized to be appropriated to carry out this section. 

SEC. 702. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES. 

(a) IN GENERAL.—Section 309 of the Controlled Substances 

Act (21 U.S.C. 829) is amended by adding at the end the following: 

‘‘(f) PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES.— 

‘‘(1) PARTIAL FILLS.—A prescription for a controlled substance in schedule II may be partially filled if— 

‘‘(A) it is not prohibited by State law; 

‘‘(B) the prescription is written and filled in accordance 

with this title, regulations prescribed by the Attorney General, and State law; 

‘‘(C) the partial fill is requested by the patient or 

the practitioner that wrote the prescription; and 

‘‘(D) the total quantity dispensed in all partial fillings 

does not exceed the total quantity prescribed. 

‘‘(2) REMAINING PORTIONS.— 

42 USC 

290aa–15 note. 

Contracts. 

Reports. 

Determination. 


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‘‘(A) IN GENERAL.—Except as provided in subparagraph 

(B), remaining portions of a partially filled prescription 

for a controlled substance in schedule II— 

‘‘(i) may be filled; and 

‘‘(ii) shall be filled not later than 30 days after 

the date on which the prescription is written. 

‘‘(B) EMERGENCY SITUATIONS.—In emergency situations, as described in subsection (a), the remaining portions 

of a partially filled prescription for a controlled substance 

in schedule II— 

‘‘(i) may be filled; and 

‘‘(ii) shall be filled not later than 72 hours after 

the prescription is issued. 

‘‘(3) CURRENTLY LAWFUL PARTIAL FILLS.—Notwithstanding 

paragraph (1) or (2), in any circumstance in which, as of the 

day before the date of enactment of this subsection, a prescription for a controlled substance in schedule II may be lawfully 

partially filled, the Attorney General may allow such a prescription to be partially filled.’’. 

(b) RULE OF CONSTRUCTION.—Nothing in this section shall be 

construed to affect the authority of the Attorney General to allow 

a prescription for a controlled substance in schedule III, IV, or 

V of section 202(c) of the Controlled Substances Act (21 U.S.C. 

812(c)) to be partially filled. 

SEC. 703. GOOD SAMARITAN ASSESSMENT. 

(a) FINDING.—The Congress finds that the executive branch, 

including the Office of National Drug Control Policy, has a policy 

focus on preventing and addressing prescription drug misuse and 

heroin use, and has worked with States and municipalities to enact 

Good Samaritan laws that would protect caregivers, law enforcement personnel, and first responders who administer opioid overdose reversal drugs or devices. 

(b) GAO STUDY ON GOOD SAMARITAN LAWS PERTAINING TO

TREATMENT OF OPIOID OVERDOSES.—The Comptroller General of 

the United States shall submit to the Committee on the Judiciary 

of the House of Representatives, the Committee on Oversight and 

Government Reform of the House of Representatives, the Committee 

on the Judiciary of the Senate, and the Committee on Homeland 

Security and Governmental Affairs of the Senate a report on— 

(1) the extent to which the Director of National Drug 

Control Policy has reviewed Good Samaritan laws, and any 

findings from such a review, including findings related to the 

potential effects of such laws, if available; 

(2) efforts by the Director to encourage the enactment 

of Good Samaritan laws; and 

(3) a compilation of Good Samaritan laws in effect in the 

States, the territories, and the District of Columbia. 

(c) DEFINITIONS.—In this section— 

(1) the term ‘‘Good Samaritan law’’ means a law of a 

State or unit of local government that exempts from criminal 

or civil liability any individual who administers an opioid overdose reversal drug or device, or who contacts emergency services 

providers in response to an overdose; and 

(2) the term ‘‘opioid’’ means any drug, including heroin, 

having an addiction-forming or addiction-sustaining liability 

Reports. 

21 USC 829 note. 

Deadline. 

Deadline. 


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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 BENEFICIARIES.— 

(1) IN GENERAL.—Section 1860D–4(c) of the Social Security 

Act (42 U.S.C. 1395w–10(c)) is amended by adding at the end 

the following: 

‘‘(5) DRUG MANAGEMENT PROGRAM FOR AT-RISK BENEFICIARIES.— 

‘‘(A) AUTHORITY TO ESTABLISH.—A PDP sponsor may 

establish a drug management program for at-risk beneficiaries under which, subject to subparagraph (B), the 

PDP sponsor may, in the case of an at-risk beneficiary 

for prescription drug abuse who is an enrollee in a prescription drug plan of such PDP sponsor, limit such beneficiary’s 

access to coverage for frequently abused drugs under such 

plan to frequently abused drugs that are prescribed for 

such beneficiary by one or more prescribers selected under 

subparagraph (D), and dispensed for such beneficiary by 

one or more pharmacies selected under such subparagraph. 

‘‘(B) REQUIREMENT FOR NOTICES.— 

‘‘(i) IN GENERAL.—A PDP sponsor may not limit 

the access of an at-risk beneficiary for prescription 

drug abuse to coverage for frequently abused drugs 

under a prescription drug plan until such sponsor— 

‘‘(I) provides to the beneficiary an initial notice 

described in clause (ii) and a second notice 

described in clause (iii); and 

‘‘(II) verifies with the providers of the beneficiary that the beneficiary is an at-risk beneficiary 

for prescription drug abuse. 

‘‘(ii) INITIAL NOTICE.—An initial notice described 

in this clause is a notice that provides to the beneficiary— 

‘‘(I) notice that the PDP sponsor has identified 

the beneficiary as potentially being an at-risk 

beneficiary for prescription drug abuse; 

‘‘(II) information describing all State and Federal public health resources that are designed to 

address prescription drug abuse to which the beneficiary has access, including mental health services 

and other counseling services; 

‘‘(III) notice of, and information about, the 

right of the beneficiary to appeal such identification under subsection (h) and the option of an 

automatic escalation to external review; 

‘‘(IV) a request for the beneficiary to submit 

to the PDP sponsor preferences for which prescribers and pharmacies the beneficiary would 

prefer the PDP sponsor to select under subparagraph (D) in the case that the beneficiary is identified as an at-risk beneficiary for prescription drug 

abuse as described in clause (iii)(I); 

Verification. 


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‘‘(V) an explanation of the meaning and consequences of the identification of the beneficiary 

as potentially being an at-risk beneficiary for 

prescription drug abuse, including an explanation 

of the drug management program established by 

the PDP sponsor pursuant to subparagraph (A); 

‘‘(VI) clear instructions that explain how the 

beneficiary can contact the PDP sponsor in order 

to submit to the PDP sponsor the preferences 

described in subclause (IV) and any other communications relating to the drug management program for at-risk beneficiaries established by the 

PDP sponsor; and 

‘‘(VII) contact information for other organizations that can provide the beneficiary with assistance regarding such drug management program 

(similar to the information provided by the Secretary in other standardized notices provided to 

part D eligible individuals enrolled in prescription 

drug plans under this part). 

‘‘(iii) SECOND NOTICE.—A second notice described 

in this clause is a notice that provides to the beneficiary 

notice— 

‘‘(I) that the PDP sponsor has identified the 

beneficiary as an at-risk beneficiary for prescription drug abuse; 

‘‘(II) that such beneficiary is subject to the 

requirements of the drug management program 

for at-risk beneficiaries established by such PDP 

sponsor for such plan; 

‘‘(III) of the prescriber (or prescribers) and 

pharmacy (or pharmacies) selected for such individual under subparagraph (D); 

‘‘(IV) of, and information about, the beneficiary’s right to appeal such identification under 

subsection (h) and the option of an automatic escalation to external review; 

‘‘(V) that the beneficiary can, in the case that 

the beneficiary has not previously submitted to 

the PDP sponsor preferences for which prescribers 

and pharmacies the beneficiary would prefer the 

PDP sponsor select under subparagraph (D), 

submit such preferences to the PDP sponsor; and 

‘‘(VI) that includes clear instructions that 

explain how the beneficiary can contact the PDP 

sponsor. 

‘‘(iv) TIMING OF NOTICES.— 

‘‘(I) IN GENERAL.—Subject to subclause (II), 

a second notice described in clause (iii) shall be 

provided to the beneficiary on a date that is not 

less than 30 days after an initial notice described 

in clause (ii) is provided to the beneficiary. 

‘‘(II) EXCEPTION.—In the case that the PDP 

sponsor, in conjunction with the Secretary, determines that concerns identified through rulemaking 

by the Secretary regarding the health or safety 

of the beneficiary or regarding significant drug 

Determination. 

Regulations. 


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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 beneficiary through the use of clinical guidelines that 

indicate misuse or abuse of prescription drugs 

described in subparagraph (G) and that are developed by the Secretary in consultation with PDP 

sponsors and other stakeholders, including individuals entitled to benefits under part A or enrolled 

under part B, advocacy groups representing such 

individuals, physicians, pharmacists, and other 

clinicians, retail pharmacies, plan sponsors, entities delegated by plan sponsors, and biopharmaceutical manufacturers; or 

‘‘(II) with respect to whom the PDP sponsor 

of a prescription drug plan, upon enrolling such 

individual in such plan, received notice from the 

Secretary that such individual was identified 

under this paragraph to be an at-risk beneficiary 

for prescription drug abuse under the prescription 

drug plan in which such individual was most 

recently previously enrolled and such identification 

has not been terminated under subparagraph (F). 

‘‘(ii) EXEMPTED INDIVIDUAL DESCRIBED.—An 

exempted individual described in this clause is an individual who— 

‘‘(I) receives hospice care under this title; 

‘‘(II) is a resident of a long-term care facility, 

of a facility described in section 1905(d), or of 

another facility for which frequently abused drugs 

are dispensed for residents through a contract with 

a single pharmacy; or 

‘‘(III) the Secretary elects to treat as an 

exempted individual for purposes of clause (i). 

‘‘(iii) PROGRAM SIZE.—The Secretary shall establish 

policies, including the guidelines developed under 

clause (i)(I) and the exemptions under clause (ii)(III), 

to ensure that the population of enrollees in a drug 

management program for at-risk beneficiaries operated 

by a prescription drug plan can be effectively managed 

by such plans. 

‘‘(iv) CLINICAL CONTACT.—With respect to each atrisk beneficiary for prescription drug abuse enrolled 

in a prescription drug plan offered by a PDP sponsor, 

the PDP sponsor shall contact the beneficiary’s providers who have prescribed frequently abused drugs 

Guidelines. 

Guidelines. 

Consultation. 

Definition. 


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regarding whether prescribed medications are appropriate for such beneficiary’s medical conditions. 

‘‘(D) SELECTION OF PRESCRIBERS AND PHARMACIES.— 

‘‘(i) IN GENERAL.—With respect to each at-risk 

beneficiary for prescription drug abuse enrolled in a 

prescription drug plan offered by such sponsor, a PDP 

sponsor shall, based on the preferences submitted to 

the PDP sponsor by the beneficiary pursuant to clauses 

(ii)(IV) and (iii)(V) of subparagraph (B) (except as otherwise provided in this subparagraph) select— 

‘‘(I) one, or, if the PDP sponsor reasonably 

determines it necessary to provide the beneficiary 

with reasonable access under clause (ii), more than 

one, individual who is authorized to prescribe frequently abused drugs (referred to in this paragraph as a ‘prescriber’) who may write prescriptions for such drugs for such beneficiary; and 

‘‘(II) one, or, if the PDP sponsor reasonably 

determines it necessary to provide the beneficiary 

with reasonable access under clause (ii), more than 

one, pharmacy that may dispense such drugs to 

such beneficiary. 

For purposes of subclause (II), in the case of a pharmacy that has multiple locations that share real-time 

electronic data, all such locations of the pharmacy shall 

collectively be treated as one pharmacy. 

‘‘(ii) REASONABLE ACCESS.—In making the selections under this subparagraph— 

‘‘(I) a PDP sponsor shall ensure that the beneficiary continues to have reasonable access to frequently abused drugs (as defined in subparagraph 

(G)), taking into account geographic location, beneficiary preference, impact on costsharing, and 

reasonable travel time; and 

‘‘(II) a PDP sponsor shall ensure such access 

(including access to prescribers and pharmacies 

with respect to frequently abused drugs) in the 

case of individuals with multiple residences, in 

the case of natural disasters and similar situations, 

and in the case of the provision of emergency services. 

‘‘(iii) BENEFICIARY PREFERENCES.—If an at-risk 

beneficiary for prescription drug abuse submits preferences for which in-network prescribers and pharmacies the beneficiary would prefer the PDP sponsor 

select in response to a notice under subparagraph (B), 

the PDP sponsor shall— 

‘‘(I) review such preferences; 

‘‘(II) select or change the selection of prescribers and pharmacies for the beneficiary based 

on such preferences; and 

‘‘(III) inform the beneficiary of such selection 

or change of selection. 

‘‘(iv) EXCEPTION REGARDING BENEFICIARY PREFERENCES.—In the case that the PDP sponsor determines that a change to the selection of prescriber or 

pharmacy under clause (iii)(II) by the PDP sponsor 

Determination. 

Review. 


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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 pharmacy for the beneficiary without regard to the preferences of the beneficiary described in clause (iii). If 

the PDP sponsor changes the selection pursuant to 

the preceding sentence, the PDP sponsor shall provide 

the beneficiary with— 

‘‘(I) at least 30 days written notice of the 

change of selection; and 

‘‘(II) a rationale for the change. 

‘‘(v) CONFIRMATION.—Before selecting a prescriber 

or pharmacy under this subparagraph, a PDP sponsor 

must notify the prescriber and pharmacy that the beneficiary involved has been identified for inclusion in 

the drug management program for at-risk beneficiaries 

and that the prescriber and pharmacy has been 

selected as the beneficiary’s designated prescriber and 

pharmacy. 

‘‘(E) TERMINATIONS AND APPEALS.—The identification 

of an individual as an at-risk beneficiary for prescription 

drug abuse under this paragraph, a coverage determination 

made under a drug management program for at-risk beneficiaries, the selection of prescriber or pharmacy under 

subparagraph (D), and information to be shared under 

subparagraph (I), with respect to such individual, shall 

be subject to reconsideration and appeal under subsection 

(h) and the option of an automatic escalation to external 

review to the extent provided by the Secretary. 

‘‘(F) TERMINATION OF IDENTIFICATION.— 

‘‘(i) IN GENERAL.—The Secretary shall develop 

standards for the termination of identification of an 

individual as an at-risk beneficiary for prescription 

drug abuse under this paragraph. Under such standards such identification shall terminate as of the earlier 

of— 

‘‘(I) the date the individual demonstrates that 

the individual is no longer likely, in the absence 

of the restrictions under this paragraph, to be 

an at-risk beneficiary for prescription drug abuse 

described in subparagraph (C)(i); and 

‘‘(II) the end of such maximum period of identification as the Secretary may specify. 

‘‘(ii) RULE OF CONSTRUCTION.—Nothing in clause 

(i) shall be construed as preventing a plan from identifying an individual as an at-risk beneficiary for 

prescription drug abuse under subparagraph (C)(i) 

after such termination on the basis of additional 

information on drug use occurring after the date of 

notice of such termination. 

‘‘(G) FREQUENTLY ABUSED DRUG.—For purposes of this 

subsection, the term ‘frequently abused drug’ means a drug 

that is a controlled substance that the Secretary determines 

to be frequently abused or diverted. 

‘‘(H) DATA DISCLOSURE.— ‘‘(i) DATA ON DECISION TO IMPOSE LIMITATION.— In the case of an at-risk beneficiary for prescription 

Regulations. 

Procedures. 

Definition. 

Standards. 

Notification. 

Time period. 

Notice. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 747 

drug abuse (or an individual who is a potentially atrisk beneficiary for prescription drug abuse) whose 

access to coverage for frequently abused drugs under 

a prescription drug plan has been limited by a PDP 

sponsor under this paragraph, the Secretary shall 

establish rules and procedures to require the PDP 

sponsor to disclose data, including any necessary 

individually identifiable health information, in a form 

and manner specified by the Secretary, about the decision to impose such limitations and the limitations 

imposed by the sponsor under this part. 

‘‘(ii) DATA TO REDUCE FRAUD, ABUSE, AND WASTE.— The Secretary shall establish rules and procedures to 

require PDP sponsors operating a drug management 

program for at-risk beneficiaries under this paragraph 

to provide the Secretary with such data as the Secretary determines appropriate for purposes of identifying patterns of prescription drug utilization for plan 

enrollees that are outside normal patterns and that 

may indicate fraudulent, medically unnecessary, or 

unsafe use. 

‘‘(I) SHARING OF INFORMATION FOR SUBSEQUENT PLAN

ENROLLMENTS.—The Secretary shall establish procedures 

under which PDP sponsors who offer prescription drug 

plans shall share information with respect to individuals 

who are at-risk beneficiaries for prescription drug abuse 

(or individuals who are potentially at-risk beneficiaries for 

prescription drug abuse) and enrolled in a prescription 

drug plan and who subsequently disenroll from such plan 

and enroll in another prescription drug plan offered by 

another PDP sponsor. 

‘‘(J) PRIVACY ISSUES.—Prior to the implementation of 

the rules and procedures under this paragraph, the Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note), related to 

the sharing of data under subparagraphs (H) and (I) by 

PDP sponsors. Such clarification shall provide that the 

sharing of such data shall be considered to be protected 

health information in accordance with the requirements 

of the regulations promulgated pursuant to such section 

264(c). 

‘‘(K) EDUCATION.—The Secretary shall provide education to enrollees in prescription drug plans of PDP sponsors and providers regarding the drug management program for at-risk beneficiaries described in this paragraph, 

including education— 

‘‘(i) provided by Medicare administrative contractors through the improper payment outreach and education program described in section 1874A(h); and 

‘‘(ii) through current education efforts (such as 

State health insurance assistance programs described 

in subsection (a)(1)(A) of section 119 of the Medicare 

Improvements for Patients and Providers Act of 2008 

(42 U.S.C. 1395b–3 note)) and materials directed 

toward such enrollees. 

Clarification. 

Procedures. 


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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 individual. 

‘‘(M) CMS COMPLIANCE REVIEW.—The Secretary shall 

ensure that existing plan sponsor compliance reviews and 

audit processes include the drug management programs 

for at-risk beneficiaries under this paragraph, including 

appeals processes under such programs.’’. 

(2) INFORMATION FOR CONSUMERS.—Section 1860D– 

4(a)(1)(B) of the Social Security Act (42 U.S.C. 1395w– 

104(a)(1)(B)) is amended by adding at the end the following: 

‘‘(v) The drug management program for at-risk 

beneficiaries under subsection (c)(5).’’. 

(3) DUAL ELIGIBLES.—Section 1860D–1(b)(3)(D) of the Social 

Security Act (42 U.S.C. 1395w–101(b)(3)(D)) is amended by 

inserting ‘‘, subject to such limits as the Secretary may establish 

for individuals identified pursuant to section 1860D–4(c)(5)’’ 

after ‘‘the Secretary’’. 

(b) UTILIZATION MANAGEMENT PROGRAMS.—Section 1860D–4(c) 

of the Social Security Act (42 U.S.C. 1395w–104(c)), as amended 

by subsection (a)(1), is further amended— 

(1) in paragraph (1), by inserting after subparagraph (D) 

the following new subparagraph: 

‘‘(E) A utilization management tool to prevent drug 

abuse (as described in paragraph (6)(A)).’’; and 

(2) by adding at the end the following new paragraph: 

‘‘(6) UTILIZATION MANAGEMENT TOOL TO PREVENT DRUG

ABUSE.— 

‘‘(A) IN GENERAL.—A tool described in this paragraph 

is any of the following: 

‘‘(i) A utilization tool designed to prevent the abuse 

of frequently abused drugs by individuals and to prevent the diversion of such drugs at pharmacies. 

‘‘(ii) Retrospective utilization review to identify— 

‘‘(I) individuals that receive frequently abused 

drugs at a frequency or in amounts that are not 

clinically appropriate; and 

‘‘(II) providers of services or suppliers that 

may facilitate the abuse or diversion of frequently 

abused drugs by beneficiaries. 

‘‘(iii) Consultation with the contractor described 

in subparagraph (B) to verify if an individual enrolling 

in a prescription drug plan offered by a PDP sponsor 

has been previously identified by another PDP sponsor 

as an individual described in clause (ii)(I). 

‘‘(B) REPORTING.—A PDP sponsor offering a prescription drug plan (and an MA organization offering an MA– 

PD plan) in a State shall submit to the Secretary and 

the Medicare drug integrity contractor with which the Secretary has entered into a contract under section 1893 with 

respect to such State a report, on a monthly basis, containing information on— 

Contracts. 

Consultation. 

Verification. 

Audits. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 749 

‘‘(i) any provider of services or supplier described 

in subparagraph (A)(ii)(II) that is identified by such 

plan sponsor (or organization) during the 30-day period 

before such report is submitted; and 

‘‘(ii) the name and prescription records of individuals described in paragraph (5)(C). 

‘‘(C) CMS COMPLIANCE REVIEW.—The Secretary shall 

ensure that plan sponsor compliance reviews and program 

audits biennially include a certification that utilization 

management tools under this paragraph are in compliance 

with the requirements for such tools.’’. 

(c) EXPANDING ACTIVITIES OF MEDICARE DRUG INTEGRITY 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 CONTRACTORS (MEDICS).— 

‘‘(1) ACCESS TO INFORMATION.—Under contracts entered 

into under this section with Medicare drug integrity contractors 

(including any successor entity to a Medicare drug integrity 

contractor), the Secretary shall authorize such contractors to 

directly accept prescription and necessary medical records from 

entities such as pharmacies, prescription drug plans, MA–PD 

plans, and physicians with respect to an individual in order 

for such contractors to provide information relevant to the 

determination of whether such individual is an at-risk beneficiary for prescription drug abuse, as defined in section 1860D– 

4(c)(5)(C). 

‘‘(2) REQUIREMENT FOR ACKNOWLEDGMENT OF REFERRALS.— 

If a PDP sponsor or MA organization refers information to 

a contractor described in paragraph (1) in order for such contractor to assist in the determination described in such paragraph, the contractor shall— 

‘‘(A) acknowledge to the sponsor or organization receipt 

of the referral; and 

‘‘(B) in the case that any PDP sponsor or MA organization contacts the contractor requesting to know the determination by the contractor of whether or not an individual 

has been determined to be an individual described in such 

paragraph, shall inform such sponsor or organization of 

such determination on a date that is not later than 15 

days after the date on which the sponsor or organization 

contacts the contractor. 

‘‘(3) MAKING DATA AVAILABLE TO OTHER ENTITIES.— 

‘‘(A) IN GENERAL.—For purposes of carrying out this 

subsection, subject to subparagraph (B), the Secretary shall 

authorize MEDICs to respond to requests for information 

from PDP sponsors and MA organizations, State prescription drug monitoring programs, and other entities delegated by such sponsors or organizations using available 

programs and systems in the effort to prevent fraud, waste, 

and abuse. 

‘‘(B) HIPAA COMPLIANT INFORMATION ONLY.—Information may only be disclosed by a MEDIC under subparagraph (A) if the disclosure of such information is permitted 

under the Federal regulations (concerning the privacy of 

Determination. 

Deadline. 

Records. 

Determination. 

Audits. 

Deadline. 

Certification. 

Time period. 


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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 recommendations for improvements in the effectiveness of 

such contractors as the Inspector General determines 

appropriate. 

(d) TREATMENT OF CERTAIN COMPLAINTS FOR PURPOSES OF

QUALITY OR PERFORMANCE ASSESSMENT.—Section 1860D–42 of the 

Social Security Act (42 U.S.C. 1395w–152) is amended by adding 

at the end the following new subsection: 

‘‘(d) TREATMENT OF CERTAIN COMPLAINTS FOR PURPOSES OF

QUALITY OR PERFORMANCE ASSESSMENT.—In conducting a quality 

or performance assessment of a PDP sponsor, the Secretary shall 

develop or utilize existing screening methods for reviewing and 

considering complaints that are received from enrollees in a 

prescription drug plan offered by such PDP sponsor and that are 

complaints regarding the lack of access by the individual to prescription drugs due to a drug management program for at-risk beneficiaries.’’. 

(e) SENSE OF CONGRESS REGARDING USE OF TECHNOLOGY TOOLS

TO COMBAT FRAUD.—It is the sense of Congress that MA organizations and PDP sponsors should consider using e-prescribing and 

other health information technology tools to support combating 

fraud under MA–PD plans and prescription drug plans under parts 

C and D of the Medicare program. 

(f) REPORTS.— 

(1) REPORT BY SECRETARY ON APPEALS PROCESS.— 

(A) IN GENERAL.—Not later than 12 months after the 

date of the enactment of this Act, the Secretary of Health 

and Human Services shall submit to the appropriate 

committees of jurisdiction of Congress a report on ways 

to improve upon the appeals process for Medicare beneficiaries with respect to prescription drug coverage under 

part D of title XVIII of the Social Security Act. Such 

report shall include an analysis comparing appeals processes under parts C and D of such title XVIII. 

(B) FEEDBACK.—In development of the report described 

in subparagraph (A), the Secretary of Health and Human 

Services shall solicit feedback on the current appeals 

process from stakeholders, such as beneficiaries, consumer 

advocates, plan sponsors, pharmacy benefit managers, 

Analysis. 

Recommendations. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 751 

pharmacists, providers, independent review entity evaluators, and pharmaceutical manufacturers. 

(2) GAO STUDY AND REPORT.— 

(A) STUDY.—The Comptroller General of the United 

States shall conduct a study on the implementation of 

the amendments made by this section, including the 

effectiveness of the at-risk beneficiaries for prescription 

drug abuse drug management programs authorized by section 1860D–4(c)(5) of the Social Security Act (42 U.S.C. 

1395w–10(c)(5)), as added by subsection (a)(1). Such study 

shall include an analysis of— 

(i) the impediments, if any, that impair the ability 

of individuals described in subparagraph (C) of such 

section 1860D–4(c)(5) to access clinically appropriate 

levels of prescription drugs; 

(ii) the effectiveness of the reasonable access 

protections under subparagraph (D)(ii) of such section 

1860D–4(c)(5), including the impact on beneficiary 

access and health; 

(iii) the types of— 

(I) individuals who, in the implementation of 

such section, are determined to be individuals 

described in such subparagraph (C); and 

(II) prescribers and pharmacies that are 

selected under subparagraph (D) of such section; 

and 

(iv) other areas determined appropriate by the 

Comptroller General. 

(B) REPORT.—Not later than July 1, 2019, the Comptroller General of the United States shall submit to the 

appropriate committees of jurisdiction of Congress a report 

on the study conducted under subparagraph (A), together 

with recommendations for such legislation and administrative action as the Comptroller General determines to be 

appropriate. 

(g) EFFECTIVE DATE; RULEMAKING.— 

(1) IN GENERAL.—The amendments made by this section 

shall apply to prescription drug plans (and MA–PD plans) 

for plan years beginning on or after January 1, 2019. 

(2) STAKEHOLDER MEETINGS PRIOR TO EFFECTIVE DATE.— 

(A) IN GENERAL.—Not later than January 1, 2017, the 

Secretary of Health and Human Services shall convene 

stakeholders, including individuals entitled to benefits 

under part A of title XVIII of the Social Security Act 

or enrolled under part B of such title, advocacy groups 

representing such individuals, physicians, pharmacists, and 

other clinicians, retail pharmacies, plan sponsors, entities 

delegated by plan sponsors, and biopharmaceutical manufacturers for input regarding the topics described in 

subparagraph (B). The input described in the preceding 

sentence shall be provided to the Secretary in sufficient 

time in order for the Secretary to take such input into 

account in promulgating the regulations pursuant to paragraph (3). 

(B) TOPICS DESCRIBED.—The topics described in this 

subparagraph are the topics of— 

Deadline. 

42 USC 

1395w–101 note. 

Applicability. 

Recommendations. 

Analysis. 


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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 prescription drug abuse under such paragraph (similar to the 

processes established under the Medicare Advantage 

program under part C of title XVIII of the Social Security Act that allow an automatic escalation to external 

review of claims submitted under such part); 

(iii) the types of enrollees that should be treated 

as exempted individuals, as described in subparagraph 

(C)(ii) of such paragraph; 

(iv) the manner in which terms and definitions 

in such paragraph should be applied, such as the use 

of clinical appropriateness in determining whether an 

enrollee is an at-risk beneficiary for prescription drug 

abuse as defined in subparagraph (C) of such paragraph; 

(v) the information to be included in the notices 

described in subparagraph (B) of such paragraph and 

the standardization of such notices; 

(vi) with respect to a PDP sponsor (or Medicare 

Advantage organization) that establishes a drug 

management program for at-risk beneficiaries under 

such paragraph, the responsibilities of such PDP 

sponsor (or organization) with respect to the 

implementation of such program; 

(vii) notices for plan enrollees at the point of sale 

that would explain why an at-risk beneficiary has been 

prohibited from receiving a prescription at a location 

outside of the designated pharmacy; 

(viii) evidence-based prescribing guidelines for opiates; and 

(ix) the sharing of claims data under parts A and 

B of title XVIII of the Social Security Act with PDP 

sponsors. 

(3) RULEMAKING.—Not later than one year after the date 

of the enactment of this Act, the Secretary of Health and 

Human Services shall, taking into account the input gathered 

pursuant to paragraph (2)(A) and after providing notice and 

an opportunity to comment, promulgate regulations to carry 

out the provisions of, and amendments made by this section. 

(h) DEPOSIT OF SAVINGS INTO MEDICARE IMPROVEMENT FUND.— 

Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)) 

is amended by striking ‘‘during and after fiscal year 2020, $0’’ 

and inserting ‘‘during and after fiscal year 2021, $140,000,000’’. 

Deadline. 

Notice. 

Determination. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 753 

SEC. 705. EXCLUDING ABUSE-DETERRENT FORMULATIONS OF 

PRESCRIPTION DRUGS FROM THE MEDICAID ADDITIONAL 

REBATE REQUIREMENT FOR NEW FORMULATIONS OF 

PRESCRIPTION DRUGS. 

(a) IN GENERAL.—The last sentence of section 1927(c)(2)(C) 

of the Social Security Act (42 U.S.C. 1396r–8(c)(2)(C)) is amended 

by inserting before the period at the end the following: ‘‘, but 

does not include an abuse-deterrent formulation of the drug (as 

determined by the Secretary), regardless of whether such abusedeterrent formulation is an extended release formulation’’. 

(b) EFFECTIVE DATE.—The amendment made by subsection (a) 

shall apply to drugs that are paid for by a State in calendar 

quarters beginning on or after the date of the enactment of this 

Act. 

SEC. 706. LIMITING DISCLOSURE OF PREDICTIVE MODELING AND 

OTHER ANALYTICS TECHNOLOGIES TO IDENTIFY AND PREVENT WASTE, FRAUD, AND ABUSE. 

(a) IN GENERAL.—Title XI of the Social Security Act is amended 

by inserting after section 1128J (42 U.S.C. 1320a–7k) the following 

new section: 

‘‘SEC. 1128K. DISCLOSURE OF PREDICTIVE MODELING AND OTHER 

ANALYTICS TECHNOLOGIES TO IDENTIFY AND PREVENT 

WASTE, FRAUD, AND ABUSE. 

‘‘(a) REFERENCE TO PREDICTIVE MODELING TECHNOLOGIES

REQUIREMENTS.—For provisions relating to the use of predictive 

modeling and other analytics technologies to identify and prevent 

waste, fraud, and abuse with respect to the Medicare program 

under title XVIII, the Medicaid program under title XIX, and the 

Children’s Health Insurance Program under title XXI, see section 

4241 of the Small Business Jobs Act of 2010 (42 U.S.C. 1320a– 

7m). 

‘‘(b) LIMITING DISCLOSURE OF PREDICTIVE MODELING TECHNOLOGIES.—In implementing such provisions under such section 

4241 with respect to covered algorithms (as defined in subsection 

(c)), the following shall apply: 

‘‘(1) NONAPPLICATION OF FOIA.—The covered algorithms 

used or developed for purposes of such section 4241 (including 

by the Secretary or a State (or an entity operating under 

a contract with a State)) shall be exempt from disclosure under 

section 552(b)(3) of title 5, United States Code. 

‘‘(2) LIMITATION WITH RESPECT TO USE AND DISCLOSURE

OF INFORMATION BY STATE AGENCIES.— 

‘‘(A) IN GENERAL.—A State agency may not use or 

disclose covered algorithms used or developed for purposes 

of such section 4241 except for purposes of administering 

the State plan (or a waiver of the plan) under the Medicaid 

program under title XIX or the State child health plan 

(or a waiver of the plan) under the Children’s Health 

Insurance Program under title XXI, including by enabling 

an entity operating under a contract with a State to assist 

the State to identify or prevent waste, fraud, and abuse 

with respect to such programs. 

‘‘(B) INFORMATION SECURITY.—A State agency shall 

have in effect data security and control policies that the 

Secretary finds adequate to ensure the security of covered 

Contracts. 

Contracts. 

Applicability. 

42 USC 

1320a–7n. 

Applicability. 

42 USC 1396r–8 

note. 

Determination. 


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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 technology, as used for purposes of section 4241(a) of the Small 

Business Jobs Act of 2010 (42 U.S.C. 1320a–7m(a)) to identify 

and prevent waste, fraud, and abuse with respect to the Medicare program under title XVIII, the Medicaid program under 

title XIX, and the Children’s Health Insurance Program under 

title XXI; and 

‘‘(2) includes the mathematical expressions utilized in the 

application of such technology and the means by which such 

technology is developed.’’. 

(b) CONFORMING AMENDMENTS.— 

(1) MEDICAID STATE PLAN REQUIREMENT.—Section 1902(a) 

of the Social Security Act (42 U.S.C. 1396a(a)) is amended— 

(A) in paragraph (80), by striking ‘‘and’’ at the end; 

(B) in paragraph (81), by striking the period at the 

end and inserting ‘‘; and’’; and 

(C) by inserting after paragraph (81) the following 

new paragraph: 

‘‘(82) provide that the State agency responsible for administering the State plan under this title provides assurances 

to the Secretary that the State agency is in compliance with 

subparagraphs (A), (B), and (C) of section 1128K(b)(2).’’. 

(2) STATE CHILD HEALTH PLAN REQUIREMENT.—Section 

2102(a)(7) of the Social Security Act (42 U.S.C. 1397bb(a)(7)) 

is amended— 

(A) in subparagraph (A), by striking ‘‘, and’’ at the 

end and inserting a semicolon; 

(B) in subparagraph (B), by striking the period at 

the end and inserting ‘‘; and’’; and 

(C) by adding at the end the following new subparagraph: 

‘‘(C) to ensure that the State agency involved is in 

compliance with subparagraphs (A), (B), and (C) of section 

1128K(b)(2).’’. 

SEC. 707. MEDICAID IMPROVEMENT FUND. 

Section 1941(b)(1) of the Social Security Act (42 U.S.C. 1396w– 

1(b)(1)) is amended to read as follows: 

‘‘(1) IN GENERAL.—There shall be available to the Fund, 

for expenditures from the Fund for fiscal year 2021 and thereafter, $5,000,000.’’. 

SEC. 708. SENSE OF THE CONGRESS REGARDING TREATMENT OF SUBSTANCE ABUSE EPIDEMICS. 

It is the sense of the Congress that decades of experience 

and research have demonstrated that a fiscally responsible approach 

to addressing the opioid abuse epidemic and other substance abuse 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 755 

epidemics requires treating such epidemics as a public health emergency emphasizing prevention, treatment, and recovery. 

TITLE VIII—KINGPIN DESIGNATION 

IMPROVEMENT 

SEC. 801. PROTECTION OF CLASSIFIED INFORMATION IN FEDERAL 

COURT CHALLENGES RELATING TO DESIGNATIONS UNDER 

THE NARCOTICS KINGPIN DESIGNATION ACT. 

Section 804 of the Foreign Narcotics Kingpin Designation Act 

(21 U.S.C. 1903) is amended by adding at the end the following: 

‘‘(i) PROTECTION OF CLASSIFIED INFORMATION IN FEDERAL

COURT CHALLENGES RELATING TO DESIGNATIONS.—In any judicial 

review of a determination made under this section, if the determination was based on classified information (as defined in section 

1(a) of the Classified Information Procedures Act) such information 

may be submitted to the reviewing court ex parte and in camera. 

This subsection does not confer or imply any right to judicial 

review.’’. 

TITLE IX—DEPARTMENT OF VETERANS 

AFFAIRS 

SEC. 901. SHORT TITLE. 

This title may be cited as the ‘‘Jason Simcakoski Memorial 

and Promise Act’’. 

SEC. 902. DEFINITIONS. 

In this title: 

(1) The term ‘‘controlled substance’’ has the meaning given 

that term in section 102 of the Controlled Substances Act 

(21 U.S.C. 802). 

(2) The term ‘‘State’’ means each of the several States, 

territories, and possessions of the United States, the District 

of Columbia, and the Commonwealth of Puerto Rico. 

(3) The term ‘‘complementary and integrative health’’ has 

the meaning given that term, or any successor term, by the 

National Institutes of Health. 

(4) The term ‘‘opioid receptor antagonist’’ means a drug 

or device approved or cleared under the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 301 et seq.) for emergency treatment of known or suspected opioid overdose. 

Subtitle A—Opioid Therapy and Pain 

Management 

SEC. 911. IMPROVEMENT OF OPIOID SAFETY MEASURES BY DEPARTMENT OF VETERANS AFFAIRS. 

(a) EXPANSION OF OPIOID SAFETY INITIATIVE.— 

(1) INCLUSION OF ALL MEDICAL FACILITIES.—Not later than 

180 days after the date of the enactment of this Act, the 

Secretary of Veterans Affairs shall expand the Opioid Safety 

Deadline. 

38 USC 1701 

note. 

Jason 

Simcakoski 

Memorial and 

Promise Act. 

38 USC 1701 

note. 

Review. 

Determination. 


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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 conducted by the health care provider. 

(3) ENHANCED STANDARDS.—The Secretary shall establish 

enhanced standards with respect to the use of routine and 

random urine drug tests for all patients before and during 

opioid therapy to help prevent substance abuse, dependence, 

and diversion, including— 

(A) that such tests occur not less frequently than once 

each year or as otherwise determined according to treatment protocols; and 

(B) that health care providers appropriately order, 

interpret and respond to the results from such tests to 

tailor pain therapy, safeguards, and risk management 

strategies to each patient. 

(b) PAIN MANAGEMENT EDUCATION AND TRAINING.— 

(1) IN GENERAL.—In carrying out the Opioid Safety Initiative of the Department, the Secretary shall require all 

employees of the Department responsible for prescribing opioids 

to receive education and training described in paragraph (2). 

(2) EDUCATION AND TRAINING.—Education and training 

described in this paragraph is education and training on pain 

management and safe opioid prescribing practices for purposes 

of safely and effectively managing patients with chronic pain, 

including education and training on the following: 

(A) The implementation of and full compliance with 

the VA/DOD Clinical Practice Guideline for Management 

of Opioid Therapy for Chronic Pain, including any update 

to such guideline. 

(B) The use of evidence-based pain management therapies and complementary and integrative health services, 

including cognitive-behavioral therapy, non-opioid alternatives, and non-drug methods and procedures to managing 

pain and related health conditions including, to the extent 

practicable, medical devices approved or cleared by the 

Food and Drug Administration for the treatment of patients 

with chronic pain and related health conditions. 

(C) Screening and identification of patients with substance use disorder, including drug-seeking behavior, before 

prescribing opioids, assessment of risk potential for patients 

developing an addiction, and referral of patients to appropriate addiction treatment professionals if addiction is 

identified or strongly suspected. 


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(D) Communication with patients on the potential 

harm associated with the use of opioids and other controlled 

substances, including the need to safely store and dispose 

of supplies relating to the use of opioids and other controlled substances. 

(E) Such other education and training as the Secretary 

considers appropriate to ensure that veterans receive safe 

and high-quality pain management care from the Department. 

(3) USE OF EXISTING PROGRAM.—In providing education 

and training described in paragraph (2), the Secretary shall 

use the Interdisciplinary Chronic Pain Management Training 

Team Program of the Department (or successor program). 

(c) PAIN MANAGEMENT TEAMS.— 

(1) IN GENERAL.—In carrying out the Opioid Safety Initiative of the Department, the director of each medical facility 

of the Department shall identify and designate a pain management team of health care professionals, which may include 

board certified pain medicine specialists, responsible for coordinating and overseeing pain management therapy at such 

facility for patients experiencing acute and chronic pain that 

is non-cancer related. 

(2) ESTABLISHMENT OF PROTOCOLS.— 

(A) IN GENERAL.—In consultation with the Directors 

of each Veterans Integrated Service Network, the Secretary 

shall establish standard protocols for the designation of 

pain management teams at each medical facility within 

the Department. 

(B) CONSULTATION ON PRESCRIPTION OF OPIOIDS.—Each 

protocol established under subparagraph (A) shall ensure 

that any health care provider without expertise in prescribing analgesics or who has not completed the education 

and training under subsection (b), including a mental 

health care provider, does not prescribe opioids to a patient 

unless that health care provider— 

(i) consults with a health care provider with pain 

management expertise or who is on the pain management team of the medical facility; and 

(ii) refers the patient to the pain management 

team for any subsequent prescriptions and related 

therapy. 

(3) REPORT.— 

(A) IN GENERAL.—Not later than one year after the 

date of enactment of this Act, the director of each medical 

facility of the Department shall submit to the Under Secretary for Health and the director of the Veterans 

Integrated Service Network in which the medical facility 

is located a report identifying the health care professionals 

that have been designated as members of the pain management team at the medical facility pursuant to paragraph 

(1). 

(B) ELEMENTS.—Each report submitted under subparagraph (A) with respect to a medical facility of the Department shall include— 

(i) a certification as to whether all members of 

the pain management team at the medical facility have 

Certification. 

Consultation. 


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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 Department; or 

(II) does not fully comply with such steppedcare model, or successor models, of pain management and other pain management policies but is 

carrying out a corrective plan of action to ensure 

such full compliance. 

(d) TRACKING AND MONITORING OF OPIOID USE.— 

(1) PRESCRIPTION DRUG MONITORING PROGRAMS OF

STATES.—In carrying out the Opioid Safety Initiative and the 

Opioid Therapy Risk Report tool of the Department, the Secretary shall— 

(A) ensure access by health care providers of the 

Department to information on controlled substances, 

including opioids and benzodiazepines, prescribed to veterans who receive care outside the Department through 

the prescription drug monitoring program of each State 

with such a program, including by seeking to enter into 

memoranda of understanding with States to allow shared 

access of such information between States and the Department; 

(B) include such information in the Opioid Therapy 

Risk Report tool; and 

(C) require health care providers of the Department 

to submit to the prescription drug monitoring program 

of each State with such a program information on prescriptions of controlled substances received by veterans in that 

State under the laws administered by the Secretary. 

(2) REPORT ON TRACKING OF DATA ON OPIOID USE.—Not 

later than 18 months after the date of the enactment of this 

Act, the Secretary shall submit to the Committee on Veterans’ 

Affairs of the Senate and the Committee on Veterans’ Affairs 

of the House of Representatives a report on the feasibility 

and advisability of improving the Opioid Therapy Risk Report 

tool of the Department to allow for more advanced real-time 

tracking of and access to data on— 

(A) the key clinical indicators with respect to the 

totality of opioid use by veterans; 

(B) concurrent prescribing by health care providers 

of the Department of opioids in different health care settings, including data on concurrent prescribing of opioids 

to treat mental health disorders other than opioid use 

disorder; and 

(C) mail-order prescriptions of opioids prescribed to 

veterans under the laws administered by the Secretary. 

(e) AVAILABILITY OF OPIOID RECEPTOR ANTAGONISTS.— 

Certification. 

Plan. 


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PUBLIC LAW 114–198—JULY 22, 2016 130 STAT. 759 

(1) INCREASED AVAILABILITY AND USE.— (A) IN GENERAL.—The Secretary shall maximize the 

availability of opioid receptor antagonists, including 

naloxone, to veterans. 

(B) AVAILABILITY, TRAINING, AND DISTRIBUTING.—In 

carrying out subparagraph (A), not later than 90 days 

after the date of the enactment of this Act, the Secretary 

shall— 

(i) equip each pharmacy of the Department with 

opioid receptor antagonists to be dispensed to outpatients as needed; and 

(ii) expand the Overdose Education and Naloxone 

Distribution program of the Department to ensure that 

all veterans in receipt of health care under laws 

administered by the Secretary who are at risk of opioid 

overdose may access such opioid receptor antagonists 

and training on the proper administration of such 

opioid receptor antagonists. 

(C) VETERANS WHO ARE AT RISK.—For purposes of 

subparagraph (B), veterans who are at risk of opioid overdose include— 

(i) veterans receiving long-term opioid therapy; 

(ii) veterans receiving opioid therapy who have 

a history of substance use disorder or prior instances 

of overdose; and 

(iii) veterans who are at risk as determined by 

a health care provider who is treating the veteran. 

(2) REPORT.—Not later than 120 days after the date of 

the enactment of this Act, the Secretary shall submit to the 

Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives 

a report on carrying out paragraph (1), including an assessment 

of any remaining steps to be carried out by the Secretary 

to carry out such paragraph. 

(f) INCLUSION OF CERTAIN INFORMATION AND CAPABILITIES IN

OPIOID THERAPY RISK REPORT TOOL OF THE DEPARTMENT.— 

(1) INFORMATION.—The Secretary shall include in the 

Opioid Therapy Risk Report tool of the Department— 

(A) information on the most recent time the tool was 

accessed by a health care provider of the Department with 

respect to each veteran; and 

(B) information on the results of the most recent urine 

drug test for each veteran. 

(2) CAPABILITIES.—The Secretary shall include in the 

Opioid Therapy Risk Report tool the ability of the health care 

providers of the Department to determine whether a health 

care provider of the Department prescribed opioids to a veteran 

without checking the information in the tool with respect to 

the veteran. 

(g) NOTIFICATIONS OF RISK IN COMPUTERIZED HEALTH

RECORD.—The Secretary shall modify the computerized patient 

record system of the Department to ensure that any health care 

provider that accesses the record of a veteran, regardless of the 

reason the veteran seeks care from the health care provider, will 

be immediately notified whether the veteran— 

(1) is receiving opioid therapy and has a history of substance use disorder or prior instances of overdose; 

Determination. 

Assessment. 

Deadline. 


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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 determined by a health care provider who is treating the veteran. 

SEC. 912. STRENGTHENING OF JOINT WORKING GROUP ON PAIN 

MANAGEMENT OF THE DEPARTMENT OF VETERANS 

AFFAIRS AND THE DEPARTMENT OF DEFENSE. 

(a) IN GENERAL.—Not later than 90 days after the date of 

enactment of this Act, the Secretary of Veterans Affairs and the 

Secretary of Defense shall ensure that the Pain Management 

Working Group of the Health Executive Committee of the Department of Veterans Affairs–Department of Defense Joint Executive 

Committee (Pain Management Working Group) established under 

section 320 of title 38, United States Code, includes a focus on 

the following: 

(1) The opioid prescribing practices of health care providers 

of each Department. 

(2) The ability of each Department to manage acute and 

chronic pain among individuals receiving health care from the 

Department, including training health care providers with 

respect to pain management. 

(3) The use by each Department of complementary and 

integrative health in treating such individuals. 

(4) The concurrent use and practice by health care providers of each Department of opioids and prescription drugs 

to treat mental health disorders, including benzodiazepines. 

(5) The use of care transition plans by health care providers 

of each Department to address case management issues for 

patients receiving opioid therapy who transition between 

inpatient and outpatient care. 

(6) The coordination in coverage of and consistent access 

to medications prescribed for patients transitioning from 

receiving health care from the Department of Defense to 

receiving health care from the Department of Veterans Affairs. 

(7) The ability of each Department to properly screen, 

identify, refer, and treat patients with substance use disorders 

who are seeking treatment for acute and chronic pain management conditions. 

(b) COORDINATION AND CONSULTATION.—The Secretary of Veterans Affairs and the Secretary of Defense shall ensure that the 

working group described in subsection (a)— 

(1) coordinates the activities of the working group with 

other relevant working groups established under section 320 

of title 38, United States Code; 

(2) consults with other relevant Federal agencies, including 

the Centers for Disease Control and Prevention, with respect 

to the activities of the working group; and 

(3) consults with the Department of Veterans Affairs and 

the Department of Defense with respect to the VA/DOD Clinical 

Practice Guideline for Management of Opioid Therapy for 

Chronic Pain, or any successor guideline, and reviews and 

provides comments before any update to the guideline is 

released. 

(c) CLINICAL PRACTICE GUIDELINES.— 

(1) IN GENERAL.—Not later than 180 days after the date 

of the enactment of this Act, the Secretary of Veterans Affairs 

and the Secretary of Defense shall issue an update to the 

Deadline. 

Deadline. 

38 USC 1701 

note. 


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VA/DOD Clinical Practice Guideline for Management of Opioid 

Therapy for Chronic Pain. 

(2) MATTERS INCLUDED.—In conducting the update under 

paragraph (1), the Pain Management Working Group, in 

coordination with the Clinical Practice Guideline VA/DoD 

Management of Opioid Therapy for Chronic Pain Working 

Group, shall work to ensure that the Clinical Practical Guideline includes the following: 

(A) Enhanced guidance with respect to— 

(i) the co-administration of an opioid and other 

drugs, including benzodiazepines, that may result in 

life-limiting drug interactions; 

(ii) the treatment of patients with current acute 

psychiatric instability or substance use disorder or 

patients at risk of suicide; and 

(iii) the use of opioid therapy to treat mental health 

disorders other than opioid use disorder. 

(B) Enhanced guidance with respect to the treatment 

of patients with behaviors or comorbidities, such as posttraumatic stress disorder or other psychiatric disorders, 

or a history of substance abuse or addiction, that requires 

a consultation or co-management of opioid therapy with 

one or more specialists in pain management, mental health, 

or addictions. 

(C) Enhanced guidance with respect to health care 

providers— 

(i) conducting an effective assessment for patients 

beginning or continuing opioid therapy, including 

understanding and setting realistic goals with respect 

to achieving and maintaining an expected level of pain 

relief, improved function, or a clinically appropriate 

combination of both; and 

(ii) effectively assessing whether opioid therapy 

is achieving or maintaining the established treatment 

goals of the patient or whether the patient and health 

care provider should discuss adjusting, augmenting, 

or discontinuing the opioid therapy. 

(D) Guidelines to inform the methodologies used by 

health care providers of the Department of Veterans Affairs 

and the Department of Defense to safely taper opioid 

therapy when adjusting or discontinuing the use of opioid 

therapy, including— 

(i) prescription of the lowest effective dose based 

on patient need; 

(ii) use of opioids only for a limited time; and 

(iii) augmentation of opioid therapy with other 

pain management therapies and modalities. 

(E) Guidelines with respect to appropriate case 

management for patients receiving opioid therapy who 

transition between inpatient and outpatient health care 

settings, which may include the use of care transition plans. 

(F) Guidelines with respect to appropriate case 

management for patients receiving opioid therapy who 

transition from receiving care during active duty to postmilitary health care networks. 

(G) Guidelines with respect to providing options, before 

initiating opioid therapy, for pain management therapies 

Assessments. 


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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 integrative health services to minimize opioid dependence. 

(H) Guidelines with respect to the provision of evidence-based non-opioid treatments within the Department 

of Veterans Affairs and the Department of Defense, 

including medical devices and other therapies approved 

or cleared by the Food and Drug Administration for the 

treatment of chronic pain as an alternative to or to augment 

opioid therapy. 

(I) Guidelines developed by the Centers for Disease 

Control and Prevention for safely prescribing opioids for 

the treatment of chronic, non-cancer related pain in outpatient settings. 

(3) RULE OF CONSTRUCTION.—Nothing in this subsection 

shall be construed to prevent the Secretary of Veterans Affairs 

and the Secretary of Defense from considering all relevant 

evidence, as appropriate, in updating the VA/DOD Clinical 

Practice Guideline for Management of Opioid Therapy for 

Chronic Pain, as required under paragraph (1), or from ensuring 

that the final clinical practice guideline updated under such 

paragraph remains applicable to the patient populations of 

the Department of Veterans Affairs and the Department of 

Defense. 

SEC. 913. REVIEW, INVESTIGATION, AND REPORT ON USE OF OPIOIDS 

IN TREATMENT BY DEPARTMENT OF VETERANS AFFAIRS. 

(a) COMPTROLLER GENERAL REPORT.— 

(1) IN GENERAL.—Not later than two years after the date 

of the enactment of this Act, the Comptroller General of the 

United States shall submit to the Committee on Veterans’ 

Affairs of the Senate and the Committee on Veterans’ Affairs 

of the House of Representatives a report on the Opioid Safety 

Initiative of the Department of Veterans Affairs and the opioid 

prescribing practices of health care providers of the Department. 

(2) ELEMENTS.—The report submitted under paragraph (1) 

shall include the following: 

(A) An assessment of the implementation and monitoring by the Veterans Health Administration of the Opioid 

Safety Initiative of the Department, including examining, 

as appropriate, the following: 

(i) How the Department monitors the key clinical 

outcomes of such safety initiative (for example, the 

percentage of unique veterans visiting each medical 

center of the Department that are prescribed an opioid 

or an opioid and benzodiazepine concurrently) and how 

the Department uses that information— 

(I) to improve prescribing practices; and 

(II) to identify high prescribing or otherwise 

inappropriate prescribing practices by health care 

providers. 

(ii) How the Department monitors the use of the 

Opioid Therapy Risk Report tool of the Department 

(as developed through such safety initiative) and 

compliance with such tool by medical facilities and 

health care providers of the Department, including 

Assessments. 

38 USC 1701 

note. 


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any findings by the Department of prescription rates 

or prescription practices by medical facilities or health 

care providers that are inappropriate. 

(iii) The implementation of academic detailing programs within the Veterans Integrated Service Networks of the Department and how such programs are 

being used to improve opioid prescribing practices. 

(iv) Recommendations on such improvements to 

the Opioid Safety Initiative of the Department as the 

Comptroller General considers appropriate. 

(B) Information made available under the Opioid 

Therapy Risk Report tool with respect to— 

(i) deaths resulting from sentinel events involving 

veterans prescribed opioids by a health care provider; 

(ii) overall prescription rates and, if applicable, 

indications used by health care providers for prescribing chronic opioid therapy to treat non-cancer, 

non-palliative, and non-hospice care patients; 

(iii) the prescription rates and indications used 

by health care providers for prescribing 

benzodiazepines and opioids concomitantly; 

(iv) the practice by health care providers of prescribing opioids to treat patients without any pain, 

including to treat patients with mental health disorders other than opioid use disorder; and 

(v) the effectiveness of opioid therapy for patients 

receiving such therapy, including the effectiveness of 

long-term opioid therapy. 

(C) An evaluation of processes of the Department in 

place to oversee opioid use among veterans, including procedures to identify and remedy potential over-prescribing 

of opioids by health care providers of the Department. 

(D) An assessment of the implementation by the Secretary of Veterans Affairs of the VA/DOD Clinical Practice 

Guideline for Management of Opioid Therapy for Chronic 

Pain, including any figures or approaches used by the 

Department to assess compliance with such guidelines by 

medical centers of the Department and identify any medical 

centers of the Department operating action plans to 

improve compliance with such guidelines. 

(E) An assessment of the data that the Department 

has developed to review the opioid prescribing practices 

of health care providers of the Department, as required 

by this subtitle, including a review of how the Department 

identifies the practices of individual health care providers 

that warrant further review based on prescribing levels, 

health conditions for which the health care provider is 

prescribing opioids or opioids and benzodiazepines concurrently, or other practices of the health care provider. 

(b) SEMI-ANNUAL PROGRESS REPORT ON IMPLEMENTATION OF

COMPTROLLER GENERAL RECOMMENDATIONS.—Not later than 180 

days after the date of the submittal of the report required under 

subsection (a), and not less frequently than annually thereafter 

until the Comptroller General of the United States determines 

that all recommended actions are closed, the Secretary of Veterans 

Affairs shall submit to the Committee on Veterans’ Affairs of the 

Senate and the Committee on Veterans’ Affairs of the House of 

Determination. 

Review. 

Evaluation. 

Procedures. 

Recommendations. 


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130 STAT. 764 PUBLIC LAW 114–198—JULY 22, 2016 

Representatives a progress report detailing the actions by the Secretary to address any outstanding findings and recommendations 

by the Comptroller General of the United States under subsection 

(a) with respect to the Veterans Health Administration. 

(c) ANNUAL REPORT ON OPIOID THERAPY AND PRESCRIPTION

RATES.—Not later than one year after the date of the enactment 

of this Act, and not less frequently than annually for the following 

five years, the Secretary shall submit to the Committee on Veterans’ 

Affairs of the Senate and the Committee on Veterans’ Affairs of 

the House of Representatives a report on opioid therapy and 

prescription rates for the one-year period preceding the date of 

the submission of the report. Each such report shall include each 

of the following: 

(1) The number of patients and the percentage of the 

patient population of the Department who were prescribed 

benzodiazepines and opioids concurrently by a health care provider of the Department. 

(2) The number of patients and the percentage of the 

patient population of the Department without any pain who 

were prescribed opioids by a health care provider of the Department, including those who were prescribed benzodiazepines 

and opioids concurrently. 

(3) The number of non-cancer, non-palliative, and nonhospice care patients and the percentage of such patients who 

were treated with opioids by a health care provider of the 

Department on an inpatient-basis and who also received 

prescription opioids by mail from the Department while being 

treated on an inpatient-basis. 

(4) The number of non-cancer, non-palliative, and nonhospice care patients and the percentage of such patients who 

were prescribed opioids concurrently by a health care provider 

of the Department and a health care provider that is not 

a health care provider of the Department. 

(5) With respect to each medical facility of the Department, 

the collected and reviewed information on opioids prescribed 

by health care providers at the facility to treat non-cancer, 

non-palliative, and non-hospice care patients, including— 

(A) the prescription rate at which each health care 

provider at the facility prescribed benzodiazepines and 

opioids concurrently to such patients and the aggregate 

of such prescription rate for all health care providers at 

the facility; 

(B) the prescription rate at which each health care 

provider at the facility prescribed benzodiazepines or 

opioids to such patients to treat conditions for which 

benzodiazepines or opioids are not approved treatment and 

the aggregate of such prescription rate for all health care 

providers at the facility; 

(C) the prescription rate at which each health care 

provider at the facility prescribed or dispensed mail-order 

prescriptions of opioids to such patients while such patients 

were being treated with opioids on an inpatient-basis and 

the aggregate of such prescription rate for all health care 

providers at the facility; and 

(D) the prescription rate at which each health care 

provider at the facility prescribed opioids to such patients 

who were also concurrently prescribed opioids by a health 


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care provider that is not a health care provider of the 

Department and the aggregate of such prescription rates 

for all health care providers at the facility. 

(6) With respect to each medical facility of the Department, 

the number of times a pharmacist at the facility overrode 

a critical drug interaction warning with respect to an interaction between opioids and another medication before dispensing such medication to a veteran. 

(d) INVESTIGATION OF PRESCRIPTION RATES.—If the Secretary 

determines that a prescription rate with respect to a health care 

provider or medical facility of the Department conflicts with or 

is otherwise inconsistent with the standards of appropriate and 

safe care, the Secretary shall— 

(1) immediately notify the Committee on Veterans’ Affairs 

of the Senate and the Committee on Veterans’ Affairs of the 

House of Representatives of such determination, including 

information relating to such determination, prescription rate, 

and health care provider or medical facility, as the case may 

be; and 

(2) through the Office of the Medical Inspector of the Veterans Health Administration, conduct a full investigation of 

the health care provider or medical facility, as the case may 

be. 

(e) PRESCRIPTION RATE DEFINED.—In this section, the term 

‘‘prescription rate’’ means, with respect to a health care provider 

or medical facility of the Department, each of the following: 

(1) The number of patients treated with opioids by the 

health care provider or at the medical facility, as the case 

may be, divided by the total number of pharmacy users of 

that health care provider or medical facility. 

(2) The average number of morphine equivalents per day 

prescribed by the health care provider or at the medical facility, 

as the case may be, to patients being treated with opioids. 

(3) Of the patients being treated with opioids by the health 

care provider or at the medical facility, as the case may be, 

the average number of prescriptions of opioids per patient. 

SEC. 914. MANDATORY DISCLOSURE OF CERTAIN VETERAN INFORMATION TO STATE CONTROLLED SUBSTANCE MONITORING 

PROGRAMS. 

Section 5701(l) of title 38, United States Code, is amended 

by striking ‘‘may’’ and inserting ‘‘shall’’. 

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

ON USE OF OPIOID ANTAGONISTS. 

(a) COPAYMENT FOR OPIOID ANTAGONISTS.—Section 1722A(a) 

of title 38, United States Code, is amended by adding at the end 

the following new paragraph: 

‘‘(4) Paragraph (1) does not apply to opioid antagonists furnished under this chapter to a veteran who is at high risk for 

overdose of a specific medication or substance in order to reverse 

the effect of such an overdose.’’. 

(b) COPAYMENT FOR EDUCATION ON USE OF OPIOID ANTAGONISTS.—Section 1710(g)(3) of such title is amended— 

(1) by striking ‘‘with respect to home health services’’ and 

inserting ‘‘with respect to the following:’’ 

‘‘(A) Home health services’’; and 

38 USC 1701 

note. 

38 USC 1701 

note. 

Notification. 

Determination. 


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(2) by adding at the end the following subparagraph: 

‘‘(B) Education on the use of opioid antagonists to reverse 

the effects of overdoses of specific medications or substances.’’. 

Subtitle B—Patient Advocacy 

SEC. 921. COMMUNITY MEETINGS ON IMPROVING CARE FURNISHED 

BY DEPARTMENT OF VETERANS AFFAIRS. 

(a) COMMUNITY MEETINGS.— 

(1) MEDICAL CENTERS.—Not later than 90 days after the 

date of the enactment of this Act, and not less frequently 

than once every 90 days thereafter, the Secretary shall ensure 

that each medical facility of the Department of Veterans Affairs 

hosts a community meeting open to the public on improving 

health care furnished by the Secretary. 

(2) COMMUNITY-BASED OUTPATIENT CLINICS.—Not later than 

one year after the date of the enactment of this Act, and 

not less frequently than annually thereafter, the Secretary 

shall ensure that each community-based outpatient clinic of 

the Department hosts a community meeting open to the public 

on improving health care furnished by the Secretary. 

(b) ATTENDANCE BY DIRECTOR OF VETERANS INTEGRATED

SERVICE NETWORK OR DESIGNEE.— 

(1) IN GENERAL.—Each community meeting hosted by a 

medical facility or community-based outpatient clinic under 

subsection (a) shall be attended by the Director of the Veterans 

Integrated Service Network in which the medical facility or 

community-based outpatient clinic, as the case may be, is 

located. Subject to paragraph (2), the Director may delegate 

such attendance only to an employee who works in the Office 

of the Director. 

(2) ATTENDANCE BY DIRECTOR.—Each Director of a Veterans 

Integrated Service Network shall personally attend not less 

than one community meeting under subsection (a) hosted by 

each medical facility located in the Veterans Integrated Service 

Network each year. 

(c) NOTICE.—The Secretary shall notify the Committee on Veterans’ Affairs of the Senate, the Committee on Veterans’ Affairs 

of the House of Representatives, and each Member of Congress 

(as defined in section 902) who represents the area in which the 

medical facility is located of a community meeting under subsection 

(a) by not later than 10 days before such community meeting 

occurs. 

SEC. 922. IMPROVEMENT OF AWARENESS OF PATIENT ADVOCACY PROGRAM AND PATIENT BILL OF RIGHTS OF DEPARTMENT 

OF VETERANS AFFAIRS. 

Not later than 90 days after the date of the enactment of 

this Act, the Secretary of Veterans Affairs shall, in as many prominent locations as the Secretary determines appropriate to be seen 

by the largest percentage of patients and family members of patients 

at each medical facility of the Department of Veterans Affairs— 

(1) display the purposes of the Patient Advocacy Program 

of the Department and the contact information for the patient 

advocate at such medical facility; and 

(2) display the rights and responsibilities of— 

Deadline. 

38 USC 1701 

note. 

Deadline. 

Deadline. 

38 USC 1701 

note. 


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(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 individuals qualified to perform the duties of the position and shall report 

directly to the Under Secretary for Health. 

‘‘(c) FUNCTION.—(1) The function of the Office is to carry out 

the Patient Advocacy Program of the Department. 

Appointment. 

38 USC 7309A. 

38 USC 1701 

note. 

Recommendations. 

Assessments. 

38 USC 1701 

note. 


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‘‘(2) In carrying out the Patient Advocacy Program of the 

Department, the Director shall ensure that patient advocates of 

the Department— 

‘‘(A) advocate on behalf of veterans with respect to health 

care received and sought by veterans under the laws administered by the Secretary; 

‘‘(B) carry out the responsibilities specified in subsection 

(d); and 

‘‘(C) receive training in patient advocacy. 

‘‘(d) PATIENT ADVOCACY RESPONSIBILITIES.—The responsibilities 

of each patient advocate at a medical facility of the Department 

are the following: 

‘‘(1) To resolve complaints by veterans with respect to 

health care furnished under the laws administered by the Secretary that cannot be resolved at the point of service or at 

a higher level easily accessible to the veteran. 

‘‘(2) To present at various meetings and to various committees the issues experienced by veterans in receiving such health 

care at such medical facility. 

‘‘(3) To express to veterans their rights and responsibilities 

as patients in receiving such health care. 

‘‘(4) To manage the Patient Advocate Tracking System of 

the Department at such medical facility. 

‘‘(5) To compile data at such medical facility of complaints 

made by veterans with respect to the receipt of such health 

care at such medical facility and the satisfaction of veterans 

with such health care at such medical facility to determine 

whether there are trends in such data. 

‘‘(6) To ensure that a process is in place for the distribution 

of the data compiled under paragraph (5) to appropriate leaders, 

committees, services, and staff of the Department. 

‘‘(7) To identify, not less frequently than quarterly, 

opportunities for improvements in the furnishing of such health 

care to veterans at such medical facility based on complaints 

by veterans. 

‘‘(8) To ensure that any significant complaint by a veteran 

with respect to such health care is brought to the attention 

of appropriate staff of the Department to trigger an assessment 

of whether there needs to be a further analysis of the problem 

at the facility-wide level. 

‘‘(9) To support any patient advocacy programs carried 

out by the Department. 

‘‘(10) To ensure that all appeals and final decisions with 

respect to the receipt of such health care are entered into 

the Patient Advocate Tracking System of the Department. 

‘‘(11) To understand all laws, directives, and other rules 

with respect to the rights and responsibilities of veterans in 

receiving such health care, including the appeals processes 

available to veterans. 

‘‘(12) To ensure that veterans receiving mental health care, 

or the surrogate decision-makers for such veterans, are aware 

of the rights of veterans to seek representation from systems 

established under section 103 of the Protection and Advocacy 

for Mentally Ill Individuals Act of 1986 (42 U.S.C. 10803) 

to protect and advocate the rights of individuals with mental 

illness and to investigate incidents of abuse and neglect of 

such individuals. 


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‘‘(13) To fulfill requirements established by the Secretary 

with respect to the inspection of controlled substances. 

‘‘(14) To document potentially threatening behavior and 

report such behavior to appropriate authorities. 

‘‘(e) TRAINING.—In providing training to patient advocates 

under subsection (c)(2)(C), the Director shall ensure that such 

training is consistent throughout the Department. 

‘‘(f) CONTROLLED SUBSTANCE DEFINED.—In this section, the 

term ‘controlled substance’ has the meaning given that term in 

section 102 of the Controlled Substances Act (21 U.S.C. 802).’’. 

(b) CLERICAL AMENDMENT.—The table of sections at the beginning of chapter 73 of such title is amended by inserting after 

the item relating to section 7309 the following new item: 

‘‘7309A. Office of Patient Advocacy.’’. 

(c) DATE FULLY OPERATIONAL.—The Secretary of Veterans 

Affairs shall ensure that the Office of Patient Advocacy established 

under section 7309A of title 38, United States Code, as added 

by subsection (a), is fully operational not later than the date that 

is one year after the date of the enactment of this Act. 

Subtitle C—Complementary and 

Integrative Health 

SEC. 931. EXPANSION OF RESEARCH AND EDUCATION ON AND 

DELIVERY OF COMPLEMENTARY AND INTEGRATIVE 

HEALTH TO VETERANS. 

(a) ESTABLISHMENT.—There is established a commission to be 

known as the ‘‘Creating Options for Veterans’ Expedited Recovery’’ 

or the ‘‘COVER Commission’’ (in this section referred to as the 

‘‘Commission’’). The Commission shall examine the evidence-based 

therapy treatment model used by the Secretary of Veterans Affairs 

for treating mental health conditions of veterans and the potential 

benefits of incorporating complementary and integrative health 

treatments available in non-Department facilities (as defined in 

section 1701 of title 38, United States Code). 

(b) DUTIES.—The Commission shall perform the following 

duties: 

(1) Examine the efficacy of the evidence-based therapy 

model used by the Secretary for treating mental health illnesses 

of veterans and identify areas to improve wellness-based outcomes. 

(2) Conduct a patient-centered survey within each of the 

Veterans Integrated Service Networks to examine— 

(A) the experience of veterans with the Department 

of Veterans Affairs when seeking medical assistance for 

mental health issues through the health care system of 

the Department; 

(B) the experience of veterans with non-Department 

facilities and health professionals for treating mental 

health issues; 

(C) the preference of veterans regarding available 

treatment for mental health issues and which methods 

the veterans believe to be most effective; 

Examination. 

38 USC 1701 

note. 

38 USC 7309A 

note. 

38 USC 

prec. 7301. 


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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 medication among veterans seeking treatment through the health 

care system of the Department as remedies for addressing 

mental health issues; and 

(F) the outreach efforts of the Secretary regarding the 

availability of benefits and treatments for veterans for 

addressing mental health issues, including by identifying 

ways to reduce barriers to gaps in such benefits and treatments. 

(3) Examine available research on complementary and 

integrative health treatment therapies for mental health issues 

and identify what benefits could be made with the inclusion 

of such treatments for veterans, including with respect to— 

(A) music therapy; 

(B) equine therapy; 

(C) training and caring for service dogs; 

(D) yoga therapy; 

(E) acupuncture therapy; 

(F) meditation therapy; 

(G) outdoor sports therapy; 

(H) hyperbaric oxygen therapy; 

(I) accelerated resolution therapy; 

(J) art therapy; 

(K) magnetic resonance therapy; and 

(L) other therapies the Commission determines appropriate. 

(4) Study the sufficiency of the resources of the Department 

to ensure the delivery of quality health care for mental health 

issues among veterans seeking treatment within the Department. 

(5) Study the current treatments and resources available 

within the Department and assess— 

(A) the effectiveness of such treatments and resources 

in decreasing the number of suicides per day by veterans; 

(B) the number of veterans who have been diagnosed 

with mental health issues; 

(C) the percentage of veterans using the resources of 

the Department who have been diagnosed with mental 

health issues; 

(D) the percentage of veterans who have completed 

counseling sessions offered by the Department; and 

(E) the efforts of the Department to expand complementary and integrative health treatments viable to the 

recovery of veterans with mental health issues as determined by the Secretary to improve the effectiveness of 

treatments offered by the Department. 

(c) MEMBERSHIP.— 

(1) IN GENERAL.—The Commission shall be composed of 

10 members, appointed as follows: 

(A) Two members appointed by the Speaker of the 

House of Representatives, at least one of whom shall be 

a veteran. 


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(B) Two members appointed by the minority leader 

of the House of Representatives, at least one of whom 

shall be a veteran. 

(C) Two members appointed by the majority leader 

of the Senate, at least one of whom shall be a veteran. 

(D) Two members appointed by the minority leader 

of the Senate, at least one of whom shall be a veteran. 

(E) Two members appointed by the President, at least 

one of whom shall be a veteran. 

(2) QUALIFICATIONS.—Members of the Commission shall 

be individuals who— 

(A) are of recognized standing and distinction within 

the medical community with a background in treating 

mental health; 

(B) have experience working with the military and 

veteran population; and 

(C) do not have a financial interest in any of the 

complementary and integrative health treatments reviewed 

by the Commission. 

(3) CHAIRMAN.—The President shall designate a member 

of the Commission to be the Chairman. 

(4) PERIOD OF APPOINTMENT.—Members of the Commission 

shall be appointed for the life of the Commission. 

(5) VACANCY.—A vacancy in the Commission shall be filled 

in the manner in which the original appointment was made. 

(6) APPOINTMENT DEADLINE.—The appointment of members 

of the Commission in this section shall be made not later 

than 90 days after the date of the enactment of this Act. 

(d) POWERS OF COMMISSION.— 

(1) MEETINGS.— 

(A) INITIAL MEETING.—The Commission shall hold its 

first meeting not later than 30 days after a majority of 

members are appointed to the Commission. 

(B) MEETING.—The Commission shall regularly meet 

at the call of the Chairman. Such meetings may be carried 

out through the use of telephonic or other appropriate 

telecommunication technology if the Commission determines that such technology will allow the members to 

communicate simultaneously. 

(2) HEARINGS.—The Commission may hold such hearings, 

sit and act at such times and places, take such testimony, 

and receive evidence as the Commission considers advisable 

to carry out the responsibilities of the Commission. 

(3) INFORMATION FROM FEDERAL AGENCIES.—The Commission may secure directly from any department or agency of 

the Federal Government such information as the Commission 

considers necessary to carry out the duties of the Commission. 

(4) INFORMATION FROM NONGOVERNMENTAL ORGANIZATIONS.—In carrying out its duties, the Commission may seek 

guidance through consultation with foundations, veteran service 

organizations, nonprofit groups, faith-based organizations, private and public institutions of higher education, and other 

organizations as the Commission determines appropriate. 

(5) COMMISSION RECORDS.—The Commission shall keep an 

accurate and complete record of the actions and meetings of 

the Commission. Such record shall be made available for public Public 

information. 

Determination. 

Deadline. 

President. 

President. 


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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 subchapter I of chapter 57 of title 5, United States Code. 

(8) STAFF.—The Chairman, in accordance with rules agreed 

upon the Commission, may appoint and fix the compensation 

of a staff director and such other personnel as may be necessary 

to enable the Commission to carry out its functions, without 

regard to the provisions of title 5, United States Code, governing 

appointments in the competitive service, without regard to the 

provision of chapter 51 and subchapter III of chapter 53 of 

such title relating to classification and General Schedule pay 

rates, except that no rate of pay fixed under this paragraph 

may exceed the equivalent of that payable for a position at 

level IV of the Executive Schedule under section 5315 of title 

5, United States Code. 

(9) PERSONNEL AS FEDERAL EMPLOYEES.— 

(A) IN GENERAL.—The executive director and any personnel of the Commission are employees under section 

2105 of title 5, United States Code, for purpose of chapters 

63, 81, 83, 84, 85, 87, 89, and 90 of such title. 

(B) MEMBERS OF THE COMMISSION.—Subparagraph (A) 

shall not be construed to apply to members of the Commission. 

(10) CONTRACTING.—The Commission may, to such extent 

and in such amounts as are provided in appropriations Acts, 

enter into contracts to enable the Commission to discharge 

the duties of the Commission under this Act. 

(11) EXPERT AND CONSULTANT SERVICE.—The Commission 

may procure the services of experts and consultants in accordance with section 3109 of title 5, United States Code, at rates 

not to exceed the daily rate paid to a person occupying a 

position at level IV of the Executive Schedule under section 

5315 of title 5, United States Code. 

(12) POSTAL SERVICE.—The Commission may use the 

United States mails in the same manner and under the same 

conditions as departments and agencies of the United States. 

(13) PHYSICAL FACILITIES AND EQUIPMENT.—Upon the 

request of the Commission, the Administrator of General Services shall provide to the Commission, on a reimbursable basis, 

the administrative support services necessary for the Commission to carry out its responsibilities under this Act. These 

administrative services may include human resource management, budget, leasing accounting, and payroll services. 

(e) REPORT.— 

(1) INTERIM REPORTS.— 

(A) IN GENERAL.—Not later than 60 days after the 

date on which the Commission first meets, and each 30- 

day period thereafter ending on the date on which the 

Time period. 

Public 

information. 


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Commission submits the final report under paragraph (2), 

the Commission shall submit to the Committees on Veterans’ Affairs of the House of Representatives and the 

Senate and the President a report detailing the level of 

cooperation the Secretary of Veterans Affairs (and the 

heads of other departments or agencies of the Federal 

Government) has provided to the Commission. 

(B) OTHER REPORTS.—In carrying out its duties, at 

times that the Commission determines appropriate, the 

Commission shall submit to the Committees on Veterans’ 

Affairs of the House of Representatives and the Senate 

and any other appropriate entities an interim report with 

respect to the findings identified by the Commission. 

(2) FINAL REPORT.—Not later than 18 months after the 

first meeting of the Commission, the Commission shall submit 

to the Committee on Veterans’ Affairs of the House of Representatives and the Senate, the President, and the Secretary 

of Veterans Affairs a final report on the findings of the Commission. Such report shall include the following: 

(A) Recommendations to implement in a feasible, 

timely, and cost-efficient manner the solutions and remedies identified within the findings of the Commission 

pursuant to subsection (b). 

(B) An analysis of the evidence-based therapy model 

used by the Secretary of Veterans Affairs for treating veterans with mental health care issues, and an examination 

of the prevalence and efficacy of prescription drugs as 

a means for treatment. 

(C) The findings of the patient-centered survey conducted within each of the Veterans Integrated Service Networks pursuant to subsection (b)(2). 

(D) An examination of complementary and integrative 

health treatments described in subsection (b)(3) and the 

potential benefits of incorporating such treatments in the 

therapy models used by the Secretary for treating veterans 

with mental health issues. 

(3) PLAN.—Not later than 90 days after the date on which 

the Commission submits the final report under paragraph (2), 

the Secretary of Veterans Affairs shall submit to the Committees on Veterans’ Affairs of the House of Representatives and 

the Senate a report on the following: 

(A) An action plan for implementing the recommendations established by the Commission on such solutions 

and remedies for improving wellness-based outcomes for 

veterans with mental health care issues. 

(B) A feasible timeframe on when the complementary 

and integrative health treatments described in subsection 

(b)(3) can be implemented Department-wide. 

(C) With respect to each recommendation established 

by the Commission, including any complementary and 

integrative health treatment, that the Secretary determines 

is not appropriate or feasible to implement, a justification 

for such determination and an alternative solution to 

improve the efficacy of the therapy models used by the 

Secretary for treating veterans with mental health issues. 

Timeframe. 

Examination. 

Analysis. 

Recommendations. 


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130 STAT. 774 PUBLIC LAW 114–198—JULY 22, 2016 

(f) TERMINATION OF COMMISSION.—The Commission shall terminate 30 days after the Commission submits the final report under 

subsection (e)(2). 

SEC. 932. EXPANSION OF RESEARCH AND EDUCATION ON AND 

DELIVERY OF COMPLEMENTARY AND INTEGRATIVE 

HEALTH TO VETERANS. 

(a) DEVELOPMENT OF PLAN TO EXPAND RESEARCH, EDUCATION, AND DELIVERY.—Not later than 180 days after the date of the 

enactment of this Act, the Secretary of Veterans Affairs shall 

develop a plan to expand materially and substantially the scope 

of the effectiveness of research and education on, and delivery 

and integration of, complementary and integrative health services 

into the health care services provided to veterans. 

(b) ELEMENTS.—The plan required by subsection (a) shall provide for the following: 

(1) Research on the following: 

(A) The effectiveness of various complementary and 

integrative health services, including the effectiveness of 

such services integrated with clinical services. 

(B) Approaches to integrating complementary and 

integrative health services into other health care services 

provided by the Department of Veterans Affairs. 

(2) Education and training for health care professionals 

of the Department on the following: 

(A) Complementary and integrative health services 

selected by the Secretary for purposes of the plan. 

(B) Appropriate uses of such services. 

(C) Integration of such services into the delivery of 

health care to veterans. 

(3) Research, education, and clinical activities on complementary and integrative health at centers of innovation 

at medical centers of the Department. 

(4) Identification or development of metrics and outcome 

measures to evaluate the effectiveness of the provision and 

integration of complementary and integrative health services 

into the delivery of health care to veterans. 

(5) Integration and delivery of complementary and integrative health services with other health care services provided 

by the Department. 

(c) CONSULTATION.— 

(1) IN GENERAL.—In carrying out subsection (a), the Secretary shall consult with the following: 

(A) The Director of the National Center for Complementary and Integrative Health of the National 

Institutes of Health. 

(B) The Commissioner of Food and Drugs. 

(C) Institutions of higher education, private research 

institutes, and individual researchers with extensive 

experience in complementary and integrative health and 

the integration of complementary and integrative health 

practices into the delivery of health care. 

(D) Nationally recognized providers of complementary 

and integrative health. 

(E) Such other officials, entities, and individuals with 

expertise on complementary and integrative health as the 

Secretary considers appropriate. 

Deadline. 

38 USC 1701 

note. 


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(2) SCOPE OF CONSULTATION.—The Secretary shall undertake consultation under paragraph (1) in carrying out subsection (a) with respect to the following: 

(A) To develop the plan. 

(B) To identify specific complementary and integrative 

health practices that, on the basis of research findings 

or promising clinical interventions, are appropriate to 

include as services to veterans. 

(C) To identify barriers to the effective provision and 

integration of complementary and integrative health services into the delivery of health care to veterans, and to 

identify mechanisms for overcoming such barriers. 

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 wellnessbased programs (as defined by the Secretary) to complement 

the provision of pain management and related health care 

services, including mental health care services, to veterans. 

(2) MATTERS ADDRESSED.—In carrying out the pilot program, the Secretary shall assess the following: 

(A) Means of improving coordination between Federal, 

State, local, and community providers of health care in 

the provision of pain management and related health care 

services to veterans. 

(B) Means of enhancing outreach, and coordination 

of outreach, by and among providers of health care referred 

to in subparagraph (A) on the pain management and 

related health care services available to veterans. 

(C) Means of using complementary and integrative 

health and wellness-based programs of providers of health 

care referred to in subparagraph (A) as complements to 

the provision by the Department of Veterans Affairs of 

pain management and related health care services to veterans. 

(D) Whether complementary and integrative health 

and wellness-based programs described in subparagraph 

(C)— 

(i) are effective in enhancing the quality of life 

and well-being of veterans; 

(ii) are effective in increasing the adherence of 

veterans to the primary pain management and related 

health care services provided such veterans by the 

Department; 

(iii) have an effect on the sense of well-being of 

veterans who receive primary pain management and 

related health care services from the Department; and 

(iv) are effective in encouraging veterans receiving 

health care from the Department to adopt a more 

healthy lifestyle. 

Deadline. 

Assessments. 

38 USC 1701 

note. 


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130 STAT. 776 PUBLIC LAW 114–198—JULY 22, 2016 

(b) DURATION.—The Secretary shall carry out the pilot program 

under subsection (a)(1) for a period of three years. 

(c) LOCATIONS.— 

(1) FACILITIES.—The Secretary shall carry out the pilot 

program under subsection (a)(1) at facilities of the Department 

providing pain management and related health care services, 

including mental health care services, to veterans. In selecting 

such facilities to carry out the pilot program, the Secretary 

shall select not fewer than 15 geographically diverse medical 

centers of the Department, of which not fewer than two shall 

be polytrauma rehabilitation centers of the Department. 

(2) MEDICAL CENTERS WITH PRESCRIPTION RATES OF OPIOIDS

THAT CONFLICT WITH CARE STANDARDS.—In selecting the medical centers under paragraph (1), the Secretary shall give priority to medical centers of the Department at which there 

is a prescription rate of opioids that conflicts with or is otherwise inconsistent with the standards of appropriate and safe 

care. 

(d) PROVISION OF SERVICES.—Under the pilot program under 

subsection (a)(1), the Secretary shall provide covered services to 

covered veterans by integrating complementary and integrative 

health services with other services provided by the Department 

at the medical centers selected under subsection (c). 

(e) COVERED VETERANS.—For purposes of the pilot program 

under subsection (a)(1), a covered veteran is any veteran who— 

(1) has a mental health condition diagnosed by a clinician 

of the Department; 

(2) experiences chronic pain; 

(3) has a chronic condition being treated by a clinician 

of the Department; or 

(4) is not described in paragraph (1), (2), or (3) and requests 

to participate in the pilot program or is referred by a clinician 

of the Department who is treating the veteran. 

(f) COVERED SERVICES.— 

(1) IN GENERAL.—For purposes of the pilot program, covered 

services are services consisting of complementary and integrative health services as selected by the Secretary. 

(2) ADMINISTRATION OF SERVICES.—Covered services shall 

be administered under the pilot program as follows: 

(A) Covered services shall be administered by professionals or other instructors with appropriate training and 

expertise in complementary and integrative health services 

who are employees of the Department or with whom the 

Department enters into an agreement to provide such services. 

(B) Covered services shall be included as part of the 

Patient Aligned Care Teams initiative of the Office of 

Patient Care Services, Primary Care Program Office, in 

coordination with the Office of Patient Centered Care and 

Cultural Transformation. 

(C) Covered services shall be made available to— 

(i) covered veterans who have received conventional treatments from the Department for the conditions for which the covered veteran seeks complementary and integrative health services under the pilot 

program; and 


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(ii) covered veterans who have not received conventional treatments from the Department for such conditions. 

(g) REPORTS.— (1) IN GENERAL.—Not later than 30 months after the date 

on which the Secretary commences the pilot program under 

subsection (a)(1), the Secretary shall submit to the Committee 

on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report on 

the pilot program. 

(2) ELEMENTS.—The report under paragraph (1) shall 

include the following: 

(A) The findings and conclusions of the Secretary with 

respect to the pilot program under subsection (a)(1), 

including with respect to— 

(i) the use and efficacy of the complementary and 

integrative health services established under the pilot 

program; 

(ii) the outreach conducted by the Secretary to 

inform veterans and community organizations about 

the pilot program; and 

(iii) an assessment of the benefit of the pilot program to covered veterans in mental health diagnoses, 

pain management, and treatment of chronic illness. 

(B) Identification of any unresolved barriers that 

impede the ability of the Secretary to incorporate complementary and integrative health services with other 

health care services provided by the Department. 

(C) Such recommendations for the continuation or 

expansion of the pilot program as the Secretary considers 

appropriate. 

Subtitle D—Fitness of Health Care 

Providers 

SEC. 941. ADDITIONAL REQUIREMENTS FOR HIRING OF HEALTH CARE 

PROVIDERS BY DEPARTMENT OF VETERANS AFFAIRS. 

As part of the hiring process for each health care provider 

considered for a position at the Department of Veterans Affairs 

after the date of the enactment of the Act, the Secretary of Veterans 

Affairs shall require from the medical board of each State in which 

the health care provider has or had a medical license— 

(1) information on any violation of the requirements of 

the medical license of the health care provider during the 

20-year period preceding the consideration of the health care 

provider by the Department; and 

(2) information on whether the health care provider has 

entered into any settlement agreement for a disciplinary charge 

relating to the practice of medicine by the health care provider. 

SEC. 942. PROVISION OF INFORMATION ON HEALTH CARE PROVIDERS 

OF DEPARTMENT OF VETERANS AFFAIRS TO STATE MEDICAL BOARDS. 

Notwithstanding section 552a of title 5, United States Code, 

with respect to each health care provider of the Department of 

Veterans Affairs who has violated a requirement of the medical 

38 USC 1701 

note. 

Time period. 

38 USC 1701 

note. 

Recommendations. 

Assessment. 


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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. 


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LEGISLATIVE HISTORY—S. 524 (H.R. 1725) (H.R. 1818) (H.R. 3680) (H.R. 3691) 

(H.R. 4063) (H.R. 4586) (H.R. 4599) (H.R. 4641) 

(H.R. 4843) (H.R. 4892) (H.R. 4969) (H.R. 4976) 

(H.R. 4978) (H.R. 4981) (H.R. 4982) (H.R. 4985) 

(H.R. 5046) (H.R. 5048) (H.R. 5052): 

HOUSE REPORTS: Nos. 114–669 (Comm. of Conference), 114–245 (Comm. on Energy and Commerce) accompanying H.R. 1725, 114–552 

(Comm. on Energy and Commerce) accompanying H.R. 1818, 

114–553 (Comm. on Energy and Commerce) accompanying 

H.R. 3680, 114–554 (Comm. on Energy and Commerce) accompanying H.R. 3691, 114–646 (Comm. on Veterans’ Affairs) accompanying H.R. 4063, 114–555 (Comm. on Energy and Commerce) accompanying H.R. 4586, 114–556 (Comm. on Energy 

and Commerce) accompanying H.R. 4599, 114–536 (Comm. on 

Energy and Commerce) accompanying H.R. 4641, 114–548 

(Comm. on Education and the Workforce) accompanying H.R. 

4843, 114–558 (Comm. on Energy and Commerce) accompanying H.R. 4969, 114–557 (Comm. on Energy and the Workforce) accompanying H.R. 4976, 114–559 (Comm. on Energy 

and Commerce) accompanying H.R. 4978, 114–561 (Comm. on 

Energy and Commerce) accompanying H.R. 4981, 114–560 

(Comm. on Energy and Commerce) accompanying H.R. 4982, 

114–547, Pt. 1 (Comm. on the Judiciary) accompanying 

H.R. 4985, 114–539 (Comm. on the Judiciary) accompanying 

H.R. 5046, 114–540 (Comm. on the Judiciary) accompanying 

H.R. 5048, and 114–541, Pt. 1 (Comm. on the Judiciary) accompanying H.R. 5052. 

CONGRESSIONAL RECORD, Vol. 162 (2016): 

Mar. 2, 3, 7–10, considered and passed Senate. 

May 13, considered and passed House, amended. 

July 8, House agreed to conference report. 

July 11–13, Senate considered and agreed to conference report. 

DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2016): 

July 22, Presidential statement. 

Æ 

Affairs is encouraged to use bonuses to incentivize high-performing 

employees in areas in which retention is challenging.’’. 

Approved July 22, 2016. 


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