PUBL198.PS

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

Public Law 114–198

114th Congress

An Act

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

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

and for other purposes.

Be it enacted by the Senate and House of Representatives of

the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) S

HORT

ITLE

.—This Act may be cited as the ‘‘Comprehensive

Addiction and Recovery Act of 2016’’.

(b) T

ABLE OF

ONTENTS

.—The table of contents for this Act

is as follows:

Sec. 1. Short title; table of contents.

TITLE I—PREVENTION AND EDUCATION

Sec. 101. Task force on pain management.

Sec. 102. Awareness campaigns.

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

ses.

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

sports injuries.

Sec. 105. Assisting veterans with military emergency medical training to meet re-

quirement for becoming civilian health care professionals.

Sec. 106. FDA opioid action plan.

Sec. 107. Improving access to overdose treatment.

Sec. 108. NIH opioid research.

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

Sec. 110. Opioid overdose reversal medication access and education grant pro-

grams.

TITLE II—LAW ENFORCEMENT AND TREATMENT

Sec. 201. Comprehensive Opioid Abuse Grant Program.

Sec. 202. First responder training.

Sec. 203. Prescription drug take back expansion.

TITLE III—TREATMENT AND RECOVERY

Sec. 301. Evidence-based prescription opioid and heroin treatment and interven-

tions demonstration.

Sec. 302. Building communities of recovery.

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

TITLE IV—ADDRESSING COLLATERAL CONSEQUENCES

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

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

AND VETERANS

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

Sec. 502. Veterans treatment courts.

Sec. 503. Infant plan of safe care.

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

Comprehensive

Addiction and

Recovery Act

of 2016.

42 USC 201 note.

July 22, 2016

[S. 524]

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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

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

Medicaid additional rebate requirement for new formulations of pre-

scription drugs.

Sec. 706. Limiting disclosure of predictive modeling and other analytics tech-

nologies to identify and prevent waste, fraud, and abuse.

Sec. 707. Medicaid Improvement Fund.

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

TITLE VIII—KINGPIN DESIGNATION IMPROVEMENT

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

designations under the Narcotics Kingpin Designation Act.

TITLE IX—DEPARTMENT OF VETERANS AFFAIRS

Sec. 901. Short title.

Sec. 902. Definitions.

Subtitle A—Opioid Therapy and Pain Management

Sec. 911. Improvement of opioid safety measures by Department of Veterans Af-

fairs.

Sec. 912. Strengthening of joint working group on pain management of the Depart-

ment of Veterans Affairs and the Department of Defense.

Sec. 913. Review, investigation, and report on use of opioids in treatment by De-

partment of Veterans Affairs.

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

substance monitoring programs.

Sec. 915. Elimination of copayment requirement for veterans receiving opioid an-

tagonists or education on use of opioid antagonists.

Subtitle B—Patient Advocacy

Sec. 921. Community meetings on improving care furnished by Department of Vet-

erans Affairs.

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

of rights of Department of Veterans Affairs.

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

of Veterans Affairs.

Sec. 924. Establishment of Office of Patient Advocacy of the Department of Vet-

erans Affairs.

Subtitle C—Complementary and Integrative Health

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

and integrative health to veterans.

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

and integrative health to veterans.

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

and related issues for veterans and family members of veterans.

Subtitle D—Fitness of Health Care Providers

Sec. 941. Additional requirements for hiring of health care providers by Depart-

ment of Veterans Affairs.

Sec. 942. Provision of information on health care providers of Department of Vet-

erans Affairs to State medical boards.

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

health care providers leaving the Department or transferring to other

facilities.

Subtitle E—Other Matters

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

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

TITLE I—PREVENTION AND EDUCATION

SEC. 101. TASK FORCE ON PAIN MANAGEMENT.

(a) D

EFINITIONS

.—In this section:

(1) S

ECRETARY

.—The term ‘‘Secretary’’ means the Secretary

of Health and Human Services.

(2) T

ASK FORCE

.—The term ‘‘task force’’ means the Pain

Management Best Practices Inter-Agency Task Force convened

under subsection (b).

(b) I

NTER

-A

GENCY

ASK

ORCE

.—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.

EMBERSHIP

.—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;

(D) the Office of National Drug Control Policy;

(2) currently licensed and practicing physicians, dentists,

and nonphysician prescribers;

(3) currently licensed and practicing pharmacists and phar-

macies;

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

research, including adolescent and young adult addiction

research;

(5) representatives of—

(A) pain management professional organizations;

(B) the mental health treatment community;

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) R

EPRESENTATION

.—The Secretary shall ensure that the

membership of the task force includes individuals representing

rural and underserved areas.

(e) D

UTIES

.—The task force shall—

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

there are gaps in or inconsistencies between best practices

for pain management (including chronic and acute pain) devel-

oped or adopted by Federal agencies;

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

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

to best practices and recommendations on addressing gaps or

inconsistencies identified under paragraph (1), as appropriate,

and submit to relevant Federal agencies and the general public

Deadline.

Recommenda-

tions.

Public

information.

Establishment.

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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 rel-

evant research;

(B) recommendations from relevant conferences and

existing relevant evidence-based guidelines;

by medical professional organizations to develop improved

pain management strategies, including consideration of dif-

ferences within and between classes of opioids, the avail-

ability of opioids with abuse deterrent technology, and

pharmacological, nonpharmacological, and medical device

alternatives to opioids to reduce opioid monotherapy in

appropriate cases;

(D) the management of high-risk populations who

receive opioids in the course of medical care, other than

for pain management;

(E) the 2016 Guideline for Prescribing Opioids for

Chronic Pain issued by the Centers for Disease Control

and Prevention; and

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

related to pain management and prescribing pain medica-

tion;

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

comments on any proposed updates and recommendations

under paragraph (2); and

(4) develop a strategy for disseminating information about

best practices for pain management (including chronic and

acute pain) to stakeholders, if appropriate.

(f) L

IMITATION

.—The task force shall not have rulemaking

authority.

(g) S

UNSET

.—The task force under this section shall sunset

after 3 years.

SEC. 102. AWARENESS CAMPAIGNS.

(a) I

ENERAL

.—The Secretary of Health and Human Services,

in coordination with the heads of other departments and agencies,

shall, as appropriate, through existing programs and activities,

advance the education and awareness of the public (including pro-

viders, patients, and consumers) and other appropriate entities

regarding the risk of abuse of prescription opioids if such drugs

are not taken as prescribed.

(b) T

OPICS

.—The education and awareness campaigns under

subsection (a) shall address—

(1) the dangers of opioid abuse;

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

disposal of prescription medications and other safety pre-

cautions; and

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

THER

EQUIREMENTS

.—The education and awareness cam-

paigns under subsection (a) shall, as appropriate—

(1) take into account any association between prescription

opioid abuse and heroin use;

(2) emphasize—

(A) the similarities between heroin and prescription

opioids; and

42 USC

290bb–25g.

Coordination.

Public

information.

Time period.

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

(B) the effects of heroin and prescription opioids on

the human body; and

(3) bring greater public awareness to the dangerous effects

of fentanyl when mixed with heroin or abused in a similar

manner.

SEC. 103. COMMUNITY-BASED COALITION ENHANCEMENT GRANTS TO

ADDRESS LOCAL DRUG CRISES.

(a) D

EFINITIONS

.—In this section:

(1) A

DMINISTRATOR

.—The term ‘‘Administrator’’ means the

Administrator of the Substance Abuse and Mental Health Serv-

ices Administration.

(2) D

IRECTOR

.—The term ‘‘Director’’ means the Director

of the Office of National Drug Control Policy.

(3) D

RUG

FREE COMMUNITIES ACT OF 1997

.—The term ‘‘Drug-

Free Communities Act of 1997’’ means chapter 2 of the National

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

(4) E

LIGIBLE ENTITY

.—The term ‘‘eligible entity’’ means an

organization that—

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

for a grant under this section, receives or has received

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

and

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

of opioids or methamphetamines at levels that are—

(i) significantly higher than the national average

as determined by the Secretary (including appropriate

consideration of the results of the Monitoring the

Future Survey published by the National Institute on

Drug Abuse and the National Survey on Drug Use

and Health published by the Substance Abuse and

Mental Health Services Administration); or

(ii) higher than the national average, as deter-

mined by the Secretary (including appropriate consid-

eration of the results of the surveys described in clause

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

(5) E

MERGING 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) L

OCAL 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

mented by local data.

(7) O

PIOID

.—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) P

ROGRAM

UTHORIZED

.—The Director, in coordination with

the Administrator, may make grants to eligible entities to imple-

ment comprehensive community-wide strategies that address local

drug crises and emerging drug abuse issues within the area served

by the eligible entity.

PPLICATION

.—

(1) I

N GENERAL

.—An eligible entity seeking a grant under

this section shall submit an application to the Director at

such time, in such manner, and accompanied by such informa-

tion as the Director may require.

(2) C

RITERIA

.—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) U

SE OF

UNDS

.—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) S

UPPLEMENT

UPPLANT

.—An eligible entity shall use

Federal funds received under this section only to supplement the

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

available from other Federal and non-Federal sources for the activi-

ties described in this section, and not to supplant those funds.

(f) E

VALUATION

.—A grant under this section shall be subject

to the same evaluation requirements and procedures as the evalua-

tion requirements and procedures imposed on the recipient of a

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

also include an evaluation of the effectiveness at reducing abuse

of opioids or methamphetamines.

(g) L

IMITATION ON

DMINISTRATIVE

XPENSES

.—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) D

ELEGATION

UTHORITY

.—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) A

UTHORIZATION OF

PPROPRIATIONS

.—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) R

EPORT

.—The Secretary of Health and Human Services

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

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

make publicly available on the appropriate website of the Depart-

ment of Health and Human Services a report determining the

extent to which informational materials and resources described

Public

information.

Web posting.

42 USC

290bb–25g note.

Contracts.

Coordination.

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

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

play youth sports, families of such teenagers and adolescents,

nurses, youth sports groups, and relevant health care provider

groups.

(b) D

EVELOPMENT OF

NFORMATIONAL

ATERIALS AND

ESOURCES

.—The Secretary may, for purposes of preventing sub-

stance use disorder in teenagers and adolescents who are injured

playing youth sports and are subsequently prescribed an opioid,

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

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

of such report and in coordination with relevant health care provider

groups, facilitate the development of informational materials and

resources described in subsection (c) for teenagers and adolescents

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

nurses, youth sports groups, and relevant health care provider

groups.

ATERIALS AND

ESOURCES

ESCRIBED

.—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) N

DDITIONAL

UNDS

.—No additional funds are authorized

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

This section shall be carried out using amounts otherwise available

for such purpose.

SEC. 105. ASSISTING VETERANS WITH MILITARY EMERGENCY MEDICAL

TRAINING TO MEET REQUIREMENT FOR BECOMING

CIVILIAN HEALTH CARE PROFESSIONALS.

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

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

‘‘SEC. 315. ASSISTING VETERANS WITH MILITARY EMERGENCY MED-

ICAL TRAINING TO MEET REQUIREMENTS FOR BECOMING

CIVILIAN HEALTH CARE PROFESSIONALS.

‘‘(a) P

ROGRAM

.—

‘‘(1) I

N GENERAL

.—The Secretary may establish a program,

in consultation with the Secretary of Labor, consisting of

awarding demonstration grants to States to streamline State

requirements and procedures in order to assist veterans who

held certain military occupational specialties related to medical

care or who have completed certain medical training while

serving in the Armed Forces of the United States to meet

certification, licensure, and other requirements applicable to

civilian health care professions (such as emergency medical

technician, paramedic, licensed practical nurse, registered

nurse, physical therapy assistant, or physician assistant profes-

sions) in the State.

‘‘(2) C

ONSULTATION 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) U

SE OF

UNDS

.—Amounts received as a demonstration

grant under this section shall be used to—

‘‘(1) prepare and implement a plan to streamline State

requirements and procedures as described in subsection (a),

including by—

‘‘(A) determining the extent to which the requirements

for the education, training, and skill level of civilian health

care professions (such as emergency medical technicians,

paramedics, licensed practical nurses, registered nurses,

physical therapy assistants, or physician assistants) in the

State are equivalent to requirements for the education,

training, and skill level of veterans who served in medical

related fields while a member of the Armed Forces of

the United States; and

‘‘(B) identifying methods, such as waivers, for veterans

who served in medical related fields while a member of

the Armed Forces of the United States to forgo or meet

any such equivalent State requirements; and

‘‘(2) if necessary to meet workforce shortages or address

gaps in education, training, or skill level to meet certification,

licensure or other requirements applicable to becoming a

civilian health care professional (such as an emergency medical

technician, paramedic, licensed practical nurse, registered

nurse, physical therapy assistant, or physician assistant profes-

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

institutions of higher education to support veterans in meeting

such requirements.

‘‘(c) R

EPORT

.—Upon the completion of the demonstration pro-

gram under this section, the Secretary shall submit to Congress

a report on the program.

‘‘(d) F

UNDING

.—No additional funds are authorized to be appro-

priated for the purpose of carrying out this section. This section

shall be carried out using amounts otherwise available for such

purpose.

‘‘(e) S

UNSET

.—The demonstration program under this section

shall not exceed 5 years.’’.

SEC. 106. FDA OPIOID ACTION PLAN.

(a) I

ENERAL

.—

(1) N

EW DRUG APPLICATION

.—

(A) I

N GENERAL

.—Subject to subparagraph (B), prior

to the approval pursuant to an application submitted under

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

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

the Secretary of Health and Human Services (referred to

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

to an advisory committee of the Food and Drug Administra-

tion to seek recommendations from such advisory com-

mittee.

(B) P

UBLIC HEALTH EXEMPTION

.—A referral to an

advisory committee under subparagraph (A) is not required

with respect to a new opioid drug or drugs if the Sec-

retary—

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

of protecting and promoting public health;

21 USC 355 note.

Determination.

Plan.

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

(ii) finds that such a referral is not necessary

based on a review of the relevant scientific information;

and

(iii) submits a notice containing the rationale for

such findings to the Committee on Health, Education,

Labor, and Pensions of the Senate and the Committee

on Energy and Commerce of the House of Representa-

tives.

(2) P

EDIATRIC OPIOID LABELING

.—The Secretary shall con-

vene the Pediatric Advisory Committee of the Food and Drug

Administration to seek recommendations from such Committee

regarding a framework for the inclusion of information in the

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

drugs in pediatric populations before the Secretary approves

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

opioid intended for use in a pediatric population.

(3) S

UNSET

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

shall cease to be effective on October 1, 2022.

(b) P

RESCRIBER

DUCATION

.—Not later than 1 year after the

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

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

Drug Administration’s evaluation of the Extended-Release/Long-

Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy,

and in consultation with relevant stakeholders, shall develop rec-

ommendations regarding education programs for prescribers of

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

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

(1) which prescribers should participate in such programs;

and

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

UIDANCE ON

VALUATING THE

BUSE

ETERRENCE OF

ENERIC

OLID

RAL

PIOID

RUG

RODUCTS

.—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) G

RANTS FOR

EDUCING

VERDOSE

EATHS

.—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) E

STABLISHMENT

.—

‘‘(1) I

N 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) M

AXIMUM GRANT AMOUNT

.—A grant awarded under

this section may not be for more than $200,000 per grant

year.

‘‘(3) E

LIGIBLE ENTITY

.—For purposes of this section, the

term ‘eligible entity’ means a Federally qualified health center

(as defined in section 1861(aa) of the Social Security Act),

an opioid treatment program under part 8 of title 42, Code

Definition.

42 USC 290dd–3.

Deadline.

Time period.

Federal Register,

publication.

21 USC 355 note.

Deadline.

Consultation.

Recommenda-

tions.

21 USC 355–1

note.

Recommenda-

tions.

Notice.

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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) P

RESCRIBING

.—For purposes of this section, the term

‘prescribing’ means, with respect to a drug or device approved

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

for emergency treatment of known or suspected opioid overdose,

the practice of prescribing such drug or device—

‘‘(A) in conjunction with an opioid prescription for

patients at an elevated risk of overdose;

‘‘(B) in conjunction with an opioid agonist approved

under section 505 of the Federal Food, Drug, and Cosmetic

Act for the treatment of opioid use disorder;

‘‘(C) to the caregiver or a close relative of patients

at an elevated risk of overdose from opioids; or

‘‘(D) in other circumstances in which a provider identi-

fies a patient is at an elevated risk for an intentional

or unintentional drug overdose from heroin or prescription

opioid therapies.

‘‘(b) A

PPLICATION

.—To be eligible to receive a grant under this

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

form and manner as specified by the Secretary, an application

that describes—

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

furnish services through use of the grant is experiencing signifi-

cant morbidity and mortality caused by opioid abuse;

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

to participate in such program; and

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

for the program has ended.

‘‘(c) U

SE OF

UNDS

.—An eligible entity receiving a grant under

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

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

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

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

approved or cleared under the Federal Food, Drug, and Cos-

metic Act for emergency treatment of known or suspected opioid

overdose.

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

and pharmacists on the prescribing of drugs or devices approved

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

for emergency treatment of known or suspected opioid overdose.

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

the Federal Food, Drug, and Cosmetic Act for emergency treat-

ment of known or suspected opioid overdose, for distribution

under the program described in paragraph (1).

‘‘(4) To offset the co-payments and other cost sharing associ-

ated with drugs or devices approved or cleared under the Fed-

eral Food, Drug, and Cosmetic Act for emergency treatment

of known or suspected opioid overdose.

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

experienced a drug overdose with appropriate treatment,

including medication-assisted treatment and appropriate coun-

seling and behavioral therapies.

‘‘(d) E

VALUATIONS BY

ECIPIENTS

.—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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130 STAT. 705 PUBLIC LAW 114–198—JULY 22, 2016

evaluation of activities funded by the grant which contains such

information as the Secretary may reasonably require.

‘‘(e) R

EPORTS BY THE

ECRETARY

.—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) A

UTHORIZATION OF

PPROPRIATIONS

.—There is authorized

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

period of fiscal years 2017 through 2021.’’.

(b) I

MPROVING

CCESS TO

VERDOSE

REATMENT

.—

(1) I

NFORMATION ON BEST PRACTICES

.—Not later than 180

days after the date of enactment of this Act:

(A) The Secretary of Health and Human Services may

provide information to prescribers within Federally quali-

fied health centers (as defined in paragraph (4) of section

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

and the health care facilities of the Indian Health Service,

on best practices for prescribing or co-prescribing a drug

or device approved or cleared under the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) for emer-

gency treatment of known or suspected opioid overdose,

including for patients receiving chronic opioid therapy and

patients being treated for opioid use disorders.

(B) The Secretary of Defense may provide information

to prescribers within Department of Defense medical facili-

ties on best practices for prescribing or co-prescribing a

drug or device approved or cleared under the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) for emer-

gency treatment of known or suspected opioid overdose,

including for patients receiving chronic opioid therapy and

patients being treated for opioid use disorders.

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) R

ULE 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) I

ENERAL

.—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) P

RIORITY AND

IRECTION

.—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) A

MENDMENT TO

URPOSE

.—Paragraph (1) of section 2 of

the National All Schedules Prescription Electronic Reporting Act

of 2005 (Public Law 109–60) is amended to read as follows:

‘‘(1) foster the establishment of State-administered con-

trolled substance monitoring systems in order to ensure that

health care providers have access to the accurate, timely

prescription history information that they may use as a tool

for the early identification of patients at risk for addiction

in order to initiate appropriate medical interventions and avert

the tragic personal, family, and community consequences of

untreated addiction; and’’.

(b) A

MENDMENTS TO

ONTROLLED

UBSTANCE

ONITORING

GRAM

.—Section 399O of the Public Health Service Act (42 U.S.C.

280g–3) is amended—

(1) in subsection (a)(1)—

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

inserting ‘‘, in consultation with the Administrator of the

Substance Abuse and Mental Health Services Administra-

tion and Director of the Centers for Disease Control and

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

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

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) M

INIMUM

EQUIREMENTS

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

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

information technology, to the extent practicable, in

order to incorporate prescription drug monitoring pro-

gram data directly into the workflow of prescribers

and dispensers to ensure timely access to patients’

controlled prescription drug history;’’;

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

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

health information technology system such as elec-

tronic health records, health information exchanges,

or e-prescribing systems;’’;

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

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

‘‘public health or safety’’; and

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

and’’; and

(vii) by adding at the end the following:

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

controlled substance monitoring program jointly works

with the applicant’s respective State substance abuse

agency to ensure information collected and maintained

by the controlled substance monitoring program is used

to inform the provision of clinically appropriate sub-

stance use disorder services to individuals in need.’’;

(B) in paragraph (3)—

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

inserting the following:

‘‘(A) I

N GENERAL

.—If a State that submits’’;

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

include timelines for full implementation of such inter-

operability. The State shall also describe the manner

in which it will achieve interoperability between its

monitoring program and health information technology

systems, as allowable under State law, and include

timelines for the implementation of such interoper-

ability’’; and

(iii) by adding at the end the following:

‘‘(B) M

ONITORING OF EFFORTS

.—The Secretary shall

monitor State efforts to achieve interoperability, as

described in subparagraph (A).’’; and

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

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

(ii) by adding at the end the following: ‘‘The Sec-

retary shall redistribute any funds that are so returned

among the remaining grantees under this section in

accordance with the formula described in subsection

(a)(2)(B).’’;

(4) in subsection (d)—

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

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

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

establishing, improving, or maintaining a controlled

substance monitoring program under this section, a

State shall comply, or with respect to a State that

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

of subsection (a)(1)’’; and

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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 ‘‘imple-

menting or improving’’ each place it appears and inserting

‘‘establishing, improving, or maintaining’’;

(6) in subsection (f)—

(A) in paragraph (1)—

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

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

‘‘misuse of a controlled substance included in schedule

II, III, or IV of section 202(c) of the Controlled Sub-

stances Act’’; and

(ii) in subparagraph (D)—

(I) by inserting ‘‘a State substance abuse

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

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

or administration’’ each place it appears and

inserting ‘‘such department, program, agency, or

administration’’ in each such place; and

(B) by adding at the end the following:

‘‘(3) E

VALUATION 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) R

ESEARCH BY OTHER ENTITIES

.—A department, pro-

gram, agency, or administration receiving nonidentifiable

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

available to other entities for research purposes.’’;

(7) by striking subsection (k);

(8) by redesignating subsections (h) through (j) as sub-

sections (i) through (k), respectively;

(9) in subsections (c)(1)(A)(iv) and (d)(4), by striking ‘‘sub-

section (h)’’ each place it appears and inserting ‘‘subsection

(i)’’;

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

‘‘(h) E

DUCATION AND

CCESS TO THE

ONITORING

YSTEM

.—

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

to—

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

controlled substance monitoring system, to the extent prac-

ticable; and

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

of the system.’’;

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

Reports.

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

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

‘‘, established or strengthened initiatives to ensure linkages

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

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

and inserting ‘‘and between controlled substance moni-

toring programs and health information technology sys-

tems, including an assessment’’;

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

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

improvement, or maintenance’’;

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

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

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

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

‘‘(n) A

UTHORIZATION OF

PPROPRIATIONS

.—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) I

ENERAL

.—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) G

RANTS TO

TATES

.—The Secretary shall make grants to

States to—

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

drug or device approved or cleared under the Federal Food,

Drug, and Cosmetic Act for emergency treatment of known

or suspected opioid overdose, as appropriate, pursuant to a

standing order;

‘‘(2) encourage pharmacies to dispense opioid overdose

reversal medication pursuant to a standing order;

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

authorized to prescribe or dispense a drug or device approved

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

for emergency treatment of known or suspected opioid overdose

may use to educate the public concerning—

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

or device; and

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

or device; and

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

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

and Cosmetic Act for emergency treatment of known or sus-

pected opioid overdose without a person-specific prescription.

‘‘(b) C

ERTAIN

EQUIREMENT

.—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) P

REFERENCE IN

AKING

RANTS

.—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 sus-

pected opioid overdose;

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

community-based organizations, substance abuse programs, or

other nonprofit entities to acquire, dispense, or administer

drugs or devices approved or cleared under the Federal Food,

Drug, and Cosmetic Act for emergency treatment of known

or suspected opioid overdose; or

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

police, fire, or emergency medical services agencies to acquire

and administer drugs or devices approved or cleared under

the Federal Food, Drug, and Cosmetic Act for emergency treat-

ment of known or suspected opioid overdose.

‘‘(d) G

RANT

ERMS

.—

‘‘(1) N

UMBER

.—A State may not receive more than one

grant under this section at a time.

‘‘(2) P

ERIOD

.—A grant under this section shall be for a

period of 3 years.

‘‘(3) L

IMITATION

.—A State may use not more than 20 per-

cent of a grant under this section for educating the public

pursuant to subsection (a)(4).

‘‘(e) A

PPLICATIONS

.—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) R

EPORTING

.—A State that receives a grant under this sec-

tion shall, at least annually for the duration of the grant, submit

a report to the Secretary evaluating the progress of the activities

supported through the grant. Such reports shall include information

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

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

Cosmetic Act for emergency treatment of known or suspected opioid

overdose under a standing order, and other information as the

Secretary determines appropriate to evaluate the use of grant funds.

‘‘(g) D

EFINITIONS

.—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) A

UTHORIZATION OF

PPROPRIATIONS

.—

‘‘(1) I

N 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) A

DMINISTRATIVE 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) T

ECHNICAL

LARIFICATION

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

TITLE II—LAW ENFORCEMENT AND

TREATMENT

SEC. 201. COMPREHENSIVE OPIOID ABUSE GRANT PROGRAM.

(a) C

OMPREHENSIVE

PIOID

BUSE

RANT

ROGRAM

.—

(1) I

N 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) G

RANTS

UTHORIZED

.—From amounts made available to

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

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

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

services primarily relating to opioid abuse, including for any one

or more of the following:

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

alternative to incarceration program, which may include—

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

include the activities described in part DD or HH of this

title;

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

substance use disorders and co-occurring mental illness

and substance use disorders;

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

described in part V of this title;

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

in part EE of this title;

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

the activities described in subsection (i) of section 2991

of this title;

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

in their children entering the child welfare system; and

‘‘(G) a community-based substance use diversion pro-

gram sponsored by a law enforcement agency.

‘‘(2) In the case of a State, facilitating or enhancing plan-

ning and collaboration between State criminal justice agencies

and State substance abuse agencies in order to more efficiently

and effectively carry out activities or services described in any

paragraph of this subsection that address problems related

to opioid abuse.

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

on carrying and administering an opioid overdose reversal drug

or device approved or cleared by the Food and Drug Administra-

tion, and purchasing such a drug or device for first responders

who have received such training to so carry and administer.

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

the unlawful distribution of opioids.

‘‘(5) Developing, implementing, or expanding a medication-

assisted treatment program used or operated by a criminal

justice agency, which may include training criminal justice

42 USC 3797ff.

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

agency personnel on medication-assisted treatment, and car-

rying out the activities described in part S of this title.

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

expanding a prescription drug monitoring program to collect

and analyze data related to the prescribing of schedules II,

III, and IV controlled substances through a centralized database

administered by an authorized State agency, which includes

tracking the dispensation of such substances, and providing

for interoperability and data sharing with each other such

program in each other State, and with any interstate entity

that shares information between such programs.

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

to prevent and address opioid abuse by juveniles.

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

(which may include demonstration projects) to utilize tech-

nology that provides a secure container for prescription drugs

that would prevent or deter individuals, particularly adoles-

cents, from gaining access to opioid medications that are law-

fully prescribed for other individuals.

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

drug take-back program.

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

and comprehensive opioid abuse response program.

‘‘(b) C

ONTRACTS AND

UBAWARDS

.—A State, unit of local govern-

ment, or Indian tribe may, in using a grant under this part for

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

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

or more—

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

nonprofit, including faith-based organizations;

‘‘(2) units of local government; or

‘‘(3) tribal organizations.

‘‘(c) P

ROGRAM

SSESSMENT

OMPONENT

; W

AIVER

.—

‘‘(1) P

ROGRAM 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) W

AIVER

.—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) A

DMINISTRATIVE

OSTS

.—Not more than 10 percent of a

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

administer such grant.

‘‘(e) P

ERIOD

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

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

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

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

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

for the activities described in section 3021(a).

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

an application, the applicant shall maintain and report such

data, records, and information (programmatic and financial)

as the Attorney General may reasonably require.

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

Attorney General and executed by the chief executive officer

of the applicant (or by another officer of the applicant, if quali-

fied under regulations promulgated by the Attorney General),

that—

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

grant meet all the requirements of this part;

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

is correct;

‘‘(C) there has been appropriate coordination with

affected agencies; and

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

this part and all other applicable Federal laws.

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

Drug Enforcement Administration to develop an integrated and

comprehensive strategy to address opioid abuse.

‘‘SEC. 3023. REVIEW OF APPLICATIONS.

‘‘The Attorney General shall not finally disapprove any applica-

tion (or any amendment to that application) submitted under this

part without first affording the applicant reasonable notice of any

deficiencies in the application and an opportunity for correction

of any such deficiencies and reconsideration.

‘‘SEC. 3024. EQUITABLE DISTRIBUTION OF FUNDS.

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

shall distribute funds in a manner that—

‘‘(1) equitably addresses the needs of underserved popu-

lations, including rural and tribal communities; and

‘‘(2) focuses on communities that have been disproportion-

ately impacted by opioid abuse as evidenced in part by—

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

heroin and other opioids;

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

and other opioids; and

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

facilities and to emergency medical services.

‘‘SEC. 3025. DEFINITIONS.

‘‘In this part:

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

enforcement officer, paramedic, emergency medical technician,

or other individual (including an employee of a legally organized

and recognized volunteer organization, whether compensated

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

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

emergencies.

42 USC 3797ff–4.

42 USC 3797ff–3.

Notice.

42 USC 3797ff–2.

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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 Administra-

tion for the treatment of opioid abuse.

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

having an addiction-forming or addiction-sustaining liability

similar to morphine or being capable of conversion into a drug

having such addiction-forming or addiction-sustaining liability.

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

means a controlled substance that is listed on schedule II,

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

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

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

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

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

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

or tribal—

‘‘(A) court;

‘‘(B) prison;

‘‘(C) jail;

‘‘(D) law enforcement agency; or

‘‘(E) other agency that performs the administration

of criminal justice, including prosecution, pretrial services,

and community supervision.

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

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

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

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

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

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

(2) A

UTHORIZATION OF APPROPRIATIONS

.—Section 1001(a)

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

of 1968 (42 U.S.C. 3793(a)) is amended by inserting after para-

graph (26) the following:

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

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

2021.’’.

(b) E

MERGENCY

EDERAL

NFORCEMENT

SSISTANCE

.—

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’’.

NCLUSION OF

ERVICES FOR

REGNANT

OMEN

NDER

AMILY

-B

ASED

UBSTANCE

BUSE

RANTS

.—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 S

TUDY AND

EPORT ON

EDERAL

GENCY

ROGRAMS

AND

ESEARCH

ELATIVE TO

UBSTANCE

SE AND

UBSTANCE

ISORDERS

MONG

DOLESCENTS AND

OUNG

DULTS

.—

(1) S

TUDY

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

recovery from, substance use by, and substance use disorders

among, adolescents and young adults. Such study shall include

an analysis of each of the following:

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

or supported pursuant to grant programs operated by Fed-

eral agencies on prevention of, treatment for, and recovery

from substance use by and substance use disorders among

adolescents and young adults, including an assessment of—

(i) such research relative to any unique cir-

cumstances (including social and biological cir-

cumstances) of adolescents and young adults that may

make adolescent-specific and young adult-specific treat-

ment protocols necessary, including any effects that

substance use and substance use disorders may have

on brain development and the implications for treat-

ment and recovery; and

(ii) areas of such research in which greater invest-

ment or focus is necessary relative to other areas of

such research.

(B) Federal agency nonresearch programs and activi-

ties that address prevention of, treatment for, and recovery

from substance use by and substance use disorders among

adolescents and young adults, including an assessment of

the effectiveness of such programs and activities in pre-

venting substance use by and substance use disorders

among adolescents and young adults, treating such adoles-

cents and young adults in a way that accounts for any

unique circumstances faced by adolescents and young

adults, and supports long-term recovery among adolescents

and young adults.

eral agencies or experts in the efforts supported by grant

programs operated by Federal agencies relating to preven-

tion of, treatment for, and recovery from substance use

by and substance use disorders among adolescents and

young adults, including gaps in research, data collection,

and measures to evaluate the effectiveness of such efforts,

and the reasons for such gaps.

(2) R

EPORT

.—Not later than 2 years after the date of enact-

ment of this Act, the Comptroller General shall submit to

the appropriate committees of the Congress a report containing

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

including—

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

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

including recommendations for such areas of research and

legislative and administrative action as the Comptroller

General determines appropriate.

SEC. 202. FIRST RESPONDER TRAINING.

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

290dd et seq.), as amended by section 110, is further amended

by adding at the end the following:

‘‘SEC. 546. FIRST RESPONDER TRAINING.

‘‘(a) P

ROGRAM

UTHORIZED

.—The Secretary shall make grants

to States, local governmental entities, and Indian tribes and tribal

42 USC 290ee–1.

Recommenda-

tions.

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-Determina-

tion and Education Assistance Act) to allow first responders and

members of other key community sectors to administer a drug

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

Cosmetic Act for emergency treatment of known or suspected opioid

overdose.

‘‘(b) A

PPLICATION

.—

‘‘(1) I

N 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) C

RITERIA

.—An entity, in submitting an application

under paragraph (1), shall—

‘‘(A) describe the evidence-based methodology and out-

come measurements that will be used to evaluate the pro-

gram funded with a grant under this section, and specifi-

cally explain how such measurements will provide valid

measures of the impact of the program;

‘‘(B) describe how the program could be broadly rep-

licated if demonstrated to be effective;

‘‘(C) identify the governmental and community agencies

with which the entity will coordinate to implement the

program; and

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

enforcement agencies will coordinate with their cor-

responding State substance abuse and mental health agen-

cies to identify protocols and resources that are available

to overdose victims and families, including information on

treatment and recovery resources.

‘‘(c) U

SE OF

UNDS

.—An entity shall use a grant received under

this section to—

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

the Federal Food, Drug, and Cosmetic Act for emergency treat-

ment of known or suspected opioid overdose available to be

carried and administered by first responders and members

of other key community sectors;

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

members of other key community sectors on carrying and

administering a drug or device approved or cleared under the

Federal Food, Drug, and Cosmetic Act for emergency treatment

of known or suspected opioid overdose; and

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

referral to appropriate treatment, which may include an out-

reach coordinator or team to connect individuals receiving

opioid overdose reversal drugs to followup services.

‘‘(d) T

ECHNICAL

SSISTANCE

RANTS

.—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) G

EOGRAPHIC

ISTRIBUTION

.—In making grants under this

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

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

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

in metropolitan statistical areas (as defined by the Office of Manage-

ment and Budget). The Secretary shall take into account the unique

needs of rural communities, including communities with an

incidence of individuals with opioid use disorder that is above

the national average and communities with a shortage of prevention

and treatment services.

‘‘(f) E

VALUATION

.—The Secretary shall conduct an evaluation

of grants made under this section to determine—

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

key community sectors equipped with a drug or device approved

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

for emergency treatment of known or suspected opioid overdose;

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

by first responders and members of other key community sec-

tors receiving training and supplies of a drug or device approved

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

for emergency treatment of known or suspected opioid overdose,

through a grant received under this section;

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

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

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

receive information about treatment services and available data

describing treatment admissions.

‘‘(g) A

UTHORIZATION OF

PPROPRIATIONS

.—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) D

EFINITION OF

OVERED

NTITY

.—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) P

ROGRAM

UTHORIZED

.—The Attorney General, in coordina-

tion with the Administrator of the Drug Enforcement Administra-

tion, the Secretary of Health and Human Services, and the Director

of the Office of National Drug Control Policy, shall coordinate

with covered entities in expanding or making available disposal

sites for unwanted prescription medications.

TITLE III—TREATMENT AND RECOVERY

SEC. 301. EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN

TREATMENT AND INTERVENTIONS DEMONSTRATION.

Subpart 1 of part B of title V of the Public Health Service

Act (42 U.S.C. 290bb et seq.) is amended by adding at the end

the following:

‘‘SEC. 514B. EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN

TREATMENT AND INTERVENTIONS DEMONSTRATION.

‘‘(a) G

RANTS

XPAND

CCESS

.—

42 USC

290bb–10.

Coordination.

21 USC 822a.

Determination.

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130 STAT. 718 PUBLIC LAW 114–198—JULY 22, 2016

‘‘(1) A

UTHORITY TO AWARD GRANTS

.—The Secretary shall

award grants, contracts, or cooperative agreements to State

substance abuse agencies, units of local government, nonprofit

organizations, and Indian tribes and tribal organizations (as

defined in section 4 of the Indian Self-Determination and Edu-

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

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

order to permit such entities to expand activities, including

an expansion in the availability of evidence-based medication-

assisted treatment and other clinically appropriate services,

with respect to the treatment of addiction in the specific geo-

graphical areas of such entities where there is a high rate

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

as in rural areas.

‘‘(2) N

ATURE OF ACTIVITIES

.—Funds awarded under para-

graph (1) shall be used for activities that are based on reliable

scientific evidence of efficacy in the treatment of problems

related to heroin or other opioids.

‘‘(b) A

PPLICATION

.—To be eligible for a grant, contract, or

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

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

and accompanied by such information as the Secretary may reason-

ably require.

‘‘(c) E

VALUATION

.—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) G

EOGRAPHIC

ISTRIBUTION

.—In awarding grants, contracts,

and cooperative agreements under this section, the Secretary shall

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

eligible entities that are not located in metropolitan statistical

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

Secretary shall take into account the unique needs of rural commu-

nities, including communities with an incidence of individuals with

opioid use disorder that is above the national average and commu-

nities with a shortage of prevention and treatment services.

‘‘(e) A

DDITIONAL

CTIVITIES

.—In administering grants, con-

tracts, and cooperative agreements under subsection (a), the Sec-

retary shall—

‘‘(1) evaluate the activities supported under such sub-

section;

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

evaluations as the Secretary considers appropriate;

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

and providers with technical assistance in connection with the

provision of treatment of problems related to heroin and other

opioids; and

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

recovery services as a critical component of the program

involved.

‘‘(f) A

UTHORIZATION OF

PPROPRIATIONS

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

SEC. 302. BUILDING COMMUNITIES OF RECOVERY.

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

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

by adding at the end the following:

‘‘SEC. 547. BUILDING COMMUNITIES OF RECOVERY.

‘‘(a) D

EFINITION

.—In this section, the term ‘recovery community

organization’ means an independent nonprofit organization that—

‘‘(1) mobilizes resources within and outside of the recovery

community to increase the prevalence and quality of long-

term recovery from substance use disorders; and

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

for substance use disorders who reflect the community served.

‘‘(b) G

RANTS

UTHORIZED

.—The Secretary shall award grants

to recovery community organizations to enable such organizations

to develop, expand, and enhance recovery services.

‘‘(c) F

EDERAL

HARE

.—The Federal share of the costs of a pro-

gram funded by a grant under this section may not exceed 50

percent.

‘‘(d) U

SE OF

UNDS

.—Grants awarded under subsection (b)—

‘‘(1) shall be used to develop, expand, and enhance commu-

nity and statewide recovery support services; and

‘‘(2) may be used to—

‘‘(A) build connections between recovery networks,

between recovery community organizations, and with other

recovery support services, including—

‘‘(i) behavioral health providers;

‘‘(ii) primary care providers and physicians;

‘‘(iii) the criminal justice system;

‘‘(iv) employers;

‘‘(v) housing services;

‘‘(vi) child welfare agencies; and

‘‘(vii) other recovery support services that facilitate

recovery from substance use disorders;

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

disorders; and

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

use disorders and recovery, including—

‘‘(i) identifying the signs of addiction;

‘‘(ii) the resources available to individuals strug-

gling with addiction and to families with a family

member struggling with, or being treated for, addiction,

including programs that mentor and provide support

services to children;

‘‘(iii) the resources available to help support

individuals in recovery; and

‘‘(iv) related medical outcomes of substance use

disorders, the potential of acquiring an infectious dis-

ease from intravenous drug use, and neonatal

abstinence syndrome among infants exposed to opioids

during pregnancy.

‘‘(e) A

UTHORIZATION OF

PPROPRIATIONS

.—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) I

ENERAL

.—

(1) I

N GENERAL

.—Section 303(g)(2) of the Controlled Sub-

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

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

and (iii) and inserting the following:

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

in subparagraph (G)).

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

will provide such drugs or combinations of drugs, the practi-

tioner has the capacity to provide directly, by referral, or in

such other manner as determined by the Secretary—

‘‘(I) all drugs approved by the Food and Drug Adminis-

tration for the treatment of opioid use disorder, including

for maintenance, detoxification, overdose reversal, and

relapse prevention; and

‘‘(II) appropriate counseling and other appropriate

ancillary services.

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

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

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

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

1 year after the date on which the practitioner submitted

the initial notification, the practitioner submits a second

notification to the Secretary of the need and intent of the

practitioner to treat up to 100 patients.

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

applicable number.

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

number patients to whom such drugs or combinations of drugs

are directly administered by the qualifying practitioner in the

office setting.’’;

(B) in subparagraph (D)—

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

notification under subparagraph (B)’’ and inserting

‘‘Upon receiving a determination from the Secretary

under clause (iii) finding that a practitioner meets

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

and

(ii) in clause (iii)—

(I) by inserting ‘‘and shall forward such deter-

mination to the Attorney General’’ before the

period at the end of the first sentence; and

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

‘‘practitioner’’;

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

‘‘(I) The physician holds a board certification

in addiction psychiatry or addiction medicine from

the American Board of Medical Specialties.’’;

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

‘‘(II) The physician holds an addiction certifi-

cation or board certification from the American

Society of Addiction Medicine or the American

Board of Addiction Medicine.’’;

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

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

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

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

and management of opiate-dependent patients, completed

not less than 8 hours of training (through classroom situa-

tions, seminars at professional society meetings, electronic

communications, or otherwise) that is provided by the

American Society of Addiction Medicine, the American

Academy of Addiction Psychiatry, the American Medical

Association, the American Osteopathic Association, the

American Psychiatric Association, or any other organization

that the Secretary determines is appropriate for purposes

of this subclause. Such training shall include—

‘‘(aa) opioid maintenance and detoxification;

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

by the Food and Drug Administration for the treatment

of opioid use disorder;

‘‘(cc) initial and periodic patient assessments

(including substance use monitoring);

‘‘(dd) individualized treatment planning, overdose

reversal, and relapse prevention;

‘‘(ee) counseling and recovery support services;

‘‘(ff) staffing roles and considerations;

‘‘(gg) diversion control; and

‘‘(hh) other best practices, as identified by the Sec-

retary.’’; and

(v) by adding at the end the following:

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

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

‘‘(II) during the period beginning on the date of enact-

ment of the Comprehensive Addiction and Recovery Act

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

practitioner, as defined in clause (iv).

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

practitioner or physician assistant who satisfies each of the

following:

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

licensed under State law to prescribe schedule III, IV,

or V medications for the treatment of pain.

‘‘(II) The nurse practitioner or physician assistant

has—

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

training addressing each of the topics listed in clause

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

professional society meetings, electronic communica-

tions, or otherwise) provided by the American Society

of Addiction Medicine, the American Academy of Addic-

tion Psychiatry, the American Medical Association, the

American Osteopathic Association, the American

Nurses Credentialing Center, the American Psychiatric

Association, the American Association of Nurse Practi-

tioners, the American Academy of Physician Assist-

ants, or any other organization that the Secretary

determines is appropriate for purposes of this sub-

clause; or

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

Secretary determines will demonstrate the ability of

Definition.

Time period.

Definition.

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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 opioid-

dependent patients in office-based settings. The Secretary shall

update such protocol in consultation with experts in opioid use

disorder research and treatment.’’.

(2) O

PIOID DEFINED

.—Section 102(18) of the Controlled Sub-

stances Act (21 U.S.C. 802(18)) is amended by inserting ‘‘or

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

(3) R

EPORTS TO CONGRESS

.—

(A) I

N GENERAL

.—Not later than 3 years after the

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

thereafter, the Secretary of Health and Human Services,

in consultation with the Drug Enforcement Administration

and experts in opioid use disorder research and treatment,

shall—

(i) perform a thorough review of the provision of

opioid use disorder treatment services in the United

States, including services provided in opioid treatment

programs and other specialty and nonspecialty set-

tings; and

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

and conclusions of such review.

(B) C

ONTENTS

.—Each report under subparagraph (A)

shall include an assessment of—

(i) compliance with the requirements of section

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

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

(ii) the measures taken by the Secretary of Health

and Human Services to ensure such compliance;

(iii) whether there is further need to increase or

decrease the number of patients a practitioner, pursu-

ant to a waiver under section 303(g)(2) of the Con-

trolled Substances Act (21 U.S.C. 823(g)(2)), is per-

mitted to treat;

(iv) the extent to which, and proportions with

which, the full range of Food and Drug Administration-

approved treatments for opioid use disorder are used

Assessment.

Consultation.

21 USC 823 note.

Consultation.

Deadline.

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

in routine health care settings and specialty substance

use disorder treatment settings;

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

support services, including the percentage of patients

receiving such services;

(vi) changes in State or local policies and legisla-

tion relating to opioid use disorder treatment;

(vii) the use of prescription drug monitoring pro-

grams by practitioners who are permitted to dispense

narcotic drugs to individuals pursuant to a waiver

described in clause (iii);

(viii) the findings resulting from inspections by

the Drug Enforcement Administration of practitioners

described in clause (vii); and

(ix) the effectiveness of cross-agency collaboration

between Department of Health and Human Services

and the Drug Enforcement Administration for

expanding effective opioid use disorder treatment.

(b) S

TATE

LEXIBILITY

.—Section 303(g)(2) of the Controlled Sub-

stances Act (21 U.S.C. 823(g)(2)) is amended by striking subpara-

graphs (I) and (J), and inserting the following:

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

shall be construed to preempt any State law that—

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

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

for maintenance or detoxification treatment in accordance with

this paragraph to a total number of patients that is more

than 30 or less than the total number applicable to the quali-

fying practitioner under subparagraph (B)(iii)(II) if a State

enacts a law modifying such total number and the Attorney

General is notified by the State of such modification; or

‘‘(ii) requires a qualifying practitioner to comply with addi-

tional requirements relating to the dispensing of narcotic drugs

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

including requirements relating to the practice setting in which

the qualifying practitioner practices and education, training,

and reporting requirements.’’.

PDATE

EGULATIONS

.—Not later than 18 months after

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

Secretary of Health and Human Services, as appropriate, shall

update regulations regarding practitioners described in subsection

(a)(3)(B)(vii) (as amended by this section) to include nurse practi-

tioners and physician assistants to ensure the quality of patient

care and prevent diversion.

TITLE IV—ADDRESSING COLLATERAL

CONSEQUENCES

SEC. 401. GAO REPORT ON RECOVERY AND COLLATERAL CON-

SEQUENCES.

(a) R

EPORT

EQUIRED

.—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 partici-

pating in or have completed a recovery program for a substance

use disorder;

(3) discusses policy bases and justifications for imposing

collateral consequences on individuals convicted of nonviolent

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

(4) provides perspectives on the potential for mitigating

the effect of the collateral consequences described in paragraph

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

a recovery program, while also taking into account the policy

interests described in paragraph (3).

(b) D

EFINITION

.—In this section, the term ‘‘collateral con-

sequence’’—

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

upon an individual as a result of a criminal conviction for

a drug-related offense—

(A) automatically by operation of law; or

(B) by authorized action of an administrative agency

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

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

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

of imprisonment or community supervision, or a fine.

TITLE V—ADDICTION AND TREATMENT

SERVICES FOR WOMEN, FAMILIES,

AND VETERANS

SEC. 501. IMPROVING TREATMENT FOR PREGNANT AND POSTPARTUM

WOMEN.

(a) G

ENERAL

MENDMENTS TO THE

ESIDENTIAL

REATMENT

ROGRAM FOR

REGNANT AND

OSTPARTUM

OMEN

.—Section 508

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

(1) in subsection (a)—

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

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

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

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

and inserting ‘‘grants, including the grants under sub-

section (r), cooperative agreements’’; and

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

‘‘for substance use disorders’’; and

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

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

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

before the period at the end;

(3) in subsection (c)—

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

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

her children’’; and

(B) in paragraph (2)—

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

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

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

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

and inserting ‘‘such a disorder’’;

(4) in subsection (d)—

(A) in paragraph (3)(A), by striking ‘‘maternal sub-

stance abuse’’ and inserting ‘‘a maternal substance use

disorder’’;

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

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

children during the periods in which the woman is engaged

in therapy or in other necessary health and rehabilitative activi-

ties.’’;

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

‘‘woman’’;

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

‘‘unit’’; and

(E) in paragraph (11)—

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

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

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

inserting a semicolon;

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

and inserting ‘‘; and’’; and

(iv) by adding at the end the following:

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

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

(5) in subsection (e)—

(A) in paragraph (1)—

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

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

use disorders’’; and

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

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

(B) in paragraph (2)—

(i) by striking ‘‘(A) Subject’’ and inserting the fol-

lowing:

‘‘(A) I

N GENERAL

.—Subject’’;

(ii) in subparagraph (B)—

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

the following:

‘‘(B) W

AIVER OF PARTICIPATION AGREEMENTS

.—

‘‘(i) I

N GENERAL

.—In the case’’; and

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

inserting the following:

‘‘(ii) D

ONATIONS

.—A determination’’; and

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

the following:

‘‘(C) N

ONAPPLICATION OF CERTAIN REQUIREMENTS

.—

With respect’’;

(6) in subsection (g)—

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

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

(B) by striking ‘‘such abuse’’ and inserting ‘‘such dis-

order’’;

(7) in subsection (j)—

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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) A

LLOCATION OF

WARDS

.—In making awards under sub-

section (a), the Director shall give priority to an applicant that

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

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

as a health professional shortage area, or an area determined

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

disorder treatment options.’’; and

(9) in subsection (q)—

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

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

and

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

and inserting ‘‘a substance use disorder’’.

(b) R

EAUTHORIZATION OF

ROGRAM

.—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’’.

ILOT

ROGRAM

RANTS FOR

TATE

UBSTANCE

BUSE

GENCIES

.—

(1) I

N 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) P

ILOT

ROGRAM FOR

TATE

UBSTANCE

BUSE

GENCIES

.—

‘‘(1) I

N GENERAL

.—From amounts made available under

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

Treatment shall carry out a pilot program under which competi-

tive grants are made by the Director to State substance abuse

agencies—

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

to support family-based services for pregnant and

postpartum women with a primary diagnosis of a substance

use disorder, including opioid use disorders;

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

identified gaps in services furnished to such women along

the continuum of care, including services provided to

women in nonresidential-based settings; and

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

State system managed by State substance abuse agencies

by encouraging new approaches and models of service

delivery.

‘‘(2) R

EQUIREMENTS

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

and containing such information as specified by the

Director, to be eligible to receive a grant under the pro-

gram;

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

State substance abuse agencies that are eligible for such

grants;

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

such a grant to support family-based treatment and other

services for pregnant and postpartum women with a pri-

mary diagnosis of a substance use disorder, including opioid

use disorders;

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

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

‘‘(E) not require that grant recipients under the pro-

gram make available through use of the grant all the

services described in subsection (d); and

‘‘(F) consider not applying the requirements described

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

depending on the circumstances of the applicant.

‘‘(3) R

EQUIRED SERVICES

.—

‘‘(A) I

N GENERAL

.—The Director shall specify a min-

imum set of services required to be made available to

eligible women through a grant awarded under the pilot

program under this subsection. Such minimum set of serv-

ices—

‘‘(i) shall include the services requirements

described in subsection (c) and be based on the rec-

ommendations submitted under subparagraph (B); and

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

described in subsection (d) and include other services

as appropriate.

‘‘(B) S

TAKEHOLDER INPUT

.—The Director shall convene

and solicit recommendations from stakeholders, including

State substance abuse agencies, health care providers, per-

sons in recovery from substance abuse, and other appro-

priate individuals, for the minimum set of services

described in subparagraph (A).

‘‘(4) D

URATION

.—The pilot program under this subsection

shall not exceed 5 years.

‘‘(5) E

VALUATION AND REPORT TO CONGRESS

.—

‘‘(A) I

N 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) R

EPORT

.—The Director of the Center for Behav-

ioral Health Statistics and Quality, in coordination with

the Director of the Center for Substance Abuse Treatment

shall submit to the relevant committees of jurisdiction of

the House of Representatives and the Senate a report

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

include, at a minimum—

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

including any resulting reductions in the use of alcohol

and other drugs;

‘‘(ii) engagement in treatment services;

‘‘(iii) retention in the appropriate level and dura-

tion of services;

Coordination.

Recommenda-

tions.

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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 combina-

tion with counseling; and

‘‘(v) other appropriate measures.

‘‘(C) R

ECOMMENDATION

.—The report under subpara-

graph (B) shall include a recommendation by the Director

of the Center for Substance Abuse Treatment as to whether

the pilot program under this subsection should be extended.

‘‘(6) S

TATE SUBSTANCE ABUSE AGENCIES DEFINED

.—For pur-

poses of this subsection, the term ‘State substance abuse agency’

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

manages the Substance Abuse Prevention and Treatment Block

Grant under part B of title XIX.’’.

(2) F

UNDING

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

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

section (a) and redesignated by paragraph (1), is further

amended by adding at the end the following new sentences:

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

previous sentence to carry out this section, not more than

25 percent of such amounts shall be made available for such

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

such subsection. Notwithstanding the preceding sentence, no

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

a fiscal year unless the amount made available to carry out

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

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

SEC. 502. VETERANS TREATMENT COURTS.

Section 2991 of the Omnibus Crime Control and Safe Streets

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

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

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

‘‘(i) A

SSISTING

ETERANS

.—

‘‘(1) D

EFINITIONS

.—In this subsection:

‘‘(A) P

EER

PEER SERVICES OR PROGRAMS

.—The term

‘peer-to-peer services or programs’ means services or pro-

grams that connect qualified veterans with other veterans

for the purpose of providing support and mentorship to

assist qualified veterans in obtaining treatment, recovery,

stabilization, or rehabilitation.

‘‘(B) Q

UALIFIED 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) V

ETERANS TREATMENT COURT PROGRAM

.—The term

‘veterans treatment court program’ means a court program

involving collaboration among criminal justice, veterans,

and mental health and substance abuse agencies that pro-

vides qualified veterans with—

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

‘‘(i) intensive judicial supervision and case manage-

ment, which may include random and frequent drug

testing where appropriate;

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

including mental health services, substance abuse serv-

ices, medical services, and services to address trauma;

‘‘(iii) alternatives to incarceration; or

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

transportation, mentoring, employment, job training,

education, or assistance in applying for and obtaining

available benefits.

‘‘(2) V

ETERANS ASSISTANCE PROGRAM

.—

‘‘(A) I

N GENERAL

.—The Attorney General, in consulta-

tion with the Secretary of Veterans Affairs, may award

grants under this subsection to applicants to establish or

expand—

‘‘(i) veterans treatment court programs;

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

veterans;

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

rehabilitation, legal, transitional, and other appro-

priate services to qualified veterans who have been

incarcerated; or

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

law enforcement, corrections, mental health, and sub-

stance abuse personnel how to identify and appro-

priately respond to incidents involving qualified vet-

erans.

‘‘(B) P

RIORITY

.—In awarding grants under this sub-

section, the Attorney General shall give priority to applica-

tions that—

‘‘(i) demonstrate collaboration between and joint

investments by criminal justice, mental health, sub-

stance abuse, and veterans service agencies;

‘‘(ii) promote effective strategies to identify and

reduce the risk of harm to qualified veterans and public

safety; and

‘‘(iii) propose interventions with empirical support

to improve outcomes for qualified veterans.’’.

SEC. 503. INFANT PLAN OF SAFE CARE.

(a) B

EST

RACTICES FOR

EVELOPMENT OF

LANS OF

AFE

ARE

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

Act (42 U.S.C. 5104(b)) is amended—

(1) by redesignating paragraphs (5) through (8) as para-

graphs (6) through (9), respectively; and

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

‘‘(5) maintain and disseminate information about the

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

relating to the development of plans of safe care as described

in such section for infants born and identified as being affected

by substance abuse or withdrawal symptoms, or a Fetal Alcohol

Spectrum Disorder;’’.

(b) S

TATE

LANS

.—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 pro-

viders, including through—

‘‘(I) addressing the health and substance use dis-

order treatment needs of the infant and affected family

or caregiver; and

‘‘(II) the development and implementation by the

State of monitoring systems regarding the implementa-

tion of such plans to determine whether and in what

manner local entities are providing, in accordance with

State requirements, referrals to and delivery of appro-

priate services for the infant and affected family or

caregiver’’.

ATA

EPORTS

.—

(1) I

N GENERAL

.—Section 106(d) of the Child Abuse Preven-

tion and Treatment Act (42 U.S.C. 5106a(d)) is amended by

adding at the end of the following:

‘‘(17) The number of infants—

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

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

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

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

services, including services for the affected family or care-

giver, under subsection (b)(2)(B)(iii).’’.

(2) R

EDESIGNATION

.—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) M

ONITORING AND

VERSIGHT

.—

(1) A

MENDMENT

.—Title I of the Child Abuse Prevention

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

adding at the end the following:

‘‘SEC. 114. MONITORING AND OVERSIGHT.

‘‘The Secretary shall conduct monitoring to ensure that each

State that receives a grant under section 106 is in compliance

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

‘‘(1) shall—

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

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

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

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

and

‘‘(2) may include—

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

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

the State plan most recently approved under section 432

of the Social Security Act;

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

of the State relating to its compliance with the require-

ments of section 106(b);

42 USC 5108.

Effective date.

42 USC 5106a

note.

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

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

monitoring; and

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

Annual Progress and Services Report most recently sub-

mitted under section 1357.16 of title 45, Code of Federal

Regulations (or successor regulations).’’.

(2) T

ABLE 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) R

ULE OF

ONSTRUCTION

.—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) I

ENERAL

.—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) I

NFORMATION

NCLUDED IN

EPORT

.—Such report

shall include information on the following:

(1) The prevalence of NAS in the United States, including

the proportion of children born in the United States with NAS

who are eligible for medical assistance under State Medicaid

programs under title XIX of the Social Security Act (42 U.S.C.

1396 et seq.) at birth, and the costs associated with coverage

under such programs for treatment of infants with NAS.

(2) The services for which coverage is available under State

Medicaid programs for treatment of infants with NAS.

(3) The settings (including inpatient, outpatient, hospital-

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

NAS and the reimbursement methodologies and costs associated

with such treatment in such settings.

(4) The prevalence of utilization of various care settings

under State Medicaid programs for treatment of infants with

NAS and any Federal barriers to treating such infants under

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

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

with NAS.

ECOMMENDATIONS

.—Such report also shall include such

recommendations as the Comptroller General determines appro-

priate for improvements that will ensure access to treatment for

infants with NAS under State Medicaid programs.

42 USC 5106a

note.

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

TITLE VI—INCENTIVIZING STATE COM-

PREHENSIVE INITIATIVES TO AD-

DRESS PRESCRIPTION OPIOID ABUSE

SEC. 601. STATE DEMONSTRATION GRANTS FOR COMPREHENSIVE

OPIOID ABUSE RESPONSE.

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

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

by adding at the end the following:

‘‘SEC. 548. STATE DEMONSTRATION GRANTS FOR COMPREHENSIVE

OPIOID ABUSE RESPONSE.

‘‘(a) D

EFINITIONS

.—In this section:

‘‘(1) D

ISPENSER

.—The term ‘dispenser’ has the meaning

given the term in section 102 of the Controlled Substances

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

‘‘(2) P

RESCRIBER

.—The term ‘prescriber’ means a dispenser

who prescribes a controlled substance, or the agent of such

a dispenser.

‘‘(3) P

RESCRIBER OF A SCHEDULE II

III

OR IV CONTROLLED

SUBSTANCE

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

controlled substance’ does not include a prescriber of a schedule

II, III, or IV controlled substance that dispenses the sub-

stance—

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

is dispensed;

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

is in short supply;

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

‘‘(D) in other situations as the Secretary may reason-

ably determine.

‘‘(4) S

CHEDULE 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) G

RANTS FOR

OMPREHENSIVE

PIOID

BUSE

ESPONSE

.—

‘‘(1) I

N GENERAL

.—The Secretary shall award grants to

States, and combinations of States, to implement an integrated

opioid abuse response initiative.

‘‘(2) P

URPOSES

.—A State receiving a grant under this sec-

tion shall establish a comprehensive response plan to opioid

abuse, which may include—

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

and addiction recovery, including education of residents,

medical students, and physicians and other prescribers of

schedule II, III, or IV controlled substances on relevant

prescribing guidelines, the prescription drug monitoring

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

overdose prevention methods;

‘‘(B) establishing, maintaining, or improving a com-

prehensive prescription drug monitoring program to track

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

which may—

Response plan.

42 USC 290ee–3.

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

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

and

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

to write prescriptions for schedule II, III, or IV con-

trolled substances to access the prescription drug moni-

toring program of the State;

‘‘(C) developing, implementing, or expanding prescrip-

tion drug and opioid addiction treatment programs by—

‘‘(i) expanding the availability of treatment for

prescription drug and opioid addiction, including medi-

cation-assisted treatment and behavioral health

therapy, as appropriate;

‘‘(ii) developing, implementing, or expanding

screening for individuals in treatment for prescription

drug and opioid addiction for hepatitis C and HIV,

and treating or referring those individuals if clinically

appropriate; or

‘‘(iii) developing, implementing, or expanding

recovery support services and programs at high schools

or institutions of higher education;

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

to prevent overdose death from opioid abuse or addiction

to prescription medications and opioids; and

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

public, providers, patients, consumers, and other appro-

priate entities regarding the dangers of opioid abuse, safe

disposal of prescription medications, and detection of early

warning signs of opioid use disorders.

‘‘(3) A

PPLICATION

.—A State seeking a grant under this sec-

tion shall submit to the Secretary an application in such form,

and containing such information, as the Secretary may reason-

ably require.

‘‘(4) U

SE 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) P

RIORITY CONSIDERATIONS

.—In awarding grants under

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

to a State that—

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

responders, health professionals, and family members who

have received appropriate training in administering a drug

or device approved or cleared under the Federal Food,

Drug, and Cosmetic Act for emergency treatment of known

or suspected opioid overdose; and

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

attorney general of the State that the attorney general

has—

‘‘(I) reviewed any applicable civil liability protec-

tion law to determine the applicability of the law with

respect to first responders, health care professionals,

family members, and other individuals who—

‘‘(aa) have received appropriate training in

administering a drug or device approved or cleared

under the Federal Food, Drug, and Cosmetic Act

Certification.

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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 bene-

fits necessary by criminal justice agencies to initiate or

continue treatment in the community, under which an

individual who is incarcerated may, while incarcerated,

enroll in services and benefits that are necessary for the

individual to continue treatment upon release from incar-

ceration;

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

States, where applicable, such as by making data available

to a prescription monitoring hub;

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

drug monitoring program database of the State are regu-

larly updated, to the extent possible;

‘‘(E) ensures that the prescription drug monitoring pro-

gram of the State notifies prescribers and dispensers of

schedule II, III, or IV controlled substances when overuse

or misuse of such controlled substances by patients is sus-

pected; and

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

policies that maximize use of prescription drug monitoring

programs by individuals authorized by the State to pre-

scribe schedule II, III, or IV controlled substances.

‘‘(6) E

VALUATION

.—In conducting an evaluation of the pro-

gram under this section pursuant to section 701 of the Com-

prehensive Addiction and Recovery Act of 2016, with respect

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

policies related to maximizing the use of prescription drug

monitoring programs and the incidence of opioid use disorders

and overdose deaths in such State.

‘‘(7) S

TATES WITH LOCAL PRESCRIPTION DRUG MONITORING

PROGRAMS

.—

‘‘(A) I

N 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) P

LAN FOR INTEROPERABILITY

.—In submitting an

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

or other unit of local government shall submit a plan

outlining the methods such county or unit of local govern-

ment shall use to ensure the capability of data sharing

with other counties and units of local government within

the state and with other States, as applicable.

‘‘(c) A

UTHORIZATION OF

UNDING

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

TITLE VII—MISCELLANEOUS

SEC. 701. GRANT ACCOUNTABILITY AND EVALUATIONS.

(a) D

EPARTMENT OF

USTICE

RANT

CCOUNTABILITY

.—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) D

EFINITION OF

PPLICABLE

OMMITTEES

.—In this section,

the term ‘applicable committees’ means—

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

‘‘(2) the Committee on the Judiciary of the House of Rep-

resentatives.

‘‘(b) A

CCOUNTABILITY

.—All grants awarded by the Attorney

General under this part shall be subject to the following account-

ability provisions:

‘‘(1) A

UDIT REQUIREMENT

.—

‘‘(A) D

EFINITION

.—In this paragraph, the term ‘unre-

solved audit finding’ means a finding in the final audit

report of the Inspector General of the Department of Justice

that the audited grantee has utilized grant funds for an

unauthorized expenditure or otherwise unallowable cost

that is not closed or resolved within 12 months after the

date on which the final audit report is issued.

‘‘(B) A

UDIT

.—Beginning in the first fiscal year begin-

ning after the date of enactment of this section, and in

each fiscal year thereafter, the Inspector General of the

Department of Justice shall conduct audits of recipients

of grants awarded by the Attorney General under this

part to prevent waste, fraud, and abuse of funds by

grantees. The Inspector General shall determine the appro-

priate number of grantees to be audited each year.

‘‘(C) M

ANDATORY EXCLUSION

.—A recipient of grant

funds under this part that is found to have an unresolved

audit finding shall not be eligible to receive grant funds

under this part during the first 2 fiscal years beginning

after the end of the 12-month period described in subpara-

graph (A).

‘‘(D) P

RIORITY

.—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) R

EIMBURSEMENT

.—If an entity is awarded grant

funds under this part during the 2-fiscal-year period during

which the entity is barred from receiving grants under

subparagraph (C), the Attorney General shall—

‘‘(i) deposit an amount equal to the amount of

the grant funds that were improperly awarded to the

grantee into the General Fund of the Treasury; and

‘‘(ii) seek to recoup the costs of the repayment

to the fund from the grant recipient that was erro-

neously awarded grant funds.

‘‘(2) N

ONPROFIT 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) D

EFINITION

.—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) P

ROHIBITION

.—A nonprofit organization that holds

money in offshore accounts for the purpose of avoiding

paying the tax described in section 511(a) of the Internal

Revenue Code of 1986 may not—

‘‘(i) be party to a contract entered into under sec-

tion 3021(b); or

‘‘(ii) receive a subaward under section 3021(b).

‘‘(C) D

ISCLOSURE

.—Each nonprofit organization that

receives a subaward or is party to a contract entered into

under section 3021(b) and uses the procedures prescribed

in regulations to create a rebuttable presumption of reason-

ableness for the compensation of its officers, directors,

trustees, and key employees, shall disclose, in the applica-

tion for such contract or subaward, the process for deter-

mining such compensation, including the independent per-

sons involved in reviewing and approving such compensa-

tion, the comparability data used, and contemporaneous

substantiation of the deliberation and decision. Upon

request, the Attorney General shall make the information

disclosed under this subparagraph available for public

inspection.

‘‘(3) C

ONFERENCE EXPENDITURES

.—

‘‘(A) L

IMITATION

.—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) W

RITTEN AUTHORIZATION

.—Written authorization

under subparagraph (A) shall include a written estimate

of all costs associated with the conference, including the

cost of all food, beverages, audio-visual equipment, hono-

raria for speakers, and entertainment.

‘‘(C) R

EPORT

.—The Deputy Attorney General shall

submit to the applicable committees an annual report on

all conference expenditures approved by the Attorney Gen-

eral under this paragraph.

‘‘(4) A

NNUAL 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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130 STAT. 737 PUBLIC LAW 114–198—JULY 22, 2016

‘‘(ii) all mandatory exclusions required under para-

graph (1)(C) have been issued; and

‘‘(iii) all reimbursements required under paragraph

(1)(E) have been made; and

‘‘(B) that includes a list of any grant recipients excluded

under paragraph (1) from the previous year.

‘‘(c) P

REVENTING

UPLICATIVE

RANTS

.—

‘‘(1) I

N 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) R

EPORT

.—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) E

VALUATION OF

ERFORMANCE OF

EPARTMENT OF

USTICE

ROGRAMS

.—

(1) E

VALUATION OF JUSTICE DEPARTMENT COMPREHENSIVE

OPIOID ABUSE GRANT PROGRAM

.—Not later than 5 years after

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

complete an evaluation of the effectiveness of the Comprehen-

sive Opioid Abuse Grant Program under part LL of title I

of the Omnibus Crime Control and Safe Streets Act of 1968,

as added by section 201, administered by the Department of

Justice based upon the information reported under paragraph

(4).

(2) I

NTERIM 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) M

ETRICS AND OUTCOMES FOR EVALUATION

.—Not later

than 180 days after the date of enactment of this Act, the

Attorney General shall identify outcomes that are to be

achieved by activities funded by the Comprehensive Opioid

Abuse Grant Program and the metrics by which the achieve-

ment of such outcomes shall be determined.

(4) M

ETRICS 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) P

UBLICATION OF DATA AND FINDINGS

.—

(A) P

UBLICATION OF OUTCOMES AND METRICS

.—The

Attorney General shall, not later than 30 days after comple-

tion of the requirement under paragraph (3), publish the

outcomes and metrics identified under that paragraph.

(B) P

UBLICATION OF EVALUATION

.—In the case of the

interim evaluation under paragraph (2), and the final

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 evalua-

tion and issue a report on such evaluation to the Committee

on the Judiciary of the House of Representatives and the

Committee on the Judiciary of the Senate. Such report

shall also be published along with the data used to make

such evaluation.

(6) I

NDEPENDENT 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.

EPARTMENT OF

EALTH AND

UMAN

ERVICES

RANT

CCOUNTABILITY

.—

(1) D

EFINITIONS

.—In this subsection:

(A) A

PPLICABLE 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) C

OVERED GRANT

.—The term ‘‘covered grant’’ means

a grant awarded by the Secretary under a program estab-

lished under this Act (or an amendment made by this

Act, other than sections 703 through 707), including any

grant administered by the Administrator of the Substance

Abuse and Mental Health Services Administration under

section 103.

RANTEE

.—The term ‘‘grantee’’ means the recipient

of a covered grant.

(D) S

ECRETARY

.—The term ‘‘Secretary’’ means the Sec-

retary of Health and Human Services.

(2) A

CCOUNTABILITY MEASURES

.—Each covered grant shall

be subject to the following accountability requirements:

(A) E

FFECTIVENESS REPORT

.—The Secretary shall

require grantees to report on the effectiveness of the activi-

ties carried out with amounts made available to carry

out the program under which the covered grant is awarded,

including the number of persons served by such grant,

if applicable, the number of persons seeking services who

could not be served by such grant, and such other informa-

tion as the Secretary may prescribe.

(B) R

EPORT ON PREVENTION OF FRAUD

WASTE

AND

ABUSE

.—

(i) I

N GENERAL

.—Not later than 1 year after the

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

coordination with the Inspector General of the Depart-

ment of Health and Human Services, shall submit

to the applicable committees a report on the policies

and procedures the Department has in place to prevent

waste, fraud, and abuse in the administration of cov-

ered grants.

Coordination.

42 USC

290aa–15.

Contracts.

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130 STAT. 739 PUBLIC LAW 114–198—JULY 22, 2016

(ii) C

ONTENTS

.—The policies and procedures

referred to in clause (i) shall include policies and proce-

dures that are designed to—

(I) prevent grantees from utilizing funds

awarded through a covered grant for unauthorized

expenditures or otherwise unallowable costs; and

(II) ensure grantees will not receive

unwarranted duplicate grants for the same pur-

pose.

ONFERENCE EXPENDITURES

.—

(i) I

N GENERAL

.—No amounts made available to

the Secretary under this Act (or in a provision of

law amended by this Act, other than sections 703

through 707) may be used by the Secretary, or by

any individual or entity awarded discretionary funds

through a cooperative agreement under a program

established under this Act (or in a provision of law

amended by this Act), to host or support any expendi-

ture for conferences that uses more than $20,000 in

funds made available by the Secretary, unless the head

of the relevant operating division or program office

provides prior written authorization that the funds

may be expended to host or support the conference.

Such written authorization shall include a written esti-

mate of all costs associated with the conference,

including the cost of all food, beverages, audio-visual

equipment, honoraria for speakers, and entertainment.

(ii) R

EPORT

.—The Secretary (or the Secretary’s des-

ignee) shall submit to the applicable committees an

annual report on all conference expenditures approved

by the Secretary under this subparagraph.

(d) E

VALUATION OF

ERFORMANCE OF

EPARTMENT OF

EALTH

AND

UMAN

ERVICES

ROGRAMS

.—

(1) E

VALUATIONS

.—

(A) I

N GENERAL

.—Not later than 5 years after the

date of enactment of this Act, except as otherwise provided

in this section, the Secretary of Health and Human Services

(in this subsection referred to as the ‘‘Secretary’’) shall

complete an evaluation of any program administered by

the Secretary included in this Act (or an amendment made

by this Act, excluding sections 703 through 707), including

any grant administered by the Administrator of the Sub-

stance Abuse and Mental Health Services Administration

under section 103, that provides grants for the primary

purpose of providing assistance in addressing problems

pertaining to opioid abuse based upon the outcomes and

metrics identified under paragraph (2).

(B) P

UBLICATION

.—With respect to each evaluation

completed under subparagraph (A), the Secretary shall,

not later than 90 days after the date on which such evalua-

tion is completed, publish the results of such evaluation

and issue a report on such evaluation to the appropriate

committees. Such report shall also be published along with

the data used to make such evaluation.

(2) M

ETRICS AND OUTCOMES

.—

(A) I

N 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) P

UBLICATION

.—The Secretary shall, not later than

30 days after completion of the requirement under subpara-

graph (A), publish the outcomes and metrics identified

under such subparagraph.

(3) M

ETRICS 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) I

NDEPENDENT EVALUATION

.—For purposes of paragraph

(1), the Secretary shall—

(A) enter into an arrangement with the National

Academy of Sciences; or

(B) enter into a contract or cooperative agreement with

an entity that—

(i) is not an agency of the Federal Government;

and

(ii) is qualified to conduct and evaluate research

pertaining to opioid use and abuse and draw conclu-

sions about overall opioid use and abuse on the basis

of that research.

(5) E

XCEPTION

.—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) A

DDITIONAL

EPORT

.—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) N

DDITIONAL

UNDS

UTHORIZED

.—No additional funds

are authorized to be appropriated to carry out this section.

SEC. 702. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES.

(a) I

ENERAL

.—Section 309 of the Controlled Substances

Act (21 U.S.C. 829) is amended by adding at the end the following:

‘‘(f) P

ARTIAL

ILLS OF

CHEDULE

II C

ONTROLLED

UBSTANCES

.—

‘‘(1) P

ARTIAL FILLS

.—A prescription for a controlled sub-

stance in schedule II may be partially filled if—

‘‘(A) it is not prohibited by State law;

‘‘(B) the prescription is written and filled in accordance

with this title, regulations prescribed by the Attorney Gen-

eral, and State law;

‘‘(C) the partial fill is requested by the patient or

the practitioner that wrote the prescription; and

‘‘(D) the total quantity dispensed in all partial fillings

does not exceed the total quantity prescribed.

‘‘(2) R

EMAINING PORTIONS

.—

42 USC

290aa–15 note.

Contracts.

Reports.

Determination.

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130 STAT. 741 PUBLIC LAW 114–198—JULY 22, 2016

‘‘(A) I

N 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) E

MERGENCY SITUATIONS

.—In emergency situa-

tions, as described in subsection (a), the remaining portions

of a partially filled prescription for a controlled substance

in schedule II—

‘‘(i) may be filled; and

‘‘(ii) shall be filled not later than 72 hours after

the prescription is issued.

‘‘(3) C

URRENTLY LAWFUL PARTIAL FILLS

.—Notwithstanding

paragraph (1) or (2), in any circumstance in which, as of the

day before the date of enactment of this subsection, a prescrip-

tion for a controlled substance in schedule II may be lawfully

partially filled, the Attorney General may allow such a prescrip-

tion to be partially filled.’’.

(b) R

ULE OF

ONSTRUCTION

.—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) F

INDING

.—The Congress finds that the executive branch,

including the Office of National Drug Control Policy, has a policy

focus on preventing and addressing prescription drug misuse and

heroin use, and has worked with States and municipalities to enact

Good Samaritan laws that would protect caregivers, law enforce-

ment personnel, and first responders who administer opioid over-

dose reversal drugs or devices.

(b) GAO S

TUDY ON

OOD

AMARITAN

AWS

ERTAINING TO

REATMENT OF

PIOID

VERDOSES

.—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.

EFINITIONS

.—In this section—

(1) the term ‘‘Good Samaritan law’’ means a law of a

State or unit of local government that exempts from criminal

or civil liability any individual who administers an opioid over-

dose reversal drug or device, or who contacts emergency services

providers in response to an overdose; and

(2) the term ‘‘opioid’’ means any drug, including heroin,

having an addiction-forming or addiction-sustaining liability

Reports.

21 USC 829 note.

Deadline.

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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) D

RUG

ANAGEMENT

ROGRAM FOR

-R

ISK

ENE

FICIARIES

.—

(1) I

N 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) D

RUG MANAGEMENT PROGRAM FOR AT

RISK BENE

FICIARIES

.—

‘‘(A) A

UTHORITY TO ESTABLISH

.—A PDP sponsor may

establish a drug management program for at-risk bene-

ficiaries under which, subject to subparagraph (B), the

PDP sponsor may, in the case of an at-risk beneficiary

for prescription drug abuse who is an enrollee in a prescrip-

tion drug plan of such PDP sponsor, limit such beneficiary’s

access to coverage for frequently abused drugs under such

plan to frequently abused drugs that are prescribed for

such beneficiary by one or more prescribers selected under

subparagraph (D), and dispensed for such beneficiary by

one or more pharmacies selected under such subparagraph.

‘‘(B) R

EQUIREMENT FOR NOTICES

.—

‘‘(i) I

N GENERAL

.—A PDP sponsor may not limit

the access of an at-risk beneficiary for prescription

drug abuse to coverage for frequently abused drugs

under a prescription drug plan until such sponsor—

‘‘(I) provides to the beneficiary an initial notice

described in clause (ii) and a second notice

described in clause (iii); and

‘‘(II) verifies with the providers of the bene-

ficiary that the beneficiary is an at-risk beneficiary

for prescription drug abuse.

‘‘(ii) I

NITIAL NOTICE

.—An initial notice described

in this clause is a notice that provides to the bene-

ficiary—

‘‘(I) notice that the PDP sponsor has identified

the beneficiary as potentially being an at-risk

beneficiary for prescription drug abuse;

‘‘(II) information describing all State and Fed-

eral public health resources that are designed to

address prescription drug abuse to which the bene-

ficiary has access, including mental health services

and other counseling services;

‘‘(III) notice of, and information about, the

right of the beneficiary to appeal such identifica-

tion under subsection (h) and the option of an

automatic escalation to external review;

‘‘(IV) a request for the beneficiary to submit

to the PDP sponsor preferences for which pre-

scribers and pharmacies the beneficiary would

prefer the PDP sponsor to select under subpara-

graph (D) in the case that the beneficiary is identi-

fied as an at-risk beneficiary for prescription drug

abuse as described in clause (iii)(I);

Verification.

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130 STAT. 743 PUBLIC LAW 114–198—JULY 22, 2016

‘‘(V) an explanation of the meaning and con-

sequences of the identification of the beneficiary

as potentially being an at-risk beneficiary for

prescription drug abuse, including an explanation

of the drug management program established by

the PDP sponsor pursuant to subparagraph (A);

‘‘(VI) clear instructions that explain how the

beneficiary can contact the PDP sponsor in order

to submit to the PDP sponsor the preferences

described in subclause (IV) and any other commu-

nications relating to the drug management pro-

gram for at-risk beneficiaries established by the

PDP sponsor; and

‘‘(VII) contact information for other organiza-

tions that can provide the beneficiary with assist-

ance regarding such drug management program

(similar to the information provided by the Sec-

retary in other standardized notices provided to

part D eligible individuals enrolled in prescription

drug plans under this part).

‘‘(iii) S

ECOND NOTICE

.—A second notice described

in this clause is a notice that provides to the beneficiary

notice—

‘‘(I) that the PDP sponsor has identified the

beneficiary as an at-risk beneficiary for prescrip-

tion drug abuse;

‘‘(II) that such beneficiary is subject to the

requirements of the drug management program

for at-risk beneficiaries established by such PDP

sponsor for such plan;

‘‘(III) of the prescriber (or prescribers) and

pharmacy (or pharmacies) selected for such indi-

vidual under subparagraph (D);

‘‘(IV) of, and information about, the bene-

ficiary’s right to appeal such identification under

subsection (h) and the option of an automatic esca-

lation to external review;

‘‘(V) that the beneficiary can, in the case that

the beneficiary has not previously submitted to

the PDP sponsor preferences for which prescribers

and pharmacies the beneficiary would prefer the

PDP sponsor select under subparagraph (D),

submit such preferences to the PDP sponsor; and

‘‘(VI) that includes clear instructions that

explain how the beneficiary can contact the PDP

sponsor.

‘‘(iv) T

IMING OF NOTICES

.—

‘‘(I) I

N 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) E

XCEPTION

.—In the case that the PDP

sponsor, in conjunction with the Secretary, deter-

mines that concerns identified through rulemaking

by the Secretary regarding the health or safety

of the beneficiary or regarding significant drug

Determination.

Regulations.

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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) A

RISK BENEFICIARY FOR PRESCRIPTION DRUG

ABUSE

.—

‘‘(i) I

N GENERAL

.—For purposes of this paragraph,

the term ‘at-risk beneficiary for prescription drug

abuse’ means a part D eligible individual who is not

an exempted individual described in clause (ii) and—

‘‘(I) who is identified as such an at-risk bene-

ficiary through the use of clinical guidelines that

indicate misuse or abuse of prescription drugs

described in subparagraph (G) and that are devel-

oped by the Secretary in consultation with PDP

sponsors and other stakeholders, including individ-

uals entitled to benefits under part A or enrolled

under part B, advocacy groups representing such

individuals, physicians, pharmacists, and other

clinicians, retail pharmacies, plan sponsors, enti-

ties delegated by plan sponsors, and biopharma-

ceutical manufacturers; or

‘‘(II) with respect to whom the PDP sponsor

of a prescription drug plan, upon enrolling such

individual in such plan, received notice from the

Secretary that such individual was identified

under this paragraph to be an at-risk beneficiary

for prescription drug abuse under the prescription

drug plan in which such individual was most

recently previously enrolled and such identification

has not been terminated under subparagraph (F).

‘‘(ii) E

XEMPTED INDIVIDUAL DESCRIBED

.—An

exempted individual described in this clause is an indi-

vidual who—

‘‘(I) receives hospice care under this title;

‘‘(II) is a resident of a long-term care facility,

of a facility described in section 1905(d), or of

another facility for which frequently abused drugs

are dispensed for residents through a contract with

a single pharmacy; or

‘‘(III) the Secretary elects to treat as an

exempted individual for purposes of clause (i).

‘‘(iii) P

ROGRAM 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) C

LINICAL CONTACT

.—With respect to each at-

risk beneficiary for prescription drug abuse enrolled

in a prescription drug plan offered by a PDP sponsor,

the PDP sponsor shall contact the beneficiary’s pro-

viders who have prescribed frequently abused drugs

Guidelines.

Consultation.

Definition.

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130 STAT. 745 PUBLIC LAW 114–198—JULY 22, 2016

regarding whether prescribed medications are appro-

priate for such beneficiary’s medical conditions.

‘‘(D) S

ELECTION OF PRESCRIBERS AND PHARMACIES

.—

‘‘(i) I

N GENERAL

.—With respect to each at-risk

beneficiary for prescription drug abuse enrolled in a

prescription drug plan offered by such sponsor, a PDP

sponsor shall, based on the preferences submitted to

the PDP sponsor by the beneficiary pursuant to clauses

(ii)(IV) and (iii)(V) of subparagraph (B) (except as other-

wise provided in this subparagraph) select—

‘‘(I) one, or, if the PDP sponsor reasonably

determines it necessary to provide the beneficiary

with reasonable access under clause (ii), more than

one, individual who is authorized to prescribe fre-

quently abused drugs (referred to in this para-

graph as a ‘prescriber’) who may write prescrip-

tions for such drugs for such beneficiary; and

‘‘(II) one, or, if the PDP sponsor reasonably

determines it necessary to provide the beneficiary

with reasonable access under clause (ii), more than

one, pharmacy that may dispense such drugs to

such beneficiary.

For purposes of subclause (II), in the case of a phar-

macy that has multiple locations that share real-time

electronic data, all such locations of the pharmacy shall

collectively be treated as one pharmacy.

‘‘(ii) R

EASONABLE ACCESS

.—In making the selec-

tions under this subparagraph—

‘‘(I) a PDP sponsor shall ensure that the bene-

ficiary continues to have reasonable access to fre-

quently abused drugs (as defined in subparagraph

(G)), taking into account geographic location, bene-

ficiary preference, impact on costsharing, and

reasonable travel time; and

‘‘(II) a PDP sponsor shall ensure such access

(including access to prescribers and pharmacies

with respect to frequently abused drugs) in the

case of individuals with multiple residences, in

the case of natural disasters and similar situations,

and in the case of the provision of emergency serv-

ices.

‘‘(iii) B

ENEFICIARY PREFERENCES

.—If an at-risk

beneficiary for prescription drug abuse submits pref-

erences for which in-network prescribers and phar-

macies the beneficiary would prefer the PDP sponsor

select in response to a notice under subparagraph (B),

the PDP sponsor shall—

‘‘(I) review such preferences;

‘‘(II) select or change the selection of pre-

scribers and pharmacies for the beneficiary based

on such preferences; and

‘‘(III) inform the beneficiary of such selection

or change of selection.

‘‘(iv) E

XCEPTION REGARDING BENEFICIARY PREF

ERENCES

.—In the case that the PDP sponsor deter-

mines that a change to the selection of prescriber or

pharmacy under clause (iii)(II) by the PDP sponsor

Determination.

Review.

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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 phar-

macy for the beneficiary without regard to the pref-

erences of the beneficiary described in clause (iii). If

the PDP sponsor changes the selection pursuant to

the preceding sentence, the PDP sponsor shall provide

the beneficiary with—

‘‘(I) at least 30 days written notice of the

change of selection; and

‘‘(II) a rationale for the change.

‘‘(v) C

ONFIRMATION

.—Before selecting a prescriber

or pharmacy under this subparagraph, a PDP sponsor

must notify the prescriber and pharmacy that the bene-

ficiary involved has been identified for inclusion in

the drug management program for at-risk beneficiaries

and that the prescriber and pharmacy has been

selected as the beneficiary’s designated prescriber and

pharmacy.

‘‘(E) T

ERMINATIONS AND APPEALS

.—The identification

of an individual as an at-risk beneficiary for prescription

drug abuse under this paragraph, a coverage determination

made under a drug management program for at-risk bene-

ficiaries, the selection of prescriber or pharmacy under

subparagraph (D), and information to be shared under

subparagraph (I), with respect to such individual, shall

be subject to reconsideration and appeal under subsection

(h) and the option of an automatic escalation to external

review to the extent provided by the Secretary.

‘‘(F) T

ERMINATION OF IDENTIFICATION

.—

‘‘(i) I

N GENERAL

.—The Secretary shall develop

standards for the termination of identification of an

individual as an at-risk beneficiary for prescription

drug abuse under this paragraph. Under such stand-

ards such identification shall terminate as of the earlier

of—

‘‘(I) the date the individual demonstrates that

the individual is no longer likely, in the absence

of the restrictions under this paragraph, to be

an at-risk beneficiary for prescription drug abuse

described in subparagraph (C)(i); and

‘‘(II) the end of such maximum period of identi-

fication as the Secretary may specify.

‘‘(ii) R

ULE OF CONSTRUCTION

.—Nothing in clause

(i) shall be construed as preventing a plan from identi-

fying an individual as an at-risk beneficiary for

prescription drug abuse under subparagraph (C)(i)

after such termination on the basis of additional

information on drug use occurring after the date of

notice of such termination.

‘‘(G) F

REQUENTLY 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) D

ATA DISCLOSURE

.—

‘‘(i) D

ATA 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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130 STAT. 747 PUBLIC LAW 114–198—JULY 22, 2016

drug abuse (or an individual who is a potentially at-

risk beneficiary for prescription drug abuse) whose

access to coverage for frequently abused drugs under

a prescription drug plan has been limited by a PDP

sponsor under this paragraph, the Secretary shall

establish rules and procedures to require the PDP

sponsor to disclose data, including any necessary

individually identifiable health information, in a form

and manner specified by the Secretary, about the deci-

sion to impose such limitations and the limitations

imposed by the sponsor under this part.

‘‘(ii) D

ATA TO REDUCE FRAUD

ABUSE

AND WASTE

.—

The Secretary shall establish rules and procedures to

require PDP sponsors operating a drug management

program for at-risk beneficiaries under this paragraph

to provide the Secretary with such data as the Sec-

retary determines appropriate for purposes of identi-

fying patterns of prescription drug utilization for plan

enrollees that are outside normal patterns and that

may indicate fraudulent, medically unnecessary, or

unsafe use.

‘‘(I) S

HARING 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) P

RIVACY ISSUES

.—Prior to the implementation of

the rules and procedures under this paragraph, the Sec-

retary shall clarify privacy requirements, including require-

ments under the regulations promulgated pursuant to sec-

tion 264(c) of the Health Insurance Portability and Account-

ability Act of 1996 (42 U.S.C. 1320d–2 note), related to

the sharing of data under subparagraphs (H) and (I) by

PDP sponsors. Such clarification shall provide that the

sharing of such data shall be considered to be protected

health information in accordance with the requirements

of the regulations promulgated pursuant to such section

264(c).

‘‘(K) E

DUCATION

.—The Secretary shall provide edu-

cation to enrollees in prescription drug plans of PDP spon-

sors and providers regarding the drug management pro-

gram for at-risk beneficiaries described in this paragraph,

including education—

‘‘(i) provided by Medicare administrative contrac-

tors through the improper payment outreach and edu-

cation program described in section 1874A(h); and

‘‘(ii) through current education efforts (such as

State health insurance assistance programs described

in subsection (a)(1)(A) of section 119 of the Medicare

Improvements for Patients and Providers Act of 2008

(42 U.S.C. 1395b–3 note)) and materials directed

toward such enrollees.

Clarification.

Procedures.

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130 STAT. 748 PUBLIC LAW 114–198—JULY 22, 2016

‘‘(L) A

PPLICATION UNDER MA

–

PD PLANS

.—Pursuant to

section 1860D–21(c)(1), the provisions of this paragraph

apply under part D to MA organizations offering MA–

PD plans to MA eligible individuals in the same manner

as such provisions apply under this part to a PDP sponsor

offering a prescription drug plan to a part D eligible indi-

vidual.

‘‘(M) CMS

COMPLIANCE REVIEW

.—The Secretary shall

ensure that existing plan sponsor compliance reviews and

audit processes include the drug management programs

for at-risk beneficiaries under this paragraph, including

appeals processes under such programs.’’.

(2) I

NFORMATION 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) D

UAL 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) U

TILIZATION

ANAGEMENT

ROGRAMS

.—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) U

TILIZATION MANAGEMENT TOOL TO PREVENT DRUG

ABUSE

.—

‘‘(A) I

N GENERAL

.—A tool described in this paragraph

is any of the following:

‘‘(i) A utilization tool designed to prevent the abuse

of frequently abused drugs by individuals and to pre-

vent the diversion of such drugs at pharmacies.

‘‘(ii) Retrospective utilization review to identify—

‘‘(I) individuals that receive frequently abused

drugs at a frequency or in amounts that are not

clinically appropriate; and

‘‘(II) providers of services or suppliers that

may facilitate the abuse or diversion of frequently

abused drugs by beneficiaries.

‘‘(iii) Consultation with the contractor described

in subparagraph (B) to verify if an individual enrolling

in a prescription drug plan offered by a PDP sponsor

has been previously identified by another PDP sponsor

as an individual described in clause (ii)(I).

‘‘(B) R

EPORTING

.—A PDP sponsor offering a prescrip-

tion drug plan (and an MA organization offering an MA–

PD plan) in a State shall submit to the Secretary and

the Medicare drug integrity contractor with which the Sec-

retary has entered into a contract under section 1893 with

respect to such State a report, on a monthly basis, con-

taining information on—

Contracts.

Consultation.

Verification.

Audits.

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130 STAT. 749 PUBLIC LAW 114–198—JULY 22, 2016

‘‘(i) any provider of services or supplier described

in subparagraph (A)(ii)(II) that is identified by such

plan sponsor (or organization) during the 30-day period

before such report is submitted; and

‘‘(ii) the name and prescription records of individ-

uals described in paragraph (5)(C).

‘‘(C) CMS

COMPLIANCE REVIEW

.—The Secretary shall

ensure that plan sponsor compliance reviews and program

audits biennially include a certification that utilization

management tools under this paragraph are in compliance

with the requirements for such tools.’’.

XPANDING

CTIVITIES OF

EDICARE

RUG

NTEGRITY

TRACTORS

(MEDIC

).—

(1) I

N 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) E

XPANDING

CTIVITIES OF

EDICARE

RUG

NTEGRITY

TRACTORS

(MEDIC

).—

‘‘(1) A

CCESS TO INFORMATION

.—Under contracts entered

into under this section with Medicare drug integrity contractors

(including any successor entity to a Medicare drug integrity

contractor), the Secretary shall authorize such contractors to

directly accept prescription and necessary medical records from

entities such as pharmacies, prescription drug plans, MA–PD

plans, and physicians with respect to an individual in order

for such contractors to provide information relevant to the

determination of whether such individual is an at-risk bene-

ficiary for prescription drug abuse, as defined in section 1860D–

4(c)(5)(C).

‘‘(2) R

EQUIREMENT FOR ACKNOWLEDGMENT OF REFERRALS

.—

If a PDP sponsor or MA organization refers information to

a contractor described in paragraph (1) in order for such con-

tractor to assist in the determination described in such para-

graph, the contractor shall—

‘‘(A) acknowledge to the sponsor or organization receipt

of the referral; and

‘‘(B) in the case that any PDP sponsor or MA organiza-

tion contacts the contractor requesting to know the deter-

mination by the contractor of whether or not an individual

has been determined to be an individual described in such

paragraph, shall inform such sponsor or organization of

such determination on a date that is not later than 15

days after the date on which the sponsor or organization

contacts the contractor.

‘‘(3) M

AKING DATA AVAILABLE TO OTHER ENTITIES

.—

‘‘(A) I

N GENERAL

.—For purposes of carrying out this

subsection, subject to subparagraph (B), the Secretary shall

authorize MEDICs to respond to requests for information

from PDP sponsors and MA organizations, State prescrip-

tion drug monitoring programs, and other entities dele-

gated by such sponsors or organizations using available

programs and systems in the effort to prevent fraud, waste,

and abuse.

‘‘(B) HIPAA

COMPLIANT INFORMATION ONLY

.—Informa-

tion may only be disclosed by a MEDIC under subpara-

graph (A) if the disclosure of such information is permitted

under the Federal regulations (concerning the privacy of

Determination.

Deadline.

Records.

Determination.

Audits.

Deadline.

Certification.

Time period.

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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) S

TUDY

.—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) R

EPORT

.—Not later than 24 months after the date

of the enactment of this Act, the Inspector General shall

submit to Congress a report on the study conducted under

subparagraph (A). Such report shall include such rec-

ommendations for improvements in the effectiveness of

such contractors as the Inspector General determines

appropriate.

(d) T

REATMENT OF

ERTAIN

OMPLAINTS FOR

URPOSES OF

UALITY OR

ERFORMANCE

SSESSMENT

.—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) T

REATMENT OF

ERTAIN

OMPLAINTS FOR

URPOSES OF

UALITY OR

ERFORMANCE

SSESSMENT

.—In conducting a quality

or performance assessment of a PDP sponsor, the Secretary shall

develop or utilize existing screening methods for reviewing and

considering complaints that are received from enrollees in a

prescription drug plan offered by such PDP sponsor and that are

complaints regarding the lack of access by the individual to prescrip-

tion drugs due to a drug management program for at-risk bene-

ficiaries.’’.

(e) S

ENSE OF

ONGRESS

EGARDING

SE OF

ECHNOLOGY

OOLS

OMBAT

RAUD

.—It is the sense of Congress that MA organiza-

tions and PDP sponsors should consider using e-prescribing and

other health information technology tools to support combating

fraud under MA–PD plans and prescription drug plans under parts

C and D of the Medicare program.

(f) R

EPORTS

.—

(1) R

EPORT BY SECRETARY ON APPEALS PROCESS

.—

(A) I

N GENERAL

.—Not later than 12 months after the

date of the enactment of this Act, the Secretary of Health

and Human Services shall submit to the appropriate

committees of jurisdiction of Congress a report on ways

to improve upon the appeals process for Medicare bene-

ficiaries with respect to prescription drug coverage under

part D of title XVIII of the Social Security Act. Such

report shall include an analysis comparing appeals proc-

esses under parts C and D of such title XVIII.

(B) F

EEDBACK

.—In development of the report described

in subparagraph (A), the Secretary of Health and Human

Services shall solicit feedback on the current appeals

process from stakeholders, such as beneficiaries, consumer

advocates, plan sponsors, pharmacy benefit managers,

Analysis.

Recommenda-

tions.

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130 STAT. 751 PUBLIC LAW 114–198—JULY 22, 2016

pharmacists, providers, independent review entity eval-

uators, and pharmaceutical manufacturers.

(2) GAO

STUDY AND REPORT

.—

(A) S

TUDY

.—The Comptroller General of the United

States shall conduct a study on the implementation of

the amendments made by this section, including the

effectiveness of the at-risk beneficiaries for prescription

drug abuse drug management programs authorized by sec-

tion 1860D–4(c)(5) of the Social Security Act (42 U.S.C.

1395w–10(c)(5)), as added by subsection (a)(1). Such study

shall include an analysis of—

(i) the impediments, if any, that impair the ability

of individuals described in subparagraph (C) of such

section 1860D–4(c)(5) to access clinically appropriate

levels of prescription drugs;

(ii) the effectiveness of the reasonable access

protections under subparagraph (D)(ii) of such section

1860D–4(c)(5), including the impact on beneficiary

access and health;

(iii) the types of—

(I) individuals who, in the implementation of

such section, are determined to be individuals

described in such subparagraph (C); and

(II) prescribers and pharmacies that are

selected under subparagraph (D) of such section;

and

(iv) other areas determined appropriate by the

Comptroller General.

(B) R

EPORT

.—Not later than July 1, 2019, the Comp-

troller General of the United States shall submit to the

appropriate committees of jurisdiction of Congress a report

on the study conducted under subparagraph (A), together

with recommendations for such legislation and administra-

tive action as the Comptroller General determines to be

appropriate.

(g) E

FFECTIVE

ATE

; R

ULEMAKING

.—

(1) I

N 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) S

TAKEHOLDER MEETINGS PRIOR TO EFFECTIVE DATE

.—

(A) I

N GENERAL

.—Not later than January 1, 2017, the

Secretary of Health and Human Services shall convene

stakeholders, including individuals entitled to benefits

under part A of title XVIII of the Social Security Act

or enrolled under part B of such title, advocacy groups

representing such individuals, physicians, pharmacists, and

other clinicians, retail pharmacies, plan sponsors, entities

delegated by plan sponsors, and biopharmaceutical manu-

facturers for input regarding the topics described in

subparagraph (B). The input described in the preceding

sentence shall be provided to the Secretary in sufficient

time in order for the Secretary to take such input into

account in promulgating the regulations pursuant to para-

graph (3).

(B) T

OPICS DESCRIBED

.—The topics described in this

subparagraph are the topics of—

Deadline.

42 USC

1395w–101 note.

Applicability.

Recommenda-

tions.

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

(ii) the use of an expedited appeals process under

which such an enrollee may appeal an identification

of such enrollee as an at-risk beneficiary for prescrip-

tion drug abuse under such paragraph (similar to the

processes established under the Medicare Advantage

program under part C of title XVIII of the Social Secu-

rity Act that allow an automatic escalation to external

review of claims submitted under such part);

(iii) the types of enrollees that should be treated

as exempted individuals, as described in subparagraph

(C)(ii) of such paragraph;

(iv) the manner in which terms and definitions

in such paragraph should be applied, such as the use

of clinical appropriateness in determining whether an

enrollee is an at-risk beneficiary for prescription drug

abuse as defined in subparagraph (C) of such para-

graph;

(v) the information to be included in the notices

described in subparagraph (B) of such paragraph and

the standardization of such notices;

(vi) with respect to a PDP sponsor (or Medicare

Advantage organization) that establishes a drug

management program for at-risk beneficiaries under

such paragraph, the responsibilities of such PDP

sponsor (or organization) with respect to the

implementation of such program;

(vii) notices for plan enrollees at the point of sale

that would explain why an at-risk beneficiary has been

prohibited from receiving a prescription at a location

outside of the designated pharmacy;

(viii) evidence-based prescribing guidelines for opi-

ates; and

(ix) the sharing of claims data under parts A and

B of title XVIII of the Social Security Act with PDP

sponsors.

(3) R

ULEMAKING

.—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) D

EPOSIT OF

AVINGS

NTO

EDICARE

MPROVEMENT

UND

.—

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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130 STAT. 753 PUBLIC LAW 114–198—JULY 22, 2016

SEC. 705. EXCLUDING ABUSE-DETERRENT FORMULATIONS OF

PRESCRIPTION DRUGS FROM THE MEDICAID ADDITIONAL

REBATE REQUIREMENT FOR NEW FORMULATIONS OF

PRESCRIPTION DRUGS.

(a) I

ENERAL

.—The last sentence of section 1927(c)(2)(C)

of the Social Security Act (42 U.S.C. 1396r–8(c)(2)(C)) is amended

by inserting before the period at the end the following: ‘‘, but

does not include an abuse-deterrent formulation of the drug (as

determined by the Secretary), regardless of whether such abuse-

deterrent formulation is an extended release formulation’’.

(b) E

FFECTIVE

ATE

.—The amendment made by subsection (a)

shall apply to drugs that are paid for by a State in calendar

quarters beginning on or after the date of the enactment of this

Act.

SEC. 706. LIMITING DISCLOSURE OF PREDICTIVE MODELING AND

OTHER ANALYTICS TECHNOLOGIES TO IDENTIFY AND PRE-

VENT WASTE, FRAUD, AND ABUSE.

(a) I

ENERAL

.—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) R

EFERENCE TO

REDICTIVE

ODELING

ECHNOLOGIES

EQUIREMENTS

.—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) L

IMITING

ISCLOSURE OF

REDICTIVE

ODELING

ECH

NOLOGIES

.—In implementing such provisions under such section

4241 with respect to covered algorithms (as defined in subsection

(c)), the following shall apply:

‘‘(1) N

ONAPPLICATION 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) L

IMITATION WITH RESPECT TO USE AND DISCLOSURE

OF INFORMATION BY STATE AGENCIES

.—

‘‘(A) I

N 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) I

NFORMATION 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.

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) P

ROCEDURAL REQUIREMENTS

.—State agencies to

which information is disclosed pursuant to such section

4241 shall adhere to uniform procedures established by

the Secretary.

‘‘(c) C

OVERED

LGORITHM

EFINED

.—In this section, the term

‘covered algorithm’—

‘‘(1) means a predictive modeling or other analytics tech-

nology, as used for purposes of section 4241(a) of the Small

Business Jobs Act of 2010 (42 U.S.C. 1320a–7m(a)) to identify

and prevent waste, fraud, and abuse with respect to the Medi-

care program under title XVIII, the Medicaid program under

title XIX, and the Children’s Health Insurance Program under

title XXI; and

‘‘(2) includes the mathematical expressions utilized in the

application of such technology and the means by which such

technology is developed.’’.

(b) C

ONFORMING

MENDMENTS

.—

(1) M

EDICAID 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

new paragraph:

‘‘(82) provide that the State agency responsible for admin-

istering the State plan under this title provides assurances

to the Secretary that the State agency is in compliance with

subparagraphs (A), (B), and (C) of section 1128K(b)(2).’’.

(2) S

TATE 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

graph:

‘‘(C) to ensure that the State agency involved is in

compliance with subparagraphs (A), (B), and (C) of section

1128K(b)(2).’’.

SEC. 707. MEDICAID IMPROVEMENT FUND.

Section 1941(b)(1) of the Social Security Act (42 U.S.C. 1396w–

1(b)(1)) is amended to read as follows:

‘‘(1) I

N GENERAL

.—There shall be available to the Fund,

for expenditures from the Fund for fiscal year 2021 and there-

after, $5,000,000.’’.

SEC. 708. SENSE OF THE CONGRESS REGARDING TREATMENT OF SUB-

STANCE ABUSE EPIDEMICS.

It is the sense of the Congress that decades of experience

and research have demonstrated that a fiscally responsible approach

to addressing the opioid abuse epidemic and other substance abuse

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130 STAT. 755 PUBLIC LAW 114–198—JULY 22, 2016

epidemics requires treating such epidemics as a public health emer-

gency emphasizing prevention, treatment, and recovery.

TITLE VIII—KINGPIN DESIGNATION

IMPROVEMENT

SEC. 801. PROTECTION OF CLASSIFIED INFORMATION IN FEDERAL

COURT CHALLENGES RELATING TO DESIGNATIONS UNDER

THE NARCOTICS KINGPIN DESIGNATION ACT.

Section 804 of the Foreign Narcotics Kingpin Designation Act

(21 U.S.C. 1903) is amended by adding at the end the following:

‘‘(i) P

ROTECTION OF

LASSIFIED

NFORMATION IN

EDERAL

OURT

HALLENGES

ELATING TO

ESIGNATIONS

.—In any judicial

review of a determination made under this section, if the determina-

tion was based on classified information (as defined in section

1(a) of the Classified Information Procedures Act) such information

may be submitted to the reviewing court ex parte and in camera.

This subsection does not confer or imply any right to judicial

review.’’.

TITLE IX—DEPARTMENT OF VETERANS

AFFAIRS

SEC. 901. SHORT TITLE.

This title may be cited as the ‘‘Jason Simcakoski Memorial

and Promise Act’’.

SEC. 902. DEFINITIONS.

In this title:

(1) The term ‘‘controlled substance’’ has the meaning given

that term in section 102 of the Controlled Substances Act

(21 U.S.C. 802).

(2) The term ‘‘State’’ means each of the several States,

territories, and possessions of the United States, the District

of Columbia, and the Commonwealth of Puerto Rico.

(3) The term ‘‘complementary and integrative health’’ has

the meaning given that term, or any successor term, by the

National Institutes of Health.

(4) The term ‘‘opioid receptor antagonist’’ means a drug

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

and Cosmetic Act (21 U.S.C. 301 et seq.) for emergency treat-

ment of known or suspected opioid overdose.

Subtitle A—Opioid Therapy and Pain

Management

SEC. 911. IMPROVEMENT OF OPIOID SAFETY MEASURES BY DEPART-

MENT OF VETERANS AFFAIRS.

(a) E

XPANSION OF

PIOID

AFETY

NITIATIVE

.—

(1) I

NCLUSION 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) G

UIDANCE

.—The Secretary shall establish guidance that

each health care provider of the Department of Veterans

Affairs, before initiating opioid therapy to treat a patient as

part of the comprehensive assessment conducted by the health

care provider, use the Opioid Therapy Risk Report tool of

the Department of Veterans Affairs (or any subsequent tool),

which shall include information from the prescription drug

monitoring program of each participating State as applicable,

that includes the most recent information to date relating to

the patient that accessed such program to assess the risk

for adverse outcomes of opioid therapy for the patient, including

the concurrent use of controlled substances such as

benzodiazepines, as part of the comprehensive assessment con-

ducted by the health care provider.

(3) E

NHANCED STANDARDS

.—The Secretary shall establish

enhanced standards with respect to the use of routine and

random urine drug tests for all patients before and during

opioid therapy to help prevent substance abuse, dependence,

and diversion, including—

(A) that such tests occur not less frequently than once

each year or as otherwise determined according to treat-

ment protocols; and

(B) that health care providers appropriately order,

interpret and respond to the results from such tests to

tailor pain therapy, safeguards, and risk management

strategies to each patient.

(b) P

AIN

ANAGEMENT

DUCATION AND

RAINING

.—

(1) I

N GENERAL

.—In carrying out the Opioid Safety Initia-

tive of the Department, the Secretary shall require all

employees of the Department responsible for prescribing opioids

to receive education and training described in paragraph (2).

(2) E

DUCATION AND TRAINING

.—Education and training

described in this paragraph is education and training on pain

management and safe opioid prescribing practices for purposes

of safely and effectively managing patients with chronic pain,

including education and training on the following:

(A) The implementation of and full compliance with

the VA/DOD Clinical Practice Guideline for Management

of Opioid Therapy for Chronic Pain, including any update

to such guideline.

(B) The use of evidence-based pain management thera-

pies and complementary and integrative health services,

including cognitive-behavioral therapy, non-opioid alter-

natives, and non-drug methods and procedures to managing

pain and related health conditions including, to the extent

practicable, medical devices approved or cleared by the

Food and Drug Administration for the treatment of patients

with chronic pain and related health conditions.

stance use disorder, including drug-seeking behavior, before

prescribing opioids, assessment of risk potential for patients

developing an addiction, and referral of patients to appro-

priate addiction treatment professionals if addiction is

identified or strongly suspected.

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130 STAT. 757 PUBLIC LAW 114–198—JULY 22, 2016

(D) Communication with patients on the potential

harm associated with the use of opioids and other controlled

substances, including the need to safely store and dispose

of supplies relating to the use of opioids and other con-

trolled substances.

(E) Such other education and training as the Secretary

considers appropriate to ensure that veterans receive safe

and high-quality pain management care from the Depart-

ment.

(3) U

SE 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).

AIN

ANAGEMENT

EAMS

.—

(1) I

N GENERAL

.—In carrying out the Opioid Safety Initia-

tive of the Department, the director of each medical facility

of the Department shall identify and designate a pain manage-

ment team of health care professionals, which may include

board certified pain medicine specialists, responsible for coordi-

nating and overseeing pain management therapy at such

facility for patients experiencing acute and chronic pain that

is non-cancer related.

(2) E

STABLISHMENT OF PROTOCOLS

.—

(A) I

N 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) C

ONSULTATION ON PRESCRIPTION OF OPIOIDS

.—Each

protocol established under subparagraph (A) shall ensure

that any health care provider without expertise in pre-

scribing analgesics or who has not completed the education

and training under subsection (b), including a mental

health care provider, does not prescribe opioids to a patient

unless that health care provider—

(i) consults with a health care provider with pain

management expertise or who is on the pain manage-

ment team of the medical facility; and

(ii) refers the patient to the pain management

team for any subsequent prescriptions and related

therapy.

(3) R

EPORT

.—

(A) I

N GENERAL

.—Not later than one year after the

date of enactment of this Act, the director of each medical

facility of the Department shall submit to the Under Sec-

retary for Health and the director of the Veterans

Integrated Service Network in which the medical facility

is located a report identifying the health care professionals

that have been designated as members of the pain manage-

ment team at the medical facility pursuant to paragraph

(1).

(B) E

LEMENTS

.—Each report submitted under subpara-

graph (A) with respect to a medical facility of the Depart-

ment shall include—

(i) a certification as to whether all members of

the pain management team at the medical facility have

Certification.

Consultation.

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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 Depart-

ment; or

(II) does not fully comply with such stepped-

care model, or successor models, of pain manage-

ment and other pain management policies but is

carrying out a corrective plan of action to ensure

such full compliance.

(d) T

RACKING AND

ONITORING OF

PIOID

.—

(1) P

RESCRIPTION DRUG MONITORING PROGRAMS OF

STATES

.—In carrying out the Opioid Safety Initiative and the

Opioid Therapy Risk Report tool of the Department, the Sec-

retary shall—

(A) ensure access by health care providers of the

Department to information on controlled substances,

including opioids and benzodiazepines, prescribed to vet-

erans who receive care outside the Department through

the prescription drug monitoring program of each State

with such a program, including by seeking to enter into

memoranda of understanding with States to allow shared

access of such information between States and the Depart-

ment;

(B) include such information in the Opioid Therapy

Risk Report tool; and

to submit to the prescription drug monitoring program

of each State with such a program information on prescrip-

tions of controlled substances received by veterans in that

State under the laws administered by the Secretary.

(2) R

EPORT ON TRACKING OF DATA ON OPIOID USE

.—Not

later than 18 months after the date of the enactment of this

Act, the Secretary shall submit to the Committee on Veterans’

Affairs of the Senate and the Committee on Veterans’ Affairs

of the House of Representatives a report on the feasibility

and advisability of improving the Opioid Therapy Risk Report

tool of the Department to allow for more advanced real-time

tracking of and access to data on—

(A) the key clinical indicators with respect to the

totality of opioid use by veterans;

(B) concurrent prescribing by health care providers

of the Department of opioids in different health care set-

tings, including data on concurrent prescribing of opioids

to treat mental health disorders other than opioid use

disorder; and

veterans under the laws administered by the Secretary.

(e) A

VAILABILITY OF

PIOID

ECEPTOR

NTAGONISTS

.—

Certification.

Plan.

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130 STAT. 759 PUBLIC LAW 114–198—JULY 22, 2016

(1) I

NCREASED AVAILABILITY AND USE

.—

(A) I

N GENERAL

.—The Secretary shall maximize the

availability of opioid receptor antagonists, including

naloxone, to veterans.

(B) A

VAILABILITY

TRAINING

AND DISTRIBUTING

.—In

carrying out subparagraph (A), not later than 90 days

after the date of the enactment of this Act, the Secretary

shall—

(i) equip each pharmacy of the Department with

opioid receptor antagonists to be dispensed to out-

patients as needed; and

(ii) expand the Overdose Education and Naloxone

Distribution program of the Department to ensure that

all veterans in receipt of health care under laws

administered by the Secretary who are at risk of opioid

overdose may access such opioid receptor antagonists

and training on the proper administration of such

opioid receptor antagonists.

ETERANS WHO ARE AT RISK

.—For purposes of

subparagraph (B), veterans who are at risk of opioid over-

dose include—

(i) veterans receiving long-term opioid therapy;

(ii) veterans receiving opioid therapy who have

a history of substance use disorder or prior instances

of overdose; and

(iii) veterans who are at risk as determined by

a health care provider who is treating the veteran.

(2) R

EPORT

.—Not later than 120 days after the date of

the enactment of this Act, the Secretary shall submit to the

Committee on Veterans’ Affairs of the Senate and the Com-

mittee on Veterans’ Affairs of the House of Representatives

a report on carrying out paragraph (1), including an assessment

of any remaining steps to be carried out by the Secretary

to carry out such paragraph.

(f) I

NCLUSION OF

ERTAIN

NFORMATION AND

APABILITIES IN

PIOID

HERAPY

ISK

EPORT

OOL OF THE

EPARTMENT

.—

(1) I

NFORMATION

.—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) C

APABILITIES

.—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) N

OTIFICATIONS OF

ISK IN

OMPUTERIZED

EALTH

ECORD

.—The Secretary shall modify the computerized patient

record system of the Department to ensure that any health care

provider that accesses the record of a veteran, regardless of the

reason the veteran seeks care from the health care provider, will

be immediately notified whether the veteran—

(1) is receiving opioid therapy and has a history of sub-

stance use disorder or prior instances of overdose;

Determination.

Assessment.

Deadline.

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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 deter-

mined by a health care provider who is treating the veteran.

SEC. 912. STRENGTHENING OF JOINT WORKING GROUP ON PAIN

MANAGEMENT OF THE DEPARTMENT OF VETERANS

AFFAIRS AND THE DEPARTMENT OF DEFENSE.

(a) I

ENERAL

.—Not later than 90 days after the date of

enactment of this Act, the Secretary of Veterans Affairs and the

Secretary of Defense shall ensure that the Pain Management

Working Group of the Health Executive Committee of the Depart-

ment of Veterans Affairs–Department of Defense Joint Executive

Committee (Pain Management Working Group) established under

section 320 of title 38, United States Code, includes a focus on

the following:

(1) The opioid prescribing practices of health care providers

of each Department.

(2) The ability of each Department to manage acute and

chronic pain among individuals receiving health care from the

Department, including training health care providers with

respect to pain management.

(3) The use by each Department of complementary and

integrative health in treating such individuals.

(4) The concurrent use and practice by health care pro-

viders of each Department of opioids and prescription drugs

to treat mental health disorders, including benzodiazepines.

(5) The use of care transition plans by health care providers

of each Department to address case management issues for

patients receiving opioid therapy who transition between

inpatient and outpatient care.

(6) The coordination in coverage of and consistent access

to medications prescribed for patients transitioning from

receiving health care from the Department of Defense to

receiving health care from the Department of Veterans Affairs.

(7) The ability of each Department to properly screen,

identify, refer, and treat patients with substance use disorders

who are seeking treatment for acute and chronic pain manage-

ment conditions.

(b) C

OORDINATION AND

ONSULTATION

.—The Secretary of Vet-

erans Affairs and the Secretary of Defense shall ensure that the

working group described in subsection (a)—

(1) coordinates the activities of the working group with

other relevant working groups established under section 320

of title 38, United States Code;

(2) consults with other relevant Federal agencies, including

the Centers for Disease Control and Prevention, with respect

to the activities of the working group; and

(3) consults with the Department of Veterans Affairs and

the Department of Defense with respect to the VA/DOD Clinical

Practice Guideline for Management of Opioid Therapy for

Chronic Pain, or any successor guideline, and reviews and

provides comments before any update to the guideline is

released.

LINICAL

RACTICE

UIDELINES

.—

(1) I

N 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.

38 USC 1701

note.

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130 STAT. 761 PUBLIC LAW 114–198—JULY 22, 2016

VA/DOD Clinical Practice Guideline for Management of Opioid

Therapy for Chronic Pain.

(2) M

ATTERS INCLUDED

.—In conducting the update under

paragraph (1), the Pain Management Working Group, in

coordination with the Clinical Practice Guideline VA/DoD

Management of Opioid Therapy for Chronic Pain Working

Group, shall work to ensure that the Clinical Practical Guide-

line includes the following:

(A) Enhanced guidance with respect to—

(i) the co-administration of an opioid and other

drugs, including benzodiazepines, that may result in

life-limiting drug interactions;

(ii) the treatment of patients with current acute

psychiatric instability or substance use disorder or

patients at risk of suicide; and

(iii) the use of opioid therapy to treat mental health

disorders other than opioid use disorder.

(B) Enhanced guidance with respect to the treatment

of patients with behaviors or comorbidities, such as post-

traumatic stress disorder or other psychiatric disorders,

or a history of substance abuse or addiction, that requires

a consultation or co-management of opioid therapy with

one or more specialists in pain management, mental health,

or addictions.

providers—

(i) conducting an effective assessment for patients

beginning or continuing opioid therapy, including

understanding and setting realistic goals with respect

to achieving and maintaining an expected level of pain

relief, improved function, or a clinically appropriate

combination of both; and

(ii) effectively assessing whether opioid therapy

is achieving or maintaining the established treatment

goals of the patient or whether the patient and health

care provider should discuss adjusting, augmenting,

or discontinuing the opioid therapy.

(D) Guidelines to inform the methodologies used by

health care providers of the Department of Veterans Affairs

and the Department of Defense to safely taper opioid

therapy when adjusting or discontinuing the use of opioid

therapy, including—

(i) prescription of the lowest effective dose based

on patient need;

(ii) use of opioids only for a limited time; and

(iii) augmentation of opioid therapy with other

pain management therapies and modalities.

(E) Guidelines with respect to appropriate case

management for patients receiving opioid therapy who

transition between inpatient and outpatient health care

settings, which may include the use of care transition plans.

(F) Guidelines with respect to appropriate case

management for patients receiving opioid therapy who

transition from receiving care during active duty to post-

military health care networks.

(G) Guidelines with respect to providing options, before

initiating opioid therapy, for pain management therapies

Assessments.

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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 integra-

tive health services to minimize opioid dependence.

(H) Guidelines with respect to the provision of evi-

dence-based non-opioid treatments within the Department

of Veterans Affairs and the Department of Defense,

including medical devices and other therapies approved

or cleared by the Food and Drug Administration for the

treatment of chronic pain as an alternative to or to augment

opioid therapy.

(I) Guidelines developed by the Centers for Disease

Control and Prevention for safely prescribing opioids for

the treatment of chronic, non-cancer related pain in out-

patient settings.

(3) R

ULE 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) C

OMPTROLLER

ENERAL

EPORT

.—

(1) I

N GENERAL

.—Not later than two years after the date

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

United States shall submit to the Committee on Veterans’

Affairs of the Senate and the Committee on Veterans’ Affairs

of the House of Representatives a report on the Opioid Safety

Initiative of the Department of Veterans Affairs and the opioid

prescribing practices of health care providers of the Depart-

ment.

(2) E

LEMENTS

.—The report submitted under paragraph (1)

shall include the following:

(A) An assessment of the implementation and moni-

toring by the Veterans Health Administration of the Opioid

Safety Initiative of the Department, including examining,

as appropriate, the following:

(i) How the Department monitors the key clinical

outcomes of such safety initiative (for example, the

percentage of unique veterans visiting each medical

center of the Department that are prescribed an opioid

or an opioid and benzodiazepine concurrently) and how

the Department uses that information—

(I) to improve prescribing practices; and

(II) to identify high prescribing or otherwise

inappropriate prescribing practices by health care

providers.

(ii) How the Department monitors the use of the

Opioid Therapy Risk Report tool of the Department

(as developed through such safety initiative) and

compliance with such tool by medical facilities and

health care providers of the Department, including

Assessments.

38 USC 1701

note.

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130 STAT. 763 PUBLIC LAW 114–198—JULY 22, 2016

any findings by the Department of prescription rates

or prescription practices by medical facilities or health

care providers that are inappropriate.

(iii) The implementation of academic detailing pro-

grams within the Veterans Integrated Service Net-

works of the Department and how such programs are

being used to improve opioid prescribing practices.

(iv) Recommendations on such improvements to

the Opioid Safety Initiative of the Department as the

Comptroller General considers appropriate.

(B) Information made available under the Opioid

Therapy Risk Report tool with respect to—

(i) deaths resulting from sentinel events involving

veterans prescribed opioids by a health care provider;

(ii) overall prescription rates and, if applicable,

indications used by health care providers for pre-

scribing chronic opioid therapy to treat non-cancer,

non-palliative, and non-hospice care patients;

(iii) the prescription rates and indications used

by health care providers for prescribing

benzodiazepines and opioids concomitantly;

(iv) the practice by health care providers of pre-

scribing opioids to treat patients without any pain,

including to treat patients with mental health dis-

orders other than opioid use disorder; and

(v) the effectiveness of opioid therapy for patients

receiving such therapy, including the effectiveness of

long-term opioid therapy.

place to oversee opioid use among veterans, including proce-

dures to identify and remedy potential over-prescribing

of opioids by health care providers of the Department.

(D) An assessment of the implementation by the Sec-

retary of Veterans Affairs of the VA/DOD Clinical Practice

Guideline for Management of Opioid Therapy for Chronic

Pain, including any figures or approaches used by the

Department to assess compliance with such guidelines by

medical centers of the Department and identify any medical

centers of the Department operating action plans to

improve compliance with such guidelines.

(E) An assessment of the data that the Department

has developed to review the opioid prescribing practices

of health care providers of the Department, as required

by this subtitle, including a review of how the Department

identifies the practices of individual health care providers

that warrant further review based on prescribing levels,

health conditions for which the health care provider is

prescribing opioids or opioids and benzodiazepines concur-

rently, or other practices of the health care provider.

(b) S

EMI

ANNUAL

ROGRESS

EPORT ON

MPLEMENTATION OF

OMPTROLLER

ENERAL

ECOMMENDATIONS

.—Not later than 180

days after the date of the submittal of the report required under

subsection (a), and not less frequently than annually thereafter

until the Comptroller General of the United States determines

that all recommended actions are closed, the Secretary of Veterans

Affairs shall submit to the Committee on Veterans’ Affairs of the

Senate and the Committee on Veterans’ Affairs of the House of

Determination.

Review.

Evaluation.

Procedures.

Recommenda-

tions.

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130 STAT. 764 PUBLIC LAW 114–198—JULY 22, 2016

Representatives a progress report detailing the actions by the Sec-

retary to address any outstanding findings and recommendations

by the Comptroller General of the United States under subsection

(a) with respect to the Veterans Health Administration.

NNUAL

EPORT ON

PIOID

HERAPY AND

RESCRIPTION

ATES

.—Not later than one year after the date of the enactment

of this Act, and not less frequently than annually for the following

five years, the Secretary shall submit to the Committee on Veterans’

Affairs of the Senate and the Committee on Veterans’ Affairs of

the House of Representatives a report on opioid therapy and

prescription rates for the one-year period preceding the date of

the submission of the report. Each such report shall include each

of the following:

(1) The number of patients and the percentage of the

patient population of the Department who were prescribed

benzodiazepines and opioids concurrently by a health care pro-

vider of the Department.

(2) The number of patients and the percentage of the

patient population of the Department without any pain who

were prescribed opioids by a health care provider of the Depart-

ment, including those who were prescribed benzodiazepines

and opioids concurrently.

(3) The number of non-cancer, non-palliative, and non-

hospice care patients and the percentage of such patients who

were treated with opioids by a health care provider of the

Department on an inpatient-basis and who also received

prescription opioids by mail from the Department while being

treated on an inpatient-basis.

(4) The number of non-cancer, non-palliative, and non-

hospice care patients and the percentage of such patients who

were prescribed opioids concurrently by a health care provider

of the Department and a health care provider that is not

a health care provider of the Department.

(5) With respect to each medical facility of the Department,

the collected and reviewed information on opioids prescribed

by health care providers at the facility to treat non-cancer,

non-palliative, and non-hospice care patients, including—

(A) the prescription rate at which each health care

provider at the facility prescribed benzodiazepines and

opioids concurrently to such patients and the aggregate

of such prescription rate for all health care providers at

the facility;

(B) the prescription rate at which each health care

provider at the facility prescribed benzodiazepines or

opioids to such patients to treat conditions for which

benzodiazepines or opioids are not approved treatment and

the aggregate of such prescription rate for all health care

providers at the facility;

provider at the facility prescribed or dispensed mail-order

prescriptions of opioids to such patients while such patients

were being treated with opioids on an inpatient-basis and

the aggregate of such prescription rate for all health care

providers at the facility; and

(D) the prescription rate at which each health care

provider at the facility prescribed opioids to such patients

who were also concurrently prescribed opioids by a health

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130 STAT. 765 PUBLIC LAW 114–198—JULY 22, 2016

care provider that is not a health care provider of the

Department and the aggregate of such prescription rates

for all health care providers at the facility.

(6) With respect to each medical facility of the Department,

the number of times a pharmacist at the facility overrode

a critical drug interaction warning with respect to an inter-

action between opioids and another medication before dis-

pensing such medication to a veteran.

(d) I

NVESTIGATION OF

RESCRIPTION

ATES

.—If the Secretary

determines that a prescription rate with respect to a health care

provider or medical facility of the Department conflicts with or

is otherwise inconsistent with the standards of appropriate and

safe care, the Secretary shall—

(1) immediately notify the Committee on Veterans’ Affairs

of the Senate and the Committee on Veterans’ Affairs of the

House of Representatives of such determination, including

information relating to such determination, prescription rate,

and health care provider or medical facility, as the case may

be; and

(2) through the Office of the Medical Inspector of the Vet-

erans Health Administration, conduct a full investigation of

the health care provider or medical facility, as the case may

be.

(e) P

RESCRIPTION

ATE

EFINED

.—In this section, the term

‘‘prescription rate’’ means, with respect to a health care provider

or medical facility of the Department, each of the following:

(1) The number of patients treated with opioids by the

health care provider or at the medical facility, as the case

may be, divided by the total number of pharmacy users of

that health care provider or medical facility.

(2) The average number of morphine equivalents per day

prescribed by the health care provider or at the medical facility,

as the case may be, to patients being treated with opioids.

(3) Of the patients being treated with opioids by the health

care provider or at the medical facility, as the case may be,

the average number of prescriptions of opioids per patient.

SEC. 914. MANDATORY DISCLOSURE OF CERTAIN VETERAN INFORMA-

TION TO STATE CONTROLLED SUBSTANCE MONITORING

PROGRAMS.

Section 5701(l) of title 38, United States Code, is amended

by striking ‘‘may’’ and inserting ‘‘shall’’.

SEC. 915. ELIMINATION OF COPAYMENT REQUIREMENT FOR VET-

ERANS RECEIVING OPIOID ANTAGONISTS OR EDUCATION

ON USE OF OPIOID ANTAGONISTS.

(a) C

OPAYMENT FOR

PIOID

NTAGONISTS

.—Section 1722A(a)

of title 38, United States Code, is amended by adding at the end

the following new paragraph:

‘‘(4) Paragraph (1) does not apply to opioid antagonists fur-

nished under this chapter to a veteran who is at high risk for

overdose of a specific medication or substance in order to reverse

the effect of such an overdose.’’.

(b) C

OPAYMENT FOR

DUCATION ON

SE OF

PIOID

NTAGO

NISTS

.—Section 1710(g)(3) of such title is amended—

(1) by striking ‘‘with respect to home health services’’ and

inserting ‘‘with respect to the following:’’

‘‘(A) Home health services’’; and

38 USC 1701

note.

38 USC 1701

note.

Notification.

Determination.

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130 STAT. 766 PUBLIC LAW 114–198—JULY 22, 2016

(2) by adding at the end the following subparagraph:

‘‘(B) Education on the use of opioid antagonists to reverse

the effects of overdoses of specific medications or substances.’’.

Subtitle B—Patient Advocacy

SEC. 921. COMMUNITY MEETINGS ON IMPROVING CARE FURNISHED

BY DEPARTMENT OF VETERANS AFFAIRS.

(a) C

OMMUNITY

EETINGS

.—

(1) M

EDICAL 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) C

OMMUNITY

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) A

TTENDANCE BY

IRECTOR OF

ETERANS

NTEGRATED

ERVICE

ETWORK OR

ESIGNEE

.—

(1) I

N 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) A

TTENDANCE 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.

OTICE

.—The Secretary shall notify the Committee on Vet-

erans’ Affairs of the Senate, the Committee on Veterans’ Affairs

of the House of Representatives, and each Member of Congress

(as defined in section 902) who represents the area in which the

medical facility is located of a community meeting under subsection

(a) by not later than 10 days before such community meeting

occurs.

SEC. 922. IMPROVEMENT OF AWARENESS OF PATIENT ADVOCACY PRO-

GRAM AND PATIENT BILL OF RIGHTS OF DEPARTMENT

OF VETERANS AFFAIRS.

Not later than 90 days after the date of the enactment of

this Act, the Secretary of Veterans Affairs shall, in as many promi-

nent locations as the Secretary determines appropriate to be seen

by the largest percentage of patients and family members of patients

at each medical facility of the Department of Veterans Affairs—

(1) display the purposes of the Patient Advocacy Program

of the Department and the contact information for the patient

advocate at such medical facility; and

(2) display the rights and responsibilities of—

Deadline.

38 USC 1701

note.

Deadline.

38 USC 1701

note.

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130 STAT. 767 PUBLIC LAW 114–198—JULY 22, 2016

(A) patients and family members of patients at such

medical facility; and

(B) with respect to community living centers and other

residential facilities of the Department, residents and

family members of residents at such medical facility.

SEC. 923. COMPTROLLER GENERAL REPORT ON PATIENT ADVOCACY

PROGRAM OF DEPARTMENT OF VETERANS AFFAIRS.

(a) I

ENERAL

.—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) E

LEMENTS

.—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

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) I

ENERAL

.—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) E

STABLISHMENT

.—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) H

EAD

.—(1) The Director of the Office of Patient Advocacy

shall be the head of the Office.

‘‘(2) The Director of the Office of Patient Advocacy shall be

appointed by the Under Secretary for Health from among individ-

uals qualified to perform the duties of the position and shall report

directly to the Under Secretary for Health.

‘‘(c) F

UNCTION

.—(1) The function of the Office is to carry out

the Patient Advocacy Program of the Department.

Appointment.

38 USC 7309A.

38 USC 1701

note.

Recommenda-

tions.

Assessments.

38 USC 1701

note.

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130 STAT. 768 PUBLIC LAW 114–198—JULY 22, 2016

‘‘(2) In carrying out the Patient Advocacy Program of the

Department, the Director shall ensure that patient advocates of

the Department—

‘‘(A) advocate on behalf of veterans with respect to health

care received and sought by veterans under the laws adminis-

tered by the Secretary;

‘‘(B) carry out the responsibilities specified in subsection

(d); and

‘‘(C) receive training in patient advocacy.

‘‘(d) P

ATIENT

DVOCACY

ESPONSIBILITIES

.—The responsibilities

of each patient advocate at a medical facility of the Department

are the following:

‘‘(1) To resolve complaints by veterans with respect to

health care furnished under the laws administered by the Sec-

retary that cannot be resolved at the point of service or at

a higher level easily accessible to the veteran.

‘‘(2) To present at various meetings and to various commit-

tees the issues experienced by veterans in receiving such health

care at such medical facility.

‘‘(3) To express to veterans their rights and responsibilities

as patients in receiving such health care.

‘‘(4) To manage the Patient Advocate Tracking System of

the Department at such medical facility.

‘‘(5) To compile data at such medical facility of complaints

made by veterans with respect to the receipt of such health

care at such medical facility and the satisfaction of veterans

with such health care at such medical facility to determine

whether there are trends in such data.

‘‘(6) To ensure that a process is in place for the distribution

of the data compiled under paragraph (5) to appropriate leaders,

committees, services, and staff of the Department.

‘‘(7) To identify, not less frequently than quarterly,

opportunities for improvements in the furnishing of such health

care to veterans at such medical facility based on complaints

by veterans.

‘‘(8) To ensure that any significant complaint by a veteran

with respect to such health care is brought to the attention

of appropriate staff of the Department to trigger an assessment

of whether there needs to be a further analysis of the problem

at the facility-wide level.

‘‘(9) To support any patient advocacy programs carried

out by the Department.

‘‘(10) To ensure that all appeals and final decisions with

respect to the receipt of such health care are entered into

the Patient Advocate Tracking System of the Department.

‘‘(11) To understand all laws, directives, and other rules

with respect to the rights and responsibilities of veterans in

receiving such health care, including the appeals processes

available to veterans.

‘‘(12) To ensure that veterans receiving mental health care,

or the surrogate decision-makers for such veterans, are aware

of the rights of veterans to seek representation from systems

established under section 103 of the Protection and Advocacy

for Mentally Ill Individuals Act of 1986 (42 U.S.C. 10803)

to protect and advocate the rights of individuals with mental

illness and to investigate incidents of abuse and neglect of

such individuals.

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130 STAT. 769 PUBLIC LAW 114–198—JULY 22, 2016

‘‘(13) To fulfill requirements established by the Secretary

with respect to the inspection of controlled substances.

‘‘(14) To document potentially threatening behavior and

report such behavior to appropriate authorities.

‘‘(e) T

RAINING

.—In providing training to patient advocates

under subsection (c)(2)(C), the Director shall ensure that such

training is consistent throughout the Department.

‘‘(f) C

ONTROLLED

UBSTANCE

EFINED

.—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) C

LERICAL

MENDMENT

.—The table of sections at the begin-

ning of chapter 73 of such title is amended by inserting after

the item relating to section 7309 the following new item:

‘‘7309A. Office of Patient Advocacy.’’.

ATE

ULLY

PERATIONAL

.—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) E

STABLISHMENT

.—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) D

UTIES

.—The Commission shall perform the following

duties:

(1) Examine the efficacy of the evidence-based therapy

model used by the Secretary for treating mental health illnesses

of veterans and identify areas to improve wellness-based out-

comes.

(2) Conduct a patient-centered survey within each of the

Veterans Integrated Service Networks to examine—

(A) the experience of veterans with the Department

of Veterans Affairs when seeking medical assistance for

mental health issues through the health care system of

the Department;

(B) the experience of veterans with non-Department

facilities and health professionals for treating mental

health issues;

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 medica-

tion among veterans seeking treatment through the health

care system of the Department as remedies for addressing

mental health issues; and

(F) the outreach efforts of the Secretary regarding the

availability of benefits and treatments for veterans for

addressing mental health issues, including by identifying

ways to reduce barriers to gaps in such benefits and treat-

ments.

(3) Examine available research on complementary and

integrative health treatment therapies for mental health issues

and identify what benefits could be made with the inclusion

of such treatments for veterans, including with respect to—

(A) music therapy;

(B) equine therapy;

(D) yoga therapy;

(E) acupuncture therapy;

(F) meditation therapy;

(G) outdoor sports therapy;

(H) hyperbaric oxygen therapy;

(I) accelerated resolution therapy;

(J) art therapy;

(K) magnetic resonance therapy; and

(L) other therapies the Commission determines appro-

priate.

(4) Study the sufficiency of the resources of the Department

to ensure the delivery of quality health care for mental health

issues among veterans seeking treatment within the Depart-

ment.

(5) Study the current treatments and resources available

within the Department and assess—

(A) the effectiveness of such treatments and resources

in decreasing the number of suicides per day by veterans;

(B) the number of veterans who have been diagnosed

with mental health issues;

the Department who have been diagnosed with mental

health issues;

(D) the percentage of veterans who have completed

counseling sessions offered by the Department; and

(E) the efforts of the Department to expand complemen-

tary and integrative health treatments viable to the

recovery of veterans with mental health issues as deter-

mined by the Secretary to improve the effectiveness of

treatments offered by the Department.

EMBERSHIP

.—

(1) I

N GENERAL

.—The Commission shall be composed of

10 members, appointed as follows:

(A) Two members appointed by the Speaker of the

House of Representatives, at least one of whom shall be

a veteran.

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130 STAT. 771 PUBLIC LAW 114–198—JULY 22, 2016

(B) Two members appointed by the minority leader

of the House of Representatives, at least one of whom

shall be a veteran.

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) Q

UALIFICATIONS

.—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

complementary and integrative health treatments reviewed

by the Commission.

(3) C

HAIRMAN

.—The President shall designate a member

of the Commission to be the Chairman.

(4) P

ERIOD OF APPOINTMENT

.—Members of the Commission

shall be appointed for the life of the Commission.

(5) V

ACANCY

.—A vacancy in the Commission shall be filled

in the manner in which the original appointment was made.

(6) A

PPOINTMENT 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) P

OWERS OF

OMMISSION

.—

(1) M

EETINGS

.—

(A) I

NITIAL MEETING

.—The Commission shall hold its

first meeting not later than 30 days after a majority of

members are appointed to the Commission.

(B) M

EETING

.—The Commission shall regularly meet

at the call of the Chairman. Such meetings may be carried

out through the use of telephonic or other appropriate

telecommunication technology if the Commission deter-

mines that such technology will allow the members to

communicate simultaneously.

(2) H

EARINGS

.—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) I

NFORMATION FROM FEDERAL AGENCIES

.—The Commis-

sion may secure directly from any department or agency of

the Federal Government such information as the Commission

considers necessary to carry out the duties of the Commission.

(4) I

NFORMATION FROM NONGOVERNMENTAL ORGANIZA

TIONS

.—In carrying out its duties, the Commission may seek

guidance through consultation with foundations, veteran service

organizations, nonprofit groups, faith-based organizations, pri-

vate and public institutions of higher education, and other

organizations as the Commission determines appropriate.

(5) C

OMMISSION 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.

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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) P

ERSONNEL 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) C

OMPENSATION OF MEMBERS

;

TRAVEL EXPENSES

.—Each

member shall serve without pay but shall receive travel

expenses to perform the duties of the Commission, including

per diem in lieu of substances, at rates authorized under sub-

chapter I of chapter 57 of title 5, United States Code.

(8) S

TAFF

.—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) P

ERSONNEL AS FEDERAL EMPLOYEES

.—

(A) I

N GENERAL

.—The executive director and any per-

sonnel of the Commission are employees under section

2105 of title 5, United States Code, for purpose of chapters

63, 81, 83, 84, 85, 87, 89, and 90 of such title.

(B) M

EMBERS OF THE COMMISSION

.—Subparagraph (A)

shall not be construed to apply to members of the Commis-

sion.

(10) C

ONTRACTING

.—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) E

XPERT AND CONSULTANT SERVICE

.—The Commission

may procure the services of experts and consultants in accord-

ance with section 3109 of title 5, United States Code, at rates

not to exceed the daily rate paid to a person occupying a

position at level IV of the Executive Schedule under section

5315 of title 5, United States Code.

(12) P

OSTAL 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) P

HYSICAL FACILITIES AND EQUIPMENT

.—Upon the

request of the Commission, the Administrator of General Serv-

ices shall provide to the Commission, on a reimbursable basis,

the administrative support services necessary for the Commis-

sion to carry out its responsibilities under this Act. These

administrative services may include human resource manage-

ment, budget, leasing accounting, and payroll services.

(e) R

EPORT

.—

(1) I

NTERIM REPORTS

.—

(A) I

N 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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130 STAT. 773 PUBLIC LAW 114–198—JULY 22, 2016

Commission submits the final report under paragraph (2),

the Commission shall submit to the Committees on Vet-

erans’ Affairs of the House of Representatives and the

Senate and the President a report detailing the level of

cooperation the Secretary of Veterans Affairs (and the

heads of other departments or agencies of the Federal

Government) has provided to the Commission.

(B) O

THER 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) F

INAL REPORT

.—Not later than 18 months after the

first meeting of the Commission, the Commission shall submit

to the Committee on Veterans’ Affairs of the House of Rep-

resentatives and the Senate, the President, and the Secretary

of Veterans Affairs a final report on the findings of the Commis-

sion. Such report shall include the following:

(A) Recommendations to implement in a feasible,

timely, and cost-efficient manner the solutions and rem-

edies identified within the findings of the Commission

pursuant to subsection (b).

(B) An analysis of the evidence-based therapy model

used by the Secretary of Veterans Affairs for treating vet-

erans with mental health care issues, and an examination

of the prevalence and efficacy of prescription drugs as

a means for treatment.

ducted within each of the Veterans Integrated Service Net-

works pursuant to subsection (b)(2).

(D) An examination of complementary and integrative

health treatments described in subsection (b)(3) and the

potential benefits of incorporating such treatments in the

therapy models used by the Secretary for treating veterans

with mental health issues.

(3) P

LAN

.—Not later than 90 days after the date on which

the Commission submits the final report under paragraph (2),

the Secretary of Veterans Affairs shall submit to the Commit-

tees on Veterans’ Affairs of the House of Representatives and

the Senate a report on the following:

(A) An action plan for implementing the recommenda-

tions established by the Commission on such solutions

and remedies for improving wellness-based outcomes for

veterans with mental health care issues.

(B) A feasible timeframe on when the complementary

and integrative health treatments described in subsection

(b)(3) can be implemented Department-wide.

by the Commission, including any complementary and

integrative health treatment, that the Secretary determines

is not appropriate or feasible to implement, a justification

for such determination and an alternative solution to

improve the efficacy of the therapy models used by the

Secretary for treating veterans with mental health issues.

Timeframe.

Examination.

Analysis.

Recommenda-

tions.

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130 STAT. 774 PUBLIC LAW 114–198—JULY 22, 2016

(f) T

ERMINATION OF

OMMISSION

.—The Commission shall termi-

nate 30 days after the Commission submits the final report under

subsection (e)(2).

SEC. 932. EXPANSION OF RESEARCH AND EDUCATION ON AND

DELIVERY OF COMPLEMENTARY AND INTEGRATIVE

HEALTH TO VETERANS.

(a) D

EVELOPMENT OF

LAN

XPAND

ESEARCH

, E

DUCATION

AND

ELIVERY

.—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) E

LEMENTS

.—The plan required by subsection (a) shall pro-

vide for the following:

(1) Research on the following:

(A) The effectiveness of various complementary and

integrative health services, including the effectiveness of

such services integrated with clinical services.

(B) Approaches to integrating complementary and

integrative health services into other health care services

provided by the Department of Veterans Affairs.

(2) Education and training for health care professionals

of the Department on the following:

(A) Complementary and integrative health services

selected by the Secretary for purposes of the plan.

(B) Appropriate uses of such services.

health care to veterans.

(3) Research, education, and clinical activities on com-

plementary and integrative health at centers of innovation

at medical centers of the Department.

(4) Identification or development of metrics and outcome

measures to evaluate the effectiveness of the provision and

integration of complementary and integrative health services

into the delivery of health care to veterans.

(5) Integration and delivery of complementary and integra-

tive health services with other health care services provided

by the Department.

ONSULTATION

.—

(1) I

N GENERAL

.—In carrying out subsection (a), the Sec-

retary shall consult with the following:

(A) The Director of the National Center for Com-

plementary and Integrative Health of the National

Institutes of Health.

(B) The Commissioner of Food and Drugs.

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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130 STAT. 775 PUBLIC LAW 114–198—JULY 22, 2016

(2) S

COPE OF CONSULTATION

.—The Secretary shall under-

take consultation under paragraph (1) in carrying out sub-

section (a) with respect to the following:

(A) To develop the plan.

(B) To identify specific complementary and integrative

health practices that, on the basis of research findings

or promising clinical interventions, are appropriate to

include as services to veterans.

integration of complementary and integrative health serv-

ices into the delivery of health care to veterans, and to

identify mechanisms for overcoming such barriers.

SEC. 933. PILOT PROGRAM ON INTEGRATION OF COMPLEMENTARY

AND INTEGRATIVE HEALTH AND RELATED ISSUES FOR

VETERANS AND FAMILY MEMBERS OF VETERANS.

(a) P

ILOT

ROGRAM

.—

(1) I

N GENERAL

.—Not later than 180 days after the date

on which the Secretary of Veterans Affairs receives the final

report under section 931(e)(2), the Secretary shall commence

a pilot program to assess the feasibility and advisability of

using complementary and integrative health and wellness-

based programs (as defined by the Secretary) to complement

the provision of pain management and related health care

services, including mental health care services, to veterans.

(2) M

ATTERS ADDRESSED

.—In carrying out the pilot pro-

gram, the Secretary shall assess the following:

(A) Means of improving coordination between Federal,

State, local, and community providers of health care in

the provision of pain management and related health care

services to veterans.

(B) Means of enhancing outreach, and coordination

of outreach, by and among providers of health care referred

to in subparagraph (A) on the pain management and

related health care services available to veterans.

health and wellness-based programs of providers of health

care referred to in subparagraph (A) as complements to

the provision by the Department of Veterans Affairs of

pain management and related health care services to vet-

erans.

(D) Whether complementary and integrative health

and wellness-based programs described in subparagraph

(C)—

(i) are effective in enhancing the quality of life

and well-being of veterans;

(ii) are effective in increasing the adherence of

veterans to the primary pain management and related

health care services provided such veterans by the

Department;

(iii) have an effect on the sense of well-being of

veterans who receive primary pain management and

related health care services from the Department; and

(iv) are effective in encouraging veterans receiving

health care from the Department to adopt a more

healthy lifestyle.

Deadline.

Assessments.

38 USC 1701

note.

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130 STAT. 776 PUBLIC LAW 114–198—JULY 22, 2016

(b) D

URATION

.—The Secretary shall carry out the pilot program

under subsection (a)(1) for a period of three years.

OCATIONS

.—

(1) F

ACILITIES

.—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) M

EDICAL CENTERS WITH PRESCRIPTION RATES OF OPIOIDS

THAT CONFLICT WITH CARE STANDARDS

.—In selecting the med-

ical centers under paragraph (1), the Secretary shall give pri-

ority to medical centers of the Department at which there

is a prescription rate of opioids that conflicts with or is other-

wise inconsistent with the standards of appropriate and safe

care.

(d) P

ROVISION OF

ERVICES

.—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) C

OVERED

ETERANS

.—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) C

OVERED

ERVICES

.—

(1) I

N GENERAL

.—For purposes of the pilot program, covered

services are services consisting of complementary and integra-

tive health services as selected by the Secretary.

(2) A

DMINISTRATION OF SERVICES

.—Covered services shall

be administered under the pilot program as follows:

(A) Covered services shall be administered by profes-

sionals or other instructors with appropriate training and

expertise in complementary and integrative health services

who are employees of the Department or with whom the

Department enters into an agreement to provide such serv-

ices.

(B) Covered services shall be included as part of the

Patient Aligned Care Teams initiative of the Office of

Patient Care Services, Primary Care Program Office, in

coordination with the Office of Patient Centered Care and

Cultural Transformation.

(i) covered veterans who have received conven-

tional treatments from the Department for the condi-

tions for which the covered veteran seeks complemen-

tary and integrative health services under the pilot

program; and

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130 STAT. 777 PUBLIC LAW 114–198—JULY 22, 2016

(ii) covered veterans who have not received conven-

tional treatments from the Department for such condi-

tions.

(g) R

EPORTS

.—

(1) I

N GENERAL

.—Not later than 30 months after the date

on which the Secretary commences the pilot program under

subsection (a)(1), the Secretary shall submit to the Committee

on Veterans’ Affairs of the Senate and the Committee on Vet-

erans’ Affairs of the House of Representatives a report on

the pilot program.

(2) E

LEMENTS

.—The report under paragraph (1) shall

include the following:

(A) The findings and conclusions of the Secretary with

respect to the pilot program under subsection (a)(1),

including with respect to—

(i) the use and efficacy of the complementary and

integrative health services established under the pilot

program;

(ii) the outreach conducted by the Secretary to

inform veterans and community organizations about

the pilot program; and

(iii) an assessment of the benefit of the pilot pro-

gram to covered veterans in mental health diagnoses,

pain management, and treatment of chronic illness.

(B) Identification of any unresolved barriers that

impede the ability of the Secretary to incorporate com-

plementary and integrative health services with other

health care services provided by the Department.

expansion of the pilot program as the Secretary considers

appropriate.

Subtitle D—Fitness of Health Care

Providers

SEC. 941. ADDITIONAL REQUIREMENTS FOR HIRING OF HEALTH CARE

PROVIDERS BY DEPARTMENT OF VETERANS AFFAIRS.

As part of the hiring process for each health care provider

considered for a position at the Department of Veterans Affairs

after the date of the enactment of the Act, the Secretary of Veterans

Affairs shall require from the medical board of each State in which

the health care provider has or had a medical license—

(1) information on any violation of the requirements of

the medical license of the health care provider during the

20-year period preceding the consideration of the health care

provider by the Department; and

(2) information on whether the health care provider has

entered into any settlement agreement for a disciplinary charge

relating to the practice of medicine by the health care provider.

SEC. 942. PROVISION OF INFORMATION ON HEALTH CARE PROVIDERS

OF DEPARTMENT OF VETERANS AFFAIRS TO STATE MED-

ICAL BOARDS.

Notwithstanding section 552a of title 5, United States Code,

with respect to each health care provider of the Department of

Veterans Affairs who has violated a requirement of the medical

38 USC 1701

note.

Time period.

38 USC 1701

note.

Recommenda-

tions.

Assessment.

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130 STAT. 778 PUBLIC LAW 114–198—JULY 22, 2016

license of the health care provider, the Secretary of Veterans Affairs

shall provide to the medical board of each State in which the

health care provider is licensed detailed information with respect

to such violation, regardless of whether such board has formally

requested such information.

SEC. 943. REPORT ON COMPLIANCE BY DEPARTMENT OF VETERANS

AFFAIRS WITH REVIEWS OF HEALTH CARE PROVIDERS

LEAVING THE DEPARTMENT OR TRANSFERRING TO

OTHER FACILITIES.

Not later than 180 days after the date of the enactment of

this Act, the Secretary of Veterans Affairs shall submit to the

Committee on Veterans’ Affairs of the Senate and the Committee

on Veterans’ Affairs of the House of Representatives a report on

the compliance by the Department of Veterans Affairs with the

policy of the Department—

(1) to conduct a review of each health care provider of

the Department who transfers to another medical facility of

the Department, resigns, retires, or is terminated to determine

whether there are any concerns, complaints, or allegations of

violations relating to the medical practice of the health care

provider; and

(2) to take appropriate action with respect to any such

concern, complaint, or allegation.

Subtitle E—Other Matters

SEC. 951. MODIFICATION TO LIMITATION ON AWARDS AND BONUSES.

Section 705 of the Veterans Access, Choice, and Accountability

Act of 2014 (Public Law 113–146; 38 U.S.C. 703 note) is amended

to read as follows:

‘‘SEC. 705. LIMITATION ON AWARDS AND BONUSES PAID TO

EMPLOYEES OF DEPARTMENT OF VETERANS AFFAIRS.

‘‘(a) L

IMITATION

.—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) S

ENSE OF

ONGRESS

.—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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130 STAT. 779 PUBLIC LAW 114–198—JULY 22, 2016

LEGISLATIVE HISTORY—S. 524 (H.R. 1725) (H.R. 1818) (H.R. 3680) (H.R. 3691)

(H.R. 4063) (H.R. 4586) (H.R. 4599) (H.R. 4641)

(H.R. 4843) (H.R. 4892) (H.R. 4969) (H.R. 4976)

(H.R. 4978) (H.R. 4981) (H.R. 4982) (H.R. 4985)

(H.R. 5046) (H.R. 5048) (H.R. 5052):

HOUSE REPORTS: Nos. 114–669 (Comm. of Conference), 114–245 (Comm. on En-

ergy and Commerce) accompanying H.R. 1725, 114–552

(Comm. on Energy and Commerce) accompanying H.R. 1818,

114–553 (Comm. on Energy and Commerce) accompanying

H.R. 3680, 114–554 (Comm. on Energy and Commerce) accom-

panying H.R. 3691, 114–646 (Comm. on Veterans’ Affairs) ac-

companying H.R. 4063, 114–555 (Comm. on Energy and Com-

merce) 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) accom-

panying H.R. 4969, 114–557 (Comm. on Energy and the Work-

force) 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) accom-

panying H.R. 5052.

CONGRESSIONAL RECORD, Vol. 162 (2016):

Mar. 2, 3, 7–10, considered and passed Senate.

May 13, considered and passed House, amended.

July 8, House agreed to conference report.

July 11–13, Senate considered and agreed to conference report.

DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2016):

July 22, Presidential statement.

Affairs is encouraged to use bonuses to incentivize high-performing

employees in areas in which retention is challenging.’’.

Approved July 22, 2016.

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