In the House of Representatives, U. S., 

May 13, 2016. 

Resolved, That the bill from the Senate (S. 524) entitled 

‘‘An Act to authorize the Attorney General to award grants 

to address the national epidemics of prescription opioid abuse 

and heroin use.’’, do pass with the following 

AMENDMENTS: 

Strike out all after the enacting clause and insert: 

1 SECTION 1. TABLE OF CONTENTS. 

2 The table of contents for this Act is as follows: 

Sec. 1. Table of Contents. 

TITLE I—PAIN MANAGEMENT BEST PRACTICES INTER-AGENCY 

TASK FORCE 

Sec. 101. Development of best practices for the use of prescription opioids. 

TITLE II—COMPREHENSIVE OPIOID ABUSE REDUCTION ACT 

Sec. 201. Short title. 

Sec. 202. Comprehensive Opioid Abuse Grant Program. 

Sec. 203. Audit and accountability of grantees. 

Sec. 204. Veterans treatment courts. 

Sec. 205. Emergency Federal law enforcement assistance. 

Sec. 206. Inclusion of services for pregnant women under family-based substance 

abuse grants. 

Sec. 207. GAO study and report on Department of Justice programs and research 

relative to substance use and substance use disorders among adolescents and young adults. 

TITLE III—JASON SIMCAKOSKI PROMISE ACT 

Sec. 301. Short title. 

Sec. 302. Improvement of opioid safety measures by Department of Veterans Affairs. 

Sec. 303. Strengthening of joint working group on pain management of the Department of Veterans Affairs and the Department of Defense. 

Sec. 304. Review, investigation, and report on use of opioids in treatment by Department of Veterans Affairs. 
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Sec. 305. Mandatory disclosure of certain veteran information to State controlled 

substance monitoring programs. 

Sec. 306. Modification to limitation on awards and bonuses. 

TITLE IV—KINGPIN DESIGNATION IMPROVEMENT ACT 

Sec. 401. Short title. 

Sec. 402. Protection of classified information in Federal court challenges relating 

to designations under the Narcotics Kingpin Designation Act. 

TITLE V—GOOD SAMARITAN ASSESSMENT ACT 

Sec. 501. Short title. 

Sec. 502. Finding. 

Sec. 503. GAO Study on Good Samaritan laws pertaining to treatment of opioid 

overdoses. 

Sec. 504. Definitions. 

TITLE VI—OPEN ACT 

Sec. 601. Short title. 

Sec. 602. Evaluation of performance of Department of Justice program. 

Sec. 603. Evaluation of performance of Department of Health and Human Services program. 

Sec. 604. Definition. 

Sec. 605. No additional funds authorized. 

Sec. 606. Matters regarding certain Federal law enforcement assistance. 

TITLE VII—INFANT PLAN OF SAFE CARE IMPROVEMENT ACT 

Sec. 701. Short title. 

Sec. 702. Best practices for development of plans of safe care. 

Sec. 703. State plans. 

Sec. 704. Data reports. 

Sec. 705. Monitoring and oversight. 

Sec. 706. Rule of construction. 

TITLE VIII—NAS HEALTHY BABIES ACT 

Sec. 801. Short title. 

Sec. 802. GAO report on neonatal abstinence syndrome (NAS). 

Sec. 803. Excluding abuse-deterrent formulations of prescription drugs from the 

Medicaid additional rebate requirement for new formulations of 

prescription drugs. 

Sec. 804. Limiting disclosure of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse. 

Sec. 805. Medicaid Improvement Fund. 

TITLE IX—CO-PRESCRIBING TO REDUCE OVERDOSES ACT 

Sec. 901. Short title. 

Sec. 902. Opioid overdose reversal drugs prescribing grant program. 

Sec. 903. Providing information to prescribers in certain Federal health care and 

medical facilities on best practices for prescribing opioid overdose reversal drugs. 

Sec. 904. Authorization of appropriations. 

Sec. 905. Cut-Go Compliance. 
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TITLE X—IMPROVING TREATMENT FOR PREGNANT AND 

POSTPARTUM WOMEN ACT 

Sec. 1001. Short title. 

Sec. 1002. Reauthorization of residential treatment programs for pregnant and 

postpartum women. 

Sec. 1003. Pilot program grants for State substance abuse agencies. 

Sec. 1004. Cut-Go Compliance. 

TITLE XI—VETERAN EMERGENCY MEDICAL TECHNICIAN SUPPORT 

ACT 

Sec. 1101. Short title. 

Sec. 1102. Assisting veterans with military emergency medical training to meet 

requirements for becoming civilian emergency medical technicians. 

TITLE XII—JOHN THOMAS DECKER ACT 

Sec. 1201. Short title. 

Sec. 1202. Information materials and resources to prevent addiction related to 

youth sports injuries. 

TITLE XIII—LALI’S LAW 

Sec. 1301. Short title. 

Sec. 1302. Opioid overdose reversal medication access and education grant programs. 

Sec. 1303. Cut-Go Compliance. 

TITLE XIV—REDUCING UNUSED MEDICATIONS ACT 

Sec. 1401. Short title. 

Sec. 1402. Partial fills of schedule II controlled substances. 

TITLE XV—OPIOID REVIEW MODERNIZATION ACT 

Sec. 1501. Short title. 

Sec. 1502. FDA opioid action plan. 

Sec. 1503. Prescriber education. 

Sec. 1504. Guidance on evaluating the abuse deterrence of generic solid oral 

opioid drug products. 

TITLE XVI—EXAMINING OPIOID TREATMENT INFRASTRUCTURE ACT 

Sec. 1601. Short title. 

Sec. 1602. Study on treatment infrastructure. 

TITLE XVII—OPIOID USE DISORDER TREATMENT EXPANSION AND 

MODERNIZATION ACT 

Sec. 1701. Short title. 

Sec. 1702. Finding. 

Sec. 1703. Opioid use disorder treatment modernization. 

Sec. 1704. Sense of Congress. 

Sec. 1705. Partial fills of schedule II controlled substances. 
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TITLE XVIII—NATIONAL ALL SCHEDULES PRESCRIPTION 

ELECTRONIC REPORTING REAUTHORIZATION ACT 

Sec. 1801. Short title. 

Sec. 1802. Amendment to purpose. 

Sec. 1803. Amendments to controlled substance monitoring program. 

1 TITLE I—PAIN MANAGEMENT 

2 BEST PRACTICES INTER3 AGENCY TASK FORCE 

4 SEC. 101. DEVELOPMENT OF BEST PRACTICES FOR THE USE 

5 OF PRESCRIPTION OPIOIDS. 

6 (a) DEFINITIONS.—In this section— 

7 (1) the term ‘‘Secretary’’ means the Secretary of 

8 Health and Human Services; and 

9 (2) the term ‘‘task force’’ means the Pain Man10 agement Best Practices Inter-Agency Task Force con11 vened under subsection (b). 

12 (b) INTER-AGENCY TASK FORCE.—Not later than De13 cember 14, 2018, the Secretary, in cooperation with the Sec14 retary of Veterans Affairs, the Secretary of Defense, and the 

15 Administrator of the Drug Enforcement Administration, 

16 shall convene a Pain Management Best Practices Inter17 Agency Task Force to review, modify, and update, as ap18 propriate, best practices for pain management (including 

19 chronic and acute pain) and prescribing pain medication. 

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

21 of— 

22 (1) representatives of— 
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1 (A) the Department of Health and Human 

2 Services; 

3 (B) the Department of Veterans Affairs; 

4 (C) the Food and Drug Administration; 

5 (D) the Department of Defense; 

6 (E) the Drug Enforcement Administration; 

7 (F) the Centers for Disease Control and 

8 Prevention; 

9 (G) the Health Resources and Services Ad10 ministration; 

11 (H) the Indian Health Service; 

12 (I) the National Academy of Medicine; 

13 (J) the National Institutes of Health; 

14 (K) the Office of National Drug Control 

15 Policy; 

16 (L) the Substance Abuse and Mental Health 

17 Services Administration; and 

18 (M) the Office of Women’s Health; 

19 (2) State medical boards; 

20 (3) subject to subsection (e), physicians, dentists, 

21 and nonphysician prescribers; 

22 (4) hospitals; 

23 (5) subject to subsection (e), pharmacists and 

24 pharmacies; 

25 (6) first responders; 
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1 (7) experts in the fields of pain research and ad2 diction research; 

3 (8) experts in the fields of adolescent and young 

4 adult addiction research; 

5 (9) representatives of— 

6 (A) pain management professional organi7 zations; 

8 (B) the mental health treatment commu9 nity; 

10 (C) the addiction treatment and recovery 

11 community; 

12 (D) pain advocacy groups; 

13 (E) veteran service organizations; and 

14 (F) groups with expertise on overdose rever15 sal; 

16 (10) a person in recovery from addiction to 

17 medication for chronic pain; 

18 (11) a person in recovery from addiction to 

19 medication for chronic pain, whose addiction began 

20 in adolescence or young adulthood; 

21 (12) a person with chronic pain; 

22 (13) an expert on active duty military, armed 

23 forces personnel, and veteran health and prescription 

24 opioid addiction; 
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1 (14) an expert in the field of minority health; 

2 and 

3 (15) other stakeholders, as the Secretary deter4 mines appropriate. 

5 (d) CONDITION ON PARTICIPATION ON TASK FORCE.— 

6 An individual representing a profession or entity described 

7 in paragraph (3) or (5) of subsection (c) may not serve as 

8 a member of the task force unless such individual— 

9 (1) is currently licensed in a State in which such 

10 individual is practicing (as defined by such State) 

11 such profession (or, in the case of an individual rep12 resenting an entity, a State in which the entity is en13 gaged in business); and 

14 (2) is currently practicing (as defined by such 

15 State) such profession (or, in the case of an indi16 vidual representing an entity, the entity is in oper17 ation). 

18 (e) DUTIES.—The task force shall— 

19 (1) not later than 180 days after the date on 

20 which the task force is convened under subsection (b), 

21 review, modify, and update, as appropriate, best 

22 practices for pain management (including chronic 

23 and acute pain) and prescribing pain medication, 

24 taking into consideration— 

25 (A) existing pain management research; 
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1 (B) research on trends in areas and com2 munities in which the prescription opioid abuse 

3 rate and fatality rate exceed the national average 

4 prescription opioid abuse rate and fatality rate; 

5 (C) recommendations from relevant con6 ferences and existing relevant evidence-based 

7 guidelines; 

8 (D) ongoing efforts at the State and local 

9 levels and by medical professional organizations 

10 to develop improved pain management strategies, 

11 including consideration of differences within and 

12 between classes of opioids, the availability of 

13 opioids with abuse deterrent technology, and 

14 pharmacological, nonpharmacological, medical 

15 device alternatives to opioids to reduce opioid 

16 monotherapy in appropriate cases and the co17 ordination of information collected from State 

18 prescription drug monitoring programs for the 

19 purpose of preventing the diversion of pain 

20 medication; 

21 (E) ongoing efforts at the Federal, State, 

22 and local levels to examine the potential benefits 

23 of electronic prescribing of opioids, including 

24 any public comments collected in the course of 

25 those efforts; 
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1 (F) the management of high-risk popu2 lations, other than populations who suffer pain, 

3 who— 

4 (i) may use or be prescribed 

5 benzodiazepines, alcohol, and diverted 

6 opioids; or 

7 (ii) receive opioids in the course of 

8 medical care; 

9 (G) the distinct needs of adolescents and 

10 young adults with respect to pain management, 

11 pain medication, substance use disorder, and 

12 medication-assisted treatment; 

13 (H) the 2016 Guideline for Prescribing 

14 Opioids for Chronic Pain issued by the Centers 

15 for Disease Control and Prevention; 

16 (I) the practice of co-prescribing naloxone 

17 for both pain patients receiving chronic opioid 

18 therapy and patients being treated for opioid use 

19 disorders; 

20 (J) research that has been, or is being, con21 ducted or supported by the Federal Government 

22 on prevention of, treatment for, and recovery 

23 from substance use by and substance use dis24 orders among adolescents and young adults rel25 ative to any unique circumstances (including so-
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1 cial and biological circumstances) of adolescents 

2 and young adults that may make adolescent-spe3 cific and young adult-specific treatment proto4 cols necessary, including any effects that sub5 stance use and substance use disorders may have 

6 on brain development and the implications for 

7 treatment and recovery; 

8 (K) Federal non-research programs and ac9 tivities that address prevention of, treatment for, 

10 and recovery from substance use by and sub11 stance use disorders among adolescents and 

12 young adults, including an assessment of the ef13 fectiveness of such programs and activities in— 

14 (i) preventing substance use by and 

15 substance use disorders among adolescents 

16 and young adults; 

17 (ii) treating such adolescents and 

18 young adults in a way that accounts for 

19 any unique circumstances faced by adoles20 cents and young adults; and 

21 (iii) supporting long-term recovery 

22 among adolescents and young adults; and 

23 (L) gaps that have been identified by Fed24 eral officials and experts in Federal efforts relat25 ing to prevention of, treatment for, and recovery 
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1 from substance use by and substance use dis2 orders among adolescents and young adults, in3 cluding gaps in research, data collection, and 

4 measures to evaluate the effectiveness of Federal 

5 efforts, and the reasons for such gaps; 

6 (2) solicit and take into consideration public 

7 comment on the practices developed under paragraph 

8 (1), amending such best practices if appropriate; 

9 (3) develop a strategy for disseminating informa10 tion about the best practices developed under para11 graphs (1) and (2) to prescribers, pharmacists, State 

12 medical boards, educational institutions that educate 

13 prescribers and pharmacists, and other parties, as the 

14 Secretary determines appropriate; 

15 (4) review, modify, and update best practices for 

16 pain management and prescribing pain medication, 

17 specifically as it pertains to physician education and 

18 consumer education; and 

19 (5) examine and identify— 

20 (A) the extent of the need for the develop21 ment of new pharmacological, nonpharma22 cological, and medical device alternatives to 

23 opioids; 

24 (B) the current status of research efforts to 

25 develop such alternatives; and 
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1 (C) the pharmacological, nonpharma2 cological, and medical device alternatives to 

3 opioids that are currently available that could be 

4 better utilized. 

5 (f) CONSIDERATION OF STUDY RESULTS.—In review6 ing, modifying, and updating, best practices for pain man7 agement and prescribing pain medication, the task force 

8 shall take into consideration existing private sector, State, 

9 and local government efforts related to pain management 

10 and prescribing pain medication. 

11 (g) LIMITATION.—The task force shall not have rule12 making authority. 

13 (h) REPORT.—Not later than 270 days after the date 

14 on which the task force is convened under subsection (b), 

15 the task force shall submit to Congress a report that in16 cludes— 

17 (1) the strategy for disseminating best practices 

18 for pain management (including chronic and acute 

19 pain) and prescribing pain medication, as developed 

20 under subsection (e); 

21 (2) the results of a feasibility study on linking 

22 the best practices described in paragraph (1) to re23 ceiving and renewing registrations under section 

24 303(f) of the Controlled Substances Act (21 U.S.C. 

25 823(f)); 
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1 (3) recommendations for effectively applying the 

2 best practices described in paragraph (1) to improve 

3 prescribing practices at medical facilities, including 

4 medical facilities of the Veterans Health Administra5 tion and Indian Health Service; 

6 (4) the modified and updated best practices de7 scribed in subsection (e)(4); and 

8 (5) the results of the examination and identifica9 tion conducted pursuant to subsection (e)(4), and rec10 ommendations regarding— 

11 (A) the development of new pharma12 cological, nonpharmacological, and medical de13 vice alternatives to opioids; and 

14 (B) the improved utilization of pharma15 cological, nonpharmacological, and medical de16 vice alternatives to opioids that are currently 

17 available. 

18 TITLE II—COMPREHENSIVE 

19 OPIOID ABUSE REDUCTION ACT 

20 SEC. 201. SHORT TITLE. 

21 This title may be cited as the ‘‘Comprehensive Opioid 

22 Abuse Reduction Act of 2016’’. 
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1 SEC. 202. COMPREHENSIVE OPIOID ABUSE GRANT PRO2 GRAM. 

3 (a) IN GENERAL.—Title I of the Omnibus Crime Con4 trol and Safe Streets Act of 1968 (42 U.S.C. 3711 et seq.) 

5 is amended by adding at the end the following: 

6 ‘‘PART LL—COMPREHENSIVE OPIOID ABUSE 

7 GRANT PROGRAM 

8 ‘‘SEC. 3021. DESCRIPTION. 

9 ‘‘(a) GRANTS AUTHORIZED.—From amounts made 

10 available to carry out this part, the Attorney General may 

11 make grants to States, units of local government, and In12 dian tribes, for use by the State, unit of local government, 

13 or Indian tribe to provide services primarily relating to 

14 opioid abuse, including for any one or more of the following: 

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

16 treatment alternative to incarceration program, 

17 which may include— 

18 ‘‘(A) pre-booking or post-booking compo19 nents, which may include the activities described 

20 in part DD or HH of this title; 

21 ‘‘(B) training for criminal justice agency 

22 personnel on substance use disorders and co-oc23 curring mental illness and substance use dis24 orders; 

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

26 activities described in part V of this title; 
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1 ‘‘(D) a drug court, including the activities 

2 described in part EE of this title; 

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

4 including the activities described in subsection 

5 (i) of section 2991 of this title; 

6 ‘‘(F) a focus on parents whose incarceration 

7 could result in their children entering the child 

8 welfare system; and 

9 ‘‘(G) a community-based substance use di10 version program sponsored by a law enforcement 

11 agency. 

12 ‘‘(2) In the case of a State, facilitating or en13 hancing planning and collaboration between State 

14 criminal justice agencies and State substance abuse 

15 systems in order to more efficiently and effectively 

16 carry out programs described in paragraph (1) that 

17 address problems related to opioid abuse. 

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

19 responders on carrying and administering an opioid 

20 overdose reversal drug or device approved by the Food 

21 and Drug Administration, and purchasing such a 

22 drug or device for first responders who have received 

23 such training to carry and administer. 
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1 ‘‘(4) Investigative purposes to locate or inves2 tigate illicit activities related to the unlawful dis3 tribution of opioids. 

4 ‘‘(5) Developing, implementing, or expanding a 

5 medication-assisted treatment program used or oper6 ated by a criminal justice agency, which may include 

7 training criminal justice agency personnel on medica8 tion-assisted treatment, and carrying out the activi9 ties described in part S of this title. 

10 ‘‘(6) In the case of a State, developing, imple11 menting, or expanding a prescription drug moni12 toring program to collect and analyze data related to 

13 the prescribing of schedules II, III, and IV controlled 

14 substances through a centralized database adminis15 tered by an authorized State agency, which includes 

16 tracking the dispensation of such substances, and pro17 viding for interoperability and data sharing with 

18 other States. 

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

20 program to prevent and address opioid abuse by juve21 niles. 

22 ‘‘(8) Developing, implementing, or expanding an 

23 integrated and comprehensive opioid abuse response 

24 program, including prevention and recovery pro25 grams. 
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1 ‘‘(9) Developing, implementing, or expanding a 

2 program (which may include demonstration projects) 

3 to utilize technology that provides a secure container 

4 for prescription drugs that would prevent individuals, 

5 particularly adolescents, from gaining access to 

6 opioid medications that are lawfully prescribed for 

7 other individuals. 

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

9 program to prevent and address opioid abuse by vet10 erans. 

11 ‘‘(11) Developing, implementing, or expanding a 

12 prescription drug take-back program. 

13 ‘‘(b) CONTRACTS AND SUBAWARDS.—A State, unit of 

14 local government, or Indian tribe may, in using a grant 

15 under this subpart for purposes authorized by subsection 

16 (a), use all or a portion of that grant to contract with or 

17 make one or more subawards to one or more— 

18 ‘‘(1) local or regional organizations that are pri19 vate and nonprofit, including faith-based organiza20 tions; 

21 ‘‘(2) units of local government; or 

22 ‘‘(3) tribal organizations. 

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

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

25 program funded under this subpart shall contain a 
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1 program assessment component, developed pursuant 

2 to guidelines established by the Attorney General, in 

3 coordination with the National Institute of Justice. 

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

5 the requirement of paragraph (1) with respect to a 

6 program if, in the opinion of the Attorney General, 

7 the program is not of sufficient size to justify a full 

8 program assessment. 

9 ‘‘(d) ADMINISTRATIVE COSTS.—Not more than 10 per10 cent of a grant made under this subpart may be used for 

11 costs incurred to administer such grant. 

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

13 part may not be longer than 4 years, except that renewals 

14 and extensions beyond that period may be granted at the 

15 discretion of the Attorney General. 

16 ‘‘SEC. 3022. APPLICATIONS. 

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

18 officer of a State, unit of local government, or Indian tribe 

19 shall submit an application to the Attorney General at such 

20 time and in such form as the Attorney General may require. 

21 Such application shall include the following: 

22 ‘‘(1) A certification that Federal funds made 

23 available under this subpart will not be used to sup24 plant State, local, or tribal funds, but will be used to 

25 increase the amounts of such funds that would, in the 
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1 absence of Federal funds, be made available for the 

2 activities described in section 3021(a). 

3 ‘‘(2) An assurance that, for each fiscal year cov4 ered by an application, the applicant shall maintain 

5 and report such data, records, and information (pro6 grammatic and financial) as the Attorney General 

7 may reasonably require. 

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

9 to the Attorney General and executed by the chief ex10 ecutive officer of the applicant (or by another officer 

11 of the applicant, if qualified under regulations pro12 mulgated by the Attorney General), that— 

13 ‘‘(A) the programs to be funded by the grant 

14 meet all the requirements of this part; 

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

16 application is correct; 

17 ‘‘(C) there has been appropriate coordina18 tion with affected agencies; and 

19 ‘‘(D) the applicant will comply with all 

20 provisions of this part and all other applicable 

21 Federal laws. 

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

23 with the Drug Enforcement Administration to develop 

24 an integrated and comprehensive strategy to address 

25 opioid abuse. 
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1 ‘‘SEC. 3023. REVIEW OF APPLICATIONS. 

2 ‘‘The Attorney General shall not finally disapprove 

3 any application (or any amendment to that application) 

4 submitted under this part without first affording the appli5 cant reasonable notice of any deficiencies in the application 

6 and opportunity for correction and reconsideration. 

7 ‘‘SEC. 3024. EQUITABLE DISTRIBUTION OF FUNDS. 

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

9 General shall ensure equitable distribution of funds based 

10 on the following: 

11 ‘‘(1) The geographic distribution of grants under 

12 this part, taking into consideration the needs of un13 derserved populations, including rural and tribal 

14 communities. 

15 ‘‘(2) The needs of communities to address the 

16 problems related to opioid abuse, taking into consider17 ation the prevalence of opioid abuse and overdose-re18 lated death in a community. 

19 ‘‘SEC. 3025. DEFINITIONS. 

20 ‘‘In this part: 

21 ‘‘(1) The term ‘first responder’ includes a fire22 fighter, law enforcement officer, paramedic, emergency 

23 medical technician, or other individual (including an 

24 employee of a legally organized and recognized volun25 teer organization, whether compensated or not), who, 

26 in the course of professional duties, responds to fire, 
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1 medical, hazardous material, or other similar emer2 gencies. 

3 ‘‘(2) The term ‘medication-assisted treatment’ 

4 means the use of medications approved by the Food 

5 and Drug Administration for the treatment of opioid 

6 abuse. 

7 ‘‘(3) The term ‘opioid’ means any drug, includ8 ing heroin, having an addiction-forming or addiction9 sustaining liability similar to morphine or being ca10 pable of conversion into a drug having such addic11 tion-forming or addiction-sustaining liability. 

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

13 substance’ means a controlled substance that is listed 

14 on schedule II, schedule III, or schedule IV of section 

15 202(c) of the Controlled Substances Act (21 U.S.C. 

16 812(c)). 

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

18 meanings given those terms in section 201 of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 321). 

20 ‘‘(6) The term ‘criminal justice agency’ means a 

21 State, local, or tribal— 

22 ‘‘(A) court; 

23 ‘‘(B) prison; 

24 ‘‘(C) jail; 

25 ‘‘(D) law enforcement agency; or 
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1 ‘‘(E) other agency that performs the admin2 istration of criminal justice, including prosecu3 tion, pretrial services, and community super4 vision. 

5 ‘‘(7) The term ‘tribal organization’ has the 

6 meaning given that term in section 4 of the Indian 

7 Self-Determination and Education Assistance Act (25 

8 U.S.C. 450b).’’. 

9 (b) AUTHORIZATION OF APPROPRIATIONS.—Section 

10 1001(a) of the Omnibus Crime Control and Safe Streets Act 

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

12 paragraph (26) the following: 

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

14 carry out part LL $103,000,000 for each of fiscal 

15 years 2017 through 2021.’’. 

16 SEC. 203. AUDIT AND ACCOUNTABILITY OF GRANTEES. 

17 (a) DEFINITIONS.—In this section— 

18 (1) the term ‘‘covered grant program’’ means a 

19 grant program operated by the Department of Justice; 

20 (2) the term ‘‘covered grantee’’ means a recipient 

21 of a grant from a covered grant program; 

22 (3) the term ‘‘nonprofit’’, when used with respect 

23 to an organization, means an organization that is de24 scribed in section 501(c)(3) of the Internal Revenue 
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1 Code of 1986, and is exempt from taxation under sec2 tion 501(a) of such Code; and 

3 (4) the term ‘‘unresolved audit finding’’ means 

4 an audit report finding in a final audit report of the 

5 Inspector General of the Department of Justice that 

6 a covered grantee has used grant funds awarded to 

7 that grantee under a covered grant program for an 

8 unauthorized expenditure or otherwise unallowable 

9 cost that is not closed or resolved during a 12-month 

10 period prior to the date on which the final audit re11 port is issued. 

12 (b) AUDIT REQUIREMENT.—Beginning in fiscal year 

13 2016, and annually thereafter, the Inspector General of the 

14 Department of Justice shall conduct audits of covered 

15 grantees to prevent waste, fraud, and abuse of funds award16 ed under covered grant programs. The Inspector General 

17 shall determine the appropriate number of covered grantees 

18 to be audited each year. 

19 (c) MANDATORY EXCLUSION.—A grantee that is found 

20 to have an unresolved audit finding under an audit con21 ducted under subsection (b) may not receive grant funds 

22 under a covered grant program in the fiscal year following 

23 the fiscal year to which the finding relates. 

24 (d) REIMBURSEMENT.—If a covered grantee is award25 ed funds under the covered grant program from which it 
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1 received a grant award during the 1-fiscal-year period dur2 ing which the covered grantee is ineligible for an allocation 

3 of grant funds under subsection (c), the Attorney General 

4 shall— 

5 (1) deposit into the General Fund of the Treas6 ury an amount that is equal to the amount of the 

7 grant funds that were improperly awarded to the cov8 ered grantee; and 

9 (2) seek to recoup the costs of the repayment to 

10 the Fund from the covered grantee that was improp11 erly awarded the grant funds. 

12 (e) PRIORITY OF GRANT AWARDS.—The Attorney Gen13 eral, in awarding grants under a covered grant program 

14 shall give priority to eligible entities that during the 2-year 

15 period preceding the application for a grant have not been 

16 found to have an unresolved audit finding. 

17 (f) NONPROFIT REQUIREMENTS.— 

18 (1) PROHIBITION.—A nonprofit organization 

19 that holds money in offshore accounts for the purpose 

20 of avoiding the tax described in section 511(a) of the 

21 Internal Revenue Code of 1986, shall not be eligible 

22 to receive, directly or indirectly, any funds from a 

23 covered grant program. 

24 (2) DISCLOSURE.—Each nonprofit organization 

25 that is a covered grantee shall disclose in its applica-
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1 tion for such a grant, as a condition of receipt of such 

2 a grant, the compensation of its officers, directors, 

3 and trustees. Such disclosure shall include a descrip4 tion of the criteria relied on to determine such com5 pensation. 

6 SEC. 204. VETERANS TREATMENT COURTS. 

7 Section 2991 of the Omnibus Crime Control and Safe 

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

9 (1) by redesignating subsection (i) as subsection 

10 (j); and 

11 (2) by inserting after subsection (h) the fol12 lowing: 

13 ‘‘(i) ASSISTING VETERANS.— 

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

15 ‘‘(A) PEER TO PEER SERVICES OR PRO16 GRAMS.—The term ‘peer to peer services or pro17 grams’ means services or programs that connect 

18 qualified veterans with other veterans for the 

19 purpose of providing support and mentorship to 

20 assist qualified veterans in obtaining treatment, 

21 recovery, stabilization, or rehabilitation. 

22 ‘‘(B) QUALIFIED VETERAN.—The term 

23 ‘qualified veteran’ means a preliminarily quali24 fied offender who— 
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1 ‘‘(i) served on active duty in any 

2 branch of the Armed Forces, including the 

3 National Guard or Reserves; and 

4 ‘‘(ii) was discharged or released from 

5 such service under conditions other than 

6 dishonorable. 

7 ‘‘(C) VETERANS TREATMENT COURT PRO8 GRAM.—The term ‘veterans treatment court pro9 gram’ means a court program involving collabo10 ration among criminal justice, veterans, and 

11 mental health and substance abuse agencies that 

12 provides qualified veterans with— 

13 ‘‘(i) intensive judicial supervision and 

14 case management, which may include ran15 dom and frequent drug testing where appro16 priate; 

17 ‘‘(ii) a full continuum of treatment 

18 services, including mental health services, 

19 substance abuse services, medical services, 

20 and services to address trauma; 

21 ‘‘(iii) alternatives to incarceration; or 

22 ‘‘(iv) other appropriate services, in23 cluding housing, transportation, mentoring, 

24 employment, job training, education, or as-
27 

•S 524 EAH 

1 sistance in applying for and obtaining 

2 available benefits. 

3 ‘‘(2) VETERANS ASSISTANCE PROGRAM.— 

4 ‘‘(A) IN GENERAL.—The Attorney General, 

5 in consultation with the Secretary of Veterans 

6 Affairs, may award grants under this subsection 

7 to applicants to establish or expand— 

8 ‘‘(i) veterans treatment court pro9 grams; 

10 ‘‘(ii) peer to peer services or programs 

11 for qualified veterans; 

12 ‘‘(iii) practices that identify and pro13 vide treatment, rehabilitation, legal, transi14 tional, and other appropriate services to 

15 qualified veterans who have been incarcer16 ated; or 

17 ‘‘(iv) training programs to teach 

18 criminal justice, law enforcement, correc19 tions, mental health, and substance abuse 

20 personnel how to identify and appropriately 

21 respond to incidents involving qualified vet22 erans. 

23 ‘‘(B) PRIORITY.—In awarding grants under 

24 this subsection, the Attorney General shall give 

25 priority to applications that— 
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•S 524 EAH 

1 ‘‘(i) demonstrate collaboration between 

2 and joint investments by criminal justice, 

3 mental health, substance abuse, and vet4 erans service agencies; 

5 ‘‘(ii) promote effective strategies to 

6 identify and reduce the risk of harm to 

7 qualified veterans and public safety; and 

8 ‘‘(iii) propose interventions with em9 pirical support to improve outcomes for 

10 qualified veterans.’’. 

11 SEC. 205. EMERGENCY FEDERAL LAW ENFORCEMENT AS12 SISTANCE. 

13 Section 609Y(a) of the Justice Assistance Act of 1984 

14 (42 U.S.C. 10513(a)) is amended by striking ‘‘September 

15 30, 1984’’ and inserting ‘‘September 30, 2021’’. 

16 SEC. 206. INCLUSION OF SERVICES FOR PREGNANT WOMEN 

17 UNDER FAMILY-BASED SUBSTANCE ABUSE 

18 GRANTS. 

19 Part DD of title I of the Omnibus Crime Control and 

20 Safe Streets Act (42 U.S.C. 3797s et seq.) is amended— 

21 (1) in section 2921(2), by inserting before the pe22 riod at the end ‘‘or pregnant women’’; and 

23 (2) in section 2927— 

24 (A) in paragraph (1)(A), by inserting 

25 ‘‘pregnant or’’ before ‘‘a parent’’; and 
29 

•S 524 EAH 

1 (B) in paragraph (3), by inserting ‘‘or 

2 pregnant women’’ after ‘‘incarcerated parents’’. 

3 SEC. 207. GAO STUDY AND REPORT ON DEPARTMENT OF 

4 JUSTICE PROGRAMS AND RESEARCH REL5 ATIVE TO SUBSTANCE USE AND SUBSTANCE 

6 USE DISORDERS AMONG ADOLESCENTS AND 

7 YOUNG ADULTS. 

8 (a) STUDY.—The Comptroller General of the United 

9 States shall conduct a study on how the Department of Jus10 tice, through grant programs, is addressing prevention of, 

11 treatment for, and recovery from substance use by and sub12 stance use disorders among adolescents and young adults. 

13 Such study shall include an analysis of each of the fol14 lowing: 

15 (1) The research that has been, and is being, con16 ducted or supported pursuant to grant programs op17 erated by the Department of Justice on prevention of, 

18 treatment for, and recovery from substance use by 

19 and substance use disorders among adolescents and 

20 young adults, including an assessment of— 

21 (A) such research relative to any unique 

22 circumstances (including social and biological 

23 circumstances) of adolescents and young adults 

24 that may make adolescent-specific and young 

25 adult-specific treatment protocols necessary, in-
30 

•S 524 EAH 

1 cluding any effects that substance use and sub2 stance use disorders may have on brain develop3 ment and the implications for treatment and re4 covery; and 

5 (B) areas of such research in which greater 

6 investment or focus is necessary relative to other 

7 areas of such research. 

8 (2) Department of Justice non-research programs 

9 and activities that address prevention of, treatment 

10 for, and recovery from substance use by and substance 

11 use disorders among adolescents and young adults, in12 cluding an assessment of the effectiveness of such pro13 grams and activities in preventing substance use by 

14 and substance use disorders among adolescents and 

15 young adults, treating such adolescents and young 

16 adults in a way that accounts for any unique cir17 cumstances faced by adolescents and young adults, 

18 and supports long term recovery among adolescents 

19 and young adults. 

20 (3) Gaps that have been identified by officials of 

21 the Department of Justice or experts in the efforts 

22 supported by grant programs operated by the Depart23 ment of Justice relating to prevention of, treatment 

24 for, and recovery from substance use by and substance 

25 use disorders among adolescents and young adults, in-
31 

•S 524 EAH 

1 cluding gaps in research, data collection, and meas2 ures to evaluate the effectiveness of such efforts, and 

3 the reasons for such gaps. 

4 (b) REPORT.—Not later than 2 years after the date 

5 of enactment of this Act, the Comptroller General shall sub6 mit to the appropriate committees of the Congress a report 

7 containing the results of the study conducted under sub8 section (a), including— 

9 (1) a summary of the findings of the study; and 

10 (2) recommendations based on the results of the 

11 study, including recommendations for such areas of 

12 research and legislative and administrative action as 

13 the Comptroller General determines appropriate. 

14 TITLE III—JASON SIMCAKOSKI 

15 PROMISE ACT 

16 SEC. 301. SHORT TITLE. 

17 This title may be cited as the ‘‘Promoting Responsible 

18 Opioid Management and Incorporating Scientific Expertise 

19 Act’’ or the ‘‘Jason Simcakoski PROMISE Act’’. 

20 SEC. 302. IMPROVEMENT OF OPIOID SAFETY MEASURES BY 

21 DEPARTMENT OF VETERANS AFFAIRS. 

22 (a) EXPANSION OF OPIOID SAFETY INITIATIVE.— 

23 (1) INCLUSION OF ALL MEDICAL FACILITIES.— 

24 Not later than 180 days after the date of the enact25 ment of this Act, the Secretary of Veterans Affairs 
32 

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1 shall expand the Opioid Safety Initiative of the De2 partment of Veterans Affairs to include all medical 

3 facilities of the Department. 

4 (2) GUIDANCE.—The Secretary shall establish 

5 guidance that each health care provider of the Depart6 ment of Veterans Affairs, before initiating opioid 

7 therapy to treat a patient as part of the comprehen8 sive assessment conducted by the health care provider, 

9 use the Opioid Therapy Risk Report tool of the De10 partment of Veterans Affairs (or any subsequent tool), 

11 which shall include information from the prescription 

12 drug monitoring program of each participating State 

13 as applicable, that includes the most recent informa14 tion to date relating to the patient that accessed such 

15 program to assess the risk for adverse outcomes of 

16 opioid therapy for the patient, including the concur17 rent use of controlled substances such as 

18 benzodiazepines, as part of the comprehensive assess19 ment conducted by the health care provider. 

20 (3) ENHANCED STANDARDS.—The Secretary 

21 shall establish enhanced standards with respect to the 

22 use of routine and random urine drug tests for all pa23 tients before and during opioid therapy to help pre24 vent substance abuse, dependence, and diversion, in25 cluding— 
33 

•S 524 EAH 

1 (A) that such tests occur not less frequently 

2 than once each year; and 

3 (B) that health care providers appropriately 

4 order, interpret and respond to the results from 

5 such tests to tailor pain therapy, safeguards, and 

6 risk management strategies to each patient. 

7 (b) PAIN MANAGEMENT EDUCATION AND TRAINING.— 

8 (1) IN GENERAL.—In carrying out the Opioid 

9 Safety Initiative of the Department, the Secretary 

10 shall require all employees of the Department respon11 sible for prescribing opioids to receive education and 

12 training described in paragraph (2). 

13 (2) EDUCATION AND TRAINING.—Education and 

14 training described in this paragraph is education and 

15 training on pain management and safe opioid pre16 scribing practices for purposes of safely and effectively 

17 managing patients with chronic pain, including edu18 cation and training on the following: 

19 (A) The implementation of and full compli20 ance with the VA/DOD Clinical Practice Guide21 line for Management of Opioid Therapy for 

22 Chronic Pain, including any update to such 

23 guideline. 

24 (B) The use of evidence-based pain manage25 ment therapies, including cognitive-behavioral 
34 

•S 524 EAH 

1 therapy, non-opioid alternatives, and non-drug 

2 methods and procedures to managing pain and 

3 related health conditions including medical de4 vices approved or cleared by the Food and Drug 

5 Administration for the treatment of patients 

6 with chronic pain and complementary alter7 native medicines. 

8 (C) Screening and identification of patients 

9 with substance use disorder, including drug-seek10 ing behavior, before prescribing opioids, assess11 ment of risk potential for patients developing an 

12 addiction, and referral of patients to appropriate 

13 addiction treatment professionals if addiction is 

14 identified or strongly suspected. 

15 (D) Communication with patients on the 

16 potential harm associated with the use of opioids 

17 and other controlled substances, including the 

18 need to safely store and dispose of supplies relat19 ing to the use of opioids and other controlled 

20 substances. 

21 (E) Such other education and training as 

22 the Secretary considers appropriate to ensure 

23 that veterans receive safe and high-quality pain 

24 management care from the Department. 
35 

•S 524 EAH 

1 (3) USE OF EXISTING PROGRAM.—In providing 

2 education and training described in paragraph (2), 

3 the Secretary shall use the Interdisciplinary Chronic 

4 Pain Management Training Team Program of the 

5 Department (or success program). 

6 (c) PAIN MANAGEMENT TEAMS.— 

7 (1) IN GENERAL.—In carrying out the Opioid 

8 Safety Initiative of the Department, the director of 

9 each medical facility of the Department shall identify 

10 and designate a pain management team of health 

11 care professionals, which may include board certified 

12 pain medicine specialists, responsible for coordinating 

13 and overseeing pain management therapy at such fa14 cility for patients experiencing acute and chronic 

15 pain that is non-cancer related. 

16 (2) ESTABLISHMENT OF PROTOCOLS.— 

17 (A) IN GENERAL.—In consultation with the 

18 Directors of each Veterans Integrated Service 

19 Network, the Secretary shall establish standard 

20 protocols for the designation of pain manage21 ment teams at each medical facility within the 

22 Department. 

23 (B) CONSULTATION ON PRESCRIPTION OF

24 OPIOIDS.—Each protocol established under sub25 paragraph (A) shall ensure that any health care 
36 

•S 524 EAH 

1 provider without expertise in prescribing analge2 sics or who has not completed the education and 

3 training under subsection (b), including a men4 tal health care provider, does not prescribe 

5 opioids to a patient unless that health care pro6 vider— 

7 (i) consults with a health care provider 

8 with pain management expertise or who is 

9 on the pain management team of the med10 ical facility; and 

11 (ii) refers the patient to the pain man12 agement team for any subsequent prescrip13 tions and related therapy. 

14 (3) REPORT.— 

15 (A) IN GENERAL.—Not later than 1 year 

16 after the date of enactment of this Act, the direc17 tor of each medical facility of the Department 

18 shall submit to the Under Secretary for Health 

19 and the director of the Veterans Integrated Serv20 ice Network in which the medical facility is lo21 cated a report identifying the health care profes22 sionals that have been designated as members of 

23 the pain management team at the medical facil24 ity pursuant to paragraph (1). 
37 

•S 524 EAH 

1 (B) ELEMENTS.—Each report submitted 

2 under subparagraph (A) with respect to a med3 ical facility of the Department shall include— 

4 (i) a certification as to whether all 

5 members of the pain management team at 

6 the medical facility have completed the edu7 cation and training required under sub8 section (b); 

9 (ii) a plan for the management and re10 ferral of patients to such pain management 

11 team if health care providers without exper12 tise in prescribing analgesics prescribe 

13 opioid medications to treat acute and 

14 chronic pain that is non-cancer related; and 

15 (iii) a certification as to whether the 

16 medical facility— 

17 (I) fully complies with the 

18 stepped-care model of pain manage19 ment and other pain management poli20 cies contained in Directive 2009–053 

21 of the Veterans Health Administration, 

22 or successor directive; or 

23 (II) does not fully comply with 

24 such stepped-care model of pain man25 agement and other pain management 
38 

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1 policies but is carrying out a corrective 

2 plan of action to ensure such full com3 pliance. 

4 (d) TRACKING AND MONITORING OF OPIOID USE.— 

5 (1) PRESCRIPTION DRUG MONITORING PROGRAMS

6 OF STATES.—In carrying out the Opioid Safety Ini7 tiative and the Opioid Therapy Risk Report tool of 

8 the Department, the Secretary shall— 

9 (A) ensure access by health care providers of 

10 the Department to information on controlled sub11 stances, including opioids and benzodiazepines, 

12 prescribed to veterans who receive care outside 

13 the Department through the prescription drug 

14 monitoring program of each State with such a 

15 program, including by seeking to enter into 

16 memoranda of understanding with States to 

17 allow shared access of such information between 

18 States and the Department; 

19 (B) include such information in the Opioid 

20 Therapy Risk Report; and 

21 (C) require health care providers of the De22 partment to submit to the prescription drug 

23 monitoring program of each State information 

24 on prescriptions of controlled substances received 
39 

•S 524 EAH 

1 by veterans in that State under the laws admin2 istered by the Secretary. 

3 (2) REPORT ON TRACKING OF DATA ON OPIOID

4 USE.—Not later than 18 months after the date of the 

5 enactment of this Act, the Secretary shall submit to 

6 the Committee on Veterans’ Affairs of the Senate and 

7 the Committee on Veterans’ Affairs of the House of 

8 Representatives a report on the feasibility and advis9 ability of improving the Opioid Therapy Risk Report 

10 tool of the Department to allow for more advanced 

11 real-time tracking of and access to data on— 

12 (A) the key clinical indicators with respect 

13 to the totality of opioid use by veterans; 

14 (B) concurrent prescribing by health care 

15 providers of the Department of opioids in dif16 ferent health care settings, including data on 

17 concurrent prescribing of opioids to treat mental 

18 health disorders other than opioid use disorder; 

19 and 

20 (C) mail-order prescriptions of opioid pre21 scribed to veterans under the laws administered 

22 by the Secretary. 

23 (e) AVAILABILITY OF OPIOID RECEPTOR ANTAGO24 NISTS.— 

25 (1) INCREASED AVAILABILITY AND USE.— 
40 

•S 524 EAH 

1 (A) IN GENERAL.—The Secretary shall 

2 maximize the availability of opioid receptor an3 tagonists approved by the Food and Drug Ad4 ministration, including naloxone, to veterans. 

5 (B) AVAILABILITY, TRAINING, AND DISTRIB6 UTING.—In carrying out subparagraph (A), not 

7 later than 90 days after the date of the enact8 ment of this Act, the Secretary shall— 

9 (i) equip each pharmacy of the Depart10 ment with opioid receptor antagonists ap11 proved by the Food and Drug Administra12 tion to be dispensed to outpatients as need13 ed; and 

14 (ii) expand the Overdose Education 

15 and Naloxone Distribution program of the 

16 Department to ensure that all veterans in 

17 receipt of health care under laws adminis18 tered by the Secretary who are at risk of 

19 opioid overdose may access such opioid re20 ceptor antagonists and training on the 

21 proper administration of such opioid recep22 tor antagonists. 

23 (C) VETERANS WHO ARE AT RISK.—For 

24 purposes of subparagraph (B), veterans who are 

25 at risk of opioid overdose include— 
41 

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1 (i) veterans receiving long-term opioid 

2 therapy; 

3 (ii) veterans receiving opioid therapy 

4 who have a history of substance use disorder 

5 or prior instances of overdose; and 

6 (iii) veterans who are at risk as deter7 mined by a health care provider who is 

8 treating the veteran. 

9 (2) REPORT.—Not later than 120 days after the 

10 date of the enactment of this Act, the Secretary shall 

11 submit to the Committee on Veterans’ Affairs of the 

12 Senate and the Committee on Veterans’ Affairs of the 

13 House of Representatives a report on carrying out 

14 paragraph (1), including an assessment of any re15 maining steps to be carried out by the Secretary to 

16 carry out such paragraph. 

17 (f) INCLUSION OF CERTAIN INFORMATION AND CAPA18 BILITIES IN OPIOID THERAPY RISK REPORT TOOL OF THE

19 DEPARTMENT.— 

20 (1) INFORMATION.—The Secretary shall include 

21 in the Opioid Therapy Risk Report tool of the De22 partment— 

23 (A) information on the most recent time the 

24 tool was accessed by a health care provider of the 

25 Department with respect to each veteran; and 
42 

•S 524 EAH 

1 (B) information on the results of the most 

2 recent urine drug test for each veteran. 

3 (2) CAPABILITIES.—The Secretary shall include 

4 in the Opioid Therapy Risk Report tool the ability of 

5 the health care providers of the Department to deter6 mine whether a health care provider of the Depart7 ment prescribed opioids to a veteran without checking 

8 the information in the tool with respect to the vet9 eran. 

10 (g) NOTIFICATIONS OF RISK IN COMPUTERIZED

11 HEALTH RECORD.—The Secretary shall modify the com12 puterized patient record system of the Department to ensure 

13 that any health care provider that accesses the record of 

14 a veteran, regardless of the reason the veteran seeks care 

15 from the health care provider, will be immediately notified 

16 whether the veteran— 

17 (1) is receiving opioid therapy and has a history 

18 of substance use disorder or prior instances of over19 dose; 

20 (2) has a history of opioid abuse; or 

21 (3) is at risk of becoming an opioid abuser as de22 termined by a health care provider who is treating 

23 the veteran. 

24 (h) DEFINITIONS.—In this section: 
43 

•S 524 EAH 

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

2 meaning given that term in section 102 of the Con3 trolled Substances Act (21 U.S.C. 802). 

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

5 States, territories, and possessions of the United 

6 States, the District of Columbia, and the Common7 wealth of Puerto Rico. 

8 SEC. 303. STRENGTHENING OF JOINT WORKING GROUP ON 

9 PAIN MANAGEMENT OF THE DEPARTMENT OF 

10 VETERANS AFFAIRS AND THE DEPARTMENT 

11 OF DEFENSE. 

12 (a) IN GENERAL.—Not later than 90 days after the 

13 date of enactment of this Act, the Secretary of Veterans Af14 fairs and the Secretary of Defense shall ensure that the Pain 

15 Management Working Group of the Health Executive Com16 mittee of the Department of Veterans Affairs–Department 

17 of Defense Joint Executive Committee (Pain Management 

18 Working Group) established under section 320 of title 38, 

19 United States Code, includes a focus on the following: 

20 (1) The opioid prescribing practices of health 

21 care providers of each Department. 

22 (2) The ability of each Department to manage 

23 acute and chronic pain among individuals receiving 

24 health care from the Department, including training 
44 

•S 524 EAH 

1 health care providers with respect to pain manage2 ment. 

3 (3) The use by each Department of complemen4 tary and integrative health and complementary alter5 native medicines in treating such individuals. 

6 (4) The concurrent use by health care providers 

7 of each Department of opioids and prescription drugs 

8 to treat mental health disorders, including 

9 benzodiazepines. 

10 (5) The practice by health care providers of each 

11 Department of prescribing opioids to treat mental 

12 health disorders. 

13 (6) The coordination in coverage of and con14 sistent access to medications prescribed for patients 

15 transitioning from receiving health care from the De16 partment of Defense to receiving health care from the 

17 Department of Veterans Affairs. 

18 (7) The ability of each Department to identify 

19 and treat substance use disorders among individuals 

20 receiving health care from that Department. 

21 (b) COORDINATION AND CONSULTATION.—The Sec22 retary of Veterans Affairs and the Secretary of Defense shall 

23 ensure that the working group described in subsection (a)— 
45 

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1 (1) coordinates the activities of the working 

2 group with other relevant working groups established 

3 under section 320 of title 38, United States Code; 

4 (2) consults with other relevant Federal agencies 

5 with respect to the activities of the working group; 

6 and 

7 (3) consults with the Department of Veterans Af8 fairs and the Department of Defense with respect to, 

9 reviews, and comments on the VA/DOD Clinical 

10 Practice Guideline for Management of Opioid Ther11 apy for Chronic Pain, or any successor guideline, be12 fore any update to the guideline is released. 

13 (c) CLINICAL PRACTICE GUIDELINES.— 

14 (1) IN GENERAL.—Not later than 180 days after 

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

16 Veterans Affairs and the Secretary of Defense shall 

17 issue an update to the VA/DOD Clinical Practice 

18 Guideline for Management of Opioid Therapy for 

19 Chronic Pain. 

20 (2) MATTERS INCLUDED.—In conducting the up21 date under subsection (a), the Pain Management 

22 Working Group, in coordination with the Clinical 

23 Practice Guideline VA/DOD Management of Opioid 

24 Therapy for Chronic Pain Working Group, shall ex-
46 

•S 524 EAH 

1 amine whether the Clinical Practical Guideline 

2 should include the following: 

3 (A) Enhanced guidance with respect to— 

4 (i) the coadministration of an opioid 

5 and other drugs, including benzodiazepines, 

6 that may result in life-limiting drug inter7 actions; 

8 (ii) the treatment of patients with cur9 rent acute psychiatric instability or sub10 stance use disorder or patients at risk of 

11 suicide; and 

12 (iii) the use of opioid therapy to treat 

13 mental health disorders other than opioid 

14 use disorder. 

15 (B) Enhanced guidance with respect to the 

16 treatment of patients with behaviors or 

17 comorbidities, such as post-traumatic stress dis18 order or other psychiatric disorders, or a history 

19 of substance abuse or addiction, that requires a 

20 consultation or comanagement of opioid therapy 

21 with one or more specialists in pain manage22 ment, mental health, or addictions. 

23 (C) Enhanced guidance with respect to 

24 health care providers— 
47 

•S 524 EAH 

1 (i) conducting an effective assessment 

2 for patients beginning or continuing opioid 

3 therapy, including understanding and set4 ting realistic goals with respect to achieving 

5 and maintaining an expected level of pain 

6 relief, improved function, or a clinically ap7 propriate combination of both; and 

8 (ii) effectively assessing whether opioid 

9 therapy is achieving or maintaining the es10 tablished treatment goals of the patient or 

11 whether the patient and health care pro12 vider should discuss adjusting, augmenting, 

13 or discontinuing the opioid therapy. 

14 (D) Guidelines to govern the methodologies 

15 used by health care providers of the Department 

16 of Veterans Affairs and the Department of De17 fense to taper opioid therapy when adjusting or 

18 discontinuing the use of opioid therapy. 

19 (E) Guidelines with respect to appropriate 

20 case management for patients receiving opioid 

21 therapy who transition between inpatient and 

22 outpatient health care settings, which may in23 clude the use of care transition plans. 

24 (F) Guidelines with respect to appropriate 

25 case management for patients receiving opioid 
48 

•S 524 EAH 

1 therapy who transition from receiving care dur2 ing active duty to post-military health care net3 works. 

4 (G) Guidelines with respect to providing op5 tions, before initiating opioid therapy, for pain 

6 management therapies without the use of opioids 

7 and options to augment opioid therapy with 

8 other clinical and complementary and integra9 tive health services to minimize opioid depend10 ence. 

11 (H) Guidelines with respect to the provision 

12 of evidence-based non-opioid treatments within 

13 the Department of Veterans Affairs and the De14 partment of Defense, including medical devices 

15 and other therapies approved or cleared by the 

16 Food and Drug Administration for the treatment 

17 of chronic pain as an alternative to or to aug18 ment opioid therapy. 

19 SEC. 304. REVIEW, INVESTIGATION, AND REPORT ON USE 

20 OF OPIOIDS IN TREATMENT BY DEPARTMENT 

21 OF VETERANS AFFAIRS. 

22 (a) COMPTROLLER GENERAL REPORT.— 

23 (1) IN GENERAL.—Not later than 2 years after 

24 the date of the enactment of this Act, the Comptroller 

25 General of the United States shall submit to the Com-
49 

•S 524 EAH 

1 mittee on Veterans’ Affairs of the Senate and the 

2 Committee on Veterans’ Affairs of the House of Rep3 resentatives a report on the Opioid Safety Initiative 

4 of the Department of Veterans Affairs and the opioid 

5 prescribing practices of health care providers of the 

6 Department. 

7 (2) ELEMENTS.—The report submitted under 

8 paragraph (1) shall include the following: 

9 (A) Recommendations on such improve10 ments to the Opioid Safety Initiative of the De11 partment as the Comptroller General considers 

12 appropriate. 

13 (B) Information with respect to— 

14 (i) deaths resulting from sentinel 

15 events involving veterans prescribed opioids 

16 by a health care provider of the Depart17 ment; 

18 (ii) overall prescription rates and pre19 scriptions indications of opioids to treat 

20 non-cancer, non-palliative, and non-hospice 

21 care patients; 

22 (iii) the prescription rates and pre23 scriptions indications of benzodiazepines 

24 and opioids concomitantly by health care 

25 providers of the Department; 
50 

•S 524 EAH 

1 (iv) the practice by health care pro2 viders of the Department of prescribing 

3 opioids to treat patients without any pain, 

4 including to treat patients with mental 

5 health disorders other than opioid use dis6 order; and 

7 (v) the effectiveness of opioid therapy 

8 for patients receiving such therapy, includ9 ing the effectiveness of long-term opioid 

10 therapy. 

11 (C) An evaluation of processes of the De12 partment in place to oversee opioid use among 

13 veterans, including procedures to identify and 

14 remedy potential over-prescribing of opioids by 

15 health care providers of the Department. 

16 (D) An assessment of the implementation by 

17 the Secretary of the VA/DOD Clinical Practice 

18 Guideline for Management of Opioid Therapy 

19 for Chronic Pain. 

20 (b) QUARTERLY PROGRESS REPORT ON IMPLEMENTA21 TION OF COMPTROLLER GENERAL RECOMMENDATIONS.— 

22 Not later than 2 years after the date of the enactment of 

23 this Act, and not later than 30 days after the end of each 

24 quarter thereafter, the Secretary of Veterans Affairs shall 

25 submit to the Committee on Veterans’ Affairs of the Senate 
51 

•S 524 EAH 

1 and the Committee on Veterans’ Affairs of the House of Rep2 resentatives a progress report detailing the actions by the 

3 Secretary during the period covered by the report to address 

4 any outstanding findings and recommendations by the 

5 Comptroller General of the United States under subsection 

6 (a) with respect to the Veterans Health Administration. 

7 (c) ANNUAL REVIEW OF PRESCRIPTION RATES.—Not 

8 later than 1 year after the date of the enactment of this 

9 Act, and not less frequently than annually for the following 

10 5 years, the Secretary shall submit to the Committee on Vet11 erans’ Affairs of the Senate and the Committee on Veterans’ 

12 Affairs of the House of Representatives a report, with re13 spect to each medical facility of the Department of Veterans 

14 Affairs, to collect and review information on opioids pre15 scribed by health care providers at the facility to treat non16 cancer, non-palliative, and non-hospice care patients that 

17 contains, for the 1-year period preceding the submission of 

18 the report, the following: 

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

20 the patient population of the Department who were 

21 prescribed benzodiazepines and opioids concurrently 

22 by a health care provider of the Department. 

23 (2) The number of patients and the percentage of 

24 the patient population of the Department without any 

25 pain who were prescribed opioids by a health care 
52 

•S 524 EAH 

1 provider of the Department, including those who were 

2 prescribed benzodiazepines and opioids concurrently. 

3 (3) The number of non-cancer, non-palliative, 

4 and non-hospice care patients and the percentage of 

5 such patients who were treated with opioids by a 

6 health care provider of the Department on an inpa7 tient-basis and who also received prescription opioids 

8 by mail from the Department while being treated on 

9 an inpatient-basis. 

10 (4) The number of non-cancer, non-palliative, 

11 and non-hospice care patients and the percentage of 

12 such patients who were prescribed opioids concur13 rently by a health care provider of the Department 

14 and a health care provider that is not health care 

15 provider of the Department. 

16 (5) With respect to each medical facility of the 

17 Department, information on opioids prescribed by 

18 health care providers at the facility to treat non-can19 cer, non-palliative, and non-hospice care patients, in20 cluding information on— 

21 (A) the prescription rate at which each 

22 health care provider at the facility prescribed 

23 benzodiazepines and opioids concurrently to such 

24 patients and the aggregate such prescription rate 

25 for all health care providers at the facility; 
53 

•S 524 EAH 

1 (B) the prescription rate at which each 

2 health care provider at the facility prescribed 

3 benzodiazepines or opioids to such patients to 

4 treat conditions for which benzodiazepines or 

5 opioids are not approved treatment and the ag6 gregate such prescription rate for all health care 

7 providers at the facility; 

8 (C) the prescription rate at which each 

9 health care provider at the facility prescribed or 

10 dispensed mail-order prescriptions of opioids to 

11 such patients while such patients were being 

12 treated with opioids on an inpatient-basis and 

13 the aggregate of such prescription rate for all 

14 health care providers at the facility; and 

15 (D) the prescription rate at which each 

16 health care provider at the facility prescribed 

17 opioids to such patients who were also concur18 rently prescribed opioids by a health care pro19 vider that is not a health care provider of the 

20 Department and the aggregate of such prescrip21 tion rates for all health care providers at the fa22 cility. 

23 (6) With respect to each medical facility of the 

24 Department, the number of times a pharmacist at the 

25 facility overrode a critical drug interaction warning 
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1 with respect to an interaction between opioids and 

2 another medication before dispensing such medication 

3 to a veteran. 

4 (d) INVESTIGATION OF PRESCRIPTION RATES.—If the 

5 Secretary determines that a prescription rate with respect 

6 to a health care provider or medical facility of the Depart7 ment conflicts with or is otherwise inconsistent with the 

8 standards of appropriate and safe care, the Secretary 

9 shall— 

10 (1) immediately notify the Committee on Vet11 erans’ Affairs of the Senate and the Committee on 

12 Veterans’ Affairs of the House of Representatives of 

13 such determination, including information relating to 

14 such determination, prescription rate, and health care 

15 provider or medical facility, as the case may be; and 

16 (2) through the Office of the Medical Inspector of 

17 the Veterans Health Administration, conduct a full 

18 investigation of the health care provider or medical 

19 facility, as the case may be. 

20 (e) PRESCRIPTION RATE DEFINED.—In this section, 

21 the term ‘‘prescription rate’’ means, with respect to a health 

22 care provider or medical facility of the Department, each 

23 of the following: 

24 (1) The number of patients treated with opioids 

25 by the health care provider or at the medical facility, 
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1 as the case may be, divided by the total number of 

2 pharmacy users of that health care provider or med3 ical facility. 

4 (2) The average number of morphine equivalents 

5 per day prescribed by the health care provider or at 

6 the medical facility, as the case may be, to patients 

7 being treated with opioids. 

8 (3) Of the patients being treated with opioids by 

9 the health care provider or at the medical facility, as 

10 the case may be, the average number of prescriptions 

11 of opioids per patient. 

12 SEC. 305. MANDATORY DISCLOSURE OF CERTAIN VETERAN 

13 INFORMATION TO STATE CONTROLLED SUB14 STANCE MONITORING PROGRAMS. 

15 Section 5701(l) of title 38, United States Code, is 

16 amended by striking ‘‘may’’ and inserting ‘‘shall’’. 

17 SEC. 306. MODIFICATION TO LIMITATION ON AWARDS AND 

18 BONUSES. 

19 Section 705 of the Veterans Access, Choice, and Ac20 countability Act of 2014 (Public Law 113–146; 38 U.S.C. 

21 703 note) is amended to read as follows: 
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1 ‘‘SEC. 705. LIMITATION ON AWARDS AND BONUSES PAID TO 

2 EMPLOYEES OF DEPARTMENT OF VETERANS 

3 AFFAIRS. 

4 ‘‘The Secretary of Veterans Affairs shall ensure that 

5 the aggregate amount of awards and bonuses paid by the 

6 Secretary in a fiscal year under chapter 45 or 53 of title 

7 5, United States Code, or any other awards or bonuses au8 thorized under such title or title 38, United States Code, 

9 does not exceed the following amounts: 

10 ‘‘(1) With respect to each of fiscal years 2017 

11 through 2021, $230,000,000. 

12 ‘‘(2) With respect to each of fiscal years 2022 

13 through 2024, $360,000,000.’’. 

14 TITLE IV—KINGPIN DESIGNA15 TION IMPROVEMENT ACT 

16 SEC. 401. SHORT TITLE. 

17 This title may be cited as the ‘‘Kingpin Designation 

18 Improvement Act of 2016’’. 

19 SEC. 402. PROTECTION OF CLASSIFIED INFORMATION IN 

20 FEDERAL COURT CHALLENGES RELATING TO 

21 DESIGNATIONS UNDER THE NARCOTICS 

22 KINGPIN DESIGNATION ACT. 

23 Section 804 of the Foreign Narcotics Kingpin Designa24 tion Act (21 U.S.C. 1903) is amended by adding at the 

25 end the following: 
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1 ‘‘(i) PROTECTION OF CLASSIFIED INFORMATION IN

2 FEDERAL COURT CHALLENGES RELATING TO DESIGNA3 TIONS.—In any judicial review of a determination made 

4 under this section, if the determination was based on classi5 fied information (as defined in section 1(a) of the Classified 

6 Information Procedures Act) such information may be sub7 mitted to the reviewing court ex parte and in camera. This 

8 subsection does not confer or imply any right to judicial 

9 review.’’. 

10 TITLE V—GOOD SAMARITAN 

11 ASSESSMENT ACT 

12 SEC. 501. SHORT TITLE. 

13 This title may be cited as the ‘‘Good Samaritan Assess14 ment Act of 2016’’. 

15 SEC. 502. FINDING. 

16 The Congress finds that the executive branch, including 

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

18 focus on preventing and addressing prescription drug mis19 use and heroin use, and has worked with States and mu20 nicipalities to enact Good Samaritan laws that would pro21 tect caregivers, law enforcement personnel, and first re22 sponders who administer opioid overdose reversal drugs or 

23 devices. 
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1 SEC. 503. GAO STUDY ON GOOD SAMARITAN LAWS PER2 TAINING TO TREATMENT OF OPIOID 

3 OVERDOSES. 

4 The Comptroller General of the United States shall 

5 submit to the Committee on the Judiciary of the House of 

6 Representatives, the Committee on Oversight and Govern7 ment Reform of the House of Representatives, the Com8 mittee on the Judiciary of the Senate, and the Committee 

9 on Homeland Security and Governmental Affairs of the 

10 Senate a report on— 

11 (1) the extent to which the Director of National 

12 Drug Control Policy has reviewed Good Samaritan 

13 laws, and any findings from such a review, including 

14 findings related to the potential effects of such laws, 

15 if available; 

16 (2) efforts by the Director to encourage the enact17 ment of Good Samaritan laws; and 

18 (3) a compilation of Good Samaritan laws in ef19 fect in the States, the territories, and the District of 

20 Columbia. 

21 SEC. 504. DEFINITIONS. 

22 In this title— 

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

24 law of a State or unit of local government that ex25 empts from criminal or civil liability any individual 

26 who administers an opioid overdose reversal drug or 
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1 device, or who contacts emergency services providers 

2 in response to an overdose; and 

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

4 heroin, having an addiction-forming or addiction-sus5 taining liability similar to morphine or being capable 

6 of conversion into a drug having such addiction-form7 ing or addiction-sustaining liability. 

8 TITLE VI—OPEN ACT 

9 SEC. 601. SHORT TITLE. 

10 This title may be cited as the ‘‘Opioid Program Eval11 uation Act’’ or the ‘‘OPEN Act’’. 

12 SEC. 602. EVALUATION OF PERFORMANCE OF DEPARTMENT 

13 OF JUSTICE PROGRAM. 

14 (a) EVALUATION OF JUSTICE DEPARTMENT COM15 PREHENSIVE OPIOID ABUSE GRANT PROGRAM.—Not later 

16 than 5 years after the date of enactment of this Act, the 

17 Attorney General shall complete an evaluation of the effec18 tiveness of the Comprehensive Opioid Abuse Grant Program 

19 under part LL of the Omnibus Crime Control and Safe 

20 Streets Act of 1968 administered by the Department of Jus21 tice based upon the information reported under subsection 

22 (d) of this section. 

23 (b) INTERIM EVALUATION.—Not later than 3 years 

24 after the date of enactment of this Act, the Attorney General 

25 shall complete an interim evaluation assessing the nature 
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1 and extent of the incidence of opioid abuse and illegal 

2 opioid distribution in the United States. 

3 (c) METRICS AND OUTCOMES FOR EVALUATION.—Not 

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

5 the Attorney General shall identify outcomes that are to be 

6 achieved by activities funded by the Comprehensive Opioid 

7 Grant Abuse Program and the metrics by which the achieve8 ment of such outcomes shall be determined. 

9 (d) METRICS DATA COLLECTION.—The Attorney Gen10 eral shall require grantees under the Comprehensive Opioid 

11 Abuse Grant Program (and those receiving subawards 

12 under section 3021(b) of part LL of the Omnibus Crime 

13 Control and Safe Streets Act of 1968) to collect and annu14 ally report to the Department of Justice data based upon 

15 the metrics identified under subsection (c). 

16 (e) PUBLICATION OF DATA AND FINDINGS.— 

17 (1) PUBLICATION OF OUTCOMES AND METRICS.— 

18 The Attorney General shall, not later than 30 days 

19 after completion of the requirement under subsection 

20 (c), publish the outcomes and metrics identified under 

21 that subsection. 

22 (2) PUBLICATION OF EVALUATION.—In the case 

23 of the interim evaluation under subsection (b), and 

24 the final evaluation under subsection (a), the Na25 tional Academy of Sciences shall, not later than 90 
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1 days after such an evaluation is completed, publish 

2 the results of such evaluation and issue a report on 

3 such evaluation to the Committee on the Judiciary of 

4 the House of Representatives and the Committee on 

5 the Judiciary of the Senate. Such report shall also be 

6 published along with the data used to make such eval7 uation. 

8 (f) ARRANGEMENT WITH THE NATIONAL ACADEMY OF

9 SCIENCES.—For purposes of subsections (a), (b), and (c), 

10 the Attorney General shall enter into an arrangement with 

11 the National Academy of Sciences. 

12 SEC. 603. EVALUATION OF PERFORMANCE OF DEPARTMENT 

13 OF HEALTH AND HUMAN SERVICES PRO14 GRAM. 

15 (a) EVALUATION OF DEPARTMENT OF HEALTH AND

16 HUMAN SERVICES PROGRAMS.—Not later than 5 years 

17 after the date of enactment of this Act, except as otherwise 

18 provided in this section, the Secretary of Health and 

19 Human Services shall complete an evaluation of any pro20 gram administered by the Secretary that provides grants 

21 for the primary purpose of providing assistance in address22 ing problems pertaining to opioid abuse based upon the in23 formation reported under subsection (d) of this section. 

24 (b) INTERIM EVALUATION.—Not later than 3 years 

25 after the date of enactment of this Act, the Secretary shall 
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1 complete an interim evaluation assessing the nature and 

2 extent of the incidence of opioid abuse and illegal opioid 

3 distribution in the United States. 

4 (c) METRICS AND OUTCOMES FOR EVALUATION.—Not 

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

6 the Secretary shall identify outcomes that are to be achieved 

7 by activities funded by the programs described in subsection 

8 (a) and the metrics by which the achievement of such out9 comes shall be determined. 

10 (d) METRICS DATA COLLECTION.—The Secretary shall 

11 require grantees under the programs described in subsection 

12 (a) to collect and annually report to the Department of 

13 Health and Human Services data based upon the metrics 

14 identified under subsection (c). 

15 (e) PUBLICATION OF DATA AND FINDINGS.— 

16 (1) PUBLICATION OF OUTCOMES AND METRICS.— 

17 The Secretary shall, not later than 30 days after com18 pletion of the requirement under subsection (c), pub19 lish the outcomes and metrics identified under that 

20 subsection. 

21 (2) PUBLICATION OF EVALUATION.—In the case 

22 of the interim evaluation under subsection (b), and 

23 each final evaluation under subsection (a), the Na24 tional Academy of Sciences shall, not later than 90 

25 days after such an evaluation is completed, publish 
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1 the results of such evaluation and issue a report on 

2 such evaluation to the Committee on Energy and 

3 Commerce of the House of Representatives and the 

4 Committee on Health, Education, Labor, and Pen5 sions of the Senate. Such report shall also be pub6 lished along with the data used to make such evalua7 tion. 

8 (f) ARRANGEMENT WITH THE NATIONAL ACADEMY OF

9 SCIENCES.—For purposes of subsections (a), (b), and (c), 

10 the Secretary shall— 

11 (1) enter into an arrangement with the National 

12 Academy of Sciences; or 

13 (2) enter into a contract or cooperative agree14 ment with an entity that is not an agency of the Fed15 eral Government. 

16 (g) EXCEPTION.—If a program described under sub17 section (a) is subject to an evaluation substantially similar 

18 to the evaluation under subsection (a) pursuant to another 

19 provision of law, the Secretary may opt not to conduct an 

20 evaluation under subsection (a) of such program. 

21 SEC. 604. DEFINITION. 

22 In this title, the term ‘‘opioid’’ has the meaning given 

23 the term ‘‘opiate’’ in section 102 of the Controlled Sub24 stances Act (21 U.S.C. 802). 
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1 SEC. 605. NO ADDITIONAL FUNDS AUTHORIZED. 

2 No additional funds are authorized to be appropriated 

3 to carry out this Act. 

4 SEC. 606. MATTERS REGARDING CERTAIN FEDERAL LAW EN5 FORCEMENT ASSISTANCE. 

6 Section 609Y of the Justice Assistance Act of 1984 (42 

7 U.S.C. 10513) is amended— 

8 (1) in subsection (a), by striking ‘‘There is’’ and 

9 inserting ‘‘Except as provided in subsection (c), there 

10 is’’; and 

11 (2) by adding at the end the following: 

12 ‘‘(c) For fiscal year 2022, there is authorized to be ap13 propriated $16,000,000, to provide under this chapter Fed14 eral law enforcement assistance in the form of funds.’’. 

15 TITLE VII—INFANT PLAN OF 

16 SAFE CARE IMPROVEMENT ACT 

17 SEC. 701. SHORT TITLE. 

18 This title may be cited as the ‘‘Infant Plan of Safe 

19 Care Improvement Act’’. 

20 SEC. 702. BEST PRACTICES FOR DEVELOPMENT OF PLANS 

21 OF SAFE CARE. 

22 Section 103(b) of the Child Abuse Prevention and 

23 Treatment Act (42 U.S.C. 5104(b)) is amended— 

24 (1) by redesignating paragraphs (5) through (8) 

25 as paragraphs (6) through (9), respectively; and 
65 

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1 (2) by inserting after paragraph (4), the fol2 lowing: 

3 ‘‘(5) maintain and disseminate information 

4 about the requirements of section 106(b)(2)(B)(iii) 

5 and best practices relating to the development of 

6 plans of safe care as described in such section for in7 fants born and identified as being affected by illegal 

8 substance abuse or withdrawal symptoms, or a Fetal 

9 Alcohol Spectrum Disorder;’’. 

10 SEC. 703. STATE PLANS. 

11 Section 106(b)(2)(B)(iii) of the Child Abuse Preven12 tion and Treatment Act (42 U.S.C. 5106a(b)(2)(B)(iii)) is 

13 amended by inserting before the semicolon at the end the 

14 following: ‘‘to ensure the safety and well-being of such in15 fant following release from the care of healthcare providers, 

16 including through— 

17 ‘‘(I) addressing the health and 

18 substance use disorder treatment needs 

19 of the infant and affected family or 

20 caregiver; and 

21 ‘‘(II) the development and imple22 mentation by the State of monitoring 

23 systems regarding the implementation 

24 of such plans to determine whether and 

25 in what manner local entities are pro-
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1 viding, in accordance with State re2 quirements, referrals to and delivery of 

3 appropriate services for the infant and 

4 affected family or caregiver’’. 

5 SEC. 704. DATA REPORTS. 

6 (a) IN GENERAL.—Section 106(d) of the Child Abuse 

7 Prevention and Treatment Act (42 U.S.C. 5106a(d)) is 

8 amended by adding at the end of the following: 

9 ‘‘(17)(A) The number of infants identified under 

10 subsection (b)(2)(B)(ii). 

11 ‘‘(B) The number of infants for whom a plan of 

12 safe care was developed under subsection 

13 (b)(2)(B)(iii). 

14 ‘‘(C) The number of infants for whom a referral 

15 was made for appropriate services, including services 

16 for the affected family or caregiver, under subsection 

17 (b)(2)(B)(iii).’’. 

18 (b) REDESIGNATION.—Effective on May 29, 2017, sec19 tion 106(d) of the Child Abuse Prevention and Treatment 

20 Act (42 U.S.C. 5106a(d)) is amended by redesignating 

21 paragraph (17) (as added by subsection (a)) as paragraph 

22 (18). 
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1 SEC. 705. MONITORING AND OVERSIGHT. 

2 (a) AMENDMENT.—Title I of the Child Abuse Preven3 tion and Treatment Act (42 U.S.C. 5101 et seq.) is further 

4 amended by adding at the end the following: 

5 ‘‘SEC. 114. MONITORING AND OVERSIGHT. 

6 ‘‘The Secretary shall conduct monitoring to ensure 

7 that each State that receives a grant under section 106 is 

8 in compliance with the requirements of section 106(b), 

9 which— 

10 ‘‘(1) shall— 

11 ‘‘(A) be in addition to the review of the 

12 State plan upon its submission under section 

13 106(b)(1)(A); and 

14 ‘‘(B) include monitoring of State policies 

15 and procedures required under clauses (ii) and 

16 (iii) of section 106(b)(2)(B); and 

17 ‘‘(2) may include— 

18 ‘‘(A) a comparison of activities carried out 

19 by the State to comply with the requirements of 

20 section 106(b) with the State plan most recently 

21 approved under section 432 of the Social Secu22 rity Act; 

23 ‘‘(B) a review of information available on 

24 the Website of the State relating to its compli25 ance with the requirements of section 106(b); 
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1 ‘‘(C) site visits, as may be necessary to 

2 carry out such monitoring; and 

3 ‘‘(D) a review of information available in 

4 the State’s Annual Progress and Services Report 

5 most recently submitted under section 1357.16 of 

6 title 45, Code of Federal Regulations (or suc7 cessor regulations).’’. 

8 (b) TABLE OF CONTENTS.—The table of contents in 

9 section 1(b) of the Child Abuse Prevention and Treatment 

10 Act (42 U.S.C. 5101 note) is amended by inserting after 

11 the item relating to section 113, the following: 

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

12 SEC. 706. RULE OF CONSTRUCTION. 

13 Nothing in this Act, or the amendments made by this 

14 Act, shall be construed to authorize the Secretary of Health 

15 and Human Services or any other officer of the Federal 

16 Government to add new requirements to section 106(b) of 

17 the Child Abuse Prevention and Treatment Act (42 U.S.C. 

18 5106a(b)), as amended by this Act. 

19 TITLE VIII—NAS HEALTHY 

20 BABIES ACT 

21 SEC. 801. SHORT TITLE. 

22 This title may be cited as the ‘‘Nurturing And Sup23 porting Healthy Babies Act’’ or as the ‘‘NAS Healthy Ba24 bies Act’’. 
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1 SEC. 802. GAO REPORT ON NEONATAL ABSTINENCE SYN2 DROME (NAS). 

3 (a) IN GENERAL.—Not later than 1 year after the date 

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

5 United States shall submit to the Committee on Energy and 

6 Commerce of the House of Representatives and the Com7 mittee on Finance and the Committee on Health, Edu8 cation, Labor and Pensions of the Senate a report on neo9 natal abstinence syndrome (in this section referred to as 

10 ‘‘NAS’’) in the United States. 

11 (b) INFORMATION TO BE INCLUDED IN REPORT.— 

12 Such report shall include information on the following: 

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

14 including the proportion of children born in the 

15 United States with NAS who are eligible for medical 

16 assistance under State Medicaid programs under title 

17 XIX of the Social Security Act at birth and the costs 

18 associated with NAS through such programs. 

19 (2) The services for which coverage is available 

20 under State Medicaid programs for treatment of in21 fants with NAS. 

22 (3) The settings (including inpatient, outpatient, 

23 hospital-based, and other settings) for the treatment of 

24 infants with NAS and the reimbursement methodolo25 gies and costs associated with such treatment in such 

26 settings. 
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1 (4) The prevalence of utilization of various care 

2 settings under State Medicaid programs for treatment 

3 of infants with NAS and any Federal barriers to 

4 treating such infants under such programs, particu5 larly in non-hospital-based settings. 

6 (5) What is known about best practices for treat7 ing infants with NAS. 

8 (c) RECOMMENDATIONS.—Such report also shall in9 clude such recommendations as the Comptroller General de10 termines appropriate for improvements that will ensure ac11 cess to treatment for infants with NAS under State Med12 icaid programs. 

13 SEC. 803. EXCLUDING ABUSE-DETERRENT FORMULATIONS 

14 OF PRESCRIPTION DRUGS FROM THE MED15 ICAID ADDITIONAL REBATE REQUIREMENT 

16 FOR NEW FORMULATIONS OF PRESCRIPTION 

17 DRUGS. 

18 (a) IN GENERAL.—The last sentence of section 

19 1927(c)(2)(C) of the Social Security Act (42 U.S.C. 1396r– 

20 8(c)(2)(C)) is amended by inserting before the period at the 

21 end the following: ‘‘, but does not include an abuse-deterrent 

22 formulation of the drug (as determined by the Secretary), 

23 regardless of whether such abuse-deterrent formulation is an 

24 extended release formulation’’. 
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1 (b) EFFECTIVE DATE.—The amendment made by sub2 section (a) shall apply to drugs that are paid for by a State 

3 in calendar quarters beginning on or after the date of the 

4 enactment of this Act. 

5 SEC. 804. LIMITING DISCLOSURE OF PREDICTIVE MOD6 ELING AND OTHER ANALYTICS TECH7 NOLOGIES TO IDENTIFY AND PREVENT 

8 WASTE, FRAUD, AND ABUSE. 

9 (a) IN GENERAL.—Title XI of the Social Security Act 

10 is amended by inserting after section 1128J (42 U.S.C. 

11 1320a–7k) the following new section: 

12 ‘‘SEC. 1128K. DISCLOSURE OF PREDICTIVE MODELING AND 

13 OTHER ANALYTICS TECHNOLOGIES TO IDEN14 TIFY AND PREVENT WASTE, FRAUD, AND 

15 ABUSE. 

16 ‘‘(a) REFERENCE TO PREDICTIVE MODELING TECH17 NOLOGIES REQUIREMENTS.—For provisions relating to the 

18 use of predictive modeling and other analytics technologies 

19 to identify and prevent waste, fraud, and abuse with respect 

20 to the Medicare program under title XVIII, the Medicaid 

21 program under title XIX, and the Children’s Health Insur22 ance Program under title XXI, see section 4241 of the Small 

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

24 ‘‘(b) LIMITING DISCLOSURE OF PREDICTIVE MOD25 ELING TECHNOLOGIES.—In implementing such provisions 
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1 under such section 4241 with respect to covered algorithms 

2 (as defined in subsection (c)), the following shall apply: 

3 ‘‘(1) NONAPPLICATION OF FOIA.—The covered al4 gorithms used or developed for purposes of such sec5 tion (including by the Secretary or a State (or an en6 tity operating under a contract with a State)) shall 

7 be exempt from disclosure under section 552(b)(3) of 

8 title 5, United States Code. 

9 ‘‘(2) LIMITATION WITH RESPECT TO USE AND

10 DISCLOSURE OF INFORMATION BY STATE AGENCIES.— 

11 ‘‘(A) IN GENERAL.—A State agency may 

12 not use or disclose covered algorithms used or de13 veloped for purposes of such section except for 

14 purposes of administering the State plan (or a 

15 waiver of the plan) under the Medicaid program 

16 under title XIX or the State child health plan 

17 (or a waiver of the plan) under the Children’s 

18 Health Insurance Program under title XXI, in19 cluding by enabling an entity operating under a 

20 contract with a State to assist the State to iden21 tify or prevent waste, fraud, and abuse with re22 spect to such programs. 

23 ‘‘(B) INFORMATION SECURITY.—A State 

24 agency shall have in effect data security and 

25 control policies that the Secretary finds adequate 
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1 to ensure the security of covered algorithms used 

2 or developed for purposes of such section 4241 

3 and to ensure that access to such information is 

4 restricted to authorized persons for purposes of 

5 authorized uses and disclosures described in sub6 paragraph (A). 

7 ‘‘(C) PROCEDURAL REQUIREMENTS.—State 

8 agencies to which information is disclosed pursu9 ant to such section 4241 shall adhere to uniform 

10 procedures established by the Secretary. 

11 ‘‘(c) COVERED ALGORITHM DEFINED.—In this section, 

12 the term ‘covered algorithm’— 

13 ‘‘(1) means a predictive modeling or other ana14 lytics technology, as used for purposes of section 

15 4241(a) of the Small Business Jobs Act of 2010 (42 

16 U.S.C. 1320a–7m(a)) to identify and prevent waste, 

17 fraud, and abuse with respect to the Medicare pro18 gram under title XVIII, the Medicaid program under 

19 title XIX, and the Children’s Health Insurance Pro20 gram under title XXI; and 

21 ‘‘(2) includes the mathematical expressions uti22 lized in the application of such technology and the 

23 means by which such technology is developed.’’. 

24 (b) CONFORMING AMENDMENTS.— 
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1 (1) MEDICAID STATE PLAN REQUIREMENT.—Sec2 tion 1902(a) of the Social Security Act (42 U.S.C. 

3 1396a(a)) is amended— 

4 (A) in paragraph (80), by striking ‘‘and’’ 

5 at the end; 

6 (B) in paragraph (81), by striking the pe7 riod at the end and inserting ‘‘; and’’; and 

8 (C) by inserting after paragraph (81) the 

9 following new paragraph: 

10 ‘‘(82) provide that the State agency responsible 

11 for administering the State plan under this title pro12 vides assurances to the Secretary that the State agen13 cy is in compliance with subparagraphs (A), (B), and 

14 (C) of section 1128K(b)(2).’’. 

15 (2) STATE CHILD HEALTH PLAN REQUIRE16 MENT.—Section 2102(a)(7) of the Social Security Act 

17 (42 U.S.C. 1397bb(a)(7)) is amended— 

18 (A) in subparagraph (A), by striking ‘‘, 

19 and’’ at the end and inserting a semicolon; 

20 (B) in subparagraph (B), by striking the 

21 period at the end and inserting ‘‘; and’’; and 

22 (C) by adding at the end the following new 

23 subparagraph: 
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1 ‘‘(C) to ensure that the State agency in2 volved is in compliance with subparagraphs (A), 

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

4 SEC. 805. MEDICAID IMPROVEMENT FUND. 

5 Section 1941(b)(1) of the Social Security Act (42 

6 U.S.C. 1396w–1(b)(1)) is amended to read as follows: 

7 ‘‘(1) IN GENERAL.—There shall be available to 

8 the Fund, for expenditures from the Fund for fiscal 

9 year 2021 and thereafter, $5,000,000.’’. 

10 TITLE IX—CO-PRESCRIBING TO 

11 REDUCE OVERDOSES ACT 

12 SEC. 901. SHORT TITLE. 

13 This title may be cited as the ‘‘Co-Prescribing to Re14 duce Overdoses Act of 2016’’. 

15 SEC. 902. OPIOID OVERDOSE REVERSAL DRUGS PRE16 SCRIBING GRANT PROGRAM. 

17 (a) ESTABLISHMENT.— 

18 (1) IN GENERAL.—Not later than 6 months after 

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

20 Health and Human Services may establish, in ac21 cordance with this section, a 5-year opioid overdose 

22 reversal drugs prescribing grant program (in this Act 

23 referred to as the ‘‘grant program’’). 
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1 (2) MAXIMUM GRANT AMOUNT.—A grant made 

2 under this section may not be for more than $200,000 

3 per grant year. 

4 (3) ELIGIBLE ENTITY.—For purposes of this sec5 tion, the term ‘‘eligible entity’’ means a federally 

6 qualified health center (as defined in section 1861(aa) 

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

8 opioid treatment program under part 8 of title 42, 

9 Code of Federal Regulations, any practitioner dis10 pensing narcotic drugs pursuant to section 303(g) of 

11 the Controlled Substances Act (21 U.S.C. 823(g)), or 

12 any other entity that the Secretary deems appro13 priate. 

14 (4) PRESCRIBING.—For purposes of this section 

15 and section 3, the term ‘‘prescribing’’ means, with re16 spect to an opioid overdose reversal drug, such as 

17 naloxone, the practice of prescribing such drug— 

18 (A) in conjunction with an opioid prescrip19 tion for patients at an elevated risk of overdose; 

20 (B) in conjunction with an opioid agonist 

21 approved under section 505 of the Federal Food, 

22 Drug, and Cosmetic Act (21 U.S.C. 355) for the 

23 treatment of opioid abuse disorder; 
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1 (C) to the caregiver or a close relative of pa2 tients at an elevated risk of overdose from 

3 opioids; or 

4 (D) in other circumstances, as identified by 

5 the Secretary, in which a provider identifies a 

6 patient is at an elevated risk for an intentional 

7 or unintentional drug overdose from heroin or 

8 prescription opioid therapies. 

9 (b) APPLICATION.—To be eligible to receive a grant 

10 under this section, an eligible entity shall submit to the Sec11 retary of Health and Human Services, in such form and 

12 manner as specified by the Secretary, an application that 

13 describes— 

14 (1) the extent to which the area to which the en15 tity will furnish services through use of the grant is 

16 experiencing significant morbidity and mortality 

17 caused by opioid abuse; 

18 (2) the criteria that will be used to identify eligi19 ble patients to participate in such program; and 

20 (3) how such program will work to try to iden21 tify State, local, or private funding to continue the 

22 program after expiration of the grant. 

23 (c) USE OF FUNDS.—An eligible entity receiving a 

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

25 following activities, but may use not more than 20 percent 
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1 of the grant funds for activities described in paragraphs 

2 (4) and (5): 

3 (1) To establish a program for prescribing opioid 

4 overdose reversal drugs, such as naloxone. 

5 (2) To train and provide resources for health 

6 care providers and pharmacists on the prescribing of 

7 opioid overdose reversal drugs, such as naloxone. 

8 (3) To establish mechanisms and processes for 

9 tracking patients participating in the program de10 scribed in paragraph (1) and the health outcomes of 

11 such patients. 

12 (4) To purchase opioid overdose reversal drugs, 

13 such as naloxone, for distribution under the program 

14 described in paragraph (1). 

15 (5) To offset the co-pays and other cost sharing 

16 associated with opioid overdose reversal drugs, such 

17 as naloxone, to ensure that cost is not a limiting fac18 tor for eligible patients. 

19 (6) To conduct community outreach, in conjunc20 tion with community-based organizations, designed to 

21 raise awareness of prescribing practices, and the 

22 availability of opioid overdose reversal drugs, such as 

23 naloxone. 

24 (7) To establish protocols to connect patients who 

25 have experienced a drug overdose with appropriate 
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1 treatment, including medication assisted treatment 

2 and appropriate counseling and behavioral therapies. 

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

4 receipt of a grant under this section, an eligible entity shall, 

5 for each year for which the grant is received, submit to the 

6 Secretary of Health and Human Services information on 

7 appropriate outcome measures specified by the Secretary to 

8 assess the outcomes of the program funded by the grant, in9 cluding— 

10 (1) the number of prescribers trained; 

11 (2) the number of prescribers who have co-pre12 scribed an opioid overdose reversal drug, such as 

13 naloxone, to at least one patient; 

14 (3) the total number of prescriptions written for 

15 opioid overdose reversal drugs, such as naloxone; 

16 (4) the percentage of patients at elevated risk 

17 who received a prescription for an opioid overdose re18 versal drug, such as naloxone; 

19 (5) the number of patients reporting use of an 

20 opioid overdose reversal drug, such as naloxone; and 

21 (6) any other outcome measures that the Sec22 retary deems appropriate. 

23 (e) REPORTS BY SECRETARY.—For each year of the 

24 grant program under this section, the Secretary of Health 

25 and Human Services shall submit to the appropriate com-
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1 mittees of the House of Representatives and of the Senate 

2 a report aggregating the information received from the 

3 grant recipients for such year under subsection (d) and 

4 evaluating the outcomes achieved by the programs funded 

5 by grants made under this section. 

6 SEC. 903. PROVIDING INFORMATION TO PRESCRIBERS IN 

7 CERTAIN FEDERAL HEALTH CARE AND MED8 ICAL FACILITIES ON BEST PRACTICES FOR 

9 PRESCRIBING OPIOID OVERDOSE REVERSAL 

10 DRUGS. 

11 (a) IN GENERAL.—Not later than 180 days after the 

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

13 Human Services (in this section referred to as the ‘‘Sec14 retary’’) may, as appropriate, provide information to pre15 scribers within federally qualified health centers (as defined 

16 in paragraph (4) of section 1861(aa) of the Social Security 

17 Act (42 U.S.C. 1395x(aa))), and the health care facilities 

18 of the Indian Health Service, on best practices for pre19 scribing opioid overdose reversal drugs, such as naloxone, 

20 for patients receiving chronic opioid therapy, patients being 

21 treated for opioid use disorders, and other patients that a 

22 provider identifies as having an elevated risk of overdose 

23 from heroin or prescription opioid therapies. 

24 (b) NOT ESTABLISHING A MEDICAL STANDARD OF

25 CARE.—The information on best practices provided under 
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1 this section shall not be construed as constituting or estab2 lishing a medical standard of care for prescribing opioid 

3 overdose reversal drugs, such as naloxone, for patients de4 scribed in subsection (a). 

5 (c) ELEVATED RISK OF OVERDOSE DEFINED.—In this 

6 section, the term ‘‘elevated risk of overdose’’ has the meaning 

7 given such term by the Secretary, which— 

8 (1) may be based on the criteria provided in the 

9 Opioid Overdose Toolkit published by the Substance 

10 Abuse and Mental Health Services Administration 

11 (SAMHSA); and 

12 (2) may include patients on a first course opioid 

13 treatment, patients using extended-release and long14 acting opioid analgesics, and patients with a res15 piratory disease or other co-morbidities. 

16 SEC. 904. AUTHORIZATION OF APPROPRIATIONS. 

17 There is authorized to be appropriated to carry out 

18 this title $5,000,000 for the period of fiscal years 2017 

19 through 2021. 

20 SEC. 905. CUT-GO COMPLIANCE. 

21 Subsection (f) of section 319D of the Public Health 

22 Service Act (42 U.S.C. 247d–4) is amended by inserting 

23 before the period at the end the following: ‘‘(except such dol24 lar amount shall be reduced by $5,000,000 for fiscal year 

25 2018)’’. 
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1 TITLE X—IMPROVING TREAT2 MENT FOR PREGNANT AND 

3 POSTPARTUM WOMEN ACT 

4 SEC. 1001. SHORT TITLE. 

5 This title may be cited as the ‘‘Improving Treatment 

6 for Pregnant and Postpartum Women Act of 2016’’. 

7 SEC. 1002. REAUTHORIZATION OF RESIDENTIAL TREAT8 MENT PROGRAMS FOR PREGNANT AND 

9 POSTPARTUM WOMEN. 

10 Section 508 of the Public Health Service Act (42 

11 U.S.C. 290bb–1) is amended— 

12 (1) in subsection (p), in the first sentence, by in13 serting ‘‘(other than subsection (r))’’ after ‘‘section’’; 

14 and 

15 (2) in subsection (r), by striking ‘‘such sums’’ 

16 and all that follows through ‘‘2003’’ and inserting 

17 ‘‘$16,900,000 for each of fiscal years 2017 through 

18 2021’’. 

19 SEC. 1003. PILOT PROGRAM GRANTS FOR STATE SUB20 STANCE ABUSE AGENCIES. 

21 (a) IN GENERAL.—Section 508 of the Public Health 

22 Service Act (42 U.S.C. 290bb–1) is amended— 

23 (1) by redesignating subsection (r), as amended 

24 by section 2, as subsection (s); and 
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1 (2) by inserting after subsection (q) the following 

2 new subsection: 

3 ‘‘(r) PILOT PROGRAM FOR STATE SUBSTANCE ABUSE

4 AGENCIES.— 

5 ‘‘(1) IN GENERAL.—From amounts made avail6 able under subsection (s), the Director of the Center 

7 for Substance Abuse Treatment shall carry out a pilot 

8 program under which competitive grants are made by 

9 the Director to State substance abuse agencies to— 

10 ‘‘(A) enhance flexibility in the use of funds 

11 designed to support family-based services for 

12 pregnant and postpartum women with a pri13 mary diagnosis of a substance use disorder, in14 cluding opioid use disorders; 

15 ‘‘(B) help State substance abuse agencies 

16 address identified gaps in services furnished to 

17 such women along the continuum of care, includ18 ing services provided to women in nonresidential 

19 based settings; and 

20 ‘‘(C) promote a coordinated, effective, and 

21 efficient State system managed by State sub22 stance abuse agencies by encouraging new ap23 proaches and models of service delivery. 

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

25 program under this subsection, the Director shall— 
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1 ‘‘(A) require State substance abuse agencies 

2 to submit to the Director applications, in such 

3 form and manner and containing such informa4 tion as specified by the Director, to be eligible to 

5 receive a grant under the program; 

6 ‘‘(B) identify, based on such submitted ap7 plications, State substance abuse agencies that 

8 are eligible for such grants; 

9 ‘‘(C) require services proposed to be fur10 nished through such a grant to support family11 based treatment and other services for pregnant 

12 and postpartum women with a primary diag13 nosis of a substance use disorder, including 

14 opioid use disorders; 

15 ‘‘(D) not require that services furnished 

16 through such a grant be provided solely to 

17 women that reside in facilities; 

18 ‘‘(E) not require that grant recipients under 

19 the program make available through use of the 

20 grant all services described in subsection (d); and 

21 ‘‘(F) consider not applying requirements de22 scribed in paragraphs (1) and (2) of subsection 

23 (f) to applicants, depending on the circumstances 

24 of the applicant. 

25 ‘‘(3) REQUIRED SERVICES.— 
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1 ‘‘(A) IN GENERAL.—The Director shall 

2 specify a minimum set of services required to be 

3 made available to eligible women through a 

4 grant awarded under the pilot program under 

5 this subsection. Such minimum set— 

6 ‘‘(i) shall include requirements de7 scribed in subsection (c) and be based on the 

8 recommendations submitted under subpara9 graph (B); and 

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

11 services described in subsection (d) and in12 clude other services as appropriate. 

13 ‘‘(B) STAKEHOLDER INPUT.—The Director 

14 shall convene and solicit recommendations from 

15 stakeholders, including State substance abuse 

16 agencies, health care providers, persons in recov17 ery from substance abuse, and other appropriate 

18 individuals, for the minimum set of services de19 scribed in subparagraph (A). 

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

21 subsection shall not exceed 5 years. 

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

23 The Director of the Center for Behavioral Health Sta24 tistics and Quality shall fund an evaluation of the 

25 pilot program at the conclusion of the first grant 
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1 cycle funded by the pilot program. The Director of the 

2 Center for Behavioral Health Statistics and Quality, 

3 in coordination with the Director of the Center for 

4 Substance Abuse Treatment shall submit to the rel5 evant committees of jurisdiction of the House of Rep6 resentatives and the Senate a report on such evalua7 tion. The report shall include at a minimum out8 comes information from the pilot program, including 

9 any resulting reductions in the use of alcohol and 

10 other drugs; engagement in treatment services; reten11 tion in the appropriate level and duration of services; 

12 increased access to the use of medications approved by 

13 the Food and Drug Administration for the treatment 

14 of substance use disorders in combination with coun15 seling; and other appropriate measures. 

16 ‘‘(6) STATE SUBSTANCE ABUSE AGENCIES DE17 FINED.—For purposes of this subsection, the term 

18 ‘State substance abuse agency’ means, with respect to 

19 a State, the agency in such State that manages the 

20 Substance Abuse Prevention and Treatment Block 

21 Grant under part B of title XIX.’’. 

22 (b) FUNDING.—Subsection (s) of section 508 of the 

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

24 by section 1002 and redesignated by subsection (a), is fur25 ther amended by adding at the end the following new sen-
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1 tence: ‘‘Of the amounts made available for a year pursuant 

2 to the previous sentence to carry out this section, not more 

3 than 25 percent of such amounts shall be made available 

4 for such year to carry out subsection (r), other than para5 graph (5) of such subsection. Notwithstanding the preceding 

6 sentence, no funds shall be made available to carry out sub7 section (r) for a fiscal year unless the amount made avail8 able to carry out this section for such fiscal year is more 

9 than the amount made available to carry out this section 

10 for fiscal year 2016.’’. 

11 SEC. 1004. CUT-GO COMPLIANCE. 

12 Subsection (f) of section 319D of the Public Health 

13 Service Act (42 U.S.C. 247d–4) is amended by striking 

14 ‘‘through 2018’’ and inserting ‘‘through 2016, $133,300,000 

15 for fiscal year 2017, and $138,300,000 for fiscal year 2018’’. 

16 TITLE XI—VETERAN EMERGENCY 

17 MEDICAL TECHNICIAN SUP18 PORT ACT 

19 SEC. 1101. SHORT TITLE. 

20 This title may be cited as the ‘‘Veteran Emergency 

21 Medical Technician Support Act of 2016’’. 
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1 SEC. 1102. ASSISTING VETERANS WITH MILITARY EMER2 GENCY MEDICAL TRAINING TO MEET RE3 QUIREMENTS FOR BECOMING CIVILIAN 

4 EMERGENCY MEDICAL TECHNICIANS. 

5 Part B of title III of the Public Health Service Act 

6 (42 U.S.C. 243 et seq.) is amended by inserting after section 

7 314 the following: 

8 ‘‘SEC. 315. ASSISTING VETERANS WITH MILITARY EMER9 GENCY MEDICAL TRAINING TO MEET RE10 QUIREMENTS FOR BECOMING CIVILIAN 

11 EMERGENCY MEDICAL TECHNICIANS. 

12 ‘‘(a) PROGRAM.—The Secretary shall establish a pro13 gram consisting of awarding demonstration grants to 

14 States to streamline State requirements and procedures in 

15 order to assist veterans who completed military emergency 

16 medical technician training while serving in the Armed 

17 Forces of the United States to meet certification, licensure, 

18 and other requirements applicable to becoming an emer19 gency medical technician in the State. 

20 ‘‘(b) USE OF FUNDS.—Amounts received as a dem21 onstration grant under this section shall be used to prepare 

22 and implement a plan to streamline State requirements 

23 and procedures as described in subsection (a), including 

24 by— 

25 ‘‘(1) determining the extent to which the require26 ments for the education, training, and skill level of 
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1 emergency medical technicians in the State are equiv2 alent to requirements for the education, training, and 

3 skill level of military emergency medical technicians; 

4 and 

5 ‘‘(2) identifying methods, such as waivers, for 

6 military emergency medical technicians to forgo or 

7 meet any such equivalent State requirements. 

8 ‘‘(c) ELIGIBILITY.—To be eligible for a grant under 

9 this section, a State shall demonstrate that the State has 

10 a shortage of emergency medical technicians. 

11 ‘‘(d) REPORT.—The Secretary shall submit to the Con12 gress an annual report on the program under this section. 

13 ‘‘(e) FUNDING.—No additional funds are authorized to 

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

15 This section shall be carried out using amounts otherwise 

16 available for such purpose.’’. 

17 TITLE XII—JOHN THOMAS 

18 DECKER ACT 

19 SEC. 1201. SHORT TITLE. 

20 This title may be cited as the ‘‘John Thomas Decker 

21 Act of 2016’’. 
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1 SEC. 1202. INFORMATION MATERIALS AND RESOURCES TO 

2 PREVENT ADDICTION RELATED TO YOUTH 

3 SPORTS INJURIES. 

4 (a) TECHNICAL CLARIFICATION.—Effective as if in5 cluded in the enactment of the Children’s Health Act of 

6 2000 (Public Law 106–310), section 3405(a) of such Act 

7 (114 Stat. 1221) is amended by striking ‘‘Part E of title 

8 III’’ and inserting ‘‘Part E of title III of the Public Health 

9 Service Act’’. 

10 (b) AMENDMENT.—Title III of the Public Health Serv11 ice Act is amended by inserting after part D of such title 

12 (42 U.S.C. 254b et seq.) the following new part E: 

13 ‘‘PART E—OPIOID USE DISORDER 

14 ‘‘SEC. 341. INFORMATION MATERIALS AND RESOURCES TO 

15 PREVENT ADDICTION RELATED TO YOUTH 

16 SPORTS INJURIES. 

17 ‘‘(a) REPORT.—The Secretary shall— 

18 ‘‘(1) not later than 24 months after the date of 

19 the enactment of this section, make publicly available 

20 a report determining the extent to which informa21 tional materials and resources described in subsection 

22 (b) are available to teenagers and adolescents who 

23 play youth sports, families of such teenagers and ado24 lescents, nurses, youth sports groups, and relevant 

25 health care provider groups; and 
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1 ‘‘(2) for purposes of educating and preventing 

2 addiction in teenagers and adolescents who are in3 jured playing youth sports and are subsequently pre4 scribed an opioid, not later than 12 months after such 

5 report is made publicly available and taking into 

6 consideration the findings of such report, develop and, 

7 in coordination with youth sports groups, disseminate 

8 informational materials and resources described in 

9 subsection (b) for teenagers and adolescents who play 

10 youth sports, families of such teenagers and adoles11 cents, nurses, youth sports groups, and relevant health 

12 care provider groups. 

13 ‘‘(b) MATERIALS AND RESOURCES DESCRIBED.—For 

14 purposes of this section, the informational materials and 

15 resources described in this subsection are informational ma16 terials and resources with respect to youth sports injuries 

17 for which opioids are potentially prescribed and subse18 quently potentially lead to addiction, including materials 

19 and resources focused on the dangers of opioid use and mis20 use, treatment options for such injuries that do not involve 

21 the use of opioids, and how to seek treatment for addiction. 

22 ‘‘(c) NO ADDITIONAL FUNDS.—No additional funds 

23 are authorized to be appropriated for the purpose of car24 rying out this section. This section shall be carried out 

25 using amounts otherwise available for such purpose.’’. 
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1 TITLE XIII—LALI’S LAW 

2 SEC. 1301. SHORT TITLE. 

3 This title may be cited as ‘‘Lali’s Law’’. 

4 SEC. 1302. OPIOID OVERDOSE REVERSAL MEDICATION AC5 CESS AND EDUCATION GRANT PROGRAMS. 

6 (a) TECHNICAL CLARIFICATION.—Effective as if in7 cluded in the enactment of the Children’s Health Act of 

8 2000 (Public Law 106–310), section 3405(a) of such Act 

9 (114 Stat. 1221) is amended by striking ‘‘Part E of title 

10 III’’ and inserting ‘‘Part E of title III of the Public Health 

11 Service Act’’. 

12 (b) AMENDMENT.—Title III of the Public Health Serv13 ice Act is amended by inserting after part D of such title 

14 (42 U.S.C. 254b et seq.) the following new part E: 

15 ‘‘PART E—OPIOID USE DISORDER 

16 ‘‘SEC. 341. OPIOID OVERDOSE REVERSAL MEDICATION AC17 CESS AND EDUCATION GRANT PROGRAMS. 

18 ‘‘(a) GRANTS TO STATES.—The Secretary may make 

19 grants to States for— 

20 ‘‘(1) developing standing orders for pharmacies 

21 regarding opioid overdose reversal medication; 

22 ‘‘(2) encouraging pharmacies to dispense opioid 

23 overdose reversal medication pursuant to a standing 

24 order; 
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1 ‘‘(3) implementing best practices for persons au2 thorized to prescribe medication regarding— 

3 ‘‘(A) prescribing opioids for the treatment of 

4 chronic pain; 

5 ‘‘(B) co-prescribing opioid overdose reversal 

6 medication with opioids; and 

7 ‘‘(C) discussing the purpose and adminis8 tration of opioid overdose reversal medication 

9 with patients; 

10 ‘‘(4) developing or adapting training materials 

11 and methods for persons authorized to prescribe or 

12 dispense medication to use in educating the public re13 garding— 

14 ‘‘(A) when and how to administer opioid 

15 overdose reversal medication; and 

16 ‘‘(B) steps to be taken after administering 

17 opioid overdose reversal medication; and 

18 ‘‘(5) educating the public regarding— 

19 ‘‘(A) the public health benefits of opioid 

20 overdose reversal medication; and 

21 ‘‘(B) the availability of opioid overdose re22 versal medication without a person-specific pre23 scription. 

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

25 under this section only if the State involved has authorized 
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1 standing orders regarding opioid overdose reversal medica2 tion. 

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

4 grants under this section, the Secretary shall give preference 

5 to States that— 

6 ‘‘(1) have not issued standing orders regarding 

7 opioid overdose reversal medication; 

8 ‘‘(2) authorize standing orders that permit com9 munity-based organizations, substance abuse pro10 grams, or other nonprofit entities to acquire, dispense, 

11 or administer opioid overdose reversal medication; 

12 ‘‘(3) authorize standing orders that permit po13 lice, fire, or emergency medical services agencies to 

14 acquire and administer opioid overdose reversal medi15 cation; 

16 ‘‘(4) have a higher per capita rate of opioid 

17 overdoses than other applicant States; or 

18 ‘‘(5) meet any other criteria deemed appropriate 

19 by the Secretary. 

20 ‘‘(d) GRANT TERMS.— 

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

22 than one grant under this section. 

23 ‘‘(2) PERIOD.—A grant under this section shall 

24 be for a period of 3 years. 
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1 ‘‘(3) AMOUNT.—A grant under this section may 

2 not exceed $500,000. 

3 ‘‘(4) LIMITATION.—A State may use not more 

4 than 20 percent of a grant under this section for edu5 cating the public pursuant to subsection (a)(5). 

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

7 under this section, a State shall submit an application to 

8 the Secretary in such form and manner and containing 

9 such information as the Secretary may require, including 

10 detailed proposed expenditures of grant funds. 

11 ‘‘(f) REPORTING.—Not later than 3 months after the 

12 Secretary disburses the first grant payment to any State 

13 under this section and every 6 months thereafter for 3 years, 

14 such State shall submit a report to the Secretary that in15 cludes the following: 

16 ‘‘(1) The name and ZIP Code of each pharmacy 

17 in the State that dispenses opioid overdose reversal 

18 medication under a standing order. 

19 ‘‘(2) The total number of opioid overdose reversal 

20 medication doses dispensed by each such pharmacy, 

21 specifying how many were dispensed with or without 

22 a person-specific prescription. 

23 ‘‘(3) The number of pharmacists in the State 

24 who have participated in training pursuant to sub25 section (a)(4). 
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1 ‘‘(g) DEFINITIONS.—In this section: 

2 ‘‘(1) OPIOID OVERDOSE REVERSAL MEDICA3 TION.—The term ‘opioid overdose reversal medication’ 

4 means any drug, including naloxone, that— 

5 ‘‘(A) blocks opioids from attaching to, but 

6 does not itself activate, opioid receptors; or 

7 ‘‘(B) inhibits the effects of opioids on opioid 

8 receptors. 

9 ‘‘(2) STANDING ORDER.—The term ‘standing 

10 order’ means a document prepared by a person au11 thorized to prescribe medication that permits another 

12 person to acquire, dispense, or administer medication 

13 without a person-specific prescription. 

14 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.— 

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

16 there is authorized to be appropriated $5,000,000 for 

17 the period of fiscal years 2017 through 2019. 

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

19 percent of the amounts made available to carry out 

20 this section may be used by the Secretary for admin21 istrative expenses of carrying out this section.’’. 

22 SEC. 1303. CUT-GO COMPLIANCE. 

23 Subsection (f) of section 319D of the Public Health 

24 Service Act (42 U.S.C. 247d–4) is amended by inserting 

25 before the period at the end the following: ‘‘(except such dol-
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1 lar amount shall be reduced by $5,000,000 for fiscal year 

2 2017)’’. 

3 TITLE XIV—REDUCING UNUSED 

4 MEDICATIONS ACT 

5 SEC. 1401. SHORT TITLE. 

6 This title may be cited as the ‘‘Reducing Unused Medi7 cations Act of 2016’’. 

8 SEC. 1402. PARTIAL FILLS OF SCHEDULE II CONTROLLED 

9 SUBSTANCES. 

10 (a) IN GENERAL.—Section 309 of the Controlled Sub11 stances Act (21 U.S.C. 829) is amended by adding at the 

12 end the following: 

13 ‘‘(f) PARTIAL FILLS OF SCHEDULE II CONTROLLED

14 SUBSTANCES.— 

15 ‘‘(1) PARTIAL FILLS.— 

16 ‘‘(A) IN GENERAL.—A prescription for a 

17 controlled substance in schedule II may be par18 tially filled if— 

19 ‘‘(i) it is not prohibited by State law; 

20 ‘‘(ii) the prescription is written and 

21 filled in accordance with the Controlled 

22 Substances Act (21 U.S.C. 801 et seq.), reg23 ulations prescribed by the Attorney General, 

24 and State law; 
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1 ‘‘(iii) the partial fill is requested by 

2 the patient or the practitioner that wrote 

3 the prescription; and 

4 ‘‘(iv) the total quantity dispensed in 

5 all partial fillings does not exceed the total 

6 quantity prescribed. 

7 ‘‘(B) OTHER CIRCUMSTANCES.—A prescrip8 tion for a controlled substance in schedule II 

9 may be partially filled in accordance with sec10 tion 1306.13 of title 21, Code of Federal Regula11 tions (as in effect on the date of enactment of the 

12 Reducing Unused Medications Act). 

13 ‘‘(2) REMAINING PORTIONS.— 

14 ‘‘(A) IN GENERAL.—Except as provided in 

15 subparagraph (B), remaining portions of a par16 tially filled prescription for a controlled sub17 stance in schedule II— 

18 ‘‘(i) may be filled; and 

19 ‘‘(ii) shall be filled not later than 30 

20 days after the date on which the prescrip21 tion is written. 

22 ‘‘(B) EMERGENCY SITUATIONS.—In emer23 gency situations, as described in subsection (a), 

24 the remaining portions of a partially filled pre-
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1 scription for a controlled substance in schedule 

2 II— 

3 ‘‘(i) may be filled; and 

4 ‘‘(ii) shall be filled not later than 72 

5 hours after the prescription is issued.’’. 

6 (b) RULE OF CONSTRUCTION.—Nothing in this section 

7 shall be construed to affect the authority of the Attorney 

8 General to allow a prescription for a controlled substance 

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

10 Substances Act (21 U.S.C. 812(c)) to be partially filled. 

11 TITLE XV—OPIOID REVIEW 

12 MODERNIZATION ACT 

13 SEC. 1501. SHORT TITLE. 

14 This title may be cited as the ‘‘Opioid Review Mod15 ernization Act of 2016’’. 

16 SEC. 1502. FDA OPIOID ACTION PLAN. 

17 Chapter V of the Federal Food, Drug, and Cosmetic 

18 Act is amended by inserting after section 569 of such Act 

19 (21 U.S.C. 350bbb–8) the following: 

20 ‘‘SEC. 569–1. OPIOID ACTION PLAN. 

21 ‘‘(a) NEW DRUG APPLICATION.— 

22 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

23 prior to the approval pursuant to an application 

24 under section 505(b) of a new drug that is an opioid 

25 and does not have abuse-deterrent properties, the Sec-
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1 retary shall refer the application to an advisory com2 mittee of the Food and Drug Administration to seek 

3 recommendations from such advisory committee. 

4 ‘‘(2) PUBLIC HEALTH EXEMPTION.—A referral to 

5 an advisory committee under paragraph (1) is not re6 quired with respect to a new drug if the Secretary— 

7 ‘‘(A) finds that such a referral is not in the 

8 interest of protecting and promoting public 

9 health; 

10 ‘‘(B) finds that such a referral is not nec11 essary based on a review of the relevant scientific 

12 information; and 

13 ‘‘(C) submits a notice containing the ration14 ale for such findings to the Committee on Health, 

15 Education, Labor, and Pensions of the Senate 

16 and the Committee on Energy and Commerce of 

17 the House of Representatives. 

18 ‘‘(b) PEDIATRIC OPIOID LABELING.—The Secretary 

19 shall convene the Pediatric Advisory Committee of the Food 

20 and Drug Administration to seek recommendations from 

21 such Committee regarding a framework for the inclusion 

22 of information in the labeling of drugs that are opioids re23 lating to the use of such drugs in pediatric populations be24 fore the Secretary approves any labeling or change to label-
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1 ing for any drug that is an opioid intended for use in a 

2 pediatric population. 

3 ‘‘(c) SUNSET.—The requirements of subsections (a) 

4 and (b) shall cease to be effective on October 1, 2022.’’. 

5 SEC. 1503. PRESCRIBER EDUCATION. 

6 Not later than 1 year after the date of the enactment 

7 of this Act, the Secretary of Health and Human Services, 

8 acting through the Commissioner of Food and Drugs, as 

9 part of the Food and Drug Administration’s evaluation of 

10 the Extended-Release/Long-Acting Opioid Analgesics Risk 

11 Evaluation and Mitigation Strategy, and in consultation 

12 with relevant stakeholders, shall develop recommendations 

13 regarding education programs for prescribers of opioids 

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

15 Cosmetic Act (21 U.S.C. 355–1), including recommenda16 tions on— 

17 (1) which prescribers should participate in such 

18 programs; and 

19 (2) how often participation in such programs is 

20 necessary. 

21 SEC. 1504. GUIDANCE ON EVALUATING THE ABUSE DETER22 RENCE OF GENERIC SOLID ORAL OPIOID 

23 DRUG PRODUCTS. 

24 Not later than 2 years after the end of the period for 

25 public comment on the draft guidance entitled ‘‘General 
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1 Principals for Evaluating the Abuse Deterrence of Generic 

2 Solid Oral Opioid Drug Products’’ issued by the Center for 

3 Drug Evaluation and Research of the Food and Drug Ad4 ministration in March 2016, the Commissioner of Food and 

5 Drugs shall publish in the Federal Register a final version 

6 of such guidance. 

7 TITLE XVI—EXAMINING OPIOID 

8 TREATMENT INFRASTRUC9 TURE ACT 

10 SEC. 1601. SHORT TITLE. 

11 This title may be cited as the ‘‘Examining Opioid 

12 Treatment Infrastructure Act of 2016’’. 

13 SEC. 1602. STUDY ON TREATMENT INFRASTRUCTURE. 

14 Not later than 24 months after the date of enactment 

15 of this Act, the Comptroller General of the United States 

16 shall initiate an evaluation, and submit to Congress a re17 port, of the inpatient and outpatient treatment capacity, 

18 availability, and needs of the United States, which shall 

19 include, to the extent data are available— 

20 (1) the capacity of acute residential or inpatient 

21 detoxification programs; 

22 (2) the capacity of inpatient clinical stabiliza23 tion programs, transitional residential support serv24 ices, and residential rehabilitation programs; 
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1 (3) the capacity of demographic specific residen2 tial or inpatient treatment programs, such as those 

3 designed for pregnant women or adolescents; 

4 (4) geographical differences of the availability of 

5 residential and outpatient treatment and recovery op6 tions for substance use disorders across the continuum 

7 of care; 

8 (5) the availability of residential and outpatient 

9 treatment programs that offer treatment options based 

10 on reliable scientific evidence of efficacy for the treat11 ment of substance use disorders, including the use of 

12 Food and Drug Administration-approved medicines 

13 and evidence-based nonpharmacological therapies; 

14 (6) the number of patients in residential and 

15 specialty outpatient treatment services for substance 

16 use disorders; 

17 (7) an assessment of the need for residential and 

18 outpatient treatment for substance use disorders 

19 across the continuum of care; 

20 (8) the availability of residential and outpatient 

21 treatment programs to American Indians and Alaska 

22 Natives through an Indian health program (as de23 fined by section 4 of the Indian Health Care Improve24 ment Act (25 U.S.C. 1603)); and 
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1 (9) the barriers (including technological barriers) 

2 at the Federal, State, and local levels to real-time re3 porting of de-identified information on drug overdoses 

4 and ways to overcome such barriers. 

5 TITLE XVII—OPIOID USE DIS6 ORDER TREATMENT EXPAN7 SION AND MODERNIZATION 

8 ACT 

9 SEC. 1701. SHORT TITLE. 

10 This title may be cited as the ‘‘Opioid Use Disorder 

11 Treatment Expansion and Modernization Act’’. 

12 SEC. 1702. FINDING. 

13 The Congress finds that opioid use disorder has become 

14 a public health epidemic that must be addressed by increas15 ing awareness and access to all treatment options for opioid 

16 use disorder, overdose reversal, and relapse prevention. 

17 SEC. 1703. OPIOID USE DISORDER TREATMENT MODERNIZA18 TION. 

19 (a) IN GENERAL.—Section 303(g)(2) of the Controlled 

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

21 (1) in subparagraph (B), by striking clauses (i), 

22 (ii), and (iii) and inserting the following: 

23 ‘‘(i) The practitioner is a qualifying practitioner 

24 (as defined in subparagraph (G)). 
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1 ‘‘(ii) With respect to patients to whom the prac2 titioner will provide such drugs or combinations of 

3 drugs, the practitioner has the capacity to provide di4 rectly, by referral, or in such other manner as deter5 mined by the Secretary— 

6 ‘‘(I) all schedule III, IV, and V drugs, as 

7 well as unscheduled medications approved by the 

8 Food and Drug Administration, for the treat9 ment of opioid use disorder, including such 

10 drugs and medications for maintenance, detoxi11 fication, overdose reversal, and relapse preven12 tion, as available; and 

13 ‘‘(II) appropriate counseling and other ap14 propriate ancillary services. 

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

16 practitioner at any one time will not exceed the ap17 plicable number. Except as provided in subclause (II), 

18 the applicable number is 30. 

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

20 than 1 year after the date on which the practitioner 

21 submitted the initial notification, the practitioner 

22 submits a second notification to the Secretary of the 

23 need and intent of the practitioner to treat up to 100 

24 patients. 
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1 ‘‘(III) The Secretary may by regulation change 

2 such total number. 

3 ‘‘(IV) The Secretary may exclude from the appli4 cable number patients to whom such drugs or com5 binations of drugs are directly administered by the 

6 qualifying practitioner in the office setting. 

7 ‘‘(iv) If the Secretary by regulation increases the 

8 total number of patients which a qualifying practi9 tioner is permitted to treat pursuant to clause 

10 (iii)(II), the Secretary shall require such a practi11 tioner to obtain a written agreement from each pa12 tient, including the patient’s signature, that the pa13 tient— 

14 ‘‘(I) will receive an initial assessment and 

15 treatment plan and periodic assessments and 

16 treatment plans thereafter; 

17 ‘‘(II) will be subject to medication adherence 

18 and substance use monitoring; 

19 ‘‘(III) understands available treatment op20 tions, including all drugs approved by the Food 

21 and Drug Administration for the treatment of 

22 opioid use disorder, including their potential 

23 risks and benefits; and 

24 ‘‘(IV) understands that receiving regular 

25 counseling services is critical to recovery. 
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1 ‘‘(v) The practitioner will comply with the re2 porting requirements of subparagraph (D)(i)(IV).’’; 

3 (2) in subparagraph (D)— 

4 (A) in clause (i), by adding at the end the 

5 following: 

6 ‘‘(IV) The practitioner reports to the Secretary, 

7 at such times and in such manner as specified by the 

8 Secretary, such information and assurances as the 

9 Secretary determines necessary to assess whether the 

10 practitioner continues to meet the requirements for a 

11 waiver under this paragraph.’’; 

12 (B) in clause (ii), by striking ‘‘Upon receiv13 ing a notification under subparagraph (B)’’ and 

14 inserting ‘‘Upon receiving a determination from 

15 the Secretary under clause (iii) finding that a 

16 practitioner meets all requirements for a waiver 

17 under subparagraph (B)’’; and 

18 (C) in clause (iii)— 

19 (i) by inserting ‘‘and shall forward 

20 such determination to the Attorney Gen21 eral’’ before the period at the end of the first 

22 sentence; and 

23 (ii) by striking ‘‘physician’’ and in24 serting ‘‘practitioner’’; 

25 (3) in subparagraph (G)— 
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1 (A) by amending clause (ii)(IV) to read as 

2 follows: 

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

4 treatment and management of opiate-dependent 

5 patients, completed not less than 8 hours of 

6 training (through classroom situations, seminars 

7 at professional society meetings, electronic com8 munications, or otherwise) that is provided by 

9 the American Society of Addiction Medicine, the 

10 American Academy of Addiction Psychiatry, the 

11 American Medical Association, the American Os12 teopathic Association, the American Psychiatric 

13 Association, or any other organization that the 

14 Secretary determines is appropriate for purposes 

15 of this subclause. Such training shall address— 

16 ‘‘(aa) opioid maintenance and detoxi17 fication; 

18 ‘‘(bb) appropriate clinical use of all 

19 drugs approved by the Food and Drug Ad20 ministration for the treatment of opioid use 

21 disorder; 

22 ‘‘(cc) initial and periodic patient as23 sessments (including substance use moni24 toring); 
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1 ‘‘(dd) individualized treatment plan2 ning; overdose reversal; relapse prevention; 

3 ‘‘(ee) counseling and recovery support 

4 services; 

5 ‘‘(ff) staffing roles and considerations; 

6 ‘‘(gg) diversion control; and 

7 ‘‘(hh) other best practices, as identified 

8 by the Secretary.’’; and 

9 (B) by adding at the end the following: 

10 ‘‘(iii) The term ‘qualifying practitioner’ 

11 means— 

12 ‘‘(I) a qualifying physician, as defined in 

13 clause (ii); or 

14 ‘‘(II) during the period beginning on the 

15 date of the enactment of the Opioid Use Disorder 

16 Treatment Expansion and Modernization Act 

17 and ending on the date that is 3 years after such 

18 date of enactment, a qualifying other practi19 tioner, as defined in clause (iv). 

20 ‘‘(iv) The term ‘qualifying other practitioner’ 

21 means a nurse practitioner or physician assistant 

22 who satisfies each of the following: 

23 ‘‘(I) The nurse practitioner or physician as24 sistant is licensed under State law to prescribe 
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1 schedule III, IV, or V medications for the treat2 ment of pain. 

3 ‘‘(II) The nurse practitioner or physician 

4 assistant satisfies one or more of the following: 

5 ‘‘(aa) Has completed not fewer than 24 

6 hours of initial training addressing each of 

7 the topics listed in clause (ii)(IV) (through 

8 classroom situations, seminars at profes9 sional society meetings, electronic commu10 nications, or otherwise) provided by the 

11 American Society of Addiction Medicine, 

12 the American Academy of Addiction Psychi13 atry, the American Medical Association, the 

14 American Osteopathic Association, the 

15 American Nurses Credentialing Center, the 

16 American Psychiatric Association, the 

17 American Association of Nurse Practi18 tioners, the American Academy of Physi19 cian Assistants, or any other organization 

20 that the Secretary determines is appro21 priate for purposes of this subclause. 

22 ‘‘(bb) Has such other training or expe23 rience as the Secretary determines will dem24 onstrate the ability of the nurse practitioner 
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1 or physician assistant to treat and manage 

2 opiate-dependent patients. 

3 ‘‘(III) The nurse practitioner or physician 

4 assistant is supervised by or works in collabora5 tion with a qualifying physician, if the nurse 

6 practitioner or physician assistant is required by 

7 State law to prescribe medications for the treat8 ment of opioid use disorder in collaboration with 

9 or under the supervision of a physician. 

10 The Secretary may review and update the require11 ments for being a qualifying other practitioner under 

12 this clause.’’; and 

13 (4) in subparagraph (H)— 

14 (A) in clause (i), by inserting after sub15 clause (II) the following: 

16 ‘‘(III) Such other elements of the requirements 

17 under this paragraph as the Secretary determines 

18 necessary for purposes of implementing such require19 ments.’’; and 

20 (B) by amending clause (ii) to read as fol21 lows: 

22 ‘‘(ii) Not later than 1 year after the date of enactment 

23 of the Opioid Use Disorder Treatment Expansion and Mod24 ernization Act, the Secretary shall update the treatment im25 provement protocol containing best practice guidelines for 
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1 the treatment of opioid-dependent patients in office-based 

2 settings. The Secretary shall update such protocol in con3 sultation with experts in opioid use disorder research and 

4 treatment.’’. 

5 (b) RECOMMENDATION OF REVOCATION OR SUSPEN6 SION OF REGISTRATION IN CASE OF SUBSTANTIAL NON7 COMPLIANCE.—The Secretary of Health and Human Serv8 ices may recommend to the Attorney General that the reg9 istration of a practitioner be revoked or suspended if the 

10 Secretary determines, according to such criteria as the Sec11 retary establishes by regulation, that a practitioner who is 

12 registered under section 303(g)(2) of the Controlled Sub13 stances Act (21 U.S.C. 823(g)(2)) is not in substantial com14 pliance with the requirements of such section, as amended 

15 by this Act. 

16 (c) OPIOID DEFINED.—Section 102(18) of the Con17 trolled Substances Act (21 U.S.C. 802(18)) is amended by 

18 inserting ‘‘or ‘opioid’ ’’ after ‘‘The term ‘opiate’ ’’. 

19 (d) REPORTS TO CONGRESS.— 

20 (1) IN GENERAL.—Not later than 2 years after 

21 the date of enactment of this Act and not less than 

22 over every 5 years thereafter, the Secretary of Health 

23 and Human Services, in consultation with the Drug 

24 Enforcement Administration and experts in opioid 

25 use disorder research and treatment, shall— 
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1 (A) perform a thorough review of the provi2 sion of opioid use disorder treatment services in 

3 the United States, including services provided in 

4 opioid treatment programs and other specialty 

5 and nonspecialty settings; and 

6 (B) submit a report to the Congress on the 

7 findings and conclusions of such review. 

8 (2) CONTENTS.—Each report under paragraph 

9 (1) shall include an assessment of— 

10 (A) compliance with the requirements of 

11 section 303(g)(2) of the Controlled Substances 

12 Act (21 U.S.C. 823(g)(2)), as amended by this 

13 Act; 

14 (B) the measures taken by the Secretary of 

15 Health and Human Services to ensure such com16 pliance; 

17 (C) whether there is further need to increase 

18 or decrease the number of patients a waivered 

19 practitioner is permitted to treat, as provided for 

20 by the amendment made by subsection (a)(1); 

21 (D) the extent to which, and proportions 

22 with which, the full range of Food and Drug Ad23 ministration-approved treatments for opioid use 

24 disorder are used in routine health care settings 
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1 and specialty substance use disorder treatment 

2 settings; 

3 (E) access to, and use of, counseling and re4 covery support services, including the percentage 

5 of patients receiving such services; 

6 (F) changes in State or local policies and 

7 legislation relating to opioid use disorder treat8 ment; 

9 (G) the use of prescription drug monitoring 

10 programs by practitioners who are permitted to 

11 dispense narcotic drugs to individuals pursuant 

12 to a waiver under section 303(g)(2) of the Con13 trolled Substances Act (21 U.S.C. 823(g)(2)); 

14 (H) the findings resulting from inspections 

15 by the Drug Enforcement Administration of 

16 practitioners described in subparagraph (G); and 

17 (I) the effectiveness of cross-agency collabo18 ration between Department of Health and 

19 Human Services and the Drug Enforcement Ad20 ministration for expanding effective opioid use 

21 disorder treatment. 

22 SEC. 1704. SENSE OF CONGRESS. 

23 It is the Sense of Congress that, with respect to the 

24 total number of patients that a qualifying physician (as 

25 defined in subparagraph (G)(iii) of section 303(g)(2) of the 
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1 Controlled Substances Act (21 U.S.C. 823(g)(2)) can treat 

2 at any one time pursuant to such section, the Secretary of 

3 Health and Human Services should consider raising such 

4 total number to 250 patients following a third notification 

5 to the Secretary of the need and intent of the physician 

6 to treat up to 250 patients that is submitted to the Sec7 retary not sooner than 1 year after the date on which the 

8 physician submitted to the Secretary a second notification 

9 to treat up to 100 patients. 

10 SEC. 1705. PARTIAL FILLS OF SCHEDULE II CONTROLLED 

11 SUBSTANCES. 

12 (a) IN GENERAL.—Section 309 of the Controlled Sub13 stances Act (21 U.S.C. 829) is amended by adding at the 

14 end the following: 

15 ‘‘(f) PARTIAL FILLS OF SCHEDULE II CONTROLLED

16 SUBSTANCES.— 

17 ‘‘(1) PARTIAL FILLS.— 

18 ‘‘(A) IN GENERAL.—A prescription for a 

19 controlled substance in schedule II may be par20 tially filled if— 

21 ‘‘(i) it is not prohibited by State law; 

22 ‘‘(ii) the prescription is written and 

23 filled in accordance with the Controlled 

24 Substances Act (21 U.S.C. 801 et seq.), reg-
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1 ulations prescribed by the Attorney General, 

2 and State law; 

3 ‘‘(iii) the partial fill is requested by 

4 the patient or the practitioner that wrote 

5 the prescription; and 

6 ‘‘(iv) the total quantity dispensed in 

7 all partial fillings does not exceed the total 

8 quantity prescribed. 

9 ‘‘(B) OTHER CIRCUMSTANCES.—A prescrip10 tion for a controlled substance in schedule II 

11 may be partially filled in accordance with sec12 tion 1306.13 of title 21, Code of Federal Regula13 tions (as in effect on the date of enactment of the 

14 Reducing Unused Medications Act of 2016). 

15 ‘‘(2) REMAINING PORTIONS.— 

16 ‘‘(A) IN GENERAL.—Except as provided in 

17 subparagraph (B), remaining portions of a par18 tially filled prescription for a controlled sub19 stance in schedule II— 

20 ‘‘(i) may be filled; and 

21 ‘‘(ii) shall be filled not later than 30 

22 days after the date on which the prescrip23 tion is written. 

24 ‘‘(B) EMERGENCY SITUATIONS.—In emer25 gency situations, as described in subsection (a), 
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1 the remaining portions of a partially filled pre2 scription for a controlled substance in schedule 

3 II— 

4 ‘‘(i) may be filled; and 

5 ‘‘(ii) shall be filled not later than 72 

6 hours after the prescription is issued.’’. 

7 (b) RULE OF CONSTRUCTION.—Nothing in this section 

8 shall be construed to affect the authority of the Attorney 

9 General to allow a prescription for a controlled substance 

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

11 Substances Act (21 U.S.C. 812(c)) to be partially filled. 

12 TITLE XVIII—NATIONAL ALL 

13 SCHEDULES PRESCRIPTION 

14 ELECTRONIC REPORTING RE15 AUTHORIZATION ACT 

16 SEC. 1801. SHORT TITLE. 

17 This title may be cited as the ‘‘National All Schedules 

18 Prescription Electronic Reporting Reauthorization Act of 

19 2015’’. 

20 SEC. 1802. AMENDMENT TO PURPOSE. 

21 Paragraph (1) of section 2 of the National All Sched22 ules Prescription Electronic Reporting Act of 2005 (Public 

23 Law 109–60) is amended to read as follows: 
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1 ‘‘(1) foster the establishment of State-adminis2 tered controlled substance monitoring systems in 

3 order to ensure that— 

4 ‘‘(A) health care providers have access to the 

5 accurate, timely prescription history information 

6 that they may use as a tool for the early identi7 fication of patients at risk for addiction in order 

8 to initiate appropriate medical interventions 

9 and avert the tragic personal, family, and com10 munity consequences of untreated addiction; and 

11 ‘‘(B) appropriate law enforcement, regu12 latory, and State professional licensing authori13 ties have access to prescription history informa14 tion for the purposes of investigating drug diver15 sion and prescribing and dispensing practices of 

16 errant prescribers or pharmacists; and’’. 

17 SEC. 1803. AMENDMENTS TO CONTROLLED SUBSTANCE 

18 MONITORING PROGRAM. 

19 Section 399O of the Public Health Service Act (42 

20 U.S.C. 280g–3) is amended— 

21 (1) in subsection (a)— 

22 (A) in paragraph (1)— 

23 (i) in subparagraph (A), by striking 

24 ‘‘or’’; 
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1 (ii) in subparagraph (B), by striking 

2 the period at the end and inserting ‘‘; or’’; 

3 and 

4 (iii) by adding at the end the fol5 lowing: 

6 ‘‘(C) to maintain and operate an existing 

7 State-controlled substance monitoring program.’’; 

8 and 

9 (B) in paragraph (3), by inserting ‘‘by the 

10 Secretary’’ after ‘‘Grants awarded’’; 

11 (2) by amending subsection (b) to read as fol12 lows: 

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

14 maintain and, as appropriate, supplement or revise (after 

15 publishing proposed additions and revisions in the Federal 

16 Register and receiving public comments thereon) minimum 

17 requirements for criteria to be used by States for purposes 

18 of clauses (ii), (v), (vi), and (vii) of subsection (c)(1)(A).’’; 

19 (3) in subsection (c)— 

20 (A) in paragraph (1)(B)— 

21 (i) in the matter preceding clause (i), 

22 by striking ‘‘(a)(1)(B)’’ and inserting 

23 ‘‘(a)(1)(B) or (a)(1)(C)’’; 
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1 (ii) in clause (i), by striking ‘‘program 

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

3 be improved or maintained’’; 

4 (iii) by redesignating clauses (iii) and 

5 (iv) as clauses (iv) and (v), respectively; 

6 (iv) by inserting after clause (ii) the 

7 following: 

8 ‘‘(iii) a plan to apply the latest ad9 vances in health information technology in 

10 order to incorporate prescription drug mon11 itoring program data directly into the 

12 workflow of prescribers and dispensers to 

13 ensure timely access to patients’ controlled 

14 prescription drug history;’’; 

15 (v) in clause (iv), as redesignated, by 

16 inserting before the semicolon at the end 

17 ‘‘and at least one health information tech18 nology system such as an electronic health 

19 records system, a health information ex20 change, or an e-prescribing system’’; and 

21 (vi) in clause (v), as redesignated, by 

22 striking ‘‘public health’’ and inserting 

23 ‘‘public health or public safety’’; 

24 (B) in paragraph (3)— 
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•S 524 EAH 

1 (i) by striking ‘‘If a State that sub2 mits’’ and inserting the following: 

3 ‘‘(A) IN GENERAL.—If a State that sub4 mits’’; 

5 (ii) by striking the period at the end 

6 and inserting ‘‘and include timelines for 

7 full implementation of such interoper8 ability. The State shall also describe the 

9 manner in which it will achieve interoper10 ability between its monitoring program and 

11 health information technology systems, as 

12 allowable under State law, and include 

13 timelines for implementation of such inter14 operability.’’; and 

15 (iii) by adding at the end the fol16 lowing: 

17 ‘‘(B) MONITORING OF EFFORTS.—The Sec18 retary shall monitor State efforts to achieve 

19 interoperability, as described in subparagraph 

20 (A).’’; and 

21 (C) in paragraph (5)— 

22 (i) by striking ‘‘implement or im23 prove’’ and inserting ‘‘establish, improve, or 

24 maintain’’; and 
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•S 524 EAH 

1 (ii) by adding at the end the following: 

2 ‘‘The Secretary shall redistribute any funds 

3 that are so returned among the remaining 

4 grantees under this section in accordance 

5 with the formula described in subsection 

6 (a)(2)(B).’’; 

7 (4) in subsection (d)— 

8 (A) in the matter preceding paragraph 

9 (1)— 

10 (i) by striking ‘‘In implementing or 

11 improving’’ and all that follows through 

12 ‘‘(a)(1)(B)’’ and inserting ‘‘In establishing, 

13 improving, or maintaining a controlled 

14 substance monitoring program under this 

15 section, a State shall comply, or with re16 spect to a State that applies for a grant 

17 under subparagraph (B) or (C) of sub18 section (a)(1)’’; and 

19 (ii) by striking ‘‘public health’’ and in20 serting ‘‘public health or public safety’’; and 

21 (B) by adding at the end the following: 

22 ‘‘(5) The State shall report to the Secretary on— 

23 ‘‘(A) as appropriate, interoperability with 

24 the controlled substance monitoring programs of 

25 Federal departments and agencies; 
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1 ‘‘(B) as appropriate, interoperability with 

2 health information technology systems such as 

3 electronic health records systems, health informa4 tion exchanges, and e-prescribing systems; and 

5 ‘‘(C) whether or not the State provides auto6 matic, real-time or daily information about a 

7 patient when a practitioner (or the designee of a 

8 practitioner, where permitted) requests informa9 tion about such patient.’’; 

10 (5) in subsections (e), (f)(1), and (g), by striking 

11 ‘‘implementing or improving’’ each place it appears 

12 and inserting ‘‘establishing, improving, or maintain13 ing’’; 

14 (6) in subsection (f)— 

15 (A) in paragraph (1)— 

16 (i) in subparagraph (B), by striking 

17 ‘‘misuse of a schedule II, III, or IV sub18 stance’’ and inserting ‘‘misuse of a con19 trolled substance included in schedule II, 

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

21 Substance Act’’; and 

22 (ii) in subparagraph (D), by inserting 

23 ‘‘a State substance abuse agency,’’ after ‘‘a 

24 State health department,’’; and 

25 (B) by adding at the end the following: 
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1 ‘‘(3) EVALUATION AND REPORTING.—Subject to 

2 subsection (g), a State receiving a grant under sub3 section (a) shall provide the Secretary with aggregate 

4 data and other information determined by the Sec5 retary to be necessary to enable the Secretary— 

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

7 program in achieving its purposes; or 

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

9 Congress required by subsection (l)(2). 

10 ‘‘(4) RESEARCH BY OTHER ENTITIES.—A depart11 ment, program, or administration receiving non12 identifiable information under paragraph (1)(D) may 

13 make such information available to other entities for 

14 research purposes.’’; 

15 (7) by redesignating subsections (h) through (n) 

16 as subsections (j) through (p), respectively; 

17 (8) in subsections (c)(1)(A)(iv) and (d)(4), by 

18 striking ‘‘subsection (h)’’ each place it appears and 

19 inserting ‘‘subsection (j)’’; 

20 (9) by inserting after subsection (g) the fol21 lowing: 

22 ‘‘(h) EDUCATION AND ACCESS TO THE MONITORING

23 SYSTEM.—A State receiving a grant under subsection (a) 

24 shall take steps to— 
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1 ‘‘(1) facilitate prescriber and dispenser use of the 

2 State’s controlled substance monitoring system; 

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

4 benefits of the system both to them and society; and 

5 ‘‘(3) facilitate linkage to the State substance 

6 abuse agency and substance abuse disorder services. 

7 ‘‘(i) CONSULTATION WITH ATTORNEY GENERAL.—In 

8 carrying out this section, the Secretary shall consult with 

9 the Attorney General of the United States and other rel10 evant Federal officials to— 

11 ‘‘(1) ensure maximum coordination of controlled 

12 substance monitoring programs and related activities; 

13 and 

14 ‘‘(2) minimize duplicative efforts and funding.’’; 

15 (10) in subsection (l)(2)(A), as redesignated by 

16 paragraph (7)— 

17 (A) in clause (ii), by inserting ‘‘; established 

18 or strengthened initiatives to ensure linkages to 

19 substance use disorder services;’’ before ‘‘or af20 fected patient access’’; and 

21 (B) in clause (iii), by inserting ‘‘and be22 tween controlled substance monitoring programs 

23 and health information technology systems’’ be24 fore ‘‘, including an assessment’’; 
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1 (11) by striking subsection (m) (relating to pref2 erence), as redesignated by paragraph (7); 

3 (12) by redesignating subsections (n) through 

4 (p), as redesignated by paragraph (7), as subsections 

5 (m) through (o), respectively; 

6 (13) in subsection (m)(1), as redesignated by 

7 paragraph (12), by striking ‘‘establishment, imple8 mentation, or improvement’’ and inserting ‘‘establish9 ment, improvement, or maintenance’’; 

10 (14) in subsection (n), as redesignated by para11 graph (12)— 

12 (A) in paragraph (5)— 

13 (i) by striking ‘‘means the ability’’ and 

14 inserting the following: ‘‘means— 

15 ‘‘(A) the ability’’; 

16 (ii) by striking the period at the end 

17 and inserting ‘‘; or’’; and 

18 (iii) by adding at the end the fol19 lowing: 

20 ‘‘(B) sharing of State controlled substance 

21 monitoring program information with a health 

22 information technology system such as an elec23 tronic health records system, a health informa24 tion exchange, or an e-prescribing system.’’; 
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1 (B) in paragraph (7), by striking ‘‘phar2 macy’’ and inserting ‘‘pharmacist’’; and 

3 (C) in paragraph (8), by striking ‘‘and the 

4 District of Columbia’’ and inserting ‘‘, the Dis5 trict of Columbia, and any commonwealth or 

6 territory of the United States’’; and 

7 (15) by amending subsection (o), as redesignated 

8 by paragraph (12), to read as follows: 

9 ‘‘(o) AUTHORIZATION OF APPROPRIATIONS.—To carry 

10 out this section, there is authorized to be appropriated 

11 $10,000,000 for each of fiscal years from 2016 through 

12 2020.’’. 

Amend the title so as to read: ‘‘An Act to authorize 

the Attorney General and Secretary of Health and 

Human Services to award grants to address the national 

epidemics of prescription opioid abuse and heroin use, 

and to provide for the establishment of an inter-agency 

task force to review, modify, and update best practices 

for pain management and prescribing pain medication, 

and for other purposes.’’. 

Attest: 

Clerk. 
114TH CONGRESS 

2D SESSION S. 524 

AMENDMENTS