II 

114TH CONGRESS 

1ST SESSION S. 636 

To reduce prescription drug misuse and abuse. 

IN THE SENATE OF THE UNITED STATES 

MARCH 3, 2015 

Mr. UDALL introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To reduce prescription drug misuse and abuse. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Increasing the Safety 

5 of Prescription Drug Use Act of 2015’’. 

6 TITLE I—HHS PROGRAMS 

7 SEC. 101. AMENDMENT TO PURPOSE. 

8 Paragraph (1) of section 2 of the National All Sched9 ules Prescription Electronic Reporting Act of 2005 (Public 

10 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 

5 the accurate, timely prescription history infor6 mation that they may use as a tool for the early 

7 identification of patients at risk for addiction in 

8 order to initiate appropriate medical interven9 tions and avert the tragic personal, family, and 

10 community consequences of untreated addiction; 

11 and 

12 ‘‘(B) appropriate law enforcement, regu13 latory, and State professional licensing authori14 ties have access to prescription history informa15 tion for the purposes of investigating drug di16 version and prescribing and dispensing prac17 tices of errant prescribers or pharmacists; and’’. 

18 SEC. 102. PRESCRIPTION DRUG MONITORING PROGRAM. 

19 (a) CONTROLLED SUBSTANCE MONITORING PRO20 GRAM.—Section 399O of the Public Health Service Act 

21 (42 U.S.C. 280g–3) is amended— 

22 (1) in subsection (a)(1)— 

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

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

25 period at the end and inserting ‘‘; or’’; and 


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1 (C) by adding at the end the following: 

2 ‘‘(C) to maintain and operate an existing 

3 State-controlled substance monitoring pro4 gram.’’; 

5 (2) by amending subsection (b) to read as fol6 lows: 

7 ‘‘(b) MINIMUM REQUIREMENTS.—The Secretary 

8 shall maintain and, as appropriate, supplement or revise 

9 (after publishing proposed additions and revisions in the 

10 Federal Register and receiving public comments thereon) 

11 minimum requirements for criteria to be used by States 

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

13 (c)(1)(A).’’; 

14 (3) in subsection (c)— 

15 (A) in paragraph (1)(B)— 

16 (i) in the matter preceding clause (i), 

17 by striking ‘‘(a)(1)(B)’’ and inserting 

18 ‘‘(a)(1)(B) or (a)(1)(C)’’; 

19 (ii) in clause (i), by striking ‘‘program 

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

21 be improved or maintained’’; 

22 (iii) by redesignating clauses (iii) and 

23 (iv) as clauses (iv) and (v), respectively; 

24 (iv) by inserting after clause (ii), the 

25 following: 


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1 ‘‘(iii) a plan to apply the latest ad2 vances in health information technology in 

3 order to incorporate prescription drug 

4 monitoring program data directly into the 

5 workflow of prescribers and dispensers to 

6 ensure timely access to patients’ controlled 

7 prescription drug history;’’; 

8 (v) in clause (iv) (as so redesignated), 

9 by inserting before the semicolon the fol10 lowing: ‘‘and at least one health informa11 tion technology system such as electronic 

12 health records, health information ex13 changes, and e-prescribing systems’’; and 

14 (vi) in clause (v) (as so redesignated), 

15 by striking ‘‘public health’’ and inserting 

16 ‘‘public health or public safety’’; 

17 (B) in paragraph (3)— 

18 (i) by striking ‘‘If a State that sub19 mits’’ and inserting the following: 

20 ‘‘(A) IN GENERAL.—If a State that sub21 mits’’; 

22 (ii) by inserting before the period at 

23 the end ‘‘and include timelines for full im24 plementation of such interoperability. The 

25 State shall also describe the manner in 


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1 which it will achieve interoperability be2 tween its monitoring program and health 

3 information technology systems, as allow4 able under State law, and include timelines 

5 for the implementation of such interoper6 ability’’; and 

7 (iii) by adding at the end the fol8 lowing: 

9 ‘‘(B) MONITORING OF EFFORTS.—The 

10 Secretary shall monitor State efforts to achieve 

11 interoperability, as described in subparagraph 

12 (A).’’; 

13 (C) in paragraph (5)— 

14 (i) by striking ‘‘implement or im15 prove’’ and inserting ‘‘establish, improve, 

16 or maintain’’; and 

17 (ii) by adding at the end the fol18 lowing: ‘‘The Secretary shall redistribute 

19 any funds that are so returned among the 

20 remaining grantees under this section in 

21 accordance with the formula described in 

22 subsection (a)(2)(B).’’; 

23 (4) in subsection (d)— 

24 (A) in the matter preceding paragraph 

25 (1)— 


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1 (i) by striking ‘‘In implementing or 

2 improving’’ and all that follows through 

3 ‘‘(a)(1)(B)’’ and inserting ‘‘In establishing, 

4 improving, or maintaining a controlled sub5 stance monitoring program under this sec6 tion, a State shall comply, or with respect 

7 to a State that applies for a grant under 

8 subparagraph (B) or (C) of subsection 

9 (a)(1)’’; and 

10 (ii) by striking ‘‘public health’’ and in11 serting ‘‘public health or public safety’’; 

12 and 

13 (B) by adding at the end the following: 

14 ‘‘(5) The State shall report on interoperability 

15 with the controlled substance monitoring program of 

16 Federal agencies, where appropriate, interoperability 

17 with health information technology systems such as 

18 electronic health records, health information ex19 changes, and e-prescribing, where appropriate, and 

20 whether or not the State provides automatic, real21 time or daily information about a patient when a 

22 practitioner (or the designee of a practitioner, where 

23 permitted) requests information about such pa24 tient.’’; 


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1 (5) in subsection (e), by adding at the end the 

2 following: 

3 ‘‘(5) The State shall— 

4 ‘‘(A) ensure that the database— 

5 ‘‘(i) is interoperable with the con6 trolled substance monitoring program of 

7 other States and other Federal agencies 

8 and across appropriate State agencies, in9 cluding health agencies, as determined by 

10 the Secretary; 

11 ‘‘(ii) is interoperable with electronic 

12 health records and e-prescribing, where ap13 propriate; and 

14 ‘‘(iii) provides automatic, real-time or 

15 daily information about a patient when a 

16 practitioner (or the designee of a practi17 tioner, where permitted) requests informa18 tion about such patient; 

19 ‘‘(B) require practitioners to use State 

20 database information to help determine whether 

21 to prescribe or renew a prescription for a con22 trolled substance; and 

23 ‘‘(C) require dispensers, or their designees, 

24 where permitted, to enter data required by the 

25 Secretary, including the name of the patient, 


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1 the date, and prescription dose, into the data2 base for a controlled substance. 

3 ‘‘(6) Notwithstanding section 543 and any 

4 other provision of law, the data required to be en5 tered under paragraph (5)(C) shall include informa6 tion with respect to methadone that is dispensed to 

7 a patient, if applicable. 

8 ‘‘(7) The State shall ensure that— 

9 ‘‘(A) any person who receives patient infor10 mation through the database may disclose and 

11 use such information only to carry out the offi12 cial duties of that person with regard to the pa13 tient; and 

14 ‘‘(B) notwithstanding subsection (f)(1)(B), 

15 no information kept in accordance with a data16 base established, improved, or maintained 

17 through a grant under this section may be used 

18 to conduct a criminal investigation or substan19 tiate any criminal charges against a patient or 

20 to conduct any investigation of a patient relat21 ing to methadone use of the patient.’’; 

22 (6) in subsections (e), (f)(1), and (g), by strik23 ing ‘‘implementing or improving’’ each place it ap24 pears and inserting ‘‘establishing, improving, or 

25 maintaining’’; 


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1 (7) in subsection (f)— 

2 (A) in paragraph (1)(B) by striking ‘‘mis3 use of a schedule II, III, or IV substance’’ and 

4 inserting ‘‘misuse of a controlled substance in5 cluded in schedule II, III, or IV of section 

6 202(c) of the Controlled Substance Act’’; and 

7 (B) by adding at the end the following: 

8 ‘‘(3) EVALUATION AND REPORTING.—Subject 

9 to subsection (g), a State receiving a grant under 

10 subsection (a) shall provide the Secretary with ag11 gregate data and other information determined by 

12 the Secretary to be necessary to enable the Sec13 retary— 

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

15 program in achieving its purposes; or 

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

17 Congress required by subsection (k)(2). 

18 ‘‘(4) RESEARCH BY OTHER ENTITIES.—A de19 partment, program, or administration receiving non20 identifiable information under paragraph (1)(D) 

21 may make such information available to other enti22 ties for research purposes.’’; 

23 (8) by striking subsection (k); 

24 (9) by redesignating subsections (h) through (j) 

25 as subsections (i) through (k), respectively; 


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1 (10) in subsections (c)(1)(A)(iv) and (d)(4), by 

2 striking ‘‘subsection (h)’’ each place it appears and 

3 inserting ‘‘subsection (i)’’; 

4 (11) by inserting after subsection (g) the fol5 lowing: 

6 ‘‘(h) EDUCATION AND ACCESS TO THE MONITORING

7 SYSTEM.—A State receiving a grant under subsection (a) 

8 shall take steps to— 

9 ‘‘(1) facilitate prescriber and dispenser use of 

10 the State’s controlled substance monitoring system; 

11 and 

12 ‘‘(2) educate prescribers and dispenser on the 

13 benefits of the system both to them and society.’’; 

14 (12) in subsection (k)(2)(A), as redesignated— 

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

16 and inserting ‘‘, established or strengthened ini17 tiatives to ensure linkages to substance use dis18 order services, or affected’’; and 

19 (B) in clause (iii), by striking ‘‘including 

20 an assessment’’ and inserting ‘‘between con21 trolled substance monitoring programs and 

22 health information technology systems, and in23 cluding an assessment’’; 


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1 (13) in subsection (l)(1), by striking ‘‘establish2 ment, implementation, or improvement’’ and insert3 ing ‘‘establishment, improvement, or maintenance’’; 

4 (14) in subsection (m)(8), by striking ‘‘and the 

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

6 of Columbia, and any commonwealth or territory of 

7 the United States’’; and 

8 (15) by amending subsection (n), to read as fol9 lows: 

10 ‘‘(o) AUTHORIZATION OF APPROPRIATIONS.—To 

11 carry out this section, there are authorized to be appro12 priated $7,000,000 for each of fiscal years 2016 through 

13 2020.’’. 

14 (b) CONFIDENTIALITY OF RECORDS.—Section 543(a) 

15 of the Public Health Service Act (42 U.S.C. 290dd–2(a)) 

16 is amended by inserting ‘‘or, with respect to methadone, 

17 as required under section 399O(e)(6)’’ before the period 

18 at the end. 

19 (c) REQUIREMENTS FOR FEDERAL HEALTH CARE

20 PROGRAMS.—Health care practitioners (as defined in 

21 paragraph (7) of section 399O(m) of the Public Health 

22 Service Act (42 U.S.C. 280g–3(m))) and dispensers (as 

23 defined in paragraph (4) of such section) who participate 

24 in or are employed by a Federal health care program or 

25 federally funded health care program, including the Indian 


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1 Health Service, the Department of Veterans Affairs, the 

2 Department of Defense, the Federal Bureau of Prisons, 

3 the Medicare program under title XVIII of the Social Se4 curity Act (42 U.S.C. 1395 et seq.), a State Medicaid plan 

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

6 1396 et seq.), the Children’s Health Insurance Program 

7 under title XXI of the Social Security Act (42 U.S.C. 

8 1397aa et seq.), and Federally qualified health centers, 

9 shall use the databases of the controlled substance moni10 toring programs under section 399O of the Public Health 

11 Service Act (42 U.S.C. 280g–3), if such databases are 

12 available to the practitioner or dispenser. 

13 SEC. 103. PILOT PROJECT. 

14 (a) IN GENERAL.—The Secretary of Health and 

15 Human Services (referred to in this section as the ‘‘Sec16 retary’’) shall award grants to one or more States to carry 

17 out a 1-year pilot project to develop a standardized peer 

18 review process and methodology to review and evaluate 

19 prescribing and pharmacy dispensing patterns, through a 

20 review of prescription drug monitoring programs (referred 

21 to in this section as ‘‘PDMP’’) in the States receiving such 

22 grants. 

23 (b) METHODOLOGY.—The recipients of a grant under 

24 this section shall develop a systematic, standardized meth25 odology to identify and investigate questionable or inapVerDate Sep 11 2014 00:25 Mar 11, 2015 Jkt 049200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S636.IS S636

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1 propriate prescribing and dispensing patterns of sub2 stances on schedule II or III under section 202 of the Con3 trolled Substances Act (21 U.S.C. 812). Such peer review 

4 methodology and prescribing and dispensing patterns shall 

5 be shared with the appropriate State health profession 

6 board. 

7 (c) REQUIREMENTS.—A State receiving a grant 

8 under this section— 

9 (1) with respect to controlled substances for 

10 which a prescriber is required to have a license 

11 issued by the Drug Enforcement Administration in 

12 order to prescribe such controlled substances, shall 

13 make the information with respect to such controlled 

14 substances from the PDMP available to State regu15 lation and licensing boards; and 

16 (2) with respect to any other controlled sub17 stances, may make the information with respect to 

18 such controlled substances from the PDMP available 

19 to State regulation and licensing boards. 

20 (d) SUBGRANTEES.—A quality improvement organi21 zation with which the Secretary has entered into a con22 tract under part B of title XI of the Social Security Act 

23 (42 U.S.C. 1320c et seq.) may serve as the subgrantee 

24 under this subsection to develop peer review processes as 

25 described in subsection (a). 


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1 SEC. 104. PRESCRIPTION DRUG AND OTHER CONTROLLED 

2 SUBSTANCE ABUSE PREVENTION. 

3 Part P of title III of the Public Health Service Act 

4 (42 U.S.C. 280g et seq.) is amended by adding at the end 

5 the following: 

6 ‘‘SEC. 399V–6. PRESCRIPTION DRUG AND OTHER CON7 TROLLED SUBSTANCE ABUSE PREVENTION. 

8 ‘‘(a) TRAINING GRANTS.— 

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

10 5-year grants to eligible entities to facilitate training 

11 in order to increase the capacity of health care pro12 viders to conduct patient screening and brief inter13 ventions, such as in health care settings, to prevent 

14 the abuse of prescription drugs and other controlled 

15 substances. The grant program under this section 

16 may be coordinated with the Screening Brief Inter17 vention and Referral to Treatment grant program of 

18 the Substance Abuse and Mental Health Services 

19 Administration, or other appropriate program. 

20 ‘‘(2) ELIGIBLE ENTITIES.—In this subsection, 

21 the term ‘eligible entity’ includes— 

22 ‘‘(A) States; 

23 ‘‘(B) continuing education entities, such as 

24 health profession boards or health accrediting 

25 bodies; and 


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1 ‘‘(C) other appropriate health or profes2 sional education organizations or institutions. 

3 ‘‘(b) FEDERAL HEALTH CARE WORKERS.—Health 

4 care providers who participate in or are employed by a 

5 Federal health care program, including the Indian Health 

6 Service, the Department of Veterans Affairs, the Depart7 ment of Defense, the Federal Bureau of Prisons, the 

8 Medicare program under title XVIII of the Social Security 

9 Act (42 U.S.C. 1395 et seq.), a State Medicaid plan under 

10 title XIX of the Social Security Act (42 U.S.C. 1396 et 

11 seq.), the State Children’s Health Insurance Program 

12 under title XXI of the Social Security Act (42 U.S.C. 

13 1397aa et seq.), and Federally qualified health centers, 

14 shall screen patients for abuse of prescription drugs or 

15 other controlled substances, conduct brief interventions, 

16 and provide referrals for known or suspected abuse of pre17 scription drugs or other controlled substances, as appro18 priate. 

19 ‘‘(c) EXPANSION OF PRESCRIBING AUTHORITY.— 

20 The Secretary, acting through the Administrator of the 

21 Health Resources and Services Administration, shall 

22 award grants to States for the purpose of evaluating the 

23 prospect of the health professions board of such States 

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1 sistants, in order to control the abuse of prescription 

2 drugs or other controlled substances with respect to spe3 cific drugs and other controlled substances, as appro4 priate.’’. 

5 SEC. 105. PRESCRIPTION DRUG ABUSE TRAINING AND 

6 SCREENING PROGRAMS. 

7 (a) CONTINUING EDUCATION GRANTS.—The Sec8 retary of Health and Human Services (referred to in this 

9 section as the ‘‘Secretary’’) shall award grants to States 

10 to develop continuing education criteria and review proc11 esses that allow State health profession boards or State 

12 agencies to certify appropriate education and training for 

13 informed and safe prescribing of opioids and other drugs 

14 on schedule II and III under section 202 of the Controlled 

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

16 (b) REGISTRATION WITH DEA.—A practitioner who 

17 registers or renews a registration under section 303(f) of 

18 the Controlled Substances Act (21 U.S.C. 823(f)) shall, 

19 at the time of registering, certify to the Attorney General 

20 that such practitioner has completed continuing medical 

21 education or nursing continuing education, as applicable— 

22 (1) in the case of a practitioner registering for 

23 the first time, with respect to prescription drug 

24 abuse; and 


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1 (2) in the case of a practitioner renewing a reg2 istration, with respect to medical understanding of 

3 the proper use of all drugs listed in the schedules 

4 under section 202 of the Controlled Substances Act 

5 (21 U.S.C. 812). 

6 (c) SCREENING PROGRAM.—The Attorney General 

7 shall require that a practitioner registered under section 

8 303(f) of the Controlled Substances Act (21 U.S.C. 

9 823(f)) conduct patient screening for potential drug mis10 use or abuse before prescribing a drug listed on schedule 

11 II or III under section 202 of the Controlled Substances 

12 Act (21 U.S.C. 812), according to standards established 

13 by the applicable State licensing body. 

14 SEC. 106. FDA REVIEW OF NALOXONE. 

15 The Secretary of Health and Human Services, acting 

16 through the Commissioner of Food and Drugs, shall con17 duct a review of naloxone to consider whether naloxone 

18 should cease to be subject to section 503(b)(1) of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)) 

20 and be available as a behind-the-counter drug, in order 

21 to increase access of such drug to community-based orga22 nizations and street outreach organizations. 

23 SEC. 107. PRESCRIPTION DRUG DISPOSAL. 

24 The Secretary of Health and Human Services shall 

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1 agency working group to encourage States and local gov2 ernments to increase opportunities for disposal of opiates, 

3 such as frequent ‘‘take-back programs’’ and fixed medi4 cine disposal sites at law enforcement public buildings, 

5 and to reduce opportunities for abuse of opiates, such as 

6 establishing opioid dispensing limits at hospital emergency 

7 departments. 

8 SEC. 108. GAO REPORT. 

9 The Comptroller General of the United States shall 

10 review prescription drug abuse programs and policies in 

11 Federal agencies and best practices with respect to pre12 scription drug abuse programs of the States and, not later 

13 than 18 months after the date of enactment of this Act, 

14 shall issue a report to Congress on its findings and rec15 ommendations on ways to reduce prescription drug abuse. 

16 TITLE II—TREAT ACT 

17 SEC. 201. SHORT TITLE. 

18 This title may be cited as the ‘‘Recovery Enhance19 ment for Addiction Treatment Act’’ or the ‘‘TREAT Act’’. 

20 SEC. 202. EXPANSION OF PATIENT LIMITS UNDER WAIVER. 

21 Section 303(g)(2)(B) of the Controlled Substances 

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

23 (1) in clause (i), by striking ‘‘physician’’ and in24 serting ‘‘practitioner’’; 

25 (2) in clause (iii)— 


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1 (A) by striking ‘‘30’’ and inserting ‘‘100’’; 

2 and 

3 (B) by striking ‘‘, unless, not sooner’’ and 

4 all that follows through the end and inserting a 

5 period; and 

6 (3) by inserting at the end the following new 

7 clause: 

8 ‘‘(iv) Not earlier than 1 year after the date 

9 on which a qualifying practitioner obtained an 

10 initial waiver pursuant to clause (iii), the quali11 fying practitioner may submit a second notifica12 tion to the Secretary of the need and intent of 

13 the qualifying practitioner to treat an unlimited 

14 number of patients, if the qualifying practi15 tioner— 

16 ‘‘(I)(aa) satisfies the requirements of 

17 item (aa), (bb), (cc), or (dd) of subpara18 graph (G)(ii)(I); and 

19 ‘‘(bb) agrees to fully participate in the 

20 Prescription Drug Monitoring Program of 

21 the State in which the qualifying practi22 tioner is licensed, pursuant to applicable 

23 State guidelines; or 


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1 ‘‘(II)(aa) satisfies the requirements of 

2 item (ee), (ff), or (gg) of subparagraph 

3 (G)(ii)(I); 

4 ‘‘(bb) agrees to fully participate in the 

5 Prescription Drug Monitoring Program of 

6 the State in which the qualifying practi7 tioner is licensed, pursuant to applicable 

8 State guidelines; 

9 ‘‘(cc) practices in a qualified practice 

10 setting; and 

11 ‘‘(dd) has completed not less than 24 

12 hours of training (through classroom situa13 tions, seminars at professional society 

14 meetings, electronic communications, or 

15 otherwise) with respect to the treatment 

16 and management of opiate-dependent pa17 tients for substance use disorders provided 

18 by the American Society of Addiction Med19 icine, the American Academy of Addiction 

20 Psychiatry, the American Medical Associa21 tion, the American Osteopathic Associa22 tion, the American Psychiatric Association, 

23 or any other organization that the Sec24 retary determines is appropriate for pur25 poses of this subclause.’’. 


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1 SEC. 203. DEFINITIONS. 

2 Section 303(g)(2)(G) of the Controlled Substances 

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

4 (1) by striking clause (ii) and inserting the fol5 lowing: 

6 ‘‘(ii) The term ‘qualifying practitioner’ 

7 means the following: 

8 ‘‘(I) A physician who is licensed under 

9 State law and who meets 1 or more of the 

10 following conditions: 

11 ‘‘(aa) The physician holds a 

12 board certification in addiction psychi13 atry from the American Board of 

14 Medical Specialties. 

15 ‘‘(bb) The physician holds an ad16 diction certification from the Amer17 ican Society of Addiction Medicine. 

18 ‘‘(cc) The physician holds a 

19 board certification in addiction medi20 cine from the American Osteopathic 

21 Association. 

22 ‘‘(dd) The physician holds a 

23 board certification from the American 

24 Board of Addiction Medicine. 

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1 ing (through classroom situations, 

2 seminar at professional society meet3 ings, electronic communications, or 

4 otherwise) with respect to the treat5 ment and management of opiate-de6 pendent patients for substance use 

7 disorders provided by the American 

8 Society of Addiction Medicine, the 

9 American Academy of Addiction Psy10 chiatry, the American Medical Asso11 ciation, the American Osteopathic As12 sociation, the American Psychiatric 

13 Association, or any other organization 

14 that the Secretary determines is ap15 propriate for purposes of this sub16 clause. 

17 ‘‘(ff) The physician has partici18 pated as an investigator in 1 or more 

19 clinical trials leading to the approval 

20 of a narcotic drug in schedule III, IV, 

21 or V for maintenance or detoxification 

22 treatment, as demonstrated by a 

23 statement submitted to the Secretary 

24 by this sponsor of such approved 

25 drug. 


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1 ‘‘(gg) The physician has such 

2 other training or experience as the 

3 Secretary determines will demonstrate 

4 the ability of the physician to treat 

5 and manage opiate-dependent pa6 tients. 

7 ‘‘(II) A nurse practitioner or physi8 cian assistant who is licensed under State 

9 law and meets all of the following condi10 tions: 

11 ‘‘(aa) The nurse practitioner or 

12 physician assistant is licensed under 

13 State law to prescribe schedule III, 

14 IV, or V medications for pain. 

15 ‘‘(bb) The nurse practitioner or 

16 physician assistant satisfies 1 or more 

17 of the following: 

18 ‘‘(AA) Has completed not 

19 fewer than 24 hours of training 

20 (through classroom situations, 

21 seminar at professional society 

22 meetings, electronic communica23 tions, or otherwise) with respect 

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1 tients for substance use disorders 

2 provided by the American Society 

3 of Addiction Medicine, the Amer4 ican Academy of Addiction Psy5 chiatry, the American Medical 

6 Association, the American Osteo7 pathic Association, the American 

8 Psychiatric Association, or any 

9 other organization that the Sec10 retary determines is appropriate 

11 for purposes of this subclause. 

12 ‘‘(BB) Has such other train13 ing or experience as the Sec14 retary determines will dem15 onstrate the ability of the nurse 

16 practitioner or physician assist17 ant to treat and manage opiate18 dependent patients. 

19 ‘‘(cc) The nurse practitioner or 

20 physician assistant practices under 

21 the supervision of a licensed physician 

22 who holds an active waiver to pre23 scribe schedule III, IV, or V narcotic 

24 medications for opioid addiction ther25 apy, and— 


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1 ‘‘(AA) the supervising physi2 cian satisfies the conditions of 

3 item (aa), (bb), (cc), or (dd) of 

4 subclause (I); or 

5 ‘‘(BB) both the supervising 

6 physician and the nurse practi7 tioner or physician assistant 

8 practice in a qualified practice 

9 setting. 

10 ‘‘(III) A nurse practitioner who is li11 censed under State law and meets all of 

12 the following conditions: 

13 ‘‘(aa) The nurse practitioner is li14 censed under State law to prescribe 

15 schedule III, IV, or V medications for 

16 pain. 

17 ‘‘(bb) The nurse practitioner has 

18 training or experience that the Sec19 retary determines demonstrates spe20 cialization in the ability to treat opi21 ate-dependent patients, such as a cer22 tification in addiction specialty accred23 ited by the American Board of Nurs24 ing Specialties or the National Com25 mission for Certifying Agencies, or a 


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1 certification in addiction nursing as a 

2 Certified Addiction Registered 

3 Nurse—Advanced Practice. 

4 ‘‘(cc) In accordance with State 

5 law, the nurse practitioner prescribes 

6 opioid addiction therapy in collabora7 tion with a physician who holds an ac8 tive waiver to prescribe schedule III, 

9 IV, or V narcotic medications for 

10 opioid addiction therapy. 

11 ‘‘(dd) The nurse practitioner 

12 practices in a qualified practice set13 ting.’’; and 

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

15 ‘‘(iii) The term ‘qualified practice setting’ 

16 means 1 or more of the following treatment set17 tings: 

18 ‘‘(I) A National Committee for Qual19 ity Assurance-recognized Patient-Centered 

20 Medical Home or Patient-Centered Spe21 cialty Practice. 

22 ‘‘(II) A Centers for Medicaid & Medi23 care Services-recognized Accountable Care 

24 Organization. 


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1 ‘‘(III) A clinical facility administered 

2 by the Department of Veterans Affairs, 

3 Department of Defense, or Indian Health 

4 Service. 

5 ‘‘(IV) A Behavioral Health Home ac6 credited by the Joint Commission. 

7 ‘‘(V) A Federally-qualified health cen8 ter (as defined in section 1905(l)(2)(B) of 

9 the Social Security Act (42 U.S.C. 

10 1396d(l)(2)(B))) or a Federally-qualified 

11 health center look-alike. 

12 ‘‘(VI) A Substance Abuse and Mental 

13 Health Services-certified Opioid Treatment 

14 Program. 

15 ‘‘(VII) A clinical program of a State 

16 or Federal jail, prison, or other facility 

17 where individuals are incarcerated. 

18 ‘‘(VIII) A clinic that demonstrates 

19 compliance with the Model Policy on 

20 DATA 2000 and Treatment of Opioid Ad21 diction in the Medical Office issued by the 

22 Federation of State Medical Boards. 

23 ‘‘(IX) A treatment setting that is part 

24 of an Accreditation Council for Graduate 

25 Medical Education, American Association 


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1 of Colleges of Osteopathic Medicine, or 

2 American Osteopathic Association-accred3 ited residency or fellowship training pro4 gram. 

5 ‘‘(X) Any other practice setting ap6 proved by a State regulatory board or 

7 State Medicaid Plan to provide addiction 

8 treatment services. 

9 ‘‘(XI) Any other practice setting ap10 proved by the Secretary.’’. 

11 SEC. 204. GAO EVALUATION. 

12 Two years after the date on which the first notifica13 tion under clause (iv) of section 303(g)(2)(B) of the Con14 trolled Substances Act (21 U.S.C. 823(g)(2)(B)), as added 

15 by this title, is received by the Secretary of Health and 

16 Human Services, the Comptroller General of the United 

17 States shall initiate an evaluation of the effectiveness of 

18 the amendments made by this title, which shall include 

19 an evaluation of— 

20 (1) any changes in the availability and use of 

21 medication-assisted treatment for opioid addiction; 

22 (2) the quality of medication-assisted treatment 

23 programs; 

24 (3) the integration of medication-assisted treat25 ment with routine healthcare services; 


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1 (4) diversion of opioid addiction treatment 

2 medication; 

3 (5) changes in State or local policies and legis4 lation relating to opioid addiction treatment; 

5 (6) the use of nurse practitioners and physician 

6 assistants who prescribe opioid addiction medication; 

7 (7) the use of Prescription Drug Monitoring 

8 Programs by waived practitioners to maximize safety 

9 of patient care and prevent diversion of opioid addic10 tion medication; 

11 (8) the findings of Drug Enforcement Agency 

12 inspections of waived practitioners, including the fre13 quency with which the Drug Enforcement Agency 

14 finds no documentation of access to behavioral 

15 health services; and 

16 (9) the effectiveness of cross-agency collabora17 tion between Department of Health and Human 

18 Services and the Drug Enforcement Agency for ex19 panding effective opioid addiction treatment. 

Æ 


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