II 

114TH CONGRESS 

1ST SESSION S. 1455 

To provide access to medication-assisted therapy, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 22, 2015 

Mr. MARKEY (for himself, Mr. PAUL, Mrs. FEINSTEIN, Mr. DURBIN, Ms. 

HIRONO, Mr. BROWN, and Ms. BALDWIN) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide access to medication-assisted therapy, and for 

other purposes. 

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 ‘‘Recovery Enhancement 

5 for Addiction Treatment Act’’ or the ‘‘TREAT Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 

8 (1) Overdoses from opioids have increased dra9 matically in the United States. 

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1 (2) Deaths from drug overdose, largely from 

2 prescription pain relievers, have tripled among men 

3 and increased five-fold among women over the past 

4 decade. 

5 (3) Nationwide, drug overdoses now claim more 

6 lives than car accidents. 

7 (4) Opioid addiction is a chronic disease that, 

8 untreated, places a large burden on the healthcare 

9 system. Roughly 475,000 emergency room visits 

10 each year are attributable to the misuse and abuse 

11 of opioid pain medication. 

12 (5) Effective medication-assisted treatment for 

13 opioid addiction, in combination with counseling and 

14 behavioral therapies, can decrease overdose deaths, 

15 be cost-effective, reduce transmissions of HIV and 

16 viral hepatitis, and reduce other social harms such 

17 as criminal activity. 

18 (6) Effective medication-assisted treatment pro19 grams for opioid addiction should include multiple 

20 components, including medications, cognitive and be21 havioral supports and interventions, and drug test22 ing. 

23 (7) Effective medication-assisted treatment pro24 grams for opioid addiction may use a team of staff 

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1 members, in addition to a prescribing provider, to 

2 deliver comprehensive care. 

3 (8) Access to medication-assisted treatments, 

4 including office-based buprenorphine opioid treat5 ment, remains limited in part due to current prac6 tice regulations and an insufficient number of pro7 viders. 

8 (9) More than 10 years of experience in the 

9 United States with office-based buprenorphine opioid 

10 treatment has informed best practices for delivering 

11 successful, high quality care. 

12 SEC. 3. EXPANSION OF PATIENT LIMITS UNDER WAIVER. 

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

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

15 (1) in clause (i), by striking ‘‘physician’’ and in16 serting ‘‘practitioner’’; 

17 (2) in clause (iii)— 

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

19 and 

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

21 all that follows through the end and inserting a 

22 period; and 

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

24 clause: 

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

2 on which a qualifying practitioner obtained an 

3 initial waiver pursuant to clause (iii), the quali4 fying practitioner may submit a second notifica5 tion to the Secretary of the need and intent of 

6 the qualifying practitioner to treat an unlimited 

7 number of patients, if the qualifying practi8 tioner— 

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

10 item (aa), (bb), (cc), or (dd) of subpara11 graph (G)(ii)(I); and 

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

13 Prescription Drug Monitoring Program of 

14 the State in which the qualifying practi15 tioner is licensed, pursuant to applicable 

16 State guidelines; or 

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

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

19 (G)(ii)(I); 

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

21 Prescription Drug Monitoring Program of 

22 the State in which the qualifying practi23 tioner is licensed, pursuant to applicable 

24 State guidelines; 

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1 ‘‘(cc) practices in a qualified practice 

2 setting; and 

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

4 hours of training (through classroom situa5 tions, seminars at professional society 

6 meetings, electronic communications, or 

7 otherwise) with respect to the treatment 

8 and management of opiate-dependent pa9 tients for substance use disorders provided 

10 by the American Society of Addiction Med11 icine, the American Academy of Addiction 

12 Psychiatry, the American Medical Associa13 tion, the American Osteopathic Associa14 tion, the American Psychiatric Association, 

15 or any other organization that the Sec16 retary determines is appropriate for pur17 poses of this subclause.’’. 

18 SEC. 4. DEFINITIONS. 

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

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

21 (1) by striking clause (ii) and inserting the fol22 lowing: 

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

24 means the following: 

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

2 State law and who meets 1 or more of the 

3 following conditions: 

4 ‘‘(aa) The physician holds a 

5 board certification in addiction psychi6 atry from the American Board of 

7 Medical Specialties. 

8 ‘‘(bb) The physician holds an ad9 diction certification from the Amer10 ican Society of Addiction Medicine. 

11 ‘‘(cc) The physician holds a 

12 board certification in addiction medi13 cine from the American Osteopathic 

14 Association. 

15 ‘‘(dd) The physician holds a 

16 board certification from the American 

17 Board of Addiction Medicine. 

18 ‘‘(ee) The physician has com19 pleted not less than 8 hours of train20 ing (through classroom situations, 

21 seminars at professional society meet22 ings, electronic communications, or 

23 otherwise) with respect to the treat24 ment and management of opiate-de25 pendent patients for substance use 

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1 disorders provided by the American 

2 Society of Addiction Medicine, the 

3 American Academy of Addiction Psy4 chiatry, the American Medical Asso5 ciation, the American Osteopathic As6 sociation, the American Psychiatric 

7 Association, or any other organization 

8 that the Secretary determines is ap9 propriate for purposes of this sub10 clause. 

11 ‘‘(ff) The physician has partici12 pated as an investigator in 1 or more 

13 clinical trials leading to the approval 

14 of a narcotic drug in schedule III, IV, 

15 or V for maintenance or detoxification 

16 treatment, as demonstrated by a 

17 statement submitted to the Secretary 

18 by this sponsor of such approved 

19 drug. 

20 ‘‘(gg) The physician has such 

21 other training or experience as the 

22 Secretary determines will demonstrate 

23 the ability of the physician to treat 

24 and manage opiate-dependent pa25 tients. 

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1 ‘‘(II) A nurse practitioner or physi2 cian assistant who is licensed under State 

3 law and meets all of the following condi4 tions: 

5 ‘‘(aa) The nurse practitioner or 

6 physician assistant is licensed under 

7 State law to prescribe schedule III, 

8 IV, or V medications for pain. 

9 ‘‘(bb) The nurse practitioner or 

10 physician assistant satisfies 1 or more 

11 of the following: 

12 ‘‘(AA) Has completed not 

13 fewer than 24 hours of training 

14 (through classroom situations, 

15 seminars at professional society 

16 meetings, electronic communica17 tions, or otherwise) with respect 

18 to the treatment and manage19 ment of opiate-dependent pa20 tients for substance use disorders 

21 provided by the American Society 

22 of Addiction Medicine, the Amer23 ican Academy of Addiction Psy24 chiatry, the American Medical 

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1 pathic Association, the American 

2 Psychiatric Association, or any 

3 other organization that the Sec4 retary determines is appropriate 

5 for purposes of this subclause. 

6 ‘‘(BB) Has such other train7 ing or experience as the Sec8 retary determines will dem9 onstrate the ability of the nurse 

10 practitioner or physician assist11 ant to treat and manage opiate12 dependent patients. 

13 ‘‘(cc) The nurse practitioner or 

14 physician assistant practices under 

15 the supervision of a licensed physician 

16 who holds an active waiver to pre17 scribe schedule III, IV, or V narcotic 

18 medications for opioid addiction ther19 apy, and— 

20 ‘‘(AA) the supervising physi21 cian satisfies the conditions of 

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

23 subclause (I); or 

24 ‘‘(BB) both the supervising 

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1 tioner or physician assistant 

2 practice in a qualified practice 

3 setting. 

4 ‘‘(III) A nurse practitioner who is li5 censed under State law and meets all of 

6 the following conditions: 

7 ‘‘(aa) The nurse practitioner is li8 censed under State law to prescribe 

9 schedule III, IV, or V medications for 

10 pain. 

11 ‘‘(bb) The nurse practitioner has 

12 training or experience that the Sec13 retary determines demonstrates spe14 cialization in the ability to treat opi15 ate-dependent patients, such as a cer16 tification in addiction specialty accred17 ited by the American Board of Nurs18 ing Specialties or the National Com19 mission for Certifying Agencies, or a 

20 certification in addiction nursing as a 

21 Certified Addiction Registered 

22 Nurse—Advanced Practice. 

23 ‘‘(cc) In accordance with State 

24 law, the nurse practitioner prescribes 

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1 tion with a physician who holds an ac2 tive waiver to prescribe schedule III, 

3 IV, or V narcotic medications for 

4 opioid addiction therapy. 

5 ‘‘(dd) The nurse practitioner 

6 practices in a qualified practice set7 ting.’’; and 

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

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

10 means 1 or more of the following treatment set11 tings: 

12 ‘‘(I) A National Committee for Qual13 ity Assurance-recognized Patient-Centered 

14 Medical Home or Patient-Centered Spe15 cialty Practice. 

16 ‘‘(II) A Centers for Medicaid & Medi17 care Services-recognized Accountable Care 

18 Organization. 

19 ‘‘(III) A clinical facility administered 

20 by the Department of Veterans Affairs, 

21 Department of Defense, or Indian Health 

22 Service. 

23 ‘‘(IV) A Behavioral Health Home ac24 credited by the Joint Commission. 

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1 ‘‘(V) A Federally-qualified health cen2 ter (as defined in section 1905(l)(2)(B) of 

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

4 1396d(l)(2)(B))) or a Federally-qualified 

5 health center look-alike. 

6 ‘‘(VI) A Substance Abuse and Mental 

7 Health Services-certified Opioid Treatment 

8 Program. 

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

10 or Federal jail, prison, or other facility 

11 where individuals are incarcerated. 

12 ‘‘(VIII) A clinic that demonstrates 

13 compliance with the Model Policy on 

14 DATA 2000 and Treatment of Opioid Ad15 diction in the Medical Office issued by the 

16 Federation of State Medical Boards. 

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

18 of an Accreditation Council for Graduate 

19 Medical Education, American Association 

20 of Colleges of Osteopathic Medicine, or 

21 American Osteopathic Association-accred22 ited residency or fellowship training pro23 gram. 

24 ‘‘(X) Any other practice setting ap25 proved by a State regulatory board or 

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1 State Medicaid Plan to provide addiction 

2 treatment services. 

3 ‘‘(XI) Any other practice setting ap4 proved by the Secretary.’’. 

5 SEC. 5. GAO EVALUATION. 

6 Two years after the date on which the first notifica7 tion under clause (iv) of section 303(g)(2)(B) of the Con8 trolled Substances Act (21 U.S.C. 823(g)(2)(B)), as added 

9 by this Act, is received by the Secretary of Health and 

10 Human Services, the Comptroller General of the United 

11 States shall initiate an evaluation of the effectiveness of 

12 the amendments made by this Act, which shall include an 

13 evaluation of— 

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

15 medication-assisted treatment for opioid addiction; 

16 (2) the quality of medication-assisted treatment 

17 programs; 

18 (3) the integration of medication-assisted treat19 ment with routine healthcare services; 

20 (4) diversion of opioid addiction treatment 

21 medication; 

22 (5) changes in State or local policies and legis23 lation relating to opioid addiction treatment; 

24 (6) the use of nurse practitioners and physician 

25 assistants who prescribe opioid addiction medication; 

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1 (7) the use of Prescription Drug Monitoring 

2 Programs by waived practitioners to maximize safety 

3 of patient care and prevent diversion of opioid addic4 tion medication; 

5 (8) the findings of Drug Enforcement Adminis6 tration inspections of waived practitioners, including 

7 the frequency with which the Drug Enforcement Ad8 ministration finds no documentation of access to be9 havioral health services; and 

10 (9) the effectiveness of cross-agency collabora11 tion between Department of Health and Human 

12 Services and the Drug Enforcement Administration 

13 for expanding effective opioid addiction treatment. 

Æ 

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