II 

113TH CONGRESS 

2D SESSION S. 2645 

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

IN THE SENATE OF THE UNITED STATES 

JULY 23, 2014 

Mr. MARKEY (for himself, Mrs. FEINSTEIN, Mr. ROCKEFELLER, Mr. BROWN, 

Ms. HIRONO, and Mr. DURBIN) 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 can decrease overdose deaths, be 

14 cost-effective, reduce transmissions of HIV and viral 

15 hepatitis, and reduce other social harms such as 

16 criminal activity. 

17 (6) Effective medication-assisted treatment pro18 grams for opioid addiction should include multiple 

19 components, including medications, cognitive and be20 havioral supports and interventions, and drug test21 ing. 

22 (7) Effective medication-assisted treatment pro23 grams for opioid addiction may use a team of staff 

24 members, in addition to a prescribing provider, to 

25 deliver comprehensive care. 


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1 (8) Access to medication-assisted treatments, 

2 including office-based buprenorphine opioid treat3 ment, remains limited in part due to current prac4 tice regulations and an insufficient number of pro5 viders. 

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

7 United States with office-based buprenorphine opioid 

8 treatment has informed best practices for delivering 

9 successful, high quality care. 

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

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

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

13 (1) in clause (i), by striking ‘‘physician’’ and in14 serting ‘‘practitioner’’; 

15 (2) in clause (iii)— 

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

17 and 

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

19 all that follows through the end and inserting a 

20 period; and 

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

22 clause: 

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

24 on which a qualifying practitioner obtained an 

25 initial waiver pursuant to clause (iii), the qualiVerDate Mar 15 2010 21:13 Jul 28, 2014 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2645.IS S2645

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1 fying practitioner may submit a second notifica2 tion to the Secretary of the need and intent of 

3 the qualifying practitioner to treat an unlimited 

4 number of patients, if the qualifying practi5 tioner— 

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

7 item (aa), (bb), (cc), or (dd) of subpara8 graph (G)(ii)(I); and 

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

10 Prescription Drug Monitoring Program of 

11 the State in which the qualifying practi12 tioner is licensed, pursuant to applicable 

13 State guidelines; or 

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

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

16 (G)(ii)(I); 

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

18 Prescription Drug Monitoring Program of 

19 the State in which the qualifying practi20 tioner is licensed, pursuant to applicable 

21 State guidelines; 

22 ‘‘(cc) practices in a qualified practice 

23 setting; and 

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

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1 tions, seminars at professional society 

2 meetings, electronic communications, or 

3 otherwise) with respect to the treatment 

4 and management of opiate-dependent pa5 tients for substance use disorders provided 

6 by the American Society of Addiction Med7 icine, the American Academy of Addiction 

8 Psychiatry, the American Medical Associa9 tion, the American Osteopathic Associa10 tion, the American Psychiatric Association, 

11 or any other organization that the Sec12 retary determines is appropriate for pur13 poses of this subclause.’’. 

14 SEC. 4. DEFINITIONS. 

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

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

17 (1) by striking clause (ii) and inserting the fol18 lowing: 

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

20 means the following: 

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

22 State law and who meets 1 or more of the 

23 following conditions: 

24 ‘‘(aa) The physician holds a 

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1 atry from the American Board of 

2 Medical Specialties. 

3 ‘‘(bb) The physician holds an ad4 diction certification from the Amer5 ican Society of Addiction Medicine. 

6 ‘‘(cc) The physician holds a 

7 board certification in addiction medi8 cine from the American Osteopathic 

9 Association. 

10 ‘‘(dd) The physician holds a 

11 board certification from the American 

12 Board of Addiction Medicine. 

13 ‘‘(ee) The physician has com14 pleted not less than 8 hours of train15 ing (through classroom situations, 

16 seminar at professional society meet17 ings, electronic communications, or 

18 otherwise) with respect to the treat19 ment and management of opiate-de20 pendent patients for substance use 

21 disorders provided by the American 

22 Society of Addiction Medicine, the 

23 American Academy of Addiction Psy24 chiatry, the American Medical Asso25 ciation, the American Osteopathic AsVerDate Mar 15 2010 21:13 Jul 28, 2014 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2645.IS S2645

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1 sociation, the American Psychiatric 

2 Association, or any other organization 

3 that the Secretary determines is ap4 propriate for purposes of this sub5 clause. 

6 ‘‘(ff) The physician has partici7 pated as an investigator in 1 or more 

8 clinical trials leading to the approval 

9 of a narcotic drug in schedule III, IV, 

10 or V for maintenance or detoxification 

11 treatment, as demonstrated by a 

12 statement submitted to the Secretary 

13 by this sponsor of such approved 

14 drug. 

15 ‘‘(gg) The physician has such 

16 other training or experience as the 

17 Secretary determines will demonstrate 

18 the ability of the physician to treat 

19 and manage opiate-dependent pa20 tients. 

21 ‘‘(II) A nurse practitioner or physi22 cian assistant who is licensed under State 

23 law and meets all of the following condi24 tions: 


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1 ‘‘(aa) The nurse practitioner or 

2 physician assistant is licensed under 

3 State law to prescribe schedule III, 

4 IV, or V medications for pain. 

5 ‘‘(bb) The nurse practitioner or 

6 physician assistant satisfies 1 or more 

7 of the following: 

8 ‘‘(AA) Has completed not 

9 fewer than 24 hours of training 

10 (through classroom situations, 

11 seminar at professional society 

12 meetings, electronic communica13 tions, or otherwise) with respect 

14 to the treatment and manage15 ment of opiate-dependent pa16 tients for substance use disorders 

17 provided by the American Society 

18 of Addiction Medicine, the Amer19 ican Academy of Addiction Psy20 chiatry, the American Medical 

21 Association, the American Osteo22 pathic Association, the American 

23 Psychiatric Association, or any 

24 other organization that the SecVerDate Mar 15 2010 21:13 Jul 28, 2014 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2645.IS S2645

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1 retary determines is appropriate 

2 for purposes of this subclause. 

3 ‘‘(BB) Has such other train4 ing or experience as the Sec5 retary determines will dem6 onstrate the ability of the nurse 

7 practitioner or physician assist8 ant to treat and manage opiate9 dependent patients. 

10 ‘‘(cc) The nurse practitioner or 

11 physician assistant practices under 

12 the supervision of a licensed physician 

13 who holds an active waiver to pre14 scribe schedule III, IV, or V narcotic 

15 medications for opioid addiction ther16 apy, and— 

17 ‘‘(AA) the supervising physi18 cian satisfies the conditions of 

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

20 subclause (I); or 

21 ‘‘(BB) both the supervising 

22 physician and the nurse practi23 tioner or physician assistant 

24 practice in a qualified practice 

25 setting. 


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1 ‘‘(III) A nurse practitioner who is li2 censed under State law and meets all of 

3 the following conditions: 

4 ‘‘(aa) The nurse practitioner is li5 censed under State law to prescribe 

6 schedule III, IV, or V medications for 

7 pain. 

8 ‘‘(bb) The nurse practitioner has 

9 training or experience that the Sec10 retary determines demonstrates spe11 cialization in the ability to treat opi12 ate-dependent patients, such as a cer13 tification in addiction specialty accred14 ited by the American Board of Nurs15 ing Specialties or the National Com16 mission for Certifying Agencies, or a 

17 certification in addiction nursing as a 

18 Certified Addiction Registered 

19 Nurse—Advanced Practice. 

20 ‘‘(cc) In accordance with State 

21 law, the nurse practitioner prescribes 

22 opioid addiction therapy in collabora23 tion with a physician who holds an ac24 tive waiver to prescribe schedule III, 


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1 IV, or V narcotic medications for 

2 opioid addiction therapy. 

3 ‘‘(dd) The nurse practitioner 

4 practices in a qualified practice set5 ting.’’; and 

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

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

8 means 1 or more of the following treatment set9 tings: 

10 ‘‘(I) A National Committee for Qual11 ity Assurance-recognized Patient-Centered 

12 Medical Home or Patient-Centered Spe13 cialty Practice. 

14 ‘‘(II) A Centers for Medicaid & Medi15 care Services-recognized Accountable Care 

16 Organization. 

17 ‘‘(III) A clinical facility administered 

18 by the Department of Veterans Affairs, 

19 Department of Defense, or Indian Health 

20 Service. 

21 ‘‘(IV) A Behavioral Health Home ac22 credited by the Joint Commission. 

23 ‘‘(V) A Federally-qualified health cen24 ter (as defined in section 1905(l)(2)(B) of 

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


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1 1396d(l)(2)(B))) or a Federally-qualified 

2 health center look-alike. 

3 ‘‘(VI) A Substance Abuse and Mental 

4 Health Services-certified Opioid Treatment 

5 Program. 

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

7 or Federal jail, prison, or other facility 

8 where individuals are incarcerated. 

9 ‘‘(VIII) A clinic that demonstrates 

10 compliance with the Model Policy on 

11 DATA 2000 and Treatment of Opioid Ad12 diction in the Medical Office issued by the 

13 Federation of State Medical Boards. 

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

15 of an Accreditation Council for Graduate 

16 Medical Education, American Association 

17 of Colleges of Osteopathic Medicine, or 

18 American Osteopathic Association-accred19 ited residency or fellowship training pro20 gram. 

21 ‘‘(X) Any other practice setting ap22 proved by a State regulatory board or 

23 State Medicaid Plan to provide addiction 

24 treatment services. 


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1 ‘‘(XI) Any other practice setting ap2 proved by the Secretary.’’. 

3 SEC. 5. GAO EVALUATION. 

4 Two years after the date on which the first notifica5 tion under clause (iv) of section 303(g)(2)(B) of the Con6 trolled Substances Act (21 U.S.C. 823(g)(2)(B)), as added 

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

8 Human Services, the Comptroller General of the United 

9 States shall initiate an evaluation of the effectiveness of 

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

11 evaluation of— 

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

13 medication-assisted treatment for opioid addiction; 

14 (2) the quality of medication-assisted treatment 

15 programs; 

16 (3) the integration of medication-assisted treat17 ment with routine healthcare services; 

18 (4) diversion of opioid addiction treatment 

19 medication; 

20 (5) changes in State or local policies and legis21 lation relating to opioid addiction treatment; 

22 (6) the use of nurse practitioners and physician 

23 assistants who prescribe opioid addiction medication; 

24 (7) the use of Prescription Drug Monitoring 

25 Programs by waived practitioners to maximize safety 


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1 of patient care and prevent diversion of opioid addic2 tion medication; 

3 (8) the findings of Drug Enforcement Agency 

4 inspections of waived practitioners, including the fre5 quency with which the Drug Enforcement Agency 

6 finds no documentation of access to behavioral 

7 health services; and 

8 (9) the effectiveness of cross-agency collabora9 tion between Department of Health and Human 

10 Services and the Drug Enforcement Agency for ex11 panding effective opioid addiction treatment. 

Æ 


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