II 

112TH CONGRESS 

1ST SESSION S. 507 

To provide for increased Federal oversight of prescription opioid treatment 

and assistance to States in reducing opioid abuse, diversion, and deaths. 

IN THE SENATE OF THE UNITED STATES 

MARCH 8, 2011 

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

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

A BILL 

To provide for increased Federal oversight of prescription 

opioid treatment and assistance to States in reducing 

opioid abuse, diversion, and deaths. 

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 ‘‘Prescription Drug 

5 Abuse Prevention and Treatment Act of 2011’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 

8 (1) Nonmedical use of prescription pain reliev9 ers is a matter of increasing public health concern. 

10 According to the Substance Abuse and Mental 


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1 Health Services Administration, the proportion of all 

2 substance abuse treatment admissions aged 12 or 

3 older that reported any pain reliever abuse increased 

4 more than 400 percent between 1998 and 2008, 

5 from 2.2 to 9.8 percent. 

6 (2) In 2008, among the population of the 

7 United States aged 12 or older, nonmedical use of 

8 prescription pain relievers was the second most prev9 alent type of illicit drug use, after marijuana use. 

10 (3) When used properly under medical super11 vision, prescription opiates enable individuals with 

12 chronic pain to lead productive lives. However, when 

13 taken without a physician’s oversight and direction, 

14 opiates can cause serious adverse health effects, re15 sulting in dependence, abuse, and death. 

16 (4) As with any controlled substance, there is a 

17 risk of abuse of methadone and other opiates. 

18 (5) Methadone is an extensively tested, federally 

19 approved, and widely accepted method of treating 

20 addiction to prescription pain relievers or opiates. 

21 (6) For more than 30 years, this synthetic pre22 scription drug has been used for pain management 

23 and treatment for addiction to heroin, morphine, 

24 and other opioid drugs. 


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1 (7) The efficacy and lower cost of methadone 

2 has resulted in its being prescribed for pain manage3 ment. 

4 (8) Prescriptions for methadone have increased 

5 by nearly 700 percent from 1998 through 2006. 

6 (9) According to the Centers for Disease Con7 trol and Prevention, the number of poisoning deaths 

8 involving methadone increased nearly 7-fold from al9 most 790 in 1999 to almost 5,420 in 2006, which 

10 is the most rapid increase among opioid analgesics 

11 and other narcotics involved in poisoning deaths. 

12 (10) The age-specific rates of methadone death 

13 are higher for persons age 35 to 44 and 45 to 54 

14 than for other age groups. However, the rate of 

15 methadone deaths in younger individuals (age 15 to 

16 24) increased 11-fold from 1999 through 2005. 

17 (11) Deaths from methadone and other opiates 

18 may actually be underreported. There is no com19 prehensive database of drug-related deaths in the 

20 United States. 

21 (12) The lack of standardized reporting by 

22 Medical Examiners precludes a uniform definition of 

23 ‘‘cause of death’’ on death certificates. 

24 (13) The Controlled Substances Act (21 U.S.C. 

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1 penses or who proposes to dispense controlled nar2 cotics, including methadone, whether for pain man3 agement or opioid treatment obtain a registration 

4 from Drug Enforcement Administration. Unfortu5 nately there is no requirement as a condition of re6 ceiving the registration that these practitioners re7 ceive any education on the use of these controlled 

8 narcotics, including methadone. 

9 (14) Current Federal oversight of methadone 

10 and other opioids is inadequate to address the grow11 ing number of opioid-related overdoses and deaths. 

12 (15) Federal legislation is needed to avert 

13 opioid abuse, misuse, and death, without reducing 

14 patient access to needed care. 

15 SEC. 3. CONSUMER EDUCATION CAMPAIGN. 

16 Part A of title V of the Public Health Service Act 

17 (42 U.S.C. 290aa et seq.) is amended by adding at the 

18 end the following: 

19 ‘‘SEC. 506C. CONSUMER EDUCATION CAMPAIGN. 

20 ‘‘(a) IN GENERAL.—The Administrator shall award 

21 grants to States and nonprofit entities for the purpose of 

22 conducting culturally sensitive consumer education about 

23 opioid abuse, including methadone abuse. Such education 

24 shall include information on the dangers of opioid abuse, 

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1 posal of prescription medications and other safety pre2 cautions, and detection of early warning signs of addic3 tion. 

4 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

5 under subsection (a), an entity shall— 

6 ‘‘(1) be a State or nonprofit entity; and 

7 ‘‘(2) submit to the Administrator an application 

8 at such time, in such manner, and containing such 

9 information as the Administrator may require. 

10 ‘‘(c) PRIORITY.—In awarding grants under this sec11 tion, the Administrator shall give priority to applicants 

12 that are States or communities with a high incidence of 

13 abuse of methadone and other opioids, and opioid-related 

14 deaths. 

15 ‘‘(d) EVALUATIONS.—The Administrator shall de16 velop a process to evaluate the effectiveness of activities 

17 carried out by grantees under this section at reducing 

18 abuse of methadone and other opioids. 

19 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

20 is authorized to be appropriated to carry out this section 

21 $15,000,000 for each of fiscal years 2012 through 2016.’’. 

22 SEC. 4. PRACTITIONER EDUCATION. 

23 (a) EDUCATION REQUIREMENTS.— 

24 (1) REGISTRATION CONSIDERATION.—Section 

25 303(f) of the Controlled Substances Act (21 U.S.C. 


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1 823(f)) is amended by inserting after paragraph (5) 

2 the following: 

3 ‘‘(6) The applicant’s compliance with the train4 ing requirements described in subsection (g)(3) dur5 ing any previous period in which the applicant has 

6 been subject to such training requirements.’’. 

7 (2) TRAINING REQUIREMENTS.—Section 303(g) 

8 of the Controlled Substances Act (21 U.S.C. 823(g)) 

9 is amended by adding at the end the following: 

10 ‘‘(3)(A) To be registered to prescribe or otherwise 

11 dispense methadone or other opioids, a practitioner de12 scribed in paragraph (1) shall comply with the 16-hour 

13 training requirement of subparagraph (B) at least once 

14 during each 3-year period. 

15 ‘‘(B) The training requirement of this subparagraph 

16 is that the practitioner has completed not less than 16 

17 hours of training (through classroom situations, seminars 

18 at professional society meetings, electronic communica19 tions, or otherwise) with respect to— 

20 ‘‘(i) the treatment and management of opioid21 dependent patients; 

22 ‘‘(ii) pain management treatment guidelines; 

23 and 


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1 ‘‘(iii) early detection of opioid addiction, includ2 ing through such methods as Screening, Brief Inter3 vention, and Referral to Treatment (SBIRT), 

4 that is provided by the American Society of Addiction 

5 Medicine, the American Academy of Addiction Psychiatry, 

6 the American Medical Association, the American Osteo7 pathic Association, the American Psychiatric Association, 

8 the American Academy of Pain Management, the Amer9 ican Pain Society, the American Academy of Pain Medi10 cine, the American Board of Pain Medicine, the American 

11 Society of Interventional Pain Physicians, or any other or12 ganization that the Secretary determines is appropriate 

13 for purposes of this subparagraph.’’. 

14 (b) REQUIREMENTS FOR PARTICIPATION IN OPIOID

15 TREATMENT PROGRAMS.—Effective July 1, 2012, a phy16 sician practicing in an opioid treatment program shall 

17 comply with the requirements of section 303(g)(3) of the 

18 Controlled Substances Act (as added by subsection (a)) 

19 with respect to required minimum training at least once 

20 during each 3-year period. 

21 (c) DEFINITION.—In this section, the term ‘‘opioid 

22 treatment program’’ has the meaning given such term in 

23 section 8.2 of title 42, Code of Federal Regulations (or 

24 any successor regulation). 


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1 (d) FUNDING.—The Drug Enforcement Administra2 tion shall fund the enforcement of the requirements speci3 fied in section 303(g)(3) of the Controlled Substances Act 

4 (as added by subsection (a)) through the use of a portion 

5 of the licensing fees paid by controlled substance pre6 scribers under the Controlled Substances Act (21 U.S.C. 

7 801 et seq.). 

8 SEC. 5. MORATORIUM ON METHADONE HYDROCHLORIDE 

9 TABLETS. 

10 (a) IN GENERAL.—Notwithstanding any other provi11 sion of law, during the period beginning on the date of 

12 enactment of this Act and ending on the date described 

13 in subsection (b), no individual or entity may prescribe 

14 or otherwise dispense a 40-mg diskette of methadone un15 less such prescription or dispensation is consistent with 

16 the methadone 40-mg diskette policy of the Drug Enforce17 ment Administration as in effect on the date of enactment 

18 of this Act, except that such prohibition shall extend to 

19 hospitals unless such hospitals provide for direct patient 

20 supervision with respect to such methadone. 

21 (b) ENDING DATE OF MORATORIUM.—The morato22 rium under subsection (a) shall cease to have force and 

23 effect— 

24 (1) on the date that the Controlled Substances 

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1 eral Register dosing guidelines for all forms of meth2 adone, in accordance with section 506D(b)(1)(A) of 

3 the Public Health Service Act (as added by section 

4 7); and 

5 (2) if, as part of such dosing guidelines, such 

6 Commission finds that 40-mg diskettes of metha7 done are safe and clinically appropriate. 

8 SEC. 6. OPERATION OF OPIOID TREATMENT PROGRAMS. 

9 Section 303 of the Controlled Substances Act (21 

10 U.S.C. 823) is amended by adding at the end the fol11 lowing: 

12 ‘‘(i)(1) An opioid treatment program that is reg13 istered under this section, and that closes for business on 

14 any weekday or weekend day, including a Federal or State 

15 holiday, shall comply with the requirements of this sub16 section. 

17 ‘‘(2) The program shall make acceptable arrange18 ments for each patient who is restricted, by Federal regu19 lation or guideline or by the determination of the program 

20 medical director, from having a take home dose of a con21 trolled substance related to the treatment involved, to re22 ceive a dose of that substance under appropriate super23 vision during the closure. 

24 ‘‘(3) The Administrator of the Substance Abuse and 

25 Mental Health Services Administration shall issue a notice 


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1 that references regulations on acceptable arrangements 

2 under this subsection, or shall promulgate regulations on 

3 such acceptable arrangements.’’. 

4 SEC. 7. ESTABLISHMENT OF THE CONTROLLED SUB5 STANCES CLINICAL STANDARDS COMMIS6 SION. 

7 Part A of title V of the Public Health Service Act 

8 (42 U.S.C. 290aa et seq.), as amended by section 3, is 

9 further amended by adding at the end the following: 

10 ‘‘SEC. 506D. ESTABLISHMENT OF THE CONTROLLED SUB11 STANCES CLINICAL STANDARDS COMMIS12 SION. 

13 ‘‘(a) IN GENERAL.—The Secretary shall establish a 

14 Controlled Substances Clinical Standards Commission (re15 ferred to in this section as the ‘Commission’), to be com16 posed of representatives from the Administration, the Cen17 ters for Disease Control and Prevention, the Food and 

18 Drug Administration, the Pain Management Consortia of 

19 the National Institutes of Health, and other agencies that 

20 the Secretary may deem necessary, to develop— 

21 ‘‘(1) appropriate and safe dosing guidelines for 

22 all forms of methadone, including recommendations 

23 for maximum daily doses of all forms as provided for 

24 in subsection (b)(1); 


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1 ‘‘(2) benchmark guidelines for the reduction of 

2 methadone abuse, as provided for in subsection 

3 (b)(2); 

4 ‘‘(3) appropriate conversion factors for use by 

5 health care providers in transitioning patients from 

6 one opioid to another; 

7 ‘‘(4) specific guidelines for initiating pain man8 agement with methadone that prescribing practi9 tioners shall comply with in order to meet certifi10 cation requirements set forth in part C of the Con11 trolled Substances Act (21 U.S.C. 821 et seq.); and 

12 ‘‘(5) patient and practitioner education guide13 lines for both methadone maintenance therapy and 

14 pain management that apply to safe and effective 

15 use and include detoxification. 

16 ‘‘(b) GUIDELINES.— 

17 ‘‘(1) PUBLICATION OF DOSING GUIDELINES.— 

18 ‘‘(A) IN GENERAL.—Not later than 2 years 

19 after the date of enactment of this section, the 

20 Commission established under subsection (a) 

21 shall publish in the Federal Register— 

22 ‘‘(i) safe and clinically appropriate 

23 dosing guidelines for all forms of metha24 done used for both pain management and 

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1 ommendations for maximum daily doses of 

2 all forms, including recommendations for 

3 the induction process for patients who are 

4 newly prescribed methadone; 

5 ‘‘(ii) requirements for individual pa6 tient care plans, including initial and fol7 low-up patient physical examination guide8 lines, and recommendations for screening 

9 patients for chronic or acute medical condi10 tions that may cause an immediate and ad11 verse reaction to methadone; 

12 ‘‘(iii) appropriate conversion factors 

13 for use by health care providers in 

14 transitioning patients from one opioid to 

15 another; 

16 ‘‘(iv) specific guidelines for initiating 

17 pain management with methadone, that 

18 prescribing physicians or other clinicians 

19 shall comply with in order to meet Drug 

20 Enforcement Administration certification 

21 and re-certification requirements; and 

22 ‘‘(v) consensus guidelines for pain 

23 management with prescription opioid 

24 drugs. 


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1 ‘‘(B) UPDATING OF GUIDELINES.—Not 

2 later than 3 years after the publication of 

3 guidelines under subparagraph (A), and at least 

4 every 3 years thereafter, the Commission shall 

5 update such guidelines. 

6 ‘‘(2) PUBLICATION OF BENCHMARK GUIDE7 LINES.— 

8 ‘‘(A) IN GENERAL.—Not later than 3 years 

9 after the date of enactment of this section, the 

10 Commission established under subsection (a) 

11 shall publish in the Federal Register— 

12 ‘‘(i) the initial benchmark guidelines 

13 for the reduction of methadone abuse to be 

14 used— 

15 ‘‘(I) by opioid treatment pro16 grams in providing methadone ther17 apy; and 

18 ‘‘(II) by entities in the initial ac19 creditation or certification, and the re20 accreditation and re-certification, of 

21 such opioid treatment programs; 

22 ‘‘(ii) a model policy for dispensing 

23 methadone to be used by pharmacists that 

24 dispense methadone, which should include 


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1 education and training guidelines for such 

2 pharmacists; 

3 ‘‘(iii) the continuing education guide4 lines that all prescribers shall comply with 

5 in order to meet Drug Enforcement Ad6 ministration certification and re-certifi7 cation requirements, as set forth in section 

8 303(g)(3) of the Controlled Substances Act 

9 (21 U.S.C. 823(g)(3)), which should in10 clude a minimum of 16 training hours at 

11 least every 3 years that include the inte12 gration of both addiction and pain man13 agement curricula; and 

14 ‘‘(iv) patient education guidelines for 

15 both opioid treatment programs and pain 

16 management, including recommendations 

17 for patient counseling prior to and during 

18 opioid addiction treatment or treatment for 

19 pain. 

20 ‘‘(B) UPDATING OF GUIDELINES.—Not 

21 later than 1 year after the publication of guide22 lines under subparagraph (A), and at least an23 nually thereafter, the Commission shall update 

24 the guidelines published under clauses (iii) and 

25 (iv) of such subparagraph. 


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1 ‘‘(3) CONSULTATION.—In developing and pub2 lishing the guidelines under this section, the Com3 mission shall consult with relevant professional orga4 nizations with expertise in the area of addiction, rel5 evant professional organizations with expertise in the 

6 area of pain management, physician groups, phar7 macy groups (including the National Association of 

8 Boards of Pharmacy), patient representatives, and 

9 any other organization that the Secretary determines 

10 is appropriate for purposes of this section. 

11 ‘‘(c) WEBSITE.—Not later than 180 days after the 

12 date of enactment of this section, the Commission shall 

13 establish and operate a Commission website. 

14 ‘‘(d) METHADONE TOOLKIT.—Not later than 1 year 

15 after the date of enactment of this section, the Commis16 sion shall establish, and distribute to practitioners that are 

17 registered to prescribe or otherwise dispense methadone, 

18 a methadone toolkit. The Commission shall make the com19 ponents of the toolkit that are available in electronic form 

20 available on the Commission website. 

21 ‘‘(e) PRACTITIONER EDUCATION PROGRAM.—The 

22 Commission shall develop a practitioner education pro23 gram that shall be used for the practitioner education de24 scribed in section 303(g)(3) of the Controlled Substances 


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1 Act, and shall make such program available to providers 

2 of such practitioner education. 

3 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

4 is authorized to be appropriated to carry out this section 

5 such sums as may be necessary for each of fiscal years 

6 2012 through 2016.’’. 

7 SEC. 8. PRESCRIPTION MONITORING PROGRAM. 

8 Section 399O of the Public Health Service Act (42 

9 U.S.C. 280g–3) is amended— 

10 (1) in subsection (d)(1), by inserting ‘‘(includ11 ing prescribers of methadone)’’ after ‘‘dispensers’’; 

12 (2) in subsection (e), by adding at the end the 

13 following: 

14 ‘‘(5) Subject to the requirements of section 543, 

15 the State shall, at the request of a Federal, State, 

16 or local officer whose duties include enforcing laws 

17 relating to drugs, provide to such officer information 

18 from the database relating to an individual who is 

19 the subject of an active drug-related investigation 

20 conducted by the officer’s employing government en21 tity.’’; and 

22 (3) by striking subsection (n) and inserting the 

23 following: 


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1 ‘‘(n) APPROPRIATIONS.—There is authorized to be 

2 appropriated to carry out this section $25,000,000 for 

3 each of fiscal years 2012 through 2016.’’. 

4 SEC. 9. MORTALITY REPORTING. 

5 Part A of title V of the Public Health Service Act 

6 (42 U.S.C. 290aa et seq.), as amended by section 7, is 

7 further amended by adding at the end the following: 

8 ‘‘SEC. 506E. MORTALITY REPORTING. 

9 ‘‘(a) MODEL OPIOID TREATMENT PROGRAM MOR10 TALITY REPORT.— 

11 ‘‘(1) IN GENERAL.—Not later than July 1, 

12 2012, the Secretary, acting through the Adminis13 trator, shall require that a Model Opioid Treatment 

14 Program Mortality Report be completed and sub15 mitted to the Administrator for each individual who 

16 dies while receiving treatment in an opioid treatment 

17 program. 

18 ‘‘(2) REQUIREMENT OF STATES THAT RECEIVE

19 FUNDING FOR THE CONTROLLED SUBSTANCE MONI20 TORING PROGRAM.—As a condition for receiving 

21 funds under section 399O, each State shall require 

22 that any individual who signs a death certificate 

23 where an opioid drug is detected in the body of the 

24 deceased, or where such drug is otherwise associated 

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1 trator by submitting a Model Opioid Treatment Pro2 gram Mortality Report described in paragraph (3). 

3 Such report shall be submitted to the Administrator 

4 on or before the later of— 

5 ‘‘(A) 90 days after the date of signing the 

6 death certificate; or 

7 ‘‘(B) as soon as practicable after the date 

8 on which the necessary postmortem and toxi9 cology reports become available to such indi10 vidual, as required by the Secretary. 

11 ‘‘(3) DEVELOPMENT.—The Administrator, in 

12 consultation with State and local medical examiners, 

13 prescribing physicians, hospitals, and any other or14 ganization that the Administrator determines appro15 priate, shall develop a Model Opioid Treatment Pro16 gram Mortality Report to be used under paragraphs 

17 (1) and (2). 

18 ‘‘(b) NATIONAL OPIOID DEATH REGISTRY.— 

19 ‘‘(1) IN GENERAL.—Not later than July 1, 

20 2012, the Administrator shall establish and imple21 ment, through the National Center for Health Sta22 tistics, a National Opioid Death Registry (referred 

23 to in this subsection as the ‘Registry’) to track 

24 opioid-related deaths and information related to such 

25 deaths. 


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1 ‘‘(2) CONSULTATION.—In establishing the uni2 form reporting criteria for the Registry, the Director 

3 of the Centers for Disease Control and Prevention 

4 shall consult with the Administrator, State and local 

5 medical examiners, prescribing physicians, hospitals, 

6 and any other organization that the Director deter7 mines is appropriate for purposes of this subsection. 

8 ‘‘(3) REQUIREMENTS.—The registry shall be 

9 designed as a uniform reporting system for opioid10 related deaths and shall require the reporting of in11 formation with respect to such deaths, including— 

12 ‘‘(A) the particular drug formulation used 

13 at the time of death; 

14 ‘‘(B) the dosage level; 

15 ‘‘(C) a description of the circumstances 

16 surrounding the death in relation to the rec17 ommended dosage involved; 

18 ‘‘(D) a disclosure of whether the medica19 tion involved can be traced back to a physi20 cian’s prescription; 

21 ‘‘(E) a disclosure of whether the individual 

22 was in an opioid treatment program at the time 

23 of death; 

24 ‘‘(F) the age and sex of the individual; and 


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1 ‘‘(G) other non-personal information such 

2 as that included in filed National Association of 

3 Medical Examiners Pediatric Toxicology Reg4 istry case reports as required under the privacy 

5 standard for the de-identification of health in6 formation pursuant to the regulations contained 

7 in part 164 of title 45, Code of Federal Regula8 tions. 

9 ‘‘(4) AUTHORIZATION.—There is authorized to 

10 be appropriated $5,000,000 for each of fiscal years 

11 2012 through 2016 to carry out this subsection. 

12 ‘‘(c) REPORT ON REGISTRY INFORMATION.—Not 

13 later than the January 1 of the first fiscal year beginning 

14 2 years after the date of enactment of this section, and 

15 each January 1 thereafter, the Director of the Centers for 

16 Disease Control and Prevention shall submit to the Sec17 retary a report, based on information contained in the 

18 Registry described in subsection (b), concerning the num19 ber of methadone-related deaths in the United States for 

20 the year for which the report is submitted.’’. 

21 SEC. 10. ADDITIONAL REPORTING. 

22 Part A of title V of the Public Health Service Act 

23 (42 U.S.C. 290aa et seq.), as amended by section 9, is 

24 further amended by adding at the end the following: 


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1 ‘‘SEC. 506F. ADDITIONAL REPORTING. 

2 ‘‘(a) REPORT ON METHADONE USAGE.— 

3 ‘‘(1) IN GENERAL.—Not later than January 1 

4 of the first fiscal year beginning 2 years after the 

5 date of enactment of this section, and each January 

6 1 thereafter, the Administrator and the Commis7 sioner of Food and Drugs shall submit to the Sec8 retary a report containing detailed statistics on 

9 methadone usage for opioid treatment and pain 

10 management. Such statistics shall include— 

11 ‘‘(A) information on the distribution of 

12 prescribed doses of methadone at federally 

13 qualified health centers, opioid treatment clin14 ics, other health-related clinics, physician of15 fices, pharmacies, and hospitals; and 

16 ‘‘(B) information relating to adverse health 

17 events resulting from such methadone usage. 

18 ‘‘(2) AVAILABILITY OF INFORMATION.—The 

19 Secretary shall make the reports submitted under 

20 paragraph (1) available to the general public, includ21 ing through the use of the Internet website of the 

22 Department of Health and Human Services. 

23 ‘‘(b) ANNUAL REPORT ON EFFECTIVENESS.—Not 

24 later than September 30, 2012, and annually thereafter 

25 until September 30, 2016, the Secretary shall submit to 

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1 cerning the effectiveness of the methadone maintenance 

2 therapy program. Such report shall evaluate the success 

3 of efforts to reduce opioid addiction and methadone-re4 lated deaths, including the impact of health care provider 

5 and patient education. 

6 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 

7 is authorized to be appropriated to carry out this section 

8 such sums as may be necessary for each of fiscal years 

9 2012 through 2016.’’. 

Æ 


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