I 
112TH CONGRESS 
1ST SESSION H. R. 1925 
To provide for increased Federal oversight of prescription opioid treatment 
and assistance to States in reducing opioid abuse, diversion, and deaths. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 13, 2011 
Mr. RAHALL (for himself, Mr. KEATING, and Mr. MCGOVERN) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on the Judiciary, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation of such provisions as fall within the jurisdiction of the committee 
concerned 
A BILL 
To provide for increased Federal oversight of prescription 
opioid treatment and assistance to States in reducing 
opioid abuse, diversion, and deaths. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Prescription Drug 
Abuse Prevention and Treatment Act of 2011’’. 
SEC. 2. FINDINGS. 
Congress makes the following findings: 
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(1) Nonmedical use of prescription pain reliev-
ers is a matter of increasing public health concern. 
According to the Substance Abuse and Mental 
Health Services Administration, the proportion of all 
substance abuse treatment admissions aged 12 or 
older that reported any pain reliever abuse increased 
more than 400 percent between 1998 and 2008, 
from 2.2 to 9.8 percent. 
(2) In 2008, among the population of the 
United States aged 12 or older, nonmedical use of 
prescription pain relievers was the second most prev-
alent type of illicit drug use, after marijuana use. 
(3) When used properly under medical super-
vision, prescription opiates enable individuals with 
chronic pain to lead productive lives. However, when 
taken without a physician’s oversight and direction, 
opiates can cause serious adverse health effects, re-
sulting in dependence, abuse, and death. 
(4) As with any controlled substance, there is a 
risk of abuse of methadone and other opiates. 
(5) Methadone is an extensively tested, federally 
approved, and widely accepted method of treating 
addiction to prescription pain relievers or opiates. 
(6) For more than 30 years, this synthetic pre-
scription drug has been used for pain management 
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and treatment for addiction to heroin, morphine, 
and other opioid drugs. 
(7) The efficacy and lower cost of methadone 
has resulted in its being prescribed for pain manage-
ment. 
(8) Prescriptions for methadone have increased 
by nearly 700 percent from 1998 through 2006. 
(9) According to the Centers for Disease Con-
trol and Prevention, the number of poisoning deaths 
involving methadone increased nearly 7-fold from al-
most 790 in 1999 to almost 5,420 in 2006, which 
is the most rapid increase among opioid analgesics 
and other narcotics involved in poisoning deaths. 
(10) The age-specific rates of methadone death 
are higher for persons age 35 to 44 and 45 to 54 
than for other age groups. However, the rate of 
methadone deaths in younger individuals (age 15 to 
24) increased 11-fold from 1999 through 2005. 
(11) Deaths from methadone and other opiates 
may actually be underreported. There is no com-
prehensive database of drug-related deaths in the 
United States. 
(12) The lack of standardized reporting by 
Medical Examiners precludes a uniform definition of 
‘‘cause of death’’ on death certificates. 
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(13) The Controlled Substances Act (21 U.S.C. 
801 et seq.) requires that every person who dis-
penses or who proposes to dispense controlled nar-
cotics, including methadone, whether for pain man-
agement or opioid treatment obtain a registration 
from Drug Enforcement Administration. Unfortu-
nately there is no requirement as a condition of re-
ceiving the registration that these practitioners re-
ceive any education on the use of these controlled 
narcotics, including methadone. 
(14) Current Federal oversight of methadone 
and other opioids is inadequate to address the grow-
ing number of opioid-related overdoses and deaths. 
(15) Federal legislation is needed to avert 
opioid abuse, misuse, and death, without reducing 
patient access to needed care. 
SEC. 3. CONSUMER EDUCATION CAMPAIGN. 
Part A of title V of the Public Health Service Act 
(42 U.S.C. 290aa et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 506C. CONSUMER EDUCATION CAMPAIGN. 
‘‘(a) IN GENERAL.—The Administrator shall award 
grants to States and nonprofit entities for the purpose of 
conducting culturally sensitive consumer education about 
opioid abuse, including methadone abuse. Such education 
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shall include information on the dangers of opioid abuse, 
how to prevent opioid abuse including through safe dis-
posal of prescription medications and other safety pre-
cautions, and detection of early warning signs of addic-
tion. 
‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 
under subsection (a), an entity shall— 
‘‘(1) be a State or nonprofit entity; and 
‘‘(2) submit to the Administrator an application 
at such time, in such manner, and containing such 
information as the Administrator may require. 
‘‘(c) PRIORITY.—In awarding grants under this sec-
tion, the Administrator shall give priority to applicants 
that are States or communities with a high incidence of 
abuse of methadone and other opioids, and opioid-related 
deaths. 
‘‘(d) EVALUATIONS.—The Administrator shall de-
velop a process to evaluate the effectiveness of activities 
carried out by grantees under this section at reducing 
abuse of methadone and other opioids. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section 
$15,000,000 for each of fiscal years 2012 through 2016.’’. 
SEC. 4. PRACTITIONER EDUCATION. 
(a) EDUCATION REQUIREMENTS.— 
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(1) REGISTRATION
CONSIDERATION.—Section 
303(f) of the Controlled Substances Act (21 U.S.C. 
823(f)) is amended by inserting after paragraph (5) 
the following: 
‘‘(6) The applicant’s compliance with the train-
ing requirements described in subsection (g)(3) dur-
ing any previous period in which the applicant has 
been subject to such training requirements.’’. 
(2) TRAINING REQUIREMENTS.—Section 303(g) 
of the Controlled Substances Act (21 U.S.C. 823(g)) 
is amended by adding at the end the following: 
‘‘(3)(A) To be registered to prescribe or otherwise 
dispense methadone or other opioids, a practitioner de-
scribed in paragraph (1) shall comply with the 16-hour 
training requirement of subparagraph (B) at least once 
during each 3-year period. 
‘‘(B) The training requirement of this subparagraph 
is that the practitioner has completed not less than 16 
hours of training (through classroom situations, seminars 
at professional society meetings, electronic communica-
tions, or otherwise) with respect to— 
‘‘(i) the treatment and management of opioid- 
dependent patients; 
‘‘(ii) pain management treatment guidelines; 
and 
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‘‘(iii) early detection of opioid addiction, includ-
ing through such methods as Screening, Brief Inter-
vention, and Referral to Treatment (SBIRT), 
that is provided by the American Society of Addiction 
Medicine, the American Academy of Addiction Psychiatry, 
the American Medical Association, the American Osteo-
pathic Association, the American Psychiatric Association, 
the American Academy of Pain Management, the Amer-
ican Pain Society, the American Academy of Pain Medi-
cine, the American Board of Pain Medicine, the American 
Society of Interventional Pain Physicians, or any other or-
ganization that the Secretary determines is appropriate 
for purposes of this subparagraph.’’. 
(b) REQUIREMENTS FOR PARTICIPATION IN OPIOID 
TREATMENT PROGRAMS.—Effective July 1, 2012, a phy-
sician practicing in an opioid treatment program shall 
comply with the requirements of section 303(g)(3) of the 
Controlled Substances Act (as added by subsection (a)) 
with respect to required minimum training at least once 
during each 3-year period. 
(c) DEFINITION.—In this section, the term ‘‘opioid 
treatment program’’ has the meaning given such term in 
section 8.2 of title 42, Code of Federal Regulations (or 
any successor regulation). 
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(d) FUNDING.—The Drug Enforcement Administra-
tion shall fund the enforcement of the requirements speci-
fied in section 303(g)(3) of the Controlled Substances Act 
(as added by subsection (a)) through the use of a portion 
of the licensing fees paid by controlled substance pre-
scribers under the Controlled Substances Act (21 U.S.C. 
801 et seq.). 
SEC. 5. MORATORIUM ON METHADONE HYDROCHLORIDE 
TABLETS. 
(a) IN GENERAL.—Notwithstanding any other provi-
sion of law, during the period beginning on the date of 
enactment of this Act and ending on the date described 
in subsection (b), no individual or entity may prescribe 
or otherwise dispense a 40-mg diskette of methadone un-
less such prescription or dispensation is consistent with 
the methadone 40-mg diskette policy of the Drug Enforce-
ment Administration as in effect on the date of enactment 
of this Act, except that such prohibition shall extend to 
hospitals unless such hospitals provide for direct patient 
supervision with respect to such methadone. 
(b) ENDING DATE OF MORATORIUM.—The morato-
rium under subsection (a) shall cease to have force and 
effect— 
(1) on the date that the Controlled Substances 
Clinical Standards Commission publishes in the Fed-
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eral Register dosing guidelines for all forms of meth-
adone, in accordance with section 506D(b)(1)(A) of 
the Public Health Service Act (as added by section 
7); and 
(2) if, as part of such dosing guidelines, such 
Commission finds that 40-mg diskettes of metha-
done are safe and clinically appropriate. 
SEC. 6. OPERATION OF OPIOID TREATMENT PROGRAMS. 
Section 303 of the Controlled Substances Act (21 
U.S.C. 823) is amended by adding at the end the fol-
lowing: 
‘‘(i)(1) An opioid treatment program that is reg-
istered under this section, and that closes for business on 
any weekday or weekend day, including a Federal or State 
holiday, shall comply with the requirements of this sub-
section. 
‘‘(2) The program shall make acceptable arrange-
ments for each patient who is restricted, by Federal regu-
lation or guideline or by the determination of the program 
medical director, from having a take home dose of a con-
trolled substance related to the treatment involved, to re-
ceive a dose of that substance under appropriate super-
vision during the closure. 
‘‘(3) The Administrator of the Substance Abuse and 
Mental Health Services Administration shall issue a notice 
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that references regulations on acceptable arrangements 
under this subsection, or shall promulgate regulations on 
such acceptable arrangements.’’. 
SEC. 7. ESTABLISHMENT OF THE CONTROLLED SUB-
STANCES 
CLINICAL 
STANDARDS 
COMMIS-
SION. 
Part A of title V of the Public Health Service Act 
(42 U.S.C. 290aa et seq.), as amended by section 3, is 
further amended by adding at the end the following: 
‘‘SEC. 506D. ESTABLISHMENT OF THE CONTROLLED SUB-
STANCES 
CLINICAL 
STANDARDS 
COMMIS-
SION. 
‘‘(a) IN GENERAL.—The Secretary shall establish a 
Controlled Substances Clinical Standards Commission (re-
ferred to in this section as the ‘Commission’), to be com-
posed of representatives from the Administration, the Cen-
ters for Disease Control and Prevention, the Food and 
Drug Administration, the Pain Management Consortia of 
the National Institutes of Health, and other agencies that 
the Secretary may deem necessary, to develop— 
‘‘(1) appropriate and safe dosing guidelines for 
all forms of methadone, including recommendations 
for maximum daily doses of all forms as provided for 
in subsection (b)(1); 
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‘‘(2) benchmark guidelines for the reduction of 
methadone abuse, as provided for in subsection 
(b)(2); 
‘‘(3) appropriate conversion factors for use by 
health care providers in transitioning patients from 
one opioid to another; 
‘‘(4) specific guidelines for initiating pain man-
agement with methadone that prescribing practi-
tioners shall comply with in order to meet certifi-
cation requirements set forth in part C of the Con-
trolled Substances Act (21 U.S.C. 821 et seq.); and 
‘‘(5) patient and practitioner education guide-
lines for both methadone maintenance therapy and 
pain management that apply to safe and effective 
use and include detoxification. 
‘‘(b) GUIDELINES.— 
‘‘(1) PUBLICATION OF DOSING GUIDELINES.— 
‘‘(A) IN GENERAL.—Not later than 2 years 
after the date of enactment of this section, the 
Commission established under subsection (a) 
shall publish in the Federal Register— 
‘‘(i) safe and clinically appropriate 
dosing guidelines for all forms of metha-
done used for both pain management and 
opioid treatment programs, including rec-
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ommendations for maximum daily doses of 
all forms, including recommendations for 
the induction process for patients who are 
newly prescribed methadone; 
‘‘(ii) requirements for individual pa-
tient care plans, including initial and fol-
low-up patient physical examination guide-
lines, and recommendations for screening 
patients for chronic or acute medical condi-
tions that may cause an immediate and ad-
verse reaction to methadone; 
‘‘(iii) appropriate conversion factors 
for use by health care providers in 
transitioning patients from one opioid to 
another; 
‘‘(iv) specific guidelines for initiating 
pain management with methadone, that 
prescribing physicians or other clinicians 
shall comply with in order to meet Drug 
Enforcement Administration certification 
and re-certification requirements; and 
‘‘(v) consensus guidelines for pain 
management 
with 
prescription 
opioid 
drugs. 
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‘‘(B) UPDATING
OF
GUIDELINES.—Not 
later than 3 years after the publication of 
guidelines under subparagraph (A), and at least 
every 3 years thereafter, the Commission shall 
update such guidelines. 
‘‘(2) PUBLICATION
OF
BENCHMARK
GUIDE-
LINES.— 
‘‘(A) IN GENERAL.—Not later than 3 years 
after the date of enactment of this section, the 
Commission established under subsection (a) 
shall publish in the Federal Register— 
‘‘(i) the initial benchmark guidelines 
for the reduction of methadone abuse to be 
used— 
‘‘(I) by opioid treatment pro-
grams in providing methadone ther-
apy; and 
‘‘(II) by entities in the initial ac-
creditation or certification, and the re- 
accreditation and re-certification, of 
such opioid treatment programs; 
‘‘(ii) a model policy for dispensing 
methadone to be used by pharmacists that 
dispense methadone, which should include 
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education and training guidelines for such 
pharmacists; 
‘‘(iii) the continuing education guide-
lines that all prescribers shall comply with 
in order to meet Drug Enforcement Ad-
ministration certification and re-certifi-
cation requirements, as set forth in section 
303(g)(3) of the Controlled Substances Act 
(21 U.S.C. 823(g)(3)), which should in-
clude a minimum of 16 training hours at 
least every 3 years that include the inte-
gration of both addiction and pain man-
agement curricula; and 
‘‘(iv) patient education guidelines for 
both opioid treatment programs and pain 
management, including recommendations 
for patient counseling prior to and during 
opioid addiction treatment or treatment for 
pain. 
‘‘(B) UPDATING
OF
GUIDELINES.—Not 
later than 1 year after the publication of guide-
lines under subparagraph (A), and at least an-
nually thereafter, the Commission shall update 
the guidelines published under clauses (iii) and 
(iv) of such subparagraph. 
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‘‘(3) CONSULTATION.—In developing and pub-
lishing the guidelines under this section, the Com-
mission shall consult with relevant professional orga-
nizations with expertise in the area of addiction, rel-
evant professional organizations with expertise in the 
area of pain management, physician groups, phar-
macy groups (including the National Association of 
Boards of Pharmacy), patient representatives, and 
any other organization that the Secretary determines 
is appropriate for purposes of this section. 
‘‘(c) WEB SITE.—Not later than 180 days after the 
date of enactment of this section, the Commission shall 
establish and operate a Commission Web site. 
‘‘(d) METHADONE TOOLKIT.—Not later than 1 year 
after the date of enactment of this section, the Commis-
sion shall establish, and distribute to practitioners that are 
registered to prescribe or otherwise dispense methadone, 
a methadone toolkit. The Commission shall make the com-
ponents of the toolkit that are available in electronic form 
available on the Commission Web site. 
‘‘(e) PRACTITIONER EDUCATION PROGRAM.—The 
Commission shall develop a practitioner education pro-
gram that shall be used for the practitioner education de-
scribed in section 303(g)(3) of the Controlled Substances 
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Act, and shall make such program available to providers 
of such practitioner education. 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section 
such sums as may be necessary for each of fiscal years 
2012 through 2016.’’. 
SEC. 8. PRESCRIPTION MONITORING PROGRAM. 
Section 399O of the Public Health Service Act (42 
U.S.C. 280g–3) is amended— 
(1) in subsection (d)(1), by inserting ‘‘(includ-
ing prescribers of methadone)’’ after ‘‘dispensers’’; 
(2) in subsection (e), by adding at the end the 
following: 
‘‘(5) Subject to the requirements of section 543, 
the State shall, at the request of a Federal, State, 
or local officer whose duties include enforcing laws 
relating to drugs, provide to such officer information 
from the database relating to an individual who is 
the subject of an active drug-related investigation 
conducted by the officer’s employing government en-
tity.’’; and 
(3) by striking subsection (n) and inserting the 
following: 
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‘‘(n) APPROPRIATIONS.—There is authorized to be 
appropriated to carry out this section $25,000,000 for 
each of fiscal years 2012 through 2016.’’. 
SEC. 9. MORTALITY REPORTING. 
Part A of title V of the Public Health Service Act 
(42 U.S.C. 290aa et seq.), as amended by section 7, is 
further amended by adding at the end the following: 
‘‘SEC. 506E. MORTALITY REPORTING. 
‘‘(a) MODEL OPIOID TREATMENT PROGRAM MOR-
TALITY REPORT.— 
‘‘(1) IN
GENERAL.—Not later than July 1, 
2012, the Secretary, acting through the Adminis-
trator, shall require that a Model Opioid Treatment 
Program Mortality Report be completed and sub-
mitted to the Administrator for each individual who 
dies while receiving treatment in an opioid treatment 
program. 
‘‘(2) REQUIREMENT OF STATES THAT RECEIVE 
FUNDING FOR THE CONTROLLED SUBSTANCE MONI-
TORING
PROGRAM.—As a condition for receiving 
funds under section 399O, each State shall require 
that any individual who signs a death certificate 
where an opioid drug is detected in the body of the 
deceased, or where such drug is otherwise associated 
with the death, report such death to the Adminis-
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trator by submitting a Model Opioid Treatment Pro-
gram Mortality Report described in paragraph (3). 
Such report shall be submitted to the Administrator 
on or before the later of— 
‘‘(A) 90 days after the date of signing the 
death certificate; or 
‘‘(B) as soon as practicable after the date 
on which the necessary postmortem and toxi-
cology reports become available to such indi-
vidual, as required by the Secretary. 
‘‘(3) DEVELOPMENT.—The Administrator, in 
consultation with State and local medical examiners, 
prescribing physicians, hospitals, and any other or-
ganization that the Administrator determines appro-
priate, shall develop a Model Opioid Treatment Pro-
gram Mortality Report to be used under paragraphs 
(1) and (2). 
‘‘(b) NATIONAL OPIOID DEATH REGISTRY.— 
‘‘(1) IN
GENERAL.—Not later than July 1, 
2012, the Administrator shall establish and imple-
ment, through the National Center for Health Sta-
tistics, a National Opioid Death Registry (referred 
to in this subsection as the ‘Registry’) to track 
opioid-related deaths and information related to such 
deaths. 
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‘‘(2) CONSULTATION.—In establishing the uni-
form reporting criteria for the Registry, the Director 
of the Centers for Disease Control and Prevention 
shall consult with the Administrator, State and local 
medical examiners, prescribing physicians, hospitals, 
and any other organization that the Director deter-
mines is appropriate for purposes of this subsection. 
‘‘(3) REQUIREMENTS.—The registry shall be 
designed as a uniform reporting system for opioid- 
related deaths and shall require the reporting of in-
formation with respect to such deaths, including— 
‘‘(A) the particular drug formulation used 
at the time of death; 
‘‘(B) the dosage level; 
‘‘(C) a description of the circumstances 
surrounding the death in relation to the rec-
ommended dosage involved; 
‘‘(D) a disclosure of whether the medica-
tion involved can be traced back to a physi-
cian’s prescription; 
‘‘(E) a disclosure of whether the individual 
was in an opioid treatment program at the time 
of death; 
‘‘(F) the age and sex of the individual; and 
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‘‘(G) other non-personal information such 
as that included in filed National Association of 
Medical Examiners Pediatric Toxicology Reg-
istry case reports as required under the privacy 
standard for the de-identification of health in-
formation pursuant to the regulations contained 
in part 164 of title 45, Code of Federal Regula-
tions. 
‘‘(4) AUTHORIZATION.—There is authorized to 
be appropriated $5,000,000 for each of fiscal years 
2012 through 2016 to carry out this subsection. 
‘‘(c) REPORT
ON REGISTRY INFORMATION.—Not 
later than the January 1 of the first fiscal year beginning 
2 years after the date of enactment of this section, and 
each January 1 thereafter, the Director of the Centers for 
Disease Control and Prevention shall submit to the Sec-
retary a report, based on information contained in the 
Registry described in subsection (b), concerning the num-
ber of methadone-related deaths in the United States for 
the year for which the report is submitted.’’. 
SEC. 10. ADDITIONAL REPORTING. 
Part A of title V of the Public Health Service Act 
(42 U.S.C. 290aa et seq.), as amended by section 9, is 
further amended by adding at the end the following: 
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‘‘SEC. 506F. ADDITIONAL REPORTING. 
‘‘(a) REPORT ON METHADONE USAGE.— 
‘‘(1) IN GENERAL.—Not later than January 1 
of the first fiscal year beginning 2 years after the 
date of enactment of this section, and each January 
1 thereafter, the Administrator and the Commis-
sioner of Food and Drugs shall submit to the Sec-
retary a report containing detailed statistics on 
methadone usage for opioid treatment and pain 
management. Such statistics shall include— 
‘‘(A) information on the distribution of 
prescribed doses of methadone at federally 
qualified health centers, opioid treatment clin-
ics, other health-related clinics, physician of-
fices, pharmacies, and hospitals; and 
‘‘(B) information relating to adverse health 
events resulting from such methadone usage. 
‘‘(2) AVAILABILITY
OF
INFORMATION.—The 
Secretary shall make the reports submitted under 
paragraph (1) available to the general public, includ-
ing through the use of the Internet Web site of the 
Department of Health and Human Services. 
‘‘(b) ANNUAL REPORT
ON EFFECTIVENESS.—Not 
later than September 30, 2012, and annually thereafter 
until September 30, 2016, the Secretary shall submit to 
the appropriate committees of Congress, a report con-
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cerning the effectiveness of the methadone maintenance 
therapy program. Such report shall evaluate the success 
of efforts to reduce opioid addiction and methadone-re-
lated deaths, including the impact of health care provider 
and patient education. 
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section 
such sums as may be necessary for each of fiscal years 
2012 through 2016.’’. 
Æ 
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