[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 507 Introduced in Senate (IS)]
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.
Be it enacted by the Senate and House of Representatives 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:
(1) Nonmedical use of prescription pain relievers 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 prevalent type of illicit drug use, after
marijuana use.
(3) When used properly under medical supervision,
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, resulting 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 prescription
drug has been used for pain management 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 management.
(8) Prescriptions for methadone have increased by nearly
700 percent from 1998 through 2006.
(9) According to the Centers for Disease Control and
Prevention, the number of poisoning deaths involving methadone
increased nearly 7-fold from almost 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 comprehensive 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.
(13) The Controlled Substances Act (21 U.S.C. 801 et seq.)
requires that every person who dispenses or who proposes to
dispense controlled narcotics, including methadone, whether for
pain management or opioid treatment obtain a registration from
Drug Enforcement Administration. Unfortunately there is no
requirement as a condition of receiving the registration that
these practitioners receive 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 growing 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 shall include information on the dangers of
opioid abuse, how to prevent opioid abuse including through safe
disposal of prescription medications and other safety precautions, and
detection of early warning signs of addiction.
``(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 section, 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 develop 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.--
(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 training
requirements described in subsection (g)(3) during 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 described 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 communications, or otherwise) with respect to--
``(i) the treatment and management of opioid-dependent
patients;
``(ii) pain management treatment guidelines; and
``(iii) early detection of opioid addiction, including
through such methods as Screening, Brief Intervention, 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 Osteopathic Association, the American
Psychiatric Association, the American Academy of Pain Management, the
American Pain Society, the American Academy of Pain Medicine, the
American Board of Pain Medicine, the American Society of Interventional
Pain Physicians, or any other organization that the Secretary
determines is appropriate for purposes of this subparagraph.''.
(b) Requirements for Participation in Opioid Treatment Programs.--
Effective July 1, 2012, a physician 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).
(d) Funding.--The Drug Enforcement Administration shall fund the
enforcement of the requirements specified 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
prescribers 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 provision 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 unless
such prescription or dispensation is consistent with the methadone 40-
mg diskette policy of the Drug Enforcement 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 moratorium under subsection (a)
shall cease to have force and effect--
(1) on the date that the Controlled Substances Clinical
Standards Commission publishes in the Federal Register dosing
guidelines for all forms of methadone, 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 methadone 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 following:
``(i)(1) An opioid treatment program that is registered 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 subsection.
``(2) The program shall make acceptable arrangements for each
patient who is restricted, by Federal regulation or guideline or by the
determination of the program medical director, from having a take home
dose of a controlled substance related to the treatment involved, to
receive a dose of that substance under appropriate supervision during
the closure.
``(3) The Administrator of the Substance Abuse and Mental Health
Services Administration shall issue a notice that references
regulations on acceptable arrangements under this subsection, or shall
promulgate regulations on such acceptable arrangements.''.
SEC. 7. ESTABLISHMENT OF THE CONTROLLED SUBSTANCES CLINICAL STANDARDS
COMMISSION.
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 SUBSTANCES CLINICAL
STANDARDS COMMISSION.
``(a) In General.--The Secretary shall establish a Controlled
Substances Clinical Standards Commission (referred to in this section
as the `Commission'), to be composed of representatives from the
Administration, the Centers 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);
``(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 management
with methadone that prescribing practitioners shall comply with
in order to meet certification requirements set forth in part C
of the Controlled Substances Act (21 U.S.C. 821 et seq.); and
``(5) patient and practitioner education guidelines 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 methadone
used for both pain management and opioid
treatment programs, including recommendations
for maximum daily doses of all forms, including
recommendations for the induction process for
patients who are newly prescribed methadone;
``(ii) requirements for individual patient
care plans, including initial and follow-up
patient physical examination guidelines, and
recommendations for screening patients for
chronic or acute medical conditions that may
cause an immediate and adverse 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.
``(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 guidelines.--
``(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 programs
in providing methadone therapy; and
``(II) by entities in the initial
accreditation 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
education and training guidelines for such
pharmacists;
``(iii) the continuing education guidelines
that all prescribers shall comply with in order
to meet Drug Enforcement Administration
certification and re-certification
requirements, as set forth in section 303(g)(3)
of the Controlled Substances Act (21 U.S.C.
823(g)(3)), which should include a minimum of
16 training hours at least every 3 years that
include the integration of both addiction and
pain management 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 guidelines under
subparagraph (A), and at least annually thereafter, the
Commission shall update the guidelines published under
clauses (iii) and (iv) of such subparagraph.
``(3) Consultation.--In developing and publishing the
guidelines under this section, the Commission shall consult
with relevant professional organizations with expertise in the
area of addiction, relevant professional organizations with
expertise in the area of pain management, physician groups,
pharmacy 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) Website.--Not later than 180 days after the date of enactment
of this section, the Commission shall establish and operate a
Commission website.
``(d) Methadone Toolkit.--Not later than 1 year after the date of
enactment of this section, the Commission shall establish, and
distribute to practitioners that are registered to prescribe or
otherwise dispense methadone, a methadone toolkit. The Commission shall
make the components of the toolkit that are available in electronic
form available on the Commission website.
``(e) Practitioner Education Program.--The Commission shall develop
a practitioner education program that shall be used for the
practitioner education described in section 303(g)(3) of the Controlled
Substances 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 ``(including
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
entity.''; and
(3) by striking subsection (n) and inserting the following:
``(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 Mortality Report.--
``(1) In general.--Not later than July 1, 2012, the
Secretary, acting through the Administrator, shall require that
a Model Opioid Treatment Program Mortality Report be completed
and submitted 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 monitoring 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 Administrator by submitting a Model Opioid
Treatment Program 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 toxicology reports
become available to such individual, as required by the
Secretary.
``(3) Development.--The Administrator, in consultation with
State and local medical examiners, prescribing physicians,
hospitals, and any other organization that the Administrator
determines appropriate, shall develop a Model Opioid Treatment
Program 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 implement, through the
National Center for Health Statistics, a National Opioid Death
Registry (referred to in this subsection as the `Registry') to
track opioid-related deaths and information related to such
deaths.
``(2) Consultation.--In establishing the uniform 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 determines 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 information 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 recommended
dosage involved;
``(D) a disclosure of whether the medication
involved can be traced back to a physician'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
``(G) other non-personal information such as that
included in filed National Association of Medical
Examiners Pediatric Toxicology Registry case reports as
required under the privacy standard for the de-
identification of health information pursuant to the
regulations contained in part 164 of title 45, Code of
Federal Regulations.
``(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
Secretary a report, based on information contained in the Registry
described in subsection (b), concerning the number 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:
``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 Commissioner of Food and Drugs shall submit to the
Secretary 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 clinics, other health-related
clinics, physician offices, 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, including through the use of the Internet
website 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
concerning the effectiveness of the methadone maintenance therapy
program. Such report shall evaluate the success of efforts to reduce
opioid addiction and methadone-related 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.''.
<all>