1.This Act may be cited as
the Methadone Treatment and Protection
Act of 2009
.
2.Congress makes the following
findings:
(1)Methadone is an
extensively tested, federally approved, and widely accepted method of effective
treatment.
(2)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.
(3)The efficacy and
lower cost of methadone has resulted in its being prescribed for pain
management.
(4)Prescriptions for
methadone have increased by nearly 700 percent from 1998 through 2006.
(5)As with any
controlled substance, there is a risk of abuse of methadone.
(6)According to the
Centers for Disease Control and Prevention, in 2005, there were 4,462
methadone-related deaths, representing an increase of 468 percent since 1999.
By contrast, all poisoning deaths by all drugs increased by 66 percent over the
same period.
(7)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.
(8)Deaths from
methadone may actually be underreported. There is no comprehensive database of
drug-related deaths in the United States.
(9)The lack of
standardized reporting by Medical Examiners precludes a uniform definition of
cause of death
on death certificates.
(10)While the
Controlled Substances Act (21 U.S.C. 801 et seq.) requires additional
registration for practitioners who dispense schedule II narcotics, including
methadone, for both pain management and addiction treatment, there is no
specific education requirements for practitioners to prescribe methadone for
pain management.
(11)Current Federal
oversight of methadone is inadequate to address the growing number of
methadone-related deaths.
(12)Federal
legislation is needed to increase Federal oversight over methadone treatment,
both as part of opioid treatment programs and as part of the treatment of pain,
without reducing patient access.
3.Consumer
education campaignPart 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:
506C.Consumer
education campaign
(a)The Administrator shall award grants to States and
nonprofit community organizations for the purpose of educating consumers about
the dangers of opioid abuse, including methadone abuse, through educational
materials that are culturally sensitive.
(b)To
be eligible to receive a grant under subsection (a), an entity shall—
(1)be a State or
nonprofit community organization; and
(2)submit to the
Administrator an application at such time, in such manner, and containing such
information as the Administrator may require.
(c)In
awarding grants under this section, the Administrator shall give priority to
applicants that are States or communities with a high-incidence of methadone
abuse and methadone-related deaths.
(d)The
Administrator shall develop a process to evaluate the effectiveness of
activities carried out by grantees under this section at reducing methadone
abuse.
(e)Authorization
of appropriationsThere is authorized to be appropriated to carry
out this section $15,000,000 for each of fiscal years 2010 through
2014.
.
4.
(a)
(1)Registration
considerationSection 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)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
opiate-dependent patients; and
(ii)pain management treatment
guidelines,
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, or any other organization that the Secretary determines is
appropriate for purposes of this
subparagraph..
(b)Requirements
for participation in opioid treatment programsEffective July 1,
2009, 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)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)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.).
5.Moratorium on
methadone hydrochloride tablets
(a)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 policy
implemented by the Drug Enforcement Administration on the date of enactment of
this Act, except that such prohibition shall extend to opioid treatment
programs and hospitals unless such programs or hospitals provide for direct
patient supervision with respect to such methadone. During such period, no take
home dosages of 40-mg diskettes of methadone shall be permitted.
(b)Ending date of
moratoriumThe 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 standards 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 standards, such Commission finds that 40-mg diskettes of methadone
are safe and clinically appropriate.
6.Operation of
opioid treatment programsSection 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.
.
7.Establishment of
the Controlled Substances Clinical Standards CommissionPart 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:
506D.Establishment
of the Controlled Substances Clinical Standards Commission
(a)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, and the Pain Management Consortia of the National
Institutes of Health, to develop—
(1)appropriate and
safe dosing standards for all forms of methadone, including recommendations for
maximum daily doses of all forms as provided for in subsection (b)(1);
(2)benchmark
standards 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
physicians 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 standards for both methadone maintenance therapy and
pain management that apply to safe and effective use and include
detoxification.
(b)
(1)Publication of
dosing standards
(A)Not later than 2 years after the date of enactment of the
Methadone Treatment and Protection Act of 2009, the Commission established
under subsection (a) shall publish in the Federal Register—
(i)safe and
clinically appropriate dosing standards 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 standards, 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; and
(iv)specific
guidelines for initiating pain management with methadone, that prescribing
physicians shall comply with in order to meet Drug Enforcement Administration
certification and re-certification requirements.
(B)Not later than 3 years after the publication of
standards under subparagraph (A), and at least every 3 years thereafter, the
Commission shall update such standards.
(2)Publication of
benchmark standards
(A)Not later than 3 years after the date of enactment of the
Methadone Treatment and Protection Act of
2009, the Commission established under subsection (a) shall
publish in the Federal Register—
(i)the initial
benchmark standards 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 standards for such
pharmacists;
(iii)the continuing
education standards 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 standards 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)Not later than 1 year after the publication of
standards under subparagraph (A), and at least annually thereafter, the
Commission shall update the standards published under clauses (iii) and (iv) of
such subparagraph.
(3)In
developing and publishing the standards 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), and any other organization that
the Secretary determines is appropriate for purposes of this section.
(c)Not
later than 180 days after the date of enactment of the
Methadone Treatment and Protection Act of
2009, the Commission shall establish and operate a Commission
website.
(d)Not later than 180 days after the date of enactment of
the Methadone Treatment and Protection Act of
2009, 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 programThe 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 appropriationsThere is authorized to be appropriated to carry
out this section such sums as may be necessary for each of fiscal years 2010
through
2014.
.
8.Prescription
monitoring programSection
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)There
is authorized to be appropriated, and there is appropriated, to carry out this
section $25,000,000 for each of fiscal years 2010 through
2014.
.
9.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:
506E.
(a)Model Opioid
Treatment Program Mortality Report
(1)Not later than October 1, 2009, 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
ProgramAs 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)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)Not later than January 1, 2010, 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 all aPD-related deaths and information related
to such deaths.
(2)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)The
registry shall be designed as a uniform reporting system for aPD-related deaths
and shall require the reporting of information with respect to each such death,
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 (paddies) 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)There
is authorized to be appropriated $5,000,000 to carry out this
subsection.
(c)Report on
Registry informationNot later than the January 1 of the first
fiscal year beginning 2 years after the date of enactment of the Methadone
Treatment and Protection Act of 2009, 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.
.
10.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:
506F.
(a)Report on
methadone usage
(1)Not later than January 1 of the first fiscal year
beginning 2 years after the date of enactment of the Methadone Treatment and
Protection Act of 2009, and each January 1 thereafter, the Administrator 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
informationThe 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 effectivenessNot later than September 30, 2010, and annually
thereafter until September 30, 2014, 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 appropriationsThere is authorized to be appropriated to carry
out this section such sums as may be necessary for each of fiscal years 2010
through
2014.
.