Center for Substance Abuse Treatment
July 22, 1999
Contact:
Jim Michie Phone: 1-800-487-4890
Leah Young Phone: 301-443-3740
Methadone programs will have to be accredited under a
new proposal announced today by the U.S. Department
of Health and Human Services. The new accreditation
program will be managed by the Substance Abuse and
Mental Health Services Administration (SAMHSA) and
replaces a 30-year-old inspection program conducted
by the Food and Drug Administration (FDA). The new
program mirrors the recommendations that have been
made over the last decade by several independent
groups, such as the Institute of Medicine, the
Congressional General Accounting Office, and a
consensus conference of the National Institutes of
Health.
Under the proposed rule, published in the Federal
Register, narcotic treatment programs would be
accredited by independent agencies in accordance
with standards established by SAMHSA’s Center
for Substance Abuse Treatment (CSAT). These
proposed standards emphasize improving the
quality of care, such as individualized treatment
planning, increased medical supervision, and
assessment of patient outcomes. This new
program relies on “best practice guidelines”
developed by CSAT over the past 10 years.
“Treatment, along with research and prevention,
is an essential part of the national strategy to
reduce drug addiction and its consequences,”
HHS Secretary Donna E. Shalala said. “The
regulatory changes we are proposing today
will help improve federal oversight of narcotic
treatment programs that use methadone by
bringing the full force of our medical and
clinical knowledge to bear on treating heroin
addiction. These reforms will help ensure a
treatment system that is good for patients,
practitioners, providers and our communities.”
While the White House Office of National Drug
Control Policy (ONDCP) estimates that there are
810,000 heroin addicts in the United States,
only 138,000 to 170,000 people currently receive
methadone or Levo-Alpha-Acetyl-Methadol
(LAAM), as part of an addiction treatment
program. There are approximately 900
methadone treatment programs in the U.S.,
including programs approved for LAAM
treatment. “These regulations will improve
access to methadone treatment programs
and give doctors more flexibility in designing
treatment plans for their patients,” said
ONDCP Director Barry R. McCaffrey.
“Research provides strong evidence to
support methadone maintenance as the
most effective treatment for heroin
addiction. Methadone therapy helps keep
more than 100,000 addicts off heroin, off
welfare, and on the tax rolls as law-abiding,
productive citizens. Without methadone
programs, these individuals will be back on
the streets, back on drugs, and back on welfare, at an enormous cost to society and to
the safety of all of us.” Accreditation has
been proven over the years to produce
effective outcomes and is a widely adopted
external quality assessment system used by
the federal government, states, managed
care firms, insurers, and others to ensure
accountability for quality treatment. The
reorganization toward accreditation follows
recommendations made by a recent National
Institutes of Health consensus panel. The
panel concluded that existing federal and
state regulations limit the ability of
physicians and other health care professionals to provide methadone maintenance
services to patients and recommended
accreditation in lieu of regulations to
improve the quality of care. The proposed
changes are also consistent with a 1995
report by the Institute of Medicine that
stressed the need to readjust the balance
among regulations, clinical practice
guidelines and quality assurance systems.
The HHS proposal details accreditation
standards and the requirements for
accrediting organizations. When the rule
is final, CSAT will enforce these
regulations. Until the program is transferred, FDA will continue to monitor
programs in accordance with existing
regulations.
The Drug Enforcement Administration is not
proposing any changes to its oversight and
monitoring activities and responsibilities as
a result of this proposal. The proposed rule
provides for a 120-day period for public
comment and a public hearing prior to
adoption of a final rule. The document
specifies a core of federal standards for
treatment that must be incorporated into
accreditation standards. CSAT is conducting
a study on a representative group of
treatment facilities that are implementing
accreditation standards developed by the
Commission on Accreditation of Rehabilitation
Facilities (CARF) and the Joint Commission on
Accreditation of Healthcare Organizations
(JCAHO). Accreditation standards will be
modified, if needed, to insure the best
quality of care for patients. The proposed
rule is available on the web at
NEW FEDERAL RULES PROPOSED TO IMPROVE QUALITY AND OVERSIGHT OF METHADONE TREATMENT
by clicking on Federal Register. Written
comments on the rule may be submitted to
Documents Management Branch (HFA-305)
Food and Drug Administration, 5630 Fishers
Lane, Room 1061, Rockville, MD 20857. The
Center for Substance Abuse Treatment (CSAT)
is part of the Substance Abuse and Mental
Health Services Administration (SAMHSA).
SAMHSA, a public health agency in the U.S.
Department of Health and Human Services,
is the lead Federal agency for improving the
quality and availability of substance abuse
prevention, addiction treatment and mental
health services in the U.S. News media
requests for information on SAMHSA’s
programs should be directed to Media
Services at 1-800-487-4890. This release
may be obtained on the Internet at
www.samhsa.gov.