SAMHSA Press Release
January 17, 2001
New federal regulations were issued today to improve the quality and
oversight of substance abuse treatment programs that use methadone and other
medication to treat heroin and similar addictions. The regulations create a new
accreditation program managed by the Substance Abuse and Mental Health Services
Administration's (SAMHSA) Center for Substance Abuse Treatment (CSAT) and
replace a 30-year-old inspection program conducted by the Food and Drug
The new program mirrors the recommendations that have been made over the last
decade by several groups, such as the Institute of Medicine, the Congressional
General Accounting Office, and the National Institutes of Health.
Under the rule, substance abuse treatment programs using methadone or
Levo-Alpha-Acetyl-Methadol (LAAM) would be accredited by non-federal agencies in
accordance with standards established by CSAT. The standards emphasize improving
the quality of care, such as individualized treatment planning, increased
medical supervision, and assessment of patient outcomes.
"Methadone has undergone more study than any other anti-addiction
medication, with uniformly beneficial results," Acting SAMHSA Administrator
Joseph H. Autry III, M.D., said. "These new regulations will give the
public and the patient assurances that the treatment being provided meets the
highest medical standards."
H. Westley Clark, M.D., J.D., M.P.H., Director of CSAT, explained that
"the accreditation system will set a higher standard of care for those
receiving methadone treatment. It should improve the quality of treatment
programs overall by allowing for more clinical judgment in treatment, help
mainstream the medical treatment of opioid dependence, and continue a federal
role, managed by SAMHSA's Center for Substance Abuse Treatment."
While the White House Office of National Drug Control Policy (ONDCP)
estimates that there are approximately 980,000 heroin addicts in the United
States, only about 20 percent currently receive methadone or LAAM, as part of an
addiction treatment program. There are approximately 1000 methadone treatment
programs in the U.S., including programs approved for LAAM treatment.
ONDCP Acting Director Edward H. Jurith said, "The new regulations are a
fundamental shift in the way we approach drug abuse treatment in our nation.
They will substantially and fundamentally reform the federal government's role
in assuring that methadone treatment programs are both effective and accountable
for results. Doctors and other health care professionals will assure the
appropriate dosage based on the best medical care for patients, with standards
developed by SAMHSA's Center for Substance Abuse Treatment."
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. Accreditation should give assurances to
communities that the highest quality medicine is being practiced.
The move to accreditation follows recommendations made by a 1997 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 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 rule specifies a core of federal standards for treatment that must be
incorporated into accreditation standards. The new regulations seek to strike a
balance between patient benefits and community concerns. The regulations of the
Drug Enforcement Administration regarding diversion of methadone remain in
CSAT has worked with the Commission on Accreditation of Rehabilitation
Facilities (CARF) and the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) in developing the state-of-the-art accreditation standards
for methadone treatment programs. They are based on "best practice
guidelines" developed by CSAT over the past 10 years.
The final rule reflects the consideration of approximately 200 comments
submitted in response to the proposed rule which was published in July, 1999.
The regulations will go into effect on March 19, 2001. At that time, the
existing FDA regulations will be rescinded. The final rule includes a
"transition plan" that allows existing treatment programs
approximately 2 years to achieve accreditation under the new system.
The Center for Substance Abuse Treatment (CSAT) is a component of the
Substance Abuse and Mental Health Services Administration (SAMHSA). SAMHSA, a
public health agency within 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 United
States. Information on SAMHSA's programs is available on the Internet at
www.samhsa.gov. News media requests should be directed to Media Services at