New Federal Regulations Issued to Improve Methadone Treatment

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

Administration (FDA).

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 News media requests should be directed to Media Services at

(800) 487-4890.