New Federal Rules for Methadone Maintenance Clinics

WASHINGTON, DC - CSAT News Release; January 17, 2001

New federal regulations have been issued 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).

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 dosing and 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, MD, said. "These new regulations will give the public and the patient assurances that the treatment being provided meets the highest medical standards."

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." 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The regulations were expected to go into effect on March 19, 2001.** At that time, the existing FDA regulations will be rescinded.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. [**It appears the effective date may now be extended to May 19, 2001. The entire Final Rule document may be accessed at: http://www.samhsa.gov/news/click5_frame.html. Mark Parrino, president of the American Methadone Treatment Association, issued a clarification memo for treatment providers on January 26, 2001. He may be contacted at AmerMeth@aol.com or 212-566-5555. -Ed.]