Consultation Document on Opioid Agonist Treatment
6. The Road Ahead:
A. Expansion of Treatment Capacity:
The National Drug Control Strategy calls for an expansion of drug treatment capacity across the board. Specifically the Strategy seeks to reduce the gap between need and capacity by 20 percent by 2002 and by 50 percent by 2007. For heroin addicts, this means that we must increase treatment capacity to reach all who are prepared to accept effective drug treatment and supervision. In support of this Strategy performance target, the President has requested $3.4 billion for drug treatment in the FY 1999 budget, an increase of $206.5 million over FY 1998.
With increased funding must come increased quality and access. Appropriate treatment needs to be based on an assessment of each individual and development of a regimen best suited to that individual's condition. Treatment must be provided in all settings in which drug abuse occurs: in inner city clinics and in suburban doctors' offices alike.
B. Development of a standardized accreditation system for methadone treatment programs with transfer of regulatory oversight for methadone from the Food and Drug Administration (FDA) to the Substance Abuse and Mental Health Services Administration (SAMHSA):
We will replace the current regulatory approach, which focuses exclusively on process standards, with a new system that is more reflective of on an outcome-oriented accreditation model. To start this process, CSAT/SAMHSA will lead the interagency effort to evaluate the accreditation process and proposed accreditation standards beginning in 1999. Based on the results of the evaluation, feedback from treatment experts, and public comments on the NPRM, a final rule will be promulgated that will introduce modernized treatment standards and an accreditation process. In the interim, programs will remain subject to FDA oversight and monitoring. Integrating regulatory oversight for methadone into CSAT/SAMHSA responsibilities for overseeing treatment services will facilitate the much-needed expansion of methadone treatment capacity while enhancing the application of clinical standards. Law enforcement (anti-diversion) responsibilities will remain with DEA.
C. Elimination of regulatory barriers to allow individual physician administration of methadone:
Methadone is a tool of proven effectiveness in treating heroin addicts. But no tool is effective in isolation. The recovering heroin addict must also be integrated back into employment and into society. As physician training in the administration of opioid agonist treatment is accomplished, we must change the ineffective regulations which hinder effective treatment and allow trained physicians to use all the counter-addiction modalities in the physician's preferred clinical setting supported by ancillary services. New regulations expanding access to methadone will be issued when testing has validated their effectiveness.
D. Tentative Timetable:
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26 September 1998
American Methadone Treatment Association meeting, release of test accreditation standards for methadone
October 1998
Publication of notice of proposed rule making
November 1998
Issuance of accreditation surveys
February 1999
Release of the 1999 National Drug Control Strategy
March 1999
Accreditation testing begins in 60 MTPs
October 1999
End of accreditation testing: evaluation
January 2000
Evaluation of accreditation complete: phased implementation of accreditation begins
Final rule published
February 2000
Release of the 2000 National Drug Control Strategy
June 2000
FDA to SAMHSA transfer
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Last Updated: March 4, 2002
