Federal Regulation of Methadone Treatment (1995) / Chapter Skim
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Implementing Standards--And Beyond
Implementing Standards--And Beyond
Pages 217-238
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From page 217... ...
some combination of regulations, clinical practice guidelines, and a formal quality assurance system, or (2) reliance on the existing norms of clinical practice without more regulations.
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From page 218... ...
In the first half of this chapter, we consider the role of regulations and their enforcement, and the concurrent use of clinical practice guidelines and formal quality assurance systems, and conclude by considering steps that can be taken now to achieve the desired balance among them. The second general topic addresses the need for federal government leadership regarding methadone treatment, especially with respect to research, federal-state relations, treatment financing, and policy guidance.
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From page 219... ...
Although some believe that these goals can be accomplished by clinical practice guidelines, the committee believes that guidelines alone are
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From page 220... ...
4. Regulations should not arbitrarily restrict physician and clinical practice by dictating the length of treatment, establishing rules without scientific or clinical justification, or limiting maximum methadone take-home doses for the sole purpose of controlling methadone diversion without weighing the benefits to the patient against the risks of diversion.
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From page 221... ...
In short, the committee does not recommend that the regulations be abandoned. It does recommend that they be reduced in scope and be supplemented clinical practice guidelines and, potentially, by formal quality assurance systems that shift responsibility for treatment decisions from regulators to clinicians.
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From page 222... ...
In this section and the next, we consider clinical practice guidelines and formal quality assurance systems as ways to complement reduced-scope regulations and shift responsibility for the provision of treatment services from regulators to clinicians. Clinical practice guidelines (or "practice parameters," as the American Medical Association calls them)
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From page 223... ...
TIPs are described by SAMHSA as "state-of-the-art guidelines for the treatment of alcohol and other drug abuse," which seek to ground substance abuse treatment practice in expert consensus and the scientific literature. (At this time, the ' The FDA and NIDA made clear that the guidance document did not represent their "formal legal opinion," nor was it meant to preclude the states from further regulating "the practice of medicine in the treatment of narcotic drug addicts."
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From page 224... ...
The committee considered guidelines as an alternative to regulations. However, since the general development of clinical practice guidelines is in its early stages, which is also true for substance abuse and methadone maintenance treatment, a good deal more work must go forward before guidelines can be regarded as an actual alternative to existing regulations.
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From page 225... ...
state, county, and municipal fiends, private insurance, and patent's out-of-pocket funds, no single revenue stream provides a strong enough incentive at this time to generate the data required of a formal QA system. This deficiency could possibly change under health care reform if substance abuse treatment is included in the basic benefit package.
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From page 226... ...
For example, we suggested in the preceding chapter treatment that patients receiving methadone maintenance treatment should be (1) evaluated comprehensively for their medical, drug and alcohol, psychosocial, criminal, and employment problems; (2)
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From page 227... ...
With respect to such time periods, we believe that an opiate-addicted patient maintained on methadone can be considered a limited "success" at three-, six-, and twelve-month intervals if his or her problems have not required hospitalization and there have been no increases in the severity of his or her medical, criminal justice, economic, family, environment, and substance abuse problems that would encourage relapse. It is necessary to measure both outcome at a given time and improvement over time, and to distinguish between the two.
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From page 228... ...
At the same time, retention in treatment is often associated with patient rehabilitation. Thus, most patients improve if they remain in methadone maintenance treatment for one or more years, during which time they are encouraged, supported, and monitored in their rehabilitation.
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From page 229... ...
This topic involves the issues of research, federal-state relations, the financing of substance abuse treatment, especially as it pertains to the use of methadone, and the need for policy guidance on substance abuse treatment within the Department of Health and Human Services. Research Issues Although the methadone regulations affect primarily the provision of treatment services, they also affect the conduct of research.
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From page 230... ...
The IOM committee on NIDA medications development made the following recommendation (IOM, 1994~: The committee recommends that action be taken to remove the adverse effects of DEA requirements, under the Controlled Substances Act (CSA) , on clinical research involving controlled substances, by holders of active FDA INDs, either by amending the CSA to exempt such investigations from applicable DEA regulations or by the alternative administrative and regulatory measures: lane development of a Memorandum of Understanding between FDA arid DEA governing the matter of dual authority over clinical research to provide exemption from DEA reporting requirements.
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From page 231... ...
Federal-State Relations The regulation, financing, and provision of treatment services for substance abuse, usually including drug and alcohol abuse, involves shared responsibilities between the federal government and the states. For example, the federal methadone regulations, including those of both FDA and DEA, rely on active participation by the states for the approval of treatment program applications, the revocation of program registrations, and certain other .
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From page 232... ...
These states are apt to be receptive to technical assistance, including that provided by clinical practice guidelines. They are likely to take a strong interest in the availability and constructive use of federal funds for treatment programs.
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From page 233... ...
This study focused on federal methadone regulations, but the experience with LAAM, which was approved by the FDA in 1993 for use in the treatment of narcotic addiction, highlights the extensive web of the state regulatory apparatus for substance abuse prevention, treatment, financing, and control. The requirements for approval of the use of this medication began at the federal level but now extend to a labyrinth of state agency requirements, which often differ from state to state, involve multiple agencies, and are subject to numerous local political interests.
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From page 234... ...
First, in fulfilling the standard-setting function of the HHS Secretary, there .is a need to maintain a federal system of regulations that proscribe certain activities, such as using medication doses to reward or punish patient's behavior, or failing to provide due process for involuntary administrative termination of treatment. In addition, guidelines should be actively developed to describe good clinical practice in methadone treatment, with state substance abuse authorities in mind as a primary user audience.
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From page 235... ...
It is hoped that increased federal funds will flow to substance abuse treatment services in the near future. Therefore, the committee recommends that HHS conduct a review of its priorities in substance abuse treatment, including methadone treatment, in a way that integrates changes in regulations and the development of practice guidelines with decisions about treatment financing.
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From page 236... ...
The current organization of drug abuse policy within the Department of HHS, as revealed in the area of methadone, results in department policy emerging from the independent activities of the pertinent Public Health Service agencies and from coordination between these agencies. The committee concludes that federal policy toward methadone treatment, and in all likelihood broader areas of drug abuse treatment, would benefit from sustained department-level policy oversight, informed by a clinical perspective, on all issues relation to regulations, practice guidelines, and treatment financing.
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From page 237... ...
Forthcoming. Treatment services in to o national studies of community-based drug abuse treatment programs.
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From page 238... ...
1990. Clinical Practice Guidelines: Directions for a New Program.
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