assurance systems. If standards are to be implemented through a combination of means, what are the appropriate relationships among these means? 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. These topics are taken up in the second half of the chapter.

Regulations and Their Enforcement

A criticism of the methadone regulations has been that they are ''process-oriented" and not outcome- or performance-oriented. In 1982, Dole and his colleagues criticized the extensive paperwork required of methadone maintenance treatment programs by federal and state regulatory authorities (Dole et al., 1982). These requirements, they wrote, had resulted in every therapeutic decision being controlled either from Washington or Albany, but had not ensured good quality services and had failed to prevent the flow of methadone to the illicit market. A "more rational approach," they argued, would involve trying "to improve the performance of the clinics'' in drug abuse treatment, including "the critical areas" of health, housing, employment, and behavioral problems. They saw no uncertainty about the primary objective of eliminating drug abuse and socially rehabilitating patients, and "no fundamental problem" in measuring achievement of these objectives. They described briefly a performance rating system that they hoped might be adopted and "used constructively" by regulatory agencies.

In 1990, the U.S. General Accounting Office (GAO) issued a report, based on a sample of 24 treatment programs, which found great variation in the "policies, goals, and practices" of methadone maintenance treatment programs. The heart of the GAO criticism was the following: "There are no federal treatment effectiveness standards for treatment programs. Instead, federal regulations are process oriented in that they establish administrative requirements for programs. Even with regard to these requirements, federal oversight of methadone maintenance treatment programs has been very limited since 1982" (GAO, 1990.)

Dole reiterated his criticism in slightly modified terms in 1992. "Guidelines" for clinicians were now viewed favorably, while "process" regulations were still regarded as pernicious in intent and effect. He argued that "a closer linkage of [patient] outcome to [medical] procedure" would be beneficial. Dole



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