8
Implementing Standards—and Beyond

The preceding chapter considered the question of how the narcotic addiction treatment standards the Secretary of HHS is obligated to issue, as currently implemented solely by regulations, affect the provision of treatment services, and how these regulations might be changed to encourage optimal clinical practice.

Two additional general issues are dealt with in this chapter. The first deals with the implementation of standards by means that go beyond exclusive reliance on regulations. As noted earlier in the report, regulations have been the exclusive means by which standards have been implemented historically. They need not be the only means. The major approaches identified by the IOM committee for implementing standards are (1) 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.

Reliance on the existing norms of clinical practice is conceptually attractive, as it embodies the proposition that methadone should be treated just like any other medication. Historical experience with methadone, however, cautions that some clinicians can be expected to exploit such a situation for personal gain, and others may act out of ignorance in ways that lead to adverse patient outcomes. Thus, the committee considered and rejected the approach of relying on existing norms.

It is the committee's view that regulations need to be supplemented by some combination of practice guidelines and quality assurance. But improving on the regulations need not wait on the development of infrastructure for guidelines and quality assurance system, nor can the regulations be abandoned entirely.

What follows is intended to provide background for the eventual integration of the three approaches—regulations, guidelines, and quality



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--> 8 Implementing Standards—and Beyond The preceding chapter considered the question of how the narcotic addiction treatment standards the Secretary of HHS is obligated to issue, as currently implemented solely by regulations, affect the provision of treatment services, and how these regulations might be changed to encourage optimal clinical practice. Two additional general issues are dealt with in this chapter. The first deals with the implementation of standards by means that go beyond exclusive reliance on regulations. As noted earlier in the report, regulations have been the exclusive means by which standards have been implemented historically. They need not be the only means. The major approaches identified by the IOM committee for implementing standards are (1) 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. Reliance on the existing norms of clinical practice is conceptually attractive, as it embodies the proposition that methadone should be treated just like any other medication. Historical experience with methadone, however, cautions that some clinicians can be expected to exploit such a situation for personal gain, and others may act out of ignorance in ways that lead to adverse patient outcomes. Thus, the committee considered and rejected the approach of relying on existing norms. It is the committee's view that regulations need to be supplemented by some combination of practice guidelines and quality assurance. But improving on the regulations need not wait on the development of infrastructure for guidelines and quality assurance system, nor can the regulations be abandoned entirely. What follows is intended to provide background for the eventual integration of the three approaches—regulations, guidelines, and quality

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--> 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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--> found a problem, however, in "the detached attitude of the medical profession," manifest in the absence of medical school teaching about addiction and the contemptuous attitude of senior faculty toward the treatment of addicts. He believed that this attitude was "not likely to persist in the mainstream of medicine beyond this generation," and that a "concerned medical profession" would exert leadership in "setting standards for optimal therapy'' as a counterweight to the regulatory bureaucracy. The critique of the regulations from these various sources thus includes a number of disparate concerns—undue administrative burden, infringement on clinical authority, and the absence of (or adverse) effect upon patient outcomes, program performance, and the quality of services provided. Some criticisms are inconsistent: for example, although the GAO adopted Dole's "process oriented" criticism that the regulations provided no standards of effectiveness, it saw the absence of federal oversight as a problem that implied a federal solution, a decidedly different view from that of Dole. The IOM committee is sympathetic to the critique of the methadone regulations. It regards the current regulations as unreasonably extensive and intrusive, and finds no compelling medical reason for regulating the therapeutic use of methadone differently from any other Schedule II controlled substance. These substances include (see 21 CFR 1308.12) opiates (such as fentanyl, hydrocodone, hydromorphone, meperidine, morphine, and oxycodone), cocaine, stimulants (such as amphetamines and methamphetamines), short-acting central nervous system depressants (such as amobarbital, pentobarbital, phencyclidine, and secobarbital), and hallucinogenic derivatives of marijuana (such as dronabinol and nabicone). The committee recognizes, however, that historically the regulations were adopted to achieve several competing objectives simultaneously—to make effective treatment available, to minimize the illicit diversion of methadone, and (implicitly) to shield treatment programs from direct public opposition. In general, regulations establish minimum performance requirements for regulated parties, proscribe certain behaviors, and provide for sanctions when proscribed behaviors occur. They may also exhort regulated parties to nonenforceable good behavior that reflects important community values. However, they also impose a burden they require paperwork; they subject the affected parties to inspections; and they may freeze institutions in place and inhibit innovation. Thus, the committee is both critical of the methadone regulations in many respects regulations and cognizant that they provide a number of positive benefits. The regulations support methadone treatment, encourage comprehensive care, and provide guidance to state authorities, hospitals, and medical practitioners. Although some believe that these goals can be accomplished by clinical practice guidelines, the committee believes that guidelines alone are

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--> not enough to assure that patients are cared for in a safe and thoughtful manner. Methadone treatment is subject to weak scrutiny by patients, who may lack the ability or motive to make rigorous judgments about the treatments, and by payers, who often lack effective means of oversight. Moreover, public support, as noted in chapter 1, is often problematic. The committee concludes, therefore, that a need exists to maintain certain enforceable requirements in order to deter substandard or unethical practices. Generalizing from the specific recommendations made in the discussion of optimal treatment, (see chapter 7) the committee developed the following general principles regarding what regulations should and should not do. These are: Regulations should require that methadone programs approved to treat opiate addiction make comprehensive care available to all opiate-addicted patients entering methadone treatment, either on-site or by referral. The range of services available to patients entering treatment should be specified, especially to those who present with a wide range of medical and psychosocial needs. Optimal care requires attention to the needs of specific patients and to ensuring that those with multiple treatment needs receive the appropriate services, including rehabilitative services. Therefore, offering methadone with only minimal counseling services on admission is inappropriate for most patients. Federal regulations should require that licensed programs have the resources on-site or readily available through documented, working, and demonstrated contractual agreement with other agencies to provide for a full range of services for patients accessing treatment. Regulations should emphasize the need for the ongoing clinical assessment of patients throughout the treatment process, rather than arbitrarily specifying periods of treatment time, with respect to the intensity, level, and types of services needed. Regulations should provide clear instructions to programs regarding the procedures for the involuntary administrative withdrawal of medication, termination of treatment, or discharge of patients, whether for disciplinary or other nontherapeutic reasons, such as threatening behavior, drug dealing, and failure to pay fees or follow program rules. These procedures should provide rights of due process to ensure safe and humane treatment of individuals. 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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--> Regulations should not promote withdrawal from methadone maintenance treatment without regard to the probability that the patient will return to opiate addiction. Regulations should prohibit any practice of basing medication dose level on patient participation in or compliance with the treatment program. 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. Implementation of this recommendation will also require additional resources, a matter discussed below. We cannot leave this discussion of regulations, however, without addressing the issues of enforcement. Throughout the study the committee heard complaints, both from its own members and from others, about how the methadone regulations are enforced. Although the report devotes relatively little space to enforcement, this limited coverage should not be understood as a dismissal of its importance. In the committee's judgment, the following points pertaining to enforcement need to be made: First, DEA should focus its attention on standards for the physical security and record-keeping associated with the safe handling, storage, and dispensing of opiate medications (including methadone and LAAM), but should have no role controlling or limiting medical practice. Second, enforcement does entail inspection. And in the multitier methadone treatment regulatory regime, which involves at least two federal agencies, state authorities, and sometimes county and municipal authorities, inspections are time-consuming, costly, redundant, and overlapping. The committee recommends that the FDA, with SAMHSA and NIDA, conduct an extensive review of methadone enforcement policies, procedures, and practices by all health agencies of government—federal, state, and local—for the purpose of designing a single inspection format, having multiple elements, that would (1) provide the basis for consolidated, comprehensive inspections conducted by one agency (under a delegation of federal authority, if necessary), which serves all agencies and (2) improve the efficiency of the provision of methadone services by reducing the number of inspections and consolidating their purposes. Third, a need exists to improve the quality of inspections, especially the competence of inspectors with respect to the nature and purpose of methadone treatment programs.

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--> To that end, the committee recommends that the relevant HHS federal regulatory agencies develop an annual training program for inspectors, whether from FDA, DEA, state agencies, or local units of government; that such a training program review all aspects of methadone treatment so that inspections can be more focused and better informed; and that this training program be designed to support the above recommendation of a consolidated review by one agency acting on behalf of all. Finally, the committee believes that is necessary for an effective enforcement effort to weed out programs that do not meet established standards. The committee does not subscribe to the proposition that any program is better than none. An effective compliance program should close or bring into compliance bad programs. The public expects and deserves as much. Clinical Practice Guidelines The historical reliance on regulations to implement narcotic addiction treatment standards has meant that alternatives have received little conceptual attention. 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) have assumed increasing prominence in health policy since 1989. In that year, the Agency for Health Care Policy and Research (AHCPR) was created with an explicit legislative mandate to develop such guidelines in collaboration with the medical community. Soon after its creation, AHCPR asked the IOM to advise it on its new guidelines responsibilities. The resulting 1990 IOM report (Field and Lohr, 1990) focused on definitions of terms, attributes of good guidelines, and certain aspects of planning and implementation. A 1992 IOM report (Field and Lohr, 1992) dealt more broadly with the development, implementation, evaluation, and revision of guidelines. The definition of guidelines in the 1990 IOM (Field and Lohr, 1990) report was: "Practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." In addition, the eight attributes of good practice guidelines that this committee identified were validity, reliability and reproducibility, clinical applicability, clinical flexibility, clarity, multidisciplinary process, scheduled review, and documentation.

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--> The AHCPR has issued a number of such guidelines since 1991, including two recent ones dealing with depression in primary care (Depression Guidelines Panel, 1993) and pain management of cancer (Jacox et al., 1994). Medical societies have also taken up guidelines development. For example, the American Academy of Child and Adolescent Psychiatry (AACAP) has issued "practice parameters" for assessing and treating attention-deficit hyperactivity disorder (AACAP, 1991). The American Psychiatric Association (APA), to take another example, issued a "Practice Guideline for Major Depressive Disorder in Adults" (APA, 1993). Similar efforts are under way in many fields of medicine and can be expected to increase in years ahead. Guidelines are also making their appearance in the substance abuse area. The first instance, as noted in chapter 5, may have been when the 1989 joint FDA-NIDA revision of the methadone regulations removed the language that was discretionary and incorporated it in a guidance document (FDA-NIDA, 1989). Although this document was intended "to provide recommendations" for medical and other services beyond those required by the regulations, it provided no review of or references to the scientific literature.1 It appeared, as noted above, just as the broader guidelines development was getting under way. The document does not provide a model for guidelines development today, but is notable for being an early indication of movement in this direction. Although the FDA issues general guidelines for clinical research in many classes of medications, these are not clinical practice guidelines. They state "the formal position of FDA" on a matter and "establish principles or practices of general applicability . . . that are not legal requirements but are acceptable to FDA for a subject matter which falls within the laws administered by the Commissioner" (21 CFR 10.90 (1991)). They bind FDA, if the sponsor of a therapeutic product wishes and agrees, for example, to the design of a Phase III clinical trial or to the endpoints of such a trial in advance of its conduct. FDA guidelines are concerned with the premarket evaluation of therapeutic products and have no binding force on the clinical use of approved products. They provide no model for methadone treatment. The most promising guidelines-related development in the substance abuse area is the work of the Center for Substance Abuse Treatment (CSAT) of SAMHSA and its Treatment Improvement Protocol (TIP) series. 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 1   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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--> CSAT TIP process may emphasize consensus somewhat more than the AHCPR science-oriented guidelines.) The development of a TIP begins with the identification by agency staff of an alcohol or other drug abuse problem that deserves consideration by experts. A topic, once identified, is reviewed by a federal government resource panel, which frames the questions for review by a second group of nonfederal experts. This second group, called a consensus panel, does the work of reviewing the literature, defining protocols, and making recommendations. Finally, a review group is asked to comment on the work of the second group. The result is a TIP, which is then widely disseminated to the substance abuse treatment community. In late 1992, CSAT released State Methadone Treatment Guidelines, which became the first TIP when republished (CSAT, 1993e). This document provides useful information and recommendations to clinicians, program administrators, state agencies, and federal officials. It takes the federal regulations of methadone as given, and does not recommend the substitution of guidelines for regulations. Currently, a second TIP is under development that addresses the matching of treatment to the type and intensity of services needed. Other TIPs have been prepared dealing with pregnant substance-using women (CSAT, 1993c), treatment of drug-exposed infants (CSAT, 1993b), screening for infectious diseases among substance abusers (CSAT, 1993a) and treating alcoholand other drug-abusing adolescents (CSAT, 1993a). The committee regards the TIPs protocols as moving in the general direction of clinical practice guidelines as defined by AHCPR. In general, the TIP process may have reached a point where an overall review of the underlying philosophy and strategy is warranted. If such a review is undertaken, the following issues general issues identified by the 1992 IOM guidelines report (Field and Lohr, 1992) should be considered: the objectives of guidelines, the intended users and their needs, the scope of a guideline, the strength of the scientific and clinical evidence for a guideline, the credibility of the guideline development process (including the acquisition of expert judgment and the reconciliation of differences), the relation of the guidelines to the desired health outcomes, the adaptation of national guidelines to local conditions, and the means for evaluating the impact of guidelines. 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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--> Formal Quality Assurance Systems Formal quality assurance (QA) systems, either governmental or private, are another way to complement reduced-scope regulations and shift responsibility for the provision of treatment services from regulators to clinicians. The evaluation of quality of care in medicine has relied on the conceptual framework posited nearly 30 years ago by Donabedian, (Donabedian A. Evaluating the quality of Medical Care. Milbank Memorial Fund Quarterly 44:166–203, July (Part 2) 1966) in which he identified structural, process, and outcome measures of quality. Although several decades ago attention was focused on structural (or input) measures, the emphasis in recent years has been on patient outcomes and the related processes of care. Assessing quality requires not only measures of outcomes and processes of care, but a way to relate the two, a nontrivial analytical task. In the substance abuse area, formal QA systems are less well developed than are practice guidelines. The basic issues that need to be considered in the design of a formal QA system include the outcome measures to be used to assess treatment effectiveness; the availability of instruments for measuring outcomes and for adjusting for severity of addiction and illness; the data systems needed to aggregate clinic level data for national and regional evaluative purposes; the relation of data systems to the financing of care; the incentives of providers to submit accurate data to the system; and systematic ways to validate the data. In addition, traditional QA systems have focused on fixed standards of treatment, whereas continuous quality improvement (CQI) is conceptually antithetical to fixed standards and emphasizes continuing improvement in performance. CQI attempts both to reduce the variation around the level of average performance and, at the same time, to improve average performance. Furthermore, most QA systems are tied in important ways to reimbursement. In the case of Medicare, the incentives for hospitals to participate in QA systems relate to the desire to be paid2. Similar reimbursement-related QA systems are now emerging in relation to managed care organizations. In substance abuse treatment, which is financed through federal block grant funds, Medicaid, state, county, and municipal funds, private insurance, and patient'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. 2   See Lohr (1990) for a review of the pertinent literature and a discussion of operational systems, such as the Medicare Peer Review Organizations and the Joint Commission on the Accreditation of Healthcare Organization.

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--> An important current effort, sponsored by NIDA, is the Methadone Treatment Quality Assurance System, a research effort now in Phase II of a three-phase study designed to assess the feasibility of a performance-based reporting and feedback system for methadone treatment programs. This effort offers the prospect of laying the foundation for a formal QA system in the future. It is some distance from completion, however, and when complete will have addressed only the research and not the infrastructure questions enumerated above. What Can Be Done Now? Steps can be taken now to augment regulations and set the stage for practice guidelines or quality assurance systems. The effectiveness of individual treatment programs can be evaluated by both "process" and "outcomes." Process Evaluation Process evaluation requires that quality be assessed by measures of the appropriate patient treatment procedures. The merit of such procedures can be defined independently of the outcomes of care. 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) offered on-site (or nearby) medical screening for diseases such as AIDS, other sexually transmitted diseases, tuberculosis, and hepatitis; (3) given on-site counseling by competent and appropriate trained and supervised professionals; and (4) provided on-site (or referrals to) professional medical, mental health, and other social services. These four processes could form the basis for QA "process criteria" standardized for clinical or administrative use, with time parameters specified for when these procedures should be measured, both initially and on a recurring basis. These QA "process criteria" could be used by a clinic as part of its own internal management practices, but also by independent evaluators as part of annual licensing or other approval review. Outcome Evaluation The committee does not recommend outcome-oriented regulations because it does not believe that regulations, with all their rigidities, should be the

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--> vehicle for outcome assessment. Nor does it believe that the determinants of methadone treatment outcomes are that well understood. The committee does believe it important to indicate, however briefly, how outcome evaluation might be improved. The use of process criteria, as indicated in the preceding section, would help standardize the assessment of therapeutic procedures by indicating whether they were done "correctly" or not. But their use does not indicate the effectiveness of the procedures, which must be defined in relation to the public health objectives for methadone maintenance treatment as well as in relation to the well-being of the individuals being treated. These objectives are the elimination of illicit opiate use and reduction of illicit non-opiate drug use; the general increase in positive social behaviors and employment; and the reduction of AIDS-transmission behaviors, crime, social violence, and the disproportionate use of medical and social services. These goals go beyond simply reducing or even eliminating excessive opiate use. We believe that they reflect public expectations for methadone maintenance treatment and that their achievement can and should be measured in any outcome evaluation. These goals do not imply that every treatment program can be expected to accomplish the full range of these objectives solely with the services it offers, most of which are designed to address some of these expectations but not all of them. Achieving the full range of expectations will require integration and coordination with treatment services that may be provided by other agencies. Evaluating the effectiveness of a methadone maintenance program, depending on its size, can be done by assessing all patients or by taking a sample of randomly selected patients. In either case, patients are followed from admission to some time later. Given the severity of the problems presented by most patients in methadone treatment and the need for a sustained period of treatment as a prerequisite for "rehabilitative" change, it is important to consider the timing of outcome assessments. It is inappropriate to consider follow-up evaluation earlier than three months after admission. It is appropriate, however, to measure patient status during the time that the patient is receiving methadone treatment. Specific time periods should be dealt with in practice guidelines, not regulations. 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. Outcome as a status measure

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--> taken at a single point in time—for example, whether a patient is employed, is using 10 bags of heroin a day, out of treatment—can provide a clear picture of the functional status of a patient at a given time. In contrast, improvement over time requires at least two measurements, typically at admission and some later time during or after treatment. For example, a patient may be found to be working twice as many days as he or she was at admission (or at the earlier measurement time), to be using half as many bags of heroin, and to have been hospitalized on average three days per year less than in the year before treatment. Repeated measures indicate whether the patient has changed in a positive social way during treatment. Both types of information—status at a given time and improvement over time—are important in assessing treatment effectiveness and should be considered together. Objective measurement for outcomes can be taken in the following ways: Medical/psychiatric—could include laboratory analyses, physical examination results, or at least a record of hospitalizations Alcohol/drug use—repeated, random evaluations with breathalyzer and urinalysis, or at the least a record of hospitalizations for substance abuse disorders Employment—verification via pay stubs or other independent information Crime—arrest records, probation/parole violations Many evaluations of methadone maintenance focus on patient retention or length of time in treatment. A logical case can be made that treatment retention is a good proxy measure of the ability of a program to engage a patient in rehabilitation and to convince him or her of the need to pursue the specified course of change. At best, however, retention is an indirect measure of the effect of treatment. Other factors, such as court, family, or employer pressure, might be as responsible for treatment retention as the direct efforts of the treatment program itself. We do not argue against the use of retention as one informative measure of treatment efficacy, only that it should not substitute for direct and valid measures of reduction in opiate and non-opiate drug use and improvement in positive social function. 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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--> Federal Government Leadership The second broad question raised in this chapter—what is needed beyond standards?—brings us to the topic of federal government leadership. 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. Since that another IOM committee was examining the NIDA Medications Development Program concurrent with this study, this committee devoted relatively limited attention to research questions. There are two issues, however, on which the committee wishes to comment. The first, which was addressed by the IOM committee that reported on the NIDA Medications Development Program, (see IOM, 1994), involves the constraints imposed by the methadone regulations on the conduct of clinical research. The second pertains to the requirement contained in the ADAMHA Reorganization Act of 1992 that 15 percent of the NIDA research budget be spent on health services research. Clinical Research Research involving the use of a new drug in human subjects, or a new application of a previously approved drug, is conducted under the Investigational New Drug (IND) regulations of FDA. If the drug in question is a controlled substance, such as methadone, LAAM, or any other opiate agonist, or if a controlled substance is used in the comparison treatment in a clinical trial in which the drug of interest is not a controlled substance, such research must still comply with the three-tiered regulation by FDA and the DEA described in detail in chapter 5. DEA regulations under the Controlled Substances Act require registration, specific kinds of record-keeping, and periodic reporting. DEA also requires that protocols for research involving schedule I controlled substances not conducted under an IND (preclinical studies) be approved by it (see IOM, 1994, pp. 74–76, for a detailed discussion).

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--> The effect of DEA regulation, as noted by the report of the IOM committee on NIDA medications development (IOM, 1994), is to create ''a clinical research environment for scheduled drugs that is extraordinarily bureaucratic from the procedural point of view and unnecessarily difficult, given the low public health risk associated with diversion'' in research conducted under the IND regulations of FDA. The present committee concurs in the basic judgment of medications development committee that this DEA regulation of clinical research is an unnecessary impediment to the conduct of such research. Since clinical research is essential to the development of new scientific and clinical information, from which answers to problems of drug addiction can be expected to emerge, we regard these regulations as contrary to the public interest. 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: The development of a Memorandum of Understanding between FDA and DEA governing the matter of dual authority over clinical research to provide exemption from DEA reporting requirements. DEA revision of 21 CFR 1301.22 and parallel regulations to provide that protocols, drug security, record-keeping, production controls, reporting, and other requirements would be governed by the FDA regulations and monitored by FDA. This would require parallel changes in FDA's IND regulations. This committee endorses the above recommendation. Health Services Research The ADAMHA Reorganization Act of 1992 required that 15 percent of the research funds of the National Institutes of Mental Health, National Institute of Alcoholism and Alcohol Abuse, and National Institute of Drug Abuse be spent in health services research. In the case of NIDA, compliance with this requirement will undoubtedly involve research on the delivery of substance

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--> abuse treatment services, some of which may involve methadone or LAAM or other controlled substances. In such investigations, it is unlikely that the medication itself will be the object of research. Rather, the issue will be how best to deliver treatment using such a medication. Such research may involve comparing the treatment setting, inpatient or outpatient, and, if the latter, whether a clinic or a physician's office is the most appropriate location for treatment. It may also involve the evaluation or assessment of the criteria for rewarding successful treatment by the granting of take-home privileges in the case of methadone, or it may also involve other health services research issues. For example, a project might examine treatment effectiveness and cost of care by providing pharmacy-based dispensing for methadone patients who have three years of perfect compliance (no opiate-positive urines) and lead stable lives. It is necessary that such health services research be permitted to experiment with various institutional arrangements and that it not be subjected a priori to regulations that force it into a pattern prescribed by the methadone regulations. That is to say, if drug delivery in such research must comply with existing methadone regulations, we will never learn whether there are safer and more effective ways to treat addiction using alternative means of drug delivery, or whether these alternative means affect the potential for drug diversion and abuse. The committee recommends that NIDA, in conjunction with SAMHSA and FDA, develop a general policy to guide health services research involving controlled substances such as methadone and LAAM, and negotiate a memorandum of understanding with the DEA to govern such research. 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 decisions. In partial response to these federal requirements, a substantial state administrative, regulatory, and financing apparatus has been established in the two decades since methadone was first approved for use in treatment of opiate addiction. In addition to substance abuse responsibilities, the states also

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--> exercise their traditional functions of licensure of professional personnel engaged in the provision of clinical services. Although the federal regulations establish a common framework regarding methadone treatment services, great variation is found among the states regarding methadone treatment services. Variations in state policies and procedures appears to be unrelated to state variation in prevalence of opiate addiction and in the characteristics of the treated patient population described in chapter 3. The report summarizes state rules in five jurisdictions—New York, California, Massachusetts, Illinois, and Florida—in Chapter 6, but does not go beyond this limited analysis. As noted in Chapter 1, however, a comprehensive description does not exist of the authorities and agencies of the states that govern medications that may be used for treatment of opiate addiction. Based on these five case studies, the knowledge of committee members, and anecdotal information acquired during the study, there appear to be three broad groups into which the several states fall. First, some states have adopted policies that are essentially consistent with the federal regulations. Second, another group of states regulate the provision of methadone treatment services more strictly than does the federal government, or in ways that are inconsistent with federal regulations as presently written. Third, some states provide no treatment services. The issues of federal-state relations vary for each grouping. In the states whose regulations and policies are the same as those of the federal government, federal regulations provide a framework or a policy baseline regarding treatment at the state government level. State decisions about financing and regulating treatment are consistent with the federal regulations. 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. They are candidates for a contractual delegation of the compliance and investigation function from the federal government. Other states impose more severe restrictions on methadone treatment services than do the federal regulations. Their regulations may discourage or restrict services, for example, by limiting the length of time a patient can receive methadone treatment, by limiting the maximum dose of methadone that may be prescribed, by prohibiting take-home medication, or by capitating reimbursement or restricting it to short-term treatment having "abstinence" as a primary goal. For the same reasons cited with respect to the federal methadone regulations, these state policies limit access to treatment and impair its quality. States that provide no treatment services represent a different situation. No language in the federal regulations requires that individual states provide

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--> methadone services for its opiate-addicted patients. Nine states have no methadone treatment services. Both philosophical and financial factors lie behind state policies to limit or deny access to methadone treatment services. Some state agencies (as well as some managed care companies) not only insist that a drug-free approach, i.e., abstinence, is preferable, but that it is the only efficacious treatment approach despite the absence of supporting data. In these cases, an understandable preference for a drug-free outcome of treatment has hardened into an ideological premise that ignores clinical evidence about the effectiveness of methadone treatment and the likelihood of relapse to opiate use when patients are withdrawn from such treatment. 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. Massachusetts, for example, has to adopt a state regulation that permits the use of LAAM, an FDA-approved medication, for the treatment of opiate addiction. In a memorandum of November 4, 1993, addressed to Dr. Frank Vocci of the NIDA Medications Development Program, among others, H. Alex Bradford, chief executive officer of the BioDevelopment Corporation, the commercial sponsor of LAAM, outlined the complexity of the state approval process. He identified "five general areas" that needed to be addressed before an individual clinic (i.e., treatment program) could purchase LAAM: Existing state treatment regulations, which covered methadone, needed to be modified for LAAM, which in many states requires legislation unless an interim administrative process is employed. The rescheduling of LAAM from a schedule I to schedule II controlled substance under state law is required in many states. The addition of LAAM to the state formulary of medications approved for treating opiate dependence is required. LAAM needed to be included in the list of reimbursable medications for treating opioid dependence. The approval of LAAM's use in the clinic by county and local organizations having responsibility for overseeing the treatment clinics in their jurisdiction is often required.

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--> State regulation of methadone treatment is beyond the scope of this report, but the committee's examination of federal methadone regulations forced it to consider this subject. Although there are too few data to make a detailed assessment of the effect of state regulatory requirements on substance abuse treatment, the committee did arrive at several general conclusions. 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. Second, the federal government should actively attempt to minimize the administrative burden associated with both federal and state government regulation of methadone treatment. It should seek compatibility of federal and state regulations, and should adopt uniform procedures that allow inspections by one level of government to be satisfactory for other levels. It should, as appropriate, consider the delegation of the inspection and compliance function to the states on a contract basis. Third, federal regulations should encourage states, through their licensing boards, to assure that medical, nursing, psychological, social work, and pharmacy practitioners have adequate educational training to provide the appropriate care in methadone treatment programs. Fourth, federal regulations should prohibit states that receive federal funding from developing regulations or contractual requirements that arbitrarily limit services and deny methadone pharmacotherapy to patients who require concurrent treatment for psychiatric illness or other addictions. SAMHSA should be authorized and directed to tie compliance with this requirement to eligibility for block grant funding. Finally, state regulation of substance abuse treatment is so extensive that the committee recommends that a comprehensive assessment of state substance abuse treatment regulations be undertaken, especially as they pertain to the treatment of opiate addiction, with an eye to developing a model state approach to the financing, treatment, and regulation of services. Financing of Treatment The committee was not asked to examine the financing of care, and the data on financing of methadone treatment, discussed in chapter 6, do not

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--> permit it to make any authoritative judgments about the adequacy of financing. However, a recent paper by Etheridge et al. (forthcoming) comparing TOPS data for 1979–1981 and DATOS data for 1991–1993 showed a marked decrease in the number and variety of services clients reported receiving. Of four treatment modalities (methadone maintenance, long-term residential, outpatient drug-free, and short-term inpatient), methadone maintenance patients reported the lowest level of drug abuse counseling and services. In addition, the personal experiences of many committee members indicate that resource constraints are substantial in many treatment programs. Financial barriers to treatment exist for opiate-dependent patients and remain a major barrier for patients awaiting admission to methadone treatment programs. Some states provide no state funding for indigent patients. In others, Medicaid does not reimburse methadone treatment for women with dependent children or patients with disabilities. Others rely on the patient's ability to pay out-of-pocket for services, resulting in high program fees, limited treatment services, and involuntary discharges for those who cannot finance their care. Although there are currently federal block grant monies to improve access to treatment, in the judgment of the committee they do not appear to meet the current treatment demand. These financing limitations create serious barriers to treatment for many patients. The committee notes two developments that pertain to treatment financing and the underlying concern of this report. First, the fiscal year 1995 budget submission sent to Congress by President Clinton in early 1994 requested increased funding for drug treatment services relative to law enforcement activities. Second, the crime bill passed by Congress in 1994 emphasizes prevention and treatment of substance abuse. 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. Policy Guidance The current organization of the Department of HHS for substance abuse prevention, treatment, and research includes the Office of Drug Policy in the Office of the Secretary, the Office of the Assistant Secretary for Health, and, within the Public Health Service, the Food and Drug Administration, the Substance Abuse and Mental Health Services Administration the National

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--> Institute of Drug Abuse, and the National Institute of Alcoholism and Alcohol Abuse. The HHS agencies concerned with methadone include SAMHSA, NIDA, and FDA. These agencies are coordinated for information exchange purposes by the Interagency Methadone Policy Review Board. Other departments and agencies having both general drug abuse and specific methadone responsibilities include DEA (within the Department of Justice) and the Office of National Drug Control Policy in the Executive Office of the President. These agencies also participate in the discussions of the interagency board. 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. The committee does not believe that such a policy oversight role requires a major organizational change within the Department of HHS. Rather, the committee believes that one official in the Office of the Assistant Secretary for Health should be designated to serve this function for the department. In this respect, the committee reaches a similar conclusion on the need for federal government leadership as did the IOM committee on the NIDA medications development program (see IOM, 1994). The committee recommends that the Secretary of HHS direct the Assistant Secretary for Health to designate one high-level official in the Office of the Assistant Secretary to be responsible for policy oversight and guidance on methadone treatment and on related drug abuse prevention and treatment issues. Summary The committee believes that essential improvements in the regulation of methadone treatment services can be implemented today, and it has chosen to pursue this approach. It finds no reason to delay recommending reasonable reforms until the infrastructure for a "outcomes-oriented" or guidelines based approach is developed. On the other hand, especially given the prospect of health care reform and the possible inclusion of substance abuse in the basic benefit package, we commend the Public Health Service's current efforts to develop such systems in anticipation of their implementation in the near future.

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--> The committee is highly supportive of guidelines and of an outcomes approach and a formal QA system for methadone treatment and believes that these options should be explored aggressively. However, the development of guidelines and the assessment of patient outcomes in medical care is in an early stage and not sufficiently robust to provide an alternative to the current system. These other approaches must complement regulations rather than be advanced as replacements for them. References American Academy of Child and Adolescent Psychiatry. 1991. AACAP official action: practice parameters for the assessment and treatment of attention-deficit hyperactivity disorder." Journal of the American Academy of Child and Adolescent Psychiatry 30(3):i–ii. American Psychiatric Association. 1993. Practice guideline for major depressive disorder in adults. American Journal of Psychiatry 150(4) (Supplement). Center for Substance Abuse Treatment (CSAT). 1993a. Guidelines for the Treatment of Alcohol- and Other Drug (AOD)-Abusing Adolescents: The Recommendations of a Consensus Panel. Treatment Improvement Protocol. Rockville, Md.: U.S. Department of Health and Human Services. Draft. CSAT. 1993b. Improving Treatment for Drug-Exposed Infants: The Recommendations of a Consensus Panel. Treatment Improvement Protocol. Rockville, Md.: U.S. Department of Health and Human Services. Draft. CSAT. 1993c. Pregnant Substance-Using Women. Treatment Improvement Protocol Series 2, Rockville, Md.: U.S. Department of Health and Human Services. (Draft) CSAT. 1993d. Screening for Infectious Diseases Among Substance Abusers: The Recommendations of a Consensus Panel. Treatment Improvement Protocol. Rockville, Md.: U.S. Department of Health and Human Services. Draft CSAT. 1993e. State Methadone Treatment Guidelines. Treatment Improvement Protocol Series 1. Rockville, Md.: U.S. Department of Health and Human Services . Depression Guideline Panel. 1993. Depression in Primary Care: Volume 1. Detection and Diagnosis. clinical Practice Guideline No. 5. AHCPR Publication No. 930550. Rockville, Md.: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. Dole, V. 1992. Hazards of process regulations: The example of methadone maintenance. Journal of the American Medical Association 267:2234–2235. Dole, VP, Nyswander, ME, Des Jarlais, D and Joseph, H. 1982. Performance-based rating of methadone maintenance programs. New England Journal of Medicine 306:169–172. Etheridge, RM, Craddock, SG, Dunteman, GH, and Hubbard, RL. Forthcoming. Treatment services in two national studies of community-based drug abuse treatment programs. Journal of Substance Abuse. FDA-NIDA. 1989. Use of Methadone in Maintenance and Detoxification Treatment of Narcotic Addicts. Guidance document issued by the Center for Drug Evaluation

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--> and Research of the Food and Drug Administration and the National Institute on Drug Abuse. Field, MJ, and Lohr, KN, eds. 1990. Clinical Practice Guidelines: Directions for a New Program. Washington, D.C.: National Academy Press. Field, MJ, and Lohr, KN, eds. 1992. Guidelines for Clinical Practice: From Development to Use . Washington, D.C.: National Academy Press. General Accounting Office. 1990. Methadone Maintenance: Some Treatment Programs Are Not Effective; Greater Federal Oversight Needed, GAO\HRD-90-104, Washington, D.C.: U.S. Government Printing Office. Institute of Medicine. 1994. Development of Anti-Addiction Medications: Issues for the Government and Private Sector, Washington, D.C.: National Academy of Sciences Press. Jacox, A, Carr, DB, Payne, R, et al. 1994. Management of Cancer Pain. Clinical Practice Guideline No. 9. AHCPR Publication No. 94-0592. Rockville, Md.: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. Lohr, KN, ed. 1990. Medicare: A Strategy for Quality Assurance, Volumes I and II. Washington, D.C.: National Academy Press.