6
Future Directions

The preceding chapters of this report respond to the provisions of the Balanced Budget Act of 1997 that asked for an assessment of “the short- and long-term benefits, and costs to Medicare” of extending Medicare coverage for certain preventive and other services. This final chapter examines some broader concerns about the processes for making coverage decisions and the research and organizational infrastructure for this decisionmaking. It also briefly examines the limits of coverage as a means of improving health services and outcomes and the limits of evidence as a means of resolving policy and ethical questions. In addition, this chapter examines how current Medicare coverage of preventive services compares to the clinical practice recommendations of the U.S. Preventive Services Task Force.

LINKING EVIDENCE TO MEDICARE COVERAGE: THE CASE OF PREVENTIVE SERVICES

One criticism of Congress’s service-by-service approach to coverage decisions about preventive services, prescription drugs, and other generally excluded categories of care is that it may favor services for high-profile conditions and technologies that have strong lobbying groups but not necessarily a strong evidence base. Another criticism is that the focus on covering specific services can distract policymakers, advocates, and clinicians from problems in the organization and delivery of services that limit the routine use of preventive services and other interventions known to be effective.

Congress first made an exception to the general coverage exclusion for preventive services in 1980 when it authorized Medicare coverage of pneumococcal



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Extending Medicare Coverage for Preventive and Other Services 6 Future Directions The preceding chapters of this report respond to the provisions of the Balanced Budget Act of 1997 that asked for an assessment of “the short- and long-term benefits, and costs to Medicare” of extending Medicare coverage for certain preventive and other services. This final chapter examines some broader concerns about the processes for making coverage decisions and the research and organizational infrastructure for this decisionmaking. It also briefly examines the limits of coverage as a means of improving health services and outcomes and the limits of evidence as a means of resolving policy and ethical questions. In addition, this chapter examines how current Medicare coverage of preventive services compares to the clinical practice recommendations of the U.S. Preventive Services Task Force. LINKING EVIDENCE TO MEDICARE COVERAGE: THE CASE OF PREVENTIVE SERVICES One criticism of Congress’s service-by-service approach to coverage decisions about preventive services, prescription drugs, and other generally excluded categories of care is that it may favor services for high-profile conditions and technologies that have strong lobbying groups but not necessarily a strong evidence base. Another criticism is that the focus on covering specific services can distract policymakers, advocates, and clinicians from problems in the organization and delivery of services that limit the routine use of preventive services and other interventions known to be effective. Congress first made an exception to the general coverage exclusion for preventive services in 1980 when it authorized Medicare coverage of pneumococcal

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Extending Medicare Coverage for Preventive and Other Services pneumonia vaccine. Table 6–1 lists the preventive services that Congress has now authorized for coverage. For several of these services, Congress has waived application of the Part B deductible and 20 percent coinsurance. Frequency limits are also specified for several services, and coverage is sometimes conditional on the presence of certain risk factors. All the covered services listed in the body of Table 6–1 involve either primary prevention (keeping people from developing disease) or secondary prevention (identifying risk factors or detecting disease early) as discussed in Chapter 3. The service noted in the footnote—outpatient self-management training and supplies for diabetics—falls in the category of tertiary preventive services, which is more typically described as patient management for those already diagnosed with a medical problem. The discussion below considers only primary and secondary preventive services. Given Medicare’s statutory goal of covering “medically necessary” services and the committee’s experience with the work of the U.S. Preventive Services Task Force (USPSTF) in assessing evidence about the effectiveness of various TABLE 6–1 Preventive Services Covered by Medicare Service (effective date of coverage) Special Provisions Pneumococcol vaccine (1981) No coinsurance; deductible not applied Hepatitis B vaccine (1984) High- or intermediate-risk beneficiaries Cervical cancer screening by Pap smear (1990) and pelvic examination (1998) Every 3 years for most beneficiaries; 20% coinsurance; deductible not applied Influenza vaccine (1991) No coinsurance, deductible not applied Breast cancer screening by mammography (1991, 1998) Every year for beneficiaries ≥40; 20% coinsurance, no deductible Colorectal cancer screening (1998) 20% coinsurance, deductible applied; details differ for different tests and risk groups Osteoporosis screening by bone densitometry (1998) For high-risk beneficiaries; 20% coinsurance and deductible applied Prostate cancer screening by prostate specific antigen (PSA) and digital rectal examination DRE (2000) No cost sharing for PSA; 20% coinsurance; deductible for DRE NOTE: In 1997, Congress also added coverage for outpatient self-management training and supplies for those diagnosed with diabetes. SOURCE: HCFA, 1999b, Carriers Manual, Chapter 3 (which includes other details about coverage administration for these services).

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Extending Medicare Coverage for Preventive and Other Services services, it is reasonable to examine the match between the services recommended by the Task Force and those now covered by Medicare. As described earlier in this report, the Task Force is charged by the Department of Health and Human Services (DHHS) with making recommendations that rely extensively on rigorous assessment of scientific evidence about the benefits and harms of preventive services provided by physicians, nurse practitioners, and other clinicians. The Task Force is not charged with making recommendations about coverage of preventive services. Its published assessments to date have not included cost-effectiveness analyses, although such analyses are planned (David Atkins, personal communication, October 1999). The list of preventive services now covered by Medicare excludes some services that the 1996 report of the U.S. Preventive Services Task Force recommended as part of a periodic health visit for asymptomatic people over age 64. The list also includes a few services that were not recommended by the Task Force. Table 6–2 lists the recommended services, which include 8 screening services and 15 counseling services. The clinical screening services recommended by the Task Force for older persons but not covered by Medicare are blood pressure testing, height and weight checks, and screening for vision and hearing impairment and problem drinking. Some of these services, in particular, blood pressure tests, are routine parts of patient visits for many older people who see a physician or nurse practitioner for a variety of reasons, including screenings covered by Medicare and care for existing medical problems. About 90 percent of Medicare beneficiaries have at least one physician visit a year (HCFA, 1998a). The other noncovered preventive services that the Task Force recommends for those over age 64 involve patient education and counseling about tobacco cessation, diet, alcohol, physical activity, seat belts, motorcycle and bicycle helmets, firearms, fall prevention, hormone replacement therapy, sexually transmitted diseases, CPR training, dental visits and dental hygiene, smoke detectors, and settings for hot water heaters. It should be noted that some education and counseling recommendations were “based on good evidence of the effectiveness of counseling per se” whereas others were made “primarily on the basis of a strong link between behavior and disease” (USPSTF, 1996, p. xxvi). Recommendations based only on the latter rationale, which were described as such, included counseling or education about physical activity, seat belt and helmet use, dental hygiene, sexually transmitted diseases, firearms, smoke detectors, and water heaters. Because Medicare beneficiaries often have one or more chronic health problems such as high blood pressure or arthritis, many Medicare-covered physician visits are likely to involve some attention to tobacco, diet, physical activity, and other risk factors covered in the Task Force list.

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Extending Medicare Coverage for Preventive and Other Services TABLE 6–2 Interventions Considered and Recommended by USPSTF for Periodic Health Examinations for Persons Age 65 and Older SCREENING Injury Prevention Blood pressure Lap/shoulder belts Height and weight Motorcycle and bicycle helmets Fecal occult blood test and/or sigmoidoscopy Fall prevention Safe storage/removal of firearms Mammogram±clinical breast exam (women ≤69 years old) Smoke detector Set hot water heater to <120°F–130°F Papanicolaou (Pap) test (women) CPR training for household members Vision screening   Assess for hearing impairment Dental Health Assess for problem drinking Regular visits to dental care provider Floss, brush with fluoride toothpaste daily COUNSELING Substance Use   Tobacco cessation Sexual Behavior Avoid alcohol/drug use while driving, swimming, boating, etc. STD prevention: avoid high-risk sexual behavior, use condoms Diet and Exercise IMMUNIZATIONS Limit fat and cholesterol; maintain caloric balance; emphasize grains, fruits, vegetables Pneumococcal vaccinee Influenza Tetanus-diphtheria (Td) boosters Adequate calcium intake (women)   Regular physical activity CHEMOPROPHYLAXIS Discuss hormone prophylaxis (women) NOTE: CPR=cardiopulmonary resuscitation; STD=sexually transmitted disease. SOURCE: Table 4, p. xviii, USPSTF, 1996. When Congress approved a number of additional preventive services for coverage in 1997, it included two services that were not among those recommended by the USPSTF. Specifically, the Task Force judged the evidence insufficient to recommend for or against osteoporosis screening by bone densitometry. Further, it judged the evidence sufficient to recommend that men not be screened for prostate cancer. Concern about such issues led the committee to consider coverage decisionmaking for preventive and other services more generally. To the extent that Medicare covers such services, it gives them a special prominence that could divert patients, clinicians, and others (1) from undertaking more beneficial actions and (2) from adequately considering the potential of some preventive services to harm people who undergo unnecessary testing or treatment based on false positive screening results. Some argue that preventive

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Extending Medicare Coverage for Preventive and Other Services services should ordinarily face stricter scrutiny than treatment services because rather than responding to sick people who need treatment, they invite healthy people to receive care. Any untoward effect of a preventive service (e.g., vaccine reaction, false positive screening result leading to unnecessary testing and treatment) puts healthy people at risk. Some have proposed that Congress delegate decisions about preventive services coverage to the USPSTF. Such delegation could be a bigger step than Congress wishes to take at this time. Moreover, such a step could damage still evolving efforts to develop credible, evidence-based recommendations for clinical care. For example, if recommendations of the Task Force were sufficient to “qualify” a service for Medicare coverage, this could put a great deal more lobbying pressure on the citizen experts who serve on that group. Also, the Task Force is not intended or constituted to consider the cost and other implications of its recommendations for the Medicare program. An alternative would be for Congress to direct DHHS to continue to support the Task Force and the Agency for Health Care Policy and Research (AHCPR) in rigorously assessing the evidence base for clinical preventive services and in evaluating the cost-effectiveness of these services. For services recommended for inclusion in a periodic health examination, Congress could then direct the Health Care Financing Administration (HCFA) through the new Medicare Coverage Advisory Committee to consider costs, cost-effectiveness, and feasibility in the context of the Medicare program. HCFA could also be directed to publish its recommendations in the Federal Register for public comment just as it now publishes its proposed coverage decisions. In addition, HCFA could, as it does now, ask AHCPR and private technology assessment organizations to review evidence for any preventive services not already evaluated by USPSTF or to reevaluate services for which new evidence or cost concerns had emerged. One objective of this general approach would be to retain the Task Force’s focus on clinical care recommendations and let HCFA focus on coverage. Regardless of where responsibility for coverage decisions is located, the information, methods, and processes used should provide decisionmakers with the best available data and analyses on the effectiveness, costs, and cost-effectiveness of health services. STRENGTHENING THE INFRASTRUCTURE FOR COVERAGE DECISIONS The committee’s application of the analytic framework outlined in Chapter 2 reinforced its view that this evidence-based approach can be a powerful tool for guiding clinical and policy decisions. For both new technologies and current practices, it helps make clear the extent to which there is good evidence about the benefits and harms of a particular intervention and points those who conduct and fund research toward important health problems and interventions for which good evidence does not exist. It puts pressure on clinicians to abandon practices

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Extending Medicare Coverage for Preventive and Other Services that are clearly not beneficial and to apply and recommend practices that have been identified as worthwhile. It likewise supports governments and others who pay for care in revising coverage, reimbursement, quality assessment, and related policies to discourage nonbeneficial services and encourage effective care. The work reported here also makes clear the value of public and private efforts to build a stronger infrastructure for clinical, public health, and other health care decisions. The term “infrastructure” here means clinical, epidemiological, health services, and other research that helps clinicians and policymakers judge the extent to which different health care strategies are effective in improving health outcomes and have benefits that exceed harms; methods for conducting valid research, measuring outcomes accurately and meaningfully, summarizing data usefully, assessing resource implications of decisions, and otherwise helping ensure the credibility and utility of research to clinicians, policymakers, and others; and organizational structures and procedures for initiating and managing knowledge-building efforts, effectively applying knowledge to clinical and policy decisions, and then monitoring results to guide future activities. Commitment to Technology Assessment The fluctuating policy support for technology assessment and evidence-based recommendations for clinical practice and coverage policy is a continuing concern. Even within the past decade, political controversies over assessments of scientific evidence have threatened the survival of AHCPR (e.g., see Butler, 1996; de long, 1995; Kahn, 1998) and put advisory groups within the National Institutes of Health at odds with each other (e.g., see Taubes, 1997a,b). The Health Care Financing Administration has had a variety of problems relating to budget constraints and workloads, disagreements about the role of cost-effectiveness analyses, challenges to its coverage advisory process, and other matters. Congress eliminated its own technology advisory agency (the OTA) in 1995 (Leary, 1995). Nonetheless, the last decade has still seen both the creation of more formal, continuing links between government and nongovernmental expertise and the expansion of tools for communicating with health professionals and the public about the evidence base for health services (Gaus, 1997; Graham, 1998). To tackle the weaknesses in the infrastructure for coverage decisionmaking and improve the value of Medicare spending will require resources. For example, adding new tasks for HCFA or other agencies without adding new resources could do more harm than good if agencies simply reroute resources from quality monitoring or other important administrative responsibilities. Although additional resources for infrastructure improvements would be minuscule compared

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Extending Medicare Coverage for Preventive and Other Services to the total budget for Medicare or the National Institutes of Health, they nonetheless could be difficult to commit under budget neutrality rules. Examples of Specific Infrastructure Weaknesses In addition to broader concerns about the depth of commitment to the conduct and use of technology assessments and effectiveness research, the committee was also struck by certain specific weaknesses in the foundation for both clinical and coverage decisionmaking. One such weakness is the still-limited use in clinical research of outcomes measures that are meaningful to patients and consumers. Meaningfulness relates to the kinds of benefits and harms identified, the magnitude of the effect of an intervention on an outcome, and individual preferences about different outcomes. Much is assumed but relatively little is known about how individuals perceive the possible benefits and harms of different health services. Physiological measures are important and convenient but not sufficient for assessing whether interventions improve health as people actually experience it (e.g., see Fleming and DeMets, 1996; Psaty, 1999). A related concern is the even sparser work to assess individual and societal preferences for the outcomes of different health interventions. Clinicians, policymakers, and health services researchers may impute their own values to patients and the public, but there is reason to question this approach. A number of investigators have documented disagreement in values or preferences, for example, when patient, family, and physician responses are compared on preferences about care at the end of life (Lynn et al., 1995, 1997; SUPPORT Principal Investigators, 1995). Without sound preference or utility information, the usefulness of cost-effectiveness analyses and other kinds of comparisons may be compromised. The calculation of quality-adjusted life years or similar summary measures of health status depends not only on evidence about the benefits and harms of interventions but also on information about how people value these outcomes. Just as knowledge of people’s preferences is limited so is knowledge of people’s understanding of the possible harms as well as the possible benefits of screening or other interventions. Even when special efforts have been made to present risk information clearly, a number of studies have found that people vary greatly in their ability to accurately interpret quantitative information about health risks and benefits and that misinterpretations are common (e.g., see Hux and Naylor, 1995; Ransohoff and Harris, 1997; Schwartz et al., 1997; Woloshin et al., 1999a). If people do not understand such information, then informed decisionmaking may be an illusion. Effective methods for communicating information to patients and consumers and helping them make informed decisions can also be considered part of the infrastructure for health care decisionmaking. These methods are crucial to the still evolving concept of shared decisionmaking, which is intended to strengthen

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Extending Medicare Coverage for Preventive and Other Services patient involvement in care decisions, especially in “close call” situations when the evidence about benefits and harms of different interventions is weak and patient perceptions are variable or poorly understood (Flood et al., 1996; Morgan et al., 1997; Pauker and Kassirer, 1997; Woolf, 1997). At its most formal, shared decisionmaking is a process in which the clinician (1) describes the available options and their associated benefits and harms (including their likelihood and magnitude and the quality of the evidence on which the estimates are based); (2) checks patient understanding of the information; (3) presents a recommendation if asked; and (4) helps the patient to assess the information and the importance of possible outcomes in his or her own life and, then, make a decision. Further research is needed to evaluate the effectiveness and feasibility of specific methods and techniques for accomplishing the shared decisionmaking tasks just described. Role of Cost and Cost-Effectiveness Analyses In addition to strengthening the information and technical foundations for cost and cost-effectiveness analyses, the role of these analyses in coverage decisionmaking needs further attention. Currently, the extent to which cost, cost-effectiveness, or both are explicitly considered in coverage decisions varies depending on who makes the decision and whether the decision involves a new technology or a previously excluded service. For example: When legislators consider preventive care, dental services, and other interventions that are now statutorily excluded from Medicare coverage, costs, if not cost-effectiveness, are routinely weighed in decisions to extend coverage. When HCFA makes coverage determinations about new technologies that fit under existing categories of covered services, its decisions are not directly governed by the “budget neutrality” rules that Congress has adopted for itself. When HCFA considers new technologies, it applies criteria of effectiveness that are not systematically applied to established technologies. During the first three decades following the establishment of Medicare, Congress appeared to be sensitive to issues of clinical effectiveness and cost-effectiveness. For example, at the behest of Congress, the now defunct Office of Technology Assessment (OTA) undertook analyses of the cost-effectiveness of several preventive services. Congress also authorized DHHS to undertake preventive services demonstration projects that included assessments of cost-effectiveness. A study of coverage exceptions from 1965 to 1990 identified evidence of favorable cost-effectiveness ratios as one factor differentiating services for which Congress had approved coverage from those not approved (Schauffler, 1993).

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Extending Medicare Coverage for Preventive and Other Services Attempts by HCFA to include cost-effectiveness among the explicit criteria for coverage decisionmaking have so far been unsuccessful.1 The point is not that resources should be allocated for cost-effectiveness analyses for all currently covered services (a massive task) or that cost-effectiveness should be the only criterion for coverage decisions. It is, rather, that the current process makes it difficult to compare the expected benefits, harms, and costs—that is, to judge the probable value—of different health care decisions. Similarly, the procedure relied on by Congress for estimating the costs to Medicare of covering a new service—although necessary for understanding budgetary implications—provides a very incomplete picture of the value for money of such an action. Although the weakness of our knowledge base is one obstacle to systematic comparisons of health care services and technologies, other factors probably play a greater role in decisionmaking. Policies that would make high costs (or cost-effectiveness) an explicit factor in coverage decisions tend to be controversial, especially if the insurance is provided without regard to income and if the decision involves an already-covered category of services. Certainly, much of the controversy about managed care plans focuses on the ways these organizations factor costs into decisions about the care available to their enrollees. In contrast, it seems easier politically to accept high costs (without respect to cost-effectiveness) as a reason for not making public or private health insurance itself available to those who lack such coverage altogether. Within these political constraints, it is still possible to take some steps that make more apparent the trade-offs involved in coverage decisions. A small step in this direction would be for Congress to encourage and support AHCPR, HCFA, and other relevant agencies in preparing cost-effectiveness analyses for informational purposes, if not for coverage decisionmaking. For example, as suggested in Chapter 4, Congress could direct the Health Care Financing Administration to develop evidence-based recommendations for covering dental care in conjunction with certain serious medical conditions and treatments. Similarly, as suggested above, for the preventive services recommended by the USPSTF, Congress could direct the Health Care Financing Administration to assess these services in the context of the Medicare program and then make coverage recommendations. This would provide Congress systematic analyses of the potential benefits, harms, and costs of covering additional preventive services. 1   For durable medical equipment, HCFA regulations provide that if a contractor determines that there is a medically appropriate and realistically feasible alternative pattern of care for which payment could be made, payment should be based on the reasonable charge for this alternative rather than a higher cost alternative for which a claim has been submitted (HCFA, 1999b, Carriers Manual, section 2100.2). This “least costly alternative” criterion may also be applied at a contractor’s discretion to other services (HCFA, 1999b, Program Integrity Manual, chapter 3, section 3.1.1).

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Extending Medicare Coverage for Preventive and Other Services In addition, the committee’s work has suggested some directions for research related to the specific clinical services and conditions reviewed here. For example, the discussion of skin cancer screening has suggested the importance of more research on the methods of identifying and targeting high-risk individuals for education and, possibly, screening. It also points to the opportunities for learning from the screening research of other nations and, by implication, the importance of the growing worldwide network of evidence-based medicine initiatives and communication. The discussion of “medically necessary dental services” has illustrated important gaps in evidence about how dental problems and dental care affect outcomes for people with a number of life-threatening medical problems. The discussion of immunosuppressive drugs for transplant recipients points to our still limited understanding of patient nonadherence to treatment recommendations. Linking Evidence to Recommendations Despite steps taken by public and private organizations to improve information and processes for coverage decisionmaking, no common standards of evidence govern the multiple decisionmakers now involved. This is particularly true for the early stages when innovative technologies first come to the attention of health plans. Moreover, the criteria for making coverage recommendations or decisions may not be explicit or public, despite calls for health plans to be more rigorous and open about these criteria (e.g., see IOM, 1989). For each of the conditions examined, the committee’s review of statements by other organizations revealed both substantive disagreement and differences in the extent to which recommendations were accompanied by descriptions of the supporting evidence. Such variability is not surprising given variations in the processes used by different organizations to develop their recommendations. All use some degree of expert judgment and consensus, but the role of evidence in informing judgment is not at all clear in many cases. This makes it difficult to identify the basis for inconsistent recommendations and judge their credibility. One additional reason for explicitly linking practice or coverage recommendations to evidence reviews is that such reviews—along with judgments about the population burden of disease, costs, and productive avenues for research—can help decisionmakers set priorities for future biomedical, clinical and health services research. THE LIMITS OF COVERAGE Even those fortunate enough to have coverage from Medicare or other sources often do not receive recommended preventive (or other) services (e.g., see Jaen et al., 1994; Morrissey et al., 1995; Roos et al., 1999). In some cases, beneficiaries fail to seek these services or their physicians fail to provide, rec-

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Extending Medicare Coverage for Preventive and Other Services ommend, or discuss these services. For services that involve referrals to other clinicians or specialized facilities, people may fail to follow up for a variety of reasons including forgetfulness, time demands, and cost. The fact that coverage fails to guarantee use of effective services is not, of course, an argument for not covering them. It is, however, an argument for paying attention to noncoverage obstacles to care and to strategies for overcoming such obstacles. Such strategies aim to strengthen the organizational infrastructure for disease prevention and health promotion. In particular, many have recognized the obstacles to implementing recommended clinical preventive measures in primary care settings and have supported practical programs and research to address these obstacles (Wolfe et al., 1996). For example, the DHHS initiative “Put Prevention into Practice” has developed a set of materials for the physician office or clinic including patient education brochures, a handbook for clinicians, posters for waiting and examination rooms, “alert” stickers for medical records, and reminder postcards (AHCPR, 1998). It cannot, of course, be assumed that such materials, even if ordered, will be used or, if used, will be effective (McVea et al., 1996). Moreover, community-based preventive programs may be more successful (and less expensive) in getting services to high-risk groups than coverage or other approaches that rely on people visiting a physician (Roos et al., 1999). This is, for example, suggested by data from Canadian provinces that have developed community-based screening programs, in part to reach people who do not use covered preventive services under the government health insurance program (de Grasse et al., 1999; Olivotto et al., 1999). One claim in favor of beneficiary enrollment in health maintenance organizations (HMOs) is that some of the obstacles to preventive care may be more effectively tackled in HMOs and similar health plans than in fee-for-service health care (e.g., see Heiser and St. Peter, 1997; Mandelson and Thompson, 1998). For example, these organizations can, in principle, mobilize their information systems to identify enrolled members who have not received preventive services from the plan and then use reminder systems to prompt these members to seek or accept recommended services. Likewise, they can use their information systems to track clinician performance in providing recommended services and then, as appropriate, employ educational efforts (e.g., evidence-based practice guidelines), performance feedback, peer comparison data, and other strategies to encourage clinicians to provide or advise recommended services.2 For 2   In addition, because the provision of certain preventive services is fairly easy to track, their provision is frequently monitored by groups assessing and comparing the performance of health plans, for example, the National Committee for Quality Assurance (NCQA, 1999). If services not demonstrated to be effective are covered and monitored, some plans could divert resources from other more effective services that were not

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Extending Medicare Coverage for Preventive and Other Services interventions with relatively short-term outcomes, health plans may also be able to assess health as well as utilization outcomes, although enrollment turnover can complicate such assessments. Studies generally show higher use of preventive services in HMOs compared to fee-for-service medicine (Gordon et al., 1998). The degree to which higher-risk individuals are more effectively reached in managed care programs is, however, less clear and, thus, an important question for further research (Amonkar et al., 1999; Schauffler and Rodriguez, 1993). In the process of examining the obstacles to the implementation of preventive services recommendations, decisionmakers may decide that one strategic step is to set priorities for the delivery of preventive services and focus resources on higher-priority services. For example, a health plan might work to increase the use of clearly effective services, especially in higher-risk groups with lower levels of utilization, while providing marginally beneficial or disputed services only to those who request and still want such services after a discussion of potential benefits and harms (Thompson, 1996). As is true for health care services themselves, the effectiveness of organizational efforts to improve the delivery of services cannot be assumed. Although evaluation is expensive and often difficult, especially when controlled studies are attempted, organizational initiatives also need to be evaluated. THE LIMITS OF EVIDENCE Lack of evidence was one difficulty this committee faced in reaching conclusions. In addition, the committee encountered a number of policy and ethical questions that could not be ignored, although their thorough examination was beyond the group’s charge. For example, the committee is hardly the first to note the many complexities created by Medicare coverage distinctions for people with and without end-stage renal disease (ESRD); for ESRD patients on dialysis versus those who receive kidney transplants; for kidney versus other transplant candidates or recipients; and for Medicare-covered transplant recipients versus other beneficiaries needing expensive outpatient drugs (IOM, 1991). Because Medicare now covers immunosuppressive drugs for up to three years after transplantation and because government policy more generally promotes guardianship of organs before and after transplantation, it seems straightforward to argue for elimination of the three-year limit. Fairly quickly, however, the question arises about whether this is fair, given that the lives and well-being of many Medicare beneficiaries with other medical problems depend on expensive prescription drugs that would continue to be excluded from coverage.     included in performance monitoring systems in order to invest in providing services that would count toward their performance score.

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Extending Medicare Coverage for Preventive and Other Services The case of immunosuppressive drugs highlights the frustrations that policymakers and clinicians can encounter in trying to develop rational and consistent coverage policies on an incremental basis as innovative technologies emerge and new evidence about established technologies accumulates. Despite such problems with incremental policy development, recent experiences with more global efforts to define a total package of covered services for Americans covered by public and private health insurance have had their own problems. These problems reflect, in part, the larger failure of comprehensive national health care reform in the early 1990s (e.g., see Budetti, 1997; Feder and Levitt, 1995; Iglehart, 1995; Yankelovich, 1995). The most comprehensive state initiative—which was undertaken by policymakers and citizens in Oregon—has been cut back in scope and has not prompted much imitation in other states (Bodenheimer, 1997a,b; Ham, 1998; Jacobs et al., 1999; Leichter, 1999). Efforts to define a comprehensive package of basic benefits present formidable technical, intellectual, and cultural challenges. Certainly, when all services are, in principle, “on the table,” divisive debates among advocates of different services become more likely. For clinical preventive services, the incremental adoption of exceptions to Medicare’s general exclusion of coverage has probably had some positive aspects. The exclusion may have been originally motivated on grounds that preventive services were relatively inexpensive and could be budgeted. Subsequent attempts to breach the exclusion have encouraged efforts to systematically assess—rather than assume—the effectiveness and cost-effectiveness of specific clinical preventive services. Such analyses appear to have helped persuade decisionmakers to authorize coverage for effective services and even to favor some of these services over treatment services by waiving beneficiary cost sharing. At the same time, however, Congress has authorized coverage for certain services for which evidence is inconclusive or disputed. More generally, whether to consider cost-effectiveness in coverage decisions about preventive and other services raises political and ethical questions that have important implications for the ways in which limited resources are distributed among different worthy purposes. Evidence cannot usually answer such fundamental political and ethical questions. It can, however, often clarify the rationales and potential consequences of different answers and help policymakers and their constituents assess the actual consequences—for good and ill—of their decisions.

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