Summary

Congress created the Medicare program in 1965 to provide health insurance for Americans age 65 or over. It later extended coverage to some individuals with disabilities or permanent kidney failure. From the outset, the program has focused on coverage for hospital, physician, and certain other services that are “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” With certain exceptions, Congress explicitly excluded Medicare coverage for preventive services, outpatient prescription drugs, and dental care.

Most sessions of Congress see proposals to expand Medicare coverage to some currently excluded services. With Medicare spending growth having far exceeded 1960s’ projections, however, the added cost of such expansions has often discouraged change. Moreover, Congress has set budget rules for itself requiring that decisions to increase most types of federal spending must be accompanied by explicit decisions to reduce spending elsewhere or to raise taxes. These rules underscore the reality that expanding Medicare coverage involves making trade-offs in the face of resource constraints.

In the Balanced Budget Act of 1997 (Public Law 105–33), Congress called for the Department of Health and Human Services to arrange for the National Academy of Sciences (NAS) to analyze “the short- and long-term benefits, and costs to Medicare” of extending coverage for certain preventive and other services. The services were screening for skin cancer; medically necessary dental services; elimination of time restrictions on coverage for immunosuppressive drugs after transplants; routine patient care costs in clinical trials; and nutrition therapy.



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Extending Medicare Coverage for Preventive and Other Services Summary Congress created the Medicare program in 1965 to provide health insurance for Americans age 65 or over. It later extended coverage to some individuals with disabilities or permanent kidney failure. From the outset, the program has focused on coverage for hospital, physician, and certain other services that are “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” With certain exceptions, Congress explicitly excluded Medicare coverage for preventive services, outpatient prescription drugs, and dental care. Most sessions of Congress see proposals to expand Medicare coverage to some currently excluded services. With Medicare spending growth having far exceeded 1960s’ projections, however, the added cost of such expansions has often discouraged change. Moreover, Congress has set budget rules for itself requiring that decisions to increase most types of federal spending must be accompanied by explicit decisions to reduce spending elsewhere or to raise taxes. These rules underscore the reality that expanding Medicare coverage involves making trade-offs in the face of resource constraints. In the Balanced Budget Act of 1997 (Public Law 105–33), Congress called for the Department of Health and Human Services to arrange for the National Academy of Sciences (NAS) to analyze “the short- and long-term benefits, and costs to Medicare” of extending coverage for certain preventive and other services. The services were screening for skin cancer; medically necessary dental services; elimination of time restrictions on coverage for immunosuppressive drugs after transplants; routine patient care costs in clinical trials; and nutrition therapy.

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Extending Medicare Coverage for Preventive and Other Services This report, which was developed by an expert committee of the Institute of Medicine, reviews the first three services listed above.1,2 It is intended to assist policymakers by providing syntheses of the best evidence available about the effectiveness of these services and by estimating the cost to Medicare of covering them. For each service or condition examined, the committee commissioned a review of the scientific literature that was presented and discussed at a public workshop. As requested by Congress, this report includes explicit estimates only of costs to Medicare, not costs to beneficiaries, their families, or others. It also does not include cost-effectiveness analyses. That is, the extent of the benefits relative to the costs to Medicare—or to society generally—is not evaluated for the services examined. The method for estimating Medicare costs follows the generic estimation practices of the Congressional Budget Office (CBO). The objective was to provide Congress with estimates that were based on familiar procedures and could be compared readily with earlier and later CBO estimates. For each condition or service, the estimates are intended to suggest the order of magnitude of the costs to Medicare of extending coverage, but the estimates could be considerably higher or lower than what Medicare might actually spend were coverage policies changed. The estimates cover the five-year period 2000–2004. In addition to the conclusions about specific coverage issues, the report examines some broader concerns about the processes for making coverage decisions and about the research and organizational infrastructure for these decisions. 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. EVIDENCE AND COST ESTIMATES FOR SELECTED SERVICES Skin Cancer Screening The three major kinds of skin cancers are melanoma, basal cell carcinoma, and squamous cell carcinoma. The latter two are often grouped together as nonmelanoma skin cancers. Melanoma accounts for less than 5 percent of reported cases of skin cancer but about 80 percent of deaths. Squamous cell carcinoma accounts for most of the rest. 1   For the other services, see Extending Medicare Reimbursement in Clinical Trials and The Role of Nutrition Therapy in Maintaining the Health of the Nation’s Elderly: Evaluating Coverage of Nutrition Services for Medicare Beneficiaries, both available from the National Academy Press (www.nap.edu). 2   As this report was being completed, Congress extended coverage of immunosuppressive drugs for up to eight months (subject to expenditure limits) for transplant recipients eligible for Medicare by reason of age or disability (P.L. 106–113).

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Extending Medicare Coverage for Preventive and Other Services Melanoma is primarily a disease of fair-skinned people. White men have a 0.38 percent lifetime risk of dying from the disease. For white women the comparable risk of dying is 0.28 percent. In comparison, the lifetime risks for white men of dying from lung or prostate cancer are 6.94 percent and 3.09 percent, respectively. For white women, the lifetime risks of dying from lung cancer or invasive breast cancer are 4.77 percent and 3.47 percent, respectively. Clinical screening is defined as the examination of the skin of an asymptomatic person by a physician or other trained individual. The main goal of a new program of skin cancer screening would be to improve survival for people with melanoma. It is the most lethal skin cancer, and treatment is not very successful for late-stage disease. Cure rates are already very high for people with basal cell carcinoma and squamous cell carcinoma, which grow slowly and rarely spread to other organs. Current Coverage Unless explicitly authorized by Congress, Medicare does not cover screening, immunizations, and similar preventive services. In recent years, Congress has approved coverage under certain circumstances for several preventive services including screening for breast cancer and colorectal cancer. Clinical screening of asymptomatic people for skin cancer is not explicitly authorized. Medicare does, however, cover a physician visit initiated by a patient concerned about, for example, a change in the color of a mole or a new skin growth. Similarly, if a physician notices a suspicious skin condition during a visit for another purpose and extends the visit to investigate further, Medicare may pay more for that visit if it meets certain criteria. In either situation, if the physician refers the patient to a dermatologist, the referral visit is also covered, as are any skin biopsies. Evidence Review, Conclusions, and Cost Estimates The committee concluded that the evidence for the effectiveness of skin cancer screening is insufficient to support positive or negative conclusions about a new program of clinical screening of asymptomatic Medicare beneficiaries. Direct evidence of the effectiveness of clinical screening for skin cancer is lacking rather than negative or ambiguous. No controlled clinical trials have tested the assumption that cancers detected through clinical screening of asymptomatic people have better outcomes than those found by patients or by physicians who discover them during visits for other purposes. A 10-year trial of screening is now underway in Australia, where skin cancers are much more common than in the United States. The indirect evidence for skin cancer screening is suggestive but not conclusive. Physicians, especially dermatologists, tend to detect thinner melanomas than patients and are more accurate in distinguishing malignant from benign skin conditions. Studies of survival following surgery indicate that thinner

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Extending Medicare Coverage for Preventive and Other Services melanomas are associated with better survival. These indirect data point to the value of early detection and treatment of skin cancer, but they are not the equivalent of direct evidence from controlled studies showing that detecting thinner melanomas through screening—compared to detection through usual care by alert health care professionals—improves survival. Clinical screening of asymptomatic people might simply (1) extend the time between diagnosis and death (lead-time bias) without improving outcomes or (2) discover many nonaggressive tumors that exist for long periods of time without causing harm, while missing fast-growing, more lethal tumors that arise between screenings (length bias). These biases are important because screening invites healthy people to put themselves at risk for untoward effects (e.g., false positive results that lead to unnecessary further testing and treatment). For a new program of skin cancer screening, the estimated net five-year cost to Medicare could range from about $150 million to nearly $900 million, depending on the screening approach adopted. The more successful a strategy was in focusing on a smaller group of higher-risk people, the less costly—and the more cost-effective—it would be. Because indirect evidence does support the benefits of early detection and early treatment as part of usual medical care, clinicians and patients should continue to be alert to the common signs of skin cancer and to investigate suspicious signs further. Medicare already covers skin examination and testing prompted by patient concern about a skin abnormality or by incidental physician discovery of an abnormality. In addition, dermatology and other organizations should continue educational programs including programs that encourage people to limit sun exposure (especially children and adolescents) and inform themselves about skin cancer risk factors. Perhaps the major challenge related to the Medicare population is identifying and implementing better ways of reaching the group at highest risk of death from skin cancer—older white males. Although evidence about the effectiveness of skin self-examination in improving health outcomes is limited, some evidence indicates that women are more likely to self-identify melanomas than men and that men are more likely than women to have a melanoma identified by a family member. It may be useful to investigate further the value of education programs that emphasize the role of family members and close friends in noticing and encouraging professional evaluation of abnormal-appearing areas of skin. Medically Necessary Dental Services In discussions about insurance coverage, the term “medically necessary dental services” has been used narrowly to mean care that occurs as the direct result of an underlying medical condition or its treatment or that has a direct effect on such a condition. Under this definition, care for serious periodontal disease would not be “medically necessary” unless, for example, it threatened the health of someone with leukemia or was caused by the disease or its treat-

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Extending Medicare Coverage for Preventive and Other Services ment (and could otherwise be health threatening if untreated). Such a restrictive definition may suggest that periodontal or other tooth-related infections are somehow different from infections elsewhere and imply that the mouth can be isolated from the rest of the body, notions neither scientifically based nor constructive for individual or public health. Therefore, this report refers to “medically necessary dental services,” using quotation marks as a reminder of the term’s specialized and restricted meaning in this discussion of Medicare coverage policy. Given the resources available, the number of conditions that the committee could review was limited. Based on earlier analyses by others, the committee identified five conditions for examination: (1) head and neck cancer, (2) leukemia, (3) lymphoma, (4) organ transplants, and (5) heart valve repair or replacement. In general, a common link is the risk of oral infection affecting or caused by the medical condition or its treatment. Current Coverage From its beginning, the Medicare program has excluded coverage for dental care to treat, fill, remove, or replace teeth or to treat the gums and other structures directly supporting the teeth. A narrow exception allows payments in connection with the provision of dental services incidental to a covered medical procedure, for example, the repair of a fractured jaw. Otherwise, the Health Care Financing Administration (HCFA) has approved Medicare coverage in two situations. One is the extraction of teeth prior to radiation therapy to the jaw, which may be appropriate for patients with extensive periodontal disease and dental abscesses but not for others whose problems can be treated with less drastic interventions. HCFA has also approved coverage for an oral examination as part of patient preparation for kidney transplantation. Evidence Review, Conclusions, and Cost Estimates The direct evidence to support coverage for “medically necessary dental services” varies depending on the medical condition to which dental services are related. No randomized clinical trials have investigated outcomes of dental care for head and neck cancer patients receiving radiation therapy to the jaws. Small retrospective studies provide limited direct evidence that replacing aggressive tooth-extraction protocols with tooth-preserving protocols prior to radiation can reduce radiation-related caries and tooth extractions that place patients at high risk for osteoradionecrosis. (Osteoradionecrosis involves bone cell death that can lead to infection, serious disfigurement, and functional impairment). Other retrospective analyses show higher rates of osteoradionecrosis for patients with inadequate dental care and preradiation extractions. Extractions are, however, appropriate for some patients. Given this limited evidence, the severe consequences of radiation-induced osteoradionecrosis, and Medicare’s investment in treating patients with head and neck cancer, it is reasonable for Medicare to

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Extending Medicare Coverage for Preventive and Other Services cover both tooth-preserving care and extractions. Patients should be referred for dental examinations as appropriate by their oncologist. Weak direct evidence suggests that the provision of dental care to prevent or eliminate acute oral infection for leukemia patients prior to chemotherapy can prevent or reduce subsequent episodes of septicemia and prevent or reduce severe oral complications of treatment. Given this limited evidence, the severe consequences of septicemia and other complications of chemotherapy, and Medicare’s investment in treating leukemia patients, it is reasonable for Medicare to cover a dental examination, cleaning of teeth, and treatment of acute infections of the teeth or gums for a leukemia patient prior to chemotherapy. Again, patients should be referred to a dentist as appropriate by their physician. The committee concluded that the evidence is insufficient to support positive or negative conclusions about dental services for patients with lymphoma, organ transplants, and heart valve repair or replacement. Indirect evidence and biologic plausibility are suggestive but not conclusive that health outcomes may be improved by eliminating oral sources of infection that may cause septicemia in immunosuppressed lymphoma or organ transplant patients or endocarditis in patients with a diseased, abnormal, or surgically repaired or replaced heart valve. The committee notes, however, that widely accepted clinical protocols for identifying and eliminating all infections and potential sources of infection before organ transplantation and certain other procedures are based largely on biological principles, animal studies, and clinical experience, not direct evidence from controlled trials. For head and neck cancer patients receiving radiation therapy, the estimated net five-year cost to Medicare for covering a limited set of dental services would be $12.9 million. For leukemia patients undergoing chemotherapy, the net cost would be $20.9 million. The estimated five-year net costs to Medicare would be $32.3 million for beneficiaries being treated for lymphoma, $24.2 for those receiving a solid organ transplant, and $117.5 million for those undergoing heart valve replacement or repair. These estimates generally assume, on average, two visits per patient with teeth. Although the evidence base for “medically necessary dental services” is limited, the committee is concerned about interpretations of the current law that might preclude further coverage exceptions for dental services that are effective in reducing infections in high-risk patients. Given therapeutic advances since the creation of Medicare and these concerns about coverage interpretation, the committee concludes that it is reasonable for Congress to update statutory language to clearly allow coverage of these kinds of dental services. Specifically, the committee suggests that Congress should direct the Health Care Financing Administration (with assistance as appropriate from the Agency for Health Care Policy and Research and the National Institutes of Health) to develop recommendations—on a condition-by-condition basis—for coverage of effective dental services needed in conjunction with surgery, chemotherapy, radiation, or pharmacological treatment for a life-threatening medical condition. The phrase “in conjunction with” would limit the window of coverage to a specified period

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Extending Medicare Coverage for Preventive and Other Services before or after surgery or other treatment but would not require that the services be provided as an immediate part of a medical procedure. This minimal revision in the 1965 statute would not alter Medicare’s basic focus on treatment of acute illness or injury. Eliminating the Time Limit on Coverage of Immunosuppressive Drugs for Transplant Recipients Successful transplantation of human organs is one of the most dramatic achievements of modern medicine. From the 1950s through the 1970s, organ transplantation was restricted by the limited effectiveness of treatment to control the body’s rejection of grafted organs. When effective immunosuppressive drugs became available in the 1980s, transplantation became an accepted treatment for an increasing number of deadly diseases. Over 20,000 transplants were performed in 1998, and estimates of the number of people living with a functioning graft range up to 125,000. Today, a major limit on transplantation is the shortage of donated organs. Nearly 65,000 people were registered on waiting lists for organ transplantation in 1998, and more than 4,500 were removed from waiting lists due to death. The high cost of immunosuppressive drugs, which may total from $5,000 to $16,000 each year, means most transplant recipients need financial assistance to pay for them. Current Coverage Immunosuppressive drugs prescribed for transplant recipients represent one of the few exceptions to Medicare’s exclusion of coverage for self-administered outpatient drugs. Coverage of the drugs is limited to three years following a transplant, an increase from the one year of coverage originally authorized in 1986. Except for kidney transplant recipients (who are covered under special legislation for people with end-stage renal disease [ESRD]), transplant recipients must qualify for Medicare by reason of age or disability. Evidence Review, Conclusions, and Cost Estimates Good evidence supports patients’ continued need for immunosuppressive therapy and their increased risk of graft loss if they cannot follow their prescribed drug regimen. Although people who lose coverage often find other options for securing sufficient drugs to maintain immunosuppression, experience and limited evidence suggest that some transplant recipients eventually lose their grafts for lack of coverage. Some return to dialysis or receive a second transplant, but others die. Given this evidence and the existing Medicare policy of supporting organ transplants, the rationale for eliminating the current time limits for coverage of immunosuppressive drugs for all solid organ transplant recipients is strong.

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Extending Medicare Coverage for Preventive and Other Services The estimated five-year net cost to Medicare of completely eliminating the three-year limit on coverage would be approximately $778 million if coverage were limited to those qualifying for Medicare by reason of age or disability.3 If coverage were also extended to kidney transplant recipients who have qualified for Medicare based on ESRD diagnosis alone (and who lose all Medicare coverage after three years), the estimated net cost would rise to approximately $1.06 billion. In addition to the economic and possible clinical consequences of time-limited drug coverage for transplant recipients, current policy has societal implications. Organs are a scarce resource for which demand far outstrips supply. Every graft failure that results in retransplantation is a special burden on this limited supply. Beyond those immediately affected, others have a strong interest in the successful maintenance of grafts to protect their potential access or that of their loved ones. Nonetheless, the case of immunosuppressive drugs highlights the ethical dilemmas and other complexities that policymakers can encounter in trying to develop rational, consistent, and fair coverage policies for all Medicare beneficiaries. This report does not examine such issues in depth, but it does look at a few broad questions about coverage decisionmaking for preventive and other services. DECIDING COVERAGE FOR PREVENTIVE AND OTHER SERVICES Medicare coverage decisions range from very broad-based decisions about whole categories of services to very narrow decisions about whether a specific service will be covered for a specific individual. In between are decisions about the general circumstances under which a specific service will be covered (e.g., that bone marrow transplant will be covered for certain cancers and not others). In general, these kinds of decisions are made at three different levels, with Congress making broad decisions about categories of coverage and coverage exceptions, HCFA focusing on the general circumstances under which a new or established service will be covered, and private contractors that administer Medicare claims for the government deciding whether specific services billed for a specific beneficiary are covered and also establishing policies for services and circumstances for which HCFA has no policy. One criticism of Congress’s service-by-service approach to coverage decisions about preventive services and other generally excluded categories of care 3   As this report was being completed, Congress approved an extension of coverage for eight months for this group of beneficiaries.

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Extending Medicare Coverage for Preventive and Other Services is that this approach 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 winning coverage for specific services, especially services of questionable effectiveness, can distract policymakers, advocates, and clinicians from nonfinancial barriers to the widespread use of preventive services and other interventions known to be effective. Linking Evidence to Medicare Coverage: The Case of Preventive Services 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 undertook analyses of the cost-effectiveness of several preventive services. Congress also authorized the Department of Health and Human Services (DHHS) to undertake preventive services demonstration projects that included assessments of cost-effectiveness. A study of congressional coverage decisions from 1965 to 1990 identified evidence of favorable cost-effectiveness ratios as one factor differentiating preventive services approved for coverage from those not approved. A comparison of the preventive services now covered by Medicare with those recommended by the United States Preventive Services Task Force (USPSTF) for asymptomatic people over age 64 shows that Medicare excludes some services that were recommended by the Task Force and includes some that were not recommended. The Task Force is charged with making evidence-based recommendations about the use of clinical preventive services as part of a periodic health examination; it does not make coverage recommendations. Of the eight screening services recommended by USPSTF for those over age 64, Medicare does not explicitly cover blood pressure testing, height and weight checks, and screening for vision and hearing impairment and problem drinking. Of the 15 recommended counseling and education services, Medicare explicitly covers only diabetes education. Some recommended 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. About 90 percent of Medicare beneficiaries have at least one physician visit a year. In 1997, Congress approved coverage for two screening 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. To the extent that Medicare covers such services, it gives them a “stamp of approval.” It could thereby help divert patients, clinicians, and others from focusing on more beneficial care and from adequately weighing the potential of some services to harm

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Extending Medicare Coverage for Preventive and Other Services healthy people who have false positive screening results and then undergo unnecessary further testing and treatment. Given the improved methods for systematically assessing scientific evidence about what works and does not work in medical care, it may be useful for decisionmakers to consider more explicit processes for linking coverage of services to evidence of their effectiveness and cost-effectiveness. For example, as suggested above, Congress could direct the HCFA to develop evidence-based recommendations for covering dental care in conjunction with certain serious medical conditions and treatments. Similarly, for the preventive services recommended by the USPSTF based on reviews of relevant evidence, Congress could direct the Health Care Financing Administration to assess these services in the context of the Medicare program and then make coverage recommendations. Such recommendations would provide Congress systematic analyses of the potential benefits, harms, costs, and cost-effectiveness of covering additional dental or preventive services. These tasks would require new resources. Adding to HCFA’s workload without adding new resources could do more harm than good, for example, if the agency simply rerouted resources from quality monitoring or other important administrative responsibilities. The Infrastructure for Making Coverage Decisions The committee’s work reinforced its view that evidence-based review of new and existing health services can be a powerful tool for guiding clinical and policy decisions. Such an approach 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 for which good evidence does not exist. It puts pressure on clinicians to abandon practices 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 analyses reported here also make clear the value of public and private efforts to build a stronger knowledge infrastructure for clinical, public health, and other health care decisions. This “infrastructure” includes Clinical, epidemiological, health services, and other research that helps clinicians, consumers, and policymakers compare the potential benefits and harms of different health care strategies; Methods and tools that are needed to conduct and present valid and useful research; and Organizational structures and procedures that must exist to initiate and manage knowledge-building efforts, effectively apply knowledge to clinical and policy decisions, and then monitor results to guide future activities.

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Extending Medicare Coverage for Preventive and Other Services Although this report did not comprehensively examine the infrastructure for coverage decisionmaking, certain weaknesses became evident in the course of this study. One weakness relates to the still-limited use in much clinical research of outcomes measures that are meaningful to patients. Physiological measures are important and convenient but not sufficient for assessing whether interventions improve health as people actually experience it. Much is assumed but relatively little is known about how individuals perceive the possible benefits and harms of different health services. Without assessments of individual and societal preferences for the outcomes of different health interventions, the usefulness of cost-effectiveness analyses and comparisons may be diminished. For example, 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. Another weakness is that, despite steps taken by public and private organizations to improve information and processes for clinical and 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. Further, despite calls for health plans and other organizations to be more rigorous and open about their criteria and evidence for making recommendations or decisions, organizational practices and statements are highly variable. 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 their development process and supporting evidence. All use some degree of expert judgment and consensus, but the role of evidence in informing judgment is not clear in many cases. This makes it difficult to judge the basis for inconsistent recommendations and identify gaps in biomedical, clinical, and health services research. The uneven consideration of cost-effectiveness and costs is a further concern. Currently, congressional decisions about extending coverage for now-excluded care are governed by budget neutrality rules that favor services projected to save the Medicare program money. Even if excluded services are more cost-effective—that is, have greater benefits relative to costs—than some already covered services, they face a high hurdle to acceptance. On the administrative side, HCFA has tried but largely failed in its efforts to include cost-effectiveness among the explicit criteria for coverage decisions. To tackle these and other weaknesses in the infrastructure for coverage decisionmaking and improve the value of Medicare spending will require resources. As noted above, adding new tasks for HCFA without adding new resources could do more harm than good. Although additional resources for infrastructure improvements would be minuscule compared to the total budget for Medicare or the National Institutes of Health, they nonetheless could be difficult to commit under current budget rules.

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Extending Medicare Coverage for Preventive and Other Services BEYOND COVERAGE The Medicare program has undoubtedly helped millions of Americans obtain needed health services. Still, even those individuals fortunate enough to have coverage from Medicare or other sources do not necessarily receive recommended care. In some cases, beneficiaries fail to seek these services or their physicians fail to provide or recommend them. That coverage fails to guarantee the use of effective services is not, of course, an argument for not covering them. It is, however, an argument for paying attention to other obstacles to care. Many organizations, including Congress and DHHS, have recognized such obstacles to implementing recommended clinical preventive measures and supported public and private actions to overcome them. For some services and populations, community-based prevention programs may be more successful (and less expensive) in getting services to high-risk groups than coverage, which involves a physician visit. Such programs—particularly those involving quick, noninvasive services such as immunizations—may seek people out in workplaces, shopping centers, and similar places. 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. BEYOND EVIDENCE The conclusions summarized above reflect the limited evidence available to support clinical or coverage decisions about many health care services. In addition, each service presents policy and ethical questions that were beyond the scope of this report. For example, decisions about coverage of immunosuppressive drugs take place in the context of a complicated set of distinctions about what (and who) Medicare does and does not cover. Thus, the availability and scope of coverage varies for people with and without an ESRD diagnosis; 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 prescription drugs. Are these distinctions fair? Should government attempt to eliminate or reduce such major disparities in coverage? Evidence cannot usually resolve such fundamental political and ethical questions. It can, however, often clarify the rationales and potential consequences of different answers. It can also help policymakers assess the actual consequences—for good and ill—of their decisions.