4
Medically Necessary Dental Services

From the outset, the Medicare program has excluded coverage “for services in connection with the care, treatment, filling, removal, or replacement of teeth or structures directly supporting the teeth” (Section 1862(a)(12) of the Social Security Act). The 1965 legislation authorizing the program provided a narrow exception that payment could be made “in the case of inpatient hospital services in connection with the provision of dental services if the individual, because of his/her underlying medical condition and clinical status, or because of the severity of the dental procedure, requires hospitalization in connection with the provision of such services.”

As described in regulations and the program manuals used by the intermediaries and carriers who administer Medicare claims, the Health Care Financing Administration (HCFA) has interpreted the statutory exceptions language to permit payments for professional dental services when they are performed as an “integral part” of covered inpatient procedures (Carriers Manual, section 2136 [HCFA, 1999b]). For example, if the extraction of a tooth in the line of a jaw fracture is integral to treatment of the jaw injury, then dental treatment (i.e., the extraction) is covered. If a beneficiary has to be hospitalized for a dental procedure (e.g., an extraction not integral to a covered medical service) to be safely performed given his or her clinical status, Medicare covers the hospital services but not the dental procedure itself. In general, Medicare-covered services that are within the scope of practice (as defined by states) for a physician as well as a dentist are covered when provided by a dentist. Examples include management of mucositis and treatment of oral infections using antibiotics.



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Extending Medicare Coverage for Preventive and Other Services 4 Medically Necessary Dental Services From the outset, the Medicare program has excluded coverage “for services in connection with the care, treatment, filling, removal, or replacement of teeth or structures directly supporting the teeth” (Section 1862(a)(12) of the Social Security Act). The 1965 legislation authorizing the program provided a narrow exception that payment could be made “in the case of inpatient hospital services in connection with the provision of dental services if the individual, because of his/her underlying medical condition and clinical status, or because of the severity of the dental procedure, requires hospitalization in connection with the provision of such services.” As described in regulations and the program manuals used by the intermediaries and carriers who administer Medicare claims, the Health Care Financing Administration (HCFA) has interpreted the statutory exceptions language to permit payments for professional dental services when they are performed as an “integral part” of covered inpatient procedures (Carriers Manual, section 2136 [HCFA, 1999b]). For example, if the extraction of a tooth in the line of a jaw fracture is integral to treatment of the jaw injury, then dental treatment (i.e., the extraction) is covered. If a beneficiary has to be hospitalized for a dental procedure (e.g., an extraction not integral to a covered medical service) to be safely performed given his or her clinical status, Medicare covers the hospital services but not the dental procedure itself. In general, Medicare-covered services that are within the scope of practice (as defined by states) for a physician as well as a dentist are covered when provided by a dentist. Examples include management of mucositis and treatment of oral infections using antibiotics.

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Extending Medicare Coverage for Preventive and Other Services TABLE 4–1 Medicare Coverage of Dental Services as Specified in Statute or by the Health Care Financing Administration Clinical Condition Medicare-Covered Service Underlying medical condition and clinical status requires hospitalization for dental care Inpatient hospital services only (Medicare Part A) Severity of dental procedure requires hospitalization for dental care Inpatient hospital services only (Medicare Part A) Any oral condition for which nondental services are covered All dental services if incident to and an integral part of a covered procedure or service performed by the same person (Medicare Part B) Neoplastic jaw disease Extractions prior to radiation and prior to oral examination if extractions occur (Medicare Part B) Renal transplant surgery Oral or dental examination on an inpatient basis (Medicare Part A if performed by hospital-based dentist; Part B if performed by a physician) Table 4–1 summarizes Medicare’s limited coverage of dental services. The summary is based on HCFA policy statements rather than on sometimes conflicting carrier policies. HCFA has explicitly approved coverage exceptions for the extraction of teeth to prepare the jaw for radiation treatment of cancer (Carriers Manual, section 2136 [HCFA, 1999b]) and for an oral examination performed as part of a comprehensive inpatient work up prior to kidney—but not other organ—transplantation (Coverage Issues Manual section 50.26 [HCFA, 1999b]). HCFA has proposed additional exceptions based on arguments that the services would reduce the risk of infection and other complications, but its Technology Advisory Committee suggested that such exceptions (which would include some approved earlier) went further than the Medicare statute allowed and that Congress needed to indicate its approval of coverage based on such an argument (TAC, 1996). Neither the statutory nor the regulatory language related to coverage exceptions for dental services is straightforward to interpret.1 Moreover, carrier inter- 1   For example, HCFA’s Carriers Manual (section 2136 [HCFA, 1999b]) instructs carriers to pay “for a covered dental procedure no matter where the service is performed. The hospitalization or nonhospitalization of a patient has no direct bearing on the coverage or exclusion.” In HCFA’s Coverage Issues Manual (section 50–26), however, oral examinations by a dentist prior to a kidney transplant are covered under Part A of the program if performed by a dentist on the hospital’s staff but under Part B only when per

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Extending Medicare Coverage for Preventive and Other Services pretation is not always consistent. For example, at least one carrier’s policies appear to approve coverage for an oral examination not only for kidney transplant patients but also for heart, liver, and other covered organ transplants, whether performed on an outpatient or an inpatient basis (e.g., see Conway, 1995; WPSIC, 1996). DEFINING MEDICALLY NECESSARY DENTAL SERVICES The 1997 Balanced Budget Act, which provided for this study, included no definition of “medically necessary dental services.” One definition of such services is found in a bill submitted earlier in 1997 (but not passed). It called for coverage of “dental services that are medically necessary as a direct result of, or will have a direct impact on, an underlying medical condition if the coverage of such services is cost-effective” (H.R. 1288, introduced April 10, 1997). It also included explicit provisions for Medicare to cover dental care related to several specific illnesses. The bill’s language—minus the wording about cost-effectiveness—is similar to that used three years earlier in a bill that included “medically necessary oral health care” in a proposed set of “basic benefits” to be covered as part of broad health care reform (H.R. 3600, introduced May 1994). This earlier proposal also included oral care intended to control pain and infection and to restore function. The committee understands these definitions of medically necessary services—particularly the one proposed in 1997—to be narrowly constructed (1) to continue the general exclusion of Medicare coverage for dental care2 but (2) to broaden the scope of the exceptions to include dental care needed to prevent or effectively manage systemic conditions including the oral complications of specific illnesses or their medical treatment. Certainly, the prevention and management of oral infection have significant health implications when such infection has the potential to increase systemic morbidity in patients who are immunocompromised or otherwise at greater risk of adverse medical outcomes because of their underlying health problems. The importance of immunosuppression as a medical problem reflects scientific and     formed by a physician. This manual (unlike the Carriers Manual) also says that a dentist is not recognized as a physician when performing such an examination. 2   As defined in HCFA’s Carriers Manual (section 2136), dental care involves care limited to the teeth and the structures directly supporting the teeth. These structures are the periodontium (connective tissue surrounding the tooth root and attaching it to its socket), which includes the gingivae (gums), dentogingival junction, periodontal membrane, cementum of the teeth (layer of bone-like mineralized tissue that covers dentin and blends with fibers of the periodontium), and alveolar process, (projecting ridge on the upper and lower jaw containing tooth sockets). Thus, dental care is understood as involving not only the teeth but also parts of the oral cavity and the structures therein.

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Extending Medicare Coverage for Preventive and Other Services therapeutic developments that have occurred in the three decades since the adoption of Medicare. From the broader perspective of individual and public health, the coverage-oriented definitions of “medically necessary dental services” are unduly narrow. The concept that such care involves only care related to an “underlying medical condition” could suggest to some for example, that periodontal or other tooth-related infections are somehow different from infections elsewhere. More generally, such narrow definitions could imply that the mouth can be isolated from the rest of the body, a notion neither scientifically based nor constructive for individual or public health.3 Thus, the remainder of this chapter 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 and, more generally, of the difficulty of precisely defining such care in most contexts.4 (Appendix C includes further examination of the concept of “medically necessary dental services.”) Given the limited time and resources available, the committee could provide an evidence-based consideration of “medically necessary dental services” only for a subset of services that might qualify for this designation. The next section of this chapter reviews the approach the committee took to selecting and assessing specific medical conditions and associated dental services. The rest of the chapter reviews the evidence for each condition and presents the estimated costs to Medicare of covering the dental services examined. The final section summarizes the committee’s findings and its conclusions about Medicare coverage for the general category of dental care needed to prevent or effectively manage nondental illnesses or injury including oral complications of other therapies. The background paper commissioned by the committee is found in Appendix C. ASSESSMENT APPROACH: INTERVENTION, POPULATION, AND OUTCOMES The selection of conditions and services for assessment was guided in part by historical context. A few months before the passage of the 1997 Balanced Budget Act, legislation had been introduced, first, to cover a specific set of “medically necessary dental services” that were described as “cost-effective” and, more generally, to provide for future coverage of other services subsequently determined to “result in reductions in expenditures…that exceed expenditures resulting from such coverage” (H.R. 1288, April 1997). This latter 3   For a discussion of the inadequate integration of oral health care with other health care, see IOM (1995a). 4   The committee retained the term “dental” services rather than using a term that might perhaps seem more inclusive such as “oral health care” to maintain consistency with its charge and the language of the BBA.

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Extending Medicare Coverage for Preventive and Other Services requirement is quite stringent; generally, services are considered to be cost-effective (i.e., to have net benefits worth the costs) whether or not they produce cost savings that fully offset direct service costs. The more restrictive language reflects the rules that Congress has adopted requiring increases in spending in one area to be offset by cuts elsewhere or by increased taxes. The five conditions listed in the 1997 bill had been presented in prior analyses of health conditions that sought to identify those for which the cost of covering inpatient dental services would likely be offset by savings related to complications avoided, especially additional hospitalization (Cameron et al., 1995; Rutkauskas, 1995). The five conditions were head and neck cancer, leukemia, lymphoma, organ transplantation, and valvular heart disease. Although the Balanced Budget Act provisions calling for this study did not mention any particular conditions, the committee decided that those identified in the prior 1997 legislative proposal were a reasonable focus for its analyses. Table 4–2 summarizes current Medicare coverage (as specified by HCFA) of dental services for these conditions. Following the general approach set forth in Chapter 2, the committee began by defining the specific dental services that would be investigated for the five identified conditions. It assumed that these services follow referral from a physician caring for a patient with one of the designated medical conditions. The dental care normally provided for these conditions includes a mix of preventive services (e.g., oral examinations to detect infections that might compromise transplant outcomes, cleaning of the teeth to eliminate potential sources of infection) and treatment services (e.g., extraction of abscessed teeth or treatment of gingival or gum enlargement associated with use of cyclosporin). The specific services examined for each condition are described in Appendix C and later sections of this chapter. The population of interest includes Medicare beneficiaries age 65 and over as well as younger people qualified for Medicare on grounds of disability or diagnosis of end-stage renal disease (ESRD). Evidence related to all age groups was reviewed. The potential beneficial outcomes investigated include reduced mortality and morbidity due to more effective prevention or management of oral problems related to the five medical conditions or to complications of their treatment. More generally, dental care may improve patient knowledge of good oral health habits. In addition, dental care may bring quality-of-life benefits related to appearance and self-esteem and enjoyment or comfort in eating. Preservation of

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Extending Medicare Coverage for Preventive and Other Services teeth is clearly valued by many, although data on the value that people place on teeth—having most of their teeth, a few teeth, or no teeth, or having good versus bad teeth—indicate that the value varies in different cultural subgroups (Hollister and Weintraub, 1993; Slade et al., 1996; Strauss and Hunt, 1993). Potential harms of dental care include the possibility that such care may exacerbate infection or infection risks; cause pain, disfigurement, or functional impairment; or delay other treatment. The literature identified by the committee focused on morbidity (including pain and other discomfort) rather than on quality-of-life outcomes. TABLE 4–2 Summary of Dental Services Currently Covered and not Covered Under Medicare for Selected Diseases or Conditions Disease or Condition Dental Services Currently Covered Under Medicare Dental Services not Currently Covered Under Medicare Head and neck cancer Extraction of teeth prior to radiation Oral examination if extractions are to be performed Oral examination if no extractions are to be done prior to radiation Preventive care to reduce risk of radiation caries (e.g., fluoride trays, supplemental topical fluoride) Treatment of radiation caries Lymphoma and leukemia Management of mucositis, hemorrhage, and related side effects of underlying disease Oral examination prior to treatment Dental treatment to reduce risk of infection or eliminate infection prior to or following treatment Organ transplantation Management of infection following transplantation Oral examination prior to renal transplant surgery on an inpatient basis Oral examination for transplants other than kidney Outpatient oral examination performed by a dentist prior to kidney transplant Dental treatment to reduce risk of infection or eliminate infection for any transplantation prior to or following transplant Heart valve repair or replacement None Oral examination prior to repair or replacement Dental treatment to reduce risk of infection or eliminate infection prior to or following repair or replacement of valve

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Extending Medicare Coverage for Preventive and Other Services FIGURE 4–1 Evidence pyramid for assessing “medically necessary dental services.” SOURCE: Adapted from IOM/NRC, 1999, p. 89. To guide its assessment of the evidence about dental care for these five conditions, the committee adapted the evidence pyramid introduced in Chapter 2 as shown in Figure 4–1. One distinguishing feature of Figure 4–1 compared to the generic pyramid is that it requires a link between a nondental condition or treatment and either dental services or dental complications. The first tier of the pyramid refers accordingly to the relationship between the medical conditions listed earlier and oral health conditions. The relationship could be manifest either as an increased risk to oral health caused by the medical condition (or its treatment) or as an increased risk to systemic health related to poor oral health. The tiers above refer to the effectiveness of dental care in treating oral problems and improving outcomes for the medical condition. A test that met all of the criteria in Figure 4–1 would clearly have benefits compared to usual care, but the extent of benefit relative to the cost to Medicare, a health plan, or society generally would still have to be considered. The committee did not formally assess the cost-effectiveness of the dental services considered here. As called for by its charge, it did estimate the cost to Medicare of covering these services. Part of this analysis included identifying any offsetting savings to Medicare that might occur as a result, for example, of shorter or avoided hospital stays or reduced use of hyperbaric oxygen therapy for complications associated with treatment for head and neck cancer. HEAD AND NECK CANCER Burden of Disease Cancers of the head and neck are commonly defined to include primary or metastatic cancers involving the oral cavity, pharynx, and larynx5 but to exclude 5   The oral cavity includes the lips, the front two-thirds of the tongue, the lining of the cheeks and lips (buccal mucosa), the floor of the mouth, the gums (lower and upper gingiva), the hard palate, and the area behind the last molar. The pharynx or throat is the part

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Extending Medicare Coverage for Preventive and Other Services cancers invoving other parts of the head, notably the eyes, skin, thyroid, and brain. The treatments, as well as head and neck cancer itself, can have serious implications for the health of the patient. Cancers of the head and neck are more common among persons age 65 and older than among younger persons. Statistics often track invasive cancers of the oral cavity and pharynx and cancers of the larynx separately (SEER, 1999).6 These two categories of head and neck cancers account for approximately 2.6 and 1.6 percent, respectively, of all cancers. An estimated 29,800 new cases of cancer of the oral cavity and pharynx are expected to be diagnosed in 1999, more than 48 percent (or nearly 14,400) in people age 65 or older (ACS, 1999a). The age-adjusted incidence rate (1992–1996) in those diagnosed at age 65 or older is 45.0 per year per 100,000 population, compared to 6.5 per 100,000 in younger persons. Five-year relative survival rates (1989–1995) do not differ greatly by age—52.3 percent for those age 65 or older and 54.1 percent for younger persons. The lifetime risk of being diagnosed with cancers of the oral cavity or pharynx is 1.47 percent for men and 0.73 percent for women, while the lifetime risk of dying of this cancer is 0.41 percent for men and 0.23 for women. For cancer of the larynx, an estimated 10,600 new cases are expected in 1999, nearly 55 percent (or about 5,800) in patients age 65 or older. The five-year age-adjusted incidence rate in those age 65 or older is 19.7 per 100,000, compared to 2.3 per 100,000 in younger persons. Five-year relative survival rates again do not differ greatly by age—63.2 percent for those age 65 or older and 65.7 percent for younger persons. The lifetime risk of being diagnosed with cancer of the larynx is 0.72 percent for men and 0.18 percent for women, while the lifetime risk of dying of this cancer is 0.22 percent for men and 0.06 for women. Most cancers of the oral cavity, pharynx, and larynx are squamous cell carcinomas (affecting the outer layers of the tissue covering the cavity and structures). Epidemiological studies have repeatedly shown head and neck cancers to be positively associated with use of tobacco and alcohol, with both independent and interactive effects. Viral exposures and nutritional deficiencies also are associated with these cancers (reviewed in Carroll et al., 1998). A dentist or physician may detect cancers of the oral cavity and upper pharynx while the lesions are still asymptomatic. This is more likely for people undergoing regular oral examinations, although evidence has been described as     of the digestive tube lying between the esophagus and the mouth and nasal cavities. The larynx, which includes the vocal cords, lies below the pharynx and connects to the trachea or windpipe. 6   Unless otherwise indicated, data are from the most recent report of the National Cancer Institute’s Surveillance Epidemiology and End-Results Program (SEER), which is available at www-SEER.ims.nci.nih.gov/publications.

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Extending Medicare Coverage for Preventive and Other Services “insufficient” to justify recommendations for or against routine screening for oral cancer (USPSTF, 1996, p. 175). In general, however, patients with cancer of the head and neck tend not to be identified until the disease is fairly advanced.7 The exception is cancer of the vocal cords, where even a very tiny tumor will result in notable hoarseness and thus is likely to be noticed sooner (reviewed in Carroll et al., 1998). Treatment of Cancers of the Head and Neck Treatment for most cancers of the head and neck involves radiation, surgery, or a combination, although some chemotherapy is also used (see Appendix C, and Carroll et al., 1998). Treatment is a team effort, involving the head and neck medical oncologist, radiation oncologist, head and neck surgeon, dentist, and other personnel. Surgery to excise cancerous tumors can impair function and appearance. Dental services may be an integral part of treatments to reduce or correct such damage. Surgery can be especially difficult and risky around the fine structures of the larynx. As a result, clinicians have pressed ahead with the development of chemotherapy (often with radiation) for laryngeal cancers.8 Anticancer drugs in general work by inhibiting cell division in active tissues, which has the side effect of inhibiting healing and growth in the healthy tissue lining the mouth. The resulting irritation and inflammation of the oral mucosa is called mucositis, which can be treated by both physicians and dentists and is discussed further below. Radiation therapy is used with surgery for most cancers of the oral cavity and pharynx. Radiation, like chemotherapy, can affect both tumor cells and healthy cells. The damage to healthy tissue depends on the size and number of radiation doses and on the location of the tumor and the therapy. Radiation therapy can be from either an external source or an implant; in some cases, both are necessary (Carroll et al., 1998). The oral side effects of cancer treatment that result from drugs, radiation, and surgery will often be managed by the physicians or surgeons overseeing treatment. For instance, they may modify the dose of anticancer drugs, take a “break” in the course of radiation therapy, or prescribe therapeutic mouthwashes 7   Less regular care and later detection of cancers may partly explain the difference between black and white subpopulations in overall five-year survival rates for oral cavity and pharyngeal cancer (32 percent and 55 percent, respectively) (reported in Landis et al., 1999). Men are also somewhat less likely than women to have regular dental examinations (CDC, 1997) and tend to have more advanced disease at the time of diagnosis. 8   Some success with chemotherapy in combination with radiation—and without surgery—has been reported for some cancers of the larynx. Surgical removal of the larynx means loss of normal speaking ability. Chemotherapy has not been shown to be as effective in other head and neck cancer sites as radiation and surgery.

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Extending Medicare Coverage for Preventive and Other Services to allow serious mucositis to heal. In any case, such management would generally fall under the scope of practice for a physician and would therefore be covered even if delivered by a dentist. Radiation therapy has additional, and specifically dental, implications that are examined next. Oral Health Problems Associated with Radiation Treatment of Cancers of the Head and Neck Because radiation therapy disrupts cell division in healthy tissue as well as in tumor(s), it also affects the function and structure of the oral mucosa (lining of the mouth) and underlying organs and tissues such as salivary glands and bone. If directed at the lymph nodes in the jaw area, radiation may impinge in varying degrees on the salivary glands, which are very sensitive to radiation effects. Radiation can irreversibly damage these glands, resulting in insufficient production of saliva, known technically as xerostomia (dry mouth). Saliva is important to keep the oral tissues moist and to buffer the acidity of the oral environment, which is critical both to reducing bacterial growth and infection and to laying down new mineral deposits that keep the teeth strong and dense. After radiation, the teeth tend to become demineralized (more porous) and to develop cavities easily, a tendency so marked that it has the special name radiation caries. Radiation for head and neck cancer is also an important contributing factor in less common but very serious adverse consequences to the underlying bone. Especially in high or multiple doses, radiation affects bone by injuring the small vessels that supply blood to the cells in the bone, so that these cells die. The death of bone cells means that remodeling, which occurs continuously in healthy living bone tissue, proceeds very slowly, as does healing, with the result that the bone becomes susceptible to infection. The bone cell death resulting from radiation is called osteoradionecrosis (ORN). In head and neck radiation, the lower jaw or mandible is the most susceptible because it is a very dense bone, having a relatively low proportion of cells and blood supply to start with. ORN can require surgery to excise the dead tissue, which can in turn leave the jaw and face badly disfigured as well as functionally impaired—with serious consequences for the patient’s quality of life. The likelihood of ORN is increased by trauma to the bone, including the trauma to the jawbone caused by a tooth extraction (Murray et al., 1980a,b, reviewed in Appendix C). The effect of such trauma on the risk of ORN is especially marked when the extraction or other trauma occurs near (before or after) the time of the radiation (Epstein et al., 1987, reviewed in Appendix C). This occurs presumably because the radiation damage to blood vessels makes healing a recent extraction wound more difficult.

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Extending Medicare Coverage for Preventive and Other Services Dental Care for Patients Undergoing Radiation Therapy for Cancer of the Head and Neck Thirty years ago, the standard of care for patients with head and neck cancer involved extracting teeth before beginning radiation therapy. HCFA has ruled that this treatment meets the criteria for coverage as an exception to Medicare’s general exclusion of dental care, even though extraction is generally carried out as a separate step rather than as an integral part of the radiation therapy. The rationale for covering such extractions was that tooth removal would preclude radiation-related caries and the possible later need for extractions that would increase the risk for ORN. In the 1970s, however, dentists began to experiment with aggressive tooth-sparing approaches to dental care before, during, and after radiation therapy for head and neck cancer. The new approach to care called for a preradiation program to improve and protect the patient’s oral health through an evaluation, careful oral hygiene, fluoride applications, restoration of the teeth that were salvageable, and removal of unrestorable or periodontally diseased teeth with adequate healing time if possible. During and after radiation, this approach called for the patient to continue very thorough oral hygiene and home fluoride treatments. After radiation therapy, the dentist provides further monitoring and restoration as needed (Keys and McCasland, 1976, as reviewed in Appendix C). None of the care involved in this tooth-preserving approach is covered by Medicare unless an extraction occurs prior to radiation, in which case the oral examination may also be covered. Absent unexpected negative research findings, the role of tooth-preserving therapy should continue to increase. Surveys of the population ages 65 to 74 taken in 1971–1974 and in 1985–1986 show that the percentage of older persons who have lost all their teeth dropped from 45 to 41.1 percent, a trend that has continued (Bloom et al., 1992; Marcus et al., 1996; MMWR, 1999; NIDR, 1987). In recent years, approximately 33 to 43 percent of patients diagnosed with head or neck cancers have already lost all their teeth (Appendix C; Lockhart and Clark, 1994; Niewald et al., 1996, Roos et al., 1996). Of those retaining some teeth, the average patient still possesses only about a third of the full complement of 32 adult teeth, and most have accumulations of plaque and some tooth decay (Lockhart and Clark, 1994; Niewald et al., 1996). The challenge is how best to manage such patients to minimize further dental and medical problems—including loss of additional teeth, bone destruction, surgical treatment, functional impairment, and disfigurement—associated with radiation therapy for patients with head and neck cancer.

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Extending Medicare Coverage for Preventive and Other Services million. This estimate takes into account $5.6 in offsetting savings from reduced medical care costs and $51.9 million in offsets related to increases in the Medicare premium that would result from increased Medicare spending for the elderly. The main procedures likely to be needed by patients with the five medical conditions are similar: examination and diagnostic radiographs; restorations where possible; extractions where restoration is not an option; and treatment of periodontal, gingival, and periapical disease. The overall cost per patient is driven primarily by the number of visits that each patient would be likely to need. The average number of dental visits per patient is based on the judgment of committee members and background paper authors. Except for head and neck cancer patients undergoing radiation therapy, visits were assumed only for patients with teeth. Head and neck cancer patients are typically examined to identify any retained tooth roots, impacted teeth not detected by visual inspection, and any residual bone pathology warranting treatment prior to radiation therapy. The proportion of older people with no teeth appears to have been declining (Bloom et al., 1992; Marcus et al., 1996; MMWR, 1999) and could reach lower levels for the period 2000–2004. This would mean more dental examinations and higher costs. The number of Medicare beneficiaries likely to experience one of the conditions mentioned was estimated using Medicare or Surveillance Epidemiology and End-Results (SEER) incidence data for the conditions applied separately to the aged and disabled Medicare Part B beneficiaries. The cost estimates assume coverage only for the year of the transplant procedure or other surgery, radiation therapy, or chemotherapy, although some patients (e.g., transplant recipients taking immunosuppressive drugs) will be at risk indefinitely. Longer periods of coverage would raise the estimates. Payments were calculated on a per-visit basis, based on 1987 data from the National Medical Expenditure Survey. Figures were adjusted to reflect the increased intensity of service likely for the treatment population compared to the general population. The figures were also adjusted for inflation since 1987 and for expected Medicare discounts, copayments, and Medicare premium offsets (see Appendix E). The cost per visit was then multiplied by the expected average number of visits per patient. Based on the research described earlier in this chapter and in Appendix C, offsetting savings due to the dental services (as opposed to increases in Medicare premiums) were applied only for head and neck cancer. As discussed in Appendix E, previous HCFA and CBO estimates of the cost to Medicare of extending coverage of medically necessary dental treatments have included a broader range of conditions and services than the committee’s estimates.

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Extending Medicare Coverage for Preventive and Other Services STATEMENTS OF OTHERS ON “MEDICALLY NECESSARY DENTAL SERVICES” The U.S. Preventive Services Task Force did not examine the narrowly focused kinds of services examined in this chapter. It has examined counseling to prevent dental and periodontal disease and stated that “counseling patients to visit a dental care provider on a regular basis, floss daily, brush their teeth daily with a fluoride containing toothpaste, and appropriately use fluoride for caries prevention and chemotherapeutic mouth rinses for plaque prevention is recommended based on evidence for risk reduction from these interventions” (USPSTF, 1996, p. 711).12 It also stated that “while examining the oral cavity, clinicians should be alert for obvious signs of oral disease” (p. 711), but it concluded that there was “insufficient evidence to recommend for or against routine screening of asymptomatic persons for oral cancer by primary care clinicians.” (p. 175). The House of Delegates of the American Dental Association (ADA) has defined “medically necessary dental care” to include care to control or eliminate infection, pain, and disease and has resolved that the ADA “make every effort on behalf of patients to see that the language specifying treatment coverage in health plans be clarified so that medical necessary adjunctive care, essential to the successful treatment of a medical condition being treated by a multidisciplinary health care team, is available to the patient” (Conway, 1995, p. 188). The ADA endorsed the AHA recommendations related to endocarditis (see below). It also recommended more research on specific heart conditions and dental procedures, following the publication of a recent study in Annals of Internal Medicine (Strom et al., 1998) that concluded that dental treatment did not appear linked to infective endocarditis and that antibiotic prophylaxis should be reconsidered. An accompanying editorial encouraged the AHA, the Infectious Diseases Society of America, and others to rise to the challenge of crafting appropriate new recommendations (Durack, 1998). To prevent bacterial endocarditis, the American Heart Association has recommended prophylactic regimens for high- and moderate-risk patients undergoing dental, oral, respiratory tract, or esophageal procedures (Bonow et al., 1998). The recommendations related to dental practice were, as noted above, endorsed by the ADA’s Council on Scientific Affairs. The recommendations were based on retrospective studies, animal studies, and in vitro susceptibility data. The AHA noted, however, that no randomized and carefully controlled human trials had established the effectiveness of antibiotic prophylaxis in protecting against endo- 12   For a population with additional health problems who would presumably be more motivated, counseling about dental hygiene would be presumed to be equally or more effective. For example, interviews with 60 liver transplant patients transplanted between 1992 and 1996 found that 75 percent reported having sought a yearly dental examination, one of the higher levels of preventive behavior reported (Zeldin et al., 1998).

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Extending Medicare Coverage for Preventive and Other Services carditis in patients with underlying structural heart disease. It also noted that most cases of endocarditis are not attributed to invasive procedures. In addition to recommendations relating to antibiotic prophylaxis, the AHA has recommended that those at risk for bacterial endocarditis should establish and maintain the best possible oral health to reduce the potential for bacteremia. They should seek regular professional care and undertake thorough self-care, including brushing of teeth, use of dental floss, and other plaque-removal techniques. For patients undergoing cardiac surgery (e.g., heart valve repair), the AHA recommended a careful preoperative evaluation and the completion of required dental treatment before cardiac surgery whenever possible to reduce the potential for late postoperative endocarditis. The American Society of Transplantation (formerly the American Society of Transplant Physicians) developed guidelines for evaluating renal transplant candidates. These include recommendations to identify and treat overt infections and assess patients for possible occult infections including dental caries (Kasiske et al., 1995). The National Institutes of Health held a Consensus Development Conference on Oral Complications of Cancer Therapies: Diagnosis, Prevention, and Treatment in 1989 (NIH, 1989). Conclusions included that (1) all cancer patients should have an oral examination before initiation of cancer therapy; (2) treatment of preexisting oral disease is essential to minimize oral complications in all cancer patients; (3) prophylactic acyclovir is beneficial in selected patients to prevent HIV reactivation. (4) precise diagnosis of mucosal lesions and specific treatment of fungal, viral, and bacterial infections are essential; (5) mucosal ulcerations should alert the cancer team to the risk of systemic infection; (6) the best current treatments for chronic xerostomia include fluorides, attention to oral hygiene, and sialagogues (agents that promote the production of saliva); (7) osteoradionecrosis can be prevented and, when present, is best managed with hyperbaric oxygen alone or with surgery; and (8) in the pediatric population, it is important to recognize the long-term consequences of radiation therapy, which include dental and developmental abnormalities and secondary malignancies. Given the limited research base, the conference also recommended that studies of oral complications be incorporated into ongoing and future cooperative clinical oncology group protocols. In 1999, the National Institute of Dental and Craniofacial Research (NIDCR), one of the National Institutes of Health, launched a health awareness campaign: Oral Health, Cancer Care, and You: Fitting the Pieces Together. Partners in this campaign include the National Institute of Nursing Research (NINR), the Centers for Disease Control and Prevention (CDC), the National Cancer Institute (NCI), and the Friends of the NIDCR. Materials are available through the National Oral Health Information Clearinghouse, an information dissemination service of NIDCR. The campaign promotes medically necessary oral care prior to, during, and after cancer treatment to prevent or reduce the

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Extending Medicare Coverage for Preventive and Other Services incidence and severity of oral complications, enhancing both patient survival and quality of life (NIDCR, 1999). COMMITTEE FINDINGS AND CONCLUSIONS The committee utilized the extensive review of literature provided by the panel of background paper authors, four experts in dental research. The committee also benefited from a two-day public workshop featuring many guest speakers and attended by members of the public with expertise in dental research and hospital-based dental practice (see Appendix A). Unfortunately, little systematic research is available to assess the prevention and management of the oral-medical problems examined in this chapter.13 Standards of practice for these problems have been developed, often on the basis of plausible biological reasoning but without much evidence from well-controlled clinical trials. The committee’s findings, as discussed in this chapter, are summarized briefly below. Its conclusions about Medicare coverage follow. Findings Cancers of the Head and Neck Disease Burden. The committee found that cancers of the head and neck are relatively common, accounting for approximately 3.3 percent of the total estimated new cancers for 1999 and about 4 percent of overall cancer prevalence. Of the estimated 40,000 new cases reported each year, almost half are diagnosed in patients age 65 or older. Treatment is associated with serious oral health risks including damage to the salivary glands, radiation-related caries, and osteoradionecrosis. Dental Care Effectiveness. The committee found that standard clinical practice for head and neck cancer patients anticipating radiation to the jaw includes reliable identification of active and potential oral health problems for which effective management exists. Evidence is limited but supports the effectiveness of tooth-preserving regimens—especially the role of topical fluoride applications—for head and neck cancer patients prior to and after radiation therapy. Evidence suggests the tooth-preserving approach (not covered by Medicare) is associated with lower rates of ORN and, thus, overall better patient outcomes than the older strategy that emphasized tooth extractions (covered by Medicare). 13   An earlier IOM report found a relatively weak base of systematic oral health research, including in university settings that are strong contributors to medical research (IOM, 1995a).

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Extending Medicare Coverage for Preventive and Other Services Benefits Versus Harms. The committee found evidence suggesting that tooth-preserving therapies are preferable to full mouth extraction not only in limiting ORN but also in avoiding some of the functional and quality of life problems associated with tooth loss. Not all patients, however, are able to adhere to the rigorous hygiene and fluoride treatment programs required by this strategy. To the extent that such patients can be identified prior to therapy, these individuals may benefit more from full mouth extraction to avoid the greater risk of extractions after radiation. Both classes of patients, however, benefit from oral examination and assessment. The committee found no types of patients that would be more likely to suffer harm from oral examination and appropriate treatment compared to no oral care. Leukemia Disease Burden. The committee found that leukemia is a relatively common form of cancer, with approximately 30,000 new cases reported annually. The incidence rate in the population age 65 or older is much greater than that in the under age 65 group, and survival rates are lower than for younger people. Leukemia patients, who are often immunosuppressed from their disease, are especially susceptible to septicemia, which is a leading cause of death. Oral health problems are common from both the disease and its treatment. Chemotherapy can cause mucositis, which can lead to serious secondary and systemic infections. Another treatment, bone marrow transplantation, also can result in oral health problems such as xerostomia, oral lesions, and oral infections, which may contribute to systemic infection. Dental Care Effectiveness. The committee found that standard clinical practice includes reliable identification of active and potential oral health problems for which effective dental and medical management exists. The committee found clinical experience to be suggestive that dental cleaning and restoration or extraction services are effective in reducing oral infection in leukemia patients as in other patients. Limited direct evidence from small studies suggests that dental treatments for leukemia patients prior to chemotherapy that is focused on the elimination of acute oral infection and prevention of bacteremia may (a) prevent or reduce subsequent episodes of septicemia and (b) prevent or reduce the severity of the common oral complications of chemotherapy associated with a prior burden of oral disease. Benefits Versus Harms. In addition to the scarcity of direct evidence about the systemic benefits of dental treatment, patient perspectives on possible benefits and harms of dental treatments related to the overall management of leukemia have not been explicitly assessed. To the extent that dental care helps to eliminate oral sources of infection and reduce patient discomfort and dys-

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Extending Medicare Coverage for Preventive and Other Services function, the committee finds it biologically plausible that dental care promotes a better overall health outcome. An experienced oncologist is in the best position to judge whether a particular leukemia patient should be referred to a dentist for further examination and treatment, taking into account the risk of any delay in the initiation of chemotherapy. Lymphoma Disease Burden. Lymphoma is more common than cancers of the head and neck or leukemia, with approximately 64,000 new cases of lymphoma reported in a year, approximately 57,000 of which are non-Hodgkin’s lymphoma. The incidence rate in the population age 65 or older is almost eight times higher for non-Hodgkin’s lymphoma and is somewhat higher for Hodgkin’s disease, compared to the population under age 65. Survival rates are lower in older people. Both non-Hodgkin’s lymphoma and Hodgkin’s disease are treated with radiation and often chemotherapy as well (especially Hodgkin’s disease), so the treatment can result in increased oral health problems such as mucositis and dental caries due to xerostomia. Dental Care Effectiveness. The committee found that standard clinical practice includes reliable identification of active and potential oral health problems for which effective dental and medical management exists. The committee located no published clinical trials providing direct evidence that dental care improves health outcomes of treatment for non-Hodgkin’s lymphoma or Hodgkin’s disease or prevents or reduces the severity of treatment-related oral problems. The committee found clinical experience to be suggestive that reduction of oral sources of infection by extraction of abscessed teeth and periodontal cleaning prior to chemotherapy may prevent some septicemias in patients with non-Hodgkin’s lymphoma or Hodgkin’s disease. Benefits Versus Harms. In addition to the lack of direct evidence about health benefits, patient perspectives on possible benefits and harms of dental treatments related to the overall management of lymphoma patients have not been explicitly assessed. To the extent that dental care helps to reduce oral infection and patient discomfort, the committee finds it biologically plausible that dental care promotes a better overall health outcome. Organ Transplantation Disease Burden. The committee found that organ transplants occur less frequently than the cancers mentioned earlier, but they have become much more common in the last 15 years, with about 20,000 organ transplants performed in the United States annually. All organ transplant recipients require some level of

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Extending Medicare Coverage for Preventive and Other Services immunosuppressive therapy, especially at the time of and just after the transplant operation, and they are therefore more susceptible to infection. The committee found no data, however, documenting infections from specifically oral sources in immunosuppressed transplant patients. Regarding the treatment following a transplant, the committee noted that gingival overgrowth is a well-known adverse effect of some immunosuppressive drugs, although it is less severe with newer products and must be managed by a physician or dentist along with other adverse drug effects. Dental Care Effectiveness. The committee found that the standard clinical practice of preparing a patient to receive a transplant includes reliable identification of active and potential oral health problems for which effective dental and medical treatments exist. The committee located no published clinical trials providing direct evidence that dental care improves health outcomes for transplant recipients. Clinical experience suggests that dental cleaning and restoration or extraction services are effective in reducing oral infection in transplant candidates, as in other patients. In general, however, controlled studies have not evaluated the overall strategy of identifying and eliminating infection prior to transplantation. The approach is based on biological principles and experience. Benefits Versus Harms. In addition to lack of direct evidence of systemic benefits, patient perspectives on possible benefits and harms of dental treatments related to the overall management of transplant surgery and maintenance have not been explicitly assessed. To the extent that it helps to reduce oral infection, the committee finds it biologically plausible that dental care promotes a better overall health outcome. Heart Valve Repair and Replacement Disease Burden. The committee found that the number of hospital stays involving heart disease paid for by Medicare has been increasing and had reached 58,800 by 1995. Endocarditis was specifically reported in 4,950 of these cases. The committee found that valvular disease causes a substantial disease burden in the Medicare population and that endocarditis, although relatively uncommon, is associated with significant mortality and morbidity. Clinicians have observed an association between oral disease (gingivitis, periodontitis, periapical disease) and endocarditis. Dental Care Effectiveness. The committee found that the standard clinical practice for preparing a patient for valve surgery includes reliable identification of active and potential oral health problems for which dental and medical treatments exist. Clinical experience is suggestive that cleaning and restoration or extraction services are effective in reducing infection in patients preparing to

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Extending Medicare Coverage for Preventive and Other Services undergo valve surgery, as in other patients. The committee located no published clinical trials providing evidence that dental care improves the overall health outcome of patients undergoing valve surgery. In addition, the committee found no controlled studies demonstrating that dental procedures increase the incidence of endocarditis by introducing oral bacteria into the bloodstream, although the committee did find the model to be biologically plausible. Poor oral health may, however, produce bacteremia in the course of routine activities such as tooth brushing or chewing. Benefits Versus Harms. In addition to the lack of direct evidence of systemic benefit or harm, patient perspectives on possible benefits and harms of dental treatments related to the overall management of patients undergoing valve surgery have not been explicitly assessed. To the extent that dental care helps to reduce oral infection, the committee finds it biologically plausible that dental care promotes a better overall health outcome. Possible Directions for Future Research The committee identified several areas in which further research would be helpful, although it did not attempt to set priorities. In general, it was disappointed to find so little evidence documenting the effectiveness of accepted clinical practices in the oral health care of patients with leukemias, lymphomas, cardiac valvular disease planned for valve replacement or repair, and organ transplants. Lack of evidence is not itself evidence that the current standards of care are inappropriate, but it does point to the desirability of studies that could help assess the benefits and harms of that care.14 Widespread acceptance of such standards, coupled with the biological plausibility of the clinical protocols for identifying and eliminating infections, may however make controlled studies difficult to design and carry out. Nonetheless, the recent retrospective case-control study of antibiotic prophylaxis to prevent endocarditis in patients with various heart conditions suggests that some trials could in fact be devised to clarify practice within standards of appropriate scientific and ethical rigor (Strom et al., 1998). Given the risk of infection and grave outcomes for such patients, the committee encourages efforts to devise and implement such studies. For example, a prospective study designed to control for differences in patient populations and other factors could compare hospitals that 14   As this report was being completed, under an Intra-Agency Agreement between the NIDCR and the AHCPR, AHCPR awarded a three-year contract to the Evidence-Based Practice Center from the Research Triangle Institute/University of North Carolina at Chapel Hill (RTI-UNC) to produce both comprehensive evidence reports and/or limited reviews on topics identified by the NIDCR. The aim is to strength the scientific basis for the diagnosis and management of dental, oral, and craniofacial conditions.

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Extending Medicare Coverage for Preventive and Other Services include a dental examination and indicated treatment as part of standard preoperative care for cardiac surgery patients with those that rely on physicians to identify patients with dental problems needing further evaluation and treatment. Controlled research is also feasible to test the effectiveness of different dental care protocols for leukemia and lymphoma patients prior to or during chemotherapy. Research on education and other strategies to encourage patient adherence to self-care regimens is important in dental care as in other areas. For example, even at the risk of tooth loss and bone damage, some patients who have undergone radiation therapy for cancers of the head and neck do not follow the recommended but very rigorous self-care routines, which may result not only in worse health outcomes but also in higher Medicare costs. The committee was interested in emerging reports linking improved oral health to improved health outcomes for people with systemic conditions not evaluated in this study. A primary example is diabetic patients for whom treatment of periodontal infection is associated with better blood glucose control (Grossi et al., 1997; Grossi and Genco, 1998; Westfelt et al., 1996). Given the prevalence of diabetes and its significance as a problem among older adults, further study of the implications of oral health status and the effect of dental care should be encouraged. In addition, the link between oral health and coronary artery disease and stroke remains an important area for further research (Beck et al., 1996). With new research suggesting a relationship between oral health status and pneumonia (an important cause of mortality and morbidity in older people), further investigation of this link and of the effectiveness of dental care and oral hygiene in preventing pneumonia also is warranted (Limeback, 1998; Scannapieco, 1999; Yonayama et al., 1999). Finally, although AIDS patients constitute a relatively small proportion of Medicare beneficiaries, the burden of suffering associated with oral problems is significant. The contribution of dental care to better health status and quality of life has so far been little studied (Capilouto et al., 1991; Migliorati et al., 1994). The results of new research on the relationships between oral and systemic diseases for these and other medical conditions not studied in this report could inform both clinical practice and future coverage policies. Conclusions The committee concluded that the direct evidence to support coverage for “medically necessary dental services” varies depending on the medical condition to which dental services are related. Such evidence is, in general, lacking rather than negative or ambiguous. More and better research is needed on the systemic implications of dental problems and dental interventions to guide clinicians in

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Extending Medicare Coverage for Preventive and Other Services caring for people with serious health problems and policymakers in supporting financial access to effective care. Although no large randomized clinical trials have investigated outcomes of dental care for head and neck cancer patients receiving radiation therapy to the jaws, the committee concluded that small retrospective studies of patients treated before and after implementation of tooth-preserving protocols provide limited direct evidence that the replacement of tooth extraction protocols with tooth-preserving protocols prior to radiation can reduce xerostomia-induced radiation caries and associated postradiation tooth extractions that place patients at high risk for osteoradionecrosis. Other retrospective analyses show higher rates of ORN for patients with inadequate dental care and preradiation extractions. HCFA has approved coverage of extractions but not of tooth-preserving strategies. 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 cover both tooth-preserving care and extractions, which may be medically appropriate for certain patients. Patients should be referred for dental examinations by their oncologist. The committee also concluded that weak direct evidence suggests that the provision of dental care targeted 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 the 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 would be referred to a dentist 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. Direct evidence through controlled clinical trials is lacking rather than negative or ambiguous. Indirect evidence and biological plausibility are suggestive that health outcomes may be improved by the elimination of oral sources of infection that may cause septicemia in the immunosuppressed lymphoma or organ transplant patient or endocarditis in the patient with a diseased, abnormal, or surgically repaired or replaced heart valve. Dental services for persons with these life-threatening illnesses do not differ from currently covered medical services that are considered prudent care but for which no controlled clinical studies exist. Widely accepted clinical protocols for identifying and eliminating all infections and potential sources of infection before transplantation are based largely on biological principles, animal studies, and clinical experience, not controlled tri-

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Extending Medicare Coverage for Preventive and Other Services als. The committee’s conclusion does not negate the value of clinical judgment in selecting appropriate individual patients for such interventions. Although the evidence base for “medically necessary dental services” is mixed and frequently based on weak research designs, the committee is concerned about interpretations of the current law that could preclude HCFA from approving further coverage exceptions for dental services to identify and eliminate oral infections or potential sources of infection for immunocompromised high-risk patients. As noted earlier, widely accepted clinical protocols for identifying and eliminating all infections and potential sources of infection before transplantation are based on biological principles and clinical experience, not controlled trials. The committee is also concerned about legislative proposals requiring that “medically necessary dental services” produce savings that exceed the direct costs of care. As described in Chapter 5, even elimination of the three-year limit on coverage of immunosuppressive drugs—drugs that clearly improve outcomes for transplant recipients—is unlikely to meet this standard. Given the scientific and therapeutic advances since the creation of Medicare in 1965 and the concerns about current coverage interpretations, the committee concludes that it is reasonable for Congress to update the statutory language relating to coverage of dental services so that it would clearly cover dental care that is effective in preventing or reducing oral and systemic complications associated with serious medical conditions and their treatment. 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 dental services needed in conjunction with surgery, chemotherapy, radiation, or pharmacological treatment for a life-threatening medical condition. The phrase “in conjunction with” would allow HCFA to limit the window of coverage to a specified period before or after surgery or other treatment but would not require that the services be provided at the same time as or as an immediate part of a surgical or other procedure. This minimal revision in the 1965 exclusion of coverage for dental services would not alter Medicare’s basic focus on treatment of acute illness or injury. If Medicare were to cover “medically necessary dental services” for some or all of the medical conditions reported here, it is uncertain how many beneficiaries in each category would avail themselves of this benefit. The referral for “medically necessary dental care” would likely come from the treating physician at the time of diagnosis or planning of the medical therapy. The patient’s physician would in this way serve as a gatekeeper for this benefit, especially among patients who are not under regular dental care. In addition, physicians would continue to manage many oral problems themselves, for example, by prescribing antibiotics and therapeutic rinses.