7
Financing of Genetic Testing and Screening Services

The cost and financing of genetic testing and counseling have had a profound impact on access to these services in the United States (OTA, 1992b). No matter what aspect of genetics is discussed, it is almost impossible to keep the discussion from turning to issues related to financing of genetic testing services, in particular the role of health insurance in genetic testing and counseling.

The United States is the only developed country in the world without a social insurance or statutory system to cover basic expenses for medical services for most or all of its population (Fields and Shapiro, 1993).1 This creates problems of access and equity, especially for low-income or high-risk individuals who are self-employed, work part-time, or are employed by small businesses and who may not be able to afford or obtain health insurance. More than 36 million people are without health insurance coverage in the United States (EBRI, 1993, p. 1).

Current activities in health insurance reform may obviate some concerns about health insurance discrimination related to genetic testing and the use of genetic information. The Ethical, Legal, and Social Implications Program (ELSI) Task Force on Insurance and Genetic Testing (ELSI Insurance Task Force, 1993)2 has already submitted its concerns to President Clinton's health insurance reform committee. Health insurance reform proposals will need to be evaluated to determine whether they adequately protect genetic information and persons with genetic disorders from discrimination and other potential social, legal, and ethical harms related to health insurance and the use of genetic information (see Chapter 8).

Even for those who have health insurance, coverage for most preventive, screening, and counseling services may be excluded. These limitations of U.S. health care coverage particularly affect genetics services, which have an impor-



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Assessing Genetic Risks: Implications for Health and Social Policy 7 Financing of Genetic Testing and Screening Services The cost and financing of genetic testing and counseling have had a profound impact on access to these services in the United States (OTA, 1992b). No matter what aspect of genetics is discussed, it is almost impossible to keep the discussion from turning to issues related to financing of genetic testing services, in particular the role of health insurance in genetic testing and counseling. The United States is the only developed country in the world without a social insurance or statutory system to cover basic expenses for medical services for most or all of its population (Fields and Shapiro, 1993).1 This creates problems of access and equity, especially for low-income or high-risk individuals who are self-employed, work part-time, or are employed by small businesses and who may not be able to afford or obtain health insurance. More than 36 million people are without health insurance coverage in the United States (EBRI, 1993, p. 1). Current activities in health insurance reform may obviate some concerns about health insurance discrimination related to genetic testing and the use of genetic information. The Ethical, Legal, and Social Implications Program (ELSI) Task Force on Insurance and Genetic Testing (ELSI Insurance Task Force, 1993)2 has already submitted its concerns to President Clinton's health insurance reform committee. Health insurance reform proposals will need to be evaluated to determine whether they adequately protect genetic information and persons with genetic disorders from discrimination and other potential social, legal, and ethical harms related to health insurance and the use of genetic information (see Chapter 8). Even for those who have health insurance, coverage for most preventive, screening, and counseling services may be excluded. These limitations of U.S. health care coverage particularly affect genetics services, which have an impor-

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Assessing Genetic Risks: Implications for Health and Social Policy tant counseling component. As discussed below, insurance reimbursement or other financing for genetic diagnosis, testing, and screening, and essential genetic counseling, is not generally available now in the United States. Moreover, the committee heard testimony at its public forum that individuals whose insurance does cover some or all genetic services may be reluctant or unwilling to file claims for such services. They may fear that the information they seek might be used to evaluate and deny their future applications for health or life insurance coverage, or might lead to higher premiums or limited coverage. Because much coverage in the United States is employment based, people may also worry that their employer will have access to the information and use it (overtly or covertly) to discriminate against them (Fields and Shapiro, 1993). Even the casual conversation of medical personnel, human resources staff, and others about genetic information may affect insurance coverage if such information is reflected in medical records or in the personnel system of self-insured companies. To avoid such impact on insurability, some genetic counselors report that they routinely advise their counselees not to seek insurance reimbursement because of the potential risk to future health and life insurance coverage for them and their families (OTA, 1992c). However, if the information is subsequently sent to primary care practitioners for follow-up care and entered in the patient's medical record, insurers may then have access to that information even if they did not reimburse for the test itself. Many people seeking genetic testing and/or genetic counseling now pay ''out-of-pocket" for such services, either because they do not have insurance coverage for such services, or because they fear the consequences of having such information known to their insurance companies or to others. To keep information about genetic testing from reaching insurers, physicians are sometimes being requested to set up separate patient records (as is now sometimes done for records of treatment for AIDS or mental disorders). When people do pay out-of-pocket for genetic diagnosis and testing, they often pay a substantial sum, especially if the testing requires complex linkage analysis. The cost of complex family studies involving linkage analysis ranges from $500 to $4,000, depending in part on the number of tests and the size of the family. The person seeking the testing must be able to pay the full costs of the testing for all relatives, or the testing may not be performed. Direct DNA testing of individuals can be considerably less expensive; such tests now cost from $50 to more than $900 per test. Future costs for DNA tests could be even lower with automation and more widespread testing, and costs of $50 to $150 for a panel of six or more DNA tests are now being discussed; however, patents and royalties resulting from the patenting and licensing of genes and gene products have the potential greatly to increase the cost of such testing, as has already occurred in DNA tests for cystic fibrosis (Beaudet, 1992). These cost estimates for direct DNA analysis do not include any of the costs of interpretation, education, and genetic counseling prior to and/or following direct DNA testing (see Chapter 4).

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Assessing Genetic Risks: Implications for Health and Social Policy Genetic counseling is generally not reimbursed directly by health insurers unless the counseling is provided or billed by a physician, although the counseling may be done by a counselor or nurse under the supervision of the physician. However, genetic education and counseling are time-consuming activities, and some physicians may not take the time or have the training required to provide these critical genetic testing services, and they also may not have appropriately trained staff. Genetic counseling is, in some instances, reimbursed indirectly as a hidden cost of the genetic testing process. Under the current reimbursement approach, genetic counseling is not recognized by third-party payers as a necessary component of any genetic diagnosis, testing, or screening procedure. Because of these reimbursement limitations, genetic testing and counseling are often accessible only to the middle class and wealthy—those with enough discretionary income to pay for genetics services out-of-pocket. WHO PAYS FOR GENETIC TESTING AND COUNSELING? Although only limited data have been available on who now pays for genetic testing and genetic counseling, third-party reimbursement for genetics services has been relatively rare. Problems of underinsured and uninsured families, and financial support for genetics services, were ranked as among the top priority issues in their respective states by state genetics services coordinators who were asked about the most important issues in genetics services facing patients and families in a 1991 Council of Regional Networks for Genetic Services survey (CORN, 1991). Many genetics services have difficulty meeting traditional standards for reimbursement by third-party payers. Until their value has been established scientifically, new genetics services are excluded as "investigational" (see below). Yet even when a service is no longer investigational, insurers may refuse reimbursement on the grounds that it is not "medically necessary" for the diagnosis or treatment of an illness. Genetic testing and screening services generally differ from diagnostic medical testing that occurs after a patient develops symptoms. Because genetic testing is often performed on asymptomatic people with a family history of the disorder, many patients report that their claims for insurance reimbursement are denied (OTA, 1992b). Geneticists, in contrast, may feel that such tests are necessary based not only on the patient's family history, but also on (1) membership in a population subgroup (by race or ethnicity) that is at a higher risk than the general population for developing a particular disorder themselves or in their offspring; (2) increased risk associated with pregnancies in women of advanced age (usually age 35 and over); and (3) screening of pregnancies for increased risk of neural tube defects, regardless of the mother's age, in order to determine whether increased risk warrants offering further prenatal genetic testing. In the future, population-wide ge-

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Assessing Genetic Risks: Implications for Health and Social Policy netic screening may be warranted, and that will require the development of appropriate reimbursement policy as well. Genetic screening may thus follow the path of certain other screening and preventive services such as mammography or immunization, which are increasingly becoming part of health insurance plans; however, counseling raises another dimension for reimbursement of genetic testing services that differs from these other screening and preventive health services. Newborn screening is another type of genetic testing for which insurance reimbursement has been limited. In the past, most states paid directly for newborn screening tests, but now more than half the states bill the birth hospital (or more rarely the birth physician or even the parents) for the cost of newborn screening (CORN, 1992). They leave the hospital (or doctor) to collect from whatever third-party coverage the parents may have. Insurance companies, however, have resisted paying for such screening in many states, so the hospitals must somehow absorb the expense (S. Panney, Maryland Department of Health and Mental Hygiene, personal communication, 1993). There are a few sources of noninsurance funding for genetics services that will reimburse out-of-pocket costs for persons without health insurance or whose insurer will not reimburse for genetic testing and counseling. Some academic laboratories have special research funding, some programs have state grants-in-aid (including funding from the Maternal and Child Health block grant funds to the states), some programs have limited private foundation funding, and some programs receive financial assistance available from genetic support groups. Such alternative sources of funding are not consistently available. However, much of the complex genetic linkage analysis today is performed in academic research laboratories, and some of these laboratories bill patients for such services. Even if the proband has insurance that would cover individual genetic testing and linkage analysis, his or her insurance company may not pay for genetic testing and linkage analysis for the whole family. Extended family members are likely to have different insurance coverage that may or may not cover such procedures, and if family members are unable or unwilling to pay the costs of their own genetic testing and linkage analysis, the procedures will not produce complete and useful results. Thus, the structure of the insurance system in the United States imposes an additional impediment to genetic testing that requires linkage analysis; patients must often pay out-of-pocket or not have access to such testing. Another barrier to coverage is the fact that most testing now performed by academic laboratories has not been approved and is therefore "investigational" under the definitions of the Food and Drug Administration. "Investigational" or "experimental" services are almost never reimbursed by third-party payers. However, most of these laboratories have not applied for or received certification under the requirements of the Clinical Laboratory Improvements Amendments of 1988. Requiring these laboratories to comply with existing federal laws (see Chapter 3) will remove some of the genetic testing and counseling these laborato-

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Assessing Genetic Risks: Implications for Health and Social Policy ries currently provide as patient care from the investigational category. Thus, one additional barrier to insurance reimbursement would be reduced. Recently, some laboratories began receiving insurance reimbursement, particularly those doing genetic testing for cancer. In addition, some patients have successfully challenged their insurer's initial refusal of payment. In a survey reported by the congressional Office of Technology Assessment (OTA, 1992b), about 40 percent of the patients were able to get their genetic test reimbursed after sending a letter from the testing laboratory to their insurer. Some patients report successfully obtaining third-party reimbursement for cystic fibrosis (CF) carrier screening, particularly during pregnancy (Bernhardt and Eierman, 1992). However, as discussed in Chapters 2 and 8, this may not be the ideal time for CF carrier testing. PRIVATE SOURCES OF PAYMENT FOR GENETICS SERVICES The majority of health insurance for the under-65 population in the United States is private health insurance, generally provided through employers (Fields and Shapiro, 1993).3 In the United States, private commercial health insurance is usually a private business enterprise, run on basic business principles of responsibility to shareholders to maintain profitability (Pokorsky, 1989). Ensuring profitability for private health insurance means providing insurance to as many people as possible, while containing outlays through a variety of methods, including limits on coverage, copayments, and deductibles. Such insurance is generally provided through indemnity plans that do not cover all services. Many health maintenance organizations (HMOs) are not for profit, but they cannot continue to operate if their coverage decisions, "open-enrollment" policies, and other practices combine to produce a continuing deficit. In this sense, even the not-for-profit insurers and managed care providers are concerned with controlling losses to their plans through coverage determinations and policies. If state insurance regulation permits, HMOs and other managed care practices may impose limits on open-enrollment periods (e.g., just a few weeks a year when they accept anyone who applies for membership) and limits on outside referrals for specialty care. The latter may impact on genetics services, which—for the most part—are outside the usual specialty services found in managed care plans. Although genetic education and counseling are essential components of any genetic testing services (see Chapters 1, 4, and 6), genetic counseling and education are not likely to be explicitly reimbursed without changes in reimbursement policies. Self-Insurance by Employers An increasing number of U.S. employers have moved to self-insurance in recent years, because it gives them more control over benefit systems and health care costs, as well as tax advantages. Federal legislation (the Employee Retire-

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Assessing Genetic Risks: Implications for Health and Social Policy ment Income Security Act, or ERISA) exempts employers from state benefits regulations. Consequently, employers may impose disease-specific dollar limits on particular diseases or conditions (see discussion of H & H Music Company case in Chapter 8), and are not required to meet specified state minimum benefit packages or to participate in high-risk insurance pools (for persons unable to get insurance otherwise). This complex subject is covered in a recent Institute of Medicine study, Employment and Health Benefits (Fields and Shapiro, 1993). It is estimated that from 50 to 60 percent of persons covered by employer-based health insurance plans participate in plans for which the company is self-insured (EBRI, 1993). Above a certain dollar limit, the increased risk assumed by the employer for employee health expenses is then often "reinsured" against major losses through traditional insurance companies (so-called stop-loss insurance). Many businesses also contract with traditional health insurance companies to administer their health insurance plans. Key Health Insurance Policy Barriers to Reimbursement for Genetics Services Group health insurance coverage of genetic testing and counseling is highly variable. Most group health insurance plans—and for that matter, Medicare—limit coverage to services determined to be "medically necessary" for the treatment of a diagnosed illness or injury; they do not cover screening tests in the absence of symptoms, and thus exclude most preventive services and immunizations, in addition to much of genetic testing, education, and counseling. Where reimbursed, genetic tests may be subject to insurance company requirements for prior approval of procedures. Prenatal genetics services are more widely covered by third parties than other genetics services; many group health insurance plans and health maintenance organizations include coverage for prenatal diagnosis if recommended by the attending physician. Where coverage exists for prenatal diagnosis, however, it rarely includes full reimbursement for the time required for education and genetic counseling before and after genetic testing, and in some instances genetic education and counseling are not covered at all. Some select group plans include more liberal coverage of genetic testing. Survey of Attitudes of Health Insurers About the Use of Genetic Information The Office of Technology Assessment (OTA) surveyed commercial insurers, Blue Cross and Blue Shield (BC/BS) plans, and health maintenance organizations that offer individual or medically underwritten group policies (OTA, 1992b). A majority of insurers believe that the wide availability of genetic testing would have a negative financial impact on their companies unless they had access to the

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Assessing Genetic Risks: Implications for Health and Social Policy results for purposes of medical underwriting.4 None of the responding companies reported that they had done any economic analysis of the costs and benefits of carrier testing or genetic tests as part of applicant screening, although one commercial company had done an analysis of prenatal coverage. Similarly, none of the companies reported any economic analysis of providing carrier screening or genetic counseling within their benefit package. However, the survey did confirm concerns about policies and practices of insurers regarding genetic testing for CF. "On balance, however, it appears that, for now, if no medical indication for the test exists, a third-party payer generally will not pay for the (CF screening) assay" (OTA, 1992a, p. 178) (see Table 7-1). The Impact of CPT Codes on Reimbursement CPT-4 (current procedural terminology) codes (standardized categories used for reimbursement of health services) do not exist for many genetic tests, since the technology is developing so rapidly. In the absence of CPT-4 codes, insurance reimbursement is not possible without special review by the insurer. Some genetic testing centers are using CPT-4 codes intended for biochemical precursors to seek reimbursement from insurers. As genetic testing becomes more widespread, the lack of CPT-4 codes for genetic testing and genetic counseling will be a major impediment to insurance reimbursement even for those people who have insurance coverage for genetic diagnosis (OTA, 1992c). A committee of the American Medical Association (AMA) establishes CPT codes, including the addition of new codes. Now that the new American College of Medical Genetics (ACMG) has been recognized by the American Board of Medical Specialties (ABMS) of the AMA, the ACMG may be able to influence the AMA committee responsible for CPT-4 codes to develop appropriate codes for genetic tests. PUBLIC SOURCES OF PAYMENT FOR GENETICS SERVICES In some instances, public financing for genetics services occurs through Medicaid, Medicare, or state genetics services programs. Medicare Medicare is primarily a program to reimburse medical expenses considered "medically necessary" for people over age 65 and certain categories of disabled persons. Medicare coverage decisions and reimbursement policies related to genetic testing now affect primarily the population of persons with disabilities, some of whom would find genetics services relevant and useful. In the future, Medicare may have a broader impact, as genetic tests are developed for more disorders common to older Americans, including complex common disorders such as heart disease, cancers, diabetes mellitus, and certain mental health disorders.

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Assessing Genetic Risks: Implications for Health and Social Policy TABLE 7-1 Reimbursement for Cystic Fibrosis Carrier Tests and Genetic Counseling Question: Do your standard individual policies and medically underwritten policies provide coverage for: Respondent At Patient Request Medically Indicated Only Not Covered No Responsea Individual Policies Carrier tests for CF?         Commercials 0 (0%) 12 (41%) 12 (41%) 5 (17%) HMOs 2 (18%) 7 (64%) 0 ( 0%) 2 (18%) BC/BS plansb 2 (8%) 16 (64%) 7 (28%) 0 ( 0%) Prenatal tests for CF?         Commercials 0 (0%) 12 (41%) 14 (48%) 3 (10%) HMOs 1 (9%) 7 (64%) 1 ( 9%) 2 (18%) BC/BS plans 3 (12%) 19 (76%) 3 (12%) 0 ( 0%) Genetic counseling?         Commercials 2 (7%) 6 (21%) 18 (62%) 3 (10%) HMOs 1 (9%) 6 (55%) 1 ( 9%) 3 (27%) BC/BS plans 1 (4%) 9 (36%) 13 (52%) 2 ( 8%) Medically Underwritten Policies Carrier tests for CF?         Commercials 0 (0%) 24 (65%) 10 (27%) 3 (8%) HMOs 1 (5%) 13 (65%) 2 (10%) 4 (20%) BC/BS plans 2 (10%) 11 (52%) 8 (38%) 0 (0%) Prenatal tests for CF?         Commercials 1 (3%) 23 (62%) 10 (27%) 3 (8%) HMOs 2 (10%) 14 (70%) 0 (0%) 4 (20%) BC/BS plans 3 (14%) 14 (67%) 4 (19%) 0 (0%) Genetic counseling?         Commercials 2 (5%) 16 (43%) 17 (46%) 2 (5%) HMOs 2 (10%) 12 (60%) 1 (5%) 5 (25%) BC/BS plans 1 (5%) 7 (33%) 12 (57%) 1 ( 5%) a Percentages may not add to 100 due to rounding. b OTA also inquired about reimbursement practices for BC/BS open enrollment nongroup policies and reports these data elsewhere. SOURCE: Office of Technology Assessment, 1992a, p. 181. One consequence of the Deficit Reduction Act of 1984 was a change in how Medicare pays for clinical laboratory tests and services furnished to outpatients and nonpatients by hospitals, and also to patients by independent laboratories and physician offices (e.g., for certain CPT-4 codes covering laboratory processes involved in conducting and reporting certain genetic tests). Medicare fee schedules

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Assessing Genetic Risks: Implications for Health and Social Policy were substantially reduced, and this reduction has subsequently been adopted by many state Medicaid programs. The low rates have reduced the number of providers who will perform these tests if Medicaid-Medicare reimbursement is the only available payment (Arkansas Medicare carrier, unpublished letter, October 1, 1991). The provisions of this 1984 legislation continues to affect reimbursement for all clinical laboratory services, including genetic tests. Medicaid Medicaid is a joint federal-state program to reimburse health care expenses for qualified low-income individuals and families. Preliminary data indicate variable coverage of genetic testing and counseling by state Medicaid programs (OTA, 1992a). OTA surveyed state Medicaid directors about their coverage and reimbursement levels for selected genetics services: amniocentesis, ultrasound, chorionic villus sampling (CVS), maternal serum alpha-fetoprotein (MSAFP) screening tests, DNA analysis, chromosomal analysis, and genetic counseling. Of the 46 states whose data are included in the OTA (1992a, p. 183) report, 44 state Medicaid programs cover MSAFP, with average reimbursement of $21.76 (and 1 requires special review); 45 state Medicaid programs cover amniocentesis, with average reimbursement of $59.32; 44 state Medicaid programs cover fetal ultrasound, with average reimbursement of $83.13 (2 require special review of "individual considerations" to decide on coverage); 31 state Medicaid programs cover CVS; 10 do not cover CVS (4 require special review and 1 did not know if CVS was covered); average CVS reimbursement was $145.90; 41 state Medicaid programs cover chromosomal analysis from amniotic fluid or chorionic villus (1 does not cover it and 4 require special review); average reimbursement is $235.68; and 26 state Medicaid programs cover DNA analysis; 6 do not cover it (8 did not know if DNA analysis was covered; 6 require special review; and "family DNA testing" is covered in New York); average reported reimbursement is $33.39. State Medicaid programs varied in whether they provided coverage of genetic counseling. As is common for many counseling services in a medical setting, genetic counseling might be covered if it were included in a general office visit code (either provided by the physician or provided by other professionals such as genetic counselors under the supervision of a physician). In 11 states, Medicaid coverage for genetic counseling is reported as part of an office visit or consulta-

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Assessing Genetic Risks: Implications for Health and Social Policy tion; 19 states did not cover genetic counseling; 3 states did not know if genetic counseling was covered; and 2 states required special review. The average reimbursement of $68.87 reported for genetic counseling actually reflected the range of reimbursements for different levels of physician office visits, rather than for genetic counseling per se (OTA, 1992a, p. 182). Medicaid reimbursement is available for some genetic laboratory testing services, but the Medicare reimbursement practice of setting "maximum allowable charges" for particular tests and then reimbursing a percentage (generally 80 percent of maximum allowable charges) has had a negative impact on Medicaid practices (Arkansas Medicare carrier, unpublished letter, October 1, 1991). Although good data are not available, estimates indicate that Medicaid pays less than half of the actual charges for some of the genetic tests for which it reimburses. It is frequently difficult to find providers of genetic testing services who will accept patients for whom Medicaid is the only reimbursement available. In addition, not all genetics centers accept state Medicaid reimbursement. "Those genetic service providers that accept Medicaid patients must subsidize the costs" (OTA, 1992a, p. 184). CHAMPUS The federal government also finances some genetic testing and screening services through the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS), the primary health insurer for military dependents and retirees. CHAMPUS has adopted basic concepts similar to those of private insurers and state Medicaid programs for genetic testing and related services. It covers genetic testing for couples identified as "high risk," for example, due to prior births of affected children, but specifically excludes routine screening of low-risk pregnancies (Charo, 1992). State Genetics Services Programs State genetics services programs vary widely (CORN, 1991). Some states provide limited genetics services directly; most states coordinate at least some genetics services, particularly with Medicaid, Medicare (which sets reimbursement rates used by state Medicaid programs), and other possible funding sources (such as programs for persons with mental retardation or developmental disabilities, or for children with special needs) to help secure funding for people who cannot afford needed genetics services. All of the 41 states responding to a recent CORN survey reported some level of coordinated state genetics services, and 60 percent of these have a full-time state genetics services coordinator (CORN, 1991). Coordinators are located in a wide variety of state agencies, although nearly 80 percent are in the state health department, usually in the maternal and child health (MCH) program. Of the 41 state programs that responded to the CORN survey, 84 percent

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Assessing Genetic Risks: Implications for Health and Social Policy were initially established with federal funding under the Genetic Diseases Act of 1976.5 Most (77 percent) still receive some support for genetics services from the state through federal Maternal and Child Health block grant funds (Public Law 997-35), to which funding from the Genetic Diseases Act was transferred in 1981. However, MCH block grants generally represented less than 25 percent of total state funding. Nearly half the programs reported a decrease in block grant funding when inflation is taken into account (CORN, 1991). Many state genetics services programs historically paid for newborn screening, but the majority now charge birth hospitals, attending physicians, or parents for newborn screening. A few state programs have more extensive authorization and funding that permits them to provide or pay for genetic testing or genetic counseling. State genetics services programs also vary in their policies toward the use of genetic testing information for abortion counseling (Clayton, 1993). Several states specifically attempt to limit use of available state genetics services when the goal is selective abortion of affected fetuses. Minnesota and Missouri provide extensive genetic testing services, but almost no funding for abortion services; Tennessee's extensive prenatal diagnosis program is limited to conditions leading to treatment in the mother or the baby, but its legislation states that "use of this program to abort unborn children is against the public policy of the State of Tennessee" (Tennessee Code Annotated, 1991, § 68-5-501-505). Thus, the committee sees (I) wide variation in policy, practice, and funding within state programs; (2) differences in reimbursement policies and practices among third-party payers concerning reimbursement for genetic testing and counseling services; and (3) regulatory, administrative, and funding barriers to coverage and reimbursement of appropriate genetics services. Federal Support for Genetics Services Programs The federal government still maintains a small amount of direct project grant funding for Special Projects of Regional and National Significance (SPRANS) through the Genetic Services Branch, Maternal and Child Health Services Bureau, Health Resources and Services Administration, in the Department of Health and Human Services. These special project grants are available on a competitive basis for genetics projects of special regional or national significance, but are not intended to replace the ongoing state funding that was transferred to block grants in 1981. These grants have funded special projects around the nation as well as many activities of the Council of Regional Networks for Genetic Services (CORN), including its genetics services data collection, newborn screening, and laboratory quality assurance activities. Special project funds have also supported activities of the Alliance of Genetic Support Groups. Federal funding has reached slightly more than $9 million for fiscal year 1993 for SPRANS grants, essentially the same level of funding received for 1992.

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Assessing Genetic Risks: Implications for Health and Social Policy RECOMMENDATIONS The committee believes that education and counseling are essential components of any genetic testing (see Chapter 4). In order to develop appropriate reimbursement for genetic testing and counseling services, the committee recommends that greater efforts be made for joint undertakings among private and public health plans and geneticists to develop guidelines for the appropriate reimbursement of genetics services. Such guidelines should address the issue of how each new genetic test should be assessed for its sensitivity and specificity in light of the availability of effective treatment, the consequences of the test, the evaluation of pilot study results, and when new tests are appropriate for use in routine clinical practice. The insurance concept of what is reimbursable (so-called medically necessary) should be defined to include appropriate genetic testing and related education and counseling, and these genetics services be reimbursed under health insurance plans. Medical necessity can often be established by a family history of the disorder. In pregnancy, medical necessity should be considered established for cytogenetic testing in pregnancies in women of advanced maternal age or those considered at high risk based on other methods of assessing risk. The committee also recommends that newborn screening and appropriate MSAFP screening in pregnant women of any age be considered within the insurance definition of what is medically appropriate, and be reimbursed under health insurance plans. To facilitate such coverage and reimbursement for genetic testing, education, and counseling, the committee recommends the establishment and updating of appropriate and specific CPT-4 diagnostic codes for these genetic testing and counseling services. Now that the ACMG has become part of the ABMS of the AMA, the ACMG should take the lead in working with the AMA committee responsible for CPT-4 codes. Finally, the committee recommends that health insurance reform proposals be evaluated to determine whether they adequately protect genetic information and persons with genetic disorders from discrimination and other potential social, legal, and ethical harms related to health insurance and the use of genetic information (see Chapters 7 and 8). NOTES 1.   The Committee on Assessing Genetic Risks had the benefit of the advice of Marilyn Field, Study Director of the Institute of Medicine (IOM) Committee on Employer Based Benefit Plans in preparing its analysis of issues of health insurance and its impact on access to genetic testing and counseling services. 2.   The full report of the ELSI Task Force on Insurance and Genetic Testing covers many of these issues in more detail and was released in May 1993 (ELSI Insurance Task Force, 1993). Committee staff followed the work of the ELSI Task Force so that the IOM committee had the benefit of this work in its own deliberations. 3.   For additional information, see the recent IOM report Employment and Health Benefits: A Connection at Risk (Fields and Shapiro, 1993).

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Assessing Genetic Risks: Implications for Health and Social Policy 4.   Medical underwriting is the evaluation of a person's insurability, usually assessed through a combination of answers to a written questionnaire and physical examination to identify certain conditions determined by medical underwriters (and underwriting manuals) to reduce life expectancy or increase medical care costs beyond actuarial norms. Standards for medical underwriting vary substantially by insurance company, and underwriting decisions are considered crucial business decisions by insurers, and are thus considered ''trade secrets" not subject to public disclosure. 5.   The National Sickle Cell Anemia, Cooley Anemia, Tay-Sachs, and Genetic Diseases Act of 1976 (Public Law 94-278) consolidated separate 1972 legislation for sickle cell anemia (Public Law 92-294) and Cooley anemia (Public Law 92-414) and added other genetic conditions into the provisions of the law. It required the development of information and education materials "to persons providing health care, to teachers and students, and to the public in general in order to rapidly make available the latest advances in the testing, diagnosis, counseling and treatment of individuals respecting genetic disease." It also required that federally assisted programs for the disorders included were to be entirely voluntary. Although this legislation was repealed in 1981, with the passage of the Maternal and Child Health Services Block Grant Act (Public Law 97-35), the requirement that programs supported with block grant funds be entirely voluntary was never repealed. REFERENCES Beaudet, A. 1992 (published in 1994). General perspectives on DNA diagnosis drawn from the cystic fibrosis experience. In Fullarton, J. (ed.) Proceedings of the Committee on Assessing Genetic Risks. Washington, D.C.: National Academy Press. Bernhardt, B., and Eierman, L. 1992. Reimbursement for cystic fibrosis (CF) DNA testing (Abstract). Meeting of the American Society of Human Genetics. San Francisco. November. Charo, A. 1992 (published in 1994). Impact of abortion law on genetic screening. In Fullarton, J. (ed.) Proceedings of the Committee on Assessing Genetic Risks. Washington, D.C.: National Academy Press. Clayton, E. 1993. Reproductive genetic testing: Regulatory and liability issues. Fetal Diagnosis and Therapy 8:(suppl. 1):39-59. Council of Regional Networks for Genetic Services (CORN). 1991. Survey of state genetic services coordinators (unpublished data). New York, N.Y. Council of Regional Networks for Genetic Services (CORN). 1992. Newborn Screening Report: 1990 (Final report, February 1992). New York, N.Y. Employee Benefit Research Institute (EBRI). 1993. Sources of health insurance and characteristics of the uninsured, Analysis of the March 1992 Current Population Survey. Issue 133. Washington, D.C. Field, M., and Shapiro, H. 1993. Employment and Health Benefits: A Connection at Risk. Washington, D.C.: National Academy Press. Insurance Task Force. 1993. Genetic Information and Health Insurance. Report of the Task Force on Genetic Information and Insurance. HIH-DOE Working Group on Ethical, Legal, and Social Implications of Human Genome Research. Bethesda, Md.: National Institutes of Health (Pub. No. 93-3686). May. Office of Technology Assessment (OTA). U.S. Congress. 1992a. Cystic Fibrosis and DNA Tests: Implications of Carrier Screening. OTA-BA-532. Washington, D.C.: U.S. Government Printing Office. Office of Technology Assessment (OTA). U.S. Congress. 1992b. Genetic Tests and Health Insurance: Results of a Survey (background paper). OTA-BP-BA-98. Washington, D.C.: U.S. Government Printing Office. Office of Technology Assessment (OTA). U.S. Congress. 1992c. Panel discussion; Panel on Population Screening for Cystic Fibrosis. Washington, D.C., March 11, 1992. Pokorsky, R. 1989. Public and government relations issues. Pp. 10-11 in The Potential Role of Genetic Testing in Risk Classification. Report of the Genetic Testing Committee to the Medical Section of the American Council of Life Insurance, Hilton Head, S.C.