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Genetic Testing: Policy Implications for Individuals and Their Families.

New developments in genetic research raise complex issues for individuals and families considering genetic testing; these need to be addressed by public policy. Greater access to genetic testing and greater financial incentives for insurance companies, employers, and other groups raise new concerns for individuals and families. Of paramount importance are issues around confidentiality; access to testing, counseling, and health services; and discrimination as a result of having been tested. This article clarifies the issues that have arisen for individuals and their families as a result of the explosion in availability of genetic tests and recommends the related need for public policy. Three major public policy areas discussed include informed consent for genetic testing, testing of minors and, confidentiality.

Fam Syst & Health 17:49-61, 1999

GENETIC TESTING: FAMILY POLICY IMPLICATIONS

The results of genetic tests can have profound psychological and social effects on individuals and families for generations. And if coping with a present or future disorder and its stressors is not enough, families under today's health policies must also be concerned about discrimination.

Three areas of public policy need to be addressed to protect client rights to the benefits of genetic testing and to protect clients against risk of discrimination as a result of genetic testing: informed consent for genetic testing, testing of minors, and confidentiality related to discrimination in employment or by insurance companies. Primary health providers must be aware of the current lack of public policy to protect clients from the potential risk of genetic testing. This paper begins with an update on the status of genetic testing, identifies current family issues relevant to genetic testing, and finally delineates the three resultant public policy issues.

HISTORY

Genetics is not a new field of science. An understanding of the basic rules of inheritance extends back as far as 1866. For decades, physicians, nurses, and social workers have been doing clinical research in the field of genetics and providing services to families with genetic disorders. Until the introduction of newborn screening in the middle of this century, no public policies existed to regulate genetic testing or to regulate the use of genetic tests--there was no apparent need. Initially there were few genetic tests available, and paying for the test and follow-up services was not an issue since they were typically part of a research protocol.

However, two recent events have dramatically changed both the availability of genetic testing and the need for public policy regarding genetic testing. The first comes from the progress of the Human Genome Project (HGP) (DHHS, 1990; Collins, 1993), which was launched in 1990 with the goal of locating all of the genes on the human chromosome and identifying their related disease or traits. Work on HGP has moved ahead of schedule, and greater knowledge about genes and their disorders have increased the availability of genetics tests. HGP holds great promise for the development of methods of prevention, treatment, and cure of genetic disorders. Currently, however, the knowledge necessary to identify the genes that cause a particular disorder has outpaced the knowledge necessary to prevent, treat, or cure genetic disease. Accordingly, in most cases, genetic testing can only identify a person's predisposition to a particular disease for which there is currently no treatment or cure. Until treatments are developed, genetic testing has the potential to cause psychological harm as well as monetary as a result of potential discrimination (Taylor-Brown & Johnson, 1998).

The second event occurred concurrently: the replacement of fee-for-service health care by managed healt care, which seeks to control overall costs of health services. Genetic test results provide an individual's genetic profile which may be used by insurance companies to control costs by limiting or refusing coverage. Health insurance carriers and other institutions involved in healthcare costs thus have a financial interest in knowing an individual's genetic test results, and this interest may give rise to discrimination.

FAMILY ISSUES

Three recent developments in our knowledge of genetics pose new issues for families: disorders that affect large segments of society are being identified; genetic testing has become more complex; and genetic testing has moved from the research setting to the primary care setting.

Common Disorders

Until recently, geneticists were primarily able to identify rare disorders that are caused by one gene and that affect less than 3% of the population. However, technology has recently improved scientists' ability to identify common disorders that occur in large segments of the population such as colon and breast cancers, high cholesterol, heart disease, Alzheimer's disease, and diabetes. Unlike the rarer one gene-one disorder maladies, these disorders are caused by complex interactions of more than one gene and an environmental trigger (Andrew, Fullarton, Holtzman, & Motulshky, 1994). In fact, Collins (1997) stated at a meeting of health professional organizations, that nearly all disease, with the possible exception of traumatic injury, is likely caused by a combination of genes and the environment.

Complexity of Genetic Tests

The interpretation of genetic test results is complex. Most genetic test results predict susceptibility to a disorder or trait rather than provide a precise diagnosis, and some are capable of testing for more than one disorder. The Task Force on Genetic Testing(1) distinguishes predictive and confirmatory tests, and recommends "stringent scrutiny" of the former, which predict "serious future disease in healthy people [or their offspring]" (Task Force, 1997). A confirmatory test substantiates with certainty that the person has or will get a specific disease or disorder. Testing healthy individuals in the absence of safe and effective interventions poses a very high psychological and societal risk for individuals and their families (Task Force, 1997).

Since most genetic tests test for susceptibility to a disorder or trait, rather than diagnose a particular disorder or trait, a positive test result does not mean a person will definitely get a disease in the future, nor does a negative test mean the person will not become ill. For example, the genes BRCA1 and BRCA2 can be identified during a predictive genetic test; mutations in these genes are found in only 5% of the population, and even if the mutation is found, 20% of the individuals with a positive test will ever get that type of breast cancer. On the other hand, even though the mutations are not present, 1 in 8 women will have breast cancer sometime in their lifetime. Therefore, a woman could test negatively for BRCA1 or BRCA2 and continue to have the same risk of developing breast cancer as the rest of the population (Geller et al., 1997). To further complicate predictive tests, the exact role of the environment in triggering a genetic disorder is not known.

Another complexity of genetic testing is that in some situations one test may reveal genes that are related to more than one disorder; their gene sequences are intertwined and inseparable for testing purposes. An example of this is the gene known as APOE which has several forms. APOE2 is a variant form related to high cholesterol, which if identified early can be treated to prevent heart disease. However, APOE4 is the gene combination related to Alzheimer's disease. One genetic test identifies both disorders--one that is definitive and treatable, the other a susceptibility to a future disorder not treatable at this time. While it is possible to modify cholesterol level by dietary modifications or medications, treatment for Alzheimer's disease is more limited. An individual may think that the test is for a single disorder only to be informed of the disposition or existence of another disorder. Both conditions have significant but different implications, and it can be overwhelming to learn about both simultaneously.

Genetic Testing in Clinical Settings

With the increased availability of genetic tests, genetic testing has moved from the laboratory to the clinical setting and has become a routine part of medical care. (Touchette, Holtzman, Davis, &, Feetham 1997) However, genetic tests are being directly marketed to primary care providers by biotechnology corporations (Peters & Stopfer, 1996). Appropriate informed consent must be used to assure that the individual's need and desire to be tested supersedes the market's monetary interest in testing.

PUBLIC POLICY

Issues in society typically drive public policy: this is the case of genetic testing. To some extent key genetic policy issues are related. For example, limitations of confidentiality of genetic test results is an essential component of informed consent. Likewise, policy regarding confidentiality, of necessity, describes a individual's rights as well as responsibilities to others regarding the results of the genetic test. Since an individual's test tests the whole family, individual family members each have the right to determine both whether they will be tested and whether they wish to be told of the test result of another family member; assuring these rights are essential to public policy.

The individual's disposition regarding the disease will affect his/her reaction to the testing. For some it may be relief, for others it may be devastating. For example, if there is a family history of a particular disorder, members of the same family may feel differently about whether to be tested and whether they want to be told that another family member is tested and the test results. For most people, finding out that you do not have a familial condition relieves stress. However, to know this, an individual must be tested. Even the decision to be tested affects people differently; some can be very comfortable not knowing their susceptibility to a familial disorder, whereas others may feel out of control and feel that not knowing is intolerable.

Likewise, people react differently to a positive test outcome. For some family members, knowing that they have a familial risk gives them a sense of being in control; they can engage in early detection screening which may save their lives; they have time and opportunity to make informed choices and to plan their life in the event of particular outcomes. If indicated, they can address certain risk factors that are a potential trigger for manifestation of the disorder, and they can consider whether to have children or to adopt. These benefits should be weighed against the potential adverse effects including increased stress levels related to the diagnosis or conversely stress of coping with uncertainty.

Clearly a genetic test that definitively identifies a disease for which there is a successful cure or treatment should be offered. For example, mental retardation can be prevented by early identification of phenylketonuria (PKU), and the life expectancy of persons with sickle cell anemia can be increased by early treatment. However, genetic diseases that can be prevented or treated are rare; typically genetic diseases can be diagnosed but not treated. It is these susceptibility tests that raise the need for public policy: namely, informed consent, testing of minors, and confidentiality.

INFORMED CONSENT

Informed consent typically involves educating individuals regarding a particular test or procedure to enable them to make an autonomous decision based on knowledge. For genetic testing, informed consent takes place in the context of pretest counseling. Accurate interpretation by the provider of the probability of a patient getting a particular disorder is central to informed consent. However, healthcare providers frequently do not know and cannot estimate the probability that a genetic disease will manifest, specially given the unknown commodity--environment. Researchers for Johns Hopkins University found that nearly one third of physicians who referred patients for genetic screening misinterpreted the results (Giardiello et al., 1997). Further, only 19% of the patients had received previous genetic counseling. If the providers have difficulty deciding appropriately when genetic screening is needed or interpreting the results, patients can be expected to have difficulties, too.(2)

Therefore, in light of the fact that most genetic tests are not definitive, that an individual's probability of getting a particular disorder is at best an educated guess, that most professional providers do not have adequate information to convey to individuals, that each individual's and family's means of coping are unique, then what are the parameters necessary for informed consent?

Parameters of Informed Consent

Informed consent for genetic testing must include a clear and easily understood explanation of the physical, psychological, and social benefits and risks related to genetic testing. Informed consent must be presented in a language and at an educational level that the person understands. Minimally, prior to deciding whether to be tested, the term susceptibility test must be defined clearly for an individual along with his or her estimated risk.

Generally, the purpose of informed consent is to assure that the patient's authorization for a test or treatment is "intentional, substantially noncontrolled, and based on substantial understanding" (Geller et al., 1997). Geller et al. (1995) also call for informed consent protocols that include educational and decision-making components. These tenets are even more critical when the test is for susceptibility to a disease.

Geller et al. (1997) report on numerous ways to educate individuals about the risks and benefits associated with genetic testing. The recommendations range from impersonal mechanisms, such as videos, brochures, and the Internet, to group discussions and individual counseling. However, a professional provider cannot assume that the individual is informed until the person is able to comprehend the consequences, including benefits and risks, of a genetic test. Informing an individual about genetic testing is a process that should not be rushed. Providers must be constantly aware of the perceived difference in power between the professional and the individual and accept an individual's decision to be tested or not without causing the individual to feel that she or he has disappointed or angered the provider. The Alliance of Genetic Support Groups has developed individual information which practitioners can utilize.(3)

Finally, informed consent must include a discussion about the limitations under current public policy of limits to confidentiality of one's genetic information. The fully informed patient can then decide to undergo or reject the test. The patient's right to make that decision must be protected by public policy. One cannot presume that all people will react to the results of a genetic test in the same way. For some, knowing you are at risk is less stressful than not knowing; for others, knowing of a risk is unbearable.

GENETIC TESTING OF MINORS

Genetic testing of minors is generally considered for three reasons: to identify birth defects or genetic disorders prenatally; to determine carrier status of familial disorders; and/or to identify susceptibility to late onset disorders for which a parent has been diagnosed. Caution must be taken in determining whether to test a minor (Andrews, et al., 1994; Wertz, Fanos, & Reilly, 1994; Fanos & Johnson, 1995a, 1995b). Often, genetic testing of minors is considered to inform or benefit--psychologically, physically, or monetarily--someone other than the child. But just because a test is available does not mean that it should be used, especially with children, infants, and even neonates, who face profound developmental risks as a result of genetic testing. Since the person to be tested cannot make the decision alone, parameters for testing minors supported by public policy are essential. The primary issues are whether to test, under what circumstances to test, and who decides to test.

Despite recommendations of genetics professionals to forego testing children and adolescents, youth are being tested for late-onset disorders as well as for carrier status (Wertz & Reilly, 1997). The Task Force on Genetic Testing (1997) states that:

"Genetic testing of children for adult onset diseases should not be undertaken unless direct medical benefit will accrue to the child and his benefit would be lost by waiting until the child has reached adulthood."

Wertz, Fanos, and Reilly (1994) report that state laws have increasingly recognized the interests of children and adolescents, acknowledging increasing respect for minors' autonomy in medical care. They propose the following guidelines for presymptomatic genetic testing (p. 879):

1. [A genetic] test may detect conditions for which treatment or preventive measures are available. Testing should be offered at the earliest age when health benefits accrue, but need not be offered before this time.

2. The [genetic] test has no health benefits for the minor, but may be useful to the minor in making reproductive decisions now or in the near future. Testing done to inform reproductive decision making should be limited to situations where the potential risk to a minor's offspring is high.

3. There are no medical benefits and no current reproductive benefits from testing, but parents or the minor request it. Minors and parents need to know the potential harm of testing, competence should not be assumed before the age of 15. Child's cognitive development should be ascertained.

4. [Genetic] testing is carried out solely for the benefit of another family member. Analogous to organ donation which is permitted if both the minor and parents agree. It cannot be forced.

The decision of whether to test a minor must be made on a case-by-case basis, and the focus of the decision must be the benefits and risks to the child, not the family, schools, insurance companies, or researchers. These concerns give rise to two operative questions with regard to testing minors: What is the real and present benefit to the child? Does the benefit outweigh present and future risk?

CONFIDENTIALITY

The need for policy that addresses confidentiality in genetic testing cannot be overstated. Two relevant issues are ownership of genetic information and discrimination. The concern about confidentiality is exemplified in the following three cases, two actual and one hypothetical.

1. An insurance company paid for a baby's delivery and continued to cover the child on his family's health policy. However, when the child was diagnosed with sickle cell anemia, the family's insurance company flagged their file and on a regular basis goes through all insurance claims, frequently refusing or only partially paying the bills. Another strategy used by the insurance company is to hold onto the bills for over a year. After a year, the insurance company is not responsible for the bills even if it knew about them earlier. The family was driven into bankruptcy, lost their home, and still owe $30,000 even though the parents remain employed and fully covered by insurance.

2. A 29 year-old African-American woman considers genetic testing for breast cancer because her sister died two years ago from breast cancer at the age of 30, and an aunt and a grandmother were treated for breast and ovarian cancer respectively. The insurance company agreed to cover the genetic test for the BRAC1 gene to determine the woman's predisposition to breast cancer. That agreement was however predicated on her making a commitment to have a double mastectomy and hysterectomy if the genetic screen was positive for the gene. The genetic test cannot predict with certainty that a woman will ever get breast cancer. Additionally, whether prophylactic surgery prevents breast cancer is still under investigation.

3. A retired couple was refused admission to a retirement community based on the housing development agent's interpretation of a health report submitted with the admission package. The agent determined that the husband's risk of Alzheimer's disease was "unacceptable". The husband became depressed, the marital relationship became strained, and the couple's privacy has been compromised (Genethics Consortium, 1997).

Ownership of Genetic Information

Who owns a person's genetic information? It would appear obvious that an individual owns his/her genetic information. However, ownership implies control of the information. In fact, insurance companies, employers, schools, and the criminal justice system may claim a right to have a person's genetic information--with or without the knowledge of the individual in question. An example of this is the third case noted above.

Public policy must protect an individual's ownership of genetic information. This begins with policy that forbids genetic testing of individuals without their explicit knowledge and consent. But even when consent is given, control of access to test results may be taken away. To prevent events such as those described above, individuals must be informed about the limitations of current public policy to protect them during the process of pre-test counseling and informed consent. Disclosure to the individual must be made regarding who will have access to the genetic information, who will disclose such information, and for what purpose. Additionally, policy must assure that persons who are given express access to genetic information must not forward it to any other party and must be held accountable for the maintenance of confidentiality of the information.

This includes family members. It cannot be assumed that all family members should or would want to be informed of their susceptibility to a genetic condition, especially those for which there is no known treatment or cure. Guilt about having passed a gene onto a future generation may be detrimental to the individual and family. Inappropriate disclosure of one individual's genetic test results to family members carries the risk not only of causing psychological stress, but of straining family relationships, and increasing the risk of coercion of family members--for example, a couple who is making family-planning decisions. The recent public television broadcast of A Question of Genes (Schwerin, 1997) gives examples of the implications of such disclosure.

Discrimination

Vice President Gore released an administration report, Genetic Information and the Workplace, which states that more and more employers are using genetic testing and monitoring as a condition of employment ("Legislation sought against gene bias," 1998).

The use of genetic information, for good or ill, has long been an issue in our society. But the quantity and complexity of genetic information that is quickly becoming available puts clients at new risk. The potential for stigmatization by society and discrimination in jobs and by insurance companies is immense. Both the National Alliance for the Mentally Ill and the Coalition for Persons with Disabilities are concerned with the potential for labeling and, in fact, eugenics based on genetics testing. It may be a worthwhile goal to prevent, treat, or cure mental illness and disability, but it would not be worthwhile to do so by ridding society of the person with the mental illness or disability.

Because the findings of genetic testing may reveal the need of future high-cost interventions, insurance companies may have significant financial incentives both to have insurees tested and to deny coverage based on those findings. These economic incentives must not outweigh the need to protect people from discrimination in jobs, by insurance companies, in school admissions, in housing, and by society in general. Primary health providers need to be aware that, currently, public policy does not address this adequately.

Insurance and Employment

As the first two cases cited above indicate, public policy must insure against discrimination by insurance companies. The Task Force on Genetic Testing (1997) states that:

No individual should be subjected to unfair discrimination by a third party on the basis of having had a genetic test or receiving an abnormal genetic test result.

Discrimination in health and life insurance is widely documented. Lapham, Kozma, and Weiss (1996) surveyed 332 members of genetic support groups and reported that respondents perceived discrimination in the following ways: 25% were refused life insurance, 22% refused health insurance, and 13% were denied or let go from a job. Hawkins (1997) reported on a federal laboratory funded by the Department of Energy that was screening all employees for syphilis, women for pregnancy, and African-Americans for sickle cell trait (a genetic blood disorder). Not only were new employees screened, but African-American and Latino employees were tested for syphilis during periodic exams, and African-Americans were retested for sickle cell even though only one screening is necessary. The only white employee to be retested was an employee married to an African-American woman.

One of the biggest expenses for employers is health insurance. Genetic screening offers employers a financial incentive to pre-screen potential employees for genetic disorders. In fact, Peters (1993) states that each person carries five to seven lethal recessive genes. In short, no one has a perfect genome. In 1993, Peters reported that 12 Fortune 500 companies did genetic testing as a routine part of pre-employment physicals. Today that number is no doubt much higher. Underwriters for insurance companies routinely deny or limit coverage for some gene-related conditions, such as sickle cell anemia, atherosclerosis, Huntington's disease, Down's syndrome, and muscular dystrophy (Zolar, 1991). In other words, in some instances, as a result of a genetic test that the job seeker may not know of, a person may be refused employment, insurance, or both.

The Working Group on Ethical, Legal, and Social Issues (NIH-DOE, 1995) submitted a report with recommendations for public policy relevant to genetic testing. At that time, the American Council of Life Insurance (ACLI) declined to sign the final report, because it urged insurers to consider a moratorium on the use of genetic information to screen out applicants at the time of employment. Insurance companies have a different concern: individuals, having discovered that they are predisposed to certain genetic disorders, may seek to increase their coverage while they are still healthy (Anonymous, 1996). Clearly both sides of the issue must continue to be examined.

CURRENT LEGISLATION

Currently, only two federal policies afford individuals protection, albeit minimal, against discrimination on the basis of genetic testing. ;they are the American with Disabilities Act of 1990 (ADA, PL 101-336) and Health Insurance Portability and Accountability Act of 1996 (HIPAA, PL 104-191). The United States Equal Employment Opportunity Commission interpreted "disability" under the ADA to include healthy persons that are carrying abnormal genes. This interpretation implies that healthy people carrying abnormal genes cannot be discriminated against for employment (Weiss, 1995). A provision of HIPAA that states group health plans may not deny coverage to an individual or the dependent of that individual on the basis of genetic information (29 CF ch. XXV). Genetic information is defined in the bill as that "information about genes, gene products, and inherited characteristics that may derive from the individual or a family member. This includes information regarding carrier status and information derived from laboratory tests that identify mutations in specific genes or chromosomes, physical medical examinations, family histories, and direct analysis of genes or chromosomes" (29 DF ch. XXV, p. 528). Thus an individual or his/her dependents cannot be denied coverage in a group plan based on a finding of a genetic condition, carrier status, or predisposition to a genetic condition through direct or indirect means. If a person's family member has a condition that may be genetically related, that person could not be excluded from coverage, either. In its analysis of HIPAA, the Alliance of Genetic Support Groups (1997) noted the above strength of HIPAA and that the bill provides protection of the privacy of medical records. There are also significant limitations in HIPAA. First, individuals who are not covered through group plans are not protected by the law. Second, because HIPAA requires that all members of a group be treated equally, it is possible for an insurer to raise the rates of an entire group based on one or more group member's genetic risk. Lastly, HIPAA does not limit an insurer's access to or release of genetic information (Department of Health and Human Services [DHHS], 1997). During the 105th Congress, 23 bills related to genetics were proposed; at the end of the session, none had made it to law. (http:\\www.thomas.loc.gov, 1997) This in spite of the fact that during the summer of 1997, the Alliance for Genetic Support Groups waged a members' campaign to advocate for a bill that was introduced concurrently in the House and Senate, (H.R. 306/Slaughter, S. 89/Snow) (Alliance, 1997). The proposed legislation, known as the Genetic Information Nondiscrimination in Health Insurance Act, made amendments to the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act, Title XVIII of the Social Security Act (Medicare) and the IRS code. In each case, those amendments would have prohibited discrimination for health insurance coverage based on genetic information or a request for genetic services.

Other issues were addressed by legislation proposed in the 1997 session of the 105th Congress. Two bills, H.R. 2198/ Stearns and H.R. 451/Ensign, offered protection from healthcare coverage discrimination for veterans and their dependents. The Stearns bill also included two other major points. First, a mandate for the National Bioethics Advisory Commission to report to Congress on standards to increase protection for the collection, storage, and use of DNA samples and genetic information. Second, protection from employment practices that would result in discrimination based on genetic information. A similar bill to prevent employment discrimination was submitted by Representatives Lowey and Lazio (H.R. 2275). Discrimination for life or disability insurance was the focus of H.R. 2216/J. Kennedy. Protection from genetic discrimination was included in the original children's health initiative proposal made by Senator Daschle (S13), but was omitted from the final law that was part of the Balanced Budget Act of 1997.

The fact that no legislation was passed to protect persons from discrimination based on genetic information is especially profound given that, in 1995, the NIH-DOE Joint Working Group on Ethical, Legal, and Social Implications of Human Genome Research and the National Action Plan on Breast Cancer published their state and federal policy recommendations. The report included definitions of genetic information, employment organizations, insurance providers, and employment discrimination, and it made recommendations for policy relevant to insurance discrimination (Hudson, Rothenberg, Andrews, Kahn, & Collins, 1995; Rothenberg et al., 1995). State policies related to genetic testing discrimination in employment go back as far as 1974. In light of the new concerns, however, the number of states that are enacting anti-discrimination policies relevant to genetic testing is growing (Rothenberg et al., 1995). As of March 1998, 14 states had enacted laws to limit employers' use of or access to genetic information. Two of those states (Florida and Louisiana) have narrow legislation providing protection to those individuals with sickle cell trait; the others place broader restrictions. In 11 states, employers may not make firing or hiring decisions based on genetic information. In 7 states, employers are not allowed access to an employee's genetic information without the express consent of the employee. Finally, in 7 states, employers may not require genetic testing as a condition of hiring or continued employment. In some of those states, however, testing is permitted for susceptibility-related disorders if requested by the employee (Wertz, 1998).

Twenty-four states have also enacted laws to restrict the use of genetic information in health insurance. Further, as many as 250 bills have been under consideration in another 33 state legislatures (Genetic Discrimination, 1998). Many of these state laws have been passed in order to protect the 13 million Americans who have individual health insurance policies and are not protected by HIPAA. Most of these bills are based on a model "Genetic Privacy Act" authored by George Annas and his colleagues at Boston University (Reilly, 1997).

FUTURE FAMILY/GENETIC POLICY ISSUES

Both the benefits and risks of genetic testing are high. Current public policies at the state or federal level are not sufficient to protect individuals from uninformed testing, broken confidentiality of test results, and discrimination. Individuals and providers need to be vigilant in efforts to develop appropriate policies.

It is relevant that none of the proposed policies address the content of genetic services. Features of the ERISA and other federal laws make it difficult for legislators to mandate specific health insurance benefits. There is, however, another possible route for the federal government to advance a policy leading to more comprehensive genetics services that will include pre-test counseling as part of the informed consent process. That route is the inclusion of comprehensive genetics services benefits in the Federal Employees Health Benefits Package (FEHBP). This action, including comprehensive genetic services in FEHBP, would have two substantial effects. The first is making those services available to a very large group of people. The federal government is the single largest employer in the United States. The second effect, and perhaps more important, is that since the FEHBP is used as a benchmark for other health benefit plans, comprehensive genetic services may be incorporated into other plans in order to match the federal package.

Though almost half of the states have genetic privacy laws, there is no consistency in those laws across states. This poses the risk differential interpretation and implementation such as occurred in implementation of the Patient Self Determination Act, a law which gave patients the right to make end of life decisions for themselves (PSDA, P.L.101-508).

Another lesson based on the lack of a unifying federal policy can be seen by examining the case of credit card companies. For some time, only two states had no limit on the amount of interest a credit card company could charge and therefore nearly all credit card companies were incorporated in those two states. This same could happen with insurance companies. Without consistent policy, states with the least restrictive policy with regard to insurance discrimination based on genetic information may suddenly become the home office of most insurance carriers.

Two other issues point to the importance of uniform federal legislation to prevent genetic discrimination. First, as noted above, state laws do not apply to employer-sponsored group plans that are covered by ERISA. Thus, nearly half of all Americans who are covered by such plans would not be protected by state genetic privacy legislation (DHHS, 1997). To remedy this concern, specific federal legislation is needed that will override ERISA.

Second, most state laws focus on the narrow description of genetic testing and apply only to information obtained from DNA tests. Genetic information can, however, be obtained through other means, such as physical or psychological indicators, pattern of inheritance, or requests for genetic testing (DHHS, 1997). Broadening the definition of genetic information would require changing the existing state laws, writing new laws in each state, or more simply, passing federal legislation.

Individuals must protect themselves at two levels, confidentiality and discrimination. Since no states can supersede a federal policy, individuals must advocate for comprehensive federal policy to protect them. But individuals must also be prepared to ask questions of their physicians about the use of all medical information and refuse to permit that information to be used in ways other than for treatment. Effective policy will help empower them to do so, as well.

Note: The authors wish to acknowledge the thoughtful comments and suggestions offered by the reviewers.

FOOTNOTES

(1) The Task Force on Genetic Testing (Task Force) is a work group of the NIH DOE Joint Committee to Evaluate Ethical, Legal, and Social Implications program of the Human Genome Project.

(2) Two groups have taken steps to overcome this: The Institute of Medicine Executive Summary (Andrews et al., 1994) addresses the needs and current limits of education of health professionals, and the National Coalition for Health Professional Education in Genetics (NCHPEG) was convened by the National Institute of Human Genome Research to address the need for health professional education (Collins, Oct. 1997).

(3) Alliance for Genetic Support Groups, 4301 Connecticut Ave., Suite 404, Washington, DC 20006. The Alliance is a consumer information and advocacy organization for persons with genetic disorders.

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ANN M. JOHNSON, PHD, MSW([dagger]) DEBORAH SCHILD WILKINSON, PHD, MPH, MSW(*) SUSAN TAYLOR-BROWN, PHD, MPH, ACSW(**)

([dagger]) Educational Specialist, Council on Social Work Education, Alexandria, VA

(*) Assistant Professor, University of Kansas School of Social Welfare, Lawrence, KS

(**) Chair, Health Concentration, School of Social Work, Syracuse University, Syracuse, NY 13244 7
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Author:JOHNSON, ANN M.; WILKINSON, DEBORAH SCHILD; TAYLOR-BROWN, SUSAN
Publication:Families, Systems & Health
Geographic Code:1USA
Date:Mar 22, 1999
Words:6651
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