Wisconsin Lawyer
Vol. 81, No. 11, November 2008

Prohibiting Genetic Discrimination

by Kevin M. Maroney

n May 21, 2008, President George W. Bush signed the Genetic Information Nondiscrimination Act (GINA) into law.¹ GINA prohibits discrimination on the basis of a person’s genetic information both in health insurance and in employment.

GINA has roots in the civil rights movement and can be traced back to civil rights concerns that arose in the 1970s after programs were established to identify carriers of sickle cell anemia. Screening of African Americans took place even though “neither prenatal diagnosis nor treatment was available at the time.”² Some state legislatures enacted legislation that mandated genetic testing of all African Americans, which led to stigmatization and discrimination. In 1972, President Richard Nixon approved legislation that funded research on the diagnosis, treatment, and control of sickle cell anemia and withheld federal funding from states that required African Americans to undergo genetic tests for the disorder.³

GINA is intended to address genetic discrimination by regulating employers and insurance companies that might otherwise use genetic information to deny jobs and health benefits to individuals. It allows employers and insurance companies to obtain and use an individual’s genetic information provided they do so solely for the limited purposes specified in the legislation.

Although GINA may reduce the public’s fear of genetic testing and increase participation in genetic research and treatment, the question remains whether the U.S. government and its research institutions are up to the task of safely regulating genetic tests and safeguarding the large databases of genetic information being created.⁴ This is especially true given that genetic testing and research have evolved rapidly, whereas federal legislation prohibiting discrimination took more than a decade to become law.

Wisconsin’s Approach to Protecting Genetic Information

Legislative efforts to protect individuals against genetic discrimination began at the state level. Some of the early state laws offered narrow protections to workers and insureds. In 1975, North Carolina prohibited employers from discriminating against any person possessing the traits for sickle cell or hemoglobin C. Florida, Louisiana, New Jersey, and New York followed suit during the next decade with similar laws prohibiting discrimination in employment.⁵ Each of these laws attempted to restrict employers’ use of genetic information.

Wisconsin was the first state to ban genetic testing and discrimination in the workplace.⁶ Similar laws have since been enacted in 34 states and the District of Columbia. Wisconsin took a comprehensive approach to protecting workers and insureds from discrimination on the basis of genetic information, enacting both labor and insurance provisions in 1991.⁷

Unlike other states’ prior laws which regulated employers’ conduct, Wisconsin focused on genetic tests themselves. The law’s workplace provisions regulate not only employers but also labor unions, employment agencies, and licensing agencies. The law also sets standards for health insurers and self-funded plans sponsored by local governments. Wisconsin’s law operates by prohibiting these regulated entities from requiring, or even requesting, that an individual obtain a genetic test. If a person does obtain a genetic test, the employer or insurer is prohibited from disclosing the fact that the person took the test or to ask for the test results.

Wisconsin’s genetic testing law includes tough enforcement provisions. It is a crime (a Class B misdemeanor) for a Wisconsin employer or labor organization to disclose the fact that a worker took a genetic test or to disclose the results of a genetic test without the test subject’s written consent.⁸

Federal Efforts

Efforts at the federal level to uniformly address genetic discrimination date back to the health care debates that accompanied the Clinton administration’s Health Security Act. Although that legislation was not enacted, two years later Congress passed the Health Insurance Portability and Accountability Act (HIPAA). HIPAA contains two protections for genetic information.

First, HIPAA’s portability provisions prevent group health plans from imposing preexisting condition exclusions on the basis of genetic information in the absence of a diagnosis related to the genetic information. HIPAA’s definition of genetic information is narrowly focused on genes, chromosomes, and genetic mutations of an individual or family member.⁹

Second, HIPAA’s nondiscrimination provisions prohibit discrimination based on genetic information in eligibility, enrollment, premiums, or contributions in the group health-plan market.

Almost immediately after HIPAA became law, health policy makers and privacy advocates began calling for additional changes to federal law to close gaps that existed in HIPAA’s regulatory framework. The Senate Labor Committee, chaired by Sen. Edward Kennedy, held five hearings from 1996 though 2002 examining issues related to genetic discrimination in health insurance and employment.¹⁰

Gaps in HIPAA Protections

HIPAA was viewed as having numerous loopholes that allowed group health plans and insurers to continue to discriminate against covered persons. First, HIPAA did not contain provisions protecting consumers attempting to buy nongroup insurance policies from discrimination on the basis of genetic information. Second, although HIPAA protected individuals in group health plans from discrimination, it did not prevent the group health plan itself from being charged higher premiums by an insurance company based on the genetic information of one or more members of the group.

Finally, HIPAA did not limit an insurer’s ability to mandate genetic tests, access genetic information, or even release genetic information. Given these narrow but important gaps in protecting genetic information, bipartisan support grew for increased protections in the context of health insurance.

Kevin M. Maroney, U.W. 1988, is an attorney with UMR, a UnitedHealth Care company,Wausau. He worked for the U.S. Department of Labor from 1988 through 2003.

As many as 12 bills were introduced in the 104th Congress to address the health insurance aspect of genetic discrimination. These bills differed significantly from Wisconsin’s comprehensive genetic protection law because they only regulated health insurance without addressing employment discrimination.

Given the bipartisan support for the health insurance provisions, some health care advocates wanted to enact the insurance provisions without taking on the challenge of enacting the labor protections for workers with genetic indicators of disease. The labor provisions lacked bipartisan support in the face of strong opposition from lobbyists for employers, who questioned the need for workplace protections, arguing that there was no genetic discrimination in employment.

During this time, the labor movement’s legislative strategy was to oppose the decoupling of the health insurance provisions from the labor provisions. Passage of the health insurance provisions on a stand-alone basis would have made it exceedingly difficult, if not impossible, for the labor provisions to be approved. This strategy meant that GINA’s enactment was, as President Bush noted, delayed for “over a decade,” but it greatly increased the likelihood that the labor protections would be enacted into law.

During this legislative stalemate President Clinton signed Executive Order 13145, which protected executive-branch federal employees from discrimination on the basis of genetic information. Although the executive order, by its very terms, did not create any new enforceable rights for federal employees, it did clarify and make uniform the administration’s policy in this area.¹¹

Under the order, the Equal Employment Opportunity Commission (EEOC) was charged with coordinating U.S. policy to prohibit discrimination in federal employment based on genetic information. The EEOC was not, however, granted the authority to enforce the order’s provisions against the federal government. Instead, the order directed the head of each executive-branch department or agency to “carry out” the order’s requirements.¹²

Policy makers may have changed their views in 2001 when the EEOC settled its first court action challenging the use of workplace genetic testing under the Americans With Disabilities Act of 1990 (ADA). According to the EEOC, the Burlington Northern Santa Fe Railroad had conducted genetic tests on railroad workers to determine if their carpal tunnel injuries were caused by a genetic mutation, known as chromosome 17 deletion. This genetic testing was conducted without the workers’ knowledge or consent, and at least one worker was threatened with termination for failing to submit a blood sample for a genetic test. The EEOC’s Milwaukee District Office conducted the investigation. A month later the railroad expressed to Bush Administration officials its support for federal legislation banning the use of genetic testing by employers.¹³

Genetic Nondiscrimination in Health Insurance

GINA will be effective for group health plans and insurance offered in connection with group health plans for plan years beginning after May 21, 2009. GINA will apply to virtually all health insurance markets, including “health insurance issuers” in the group, individual, and Medigap markets, employer-sponsored group health plans (including self-funded ERISA plans), state and local government plans, and church plans. 

Unlike HIPAA, GINA prevents state and local government plans from opting out of the legislation.¹⁴ In addition, GINA applies to third-party administrators of Medigap policies or other persons acting on behalf of a Medigap issuer.

GINA prohibits group health plans or issuers from adjusting premiums (or contributions) on the basis of genetic information. This broad prohibition applies equally to the group, individual, and Medigap markets. A rule of construction, however, allows issuers to increase the premium charged to an employer based on the manifestation of a disease or disorder in an individual, even when that disease or disorder is genetically indicated.

GINA builds on HIPAA’s protections of genetic information in several ways. HIPAA’s definition of genetic information focuses on the genes, chromosomes, and genetic mutations of an individual or family member. Under GINA, genetic information is broadly defined to include information about genetic tests, genetic tests of family members, and the manifestation of a disease or disorder in a family member, as well as genetic counseling or education. GINA’s protections regarding genetic information extend to a fetus carried by a pregnant woman and embryos created by assisted reproductive technology.

GINA operates in large part by prohibiting issuers and group health plans from collecting genetic information for underwriting purposes. The term underwriting purposes is specifically defined to include enrollment and eligibility determinations, the application of preexisting condition exclusions, activities related to the creation, renewal, or replacement of health coverage, and premium (or contribution) calculations. Because the HIPAA privacy regulation allowed the use of genetic information for underwriting purposes in the group market, GINA instructs the Secretary of Health and Human Services (HHS) to amend the privacy rule to prohibit use of genetic information for underwriting purposes.

HIPAA’s portability provisions that affect the individual insurance market are modified by GINA to restrict the use of preexisting condition exclusions based on genetic information. Issuers in the individual market may no longer use genetic information, in the absence of the manifestation of a disease or disorder, for purposes of preexisting condition exclusions.

Exceptions to GINA’s Prohibitions. GINA allows issuers and group health plans to obtain genetic information when it is incidental to the requesting of other information, such as family history information, provided it is not used for underwriting purposes.

GINA, however, restricts an issuer’s or group health plan’s ability to request or require that an individual take a genetic test. Under the law, issuers or plans generally may not request that an individual undergo a genetic test, except in the case of voluntary research conducted in accordance with federal regulations governing research on human subjects.

A group health plan or issuer can use the results of a genetic test in making determinations regarding claims payment, as is currently the case under the health care operations exception contained in the HIPAA privacy rule. Health care professionals who work for or with a bona fide wellness program may notify an individual about the availability of a genetic test and provide information about the test but may not request or require that an individual take a genetic test.

Enforcement Provisions. GINA imposes on the Secretary of Labor enforcement responsibilities for private sector group health plans and issuers. When a violation occurs, the Secretary of Labor is authorized to impose civil penalties of $100 per day per affected participant; the penalty increases to $2,500 per day for violations committed after the receipt of a notice from the Secretary. More serious violations are subjected to penalties in the amount of $15,000 per day, with an outside cap of the lesser of 10 percent of claims paid during the prior year or $500,000. The Secretary of HHS has virtually identical civil penalty authority to enforce GINA’s Public Health Service Act provisions, which set standards for the group and individual insurance markets, as well as group health plans sponsored by state and local governments.¹⁵ The Commissioner of the IRS is authorized to use excise tax provisions to enforce GINA for plans subject to IRS jurisdiction, such as health plans sponsored by churches. GINA requires the Labor Department, the HHS, and the IRS to execute a memorandum of understanding to coordinate interpretive rulings and enforcement strategy.

Prohibiting Employment Discrimination Based on Genetic Information

Like Wisconsin’s genetics law, GINA’s labor provisions apply to private and public sector employers, labor organizations, and employment agencies. GINA prohibits employers from failing to hire, discharging, or otherwise discriminating against an employee with respect to compensation, terms, conditions, or privileges of employment on the basis of the employee’s genetic information. Nor may these entities limit, segregate, or classify employees in any way that would deprive an employee of opportunity on the basis of genetic information. These labor provisions will apply to covered employers effective Nov. 21, 2009 (18 months after the effective date.)

Under GINA, employers may not request, require, or purchase genetic information of an employee or the employee’s family members. Administrators of wellness and genetic counseling programs may obtain genetic information as long as the employee voluntarily authorizes the disclosure in writing and the results do not disclose the identity of specific individuals. Another exception allows employers to request or require family history information when it is needed to comply with a certification under the Family and Medical Leave Act.¹⁶ The bill also contains the so-called water-cooler exception, for family history information that is inadvertently obtained through casual conversations with an employee.

The final exception to the general rule against acquiring genetic information allows genetic monitoring of biological effects of toxic substances in the workplace. An employer wishing to conduct testing must provide written notice to its employees, and obtain their consent, unless the monitoring is mandated by federal or state law. Any person subject to testing must be provided with the results of the tests. Any monitoring must be done in compliance with genetic monitoring regulations issued by the Occupational Safety and Health Act (or its state equivalent), the Federal Mine Safety and Health Act, or the Atomic Energy Act. The results of any such monitoring may be disclosed only in the aggregate without any individual identifiers. Congress included a final exception for employers that conduct DNA analysis for law enforcement purposes or for human remains identification solely for quality control purposes to detect sample contamination.

GINA incorporates the remedies and procedures contained in the Title VII of the Civil Rights Act of 1964, as amended.¹⁷ Private sector employers who violate GINA’s provisions can be subject to compensatory and punitive damages. GINA specifies similar remedies and procedures for state, federal, and congressional employees.

GINA specifically provides that genetic discrimination claims cannot be made using the disparate-impact theory of discrimination. Generally, disparate impact occurs when the employer does not act in a manner that is overtly discriminatory but instead engages in practices that, although appearing to be neutral, actually discriminate against a protected class under Title VII. GINA requires the creation of a commission six years after the date of enactment to review advances in the science of genetics and to recommend whether to allow disparate-impact causes of action.

Future Trends in Genetic Privacy

During the decade that it took Congress to enact GINA, tremendous advances in knowledge concerning genes took place. These advances have changed virtually all areas of biomedical research and promise to transform health care. Some people have stated the enactment of GINA will “unlock the great promise of the Human Genome Project by alleviating the most common fears about genetic testing.”¹⁸

Through the imposition of strict standards and tough penalties, GINA can be expected to reduce the misuse of genetic information and increase the likelihood that patients will avail themselves of genetic tests to treat medical conditions without having to fear that they will lose their job or health insurance. This civil rights privacy law ought be effective with respect to employers and insurance companies. But these entities lend themselves to traditional regulation.

What might be harder to control is the misuse of genetic information by emerging businesses that are not employers or insurers. Individuals increasingly are voluntarily submitting DNA samples to Web-based vendors of genetic tests. The U.S. General Accounting Office has found that many genetic tests being marketed directly to consumers mislead consumers by making predictions that are “medically unproven and meaningless.”¹⁹ In addition, the HHS Advisory Committee on Genetics, Health and Society has found “significant gaps in the U.S. system of oversight of genetic testing that can lead to harms.”²⁰

Although genetic tests are available for more than 1,000 diseases or conditions, the FDA has reviewed and approved only about a dozen of the tests.²¹ As demand rises for new genetic tests, more consumers will submit their DNA samples to commercial vendors of genetic tests who will operate entirely outside of GINA’s traditional regulatory and enforcement provisions.

While individual consumers are providing DNA samples to genetic test vendors, the federal government is requiring that scientists and researchers conducting federally funded research with a genetic component submit their subjects’ genetic information to a central database known as dbGAP (database of genotypes and phenotypes).²² Although this genetic database, sponsored by the National Institutes of Health, contains safeguards to ensure that individual identifiers are not included as part of the data set, the standards might not be sufficient to safeguard the data. Moreover, published studies have shown that, because only a small amount of DNA is needed to identify an individual, a person’s identity can be matched from deidentified data sets using reference data.²³ 

Conclusion

GINA created important new rights that will advance the cause of genetic protection in the workplace and in the context of health benefits. GINA’s stated goal of increasing confidence in genetic testing, however, may be eroded because of emerging threats to genetic privacy that exist largely outside GINA’s legal framework. The concern is that, despite GINA’s enactment, these future trends may reduce the public’s willingness to participate in genomic research and undergo genetic tests to treat disease.

Endnotes

Wisconsin Lawyer