By Mark A. Rothstein


It is hard to be critical of the Genetic Information Nondiscrimination Act of 2008 (GINA). After all, it's the first federal law enacted to prohibit genetic discrimination, and passing it took 13 years of work by people whose goals I share. In analyzing the law, however, it is apparent that GINA fails to resolve or even address many of the basic concerns that drove the legislative effort. It is also clear why, despite 13 years of wrangling on Capitol Hill, the final version of GINA was passed unanimously in the Senate and received only one negative vote in the Houses of Representatives - and that from inveterate naysayer, Representative Ron Paul.

GINA was not enacted in response to a wave of genetic discrimination, defined as the adverse treatment of an individual based on genotype. There have been very few documented cases of such discrimination. To some degree, GINA was enacted to prevent genetic discrimination in the future when health records will routinely contain genetic information and genetic testing will be so inexpensive that it's cost-effective to perform it on a widespread basis. The real reason for enacting GINA was to assure people that they could undergo genetic testing without fear of genetic discrimination. As any clinical geneticist or genetic counselor will tell you, these fears are real.

According to section 2(5) of GINA, federal legislation "is necessary to fully protect the public from discrimination and allay their concerns about the potential for discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research, and new therapies." The phrase "fully protect the public" is a curious choice of wording. GINA did extend protection against genetic discrimination to the few states that had not previously enacted a law prohibiting genetic discrimination in health insurance or the one-third of the states without a law banning genetic discrimination in employment. Yet, the method of protection, similar to state approaches, is not fully protective in any way. Therefore, it would be more accurate to say that GINA "fully covers" the public; it certainly does not provide "full protection."  

There are three major flaws with GINA. First, it applies only to two aspects of the problem, discrimination in health insurance and employment. To allay public concerns about genetic discrimination, it's necessary to prohibit the adverse treatment of individuals in numerous settings. GINA does nothing to prohibit discrimination in life insurance, disability insurance, long-term care insurance, mortgages, commercial transactions, or any of the other possible uses of genetic information. It remains to be seen whether GINA's limited applicability, coupled with its inadequate protections in health insurance and employment, will be enough to reassure the public that undergoing genetic testing will not endanger their economic security.

Second, GINA's prohibition on genetic discrimination in health insurance is largely a mirage. The Health Insurance Portability and Accountability Act (HIPAA) contains a little-known provision prohibiting employer-sponsored group health plans from denying individuals coverage, charging them higher rates, or varying their coverage based on "genetic information."  Significantly, HIPAA prohibits discrimination by group health plans on the basis of any health information. Because HIPAA prohibits genetic discrimination for the largest source of private health coverage (group plans), GINA's main value is to cover people with individual health insurance policies in the few states that did not previously enact a state genetic nondiscrimination law.

Unfortunately, the protections afforded individuals under either state laws prohibiting genetic discrimination in health insurance or GINA are not particularly robust or valuable. (Because state laws and GINA are similar in substance, for simplicity, I'll merely refer to GINA.) The problem is that GINA only applies to asymptomatic individuals. There are few incentives for health insurers to discriminate against asymptomatic individuals and few laws to prohibit them from discriminating against symptomatic individuals.

An example will bring this problem more clearly into focus. Under GINA, it is unlawful for an individual health insurance company to refuse offer coverage, charge higher rates, or exclude certain conditions on the basis of genetic information, including the results of a genetic test. For example, it would be unlawful to deny coverage to a woman with a positive test for one of the breast cancer mutations. Now, suppose some months or years later, the woman develops breast cancer. GINA simply does not apply. The insurance company's permissible response would depend on state insurance law. In virtually every state, the health insurance company could lawfully react to the changed health status of the individual by refusing to renew the policy (at its typically annual renewal date), increase the rates to reflect the increased risk (and the rates might double or triple), or renew the policy but exclude coverage for breast cancer.

GINA does have some limited value in this scenario. Because of GINA, an at-risk woman is no worse off in terms of insurability due to having a genetic test, and there might be psychological or medical benefits from being tested, depending on the results. Yet, the overall picture in terms of health policy remains bleak. So long as individual health insurance is medically underwritten at the initial application and for renewals, individuals who are ill or more likely to become ill are extremely vulnerable. Many advocates and policy makers have concentrated on the issue of genetic discrimination in health insurance, but the issue is much broader and cannot be resolved by such a narrow focus. To state the obvious: Under any system of universal access to health care, the issue of genetic discrimination in health insurance disappears.      

Third, the employment provisions of GINA are ineffective, but for different reasons. As with health insurance, the employment provisions only apply to individuals who are asymptomatic. The Americans with Disabilities Act (ADA) covers individuals who have substantially limiting impairments and therefore the ADA would prohibit discrimination against symptomatic individuals, regardless of the cause of their condition.

GINA makes it unlawful for an employer to request, require, or purchase genetic information regarding an applicant or employee. This is an important issue, because individuals are concerned with employers merely having access to their genetic information. The problem is that the provision is infeasible and therefore is not being followed.

Under the ADA, after a conditional offer of employment, it is lawful for an employer to require individuals to undergo a preplacement medical examination and to sign an authorization releasing all of their medical records to the employer. In effect, GINA now qualifies this by saying that employers can require the release of all medical information except genetic information. GINA defines genetic information as the genetic tests of the individual, genetic tests of the individual's family members, and family health histories. Because this information is commonly interspersed in medical records there is no practical way for the custodians of the health records (e.g., physicians, hospitals) to send only non-genetic information. In practice, when presented with a limited or unlimited request, the custodians usually send the entire records.       

The development and adoption of electronic health records (EHRs) and networks hold the possibility of using health information technology to limit the scope of health information disclosed for any particular purpose. Unfortunately, there have been no efforts undertaken to design health records with the capacity to segment or sequester sensitive health information (including but not limited to genetic information) to facilitate more targeted access or disclosures. Without such efforts, health privacy will decline precipitously with the shift to EHRs because records increasingly will be comprehensive (i.e., containing information generated by substantially all health care providers) and longitudinal (i.e., containing information over an extended period of time). Thus, when employers and other third parties require access to an individual's health records the amount of information they receive will be much more extensive than they receive today. 

GINA represents an incremental approach to problems that do not lend themselves to incremental approaches. Numerous entities have economic interests in learning about an individual's current or likely future health. GINA consists of halfway measures limited to health insurance and employment that do not provide adequate assurances to the public that genetic information will not be used to their detriment in other ways. GINA prohibits genetic discrimination in individual health insurance against people when they are asymptomatic, but fails to provide them with what they need most - health coverage when they are ill. GINA prohibits employers from requesting or requiring the release of genetic information in comprehensive health records at a time when it is infeasible to separate genetic information from other health records.

If GINA serves to declare the unacceptability of genetic-based discrimination and begins a process of careful consideration of a wide range of health related issues, then it will be valuable. But it is far from clear that GINA will have such an effect. It is not clear that GINA, by singling out genetic information for special treatment, will not increase the stigma associated with genetics and encourage other condition-specific, rather than comprehensive, legislation. It is not clear whether GINA will be the first step to meaningful legislation or cause legislative fatigue based on the erroneous assumption that the issues already had been resolved. It is not clear whether consumers will understand GINA's limitations or mistakenly rely on its presumed protections. In the short term, the worst thing that could happen is for advocates of genetic rights and fairness in health care to be satisfied with GINA or exult in its enactment.             


Mark A. Rothstein, J.D., is Director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine, where he holds the Herbert F. Boehl Chair of Law and Medicine. He also holds the Chair for the Subcommittee on Privacy and Confidentiality of the National Committee on Vital and Health Statistics and is President of the American Society of Law, Medicine and Ethics.

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