U.S. House of Representatives: Committee on Energy and Commerce, RepublicansPrepared Witness Testimony: Rothenberg, Karen H.

Subcommittee on Commerce, Trade, and Consumer Protection
July 11, 2001
12:00 Noon
2322 Rayburn House Office Building

Good afternoon, Chairman Stearns and members of the Subcommittee. It is a pleasure to be here today. I am Karen H. Rothenberg, the Dean, Marjorie Cook Professor of Law, and the founding Director of the Law & Health Care Program at the University of Maryland School of Law. I have been working for the last seven years on issues directly related to genetic testing and its legal, ethical and social implications, and I have written numerous publications on genetics and related legal issues in health care. Over the last few years I also contributed to a series of studies on legislative approaches to genetic information in both health insurance and workplace contexts which were published in Science.

My remarks will focus on the legal, ethical, and public policy implications related to the potential for discrimination in health insurance based on predictive genetic testing. Toward this goal, I will first examine whether genetic information is different than other types of medical information and whether it requires a special public policy approach. I will then examine what role legislative approaches may play in addressing the use, misuse, and privacy of genetic information, particularly in the health insurance context. I will conclude that effective genetic nondiscrimination legislation requires a comprehensive approach, including strong privacy protections and enforcement mechanisms, at the federal level.

Genetic information is personal, powerful, predictive, pedigree-sensitive, permanent, and prejudicial. As a result, it is information people commonly wish to keep private, although DNA databanks and computer technologies make protecting people's privacy increasingly difficult. Most individuals expect that all medical information should be protected. The potentially harmful risks associated with genetic information may demand that we pay special attention to its use, misuse and privacy.

While most Americans are optimistic about the use of genetic information to improve health, many are concerned that genetic information may be used by insurers and employers to deny, limit or cancel their health insurance. This concern is affecting the choices individuals make about their own health care and their decisions whether to participate in research. In a Time/CNN poll conducted in June, 2000, 75% of those polled indicated they would not want their health insurance company to have information about their genetic code.

Genetic information has implications not only for the individual, but also for his or her blood relatives, including parents, siblings, cousins and future offspring. Thus, the intergenerational impact of genetic information (and inheritability) makes the risk for misuse, including stigma and discrimination, significant and unique. Genetic information may be linked to certain ethnic and racial groups, many of whom have suffered from discrimination and eugenic policies that historically were "justified" by genetic findings. For example, restrictive immigration laws against Eastern Europeans in the 1920s, sterilization policies, Nazi atrocities, and insurance and employment discrimination against carriers of the sickle cell trait were justified by the power of genetic information. Even the discovery in the mid-90s of specific gene mutations that may be associated with higher rates of breast and ovarian cancer in the Ashkenazi Jewish community has raised concerns about how this information may be used to discriminate against them. The African American and Indian communities are also very concerned about behavioral genetic studies on violence and alcoholism.

An individual's genetic makeup is unique and cannot be altered. Even though a predictive test result is not a diagnosis, it is still powerful information and there is risk for misinterpretation by both providers and patients. People may believe that their fate is predetermined genetically and there is nothing they can do to change it.

The fear of genetic discrimination in the health insurance context is a reality. It is argued that individuals who might otherwise choose genetic testing will decline it based on their fear that they or their family members will not be able to obtain or maintain health insurance coverage. As a result, the future of research on the benefits and risks of testing for genetic conditions, including susceptibility to such common diseases as cancer and heart disease, may also be inhibited. Thus, now that the mapping of the human genome has been accomplished and as new genetic tests emerge, policy makers need to evaluate the development of legislative and regulatory strategies to address these concerns.

In the 1970s, a few states began to pass legislation that addressed genetics issues recognizing even then the potential for discrimination. North Carolina, for example, passed legislation prohibiting health insurers from refusing to issue insurance or charging higher premiums based on the sickle cell trait or hemoglobin C trait. By 1991, a new generation of state legislation began to evolve with the passage of a Wisconsin law prohibiting health insurers from:

requiring or requesting an individual or a member of the individual's family to obtain a genetic test;
requiring or requesting directly or indirectly into the results of a genetic test;
conditioning the provision of insurance coverage or benefits on genetic testing; or
considering genetic testing in the determination of rates.

This approach attempts to integrate protection against discrimination in insurance practices, coverage, benefits, and rates with some privacy protection for the individual and his/her family. Similar approaches have been incorporated to varying degrees in legislation passed in 39 other states. Conversely, a dozen states have no legislative protections in place regarding health insurance. In fact, of the 18 states represented by the members of this subcommittee, three states have no legislation that addresses genetic nondiscrimination in health insurance. As for the 38 states with legislation in this area, the states vary regarding the substance of the protections they afford. This creates a patchwork of protections within our nation.

The development of public policy to address genetic information and health insurance must be analyzed in the context of a complex and inadequate health insurance system, the uncertainty about the future scope and impact of genetic testing, and the political realities of a pluralistic society. The current patchwork of state legislative approaches does not provide a comprehensive solution to genetic discrimination and health insurance.

Just a few years ago, with the exception of a few states, these laws focused narrowly on genetic tests, rather than more broadly on genetic information generated by family history, physical examination, or the medical record. Now the trend is to include family history into the definition of genetic information. Meaningful protection against genetic discrimination requires that insurers be prohibited from using all information about genes, gene products, or inherited characteristics to deny or limit health insurance coverage.

Second, a large proportion of the population receives health benefits from self-funded plans not subject to state insurance laws. The federal ERISA preemption prevents a statewide approach to regulating the use of genetic information by all plans providing health benefits.

With these policy considerations in mind, as early as 1995 the following recommendations were developed by the National Action Plan on Breast Cancer (NAPBC) and the Working Group on Ethical, Legal and Social Implication of the Human Genome Project (ELSI) for both state and federal policy makers to protect against genetic discrimination:

Insurance providers should be prohibited from using genetic information, or an individual's request for genetic services, to deny or limit any coverage or establish eligibility, continuation, enrollment or contribution requirements.
Insurance providers should be prohibited from establishing differential rates or premium payments based on genetic information, or an individual's request for genetic services.
Insurance providers should be prohibited from requesting or requiring collection or disclosure of genetic information.
Insurance providers and other holders of genetic information should be prohibited from releasing genetic information without prior written authorization of the individual. Written authorization should be required for each disclosure and include to whom the disclosure would be made.

The recommendations further provide that genetic information be defined as "information about genes, gene products, or inherited characteristics that may derive from the individual or a family member." Insurance provider is defined as "an insurance company, employer, or any other entity providing a plan of health insurance or health benefits including group and individual health plans whether fully insured or self-funded." These recommendations remain valid today.

As you know, in the last few years, a number of members of the Senate and the House have taken a leadership role in introducing federal legislation that integrates these recommendations. Although none of these proposals have passed, they have influenced other health insurance legislation. The Health Insurance Portability and Accountability Act of 1996, or HIPAA, specifically prohibits a group health insurance plan from using "genetic information" to establish rules for eligibility or continued eligibility. It also provides that genetic information shall not be treated as a preexisting condition "in the absence of the diagnosis of the condition related to such information." Thus, a healthy woman who tests positive for a BRCA1 mutation would not be deemed to have a pre-existing condition related to breast cancer and this genetic information could not be used in the determination of eligibility for a group insurance plan, including self-funded plans. This is a significant first step in the evolution of federal legislation, but it is only a first step, and gaps remain.

Of course, this incremental approach to health care reform does not provided the comprehensive protection outlined in the NAPBC/ELSI recommendations. It does not prohibit insurers from requiring or requesting genetic testing or requiring or requesting the results of genetic testing. Thus, the burden is on the individual to prove that the insurer did not use genetic information to deny coverage or affect the terms and conditions of insurance. Nor does it prevent a plan from excluding all coverage for a particular condition, or imposing lifetime caps on all benefits or on specific benefits. It appears that this form of discrimination against women with breast cancer and/or a genetic predisposition to breast cancer, for example, would be permitted as long as plan characteristics are not "directed at individual sick employees or dependents." Absent other contractual and legal protections, plans could exclude, for example, prophylactic surgery specifically. HIPAA provides even less protection for employees not in group plans and provides no coverage for the uninsured. Thus, even if the uninsured had access to genetic testing, the risk of future insurance discrimination would be a reality. In addition, the uninsured would not benefit from genetic information if they could not afford to pay for the related prevention and intervention strategies, including more frequent mammograms and surgical interventions.

State anti-discrimination statutes also integrate various levels of privacy protection. At the federal level, the recently published HHS Privacy Rule fails to provide the kind of protection that can be uniquely afforded by strong anti-discrimination legislation. For example, whereas the Privacy Rule protects individuals from the unauthorized release of their health information, it does not prevent inquiries into their genetic makeup. Meaningful privacy protections will prohibit insurance companies from requesting or requiring genetic information, and performing genetic tests. Also, the current Privacy Rule applies only to health care providers, not to insurance companies or employers that are not also health care providers. This is a gap that must be filled.

Finally, federal legislation must include a strong enforcement provision, so that individuals who experience genetic discrimination or privacy violations not only will have the right to seek legal redress, but will have access to meaningful remedies.

Perhaps our greatest public policy challenge will be to determine when, if at all, it will be appropriate to make the transition from predictive testing for high-risk individuals and families within a research context to testing for the general population. Will the commercial market promote testing for the general population before we have been able to carry out the benefit/risk analysis even in the high-risk population? As the flow of genetic information increases, so too will the risk of its misuse. Should testing be restricted until we enact anti-discrimination and genetic privacy legislation nationwide? What implications will testing have on cancer surveillance and prevention strategies within our healthcare system? How will individuals be able to integrate predictive testing results with health behavior, lifestyle, and environmental factors that may significantly contribute to cancer morbidity and mortality? These questions have no simple answers.

Thus, given the varied state approaches that have developed in recent years, and the noteworthy but incomplete federal approaches, it is imperative that we develop comprehensive federal strategies to protect the public. For today, we face the onset of a revolution. Federal legislation stands to offer a pre-emptive strike in favor of genetic privacy and against genetic discrimination, potentially helping individuals to avoid doing battle alone in the health insurance arena.

Thank you.

SUMMARY

Genetic information is personal, powerful, predictive, pedigree-sensitive, permanent, and prejudicial. As a result, it is information people commonly wish to keep private.
State legislative approaches attempt to integrate protection against discrimination in insurance practices, coverage, benefits, and rates with some privacy. This creates a patchwork of protections within our nation.
At the federal level, the Health Insurance Portability and Accountability Act of 1996, or HIPAA, is a first step in the evolution of federal legislation, but significant gaps remain. The recently published HHS Privacy Rule also fails to provide the kind of protection that can be uniquely afforded by strong anti-discrimination legislation. Meaningful anti-discrimination legislation must include comprehensive privacy protections.
Neither the current state-level approach nor the federal-level approaches provide the comprehensive protection needed. The recommendations developed by the National Action Plan on Breast Cancer (NAPBC) and the Working Group on Ethical, Legal and Social Implication of the Human Genome Project (ELSI) to protect against genetic discrimination continue to provide the standard for public policy.

Insurance providers should be prohibited from using genetic information, or an individual's request for genetic services, to deny or limit any coverage or establish eligibility, continuation, enrollment or contribution requirements.

Insurance providers should be prohibited from establishing differential rates or premium payments based on genetic information, or an individual's request for genetic services.

Insurance providers should be prohibited from requesting or requiring collection or disclosure of genetic information.

Insurance providers and other holders of genetic information should be prohibited from releasing genetic information without prior written authorization of the individual. Written authorization should be required for each disclosure and include to whom the disclosure would be made.

Additionally, federal legislation must include a strong enforcement provision, so that individuals who experience genetic discrimination or privacy violations not only will have the right to seek legal redress, but will have access to meaningful remedies.

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The Potential for Discrimination in Health Insurance Based on Predictive Genetic Tests