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The Potential for Discrimination in Health Insurance Based on Predictive Genetic Tests
Subcommittee on Commerce, Trade, and Consumer Protection
Ms. Mary Davidson
Good afternoon. My name is Mary Davidson, Executive Director of the Genetic Alliance. The Genetic Alliance requests your assistance in enacting legislation that prohibits genetic discrimination. Policy Development Outstripped by Escalating Genetic Discoveries Thanks to Congressional vision and your support for the Human Genome Project, these are remarkable and historic times. Earlier this year, the 3 billion letters of the DNA instruction book were published. And now scientists all over the world are using this genetic map to unravel the mysteries of heart disease, cancer, diabetes, mental illness, asthma, multiple sclerosis -- since all diseases, with perhaps the exception of trauma, have a hereditary component. Already there are individuals and families whose lives have been touched in profound ways by biomedical technologies never before imagined. From the perspective of science, medicine and policy, we are confronting a 'brave new
world' with entirely new challenges. Genetic research is moving at breakneck speed, taxing our
ability to craft timely public policies that safeguard the promise of genetics to improve health.
Surveys and polls tell us that the public is worried about the balance between benefit and harm
posed by these new technologies. Based on these concerns, growing numbers of individuals and
families have decided not to pursue genetic tests or services - the hard-earned products of
genetics research. In the Midst of the Genetics Revolution, Healthcare Consumers Have No Safety Net I am here today to bring attention to these two central facts. · In the midst of the Genetics Revolution, people who could benefit from the new technologies are afraid to use them. They are afraid to have genetic tests or participate in research because they fear losing their insurance and their jobs if their insurance companies and their employers learn the results of those tests. · Congress could put these fears to rest once and for all by enacting Federal legislation that makes it illegal for insurance companies to deny coverage and for employers to refuse to hire, promote or fire people based on genetic test results. This would encourage people to take advantage of the rapid advances in genetic testing and other new technologies that can improve public health, alleviate human suffering and extend productivity. These protections will ensure true nondiscrimination and facilitate the future sustainability of the biotechnology and healthcare industries.(1) Speaking on Behalf of the Genetic Alliance, Families and the Public I speak today on behalf of the Genetic Alliance - the largest genetics coalition worldwide, representing more than 300 lay advocacy, research, health professional, public and private sector organizations and their millions of members. The mission of the Genetic Alliance is to promote healthier lives for everyone impacted by genetics. Since 1986, we have worked to speed the translation of scientific and technological advances into quality healthcare and consumer-informed public policies. The Genetic Alliance Helpline and Discrimination Survey put us into daily contact with people with stories to tell about the benefits as well as liabilities of genetic testing. Annually, we're in touch with over 100,000 people about genetics and related issues. I also speak today on behalf of known and unknown victims of genetic discrimination - individuals like Terri Seargent and Dave Escher, who have already felt the sting of genetic discrimination, and others out there who are struggling for their rights and still others who have chosen not to forsake their privacy and anonymity. Their struggles reaffirm the principle that "Genetic information is inherently personal and must be treated as confidential and proprietary." (Alliance Guiding Principle) We're All At Risk. "Genetics Is About ALL of US" Finally, I am here today representing those who don't yet understand that 'Genetics is about ALL of us.' Because every man, woman and child has some genetic predisposition, condition or disease resulting from inherited or acquired genetic changes. Tests are currently available for approximately 700 genes, most of which are associated with relatively rare disorders. However, that number will soon grow to the thousands with an understanding of the genetics of more common health problems. For the most part, these will be predictive tests, opening windows to early detection and prevention of diseases currently thought to be untreatable. It will be possible to identify the 40 disease-causing mutations that scientists estimate that we all carry. And we will be able to search for diagnoses and predictors for multiple diseases, disorders and conditions, on the surface of one tiny microchip, perhaps available at our local drugstore. For every person identified with a genetic disease, there are usually 4 to 7 non-symptomatic family members who would benefit from the knowledge gained from a genetic test. This will also create an explosion in the ability to identify risk factors and make predictions for a broad range of health problems - from rare conditions to common complex diseases. This is wonderful and will help so many of us live healthier and more productive lives. With this explosion comes a sense of greater risk for disease. Our real risk has not changed, but our awareness of risk has. And we don't even understand the exact implications of these newly identified risks. It may take us 100 years to determine whether certain risk factors are meaningful or not and to what degree, taking mitigating and co-mingling factors of other genes and the environment into account. It is now even more apparent that genetic conditions are universal and we are all increasingly at risk for genetic discrimination. What Is Genetic Discrimination? Genetic discrimination is the inappropriate use, or misuse, of genetic information in making health insurance and employment decisions. Discrimination based on predictive information is just one of several categories of misuse of genetic information that people are reporting. What Is A Predictive Genetic Test? These are tests for conditions like breast and ovarian cancer, Alzheimer's and Parkinson's Disease, Alpha-One, colon cancer and others. Test results indicate the risk or probability or likelihood of a disease occurring over our lifetime. Positive test results simply mean that one's risk is higher than the average person. The condition may or may not happen at all. Does Genetic Discrimination Based on Predictive Genetic Tests Really Happen? Through our Genetics Helpline and Discrimination Survey, people have come to the Genetic Alliance with their stories about the unauthorized use of genetic information in employment and insurance coverage decisions. This should not come as a surprise. We live in a society with a long history of discrimination based on ethnicity, class, gender, physical and mental impairment and now genetics. And we already witnessed the tragic consequences of discrimination based on sickle cell disease test results in the 1970's. If Genetic Discrimination Is A Serious Problem, Why Aren't People Coming Forward? Why Aren't There Any Test Cases? First, people don't know what to make of genetics - much less genetic discrimination. Without a sound scientific and social compass, they are unable to assess the fairness of the situation in which they find themselves. Second, our legal rights are equally obscure. State and federal laws and regulations make up a complex patchwork of protections that vary by state, health plan and employment situation and create major obstacles to legal action. Third, there are cases out there that have not yet seen the light of day. When people lose their health insurance or employment, they hold tight to the last vestiges of privacy and anonymity at all costs and are reluctant to get burned twice. Fourth, we know that the door is wide open for discrimination and that this potential will certainly increase with all the new predictive tests on the horizon. Is the Public Concerned about Testing and Research? We know that people are deciding not to have predictive tests and not to participate in research based on fears that insurance companies and employers will use this information to cancel healthcare insurance and deny them jobs. (2) Let's Put a Personal Face on this Growing Problem. Gail, a physician, knew about BRCA1 and 2 testing - predictive tests that indicate a predisposition to breast and ovarian cancers in some women. Because of a strong family history of breast and ovarian cancer, she opted to take the genetic test under an assumed name. In course of a gynecological exam and while she awaited test results, a possible abnormality on an abdominal ultrasound was noticed and confirmed by a radiologist. Because Gail's risk factors were not recorded in her medical record, he let it go. Had he known her history, a very different course of action would have been taken. Fortunately, this story has a happy, though sobering, ending. Because Gail is a physician, she understood the problem and took charge of her own medical care. She requested a follow-up study, her genetic test came back negative and everything turned out to be OK. However this story is wake-up call for what MIGHT have happened. Without a safety net, there was no way for Gail to use critical information about her own health without fear of discrimination and losing her health insurance. It is hard to believe that in one of the most advanced nations on earth, we are driven to undergo anonymous genetic testing for fear we will lose our insurance and access to healthcare. Gail felt that she had no safety net.
Why the Potential for Genetic Discrimination Based on Predictive Tests? The door to discrimination is wide open because most state laws do not prohibit the use of predictive test information in health insurance determinations. About half of the states do provide some form of nondiscrimination protection. However, in most cases, state protections are inadequate and do not address predictive information specifically. State laws are generally described as a colorful, complex and inconsistent patchwork of definitions, provisions and right to action and often do not address predictive information specifically. Looking to existing Federal protections, HIPAA's protective jurisdiction is also variable and inadequate, depending on whether someone belongs to an individual or group health plan or his employer is self-insured. In the individual market, there are no protections whatsoever. The genetic condition can be excluded or the premium set as high as the market and consumer can bear. Because there are no restrictions or ceilings to the premium, access can be effectively blocked by pricing someone out of the market. In the small group market, the group member is protected to the degree that rate hikes - resulting from member medical treatments or increased risk - are spread across the group pool. The employer is responsible for how the increased tab for premium increases is covered or shared with employees. In the small business situation, these HIPAA protections result in serious potential vulnerabilities, both for the employee and the business owner. Increased premiums may threaten the solvency of a small business and put owners on the alert for employees whose medical condition and treatments are causing group rate hikes. In a small work environment, health and personal issues are sometimes common knowledge and the identified employee known to all. As has been well documented in the recent EEOC case involving Terri Sergeant and her former small business employer, HIPAA regulations leave both the employee and small businesses vulnerable to the misuse of genetic information in making employment decisions.(3) With regard to protection under the Americans with Disabilities Act (ADA), people with predictive genetic information will probably not fare too well, given the trend in the courts over recent years. When Congress passed the ADA in 1990, Congress intended that the law would cover individuals with a broad range of diseases, such as epilepsy, diabetes, breast cancer, heart conditions and mental illness. Indeed, some Members of Congress even explained that the ADA would protect people who experience discrimination on the basis of predictive genetic information, on the grounds that such individuals would be "regarded" as disabled and hence covered under the law. (4) Unfortunately, soon after the ADA went into effect in 1992, and culminating in a trio of cases by
the Supreme Court in 1999, the ADA's scope of coverage has been significantly restricted. Thus,
in many cases, individuals with conditions such as cancer, epilepsy, diabetes, heart and
respiratory conditions, mental illness, and a range of other health conditions, who have alleged
discrimination based on such conditions, have been turned away at the courtroom door on the
grounds that they are not sufficiently "disabled" to receive legal protection under the ADA.(5) In
essence, the courts have required that to be covered under the ADA, an individual must be so
debilitated by his or her impairment that it is difficult for the person to function at all. Moreover,
if such an individual can take medication or receive a device (such as a pacemaker) that will
enable the person to function, he or she will not be considered "disabled" under the ADA. In
addition, even if an employer refuses to hire an individual expressly because of a health
condition, this will not be sufficient to claim that the employer "regarded" the individual as
disabled unless the individual can also prove that the employer believes many other employers
would act the same way. The same reasoning that has eliminated legal protection under the ADA
for individuals with a range of health conditions will likely be used to deny coverage under the
ADA for individuals with predictive genetic information or family histories regarding such
conditions. Predictive Tests Are Not Relevant to Decisions about Health Insurance Coverage First of all, the person may not ever manifest the condition. One's actual risk depends on interactions with other genes and with the environment. There is just so much that we don't know at this time and may never know, since we're talking about tremendous levels of complexity. Second, we don't yet really know the exact level of risk indicated by the test results. The meaning of test results will evolve over time with longitudinal research that follows participants over their lifetime, assessing the interplay with other genes and the environment and the actual expression or incidence of the condition. And while the current risk percentages reflect scientists' best guesses, this is not good enough if the results can be used to deny health coverage and employment and disrupt productive lives. Third, test results do not translate directly into healthcare dollar costs for any one particular person. Everything in medicine today is measured in terms of evidence-based and outcomes research and cost benefit analysis. However, the use of predictive test results to make health insurance decisions doesn't fit this paradigm. Predictive tests are not linear, black and white measures of healthcare dollar liability for you or me; currently they may have some meaning for pools of people, but not individuals. The science is too new and the variability of expression for two identical genotypes too great. We cannot measure healthcare dollars or future productivity based on computations using genetic test results as the yardstick. Fourth, it is impossible to lump all predictive tests in one category. Health dollars could even be saved through the development of preventative treatments that forestall the occurrence of an expensive chronic conditions. In the case of hemochromatosis, for example, early identification could lead to phlebotomy treatments that stop the development of an otherwise insidious, chronic, expensive and possibly fatal condition. And finally, we all have flawed genes. With so many predictive tests already on the radar screen, we will all be at risk for genetic discrimination. The Use of Predictive Tests in Health Insurance Determinations Puts People at Increased Risk for New Social and Medical Harms and Poses New Societal Burdens. First of all, the use of predictive tests in health insurance determinations impacts individuals and their families in the most personal ways - loss of privacy, healthcare, and employment. That is why people are choosing not to have genetic tests that could, in some cases, save their lives. This was the case with Gail and with countless others who choose to safeguard access to healthcare for their families by deciding not to risk their employment which provides their health insurance. We know that this strategy, while logical, can put the individual at medical risk, the family at financial risk, and sometimes results in serious, even fatal, health consequences. Second, employers may fear hiring or promoting or retaining someone whose test results or recommended treatment threatens to raise the group insurance rate. We have already seen this happen in the case of Terri Seargent who was essentially symptom-free - jogging several miles every day - but was fired from her job after her employer learned about her positive genetic test results and preventative medical treatment. Third, falling public confidence impacts everyone. We're all waiting for the benefits of biomedical research. However, without nondiscrimination assurances, people will not participate in the very studies that could lead to more precise interpretations of 'risk' measures, better understanding about interplay between gene and environment and other genes, and the development of preventative treatments - sometimes for their own condition. Finally, the real measure of genetic discrimination is the potential for broad societal impact and burden. If we systematically exclude individuals and families from healthcare and jobs on the basis of genetic make-up, we are risking the creation of an uninsurable and unemployable genetic underclass at enormous public, moral and economic cost. Genetic Alliance Recommends These Core Principles To Guide Policy Decision-Making· We all possess imperfect genes that will become equally and increasingly transparent with tomorrow's technologies. · Health insurance and employment in this country are intrinsically linked. Legislation must address genetic nondiscrimination protections in both health and employment. They are inseparable. · It is important to take a broad view of the implications and impact of predictive genetic test results for individuals and families and for the small business employer. · Without Federal legislation protections, genetic discrimination will affect increasing numbers of individuals and families and pose unfathomable social harms. The focus of civil rights advocacy in the 21st century will be genetic discrimination. · Risk-based health insurance may not work in this new genomics age. How can we have a risk-based health insurance system when the meaning of the risks that are being identified through new genetic tests is unknown? The science is literally galloping ahead of our ability to understand this new information. And this distorts the usefulness of information resulting from genetic tests. Genetic Alliance Advocates for Comprehensive Federal Nondiscrimination Legislation Looking to HR 602 as a Model for Legislation · Legislation must cover all genetic information - including family history, medical tests and healthcare service records - which can be used to predict future health risks in healthy individuals. · Legislation must ensure that those entities holding genetic information about individuals will not disclose it to third parties without the written permission of the individual. · Legislation must provide individuals who experience genetic discrimination the right to seek redress through courts of law, with access to meaningful remedies. · Legislation must prohibit both health insurers and employers from collecting predictive
genetic information and from using it to discriminate in the health care system and the
workplace. Opposition to Unwarranted Discrimination in Health Insurance and the Workplace Finally, I want to point out that this testimony has focused on the hardships faced by those
who experience discrimination based on predictive genetic information or family histories.
However, we urge you to consider the fact that if these individuals This is why we can not stop at legislation like HR 602 alone without clarifiying the ADA
and considering the need for additional protective legislation. When a healthy individual tests
positive for a gene that could cause a condition like Alzheimer's or bipolar disease, it is not
always clear if signs of that condition have occurred. To ensure that people will not be afraid to
seek treatment and receive a diagnosis, we need to assur Safeguarding the Potential of Genetics to Improve Health. Completion of the sequencing of the genome is a wonderful and inspiring scientific accomplishment, however it has also accelerated the need for universal protections of genetic information that help to describe future risks for health and disease. Assurances against the abuse of personal genetic information will safeguard our hopes for improving public health through new genetics knowledge and technologies. Congress demonstrated extraordinary vision in funding the mapping of the human genome. It requires an equal measure of vision and courage to pass the legislation that makes it possible for people to benefit from the new tests and technologies and creates a safety net for healthcare consumers. Otherwise, the remarkable achievements of the Human Genome Project will be rendered meaningless. In a country founded on precepts which offer protections against discrimination, on
the basis of sex, race or religion, we certainly have room for perhaps the most basic factor
of all - our genes, representative of both our shared inheritance and the essence of our
diversity. The Genetic Alliance calls for the unequivocal prohibition of genetic
discrimination in health insurance and employment, and all other aspects of life. Every
American - regardless of genetic inheritance - is entitled to the protection that Congress
alone can provide. Thank you very much for this opportunity to present testimony on this important
topic.
1. 1.1 p. 2 - Footnote - Insurance Industry Sustainability: Research focusing not only on survival rates and the probability of future disease, but also on future health care needs and the availability, effectiveness, and potential cost savings of early intervention, is of great potential benefit. Not only would patients better understand their prognoses, but physicians could improve treatment modalities, and plan sponsors and insurers could better evaluate the appropriateness of covering specific tests, their likely impact on insurance costs, and their potential implications for risk classification in the individual market. Some of the key questions that remain are: - How accurately will genetic tests predict future health care needs? - Will meaningful interventions be available for genetic disease? - Will genetically based treatments become available? - What impact will genetic technology have on overall medical care expenditures? Policy-makers need a clear understanding of these issues so that proposals regulating the use of genetic testing information can find the best balance between the concerns of the public, the predictive ability of genetic test results, and the affordability of health insurance.
2. p. 5 - Footnote: Genomics and Managed Care: Preparing for the Revolution By: Carl Peterson [Healthplan 41(5):14-20, 2000. © 2000 AAHP "Concern among consumers is high. In a mid-June Time/CNN poll of 1,200 U.S. adults, three-quarters of respondents feared having health insurers gain access to disease predisposition data. An even greater number (84 percent) were concerned about government access to personal genetic information." p.5 - Footnote: Genomics Research- However, Knowledge and Understanding Remain Modest Release Harris Interactiv Polling Date:6/19/01 1,000 Adults polled June 2001When asked what their greatest fears are, the answers given most often are that genetic information may be misused (45%)" p. 5 - Footnote: In genetic testing studies at the National Institutes of Health, 32 percent of eligible people who were offered a test for breast cancer declined to take it because of concerns about loss of privacy and potential for discrimination in health insurance. May 2001 3. p. 6 - Footnote: Congressional Research Service Report for Congress RL30006: Genetic Information: Legal Issues Relating to Discrimination and Privacy The Health Insurance Portability and Accountability Act of 1996 P.L. 104-191, the Health Insurance Portability and Accountability Act of 1996, has been hailed as taking "important steps toward banning genetic discrimination in health insurance" but has also been criticized as not going far enough. The Act prohibits a group health plan or issuer of a group health plan from using genetic information to establish rules for eligibility or continued eligibility and 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. It also prohibits a group health plan or issuer of a group health plan from using genetic information in setting a premium contribution. However, the Act would not prohibit group health plans or issuers of plans (i.e., insurers) from requiring or requesting genetic testing, does not require them to obtain authorization before disclosing genetic information, and does not prevent them from excluding all coverage for a particular condition or imposing lifetime caps on all benefits or on specific benefits. In addition, this Act does not address the issues of the use of genetic information in contexts other than health insurance such as employment. 4. See, e.g., 136 Cong. Rec. H4627 (statement of Rep. Waxman). 5..Footnote: For a comprehensive discussion of how the ADA's coverage has been significantly restricted, see 1 Feldblum, Definition of Disability Under Federal Anti-Discrimination Law: What Happened? Why? And What Can We Do About It?, 21 Berkeley Journal of Labor and Employment Law 91 (2000)
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