On March 8, the House Energy and Commerce Subcommittee on Health held a hearing on the Genetic Information Nondiscrimination Act (GINA) of 2007 (H.R. 493). The measure would prohibit employers from using individuals’ genetic information when making hiring, firing, job placement, or promotion decisions. It also would make it illegal for group health plans and health insurers to deny coverage to healthy individuals or charge them higher premiums based solely on a genetic predisposition to a specific disease. The House Education and Labor Committee approved the bill on February 14 (see The Source, 2/16/07). The Senate Health, Education, Labor and Pensions Committee approved its version of the bill on January 31 (see The Source, 2/2/07).
The first panel of witnesses focused on the bill’s interaction with existing health, privacy, and anti-discrimination laws. The second panel of witnesses consisted of policy experts from the insurance and public health fields.
“We stand at a critical time in the development of medicine: the mapping of the human genome has provided powerful new tools to understand the genetic basis of disease, but our ability to fully realize the promise of personalized medicine is limited by legitimate fear of how this powerful information could be abused,” said Dr. Francis Collins, director of the National Human Genome Research Institute at the National Institutes of Health (NIH). Dr. Collins said that without GINA, “we may never realize the full potential of genomic research, and more importantly, of individualized approaches to health care.” He described two cases in which fear kept individuals from revealing genetic information or consenting to a genetic test: in the first, a colon cancer survivor participating in an NIH study learned she carried a gene that increased her risk of the disease. She shared the information with her four sisters, none of whom elected to undergo genetic testing for fear they would lose their health insurance coverage. The second case involved a woman who tested positive for a gene associated with an increased risk of ovarian cancer. She did not share the information with her physician for fear her insurance company would cancel her coverage; a subsequent screening test missed an early-stage tumor. Dr. Collins urged the subcommittee to pass GINA, saying that that inaction would “result in a continuation of the current one-size-fits-all medicine, ignoring the abundant scientific evidence that the genetic differences among people help explain why some of us benefit from a therapy while others do not, and why some of us suffer severe adverse effects from a medication, while others do not.”
Sharon Terry, president and CEO of the Genetic Alliance, described her own family’s struggle with genetic illness; her children were diagnosed with a condition that will “rob them of their vision in the prime of their life.” Ms. Terry pointed out that GINA will not protect her children: “They have manifested disease, and this bill, appropriately, does not protect them. This is a critical point often obscured in many of the argument against the legislation. This bill is not about those who already have signs or symptoms of disease, but rather about those who carry a genetic mutation, which increases their chances to develop a disease or condition.” Saying “we are all vulnerable,” Ms. Terry said the bill was “simply about preventing the misuse of genetic information that which makes up every one of us, our shared inheritance, and that which makes us unique.”
Speaking on behalf of America’s Health Insurance Plans (AHIP), Dr. William Corwin, the medical director for clinical policy at Harvard Pilgrim Health Care, testified about how genetic tests may improve the quality and efficacy of care. He told the subcommittee about MammaPrint, a test that indicates whether or not a woman is likely to have a breast cancer relapse, and HER-2 screening, a test that indicates whether a breast tumor would be receptive to specific treatment therapies. Dr. Corwin said that AHIP “agrees with the intent of the bill,” but suggested several changes, including: encouraging medically-indicated testing; allowing health insurance plans to request genetic tests to promote screening; narrowing the definition of “genetic information” contained in the bill to exclude tests that may be linked to a person’s family history but are not genetic such as cholesterol tests; and specifying that employer-sponsored health care plans are not subject to civil action.
“NAHU [National Association of Health Underwriters] believes that health insurance or employment discrimination based on the genetic information of an otherwise healthy individual should be prohibited, provided that the definition of the ‘prohibited information’ is carefully, clearly, and narrowly defined,” said Executive Vice President and CEO Janet Trautwein. Ms. Trautwein outlined the privacy and nondiscrimination statutes already in place under the Health Insurance and Portability and Accountability Act of 1996 (P.L. 104-191). She also described the challenges facing health underwriters, particularly in the individual (rather than employer-sponsored) market, including “adverse selection” or that individuals are “much more likely to seek health insurance coverage when they think they need it…These sicker individuals consume more health care and, because the cost of health insurance coverage is directly related to the cost of medical care by those who are insured, the cost of health insurance rises.” Ms. Trautwein highlighted other industries that employ risk assessments, such as banks, property insurers, and credit care companies, saying that “health insurance underwriting works the same way the more information the underwriter has, the better the rates will be for most applicants.” She echoed Dr. Corwin in calling for the subcommittee to narrow the definition of “genetic information” contained in the bill: “Lawmakers must realize the impact their actions will have on the cost of health insurance today and in the years ahead. Great care should be taken to craft legislation that is very specifically related to a prohibition of the use of genetic tests that are truly predictive in nature. Overly broad definitions will impede the normal underwriting process and increase the cost of coverage, resulting in reduced access to quality health care.”
Karen Pollitz, a healthy policy researcher at Georgetown University, testified on the medical underwriting practices of health insurance companies. Ms. Pollitz shared the results of a recent study in which four pairs of hypothetical applications were submitted to health insurance companies. The pairs were identical in race, age, and sex, but one individual in each of the four pairs had received a positive genetic test indicating an elevated risk of a specific condition. “Underwriters were also asked what actions they would take based on an applicant’s receipt of genetic services. Specifically, they were asked to consider an applicant with a BRCA1 mutation whose doctor had discussed or recommended preventive surgery to reduce her future risk of [breast] cancer. Thirteen underwriters responded to this question. Of those five said they would take an adverse action based on discussion of risk-reducing options. Ten said they would act on a physician’s recommendation of such options…underwriters would deny coverage, surcharge premiums, or impose exclusion riders to limit covered benefits,” she said. Ms. Pollitz concluded, “Advances in genetic science may make possible dramatic improvements in medicine and public health that can reduce or prevent the incidence of many serious and expensive health conditions. For that day to come, patients will need assurances that they can both learn their genetic status and take appropriate actions to reduce their risk and improve their health without endangering their insurability.”
Testifying on behalf of the Genetic Information Nondiscrimination in Employment Coalition, Burton Fishman said, “We believe there is no need to require that employers, who have devoted long months of effort to master the privacy rules of HIPAA [Health Insurance Portability and Accountability Act (P.L. 104-191)], must now learn another, more expansive regimen for an ill-defined, endlessly growing body of information. We believe that predictive genetic information should be the focus of the bill and that this information can be acquired without inadvertently preventing the prompt provision of care or the slowing of the very research at the heart of this law. We believe that predictive genetic information can be protected without needlessly complicating the work of employers and burdening the lives of employees.” Mr. Fishman also suggested several improvements to GINA, including clarifying the bill’s liability provisions (included in earlier testimony before the House Education and Labor Subcommittee on Health, Employment, Labor and Pensions, please see The Source, 2/2/07).
During questions, Rep. Sue Myrick (R-NC) asked Dr. Collins about participation in clinical trials; specifically, she wanted to know if the provisions in the bill would protect individuals participating in biomedical research studies. Dr. Collins said that the definition of “genetic information” in the bill includes protection for the receipt of genetic counseling and any other genetic services. He said a clinical trial investigating the genetic component of any condition or disease would provide such services to participants and as such would be covered under H.R. 493.
Rep. Lois Capps (D-CA) asked Dr. Collins to provide some examples of situations in which the bill is needed to protect the privacy rights of individuals. He said that although the BRCA1 and BRCA2 genetic tests for breast and ovarian cancer have been available for quite some time, “only a tiny fraction of women at risk for these cancers are taking advantage of the test” because they fear insurance and/or employment reprisals.
Additional witnesses included: Christopher Kuczyski, director of the Americans with Disabilities Act policy division of the Equal Employment Opportunity Commission; Susan D. McAndrew, deputy director for health information privacy at the Department of Health and Human Services’ Office for Civil Rights; Frank Swain, senior vice president at B&D Consulting; and Dr. Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University.