TESTIMONY OF JOHN W. ROWE, M.D.
CHAIRMAN AND CEO, AETNA INC.
BEFORE
THE HOUSE JUDICIARY SUBCOMMITTEE
ON THE CONSTITUTION
Thank you for inviting me to testify today on this important issue. I am John W. Rowe, Chairman and CEO of Aetna, one of the nation’s leading providers of health care and related group benefits with 2001 revenue of $25.2 billion, serving approximately 14.4 million health care members, 11.9 million dental members and 12.0 million group insurance customers as of June 30, 2002. The company has an expansive nationwide network of more than 527,000 health care services providers, including approximately 321,000 primary care and specialist physicians and 3,300 hospitals. Aetna provides health care and related benefits to employer and plan sponsor customers in all 50 states.
I appreciate the opportunity to speak with you about genetic testing, privacy of genetic information and the role of health plans which are providing coverage for members at high risk for certain treatable diseases. We are in an exciting period in medicine. New techniques have allowed scientists to learn a great deal about how genes work and how genes are linked to disease. Tests for gene mutations have made it possible not only to detect disease, but predictive gene testing holds the promise of saving thousands of lives through prevention or early detection. With these advancements, it also is critically important to assure the public that their confidential information will be protected.
I will review the current status of genetic testing as I see it, including some facts and myths regarding the insurance industry, and finish by iterating the guidelines that Aetna recently proposed as a standard for the industry in this area.
There are two distinct issues here. One is assuring that genetic information is not used for discriminatory purposes in insurance. The second is the use of genetic information as part of a benefit covered by health insurance, the issue of medical management.
CURRENT STATUS OF GENETIC TESTING
As for the facts, the current situation can be defined with five general statements.
1) Medical science can detect the presence of a growing inventory of genes that influence either the development of a disease or the effectiveness and/or safety of a specific treatment.
There are basically two kinds of disease related genes. In one case, if you have the gene, you get the disease 100% of the time. One such example is Huntington’s Disease. If you have an identical twin with Huntington’s Disease, you’re going to get Huntington’s Disease. A second category of genes are susceptibility genes. These genes increase the likelihood of developing a given disease, but don’t make it a certainty. This is true of the commonly discussed breast cancer genes - BRCA 1 and 2. As a result of the human genome project, the repertoire of susceptibility genes that we can now measure has increased dramatically.
2) Health plans can play an important role in providing access to clinically useful testing and the proper interpretation of tests results.
3) There is substantial public interest in genetic testing as well as concern regarding the potential for the inappropriate use of genetic testing.
4) Legislation specifically prohibiting health plan’s discriminatory use of genetic information is present in most states but varies considerably from state to state.
5) There is a pressing need for the health insurance industry to establish guidelines for covering genetic testing and the interpretation of the test results.
Unfortunately, with progress often comes misconception which frequently turns into myth. One myth relates to the prevalence of discrimination. Regarding the strong public concern regarding privacy and the potential use of information to disadvantage individuals for health insurance, there is a difference between the perception of how medical information is used and reality. The record does not appear to include any identifiable cases in which people have been discriminated against in health insurance based on genetic information. Professors Hall and Rich from Wake Forest University in a paper in the American Journal of Human Genetics evaluated the effect of state laws in reducing the extent of genetic discrimination by health insurers (Hall, Mark A; Rich, Stephen S: Laws Restricting Health Insurers’ Use of Genetic Information: Impact on Genetic Discrimination. American Journal of Human Genetics, 66:293-307, 2000). They found, and I quote:
“… that there are almost no well-documented cases of health insurers either asking for or using presymptomatic genetic test results in their underwriting decisions, either (a) before or after these laws have been enacted or (b) in states with or without these laws. … that a person with a serious genetic condition who is presymptomatic faces little or no difficulty in obtaining health insurance. Furthermore, there are few indications that the degree of difficulty varies according to whether a state regulates the use of genetic information.”
Another myth is that our health insurance coverage decisions are arbitrary. At Aetna, we’ve developed a comprehensive process for deciding whether or not a specific genetic test should be covered. Our policies are based on the assumption that use of the genetic information will positively affect the course of treatment of our member. The coverage policy analysis begins with a review of the peer reviewed medical literature and the formal opinions of national professional organizations such as the American College of Medical Genetics, American College of OB/GYN, and government agencies such as Medicare on whether they believe a given genetic test should be covered. After these nationally accepted professional sources, we turn next to a review by expert physicians in our network. Then we go to a participant provider review, of how, for instance, do the practicing obstetricians and gynecologists feel about it rather than just the experts in breast cancer or ovarian cancer. We then disseminate the finalized guidelines for wide review and publish a coverage policy bulletin -- we have about 150 or 160 of these available on our website.
Another myth is that genetic testing will break the bank. The reality is, I believe, that genetic testing of individuals with pronounced susceptibility to a treatable or preventable disease is cost effective.
A good example is breast cancer. In screening for the breast cancer genes (BRCA 1 and 2) in carefully selected patients, the cost is low, and the risk of misinterpretation is much less and potential clinical benefits are more certain than in lower risk groups. In a study by Eccles et al in the British Journal of Cancer in ’98 (Eccles, DM; Englefield, P; Soulby, MA; Campbell, IG: BRCA1 Mutations in Southern England. British Journal of Cancer, 1998; 77(12), 2199-2203), the cost per gene mutation detected, if screening every woman, is $170,000. If screening just women under 40 who are already diagnosed with breast cancer to see if their cancer is this genetic variant, the cost is $1,700. And if testing women who have a strong family history, the cost was $489 per detected gene mutation. And if a woman has BRCA 2, there is something she can do. She can take Tamoxifen, an anti-estrogen, or have surgical removal of her breasts, to reduce the risk. The key to appropriate screening is the person screened has to be in a high risk group and there has to be something you would do clinically, based on the test results.
APPEALING RHETORIC - BAD RESULTS
Some individuals suggest that the safest way to assure that health insurers do not use genetic information to disadvantage members will be to prevent the insurers from having the information. This approach is both unnecessary and counter-productive and will impair insurers capacity to provide appropriate service to its members. Let me provide two straightforward examples.
For individuals known to have the gene for the familial form of colorectal cancer, their best interest, in terms of cancer prevention, survival and cost effective care, is to have frequent screenings via colonoscopy, perhaps at 6 month intervals rather than the much longer intervals recommended for the general population (Vasen, HFA; van Ballegooijen, M; Buskens, E; Kleibeuker, JK; Taal, BG; Griffioen, G; Nagengast, FM; Menko, FH; Meera, Kahn P: A Cost-Effectiveness Analysis of Colorectal Screening of Hereditary Nonpolyposis Colorectal Carcinoma Gene Carriers. Cancer, 1998; 82(9), 1632-1637).
If the insurance company knows that the individual is at high risk due to a genetic link, the individual will be able to obtain coverage for preventive screening at more frequent intervals than recommended for the general population. Additionally, if the insurance company is informed of the results of predictive gene testing, they can reach out to these individuals to ensure that they receive the necessary preventive screening. In addition to influencing the likelihood of developing a disease, genes may determine the response to a specific treatment. We have long known that individuals differ in their response to medication - both in having the desired therapeutic effect or having a serious adverse side effect. Now we can test for the presence of genes that govern some of these differences. For instance, in the case of a medication, Ziagen, which is effective in AIDS, certain individuals have adverse reactions that can be fatal. Eighty percent of those with the reactions have a specific gene that can be tested for, thus avoiding the adverse reaction in those patients.
Since health plans have sophisticated information systems and administrative data of the prescription medications individuals take, the health plan could provide a busy physician with a large practice a list of the individuals in the physician’s practice, and insured by the health plan, who are known to have the genetic characteristic susceptible to certain medications. In such a case, the physician then could take steps to assure that those individuals avoid the use of a specific medication which could place the patient at risk for a serious adverse reaction.
These examples - colorectal cancer screening and predicting response to medication (pharmacogenetics) - are but two of many possible instances in which it would be very important for the provision of high-quality, cost-effective health care for the results of genetic tests to be available to the insurers.
With these considerations in mind and with the appreciation of the fact that HIPAA already provides substantial protection relative to individual privacy, Aetna has recently offered the following guidelines which we hope will serve as a benchmark for the industry.
We feel that health plans should make available products to their self-insured plan sponsors and their fully insured customers that:
1. Cover genetic testing in individuals shown to be at risk where results may affect the course of treatment of the insured.
2. Cover genetic testing for a family member where the family member is not otherwise insured and results may affect the course of treatment of an at risk insured.
3. Cover consultation with qualified counselors and physicians and facilitate the appropriate interpretation of genetic testing results.
4. Support physician education in the appropriate interpretation and use of genetic tests, including guidance in selection of medication (pharmacogenetics).
5. Work with physicians to promote confidentiality and to use genetic information for the maximum benefits of the member.
And Health plans should not:
1. Establish rules for health coverage eligibility based on genetic testing.
2. Request or require genetic testing results as a condition to providing health insurance coverage.
3. Use genetic testing for risk selection or risk classification purposes in providing health coverage.
4. Disclose genetic testing results that may come into their possession without member authorization.
Health insurers aim to facilitate the cost effective utilization of the scientific method to enhance the health status of individuals. Individuals must be protected from discrimination, while having the advantage of appropriate use of genetic information to enhance their health status. Aetna has proposed guidelines to serve as a benchmark for the industry. We believe that genetic testing should be seen as an effective tool to enhance the health status of individuals and are working hard to accomplish that goal.