On May 21, President Bush signed the Genetic Information Nondiscrimination Act (GINA). GINA prohibits discrimination by insurance companies or employers on the basis of “genetic information” about an individual or his or her family members. The protections conferred by GINA should greatly expand the use of, and reimbursement for, genetic diagnostic products and personalized treatment options.
Genetic information can be used in two main ways to diagnose and treat individual patients:
(1) Risk Prediction: certain genetic mutations are associated with disease, and the detection of these mutations can predict the risk of an individual having that disease. For some conditions, such as cystic fibrosis, the presence of some mutations is 100% predictive of developing the disease. In other cases, such as breast cancer, different mutations in the BRCA genes have different penetrance. In complex conditions, such as heart disease, many mutations at different loci can potentially combine with environmental factors to increase risk.
(2) Pharmacogenomics: certain genetic mutations can predict the response that a specific patient will have to a specific medicine. For example, administering the HercepTest determines whether a breast cancer patient will respond to Herceptin therapy.
In addition to companies addressing these two markets, a number of companies are offering wholegenome analyses, including Navigenics, 23andMe and DeCode Genetics.
Patients who take advantage of these technologies will, once the law goes into effect, be protected against employment and health insurance discrimination.
PROHIBITIONS AGAINST DISCRIMINATION
Title I of GINA enacts changes to the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHSA) and the Internal Revenue Code to prohibit group and individual health insurers from making adjustments to premium or contribution amounts or making underwriting decisions based on genetic information. It prohibits insurers from denying coverage of a pre-existing condition based on genetic information. Title I of GINA also requires the Secretary of Health and Human Services (HHS) to implement changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy regulations to cover genetic information.
Title II of GINA enacts prohibitions against discrimination in employment, including failing to hire or discharging an employee, or practising discrimination in relation to training or retraining opportunities, based on genetic information. It also requires confidential treatment of any genetic information in the employer’s possession. As passed by the House and Senate, GINA does not provide a cause for “disparate impact” claims arising from facially neutral employment practices that have an unjustified adverse impact on members of a protected class. It does, however, call for a study commission to be formed six years after the act’s passage, which will recommend at that time whether a disparate impact cause of action should be provided.
REQUESTS OR RECOMMENDATIONS FOR TESTING
GINA prohibits, with limited exceptions, an insurer or an employer from requesting or requiring that an individual take a genetic test. However, it does not prohibit a physician from requesting a genetic test nor does it prohibit an insurer from obtaining or using the results of a genetic test “in making a determination regarding payment.”
Canada, with its single-payer health care systems, has not passed any directly parallel laws, although genetic information would be protected by federal privacy legislation and by some provincially enacted privacy and personal health information statutes. Canadian human rights regimes may also be seen to provide an extra blanket of protection in the event of discrimination based on genetic information.
CONSEQUENCES FOR PERSONALIZED MEDICINE
Estimates of the potential impact of GINA can be made by reference to pre-GINA data. A frequently cited example is that nearly one-third of women offered genetic testing for breast cancer risk by the NIH turned it down, citing insurance concerns. Anecdotally, many patients who undergo genetic testing choose to pay out of pocket to prevent giving their insurers access to the results. While GINA will alleviate many of these concerns, the bill only addresses health insurance, so patients concerned about other forms of insurance, such as life insurance or long-term care insurance, may still be reluctant to undergo testing.