Federal Rule Limits Use Of Genetic Test Results

Federal regulators recently issued an interim final rule to implement a 2008 law barring insurers and employers from using Americans' genetic information to deny them insurance coverage, change their rates, or discriminate against them in the workplace. But more protections may be needed.

The departments of Health and Human Services (HHS), Treasury, and Labor issued the rule on October 1 to implement provisions of the Genetic Information and Nondiscrimination Act of 2008 (GINA, PL 110-233), which states that health insurers cannot cancel, deny, refuse to renew, or change the terms or premiums of coverage based solely on an individual's genetic risk of a specific disease. It also forbids employers from using a person's genetic information when making hiring, firing, promotion, and other employment-related decisions.

A 90-day public-comment period has been set for the interim final rule, closing on January 5, 2010.

“Echoing the late Sen. Ted Kennedy, our efforts to protect Americans undergoing genetic testing from having the results of that testing used against them by their insurance companies is one of the first major new civil rights of the new century,” said HHS Secretary Kathleen Sebelius in a written statement about the rule.

Under the rule, insurers cannot request, require, or buy genetic information, and they are generally prohibited from asking individuals or family members to undergo a genetic test. The rule, however, allows three potential exceptions to the overall ban on requests for someone to undergo genetic testing—when a “health care professional” requests one, for payment-determination questions, and for research purposes. The rule also defines genetic information, genetic services, genetic testing, and related terms and phrases.