The Departments of Health and Human Services (HHS), Labor and the Treasury have issued new regulations regarding the implementation of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA). The interim final rule provides that genetic information is not to be used adversely in determining health care coverage. That protection, the HHS feels, will lead to more persons obtaining genetic testing.

"Echoing the late Senator 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. "Consumer confidence in genetic testing can now grow and help researchers get a better handle on the genetic basis of diseases. Genetic testing will encourage the early diagnosis and treatment of certain diseases while allowing scientists to develop new medicines, treatments, and therapies."

The interim final rule with request for comments and the notice of proposed rulemaking have been published in the Federal Register. The proposed rule published modifies the HIPAA Privacy Rule pursuant to GINA Title I HHS, to clarify that genetic information is health information under the rule and to prohibit the use or disclosure of genetic information for underwriting purposes. Underwriting purposes are defined as including changing deductibles or other cost-sharing mechanisms, or providing discounts, rebates, payments in kind, or other premium differential mechanisms in return for activities such as completing a health risk assessment (HRA) or participating in a wellness program.

GINA and the interim final regulations expand the HIPAA prohibitions against discrimination based on health factors, and prohibiting group health plans and health insurance issuers offering group health plan coverage from adjusting premium or contribution amounts for a group health plan or group of similarly situated individuals on the basis of genetic information. Insurers are prohibited from using genetic information to deny coverage, raise premiums, or impose pre-existing condition exclusions. Plans and issuers are generally prohibited from asking individuals or family members to undergo a genetic test.

The Interim final rules contain the addresses where comments may be sent for a 90-day period.

Adapted in part from information in the Interim final rules with request for comments and an HHS press release.

The interim rules may be accessed at: http://www.federalregister.gov/OFRUpload/OFRData/2009-22504_PI.pdf

The HHS press release: http://www.hhs.gov/news/press/2009pres/10/20091001b.html

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