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Two new federal rules add additional protections to patient privacy under the Genetic Information Nondiscrimination Act of 2009.

The Departments of Labor, Treasury, and Health and Human Services have issued an interim final rule to prohibit group health plans and health insurance issuers in the group market from:

* increasing premiums for the group based on the results of one enrollee's genetic information,
* denying enrollment,
* imposing pre-existing condition exclusions, and
* conducting other forms of underwriting based on genetic information.

The interim final rule, which includes requests for comment, also prohibits issuers in the individual market from using genetic information to deny coverage, raise premiums or impose pre-existing condition exclusions. Further, group health plans and issuers in both the group and individual markets cannot request, require or buy genetic information for underwriting purposes, or in connection with enrollment. They also are "generally" prohibited from asking individuals or family members to undergo a genetic test, according to the federal agencies.

HHS' Office for Civil Rights has issued a proposed rule modifying the HIPAA privacy rule to prohibit insurers from using or disclosing genetic information for underwriting purposes. The proposed rule clarifies that genetic information is health information and prohibits "the use and disclosure of genetic information by covered health plans for eligibility determinations, premium computations, applications of any pre-existing condition exclusions, and any other activities related to the creation, renewal or replacement of a contract of health insurance or health benefits," according to the agencies. Violations could result in a fine of $100 to $50,000 for each violation. The proposed rule has a 60-day comment period.

The multi-agency interim final rule and proposed rule will be published in coming days in the Federal Register. The interim final rule is available at federalregister.gov/OFRUpload/OFRData/2009-22504_PI.pdf, with additional information at dol.gov/ebsa. The HHS Office for Civil Rights proposed rule is available for viewing at hhs.gov/ocr/privacy.

--Joseph Goedert