New final interim rules have been issued by the departments of Health and Human Services (HHS), Labor, and Treasury to ensure that individual genetic information will not be used adversely when determining healthcare coverage.
The rule implements Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA) that will prohibit group health plans and group health insurance issuers from:
- Increasing premiums for the group based on the results of an enrollee's genetic information
- Denying enrollment
- Imposing pre existing condition exclusions
- Performing other forms of underwriting based on genetic information
The new regulations also will ban group health plans and health insurance issuers in both group and individual markets from requesting, requiring, or buying genetic information for underwriting purposes either before—or in connection with—enrollment. In addition, plans and issuers will be prohibited as well from asking individuals or family members to undergo genetic tests.
The new rules are seen as a way to encourage more individuals to participate in genetic testing in order to identify and prevent various illnesses, according to HHS Secretary Kathleen Sebelius. "Genetic testing will encourage the early diagnosis and treatment of certain diseases, while allowing scientists to develop new medicines, treatments, and therapies."
The new rule modifies the HIPAA Privacy Rule by clarifying that genetic information is health information and specifically prohibits the use and disclosure of genetic information by covered health plans for:
- Eligibility determinations
- Premium computations
- Applications of any pre existing condition exclusions
- Any other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.
With the new rule, the use or disclosure of genetic information in violation of the HIPAA Privacy Rule could result in a fine of $100 to $50,000 or more.