<nobr>Oct 6, 2009</nobr>

Agencies Release Interim Final Regulations on Genetic Information Nondiscrimination

The U.S. Departments of Health and Human Services, Labor, and Treasury on October 1 released interim final regulations implementing Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA) (P.L. 110-233).

Title I of GINA amended ERISA, the Public Health Service Act, the Internal Revenue Code, and the Social Security Act to prohibit discrimination in health coverage based on genetic information. Title II of GINA prohibits discrimination in employment based on genetic information, and limits the acquisition and disclosure by employers and other entities covered by GINA Title II of such information. These interim final regulations only interpret Sections 101 through 103 of Title I of GINA.

Under GINA, and the interim final rule, group health plans and issuers in the group market cannot: increase premiums for the group based on the results of one enrollee's genetic information; deny enrollment; impose pre-existing condition exclusions; or do other forms of underwriting based on genetic information. In addition, group health plans and health insurance issuers in both the group and individual markets cannot request, require or buy genetic information for underwriting purposes or prior to and in connection with enrollment.

These interim final regulations will be effective 60 days after publication in the Federal Register, and comments are due on or before 90 days after publication in the Federal Register.

Proposed Regulations on HIPAA Privacy Rule

The Office of Civil Rights at HHS also released proposed regulations addressing the Health Insurance Portability and Accountability Act (HIPAA) privacy rule to prohibit health plans from using or disclosing genetic information for underwriting purposes.

The proposed rule modifies the HIPAA privacy rule to clarify that genetic information is health information and to prohibit the use and disclosure of genetic information by covered health plans for eligibility determinations, premium computations, applications of any pre-existing condition exclusions, or any other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.

HHS said that in combination with the new penalties for violations of the HIPAA Privacy Rule, as provided for by the American Recovery and Reinvestment Act of 2009, a 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 for each violation.

Comments on the proposal regulations are due 60 days after being published in the Federal Register.

Questions or comments on these issues should be addressed to either Gretchen Young (gyoung@eric.org) or Adam Solander (asolander@eric.org).

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Websites:

HHS Release

Interim Final Rule

OCR Proposed Rule

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