Agencies Ask for Comments on GINA's Impacts

DOL's Employee Benefits Security Administration, the IRS, and the Centers for Medicare & Medicaid Services Comments are inviting comments until Dec. 9 about the impact on employment-based health coverage of the Genetic Information Nondiscrimination Act of 2008, known as GINA. The law prohibits discrimination in health coverage based on genetic information, which includes individuals' genetic tests, the genetic tests of family members, and a disease or disorder in family members.

GINA takes effect for group health plans and health insurers in the group market for plan years beginning after May 21, 2009. For health insurance issuers in the individual market, the provisions are effective for insurance coverage sold, issued, renewed, in effect, or operated in that market after May 21, 2009.

GINA includes a research exception under which a group health plan or a health insurer may request a participant or beneficiary to undergo a genetic test if these conditions are met: The request is made in writing pursuant to research that complies with federal regulations; the participant or beneficiary clearly states compliance is voluntary and non-compliance will have no effect on enrollment status or premium contribution amounts; none of the genetic information collected can be used for underwriting purposes; and federal authorities are notified about the research activities.

In their notice today, the federal agencies ask for comments on, among other things, what policies, procedures, or practices of group health plans and health insurers may be impacted by regulations under GINA? What direct or indirect costs would result? What direct or indirect benefits would result? Which stakeholders will be affected? What special consideration, if any, is needed for small employers or small plans? To what extent do group health plans and health insurers currently use genetic information? How do they obtain it, and under what circumstances do they now request or require an individual to take a genetic test?

To comment, visit www.regulations.gov and search for RIN 0938-AP37.

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