Genetic Information Nondiscrimination Act - Agencies Issue Requests for Public Comments

The Department of Labor's Employee Benefits Security Administration (EBSA), the Department of Health and Human Services (HHS), and the Internal Revenue Service have issued a request for public comments concerning issues arising under the Genetic Information Nondiscrimination Act of 2008 (GINA). GINA, enacted in May, prohibits health insurance and employment discrimination on the basis of genetic information.

The agencies seek comments that might contribute to the analyses that will be performed under the requirements of GINA, both generally and with respect to the following specific areas: (a) what policies, procedures, or practices of group health plans and health insurance issuers might be affected by regulations under GINA? What direct or indirect costs and benefits would result? Which stakeholders will be affected by such costs and benefits? (b) Are there unique costs and benefits for small employers or small plans? What special consideration, if any, is needed for small employers or small plans?

Specifically, the agencies request comments on the following nine issues:

(1) To what extent do group health plans and health insurance issuers currently use genetic information, such as family medical history, and for what purposes? For example, is genetic information currently used for group rating purposes, or for purposes of a wellness program that otherwise complies with the nondiscrimination requirements of the Health Insurance Portability and Accountability Act?
(2) How do plans and issuers currently obtain genetic information (for example, through health risk assessments)?
(3) Under what circumstances do plans or issuers currently request or require an individual to take a genetic test?
(4) Under what circumstances do plans or issuers currently ask for the results of a genetic test in order to make a determination regarding payment of benefits? What is the minimum amount of information necessary for a plan or issuer to make a determination under such circumstances?
(5) What types of research do plans or issuers currently conduct or support using genetic tests?
(6) Would a model notice be helpful to facilitate disclosure to plan participants and beneficiaries regarding a plan's or issuer's use of the research exception? In this regard, what information would be most helpful to participants and beneficiaries?
(7) Would a model form be helpful for reporting to the agencies by a plan or issuer claiming the research exception? In this regard, what information should plans and issuers report?
(8) When might genetic information be collected incidentally?
(9) What terms or provisions (such as genetic information, genetic test, genetic services, or underwriting) would require additional clarification to facilitate compliance? What specific clarifications would be helpful?

The deadline for comments is December 9.

Comments to the Office of Health Plan Standards and Compliance Assistance, EBSA, should be sent to: Room N-5653, U.S. Department of Labor, 200 Constitution Avenue, N.W., Washington, DC 20210. Attention: GINA Comments; via e-mail at E-OHPSCA.EBSA@dol.gov.; or via the Internet to http://www.regulations.gov.

Comments to the HHS, identified by code CMS-4137-NC, should be submitted to the Centers for Medicare and Medicaid Services, HHS, Attention: CMS-4137-NC, P.O. Box 8017, Baltimore, MD 21244-8010; or via the Internet to the same Web address.

Comments to the IRS, identified by code REG-123829-08, should be submitted to CC:PA:LPD:PR (REG-123829-08), Room 5205, IRS, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044

For further information, contact Amy Turner of the EBSA at (202) 693-8335; Russ Weinheimer of the IRS at (202) 622-6080; or Adam Shaw of the HHS at (877) 267-2323 ext. 61091.

The request for comments was published in the Federal Register on October 10.

Reprinted with permission. © CCH

(Submitted Oct. 2008)

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