The Genetic Information Nondiscrimination Act of 2008 (“GINA”) prohibits genetic-based discrimination against individuals with respect to their employment and health insurance. GINA amended ERISA, the Public Health Service Act, the Internal Revenue Code and the Social Security Act as they relate to Medigap and the regulations under HIPAA, to provide that genetic information be treated as protected health information under the HIPAA privacy regulation.

GINA defines “genetic information” broadly as: “with respect to any individual, information about (i) such individual’s genetic tests, (ii) the genetic tests of family members of such individual, and (iii) the manifestation of a disease or disorder in family members of such individual.” Genetic information does not include information about the sex or age of any individual, but does include information regarding an individual’s fetus or embryo. Under GINA, “genetic test” means an analysis of human DNA, RNA, chromosomes, proteins or metabolites that detects genotypes, mutations or chromosomal changes. GINA further defines “family member” as a dependent of such individual or any other individual who is a first-degree, second-degree, third-degree or fourth-degree relative of such individual or the individual’s dependent.

GINA imposes nondiscrimination restrictions with respect to coverage costs on group health plans (including small plans) and insurance issuers, and limits their ability to collect genetic information. Group health plans and issuers may not adjust premium or contribution amounts for the group covered under such plan on the basis of genetic information. A health insurance issuer offering health insurance coverage in connection with a group health plan, however, may increase the premium for an employer based on the manifestation of a disease or disorder of an individual who is enrolled in the plan. GINA further provides that a group health plan or issuer shall not request or require an individual or a family member of such individual to undergo a genetic test. This does not, however, limit the ability of a health care professional who is providing health care services to an individual to request that such individual undergo a genetic test. Under GINA, group health plans and issuers are not prohibited from obtaining and using the results of a genetic test to make a determination regarding payment of claims, but the group health plan or issuer may only request the minimum amount of information necessary to make such determination. Group health plans and issuers also may, but are not required to, request that a participant or beneficiary undergo genetic testing, subject to certain conditions.

GINA prohibits group health plans and issuers from requesting, requiring, or purchasing genetic information (i) for underwriting purposes or (ii) with respect to any individual, prior to such individual’s enrollment under the plan or coverage in connection with such enrollment. A group health plan or issuer will not be in violation of GINA if the group health plan or issuer incidentally obtains genetic information regarding any individual after requesting, requiring or purchasing other information concerning such individual.

Violations of GINA can result in a range of civil penalties based on factors such as the timing of the discovery of such violation, whether the violation is de minimis in nature and whether the violation is knowing and intentional. Violations corrected prior to the plan or issuer receiving a notification from the appropriate governmental body may be assessed a penalty of $100 per day. For failures not corrected prior to such notification, the minimum penalty for a de minimis violation is $2,500 and for a more than de minimis violation, $15,000. If a failure (i) is due to reasonable cause and not willful neglect and (ii) is corrected within 30 days, no penalty shall apply. If failure (i) is due to reasonable cause and (ii) is not corrected within 30 days, the penalty shall not exceed the lesser of: (i) 10% of the aggregate amount paid or incurred for its group health plan by the plan sponsor during the preceding taxable year or (ii) $500,000.

Effective Date

The provisions of GINA applicable to group health plans and issuers are effective for plan years beginning after May 21, 2009 (i.e., for calendar year plans, January 1, 2010). The Secretaries of Labor, Health and Human Services and the Treasury shall issue final regulations implementing GINA.

Action Required

Plan Sponsors should review their plan operations to ensure compliance with the requirements of GINA.