The Department of Labor (DOL), Internal Revenue Service (IRS), and the Centers for Medicare and Medicaid (CMS) have published in the Federal Register interim final rules (pdf) governing Sections 101 through 103 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA). Title I of GINA amended the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHS Act), the Internal Revenue Code of 1986 (Code), and the Social Security Act (SSA) to prohibit discrimination in health coverage based on genetic information. Sections 101-103 contain provisions banning discrimination based on genetic information in health insurance coverage and group health plans. The EEOC has not yet issued final rules interpreting Title II of GINA, which prohibits discrimination in employment based on genetic information, and limits the acquisition and disclosure by employers and other entities of such information.

In general, Title I of GINA prohibits group health plans and health insurance issuers from adjusting contribution amounts or premiums for the group based on the genetic information of any plan participant, prohibits plans from requesting or requiring individuals or their family members to undergo a genetic test and from requesting, requiring or purchasing genetic information for underwriting purposes or prior to an individual's enrollment.

The interim rules, among other things, define a number of terms in GINA. The new rules explain that “genetic information,” with respect to an individual, is defined as information about the individual’s genetic tests or the genetic tests of family members, the manifestation of a disease or disorder in family members of such individual (i.e. family medical history), or any request of or receipt by the individual or family members of genetic services. The definition further clarifies that genetic information does not include information about the sex or age of any individual. In addition, the regulations explain how GINA applies to genetic information about a fetus or embryo.

The prohibitions described above, when read in conjunction with the Act’s broad definition of genetic information, impose significant limitations on employers’ requests that employees complete a health risk assessment. Under the new rules, employers may not ask an employee to complete a health risk assessment that contains questions about family history until after the effective date of coverage. After coverage goes into effect, employers cannot request completion of such an assessment if they offer any premium differential, such as a reduction in the employee’s contribution.

For purposes of Title I only, the regulations adopt the definition of “genetic test” from the statute, which defines such a test as “an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, if it detects genotypes, mutations, or chromosomal changes.” The regulations point out that this definition of “genetic test” differs from that contained in Title II of GINA, which governs genetic discrimination in employment. 

In regard to GINA’s impact on HIPAA, the Department of Health and Human Services (HHS) has also published in the Federal Register a proposed rule (pdf) interpreting Section 105 of GINA, which requires HHS to revise the HIPAA privacy regulations to clarify that genetic information is health information under the rule and prohibits the use or disclosure of genetic information for underwriting purposes. According to HHS’ proposal, the rules modify the HIPAA Privacy Rule to: (1) explicitly provide that genetic information is health information for purposes of the Rule; (2) prohibit health plans from using or disclosing protected health information that is genetic information for underwriting purposes; (3) revise the provisions relating to the Notice of Privacy Practices for health plans that perform underwriting; (4) make a number of conforming modifications to definitions and other provisions of the Rule; and (5) make technical corrections to update the definition of “health plan.”

In its commentary to the regulations, HHS pointed out that the change to the Privacy Notice would be material and, therefore, would require notification of the change to the named insured or the named plan participant. HHS requested further comment on how this notification could be accomplished in a manner that would be less burdensome and expensive than distributing a revised Privacy Notice. Employers should watch for additional guidance on this issue.

The IRS’ proposed rule (pdf) cross-references the interim rules, which prohibit using an individual’s genetic information to adjust group premium or contribution rates.

Comments on the interim final rules must be made by January 5, 2010, and can be submitted electronically through the federal eRulemaking Portal:http://www.regulations.gov, to any of the agencies involved in this rulemaking. Comments to the DOL can also be make via email: E-OHPSCA.EBSA@dol.gov. Written comments to the DOL may also be sent or hand-delivered to: Office of Health Plan Standards and Compliance Assistance, Employee Benefits Security Administration, Room N-5653, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210, Attention: RIN 1210-AB27. All comments to the DOL must include the identification number: RIN 1210-AB27.

Comments submitted to the CMS must be identified with CMS-4137-IFC, and can be sent to Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4137-IFC, P.O. Box 8017, Baltimore, MD 21244-8010. Hand-delivered comments may be brought to either 7500 Security Boulevard, Baltimore, MD 21244-1850 or Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW, Washington, DC 20201.

Comments to the IRS are to be sent to: CC:PA:LPD:PR (REG-123829-08), Room 5205, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Hand-delivery may be made to: CC:PA:LPD:PR (REG-123829-08), Courier’s Desk, Internal Revenue Service, 1111 Constitution Avenue, NW, Washington DC 20224. Comments to the IRS must be identified with: REG-123829-08.

Written comments (one original and two copies) on the HHS proposed rule must be received by December 7, 2009 at the following address: U.S. Department of Health and Human Services, Office for Civil Rights, Attention: GINA NPRM (RIN 0991-AB54), Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue, S.W., Washington, D.C. 20201. 

Philip L. Gordon contributed to this entry.