Recent regulations under the Genetic Information Nondiscrimination Act (“GINA”) contain broad restrictions on the collection of family medical history through health risk assessments and similar arrangements. Although certain narrow exceptions apply, most employers will have little choice but to eliminate any questions on family medical history that may appear in health risk assessments and wellness programs, and to contact vendors of such arrangements to ensure that such information is not solicited in any health or wellness material. The regulations are effective as of the first plan year beginning on and after December 7, 2009 for group health plans that adjust premiums, co-pays, or deductibles based on completion of health risk assessments that include questions on family medical history. Penalties for violation of Title I of GINA include civil penalties under ERISA and excise taxes under the Internal Revenue Code.

GINA contains two parts. Title I provides that health plans and health insurers may not use genetic information for underwriting purposes, request or require genetic information prior to enrollment, or require an employee or the employee’s family members to take a genetic test. For health plans, Title I is effective for plan years beginning on and after May 21, 2009 (January 1, 2010, for calendar year health plans – the regulations are effective for plan years beginning on and after December 7, 2009 and, thus, are also effective January 1, 2010 for calendar year plans). The Internal Revenue Service (“IRS”), Department of Labor (“DOL”) and Centers for Medicare & Medicaid Services have regulatory authority over Title I and they jointly issued the recent interim regulations.

Title II prohibits employment discrimination based on genetic information. The Equal Employment Opportunity Commission (“EEOC”) has regulatory authority under Title II and has issued proposed regulations discussed below.

How the Prohibitions Affect Enrollment and Eligibility
The Title I regulations prohibit the collection of genetic information prior to or in connection with enrollment. Because many employers ask employees to provide health information in connection with annual enrollment, employers may need to act now to comply with the regulations. The regulations under Title I not only prohibit the collection of family medical history prior to enrollment, but prohibit the use of such information to determine eligibility for enrollment in a disease management program. See 26 C.F.R. § 54.9802-3T; 29 C.F.R. § 2590.702-1. The Title I regulations provide an exception for the “incidental collection of genetic information.” Open-ended questions pose a problem. If a health risk assessment or similar arrangement includes an open-ended question that may prompt an individual to offer family medical history, the information will not be treated as the incidental collection of genetic information (and may result in a violation of GINA) unless there is an explicit statement that genetic information should not be provided.

How the Prohibitions Affect Incentives Offered Through Health Plans
The Title I regulations view health plans that offer an incentive (i.e., a reduction in premiums) in connection with the collection of family medical history in a health risk assessment as using genetic information for “underwriting purposes.” This is the case even though the incentive is not connected to an employee’s genetic information but rather based on whether the employee completes a health risk assessment.

Title II and the EEOC Proposed Regulations
Title II of GINA allows employers to request family medical history in health risk assessments, as long as those arrangements are not linked to a group health plan through incentives or otherwise. Such arrangements may only include questions on family medical history if employees are provided certain written disclosures and agree in writing to make the information available. Title II is effective November 21, 2009. The EEOC has regulatory authority over Title II and has issued proposed regulations.

The EEOC completed final regulations under Title II of GINA several months ago, but they are being reviewed by the Office of Management and Budget and have not yet been released. Among the items being considered by the EEOC is whether an employee’s decision to provide genetic information is “voluntary” if an employer offers an incentive. Another concern is how they will address the relationship between Titles I and II of GINA. The Title II proposed regulations suggest that there is a “firewall“ between Title I and II, and that employers cannot be liable for the separate penalties under each section for the same act or omission. See 29 C.F.R. § 1635. This is based on Section 209(a) of GINA. Hopefully, the EEOC’s final regulations will clarify the scope of the firewall. Employers should review their practices in light of the proposed regulations to determine if action is necessary.

GINA and HIPAA Privacy and Security
GINA also provides that genetic information is to be treated as protected health information under HIPAA. Section 105 of GINA amends the Social Security Act to apply HIPAA privacy rules to genetic information. The Department of Health and Human Services (“HHS”) has issued proposed regulations that amend the HIPAA privacy regulations. Employers should consider reviewing their HIPAA privacy policies with respect to genetic information.

Many employers are discovering they need to revise their enrollment practices and wellness programs based on the restrictions under Title I regulations. If you have questions about the regulations and the impact on your health plan, please contact the attorney in the Benefits and Compensation practice group with whom you work.