On October 7, 2009 the Departments of Treasury, Labor and Health and Human Services ("Federal Agencies") released interim final regulations under the Genetic Information Nondiscrimination Act of 2008 ("GINA").  GINA, among other things, prohibits group health plans from collecting genetic information either for underwriting purposes or prior to or in connection with enrollment.  GINA went into effect on May 21, 2009 (or January 1, 2010 for calendar-year plans) and newly-released regulations will become effective for plan years starting on or after December 7, 2009.  The Federal Agencies may impose a civil penalty of $100 per violation on a plan sponsor for GINA violations.

In general, GINA prohibits group health plans and health insurance issuers from:

• adjusting premium or contribution rates based upon genetic information;
•  requiring or requesting that an individual or family member undergo a genetic  test;
• requesting, requiring, or purchasing genetic information prior to or in connection  with enrollment; and
• using or disclosing protected health information that is genetic information for  underwriting purposes.

GINA and its corresponding regulations define "genetic information" broadly.  Genetic information is defined, with respect to an individual, as information about the individual's genetic tests or the genetic tests of family members, the manifestation of a disease or disorder in the 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 regulations also clarify that genetic information does not include information about the sex or age of any individual. Family members are defined as any dependents, first degree relatives (parents, spouses, siblings and children), second-degree relatives (grandparents, grandchildren, aunts, uncles, nephews and nieces) and third and fourth degree relatives.

The major impact of these new rules will fall upon group health plans that conduct health risk assessments ("HRAs") in connection with enrollment or disease management programs.  The new GINA regulations significantly limit the type of information that can be requested.  HRAs commonly ask for information related to an individual's and/or their family's medical history.  Under the new guidance, wellness programs that request genetic information and offer rewards or incentives for participation violate the prohibition on the collection of genetic information for underwriting purposes.  This is true even if rewards are not based on the outcome of the assessment, and regardless of the amount and type of reward.  

Further, the regulations also prohibit the collection of genetic information prior to, or in connection with enrollment in the group health plan, whether or not a reward is provided with this collection.  For example, a group health plans will violate GINA if it requests participants to complete an HRA prior to enrollment, and that HRA includes questions about family medical history.  This is true even if the request to complete the HRA comes after enrollment in the plan and completing it has no impact on enrollment in the plan.  Further, group health plans may not collect genetic information through an HRA to determine eligibility for additional benefits under the plan, including disease management programs.
 
This means that plans may ask for individual or family medical history in an HRA only if no rewards are provided for participation in the HRA, the request is made after the effective date of coverage and is not made in connection with enrollment in the plan and completion of the HRA does not qualify the individual for any additional benefits. In addition, the regulations make clear that if an HRA asks an open-ended question (e.g, "Is there anything else relevant to your health that you would like us to know?), the question should be immediately followed by an instruction that the individual should not to reveal any genetic information in their answer. 

With these newly-issued GINA regulations, and the current open-enrollment season in effect, group health plan sponsors must be cognizant of the new prohibition on the collection of genetic information. Plan sponsors should review and update their health plans, especially their HRAs and wellness policies, prior to January 1, 2010 (for calendar year plans) to ensure compliance with GINA.  Further, plan sponsors need to coordinate with their third party administrators to ensure any documents provided by such administrators do not request any genetic information from plan participants.