New GINA Regulations Significantly Limit Health Risk Assessments

The U.S. Departments of Labor, Health and Human Services, and the Treasury recently enacted interim final regulations regarding clarification and implementation of the Genetic Information Nondiscrimination Act of 2008 (GINA) that will have a significant effect on the use of health risk assessments in employer health and wellness programs. Published in the Federal Register on October 7, 2009, these regulations implement GINA’s provisions governing the use and collection of genetic information, and as a result, many health risk assessments will need to be modified to comply with the provisions. The regulations are effective for plan years starting on or after December 7, 2009, and the effective date for calendar year plans is January 1, 2010.

GINA Background
As you may recall, GINA was enacted in May 2008 to prohibit discrimination on the basis of genetic information in healthcare and employment (see Compliance Alert dated May 30, 2008). Title I of GINA addresses the use and collection of genetic information by group health plans, while Title II addresses employment practices. The recently published regulations apply only to group health plans and health insurance carriers as covered under Title I.

Definitions Provided
According to the original GINA text, group health plans are prohibited from requesting genetic tests, obtaining genetic information prior to enrollment, and requesting genetic information for underwriting purposes. To further clarify this requirement, the new regulations provide expansive definitions of the following key terms:

• “Genetic information” includes an individual’s genetic tests, request for/receipt of genetic services, and family medical history (such as a disease or disorder in the employee’s family members).
  
  
• “Family Members” includes an individual’s dependents under the group health plan; and first, second, third, or fourth degree of relative (regardless of whether they are covered under the plan). For the purposes of this definition, relatives by marriage and adoption are treated the same as blood relatives, and individuals who are not full-blood relatives (such as half sisters/brothers) are treated the same as blood relatives.
  
  
• “Underwriting” includes any rules for determining eligibility, computing premiums or contributions, and applying pre-existing condition exclusions. Given these broad definitions, “underwriting purposes” includes not only insurance rating and pricing, but also any changes in deductibles or cost sharing, discounts, rebates, payments, or other means used to adjust premiums based on the completion of a health risk assessment (HRA).
  
  

Effects on Health Risk Assessments and Wellness Programs
GINA’s prohibitions, as clarified in the new regulations, will require employers to reexamine their wellness programs, especially in relation to health risk assessments (HRAs). In addition, employers will need to coordinate with their wellness and HRA vendors to ensure compliance with GINA’s mandates. As specified in the new regulations, the following plan designs are likely to violate GINA:

• Disease management programs that require an HRA prior to enrollment in the plan
  
• HRAs that request genetic information prior to or in connection with enrollment (a request is considered to be made prior to enrollment as long as it is made prior to the effective date of plan coverage)
  
• Programs that provide a reward or penalty in exchange for completing an HRA that asks for genetic information
  
  

The regulations clarify that genetic information can be requested after enrollment provided there is no reward or penalty in connection with completing the HRA. Additionally, employers can still provide financial rewards or penalties for completion of an HRA; however, the HRA should not include questions relating to genetic information.

The regulations also suggest the option of a bifurcated HRA approach where an employer requests the employee to complete two separate HRAs after enrollment in the plan. One HRA provides a reward for completion and does not request any family medical history or other genetic information, and the second HRA is purely voluntary, provides no reward for completion, and seeks information regarding family medical history and other genetic information.

It should be noted that there is no violation of GINA if (1) genetic information is obtained incidentally, AND (2) the collection of the information could not be reasonably anticipated.

For a full copy of the interim final regulations, including examples illustrating the rules, please click here. Should you have additional questions regarding these new regulations, please contact our office at (919) 403-1986.

Important Notice: Hill, Chesson & Woody does not engage in the practice of law, accounting, or medicine. Therefore, the contents of this communication should not be regarded as a substitute for legal, tax, or medical advice.

October 20, 2009

Hill, Chesson & Woody Employee Benefit Services

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