Interim Regulations Under Genetic Information Nondiscrimination Act Will Affect Wellness Programs

On October 1, 2009, the Internal Revenue Service (IRS), Department of Labor (DOL) and Centers for Medicare and Medicaid Services (CMS) issued joint final interim regulations under the Genetic Information Nondiscrimination Act (GINA). The regulations affect group health plans for plan years beginning on or after December 6, 2009.

GINA prohibits group health plans from collecting genetic information either for underwriting purposes or prior to or in connection with enrollment. Genetic information specifically includes family medical history. Since GINA was issued, group health plan sponsors have been concerned about its impact on voluntary wellness programs, including health risk assessments, that typically request family medical history, and sometimes other genetic information.

Regulations Prohibit Offering Rewards in Exchange for Genetic Information

Under the terms of the regulations, wellness programs that request genetic information and offer rewards for participation violate the prohibition on 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 or type of reward.

The regulations define the underwriting prohibition broadly to prohibit changing deductibles or cost-sharing mechanisms; providing discounts, rebates, payments in kind or additional benefits, such as participation in disease management programs; or making other types of premium differential mechanisms in return for completing a health risk assessment or participating in a wellness program.

Collecting Genetic Information Prior to Enrollment Is Also Prohibited

The regulations also prohibit collection of genetic information prior to, or in connection with enrollment in the group health plan, whether or not a reward is involved with such collection.

A group health plan that asks enrollees to complete a health risk assessment prior to enrollment, and includes questions about the individual's family medical history, will violate GINA even if there is no reward or penalty for completing the health risk assessment. An exception is provided for incidental collection of genetic information, but only if the plans' health risk assessments explicitly state that genetic information should not be provided.

A collection of genetic information is considered prior to enrollment if it is before the individual's effective date of coverage under the plan or health insurance coverage. Whether a plan is collecting information before an individual's effective date of coverage is determined at the time of collection. If a plan or issuer collects genetic information with respect to an individual in circumstances that otherwise would not render the collection impermissible—and at that time it is not being collected in connection with a future enrollment—the fact that a future enrollment may occur does not mean that the genetic information was collected before the enrollment.

What Should Group Health Plan Sponsors Do?

To ensure compliance with the interim regulations, group health plan sponsors should consider the following.

1. Health risk assessments and other wellness programs requesting genetic information can be restructured so that no rewards are provided for participation and the request is not made prior to or in connection with plan enrollment.
2. Rewards can still be offered for completion of health risk assessments so long as the health risk assessment does not request any genetic information—even incidentally. This means that all such health risk assessments should have a disclaimer stating that genetic information should not be provided. The regulations contain safe harbor language for this purpose.
3. Group health plans can offer two health risk assessments—one that requests no genetic information and provides a reward for participation, and a second that requests genetic information, is offered after and unrelated to enrollment, provides no reward, and specifically states that participation in the second has no effect on the reward provided for participation in the first.
4. Employers can still collect genetic information as part of a voluntary wellness program that has no connection to the group health plan, so long as employees participating in the program provide a prior knowing, voluntary and written authorization, and the employers receive no individually identifiable genetic information. It is unclear, however, what sort of reward can be offered for participation in an employer-sponsored wellness program without making participation "involuntary."

Group health plans sponsoring wellness programs that request genetic information will need to work closely with their wellness vendors to ensure the wellness programs they are offering comply with the new regulations. Most plan sponsors will need to act quickly to make changes in time for 2010 open enrollment.