The Department of Labor’s Employee Benefits Security Administration (EBSA) has issued guidance in the form of Frequently Asked Questions (FAQs) that explains how the Genetic Information Nondiscrimination Act (GINA) impacts employer-provided group health plans and insurance providers. Among other things, Title I of GINA prohibits group health plans and health insurance issuers from discriminating based on genetic information, and prohibits the collection of such information, including family medical history, prior to or in connection with plan enrollment or for insurance underwriting purposes. As explained in the FAQs, unlike the provisions of Title I of the Health Insurance Portability and Accountability Act (HIPAA) that exempt very small health plans with less than two participants who are current employees, the nondiscrimination provisions of GINA apply to all group health plans.

The guidance provides responses to 14 GINA-related questions, ranging from general GINA definitions to specific inquires about how GINA impacts wellness programs and under which circumstances a health plan may obtain the results of a genetic test. For instance, the guidance explains that GINA expands HIPAA’s genetic information nondiscrimination protections by offering additional underwriting protections, prohibiting insurers from requesting or requiring genetic testing, and restricting the collection of genetic information. While plans and issuers are generally prohibited from asking or requiring an individual to undergo a genetic test, the guidance emphasizes that a health care professional providing health care services to that individual is permitted to request such a test. Moreover, a plan or issuer is permitted to obtain the minimum amount of information necessary from a genetic test in order to determine payment of claim for benefits. If a plan conditions payment on the medical appropriateness of an item or service and the medical appropriateness depends on the genetic makeup of the patient, then the plan is permitted to condition payment for the item or service on the outcome of the genetic test. The plan may also refuse payment in that situation if the individual does not undergo the genetic test. GINA also permits a plan or issuer to request an individual to undergo a genetic test for research purposes under certain conditions.

The guidance provides examples of certain tests that are not considered genetic tests, including: an HIV test, complete blood count, cholesterol test, liver function test, or test for the presence of alcohol or drugs.

Premium Adjustments

Another departure from HIPAA’s protections includes GINA’s prohibition on a group health plan’s adjustment of the insurance premium or contribution amounts that an employer or group of similarly-situated individuals must pay under the plan based on genetic information. According to the FAQs, this is a change from HIPAA’s nondiscrimination requirements, which permitted plans to adjust such premiums or contributions for group health plans based on genetic information, in addition to other factors. Thus, even genetic information collected prior to GINA’s effective date of May 21, 2009 cannot be used to alter premiums. The guidance explains, however, that under both statutes a plan can “charge a higher overall, blended per-participant amount based on the manifestation of a disease or a disorder of an individual enrolled in the plan,” but cannot “use the manifestation of a disease or disorder in one individual as genetic information about other group members to further increase the group premium.” The costs associated with providing benefits for covered genetic tests or services may, however, be factored into the ultimate premium or contribution cost.

Health Risk Assessments and Wellness Programs

GINA prohibits the collecting of genetic information, such as family medical history, prior to or in connection with plan enrollment or for underwriting purposes. The guidance restates the broad interpretation of “underwriting purposes” contained in the Interim Final Regulations to include offering a financial reward in return for completing a Health Risk Assessment (HRA) or participating in a wellness program. Therefore, the guidance explains that plans and issuers cannot offer rewards, such as a premium discount, in return for the provision of genetic information, including family medical history collected as part of a Health Risk Assessment (HRA) or wellness program. Health plans and insurance issuers must ensure that their HRAs that are conducted prior to or in connection with enrollment do not include questions that could be interpreted as seeking genetic information, and should explicitly state that genetic information should not be provided. On the other hand, a plan may use an HRA that requests family medical history “if it is requested to be completed after and unrelated to enrollment and if there is no premium reduction or any other reward for completing the HRA.”

The guidance notes that a plan is permitted to use two separate HRAs – one that collects genetic information after and unrelated to enrollment and is not tied to a reward, and one that does not obtain such information, which may be tied to an incentive. The FAQs further explain that under GINA, group health plans may also reward:

• participation in an annual physical examination with a physician (or other health care professional) who is providing health care services to the individual, even if the physician may ask for family medical history as part of the examination;
• more favorable cost-sharing for preventive services, including genetic screening; and
• participation in certain disease management or prevention programs. The incentives to participate in such programs must also be available to individuals who qualify for the program but have not volunteered family medical history information through an HRA.

The constraints on incentive-based wellness programs under GINA’s regulatory approach appear at odds with provisions in the Patient Protection and Affordable Care Act designed to increase the use and effectiveness of employer-sponsored wellness programs. Specifically, the Affordable Care Act recognizes the value of incentive-based wellness programs by increasing the amount of the reward allowed under the current HIPAA regulations beginning in 2014. As reflected in the Affordable Care Act, incentive-based wellness programs can be an effective tool for employers seeking to reduce health care costs and improve the productivity of their workforce. However, employers must carefully navigate GINA’s restrictions when designing and implementing wellness programs.

This entry was written by Ilyse Schuman.