Title I of the Genetic Information Nondiscrimination Act of 2008 (“GINA”) generally prohibits group health plans, health insurance issuers in the group and individual markets and issuers of Medicare supplemental policies from using genetic information to discriminate and from collecting genetic information. (For background on this issue, please see our prior Legal Alert entitled, Landmark Genetic Nondiscrimination Legislation, May 21, 2008.)

The much-anticipated interim final regulations were issued on October 7, 2009, with respect to Sections 101 through 103 of GINA and apply to group health plans and group health insurance for plan years beginning on or after December 7, 2009 (i.e., January 1, 2010 for calendar year plans) and apply to the individual market for coverage sold, renewed, issued, or in effect on or after December 7, 2009. At the same time, GINA also directed the Department of Health and Human Services (“HHS”) to revise the HIPAA privacy regulations with respect to genetic information. On October 7, 2009, HHS also issued proposed regulations with respect to this aspect of GINA. The HHS proposed regulations are addressed in a separate Legal Alert.

Overview

Title I of GINA, as interpreted by the interim final regulations, prohibits plans from –

  • Increasing group premiums or contributions based on genetic information;
  • Requesting or requiring an individual or family member to undergo a genetic test (other than for certain limited exceptions, including a plan’s right to condition payment for a medical service on medical appropriateness which may in turn depend on the genetic information of the individual); and
  • Requesting, requiring or purchasing genetic information prior to or in connection with enrollment, or at any time for underwriting purposes.

It is also important to note that unlike the other provisions of the HIPAA portability and nondiscrimination rules, GINA does apply to group health plans with fewer than two participants who are current employees. In other words, GINA does apply to a separate retiree medical plan.

Important Definitions

The interim final regulations contain definitions that are important in applying the limitations of GINA, including –

Genetic Information: Genetic information means information about an individual’s genetic tests, the genetic tests of that individual’s family members, and the manifestation of a disease or disorder in family members of the individual. It also includes any request for, or receipt of, genetic services or participation in clinical research that includes genetic services. However, genetic information does not include the individual’s gender or age.

Family Member: Family member means an individual who may become eligible for coverage because of his or her relationship to the participant or any other person who is a 1st, 2nd, 3rd or 4th degree relative of the individual or dependent of the individual (including relatives by marriage or adoption).

Impact on Wellness Programs

General Rule: Genetic information (which includes family medical history as noted above) cannot be collected either for “underwriting purposes” or “prior to or in connection with enrollment.” There is an exception for genetic information obtained incidental to the collection of other information, provided the collection is not for underwriting purposes. However, if it is reasonable to anticipate that genetic information will be received, the incidental collection exception does not apply, unless the collection explicitly provides that genetic information should not be disclosed.

Underwriting Purposes: As set forth above, genetic information cannot be collected for underwriting purposes. Underwriting is defined broadly and means with respect to any plan –

  • Rules for, or determination of, eligibility (including enrollment and continued eligibility) for benefits under the plan or coverage, including changes in deductibles or other cost-sharing mechanisms in return for certain activities, such as completion of a wellness program or HRA;
  • Calculation of premium or contribution amounts (including rebates, discounts, or other payments or premium differentials in return for activities such as completing an HRA or participating in a wellness program);
  • The application of a preexisting condition exclusion; and
  • Other activities related to the creation, renewal or replacement of a contract for health insurance or health benefits.

Prior to or in Connection with Enrollment: Even if genetic information is not collected for underwriting purposes, it also must not be collected prior to or in connection with enrollment. “Enrollment” means before the effective date of plan coverage. Whether genetic information is collected prior to “enrollment” is determined at the time that it is collected. The preamble to the interim final regulations provide helpful examples in this regard as follows –

  • If the plan collects genetic information after initial enrollment, and the individual later drops coverage and re-enrolls, the collection of genetic information after the initial enrollment would not be considered prior to that later re-enrolment.
  • If enrolled individuals must re-enroll during an annual enrollment period, the collection of information after the initial enrollment will not be considered to be made prior to a subsequent re-enrollment unless the collection affects the subsequent re-enrollment.
  • If a plan collects genetic information permissively and then transfers it to a different plan in connection with a merger or acquisition, the transfer will not be considered a collection prior to enrollment under the second plan if the information will not affect the enrollment status of the individuals.

HRAs May Impermissibly Collect Genetic Information: Wellness programs that provide incentives for completing health risk assessments (“HRA”) that request genetic information (such as family medical history) violate GINA if the incentive is determined to be for underwriting purposes. Under the interim final regulations, the payment of virtually any type of incentive will be classified as for underwriting purposes, including any discount or rebate in premiums/contributions and any discount, rebate or other change in a deductible, co-payment or co-insurance. Although somewhat unclear under the interim final regulations, it appears that an incentive credited to a health flexible spending arrangement or health reimbursement arrangement would also violate the underwriting prohibition. This is the result even if the incentives are not based on the outcome of the HRA.

A Path for HRA Compliance: Based on the above rules and additional examples provided in the interim final regulations, there are a number of different strategies that plans can utilize to comply with the interim final regulations. All of the following strategies assume that the HRA is not provided in connection with enrollment.

  • Remove the Incentives: The plan can remove any incentives for completing an HRA that includes genetic information questions. While easy to accomplish, not paying an incentive is likely to significantly reduce the level of HRA participation.
  • Remove the Genetic Information Questions: The plan can continue to provide an incentive for HRA completion, if all questions relating to genetic information are removed. Again, while this is easy to accomplish, removing genetic information questions will likely significantly reduce the HRA’s effectiveness.
  • HRA Bifurcation: The interim final regulations officially endorse a two-HRA approach, whereby one HRA includes all non-genetic information questions and a second HRA includes all genetic information questions. Any incentive is then only paid for completing the non-genetic information HRA, while the genetic information HRA has no incentive. This could also be accomplished using a single HRA, if the HRA was properly structured and appropriate disclaimers and instructions were included.
  • Non-Plan Incentives: GINA only applies with respect to the operation of an ERISA group health plan. Therefore, if a monetary incentive is paid outside of the plan, and treated as taxable wages, this type of incentive should not violate GINA, thereby allowing the HRA to include genetic information questions.

Impact on Disease Management Programs

Similar to the impact on HRAs, disease management programs are also affected if they utilize HRA results to determine eligibility. The interim final regulations include two similar, yet distinct, examples on this issue. First, if an HRA includes genetic information questions, and the results of those questions are used, in whole or in part, to determine whether an individual is eligible for a disease management program, the request of genetic information included in the HRA violates the underwriting prohibition. This is because the genetic information is used to determine if the individual is eligible for additional benefits under the plan (i.e., the disease management program).

As noted above, a plan may limit benefits based on medical appropriateness, and the determination of medical appropriateness is not an underwriting purpose. If the determination of medical appropriateness depends on genetic information, the plan can condition the benefit on genetic information, provided it only requests the minimum information necessary to make the determination. However, this exception does not apply if the individual is not seeking a benefit under the plan.

This exception for medical appropriateness impacts the second example in the interim final regulations. The second example provides that a plan may condition benefits under a disease management program upon a showing by an individual that the individual is eligible for the disease management program, even if such showing involves genetic information. However, the genetic information can only be used to make a determination that the disease management program is medically appropriate for the individual.

Although these two examples appear similar, the difference appears to be that in the first example the plan is automatically determining who is eligible (which violates the underwriting prohibition), while in the second example the individual must formally apply for participation in the disease management program and if the individual is refused participation he/she can submit genetic information to prove eligibility. However, such a distinction cuts a fine line, and hopefully additional guidance on this issue will be forthcoming.