On October 7, 2009, the Departments of Labor, Health and Human Services, and Treasury jointly issued interim final regulations regarding the Title I restrictions under the Genetic Information Nondiscrimination Act of 2008 (GINA). GINA generally restricts the collection and use of genetic information by group health plans and insurers (Title I) and by employers and labor organizations (Title II).
This article focuses on how the new regulations for Title I of GINA will immediately affect employer-sponsored wellness programs tied to group health plans. Although just recently published, the Title I interim final regulations become effective for plan years beginning on or after December 7, 2009 (January 1, 2010 for calendar year plans) and carry significant penalties for violations under both GINA and related HIPAA compliance requirements.
Employers sponsoring group health plans should carefully review their welfare plan documents and contact appropriate third-party administrators to ensure compliance with the new GINA regulations, including the following changes affecting wellness programs. At this point, however, the current annual open enrollment period is already over or under way for most group health plans and employers may face difficulty revamping their wellness programs in time for the 2010 plan year.
1. No Incentives for Completing HRAs That Collect Genetic Information
Under the new GINA regulations, the prohibition on collecting genetic information for “underwriting purposes” is broadly interpreted to cover not only collection for eligibility and premium computation purposes, but also for other purposes that may provide premium discounts, rebates, or other rewards as incentives for completing a Health Risk Assessment (HRA). Importantly, genetic information under GINA includes family medical history, affecting many questions commonly asked in any comprehensive screenings.
Compliant Alternatives: The GINA regulations require that HRAs offered during the current annual open enrollment period must already be compliant with these new regulations for use in the upcoming plan year. The GINA regulations suggest the following alternatives to bring HRAs into compliance:
- Stop providing incentives – Discontinue all incentives for participants who complete HRAs.
- Stop asking for genetic information – Revise the HRA to exclude questions relating to genetic services, counseling, and diseases, which includes questions asking for family medical history.
- Two separate HRAs – Offer an incentive to complete an HRA that does not collect genetic information, but provide a separate HRA without incentives to collect genetic information.
- Provide incentive outside of plan – Offer participants a taxable incentive paid outside of the group health plan to complete an HRA, although such outside offering must comply with Title II of GINA.
2. No Incidental Collection of Genetic Information in HRAs Offering Incentives
Even if an incentivized HRA does not directly ask for genetic information, open-ended questions may result in the incidental collection by participants voluntarily disclosing such information. For example:
“Is there anything else relevant to your health that you would like us to know or discuss with you?
Compliant Alternative: If open-ended questions are reasonably likely to solicit responses containing genetic information, the HRA must contain an explicit notice that participants should not provide genetic information, such as the example provided in the GINA regulations:
“In answering this question, you should not include genetic information. That is, please do not include any family medical history or any information related to genetic testing, genetic services, genetic counseling, or genetic disease for which you believe you may be at risk.”
If participants disclose genetic information on the incentivized HRA, despite receiving the notice above, such collection will not violate GINA, provided that the information is not subsequently used for underwriting purposes.
3. No HRAs That Collect Genetic Information from Enrolling Participants Before Effective Date of Coverage
HRAs may not be used to collect genetic information prior to, or in connection with, participants enrolling in a group health plan. The prohibition applies until the effective date of coverage under the group health plan. Whether an HRA offers incentives for completing this HRA has no bearing on the prohibition.
Compliant Alternative: Employers may continue to offer HRAs that do not contain genetic information questions prior to a participant’s effective coverage date and then provide a supplemental HRA asking for genetic information after the effective date of coverage.
Note that the GINA regulations permit HRAs during subsequent annual open enrollments, so long as collection of the genetic information will not be used to affect participants’ eligibility or benefits for the upcoming plan year.
4. No Use of Genetic Information in HRAs to Determine Eligibility for Disease Management Programs
When it receives genetic information in a HRA without incentives, a group health plan may not use the information as a basis for eligibility in a disease management program. This screening is considered using genetic information for underwriting purposes in violation of GINA.
Compliant Alternative: Although only slightly different procedurally, when a participant indicates interest in receiving additional benefits under a disease management program, the GINA regulations permit group health plans to request genetic information to determine whether the program is medically appropriate for the individual. However, plans may only request the minimum amount of genetic information necessary to make the determination.