In October of 2009, the Internal Revenue Service, Department of Labor and Department of Health and Human Services jointly released an advanced copy of interim final regulations on the Genetic Information Nondiscrimination Act (GINA).GINA’s group health plan provisions are effective for plan years beginning on or after December 7, 2009. For calendar year plans the effective date will be January 1, 2010.
These regulations will be effective for group health plans beginning on or after 60 days after the regulations are formally published in the federal register.
The following questions and answers describe what GINA is, what GINA requires or prohibits, what genetic information or testing is and how GINA affects wellness programs.
What is “GINA?”
In regard to group health plans, GINA amended §702 of the Employee Retirement Income Security Act of 1974 (ERISA) to:
- Prohibit enrollment restriction and premium adjustment on the basis of genetic information or genetic services
- Prevent group health plans and insurance companies from requesting or requiring that an individual take a genetic test
- Cover all health plans, including those under ERISA, stateregulated plans, and the individual market
GINA also prohibits:
- Group health plans and health insurers from setting premiums or employee contribution levels based on genetic information
- Mandatory genetic testing by group health plans or health insurers
- Procedures for protecting information including procedures for storing or maintaining critical documents and records
- Group health plans and health insurers from requesting, requiring, or purchasing genetic information for underwriting purposes; or from seeking such information from individuals who have not yet enrolled
What is Gentic Information?
Genetic information is defined as information about an individual's genetic tests, information about the genetic tests of an individual’s family members, or information about the manifestation of a disease or disorder in an individual's family.
How does GINA affect wellness programs?
The regulations further provide that genetic information is considered collected prior to enrollment if it is collected before the individual’s effective date of coverage under the plan.
The regulations clarify that underwriting purposes include changing deductibles or other cost-sharing mechanisms or providing discounts, rebates, payments in kind or other premium differential mechanisms in return for activities such as completing a health risk assessment (HRA) or participating in a wellness program. The regulations also provide that genetic information includes the collection of family medical history. Any wellness program that provides rewards for completing HRAs that request genetic information, including family medical history, violates the prohibition against requesting genetic information for underwriting purposes. This is the result even if rewards are not based on the outcome of the assessment.
Genetic information can be collected as long as no rewards are provided (and if the request is not made prior to or in connection with enrollment). A group health plan or health insurer can provide rewards for completing a HRA as long as the HRA does not collect genetic information.
Conclusion
GINA impacts HRAs in two areas:
- HRAs cannot request genetic information prior to enrollment in the Plan
- No rewards or penalties may be offered in conjunction with a HRA that requests genetic information, even if the request is made after the enrollment
As a result of the regulations, employers and administrators:
- Should review all wellness and disease management plans to determine how a HRA is used and what information is requested
- Remove any financial incentives or penalties if genetic information is collected in the HRA
- Remove any genetic information from the HRA if financial incentives or penalties want to be offered
Commentary on the Current and Future Impact on HRA Providers Family health history questions in HRA’s are intended for the employee or spouse completing the HRA’s benefit only. The answers from the family health history questions are integrated with other health information such as blood work and behavior related questions the employee answers. The intent of these questions is for these factors to be put into algorithms to determine elevated risk of future health concerns such as certain types of cancer, or heart disease and alert the person to this elevated risk. People at higher risk are given information on how to better manage or reduce that risk. The family history may alert someone who is otherwise extremely healthy to be more conscious of making positive decisions that can reduce family history based risk through increased screening or other behavior changes.
Most screening companies and carriers that use an HRA determined that incentive-based screenings can not have family history questions under GINA. HRA companies closely follow HIPAA and other privacy-related laws having a direct interest and excellent track record in properly using such information.
There is some opinion that removing family history questions from HRAs was not an original intent of the law. DMAA, The Care Continuum Alliance, said it supports the intent of GINA to prohibit inappropriate use of genetic information in the provision and pricing of health benefits. “However, DMAA believes the definition of ‘underwriting’ included in the interim final regulations far exceeds Congressional intent and will have dramatic and unintended consequences on programs designed to support at-risk and chronically ill individuals.”
To avoid any confusion and to ensure all employers are in compliance with the law, most screening companies that asked family history questions in an HRA have decided to remove them completely. The alternative is to have two versions of an HRA, one for employers who do not offer incentives and another HRA for employers who do offer incentives. Given the increasing number of employers who realize the importance in offering incentives, using one HRA seems to be the route of choice. However your HRA provider has decided to change under GINA, it is important to make sure they have properly addressed this issue.