The EEOC’s Final Rule on GINA and Employer-Sponsored Wellness Programs to Take Effect This Month

Gina name tagOn May 17, 2016, the Equal Employment Opportunity Commission (EEOC), which is the agency charged with enforcing Title II of the Genetic Information Nondiscrimination Act (GINA), issued a final rule changing how employers can set up incentives for the wellness programs they sponsor for their employees.

As previously reported on Genomics Law Report, on October 30, 2015 the EEOC had issued a proposed rule to amend the GINA regulations in an attempt to harmonize them with the Affordable Care Act’s promotion of employer wellness programs to lower health care costs. The EEOC indicated it had received more than 3000 public comments before the close of the comment period on January 28, 2016.

In short, the final rule allows employers to offer financial and in-kind incentives for an employee’s spouse to provide information about the spouse’s current or former health status as part of a health risk assessment in connection with a voluntary employer-sponsored wellness program so long as certain requirements are met.

The final rule applies to all employer-sponsored wellness programs, whether those programs are participatory or health-outcome based, if the program offers an inducement for an employee’s spouses to provide information about his/her current or former health status or take a medical exam. GINA generally prohibits an employer from acquiring genetic information, which includes not only genetic test results but also medical history of an employee or the employee’s family members (with “family member” defined by the statute to be very broad so as to include biological and adoptive children, spouses, and relatives up to the fourth degree). This final rule clarifies that while a wellness program cannot offer an inducement to an employee for acquisition of genetic information, the wellness program may offer a limited inducement to acquire such information from the employee’s spouse. The incentive cannot exceed 30% aggregate of employee’s cost for self-only coverage through the plan. No new authorizations are required by the final rule.

The wellness program must be voluntary, which means that participation in the program cannot be required, health insurance benefits cannot be denied to those who do not participate, those who do not participate or do not meet certain health outcomes cannot be retaliated against, an explanatory notice must be provided, and incentive limits must be respected. The wellness program also must be designed in such a way that it is “reasonably designed” to promote health and prevent disease.

The EEOC insists the rule is limited to the narrow issue of inducements for wellness programs and further insists “[t]he absolute prohibition on the use of genetic information to make employment decisions enshrined in Title II of GINA remains intact.” Nevertheless, it has drawn sharp criticisms. The American Society of Human Genetics (ASHG) issued an immediate statement opposing the EEOC’s final rule, explaining the revisions to GINA deal a heavy blow to genetic privacy protections. Genetic Alliance, which had assembled an extensive list of groups and individuals in strong opposition to the proposed rule, issued a brief statement that the final rules “undermine the core protections of GINA.” The U.S. Chamber of Commerce also issued a statement condemning the EEOC’s final rule, saying the rules create “complicated, confusing, and contradictory requirements over an area which is already heavily regulated.” The Chamber also predicted the EEOC’s final rules “will have a chilling effect” on wellness programs.

Criticism aside, the final rule is effective July 18, 2016 and will apply prospectively: wellness program compliance will be required for the first day of the first wellness plan year that begins on or after January 1, 2017. The EEOC has posted Q&A and a Small Business Fact Sheet online to help people understand it.

Filed under: Genomic Policymaking, Genomics & Medicine, GINA, Legal & Regulatory, Privacy, Privacy, Privacy
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