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Proposed GINA rule clarifies narrow exception for employer-sponsored wellness programs

By Pamela Wolf, J.D.

The EEOC has released its long-anticipated proposed GINA regulations pertaining to employer-sponsored wellness programs. The proposal, which would make six substantive changes to current GINA regulations, is crafted to remain consistent with the EEOC’s proposed ADA wellness program regulations, as well as the Affordable Care Act (ACA). It clarifies a narrow exception to the general rule that no incentives may be provided for an employee’s genetic information to permit employer-sponsored wellness programs to provide limited financial and other inducements in exchange for an employee’s spouse providing information about his or her current or past health status. The total inducement, however, is capped at 30 percent.

The proposed GINA regulatory amendments were published in the Federal Register on October 30.

As the popularity of wellness programs has increased, employers have anxiously awaited clarification from the EEOC as to how those programs may be constructed to avoid running afoul of both the ADA and GINA. Other concerns have been directed to the intersection of the EEOC’s ADA and GINA regulations and ACA requirements that pertain to employer-sponsored wellness programs.

Voluntary wellness program exception. Under GINA, as the EEOC pointed out in its regulatory proposal, there are only six very limited circumstances under which an employer may request, require, or purchase genetic information about an applicant or employee. One of those exceptions to GINA’s acquisition prohibition permits employers offering health or genetic services, including those offered as part of voluntary wellness programs, to request genetic information as part of these programs, as long as certain requirements are met.

The EEOC’s current regulations implementing Title II of GINA make clear that one of those requirements is that the wellness program may not condition any inducements to employees on their provision of genetic information. This requirement is derived from Title I of GINA’s explicit prohibition against adjusting premium or contribution amounts on the basis of genetic information.

Information aimed to promote health or prevent disease. The first change to GINA regulations that the EEOC has proposed is an explanation that employers may request, require, or purchase genetic information as part of health or genetic services only when those services are “reasonably designed to promote health or prevent disease.” To meet this standard, “the program must have a reasonable chance of improving the health of, or preventing disease in, participating individuals, and must not be overly burdensome, a subterfuge for violating Title II of GINA or other laws prohibiting employment discrimination, or highly suspect in the method chosen to promote health or prevent disease,” the EEOC said.

What would not meet this standard? Collecting information on a health questionnaire without providing follow-up information or advice would not be reasonably designed to promote health or prevent disease, according to the notice of proposed rulemaking. Likewise, a program would not be reasonably designed to promote health or prevent disease where it imposes, as a condition of obtaining a reward, “an overly burdensome amount of time for participation, requires unreasonably intrusive procedures, or places significant costs related to medical examinations on employees,” the EEOC explained. Nor would a program be reasonably designed when it exists just to shift costs from the covered entity to particular employees based on their health.

Health risk assessments. The EEOC also proposed to amend its regulations to provide that a covered entity may offer, as part of its health plan, an inducement to an employee whose spouse:

1.

is covered under the employee’s health plan;

2.

receives health or genetic services offered by the employer, including as part of a wellness program; and

3.

provides information about his or her current or past health status as part of a health risk assessment (HRA).

However, the employer would be prohibited from offering an inducement in return for the spouse providing his or her own genetic information, including results of his or her genetic tests.

Authorization. The HRA would need to otherwise comply with the requirements that pertain to employees, including that the spouse provide prior, knowing, voluntary, and written authorization when providing his or her own genetic information, and the authorization form must describe confidentiality protections and restrictions on disclosure of genetic information. Employers would be required to also obtain authorization from the spouse when collecting information about the spouse’s past or current health status (a separate authorization for the acquisition of this information from the employee is unnecessary).

30-percent inducement cap. The proposal would limit the total inducement to the employee and his or her spouse to 30 percent of the total annual cost of coverage for the plan in which the employee and any dependents are enrolled. This limit would include any inducement for a spouse’s current or past health status information and any other inducements to the employee, as permitted under Title I of the ADA, for the employee’s participation in a wellness program that includes disability-related questions or medical exams.

According to the EEOC, this type of inducement limit generally parallels limits in Section 1201 of the ACA, which explains that when dependents of employees, such as spouses, are permitted to fully participate in a health-contingent wellness program, the reward offered must not exceed the applicable percentage of the total cost of the coverage in which an employee and dependents are enrolled. The limited exception that the EEOC proposes to make under Title II of GINA thus permits a practice that is synced-up with Title I of GINA and the ACA. While the proposed revisions may differ in some ways from the wellness program standards under the ACA and its implementing regulations, the EEOC said it believes employers will be able to comply with both ACA wellness requirements and the proposed GINA regulations.

Apportionment of inducements. The proposed rule also describes the manner in which inducements for employees and spouses must be apportioned. The maximum share of the inducement attributable to the employee’s participation in an employer wellness program (or multiple employer wellness programs requesting such information) would be equal to 30 percent of the cost of self-only coverage—the maximum amount the EEOC has set in its proposed ADA regulations as an inducement for an employee to answer disability-related inquiries or take medical examinations in connection with a wellness program that is part of a group health plan. The remainder of the inducement—equal to 30 percent of the total cost of coverage for the plan in which the employee and any dependents are enrolled minus 30 percent of the total cost of self-only coverage—could be offered in exchange for the spouse providing information to an employer wellness program (or multiple employer wellness programs requesting such information) about his or her current or past health status.

The proposed regulations would permit a wellness program to offer inducements in accordance with HIPAA and the ACA without regard to the limits on apportionment set forth in the EEOC’s proposed GINA rule if neither the employee nor the employee’s spouse are required to provide current or past health status information, so long as the wellness program otherwise complies with ADA and GINA requirements.

Sale of genetic information, disclosure waiver. The EEOC’s proposed rule would bar a covered entity from conditioning participation in a wellness program or an inducement on an employee (or the employee’s spouse or other covered dependents) agreeing to the sale of genetic information or waiving protections provided under Section 1635.9, which prohibits disclosure of genetic information, except in six narrowly defined circumstances.

Additional example for exception. The proposed rule would add another example to 29 CFR 1635.8(c)(2) to clarify that an employer is not barred from seeking information, through medical questionnaires, medical examinations (e.g., to detect high blood pressure or high cholesterol), or both, concerning the current or past health status of an employee’s spouse who is covered by the employer’s group health plan and is completing a HRA voluntarily in compliance with 29 CFR 1635.8(b)(2). This provision explains two circumstances under which employers are permitted to request, require, or purchase genetic information or information about the past or current health status of an employee’s family members who are receiving health or genetic services on a voluntary basis. Such acquisitions are only permitted if all of the requirements for seeking genetic information as part of a voluntary health or genetic service, including the authorization and inducement rules, are met.

Types of inducements. The final revision in the proposed regulations would remove the term “financial” as a modifier of the type of inducements discussed in the regulations and clarify that the term “inducements” encompasses both financial and in-kind inducements, such as time-off awards, prizes, or other things of value, in the form of either rewards or penalties. The EEOC noted its awareness that inducements other than those that might be considered purely financial are often used and said it wants the regulations to apply to all such inducements.

Narrow exception to general rule. The EEOC said in a press release that it believes the approach it adopted in the proposed rule harmonizes the two titles of GINA, which both regulate employer wellness programs that are part of group health plans, as a coherent whole. The agency at the same time recognized that the change wrought by the proposal creates an exception to the general rule that no incentives may be provided for an employee’s genetic information. As a result, the EEOC has interpreted the exception as narrowly as possible. For example, the exception applies to information on the current and past health status of spouses, but not of children. Why? Because the possibility that an employee may be discriminated against based on genetic information is greater when the employer has access to information about the health status of the employee’s children as opposed to the employee’s spouse.

“Our goal in developing this proposed rule is to provide clarity for employees and employers,” remarked EEOC Chair Jenny R. Yang. “We spent considerable time working with our partners at the U.S. Departments of Labor, Health and Human Services, and Treasury to construct a rule that protects workers and their families while encouraging wellness programs that benefit employers and employees alike.”

Expert weighs in. Dilworth Paxson LLP Partner Eric Meyer, who also serves on Wolters Kluwer Employment Law Daily’s Editorial Advisory Board, weighed in with his impression of the proposed GINA regulations. “I applaud the EEOC for proposing pragmatic rules, which are generally consistent with both the letter and spirit of GINA, as well as its prior proposed regulations under the ADA,” he said. He also noted that no proposed rules are perfect. Meyer said that in certain areas, the proposed rules “expose gray areas and may create some ambiguity”—he pointed to the proposal’s use of phrases such as “reasonable chance” and “overly burdensome.”

Meyer concluded: “Overall, however, companies should have enough latitude within the confines of GINA and these proposed rules to operate effective employer-sponsored wellness program, which reap universal benefits.”

The EEOC will accept comments on the proposed rule through December 29, 2015.