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Last month, the Equal Employment Opportunity Commission (EEOC) issued final regulations under Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA). The regulations are effective January 10, 2011, and impact both employment practices and wellness programs – particularly those that include a health risk assessment (HRA). The new Title II regulations are consistent with, but not identical to, regulations issued under Title I last year. As a practical matter, employers offering wellness programs must ensure compliance with both sets of regulations.1

Background on GINA Titles I & II

GINA protects individuals against discrimination based on genetic information in health coverage and in employment. Genetic information includes, for example, family medical history and information about an individual’s or family member’s genetic tests.2

The law is divided into two sections, or Titles, both of which took effect in 2009. Title I applies to group health plans and health insurance issuers. Last year, the Departments of Labor, Treasury and Health and Human Services issued interim final regulations under Title I, effective for plan years beginning on or after December 7, 2009. In general, the Title I regulations prohibit plans and insurers from collecting genetic information (such as through an HRA) prior to or in connection with enrollment, or collecting genetic information after enrollment if the individual will either be rewarded for providing the information or penalized for not doing so.

Title II applies to employers. The Title II regulations delineate the general rule prohibiting discrimination against employees or applicants based on genetic information, prohibit employers (with certain exceptions) from requesting, requiring or purchasing genetic information, and strictly limit the disclosure of genetic information. This Bulletin focuses on the impact of the Title II regulations on wellness programs.

Employers may request genetic information through “voluntary wellness programs”

As noted above, the EEOC’s Title II regulations generally prohibit employers from requesting, requiring or purchasing genetic information. However, there’s an exception for genetic information requested through certain health or genetic services, including such services offered as part of a “voluntary wellness program.” A voluntary wellness program is a wellness program that meets all of the following requirements:

  • Individuals cannot be required to disclose genetic information, nor penalized for choosing not to provide genetic information.
  • Individuals participating in the program must give prior, voluntary, knowing and written authorization. The authorization form must be understandable and describe the type of genetic information that will be obtained, how it will be used, and the restrictions on further disclosure of genetic information. The authorization may be provided electronically.
  • The employer may only receive aggregated genetic information that does not identify specific individuals. (Genetic information identifying an individual can only be provided to that individual and the health care provider performing the health or genetic services. Note that this is consistent with HIPAA, as identifying genetic information is “protected health information” for purposes of the HIPAA Privacy Rule.)

Although employers cannot penalize individuals for choosing not to provide genetic information, they may offer a financial incentive (e.g., a premium discount) to complete an HRA that includes some questions seeking genetic information, so long as it’s made clear that the questions seeking genetic information are optional and individuals will receive the incentive whether or not they answer the optional questions.

Example: ABC Co. offers $150 to employees who complete an HRA with 100 questions, the last 20 of which concern family medical history and other genetic information. The instructions for completing the HRA make clear that the $150 incentive will be provided to all employees who respond to the first 80 questions, whether or not they answer the last 20 questions concerning genetic information. ABC Co. does not violate GINA Title II by offering the HRA.

Note: In order to comply with GINA Title I, the HRA can only be offered after enrollment.

In addition, employers may offer a financial incentive to participate in a disease management or prevention program to individuals who voluntarily provided genetic information that indicates they are at an increased risk of acquiring a health condition in the future, so long as the opportunity to participate in the program and receive the incentive is also offered to individuals with current health conditions and/or individuals whose lifestyle choices put them at increased risk of developing a health condition.

Example: Certain ABC Co. employees voluntarily disclosed a family medical history of diabetes, heart disease, or high blood pressure on the HRA. ABC Co. offers these employees, along with employees who currently have one of these conditions, $150 to participate in a wellness program designed to encourage weight loss and a healthy lifestyle. Program participants who succeed in losing weight or lowering their blood pressure, glucose and cholesterol levels receive an additional $150. ABC Co. does not violate Title II by offering the wellness program, and the wellness program should comply with Title I.3

Inadvertent disclosure safe harbor for wellness programs that do not request genetic information

If an employer offers a wellness program that requests medical but not genetic information, and the employer warns program participants and/or health care providers not to provide genetic information using the following “safe harbor” language, the employer will not be in violation of GINA Title II if it receives any genetic information from a participant:

The Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits employers and other entities covered by GINA Title II from requesting or requiring genetic information of an individual or family member of the individual, except as specifically allowed by this law. To comply with this law, we are asking that you not provide any genetic information when responding to this request for medical information. “Genetic information,” as defined by GINA, includes an individual’s family medical history, the results of an individual’s or family member’s genetic tests, the fact that an individual or an individual’s family member sought or received genetic services, and genetic information of a fetus carried by an individual or an individual’s family member or an embryo lawfully held by an individual or family member receiving assistive reproductive services.

In the absence of such “safe harbor” language, a facts and circumstances test would apply to determine whether the disclosure was inadvertent. Under this standard, disclosure of genetic information is considered inadvertent only if the request for medical information was “not likely to result” in the employer obtaining the genetic information. An example (from the regulations) would be if the employer receives genetic information as part of an overly broad response to a tailored request for medical information.

Similar rules exist under the Title I regulations.

What steps should an employer take now?

1. Employers that offer a wellness program through which genetic information is requested may need to revise the program in order for it to qualify as a “voluntary wellness program.”

2. Employers that offer a wellness program that does not request genetic information should consider implementing the model safe harbor language (above) that warns individuals not to provide genetic information.

3. As the EEOC’s Title II regulations prohibit discrimination on the basis of genetic information in all aspects of employment and also address genetic information disclosure and confidentiality issues outside of the wellness program context, including a FMLA-related exception to the disclosure rules, employers should familiarize themselves with the new rules regardless of whether they offer wellness programs. The EEOC has published two informational documents on the regulations. One of these is a Q&A aimed at helping small businesses comply with the law, although larger employers may find this instructive as well. Links to these documents can be found at:

Not Intended As Legal Advice.

  1. State and other federal laws, such as the Health Insurance Portability and Accountability Act (HIPAA) and the Americans with Disabilities Act (ADA), may also apply.
  2. “Genetic tests” are tests used to determine whether an individual has a certain genetic variant that is associated with an increased risk of acquiring a disease in the future – for example, a test for a genetic variant of Huntington’s Disease, or carrier screenings of adults using genetic analysis to determine the risk of conditions such as cystic fibrosis, sickle cell anemia, spinal muscular atrophy, or fragile X syndrome in future offspring. Examples of tests that are not genetic tests include an HIV test, a cholesterol test, and a test for the presence of drugs or alcohol. The regulations issued under GINA Titles I & II define genetic tests and other key terms in greater detail.
  3. The Title II regulations require that the incentives to participate in a disease management program also be made available to individuals with current health conditions and/or individuals whose lifestyle choices put them at increased risk of developing a health condition. However, the Title I regulations indicate that the incentives must be available to all individuals who qualify for the program – which may be a broader category of individuals than those described in the Title II regulations. This is an example of one of the many subtle differences between the two sets of regulations.