On November 9, 2010, the Equal Employment Opportunity Commission (“EEOC”) published the final rule to implement Title II of the Genetic Information Nondiscrimination Act of 2008 (“GINA”), clarifying its interpretation of many portions of the Act. GINA prohibits employers and health insurers from discriminating on the basis of “genetic information” and strictly limits the collection of such information. There are three routes to employer liability under GINA: (1) discrimination based on an employee’s genetic information or the genetic information of a family member; (2) unlawful collection of genetic information; and (3) failure to properly maintain and preserve the confidentiality of genetic information. The final regulations provide greater clarity on several key aspects of the law, including the inadvertent acquisition of genetic information, the acquisition of genetic information through wellness programs, the storage of genetic information, GINA’s interplay with other federal, state or local laws, and the definition of various terms within the Act.
Acquisition of Genetic Information
The text of GINA made clear that employers were strictly limited in their acquisition of genetic information about employees. The new regulations add clarity to the types of activity that will be considered prohibited collection, including obtaining that information through internet searches aimed or likely to result in acquisition of genetic information, actively listening to third-party conversations, searching an individual’s personal effects in order to obtain genetic information, and making requests about health status that are likely to result in the disclosure of genetic information.
The general prohibition against requesting, requiring or purchasing genetic information does not apply to “inadvertent” acquisition of such information (e.g., when requesting health information in order to determine a reasonable accommodation in compliance with the ADA or for confirming qualifications for FMLA leave.)
However, employers should be aware that a lawful request for medical information that leads to the acquisition of genetic information will not be considered inadvertent if the request fails to explicitly direct the health care provider not to provide genetic information. The regulations provide sample language that employers are directed to use and will constitute sufficient warning to medical providers:
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.
The language is not necessary if the request is not likely to result in obtaining genetic information. This is most likely to occur if a request is narrowly tailored — for instance, if an employer is only requesting the result of an MRI.
Other examples of inadvertent acquisition of genetic information include: inadvertently overhearing a conversation; information gained through casual or water cooler type conversation; unsolicited information (for example, an unsolicited email from an employee); or through social media the employer has permission to access.
Employers with wellness programs should be aware of very specific restrictions laid out in the final rule. The first requirement is that providing genetic information cannot be required to participate in the program. In addition, employees may not be penalized for failing to provide the information, and there cannot be a financial inducement for providing the information. Employers may offer financial inducements for completing health risk assessments that include questions involving genetic information, but it must be clear that the inducement is available whether or not genetic information is provided. The regulations provide examples to illustrate how this provision operates.
Employers using a wellness program must use written authorization forms to demonstrate that participation in the program is voluntary. These forms must be written in a manner reasonably likely to be understood; describe the genetic information that is being obtained and its purpose; and describe the restrictions on disclosure of the information.
Confidentiality of Personnel Files
Employers are not required to remove existing genetic information from personnel files that was in place prior to the implementation of GINA on November 21, 2009. Nevertheless, it is generally recommended that genetic information be placed in separate confidential medical files. This can be the same files maintained for and subject to Section 102(d)(3)(B) of the Americans with Disabilities Act (“ADA”).
Interplay with Other Laws
The EEOC’s regulations go into detail regarding the interaction between GINA and various federal, state and local laws. The regulations specifically note that state or local laws providing “equal or greater protections than GINA” from genetic discrimination or from “improper access to information” are not pre-empted by GINA.
The regulations also note that “the acquisition, use, and disclosure of medical information that is not genetic information about a manifested disease, disorder, or pathological condition is subject to applicable limitations under sections 103(d)(1) - (4) of the ADA.”
The final regulations have also provided more detailed information on the definition of various terms used in GINA.
Employee - Will include both current and former employees.
Family Member - Refers to a dependent, as that term is used in the Employment Retirement Income Security Act (“ERISA”) but is limited to “persons who are or become related to an individual through marriage, birth, adoption, or placement for adoption.” Family members also include persons related “from the first to the fourth degree.”
Genetic Information - The regulations define Genetic Information as (i) an individual genetic test; (ii) the genetic tests of the individual's family members; (iii) the manifestation of the disease or disorder in family members of the individual (family medical history); (iv) an individual’s request for, or receipt of, genetic services, or the participation in clinical research that includes genetic services by the individual or a family member of the individual; or (v) the genetic information of a fetus carried by an individual or by a pregnant woman who is a family member of the individual or a family member of the individual; or (vi) the genetic information of a fetus carried by an individual or by a pregnant woman who is a family member of the individual and the genetic information of any embryo legally held by the individual or family member using an assisted reproductive technology.
Genetic information does not include information about sex or age of the individual, the sex or age of family, or the information about the race or ethnicity of the individual or family members that is not derived from a genetic test.
All employers should review their procedures to ensure compliance with GINA and the new regulations, especially with regard to the collection of employee medical information for FMLA, ADA or other purposes. Employers should also review their wellness programs and conduct a review of personnel files to ensure they are in compliance with the regulations