GINA Update 09.29.2011


February 22, 2011
GINA Update: FMLA and ADA Medical Certification

In a previous white paper, we discussed the various changes brought about by the final regulations for Title II of the Genetic Information Nondiscrimination Act (GINA). Now that the final regulations are effective, the exact impact of GINA on FMLA- and ADA-related requests for medical information is becoming clearer.

Title II of GINA prohibits the use of genetic information in making decisions related to any terms, conditions, or privileges of employment (e.g., hiring, firing, and opportunities for advancement). The law restricts employers and other entities covered by Title II from requesting, requiring, or purchasing genetic information, with limited exceptions. GINA does not require specific intent to acquire genetic information to violate the law’s provisions.

Title II applies to private employers and state and local government employers with 15 or more employees, employment agencies, labor unions, and joint labor-management training programs.

Under GINA, a “request” for genetic information includes making requests for information about an individual’s current health status in a way that is likely to result in a covered entity obtaining genetic information. For this reason, employers requiring FMLA or ADA medical certification of an employee’s serious health condition or for the serious health condition of an employee’s family member should be concerned with GINA.

Genetic Test or Not?
The final GINA regulations offer numerous examples covered “genetic tests.” For example, tests used to determine whether an individual has a certain genetic variant associated with predisposition to a disease are considered genetic tests (e.g., breast cancer and the BRCA1 or BRCA2 gene, Huntington’s disease, cystic fibrosis, or sickle cell anemia). Examples of tests that are not genetic tests include HIV tests, cholesterol tests, and any test for the presence of drugs or alcohol.

“Genetic information” means information about an individual’s genetic tests, the genetic tests of family members of the individual, the manifestation of a disease or disorder in family members. It also includes information regarding participation in clinical research that includes genetic services by the individual or a family member of the individual. Also covered is genetic information related to pregnancy (or a family member of a pregnant woman), genetic information about the fetus and an individual using assisted reproductive technology, or genetic information about an embryo.

Exceptions. There are six narrowly defined situations in which a covered entity may acquire genetic information:

  1. Where the information is acquired inadvertently (e.g., overheard in an office discussion);
  2. As part of health or genetic services (including a wellness program) that a covered entity provides on a voluntary basis;
  3. In the form of family medical history to comply with the certification requirements of the Family and Medical Leave Act, state or local leave laws, or certain employer leave policies;
  4. From sources that are commercially and publicly available, such as newspapers, books, magazines, and even electronic sources;
  5. As part of genetic monitoring that is either required by law or provided on a voluntary basis; and
  6. By employers who conduct DNA testing for law enforcement purposes as a forensic lab or for human remains identification.

For the FMLA exception number 3, GINA allows an employer to acquire family medical history as part of the FMLA’s certification process. This statutory exception is available only when an employee is asking for leave to care for a family member with a serious health condition (not for the employee’s own serious health condition). According to EEOC, this narrow exception exists because under the FMLA, family medical history (i.e., information about the manifestation of a disease or disorder in family members of the individual) must be provided as part of the certification process.

GINA and the ADA
Employers do not violate GINA if their acquisition of genetic information is inadvertent. As with the FMLA, to be covered by this exception, employers requesting medical information from an individual or healthcare provider must direct the individual or provider not to provide genetic information.

Employers should include the notice on any request for documentation to support an employee’s request for reasonable accommodation.

Under both FMLA and ADA, acquisition of genetic information is also considered inadvertent (and not a violation of GINA) if a manager or supervisor learns genetic information about an employee by overhearing a conversation between the employee and others or by receiving it during casual conversation with the employee or others.

The “inadvertent” exception does not apply if an employer follows up with probing questions, such as whether other family members have the condition or whether the employee has been tested for the condition.

Using the Safe Harbor Statement
An employer that receives genetic information in response to a request for medical information under FMLA or the ADA will be in violation of GINA unless the employer specifically directs the individual or health care provider not to provide genetic information.

In order to do so, the employer must provide a “safe harbor” statement accompanying the request for medical certification. The prudent employer should provide a safe harbor statement for both the certification of the employee’s own serious health condition and for the serious health condition of the employee’s seriously ill family member (under FMLA). A slightly modified statement will be required for the certification of a family member. See below for details.

The GINA regulations provide model “safe harbor” language for the affirmative warning. According to the regulations, if an employer provides the safe harbor notice with the request for medical certification, any receipt of genetic information in response to the request will be considered inadvertent (and will not violate GINA).

The following is the model safe harbor statement provided in the regulations implementing GINA: Model Safe Harbor Statement (GINA)

“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 employees or their family members. In order 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.”

Safe Harbor Statement for Medical Certification of Family Members

When requesting medical certification for FMLA leave to care for a family member with a serious health condition, employers should include the following statement at the end of the model safe harbor language statement:

“Please note that information about the health condition of your patient may be provided as needed to complete the certification request.”

As with the initial medical certification, GINA also requires that the employer notify the employee and his or her healthcare provider not to provide genetic information as part of the fitness-for-duty certification.

Genetic information and confidentiality. No matter how an employer obtains genetic information, the information must be treated as a confidential medical record and kept separate from personnel files. Access to medical files should be strictly limited. Information may be kept in the same files that an employer uses for confidential medical information under the FMLA or the ADA as long as FMLA’s or the ADA’s confidentiality requirements are met.

GINA poster. EEOC has revised its employment law poster to reflect GINA’s requirements. The revised poster is available on, or through EEOC’s website at Employers also have the option of posting a supplement alongside their current EEOC poster to comply with GINA’s notice requirement.

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