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Legislative update

Impact of GINA regulations on medical questionnaires, fitness for duty exams, and wellness programs

The final regulations for Title II of the Genetic Information Nondiscrimination Act went into effect on Jan. 10, 2011. The most immediate implication is that employers must review and update their practices and medical forms to ensure compliance. Employers should look at their medical examination forms, and the questions they routinely ask employees or applicants. Those with wellness programs need to understand the strict requirements for exceptions under the act. Employers should also include notices on all requests for medical information.

The regulations generally apply to employers with at least 15 employees. They prohibit employers from discharging, refusing to hire, or otherwise discriminating on the basis of genetic information and from intentionally acquiring genetic information about applicants and employees. The penalties for violating the regulations can be stiff.
Here are some best practices for employers:

  1.  Fitness-for-duty exams
    While employers may conduct fitness-for-duty exams or a pre-hire physical after extending a conditional offer of employment, they may not obtain genetic information in the process. Be sure to instruct health care providers not to collect such information as part of the exam.
  2. Include safe harbor language when requesting medical information
    Whether it’s medical information for return-to-work or accommodations for a disabled employee, all requests for medical information must include “safe harbor” language, such as that included in the final regulation. As long as the employer includes the safe harbor language when requesting medical information, the employer’s receipt of any genetic information in response to a lawful request for medical information will be deemed inadvertent and not in violation of GINA. The EEOC provides the following example of safe harbor language:

    “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.”

    Without this language or an acceptable alternative, legal requests for medical information could violate GINA if the provider includes genetic information. All medical questionnaires and other forms requesting medical information should be updated to include the safe harbor language.
  3. Understand the voluntary wellness program exemption
    When an employer meets specific requirements, GINA does permit employers to acquire genetic information for health or genetic services offered by the employer, including such services offered as part of a wellness program.

    The requirements include:
    • Disclosure must be voluntary. The employer may not require an individual to provide genetic information, nor penalize an individual who refuses to provide information.
    • Prior authorization. The employee must provide prior, knowing, voluntary and written authorization, which is clearly written so that the employee is reasonably likely to understand it; describes the type of genetic information that will be obtained and the general purposes for which it will be used; and describes the restrictions on the disclosure of the information. The authorization can be in electronic form, but must be recorded prior to asking for the genetic information.
    • Financial incentives and rewards available to all. The wellness plan exception prohibits the employer from offering financial inducements for individuals to provide genetic information - but allows financial inducements for completion of health risk assessments. Any incentive or reward offered for participating must be available to all workers who qualify for the program — those who volunteered genetic information and those who did not.
    • Health risk assessment genetic information questions. Because obtaining family medical information is often a key part of a wellness assessment, the regulations allow employers to include questions about family medical history or other genetic information on a health risk assessment “so long as the employer specifically identifies those questions and makes clear that the participant need not respond to those questions that request genetic information in order to receive the incentive.” Employers should review and modify health risk assessment forms as necessary. The regulations indicate that using a “bifurcated” health risk assessment would not violate GINA.
  4. Review personnel procedures and forms and train HR and managers about compliance

More information can be found at and it is best to seek legal counsel for guidance.