- EEOC Releases Final Regulations Regarding Genetic Testing and Acquisition of Genetic Information
- November 15, 2010 | Authors: Francis P. Alvarez; Joseph J. Lazzarotti; Joseph J. Lynett; Michael J. Soltis
- Law Firms: Jackson Lewis LLP - White Plains Office ; Jackson Lewis LLP - Stamford Office
The Equal Employment Opportunity Commission has issued long-awaited final regulations for the employment provisions (Title II) of the Genetic Information Nondiscrimination Act (GINA). GINA restricts the acquisition, use, and disclosure of genetic information in the employment context. The Final Regulations, among other things, clarify the meaning of a “genetic test,” the circumstances under which the acquisition of genetic information is permissible, and requirements for employer compliance with GINA’s confidentiality and posting requirements.
In general, Title II of GINA, which took effect on November 21, 2009, prohibits 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. Congress defined genetic information broadly to include information about the following: (1) an individual's genetic tests; (2) the genetic tests of the individual's family members; and (3) the manifestation of a disease or disorder in a family member. The law imposes strict confidentiality requirements on genetic information.
The EEOC published proposed regulations under Title II of GINA on March 2, 2009. A period of public comment followed, and the EEOC issued its Final Regulations on November 9, 2010. The Regulations will take effect 60 days later.
Meaning of Genetic Tests
In its Final Regulations, the EEOC identifies many specific tests that will be considered “genetic tests” and within GINA’s reach. They include, but are not limited to:
•Certain genetic tests that might determine whether individuals are genetically predisposed to breast cancer, colon cancer, or Huntington’s Disease;
•Carrier screening to detect the risk of conditions such as cystic fibrosis, sickle cell anemia, spinal muscular atrophy, or fragile X syndrome in future offspring;
•Preimplantation genetic diagnosis performed on embryos created using in vitro fertilization;
•Pharmocogenetic tests to predict how an individual might react to a drug or particular dosage of a drug;
•DNA testing to detect genetic markers associated with information about ancestry; and
•DNA testing that reveals family relationships such as paternity.
Information about the race or ethnicity of an employee or his or her family members, not derived from a genetic test, is not protected genetic information according to the EEOC.
The Final Regulations also clarify that a test for infectious and communicable diseases that may be transmitted through food handling, complete blood counts, cholesterol tests, and liver-function tests are not covered genetic tests.
Limits on Employers’ Ability to Collect Genetic Information
GINA also broadly prohibits employers and others from requesting, requiring, or purchasing genetic information. Certain limited exceptions apply and the Final Regulations shed considerable light on at least two: (1) where an employer or another covered entity inadvertently requests, requires, or obtains genetic information; and (2) where a covered entity offers health or genetic services, including such services offered as part of a voluntary wellness program.
Inadvertent Acquisition of Genetic Information
The Final Regulations focus particular attention on requests for medical information that inadvertently acquire genetic information. The Regulations essentially impose a duty on employers and other covered entities to prevent such occurrences. An employer’s receipt of genetic information will “not generally be considered inadvertent” unless the employer/covered entity has directed the employee not to provide genetic information when responding to an otherwise lawful request for medical information. The EEOC provides the following sample Notice that, if used when requesting medical information, will protect employers:
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.
Employers seeking to reduce their exposure to GINA claims should consider including this or a similar notice in all requests for employee medical information (e.g., requests made in connection with an employee’s request for a reasonable accommodation pursuant to the ADA and requests for leave or return to work certifications under the FMLA or another federal, state, or local leave law).
Even without this Notice, the acquisition of genetic information may still be considered inadvertent if the employer’s request was not “likely to result in a covered entity obtaining genetic information.” An overly broad response received in response to a tailored request for medical information, for example, would be considered inadvertent.
Other situations where receipt of medical information may be considered inadvertent include the following:
• Where managers or supervisors learn genetic information about an individual by overhearing a conversation between the individual and others.
• During casual conversations that include responses to an ordinary expression of concern about the employee or a parent or child that is the subject of the conversation. However, this exception does not apply where an employer follows up with more probing questions concerning a family member’s general health.
• When employers receive unsolicited genetic information, including in e-mails about the health of an employee or an employee’s family member.
• When employers inadvertently learn of genetic information from a social media platform.
Health and Genetic Services, including Voluntary Wellness Programs
GINA also permits employers to acquire genetic information as part of an employer’s “health or genetic services, including such services offered as part of a voluntary wellness program.” The Final Regulations shed light on when a wellness program is “voluntary”—particularly a program that includes financial inducements. The EEOC essentially adopts the same standard it has adopted in Enforcement Guidance under the Americans with Disabilities Act (ADA): a wellness program is voluntary if it neither requires employees to participate nor penalizes employees for non-participation.
The GINA Regulations, however implicitly permit employers to use financial inducements in wellness programs that seek genetic information under some circumstances; this is significant as some comments to the proposed regulations sought a rule that any financial inducement would render a wellness program involuntary. The EEOC confirms that, for this “health and genetic services” exception to apply, employees must provide knowing, voluntary, and written authorization that meets the following minimum standards: i) be written in a manner that the individual providing the genetic information is reasonably likely to understand; ii) describe the type of genetic information to be obtained; and iii) describe the restrictions on disclosure of genetic information.
The EEOC also confirms that covered entities may offer financial inducements for completion of health risk assessments that include questions about family medical history or other genetic information, so long as the covered entity makes clear, using “language reasonably likely to be understood by those completing the health risk assessment, that the inducement will be made available whether or not the participant answers questions regarding genetic information.”
Similarly, covered entities may offer financial inducements to individuals voluntarily providing genetic information for participating in disease management or other programs to promote healthy lifestyles or to meet particular health goals if such programs are also “offered to individuals with current health conditions and/or to individuals whose lifestyle choices put them at increased risk of developing a condition.” The EEOC provides specific examples of appropriate situations.
Employers that offer wellness programs must still consider whether Title I of GINA (covering group health insurance plans) may restrict the use of financial incentives to obtain genetic information in wellness programs. Employers still must comply with the (ADA), the Health Insurance Portability and Accountability Act (HIPAA), and other laws, as well as GINA.
Confidentiality and Posting Requirements
Like the ADA, GINA requires employers to keep records containing genetic information on separate forms and in separate medical files and to treat them as confidential medical records. According to the Final Regulations, genetic information placed in an employee’s personnel file before November 21, 2009 does not need to be removed from the file. However, the prohibitions against disclosing or using genetic information apply to all such information, regardless of when it was obtained.
The Final Regulations also provide that every covered entity “shall post and keep posted in conspicuous places upon its premises where notices to employees, applicants for employment, and members are customarily posted a notice to be prepared or approved by the Commission setting forth excerpts from or, summaries of, the pertinent provisions of this regulation and information pertinent to the filing of a complaint.”
Impact on Employers
“Efforts to manage employee disabilities proactively and prevent illness through voluntary wellness programs just became significantly more complicated,” commented Frank Alvarez, the National Coordinator of Jackson Lewis’ Disability, Leave and Health Management Practice Group. “Employers must now have employees sign ‘authorizations’ before providing family medical histories and provide ‘notices’ directing doctors not to provide genetic information while conducting routine medical evaluations. Given the privacy concerns, most employers understand the reason for such safeguards, but complying with the Title II Regulations will be more challenging than many might expect. Employers soon will find themselves busy revising many medical examination forms, questionnaires, and procedures.”
Alvarez also highlights the continued need for educating managers and supervisors on this new law. “Employers must train managers and supervisors on their obligations to keep information about the health of employees and their family members confidential, even if they obtain it lawfully or inadvertently.” Alvarez thinks GINA ultimately may force employers to rethink how they obtain and store employee medical and genetic information. “It’s getting ever more complicated. We may see more outsourcing to third parties to create a firewall between employers and their employees’ health and genetic information. The whole point of GINA is to encourage individuals to learn about their health risks and to make the most of the enormous advances in medical science and genetic testing. The EEOC clearly intends to do its part in giving employees the protections they need to achieve that objective.”