Posted on December 16, 2010 by James A. Burns, Jr.

New EEOC Rules Require U.S. Employers To Revise Procedures for Acquiring and Using Medical Information

On January 10, 2011, employers will become subject to new regulations issued by the U.S. Equal Employment Opportunity Commission (“EEOC”) that interpret the Genetic Information Nondiscrimination Act of 2008 (“GINA”). Employers must now comply with GINA’s tough restrictions on the acquisition, use, and disclosure of genetic information about applicants, employees, former employees, and all such individuals’ family members. In particular, employers must take affirmative steps to avoid receiving genetic information about applicants, employees, or any of their family members.

The following addresses some key questions about how the new EEOC regulations will affect employers.

Who is covered by GINA?

GINA applies to any private sector employer that has at least 15 employees, as well as all federal and state government employers regardless of size. The law also applies to labor unions, employment agencies, and joint labor-management programs. 

What does GINA prohibit?

GINA prohibits an employer from taking the following actions with respect to an applicant, employee, or former employee:

  • Requesting, purchasing, or requiring such a person to provide “genetic information,” whether or not the employer intends to violate GINA
  • Discriminating against or harassing such a person based on genetic information, such as by using such information to make an employment decision
  • Retaliating against an applicant, employee, or former employee because he or she opposed any act that he or she reasonably believed to be prohibited by GINA, filed a charge under GINA, or helped someone else file such a charge

What is “genetic information”?

The new rules broadly define “genetic information” to include:

  • Information about a “genetic test” of an applicant, employee, or former employee, or any of his or her “family members”
  • The manifestation of a disease or disorder in any family member of an applicant, employee, or former employee (i.e., family medical history)
  • A request for or receipt of genetic services (such as a genetic test or genetic counseling), or participation in a clinical research that includes genetic services, by an applicant, employee, former employee, or any of his or her family members
  • Genetic information of a fetus carried by an applicant, employee, former employee, or any family member of such an individual, and genetic information about any embryo legally held by such an individual or family member who is using assisted reproductive technology

The regulations broadly define an individual’s “family members” as anyone who is: (1) a dependent of that individual as the result of marriage, birth, adoption, or placement for adoption; or (2) a first-degree, second-degree, third-degree, or fourth-degree relative of the individual, or of a dependent as defined above, including everyone from great-great-grandparents through great-great-grandchildren, as well as siblings, half-siblings, uncles, aunts, nephews, nieces, first cousins, and children of first cousins.

What is a “genetic test”?

GINA defines a “genetic test” as “an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes.” The regulations provide these examples:

  • Tests to determine whether an individual has a genetic variant evidencing a predisposition to breast cancer or associated with colon cancer, or a genetic test for Huntington’s Disease
  • Carrier screening for adults using genetic analysis to determine the risk of conditions such as cystic fibrosis and sickle cell anemia
  • Amniocentesis and other evaluations used to determine the presence of genetic abnormalities in a fetus during pregnancy
  • Preimplantation genetic diagnosis performed on embryos created using in vitro fertilization
  • Newborn screening analysis to detect or indicate genotypes, mutations, or chromosomal changes
  • DNA testing that reveals family relationships (e.g., paternity tests)
  • DNA testing that indicates the presence of genetic markers associated with ancestry

The regulations give as examples of medical tests that are not “genetic tests,” complete blood counts, cholesterol tests, liver function tests, drug and alcohol tests, and tests for communicable and infectious diseases that may be transmitted through food handling.

What sort of actions by an employer are treated as prohibited “requests” for genetic information?

The regulations broadly define what it means for an employer to unlawfully “request” genetic information, citing these examples:

  • Conducting an Internet search that is likely to result in obtaining genetic information about an applicant, employee, or any of his or her family members, even if that information is publicly available
  • Actively listening to third-party conversations in which genetic information is being discussed
  • Searching an individual or his or her property to obtain genetic information
  • Requesting information about the medical condition or health status of an individual or any of his or her family members in a way that is likely to result in obtaining genetic information

At the same time, GINA does not prohibit an employer from “inadvertently” obtaining genetic information. The regulations clarify that exception by citing these examples of inadvertent actions by managers or supervisors that do not cross the line:

  • A manager or supervisor learns genetic information during a casual conversation, such as in response to an ordinary expression of concern about how an employee or family member is feeling, so long as the manager or supervisor does not follow up by seeking more information such as whether other family members have the disease or whether the employee or any family member has been tested for it
  • A manager or supervisor inadvertently overhears a conversation in which genetic information is discussed
  • A manager or supervisor learns the information from visiting a social media site that he or she had permission to visit, if he or she was not visiting the site to obtain genetic information

How does GINA affect employer requests for medical information in connection with FMLA leaves or to evaluate an employee’s restrictions, or when an employer sends an applicant or employee for a medical exam?

The regulations state that an employer’s requests for medical information from an applicant or employee violate GINA if they may result in the employer acquiring genetic information, unless the employer specifically instructs the individual or health care provider to whom the request is directed not to provide any such information. Employers may do that by using the following “safe harbor” language when they request medical information:

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 of 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 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 regulations also make clear that such a warning is mandatory when an employer asks a health care provider to conduct an employment-related medical examination. Employers that condition employment on applicants undergoing post-offer medical exams, and those that require employees to undergo medical exams while employed, should thus provide the “safe harbor” language quoted above to the applicant or employee, as well as to the examining health care provider.

Does that mean that employers should change the forms they use to request medical information from or about employees, such as FMLA medical certification forms?

Yes. Employers should include the EEOC’s model “safe harbor” language in any documents they use to request medical information, such as requests to evaluate whether an employee has a disability, what sort of accommodation an applicant or employee may require, and fitness-for-duty certifications. In most cases, employers who use the U.S. Department of Labor’s FMLA medical certification forms should attach a statement to the form containing the same language. Because the EEOC regulations specifically allow employers to seek “family medical history” in order to comply with the FMLA, however, employers should consider modifying the “safe harbor” language when asking employees to complete a medical certification to support a request for FMLA leave to care for a parent, spouse or child with a serious health condition.

If an employer obtains genetic information despite not having asked for it, what obligations does the employer have?

The regulations require employers to take specific steps to keep such information confidential.

First, employers must keep all documents containing genetic information about an individual and his or her family members in separate medical files and treat them as confidential medical records (although they can be stored in the same confidential medical file that the employer maintains under the Americans with Disabilities Act (“ADA”)). Employers need not go back and remove genetic information that was placed in personnel files before November 21, 2009 (when GINA took effect), but they cannot use or disclose any such information.

Second, an employer that has genetic information (even if inadvertently obtained) cannot disclose it except:

  • To the employee (or family member if the family member is receiving the genetic services) about whom the information relates upon receipt of the employee’s written request
  • As directed and authorized by a court order that specifically requires disclosing genetic information, if the employer informs the employee about the court order and any genetic information it disclosed in response. Because this exception applies only to court orders, the EEOC’s comments to the new rule make clear that employers should not disclose any genetic information in response to discovery requests or subpoenasunless and until a court enters an order specifically requiring the employer to produce information that the court has recognized is protected by GINA.
  • To the extent that the disclosure is consistent with requirements of the FMLA or a similar state or local law. For example, an employee’s supervisor who receives a request from an employee to take time away from work to care for a child with a serious health condition may forward that request to persons in Human Resources responsible for administering FMLA requests.
  • To government officials investigating GINA compliance, where the information is relevant to the investigation
  • To a government public health agency, in limited circumstances involving contagious and highly hazardous diseases

How does GINA affect employers that offer employees incentives to participate in voluntary health assessments or wellness programs?

The regulations allow employers to offer employees financial incentives to participate in health assessments or wellness programs only if employers obtain knowing, voluntary authorizations from employees, specifically identify which parts of any health assessment seek genetic information, assure employees that their failure or refusal to answer those questions will not affect their eligibility to receive any incentive, and take steps to ensure that no individually identifiable genetic information is provided to the employer. Employers must also continue to be sure thatany voluntary wellness program complies with Title I of GINA (which covers group health insurance plans), the ADA, and the Health Insurance Portability and Accountability Act (“HIPAA”).

What should an employer do to minimize its risk in this area?

  • Update its policies to prohibit discrimination or harassment based on genetic information, to prohibit using its computer systems in any way that is likely to obtain genetic information, and to make clear that the employer will not seek to obtain any genetic information about any employee or family member.
  • Train HR personnel, managers, and supervisors about GINA, including the law’s broad definition of “genetic information” and how it limits asking some questions about the health conditions of employees and their family members regardless of motivation.
  • Make sure that workplace postings include the EEOC’s revised notice that mentions GINA (available here).
  • Use the EEOC’s model “safe harbor” language when seeking medical information from or about an applicant or employee.
  • Maintain lawfully obtained genetic information about an individual or his or her family members in a separate, confidential medical file, and implement practices to prohibit its disclosure except as permitted by the regulations.

For more information about the new EEOC regulations or GINA, please contact the author of this entry or the Reed Smith attorney with whom you usually work.
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Posted on October 30, 2009 by James A. Burns, Jr.

EEOC Revises Mandatory Workplace Poster

U.S. employers with 15 or more employees must post workplace notices to inform applicants and employees about their rights under federal anti-discrimination laws. The Equal Employment Opportunity Commission (EEOC) has recently published an updated version of its required “Equal Employment Opportunity is The Law” poster, updated to refer to the employment provisions of the Genetic Information Nondiscrimination Act (GINA) that will go into effect November 21, 2009, as well as changes resulting from the ADA Amendments Act of 2008 that took effect in January.

All employers should replace their existing federal EEO poster with the new version, or add a new supplementary poster, also available from the EEOC. Links to the new poster and the supplement, as well as instructions on how to order multiple printed copies from an EEOC clearinghouse, can be found at the EEOC's website. The EEOC says that Spanish, Chinese, and Arabic versions of the posters will become available before GINA takes effect.

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Posted on May 19, 2008 by James A. Burns, Jr.

U.S. Congress Passes Ban on Genetic Discrimination

This post was written by James A. Burns, Jr. and Rachel C. Shim.

By overwhelming margins, the House and Senate have passed legislation that will prohibit discrimination in employment and medical insurance based on genetic information and tests. The White House has made clear that President Bush will sign the bill.

The Genetic Information Nondiscrimination Act (“GINA” or the “Act”) will prohibit employers, employment agencies and labor unions from discriminating against applicants or employees based on information about genetic tests of, or the receipt of genetic counseling or other services by, an individual or his or her family members. GINA will also preclude group health plans and issuers of health insurance from discriminating against individuals based on genetic information, and will bar insurers from requiring genetic tests.

Employers, Employment Agencies and Labor Unions

GINA makes it unlawful for an employer, employment agency or labor union to discriminate against any applicant or employee based on “genetic information,” which the Act defines as information about the genetic tests of such an individual or any of his or her family members; information about the manifestation of a disease or disorder in any such family members; or information about a request for or receipt of a genetic test, genetic counseling, or genetic education by the individual or any of his or her family members. The Act also prohibits requesting, requiring or purchasing genetic information with respect to an employee or family member. Employers are nonetheless permitted to request or require that an employee provide a family medical history in compliance with the certification provisions of the Family and Medical Leave Act (“FMLA”) or comparable state laws, or where the employer’s request or requirement is “inadvertent.” Another exception permits requesting or requiring information used for legally mandated genetic monitoring of the biological effects of toxic substances in the workplace, but only if the monitoring complies with federal and state regulations, and the employee expressly consents and is given the results.

Like medical information under the Americans with Disabilities Act, genetic information must be treated as confidential, maintained on separate forms, and stored in separate medical files. If a covered entity receives a court order directing it to provide genetic information, it cannot do so unless the disclosure is specifically authorized by the order and the employee either knew about the order before it was secured, or is told about the order and any genetic information to be produced before production takes place. Employers may also disclose such information in connection with the employee’s compliance with the certification provisions of the FMLA or comparable state laws.

Other provisions of the Act, including its prohibition against retaliation and the range of available remedies, mirror those found in Title VII of the Civil Rights Act of 1964. Prevailing plaintiffs may thus recover lost wages and benefits; compensatory and punitive damages of up to $300,000, costs and attorneys’ fees; and equitable relief such as reinstatement. To allay business concerns, however, GINA does not permit employees to bring “disparate impact” claims asserting that a facially neutral policy or practice has a discriminatory adverse effect based on a protected characteristic.

Group Health Plans and Insurers

Under the Act, group health plans and insurers cannot discriminate against an individual with regard to premiums based on genetic information, nor can they require an individual to undergo a genetic test (except in certain limited circumstances for research purposes). The Act also bars group health plans and insurers from requesting, requiring or purchasing genetic information about an individual, or using for underwriting purposes any genetic information that they acquire.

GINA’s full impact on employers that provide group health plans is not yet clear, as the agencies charged with administering the new law have been given one year from the date the Act takes effect to issue regulations. Nevertheless, employers that provide fully insured group health plans will most likely be able to rely on their insurers to satisfy at least some requirements of the Act. In addition, GINA requires the Department of Health and Human Services (“HHS”) to amend regulations issued under the Health Insurance Portability and Accountability Act (“HIPAA”) to include genetic information within the definition of protected health information. This should allow insurers and group health plans to use genetic information for payment, treatment and health care operations, and thereby ensure that the Act does not bring the day-to-day administration of a group health plan to a halt.

Once GINA takes effect, however, employers will need to pay close attention to ensuring that their group health plans comply with its requirements, because penalties for a violation are steep. Under the Act, the Secretary of Labor may impose a penalty of up to $100 per day per participant or beneficiary to whom a failure relates. The Act also allows an excise tax to be imposed under Section 4980D of the Internal Revenue Code. While employers will be able to correct errors and be excused from unintentional, unknowing mistakes, employers that fail to take action to ensure compliance could be hit hard.

Effective Dates

To provide enough time for those covered by the Act to prepare for its restrictions and for the agencies charged with issuing regulations to do so, GINA will not take effect until next year. Those parts of the Act that cover group heath plans and health insurers will take effect 12 months after the bill is signed, while the employment discrimination provisions will take effect six months after that.

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