EEOC Settles First Case Alleging Genetic Information Bias

Last week the Equal Employment Opportunity Commission (EEOC) settled its first lawsuit involving a discrimination claim based on an applicant’s genetic history. The lawsuit alleged that Fabricut, a fabric distributor, violated the Genetic Information Nondiscrimination Act (GINA) when it requested a family medical history in its post-offer medical examination to a temporary employee and then violated the Americans with Disabilities Act (ADA) by denying a regular position to the temporary employee because it regarded her as having carpal tunnel syndrome.

After offering the plaintiff a permanent position, the company subjected her to pre-employment drug testing and a physical exam. The exam included a questionnaire that asked her to disclose the existence of medical conditions – including heart disease, hypertension, cancer, tuberculosis, diabetes, arthritis, and mental disorders – that ran in her family. The applicant was also subjected to further medical evaluations to determine whether she suffered from carpal tunnel syndrome.

In addition to the ADA claim based on the company’s conclusion that she suffered from carpal tunnel syndrome – despite her own physician’s finding to the contrary – the plaintiff alleged that the medical questionnaire violated her rights under GINA. Among other provisions, Title II of GINA prohibits the use of genetic information in making employment decisions, restricts acquisition of genetic information by employers and other entities covered by Title II, strictly limits the disclosure of genetic information, and prohibits retaliation against employees who complain about genetic discrimination. GINA was enacted in 2008, and took effect in 2009. The agency issued final regulations on Title II a year later. 

According to EEOC, the lawsuit and settlement were both filed on May 7, 2013. The company has agreed to pay the plaintiff $50,000, as well as take remedial actions. In a press release, EEOC Regional Attorney Barbara Seely said: “We believe that when Fabricut fully understood and appreciated what happened, it took action to remedy the situation, as this quick settlement demonstrates,” adding, “Although GINA has been law since 2009, many employers still do not understand that requesting family medical history, even through a contract medical examiner, violates this law.”

EEOC Final Rule Extends Recordkeeping Requirements to GINA-Covered Entities

Because the Equal Employment Opportunity Commission (EEOC) received no adverse comments to a proposed rule extending certain recordkeeping and reporting requirements to entities covered by the employment discrimination provisions (Title II) of the Genetic Information Nondiscrimination Act (GINA), the agency is adopting the proposal as final. Title II of GINA prohibits the use of genetic information in making employment decisions, restricts acquisition of genetic information by employers and other entities covered by Title II, strictly limits the disclosure of genetic information, and prohibits retaliation against employees who complain about genetic discrimination. The EEOC issued final regulations implementing the employment provisions of GINA in November 2010.

The final recordkeeping rule “does not require the creation of any documents or impose any reporting requirements,” but rather amends current Title VII and Americans with Disabilities Act (ADA) recordkeeping regulations to add references to GINA. These recordkeeping regulations under Title VII and the ADA “require all covered entities to preserve all employment and personnel records that they make or keep for a specified period of time, and to preserve all records relevant to a Title VII or ADA charge until the charge is resolved.” The same obligations are now applicable for GINA-related charges.

The final rule becomes effective on April 3, 2012.

EEOC Opinion Letter Addresses GINA's Impact on Employer Wellness Programs

In an informal discussion letter, (pdf) the Equal Employment Opportunity Commission’s Office of Legal Counsel reiterates the position that an employer-provided wellness program that offers financial inducements to provide genetic information as part of a wellness program runs afoul of Title II of the Genetic Information Nondiscrimination Act (GINA). Among other restrictions, GINA limits the ability of health insurers and employers to collect genetic information, which includes family medical history. Whether and to what extent employer-provided wellness programs and health surveys that solicit information about family medical history violate GINA and other statutes and regulations is a rising concern for employers.

As discussed in the EEOC letter, which was written in response to a request for guidance on this issue, Title II of GINA does permit employers to gather genetic information about employees and their family members when it offers health or genetic services – including wellness programs – on a voluntary basis. The EEOC issued a final rule implementing the employment provisions of GINA in November 2010. As outlined in the rule and the discussion letter, prior consent to participate in a wellness program must be voluntary, knowing, and written. In addition, “while individualized genetic information may be provided to the individual receiving the services and to his or her health or genetic service providers, genetic information may only be provided to the employer or other covered entity in aggregate form.” The EEOC letter notes that the final rule states that employers may not offer financial inducements for employees to provide genetic information as part of a wellness program. However, the final rule provides that employers may offer a financial inducement for completing a health risk assessment that includes questions about genetic information so long as the employer identifies such questions and makes clear that the employee is not required to answer the questions about genetic information in order to receive the financial inducement.

The EEOC letter further explains that an employer may use the voluntarily-provided information about the employee “to guide that individual into an appropriate disease management program,” provided it opens the program up to all employees if the program includes financial incentives to participate or reach certain health-related outcomes. The EEOC letter declined to address the concern that an example used in the GINA Title II final rule to illustrate this point is at odds with the regulations implementing Title I of GINA, which restricts the use of genetic information by group health plans and health insurance issuers. The reason given in the letter for failing to explain the apparent inconsistency between the two regulations was that the EEOC is not responsible for enforcing Title I. However, the letter states that the Commission’s goal in formulating its position on wellness program incentives and the examples cited was to be consistent with the Title I rules.

The Commission further declined to take a position on whether and to what extent Title I of the Americans with Disabilities Act (ADA) would permit an employer to offer financial incentives to participate in a wellness program that included disability-related inquiries or medical exams, but stated that it would take any comments on this issue under advisement.

Despite the guidance provided in the EEOC letter, much still remains unclear. In October 2010, the Department of Labor’s Employee Benefits Security Administration (EBSA) issued guidance in the form of Frequently Asked Questions (FAQs) that discussed the interaction between GINA’s restrictions and employer-provided group health plans and insurance providers. As previously discussed, this guidance outlines certain constraints placed on insurance plans and issuers in providing incentive-based wellness programs, which appear at odds with the provisions in the Patient Protection and Affordable Care Act that are designed to increase the use and effectiveness of employer-sponsored wellness programs. Specifically, the Affordable Care Act recognizes the value of incentive-based wellness programs by increasing the amount of the reward allowed under the current HIPAA regulations beginning in 2014. As reflected in the Affordable Care Act, incentive-based wellness programs can be an effective tool for employers seeking to reduce health care costs and improve the productivity of their workforce.

Given the complexity and apparent inconsistency of the federal statutes and rules governing wellness programs, employers are cautioned to consider all applicable legal requirements when designing their wellness program.

EEOC Proposes to Extend Recordkeeping Requirements to GINA-Covered Entities

The Equal Employment Opportunity Commission (EEOC) has issued a proposal to extend its recordkeeping requirements under Title VII of the Civil Rights Act and the Americans with Disabilities Act (ADA) to employers covered by the employment discrimination provisions (Title II) of the Genetic Information Nondiscrimination Act (GINA). Title II of GINA prohibits the use of genetic information in making employment decisions, restricts acquisition of genetic information by employers and other entities covered by Title II, strictly limits the disclosure of genetic information, and prohibits retaliation against employees who complain about genetic discrimination. The EEOC issued final regulations implementing the employment provisions of GINA in November 2010.

The agency’s proposed rule, published in the June 2 edition of the Federal Register, seeks to amend its current Title VII and ADA recordkeeping regulations to add references to GINA. According to the EEOC, the proposal does not request the creation of additional documents nor does it impose any reporting requirements under GINA, “but merely require[s] employers to maintain the records that they do create,” although the agency reserves the right in the future to issue reporting regulations “as may be necessary to accomplish the purposes of GINA.”

Comments on this proposal are due on or before August 1, 2011, and may be submitted through the federal eRulemaking portal, or by mail to Stephen Llewellyn, Executive Officer, Executive Secretariat, Equal Employment Opportunity Commission, 131 M Street, NE., Suite 6NE03F, Washington, DC 20507. Written comments of six or fewer pages may be faxed to the Executive Secretariat at (202) 663-4114.

EEOC Releases Additional Guidance Documents on Final GINA Rule

The Equal Employment Opportunity Commission (EEOC) has posted on its website two new guidance documents on the recently published final rule implementing the employment provisions of the Genetic Information Nondiscrimination Act (GINA). Title II of GINA prohibits the use of genetic information in making employment decisions, restricts acquisition of genetic information by employers and other entities covered by Title II, strictly limits the disclosure of genetic information, and prohibits retaliation against employees who complain about genetic discrimination. The first guidance document provides background information on the Title II rule, while the second focuses on questions that might arise for small businesses.  Both guidance materials are presented in question and answer format, and clarify many of the provisions contained in the final rule.

Among other things, both documents explain that Title II applies to private employers with 15 or more employees, employment agencies, labor unions, and joint labor-management training programs, and discuss the protections afforded by the law, along with the statutory exceptions. The documents also shed light on the interplay between GINA and other anti-discrimination laws. Notably, the guidance discusses how discrimination against some genetic-based conditions, such as certain types of breast cancer, would not be covered under GINA, but could be prohibited under the Americans with Disabilities Act (ADA). The guidance explains that GINA “is concerned primarily with protecting those individuals who may be discriminated against because an employer thinks they are at increased risk of acquiring a condition in the future. Someone who is discriminated against because she actually has breast cancer or another condition would not be protected by GINA, even if the condition has a genetic basis.” The guidance notes that amendments to the ADA, however, would make it easier for an employee with such a condition to be considered “disabled” and thus protected from discrimination on this basis.

The Q&As also explain that while an employer may conduct a post-offer medical examination/inquiry or fitness-for-duty examination consistent with ADA requirements, GINA prevents the employer from requesting or requiring an individual to provide genetic information, including family medical history, during a medical examination related to employment. In addition, an employer must tell its health care providers in advance not to collect genetic information as part of an employment-related medical exam.

On the other hand, the guidance states that GINA includes an exception that permits an employer to acquire an employee’s family medical history as part of the certification process under the Family and Medical Leave Act (FMLA). According to the Q&As, such an exception to the prohibition on collecting an individual’s family medical history is needed when the employee is seeking leave to care for a family member with a serious health condition, since information about the manifestation of a disease or disorder is required as part of the FMLA (or analogous state or local leave law) certification process.

The guidance clarifies a number of other issues under the final rule, such as what an employer must do to comply with GINA when lawfully requesting health-related information; when an employer’s acquisition of genetic information would be deemed inadvertent and thus not unlawful; under what conditions may an employer conduct genetic monitoring to determine if employees are being affected by harmful substances in the workplace; and how Title II applies to employment decisions concerning the provision of health benefits. The Q&A documents also include model language provided in the final rule that an employer may use as a warning for employees not to provide genetic information when providing the employer with health-related information.

For more information on the final rule and its requirements, see Littler’s ASAP: EEOC Issues Long-Awaited Final Regulations on the Genetic Information Nondiscrimination Act.

EEOC Issues Final GINA Regulations

Nearly a year after the employment provisions of the Genetic Information Nondiscrimination Act (GINA) took effect, the Equal Employment Opportunity Commission (EEOC) has issued a final rule (pdf) implementing these sections. Title II of GINA – which took effect on November 21, 2009 – prohibits the use of genetic information in making employment decisions, restricts acquisition of genetic information by employers and other entities covered by Title II, and strictly limits the disclosure of genetic information. Title II also prohibits retaliation against employees who complain about genetic discrimination. According to the EEOC, the final rule implements the various provisions of Title II consistent with Congress’s intent, provides some additional clarification of those provisions, and explains in greater detail the sections where Congress incorporated by reference provisions from other statutes. The final rule becomes effective 60 days after its publication in the Federal Register, which is scheduled for November 9, 2010.

General Purpose of GINA

The EEOC explains that among other things, Title II of GINA restricts an employer from “requesting, requiring, or purchasing genetic information.” The agency removed reference to the “deliberate acquisition” of genetic information, which had been included in the proposed regulations, in response to comments that the use of the term “deliberate acquisition” of genetic information suggested that an employer must have a specific intent to acquire genetic information in order to violate the law. The EEOC agreed that employers can violate GINA without a specific intent to violate the law by engaging in activity that presents a “heightened risk” of acquiring genetic information, such as when employers fail to inform an individual from whom they have requested documentation about a manifested disease or disorder not to provide genetic information.

The final rule also clarifies that GINA does not apply to actions of an employer that do not pertain to the individual’s status as an employee. For instance, a hospital conducting a medical examination of an individual who happens to work there would not be subject to Title II restrictions, so long as the examination is unrelated to the individual's employment.

Definitions

With respect to the definitions contained in the Act, the EEOC notes that the final rule adopts the language from the proposed regulations, such as the inclusion of applicants and former employees in the definition of employee. As for the definitions of the six terms that are unique to GINA, the final rule provides additional guidance.

For the definition of family member, the rule stipulates that dependents covered by Title II are limited to persons who are or become related to an individual through marriage, birth, adoption, or placement for adoption. The EEOC explains that even though adoptees might not be genetically related to the covered employee, “the acquisition of information about the occurrence of a disease or disorder in an applicant’s or employee’s adopted child could certainly result in the type of discrimination GINA was intended to prohibit,” and therefore is included in the definition.

The term genetic information is defined as information about: (1) an individual’s genetic tests; (2) the genetic test of that individual’s family members; (3) family medical history; (4) and individual’s request for, or receipt of, genetic services, or the participation in clinical research that includes genetic services by the individual or family member of the individual; or (5) genetic information of a fetus carried by an individual or by an pregnant woman who is a family member of the individual and the genetic information of any embryo legally held by the individual using an assisted reproductive technology. With respect to the definition of family medical history, the EEOC declined to limit such information to “inheritable” diseases or disorders. The EEOC had invited comments on the scope of the term “genetic test.” In response the final rule includes examples of kinds of tests that are considered genetic tests. The final rule also includes examples of tests that are not considered genetic tests, such as complete blood counts, cholesterol tests, and liver-function tests. In addition, a test for the presence of alcohol or illegal drugs is not considered a genetic test.

Prohibited Acts

Under GINA, employers are prohibited from discriminating against employees on the basis of genetic information in regard to hiring, discharge, compensation, terms, conditions, or privileges of employment. In the preamble to the final rule, the EEOC notes that claims of harassment on the basis of genetic information are cognizable.

Limiting, Segregating, and Classifying

GINA prohibits employers from limiting, segregating, or classifying employees based on genetic conditions. The rule clarifies, however, that an employer may limit or restrict an employee’s job duties based on genetic information if it is required to do so by law or regulation mandating genetic monitoring such as regulations administered by the Occupational Safety and Health Administration (OSHA). The rule also makes clear that neither the statute or final regulation creates a cause of action for disparate impact.

Causing an Entity to Discriminate

GINA prohibits employment agencies, labor organizations, and apprenticeship or other training programs from causing an employer to discriminate on the basis of genetic information. The rule notes that because GINA incorporates Title VII’s definition of employer, including the application of common law agency principles, the law prohibits an employer from engaging in actions that would cause another entity acting as its agent to discriminate. For instance, an employer cannot ask an employment agency to screen its candidates in a manner that would violate GINA.

Acquisition of Genetic Information

GINA prohibits employers from requesting, requiring, or purchasing genetic information about an employee or family member except in limited circumstances. The final rule provides that the request of genetic information:

includes conducting an Internet search on an individual in a way that is likely to result in a covered entity obtaining genetic information; actively listening to third-party conversations or searching an individual’s personal effects for the purpose of obtaining genetic information; and 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.

The new rule does, however, clarify that “a request for information about whether an individual has a manifested disease, disorder, or pathological condition does not violate GINA simply because a family member of the individual to whom the request was made works for the same employer, is a member of the same labor organization o is participating in the same apprenticeship program as the person from whom the information was requested.”

The rule explains other situations in which obtaining genetic information would be permissible:

Inadvertent Receipt of Genetic Information

An employer that inadvertently requests or requires family medical history does not violate GINA. As the EEOC notes, Congress intended this exception to address the so-called “water cooler problem.” Commenters to the proposed rule expressed concern that employers could still be found liable for inadvertently acquiring genetic information under certain circumstances. The rule explains that inadvertently receiving any genetic information, not just family medical history, would not result in liability. For example, an employer would not violate GINA if, through a casual conversation or in response to a general question such as “how are you?”, inadvertently elicits genetic information.

The final rule also includes a “safe harbor” provision explaining that when an employer warns anyone from whom it requests health-related information not to provide genetic information, it is not liable under GINA if the individual does indeed provide genetic information to the employer. If the employer acquires genetic information in response to a lawful request for medical information, the acquisition of genetic information will not be considered “inadvertent” until the employer directs the individual and/or health care provider not to provide genetic information. The final rule includes a model notice that the employer can use for satisfying the “safe harbor” warning. The EEOC notes that a warning is mandatory when an employer requests a health care professional to conduct an employment-related medical examination on the employer’s behalf.

Another example of the inadvertent acquisition of genetic information is when an employer requests medical documentation in response to an employee’s request for a reasonable accommodation under the Americans with Disabilities Act (ADA). The final rule cautions, however, that “in order to be considered a lawful request for documentation made in response to an individual seeking a reasonable accommodation under the ADA or state or local law, the request for medical documentation can be made only when the disability and/or the need for accommodation is not obvious.” The EEOC adds that, like any request for medical documentation, the request for documentation as part of the reasonable accommodation process should include the warning and notice language noted above.

The final rule also recognizes that an employer that inadvertently receives genetic information in response to a lawful request for medical information – such as part of an employee’s request for leave under the Family and Medical Leave Act (FMLA) for their own serious health condition – would not violate GINA. According to the EEOC, acquisition of genetic information in such a situation is not unlawful under GINA “if the covered entity affirmatively warns individuals and health care providers from whom they are seeking medical documentation not to provide genetic information, or, in the absence of such a warning, where the request for medical information was not likely to result in the acquisition of genetic information.”

Wellness and Disease Management Programs

GINA also allows employers and other covered entities to obtain genetic information in connection with a employer-provided health or genetic services, including wellness programs under certain circumstances. As explained in the proposed rule, the individual participating in the program must provide prior knowing, voluntary, and written authorization. As discussed in the rule, this means that the employer must use an authorization form that is written in language “reasonably likely to be understood by the individual from whom the information is sought; describes the information being requested; and describes the safeguards in place to protect against unlawful disclosure.” The employer may not receive individually identifiable genetic information.

The proposed rule did not define the term “voluntary” for purposes of this exception. Many commenters sought clarification regarding the permissible level of inducement to participate in a wellness program an employer could provide without running afoul of GINA. Interim Final Regulations implementing Title I of GINA prohibit a group health plan from offering a financial incentive for completion of a health risk assessment that seeks genetic information, including family medical history. Concerns have been raised that this interpretation would chill the use and effectiveness of wellness programs. Such a restriction appears contrary to provisions on the Patient Protection and Affordable Care Act designed to encourage the use of wellness programs.

In the final GINA Title II regulations, the EEOC takes a position similar to the Title I regulations, concluding that “covered entities may offer certain kinds of financial inducements to encourage participation in health or genetic services under certain circumstances, but they may not offer an inducement for individuals to provide genetic information.” For example, an employer could offer incentives to employees that complete a health risk assessment that includes questions about family medical history or other genetic information 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. Such a “bifurcated” health risk assessment would not violate Title II of GINA.

The final rules also allow employers to offer financial inducements for participation in disease management programs based on voluntarily provided genetic information as long as the employer offers the program and inducements to individuals with current health conditions and/or individuals whose lifestyle choices put them at increased risked of developing a condition.

Compliance with FMLA Certification Requirements

GINA allows employers to request family medical history to comply with the certification requirements of the FMLA or state or local family and medical leave laws. Employers may also request family medical history pursuant to a policy, even in the absence of a leave law, that permits the use of leave to care for a sick family member and that requires all employees to provide information about the health conditions of family members to substantiate the need for leave.

Publicly Available Information

GINA makes an exception for information obtained from publicly available sources. Many commenters requested further explanation of what constitutes a “publicly available” source. In response, the EEOC notes that if a media source, such as database or website, requires permission for access from a specific individual, as opposed to a media source that similarly requires users to obtain a username and/or password, or if access is conditioned on membership in a particular group such as a professional organization, then the acquisition of genetic information though these channels does not fall under the “publicly available” exception. Thus, the determining factor is “whether access requires permission of an individual or is limited to individuals in a particular group, not whether the source is categorized as a social networking site, personal website, or blog.”

However, the rule explains that intent can be a factor in determining whether an entity violates Title II. For example, if an employer intentionally performs an internet search to see if an employee or applicant has a genetic condition, he or she violates GINA even if the information is discovered on a publicly available site.

Similarly, the exception will not apply if an employer obtains information from a media source, whether or not it is commercially and publicly available, if the employer is likely to obtain genetic information from that source, such as a website or database that focuses on genetic testing and/or contains individually identifiable health information.

Genetic Monitoring

GINA permits employers to engage in genetic monitoring of the biological effects of toxic substances in the workplace, provided they notify employees that it will do so, and where not required by law to conduct such monitoring, obtain the individual’s consent. The final rule also includes a provision stating that an employee who refuses to participate in a voluntary genetic monitoring program should be informed of the potential risks, but cannot be discriminated against on this basis.

Disclosure of Genetic Information

Employers that possess written genetic information are required to store such information in a separate confidential medical file, as required under the Americans with Disabilities Act. However, genetic information placed in personnel files prior to November 21, 2009 need not be removed. Ordinarily, the disclosure of genetic information is prohibited under GINA. The Act, however, lays out a number of exceptions to this rule. For example, GINA permits an employer to disclose genetic information to the employee or family member to whom the information relates upon written request. Employers may also disclose genetic information to an occupational or other health researcher if the research is conducted according to applicable federal regulations. Employers may also disclose genetic information if compelled by court order. The rule explains that this exception does not allow disclosures in other circumstances during litigation, such as in response to discovery requests or subpoenas that are not governed by an order specifying that genetic information must be disclosed. Therefore, the rule emphasizes, an employer’s refusal to provide genetic information in response to a discovery order, subpoena, or court order that does not specify that genetic information must be disclosed is consistent with the requirements of GINA.

Yet another exception allows an employer to disclose relevant genetic information consistent with the requirements of the FMLA or similar state or local law. As an example, the rule explains that an employee’s supervisor who receives a request for FMLA leave from an employee who wants to care for a child with a serious health condition may forward this request to those who need to know the information because of responsibilities relating to the handling of FMLA requests.

Liability Under Title I and Title II of GINA

Title I of GINA, which applies generally to group health plans, prohibits discrimination in group premiums based on genetic information and the use of genetic information as a basis for determining eligibility or setting premiums, among other things. The Title II rule includes a section creating a “firewall” between GINA Titles I and II so that violations of Title I are addressed and remedied under the regulations applicable to Title I and not through Title II and other employment discrimination procedures. The new rule explains, however that employers could still face liability under Title II even if their actions involve access to health benefits, “because such benefits are within the definition of compensation, terms, conditions, or privileges of employment.” Examples of such liability include the following situations:

  • If an employer contracts with a health insurance issuer to request genetic information, the employer has committed a Title II violation. In addition, the plan and issuer may have violated Title I of GINA.
  • If an employer directs its employees to undergo mandatory genetic testing in order to be eligible for health benefits, the employer has committed a Title II violation.
  • If an employer or union amends a health plan to require an individual to undergo a genetic test, then the employer or union is liable for a violation of Title II. In addition, the health plan’s implementation of the requirement may violate Title I.

The rule emphasizes, however, that the anti-discrimination provisions in GINA do not require employers to provide employees with any specific benefits or specialized health coverage, or offer health benefits that relate to any specific genetic disease or disorder.

Practical Steps for Employers

  • Train human resources personnel, managers, recruiters about compliance with GINA.
  • Revise EEO policies to include prohibitions against discrimination based on genetic information and associated retaliation.
  • Discontinue requests to applicants and employees for family medical history except in the limited circumstances permitted in connection with a wellness or disease management program.
  • Whenever requesting or requiring an employee or medical professional to provide documentation, such as in connection with a post-offer, pre-employment medical examination, a fitness-for-duty exam or a request for a reasonable accommodation or leave, add a statement that family medical history or other genetic information should not be provided.
  • Inventory personnel records such as FMLA certifications seeking leave for the serious illness of a family member that contain genetic information about an employee, store those records in a confidential medical file, and strictly limit access to those with a need to know.
  • Implement procedures to prevent the disclosure of genetic information in response to a subpoena or civil discovery and to permit disclosure only when specifically required to comply with a court order.
     

EBSA Clarifies GINA Provisions for Insurance Providers and Group Health Plans

The Department of Labor’s Employee Benefits Security Administration (EBSA) has issued guidance in the form of Frequently Asked Questions (FAQs) that explains how the Genetic Information Nondiscrimination Act (GINA) impacts employer-provided group health plans and insurance providers. Among other things, Title I of GINA prohibits group health plans and health insurance issuers from discriminating based on genetic information, and prohibits the collection of such information, including family medical history, prior to or in connection with plan enrollment or for insurance underwriting purposes. As explained in the FAQs, unlike the provisions of Title I of the Health Insurance Portability and Accountability Act (HIPAA) that exempt very small health plans with less than two participants who are current employees, the nondiscrimination provisions of GINA apply to all group health plans.  Continue reading this entry at Littler’s Healthcare Employment Counsel.

Federal Agencies Publish Interim Final Rules Prohibiting Discrimination Based on Genetic Information in Health Insurance Coverage and Group Health Plans

The Department of Labor (DOL), Internal Revenue Service (IRS), and the Centers for Medicare and Medicaid (CMS) have published in the Federal Register interim final rules (pdf) governing Sections 101 through 103 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA). Title I of GINA amended the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHS Act), the Internal Revenue Code of 1986 (Code), and the Social Security Act (SSA) to prohibit discrimination in health coverage based on genetic information. Sections 101-103 contain provisions banning discrimination based on genetic information in health insurance coverage and group health plans. The EEOC has not yet issued final rules interpreting Title II of GINA, which prohibits discrimination in employment based on genetic information, and limits the acquisition and disclosure by employers and other entities of such information.

In general, Title I of GINA prohibits group health plans and health insurance issuers from adjusting contribution amounts or premiums for the group based on the genetic information of any plan participant, prohibits plans from requesting or requiring individuals or their family members to undergo a genetic test and from requesting, requiring or purchasing genetic information for underwriting purposes or prior to an individual's enrollment.

The interim rules, among other things, define a number of terms in GINA. The new rules explain that “genetic information,” with respect to an individual, is defined as information about the individual’s genetic tests or the genetic tests of family members, the manifestation of a disease or disorder in family members of such individual (i.e. family medical history), or any request of or receipt by the individual or family members of genetic services. The definition further clarifies that genetic information does not include information about the sex or age of any individual. In addition, the regulations explain how GINA applies to genetic information about a fetus or embryo.

The prohibitions described above, when read in conjunction with the Act’s broad definition of genetic information, impose significant limitations on employers’ requests that employees complete a health risk assessment. Under the new rules, employers may not ask an employee to complete a health risk assessment that contains questions about family history until after the effective date of coverage. After coverage goes into effect, employers cannot request completion of such an assessment if they offer any premium differential, such as a reduction in the employee’s contribution.

For purposes of Title I only, the regulations adopt the definition of “genetic test” from the statute, which defines such a test as “an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, if it detects genotypes, mutations, or chromosomal changes.” The regulations point out that this definition of “genetic test” differs from that contained in Title II of GINA, which governs genetic discrimination in employment. 

In regard to GINA’s impact on HIPPA, the Department of Health and Human Services (HHS) has also published in the Federal Register a proposed rule (pdf) interpreting Section 105 of GINA, which requires HHS to revise the HIPPA privacy regulations to clarify that genetic information is health information under the rule and prohibits the use or disclosure of genetic information for underwriting purposes. According to HHS’ proposal, the rules modify the HIPAA Privacy Rule to: (1) explicitly provide that genetic information is health information for purposes of the Rule; (2) prohibit health plans from using or disclosing protected health information that is genetic information for underwriting purposes; (3) revise the provisions relating to the Notice of Privacy Practices for health plans that perform underwriting; (4) make a number of conforming modifications to definitions and other provisions of the Rule; and (5) make technical corrections to update the definition of “health plan.”

In its commentary to the regulations, HHS pointed out that the change to the Privacy Notice would be material and, therefore, would require notification of the change to the named insured or the named plan participant. HHS requested further comment on how this notification could be accomplished in a manner that would be less burdensome and expensive than distributing a revised Privacy Notice. Employers should watch for additional guidance on this issue.

The IRS’ proposed rule (pdf) cross-references the interim rules, which prohibit using an individual’s genetic information to adjust group premium or contribution rates.

Comments on the interim final rules must be made by January 5, 2010, and can be submitted electronically through the federal eRulemaking Portal:http://www.regulations.gov, to any of the agencies involved in this rulemaking. Comments to the DOL can also be make via email: E-OHPSCA.EBSA@dol.gov. Written comments to the DOL may also be sent or hand-delivered to: Office of Health Plan Standards and Compliance Assistance, Employee Benefits Security Administration, Room N-5653, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210, Attention: RIN 1210-AB27. All comments to the DOL must include the identification number: RIN 1210-AB27.

Comments submitted to the CMS must be identified with CMS-4137-IFC, and can be sent to Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4137-IFC, P.O. Box 8017, Baltimore, MD 21244-8010. Hand-delivered comments may be brought to either 7500 Security Boulevard, Baltimore, MD 21244-1850 or Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW, Washington, DC 20201.

Comments to the IRS are to be sent to: CC:PA:LPD:PR (REG-123829-08), Room 5205, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Hand-delivery may be made to: CC:PA:LPD:PR (REG-123829-08), Courier’s Desk, Internal Revenue Service, 1111 Constitution Avenue, NW, Washington DC 20224. Comments to the IRS must be identified with: REG-123829-08.

Written comments (one original and two copies) on the HHS proposed rule must be received by December 7, 2009 at the following address: U.S. Department of Health and Human Services, Office for Civil Rights, Attention: GINA NPRM (RIN 0991-AB54), Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue, S.W., Washington, D.C. 20201. 

Philip L. Gordon contributed to this entry.
 

EEOC Issues its Spring Regulatory Agenda

Within the next six months, the Equal Employment Opportunity Commission (EEOC) expects to develop and/or issue six regulations affecting workplace laws and practices. According to the agency’s spring regulatory agenda released on Monday, regulations implementing the employment provisions of the Genetic Information Non-Discrimination Act (GINA) are expected to be issued by the end of this month. The EEOC’s proposed GINA regulations were published earlier this year.

The EEOC will also move forward with regulations regarding the equal employment provisions of the Americans With Disabilities Act Amendments Act (ADAAA).  The ADAAA, enacted in 2008, expanded the definition of “disability” under the Americans with Disabilities Act (ADA) in light of a number of Supreme Court decisions. In December 2008, the EEOC commissioners deadlocked along party lines on whether to approve former Chair Naomi Earp’s proposed regulations.  According to the EEOC’s agenda, a notice of proposed rulemaking will be issued by August of this year.

The Age Discrimination in Employment Act (ADEA) will be subject to two rules as a result of the Supreme Court’s decisions in Smith v. City of Jackson and Meacham v. Atomic Knolls Laboratory. In Smith, the Court held that an employer could defend against a disparate impact claim under the ADEA by showing that its alleged adverse employment decision was due to reasonable factors other than age. In Meacham, the Court ruled that employers bear the burden of providing this defense. The proposed regulations, therefore, address this disparate impact burden of proof under the ADEA.  Final regulations on this issue are expected by March of 2010.  In addition, the EEOC intends to publish a notice of proposed rulemaking to amend its current regulations on what constitutes “reasonable factors other than age” by August of this year.

In a more procedural vein, the EEOC intends to issue a notice of proposed rulemaking by the end of next month to make changes and corrections to the federal sector equal employment opportunity complaint process. The agency also plans to revise its race and ethnicity data collection method to make employee self-identification the preferred method for collecting such data to conform with current reporting instructions for the EEO-1 Report.

Legislative and Regulatory News for the Week of March 1

The following is a summary of the legislative and regulatory news for the week of March 1, 2009:

EFCA

The introduction of the Employee Free Choice Act may occur sooner than anticipated.

Employment Discrimination

The United States Commission on Civil Rights (USCCR) has re-opened the period for public comment on English-only policies in the workplace.  In addition, the Equal Employment Opportunity Commission (EEOC) has published its proposed rules governing the employment provisions of the Genetic Information Non-Discrimination Act (GINA).

Work-Family Balance

The Working Families Flexibility Act (H.R. 1274) was introduced.  This bill would provide employees with a statutory right to request flexible work terms and conditions.

Proposed GINA Regulations are Published

The Equal Employment Opportunity Commission (EEOC) has published in the Federal Register its proposed regulations for Title II of the Genetic Information Non-Discrimination Act (GINA). GINA – which, among other things, prohibits employment discrimination based on genetic information, bars the intentional acquisition of genetic information about applicants and employees, and imposes strict confidentiality requirements – mandates that the EEOC issue implementing regulations by May 21 of this year. Title II of GINA, which governs the employment provisions of the Act, takes effect on November 21, 2009.  Comments on the proposed regulations are due by May 1, 2009.

GINA was enacted on May 21, 2008 as Pub. L. 110-233, and codified at 42 U.S.C. 2000ff et. seq. Title I of GINA applies to group health plans sponsored by private employers, unions, and state and local government employers, among other entities. Title II prohibits genetic discrimination in the employment context, prohibiting the deliberate acquisition and disclosure of genetic information by employers. Title II also prevents employers from making adverse employment decisions based on an employee’s or applicant’s genetic information. In drafting implementing regulations for GINA, the EEOC borrowed many terms and concepts it has used for other employment anti-discrimination laws, such as the Americans with Disabilities Act (ADA) and Title VII of the Civil Rights Act.

The GINA proposed regulations are divided into 12 sections that will ultimately be codified at 29 C.F.R. § 1635. Although all areas are eligible for comment, the EEOC is seeking input in a few specific areas; particularly those the EEOC acknowledges certain terms and concepts that are unique to GINA which are outside the EEOC’s scope. In addition to consulting with the National Human Genome Research Institute, the EEOC is inviting comments regarding certain definitions particular to GINA. Of note, the definition of “genetic test” – an “analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes” – contains terms that are not common in employment discrimination law. Other terms and phrases specific to GINA over which the EEOC welcomes comment include “family member,” “family medical history,” “genetic monitoring,” “genetic services,” and “manifestation” of a genetic condition or disease.

The regulations also clarify that a test to detect the presence of a virus that is not composed of DNA, RNA, chromosomes, proteins, or metabolites does not render it a “genetic test” under the Act, nor are drug and alcohol tests. The EEOC is seeking comment on whether other types of tests should be included/excluded from the “genetic test” umbrella.

Under GINA, an employer may not “request, require, or purchase genetic information” about an applicant or employee. One of the six exceptions to this rule under the Act includes any voluntary disclosure. The EEOC therefore seeks comment about how this voluntary exception would apply to a voluntary employer-provided wellness program.

GINA also makes an exception for the purchase of commercially and publicly available material that may include a family medical history. The regulations explain, for example, that an employer would not violate GINA if it discovered an employee had the breast cancer gene by reading an article profiling individuals who knew they had that gene. The statute provides a list of media sources that may make an individual’s genetic information publicly available, such as newspapers, magazines, periodicals, and books. The regulations add to that list information obtained through electronic media, such as the Internet, television, and movies. The EEOC seeks input as to whether other types of sources should be added to this list.

The statute also includes a narrow exception for employers that engage in DNA testing for law enforcement purposes as a forensics lab or for purposes of human remains identification. Under GINA, these employers may request or require “genetic information of such employer’s employees, apprentices, or trainees, but only to the extent that such genetic information is used for analysis of DNA identification markers for quality control to detect sample contamination and maintained in a manner consistent with such use.” The EEOC thus seeks public comment on how this exception would impact law enforcement.

With respect to the protections offered under Title I of GINA, the regulations explain that if Title I offers a remedy for a special insurance-related practice or act, then that practice or act cannot be challenged and no remedy may be sought under Title II.

The regulations also emphasize that some of the employer inquiries that are deemed permissible under the ADA are now unlawful under GINA. For example, the ADA had permitted employers under certain circumstances to obtain medical information – including genetic information – from post-offer applicants. GINA, however, proscribes the solicitation of any genetic information, including family medical history, from such applicants or employees, except under very limited circumstances.

Finally, the regulations explain the interplay between GINA and other employment laws, including the ADA and the Family and Medical Leave Act (FMLA)

Comments on these proposed regulations may be sent by mail to Stephen Llewellyn, Executive Officer, Executive Secretariat, Equal Employment Opportunity Commission, 131 M Street, NE., Suite 6NE03F, Washington, DC  20507, or by facsimile (six or fewer pages only) to (202) 663-4114. Alternatively, comments may be submitted online at http://www.regulations.gov. All comment submissions must include the agency name (EEOC) and docket number or the Regulatory Information Number (RIN): 3046-AA84.

According to the EEOC, the typical human resources professional will need to dedicate, at most, three hours to gain a satisfactory understanding of the new requirements imposed under GINA. For more information on GINA, see Littler’s ASAP: Genetic Antidiscrimination Law Creates New Compliance Challenges for Employers by: Philip L. Gordon and Jennifer L. Mora.
 

Legislative and Regulatory News for the Week of February 22

The following is a summary of the legislative and regulatory news for the week of February 22, 2009:

Agency Changes

Hilda Solis was officially confirmed as the next U.S. Secretary of Labor.  President Obama has chosen Seth Harris to take the number two position at the Department of Labor (DOL).  Obama has also announced his plans to nominate John Morton to be the Assistant Secretary for Immigration and Customs Enforcement (ICE) and Janet Napolitano, Homeland Security Secretary, has named Esther Olavarria as Deputy Assistant Secretary for Policy. 

EFCA

Resident labor expert, former NLRB Chair Bob Battista, answers a series of questions employers may have regarding the Employee Free Choice Act (EFCA).  Meanwhile, Republican lawmakers in both the House and Senate have introduced bills to preserve union secret ballot elections.

Employee Benefits

The Internal Revenue Service (IRS) published its final rule regarding automatic contributions to 401(k) plans and similar types of defined contribution plans.  President Obama’s budget proposal would provide funds for the establishment of automatic workplace direct deposit for individual retirement accounts.

Employment Discrimination

The Equal Employment Opportunity Commission (EEOC) has announced that it will publish a set of proposed regulations for the employment provisions of the Genetic Information Non-Discrimination Act (GINA).  Meanwhile, the Obama administration has announced its intent to revoke the provider conscience rule.

Immigration

Although the E-Verify program was ultimately cut from the stimulus package, Congress will likely reauthorize it before it expires on March 6.  Meanwhile, the House-passed omnibus bill (H.R. 1105) would extend both E-Verify and the EB-5 visa programs until September 30.  President Obama’s budget proposal would appropriate $110 million to the Department of Homeland Security to continue E-Verify.

Labor/Management Relations

The House-passed appropriations bill (H.R. 1105) would increase funding for several domestic agencies that enforce labor and employment laws.  President Obama has unveiled his own budget proposal that would significantly increase spending for these agencies as well.
 

EEOC Announces Notice of Proposed Rulemaking for the Genetic Information Non-Discrimination Act

The Equal Employment Opportunity Commission (EEOC) announced that it will seek public comment on proposed regulations implementing the employment provisions of the Genetic Information Non-Discrimination Act (GINA). The proposed regulations are expected to be published in tomorrow’s edition of the Federal Register. Comments will be due 60 days after the publication date.

GINA – which, among other things, prohibits employment discrimination based on genetic information, bars the intentional acquisition of genetic information about applicants and employees, and imposes strict confidentiality requirements – mandates that the EEOC issue implementing regulations by May 21 of this year. Title II of GINA, which governs the employment provisions of the Act, takes effect on November 21, 2009.

For more information on GINA, see Littler’s ASAP: Genetic Antidiscrimination Law Creates New Compliance Challenges for Employers by: Philip L. Gordon and Jennifer L. Mora.