New GINA Genetic Information Based Employment Discrimination & Confidentiality Mandates Take Effect


Updated Employment Poster, Policies & Procedures Required Immediately

Employers, unions, employment agencies, employment training agencies and their agents face significant new employment discrimination liability risks if they violate new genetic information-based employment non-discrimination or fail to comply with genetic information confidentiality requirements that took effect under Title II of the Genetic Information Nondiscrimination Act (GINA) on Saturday, November 21, 2009.  Employers need immediately to update their employment posters, carefully audit their existing records and practices to identify existing information and practices that may create special risks under GINA and take appropriate action to comply with the GINA rules. Employers needing an updated poster can find a copy on the Equal Employment Opportunity Commission website here.

Under the newly effective employment provisions of Title II of GINA, Federal law now prohibits employers of 15 or more employees and certain other entities from using individuals’ “genetic information” when making hiring, firing, job placement, or promotion decisions, requires “genetic information” be kept separately and confidential, and prohibits retaliation. 

When assessing their risk under GINA, employers should be careful not to overlook or underestimate the genetic information collected or possessed by their organizations and the risks attendant to this information.  Many employers will be surprised by the breadth of the depth of “genetic information.”   GINA defines “genetic information” broadly as including not only information about genetic tests about an individual or his family member as well as information about the “manifestation of a disease or disorder in family members of such individual.   GINA also specifies that any reference to genetic information concerning an individual or family member includes genetic information of a fetus carried by a pregnant woman and an embryo legally held by an individual or family member utilizing an assisted reproductive technology.  Pending issuance of regulatory guidance, GINA’s inclusion of information about the “manifestation of a disease or disorder in family members” is likely to present a liability trap door for many unsuspecting employers.

Failing to properly address GINA compliance could expose employers to substantial risk.  Violation of the employment provisions of Title II subjects an employer to potentially significant civil judgments like those that generally are available for race, sex, and other federal employment discrimination claims covered by the Civil Rights Act.  Accordingly, employers and others who have not already done so should act quickly to review and update their policies and procedures to manage their new compliance and liability exposures under GINA Title II.

While the agency responsible for construing and enforcing Title II of GINA, the Equal Employment Opportunity Commission (EEOC), to date has published only limited guidance about it, the absence of this final guidance should not be read by employers as a sign their compliance may be delayed.  While not yet issued in final form, proposed regulations interpreting Title II of GINA accessible here published by the EEOC in March, 2009  and a subsequently released factsheet accessible here published by the EEOC in May, 2009 titled “Background Information for EEOC Notice of Proposed Rulemaking On Title II of the Genetic Information Nondiscrimination Act of 2008” provide insights about how the EEOC may be expected to view its provisions.   While many employers have delayed taking action to update their policies and procedures in hopes that final guidance would be forthcoming before Title II took effect, time has now run out.  Accordingly, employers who have not already done so should act quickly to implement all necessary changes to position themselves to defend against a potential claim that their organization may have violated GINA Title II. 

Employment-Related Genetic Information Nondiscrimination Rules In Focus

Applicable to employers, unions, employment agencies, employment training agencies and their agencies based on genetic information by employers, Title II imposes sweeping prohibitions against employment discrimination based on genetic information.  Title II generally has three components:

Employment Discrimination Prohibited.  Section 202 of GINA makes it illegal for an employer:

  • To fail or refuse to hire, or to discharge, any employee, or otherwise to discriminate against any employee with respect to the compensation, terms, conditions, or privileges of employment of the employee, because of genetic information with respect to the employee;
  • To limit, segregate, or classify the employees of the employer in any way that would deprive or tend to deprive any employee of employment opportunities or otherwise adversely affect the status of the employee as an employee, because of genetic information with respect to the employee; or
  • To request, require, or purchase genetic information with respect to an employee or a family member of the employee except as specifically permitted by GINA and otherwise applicable law.

GINA §§ 203 and 204 extend similar prohibitions to employment agencies, labor unions and training programs.

Confidentiality Mandates. Under GINA § 206, an employer, employment agency, labor organization, or joint labor-management committee that possesses genetic information about an employee or member must protect the confidentiality of that information.  Under its provisions, employers and other covered entities must:

  •  Treat the genetic information as a confidential medical record of the employee or member and maintain it on separate forms and in separate medical files in the same manner as required for other medical records required to be maintained as confidential by Americans With Disabilities Act § 102(d)(3)(B); and
  • Only disclose it in the narrow circumstances specifically allowed by GINA.

Anti-Retaliation.  GINA also prohibits retaliation or other discrimination against any individual because such individual has opposed any act or practice prohibited by GINA, for making a charge, testifying or assisting or participating in any manner in an investigation, proceeding, or hearing under GINA. 

GINA’s Additional Group Health Plan Nondiscrimination & Privacy Rules Also Require Attention

In addition to taking appropriate steps to comply with the employment rules of Title II of GINA, employers and their group health plan fiduciaries and service providers also should ensure that the group health plan has been appropriately updated to comply with the group health plan nondiscrimination and privacy mandates of Title I of GINA. 

Effective for all group health plan years beginning on or after May 21, 2009, GINA’s new restrictions on the collection and use of genetic information by group health plans added under Title I of GINA are accomplished through the expansion of a series of already existing group health plan nondiscrimination and privacy rules.  GINA’s group health plan provisions amend and expand the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Employee Retirement Income Security Act of 1974 (ERISA), Title VII of the Civil Rights Act, the Public Health Service Act, the Internal Revenue Code of 1986, and Title XVIII (Medicare) of the Social Security Act to implement sweeping new federal restrictions on the collection, use, and disclosure of information that falls within its broad definition of “genetic information” by  group health plans.  For individual health insurers, GINA’s restrictions take effect May 22, 2009.  The broad definition of the term “genetic information” in GINA will require group health plan sponsors and insurers to carefully review and update their group health plan documents, communications, policies and practices to comply with forthcoming implementing regulations to avoid liability under new GINA’s rules governing genetic information collection, use, protection and disclosure in a series of areas.  

In this respect, wellness and disease management programs are likely to require special scrutiny and attention. GINA’s inclusion of information about the “manifestation of a disease or disorder in family members” raises potential challenges for a broad range of group health plan health assessment and other wellness and disease management programs which provide financial incentives or condition eligibility on the provision of family health histories or other information that could be construed as genetic information.  The implications of these GINA prohibitions are further complicated by recent changes in the disability nondiscrimination rules and guidance under the Americans With Disabilities Act.

Title I of GINA generally prohibits group health plans from collecting genetic information for underwriting or eligibility purposes.  It also expands already existing federal rules prohibiting group health plans from discriminating among individuals for purposes of determining eligibility or setting premiums based on health status previously enacted as part of HIPAA.   These existing rules already prohibit group health plans and health insurance issuers from discriminating based on health related factors including genetic information for purposes of determining eligibility or premiums. GINA expands these existing nondiscrimination requirements to further regulate group health plan’s use and collection of genetic information.   Under GINA’s nondiscrimination rules, group health plans and health insurers may not:

  • Request, require or purchase genetic information for underwriting purposes or in advance of an individual’s enrollment;
  • Adjust premiums or contribution amounts of the group based on genetic information;
  • Request or require an individual or family member to undergo a genetic test except in limited situations specifically allowed by GINA;
  • Impose a preexisting condition exclusion based solely on genetic information, in the absence of a diagnosis of a condition;
  • Discriminate against individuals in eligibility and continued eligibility for benefits based on genetic information; or
  • Discriminate against individuals in premium or contribution rates under the plan or coverage based on genetic information, although such a plan or issuer may adjust premium rates for an employer based on the manifestation of a disease or disorder of an individual enrolled in the plan.

GINA also prohibits insurers providing individual health insurance from establishing rules for eligibility, adjusting premiums or contribution amounts for an individual, imposing preexisting condition exclusions based on, requesting or requiring individuals or family members to undergo genetic testing.

Of particular concern to many plan sponsors and fiduciaries are the potential implications of these new rules on existing wellness and disease management features group health plans. Of particular concern is how regulators will treat the collection of family medical history and certain other information as part of health risk assessments used in connection with these programs. Although official guidance is still pending, many are concerned that regulators will construe certain commonly used practices of requiring covered persons to provide family medical histories or other genetic information through health risk assessments (HRAs) to qualify for certain financial incentives as a prohibited underwriting practice under GINA.  Even where health risk assessments are not used, however, most group health plan sponsors should anticipate that GINA will require specific amendments to their plan documents, communications and processes.

Taking timely action to comply with these nondiscrimination and collection prohibitions is important.  Under amendments to ERISA made by GINA, group health plan noncompliance can create significant liability for both the plan and its sponsor.  Participants or beneficiaries will be able to sue noncompliant group health plans for damages and equitable relief.  If the participant or beneficiary can show an alleged violation would result in irreparable harm to the individual’s health, the participant or beneficiary may not have to exhaust certain otherwise applicable Department of Labor administrative remedies before bringing suit.  In addition to these private remedies, GINA also authorizes the imposition of penalties against employers and other sponsors of group health plans that violate applicable requirements of GINA of up to $500,000. The minimum penalties generally are set at the greater of $100 per day or a minimum penalty amount ranging from $2,500 for de minimus violations corrected before the health plan received notice of noncompliance to $15,000 in cases in which the violations are more than de minimus.  GINA also includes language allowing the Secretary of Labor to reduce otherwise applicable penalties for violations that could not have been identified through the exercise of due diligence or when the plan corrects the violation quickly.

GINA Amendments To Health Plan Privacy Rules Under HIPAA

In addition to its nondiscrimination rules, GINA also amends HIPAA to make clear that “genetic information” as defined by HIPAA is protected health information protected by HIPAA’s Privacy & Security Standards of HIPAA. This means that it will require that all genetic information be treated as protected health information subject to the Privacy and Security Standards applicable to group health plans covered by HIPAA. Although the statutory provisions that accomplish these changes are deceptively simple, compliance with these requirements likely will require group health plans and their business associates to amend existing privacy policies, notices and practices to appropriately restrict disclosures for underwriting, operations and certain other uses to withstand scrutiny under the GINA privacy rule amendments. 

When contemplating these changes, many plan sponsors and administrators also will want to consider and begin preparing to comply with other refinements to their existing privacy and security practices required in response to HIPAA privacy and security rule amendments enacted as part of the HITECH Act provisions of the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”) provisions of the American Recovery and Reinvestment Act of 2009 (ARRA).  As GINA specifies that violations of its privacy rule restrictions trigger the same sanctions as other privacy rule violations, group health plans and their business associates also should give due consideration to these penalty exposures.  The HITECH Act amended and increased civil penalties for HIPAA privacy violations in many circumstances effective February 17, 2009.  

GINA’s fractured assignment of responsibility and authority to develop, implement and enforce regulatory guidance of its genetic information rules can create confusion for parties involved in compliance efforts. Because the group health plan requirements of Title I of GINA are refinements to the group health plan privacy and nondiscrimination rules previously enacted as part of HIPAA, GINA specifically assigned authority to construe and enforce its group health plan requirements to the agencies responsible for the interpretation and enforcement of those original rules:  (1) the Department of Labor Employee Benefit Security Administration (EBSA); (2)  the Internal Revenue Services (IRS), and (3) the Department of Health & Human Services. 

These three agencies in early October published the interim final regulations construing the group health plan manatees of Title II of GINA, which are available for review here.  Group health plans, their employer and other sponsors, fiduciaries and service providers should act quickly to review and update their group health plan documents, procedures and other materials to comply with these new mandates.

Cynthia Marcotte Stamer and other members of Curran Tomko and Tarski LLP are experienced with advising and assisting employers with these and other labor and employment, employee benefit, compensation, and internal controls matters. If your organization needs assistance with assessing, managing or defending these or other labor and employment, compensation or benefit practices, please contact the author of this article, Curran Tomko Tarski LLP Labor & Employment Practice Group Chair Cynthia Marcotte Stamer.  Board Certified in Labor & Employment Law by the Texas Board of Legal Specialization and Chair of the American Bar Association RPTE Employee Benefits & Other Compensation Group and a nationally recognized author and speaker, Ms. Stamer is experienced with assisting employers and others about compliance with federal and state equal employment opportunity, compensation, health and other employee benefit, workplace safety, and other labor and employment laws, as well as advising and defending employers and others against tax, employment discrimination and other labor and employment, and other related audits, investigations and litigation, charges, audits, claims and investigations by the IRS, Department of Labor and other federal and state regulators. Ms. Stamer has advised and represented employers on these and other labor and employment, compensation, health and other employee benefit and other personnel and staffing matters for more than 22 years. Ms. Stamer also speaks and writes extensively on these and other related matters. For additional information about Ms. Stamer and her experience or to access other publications by Ms. Stamer see here or contact Ms. Stamer directly.   For additional information about the experience and services of Ms. Stamer and other members of the Curran Tomko Tarksi LLP team, see here.

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©2009 Cynthia Marcotte Stamer. All rights reserved. 

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