GINA Discussion Topic At February HHS Advisory Committee on Genetics, Health & Society Meeting G

December 16, 2009

By Cynthia Marcotte Stamer

Employers are facing new headaches and liabilities under new federal genetic information nondiscrimination and privacy rules for employers and health plans enacted under the Genetic Information Nondiscrimination Act. GINA’s genetic information nondiscrimination and confidentiality rules for employers became effective on November 21, 2009.  Its separate genetic information nondiscrimination and privacy mandates for group health plans generally apply to post May 20, 2009 plan years.  Employer and health plan efforts to comply with these mandates has been complicated both by the challenges they create for certain wellness, disease management, environmental safety and other obligations, and the absence of final regulations.

With the compliance deadline now passed, many employers and health plans now are struggling to maintain viable wellness, safety and disease management programs within the allowable parameters of GINA and the newly tightened disability discrimination requirements of the Americans With Disabilities Act.  In the face of these challenges, many employers are arguing that these regulations should be revised in order to allow and encourage employers and their health plans to provide beneficial disease management, wellness and safety programs made too risky by the current regulatory structure. 

The Department of Health & Human Services (HHS) plans to hold a public meeting of the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) of the U.S. Public Health Service on February 4-5, 2009.  As part of the planned agenda, SACGHS will get an update from Federal agencies on activities related to the implementation of the Genetic Information Nondiscrimination Act, the coverage and reimbursement of genetic tests, the oversight of genetic testing, and the retention and use of residual dried blood spot specimens after newborn screening. The meeting will offer the opportunity for members of the public to attend the meeting on a space available basis or to view a Webcast.

The SACGHS  meeting will be held from 8:30 a.m. to approximately 5:30 p.m. on Thursday, February 4, 2010, and from 8 a.m. to approximately 3 p.m. on Friday, February 5, 2010, at the Omni Shoreham Hotel, 2500 Calvert Street, NW., Washington, DC 20008.

Other announced agenda items include:

  • The review of a revised report on gene patents and licensing practices;
  • The review of a public consultation draft report on genetics education and training;
  • An information-gathering session on the mechanisms and policies related to genomic data sharing;
  • A preliminary discussion to help plan a future session on implications of an affordable genome;
  • A report on activities of the Clinical Utility and Comparative Effectiveness Task Force; and
  • Updates from Federal agencies on activities related to the implementation of the Genetic Information Nondiscrimination Act, the coverage and reimbursement of genetic tests, the oversight of genetic testing, and the retention and use of residual dried blood spot specimens after newborn screening.

For more information about registration for the meeting, submission of comments and other details, here.

If you have questions about or need assistance evaluating, commenting on or responding to the  GINA, or other employment, health or other employee benefit, workplace health and safety, corporate ethics and compliance or other concerns or claims, 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, Ms. Stamer is experienced with assisting employers and others about compliance with federal and state equal employment opportunity, compensation and employee benefit, workplace safety, and other labor and employment, 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, employee benefit and other personnel and staffing matters for more than 20 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.


May 13, 2009

Recent concerns over the H1N1 Swine Flu (swine flu) pandemic and warnings of a possible resurgence of the swine flu pandemic or some other pandemic in the future is forcing many employers to question when concerns that an employee suffers from a contagious disease can justify the employer making inquires about the health of an employee or the exclusion of the employee from the workplace. New guidance set forth in the “U.S. Equal Employment Opportunity Commission ADA-Compliant Employer Preparedness For the H1N1 Flu Virus” (Guidance) published by the U.S. Department of Labor Equal Employment Opportunity Commission (EEOC) on May 4, 2009 provides some insights for employers about the EEOC’s perspective on these questions. 

The Guidance details the EEOC’s answers to certain basic questions about when the EEOC views certain workplace preparation strategies for responding to the 2009 flu virus as compliant with the Americans with Disabilities Act (ADA).  Employers considering updates to their current pandemic and infectious disease response plans are cautioned that in addition to potential ADA exposures, practices for periods after November 21, 2009 also generally must be tailored to comply with new restrictions on employer’s collection of and discrimination based on genetic information based on the Genetic Information Nondiscrimination Act of 2008 (GINA).  Proposed regulations interpreting the employment provisions of GINA published by the EEOC in March 2009 do not specifically address the implications of GINA on employer planning or response to pandemic concerns.

ADA Concerns Apply To Employers  Planning For & Applying Swine Flu Response 

Title I of the Americans with Disabilities Act (ADA) protects applicants and employees from disability discrimination. Among other things, the ADA regulates when and how employers may require a medical examination or request disability-related information from applicants and employees, regardless of whether the individual has a disability.  The Guidance confirms that the EEOC views this requirement as affecting when and how employers may request health information from applicants and employees regarding H1N1 flu virus.  

Effective January 1, 2009, Congress amended the Americans with Disabilities Act pursuant to the Americans with Disabilities Act Amendments Act of 2008 (ADAAA) to change the way that the ADA’s statutory definition of the term “disability” historically has been interpreted by certain courts.  The ADAAA amendments generally are intended and expected to make it easier for certain individuals to qualify as disabled under the ADA.  While the Guidance announces that the EEOC intends to revise its ADA regulations to reflect the broader group of persons protected as disabled under the ADAAA amendments, it also indicates that the EEOC does not perceive that the ADAAA changes the actions prohibited by the ADA as they relate to common pandemic planning and response activities.  Consequently, the Guidance states that the EEOC views the  guidance in “Disability-Related Inquiries & Medical Examinations of Employees Under the ADA” published by the EEOC in 2000 and its “Enforcement Guidance: Preemployment Disability-Related Questions & Medical Examinations” published in 1995 as setting forth the governing rules for medical testing, inquires and other pandemic response planning under the ADA.

Under the ADA, an employer’s ability to make disability-related inquiries or require medical examinations is analyzed in three stages: pre-offer, post-offer, and employment.

  • At the first stage (prior to an offer of employment), the ADA prohibits all disability-related inquiries and medical examinations, even if they are related to the job.
  • At the second stage (after an applicant is given a conditional job offer, but before s/he starts work), an employer may make disability-related inquiries and conduct medical examinations, regardless of whether they are related to the job, as long as it does so for all entering employees in the same job category.
  • At the third stage (after employment begins), an employer may make disability-related inquiries and require medical examinations only if they are job-related and consistent with business necessity.
  • The ADA requires employers to treat any medical information obtained from a disability-related inquiry or medical examination (including medical information from voluntary health or wellness programs), as well as any medical information voluntarily disclosed by an employee, as a confidential medical record. Employers may share such information only in limited circumstances with supervisors, managers, first aid and safety personnel, and government officials investigating compliance with the ADA.

Employers deviating from these requirements when administering their pandemic planning or response risk disability discrimination liability under the ADA unless they otherwise can defend their action under one of the exceptions to the ADA’s disability discrimination prohibitions.  When making post-offer inquiries or requiring post offer examinations or imposing other conditions for safety reasons, the Guidance and EEOC in unofficial discussions have emphasized the importance of the employer’s ability to demonstrate the job or safety relevance of the medical inquiry or examination based on credible scientific evidence such as the latest scientific evidence available from the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC). 

Other than emphasizing the importance of acting appropriately in response to credible scientific evidence and pointing to preexisting guidance, the Guidance does not extensively address with specificity the circumstances under which the EEOC will view any particular action taken by an employer as defensible under the safety or other exceptions of the ADA.  Likewise, the Guidance does not discuss in any details the conditions, if any, under which the EEOC would view suffering, a history of suffering or association with or exposure to swine flu as qualifying an individual as disabled or perceived to be disabled for purposes of the ADA.  Consequently, employer must rely on other less specifically tailored guidance for purposes of assessing the defensibility of a proposed action on these grounds.

Planning for Absenteeism Under ADA

When planning for a possible pandemic, employers must be careful about when and how they ask employees about factors, including chronic medical conditions that may cause them to miss work in the event of a pandemic.  According to the Guidance, an employer may survey its workforce to gather personal information needed for pandemic preparation if the employer asks broad questions that are not limited to disability-related inquiries.  An inquiry would not be disability-related if it identified non-medical reasons for absence during a pandemic (e.g., mandatory school closures or curtailed public transportation) on an equal footing with medical reasons (e.g., chronic illnesses that weaken immunity). The Guidance includes a sample of what the EEOC views as ADA-compliant survey that could be given to all employees before a pandemic.

The Guidance also indicates that where appropriate safeguards are applied to comply with the ADA, it also may be appropriate for an employer under certain limited circumstances, to require entering employees to have a medical test post-offer to determine their exposure to the influenza virus.  According to the EEOC, the ADA permits an employer to require entering employees to undergo a job relevant medical examination after making a conditional offer of employment but before the individual starts work, if all entering employees in the same job category must undergo such an examination.  Thus, the Guidance reflects that the requirement by an employer as part of its pandemic influenza preparedness plan that all entering employees in the same job categories undergo the same post offer medical testing for the virus in accordance with recommendations by the WHO and the CDC in response to a new influenza virus may be ADA-compliant.

Infection Control in the Workplace Under the ADA

The Guidance also discusses the EEOC’s perceptions about the ADA implications of employer use of certain infection control practices in the workplace during a pandemic provided that the requirements are applied in a nondiscriminatory fashion consistent with the ADA.  For instance, the Guidance states that employers generally may apply with following infection control practices without implicating the ADA:

  • Require all employees to comply with certain infection control practices, such as regular hand washing, coughing and sneezing etiquette, and tissue usage and disposal without implicating the ADA;
  • May require employees to wear personal protective equipment provided that where an employee with a disability needs a related reasonable accommodation under the ADA (e.g., non-latex gloves, or gowns designed for individuals who use wheelchairs), employer provides these accommodations absent undue hardship;
  • Encourage or require employees to telework as an infection-control strategy, based on timely information from public health authorities about pandemic conditions or offer telework as a possible reasonable accommodation.  

In all cases, of course, the Guidance cautions that employers must not single out employees either to telework or to continue reporting to the workplace on a basis prohibited by the ADA or any of the other federal Equal Employment Opportunity laws.

Impending GINA Rules

 As signed into law, GINA amends Title VII of the Civil Rights Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Employee Retirement Income Security Act of 1974 (ERISA), 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  “genetic information” by employers, employment agencies, labor organizations, joint labor-management committees, group health plans and insurers and their agents.  GINA’s group health plan restrictions are scheduled to take effect May 21, 2009.  The employment related genetic testing rules of GINA take affect November 21, 2009.  Employers and other covered entities will need to carefully review and timely update their pandemic and other infectious disease response practices as well as their group health plan, family leave, disability accommodation, and other existing policies in light of these new federal rules.

Although EEOC has not finalized its implementing regulations for GINA yet, employers should anticipate that GINA will impact their pandemic and other related practices.  The implications of GINA for employers and other entities covered by its provisions because of its broad definition of genetic information. 

Under GINA, “genetic information” is defined to mean with respect to any individual, information about:

  • Such individual’s genetic tests;
  • The genetic tests of family members of such individual; and
  • 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 final regulatory guidance, Gina’s inclusion of information about the “manifestation of a disease or disorder in family members” raises potential challenges for a broad range of wellness and safety, leave, and other employment and benefit practices, particularly as apparently will reach a broader range of conditions than those currently protected under the disability discrimination prohibitions of the Americans With Disabilities Act (“ADA”).  

Depending on the contemplated inquiry or practice, certain inquiries or actions intended for use as part of an employer’s pandemic preparedness or response activities could fall within the scope of GINA’s protections. For this reason, employers also should consider the potential treatment of a proposed pandemic preparation or response activity intended to be applied after GINA takes effect in light of GINA.  Additionally, employers also should consider the risk that information collected under existing or previously applied pandemic or other infectious disease prevention and response activities might qualify for additional protection when GINA takes effect in November, 2009.

Other Resources

Businesses, health care providers, schools, government agencies and others concerned about preparing to cope with pandemic or other infectious disease challenges also may want to review the following resources authored by Curran Tomko Tarski LLP partner Cynthia Marcotte Stamer:

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 its wage and hour or other labor and employment, compensation or benefit practices, please contact Ms. Stamer at, (214) 270-2402; or your favorite Curran Tomko Tarski, LLP attorney.  For additional information about the experience and services of Ms. Stamer and other members of the Curran Tomko Tarksi, LLP team, see the