More Practical Advice on the New GINA Regulations

Last month we posted on the EEOC’s GINA regulations and discussed the inadvertent disclosure exception and family medical history. This post follows up by discussing the impact of the regulations on FMLA certifications and by providing some recommended affirmative steps employers should take now.

As we discussed last month, the regulations recognize that employers may inadvertently obtain genetic information when they request that health care providers complete certification forms to support a leave under the Family and Medical Leave Act (“FMLA”) or an accommodation under the Americans with Disabilities Act (“ADA”). The regulations, however, create a “safe harbor” for employers who use the following language when requesting medical information to certify an employee’s own serious health condition under the FMLA:
 

The Genetic Information Nondisclosure Act of 2008 (GINA) prohibits employers and other entities covered by GINA Title II from requesting or requiring genetic information of an individual or family member of the individual, except as specifically allowed by this law. To comply with this law, we are asking that you not provide any genetic information when responding to this request for medical information. ‘Genetic Information’ as defined by GINA, includes an individual’s family medical history, the results of an individual’s or family member’s genetic tests, the fact that an individual or an individual’s family member sought or received genetic services, and genetic information of a fetus carried by an individual or an individual’s family member or an embryo lawfully held by an individual or family member receiving assistive reproductive services.

Employers should not use the “safe harbor” language when they are requesting information to certify a family member’s serious health condition, as opposed to the employee’s own serious health condition. GINA includes an additional exception that allows employers to ask for “family medical history” when seeking certification of a family member’s serious health condition.

In light of the new GINA regulations, employers should take affirmative steps to reduce the risk of inadvertently obtaining genetic information about their employees, including the following:

  • Update FMLA certification forms to include “safe harbor” language, when appropriate.
  • Include “safe harbor” language on other requests for medical information, such as requests for documentation of an employee’s need for an accommodation and fitness-for- duty certification.
  • Inform health care providers not to gather family medical history or other genetic information during fitness-for-duty examinations or during medical examinations to certify an individual’s ability to perform his or her job.
  • Educate HR personnel, managers and supervisors about what constitutes protected genetic information and how to avoid making inadvertent requests for such information.
  • Ensure that internal policies and procedures comply with the new GINA regulations.
  • Review workplace “wellness programs” to ensure that the health assessment and other forms do not require the disclosure of genetic information without the employee’s prior voluntary, knowing, and written authorization.
  • Post the new EEO poster which contains added information about GINA.
  • Ensure that the genetic information, like medical information, is maintained in a confidential file, separate from the employee’s personnel file.
     

GINA and Family Medical History: A Summary of Practical Concerns for Employers

GINA, the Genetic Information Nondiscrimination Act, took effect more than a year ago. Last month, the EEOC issued final regulations on GINA, as well as question and answer guidance on what the regulations mean for employers. The regulations are effective January 10, 2011. Most employers will not deliberately seek specific genetic information about employees or applicants and will not ever have to worry about many aspects of GINA. Because, however, GINA defines the term “genetic information” to include family medical history, the statute and regulations do raise some practical concerns for many employers who may end up with such information unintentionally. This post discusses those practical concerns.

What Does Gina Prohibit?

GINA was passed out of concern that employers might obtain information about an individual’s genetic predisposition toward certain medical conditions and use that information to weed out individuals who might create a future risk of increased costs based on potential disease. GINA prohibits an employer from discriminating in any term or condition of employment based on an employee’s or applicant’s “genetic information.” It also prohibits an employer (with narrow exceptions) from requesting, requiring or purchasing genetic information.

Practical Concerns: Family Medical History

Some of you reading this are no doubt thinking that you need not worry about GINA because your organization never asks employees for their genetic information. Even if your organization does not do so, you still have to be concerned about GINA. The term “genetic information” includes an employee’s or applicant’s family medical history (and several other types of information). The idea is that if an employer knows an employee’s mother died from breast cancer, it will believe the employee is likely to contract breast cancer at some point, and will act on that assumption to the employee’s detriment. And employers are very likely at some point to come into possession of information about employees’ family medical history, either through an otherwise legitimate request for employee medical information or through happenstance. GINA’s regulations deal with both situations.

The “Water Cooler” Exception

Both the statute and the regulations contain an exception to the ban on obtaining genetic information when the information is obtained inadvertently. This so called ‘water cooler” exception was designed to cover a supervisor who accidentally comes into possession of information about family medical history, for example, when she overhears an employee talking about family medical history. The exception also applies, however, when a supervisor receives information about family medical history in response to a general question about the well being of an employee or an employee’s family member, for example, in response to questions like, “how are you?” or “how’s your daughter?” The inadvertent acquisition exception also applies to information obtained through social media, for example where a supervisor and employee are connected on a social networking site and the supervisor thereby obtains information about family medical history posted on the site by the employee.

Legitimate Requests for Employee Medical Information

Employers may also come into possession of family medical history when an employee’s health care provider sends the information to the employer in connection with an entirely legitimate employer request for employee medical information. The inadvertent disclosure rules can also apply to information obtained in this fashion, but employers should take special precautions. The regulations state that when an employer makes a lawful request for employee health information (for example to support an employee request for an ADA reasonable accommodation, or to support a claim for sick leave) the employer should warn the employee and/or the health care provider not to provide genetic information, including family medical history. The regulations contain suggested language for the warning. The warning should be in writing, but may be oral if the employer does not typically make requests for employee medical information in writing. Failure to provide the warning does not mean that the employer has violated GINA, but, if the employer receives family medical history in response, it will be required to show that it did not make the request in a way that was likely to result in the employer obtaining family medical history or other genetic information. Because the employer will have that burden if it does not provide the required warning, it is prudent to use the recommended warning language.

An employer may also come into possession of information about family medical history when it obtains the results of a post-offer medical examination or a fitness-for-duty examination. GINA prohibits an employer from requesting family medical history in connection with such an examination. Moreover, the regulations require an employer to give a written warning not to provide such information to the health care provider conducting the examination. If the health care provider gives the employer such information anyway, the employer is required to take reasonable steps to ensure it does not happen again.

FMLA Leave to Care for a Sick Family Member

The regulations permit an employer to receive family medical history information when the employee has requested FMLA leave to care for a family member with a serious health condition, and the employer seeks substantiation of the need for leave.

Confidentiality Obligations

If an employer does come into possession of family medical history information, it must keep that information confidential, and may only disclose it under limited circumstances. While the information cannot be maintained in the employee’s personnel file, it may be stored in an employee’s separate ADA file.
 

Procedures Should Be Implemented To Comply With New Self-Reporting And Excise Tax Payment Requirements For Certain Health Plan Violations

Starting January 1, 2010, employers and certain other entities that administer group health plans will be required, for the first time, to report on an Internal Revenue Service ("IRS") form certain types of group health plan violations and pay the applicable excise taxes. Violations that must be reported include a failure to satisfy health coverage continuation requirements under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended ("COBRA"), certain requirements under the Health Insurance Portability and Accountability Act ("HIPAA"), certain mental health benefit parity requirements, childbirth hospital stay requirements, and certain health coverage continuation requirements for seriously ill higher education students. Administrators of group health plans were not required to self-report such violations when they were discovered, and the lack of such self-reporting often resulted in any applicable excise taxes not being paid. The IRS has issued regulations that will require such violations to be self-reported, and will require any applicable excise taxes to be paid in a timely manner.


Steps that should be implemented by employers to comply with these new requirements include:

making sure that employees or other persons who are involved in the administration of each applicable group health plan are informed about these new requirements;

implementing procedures that will help ensure the timely discovery of applicable group health plan violations, the timely submission of the IRS form reporting such violations, and the timely payment of all applicable excise taxes; and

to the extent an employer's group health plan is administered by another entity (e.g., a third party administrator, an insurance company or a health maintenance organization), reviewing any agreement with such entity to see if any changes are needed to help ensure compliance with these new requirements.

 

Taxpayers Required To Comply With These New Requirements

The new self-reporting and excise tax payment requirements for certain group health plan violations generally apply to: (1) employers who sponsor a group health plan that is subject to the requirements described in the following paragraph ("Covered Health Plan"); (2) unions and other employee organizations who sponsor a Covered Health Plan; (3) third party administrators of Covered Health Plans (e.g., a third party administrator of a self-insured Covered Health Plan); and (4) certain other third parties who are responsible for providing benefits under a Covered Health Plan (e.g., insurance companies or health maintenance organizations).

Types of Violations That Are Covered By These New Requirements

Violations that must be reported include a failure to comply with the following requirements:


COBRA Health Coverage Continuation Requirements -- Group health plans that are subject to COBRA are required to comply with certain coverage continuation requirements.

HIPAA Preexisting Condition, Creditable Coverage and Special Enrollment Requirements -- Group health plans that are subject to HIPAA are required to, among other things, comply with limitations on preexisting exclusions, certification of creditable coverage requirements, and special enrollment requirements.

HIPAA Nondiscrimination Requirements Based on Health Status Factors -- Group health plans that are subject to HIPAA are not allowed to discriminate based on a health status factor.

Genetic Information Nondiscrimination Requirement -- The Genetic Information Nondiscrimination Act ("GINA") prohibits, among other things, discrimination based on genetic information.

Mental Health Parity Requirements -- The Mental Health Parity and Addiction Equity Act imposes certain parity requirements between mental health benefits and medical/surgical benefits.

Childbirth Hospital Stay Requirements -- The Newborns' and Mothers' Health Protection Act imposes requirements regarding minimum hospital lengths of stay in connection with childbirth.

Health Coverage Continuation Requirements for Seriously Ill Higher Education Students -- Michelle's Law imposes certain health coverage continuation requirements for dependent university and college students with serious medical conditions.

Comparable Contribution Requirements for Health Savings Accounts and Medical Savings Accounts -- Health savings accounts ("HSAs") and Archer medical savings accounts ("MSAs") are subject to requirements that help ensure that comparable contributions are made for nonhighly compensated employees.

Excise Taxes That Apply To Such Violations

The applicable excise taxes vary depending upon the type of violation involved. An excise tax of $100 a day per affected beneficiary generally applies to a violation of the COBRA health coverage continuation requirements. An excise tax of $100 a day per affected individual generally applies to violations of: (1) HIPAA's preexisting condition, creditable coverage, and special enrollment requirements; (2) HIPAA's nondiscrimination requirements based on health status factors; (3) GINA's genetic information nondiscrimination requirement; (4) the mental health parity requirements; (5) the childbirth hospital stay requirements; and (6) the health coverage continuation requirements for seriously ill higher education students. A violation of the comparable contribution requirements for HSAs and MSAs generally will be subject to an excise tax of 35 percent of the aggregate amount contributed to the HSAs or MSAs for all employees within the applicable calendar year.

IRS Form That Must be Filed If a Violation Occurs

If a violation of one of the requirements described above occurs, the applicable employer generally will be required to report that violation on IRS Form 8928 and will be required to pay the applicable excise taxes. If a COBRA health coverage continuation requirement is involved, the applicable third party administrator or insurer could be responsible for filing Form 8928 and paying the applicable excise taxes. If a violation occurs with respect to a multiemployer plan, the plan will be responsible for filing Form 8928 and paying the applicable excise taxes.

Deadline For Filing the Required IRS Form and Paying the Applicable Excise Taxes

For all violations described above other than a violation of the comparable contribution requirements for HSAs and MSAs, a Form 8928 generally must be filed and the applicable excise tax generally must be paid by the due date for filing the federal income tax return for the applicable taxpayer. If a violation of the comparable contribution requirements for HSAs and MSAs occurs, a Form 8928 generally must be filed and the applicable excise tax generally must be paid by April 15th of the calendar year that follows the calendar year in which the violation occurred. Special requirements apply with respect to extensions, multiemployer plans, and multiple employer plans.

Exceptions To the Excise Tax Requirements

With respect to all violations described above other than a violation of the comparable contribution requirements for HSAs and MSAs, exceptions to the excise taxes apply:

if the responsible party did not know, and would not have known even if reasonable diligence had been exercised, that the violation existed; or

if the violation was due to reasonable cause and not willful neglect, and was corrected within 30 days after the first day the responsible party knew, or exercising due diligence, would have known that the violation had occurred (the violation will be considered corrected if the violation is retroactively undone to the extent reasonably possible and the affected individual is put in a financial position as beneficial as the individual would have been in had the violation not occurred).

If a violation of the comparable contribution requirements for HSAs and MSAs occurs, the IRS can waive the excise tax if it is excessive and the failure is due to reasonable cause and not willful neglect.

Penalties That Apply If These Filing and Excise Tax Requirements Are Not Satisfied

A failure to satisfy these filing and excise tax requirements could result in late penalties of up to 50 percent, and interest charges.

Effective Date of These New Filing and Excise Tax Requirements

These new filing and excise tax requirements apply to any Form 8928 that is due on or after January 1, 2010.

 

Genetic Information Nondiscrimination Act Takes Effect on November 21

Eighteen months after it was first signed into law by President Bush, Title II of the Genetic Information Nondiscrimination Act of 2008, also known as GINA, will take effect this Saturday, November 21, 2009. Title II prohibits employment discrimination based on genetic information, and imposes confidentiality obligations on employers who obtain such information.  Title II's requirements are described below.

 

In enacting GINA, Congress lauded the many advances in genetic research in recent years that may spur major medical breakthroughs in the detection, treatment and prevention of illnesses and diseases. It also found, however, that with this progress came increasing concern about the possible misuse of genetic information to discriminate in employment and health insurance coverage. As an example, Congress cited to legislation passed by some state legislatures in the 1970s mandating sickle cell anemia screening as a covert means of screening African-American applicants out of the workplace.

Employees appear to share Congress’s concern. In one national survey, 63% of participants indicated they would not take genetic tests for disease if the results could be accessed by their employers or health insurers. Another recent poll found 93% of respondents opposed to the use of genetic information by health insurers and employers.

Enacted in response to these growing concerns, Title II prohibits employers from using genetic information in making any decisions about hiring, firing, promotions or any other term or condition of employment. It also forbids employers from intentionally acquiring genetic information, imposes strict confidentiality obligations on those who do come into possession of such information, and prohibits retaliation against individuals who challenge acts made illegal by GINA or who have filed a charge or otherwise participated in an investigation, proceeding or hearing under the law. Although New York’s Human Rights Law has prohibited discrimination on the basis of genetic characteristics since 1995, the new federal law imposes restrictions not found in the state statute.

Title II’s protections extend to applicants, employees and former employees, and its restrictions apply to private and state and local government employers with 15 or more employees, employment agencies, labor unions, joint labor-management training programs, Congress and federal executive branch agencies.

Genetic Information
What is considered “genetic information” under the new law? The term encompasses not only information about an employee’s own genetic tests, but also information about the tests of the employee’s family members and the manifestation of diseases or disorders in those family members (i.e., family medical history). Covered “family members” can be those as distant as 4th degree relatives, including great-great grandparents and first cousins once removed. The term genetic tests generally refers to analyses of human DNA, RNA, chromosomes, proteins or metabolites that detect genotypes, mutations or chromosomal changes. Thus, a test to determine the likelihood that an individual will develop Huntington’s Disease is a genetic test and the results would constitute “genetic information” for purposes of GINA. On the other hand, information about the sex or age of a person is expressly carved out as not constituting genetic information.

Acquisition of Genetic Information
The new law imposes strict limitations on the acquisition of genetic information by employers. More specifically, employers are prohibited from requesting, requiring or purchasing genetic information about an employee or the employee’s family member except in very limited circumstances. One such exception, the so-called “water cooler” exemption, excuses employers who inadvertently learn genetic information. Examples may include a supervisor who overhears one employee tell another that her father has Alzheimer’s Disease or a manager who learns genetic information in response to a general health inquiry such as “how are you?” Another exception shields employers that acquire genetic information through responses to lawful requests for medical certifications under the federal Family and Medical Leave Act (“FMLA”) or similar state leave laws. Additional exceptions cover genetic information acquired through employer-offered health and genetic services, such as “wellness” programs, as well as to information obtained through commercially and publicly available sources such as newspapers or magazines. This last exception, however, does not apply to genetic information contained in medical databases or court records.

Notwithstanding these exceptions, Title II imposes a significant new restriction on the permissible scope of post-offer medical examinations. Although the Americans with Disabilities Act has for years allowed employers to require that all persons offered a position in a particular job category undergo a medical examination, they will no longer be permitted to obtain family medical history information or require that the individual submit to genetic testing as part of that examination.

Most importantly, regardless of whether the genetic information has been lawfully acquired or not, employers are strictly prohibited from using that information in making any employment-related decisions such as hiring, promotions, or termination.

Confidentiality
On top of its strict limitations on the acquisition of genetic information, the statute also imposes significant confidentiality obligations on employers that possess such information. First, genetic information must be treated as a confidential medical record. If the information is in writing, it must be maintained in a medical file separate and apart from other personnel information. The information may be maintained in the same file as medical information subject to the ADA’s confidentiality requirements. Notably, genetic information obtained through commercially or publicly available sources – for example, information about the cause of death reported in a newspaper obituary – need not be maintained in the separate medical file.

Additionally, GINA prohibits the disclosure of genetic information unless such disclosure is: (i) to the employee (or family member, in limited circumstances) at his or her written request; (ii) to an occupational or other health researcher conducting research in compliance with specific federal regulations; (iii) in response to a court order so long as disclosure is limited only to genetic information expressly authorized by the order and the affected individual is notified of the order and the content of the disclosure; (iv) to government officials investigating compliance with GINA, provided the information is relevant to the investigation; (v) to comply with certification provisions of the FMLA and related state family and medical leave laws; or (vi) to public health agencies, limited to family medical history information related to a contagious disease that poses an imminent hazard of death or life-threatening illness and where notice is also given to the employee of the disclosure.

Remedies
Remedies available for violations of Title II are the same as those available under Title VII. Unlike Title VII, however, GINA does not currently provide a cause of action for “disparate impact.” A commission will, however, be established six years after Title II becomes effective to review genetic science developments and to make recommendations to Congress as to whether a “disparate impact” cause of action should be added to the statute.

The Equal Employment Opportunity Commission (“EEOC”) has been charged with enforcing Title II. To that end, the EEOC issued proposed regulations in March 2009, but has yet to issue the final regulations. It has, however, issued an updated “EEO is the Law” poster to reflect the changes implemented by the new law. Employers have the choice of either printing and posting the new updated poster, printing and posting a supplemental poster  alongside the EEOC’s 2002 “EEO is the Law” or the Office of Federal Contract Compliance Programs 2008 “EEO is the Law” posters, or ordering a new poster through the EEOC Clearinghouse.