GINA Interim Final Regulations: Highlights and the Potential Impact on Group Health Plans

Posted on November 19, 2009 by Brian Hall

On October 7, 2009, the DOL, IRS, and HHS issued interim final regulations implementing Sections 101 to 103 of the Genetic Information Nondiscrimination Act of 2008 (GINA). For group health plans, these regulations become effective on the first day of the plan year beginning on or after December 7, 2009. For the individual market, the regulations are effective December 7, 2009. The new regulations broaden GINA’s general prohibition on requesting or requiring an individual or their family member to undergo genetic testing. Of note is the new rule that health plans may not provide incentives to induce participants to fill out health risk assessments that ask for family medical history. Under the regulations’ expanded definition of "underwriting purposes", providing an incentive under these circumstances violates GINA’s prohibition against requesting genetic information for underwriting purposes. The regulations also clarify that sponsors and administrator may obtain and use the results of genetic tests to aid in payment determinations so long as they only request the minimum amount of information necessary to make the determination. In nearly all other cases, sponsors and administrators may not request or require that an individual or their family member undergo genetic testing.

To ensure compliance with these new regulations, sponsors and administrators must familiarize themselves with the new regulations and update their policies and procedures. They must also examine their health risk assessments and wellness programs to ensure they do not violate the new rules. A copy of Porter Wright's Employee Benefits Practice Group's Law Alert, which addresses some of the major changes included in the regulations, can be found here.

 

In addition, keep in mind that Title II of GINA, which prohibits employers from discriminating on the basis of genetic information goes into effect on November 21, 2009. Generally, Title II prohibits employers from discharging, refusing to hire, or otherwise taking adverse employment action against applicants or employees based on their genetic information. It also prohibits employers from intentionally acquiring or disclosing genetic information about applicants and employees. Finally, Title II requires employers to maintain any genetic information in its possession separate from employee personnel files in accordance with the medical confidentiality provisions of the ADA.

 

 

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EEOC Issues Proposed Rules to Implement Title II of GINA

Posted on March 4, 2009 by Jenny Swinerton

On March 2, 2009, the Equal Employment Opportunity Commission (EEOC) issued proposed rules to implement Title II of the Genetic Information Nondiscrimination Act (GINA).

GINA, which was signed into law on May 21, 2008, prohibits health insurers and employers from discriminating on the basis of genetic information. The EEOC is responsible for developing implementing regulations by May 21, 2009 for Title II, which applies to private and government employers. (See former blog post on May 21, 2008 entitled “Dream of GINA Now a Reality”). Generally, Title II prohibits employers from discharging, refusing to hire, or otherwise taking adverse employment action against applicants or employees based on their genetic information. It also prohibits employers from intentionally acquiring genetic information about applicants and employees. Title II of the Act will become effective on November 21, 2009. 

The proposed regulations provide additional guidance regarding some of the terms used in the Act. For example, the regulations define “employee” to cover not just current employees but also applicants and former employees. The proposed regulations defined “genetic information” as information from genetic tests, the genetic tests of family members, family medical history, and genetic information of a fetus carried by an individuals or an individual’s family member receiving assistive reproductive services. The proposed regulations also clarify that drug and alcohol tests are not “genetic tests.”

GINA provides six exceptions to the statutory sections prohibiting employers from acquiring genetic information. The proposed regulation addresses each of the exceptions, which are:

(1)   where the employer inadvertently obtains genetic information (sometimes referred to as the “water cooler” exception);

(2)   where the employer offers qualifying health or genetic services, including such services offered as part of a voluntary wellness program;

(3)   where the employer requests family medical history to comply with the certification provisions of the Family and Medical Leave Act (FMLA) or state or local family and medical leave laws;

(4)   where the employer acquires genetic information from documents that are commercially and publicly available, including print and Internet publications, except that an employer may not research medical databases or court records for the purpose of obtaining genetic information about an individual;

(5)   where the employer acquires genetic information for use in the genetic monitoring of the biological effects of toxic substances in the workplace, provided that the employer complies with monitoring restrictions provided in the proposed regulation; and

(6)   where an employer that conducts DNA analysis for law enforcement purposes requires genetic information of its employees, apprentices, or trainees for quality control purposes to detect sample contamination.

In the proposed rule, the EEOC specifically seeks comments on three of these exceptions: (1) what constitutes “voluntary” with respect to the employer-provided wellness program exception; (2) what should be included in the “commercially and publicly available” exception, particularly with respect to blogs and social networking sites; and (3) how the law enforcement exception should be applied.

The proposed regulations also reiterate the statutory prohibition against retaliation where an individual opposes any act made unlawful by GINA, files a charge of discrimination, or gives testimony in connection with a charge. In addition, the proposed regulations make clear that employers may not “limit, segregate, or classify” employees because of genetic information.

Finally, Title II of GINA limits an employer’s ability to obtain genetic information after making a job offer. Thus, even though the Americans with Disabilities Act currently permits an employer to obtain family medical history of all employees to whom it has offered a particular job, such action will be prohibited upon GINA’s effective date.
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