GINA

The Genetic Information Nondiscrimination Act (GINA) was signed into law in May 2008 after 13 years of debate. Title I of GINA prohibits health insurers from using genetic information to deny coverage or to set premiums or payment rates. Title II prohibits employers from requesting genetic information or using genetic information in hiring, firing and other employment-related decisions. This page aggregates all of the Genomics Law Report’s GINA coverage, including the Act’s implementation by regulatory agencies, courts and businesses.

The EEOC’s Final Rule on GINA and Employer-Sponsored Wellness Programs to Take Effect This Month

Gina name tagOn May 17, 2016, the Equal Employment Opportunity Commission (EEOC), which is the agency charged with enforcing Title II of the Genetic Information Nondiscrimination Act (GINA), issued a final rule changing how employers can set up incentives for the wellness programs they sponsor for their employees.

As previously reported on Genomics Law Report, on October 30, 2015 the EEOC had issued a proposed rule to amend the GINA regulations in an attempt to harmonize them with the Affordable Care Act’s promotion of employer wellness programs to lower health care costs. The EEOC indicated it had received more than 3000 public comments before the close of the comment period on January 28, 2016.

In short, the final rule allows employers to offer financial and in-kind incentives for an employee’s spouse to provide information about the spouse’s current or former health status as part of a health risk assessment in connection with a voluntary employer-sponsored wellness program so long as certain requirements are met.
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Filed under Genomic Policymaking, Genomics & Medicine, GINA, Legal & Regulatory, Privacy, Privacy, Privacy

Genetic information as “perceived disability”: Chadam v. PAUSD

Chadam v. PAUSD, as previously covered on Genomics Law Report, is a case in which parents of a school boy are alleging that a school district violated their son’s rights when it made the decision that it would transfer the boy to another school because of his genetic information. Specifically, the allegation is that when the boy moved to the area and registered for school, (1) the school district learned of the boy’s genetic information related to cystic fibrosis, (2)  the boy was regarded as disabled by the school district, and (3) on the basis of this perceived disability, the school district decided to transfer the boy to another school to protect two other students at the school who have cystic fibrosis. The school district’s decision was apparently based on the idea that the boy, because of his genetic markers, posed a cross-infection risk to the students with cystic fibrosis. Individuals with cystic fibrosis, because their respiratory symptoms create host environments favorable to microbiological pathogens, are often separated from one another to minimize risk of spreading germs to one another. Mere carriers of the genetic markers associated with cystic fibrosis do not pose such cross-infection risks.

This case unequivocally does not involve GINA, a federal nondiscrimination statute that has very limited scope and does not protect individuals from discrimination in education. While the facts alleged could have supported a clear claim for violation of California’s genetic nondiscrimination statute, CalGINA, which affords broader protections than the federal statute, the attorney for the Chadams did not raise that claim. Instead, this case alleges violations of two federal antidiscrimination statutes, the Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act. Title II of the ADA requires public education to be free from discrimination, and Section 504 requires all federally funded programs and activities to be free from discrimination. Under both provisions, individuals cannot be excluded from participating in or enjoying the benefits of education because of disability. The statutes protect three basic classes of individuals: (1) those who have a disability (i.e., those who have a physical or mental condition that substantially limits a major life activity); (2) those with a history or record of having a disability; and (3) those with a perceived disability (i.e., those “regarded as” having a disability). (For more information, see A Guide to Disability Rights Laws published by the Civil Rights Division of the US Department of Justice)

The plaintiffs in Chadam have appealed the trial court’s decision to grant the school district’s motion to dismiss the case (a Rule 12(b)(6) motion). In granting the school district’s motion, the court basically decided that even if it assumed all of the facts alleged by the plaintiffs to be true and drew all reasonable inferences in favor of the plaintiffs, there would not be a valid claim upon which relief could be granted. On appeal, the United States Court of Appeals for the Ninth Circuit, which covers California, will focus on whether the district court erred in reaching that decision. The court of appeals will consider the motion de novo—that is, will give no deference to the trial court’s decision—and determine whether the facts alleged in the pleadings, when read in the light most favorable to the plantiffs, state a claim for relief that is plausible. The amicus brief filed by the United States (Department of Justice and Department of Education) urges the Ninth Circuit to reverse the district court’s decision and remand the case, stating that the plaintiffs have alleged sufficient facts to support a claim of intentional discrimination under Title II of the ADA and Section 504.

Is there judicial precedent for ADA protection of genetic information?

About 15 years ago, long before Congress passed the Genetic Information Nondiscrimination Act, there was a case in which individuals sought ADA protection from genetic discrimination. That case involved the Burlington Northern Santa Fe Railroad (BNSF), which allegedly had been using employees’ genetic information in connection with work-related carpal tunnel syndrome claims. The case was never decided by a court, however. In 2001 the Equal Employment Opportunity Commission (EEOC) and BNSF settled the EEOC’s request for injunctive relief to stop the company’s genetic testing, and in 2002 the EEOC and BNSF settled the request for damages with an agreement to compensate individuals with up to $2.2 million. While the settlement agreement was subject to approval by the Eastern District of Wisconsin (see 2002 WL 32155386), this case did not set judicial precedent that the ADA protects individuals from decisions based on genetic information.

Does the relevant legislative history suggest that individuals are protected from genetic discrimination because of “perceived disability”?

To answer this question, it is useful to start with legal scholar Mark Rothstein’s thorough 1992 analysis of the law regarding genetic discrimination and possible protection under the ADA as it existed at that time. See Mark A. Rothstein, Genetic Discrimination in Employment and the Americans with Disabilities Act, 29 Hous. L. Rev. 23 (1992).

In the early 1990s, in a letter to a Congressional committee chair, the EEOC actually rejected the idea that the ADA prohibits genetic discrimination against asymptomatic individuals, instead taking the position that the ADA would only protect an individual once the condition existed and symptoms were present. The EEOC’s technical assistance manual in 1992 also noted that genetic predisposition and family history are not “impairments” protected by the ADA. Nearly 10 years later, following the issuance of the Executive Order 13145 in 2000 that protects federal employees from genetic discrimination, the EEOC provided guidance indicating that instances of disparate treatment on the basis of genetic test results or family medical history would support a claim that an individual was “regarded as” having a disability and thus protected under the ADA and Rehabilitation Act.

As a matter of history, Congress and advocates alike did not believe that the ADA or Section 504 were sufficient to protect individuals from genetic nondiscrimination. In the statutory text of GINA, Congress found, “Federal law addressing genetic discrimination…is incomplete in both the scope and depth of its protections.” (PL 110-233, Finding 5).

To date, there are no direct cases on point deciding that genetic information is a “perceived disability” under the ADA and Section 504 or, conversely, ruling out that possibility.

What are the implications of this case?

Ultimately, a broad ruling in Chadam that genetic information alone is a sufficient basis to bring an action for “perceived disability” could dramatically expand individual genetic nondiscrimination protection—at least in the Ninth Circuit. Courts in other federal circuits would not be bound by a Ninth Circuit decision and could choose whether or not to follow it. That reality, combined with the strong public reactions to this case, suggests that Congress has important work to do to strengthen genetic nondiscrimination protections in education and other sectors of society currently not addressed directly by federal statutes.

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Filed under Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, GINA, Pending Litigation

Genetic Discrimination Case Against School District is Appealed to Ninth Circuit

classroom-1534186As Stephanie M. Lee reported for Buzzfeed in a well-written account (which contains links to the relevant court documents), an appeal was filed in January with the Ninth Circuit Court of Appeals in the case of Chadam v. Palo Alto Unified School District (4:13-CV-04129-CW). At issue in the case is whether the school district violated a boy’s rights when it decided to force him to transfer schools. The student’s parents allege the transfer decision was because he is a carrier of a genetic variant associated with Cystic Fibrosis or CF (although he has not exhibited symptoms of the disease), and the appeal argues the trial court erred in dismissing the complaint that the school district’s decision to transfer violated his rights under Title II of the American’s with Disabilities Act or ADA (42 U.S.C.A. §12131 et seq.), Section 504 of the Rehabilitation Act of 1973 (29 U.S.C.A. § 794), and the First Amendment of the U.S. Constitution. At the trial court level, the school district successfully defended its decision to transfer the boy by arguing it relied on medical advice and made the decision in an attempt to protect other children at the school who have CF.
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Filed under Badges, Genomics & Medicine, Genomics & Society, GINA, Privacy

EEOC Tries to Harmonize ACA’s Promotion of Employer Wellness Programs with GINA’s Ban Against Employer Access to Genetic Information of Employees and Employees’ Family Members

Gina name tagThe Equal Employment Opportunity Commission (EEOC) is responsible for enforcing Title II of the Genetic Information Nondiscrimination Act (GINA), which prohibits employers from requesting genetic information (defined broadly) from their prospective, current, or former employees. GINA contains only six limited exceptions to this prohibition, one of which is an exception for wellness programs in which the employee’s participation is voluntary.

On October 30, 2015 the EEOC issued a proposed rule to amend GINA regulations in an attempt to harmonize them with the Affordable Care Act’s promotion of employer wellness programs to lower health care costs.
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Filed under Badges, General Interest, GINA, Legal & Regulatory, Privacy, Privacy, Privacy

EEOC Files and Settles Its First GINA-based Employment Discrimination Lawsuit on May 7, 2013

Stethoscope & Laptop Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

The Equal Employment Opportunity Commission (EEOC) issued a statement that it had filed a lawsuit against Fabricut, Inc. on May 7, 2013 in the U.S. District Court for the Northern District of Oklahoma, making it the first lawsuit brought by the agency to enforce genetic nondiscrimination rights afforded by Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA). A consent decree was filed concurrently, thereby settling the lawsuit on the same day.
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Filed under General Interest, Genetic Testing/Screening, GINA, Legal & Regulatory

The Burden of Enforcing GINA: EEOC v. Nestle Illustrates One Challenge in Pursuing Genetic Discrimination Claims

The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law making it illegal for insurers and employers to acquire and to use genetic information in certain contexts. Specifically, Title II of GINA prohibits employers with more than 15 employees, employment agencies, labor organizations, and joint labor-management training and apprenticeship program committees from using genetic information when making employment decisions (e.g. hiring, firing, promotions, placement, compensation, privileges, seniority, etc).

The employment discrimination provisions took effect on November 21, 2009, with an air of uncertainty, as the Final Rules implementing Title II of GINA were not issued by the Equal Employment Opportunity Commission (EEOC) until a year later (See 75 Fed Reg 68912-68939 [pdf], issued November 9, 2010) and did not take effect until January 10, 2011. (See previous GLR coverage of GINA Title II here and of GINA generally here).


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Alabama’s “Genetic Information Privacy Act” & the Ongoing Need for Personal Genomics Leadership

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

Thanks to technological innovation and a corresponding decline in cost, an increasing number of individuals are finding themselves with the task – or at least the opportunity – of accessing and interpreting their own genetic information. Over the past year, several state legislatures have taken notice.

Following on the heels of legislation passed or proposed in California, Vermont and Massachusetts, the Alabama House of Representatives is considering a bill by Representative Henry (pre-filed on January 23, 2012 and scheduled for first read on February 7, 2012) titled the “Genetic Information Privacy Act” (2012 AL H.B. 78). While the bill is relatively brief, its effects as written may reach far beyond those intended.

A New Bar for Informed Consent. First, the bill in its current form would require signature on separate informed consent documents to obtain, retain, or disclose genetic information. As drafted the bill would provide an exception for the insurance industry, permitting a single, integrated informed consent document if the genetic information is being obtained, retained, or disclosed “for the purpose of obtaining insurance” (Page 4, Line 25).


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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, GINA, Industry News, Informed Consent, Legal & Regulatory, Pending Regulation, Privacy

A New Law to Raise GINA’s Floor in California

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a post-doctoral researcher at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

Earlier this fall, California Governor Jerry Brown signed SB559 (pdf), the bill referred to as “CalGINA” (i.e., the California Genetic Information Nondiscrimination Act). The bill was double-jointed with AB887 (pdf), the Gender Nondiscrimination Act, which ultimately meant that CalGINA would only take effect if Governor Brown also signed AB887 into law. He did so on October 9, 2011, so both laws are scheduled to take effect on January 1, 2012.
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Filed under Genomic Policymaking, GINA, Legal & Regulatory, Pending Regulation

Weekly Roundup: UK Insurance Genetics Moratorium Renewed & Breast Cancer Patents, Research in the News

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.

UK Insurers Continue Moratorium on Predictive Genetic Tests. In 2008 the United States passed the Genetic Information Nondiscrimination Act (GINA). Title I of GINA prohibits health insurers from using genetic information to deny coverage or to set premiums or payment rates. Title II of GINA addresses the use and misuse of genetic information by employers. In the United Kingdom, which provides universal health coverage through the government-funded National Health Service (NHS), discussion of genetic nondiscrimination has largely focused on the employment context (see, e.g., the 2009 report on Genomic Medicine from the House of Lords). To date, however, the United Kingdom has not enacted a formal prohibition on the use of genetic information by either employers or insurers.


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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, GINA, Industry News, International Developments, International News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP

Considering the Impact of Yet Another Proposal for Genetic Legislation

Last month we examined Massachusetts’ proposed Genetic Bill of Rights. Last week, we looked at a similar proposal to expand individuals’ property and privacy rights in genetic information proposed in the Vermont legislature. Today, we head west to California to examine another piece of recently introduced genetic legislation.

A New Padilla Proposal. The California proposal comes from state Senator Alex Padilla. If Padilla’s name sounds familiar, it is likely because he is the same Senator Padilla who introduced a widely discussed “bioinformatics bill” to the California legislature two years ago. That bill (S.B. 482) was drafted with the close participation of direct-to-consumer (DTC) genetic testing company 23andMe, and 23andMe and Senator Padilla later co-sponsored a policy forum in San Francisco on “genomics and the consumer” (at which I presented).

Unlike Padilla’s earlier effort, which would have significantly altered the regulatory environment for so-called “post-CLIA bioinformatics services” (basically, genetic interpretation performed after the generation of genetic genotype or sequence data in a CLIA environment), 2011’s effort (S.B. 559 (pdf)) will almost certainly be viewed as a much less controversial proposal.


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Filed under General Interest, Genomic Policymaking, Genomics & Society, GINA, Legal & Regulatory, Pending Regulation