By Bonnie Epstein, MA, MS & Cheryl E. Harper, MS, CGC | Genomic Services, Advanced Diagnostics | Quest Diagnostics

May 21, 2019 Insights

On May 21, 2008, former President George W. Bush signed into law the Genetic Information Non-discrimination Act of 2008 (GINA). This legislation was the culmination of a 13-year legislative journey to ensure that an individual’s genetic information could not be used for discriminatory practices.  At the time, GINA was heralded by the American Society of Human Genetics (ASHG) as “the first civil rights bill of the new century of the life sciences.” Francis Collins, MD, PhD, then-Director of the National Human Genome Research Institute (NHGRI) and later Director of the National Institutes of Health (NIH), praised GINA as “a great gift to all Americans.”

Passage of GINA was in response to the growing fears among the public of how genetic information would be used by health insurers and other groups as a result of the tremendous advancements in the field of genetics and genomics. Even with the protections provided under GINA, there is considerable uncertainty in the general public about the appropriate uses of genetic information and what information is and is not protected by GINA. In this article, we hope to highlight and clarify the basic tenets of GINA and provide resources for those interested in learning more about the processes that have been put into place as a result of this law.

Background

GINA is a federal law that protects individuals from discrimination based on genetic information by both health insurance organizations (Title I) and employers (Title II). GINA also provides protections against unauthorized disclosure of genetic information and outlines instances when unauthorized disclosures may be allowed.

Health Insurance

What GINA requires of health insurers

As of December 7, 2009, most health insurers are prohibited from using genetic information to deny coverage, increase premiums, impose pre-existing condition exclusions, or to determine contribution amounts, or other coverage terms. Health plans covered by GINA are most employer-sponsored group plans, individually purchased plans, as well as Medicare and Medicaid plans.

Bottom Line: Health insurers CANNOT use an individual’s genetic information to make decisions about eligibility, coverage, or premiums. Additionally, health insurers cannot request or require individuals or their family members to undergo genetic testing or provide genetic information. Example: If you have a family history of a genetic cause of cancer, you cannot be denied or charged more for coverage; the insurer cannot request that you undergo genetic testing for cancer or provide results of any genetic tests.

Insurance plans not covered by GINA

GINA does NOT apply to health plans covering the US military (TRICARE), veterans (Veteran’s Administration), Indian Health Service, and federal employees. These groups have separate policies in place that have similar protections to GINA.

Employers

What Gina requires of employers

As of January 10, 2011, employers are prohibited from using genetic information to make decisions about hiring, firing, promoting, determining wages, and other privileges or employment terms. Additionally, employers may not use genetic information to limit, segregate, classify, or otherwise mistreat an employee. Employers are also prohibited from requesting, requiring, or purchasing genetic information of a potential or current employee, or his or her family members.

There are instances in which an employer may legally come into possession of an employee’s genetic information, such as inadvertent or accidental disclosure, publicly available information, voluntary disclosure by the employee, or when an employee applies for Family and Medical Leave. If an employer does possess genetic information for an employee, GINA requires the employer to keep this information confidential and in a separate medical file.

Employee wellness programs

There has been debate about whether employee wellness programs are included under GINA because these programs are often administered by a third party rather than by the insurer. In 2016, an amendment was made that allows employers to offer an inducement of no greater than 30% reduction of the cost of the employee portion of the sponsored health plan if the employee provides protected health information (PHI). These protections apply to spouses covered in an employee’s health plan as well.

Employers not covered under GINA

GINA protections do not apply to employers with fewer than 15 employees, members of the US military, or employees of the federal government; the military and federal employees have similar protections to GINA in separate policies.

Bottom Line: Employers are prohibited from using genetic information in employment decisions including hiring, firing, promoting, wages, other employment terms.  Employers cannot use genetic information to restrict or mistreat any employee. Employers are not allowed to request, require, or purchase genetic information about a current or prospective employee or employee family member.

Filing claims against employers

According to the EEOC website, charges of violations of GINA against an employer can be placed with the EEOC within 180 days of the alleged violation or within 300 days if a state or local agency enforces a law that prohibits employment discrimination on the basis of the acquisition or use of genetic information. Since 2010, EEOC has received more than 700 charges under GINA and has resolved nearly 600 of those charges.

GINA Protections and HIPAA

In 2013, the Health Insurance Portability and Accountability Act (HIPAA) was amended to include genetic information as PHI and accorded the same privacy protections as other PHI.

Bottom line: Insurers and employers must safeguard genetic information they possess as they do for other PHI and require written informed consent before disclosing information to a third party.

GINA and Clinical Research

GINA has implications for individuals participating in research studies. The Office for Human Research Protections (OHRP) within HHS has issued guidance on integrating GINA into clinical research, including information on GINA’s research exemption, considerations for Institutional Review Boards, and integrating information on GINA into informed consent forms. To comply with GINA, informed consent forms should include information on any risks associated with participation in the research project and a statement describing how the confidentiality of records will be maintained. NHGRI has developed an informed consent resource for participants in genomics research.

Other types of Insurance

Other types of insurance such as life, disability, and long-term care insurance are NOT covered in GINA. If a state has more restrictive laws than are provided in GINA, state law supersedes GINA regulations.

Effects of GINA Now and in the Future

Because of GINA protections we should feel more confident that as genomic medicine is poised to revolutionize medicine, patients will be able to utilize advances in genetic testing to create highly personalized care and treatment plans without fear of discrimination. Furthermore, patients should no longer fear discrimination as a result of participating in medical research involving genetic testing. The hope is that more individuals will agree to participate in research studies, resulting in doctors and scientists being able to create new lifesaving treatments and cures based upon a more robust study population.

On this anniversary of GINA, we celebrate how these protections have impacted the lives of so many and continue to strive for even greater advances for the future.

For additional information about GINA protections, please visit the following sites: