What It Is
Sets guidelines aimed at reducing genetic discrimination in employment and health insurance.
The Genetic Information Nondiscrimination Act of 2018 (GINA; PL 110-233) seeks to establish protections against genetic discrimination in employment and health insurance. This Act was signed into law in 2008 following decades of political discussion around the consequences of the rapid expansion of genetic test availability and concerns of genetic privacy. GINA comprises three separate titles addressing genetic discrimination in health insurance, employment practices, and various provisions, respectively. Senator Ted Kennedy (D-MA) famously called GINA “the first civil rights bill of the new century of the life sciences.”
The legislation clearly defines genetic information as “information about (i) such individual’s genetic tests, (ii) the genetic tests of family members of such individual, and (iii) the manifestation of a disease or disorder in family members of such individual.” Additionally, a genetic test is defined by GINA as “an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, that detects genotypes, mutations, or chromosomal changes.” Finally, genetic services are defined by GINA as “(i) a genetic test, (ii) genetic counseling (including obtaining, interpreting, or assessing genetic information), or (iii) genetic education.”
Title I – Health Insurance
Title I of GINA outlines provisions to prevent genetic discrimination in health insurance by amending the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1182), the Public Health Service Act (42 U.S.C. 300gg), and the Internal Revenue Code of 1986, among others. Among other measures, GINA:
- States that genetic data cannot be used in setting health insurance premium costs nor considered a preexisting condition;
- Prohibits health insurance companies from requiring individuals to submit to genetic testing;
- Stipulates that genetic information cannot be used for underwriting purposes, and as such no individual should be denied health care insurance due to genetic information;
- Indicates that health insurance companies may be fined if they violate these stipulations; and
- Amends the Social Security Act to include genetic information in the Health Insurance Portability and Accountability Act (HIPAA), meaning genetic data are protected by HIPAA privacy statutes.
The Department of the Treasury (DOT), Department of Health and Human Services (HHS), and Department of Labor (DOL) were required to issue final regulations pertaining to Title I of GINA within one year of enactment. On October 7, 2009, DOT, HHS, and DOL issued a final rule to enact GINA’s regulations regarding both individual and group health insurance plans. On January 25, 2013, HHS issued a final rule to amend HIPAA in accordance with GINA’s clauses regarding privacy and confidentiality of genetic information.
Title II – Employment
Title II of GINA seeks to protect individuals from genetic discrimination in employment practices. Specifically, GINA forbids employers from either refusing to hire, firing, limiting opportunities for, or otherwise discriminating against an employee due to their genetic information. The law expressly bans employers from requesting, requiring, or purchasing an employee’s genetic information except in select situations including when employers need to monitor the genetic effects of toxic substances, among others. Importantly, employers that gather these data still cannot discriminate against the employee. These statues apply to employers, employee agencies, labor organizations, and training programs. To further protect genetic information, GINA requires particular storage and maintenance of these data similar to the storage of confidential medical records under the Americans with Disabilities Act (42 U.S.C. 12112(d)(3)(B)). Only under limited circumstances, including circumstances concerning contagious disease or if ruled by court order, may employers release genetic information.
The Equal Employment Opportunity Commission (EEOC) was required to issue final regulations pertaining to Title II of GINA within one year of enactment. On November 9, 2010, EEOC issued a final rule to enact GINA’s stipulations regarding genetic discrimination within employer practices. On May 17, 2016, EEOC issued a follow-up final rule to clarify GINA’s regulations specific to employer-sponsored wellness programs. Specifically, the rule limited the amount of power employers have to entice their employees to disclose genetic information pertaining to a disease or disorder during a health risk assessment in an employer-sponsored wellness program.
Genetic discrimination protections under GINA extend only to two primary areas: health insurance and employer practices. Importantly, GINA does not protect individuals from genetic discrimination outside of this scope. In particular, GINA does not prevent genetic discrimination with regard to education, life insurance, long-term care, or disability insurance. Approximately half of the states have enacted genetic discrimination laws to supplement GINA, although these laws vary in scope and area of focus.
Understanding how an individual’s DNA contributes to traits (e.g. disease predictability) has been a burgeoning field of contemporary science. In particular, the April 2013 completion of the Human Genome Project, a program designed to map and understand all the genes within human DNA, has become a milestone in genetics research. As such, tests to identify parts of or the entirety of an individual’s genetic sequence became more prevalent. According to the National Human Genome Research Institute within the National Institutes of Health, GINA provided reprieve to individuals concerned about their genetic privacy during a time in which access to genetic information was on the rise. A 2013 article, released five years after GINA was passed, in Genetic Testing and Molecular Biomarkers indicated that individuals believe that their genetic information might interfere with their ability to obtain health insurance (51.3%) and find a job (16%).
Federal legislation to restrict genetic discrimination was first introduced in 1995 by Representative Louise Slaughter (D-NY-28) and Senator Olympia Snowe (R-ME). This original bill, the Genetic Information Nondiscrimination Act in Health Insurance of 1995 (HR 2748, 104th Congress), did not pass either the House of Representatives or the Senate. Subsequently, many pieces of related legislation were introduced in each congressional session until GINA was passed by the 110th Congress.
The legislation refers to specific examples of genetic discrimination faced by individuals within health care and employer practices as giving impetus for these provisions in GINA. Specifically, the bill references genetic discrimination experienced by African Americans in the 1970s, when state legislatures began to enforce mandatory genetic screening of all African Americans for sickle cell trait, the genetic indicator of developing sickle cell disease. These laws ultimately led to stigmatization and discrimination among those affected. Additionally, the bill refers to the 1998 Norman-Bloodsaw v. Lawrence Berkeley Laboratory case as an example of genetic discrimination in the workplace. The case describes an employer, Lawrence Berkeley Laboratory, conducting genetic testing during a pre-employment health screening without proper consent or knowledge among the employees affected.
Explainer EditorsAndrew Pericak, MEM
Duke SciPol, “Genetic Information Nondiscrimination Act of 2008 (GINA)” available at https://scipol.org/learn/science-library/genetic-information-nondiscrimination-act-2008-gina (11/12/18).
Explainer Last Updated DateMonday, November 12, 2018
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