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Groundbreaking genetic non-discrimination bill signed into law
This law should encourage individuals to take full advantage of genetic advances in both health care delivery and research.
On May 21, 2008, the path to personalized medicine became a little smoother as the Genetic Information Nondiscrimination Act of 2008 — or GINA — was signed into law. This law prohibits employers and health insurers from discriminating against individuals based on their genetic information. Physicians must be aware of GINA’s protections so that they can discuss them with their patients when advising them of the benefits and risks associated with genetic screening, counseling, testing and therapies.
Although GINA passed with wide bipartisan support, genetic nondiscrimination legislation was debated in Congress for more than 13 years. When Representative Slaughter introduced the first version of the bill in 1995, many thought that the need for genetic nondiscrimination legislation was premature. She and other key players, such as Senator Ted Kennedy, patient advocacy organizations, civil rights organizations, and physician organizations such as the American Society of Clinical Oncology and the American Society of Hematology, spent over a decade working to pass this law.
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Once this law takes effect, it should remove the fear associated with genetic discrimination and benefit clinical research and health care delivery. GINA’s health insurance provisions will take effect in May 2009; the employment provisions take effect six months later in November 2009. The Equal Employment Opportunity Commission (EEOC) is expected to release final regulations interpreting the law by May 2009.
GINA prohibits health insurers and employers from misusing genetic information. An individual’s “genetic information” is defined broadly in GINA as “information about (1) such individual’s genetic tests, (2) the genetic tests of family members of such individual, and (3) the manifestation of a disease or disorder in family members of suchindividual.” Genetic information could also include information about the participation of a person or family member in research that includes genetic testing, counseling or education.
GINA prohibits group, individual and Medigap health insurers from using an individual’s genetic information to determine eligibility, or to adjust premium or contribution amounts. It also prohibits an insurer from requesting or requiring an individual to take a genetic test. GINA builds upon existing medical privacy provisions in the Health Insurance Portability and Accountability Act by restricting the ability of group, individual and Medicare supplemental plans from using, disclosing, requesting, requiring or purchasing individually identifiable genetic information for purposes of enrollment, establishing underwriting, setting enrollment eligibility criteria, setting premium rates or in formation of a plan. However, GINA does not limit the authority of a health care professional who is employed by or affiliated with a health plan from notifying an individual about genetic tests as part of a wellness program.
GINA's Path to Approval |
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GINA prohibits employers from using an individual’s genetic information in making decisions about hiring, promoting, job assignments or firing. It also prohibits employers from requesting, requiring or purchasing genetic information about an individual or his or her family members.
Enforcement and remedies
GINA provides significant remedies and penalties in both the healthinsurance and employment context. An individual may bring a civil action to enforce his or her rights under GINA without being required to exhaust administrative remedies upon a showing that exhaustion would cause irreparable harm to his or her health. If a claimant is successful, a court may order retroactive reinstatement of health plan coverage and/or award penalties of up to $1,000 for each day of noncompliance.
Employees who believe that they have been discriminated against on the basis of their genetic information must file a charge of discrimination with the EEOC. If litigation is subsequently filed in federal court, the damages closely mirror those in Title VII of the Civil Rights Act of 1991 (which prohibits discrimination on the basis of race, color, religion, sex and national origin). Penalties of up to $100 per day may be imposed, with a minimum penalty of $2,500 for de minimus violations and $15,000 for significant violations. Maximum penalties for unintentional violations are capped at the lesser of 10% of the amount paid by the employer for its group health plans during the prior year, or $500,000. An individual may seek compensatory as well as punitive damages if he or she is able to demonstrate that an employer acted maliciously or with reckless indifference to the individual’s rights. For a violation resulting from willful neglect or intentional misconduct, there is no cap on the penalty amount.
History of protection
GINA is the first and only federal bill of its kind. Until now, a patchwork of state laws and federal regulations that have gone largely untested were the only form of protection against genetic discrimination. These laws and regulations vary widely in their scope and in the level of protection that they offer. GINA has now set the national standard for protections.
Fear of genetic discrimination
Fear of discrimination has kept many individuals from considering genetic tests recommended by their physicians or from having the results of such tests included in their medical records. This fear has also caused them to prevent their family members from doing so as well. When participants in a 2008 survey conducted by the Genetics & Public Policy Center at Johns Hopkins University were asked whether they would consider participating in genetics research, 93% of them said it was important that it be illegal for insurers or employers to get their information.
Prevalence of genetic tests
When the first genetic nondiscrimination bill was introduced, there were only about 300 genetic tests available. Today, genetic tests that assess genotypes, mutations, or chromosomal changes are available clinically for more than 1,200 diseases. Most of these tests are used solely to predict an individual’s risk of developing cancer. Tests that indicate predisposition to disease may enable individuals to employ certain disease management strategies that could manage their risk and possibly avert it. For example, there are tests that determine hereditary predisposition to breast, ovarian, colon, endometrial, melanoma and pancreatic cancer. Many of these tests are available in a clinical setting, and some of these, such as Myriad’s BRACAnalysis, a genetic test for breast cancer, are even being marketed directly to consumers. Other tests may classify the genetic properties of an existing cancer tumor to help determine the best course of therapy. Still other genetic tests, such as those for cystic fibrosis or Huntington’s disease, may indicate if someone is a carrier of a disorder. As more Americans learn of the new protection for genetic information, there is likely to be a surge in demand for all forms of genetic testing.
Although GINA offers groundbreaking protection against genetic discrimination in employment and health insurance, it does not prohibit genetic discrimination in all arenas. For example, the law stops short of preventing life insurance, long-term care, or disability insurance companies from using genetic information against individuals for purposes of obtaining or maintaining their plans. In addition, GINA does not prohibit medical underwriting based on current health status. Despite these limitations, GINA opens the door to personalized medicine for many who were afraid to avail themselves of the advantages of genetic technologies.
Alana Wexler, Esq., is an attorney at Arent Fox LLP in Washington, DC. Allison Weber Shuren, MSN, JD, assigned, coordinated and edited this article prior to publication. Ms. Shuren may be reached at Arnold & Porter LLP, Washington DC.
For more information:
- Hudson KL. Prohibiting genetic discrimination. N Engl J Med. 2007;356:2021-2023.