From Speculation to Reality: Personalized Medicine and the Genetic Information and Nondiscrimination Act

24 November 2009 Publication
Author(s): Kevin G. Fitzgerald Antoinette F. Konski Shirley P. Morrigan Judith A. Waltz

Legal News Alert: Life Sciences

This past weekend, the Genetic Information Nondiscrimination Act of 2008 (GINA) became effective. Considered by some as the most important new antidiscrimination law in two decades, GINA prohibits employers from requesting genetic testing or considering someone’s genetic background in hiring, firing, or promotion. The implementation of GINA also should facilitate the collection and analysis of patient genetic information that is necessary to move the promise of personalized medicine from speculation to reality.

Personalized medicine seeks to tailor therapies to the individual patient, taking into account the individual’s characteristics and genomics. Application of the technology allows health care to move from a one-size-fits-all approach to one that identifies the most effective therapy for each individual patient. Much of this research relates a genetic characteristic of a patient to a treatment option or pre-disposition to a disease such as cancer. However, discovering and validating a correlation requires the analysis of a large number of patient samples and medical histories. Implementation of GINA should facilitate the collection of such information because the act protects patient confidentiality.

GINA was signed by President George W. Bush on May 22, 2008 and aims to:

establish … a national and uniform basic standard [that] is necessary to fully protect the public from discrimination and allay their concerns about the potential for discrimination, thereby allowing individuals to take advantage of genetic testing, technologies, research and new therapies.

Recently, in proposed and interim final rules (Rules) published in the Federal Register on October 7, 2009, the U.S. Department of Health & Human Services (HHS) and other agencies sought to strengthen patient protection provided under GINA. The HHS, working in conjunction with the U.S. Department of Labor and the U.S. Department of the Treasury, proposed to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to, among other things, (1) explicitly provide that genetic information is health information for purposes of the rule and (2) prohibit health plans from using or disclosing protected health information (PHI), which would include genetic information, for underwriting purposes. In addition, while GINA’s prohibition on using or disclosing genetic information for underwriting purposes currently applies only to certain health plans, HHS clarifies in the Rules that such prohibitions apply to all health plans that are subject to HIPAA.

When announcing the Rules, HHS Secretary Kathleen Sebelius stated that by protecting Americans undergoing genetic testing from having the results of such tests used against them by their insurance companies, “… consumer confidence in genetic testing can now grow and help researchers get a better handle on the genetic basis of diseases. Genetic testing will encourage the early diagnosis and treatment of certain diseases while allowing scientists to develop new medicines, treatments, and therapies.” Under the Rules, group health plans and health insurance issuers in both the group and individual markets cannot request, require, or buy genetic information for underwriting purposes or prior to and in connection with enrollment. Thus, insurers cannot increase premiums, deny coverage, or have pre-existing condition exclusions based on genetic information. Health plans and issuers also are generally prohibited from asking individuals (or family members) to undergo genetic testing. Many believe that this privacy protection for genetic PHI will promote participation in genetic research and therapies by insureds who might otherwise avoid them for fear that results could be adverse to their health insurance premiums and coverage. Violations of this proposed rule could result in a monetary fine for the unauthorized use or disclosure of genetic information.

Legal News Alert is part of our ongoing commitment to providing up-to-the-minute information about pressing concerns or industry issues affecting our insurance clients and colleagues.

Please contact your Foley attorney or the individuals listed below if you have any questions about these issues or want additional information regarding life sciences matters:

Antoinette F. Konski
Biotechnology & Pharmaceutical Practice
Palo Alto, California

Kevin G. Fitzgerald
Chair, Insurance Industry Team
Milwaukee, Wisconsin

Shirley P. Morrigan
Health Care Industry Team
Los Angeles, California

R. Michael Scarano Jr.
Vice Chair, Health Care Industry Team
San Diego / Del Mar, California

Judith A. Waltz
Co-Chair, Life Sciences Industry Team
San Francisco, California

Kenyatta Bolden
Insurance Industry Team
Milwaukee, Wisconsin