On October 1, 2009, the U.S. Department of Health & Human Services (HHS) issued an interim final rule that proposes to amend the HIPAA Privacy Rule to provide greater protection to individuals' genetic information. The proposed interim final rule was promulgated to bring the HIPAA Privacy Rule in line with the Genetic Information Nondiscrimination Act of 2008 (GINA). Signed by President George W. Bush on May 22, 2008, GINA 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. (see GINA, Section 5).

To that end, GINA generally prohibits discrimination based on an individual's genetic information with respect to both health coverage and employment.

HHS, working in conjunction with the Department of Labor and the Treasury, proposes to modify the 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 proposed interim final rule that such prohibitions apply to all health plans that are subject to HIPAA.

When announcing the proposed interim final rule, 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 proposed interim final rule, 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.

In conjunction with the interim final rule, HHS, through its Office of Civil Rights, issued a notice of proposed rulemaking with a 60-day period for public comment starting upon the rule's publication in the Federal Register. As of the date of publication of this alert, the rule has yet to be published in the Federal Register and, as such, the 60-day comment window has not commenced. The interim final rule will be adopted in final form after post-comment revisions have been made.

A copy of the HHS press release can be viewed here: http://www.hhs.gov/news/press/2009pres/10/20091001b.html.