Effective December 7, 2009 interim final regulations implementing the Genetic Information Nondiscrimination Act of 2008 (“GINA”) became applicable to group health care insurers for plan years beginning on or after December 7, 2009 and ushered in GINA’s anti-discrimination provisions relating to health coverage based on genetic information.
GINA provides additional protection to an individual’s genetic information and modifies the HIPAA privacy regulations to clarify that genetic information is protected health information. The interim final regulations prohibit covered health plans from using genetic information for eligibility determinations, premium computations, application of any pre-existing condition exclusions, and any other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.
The interim final GINA regulations specifically prohibit group health plans and health insurance issuers, in both group and individual markets, from requesting, requiring or buying genetic information about an individual and the individual’s family members prior to enrollment and after enrollment in the health coverage. In addition, plans and issuers are prohibited from asking individuals or family members to submit to a genetic test. Further, plans and issuers cannot increase a group premium or contribution amounts based on genetic information. The regulations clarify that a post-enrollment request for genetic information does not violate GINA so long as the genetic information obtained after enrollment does not impact future enrollment.
The interim final GINA regulations define “genetic information” as: (i) an individual’s “genetic tests”; (ii) the “genetic tests” of “family members” of the individual; and (iii) the manifestation of a disease or disorder in the individual’s family members. Generally, a genetic test is any test that both analyzes human DNA, RNA, chromosomes, proteins or metabolites and detects genotypes, mutations or chemical changes. Accordingly, for the purposes of GINA, an HIV test, complete blood count, cholesterol test, liver function test or test for the presence of alcohol or drugs is not a genetic test. A disease or disorder is considered manifested if it has been diagnosed or could reasonably be diagnosed by a health care professional with appropriate training or expertise.
The GINA regulations broaden the scope of ERISA by introducing the concept of “family member” and protect family member information in two ways. First, protected genetic information of an individual includes information about the manifestation of a disease or disorder in the individual’s family members. Second, a plan or issuer may not require an individual or an individual’s family member to submit to a genetic test. The statute’s anti-discrimination provision defines family member broadly to include dependents and first-, second-, third-, or fourth-degree relatives of the individual or of the individual’s dependents.
The GINA regulations require that covered entities obtain and post notices informing covered individuals of their rights under GINA. The entities covered by GINA generally include all private employers with 15 or more employees, most public sector employers and employment agencies and labor organizations. Notices can be obtained at http://pbcompliance.com/gina09?id=2954167154&L=09fedgina37A&S.
Use or disclosure of genetic information in violation of HIPAA’S privacy rules can result in a fine of $100 to $50,000. Failure to display all required State and Federal posters can result in fines of up to $17,000.
For additional information regarding the GINA regulations, please contact Patrick McGovern or Kristina Chubenko.
This alert is provided for educational and informational purposes only and is not intended and should not be construed as legal advice. It is recommended that readers not rely on this publication but that professional advice be sought for individual matters.