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October 29, 2008

 

AGENCIES REQUEST COMMENTS ON THE GENETIC
INFORMATION NONDISCRIMINATION ACT OF 2008

On October 10, 2008, the three federal agencies responsible for enforcement of the group health plan requirements of the Genetic Information Nondiscrimination Act of 2008 (GINA) — the U.S. Departments of Labor (DOL), Health and Human Services (HHS) and Treasury — published a request for information (RFI) in the Federal Register.1 The RFI seeks comments on various aspects of GINA, and requests comments on or before December 9, 2008. Comments can be submitted via mail, e-mail, and hand delivery, and may be submitted online via the Federal eRulemaking Portal: http://www.regulations.gov


Background on GINA

GINA was enacted on May 21, 2008. The law amends the Employee Retirement Income Security Act, the Public Health Service Act and the Internal Revenue Code. GINA prohibits group health plans and health insurance issuers from discriminating in health coverage based on genetic information.2 GINA prohibits group health plans and health insurance issuers from:

  • Adjusting premium or contribution rates for the group on the basis of the genetic information of individuals in the group,
  • Requiring or requesting that an individual or family member undergo a genetic test,
  • Requesting, requiring, or purchasing genetic information for underwriting purposes or prior to enrollment in the plan, and
  • Using or disclosing protected health information (PHI) that is genetic information for underwriting purposes.

The DOL, HHS and Treasury, which are responsible for enforcement of the group health plan requirements of GINA, are required to issue final regulations within one year of enactment. The law is effective for plan years beginning on or after May 21, 2009 (e.g., January 1, 2010 for calendar year plans).


The RFI

The agencies will accept comments on any aspect of GINA, but specifically request comments on the following topics related to group health plans:

  • To what extent do group health plans and health insurance issuers currently use genetic information, such as family medical history, and for what purposes? For example, is genetic information currently used for group rating purposes, or for purposes of a wellness program that otherwise complies with the nondiscrimination requirements of the Health Insurance Portability and Accountability Act (HIPAA)?
  • How do plans and issuers currently obtain genetic information (for example, through health-risk assessments or through various medical information clearinghouses)?
  • Under what circumstances do plans or issuers currently request or require an individual to take a genetic test?
  • Under what circumstances do plans or issuers currently ask for the results of a genetic test in order to make a determination regarding payment of benefits? What is the minimum amount of information necessary for a plan or issuer to make a determination under such circumstances?
  • What terms or provisions (such as genetic information, genetic test, genetic services, or underwriting) would require additional clarification to facilitate compliance? What specific clarifications would be helpful?

The questions represent a broad spectrum of issues that the agencies will have to address in GINA regulations. The impact of GINA on health risk assessments and the definition of underwriting under the law are of particular importance to sponsors of group health plans.


       

As with all issues involving the interpretation or application of laws and regulations, plan sponsors should rely on their attorneys for authoritative advice on the interpretation and application of GINA. The Segal Company is available to review the impact of GINA on a plan or to assist in development of comments to the agencies.

1 The RFI is available on the following Web page: http://edocket.access.gpo.gov/2008/pdf/E8-24194.pdf. (Click on the following text to return to Capital Checkup.)
   
2 For information about GINA, see one of The Segal Company’s June 2008 Bulletins: “A New Genetic Information Nondiscrimination Act Regulates Group Health Plans” or “Implications of the New Genetic Information Nondiscrimination Act for Public Sector Health Plans”. (Click on the following text to return to Capital Checkup.)

 

Capital Checkup is The Segal Company's periodic electronic newsletter summarizing activity with respect to health care and related subjects. Capital Checkup is for informational purposes only. It is not intended to provide guidance on current laws or pending legislation. On all issues involving the interpretation or application of laws and regulations, plan sponsors should rely on their attorneys for legal advice. A separate web page lists back issues of Capital Checkup.

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