Earlier today, the U.S. Department of Health and Human Services, together with the U.S. Departments of Labor and the Treasury, published interim final regulations implementing Title I of the Genetic Information Nondiscrimination Act (GINA). HHS also published a proposed rule modifying the Standards for Privacy of Individually Identifiable Health Information (Privacy Rule), originally promulgated under the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

GINA's Mandate

In response to growing concerns that the results of genetic testing were being misused by both health insurance issuers and employers and that employees consequently were reluctant to undergo potentially life-saving genetic tests, President Bush signed GINA into law on May 21, 2008.

Title I of GINA prohibits discrimination in health insurance coverage based on genetic information. It prohibits group health plans, health insurance issuers, and issuers of Medicare supplement policies from collecting genetic information and discriminating based on such information. Title II of GINA prohibits employers, employment agencies, and labor unions from discriminating against employees or applicants on the basis of their or their family members’ genetic information and, except in limited circumstances, requesting or obtaining such genetic information.

Under GINA, genetic information must be treated as confidential medical information and maintained in accordance with the restrictions on access to confidential medical information set forth in the Americans with Disabilities Act (ADA).

For more information about the passage of GINA, please click here.

Interim Final Regulations under GINA

The new interim final regulations implement restrictions on the collection and use of genetic information. Specifically, the regulations:

  • Expand the HIPAA prohibitions against discrimination based on a health status factor by prohibiting group health plans and health insurance issuers offering health coverage in connection with a group health plan from adjusting premium or contribution rates based on genetic information, whether such information is lawfully obtained or not. This is a change from existing law, which allowed group health plans and health insurance issuers, in some circumstances, to adjust premium or contribution amounts based on genetic information for the group but not for individuals. Plans are still permitted to increase premium or contribution amounts based on the manifestation of a disease or disorder of an individual in the plan. However, the disease or disorder of one individual may not be used as genetic information about other group members to further increase the premium or contribution amount.
  • Change the definition of genetic information that applied under the 2004 final HIPAA portability regulations.
  • Prohibit health plans from requiring genetic testing of participants or their family members.
  • Prohibit group health plans and health insurance issuers from collecting genetic information for either underwriting purposes or in connection with enrollment. Although the regulations include a limited exception for the incidental collection of information, this change will significantly affect how group health plans and health insurance issuers structure wellness programs including health risk assessments (HRAs). For example, the regulations clarify that if it is reasonable to anticipate that genetic health information will be received as a part of a collection of information, the collection should explicitly state that genetic information should not be provided.
  • Bring into question wellness programs that provide rewards for completing HRAs requesting genetic information. This appears to be a departure from the 2006 final HIPAA nondiscrimination rules regarding wellness programs.
  • Clarify that it is permissible for group health plans or health insurance issuers to, in some circumstances, request the minimum amount of genetic information necessary to make determinations regarding payment and medical appropriateness of benefits.

The interim final regulations become applicable to group health plans and health insurance issuers beginning on the first day of the plan year beginning on or after December 6, 2009 (January 1, 2010, for calendar year plans). In the individual market, the regulations become applicable with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated on or after December 6, 2009.

For the full text of the interim final regulations, please click here.

Proposed Regulations Under GINA – HIPAA

HHS also published today a proposed rule modifying HIPAA's Privacy Rule to comply with GINA's mandates. The proposed rule would:

  • Amend the definition of "protected health information" (PHI) under HIPAA to explicitly include genetic information as defined under GINA.
  • Prohibit health plans from using or disclosing PHI that is genetic information for underwriting purposes.
  • Revise HIPAA provisions relating to the Joint Notice of Privacy Practices for health plans that provide underwriting.
  • Add to the Privacy Rule several terms defined in GINA.
  • Clarify that health care providers may use genetic information in certain circumstances but must protect genetic information as they protect all PHI.

HHS is soliciting public comments on the proposed rule. The public comment period will close on December 6, 2009. For further information regarding the public comment process and for the full text of the proposed rule, please click here.

Employers should review their group health plans to determine how genetic information is used under the plans. Group health plans that include health risk assessments as part of wellness initiatives should be evaluated to ensure compliance with the new regulations.

Ballard Spahr attorneys can help you make and implement any required changes as seamlessly and efficiently as possible. Please contact Brian D. Pedrow (215.864.8108 or pedrow@ballardspahr.com), or any member of Ballard Spahr's Labor, Employment and Immigration Group or Employee Benefits and Executive Compensation Group for more information.


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