Regulations to Implement Title I of GINA Move One Step Closer to Finalization

In October 2009, the Genetic Information Nondiscrimination Act (GINA) reached a major milestone when the agencies released the regulations outlining their interpretation of the protections afforded by Title I of this civil rights law.  The interagency team tasked with implementing GINA released these regulations as interim final, giving members of the regulated community six months to fully comply with GINA.  Despite this interim status, these regulations officially became effective on December 7, 2009. 

After the passage of GINA, the agencies solicited comments and information from the public to aid their drafting of the regulations.  In response to concerns about GINA limiting the use of genetic information in making payment determinations, the interim final regulations provide a safe harbor that allows insurers to condition payment on the outcome of a genetic test as long as this policy is applied uniformly to all plan members and uses the minimal amount of information necessary to make a determination.  For example, an insurer can request a beneficiary’s BRCA mutation status before covering the cost of a yearly mammogram starting at age 30. 

In October 2009, the Office of Civil Rights (OCR) at the Department of Health and Human Services (HHS) also released their regulations amending the Privacy Rule issued under the Health Insurance Portability and Accountability Act of 1996.  The regulations were released in draft form with a comment period expiring on December 7, 2009.  There are two sections of the draft regulations that prompted the most comments from the community.  First, the draft regulations extend the Title I protections beyond health insurers to long-term care policies, excepted benefit plans (vision, dental, etc.), the military and veteran’s health care plans, and others.  GINA advocates applauded this interpretation while others question whether or not this extension is consistent with the intent of Congress. 

The second area of contention has to do with the definition of underwriting as it applies to employer based wellness programs.  The OCR draft regulations allow the collection of genetic information (including family history) in wellness programs as long as the programs are voluntary.  They interpret GINA to prohibit the use of financial incentives beyond premium sharing, such as cash, gym memberships and other gifts, in exchange for the completion of a health risk assessment that collects genetic information.  The draft regulations view these incentives as penalties to those who choose to keep their genetic information private, and hence, the wellness program is not considered to be voluntary. 

Over 250 organizations advocating for GINA sent a letter to the agencies supporting their interpretation of underwriting as it applies to wellness programs.  At the same time, supporters of using financial incentives to encourage enrollment in employer based wellness programs that collect genetic information have also sent comments to the agencies requesting a modification to the draft regulations.  Additionally, they have tried to seek assistance from Congress, requesting an amendment to the pending health care reform legislation in the Senate to allow financial incentives when collecting genetic information in wellness programs.  With the comment period now closed, advocates on both sides of the issue patiently await the outcome of their lobbying efforts and the final OCR regulations.

Tags: GINA