Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA)

A Summary of Joint Final Interim GINA Regulations

On October 1, 2009, the Internal Revenue Service, Department of Labor and Department of Health and Human Services released the joint, final interim regulations under Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA). These final regulations will be effective December 7, 2009.

About the Regulations

In general, Title I of GINA prohibits health plans from discriminating against covered individuals based on genetic information. "Genetic information" includes family medical history and information regarding individuals' and family members' genetic tests and genetic services.

Specifically, Title I of GINA states that health insurers may not use genetic information to make eligibility, coverage, underwriting, or premium-setting decisions. Health insurers may not request or require individuals or their family members to undergo genetic testing or to provide genetic information. Further, they cannot use genetic information obtained intentionally or unintentionally in decisions about enrollment or coverage. Finally, the use of genetic information as a preexisting condition is prohibited in both the Medicare supplemental policy and individual health insurance markets.

There are two exceptions to Title I of GINA:

• First, health insurers may request genetic information in the case that coverage of a particular claim would only be appropriate if there is a known genetic risk.
  
  
• Second, in the context of research, when working in collaboration with external research entities health insurers may request (but not require) in writing that an individual undergo a genetic test. The individual may do so voluntarily, but refusal to participate will have no negative effect on his or her premium or enrollment status. The collected genetic information may be used for research purposes only, and not for underwriting decisions.

The Title I regulations attempt to clarify the intent of the law by modifying the Privacy Rule to state that genetic information is health information and to prohibit the use and disclosure of genetic information by covered health plans for underwriting purposes, which include eligibility determinations, premium computations, applications 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.

Title II of GINA, which prohibits employers from discriminating against employees based on genetic information, is scheduled to become effective November 21, 2009. However the Equal Employment Opportunity Commission (EEOC) has not yet issued final regulations.

More Information

• Read the interim regulation
• Frequently Asked Questions About the Genetic Information Nondiscrimination Act

How To Comment

The Interim Final Rule was issued October 7, 2009 with a 60-day comment period. This rule is online, along with directions on how to send your comments to the relevant agencies, including the Department of Labor, the Department of Health and Human Services (HHS), and the Internal Review Service, at Prohibiting Discrimination Based on Genetic Information.

You can also go to the Federal eRulemaking Portal at www.regulations.gov, enter the ID number of the document (IRS-2008-0103) and then follow the instructions there to comment.

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Last Reviewed: February 25, 2012