Feds Issue Genetic Testing Protections

October 2, 2009 (PLANSPONSOR.com) - Federal regulators have issued new rules giving Americans greater protections to shield them from having their genetic information used against them in the insurance market.

A news release said an interim final rule will help ensure genetic information is not used adversely in determining health care coverage and will encourage more individuals to participate in genetic testing. The new rules are designed to implement Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA).

According to GINA, and the interim final rule, group health plans and issuers in the group market cannot:

  • increase premiums for the group based on the results of one enrollee’s genetic information;
  • deny enrollment;
  • impose pre-existing condition exclusions; or
  • do other forms of underwriting based on genetic information.

Also, under GINA and the new interim final regulations, group health plans and health insurance issuers in both the group and individual markets cannot request, require, or buy genetic information for underwriting purposes or prior to and in connection with enrollment.

“Echoing the late Senator Ted Kennedy, our efforts to protect Americans undergoing genetic testing from having the results of that testing used against them by their insurance companies is one of the ‘first major new civil rights’ of the new century,” said HHS Secretary Kathleen Sebelius, in the news release. “Consumer confidence in genetic testing can now grow and help researchers get a better handle on the genetic basis of diseases. Genetic testing will encourage the early diagnosis and treatment of certain diseases while allowing scientists to develop new medicines, treatments, and therapies.”

The news release said HHS also issued a notice of proposed rulemaking, with a 60-day comment period, to proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule to prohibit health plans from using or disclosing genetic information for underwriting purposes.

The proposed rule modifies the HIPAA privacy rule pursuant to GINA Title I to clarify that genetic information is health information and to prohibit the use and disclosure of genetic information by covered health plans for 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. 

In combination with the new penalties for violations of the HIPAA privacy rule as provided for by the American Recovery and Reinvestment Act of 2009, a use or disclosure of genetic information in violation of the HIPAA privacy rule could result in a fine of $100 to $50,000 or more for each violation.

More information is available here .