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Feds Issue Genetic Testing Protections
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
.