New Rules Protect Patients` Genetic Information

WASHINGTON--(Business Wire)--
Individuals` genetic information will have greater protections through new
regulations issued today by the U.S. Departments of Health and Human Services
(HHS), Labor, and the Treasury.

The interim final rule will help ensure that genetic information is not used
adversely in determining health care coverage and will encourage more
individuals to participate in genetic testing, which can help better identify
and prevent certain illnesses.

"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. "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 interim final rule with request for comments and the notice of proposed
rulemaking implement Title I of the Genetic Information Nondiscrimination Act of
2008 (GINA). Under 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. In the individual health insurance market, GINA prohibits
issuers from using genetic information to deny coverage, raise premiums, or
impose pre-existing condition exclusions.

Further, 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. Finally, plans and issuers are generally
prohibited from asking individuals or family members to undergo a genetic test.

"Today`s genetic technologies yield data that are vital to helping Americans
make personal, medical decisions. It is essential that we protect such
information and ensure it is not misused by health plans or insurers," said
Labor Secretary Hilda L. Solis. "The rules issued today protect individuals
against the unwarranted use of information related to their personal health
because no one should have to fear that disclosure of their medical data will
put their job or health coverage at risk."

Additionally, HHS, through its Office for Civil Rights (OCR), issued a notice of
proposed rulemaking with a 60-day comment period, to propose 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 published today 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.

Please visit http://www.federalregister.gov/OFRUpload/OFRData/2009-22504_PI.pdf
to view the new regulations and www.dol.gov/ebsa for more information about
them. For additional information on the OCR notice of proposed rulemaking,
please visit: www.hhs.gov/ocr/privacy.

Note: All HHS press releases, fact sheets and other press materials are
available at http://www.hhs.gov/news.

HHS Press Office
202-690-6343
or
DOL Press Office
202-693-8666

Copyright Business Wire 2009