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HHS Offers GINA Clarifications for Health Insurance

NEW YORK (GenomeWeb News) – The US government moved closer yesterday to fully implementing rules that will protect Americans from having genetic information used by health insurers or by employers to deny them coverage, change their rates, and discriminate against them in the workplace.

These protections were made into law with the passage of the Genetic Information and Nondiscrimination Act of 2008, and the Department of Health and Human Services now has released a specific set of rules that will change the existing regulations and codes, such as those covered by the Health Insurance Portability and Accountability Act's Privacy Rule.

HHS has posted the interim final rules for a 60-day public comment period. Dealing with the sections of GINA that applies to health insurers, or Title I, the rules include definitions of the key terms on which parts of the law will rest and penalties for violating the laws.

"Consumer confidence in genetic testing can now grow and help researchers get a better handle on the genetic basis of diseases," HHS Secretary Kathleen Sebelius said in a statement. "Genetic testing will encourage the early diagnosis and treatment of certain diseases while allowing scientists to develop new medicines, treatments, and therapies."

Under GINA and the proposed rule, group health plans and issuers in the group market cannot raise premiums for the group based on results of one enrollee's genetic information, deny enrollment, exclude consumers due to pre-existing conditions, or use genetic information in other forms of underwriting. Likewise, for the individual health insurance market, GINA prohibits issuers from using genetic information to deny coverage, raise premiums, or impose pre-existing condition exclusions.

Under GINA and the new rules, insurers in both group and individual markets would be prohibited from requesting, requiring, or buying genetic information, and they are generally prohibited form asking individuals or family members to undergo a genetic test.

Using an extension of the HIPAA Privacy Rule from the American Recovery and Reinvestment Act, a use or disclosure of genetic information could result in a fine of $100 to $50,000 or more for each violation.

The rules also define genetic information, genetic services, genetic testing, and related terms and phrases. Genetic information is defined as "information about the individual's genetic tests or the genetic tests of family members… [and] family medical history." This definition also clarifies that "genetic information" does not cover information about an individual's sex or age.

The regulations also hold the statutory definition of genetic testing, in which a test "provides an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, if it detects genotypes, mutations, or chromosomal changes."

Some exceptions to the rules are proposed. For example, an insurer may request to use genetic information about an individual on payment matters for certain treatment decisions that could be informed by pharmacogenomic testing.

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