New Rules Protect Patients' Genetic Information

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.

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FDA Issues Final Regulation on Dental Amalgam

The U.S. Food and Drug Administration yesterday issued a final regulation classifying dental amalgam and its component parts – elemental mercury and a powder alloy—used in dental fillings. While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients.

The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.

The special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.

Specifically, the FDA recommended that the product labeling include:

* A warning against the use of dental amalgam in patients with mercury allergy;
* A warning that dental professionals use adequate ventilation when handling dental amalgam;
* A statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.

Dental amalgam is a “pre-amendment device,” which means that it was in use prior to May 28, 1976, when the FDA was given broad authority to regulate medical devices. That law required the FDA to issue regulations classifying pre-amendment devices according to their risk into class I, II, or III. Although the FDA previously had classified the two separate parts of amalgam – elemental mercury and the metal powder alloy – it had not issued a separate regulation classifying the combination of the two, dental amalgam. During this time, however, dental amalgam has been subject to all applicable provisions of the law.

Yesterday’s regulation also reclassifies the mercury component of dental amalgam from Class I (low risk) to Class II (moderate risk).

Over the past six years, the FDA has taken several steps to assure that the classification of dental amalgam is supported by strong science.

In 2002, the agency issued a proposed rule to classify dental amalgam and identify any special controls necessary for its safe and effective use.

Due to a high number of comments on that rule, the agency held an advisory committee meeting in 2006, inviting dental and neurology experts to review existing scientific data on dental amalgam, especially with regard to its toxicity in pregnant women and children.

The agency drafted a review of recent and relevant peer-reviewed scientific literature on exposure to dental amalgam mercury. The advisory committee asked that the agency conduct an even deeper review of the scientific literature on this topic. In all, the agency considered some 200 scientific studies.

On April 28, 2008, the FDA reopened the comment period on the 2002 proposed classification in order to elicit the most up-to-date comments and information related to classification of dental amalgam. Today’s rule reflects the years of agency review on this topic.

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