TRENDS & PERSPECTIVES
At a recent meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC), CMS officials announced that the agency decided not to publish a draft proposed rule on creating a genetic testing subspecialty. The reasons given for this decision included concerns raised by the Department of Health and Human Services (HHS) such as ethical, social, and legal issues related to the Clinical Laboratory Improvement Amendments (CLIA).
Judy Yost, director in the division of laboratory services at CMS, said that “CMS determined that there would not be CLIA genetic testing standards for the following reasons: a CLIA regulation would not resolve the problem that genetic tests are not currently FDA approved, and therefore not necessarily clinically validated. CLIA regulation would also not address the concern that there is currently no proficiency testing for such tests, since there are little or no proficiency testing materials available for these tests at this time. In addition, CMS has no data that indicate there are any more problems in genetic testing labs compared to labs performing other types of tests.”
In response to CMS’s decision, the Genetics and Public Policy Center, Public Citizen, and Genetic Alliance submitted a joint petition for rulemaking to CMS. According to the petition, better oversight of genetic testing laboratories by CMS is “critical to ensuring the quality of genetic testing in the United Sates,” and failure to provide it “poses a risk to the public’s health.”
“The promise of genetics to improve health and healthcare will not be realized unless laboratories performing genetic tests provide accurate and reliable test results,” the petitioners declared.
The petition pointed to nearly a decade of inaction by CMS in developing a genetic specialty, despite numerous calls by government advisory bodies and expert committees to do so. In April 2006, HHS placed issuance of a proposed rule for a genetic testing specialty on its regulatory agenda for completion by November. Many organizations received assurances that CMS would finally create a genetic specialty under CLIA. However, in July 2006, CMS reneged on those assurances in communications with Genetic Alliance and discussions with the Genetics and Public Policy Center.
Some analysts believe that CMS’s decision could be detrimental to IVD manufacturers and harmful to the development of genetic tests.
“CMS’s decision will have a negative effect on the IVD industry and the laboratory industry,” says Jeffrey N. Gibbs, JD, director at Hyman, Phelps & McNamara (Washington, DC). “Many groups had expected the creation of a genetic subspecialty. If adopted, it would have led to greater public confidence in genetic testing.
But CMS’s failure to create the subspecialty subjects CMS to heavy criticism, and unnecessarily generates controversy regarding the adequacy of federal regulation of genetic testing. In addition, CMS’s decision has cast genetic testing in a negative light in the public domain, with attendant negative publicity. This could have easily been avoided if CMS had moved forward with the subspecialty as expected.”
Other analysts feel that finding the right balance between establishing proper regulations and satisfying the needs of IVD manufacturers will be challenging.
“Holding off on instituting a proposed rule on creating a genetic testing subspecialty under CLIA reflects the real difficulty for CMS to issue a clear mandate that will provide for quality results in the labs while maintaining a reasonable incentive for the IVD industry to continue to develop important genetic tests,” says Katie M. Smith, PhD, director of medical research at Biogen Idec Inc. (San Diego).
