IVD Technology Magazine
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Originally published March, 1998

IVD Technology News

Coalition calls for CLIA reforms

If you thought reforming FDA was an uphill battle, consider the complexities involved in improving the functioning of the agencies involved in administrating the Clinical Laboratories Improvement Amendment of 1988.

That's the apparent goal of the Partners for Public Health and Government Efficiency, a coalition of manufacturers that is now preparing a citizen's petition to request that the Centers for Disease Control and Prevention (CDC) and the Health Care Financing Administration (HCFA) "initiate negotiated rule making to better define the process for the categorization of waived tests" under CLIA. If successful, the petition would force the agencies to abandon the notice-and-comment rule making they began in September 1995 (Federal Register, 60 FR 47534—47543), replacing it with a rule-making committee that would include "laboratory groups, medical professional societies, patient groups, and manufacturing associations."

According to primary author Bradley Merrill Thompson, of the law firm of Baker & Daniels (Indianapolis), the petition's primary goal is to reform the administrative procedures relating to CLIA. "The procedures now being used restrict timely and useful comment, and can too easily result in rules that do not meet current needs. We'd like to see CDC and HCFA working with the public to come up with a more reasonable approach."

The draft petition offers a number of grounds for its acceptance, beginning with "the new structure of the health-care system, changes in technology, and the industry's experience with the guidelines that embody the proposed rule." It also argues that changes in the statutory framework—including passage of the FDA Modernization Act of 1997—have altered the basis for the agencies' proposed rules, making it necessary to start over.

The coalition sharply criticizes CDC for misinterpreting CLIA requirements and refusing to automatically grant waived status to tests that FDA had previously cleared for home use—an issue that was the subject of a revision in the modernization act. Nevertheless, the coalition stops short of recommending that responsibility for categorizing the complexity of laboratory tests be returned to FDA (a suggestion that garnered some support in the Senate last year).

At press time, the IVD task force of the Health Industry Manufacturers Association was said to be examining a draft of the petition to determine whether to throw its weight behind the reform move. But with seats at the negotiating table at stake, the petition seems destined to gain widespread support from a variety of interested parties.—Steve Halasey