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This article was originally published in The Gray Sheet

Executive Summary

CLIA '88: COMPLEXITY CATEGORIZATION OF NEW TESTS BY FDA should begin "in the very near future," according to Kaiser Aziz, associate director for clinical chemistry and toxicology in the device center's division of clinical laboratory devices. Speaking July 12 at an American Association for Clinical Chemistry conference in New York City, Aziz remarked that FDA, the Centers for Disease Control and Prevention, and the Health Care Financing Administration are "trying to work out an arrangement where FDA will start the complexity [categorization] in the...very near future." FDA, CDC and HCFA share responsibility for implementing the Clinical Laboratory Improvement Amendments of 1988. Under CLIA '88, FDA is responsible for assigning complexity categorizations to new tests and for reviewing quality control labeling to determine if it meets CLIA QC requirements. FDA was expected to begin both activities in September 1992, but the agency has faced delays in starting its CLIA program. Aziz said that earlier implementation of test categorization "makes sense because then we could take care of the complexity right away, which would address the needs of the manufacturers and the laboratorians." Aziz noted that the agency would "then perhaps phase in the QC validation over time." The diagnostics industry has been urging FDA to begin categorization of new tests. In a Feb. 11 letter to HHS Secretary Donna Shalala, the Health Industry Manufacturers Association sought "appropriate action so that FDA may commence the complexity categorization process immediately." HIMA cited the "untenable situation for manufacturers," which "are not able to market products to the intended user because of the lack of a product complexity rating" ("The Gray Sheet" March 1, p. 6). Until new tests receive a complexity assessment, they are placed in the most stringent "high complexity" category. FDA also addressed the impending September 1994 deadline for full implementation of CLIA QC requirements, another major concern of in vitro diagnostic manufacturers and clinical laboratories. After Sept. 1, 1994, labs using moderate and high complexity tests may either follow FDA-cleared quality control instructions or the QC requirements spelled out in CLIA. Since Sept. 1, 1992, labs using moderate complexity tests have had the option of following existing QC labeling in order to fulfill CLIA requirements, while labs using high complexity tests have had to follow the CLIA QC instructions. Full implementation of QC requirements was delayed until 1994 to allow FDA time to review labeling of all new and existing tests. However, because FDA has not yet been able to begin its CLIA duties, reviewing the estimated 3,000-9,000 tests expected to be submitted will pose a significant challenge for the agency. Fred Lasky, PhD, Eastman Kodak Company, asked when FDA is going to decide "whether [the September 1994] deadline will hold, whether that deadline will be canceled, whether the FDA is going to do something differently. Because our lives...will change dramatically on Sept. 1 one way or another." Aziz responded that FDA is still considering several approaches and that "one option" is to extend the deadline. Another possibility "is to basically get the funds [from HCFA] in time and get the...personnel and pull them up to speed." Aziz estimated that "if that happens within the next five or six months, we should be able to deliver some 510(k) September 1994 plus or minus four or five months." FDA has been in discussions with HHS staffers for several months about ways to resolve the agency's difficulty in implementing CLIA ("The Gray Sheet" March 1, p. 6). One of FDA's problems, and the reason it has not yet begun complexity categorization or QC labeling validation, is a lack of funding from HCFA. CLIA is supposed to fund itself through laboratory user fees, but HCFA has faced collection shortfalls. HCFA staffer Judy Yost explained that the agency "had anticipated [that]...anywhere from 180,000- 220,000 laboratories" would be registered but that only 150,000 labs currently are registered. In addition, HCFA expected that 15-20% of labs would be waived. "Currently, 42% of all the laboratories are waived," Yost said, "and that means no compliance fees" from those labs. Government officials at the conference also responded to attendees questions on whether CLIA requirements would be reduced for some laboratories such as physician office labs. Ronald Feld, University of Iowa Hospital, Iowa City, asked about the "strong rumor, backed up by something Hillary Clinton said to the [American Medical Association], that physician office labs are going to be exempt from CLIA." Feld noted that "this is going to create a very difficult situation, obviously, if you have half the laboratories regulated and half not regulated." At the AMA House of Delegates meeting on June 13, Clinton spoke of the need to "simplify and eliminate the burden from regulation" created by CLIA ("The Gray Sheet" June 21, I&W-4). CDC staffer Joe Boone acknowledged that "there have been some open promises made, but there has to be legislative relief before we as an agency can do anything differently." CDC, Boone said, is "still operating under the assumption that CLIA is going to be effective for everyone." Yost added that HHS Assistant Secretary for Health Philip Lee and HCFA Administrator Bruce Vladeck "have agreed in part with recommendations that [CDC has] made to essentially streamline the program without jeopardizing any quality aspects of the requirements." CDC recommendations include a proposal to create a new test complexity categorization between the moderately complex and waived groups that would reduce personnel and facility inspection requirements ("The Gray Sheet" June 28, p. 9).

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