DELAY OF EFFECTIVE DATE FOR CLIA QUALITY CONTROL REQUIREMENTS UNDER CONSIDERATION; AGENCIES TO BRIEF SHALALA ON CLIA IMPLEMENTATION PROBLEMS

A delay of the effective date of the quality control requirements of the Clinical Laboratory Improvement Amendments of 1988 is one of several topics expected to be discussed at an upcoming meeting between HHS Secretary Donna Shalala and officials from FDA, the Health Care Financing Administration and the Centers for Disease Control and Prevention. The briefing, which is expected to occur in the next several weeks, will focus on problems with implementation of CLIA. The FDA, HCFA and CDC staffers are planning to present several possible strategies for overcoming implementation difficulties, including changing CLIA regulations in order to delay the effective date for laboratory QC requirements. The QC requirements are slated to go into effect on Sept. 1, 1994. Delaying the date would provide FDA with additional time to review 510(k)s for in vitro diagnostic quality control labeling, a process that is supposed to be completed before the effective date. Initially, FDA was expected to begin the labeling review on Sept. 1, 1992, the start of a two-year "phase-in" period designed to allow FDA time to clear labeling of new and existing tests. However, because of problems in gearing up for the new program, FDA staffers now say reviews are not likely to begin before September 1993. Under CLIA, FDA's Center for Devices and Radiological Health is charged with reviewing IVD instructions to determine if they can serve as an alternative to many of the QC requirements outlined in CLIA regs. The agency is expecting that because of market forces, most IVD firms will try to obtain the labeling clearance. As a result, FDA is estimating that it will receive as many as 9,000 510(k)s from manufacturers seeking labeling clearance for existing tests. Without an extension, FDA will be hard-pressed to complete the reviews by September 1994. Delaying the effective date has the support of the Health Industry Manufacturers Association. In a Feb. 11 letter to Shalala, HIMA asks the department to "allow FDA an additional two years from the Sept. 1, 1994 deadline." HIMA maintains that "not only would an extension allow FDA to spread the resource demands over a longer period of time, it would provide a more reasonable framework for the review of up to 10,000 product applications expected under CLIA." One of the reasons FDA has not initiated CLIA labeling reviews is that its efforts to hire additional staff for the program have been stymied by a lack of funding from the Health Care Financing Administration. HCFA has lead responsibility for implementing CLIA and is collecting user fees from laboratories to fund implementation of the regs. While some funds have been transferred to FDA, the agency has not received roughly $1 mil. for hiring staffers that was expected several months ago. As a result, CDRH has suspended CLIA recruiting activities initiated in late 1992. Underfunding of the CLIA program overall, as well as conflicting HHS funding priorities, are the principal reasons why FDA has been given the additional resources, according to HCFA. HCFA says the entire CLIA program currently is underfunded because Congress did not appropriate start-up funds and user fee collection has not yet begun in earnest. In addition, HCFA is placing top priority on implementation of the laboratory inspection program, which is scheduled to be fully under way in March. HCFA also has had to pay a group of contractors that is collecting the user fees and setting up databases. In its Feb. 11 letter to Shalala, HIMA says it is "very concerned about FDA's ability to fully implement its new procedures under CLIA without sufficient and sustainable funding." HIMA notes that "the resource demands on FDA to procure new equipment and adequately staff and train new employees [for CLIA] are substantial." The association adds: "It is not unreasonable for FDA to be reluctant to proceed with CLIA without some level of financial commitment or permission to revise the program. FDA should be granted the funding promised by the Department to carry out its CLIA responsibilities." HIMA makes several additional suggestions for how FDA could overcome difficulties in implementing CLIA. For example, the association suggests "streamlining" FDA's labeling review program "by focusing on new, rather than on both existing and new products." HIMA feels that QC instruction validation requirements could be eased for existing products because their adequacy has been demonstrated through use by labs. FDA's draft guidance document on CLIA 510(k)s proposes less stringent validation requirements for many existing tests, but does not eliminate them ("The Gray Sheet" Jan. 18, p. 3). In addition to delays in reviewing QC labeling, another concern of HIMA's is FDA's program for determining test complexity categorizations for new tests. The association maintains that "FDA has not performed complexity categorizations on any new products cleared for marketing" since Sept. 1. HIMA says that roughly 225 new tests have been cleared since that date. "Apparently, FDA is not prepared to initiate the complexity categorization process [for new tests] until funding is forthcoming." CDC is responsible for categorizing existing tests. HIMA explains that "products without complexity ratings may be used only by laboratories that meet CLIA's most stringent requirements for 'highly complex' tests." HIMA says it "has heard from a number of our members who are not able to market products to the intended user because of the lack of a product complexity rating," which "creates an untenable situation for manufacturers." The association implores HHS "to take appropriate action so that FDA may commence the complexity categorization process immediately." HIMA's statements regarding FDA's categorization efforts appear to conflict with a description of the program provided in November by Thomas Tsakeris, director of the division of clinical laboratory devices in the device center's office of device evaluation. At that time, Tsakeris stated that roughly 70 new tests had been categorized since September ("The Gray Sheet" Nov. 23, 1992, p. 3). However, HIMA says that if FDA has made categorization decisions, it has not disclosed them to manufacturers. Tsakeris said in November that FDA was planning to issue a Federal Register notice by January that would list any additional categorizations. The agency has not yet published the notice. In addition to discussing a delay of the effective date for the QC requirements, Shalala and the Public Health Service officials also may consider the withdrawal of FDA from the CLIA program at their upcoming meeting. In its letter to the secretary, HIMA emphasizes that it would not support FDA's withdrawal. Because the responsibility for reviewing QC labeling would be transferred to another agency, HIMA believes that CLIA would "serve as a 'gatekeeper' for new technology by requiring another layer of regulatory review before [IVD] products can be sold to customers." HIMA adds: "Pledging FDA's participation will help ensure that these products receive the proper regulatory review, without creating unnecessary and duplicative processes within the Department." HIMA concludes that "with the exception of the unresolved issues related to complexity categorizations," it "generally has been pleased with FDA's progress to date and appreciates FDA's efforts to work with manufacturers in a cooperative and constructive fashion." The association adds: "The challenge now is for FDA's CLIA program to proceed in a practical and expeditious manner."