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CLIA '88 lurches ahead as Congress prods.

Federal regulators insist they are making headway in implementing the Clinical Laboratory Improvement Amendments (CLIA) of 1988, despite Congressional charges that the agency is dragging its feet.

The latest target date for effective CLIA rules is approximately May 1992, according to Health Care Financing Administration (HCFA) chief Gail Wilensky, Ph.D. "We have worked hard on these laboratory regulations and have made steady progress," she testified before the House Energy and Commerce Subcommittee on Oversight and Investigations.

Wilensky and other Administration representatives were clearly playing defense at the hearing as they faced some tough rhetoric from panel chairman John Dingell (D-Mich.).

"Today not one component of [this] critical legislation is in place. Indeed, many of the questions we will be asking today are the very same questions that I and my colleagues asked in 1988," Dingell said in an opening statement. Among the Congressman's specific complaints: * Information on the problems in laboratory testing remains sparse, largely because HCFA has failed to complete any of the five studies that were to be the basis of the regulations. * HCFA's "bureaucratic paralysis" is catching. Many states have adopted a "wait and see" attitude before moving ahead with their own form of laboratory regulation. * The workability of the proposed regulations is suspect, with portions of the four main components said to contradict each other. * Regulation of physician office laboratories (POLs) may be ignored through a "back-door method of manipulating the waiver provision" in the law. Dingell suspects that the Office of Management and Budget (OMB) may be pushing to exempt POLs due to the high cost of regulating them.

OMB official James MacRae testified that the agency filed written comments with HCFA mainly because it had "significant concerns regarding the proposed rules' implications for quality of care, access to care, and cost containment." He further denied that OMB is stalling the rule-making process, stating that the agency completed its review of the four CLIA components in an average of 37 days each.

For her part, Wilensky detailed the huge task of analyzing nearly 60,000 comments it received on the main portions of the CLIA proposals. The biggest challenge ahead, according to Wilensky, is resolution of the three-tiered complexity model that lies at the heart of CLIA '88.

The proposed regulations anticipated that most Level II labs (those performing complex tests and confronting extensive personnel standards) would resemble the traditional independent lab, said Wilensky. But HCFA learned through comments that many small labs, including POLs, are able to conduct a wide range of tests with sophisticated but easy-to-operate equipment. Hence most of those facilities would fall under Level II requirements.

On the other hand, Wilensky said, many technical experts are concerned over excessive reliance on "goof-proof" instruments operated by unskilled persons.

"Our challenge is to weigh these comments and try to find accommodation for the small laboratories without compromising the quality of laboratory testing." Wilensky told Congress.

A main problem with the proposed regulatory scheme has been a lack of consensus in the scientific community over which tests belong in the waivered, Level I, and Level II categories.

The Centers for Disease Control, with primary responsibility for development of the complexity model, originally took the position that no tests should receive a regulatory waiver. But the proposed regs ultimately placed 28 tests in that category.

The reversal became a bone of contention for Dingell, who compared the change to the lightning bolt that struck Saint Paul on his way to Damascus. William Roper, M.D., director of the CDC, explained that the proposal on waivered tests was more like a trial balloon and acknowledged that alternatives to the current model were being explored.

Roper observed that providers in rural areas and public health agencies in particular have raised concerns over the complexity model's effect on access to care and vital prevention programs. "CDC, as the nation's prevention agency, will be sensitive to these concerns, as well as to those expressed by the private sector," he said.

One refinement endorsed by the American Medical Association (AMA) is the addition of a Level "A" unique to POLs. Under the plan outlined at the hearing, a physician would interpret tests directly and supervise all involved personnel. The testing would be consistent with the doctor's specialty, training, and experience and would be done only on the physician's own patients. The lab would be required to participate in a proficiency testing (PT) program.

Administration officials estimated that final rules on the complexity model would be issued next winter, and would take effect four months after publication.

Other components of CLIA '88 are on a faster track (see Figure I). For example, final rules on user fees were expected out near press time. Once published, Wilensky said HCFA would notify some 640,000 labs and ask them to apply for two-year provisional certificates at a cost of $261.

Through that process, HCFA expects to raise a substantial pool of start-up money for CLIA regulation. But Dingell, who helped write the statute, questioned HCFA's legal authority to issue such certificates before the standards are in place. His remarks fueled speculation that the AMA or some other group might challenge the agency in court.

Other action is forthcoming on CLIA deeming authority, under which private, nonprofit accreditation organizations or state licensure agencies can qualify to approve laboratories. Wilensky reported that public comments have been reviewed and that final rules would be issued in October.

The HCFA administrator also noted that the comment period on proposed enforcement sanctions or penalties closed June 3, with final rules expected by winter.

The House subcommittee hearing, the first in a series that will keep HCFA's feet to the fire, presented another chance for groups to repeat ongoing concerns over the proposed CLIA regulations.

Loyd R. Wagner, M.D., president of the College of American Pathologists, said the CAP continues to oppose personnel standards below the technical supervisor level. If additional standards were adopted as is, "Many laboratories would be forced to close because of high costs or the inability to find personnel meeting the proposed qualifications," he said. "Physician office laboratories and rural hospitals will find it extremely difficult if not impossible to meet the requirements. The consequences will be reduced patient access, increased cost, and delays in reporting results."

Wagner also repeated charges that testing 20 slides in each PT event for cytology twice a year is excessive and not required by the CLIA statute. In addition, he said that the 500-slide rescreening requirement following a PT failure would be unnecessarily disruptive to laboratories.

"The above requirements should be eliminated because they have no scientific validity, do not improve the quality of cytology services, and are excessively punitive," Wagner claimed. "They would force laboratories to either discontinue this service or substantially increase backlogged cases because screeners would have to spend their time rescreening previously reviewed slides."

CDC's Roper noted the general concern that the proposed rules place too much emphasis on PT performance as a yardstick. Many in the lab community, he acknowledged, contend that if labs adhere to other regulations, such as personnel standards and quality control and quality assurance provisions, the need to rely on PT performance is reduced.

Roper and Wilensky hinted that personnel requirements and PT provisions would be among the changes considered before final implementation of CLIA '88.

Roper stated that launching the five impact studies mandated by CLIA "has proven difficult because of the breadth of the questions posed." He noted, however, that the main contractor is scheduled to present final design and implementation plans by Dec. 31, with a completion target of early 1992. In the interim, the AMA and three other health industry groups are sponsoring a separate analysis of CLIA's effects. Their report is due this October.
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Title Annotation:Clinical Laboratory Improvement Amendments of 1988; includes timetable
Publication:Medical Laboratory Observer
Date:Jul 1, 1991
Previous Article:To document performance, put it in writing.
Next Article:How ethical dilemmas induce stress.

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