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CLIA issues help unify lab groups.

An interesting display of cooperation is marking government relations in Washington as laboratory organizations crystallize their priorities for 199 1.

Still at center stage are the Clinical Laboratory Improvement Amendments of 1988, but the winding path toward implementation has aligned some unlikely bedfellows. Specifically, some professional groups feel they have been trampled by factions seeking to delay full CLIA implementation, and they are responding with special efforts to clarify their positions. The process is pointing up some other areas of common ground that may result in a more united front as groups work with the Government this year.

The recent chain of events links back to the National Congress on CLIA '88 held in Washington last August. The two-day meeting, hosted by the National Committee for Clinical Laboratory Standards, drew some 300 participants into discussions on what aspects of the proposed CLIA regulations should be modified before they are finalized. A summary of key findings and a complete transcript of those discussions were presented to the Health Care Financing Administration before the end o the public comment period.

Although the NCCLS congress had to be arranged quickly, it generally received high marks from attendees for providing a valuable industry forum. Later, however, some groups found fault with the messages being given to HCFA.

In early September, George D. Lundberg, M.D., president of the American Society of Clinic thologists, addressed some of those issues in a letter to NCCLS President David Jeffers. ASCP, Lundberg wrote, "is dismayed and deeply concerned" about the summary of key findings.

"In particular," said Lundberg, "we do not believe that there was a very strong feeling that the concept of site neutrality is basically flawed.' To the contrary, site neutrality is a major element of the legislative intent of CLIA 88 and a requirement which Congress felt was demanded by the citizens. Had such a statement been presented at the plenary session, ASCP and others would most certainly have dissented. "

While Lundberg called the conclave "a monumental and worthwhile effort," he encouraged NCCLS to withdraw and revise the summary document.

Similarly, a group of 40 meeting participants issued a letter of concern to HCFA Administrator Gail Wilensky, Ph.D., in midOctober. It said that they "most emphatically disagree with the [congress summary] statements suggesting that the concept of site neutrality is flawed. To the contrary, we believe that patients are entitled to quality laboratory testing, regardless of where that testing is performed. We believe that 'site neutrality,' as implemented by CLIA 88 regulations, is essential in insuring that the goal is reached. "

That letter was signed by individuals from such groups as the American Society for Medical Technology, American Association of Bioanalysts, International Society for Clinical Laboratory Technology, and ASCP.

Other tremors were felt when certain HCFA officials made it known they favor the issuance of a new notice of proposed rulemaking (NPRM) that would reflect the many changes being considered for CLIA.

In last fall's budget debate, Sen. Don Nickles (R-Okla.) pushed for a provision that would delay a complete rollout of CLIA, expressing concern that the law could jeopardize access to lab services in rural areas. Nickles specifically asked that the Administration complete a study on the correlation between established personnel standards and the accuracy and reliability of test results.

Nickles's proposal did not make it into the final budget reconciliation bill, but it did surface in language in the Senate Appropriations Committee report. Thus, while the provision does not carry the weight of law, sources suggest it was enough to further encourage a slowdown at HCFA.

On Nov. 20, 11 lab associations sent a letter to Wilensky asking for a meeting to discuss their concerns. While each group has its own problems with the particulars of CLIA 88, they do not want to see the regulations opened up to a new NPRM. The proposed regs drew more than 45,000 public comments, and some representatives fear a new process would indefinitely delay bringing certain segments, such as POLS, under regulation. This, they argue, would create an uneven playing field for labs that are already regulated.

"As you are aware," the letter to Wilensky stated, major portions of the proposed CLIA 88 rule (quality assurance, quality control, patient test management, and cytology) are already in effect for 12,000 hospital and independent laboratories. In addition, the CLIA 88 sections on proficiency testing go into effect for most of our laboratories on Jan. 1, 1991.

"While we can appreciate that HCFA wishes to assure that the public has a full opportunity to participate in the notice and comment process, we are also concerned that still further delay in the implementation of CLIA is not in the public interest."

The letter was endorsed by the AAB, ASCP, ASMT, ISCLT, American Association for Clinical Chemistry, American Clinical Laboratory Association, American Medical Technologists, American Society of Cytology, American Society for Cytotechnology, American Society for Microbiology, and Association of State and Territorial Public Health Laboratory Directors.

The prospect of further delay puts regulated labs in a tricky situation, given that each has its own vision of how the final rules should be amended-particularly with regard to personnel requirements.

"We don't want to be in the possition of demanding implementation of this terrible rule, but not implementing it soon leaves 12,000 labs in a very bad position," says Cathy Cohen, director of ASCP's Washington office. Her contacts indicate strong sentiment at HCFA for a new NPRM, although Wilensky reportedly favors issuing final rules this summer.

The Nov. 20 letter also repeated the claim that many in the lab community support site neutrality, despite the summary findings from the CLIA congress.

Commenting on the results of that meeting, AAB's Mark Birenbaum, Ph.D., says, "Some of the professional associations felt they were being dominated by some components, namely the doctors and manufacturers. . . . There was no program at that conference to fully debate whether the concept [of site neutrality] is flawed. "

Jeffers of NCCLS said there would be no effort to withdraw or revise congress findings, but the group did send HCFA a letter noting some dissension and pledging to forward all letters of complaint it receives. Jeffers, meanwhile, continues to believe the congress accomplished what it set out to do. "We said out front it would not be a consensus conference, and nothing that was enacted and went to HCFA was intended to reflect a consensus." He says the key findings were an attempt to summarize areas of essential agreement, and maintains the report was reasonably accurate, since no binding votes were taken.

At this writing, there was no indication whether Wilensky would agree to the meeting requested by the lab groups. But officials remained hopeful and noted that the unanimity itself was encouraging.

"I think it's significant that this many groups representing the lab industry would get together to express their concerns about the direction of CLIA implementation," says attorney Bob Waters, an AAB Washington representative.

Can officials from the 11 groups gather in one room with Wilensky without turning it into a free-for-all on specific revisions? Having helped coordinate the first letter and being familiar with the individuals involved, Waters is confident they can present a cohesive message. The very process of working together on even one or two issues may highlight other areas where leading lab groups have common concerns.

For example, there is a widely shared worry that the Administration will revive some form of competitive bidding demonstration project. Variations on the theme first advanced several years ago are reportedly gaining increased attention at HCFA. It may take a coalition-strength effort to keep the idea on ice.

Further, all lab groups will be keeping tabs on the effect of new Federal budget rules. In the fiscal 1991 agreement, Congress passed a three-year suspension of the Gramm-Rudman law on deficit reduction.

Instead, discretionary spending such as that for defense must meet specified targets or face automatic reductions. Meanwhile, entitlement programs such as Medicare and Medicaid will encounter a payas-you-go mechanism. The latter means that if Congress passes any benefit expansion without raising taxes or cutting spending elsewhere to pay for it, entitlement programs will suffer automatic, across-the-board reductions.

It remains unclear what specific effect the new rules might have in the next round of budget negotiations. The implications could emerge as another rallying point for lab groups as they uniformly try to fend off additional reimbursement cuts. n
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Title Annotation:Clinical Laboratory Improvement Amendments
Publication:Medical Laboratory Observer
Date:Jan 1, 1991
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