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Lab groups assess CLIA '88 regs.

Lab groups assess CLIA '88 regs With proposals to implement the Clinical Laboratory Improvement Amendments of 1988 finally on the table, professional laboratory organizations are circling the wagons for what promises to be a lengthy regulatory struggle.

As of early July, most groups were still in the process of polling members to shape their formal comments. But the prevailing mood was one of relief, as Washington representatives finally saw the May 21 proposed regulations in black and white. "We're glad to see the proposals at last, even though we would like to have a longer comment period," said Pamela Nash, a government relations specialist with the American Association for Clinical Chemistry (AACC).

The official public comment period was set to end Aug. 20, but at press time the American Medical Association (AMA) was considering petitioning Congress for an extension. The Health Care Financing Administration (HCFA) denied an earlier extension request, and it was uncertain whether Congress would be receptive.

The picture was further muddied by HCFA's inability to produce supplemental proposals on standards for provisional certification and fees, standards for private and state accreditation programs, and penalties for non-compliance. Those provisions were still awaiting final Administration approval at this writing.

In the proposed regulatory structure, HCFA has divided all testing into three categories: exempt, Level I, and Level II. Officials determined that 28 procedures are so simple and low-risk that they require only minimal Federal regulation. Eleven procedures were designated for Level I, and the remainder fall into Level II (see Washington Report, July MLO).

It appears that most independent and hospital labs would have little trouble complying with the proposals' main provisions regarding personnel standards. But a number of controversies remain relative to proficiency testing (PT). And it appears that physicians' office labs (POLs) would be particularly hard hit by the regulations.

One of the biggest areas of concern is PT for cytology. At issue is HCFA's requirement that each individual examining gynecologic preparations be tested twice a year. Further, anyone failing a test must be provided remedial training and have at least their last 500 slides reexamined by someone who passed their most recent PT event.

Cathy Cohen, Washington office director of the American Society of Clinical Pathologists (ASCP), said her group is seeking clarification that Congress "intended to test the lab, not the individual." Returning to Capitol Hill, ASCP and other groups convinced several original CLIA sponsors to press HCFA on its cytology proposals.

In a letter to HCFA Administrator Gail Wilensky, Ph.D, Sen. William Cohen (R-Maine) said the relevant section of the CLIA statute "was not intended and should not be interpreted as mandating a minimum of two testing events per year for individuals screening slides, as is required for laboratories under proficiency testing standards."

In the House, Representatives John Dingell (D-Mich.), Barbara Mikulski (D-Md.), Henry Waxman (D-Calif.), and Ron Wyden (D-Ore.) signed a similar request for reconsideration. Their letter noted that a wide range of groups and individuals have expressed "grave reservations about the feasibility of implementing certain regulatory proposals in the area of cytology."

Conceding that the law is subject to different interpretations, the Representatives repeated their intent that cytology rules not be drawn "in such a way that the program will be unimplementable or will lead to seriously decreased access to laboratory services. For a law to be enforceable, it must be workable." The May 31 letter asked HCFA to explain its position within two weeks, but no reply had been filed by press time.

A spokesman for the College of American Pathologists (CAP) said the group has ongoing concerns that the regulations would exacerbate the shortage of cytotechnologists, noting it would be difficult for labs to retain a person who fails the stringent PT requirements.

The personnel shortage could be improved if HCFA finds a way to qualify cytotechnologists who do not meet the current independent lab requirements. Options open to comment include a grandfather provision for individuals working in hospitals prior to 1969, recognition of an accrediting agency's standards, and a qualification exam. At this writing, it was uncertain what position ASCP or CAP would take on those possibilities.

Both CAP and the American Society for Medical Technology (ASMT) are upset that HCFA intends to enforce PT by specialty and subspecialty rather than by analyte. This, they say, could cost labs their reimbursement for an entire business segment rather than for one specific test. And while HCFA may not be willing to revamp its strategy, ASMT government relations committee chair Elissa Passiment is hopeful the agency will at least make some refinements in the regulatory subspecialties.

Passiment said ASMT was pleased that HCFA retained personnel standards in its proposals, although some changes are desirable. The group sees "no reason why an MT with a baccalaureate degree and appropriate experience should not qualify as laboratory director or technical supervisor," she explained.

On other fronts, both ASMT and AACC are concerned that some waivered tests don't meet HCFA's own criteria for safe and simple procedures. "That applies to all the microscopic work because it certainly requires advanced technical skills and independent judgment," Passiment said. AACC's Nash declined to specify which tests her group might question, but she hinted that about 8 of the 28 waivered tests appear problematic. AACC is also likely to take issue with provisions that allow doctors to do emergency lab testing under specific conditions.

"At this point, we're trying to determine the size of the truck that might be driven through this loophole of waivered testing," Nash commented.

If anything, physicians are worried that this "loophole" isn't nearly big enough for most POLs to squeak through. At a late June meeting, the AMA House of Delegates passed a resolution criticizing the "very limited number of waivered tests" and citing the "negative impact of these proposed regulations on patient care and access."

The American Society of Internal Medicine (ASIM) was also drafting its comments near press time, but members expressed some long-standing reservations about the regulatory approach. ASIM trustee Stephen Kroger, M.D., said HCFA's choice of regulating by analyte instead of test methodology "is an ongoing concern, and I don't see any relief from it" in the proposals.

For example, he noted that modern POL instruments can test for a range of substances. Yet two tests might fall under different regulatory categories even though they are performed with the same instrument. Equipment suppliers share these concerns and are mounting their own lobbying efforts to produce changes.

Doctors also claim HCFA is underestimating the proposals' scope of impact on office labs. The agency has estimated 80 per cent of all POLs would fall into either the waivered or Level I category. But according to Dr. Kroger, "HCFA made a guess at that. They have no data to support it, and I don't know where they got that number."

Dr. Kroger believes that two-thirds of all POLs would fall into Level II, with its requirements for a pathologist lab director and degreed technologists. Groups of perhaps three doctors in a single specialty would be especially hard pressed to afford the personnel requirements. Dr. Kroger estimates the rules would force at least 50 per cent of all POLs to cease operation.

Even if labs could afford the personnel costs, Dr. Kroger questioned whether supply would cover demand. In his own location of Longmont, Colo., "Pathologists simply aren't available. And that's just on the director level."

Kathy Konka, government relations director for the Medical Group Management Association (MGMA) in Denver, said early indications confirm that smaller groups would be hit hard, more so by the personnel standards than waiver or certification fees. About 50 to 70 per cent of the group's members have POLs, and most with more than three or four doctors would fall into Level II, she said.

"The early consensus of our task force is that there needs to be another level between I and II," Konka explained. "There's not much reward for just being in Level I; it's not worth the effort to be in that category and only be able to do 11 more tests than a waivered lab."

MGMA can't estimate how many groups might restrict or eliminate testing. But if the regulations aren't changed, "There could be a big market for used lab equipment," Konka predicted.

Clearly, doctors will be asking themselves some important questions about their lab activities in the months ahead.
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Title Annotation:Clinical Laboratory Improvement Amendments
Publication:Medical Laboratory Observer
Date:Aug 1, 1990
Previous Article:A major crisis looms for labs.
Next Article:Lab staffing in the shortage era.

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