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Laboratories fare well under revised hospital regulations.

Laboratories fare well under revised hospital regulations

Hospital laboratories and personnel generally fared well under revised Federal regulations governing participation in Medicare and Medicaid.

The final rules, published in the June 17 Federal Register, give priority to the comprehensive needs of patients rather than cumbersome procedural requirements. The tone appears to be in keeping with Administration intentions to protect patient care while giving providers more leeway in internal operations.

Provisions with the greatest significance for laboratorians include laboratory directorship, guidelines for performing autopsies, computerization of medical records, and the definition of "physicians.'

Announcing the rules, Health and Human Services Secretary Otis Bowen stated: "These regulations are intended to simplify and clarify requirements and focus on the outcome of patient care. The emphasis is on results for the patient rather than just procedures and paperwork. This approach will promote cost-effectiveness while assuring quality of care. It will offer better protection to patients while reducing some unnecessary administrative burdens on small hospitals.'

Bowen added: "The regulations are the first substantial revisions of the conditions of participation since the inception of Medicare 20 years ago, and they reflect the many changes in medicine and hospital procedures that have taken place during that time.' The rules will directly affect some 1,500 smaller hospitals --most of them in rural areas --and nearly 7,000 facilities that participate in the two health programs.

Of greatest important to laboratorians are provisions affecting hospital lab directorship and other personnel requirements. The rules contain both good news and bad news, depending on your level of professional training.

During a public comment period, the Health Care Financing Administration received input from two generally opposed camps. One argued that hospital labs should be directed by a doctor of medicine or osteopathy, due to the medical nature of decisions in the lab. The other camp favored direction by personnel with doctoral degrees in other areas, in part because technical supervision and the ability to interpret tests require specialized knowledge rather than specific credentials.

In response, HCFA made a distinction between services that must be supervised by a doctor of medicine or osteopathy, and those that can be directed by a lab specialist with a doctoral degree. For example, anatomical pathology services must be supervised by a pathologist, and transfusion services must be supervised by a pathologist or other doctor of medicine or osteopathy trained in that discipline.

HCFA noted: "We have not adopted the comment suggesting that we include a general provision that would allow nondoctoral scientists to serve as directors at this time.'

The latter statement thwarted the hopes of some professional groups that had submitted comments. Lynn Podell, director of the American Society for Medical Technology's Washington office, said: "We are disappointed that the lab director standard was left at the status quo, but we're hopeful that over the next year the standard will be modified.'

Officials did, in fact, leave the door open to later modification. As they noted: "The Department currently has under way a thorough review of all clinical laboratory regulations. During the next year, we will be proposing regulatory and other reforms intended to reduce regulatory burdens, remove inconsistencies, and eliminate unnecessary credentialing requirements while continuing to insure patient health and safety.'

Loosely translated from bureaucratese: "We already have a lot of research on clinical labs in hand, but we's not yet sure what we're going to do with it.'

Nonpathologists did gain one measure of immediate satisfaction in a provision eliminating preferred status for the American Society of Clinical Pathologists' certification of lab personnel. That was included "in order to permit fair competition for technologist positions by otherwise qualified nonregistered professionals,' according to HCFA.

ASMT's Podell noted her group has "long argued that was an artificial preference, and that there are a variety of options available for certification. We're just happy to see it formalized.'

Still, other Washington analysts representing pathologists opined the provision would have little practical impact. One commented that the private sector has effectively decided which certification standards are appropriate to a given instance, thus leaving the Government proclamation moot.

Virtually all laboratory personnel can take heart in new rules affecting autopsies and medical record keeping.

Regarding the former, HCFA, in essence, agreed with professional comments on the importance of autopsies in advancing medical knowledge. The original proposal would have deleted the requirement for the procedure in certain situations, since it usually requires consent from the next of kin.

But according to the final rule, HCFA "agrees with commenters' statements on the value of autopsies and we are convinced that autopsies are an essential educational tool that contributes to the quality of care furnished by a hospital. Therefore we have revised the regulations to require that the medical staff should attempt to secure autopsies in all cases of unusual deaths and of medicolegal and educational interest.'

Other sections of the 30-page, fine-print regulations now permit the signing of medical records either in writing or by computer entry. Association officials believe this permission will be of great help to laboratory managers who are increasingly turning to computers for their record keeping.

At the same time, HCFA acknowledged professional concerns over assumed computer sophistication. Final language requires "timely' rather than "immediate' retrieval capabilities, thus allowing some leeway for different technical capabilities.

In other provisions, effective Sept. 15, HCFA clarified its use of the term "physician' in medical staff requirements. Revision was primarily a concern of the American Medical Association, although changes were supported by groups including ASCP.

Originally (January 1983), the agency sought to reduce confusion in references to "physicians,' specifying the term as including dentists, podiatrists, optometrists, and chiropractors.

After reviewing public comments, the agency decided its terminology would create more, not less, confusion regarding which practitioners might perform certain services. Therefore, it stated: "We have revised the final regulations to eliminate the use of the term "physician' and to state more specifically which categories of practitioners will be permitted to perform certain functions and actions.' For example, some services must be supervised by a pathologist, as noted in requirements for lab services.

In most instances, HCFA will replace the term "physician' with "medical staff,' in order to give hospitals maximum flexibility in granting privileges and organizing their professional staff. However, the agency did stipulate that the director of that medical staff be a doctor of medicine or osteopathy, and rejected some recommendations that those duties may be handled by a committee. The latter idea was rejected on grounds that a division of responsibilities could lead to inconsistent application of health care standards.

Ruling may allow challenges to payment methods

Medicare Part B providers were buoyed by a recent Supreme Court decision that might pave the way for legal challenges to HCFA payment methodologies.

In Bowen v. Michigan Academy of Family Physicians (No. 85-225), the Court ruled that providers may not challenge individual amounts in reimbursement claims but may attack the methods by which those pay rates were computed.

A majority opinion states that HCFA's authority to administer the complex Medicare program "carries with it the correlative responsibility to explain the rationale and factual basis for its decision, even though we show respect for the agency's judgement in both.'

The specifics of the recent case aren't germane to clinical lab services. But legal analysts in Washington believe the ruling opens the door to challenges from other categories of Part B providers. Many such professionals, including those in the home health care industry, have been rankled by what they perceive to be HCFA's arbitrary rate slashing in the name of cost containment.

The decision "changes the basic landscape' of Part B judicial review, according to one Washington attorney versed in health care issues.
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Title Annotation:column
Publication:Medical Laboratory Observer
Article Type:column
Date:Aug 1, 1986
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