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Final (?) CLIA regulations create new testing category.

FINAL REGULATIONS implementing the Clinical Laboratory Improvement Amendments of 1988 create a new certificate category for physician-performed microscopy procedures and add a ninth test to the list of "waived" procedures.

The parting shot from the Bush Administration was published Jan. 19--the day before President Clinton was sworn in--and became effective on that date, although public comments are being accepted through March 22.

Perhaps the most significant change from the previous "final" CLIA regs issued Feb. 28 of last year involves the certificate for physician labs performing six microscopic tests. They are: wet mounts, including preparations of vaginal, cervical, or skin specimens; all potassium hydroxide preparations; pinworm examinations; fern tests; post-coital qualitative exams; and urine sediment exams.

Although the six tests are still technically considered to be of "moderate" complexity, physician labs performing them may now apply for a special two-year operating certificate that costs $150. Labs holding these certificates, which allow performance of any or all six microscopy exams plus any or all waived tests, will not be subject to routine inspections. They will, however, be held to personnel standards that are more stringent than those for laboratories performing tests of moderate complexity.

Specifically, labs in the new category must have a physician serve as laboratory director. The tests must be performed personally by the doctor on his or her own patients, or patients of a group medical practice to which the doctor belongs. A lab that has non-physicians performing these tests may not take advantage of the new category.

The Health Care Financing Administration (HCFA) explained its offset to the inspection requirements of CLIA this way: "Because physicians have extensive medical training greater than that required by these regulations for personnel performing moderately complex tests, and because these tests are done in the context of a patient examination, we believe there is assurance that accuracy of testing can be maintained despite the lack of routine inspections."

HCFA officials say they made the changes after doctors and others convinced them that the microscopy tests "have unique characteristics that are not adequately addressed within the moderate complexity category." For example, specimens for the tests are labile and need to be examined immediately so the accuracy of the results is not compromised. What's more, there are no recognized quality control procedures available for these tests.

Another key change in the regulations adds a ninth test to the list of those procedures qualifying for a certificate of waiver, following a recommendation by the Clinical Laboratory Improvement Advisory Committee. HCFA refers to it generically as "hemoglobin by single-analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout."

HCFA determined that such test systems, previously slotted as moderately complex, fit the requirements for waiver. That is, they are simple and accurate with little or no likelihood of an erroneous result, and pose scant risk if performed incorrectly. Currently only one instrument, the Swedish product Hemo-Cue, is believed to satisfy HCFA's description. But some observers think the waiver could crack open the door to other manufacturers with similar systems.

Following is a rundown of other significant CLIA '88 changes detailed in the Jan. 19 Federal Register:

* HCFA has modified its definition of "physician" to include licensed podiatrists, allowing them to serve in the same personnel categories as doctors of medicine and osteopathy.

* Dentists qualified in pathology may now serve as laboratory directors or technical supervisors in the area of oral pathology.

* A delay is continued for the effective date of on-site supervision of high complexity testing personnel, pending further study by HCFA. Such personnel may still perform in the absence of that supervision, provided their work is checked by the general supervisor within 24 hours.

* Individuals who qualified, or could have qualified, as general supervisors under the March 14, 1990, regulations may still perform in that capacity. This adjustment recognizes the credentials of those individuals who have successfully participated in a Government examination that was discontinued in 1987.

* Both announced and unannounced inspections will be allowed, consistent with statutory authority.

* Hospitals with various buildings on the same campus may hold a single certificate, as long as the buildings are contiguous. If a large hospital has several campuses (several miles apart, for example), a separate certificate for each campus would be required.

* CLIA implementation affecting workplace drug testing will be delayed pending further investigation by HCFA.

* Cytology slide preparations need not be evaluated on site and may be referred to another appropriately certified laboratory for consultation or evaluation.

Politically, the rules creating a new certificate for physician microscopy testing survived several rough-and-tumble final days of the Bush Administration. Some physician camps wanted the new category to embrace a broader range of tests and sought to hold out in prospect of a better deal from President Clinton. Others saw the window of opportunity closing and pressed for the bird in hand.

Groups representing nurses and other clinicians also resisted release of the rules because their members would not be able to take advantage of the microscopy certificate.

In the published rules, however, HCFA officials sought to emphasize that "creation of this new category of testing does not mean that properly trained individuals other than physicians may not perform these procedures" in labs certified for moderate complexity. They also detailed their intention to take up the matter of non-physicians performing microscopy tests with the advisory council, and asked for public comment as well.

Among the questions HCFA would like answered are these: When microscopy tests are performed in the context of a physical examination, who usually performs them? What percentage of these tests are usually performed by a physician, versus by other health care practitioners? Who are the other practitioners performing the tests? What are the quality access and cost implications of limiting this exception to one set of professionals?

Similar questions have been raised on Capitol Hill, where such lawmakers as Sen. John Chafee (R-R.I.) note that many public health clinics and other facilities rely on non-physicians to perform this testing. The new regulations, he believes, would compromise patient care. At the confirmation hearing for Donna Shalala, the new Secretary of Health and Human Services (HHS), Chafee asked Shalala to consider adjustments in the personnel requirements for microscopy. She agreed to review them.

Other developments have raised doubts about just how final the final CLIA regulations are. In one move, the American Association of Bioanalysts (AAB) announced support for a lawsuit asking the Government to implement CLIA with consumer protection in mind. The Consumer Federation of America and Public Citizen filed the suit seeking a review of the HCFA regulations, contending that they undermine the legislative intent of CLIA '88.

AAB President Haroutune Dekirmenjian, Ph.D., expressed his group's concern that "the final regulations contain too many waivers that allow tests to be conducted without necessary regulations." Addressing concerns over the physician microscopy category, Dekirmenjian said the Clinton Administration "must strengthen the CLIA regulations, to prevent needless danger to consumers."

In the interim, doctors can take a measure of satisfaction in the special recognition bestowed upon them by the departing Bush Administration. Ironically, however, the gesture comes as too little too late for the many physicians who have decided to get out of lab testing altogether.

HCFA officials report that some 60,000 of the CLIA application forms it mailed to physicians have been returned, and that at least 4,000 came back with scrawled notes that they are no longer testing. In addition, many doctors are reportedly confused over the type of registration information HCFA needs, in some cases failing to identify the tests they perform by specialty. HCFA is following up with those lab directors in an effort to spell out what information is required.

Stark offers new self-referral bill

House Ways and Means Health Subcommittee Chairman Pete Stark has introduced a new bill seeking a broader ban to keep physicians from referring patients to facilities in which they have a financial interest.

Currently, Federal law only prohibits Medicare payment for clinical laboratory services that are furnished through self-referral. The California Democrat now wants to extend the ban to all other payers and other services as well.

Those additional services include physical therapy, occupational therapy, radiology, durable medical equipment, enteral/parenteral nutrition, outpatient prescription drugs, and ambulance. The ban would affect Medicare, Medicaid, Blue Cross and Blue Shield, commercial insurers, and health maintenance organizations (HMOs).

"The evidence is overwhelming that referral relationships result in overcharging and overutilization," Stark remarked upon introducing H.R. 345.
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Title Annotation:Washington Report; Clinical Laboratory Improvement Amendments of 1988
Author:Albertson, David
Publication:Medical Laboratory Observer
Article Type:Column
Date:Mar 1, 1993
Words:1416
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