April 14, 2005

In This Issue . . .

Managing Alternative Specimen Types: How Clinical Labs are Dealing with Billing, Validating, and Other Common Headaches
Many clinical laboratory directors receive requests to run assays on specimen types which the test insert sheet says are not FDA-approved. This month, Strategies looks at what CMS has to say about alternative specimen types, and how one lab director manages requests for these assays.

Managing Alternative Specimen Types: How Clinical Labs are Dealing with Billing, Validating, and Other Common Headaches

It’s not uncommon for physicians to request that clinical laboratories run an assay on a specimen type that is not FDA approved for that specific assay. This leaves many laboratorians wondering how to validate the results after running these alternative specimen types, and how to code the test for billing purposes. This month, Strategies looks at two lab directors’ views on managing alternative specimen types and CMS’ thoughts on these questions.

Laboratorians face a dilemma when dealing with requests for tests on alternative specimen types. When performing an assay on a specimen type that the insert literature indicates has not been approved by the FDA, how should laboratorians code the test in order to submit for reimbursement in a way that maintains compliance with Clinical Laboratory Improvement Amendments (CLIA)?

For example, a physician requests that a vancomycin assay be run on cerebrospinal fluid (CSF), rather than serum or plasma, to evaluate a patient’s antibiotic level. Should labs use the serum code and charge as a serum, or put the test under a separate code? If they use the serum code do they put a disclaimer that it is an alternative specimen type and then ignore the reference ranges, or would this constitute fraud according to Medicare regulations? Also, because this test is not FDA-approved, what kind of result verification is necessary?

“As far as the laboratory is concerned, probably the first thing to do is contact the manufacturer and check with them, because they may have done some additional studies and may be able to provide some insight,” said one CMS official. “The laboratory should also notify the physician that the test has not been approved by the FDA for that specimen type and that the results may or may not be useful.” In addition, the lab must perform a study to establish the performance specifications with this specimen to check and see how the test is working, the official added. It’s also important to include on the report what the lab has done, as far as modifying the specimen and assay. The normal range for an alternative specimen might not be the same.

CLIA’s performance specification guidelines are detailed in CLIA Regulation 493.1253.
Under these guidelines, the laboratory is responsible for establishing the performance specifications for each modified FDA-cleared or approved test system. “‘Modified by the laboratory,’ means any change to the assay that could affect its performance specifications for sensitivity, specificity, accuracy, or precision, etc.,” states the guideline. This refers to any change in specimen or in the use of a different sample matrix (plasma vs. urine). To establish these specifications, the lab must follow CLIA’s interpretative guidelines to verify accuracy, precision, and analytical sensitivity. But this could take not only hours but weeks for each alternative specimen type assay, said Ron Feld, PhD, Director, Clinical Chemistry, University of Iowa Hospital and Clinics’ Department of Pathology in Iowa City. It’s unrealistic to think that any clinical laboratory has the time or the resources to establish such performance specifications, he added.

Coding and Validating

One lab director working at a facility in the Western half of the U.S. said that his lab gets quite a few requests to run alternative specimen type assays, although they generally do not bill for some of these kind of tests, unless there is an appropriate CPT code. For some assays, such as glucose in renal dialysis fluid, the laboratory information system (LIS) has a separate test code. For other tests, including vancomycin in CSF, the LIS has a generic code in fluid. “It's really a two-test panel,” he said. “One test code is for the result and the other is for the name of the fluid. The result code has no reference range defined.”

As for clarifying the results with the physician, the director said that his lab assumes that the physician ordering a fluid test knows what to expect in terms of results. “We don't always append a disclaimer, since some of these orders are quite common, such as gentamicin or lactate in CSF. The disclaimer would tell the doctors nothing they don't already know, and they know from experience that the test gives valid results on that fluid,” he said. “We leave the disclaimer to the discretion of the lab director, but it is generally appended [only] to results where we have little or no clinical experience with the test/specimen combination.”

Billing Questions Still Unresolved

CMS declined to comment on the billing issues surrounding alternative specimen type testing, but it’s not surprising that many labs don’t attempt to get a reimbursement payment, as it’s clearly safer to forgo reimbursement than to run afoul of CLIA regulations. “Unless you have a specific ordering code and your intermediary has agreed to pay for it, then you just have to forget about getting reimbursed,” explained Feld. “What you cannot do is order it under a serum code, put a comment that the specimen is not serum and [that the physician should] ignore the reference ranges, and then charge as if it [were] serum.”

Guidance Ahead?

Some clarification, at least on the validation end, might be available in the future, if the Clinical Laboratory Standards Institute (CLSI, formerly the NCCLS) moves forward with drafting guidelines on analyzing body fluids. While still in the early draft stage, these proposed guidelines would focus on the application of widely available analytic methods for testing body fluids and for reporting and interpreting those results. According to a recent CLSI catalog, the guidelines would define the common clinical situations for testing body fluids, acceptable practice for measuring analytes without extended method validation for abnormal body fluid, influence of biologic and analytic variation on interpretation of results, and variability in comparing results between different instrument manufacturers.

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