October 7, 2002 - Payment Determinations Recommended by CMS for the 2003 Laboratory Fee Schedule

The American Society for Microbiology (ASM) welcomes the opportunity to provide comments to the Centers for Medicare and Medicaid Services (CMS) regarding the tentative payment determinations for the 2003 Medicare Clinical Laboratory Fee Schedule, as recommended by the Centers for Medicare and Medicaid Services and posted on the CMS web site on September 18, 2002.The ASM is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good.The Society represents more than 40,000 microbiologists, including scientists and science administrators working in a variety of areas, including biomedical, environmental, and clinical microbiology.

The ASM disagrees with CMS's recommendation to crosswalk the proposed code 8725X: Virus isolation; including identification by non-immunologic methods, other than by cytopathic effect (e.g. virus specific enzymatic activity), to 87253.Rather, ASM recommends that code 8725X be subjected to a gap fill process.This code describes a novel technology which we consider to be non-equivalent to the existing virus isolation codes.

This proposed code, 8725x, may be used as an alternative to previously described codes for isolation of viral agents in eukaryotic cell cultures.The basis of the procedure is the use of cell culture lines that have been modified by genetic engineering to produce a detectable signal when productively infected with a specific virus.Thus isolation and specific identification are accomplished concomitantly.This is in contrast to conventional cell culture (87252) in which specific viral identification of microscopically observed CPE or based on clinical suspicion of a specific virus type necessarily involves an additional immunologic or non-immunologic procedure (87253).On a step-by-step basis, the proposed code is procedurally similar to shell vial isolation including immunologic identification (87254), except the identification component is nonimmunologic.The only currently commercially available product is used for the specific isolation and identification of herpes simplex virus.The specificity of the cell lines is expected to be such that each individual virus sought will require a unique cell line and would justify documentation with an additional replicate of the proposed code.

Viral culture is performed to detect the presence of viable virus in clinical specimens and provides supporting evidence for the role of a specific virus in disease.The specific virus sought will depend upon the clinical circumstances.For example, herpes simplex virus may be a diagnostic consideration in the case of oral or genital vesicular lesions.Viral culture is often performed in concert with other diagnostic methods such as antigen detection, molecular testing, and/or serology.The choice of methods depends on clinical factors such as the type of suspected agent, the stage of the disease, and the antecedent use of antiviral therapy.

Again, ASM appreciates the opportunity to participate in this process and would be happy to answer any additional questions you may have.