August 7, 2002 - Payment Determinations for Calendar Year 2003 for New Clinical Laboratory Tests

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Centers for Medicare and Medicaid Services (CMS) regarding payment methodology to be used for new codes which will be included in the 2003 Medicare Clinical Laboratory Fee Schedule, as announced in the November 23, 2001 Federal Register [CMS-1190-NC].My name is Dr. Vickie Baselski and I am a member of ASM's Public and Scientific Affairs Board (PSAB) Committee on Professional Affairs.I am accompanied by Dr. Alice Weissfeld, who chairs the PSAB Committee on Professional Affairs.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.

Many of our members have primary involvement in the clinical laboratory community including individuals directing clinical microbiology or immunology laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use, and researchers involved in evaluating the performance of new technologies.Thus, our Society has a significant interest in the process of establishing reasonable reimbursement for medically necessary laboratory testing to ensure quality patient care for Medicare beneficiaries. The ASM's Public and Scientific Affairs Board Committee on Professional Affairs reviewed the "2003 New Laboratory Tests" document which was posted on the CMS website and sent to the ASM via e-mail on June 14, 2002.We also solicited input from ASM's practicing clinical microbiology members regarding the proposed codes via ASM discussion listserves. Attached to this statement is a table outlining the ASM's recommendations with respect to payment determinations for new Current Procedural Terminology (CPT) microbiology codes announced for 2003, including on 8725X Virus isolation; 8726X Enterovirus, direct fluorescent antibody; 8727X Cytomegalovirus, direct fluorescent antibody; and 8905X Leukocyte count, fecal.Summarized are comments on the (1) Nature of the test method, (2) Clinical applications, (3) Costs, and (4) Recommendation(s) based on the payment methodology of "cross walking" and "gap filling" referred to in the June 14 electronic document:

Proposed code 8725X: Virus isolation; including identification by non-immunologic methods, other than by cytopathic effect (e.g. virus specific enzymatic activity)

Nature of the test method:

This proposed CPT-4 code 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.

Applications:

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.

Costs:

The costs of virus isolation using specific modified cell lines that accomplish isolation and detection in a concomitant fashion are reported by the manufacturer to potentially generate some cost savings over conventional methods in the case of herpes simplex virus. ASM clinical microbiologists whom we consulted, confirm that the single commercially available method may have lower reagent costs than isolation in tube culture (87252) with immunologic confirmation (87253) or in shell vial culture including immunologic confirmation (87254). However, labor costs are reported to be comparable for all viral isolation codes.

Recommendation:

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.We acknowledge the close procedural similarity and clinical utility to shell vial culture (87254), however, we do not support a crosswalk to 87254 because of its inclusion of an immunologic confirmation. Additionally, it should be acknowledged that the National Limitation Amount (NLA) for 87254 is inherently unreasonable relative to other viral isolation procedures which provide entirely comparable clinical data.

Comments:

CMS or the American Medical Association (AMA) may need to issue specific guidance on the use of this proposed code in contrast to 87253 (virus isolation; tissue culture, additional studies or definitive identification, e.g. hemadsorption, neutralization, immunologic). The descriptor for 87253 is currently inclusive of non-immunologic methods and several ASM clinical microbiologists consulted expressed an opinion that use of the proposed code requires clarification.

Proposed code 8726X: Enterovirus, direct fluorescent antibody

Nature of the test method:

This code in the series 87260-87299 is specified for use with "primary source (clinical) specimens" for "infectious agent detection by immunofluorescent technique."It is intended to replace 2002 code 87199 which was apparently placed out of numerical sequence. The test method involves the application of a clinical specimen to a microscope slide followed by the sequential application of one or more reagents including specific antibody(ies) which will bind to enteroviral antigens in infected host cells. At least one reagent in the process is labeled with a fluorescent compound, and detection of enterovirus infected cells is accomplished by fluorescent microscopy. Reports may include a qualitative, semi-quantitative or quantitative indication of the presence of viral antigen as well as interpretive comments regarding other observations of clinical relevance.

Applications:

Clinical applications for a primary source enterovirus direct fluorescent antibody test are not well established. The current methods of choice for enteroviral infections are tissue culture and more recently, nucleic acid amplification in the setting of meningitis. Further, the ASM is unaware of any of any products cleared by the Food and Drug Administration (FDA) for this proposed code. Therefore any use of this code would likely be either investigational or in accordance with Analyte Specific Reagent (ASR) rules.

Costs:

The costs of performing an immunofluorescent antigen detection test should be roughly equivalent to the costs of performing this method for any other antigen in the 87260-87299 series.

Recommendation:

ASM recommends that 8726X be crosswalked to code 87260 (infectious agent antigen detection by immunofluorescent technique; adenovirus) at 100% of the NLA. This is the same recommendation made last year for code 87199 now being replaced by this proposed code.

Comments:

It is recommended that the final CPT-4 code book place both proposed code 8726X and proposed code 8727X in correct numerical and alphabetical sequence, and that code descriptors be brought into compliance with the other code in this series (infectious agent antigen detection by immunofluorescent technique rather than direct fluorescent antibody).

Proposed code 8727X: Cytomegalovirus, direct fluorescent antibody

Nature of the test method:

This code in the series 87260-87299 is specified for use with "primary source (clinical) specimens" for "infectious agent detection by immunofluorescent technique." It is intended to replace 2002 code 87198 which was apparently placed out of numerical sequence. The test method involves the application of a clinical specimen to a microscope slide followed by the sequential application of one or more reagents including specific antibody(ies) which will bind to cytomegalovirus (CMV) antigens in infected host cells. At least one reagent in the process is labeled with a fluorescent compound, and detection of CMV infected cells is accomplished by fluorescent microscopy. In preparation of a sample to assess for the presence of CMV antigens in circulating leukocytes, a time sensitive and labor intensive concentration step is required which is compatible with the intent of code 87015 (concentration, any type, infectious agents). In addition, it is necessary to perform a measurement of the actual leukocyte count so that the slide preparation may be made appropriately and so that quantitative results may be reported accurately. This procedure justifies the additional use of code 85007. Reports may include a qualitative, semi-quantitative or quantitative indication of the presence of viral antigens as well as interpretive comments regarding other observations of clinical relevance.

Applications:

This test procedure is most commonly used in the documentation of CMV infection in immunocompromised patients, particularly hematopoietic stem cell or solid organ transplant patients. The most common application is the quantitation of circulating viral antigen load in peripheral blood leukocytes, termed an "antigenemia" test. The antigenemia test detects a specific antigen termed "pp65" which correlates with clinical disease progression in CMV infected patients. Results are used to ascertain the need for pre-emptive or therapeutic antiviral therapy. The use of antigen detection by an immunofluorescent technique for other specimen types has not been as well established, but has occasionally been reported for use with lower respiratory specimens, urine sediment specimens, and biopsies of affected internal organs. While FDA-cleared reagents for antigenemia testing are available, tests on other specimen types are generally performed on an investigational or ASR basis.

It should be noted that the proposed code is only appropriate for CMV immunodetection formats using immunofluorescence. However, there is another CMV "antigenemia" product available which uses immunoperoxidase staining to detect antigens of CMV. There is not currently a specific code for this alternative but equivalent method for which reimbursement should be comparable.

Costs:

The costs of performing an immunofluorescent antigen detection test should be roughly equivalent to the costs of performing this method for any other antigen in the 87260-87299 series. However, there are additional significant costs for the specimen preparation component of the "antigenemia" application. These costs justify the use of additional codes for concentration (87015) and WBC cell count (85007).

Recommendation:

ASM recommends that 8727X be crosswalked to code 87260 (infectious agent antigen detection by immunofluorescent technique; adenovirus) at 100% of the NLA. This is the same recommendation made last year for code 87198 now being replaced by this proposed code.

Comments:

Consideration should be given to establishing a unique code for the immunoperoxidase modification of the antigenemia test, and possibly to the development of a CMV antigenemia code in general.

Proposed code 8905X: Leukocyte count, fecal

Nature of the test method:

Leukocytes may be microscopically detected in fecal samples by a variety of methods ranging from wet mount observation of methylene blue enhanced material, to the use of common differentiating stains (e.g. Wright-Giemsa, Gram), and in some case even using complex stains like Trichrome. The analyte sought by any of these methods is "leukocytes", which are often differentiated into major categories (e.g. neutrophils, lymphocytes, eosinophils). Leukocytes are generally reported only semiquantitatively (e.g. rare, few, moderate, many) after observation of an adequate number of low or high power fields. In only a minority of cases is an actual differential performed (i.e. determination of percentages of each type present). The ASM is unaware of any sites performing a "count" as is often done for body fluids. An informal poll of ASM clinical microbiologists indicates that a vast majority perform a simple semiquantitative analysis; fewer members reported that they perform a differential; and, no one reported that they perform an actual count. Methods cited in response to the poll included methylene blue wet mounts, Gram stain, Wright-Giemsa, Safrinin only, and trichrome.

Applications:

This test is used to determine whether there is evidence of inflammation in the intestinal tract due to either infectious or more often, noninfectious causes. The procedure must be performed soon after defecation due to the rapid deterioration of leukocytes. For this reason, the test has decreased in utilization, and in many cases has been replaced by a test for fecal lactoferrin, a more stable indicator of inflammation. For assessment of likelihood of microbial infection, the test has lower than acceptable sensitivity and specificity.

Costs:

Costs for reagents vary according to method used, but are roughly equivalent to other methods used to microscopically detect and identify leukocytes. Costs for labor are generally equivalent regardless of method since the analyte sought is the same.

Recommendation:

Based on coding convention to seek equivalence in analyte and method, ASM recommends that 8905X be crosswalked to 89190 (nasal smear for eosinophils) at 100% of the NLA. We do not recommend a crosswalk to 87205, Gram stain because of the variability in staining methods used by our members.

Comment:

This proposed code does not represent a new or emerging technology. We do not recommend setting the NLA at 100% of the median, as established for such technologies in the Benefits Improvement and Protection Act of 2000 (BIPA).

In closing, ASM appreciates the opportunity to participate in CMS's public meeting as mandated by BIPA and as recommended by the Institute of Medicine (IOM) in its report on Medicare Laboratory Payment Policy.It is our belief that the "open process" that CMS has established will ensure that quality laboratory medicine for Medicare beneficiaries will result.ASM stands ready to work with you throughout this process.

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