July 26, 2004 – Payment Determinations for Calendar Year 2005 for New Clinical Laboratory Tests

List of ASM Reviewers

The ASM Statement on Payment Determinations for Calendar Year 2005 for New Clinical Laboratory Tests, was sent to the following ASM members for review: PSAB Committee on Professional Affairs: Alice Weissfeld, PhD; Vickie Baselski, PhD; Kay Buchanan, PhD; Roberta Carey, PhD; Linda Cook, PhD; Lynne Garcia, MS, MT; Mark Larocco, PhD; Susan Mottice, PhD; David Sewell, PhD; Jim Snyder, PhD

PSAB Committee on Laboratory Practices: Joseph Campos, PhD; Michelle Alfa, PhD; Joan Barenfanger, MD; Patricia Charache, PhD; Richard Haberberger, Jr., PhD; Ella Swierkosz, PhD; Ronald Zabransky, PhD

Immunology Working Group: Linda Cook, PhD; Barbara Detrick, PhD; Tom Alexander, PhD; Ron Harbeck, PhD; Irene Check, PhD; Maurice OGorman, PhD; Harry Prince, PhD; John Schmitz, PhD; Charles Repetti, PhD


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 2005 Medicare Clinical Laboratory Fee Schedule, as announced in the Federal Register on May 28, 2004 [CMS-11266-N]. 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, professionally employed as scientists and science administrators working in a variety of areas, including biomedical, environmental, and molecular fields as well as in clinical microbiology and immunology.

Many of our members have primary involvement in clinical laboratory medicine 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 developing and evaluating 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.

Attached to this statement is a summary table outlining the ASM’s recommendations with respect to payment determinations for select new Current Procedural Terminology (CPT) codes to be included in the 2005 Medicare Laboratory Fee Schedule. Also included is a detailed analysis which provides a more comprehensive assessment of requested information. Recommendations are based on the consensus of ASM’s Public and Scientific Affairs Board Committee on Professional Affairs, which reviewed the “2005 New Laboratory Tests” document on the CMS web site and provided comment. For each code, the following information is provided, as outlined in the May 28, 2004 Federal Register:

  • New code and descriptor
  • Test purpose and method
  • Costs
  • Charges
  • ASM recommendation on payment methodology

New code and descriptor:
8300x Helicobacter pylori; blood test for urease activity, non-radioactive isotope (e.g. C-13)

Test purpose and method:
The whole blood test for Helicobacter pylori urease activity is intended for use in the qualitative detection of C-13 in a single blood sample collected by venipuncture in sodium heparin tubes obtained after the ingestion of C-13 labelled urea. Helicobacter pylori infecting human gastric epithelium produces abundant urease enzyme which converts the C-13 urea into 13CO2 and ammonia. The 13CO2 is absorbed into the bloodstream and results in an increase in the ratio of 13CO2 to naturally occurring 12CO2. Analysis of the blood samples for increased levels of 13CO2 may be performed using Gas Isotope Ratio Mass Spectrometry or equivalent methodology. A qualitative interpretation is made by comparison to a cutoff ratio derived from analyses performed on histologically infected and non-infected patients. The test is used primarily for diagnostic purposes in symptomatic patients but may have future indications for test-of-cure purposes. A similar test performed on breath samples collected before and after ingestion of labeled urea (the Urea Breath Test) has been previously coded using 83014 for labeled urea administration and collection of two breath samples and 83013 for the detection of 13CO2 in the pre- and post-samples. While these code descriptors were previously altered in 2001 to allow use with both blood and breath samples, the proposed approach increases the specificity of the existing codes.

Costs:
Costs for testing are separable into two components: (1) Drug (labeled urea) acquisition, administration, and sample collection by venipuncture, and (2) Single sample analysis using mass spectrometry.

Charges:
Charges are also established to reflect the two distinct processes described for costs.

ASM recommendation on payment methodology:

(1) Labeled urea administration and sample collection should be crosswalked to 83014. Although a single sample is collected by venipuncture as opposed to collection of two breath samples, the most significant cost component is the labeled urea acquisition and administration. (2) The gas isotope ratio mass spectrometry analytical procedure is methodologically comparable to that used is breath tests and should be crosswalked to 83013.

New code and descriptor:
8363x Lactoferrin, fecal, qualitative

Test purpose and method:
Lactoferrin is a glycoprotein expressed by activated neutrophils. The detection of lactoferrin in a fecal sample therefore serves as a surrogate marker for inflammatory cells in the intestinal tract. These cells are frequently labile in transport and may not be detected by common microscopic methods; thus, the lactoferrin assay has improved sensitivity. Detection of fecal lactoferrin allows the differentiation of inflammatory and noninflammatory intestinal disorders which may be subject to different clinical management strategies. The lactoferrin analyte may be qualitatively detected by two distinct methods: (1) A latex agglutination procedure (most commonly used), and (2) A microwell enzyme immunoassay procedure. The former method has been used primarily in the evaluation of patients with diagnoses of infectious gastroenteritis to identify invasive etiologies (e.g. Shigella, Salmonella, Campylobacter), while the latter method has been developed primarily as a diagnostic aid to identify patients with active inflammatory bowel disease (IBD) vs. patients with active noninflammatory irritable bowel syndrome (IBS).

Costs:
Costs represent a composite of antibody-based assay reagents for either assay format, and a labor component to perform either the manual or semi-automated EIA assay.

Charges:
Charges are established based on the composite costs described above.

ASM recommendation on payment methodology:

Fecal lactoferrin testing should be crosswalked to 83516, a generic immunoassay code for analytes other than infectious agents. However, at some future point, consideration may be given to establishment of analyte and method specific codes for lactoferrin.

New code and descriptor:
8416x Protein, electrophoretic fractionation and quantitation; other fluids with concentration (e.g. urine, CSF)

Test purpose and method:
Protein electrophoresis on samples other than serum is used to determine the types and quantity of protein present in body fluids. This test is most often performed on either urine or CSF specimens but may occasionally be performed on other body fluids. After an initial concentration procedure, the specimen is then subjected to electrophoresis to fractionate the proteins present in the sample. Urine is most often examined to determine the function of the kidney filtration apparatus. A variety of conditions can cause damage to the kidney and lead to protein leakage. When this test is used to show the presence of different types of proteins and their relative concentrations in the urine, the severity of damage to the filtration membranes of the glomeruli can be determined. The test can be made semi-quantitative by performing it in concert with a test for total urine protein (84156) and the use of scanning equipment capable of determining relative concentrations of each separated protein. This test may also be used as a first step in the detection of monoclonal immunoglobulin or light chain proteins in the urine secondary to multiple myeloma or light chain disease malignancies. A third use of the test is the detection of “oligoclonal” bands of immunoglobulin present in CSF secondary to multiple sclerosis.

Costs:
Costs for this procedure are similar to those of the current serum protein electrophoresis costs (84165), with additional significant costs associated with the personnel and equipment used for concentration.

Charges:
Charges are established to reflect the costs associated with materials and equipment as well as labor for the preanalytical concentration, analytical electrophoresis, and postanalytical interpretation processes.

ASM recommendation on payment methodology:

Because of the additional expenses related to concentration prior to the electrophoresis for samples other that serum, the recommendation is to crosswalk the proposed code to the existing serum electrophoresis code (84165) with an additional component to account for the concentration. No specific CPT-4 code exists for the concentration portion of this test. However, a precedent for documenting similar work associated with concentration techniques may be found with microbiology code 87015 (Concentration (any type), for infectious agents).

New code and descriptor:
8606X B cells, total count

Test purpose and method:
A total B cell count is used to identify and quantify the number of B cells present in a cell preparation. The test can be done with whole blood, cellular fluids, bone marrows, and a variety of tissues. The B cells are identified by the addition of a fluorescent-tagged monoclonal antibody specific for a B-cell specific surface or cytoplasmic marker. The cells can then be examined with the use of a flow cytometer or similar instrument capable of detecting single-cell fluorescence and the number of B cells determined. Total cells per volume can then be determined using a variety of methods, the most common of which is the addition of fluorescent beads to the solution prior to analysis by the instrument. The test may be performed as part of the analysis of lymphocytes present during a variety of immune-suppression causing conditions, including viral infections such as HIV-1, primary or secondary immunodeficiencies, or treatment with any other immunosuppressive therapy. The test may also be useful to monitor response to specific B-cell targeted immunotherapy in lymphoma or autoimmune diseases.

Costs:
Costs of this procedure are comparable to other single analyte determination by flow cytometric methods, such as determination of total T cells (86359). The proposed code for B cells, total count and the T cells, total count procedure use common cell preparation, monoclonal staining processes, and analytical procedures.

Charges:
Charges reflect both the costs of the monoclonal antibody reagents, as well as additional costs deriving from preanalytical processes and equipment and associated labor costs.

ASM recommendation on payment methodology:

The recommendation is to crosswalk the proposed 8606x, B cells, total count test to the existing code for T cells, total count (86359) because of the extensive similarities between the test processes.

New code and descriptor:
8633x Immunofixation electrophoresis; other fluids with concentration (e.g. urine, CSF)

Test purpose and method:
The purpose of immunofixation electrophoresis on body fluids is to detect abnormal immunoglobulin present in urine, CSF, or occasionally other body fluids. The sample is first concentrated, then electrophoresis is used to fractionate the proteins and immunoglobulins present in the sample, and finally, antiserum specific for the immunoglobulin or protein to be detected is used to identify separated bands. The number of electrophoresis procedures performed and the number of different antisera used is determined by the immunoglobulin or protein to be detected. Detection of light chain disease or myeloma usually requires at least 5 different antiserum preparations, specific for IgG, IgM, IgA, Kappa, and Lambda light chains, although IgE, IgD, and free Kappa or Lambda antisera may also be necessary for complete analysis. The test may also be used for identification of fibrinogen which may be present in the urine and cause interpretation difficulties. CSF and fluids suspected to be CSF can be identified using this test for the detection of beta-transferrin, which is present only in CSF. Detection of beta-transferrin which confirms the presence of CSF can be an extremely sensitive indicator of CSF leakage from the brain. This test can also be used to confirm the CSF “oligoclonal” immunoglobulin bands present in CSF of multiple sclerosis patients.

Costs:
Costs for this procedure are similar to those of the current serum immunofixation electrophoresis costs (86334), with additional significant costs associated with the personnel and equipment used for concentration.

Charges:
Charges are established to reflect the costs associated with materials and equipment as well as labor for the preanalytical concentration, analytical electrophoresis, immunofixation, and postanalytical interpretation processes.

ASM recommendation on payment methodology:

Because of the additional expenses related to concentration required on samples other than serum, the recommendation is to crosswalk to the existing serum immunofixation code (86344) with an additional component to account for the concentration. No specific CPT-4 code exists for the concentration portion of this test. However, a precedent for documenting similar work associated with concentration techniques may be found with microbiology code 87015 (Concentration (any type), for infectious agents).

New code and descriptor:

8637X Natural Killer (NK) cells, total count

Test purpose and method:
NK (Natural Killer cell) counts are used to identify and quantify the number of NK cells present in a cell preparation. The test can be done with whole blood, cellular fluids, bone marrows, and a variety of tissues. NK cells are identified by the addition of a fluorescent-tagged monoclonal antibody specific for an NK-cell specific surface or cytoplasmic marker. The cells can then be examined with the use of a flow cytometer or similar instrument capable of detecting single-cell fluorescence and the number of NK cells determined. Total cells per volume can then be determined using a variety of methods, the most common of which is the addition of fluorescent beads to the solution prior to analysis by the instrument. The test may be performed as part of the analysis of lymphocytes present during a variety of immune-suppression causing conditions, including viral infections such as HIV-1, primary or secondary immunodeficiencies, or treatment with any other immunosuppressive therapy.

Costs:
Costs of this procedure are comparable to those with similar methods for a single determination of total T cells (86359). The NK cells, total count and the T cells, total count tests use common cell preparation, monoclonal staining, and analysis procedures.

Charges:
Charges reflect both the costs of the monoclonal antibody reagents, as well as additional costs deriving from preanalytical processes and equipment and associated labor costs.

ASM recommendation on payment methodology:

The recommendation is to crosswalk the proposed 8606x, NK cells, total count test to the existing T cells, total count (86359) because of the similarities between the tests.

New code and descriptor:
8658X Stem cells (i.e. CD34), total count

Test purpose and method:
The test is used to identify and quantify the number of stem cells present in a cell preparation. The test can be done with whole blood, cellular fluids, bone marrow, and a variety of tissues. The most common clinical sample type tested is cell-pheresis product or bone marrow harvested for use in stem cell allogeneic or autologous transplantation. The test is also commonly used to determine the adequacy of stem cell concentrations in donors prior to the initiation of pheresis. Stem cells are identified by the addition of a fluorescent-tagged monoclonal antibody specific for a stem cell specific surface marker to a suspension of cells to be tested. Because of the low quantity of the cells present in most samples (
Costs:
Costs for the determination are significantly higher for the Stem Cells, Total Count procedure than for the other existing or proposed T, B, or NK Cells, Total Count tests. This is due to the necessity for use of 2-3 monoclonal antibodies as well as the necessity for use of quantitative beads and viability staining. In addition, the instrument analysis must be carefully monitored by personnel to ensure the accuracy of the very low quantity stem cell counts. Finally, complex calculations are necessary to determine the number of stem cells present in each pheresis product. In sum, reagent and labor costs for this test are at least 3-4 times higher than for the other three existing and proposed total cell count tests.

Charges:
Charges are established to reflect the increased complexity of stem cell analysis compared to single marker testing, as well as the need to accurately quantitate cells present and assess viability. Charges are therefore significantly greater than a B cell, T cell, or NK cell total count procedure.

ASM recommendation on payment methodology:

The ASM recommendation is to crosswalk this code to a composite of other codes representing the 3 main processes in the assay. We recommend a crosswalk to 86359 T cell, total count which accounts for the initial antibody plus 86361, CD4 T cells to account for the minimum processing and use of a second antibody in accordance with ISHAGE protocols. An additional crosswalk to 86361 will account for processes involved in viability determination. Reimbursement for this test should reflect the complicated nature of the assay, the importance of adherence to the complex protocol, and the extensive training of personnel who perform the testing, in order to ensure that adequate stem cells are present in all cellular products used in stem cell transplantation.

New code and descriptor:
8780X Infectious agent detection by immunoassay with direct optical observation; Respiratory syncytial virus

Test purpose and method:
The RSV direct optical immunoassay test is a mulistep immunoassay which involves the extraction and detection of protein antigens unique to RSV (e.g. nucleoprotein and fusion protein) using a specific antibody detection reagent. Direct optical immunoassay technology enables the direct visual detection of the specific immunological reaction between the analyte antigens and specific antibody test reagents. For example, the Thermo OIA product produces a physical change in the optical thickness of molecular thin films. This change in thickness alters the reflected light path and is visually perceived as a color change with a positive result appearing as a purple spot on a predominantly gold background. When antigen is not present in the specimen, no binding takes place, the optical thickness remains unchanged, and the surface retains the original gold color indicating a negative result. Alternative products use varying visual detection techniques. The test format is intended for use in an acute care setting to produce rapid results for patient management.

Costs:
Costs for this assay are comparable to costs for other immunoassays with direct optical observation in the CPT series 87810-87899.

Charges:
Charges reflect both the cost of the unit test device as well as the labor required to perform the test.

ASM recommendation on payment methodology:

Crosswalk the proposed code for RSV to 87802 due to comparability to other codes in the Infectious agent detection by immunoassay with direct optical observation series.

New code and descriptor:
8818X Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; first marker

Test purpose and method:
The purpose of this procedure is to clearly identify cells that express a given antigenic determinant on their cell surface, cytoplasm, or nucleus. A large variety of monoclonal antibodies tagged with a fluorescent color can be used to clearly identify the lineage and functional characteristics of individual cells. Any cellular sample which can be made into a single cell suspension can be tested to determine the numbers and types of cells present. The most common clinical usage of this testing is to determine the lineage and maturation stage of leukemia or lymphoma cells present in blood, bone marrow, CSF, lymph nodes, and other tissue. Other common usages include the determination of cytokine expression or nuclear protein expression of cells in peripheral blood, bone marrow, or infiltrative cells in tissues. The sample to be tested is stained with one or more monoclonal antibodies and then analyzed with a flow cytometer or similar instrument to determine the presence of cells with the marker(s) of interest, and the fluorescent intensity is noted for each positive cell present. The presence of a group of specific antigenic determinants and the intensity of their fluorescent intensity can be used to identify the specific cell type. Using carefully designed combinations of antibodies directed towards different cell or cytoplasmic markers, malignant or unusual cell types can be identified and their cell lineage and other characteristics determined. This process is critical in the identification of and assessment of proper therapy for almost all known leukemia and lymphoma malignancies. The testing can also be extremely useful in identifying and characterizing a variety of primary and secondary immunodeficiencies, as well as for monitoring responses to a variety of biological response modifiers and other types of immune-based therapies.

Costs:
The cost of this test should reflect the sample processing expenses. However, this varies somewhat depending on the sample type, but always involves reagent costs as well as significant personnel costs to prepare samples to be tested. In addition, the reagent costs for the monoclonal antibodies used in the analysis should be included. Further, significant costs are associated with the analysis of the cells using costly instrumentation that requires significant operator training, complicated maintenance routines, and close monitoring during analysis.

Charges:
Charges reflect the initial processing expenses, and analytical costs including instrumentation with incremental increases applied for each specific antibody reagent used in defining the particular clinical situation.

ASM recommendation on payment methodology:

ASM supports the placement of this code on the clinical laboratory fee schedule. The recommendation is to crosswalk this test to 86359, T cells, Total Count. Initial costs for processing of samples, and for testing for the initial marker is similar between this new code and the current T cells, Total Count code. Based on the newly proposed technical codes for use in Flow Cytometry, the majority of the reagent and personnel costs for processing the sample as well as the costs associated with the first marker reagent are reflected in this reimbursement.

New code and descriptor:
8818X Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; each additional marker

Test purpose and method:
The purpose of this procedure is to clearly identify cells that express a given antigenic determinant on their cell surface, cytoplasm, or nucleus. A large variety of monoclonal antibodies tagged with a fluorescent color can be used to clearly identify the lineage and functional characteristics of individual cells. Any cellular sample which can be made into a single cell suspension can be tested to determine the numbers and types of cells present. The most common clinical usage of this testing is to determine the lineage and maturation stage of leukemia or lymphoma cells present in blood, bone marrow, CSF, lymph nodes, and other tissue. Other common usages include the determination of cytokine expression or nuclear protein expression of cells in peripheral blood, bone marrow, or infiltrative cells in tissues. The sample to be tested is stained with one or more monoclonal antibodies and then analyzed with a flow cytometer or similar instrument to determine the presence of cells with the marker(s) of interest, and the fluorescent intensity is noted for each positive cell present. The presence of a group of specific antigenic determinants and the intensity of their fluorescent intensity can be used to identify the specific cell type. Using carefully designed combinations of antibodies directed towards different cell or cytoplasmic markers, malignant or unusual cell types can be identified and their cell lineage and other characteristics determined. This process is critical in the identification of and assessment of proper therapy for almost all known leukemia and lymphoma malignancies. The testing can also be extremely useful in identifying and characterizing a variety of primary and secondary immunodeficiencies as well as for monitoring responses to a variety of biological response modifiers and other types of immune-based therapies.

Costs:
As this code would be used exclusively in conjunction with code 8818x, Flow cytometry, First Marker, the costs for this test should reflect the incremental reagent costs necessary for sample preparation and an additional monoclonal antibody, as well as additional analytical labor costs.

Charges:
Charges would reflect primarily the incremental increases applied for each specific antibody reagent used in defining the particular clinical situation.

ASM recommendation on payment methodology:

ASM supports the placement of this code on the clinical laboratory fee schedule.  The recommendation would be to cross-walk this code to the existing 86361, T cells, absolute CD4 counts. The 86361 code, usually used in conjunction with the 86359, T cells, absolute count, reflects expenses similar to those of Flow cytometry, additional marker in that it accounts for additional cell processing, monoclonal antibody, and analysis costs required for the addition of a single monoclonal antibody to an existing patient sample.

New code and descriptor:
8818X Flow cytometry, interpretation; 2-8 markers
8818X Flow cytometry, interpretation; 9 to 15 markers
8818X Flow cytometry, interpretation; 16 or more markers

Test purpose and method:
This test will most often be performed in conjunction with the proposed new 8818x tests, Flow cytometry, first marker and Flow cytometry, each additional marker, or may potentially be used in conjunction with several of the T, B, NK, or Stem cell, Total Cells tests. Once the instrument has completed the collection of data, a significant amount of time must be taken by personnel to evaluate and interpret the data for each marker that has been tested. When determined necessary, analysis parameters must be manually adjusted when automatic settings are not correctly done by the instrument, and then a complicated synthesis of the data from all cell populations and monoclonal antibodies must be done to reach final conclusions for each group of patient samples. Review must ensure that all cells have been identified and characterized and that results with different markers are consistent with established characteristics for each normal and malignant cell type that may be present. Once analysis has been completed, a complex interpretative report may be prepared. The number of markers used for any individual case is determined by medical or technical experts in the laboratory who, based on the available clinical and laboratory information, determine the appropriate number and specificity of monoclonal antibodies used to clearly define the malignancy present.

Costs:
Costs for this test are entirely personnel related. Final analysis of each sample requires a significant amount of time to be spent on each individual result. Results often require correlation with other laboratory data prior to completion of the interpretation. Creation of a summary report that incorporates data from each of the associated 8818x tests is also necessary which requires additional time. This procedure represents one of the most technically demanding tests in the laboratory and personnel who perform this procedure should be classified as a CLIA clinical consultant.

Charges:
Charges should reflect the technical labor associated with review of the laboratory data prior to release.

ASM recommendation on payment methodology:

ASM supports the placement of this code on the clinical laboratory fee schedule. The recommendation would be to cross-walk these new interpretation codes for flow cytometry to the similar interpretation code 83912, Molecular Diagnostics, Interpretation and Report, with one unit of 83912 considered equivalent to the interpretation for one monoclonal antibody. A precedent for incorporating 83912 into the clinical laboratory fee schedule was set in 2001 with the composite crosswalks for HIV genotyping (87901). Both the interpretation of molecular gels, strips, sequence data and the interpretation of a single monoclonal antibody result require the expertise of a competent CLIA clinical consultant who has significant previous experience and is capable of synthesizing multiple pieces of information in order to determine the correct interpretation of the data. Based on these considerations, the recommendation would be to set reimbursement as follows:

8818x Flow cytometry, interpretation; 2 to 8 markers:
  Crosswalk to the median number of 5 x 83912
8818x Flow cytometry, interpretation; 9 to 15 markers:
Crosswalk to the median number of 12 x 83912
8818x Flow cytometry, interpretation; 16 or more markers:
  Crosswalk to 16 x 83912

Although 83912 has historically been billed using a -26 modifier for professional component fees, use of the proposed 8818x code for interpretation under the clinical laboratory fee schedule recognizes the significant technical consultant review processes required to perform accurate flow cytometric procedures. Additional physician consultations which correlate comprehensive patient findings with the flow cytometry results should still be billable using the 80500 or 80502 clinical pathology consultation codes.

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