August 1, 2005 - ASM Comments on 2005 Clinical Laboratory Fee Schedule

Centers for Medicare & Medicaid Services
Center for Medicare Management
Division of Ambulatory Services
Mailstop: C4-07-07
7500 Security Boulevard
Baltimore, MD 21244-1850

To Whom It May Concern:

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments on Publication 100-04 (Change Request 3526), “2005 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment.” 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 43,000 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 clinical laboratory medicine including individuals directing clinical microbiology, immunology, or molecular diagnostic laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use in these laboratories, and researchers involved in developing and evaluating the performance of new technologies. Thus, the ASM has significant interest in the process of establishing reasonable reimbursement for medically necessary laboratory testing to ensure quality patient care for Medicare beneficiaries.

Our specific comments are as follows:

Code 83630 (Lactoferrin, fecal, qualitative):

ASM is recommending a revision to the 2005 crosswalk to include code 87015 (Concentration, any type, infectious agents) in addition to code 83516 (Immunoassay for analyte other than infectious agent antibody or infectious agent antigen, qualitative or semiquantitative; multiple step method). This recommendation is consistent with the ASM recommendation for 2006 new code, 8363X (Lactoferrin, fecal, quantitative) and accounts for the additional processing steps required to analyze feces by immunoassay methodology.

Code 86587 (Stem cells (i.e., CD34), total count:

ASM is recommending a revision to the 2005 crosswalk that acknowledges the increased complexity of the flow cytometry method for stem cell analysis as compared to those for other lymphocyte types (i.e. 86359, T cells, total count; 86064, B cells, total count; 86379, NK cells, total count). The International Society of Hematotherapy and Graft Engineering (ISHAGE) has established a specific protocol for stem cell determinations which requires at least two monoclonal antibodies (CD34 and CD45), a viability determination, and an accurate cell count (J Hematotherapy, 1996, June; 5(3):213-226). This protocol requires a complex instrument gating scheme to ensure correct identification and enumeration of viable cells. The results are given as total CD4+ stem cells per unit volume, which requires yet another sophisticated gating strategy using carefully measured fluorescent beads. A simple crosswalk to 86359 (T cells, total count) does not account for this increased complexity. Therefore, ASM recommends a revision to include code 86361 (T cells, absolute CD4 count) in addition to code 86359 (T cells, total count) for payment for code 86587 in order to account for more than a single flow procedure in the analysis.

Code 87517 (Infectious agent by nucleic acid; hepatitis B virus quantification) and code 87522 (Infectious agent by nucleic acid; hepatitis C quantification):

Viral load determinations are a critical component of management of viral hepatitis caused by hepatitis B virus (HBV) and hepatitis C virus (HCV). Similar to HIV-1 quantification (code 87536), these procedures are available in FDA-cleared or approved formats and costs of testing are comparable to those for HIV. The discrepancy between payment for HIV-1 viral load, code 87536 ($118.89) and payment for HBV viral load, code 87517, and HCV viral load, code 87522 ($59.85) does not reflect the economic reality of testing. Given the large number of Medicare beneficiaries afflicted by these serious chronic diseases, and the potential for decreased access to laboratory testing due to inadequate reimbursement, ASM recommends that a revision to payment for HBV (87517) and HCV (87522), quantification codes be made, matching those payments to that for HIV-1, quantification (87536).

Code 87566 (Infectious agent by nucleic acid; Mycobacterium tuberculosis):

The direct specimen amplified molecular tests for Mycobacterium tuberculosis are FDA-cleared or approved tests kits for use particularly with smear-positive samples for rapid confirmation of patients as tuberculosis cases. Rapid identification allows for timely institution of management protocols including contact tracing and prophylaxis of additional cases, both critical to the future control of tuberculosis in the United States. However, to be clinically effective, these tests must be run in a timely fashion, generally in very small batches, including single sample testing in many situations. However, the current reimbursement does not take into consideration the actual clinical utility of the test and the higher costs associated with small batch or single sample testing. Therefore, ASM recommends a revision to the fee schedule, adjusting payment for 87566 (amplified M. tuberculosis testing) to a level 2X the current fee (2 x $49.04 = $98.08).

Thank you for the opportunity to provide comments on the 2005 Annual Update for the Clinical Laboratory Fee Schedule. Please contact Suzy Leous, Manager, Public Affairs at 202-942-9262 or, if you require additional information or reference materials.


Alice S. Weissfeld, Ph.D.,Chair Committee on Professional Affairs
Public and Scientific Affairs Board