July 14, 2008 - Payment Determinations for Calendar Year 2009 for New Clinical Laboratory Tests

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) regarding payment methodology to be used for new codes which will be included in the 2009 Medicare Clinical Laboratory Fee Schedule, as announced in the Federal Register on June 14, 2008 [CMS-1402-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 approximately 42,000 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, clinical immunology, and molecular diagnostics.

Many of ASM’s members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology, immunology, and molecular diagnostic laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use, and researchers involved in developing and evaluating new technologies. Therefore, 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.

Below is a summary statement outlining the ASM’s recommendations with respect to payment determinations for new Current Procedural Terminology (CPT) code 879XX to be included in the 2009 Medicare Clinical Laboratory Fee Schedule. We have limited our comments to this one new microbiology test that was listed on CMS’s website, and our recommendation is based on the consensus of ASM’s Public and Scientific Affairs Board Committee on Professional Affairs and Committee on Laboratory Practices, which reviewed the “New Clinical Laboratory Tests for 2009” document on the CMS website and provided comment. Our comments include the following information, as outlined in the June 14, 2008 Federal Register notice:

  • New test code and descriptor
  • Test purpose and method
  • Test costs
  • Test charges (i.e. the National Limitation Amount)
  • Recommendation and rationale on payment methodology

New test code and descriptor:

879XX Infectious agent enzymatic activity other than virus (e.g. sialidase activity in vaginal fluid)

Test purpose and method:

This new code is intended for use in detecting infectious agents associated with clinical disease directly in clinical specimens using as a surrogate marker a specific enzyme associated with the infectious agents. The method used is typically visual observation of the specific enzymatic activity upon a chromogenic substrate. Examples of tests that use this methodology include:

  • OSOM BV Blue®, which detects sialidase activity associated with bacterial agents of bacterial vaginosis including Gardnerella, Bacterioides, Prevotella, and Mobiluncus in vaginal fluid samples.
  • Quidel Quickvue Vaginalis Test®, which detects proline aminopeptidase associated with Gardnerella in vaginal fluid samples.
  • CLO-type assays (several are commercially available), which detect urease enzyme in unprocessed gastric biopsy samples associated with Helicobacter pylori gastritis and related syndromes (Note: this waived procedure is currently mapped to CPT code 87077QW, “Culture, bacterial, aerobic isolate, additional methods required for definitive identification, each isolate” as an aberration resulting from the 2001 deletion of code 87072, “Culture or direct bacterial identification method, each organism, by commercial kit, any source except urine”).
  • ZStatFlu®, which detects neuraminidase activity associated with influenza viruses in pharyngeal swabs (Note: this waived procedure is currently mapped to 87449QW, “Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method, not otherwise specified, each organism.” The new descriptor more closely describes this assay, and it is not clear why direct viral enzyme detection is excepted from the descriptor).

Test Costs:

Reagents costs for detection of enzymes associated with microbial agents directly in clinical specimens are approximately $9-10 per assay. Considering quality control and labor, direct costs approximate $15 per assay.

Test Charges:

Charges are comparable to other visual readout assays for microbial agents of infection, often employing antigen detection methods using immunoassays with direct optical observation and reflect direct and indirect costs. The NLA for these methods (e.g. 87802) is $16.76

ASM Recommendation and Rationale:

The ASM recommends a crosswalk to 82657, “Enzyme activity in blood cells, cultured cells, or tissue, not elsewhere specified, nonradioactive substrate, each specimen” because the analyte and method are similar to this code. However, because assays represented by the proposed code, 879XX, will be performed on samples not requiring extensive tissue processing, we further recommend a reduction equivalent to the NLA for 87176, “Homogenization, tissue, for culture.” Therefore the recommended NLA would be $25.23 (82657) less $8.22 (87176) equaling $17.01.

Thank you for the opportunity to comment.