July 16, 2007 - Payment Determinations for Calendar Year 2008 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 2008 Medicare Clinical Laboratory Fee Schedule, as announced in the Federal Register on May 25, 2007 [CMS-1546-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 our 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.

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 2008 Medicare Clinical Laboratory Fee Schedule. Comments are limited to procedures which are likely to be performed in laboratories performing microbiologic, immunologic, or molecular diagnostic testing. Recommendations are 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 2008” document on the CMS web site and provided comment. For each code, the following information is provided, as outlined in the May 25, 2006 Federal Register notice:

  • New test code and descriptor
  • Test purpose and method
  • Test costs (presented in general terms as specific data are not generally publicly available)
  • Test charges (presented as the 2007 National Limitation Amount in the Clinical Laboratory Fee Schedule or where appropriate, from the Physician Fee Schedule)
  • ASM recommendation on payment methodology
  • ASM rationale for payment recommendation

The ASM appreciates the opportunity to make recommendations on payment levels for new 2008 CPT codes. Should additional information or reference materials be required, ASM stands ready to assist in any way possible.