July 14, 2009 - Payment Determinations for Calendar Year 2010 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 2010 Medicare Clinical Laboratory Fee Schedule, as announced in the Federal Register on May 22, 2009 [CMS-1407-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.

Attached 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 2010 Medicare Clinical Laboratory Fee Schedule.  We have limited our comments to those tests listed on CMS’s website which affect our constituency, and our 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 2010” document on the CMS website and provided input.  Our comments include the following information, as outlined in the May 22, 2009 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

The ASM greatly appreciates the opportunity to comment on fee-setting for 2010 CPT codes in this public forum. If additional supporting materials are required for our comments and recommendations, we will provide them on request.