July 12, 2012 - Payment Determinations for Calendar Year 2013 for New Clinical Laboratory Tests

For More Information

ASM Recommendations


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 certain new codes which will be included in the 2013 Medicare Clinical Laboratory Fee Schedule, as announced in the Federal Register on May 29, 2012 [CMS-1441-N].  The American Society for Microbiology, headquartered in Washington, D.C., is the largest single life science association, with almost 40,000 members worldwide. Its members work in educational, research, industrial, and government settings on issues such as the environment, the prevention and treatment of infectious diseases, laboratory and diagnostic medicine, and food and water safety. The ASM’s mission is to advance the microbiological sciences as a vehicle for understanding life processes and to apply and communicate this knowledge for the improvement of health and environmental and economic well being worldwide.

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 outlining the ASM’s recommendations with respect to payment determinations for certain new Current Procedural Terminology (CPT) codes.  We have limited our comments to those tests that commonly 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 codes to be addressed and provided input.  Our comments include the following information, as outlined in the May 29, 2011 Federal Register notice:

  • New test code(s) and descriptor
  • Test purpose and method
  • Costs
  • Charges
  • Recommendation (cross-walking or gap-fill) and data on which recommendation is based

We are not at this time submitting recommendations on the new Molecular Pathology Tier 1 and Tier 2 codes, or the Multianalyte Assays with Algorithmic Analyses but anticipate commenting on the issue of fee schedule placement in response to the 2013 Proposed Physician Fee Schedule.

We greatly appreciate the opportunity to comment on fee setting for 2013 CPT codes in this public forum.  If additional supporting materials are required for our comments and recommendations, we will provide them on request.