July 19, 2011 - Payment Determinations for Calendar Year 2012 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 2012 Medicare Clinical Laboratory Fee Schedule, as announced in the Federal Register on February 25, 2011 [CMS-1347-N].  The American Society for Microbiology, headquartered in Washington, D.C., is the largest single life science association, with over 38,000 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. 

Posted in the box on the right side of this page is a summary outlining the ASM’s recommendations with respect to payment determinations for new Current Procedural Terminology (CPT) code 873XX to be included in the 2012 Medicare Clinical Laboratory Fee Schedule, and comments for reconsideration of HCPCS code G0435. We have limited our comments to those tests that 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 February 25, 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 greatly appreciate the opportunity to comment on fee setting for 2012 CPT codes in this public forum.  If additional supporting materials are required for our comments and recommendations, we will provide them on request.