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 2015 Medicare Clinical Laboratory Fee Schedule (CLFS) as outlined in the March 25 Federal Register [CMS–1610–N].The ASM is the largest single life science association, with over 39,000 members worldwide. Its members work in environmental, educational, research, industrial, and government settings on issues such as 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 ASM 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 laboratory products for use, and researchers involved in development and evaluation of 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 are the ASM’s recommendations for payment determinations for new Current Procedural Terminology (CPT) codes to be included in the 2015 Medicare CLFS. 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:

  • 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. If additional supporting materials are required, we will provide them on request.