Audit of CMS Clinical Laboratory Fee Schedule Rate-Setting Process for Public Health Emergencies

Medicare Part B pays for most clinical diagnostic laboratory tests (CDLTs) under the Clinical Laboratory Fee Schedule (CLFS). As a result of the Protecting Access to Medicare Act of 2014 (PAMA), beginning in 2018, CMS sets CLFS reimbursement rates based on the weighted median of private payer rates reported to CMS. A rate is set for each CDLT's Healthcare Common Procedure Coding System (HCPCS) code. The data are reported every 3 years, beginning January 1, 2017. (Reporting was postponed from January 1, 2020, to January 1, 2022, because of the pandemic.) For new CDLTs, CMS or its Medicare administrative contractors set reimbursement rates using "cross-walking" or "gap-filling" methodologies. CMS determines the basis (i.e., cross-walking or gap-filling) after it solicits and receives public comments, announces and holds its CLFS annual public meeting regarding new CDLTs, and considers comments and recommendations (and accompanying data) received, including recommendations from an outside advisory panel. The objective of this audit is to determine whether CMS's procedures for clinical diagnostic laboratory test rate-setting could be improved for future public health emergencies.

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
Completed	Centers for Medicare and Medicaid Services	Audit of CMS Clinical Laboratory Fee Schedule Rate-Setting Process for Public Health Emergencies	Office of Audit Services	W-00-21-35875; W-00-22-35875	2025