On behalf of the Coalition for 21st Century Medicine (C21), we welcome the opportunity to provide input to the Advisory Panel on Clinical Diagnostic Laboratory Tests and the Centers for Medicare & Medicaid Services (CMS). In particular, we want to provide our recommendations on the application and designation process for Advanced Diagnostic Laboratory Tests (ADLTs). As CMS works to develop the sub-regulatory guidance for the ADLT application and designation process, the Advisory Panel has a critical role in providing input on implementation of the new ADLT payment category.
Additionally, we urge the Advisory Panel to review and comment on the 2016 Preliminary Gapfill Payment Determinations for the Multianalyte Assays with Algorithmic Analyses (MAAA) and Genomic Sequencing Procedure (GSP) Current Procedural Terminology (CPT®) codes as recently submitted by the Medicare Administrator Contractors. The Advisory Panel previously considered these codes at the August and October 2015 Panel meetings. The Preliminary National Limitation Amounts (Preliminary NLAs), if finalized, would represent drastic reductions in payment rates for these innovative tests in the magnitude of approximately 30% to 90%.