Position Statements

…The Coalition appreciates CMS’ efforts to determine the appropriate methodology to price new or substantially revised codes on the Clinical Lab Fee Schedule (CLFS), but we disagree with CMS’ preliminary decision to use crosswalking as the methodology for determining pricing for the nine recently established codes for eight Multianalyte Assays with Algorithmic Analyses (MAAAs) that are subject to review for 2016. As you know the codes presented for pricing determinations at this year’s July public meeting, and which were subsequently reviewed by the CLFS Advisory Panel, are not new tests; rather, they are merely new codes.

The Coalition for 21st Century Medicine (C21) is pleased to submit these written comments as a supplement to our presentation to the Advisory Panel on Clinical Diagnostic Laboratory Tests for the October 19, 2015 public meeting. As the Advisory Panel and the Centers for Medicare & Medicaid Services (CMS) consider the framework for implementing the provisions of Section 216 of the Protecting Access to Medicare Act (PAMA), we would like to share our perspective pertaining to the definition of Advanced Diagnostic Laboratory Tests (ADLTs) and the ADLT application process.

On August 26, 2015, the Advisory Panel on Clinical Diagnostic Laboratory Tests met for the first time, and made recommendations regarding pricing methodologies for new codes subject to pricing determinations for CY 2016. With respect to nine codes representing eight Multianalyte Assays with Algorithmic Analyses (MAAAs), the Panel recommended that CMS establish payment amounts for these tests using the gapfill methodology. On September 25th, the Centers for Medicare and Medicaid Services recommended that payment amounts for these tests be determined using the cross-walk methodology. The Coalition for 21st Century Medicine recommends that the Panel affirm its August 26th recommendation that CMS use gapfilling to establish payment amounts for the nine MAAA codes under review for CY 2016.