Reimbursement Position Statements

…The National Limitation Amounts must be adjusted in the 2016 Final Gapfill Payment Determinations to comply with the regulatory criteria for gapfill, to avoid substantial fluctuations in payment prior to and with the implementation of Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA 216), and to assure continued access to these advanced diagnostic tests, which the regional MACs where the laboratories are located have determined to be reasonable and necessary and valuable services for Medicare beneficiaries.

We are writing to follow up on our meeting on January 4, 2016 regarding the timeline for the designation, coding and payment of New Advanced Diagnostic Laboratory Tests (ADLTs). The Coalition members appreciate your time and found the meeting very productive. As the agency is in the final stage of the rulemaking process, we want to respond to several of the points that were raised at the meeting.

…C21 strongly supported the enactment of the Clinical Laboratory Fee Schedule (CLFS) reform provisions in Section 216 of the Protecting Access to Medicare Act (PAMA). These reforms, the first major reforms to the CLFS since 1984, establish a transparent market-based payment model, and ensure the Medicare program benefits from the dynamics of the private market place. This new system will ensure continued advancements in diagnostic innovation by providing a pathway to consistent coding and pricing decisions for all diagnostics.

…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.