Position Statements

Letter to Glenn McGuirk (Division of Ambulatory Services, Hospital and Ambulatory Payment Policy Group, Centers for Medicare & Medicaid Services) Regarding 2016 Preliminary Gapfill Payment Determinations for New MAAA CPT Codes

…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.

Coalition for 21st Century Medicine Comments on Expected Ariosa Cert Petition

The collective experience of the Members of the Coalition for 21st Century Medicine in trying to obtain much needed patent protection for their novel, life-saving technologies has led to one inescapable conclusion: It is critical to the future of precision medicine that the Supreme Court review the Federal Circuit’s decision in Ariosa Diagnsotics, Inc. v. Sequenom, Inc.

Letter to Marc Hartstein (Director, Hospital and Ambulatory Payment Policy Group, Centers for Medicare & Medicaid Services) Regarding Timeline for New ADLT Designation, Coding, and Payment

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.

Comments on the “Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System” Proposed Rule

…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.