On behalf of the Coalition for 21st Century Medicine (C21), we appreciate the opportunity to comment on the CY 2018 Physician Fee Schedule Proposed Rule. We are writing in response to the Centers for Medicare & Medicaid Services’ (CMS’) solicitation of public input on the implementation of the new private payor-rate based Medicare Clinical Diagnostic Laboratory Tests Payment System promulgated under Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA). C21 appreciates the work that CMS has performed over the past year in implementing PAMA’s private payor rate-based Clinical Laboratory Fee Schedule (CLFS). We continue to support the implementation of PAMA on the schedule set out in the CLFS Final Rule, which sets an effective date of January 1, 2018 for the new market-based payment rates. Additionally, we respectfully request that CMS release the application for Advanced Diagnostic Laboratory Test (ADLT) status as soon as practicable to enable qualifying tests to be designated in advance of CY 2018.
The Coalition for 21st Century Medicine represents some of the world’s most innovative diagnostic technology companies, clinical laboratories, researchers, physicians, venture capitalists, and patient advocacy groups – all linked by a common mission to develop and make available state-of-the-art diagnostics that improve patient health.