Coalition for 21st Century Medicine Applauds FDA Decision to Wait to Publish Final LDT Guidance

Coalition of innovative diagnostic test manufacturers agrees that major implementation challenges with proposed regulatory policies should be resolved prior to implementation to avoid disruption of patient services Washington, D.C. – On November 18, 2016, officials from the U.S. Food & Drug Administration (FDA) communicated informally with key stakeholders, including the Coalition for 21st Century Medicine, … Continued

Coalition for 21st Century Medicine Seeks Reconsideration of Drastic Gapfill Cuts to Innovative Advanced Diagnostic Laboratory Tests

Final rates inconsistent with extensive pricing information submitted to MACs, and contrary to the goals of PAMA and the promotion of precision medicine Washington, D.C. – Today, the Centers for Medicare & Medicaid Services (CMS) released the 2016 Final Gapfill Payment Determinations for new CPT codes for a number of well-established, Medicare covered advanced diagnostic … Continued

Coalition for 21st Century Medicine Supports the PAMA Final Rule and Plans to Comment on the 2016 Preliminary Gapfill Determinations

Coalition’s message is to promote innovation in Advanced Diagnostic Laboratory Tests that improves patients’ outcomes Washington, D.C. – On June 17, the Centers for Medicare & Medicaid Services (CMS) released the final regulations to implement the new market based payment system for advanced diagnostic laboratory tests (ADLTs). The Coalition for 21st Century Medicine (C21) has … Continued

Coalition for 21st Century Medicine United in Opposition to the Centers for Medicare & Medicaid Services’ 2016 Preliminary Determination

On Friday, September 25, 2015, the Centers for Medicare & Medicaid Services (CMS), which administers the Medicare program, released the Preliminary Determinations for the Calendar Year 2016 Clinical Laboratory Fee Schedule (CY2016 CLFS) for new test codes, including new codes for several well-established, Medicare covered advanced diagnostic laboratory tests (ADLTs) developed and performed by members of the Coalition for 21st Century Medicine (C21).