Press Releases

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).

Statement from The Coalition for 21st Century Medicine Regarding the FDA’s Draft Guidance Framework for Regulating Lab-Developed Tests

Laboratory developed tests (LDTs) are currently subject to comprehensive regulations under the Clinical Laboratory Improvement Amendments (CLIA). The Food and Drug Administration (FDA) announced that it intends to regulate LDTs as medical devices and outlined the structure of a regulatory framework that the agency intends to implement once a Guidance Document is finalized.