Yesterday, the Coalition for 21st Century Medicine (C21) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on proposed changes to how the agency determines payments for clinical laboratory services under Medicare’s Clinical Diagnostic Laboratory Fee Schedule.
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).
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.