Position Statements

Letter to CMS on the New Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2015

On behalf of the Coalition for 21st Century Medicine, I am writing to thank you for the recently released CY2015 Clinical Laboratory Fee Schedule (CLFS) Preliminary Payment Determinations. We agree with CMS’ decision to gapfill the payment rates for the new Multianalyte Assays with Algorithmic Analyses (MAAAs), Genomic Sequencing Procedures (GSPs) and other Molecular Multianalyte Assays codes.

Testimony of Kathy Wilsey at the House Energy & Commerce Subcommittee on Health Hearing on ’21st Century Cures: Examining the Regulation of Laboratory Developed Tests’

The United States is at crossroads in the ongoing revolution of personalized medicine, and could fulfill the promise of “21st Century Cures” — early, rapid, and comprehensive diagnosis; and individualized, targeted treatments against serious and life-threatening diseases — only if regulators and public and private insurers align toward the objective.

2015 Physician Fee Schedule and Clinical Laboratory Fee Schedule Comment Letter

The Coalition for 21st Century Medicine (C21) submits these comments to the 2015 Physician Fee Schedule proposed rulemaking to provide information helpful to the Agency’s implementation of the clinical diagnostic laboratory test coverage provisions contained in the recently enacted Protecting Access to Medicare Act of 2014 (PAMA).

Statement from The Coalition for 21st Century Medicine Regarding the FDA’s Draft Guidance Framework for Regulating Lab-Developed Tests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