REGULATORY

REGULATORY

The Regulatory Workgroup engages with stakeholders to discuss the appropriate regulatory framework for advanced diagnostic tests... Read More »
REIMBURSEMENT

REIMBURSEMENT

The Reimbursement Workgroup is playing a lead role in crafting the future of coding, coverage, and payment for ADLTs... Read More »
INTELLECTUAL PROPERTY

INTELLECTUAL PROPERTY

The Intellectual Property Workgroup is deeply committed to advocacy for protection of intellectual property rights for innovators... Read More »

Advanced Diagnostics Are Key to the Future of Quality, Affordable Healthcare

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.

Latest Position Statement

Letter to Andrew Slavitt (Acting Administrator, Centers for Medicare & Medicaid Services) Regarding 2016 Preliminary Gapfill Payment Determinations for New Genomic Sequencing Procedures Test Codes

On behalf of the Coalition for 21st Century Medicine (C21), we welcome the opportunity to provide input to the Advisory Panel on Clinical Diagnostic Laboratory Tests and the Centers for Medicare & Medicaid Services (CMS). In particular, we want to provide our recommendations on the application and designation process for Advanced Diagnostic Laboratory Tests (ADLTs). As CMS works to develop the sub-regulatory guidance for the ADLT application and designation process, the Advisory Panel has a critical role in providing input on implementation of the new ADLT payment category.

Additionally, we urge the Advisory Panel to review and comment on the 2016 Preliminary Gapfill Payment Determinations for the Multianalyte Assays with Algorithmic Analyses (MAAA) and Genomic Sequencing Procedure (GSP) Current Procedural Terminology (CPT®) codes as recently submitted by the Medicare Administrator Contractors. The Advisory Panel previously considered these codes at the August and October 2015 Panel meetings. The Preliminary National Limitation Amounts (Preliminary NLAs), if finalized, would represent drastic reductions in payment rates for these innovative tests in the magnitude of approximately 30% to 90%.

Welcome from the Coalition Steering Committee

Kim Popovits“The value of molecular diagnostics in delivering precision medicine in healthcare is simply way too high to ignore. Genomic medicine should and will be the future. In our efforts to help more patients improve their health outcomes, we must develop a framework for regulatory and reimbursement pathways that inspires innovation and investment in this important field.” – Kim Popovits, President and CEO, Genomic Health

Join the Coalition

US CapitolNever has your membership in the Coalition been more important than it is now, as we look forward to enacting the most significant health-related legislation of the decade and stand on the cusp of a revolution in the delivery of personalized health care. Join Now »

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  • Castle Biosciences Incorporated
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  • GE
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  • Genomic Health
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  • Sera Prognostics
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