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 in Response to the Centers for Medicare & Medicaid Services Physician Fee Schedule Proposed Rule for Calendar Year 2018 (Implementation of Medicare Clinical Diagnostic Laboratory Tests Payment System)

On behalf of the Coalition for 21st Century Medicine (C21), we appreciate the opportunity to comment on the CY 2018 Physician Fee Schedule Proposed Rule. We are writing in response to the Centers for Medicare & Medicaid Services’ (CMS’) solicitation of public input on the implementation of the new private payor-rate based Medicare Clinical Diagnostic Laboratory Tests Payment System promulgated under Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA). C21 appreciates the work that CMS has performed over the past year in implementing PAMA’s private payor rate-based Clinical Laboratory Fee Schedule (CLFS). We continue to support the implementation of PAMA on the schedule set out in the CLFS Final Rule, which sets an effective date of January 1, 2018 for the new market-based payment rates. Additionally, we respectfully request that CMS release the application for Advanced Diagnostic Laboratory Test (ADLT) status as soon as practicable to enable qualifying tests to be designated in advance of CY 2018.

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 ยป