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 New Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2018

On behalf of the Coalition for 21st Century Medicine, and in follow-up to the comments we presented during the public meeting held on July 31, 2017, we are pleased to submit these additional comments for your consideration as you finalize your CY2018 Clinical Laboratory Fee Schedule (CLFS) Preliminary Payment Determinations.

The Coalition comprises many of the world’s most innovative diagnostic technology companies, clinical laboratories, physicians, venture capital companies, and patient advocacy groups. Given the Coalition’s mission to facilitate development and commercialization of innovative diagnostics to inform important patient management decisions, we have a keen interest in the agency’s CLFS payment policies and determinations – especially those addressing coding and payment for: (1) Multianalyte Assays with Algorithmic Analyses (MAAA) and (2) Genomic Sequencing Procedures and other Molecular Multianalyte Assays.

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