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


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


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

Comments in Response to the Centers for Medicare & Medicaid Services Hospital Outpatient Prospective Payment System Proposed Rule for Calendar Year 2017

On behalf of the Coalition for 21st Century Medicine, we appreciate the opportunity to submit our comments in response to the Centers for Medicare & Medicaid Services (CMS) Hospital Outpatient Prospective Payment System Proposed Rule for Calendar Year 2017. We are writing in support of CMS’ proposal to expand the laboratory test packaging policy exception to also include Advanced Diagnostic Laboratory Tests. We believe, however, that the exception should be further expanded to include all Multianalyte Assays with Algorithmic Analyses protein based tests which are also not routinely performed by hospitals and are generally less tied to the hospital primary service than more routine laboratory tests.

In addition, we are writing on a related policy matter that is impacted by the agency’s packaging policy proposal. Specifically, we are requesting that CMS update its “date of service” regulations at 42 C.F.R. § 414.510 so that hospitals are not required to bill for clinical diagnostic laboratory tests that are excluded from packaging and are performed by an independent laboratory.

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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