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 CMS Regarding Hospital Outpatient Prospective Payment System, Proposed Rule — Laboratory Date of Service and Packaging Policy

On behalf of the Coalition for 21st Century Medicine (C21), we appreciate the opportunity to comment on the CY 2022 Hospital Outpatient Prospective Payment System (HOPPS) Proposed Rule. C21 continues to strongly support both the existing laboratory date of service (DOS) exceptions policy at 42 CFR 414.510(b)(5) and outpatient packaging exclusion, which have expanded beneficiary access to innovative clinical laboratory testing. As a follow up to the agency’s inclusion of cancer-related protein-based multi-analyte assays with algorithmic analyses (MAAA) tests in the DOS policy and outpatient packaging exclusion in last year’s rulemaking, we are writing to ensure consistency in applying the DOS policy and outpatient packaging exclusion to tests with a pattern of clinical use that is not connected with the primary hospital outpatient service. As discussed below, we recommend that CMS make the following adjustments to its current application of these policies:

1. Apply the laboratory DOS policy and packaging policy exclusion to MAAA tests described by Proprietary Laboratory Analyses (PLA) codes; and
2. Make the laboratory DOS policy and packaging policy exclusion applicable to all MAAA tests if they are unrelated to the primary hospital outpatient service.

Welcome from the Coalition Steering Committee

Bonnie Anderson Headshot“Advanced genomic diagnostics are key to realizing the promise of Precision Medicine. By enabling smarter, more targeted and more personalized medicine, we can improve patient outcomes and reduce the use of healthcare resources. To achieve this potential, we must ensure regulatory, reimbursement and legal frameworks that recognize the value of our tests and encourage continued innovation and investment in this important field.” — Bonnie Anderson, Chairman of the Board and CEO, Veracycte

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

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