MolDX Submission & Medicare Reimbursement Support

MolDX Submission & Medicare Reimbursement Support for Molecular Diagnostics

Expert guidance to help your test achieve CMS coverage through successful MolDX submissions and payer-aligned evidence.

What is a MolDX Submission and Medicare Reimbursement?

MolDX is a program under Medicare that evaluates molecular diagnostic tests for coverage. A successful MolDX submission demonstrates clinical utility, enabling your test to gain Medicare reimbursement and national market access.

Why MolDX Coverage Matters

MolDX is the gateway to Medicare reimbursement for molecular diagnostics. Whether you’re commercializing an LDT, NGS panel, or FDA-cleared test, MolDX determines if your test is covered—and reimbursed—under Medicare.

Who We Help

PCR diagnostics (UTI, STI, respiratory, GI)
Oncology and pharmacogenomic panels
Companion diagnostics
Labs transitioning from LDT to FDA pathways

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Our MolDX Services

Pre-submission Strategy: Coverage assessment, precedent LCDs, endpoint planning
Clinical Utility Trials: RWE study design, site recruitment, statistical planning
Dossier Preparation: Analytical/clinical validation, economic models, CPT/Z-code support
Engagement & Follow-up: MAC liaison (Palmetto, Noridian), response to reviewer queries, resubmission support

Why Choose dicentra?

Proven success with MolDX submissions and LCD recognition
Integrated team of regulatory, clinical, and payer experts
U.S. and Canadian coverage pathway experience
Cost-effective trial design with payer priorities in mind

Ready to Pursue MolDX Coverage for Your Diagnostic Test?

Let dicentra help you assess your readiness, identify gaps, and design a winning submission.

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