Coverage rules are specific.
MolDX sets out the genes and variant types it expects a panel to cover. Insufficient gene coverage will result in a technical assessment denial by MolDX .
Reimbursement Services
Plan reimbursement while you validate, not after you launch.
A validated NGS test only pays for itself when payers cover it. Our reimbursement specialists work alongside your validation to build the coverage dossier, set up compliant coding and protect payment, so your test is ready to be paid for when it goes live.
The problem
A validated test is not yet a paid test.
The work that decides whether you get paid starts long before the first claim. Labs that leave reimbursement until later find out too late that a panel is missing content a payer requires, or that a dossier needs another round.
More payers now expect MolDX.
MolDX governs Medicare coverage in around half of US states, and some large commercial payers have started asking for it too .
Submissions are hard to get right alone.
Dossiers are detailed, reviewers are exacting, and a denial can mean no Medicare payment for that test .
Research-use-only kits have limits.
Research-use-only kits come with limits on what their vendors can say about clinical validation, coding or payment. We can help with all three .
How we help
Reimbursement built into your assay from the start.
We review every assay through the lens of reimbursement, from panel content to the claim. Our support follows the three stages that decide whether a test gets paid.
COVERAGE
Build the evidence payers need.
We check your panel against MolDX requirements and clinical guidelines, then help you prepare the technical assessment dossier, validation summaries and Z-code application .
CODING
Bill correctly for the work you do.
We advise on ICD-10 and CLFS coding options for each assay and help you design disease-specific subpanels that map to billable codes .
PAYMENT
Protect revenue after launch.
We review your prior authorization workflow and give you templates for pre-authorization, letters of medical necessity and appeals at each level .
Take the full program or only the parts you need. We support both research-use-only and IVD assays , and CGW produces MolDX-compliant reports in combination with our revenue cycle services .
Why labs work with us
Why labs work with us on reimbursement.
Specialists from diagnostics revenue cycle.
Our team has run reimbursement at diagnostic labs, including MolDX submissions and payer appeals. We bring that experience to your test .
Content checked against payer requirements.
We have mapped germline disease states against ClinVar, NCCN guidelines and Medicare payer policies, so your panels are designed to be billable .
A financial model before you commit.
We estimate what your test costs to stand up and run, from kits and sequencing to equipment and staffing, against expected reimbursement .
One partner from validation to report.
Reimbursement support connects to CGW and the PierianDx Knowledgebase, so your evidence, coding and reports stay consistent .
What's included
What's included.
Expert consultationPayer mix, prior authorization, templates and coding
- Medicare MAC and payer mix analysis
- Prior authorization workflow review
- Templates for pre-authorization, appeals by level and letters of medical necessity
- ICD-10 and CLFS coding options by assay
Assay launch preparationSubpanels, pricing, integration and payer contracting reviews
- Assay overview and description
- Subpanel and disease-specific test review
- Pricing review
- IT and revenue cycle integration overview
- Payer contracting review
- Patient financial assistance program review
MolDX and market access dossiersValidation summaries, technical assessment and Z-code application
- Analytical and clinical validation summaries for solid tumor, myeloid and hereditary cancer panels
- Technical assessment checklist and questionnaire
- Validation sample data master list
- Z-code application
- Executive summary, intended use and supporting documents
Clinical Services
More ways we support your lab.
Reimbursement is one of three areas of Clinical Services, alongside laboratory readiness and clinical operations.
Planning a new NGS test? Talk to us before you validate.
The earlier we review your assay, the fewer surprises at submission. Tell us about your test and we'll show you where reimbursement risk sits and what it takes to get it covered.
FAQ
Questions about reimbursement
Can you guarantee coverage or payment?
We help you prepare and plan. Payers decide coverage and payment .
When should we involve you?
Before you validate. The earlier we review your assay, the fewer surprises at submission.
Do we have to take the whole program?
No. Take the full program or only the parts you need .