Coding, coverage, and payment strategy for an epigenetic diagnostics platform.

A molecular diagnostics company had built a methylation-based testing platform capable of producing multiple disease-specific outputs from a single blood draw. The science was strong, but commercial value depended entirely on the reimbursement trifecta that determines whether any lab test generates revenue: a billing code, a coverage decision, and an established payment rate.

The company needed to move a portfolio of tests through all three stages of that process — and to sequence the effort so that revenue could build while the slower coverage and payment decisions matured.

Wellguidant supported the company across the full coding-to-payment lifecycle, treating it as three distinct but sequential workstreams.

• Coding (completed): Supported the development and submission of the platform's proprietary laboratory analysis (PLA) code applications through the AMA review process, establishing the billing infrastructure that lets each test be identified, ordered, and claimed independently — and that creates meaningful competitive lead time given the multi-month application timeline.
• Coverage (ongoing): Mapped each test against the existing Medicare coverage landscape, identifying where established LCD frameworks could apply, where new coverage policy would need to be developed, and where specific indications faced elevated risk from existing non-coverage policy. Helped structure the evidence-development priorities — analytical validity, clinical validity, and clinical utility — that a MolDx technical assessment requires, and identified parallel coverage pathways (such as Medicare Advantage contracting) that could generate revenue independent of the FFS coverage timeline.
• Payment (ongoing): Analyzed the CMS rate-setting pathways available to the codes — crosswalk versus gap-fill — and benchmarked appropriate methylation-test comparators to support a defensible pricing position, while preparing the company to participate in the CMS pricing process.

The company moved from a strong scientific platform to a structured, sequenced reimbursement strategy: coding established, coverage actively in development with prioritized evidence and clear pathway logic, and a benchmarked payment position ready for CMS engagement. The work gave the company — and its stakeholders — a realistic, stage-by-stage view of where revenue could begin and what each remaining gate required.

In molecular diagnostics, coding is the easy part to celebrate and the wrong place to stop. Coverage and payment are where revenue is actually won or lost, and they run on regulatory timelines that don't bend to a client's revenue model. By treating all three as a connected sequence — and being candid about which gates were cleared versus still open — we helped the company build a commercialization plan grounded in reimbursement reality.