REGULATION, REIMBURSEMENT & MARKET ACCESS

Clear the path to payment

OVERVIEW

The FDA proves you’re safe and effective. CMS and payers decide whether you get paid. We make sure your evidence answers both — the first time.

Coverage, coding, and payment are where cleared products stall, and the reason is almost always evidence: the data that satisfied the FDA isn’t the data CMS, commercial payers, or coding bodies need to say yes. We map those requirements before you generate evidence, not after, so you don’t discover the gap through a denial letter. Led by Dr. Steven Farmer who, as former CMS Chief Strategy Officer for Coverage helped set the standards you now have to meet.

We Develop the evidence you need to convince Public and Private payers that you’ve got a big idea that works.

WHAT WE DO

Get covered, coded, and paid.

Evidence
Strategy Review

A clear map of what the FDA, CMS, commercial payers, and coding bodies will each require, measured against the evidence you already have, are gathering, and plan to gather. We find the gaps before they force costly repeat studies so that you generate evidence once, and generate it right.

Regulatory & Reimbursement Review

A landscape read of your coverage, coding, and payment path across Medicare, Medicaid, and commercial payers, along with federal-payer strategy and a plain-language FAQ that is informed by former FDA and CMS advisors and paired with a market and product assessment.

Collaboration
Through Market Access

FDA and CMS submission support and CPT code development with our regulatory team.

IS THIS YOU?

Who it’s for:

Founders and scale-ups generating clinical evidence, enterprise device manufacturers aligning evidence across a portfolio, and the investors who need to know a product is reimbursable before they commit.