--- title: "Reimbursement - MedTech Roadmap | MedTech Launch Guide" description: "Coding, coverage, payment - the three legs every payer requires. FDA clearance grants the right to sell. CMS coverage determines whether anyone will buy. Reim" lang: en json-ld: | { "@context": "https://schema.org", "@type": "Article", "headline": "Reimbursement - MedTech Roadmap", "description": "FDA clearance grants the right to sell. CMS coverage determines whether anyone will buy. Reimbursement strategy needs to start at the same time as the clinical trial - not after clearance - because CPT applications take 18–36 months and coverage determinations require evidence already in the literature.", "url": "https://medtechlaunchguide.com/roadmap/reimbursement", "mainEntityOfPage": "https://medtechlaunchguide.com/roadmap/reimbursement", "articleSection": "Reimbursement", "isPartOf": { "@type": "CollectionPage", "name": "MedTech Founder Roadmap", "url": "https://medtechlaunchguide.com/roadmap" }, "publisher": { "@type": "Organization", "name": "MedTech Launch Guide", "url": "https://medtechlaunchguide.com" } } --- [Skip to content](#main) [ MedTech Launch Guide Education Hub for Founders ](/) [Roadmap](/roadmap) [Topics](/topics) Tools [Pulse](/pulse)Search ⌘K[Start Here](/start) Search ⌘K [Roadmap](/roadmap)/ [01 · IP Protection](/roadmap/ip-protection)[02 · Regulatory Pathway](/roadmap/regulatory-pathway)[03 · Clinical Evidence](/roadmap/clinical-evidence)[04 · Reimbursement](/roadmap/reimbursement)[05 · Cybersecurity](/roadmap/cybersecurity)[06 · Business Model](/roadmap/business-model)[07 · Go-To-Market](/roadmap/go-to-market) Step 04 of 7 · Roadmap # Reimbursement Coding, coverage, payment - the three legs every payer requires When to start Before the pivotal clinical study; in parallel with regulatory pathway selection Duration CPT Cat I: 24–36 months · NCD: 9–12 months · Commercial coverage: 6–18 months per payer Indicative cost USD 100K–500K (consulting + dossier) before payer engagement FDA clearance grants the right to sell. CMS coverage determines whether anyone will buy. Reimbursement strategy needs to start at the same time as the clinical trial - not after clearance - because CPT applications take 18–36 months and coverage determinations require evidence already in the literature. ## The three legs Coding: Does a CPT/HCPCS code exist for the procedure? Coverage: Will Medicare and commercial payers pay for it? Payment: At what rate? Missing any leg means you have an FDA-cleared device that nobody can bill for. ## Choose your code strategy Category III CPT (temporary tracking) is faster but does not guarantee payment. Category I requires demonstrated widespread use and is the prerequisite for predictable national reimbursement. HCPCS Level II covers products and supplies where CPT doesn't fit. ## Use TCET if eligible FDA-designated Breakthrough Devices can apply for CMS's Transitional Coverage for Emerging Technologies - time-limited Medicare coverage paired with evidence development. Materially shortens the gap between clearance and revenue. Artifacts to ship - Coding analysis (CPT, HCPCS, ICD-10) + gap assessment - Health-economic model (budget-impact + cost-effectiveness) - Coverage dossier per AMCP format - Payer engagement plan (CMS + top commercial plans) - CPT Cat I or III application (filed via AMA) Common pitfalls - Treating reimbursement as a post-launch problem - guarantees a 2-year revenue gap - Building economic evidence after the trial enrolls (you can't add endpoints retroactively) - Pricing the device against the procedure's professional fee instead of the facility payment - Ignoring private payers because Medicare 'covers it' - most patients aren't on Medicare Primary sources - [AMA CPT Application Coding ](https://www.ama-assn.org/practice-management/cpt/applying-cpt-codes) - [CMS Coverage Resources Coverage ](https://www.cms.gov/medicare/coverage/center) - [CMS TCET Pathway Breakthrough ](https://www.cms.gov/medicare/coverage/coverage-with-evidence-development) - [AdvaMed Reimbursement Trade body briefs ](https://www.advamed.org/issues/payment/) [ Previous Clinical Evidence Step 03 · IDE, IRB, ClinicalTrials.gov - generate the data FDA and CMS both want ](/roadmap/clinical-evidence)[ Next Cybersecurity Step 05 · FD&C Act Section 524B - premarket package + lifelong postmarket plan ](/roadmap/cybersecurity) MedTech Launch Guide The independent education hub for medtech innovators bringing devices to the US market - paired with a live pulse of what FDA, CMS, CISA and investors are doing right now. 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