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.
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.
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.