A cleared device that no one pays for doesn't have a business, and investors know it, which is why "what's the reimbursement path?" comes up early in diligence. "We'll figure it out after clearance" tells an investor the risk hasn't been looked at.
1 Coding, coverage and payment are three separate problems
A CPT code (coding) doesn't guarantee a payer will cover the procedure (coverage), and coverage doesn't set the rate (payment). Each is its own hurdle. Medicare's national and local coverage determinations are public in CMS's Medicare Coverage Database, and the AMA maintains CPT, including Category III codes, a temporary set for emerging technologies, services and procedures.
How to close it
Map all three for your procedure. Even a directional thesis (comparable codes, the payer logic, the gap you'll need to close) beats silence.
2 Comparable-code reasoning is what investors look for
A strong pre-raise reimbursement story benchmarks against an existing, paid procedure the device is analogous to, and explains the path from there.
The trap
Assuming a Category III code, a new-technology add-on payment (NTAP) or a coverage decision will arrive on your timeline. Model the realistic case. NTAP itself is changing: the FY 2027 inpatient final rule ends the alternative pathway that let Breakthrough Devices qualify without showing substantial clinical improvement, for applications beginning in fiscal year 2028, with devices designated Breakthrough by September 30, 2026 grandfathered. See our article on RAPID and the NTAP change.
3 Reimbursement risk compounds clinical risk
If coverage hinges on evidence you don't yet have, your clinical plan and your reimbursement plan are the same plan. Investors look for that link.
How to close it
Tie the clinical readout that proves your endpoint to the coverage decision it supports: one narrative, not two.
The bottom line
You don't need reimbursement solved before you raise. You need to show you understand coding, coverage and payment, have a benchmarked thesis, and know which evidence supports which decision. That turns an open question into a managed risk.
References
- CMS. "Medicare Coverage Database." cms.gov
- American Medical Association. "Category III Codes." ama-assn.org
- Holland & Knight. "CMS Releases Fiscal Year 2027 IPPS and LTCH Final Rule." August 2026. hklaw.com
- Gardner Law. "CMS Grandfathers Certain Breakthrough Devices for NTAP and TPT." 2026. gardner.law
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