Study 1 · The commercialization of clinical AI
Cleared to Paid
Who pays for clinical AI, and why insurers pay for so little of it. A study in five phases; the first, on the money, is out now.
Phase 1 published Oct 13th 2026
Phase 1 · The money
Cleared, but rarely reimbursed
The FDA has cleared 1,614 AI medical devices. Only 78 have ever had a way to be paid per use. Who pays for the rest?
The Food and Drug Administration has cleared 1,614 medical devices that use artificial intelligence, and it clears more each year. Only 78 of them, fewer than one in 20, have ever had a way to be paid for each use: a billing code, a Medicare laboratory code or an inpatient add-on payment. Today 73 still do.
Only 78 of 1,614 have ever had a per-use payment route
FDA AI-enabled devices by payment route, one square per device
- Per-use route today (73)
- Route has ended (5)
- Never had one (1,536)
A device counts only when a CMS rule, a Medicare contractor or its maker names it for a code, so 78 is a floor. See who pays for every device in the full report.
Show the numbers
| Payment route | Devices | Share |
|---|---|---|
| Per-use route in force | 73 | 4.5% |
| Per-use route ended | 5 | 0.3% |
| Never had a per-use route | 1,536 | 95.2% |
| All devices | 1,614 | 100% |
Sources: FDA; CMS; Medicare contractors; makers' coding guidesHealthcare AI Insights
Where insurers do pay, the money is concentrated. Medicare's payments to doctors for AI codes reached $10.3m in 2024. Analysis of coronary CT scans took 96% of it.
Everything else is paid for some other way, mostly by hospitals and imaging groups out of their own budgets. Even AI built into scanners is usually sold separately: where makers' documents say how they sell such features, 154 of 195 are options, licences or upgrades rather than part of the machine's price.
Three in four are paid from a buyer's budget
FDA AI-enabled devices by who pays, % of total
- 5.0%Paid per use (80 devices): the 78 named for a billing code, lab code or add-on, plus 2 maker-run services some insurers pay per use
- 4.0%No extra payment (65): rides on a service insurers already pay for
- 15.0%Inside a hardware price (242): scanner features, medtech systems, consumer devices
- 76.0%From a buyer's budget (1,227): standalone software, scanner options and upgrades, per-case services
The three unpaid groups rest partly on inference from who filed each device. The hardware share is an upper bound: scanner features whose packaging could not be checked stay counted as hardware.
Sources: FDA; CMS; makers' documentsHealthcare AI Insights
The pattern holds abroad. Across 36 payment arrangements in America, China, Germany and Britain, per-use payment appears only for AI that produces a result of its own, such as a measurement or a risk score, and for AI that treats. Insurers, in short, pay for answers, not for help.
Why? One hypothesis is a verification tax. AI that promises efficiency is hard to price while a clinician still checks every case, because the time it saves is hard to see. That may explain why AI scribes have spread fastest: their mistakes are cheap to fix. A later article in the series tests the idea.
The series in five phases
Phase 1 · Live now
The money
Who pays for clinical AI, and for what?
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Phase 1 · Article 1 · Coming
Paid for, but not by insurers
Regulators approve AI devices by the hundred. Insurers pay per use for only a few; for the rest, hospitals pay, betting on time savings that are hard to bank.
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Phase 1 · Article 2 · Coming
Pay for answers, not for help
Two questions predict it: does the AI produce a result of its own, and is it inside a service that is already paid?
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Phase 1 · Article 3 · Coming
Follow the money, not the model
Who captures the value of medical AI? Mostly not the companies selling AI software to hospitals.
Phase 2 · Next
The buyer
Who actually uses paid AI, and does evidence decide?
Planned: Paid AI clusters in a few places · The verification tax · The payer becomes the buyer
Phase 3 · Later
The builders
Who wins, who gets bought, and where should AI companies sell?
Planned: The scanner eats the software · Europe's third way · From approval to payment, market by market
Phase 4 · Later
The verdict
What held up, and what did I get wrong?
Planned: What I got wrong · In their own words
Phase 5 · Later
The next wave
What changes when AI is not a regulated device?
Planned: Scribes that bill
Planned titles may change as the research goes on.