Cleared. Now who pays?

Clearance answers one of four questions

1. Is it cleared? A U.S. Food and Drug Administration (FDA) 510(k) or De Novo, or a Health Canada licence, clears the device for a stated indication in one market. Every claim you make stays inside that indication.

2. Is there a billing code? Can a hospital, clinic or physician bill for using your device under a code that fits what it does? If no code fits, what’s the path to one, and how long will it take?

3. Does anyone know it exists? The clinicians and administrators who need it have to hear about it, and in a market of a few hundred buyers, I want them hearing it from a peer at one of your first sites.

4. Does it move the needle on value? Different enough, and it matters enough, that someone pays for it gladly.

Coding, coverage and payment run on separate tracks

In the United States, the Centers for Medicare and Medicaid Services (CMS) puts it plainly in its guide for medical technology companies: “Coding, coverage, and payment of technologies and services are distinct, but related aspects under Medicare.” The same page says their timelines and procedures “are not necessarily carried out in any particular order.”

• Coding. Is there a code that describes the device or the procedure it’s used in?
• Coverage. Will the payer agree to pay for it at all, and for which patients?
• Payment. How much, to whom, and in which care setting: the hospital, the clinic or the physician?

For new procedures, the American Medical Association (AMA) keeps Category III (the third section) of its Current Procedural Terminology (CPT) codes, which it describes as “a temporary set of codes for emerging technologies, services and procedures”. The AMA releases them three times a year.

In Canada, Health Canada licenses devices above Class I (its lowest risk class), and in Health Canada’s own words, “The provinces and territories are responsible for delivering health care services.” So I ask the payment questions again for each province you plan to sell into.

Sources, checked 29 October 2026: CMS, Getting Started; AMA, Category III codes; Health Canada, Canada’s health care system.

What changed in 2026, as of 29 October

On 11 August 2026, CMS published a proposed coverage pathway in the Federal Register, the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. For the devices it covers, if the device’s clinical study shows the agreed health outcomes improved for Medicare patients, a proposed national coverage determination would be posted on the day of FDA market authorization, and CMS’s goal is a final one about 60 days later for Class II (the middle of FDA’s three risk classes) devices and 90 days later for Class III (the class with the greatest risk) devices.

The door is narrow. It takes an FDA Breakthrough Device designation, and a study under an investigational device exemption (IDE) that enrols Medicare beneficiaries and measures health outcomes FDA and CMS have agreed on. The device enters at the IDE pre-submission stage, before that study starts. As proposed, a device that already has FDA market authorization can’t use it: CMS points those devices to a national coverage determination outside RAPID, to local coverage, or to decisions claim by claim. So if your device is already cleared, RAPID is a route to plan for your next one. Comments closed on 13 October 2026. As of 29 October, the Federal Register shows no final version, so I check it again every quarter.

Source: Federal Register, volume 91, page 51710, 11 August 2026; FDA risk classes from Classify Your Medical Device.

Value means different enough, and it matters enough

That’s my definition of sales on my about page, and it holds at a hospital too. Who gains when a site uses your device: the hospital, the clinic, the physician, the payer, the patient? In which care setting does the case add up? What will the site’s value analysis want to see from your first 2 or 3 sites before it says yes?

The people who need it have to hear about it

The third question gets answered by the engine on the medical device page: a list built from public signals, an evidence page written for clinicians, and your first sites as references, each with their permission.

Where I fit in the payment work

Your reimbursement and regulatory specialists answer the payment questions for your device. I build the go-to-market plan around their answers: which sites to approach first, in which care setting, with which evidence, and in what order.

Tell me your origin story

We book 1 to 2 hours. It’s recorded, with a mutual non-disclosure agreement in place at booking, so you can talk openly about why you’re building this, your first sites, your pricing and the pipeline decisions keeping you up at night. For a device company I add the four questions after clearance to the agenda.

Within 24 hours you get a written playbook, broken into steps your team can take. For a device company it carries one more page: for each of the four questions, what’s known, what’s still unknown, and who on your side answers it.

It costs $25, basically enough to cover the tokens to analyze our call and build out your report. If the session isn’t worth your hour, I’ll refund double: $50. And if anything stalls, you hear from me within one business day.