Cleared doesn't code. Coded doesn't cover.

A device company clears a product, breathes out, and immediately gets asked by its own commercial team: what’s the code, and will it be paid? Those are not follow-up questions to the clearance. They are two separate determinations, made by a separate federal agency, on two separate timelines that FDA’s own clearance process has no power to resolve and no record of at all.

Three decisions, two agencies

FDA marketing authorization — 510(k) clearance, a De Novo grant, PMA approval, or a documented exemption — answers one question: can this device be legally sold. A HCPCS Level II code from the Centers for Medicare & Medicaid Services answers a second, unrelated one: does a standardized billing identifier exist for a claim to even name this device on. A coverage determination — national or local — answers a third: will Medicare pay for it. A device can clear the first bar and still have no settled answer to either of the other two, for years.

Clearance is paperwork for the coding application, not an answer to it

CMS’s own HCPCS Level II application requires an applicant to name the device’s FDA marketing-authorization pathway and attach the authorization itself — or, for an exempt device, explain the exemption’s basis. That is the clearance’s entire role in the coding process: a required attachment, reviewed alongside the benefit-category and payment questions CMS decides on its own. CMS runs the non-drug, non-biological review twice a year, applications due the first business day of January and July, with decisions published afterward as a dated narrative summary — not a rolling queue, and not triggered by the clearance date. A device cleared in March can wait months for the next cycle to even open a code application, and the code itself may never issue: plenty of cleared devices bill under an existing or miscellaneous code instead of ever getting one of their own.

A code is not a coverage decision

Getting a HCPCS code only means a claim can name the device; it says nothing about whether Medicare pays the claim. That question runs through 42 U.S.C. § 1395y(a)(1)(A) — Social Security Act § 1862(a)(1)(A) — which bars payment for an item or service that is not reasonable and necessary for diagnosis or treatment. CMS can settle that question nationally with a National Coverage Determination, binding on every Medicare Administrative Contractor. Absent one, each MAC decides for itself through a Local Coverage Determination — which means the same coded, cleared device can be reasonable and necessary in one MAC’s jurisdiction and not covered at all in the jurisdiction next to it, at the same time, both decisions correct under the rule that produced them.

Clearance says the device may be sold. A code says a claim can name it. Coverage says someone will pay. Three different tests, three different records, and clearing one proves nothing about the other two.

A 2026 reminder that the categories keep moving

The boundary between “needs its own code” and “doesn’t” is not fixed either. Effective January 1, 2026, CMS folded FDA-regulated human cells, tissues, and cellular and tissue-based products, along with 510(k)-cleared and PMA-approved skin substitutes, into the same biannual public-meeting review process that non-drug, non-biological HCPCS applications already went through — products that, under the prior cycle, moved through coding by a different route. The FDA side of that product category did not change at all; the CMS side did.

The practice

FDA Radar’s own record stops exactly where this question starts: what we monitor is Federal Register notices, warning letters, device recalls, and 510(k) clearances and classifications — not HCPCS applications, not coverage determinations, not the Medicare Coverage Database. A clearance alert tells a team its device can now be sold; it is not, and was never meant to be, a signal that a bill for it will be paid. Those live in a separate system, on a separate clock, decided by people who have never read the 510(k). Whether a specific product needs its own code, or clears a specific MAC’s coverage bar, is a reimbursement-strategy question for your own team working your own facts — this is a description of how the three determinations relate, regulatory intelligence and method, never regulatory or reimbursement advice about any specific device’s coding or coverage.