idea-018 · viability deck

Every slide states a condition that would have to be true, then reports where it stands using the candidate file's own claim and its own confidence tag. A deck never upgrades a tag, invents a number, or recommends anything, and there is no ask slide.

Nonunion PEMF Bone Growth Stimulator — viability

The chair: the investor, and the operator who has to run this as a business.

How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-018.md: the number is the claim's position in its ## Claims list and the tag is the one the candidate file carries today, copied and never adjusted here. A no-claim marker means nothing in the file speaks to the condition. See docs/deck-spec.md.

No number appears on this deck that is not in a claim, and there is no ask slide. A raise amount would be a fabricated figure.

What changed since the last build. On 2026-09-29 the Verifier cached the CMS (Centers for Medicare & Medicaid Services) HCPCS (Healthcare Common Procedure Coding System), DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) fee schedule and DMEPOS utilisation files. Four money claims moved to verified: the code exists (claims 13, 14), the price (claim 16verified), separate payment (claim 23verified), and the size of the E0748 (a HCPCS code for durable medical equipment) line this candidate gives up (claim 18verified). One moved to refuted: the E0747 volume guess (claim 15refuted). The money question is therefore less uncertain than it was, and the answer the new data gives is a smaller line than the Generator assumed. Verification also surfaced a question the file had not asked. Every E0747 fee line carries a KF modifier, and whether a Class II (FDA device class II) device bills on those lines is open (Slide 2).

Slide 1 — Who pays, from which budget

Would have to be true: Medicare Part B (Medicare Part B) would have to pay a DMEPOS supplier for the device under HCPCS E0747, as a separately billed DME (durable medical equipment) item, for beneficiaries meeting NCD 150.2 (a Medicare national coverage determination number)'s nonunion criteria. Medicare Advantage (Medicare Advantage) plans and commercial insurers would have to pay on comparable terms for patients outside fee-for-service.

Where it stands: The Medicare fee-for-service budget line is verified end to end at the level of rules. NCD 150.2 covers the non-invasive stimulator for nonunion of long bone fractures on a closed list claim 8verified. E0747 exists with the non-spinal electrical descriptor claim 13verified. It is priced and paid to suppliers as its own line in DMEPOS category IN rather than folded into a facility payment claim 23verified. Medicare Advantage is bound by regulation to follow NCDs, but whether plans do so in practice, and whether commercial payers cover on comparable terms, is unchecked claim 34unconfirmed. The coverage-at-authorisation lane is not available either. RAPID, as published for comment, is for Breakthrough-designated devices, and the conclusion that this route falls outside it is the Generator's inference claim 22unconfirmed.

What would settle it: Commercial payer medical policies for non-invasive bone growth stimulators (a handful of large national insurers). No connector reads them, so a human would retrieve them. For Medicare Advantage in practice, the prior-authorisation criteria of the largest plans.

If it's false: If the commercial and MA (Medicare Advantage) side does not pay on NCD (national coverage determination) terms, the business is Medicare fee-for-service only. That is the smallest reading of the TAM (total addressable market) on Slide 3, and it is the only one the file has measured.

Slide 2 — The three reimbursement questions

Would have to be true: A code would have to exist for this device. The amount paid on that code would have to reach this device, a Class II 510(k) (premarket notification) entrant. The coverage policy's documentation conditions would have to be ones a new-entrant supplier can meet.

Where it stands:

Code exists: yes. E0747 carries the claimed descriptor verbatim claim 13verified. E0748 and E0760 exist alongside it claim 14verified.
Payment amount: the E0747 new-purchase allowance is $4,743.80–$5,580.94 non-rural, July 2026; rental runs $471.38–$554.57 a month claim 16verified. Every E0747 line carries a second modifier, KF, and there is no line without it. The Verifier did not check what KF means, and the file does not answer whether a device cleared as Class II under 890.5870 bills on those lines at that fee. This deck put that condition on record claim 45unverified. The allowance is Medicare's allowed amount. It is not what the manufacturer realises after the supplier's margin, and no claim carries that margin.
Coverage policy: NCD 150.2 covers the indication claim 8verified. Its radiographic nonunion definition is the one the intended_use: restates claim 9verified. The DME MAC (durable medical equipment Medicare administrative contractor) policy article A52513, which would carry the documentation conditions, is visible in the cached index with an effective date of 2026-05-18, but nobody has read it claim 12unconfirmed.

What would settle it: A human reads the HCPCS definition of the KF modifier and the DME MAC guidance on which devices bill on KF lines after the reclassification. A human opens A52513 and its parent LCD (local coverage determination) L33796 (a Medicare local coverage determination number). The Verifier's note on claim 12unconfirmed infers that L33796 was revised at reclassification, but that is unchecked. One reading session could settle both.

If it's false: If a Class II device cannot bill on the KF lines and no non-KF line exists, the verified price on this slide does not apply to this device, and the reimbursement factor's strongest leg belongs to the incumbents only. Slide 3's price leg would go blank.

Slide 3 — TAM, decomposed

Would have to be true: The Medicare E0747 line, plus whatever non-Medicare volume exists, times the price this device can bill, times a share a new entrant can take from the incumbents, would have to be large enough to carry a business. Each factor is below.

Where it stands:

Population: the Generator's estimate of nonunions as 5–10% of about six million US fractures a year is unsourced and permanently unconfirmed without a licensed source claim 17unconfirmed.
Rate / volume: the checkable leg failed. The Generator guessed low tens of thousands of Medicare E0747 services a year. The cached DMEPOS utilisation file shows 6,912 (4,881 purchases, 2,031 rental months), about 4,900–5,400 beneficiaries, in data year 2024 claim 15refuted. That is Medicare fee-for-service only and is a floor. No claim carries non-Medicare volume.
What the narrowing gave up, now measured: the spinal-fusion adjunct line E0748 runs at 28,270 services, about four times E0747 by services and about five times by beneficiaries, at a similar purchase fee claim 18verified.
Price: $4,743.80–$5,580.94 per new purchase, allowed claim 16verified, subject to the KF question on Slide 2 claim 45unverified.
Reachable share: whether a new entrant takes any share of E0747 from Orthofix, Zimmer Biomet and Bioventus is unverifiable without a licensed source claim 35unconfirmed.

What would settle it: Non-Medicare volume needs a commercial-claims or all-payer source that a human would have to license and attach. Share needs primary research with DMEPOS suppliers and prescribers (the desirability deck, Slide 3). The population leg can only be settled by a licensed epidemiology source. Volume and price are already settled for Medicare FFS (fee-for-service).

If it's false: This slide is where the refutation lands. With volume refuted downward, the Stage 2 TAM draft (built on "low tens of thousands") rests on a premise the file now contradicts. The rubric says a refuted claim pulls its factor down, and the Stage 5 TAM floor sits on this factor. Rescoring it is the Scorer's job, not this deck's.

Slide 4 — Capital to first dollar

Would have to be true: The first E0747 claim could be billed only after three steps. The device would have to be built to the 890.5870 special controls. It would have to clear 510(k) against a predicate FDA (US Food and Drug Administration) accepts. Its clinical-data requirement would have to be met without a new trial on the scale of a PMA (premarket approval). The cost and calendar of that sequence would have to be fundable, and neither figure appears in any claim.

Where it stands: The route exists. The reclassification final order took effect 2026-05-18 claim 1verified. The regulation's indication language includes established nonunion claim 2verified. Before that date the route was PMA only claim 5verified. Whether the narrow label keeps the device inside that route is an FDA judgement claim 7unconfirmed. There is no 510(k) cleared under LOF or LPQ, ever, so there is no predicate under the new regulation claim 20verified. Whether a pre-reclassification PMA device serves as a predicate is unresolved. The final order assumes legally marketed predicates exist but does not say this claim 38unconfirmed. The special controls require clinical data, with imaging, in every 510(k) under this regulation claim 3verified, so this is not a bench-only submission. Whether a new entrant can meet that requirement by relying on an incumbent's clinical data is carried on the feasibility deck claim 47unverified. The cost of reaching first billing is blank, and so is the calendar [no claim].

What would settle it: An FDA pre-submission (Q-Sub) asking about the predicate, the scope of the label, and clinical-data reliance in a single meeting. That is a human act, and the Verifier notes on claims 7 and 38 both name it. The cost and calendar can only be estimated once that answer is in. No figure should appear on this slide before then.

If it's false: If there is no usable predicate or no reliance, the "cheap pathway" becomes a 510(k) with its own clinical study, or a De Novo (De Novo classification request). Factor 7 then takes the damage, and so does the premise of the whole candidate: that the reclassification made this fast.

Slide 5 — What stops a fast-follower

Would have to be true: Something other than the pathway would have to protect the business. It could be a patent on the garment coil geometry or the tamper-evident log that a competitor cannot design around. It could be a documentation advantage that suppliers or payers actually pay for.

Where it stands: The pathway protects nothing. The 510(k) door opened for every incumbent and entrant on the same day; the premise is solid and the inference is reasoning claim 21unconfirmed. Whether patent protection on the two differentiators is obtainable, and would deter anyone, is a legal judgement no connector makes claim 36unconfirmed. No patent search of any kind has been run claim 26unconfirmed. Whether suppliers and payers value a device-generated adherence log is the entire commercial case for the differentiator, and it is an explicit assumption claim 30unconfirmed.

What would settle it: A patentability search on the coil geometry and the logging function, through PatentsView or EPO (European Patent Office) OPS or by counsel. A human reading of A52513 (Slide 2) to see whether DME MACs require wear-time documentation at all. If they do not, the log has no documentation value to sell. DMEPOS supplier interviews.

If it's false: With no patent and no paid-for documentation value, the moat is empty. Everything this device does, an incumbent with established distribution can match with a product-line extension.

Slide 6 — Who is already there

Would have to be true: The incumbents would have to leave room. Either they would not ship a low-profile or adherence-logging nonunion device first, or their established DMEPOS relationships would have to be something a new entrant can get past.

Where it stands: The incumbent field (Orthofix, Zimmer Biomet, Bioventus) is named from background knowledge. No PMA, K-number or GUDID (Global Unique Device Identification Database) record has been confirmed claim 19unconfirmed. None of them has used the new 510(k) route yet. The openFDA clearance query for LOF and LPQ since 2026-05-18 returned zero claim 20verified. That is a real empty result, not white space: they are on the market under PMAs. Whether any of them will ship a low-profile or logging device first is a forecast no connector answers claim 37unconfirmed. No funding, launch or recall data has been retrieved for any incumbent.

What would settle it: A PMA or GUDID lookup for the incumbent products (no connector here performs it; a human could). A periodic clearances scan on LOF and LPQ as a pointer to who files first. It gives a pointer, not a tag.

If it's false: If an incumbent ships the same differentiators first, this candidate is a late me-too on its only distinctive feature, and Slide 5 has nothing left.

Slide 7 — The cheapest way to find out

Would have to be true: A single human reading session would have to settle whether this device can bill at the verified E0747 price. It would read the KF modifier definition, the DME MAC guidance on Class II billing after reclassification, and policy article A52513 with LCD L33796. That session costs hours, not a study.

Where it stands: Not done. The KF question is a condition this deck put on record claim 45unverified, and the article is unread claim 12unconfirmed.

What would settle it: A human opens the three documents at the CMS and DME MAC sources the Verifier's claim-12 note identifies. Each thing they find becomes its own claim line for the Verifier.

If it's false: If the documents show a Class II device cannot use the KF lines, Slides 2 and 3 need a price the file does not have, and the reimbursement question reopens from the start.

Slide 8 — Where this deck outruns the file

Every condition above with nothing verified behind it. Read this slide first. This deck carries more verified material than the other two (claims 1, 2, 3, 5, 8, 9, 13, 14, 16, 18, 20, 23). All of it describes the rules and the Medicare line, and none of it describes whether this entrant gets paid or takes share.

A Class II 510(k) device bills on the KF-modified E0747 lines — claim 45unverified — human reading of the KF definition and DME MAC guidance (written back by this deck).
A52513's documentation conditions — claim 12unconfirmed — a human opens A52513 and L33796.
Commercial and Medicare Advantage cover on NCD terms — claim 34unconfirmed — commercial payer policies, retrieved by a human.
The RAPID lane is out of reach — claim 22unconfirmed — the notice is open for comment until 2026-10-13; read the final version when it issues.
The E0747 volume the TAM was drafted on — claim 15refuted — already settled downward; the Scorer's move, not this deck's.
Non-Medicare volume — [no claim] — a licensed all-payer source a human attaches.
The nonunion population — claim 17unconfirmed — a licensed epidemiology source.
A new entrant's share of E0747 — claim 35unconfirmed — supplier and prescriber research.
The manufacturer's realised price after the supplier's margin — [no claim] — supplier interviews.
The narrow label stays in the 510(k) route — claim 7unconfirmed — FDA pre-submission.
A pre-reclassification PMA device is a usable predicate — claim 38unconfirmed — FDA pre-submission.
Clinical-data reliance on an incumbent — claim 47unverified — FDA pre-submission (carried on the feasibility deck).
Cost and calendar to first billing — [no claim] — estimable only after the pre-submission answer.
The pathway confers no exclusivity — claim 21unconfirmed — reasoning; it stands until someone shows otherwise.
Patent protection on the differentiators — claim 36unconfirmed — patentability search by counsel.
The FTO (freedom to operate) field — claim 26unconfirmed — see the feasibility deck, Slide 7.
Suppliers and payers value the adherence log — claim 30unconfirmed — A52513 plus supplier interviews.
The incumbent field is as named — claim 19unconfirmed — a PMA or GUDID lookup.
No incumbent ships the differentiators first — claim 37unconfirmed — a forecast; watch LOF and LPQ clearances.

Slide 9 — The load-bearing condition

If only one thing from this chair could be checked: whether a non-invasive bone growth stimulator cleared as Class II under 21 CFR (Title 21 of the Code of Federal Regulations) 890.5870 can bill Medicare on the KF-modified E0747 fee schedule lines at the verified allowance claim 45unverified.

This one rather than the others: every other money condition on this deck assumes this device gets the price the file verified. The price is the strongest leg the file has. The volume leg is now refuted downward, and the share leg is permanently unverifiable without a licensed source. If the price does not reach a Class II entrant, the verified reimbursement stack (claims 8, 13, 16, 23) describes the incumbents' business, not this one. It is also the cheapest condition on the deck to settle: a reading task, not a study.

Naming it is not a recommendation, a gate, or a kill.

Words on this page24 abbreviation(s) and code(s), with what each stands for — copied from _shared/plain-language.md

21 CFR: Title 21 of the Code of Federal Regulations — the US food-and-drug rulebook; a number after it is one regulation, often the one that classifies a device type
510(k): premarket notification — the FDA route for a device shown to be as safe and effective as one already on the market; months, no clinical trial as a rule
Class II: FDA device class II — moderate-risk devices, usually cleared by 510(k)
CMS: Centers for Medicare & Medicaid Services — the US agency that runs Medicare, and so decides what Medicare pays for
De Novo: De Novo classification request — the FDA route for a new, lower-risk device with no comparable product to point at; longer than a 510(k), usually needs clinical data
DME: durable medical equipment — equipment a patient uses at home, such as a pump or a stimulator, that Medicare pays for under its own rules
DME MAC: durable medical equipment Medicare administrative contractor — one of the four regional contractors that process Medicare's home-equipment claims and write its local coverage rules
DMEPOS: durable medical equipment, prosthetics, orthotics and supplies — the Medicare benefit and fee schedule that home equipment is paid under
E####: a HCPCS code for durable medical equipment — one billing code for a piece of home equipment; the letter E and four digits
EPO: European Patent Office — the European patent office
FDA: US Food and Drug Administration — the US regulator that clears or approves a device before it can be sold
FFS: fee-for-service — the traditional form of Medicare that pays per item or service
FTO: freedom to operate — whether a product can be sold without infringing someone else's live patent
GUDID: Global Unique Device Identification Database — the FDA's public list of marketed devices by their identifier
HCPCS: Healthcare Common Procedure Coding System — the US billing codes for equipment, supplies and some services; a code is how a payer recognises what to pay for
L#####: a Medicare local coverage determination number — the public id of one local coverage rule; the letter L and five digits
LCD: local coverage determination — a Medicare contractor's rule, valid in its region, saying when something is covered
MA: Medicare Advantage — Medicare delivered through a private insurer; must cover at least what Medicare covers
Medicare Advantage: Medicare Advantage — Medicare delivered through a private insurer; must cover at least what Medicare covers
Medicare Part B: Medicare Part B — the part of Medicare that pays for outpatient care and equipment used at home
NCD: national coverage determination — a Medicare rule, valid everywhere in the US, saying whether and when something is covered
NCD ###.#: a Medicare national coverage determination number — the public id of one national coverage rule
PMA: premarket approval — the FDA route for the highest-risk devices; years and clinical trials
TAM: total addressable market — how much money the whole market would be worth if every possible buyer bought

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