idea-009 · 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.
The chair: the investor, and the operator who would have to run this as a business — paying for textile tooling, getting a wrap coded, getting it into DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) suppliers' stock, and being paid one wrap at a time out of Medicare Part B (Medicare Part B).
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points at a numbered line of the ## Claims list in knowledge-base/candidates/idea-009.md (numbered by position) and carries the tag that line carries there, copied and never adjusted here. [no claim] would mean nothing in the file speaks to a condition. No number appears on this deck that is not in a claim, and there is no ask slide. See docs/deck-spec.md.
What moved since the last build: the CMS (Centers for Medicare & Medicaid Services) files arrived. The A6583 (a HCPCS code for a supply) allowable, the payment rule and the 2024 billed volume are now verified, and the premise that the product was "sized to the descriptor's 30-50 mmHg (millimetres of mercury) band" is refuted — the descriptor names no band. So this deck is no longer asking what Medicare pays; it is asking whether a new manufacturer gets any of it.
Would have to be true: Medicare Part B, through its lymphedema compression treatment items benefit, would have to be the budget that pays for an adjustable-strap below-knee wrap dispensed to a beneficiary with lymphedema — and the volume outside Medicare fee-for-service would have to be payable on comparable terms, or the business is sized to fee-for-service alone.
Where it stands: The Medicare half is the best-evidenced condition on any of the three decks. The benefit lists "gradient compression wraps with adjustable straps" by name claim 42verified; the payment basis is 80% of the lesser of actual charge or a payment amount for items furnished on or after 1 January 2024 claim 43verified; the deductible applies and the July 2026 non-rural allowable for A6583 is $160.13 per wrap claim 11verified. The benefit's popular-title attribution alone keeps one line open, not its substance claim 10unconfirmed. The other half is open: whether Medicare Advantage (Medicare Advantage), Medicaid and commercial payers pay comparably claim 35unconfirmed, and whether fee-for-service is even the majority of US wrap volume claim 64unverified. A cash-pay channel above the coinsurance is an assumption claim 55unconfirmed.
What would settle it: The Medicare half needs nothing further. For the rest: published Medicare Advantage and state Medicaid DME (durable medical equipment) fee schedules and medical policies for A6583, read by a human (no connector reads non-FFS (fee-for-service) payer policy), and a supplier's payer-mix figures for A6583 dispensing.
If it's false: If non-FFS payers pay materially less, Slide 3's volume operand shrinks to the fee-for-service floor and the patient's out-of-pocket position on the desirability deck (its Slide 4) changes by payer.
Would have to be true: This manufacturer's wrap would have to be coded to A6583, paid at the fee-schedule allowable, and covered for the diagnoses and quantities the indicated population actually needs — three separate conditions, of which the first two now have verified backing for the code and none for this product.
Where it stands:
What would settle it: The DME MAC (durable medical equipment Medicare administrative contractor) lymphedema compression treatment items policy article and any LCD (local coverage determination), read directly with the L- or A-number pulled from the Medicare Coverage Database (the cached file holds no LCD rows, so the connector's refuted there is a cache artefact the file explains, not a finding). The PDAC coding-verification requirements for A6583, asked of the PDAC by a human.
If it's false: A code and a price that this manufacturer cannot bill under is worth nothing to it. A quantity limit below the wrap's replacement need caps revenue per patient below what Slide 3 assumes.
Would have to be true: Annual US wraps billed under A6583, times the manufacturer's net price per wrap after the supplier's margin, times the share a new brand obtains, would have to cover Slide 4's capital — and two of those three operands are blank.
Where it stands:
unverifiable by design claim 17unconfirmed.
What would settle it: Volume: re-run procedures A6583 when the data-year-2025 DMEPOS utilisation file is released. Price: a licensed lymphedema-DME market report, or supplier purchase invoices, attached by a human. Share: fitter and supplier switching interviews (Slide 6).
If it's false: With a verified volume floor and no price or share, no revenue figure can be written, and none is. If the net price after the supplier's margin is thin, the verified volume does not become a business.
Would have to be true: The tooling, fitter training, PDAC coding verification and DMEPOS-supplier onboarding needed to reach a first billable A6583 claim would have to be financeable within a launch-stage budget and short enough to plan a calendar against — which holds only if the device is on the exempt route the feasibility deck asks about.
Where it stands: The exempt route's scope is partly verified: § 880.5780(b) is Class I, exempt from premarket notification and from part 820 except records and complaint files claim 2verified. Whether this inelastic, lay-applied wrap falls inside it is the feasibility deck's load-bearing question claim 6unconfirmed; if it does not, the capital line becomes a submission claim 56unconfirmed. The capital and time claim is stated without a figure, deliberately claim 22unconfirmed; its financeability claim 52unconfirmed and the registration-to-first-claim turnaround claim 51unconfirmed are open. That the wrap can be made at a landed cost below incumbents' wholesale price is recorded, unchecked claim 63unverified. No dollar or month figure exists anywhere in the file, and none is written here.
What would settle it: A Tier 3 human estimate of tooling and onboarding cost; the PDAC and the CMS-855S enrolment process asked for turnaround by a human; the feasibility deck's Slide 3 answered first.
If it's false: If the route is not exempt, this is not a slightly slower business but a different one, as the file puts it: a submission, a predicate question and a different calendar.
Would have to be true: The four named incumbents would have to be unable or unwilling to add an equivalent strap tension indicator to their existing wraps — because an indicator patent is grantable and enforceable, or because they would rather license it.
Where it stands: The file calls this a weak moat in its own words claim 20unconfirmed. The exempt route is an open door to incumbents and entrants alike, and the open A6583 descriptor claim 44verified is open to any adjustable-strap wrap. Incumbent non-response is an assumption claim 34unconfirmed, and the file records as a lead that one named incumbent, Essity, has a Canadian application titled "Compression garment with indicator" claim 41unconfirmed. Patentability of the indicator is recorded, unchecked claim 66unverified. The licensing alternative is an assumption claim 54unconfirmed.
What would settle it: A human prior-art search and patentability opinion on the indicator; the Essity family's claims and any US counterpart read by a patent professional; incumbent business-development conversations for the licensing question.
If it's false: An incumbent with the channel adds an indicator and the new entrant's one differentiator is gone — Slide 3's share operand goes toward nothing.
Would have to be true: Certified fitters and DMEPOS suppliers would have to stock and dispense a new brand against the four established ones — in a channel where, per the file, the fitter rather than the patient usually chooses the product.
Where it stands: An assumption claim 24unconfirmed. The size of the field is unmeasured, not four: the four named firms are the Generator's list claim 33unconfirmed, and a 510(k) (premarket notification) query is structurally uninformative for an exempt generic type claim 7unconfirmed. Whether any manufacturer beyond the four has been coded to A6583 since 2024 is recorded, unchecked claim 61unverified. Whether a small number of suppliers dispense most A6583 volume — which would make a handful of buyers the whole channel — is recorded, unchecked claim 60unverified.
What would settle it: The PDAC DMECS product list for A6583 and FDA (US Food and Drug Administration) Establishment Registration & Device Listing by product code, both read by a human (no connector reaches either); supplier-level A6583 volumes from the CMS DMEPOS supplier file; interviews with the largest dispensing suppliers.
If it's false: A product the channel will not stock is not dispensed, however it is coded and priced. This is also the gate on the desirability deck's Slide 3 supplier link.
Would have to be true: The PDAC's published product list for A6583 would have to show a manufacturer beyond the four named incumbents coded since 2024 — the cheapest observable sign that a new entrant can get onto the code — and the DME MAC policy article would have to impose no fitting or quantity condition that shuts a new manufacturer out.
Where it stands: Both unread. claim 61unverified, claim 32unconfirmed, claim 65unverified, claim 45unconfirmed.
What would settle it: A human reading the PDAC DMECS classification list for A6583 and the DME MAC lymphedema compression policy article; no connector reaches either.
If it's false: If only incumbents appear and the policy ties payment to a fitter the entrant does not control, the verified price and volume on Slides 1-3 belong to someone else.
Every condition above with nothing verified behind it, plus the open halves of the two slides that do have verified backing.
Slide 1's Medicare half is the one condition on this deck with verified backing throughout. The rest of the deck rests on unconfirmed and unverified.
If only one thing from this chair could be checked: whether a new manufacturer's adjustable-strap wrap can be coded to A6583 by the PDAC without a clinical study and without already being in the fitter channel claim 32unconfirmed — with the PDAC's own product list for A6583 as the cheapest window onto it claim 61unverified.
This one rather than the others because the file has now verified what the code pays and how often it was billed; the refuted descriptor premise claim 8refuted means the code is not reserved for a product sized to it. What the file cannot yet say is whether any of that money is reachable by someone new. Price, volume and moat all come after that answer.
Naming it is not a recommendation, a gate, or a kill. It is the answer to "check what first."
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