idea-019 · business case

Who pays, from which budget, how much, and 2-4 commercial routes to first revenue — every figure below traces to a copied claim or a declared assumption, and the routes are laid out unranked. Choosing a commercial strategy is a Tier 3 act, so this page presents options and stops.

Posture-Triggered Abdominal Compression for nOH — business case

Intended use: For prescription use in the home by adults with symptomatic neurogenic orthostatic hypotension due to primary autonomic failure (Parkinson disease, multiple system atrophy, or pure autonomic failure) who remain symptomatic despite non-pharmacologic measures, to apply servo-controlled abdominal compression automatically on assumption of an upright posture and to release it on return to a seated or recumbent posture, to reduce orthostatic symptom burden and increase upright standing time.

Read this first. The previous build of this case said Medicare would pay for the controller as a capped monthly rental. That premise is refuted. The July 2026 DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) fee schedule puts E0650 (a HCPCS code for durable medical equipment), E0651 and E0652 in the inexpensive-or-routinely-purchased category on every pricing line, not capped rental claim 117refuted. The loop record's IR-20 claim 117 came back refuted absorbed this, because the P0 the original shape shape was always a patient-owned purchase. This case is rebuilt on that cadence. A placement in the compressor family is paid once, and the only recurring line left is replacement garments, which nobody has checked. A published allowable now exists for every family code claim 107verified. But three things are still open: which code the device would bill under, whether its cost clears that code's allowable, and whether any coverage policy reaches nOH (neurogenic orthostatic hypotension). So the page shows what one placement is paid, and not whether that is enough.

Who pays

The chain has four links, and the file has verified evidence for only one of them. That one is the rule saying Medicare Advantage (Medicare Advantage) follows Traditional Medicare's benefit and coverage outcome.

Writes the cheque: Medicare Part B (Medicare Part B), through a DME (durable medical equipment) Medicare Administrative Contractor, paying a DMEPOS supplier for an item furnished to a beneficiary at home, as a one-time purchase in the compressor family claim 117refuted. That holds only if the device is in the DME benefit category and separately billable. This is design intent, not a finding claim 32unconfirmed. The regulatory definition it would have to meet is split in two: the durability conditions claim 119unconfirmed and the medical-purpose and home-use conditions claim 121unconfirmed. Whatever CMS (Centers for Medicare & Medicaid Services) decides also binds Medicare Advantage plans, because 42 CFR 422.101(b) makes MA (Medicare Advantage) organisations follow NCDs and Traditional Medicare benefit-category rules claim 120verified. The beneficiary pays a coinsurance share of the allowable [assumption A8 A bench rig can demonstrate that the device…]. Whether they will is open claim 36unconfirmed.
Who collects it: there are two shapes, and they put different money in the manufacturer's hands. In the first, a third-party DMEPOS supplier buys the device, furnishes it, bills the purchase allowable, and pays the manufacturer an acquisition price below that allowable [assumption A1 No FDA 510]. Whether any supplier would carry a device with no device-specific code is open claim 37unconfirmed. In the second, the manufacturer enrols as its own DMEPOS supplier and collects the allowable directly [assumption A2 No granted De Novo request in the FDA De…].
Out of which budget line: Part B durable medical equipment. **The comparator is not in that budget.** Midodrine and droxidopa are pharmacy-dispensed drugs, outside the Part B device benefit claim 11unconfirmed. That tag is held for a tooling reason: there is no drug-label connector. Guidelines place passive elastic binders on the non-pharmacologic rung claim 78verified, claim 79verified. Those binders sit under a Class I musculoskeletal regulation with no haemodynamic indication claim 54verified. No claim in the file names a payer line for them.
Against which comparator: pressor drugs whose use is limited by supine hypertension (claim 82verified for prevalence, claim 69verified for the droxidopa pivotal's supine-pressure finding), and passive binders that are hard to wear at effective pressures (claim 73verified for context; claim 70unconfirmed and claim 71verified for garment non-use in older OH (orthostatic hypotension) patients).
Stops buying instead: nothing within the budget that would pay. The intended use puts the device "over or alongside" a pressor drug claim 24unconfirmed. If the device did displace drug spend, the saving would land in the pharmacy benefit, not in Part B DME. From the Part B payer's side this is additive spend, and no claim in the file says otherwise. A coverage request (2e) would have to argue on outcomes, not on offset, because no offset is on record.
Who is outside the chain: commercial, Medicaid, VA and cash-pay patients. Nothing in the file prices them. The Medicare share of the population is open claim 44unconfirmed. The under-65 part of the MSA (multiple system atrophy) population is what a Medicare-only chain misses: claim 80verified counts MSA from age 30, and the ampreloxetine MSA subgroup in claim 87verified averaged 63, as the Verifier's note on claim 44unconfirmed records. The cash-pay route puts a different payer, the patient, over the whole population [assumption A3 openFDA device classification lists product…].

Reimbursement path

Six questions that the rubric's Factor 2 collapses into one number. Each has its own evidence position and one basis. No score, no tier, no composite. Read the coverage line first. Then note that the one verified pillar is a verified obstacle, and that the new verified fact this rebuild uses (the fee schedule) sits inside row 2b without settling it.

#	Question	Finding	Basis
2a	Coding route — Cat I / Cat III / unlisted / HCPCS (Healthcare Common Procedure Coding System) II / none	HCPCS Level II. No existing code describes this device, and a CMS decision picks the route. The pneumatic-compressor family exists (E0650, E0651, E0652), as do the trunk and chest appliance codes (E0656, E0657) and the miscellaneous E1399 claim 10unconfirmed. That tag is held by its negative half; the code-existence half reads verified in the note. Every non-segmental appliance descriptor in E0650-E0676 names a limb, and none names an abdominal appliance or a posture-triggered sustained-pressure device. So the device bills under an accepted descriptor mismatch, under a new code, or under E1399, and choosing among those is a PDAC (Pricing, Data Analysis and Coding contractor)/CMS coding determination claim 115unconfirmed. That CMS will assign a billable code at all is a future act claim 40unconfirmed. Since the fee schedule landed, this row also sets the price. The one-time purchase allowable differs about sevenfold between E0650 and E0652 (see 2b), so the coding outcome is also the payment outcome. This is not a CPT (Current Procedural Terminology) question. No CPT code is involved, so `cpt` was not run and no descriptor is quoted	claim 115unconfirmed
2b	Payment adequacy — does the rate clear a stated cost floor	A rate now exists on one side. There is no cost floor on the other, so adequacy is still open. The July 2026 DMEPOS fee schedule publishes an allowable for E0650, E0651, E0652 and E0656 claim 107verified. The compressors are category IN and are paid as a purchase, not capped rental claim 117refuted. Non-rural new-purchase (NU) allowables across the contiguous states and DC: E0650 $872.43-$1,026.39, E0651 $1,112.52-$1,308.85, E0652 $6,422.01-$7,555.31. These are allowed amounts, and coinsurance comes out of them; the Verifier read them into the note on claim 96unconfirmed and claim 23unconfirmed, and both tags are held by their unsourced halves. The cost side is an unbuilt cost model: a controller plus the garments consumed over its life claim 92unconfirmed. The proposition that this clears the allowable, at planned volume and at a tenth of it, is the one this row turns on, and it has no cost figure behind it claim 96unconfirmed. Which allowable is the denominator is 2a's question	claim 96unconfirmed
2c	Practice-expense headroom — does the PE portion cover the device	No practice-expense portion exists on this route, by construction, provided the device is DME. A supplier-billed home item is not furnished incident to a physician service, so no PFS (physician fee schedule) practice-expense RVU (relative value unit) carries its cost. `rvu E0650` → refuted: "not priced under the PFS … it may still be paid under OPPS, the ASC list or DMEPOS, none of which this connector reads". The condition on this row is the benefit category. If CMS did not treat the device as DME, no PE line would pick it up either, because nothing in the file puts it in an office service	claim 32unconfirmed
2d	Site of care & bundling — office/facility differential, DRG or APC packaging	Home, supplier-billed. There is no facility claim to package the device into, but there is a bundling question inside DME, and after the refutation it is the only recurring line. No inpatient DRG or packaged OPPS code applies to an item dispensed to a patient's home. `apc E0650` → unconfirmed, no `data/opps_addendum_b.csv`, which is a tooling gap and not a finding; `drg` has no cache either and no DRG is in question. The exposure that bites is the garments. Whether Part B pays separately for replacement bladders and garments, or treats them as included in the compressor payment, is unchecked claim 122unconfirmed. The Verifier's note on that claim records that the fee schedule prices appliance codes as separate lines, but separate payability is a DME MAC (durable medical equipment Medicare administrative contractor) policy-article rule that nobody has read. Residual cadence exposure: the trunk and chest appliances are category CR, with E0656 priced on a monthly rental line only, $82.35 non-rural claim 107verified. If CMS coded this device's garment as a trunk appliance, that half of the system would be paid as a capped rental, not a purchase	[gap: neurogenic-orthostatic-hypotension.reimbursement.pneumatic-appliance-replacement-payment]
2e	Coverage — has any payer agreed to pay for this indication	No payer. The verified evidence runs against coverage. By its own device description, NCD 280.6 (a Medicare national coverage determination number) covers an arm or leg garment that is intermittently inflated and deflated. It does not reach a sustained-pressure abdominal device claim 116verified. Its covered indications are lymphedema and venous stasis ulcers, not OH claim 9verified. A future NCD (national coverage determination) or LCD (local coverage determination) reaching nOH is a CMS/DME MAC (Medicare administrative contractor) act nobody has been asked to take claim 41unconfirmed. The DME MAC LCD L33829 (a Medicare local coverage determination number) has never been read claim 118unconfirmed. No accelerated route is open today: RAPID is a notice whose comment period closes 2026-10-13 claim 15verified, TCET is paused claim 16verified, and MCIT was repealed before it operated claim 18verified. The same notice excludes a device "already the subject of a controlling Medicare NCD" claim 13verified, and whether 280.6 would be read as controlling here is a CMS judgment. Because MA follows NCDs claim 120verified, one coverage decision governs both books. The refutation of claim 117refuted changes nothing here: a purchase allowable is still not coverage	claim 116verified
2f	Ex-US pathway — DE NUB/G-DRG, UK NICE (National Institute for Health and Care Excellence)/OPCS-4	Permanently unconfirmed, and not for lack of research. `launch_jurisdiction:` is US. No connector in this repo reaches a non-US payment system, and no claim in the candidate speaks to one in either direction. The two non-US clinical anchors in the file (the Innsbruck binder cohort and the EFNS guideline) are clinical facts, not payment facts	— none

Pillars on verified claims: 1/6 · on assumptions: 0 · queued as research: 1

Of the other four pillars, 2a, 2b and 2c rest on unconfirmed claims and 2f rests on nothing. The one verified pillar (2e) verifies an obstacle: the existing national coverage determination does not reach this device. What is verified is that no coverage exists, not that some does. The line moved from the previous build (1 verified · 0 assumptions · 2 research) in one place only. 2b no longer waits on a fetch, because the fee schedule is read, but it now rests on the cost-of-goods claim the rate has to be set against. That claim is unconfirmed, so the row is not counted as verified.

Three distinctions kept apart deliberately:

A code existing is not payment, and payment is not coverage. The family codes exist (2a). The rates are published (2b). No policy reaches the indication (2e). These are three separate facts, and a published allowable for E0650 says nothing about whether this device bills under E0650 claim 115unconfirmed or whether a DME MAC would pay it for nOH claim 41unconfirmed.
Packaging does not bite at a facility here. It bites between the pump and the garment. No DRG or APC applies to a home DME item. The equivalent exposure is whether garments are paid separately or folded into the compressor purchase claim 122unconfirmed.
2f is a permanent unconfirmed. A future ex-US plan would start this section over, not extend it.

Verdicts recorded where a check was run, whatever came back. Every run was made cold during this build:

python3 -m connectors payment E0650|E0651|E0652 --jurisdiction US → verified, local cache of the CMS DMEPOS fee schedule, July 2026, category IN on every line. Re-running a lookup does not create a new basis. The figures travel as claim 107verified (that they are published) and claim 96unconfirmed (the amounts, in the Verifier's note).
python3 -m connectors payment E0656 --jurisdiction US → verified, RR line only, category CR, as recorded at claim 107verified.
python3 -m connectors hcpcs E1399 --jurisdiction US → verified, "Durable medical equipment, miscellaneous", as recorded at claim 115unconfirmed.
python3 -m connectors coverage E0650 --jurisdiction US → refuted: No NCD or LCD in the cached coverage file names E0650. The Verifier recorded at claim 118unconfirmed and claim 122unconfirmed that control codes also refute against this cache while NCD 280.6 plainly governs these devices. So this verdict describes the cache, not the policy, and it is not used as a basis.
python3 -m connectors procedures E0650|E0651|E0652 --jurisdiction US → verified, the CMS DMEPOS utilization file, with the service year not stated in the file. These are limb-compressor volumes for lymphedema and venous disease, recorded at claim 25verified and quoted under the money model as context only.
python3 -m connectors rvu E0650 --jurisdiction US → refuted, not priced under the PFS. That is expected for a DMEPOS code, and it is the basis for 2c's "no PE portion", read together with claim 32unconfirmed.
python3 -m connectors apc E0650 --jurisdiction US → unconfirmed, no OPPS cache. It is not load-bearing for a home DME item.

The money model

The size comes from the market model and is not rebuilt here. That model predates the refutation. Its coverage line reads three of twelve legs on verified claims, and its modeled band is "not computable". Its controller-payment and persistence legs, and its framing of the unit as "one placement cycle" across a rental period, rest on the capped-rental reading that claim 117refuted now contradicts. Its bracketed citations have not moved, so stale.py does not flag it. It needs a rebuild anyway (/market-model idea-019). This case therefore quotes only its three bounded upstream legs, which the refutation does not touch. It then sets out the unit economics the file can support, on the purchase cadence.

Line	Figure	Backing
US people with Parkinson disease, age 45+ (market model leg 1)	680,000 counted in 2010; about 930,000 projected for 2020 (a projection, not a count); the authors call both minimum estimates	claim 81verified
The unconfirmed PD (Parkinson disease) headline the leg replaces	about one million, plus 90,000 newly diagnosed per year; not used	claim 21unconfirmed
Share of PD with neurogenic OH (leg 2)	26% pooled; the market model's Low of 19.6% applies the same paper's publication-bias adjustment to that figure; heterogeneity I² 96%	claim 22verified
US people with MSA, age 30+ (leg 3)	41,133 on the one-claim definition, 2021; the two-claim definition roughly halves it	claim 80verified
MSA nOH share, PAF (pure autonomic failure) count, diagnosed-and-still-symptomatic share (legs 4-6)	not established	claim 24unconfirmed
Medicare share of the eligible population (leg 7)	not established	claim 44unconfirmed
Share in which the device is covered and paid (leg 8)	not established; a future coverage act	claim 41unconfirmed
Medicare Advantage inside the same benefit decision as fee-for-service	yes, for basic benefits	claim 120verified
How the compressor family is paid	a one-time purchase (category IN), not a capped monthly rental; the capped-rental reading is refuted	claim 117refuted
Whether an allowable is published for each family code	yes, for E0650, E0651, E0652 and E0656	claim 107verified
New-purchase allowable per placement, by code (non-rural, contiguous states and DC)	E0650 $872.43-$1,026.39 · E0651 $1,112.52-$1,308.85 · E0652 $6,422.01-$7,555.31; tag held by the claim's cost-of-goods half	claim 96unconfirmed
Which of those codes the device bills under	not established; a coding determination, and it moves the allowable about sevenfold	claim 115unconfirmed
If paid through the rental line instead of a purchase	total payments capped at the purchase allowable	[assumption A7 A torso-mounted accelerometer or…]
Split of the allowable between Medicare and the beneficiary	Medicare 80%, beneficiary 20% of the lesser of charge and fee schedule	[assumption A8 A bench rig can demonstrate that the device…]
Whether the beneficiary pays that residual	not established	claim 36unconfirmed
How often one beneficiary's controller can be paid for	at most once per five-year reasonable useful lifetime in ordinary use	[assumption A9 A posture-triggered abdominal compression…]
What one placement is, physically	a reusable controller, single-patient multi-use garments, and a charger, with different service lives	claim 92unconfirmed
Garments consumed per placement per year	more than one	[assumption A6 Mechanism and clinical-risk reasoning]
Whether those garments are paid separately	not established; now the only recurring line	claim 122unconfirmed
If the garment were coded as a trunk appliance	capped rental, E0656 at $82.35 per rental month non-rural	claim 107verified
Manufacturer revenue per placement, third-party supplier shape	the supplier's one-time acquisition price, below the purchase allowable the supplier collects	[assumption A1 No FDA 510]
Manufacturer revenue per placement, manufacturer-as-supplier shape	the purchase allowable itself, less the cost of being a supplier	[assumption A2 No granted De Novo request in the FDA De…]
Cost of goods per placement against the allowable	not established on the cost side; the proposition is that it clears at planned volume and at one-tenth of it	claim 96unconfirmed
Share won, price to the buyer, gross margin	not established; no claim in the file carries any of the three, and this case does not supply them	claim 24unconfirmed
Cash price the patient would pay with no payer	not established	[assumption A3 openFDA device classification lists product…]
Does contribution margin cover the programme's fixed cost before a 510(k) (premarket notification) follower arrives	open; the last line of the chain and the one the other lines feed	claim 123unconfirmed
Largest single fixed-cost item in that programme	the sham-controlled pivotal study	[assumption A5 This candidate's own bladder geometry and…]
Context only, never a floor: Medicare FFS (fee-for-service) purchase beneficiaries for the incumbent limb compressors	E0650 97 · E0651 34,399 · E0652 6,792; lymphedema and venous volumes, not nOH patients; service year not stated in the file	claim 25verified

Read the bolded rows together: what changed and what did not. With the compressor family in category IN, a placement pays once claim 117refuted. The fleet-and-annuity reading of the previous build is gone. Under A1 No FDA 510, the manufacturer sells one controller per placement into a supplier's inventory at a price below the purchase allowable [assumption A1 No FDA 510]. The supplier does not recycle a rented controller to the next beneficiary, because title passes on purchase. Under A2 No granted De Novo request in the FDA De…, the manufacturer collects the allowable once and carries the supplier's accreditation, delivery, fitting, documentation and collections [assumption A2 No granted De Novo request in the FDA De…]. These are still two businesses. The file does not choose between them, and neither does this case.

What the refutation made heavier. A one-time payment puts all the weight on two lines. The first is whether cost of goods clears the allowable of whichever code applies claim 96unconfirmed. That allowable swings about sevenfold with the coding outcome claim 115unconfirmed. The second is whether anything is paid after the purchase: garments, if separately payable claim 122unconfirmed and short-lived [assumption A6 Mechanism and clinical-risk reasoning], and a replacement controller no sooner than the reasonable useful lifetime [assumption A9 A posture-triggered abdominal compression…]. If garments are bundled, the placement is a single controller event, repeated at most once per lifetime.

The unit is a placement, and no annual revenue line is written. Turning placements into a year needs two inputs. One is the rate at which new patients become eligible. That incidence leg is draftable in the market model's gap register and is not yet a claim. The other is the replacement interval [assumption A9 A posture-triggered abdominal compression…]. The incumbent-compressor volume above is not a substitute. It is paid under an NCD that does not reach this device claim 116verified.

State the market and adoption verdicts explicitly, from cold runs during this build:

python3 -m connectors market "Most US adults with symptomatic nOH due to primary autonomic failure who would be prescribed this device are Medicare beneficiaries" → unverifiable: "no free, authoritative, machine-queryable source. Stays unconfirmed permanently unless a human attaches a licensed report". This is the verdict already recorded at claim 44unconfirmed.
python3 -m connectors market "The contribution margin US sales of this device can generate at the Medicare purchase allowable covers the fixed development programme before a 510(k) follower arrives" → unverifiable, the same verdict recorded at claim 123unconfirmed.
The addressable-share and PD-population verdicts are already recorded, unchanged, at claim 24unconfirmed and claim 21unconfirmed, and were not re-run.
python3 -m connectors adoption "Neurologists and autonomic specialists would prescribe a device in an indication currently managed with midodrine and droxidopa and accept DME prior-authorization burden" → unverifiable: "needs primary research (interviews, survey, published preference study) … Do NOT substitute a model's own estimate of stakeholder behaviour". Recorded at claim 29unconfirmed.
python3 -m connectors adoption "A DMEPOS supplier will stock, deliver, fit and bill the device without a device-specific HCPCS code" → unverifiable. Recorded at claim 37unconfirmed.
python3 -m connectors adoption "Adults with symptomatic nOH or their families will pay the full purchase price out of pocket where no payer pays" → unverifiable. Recorded at claim 126unconfirmed, this case's A3 openFDA device classification lists product….

The revealed-behaviour twins of these class-3 questions are already rows filed by the market model: home pneumatic-compressor persistence, and droxidopa uptake after launch. This case files no further rows.

Path to first revenue

The device does not exist yet: no prototype, and no bench, animal or human data on this design claim 8unconfirmed. Its defining feature, posture-triggered activation, has no clinical precedent. The published efficacy study activated its binder manually less than two minutes before standing claim 73verified. The one posture-triggered analog was tested in healthy volunteers at about 11 mmHg (millimetres of mercury) claim 86verified.
The sham-controlled trial of the closest analog has no results: NCT03482297 (a ClinicalTrials.gov registration number) completed with 28 enrolled and nothing posted or published claim 98unconfirmed.
What must exist before a Medicare dollar: a marketing authorization, most plausibly a De Novo (De Novo classification request) request for a Class II (FDA device class II) device, given no granted De Novo by device name claim 55verified and a classification FDA (US Food and Drug Administration) has not made claim 102unconfirmed; clinical data FDA would accept claim 106unconfirmed, probably under an IDE claim 47unconfirmed; a billing code route claim 40unconfirmed; and a coverage policy reaching nOH claim 41unconfirmed. The file's own reading is that these three steps cannot substantially run in parallel claim 42unconfirmed.
What that first Medicare dollar is: one purchase allowable per placement, paid once, in a range set by the code assigned: from E0650's $872.43 low to E0652's $7,555.31 high, non-rural claim 96unconfirmed, less the beneficiary's coinsurance share [assumption A8 A bench rig can demonstrate that the device…].
What must exist before a cash dollar: the same marketing authorization. The code and coverage steps drop out, and willingness to pay the full price replaces them [assumption A3 openFDA device classification lists product…].
What must exist before a claim-stripped dollar: a 510(k) under a Class II regulation, 890.5650 or 870.5800, because the Class I exempt truncal-orthosis route does not reach a powered inflatable garment claim 105unconfirmed, claim 54verified. It also needs labelling FDA would not read as an OH intended use [assumption A4 PMID 27271310].
Calendar to first dollar: not established on any route. No claim in the file carries a duration for the pivotal study, the De Novo review, a HCPCS coding cycle or a coverage request, and this case does not supply one. The sequencing constraint is on record claim 42unconfirmed. The durations are not.
Capital to first dollar: not established on any route. The programme's components are listed claim 123unconfirmed, and the largest is taken to be the pivotal study [assumption A5 This candidate's own bladder geometry and…]. No figure exists for any of them.
An IP (intellectual property) question sits across every route that keeps the therapeutic claim: a live, on-mechanism Vanderbilt publication family, filed 2013-11-04 with a naive expiry of 2033-11-04 and grant status unknown claim 26verified. Whether it is available to license is open claim 43unconfirmed, and the wider field has not been searched claim 27unconfirmed.

Routes

Four routes to a first dollar, in no order. The first three share a regulatory spine and diverge on who pays. None is ranked here, and choosing between them is a human decision. The refutation of claim 117refuted changed the payment cadence under Route A. It did not add, remove or reorder a route.

Route A — Medicare Part B DME benefit, full therapeutic claim

Requires: a De Novo grant carrying the orthostatic symptom-burden and upright-time claim claim 102unconfirmed, on clinical data FDA accepts claim 106unconfirmed; a DME benefit-category result claim 32unconfirmed, claim 121unconfirmed; a billing code route, whether an accepted family descriptor, E1399 or a new code claim 115unconfirmed, which also fixes the one-time allowable the placement earns claim 96unconfirmed; a coverage policy reaching nOH against an NCD that describes a limb garment claim 41unconfirmed, claim 116verified; and a billing entity, either a third-party supplier [assumption A1 No FDA 510], claim 37unconfirmed or the manufacturer enrolled as one [assumption A2 No granted De Novo request in the FDA De…]. One coverage decision reaches fee-for-service and Medicare Advantage alike claim 120verified.
Costs: the full programme in claim 123unconfirmed: prototype and bench, a home feasibility study claim 99unconfirmed, a sham-controlled pivotal study claim 100unconfirmed, a De Novo request, a HCPCS application and a coverage request, largely in sequence claim 42unconfirmed. The largest item is taken to be the pivotal study [assumption A5 This candidate's own bladder geometry and…]. No time or capital figure exists in the file.
Killed by: a CMS determination that the device is not separately billable durable medical equipment claim 32unconfirmed. Without that, Part B DME has nothing to pay under, however the code, allowable and coverage questions resolve.

Route B — Cash-pay, full therapeutic claim

Requires: the same De Novo grant claim 102unconfirmed on the same clinical data claim 106unconfirmed; patients or families paying the full price with no payer behind them [assumption A3 openFDA device classification lists product…]; and a channel that reaches prescribers, since the intended use is prescription-only. It does not require a code claim 115unconfirmed or a coverage policy claim 41unconfirmed. How a supplier furnishes a non-covered item to a Medicare beneficiary is not in the file.
Costs: the programme in claim 123unconfirmed less the HCPCS application and the coverage request. The pivotal study stays in, and is taken to be the largest item [assumption A5 This candidate's own bladder geometry and…]. The published compressor allowables claim 107verified are Medicare amounts for other indications, not a cash price. The file records no price for any comparator garment or drug. No time or capital figure exists in the file.
Killed by: a priced test showing that people with nOH and their families will not pay the device's full price out of pocket [assumption A3 openFDA device classification lists product…].

Route C — Breakthrough designation and the RAPID coverage pathway

Requires: Breakthrough designation, under a statute no connector here reads claim 20unconfirmed; eligibility under a notice that names Class II and III Breakthrough devices at the IDE presubmission stage claim 12verified; separate payability claim 13verified, claim 32unconfirmed; no controlling NCD, which puts NCD 280.6 in question claim 13verified; an IDE that enrols Medicare beneficiaries claim 33unconfirmed; and the notice finalized, since it is still under comment claim 15verified. The fallback pathway is paused claim 16verified and was capacity-limited when open claim 17verified, and the previous instrument was repealed before it operated claim 18verified.
Costs: Route A's programme claim 123unconfirmed, with the pivotal study designed from the start around outcomes FDA and CMS agree on for Medicare beneficiaries claim 12verified. The largest item is taken to be the pivotal study [assumption A5 This candidate's own bladder geometry and…]. No time or capital figure exists in the file.
Killed by: a final instrument that keeps eligibility limited, as the notice now reads, to Breakthrough devices planning a PMA (premarket approval), plus 510(k) devices whose predicate was De Novo-authorized within 18 months claim 12verified, claim 19verified. A first-of-kind De Novo request is in neither group.

Route D — Claim-stripped garment, no orthostatic claim

Requires: the same hardware labelled and advertised with no orthostatic-hypotension, blood-pressure or symptom claim, which is the third device_class row the Generator carries; a 510(k) under a Class II regulation (890.5650 or 870.5800), not the Class I exempt truncal-orthosis route claim 105unconfirmed, claim 54verified; FDA not reading the posture-triggered design, or its distribution to nOH patients, as an OH intended use [assumption A4 PMID 27271310]; and buyers paying cash, since no code, benefit category or coverage argument applies to a device with no medical claim to reimburse.
Costs: bench, biocompatibility claim 93unconfirmed and electrical-safety and software conformance claim 94unconfirmed work for a 510(k). No sham-controlled symptom study is needed for the authorization itself. The file carries no estimate of what a 510(k) under either regulation would require clinically, and no time or capital figure.
Killed by: an FDA position, from a Q-Sub or from a reading of 21 CFR (Title 21 of the Code of Federal Regulations) 801.4, that a posture-triggered abdominal compressor sold to people with nOH carries an orthostatic-hypotension intended use whatever its label says [assumption A4 PMID 27271310].

What all four share. Each route rests on at least one assumption this case declared. Only Route A now has a published payment amount on record claim 107verified, and it is a range across three codes whose selection is open, set against a cost nobody has built. Routes A and C also share the coverage question, B and D share a cash buyer, and A, B and C share the pivotal study. Most of the file's unresolved evidence is common to more than one route, so resolving it moves several routes at once and does not sort them.

Assumption register

Every assumption cited above, with what would settle it and who could run it. Five are already on file from the previous build (claims 125-129) and were not re-appended. Four are new this build and were appended as unverified claims 136-139.

#	Assumption	Falsifier	Owner
A1 No FDA 510	With a third-party DMEPOS supplier and the compressor family paid as a purchase (category IN), the manufacturer's revenue per placement is the supplier's one-time acquisition price for controller and garments, below the NU purchase allowable the supplier collects (claim 136unverified, new this build; it replaces claim 124unconfirmed, whose capped-rental premise is refuted)	Acquisition-price quotes for an E0650-E0652 home pump from three or more accredited DMEPOS suppliers, set against the published NU allowables. Revealed-behaviour twin: what a publicly reporting pneumatic-compression manufacturer discloses in its annual filing about revenue through DME suppliers versus direct billing	80_commercial (supplier interviews); 45_research (filings)
A2 No granted De Novo request in the FDA De…	A manufacturer can enrol as its own accredited DMEPOS supplier under 42 CFR 424.57 and bill the DME MAC directly for its own device (claim 125unconfirmed, on file)	The Verifier's `regulation 424.57 --expect "manufacturer"` returned unconfirmed, a missing phrase and not a refutation, and a re-run this build returned the same. What settles it is a human read of the 424.57(c) supplier standards and CMS-855S enrolment rules for any bar on a manufacturer billing its own product	Market access (human read)
A3 openFDA device classification lists product…	Adults with symptomatic nOH, or their families, will pay the device's full price out of pocket where no payer pays (claim 126unconfirmed, on file)	A priced deposit or pre-order test among at least 20 patients recruited through autonomic or movement-disorder clinics. Revealed-behaviour twin: published cash-pay uptake of a non-covered home device in a Parkinson disease population	80_commercial with a clinical partner
A4 PMID 27271310	A powered abdominal garment labelled with no OH, BP or symptom claim can be sold to people with nOH without FDA treating its posture-triggered design or its distribution as an OH intended use under 21 CFR 801.4 (claim 127unconfirmed, on file)	A Q-Sub on the claim-stripped labelling. The 801.4 text is a registry read, and its "design or composition … circumstances surrounding the distribution" language bears against the proposition without settling it	Regulatory (Q-Sub, human-run)
A5 This candidate's own bladder geometry and…	The sham-controlled pivotal study is the largest single fixed-cost item in the development programme (claim 128unconfirmed, on file)	A costed programme: CRO quotes for the pivotal and feasibility studies, the FDA De Novo user fee in force, and a coding and coverage consultant estimate, compared line by line	Operations-NPI (new product introduction) / human
A6 Mechanism and clinical-risk reasoning	A single-patient multi-use abdominal garment worn every upright period and cleaned on its labelled regimen lasts less than a year, so each placement uses more than one garment a year (claim 129unconfirmed, on file)	Bench wear and laundering-cycle testing of a candidate garment to seam or bladder failure. Registry twin: the replacement frequency that L33829 and its policy article allow for pneumatic appliances, which sits inside 2d's commissioned row	Engineering (bench); 45_research (the LCD read)
A7 A torso-mounted accelerometer or…	Under 42 CFR 414.220(b), an IN-category item is paid on a rental basis or as a lump-sum purchase, and total payments may not exceed the purchase fee schedule amount, so the RR line cannot earn more than the NU allowable (claim 137unverified, new)	`regulation 414.220 --title 42 --expect "may not exceed the fee schedule amount recognized for the purchase"`. A probe this build returned the paragraph (b) text; the Verifier's run is what tags it	Verifier (registry text)
A8 A bench rig can demonstrate that the device…	Under 42 CFR 414.210(a), Medicare pays for DME on the basis of 80 percent of the lesser of actual charge and fee schedule amount, leaving the beneficiary the remaining 20 percent (claim 138unverified, new)	`regulation 414.210 --title 42 --expect "80 percent of the lesser of"`. A probe this build found the phrase. The beneficiary-share half is the arithmetic complement, which a human read of the Part B coinsurance rule confirms or corrects	Verifier (registry text); market access (coinsurance read)
A9 A posture-triggered abdominal compression…	Under 42 CFR 414.210(f), Medicare does not pay to replace a DME item for the same beneficiary before its reasonable useful lifetime, five years unless CMS sets another, except for loss, theft or irreparable damage, so a controller is paid at most once per five years in ordinary use (claim 139unverified, new)	`regulation 414.210 --title 42 --expect "reasonable useful lifetime"`, then `--expect "5 years"` read in context of paragraph (f). A probe found both phrases but not their context. Then a human check that no shorter lifetime is set for E0650-E0652	Verifier (registry text); market access (human read)

Cheapest falsifiers: A7 A torso-mounted accelerometer or…, A8 A bench rig can demonstrate that the device… and A9 A posture-triggered abdominal compression…. Each is a CFR paragraph the regulation connector already reads, and a probe during this build found the key phrase for each. Of the three, A9 A posture-triggered abdominal compression… moves the most. It is the replacement interval that, together with an incidence leg, would turn "one placement" into an annual revenue line. It is also the one where the connector found the phrase without showing its context, so a Verifier run plus a read of paragraph (f) settles it or corrects it.

Where this case outruns the file

Every quantity this case needs and nothing in the file supplies. These are the work items.

Which code, and therefore which allowable. The rates are published (claim 107verified), but the device's code is a PDAC/CMS determination (claims 40, 115). E0650 and E0652 differ about sevenfold. This is now the single largest price uncertainty, and a Pre-Sub-informed coding enquiry is what reaches it (REQ-0126 Which classification outcome does…, REQ-0142 Draft the Pre-Submission per the loop record).
Cost of goods per placement (claims 92, 96). This is an unbuilt cost model for an unbuilt device (claim 8unconfirmed). With a one-time payment, it is what 2b turns on.
Whether garments are paid separately (claim 122unconfirmed) and how long they last (A6 Mechanism and clinical-risk reasoning). Together these decide whether any recurring line exists after the purchase. L33829 and its policy article have never been read (claim 118unconfirmed, REQ-0125 Full-text retrieval of DME MAC LCD L33829…).
The replacement interval for the controller (A9 A posture-triggered abdominal compression…), and the incidence leg that converts placements into a year (draftable in the market model's gap register, not yet a claim).
Manufacturer price to a supplier (A1 No FDA 510), and whether the manufacturer can skip the supplier (A2 No granted De Novo request in the FDA De…).
claim 124unconfirmed is left behind, not removed. It was the previous build's A1 No FDA 510, and it assumes a capped-rental placement that the fee schedule contradicts (claim 117refuted). It stays on file, because claims are append-only, and this case no longer relies on it. A1 No FDA 510 (claim 136unverified) states the purchase-cadence version.
The market model's rental framing. Its legs 9 and 11 and its "one placement cycle" unit rest on the refuted reading. stale.py does not see this, because its bracketed tags did not move. /market-model idea-019 is the next pass for the size question.
Share won, price to the buyer and gross margin. No claim carries any of them, and this case does not invent them.
Calendar and capital to first dollar on every route. The components are listed (claim 123unconfirmed), and the largest is guessed at (A5 This candidate's own bladder geometry and…). There is no duration and no amount.
Payer mix (claim 44unconfirmed) and the Medicare share of the eligible population. This is the market model's leg 7, a filed row.
Whether beneficiaries carry the coinsurance (claim 36unconfirmed, with A8 A bench rig can demonstrate that the device… for its size), and **a cash price anyone would pay** (A3 openFDA device classification lists product…). The file records no price for any comparator: garment, stocking or drug.
Any drug-spend offset. Nothing in the file says the device reduces pressor use. If it did, the saving would sit in a different benefit from the one paying for the device.
What coverage would require. L33829 is unread (claim 118unconfirmed), and whether NCD 280.6 would be treated as controlling for RAPID is a CMS judgment (claim 13verified).

Words on this page35 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
CPT: Current Procedural Terminology — the US billing codes for what a clinician does; owned by the American Medical Association
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
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
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
IP: intellectual property — patents and the other rights that let a company stop others copying it
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
MAC: Medicare administrative contractor — a regional contractor that processes Medicare claims and writes local coverage rules
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
mmHg: millimetres of mercury — the unit blood pressure, and the suction of a wound pump, are measured in
MSA: multiple system atrophy — a rare degenerative brain disease that, among other things, breaks blood-pressure control
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
NCT########: a ClinicalTrials.gov registration number — the public id of one registered clinical trial
NICE: National Institute for Health and Care Excellence — the English body whose guidelines say what the NHS should use
nOH: neurogenic orthostatic hypotension — blood pressure that falls on standing because the nerves that should tighten the blood vessels have failed
NPI: new product introduction — taking a design into manufacture: tooling, suppliers, first production
OH: orthostatic hypotension — blood pressure that falls on standing
PAF: pure autonomic failure — a rare condition in which only the nerves controlling automatic functions such as blood pressure fail
PD: Parkinson disease — Parkinson disease
PDAC: Pricing, Data Analysis and Coding contractor — the Medicare contractor that decides which billing code a specific product falls under
PFS: physician fee schedule — the Medicare price list for what clinicians do
PMA: premarket approval — the FDA route for the highest-risk devices; years and clinical trials
RVU: relative value unit — the unit Medicare uses to price a clinician's work

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