idea-001 · stage 6 · yours

Home Stress-Incontinence Stimulator

wrapped status: wrapped packet 06a999ac0b67

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The bet

A urogynecologist or pelvic floor physical therapist prescribes a woman with stress urinary incontinence a home stimulator after she has failed four weeks of pelvic muscle exercise. A DME (durable medical equipment) supplier rents it to her under E0740 (a HCPCS code for durable medical equipment), and Medicare or a commercial plan pays the supplier a fixed monthly allowable claim 9verified, claim 193verified. The prescriber picks it instead of a cleared single-channel EMG (electromyography)-triggered device: the MyOnyx is listed and offered for US sale claim 167refuted, K243079 (an FDA 510(k) clearance number) is cleared for prescription home use claim 153verified, and K220161 is cleared over the counter. The reason to pick it is that those triggers fire on the pelvic floor channel alone claim 202verified. Pelvic floor EMG also rises on a strain claim 150unconfirmed, so they may stimulate the manoeuvre the therapy exists to correct. This device withholds stimulation when the abdominal reference says she is straining. The shape is chosen because it is the only answer on the record to the specific failure IR-56 claim 167 came back refuted found: the closed loop is sold already, and a differentiator has to name something the sold implementation does not do. The bet is that the withhold is real in these women, that she can run it alone at home, that no incumbent already does it, and that the rental money clears the cost of an extra electrode every session.

Evidence

verifiedunconfirmedrefutednot yet checked

27/218

verified

177

unconfirmed

refuted

4/4

core factors

The claim ledger →

First in the assessment's queue

criticalB4 Clinicians have to be willing to send a woman home with a stimulator instead of treating her in the clinic, and to write down the failed four weeks of exercise the coverage rule demands first. If they will not, there is no prescription and no business.
Precisely: Prescribers will send a woman home with a stimulator instead of retaining her in clinic, and will produce the documented failed four-week exercise trial the indication requires
fatal if false
cheap to find out
Adjacent cases — 6 found elsewhere
What happened to prescribing of home devices whose coverage requires documented failure of a conservative trial →
- Pelvic floor electrical stimulation and biofeedback for urinary incontinence (Medicare NCD 230.8 (a Medicare national coverage determination number), NCD (national coverage determination) 30.1.1) — No retrieved study reports prescribing volume, prescriber specialty, or denial rates for home pelvic floor stimulators under NCD 230.8. What is measured is uptake of the conservative step itself: among women referred to …
- CPAP continued coverage (LCD (local coverage determination) L33718 (a Medicare local coverage determination number)) — In manufacturer telemonitoring data on 789,260 US patients initiating CPAP (November 2015–October 2018), 72.6% met CMS (Centers for Medicare & Medicaid Services) adherence criteria, from 51.3% in women aged 18–30 to 80.6% in men aged 71–80. In 42 PAP-naive …
- Pneumatic compression devices for lymphedema (NCD 280.6; LCD L33829, retired) — In 26,902 commercially insured lymphedema patients (2012–2016), patients with phlebolymphedema and venous leg ulcer were 9.6% of the cohort, 7.8% of the conservative-care group and 17.7% of the device group, making up …
- TENS for chronic pain (LCD L33802; NCD 160.27) — For chronic low back pain the trial pathway ended: NCD 160.27 (effective 2012-06-08) covers TENS for CLBP only within an approved clinical study. In 2017, 10 of 15 Medicaid plans covered TENS for low back pain, and …
- Power mobility devices under Medicare prior authorisation — One university clinic built an electronic transmission of the order and supporting documents from its EHR (electronic health record) to a MAC (Medicare administrative contractor). Traditional Medicare power wheelchair vendors fell from over 1,292 to 986 between 2015 and 2022, and …
- Physician ownership of physical therapy after knee replacement (self-referral) — Among Medicare total knee replacement patients (2007–2009), those treated at a physician-owned PT (physical therapist) clinic received on average 8.3 more PT visits than patients of non-self-referring surgeons.
What happened somewhere else. Not evidence for this bet until a line is copied into the claims and the Verifier passes it.
criticalB2 What Medicare pays the rental supplier each month has to cover the whole kit for one woman: a controller that comes back, a probe that does not, the app, and a fresh skin electrode every session. If the monthly payment does not cover that, nobody makes money and there is no business.
Precisely: What the manufacturer collects per beneficiary clears what it costs to field the P2 the discriminating trigger system for that beneficiary — a returnable controller, a single-patient probe, an app pathway and a self-placed skin electrode every session — paid as E0740 capped-rental months
fatal if false
project to find out
Adjacent cases — 5 found elsewhere
How manufacturers of home devices paid as Medicare capped-rental DMEPOS items have made per-beneficiary economics work →
- Empi (DJO) — TENS and the Innova E0740 system, manufacturer as its own biller — Empi net sales were $154.7M (2013), $141.6M (2014) and $95.3M (2015); 2013 cost of sales was $37.0M against SG&A of $68.8M. In 2012 TENS entered competitive bidding in nine areas; Empi won in two but "did not enter into …
- Zynex — home TENS/NMES/IFC, manufacturer as DME supplier, supply-line revenue — FY2024 net revenue was $192.4M, of which devices were 31% and supplies (electrodes, batteries, shipped monthly) 69%; cost of revenue was 20% and sales and marketing 45% of revenue. Its own E0740-type product, InWave …
- Orthofix — PMA (premarket approval) bone growth stimulators, rental versus sale — Spine Regenerative Stimulation sales were $164.7M in 2012 (35% of net sales), and the company reported bone growth stimulation products "are exempt from this competitive bidding process"; company-wide gross margin was …
- Medicare TENS — trial rental then purchase, and the 2012 low-back-pain non-coverage — allowed Medicare TENS charges rose from $12,802,927 (1985) to $40,111,359 (1987); in a sample of 126 beneficiaries contacted from 1986 claims, OIG (Office of Inspector General) found 33% should not have been paid, and among purchasers, 53 of 55 with …
- Axena Health Leva — home intravaginal pelvic floor device on commercial and pharmacy channels — Axena announced a new HCPCS (Healthcare Common Procedure Coding System) Level II code effective 2024-04-01, described as "a clear path as a medical benefit through patients' durable medical equipment coverage", alongside "its previously established pharmacy code".
What happened somewhere else. Not evidence for this bet until a line is copied into the claims and the Verifier passes it.
criticalB5 A woman has to be willing to start using an internal device at home, stick on a skin electrode every session, pay a monthly share of the cost, and still be using it three months later, when a device that does not go inside the body is already on sale. If women stop, the rental income stops and there is no business.
Precisely: Women will start an intravaginal home device whose every session now includes placing a skin electrode, and still be using it at twelve weeks, at a recurring monthly cost share, given that a non-invasive external alternative is already on the market
fatal if false
project to find out
Adjacent cases — 5 found elsewhere
Continuation of self-inserted intravaginal devices when a non-invasive alternative exists, and what raised it →
- Vaginal dilators after pelvic radiotherapy — In 109 women after pelvic radiotherapy (diary-recorded, 12 months), "mean percent adherence over 12months was 42%"; adherence "was highest in the first quarter (56%), but fell to 25% by the fourth". In 42 women after …
- Self-managed vaginal pessary for prolapse (TOPSY) — 340 UK women were randomised (self-management n=169, clinic care n=171). The self-management package was "a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a local clinic …
- Contraceptive vaginal ring versus the oral pill — In 273 US students randomised to ring (n=136) or pill (n=137) for three cycles, ring users reported more perfect use in the first two months, but "at 6 months, only 31 (26%) of 117 contraceptive vaginal ring users and …
- Dapivirine vaginal ring versus daily oral PrEP (MTN-034/REACH) — 247 participants aged 16–21 in South Africa, Uganda and Zimbabwe (2019–2021) were randomised to 6 months of each product in crossover; "High adherence was observed in 753 (57%) of the 1316 oral PrEP visits and 806 (57%) …
- Disposable intravaginal SUI (stress urinary incontinence) inserts and continence pessary — An RCT (randomised controlled trial) of continence pessary versus a disposable intravaginal continence device (Poise Impressa) planned 138 participants but "Due to slow enrollment, the study was stopped after 16 months with 50 participants …
What happened somewhere else. Not evidence for this bet until a line is copied into the claims and the Verifier passes it.

The whole assessment →

The chairs

Regulatory: conditionalClinical & Scientific: conditionalMarket Access: conditionalTechnology & R&D: conditionalOperations & NPI: abstainsLegal & IP: conditionalCommercial: abstains

7 of 7 departments have stated a position. The argument →

Still open

52 open question(s) between departments
4 pivot option(s) still on the table

What a decision does

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Words on this page17 abbreviation(s) and code(s), with what each stands for — copied from _shared/plain-language.md

CMS: Centers for Medicare & Medicaid Services — the US agency that runs Medicare, and so decides what Medicare pays for
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
E####: a HCPCS code for durable medical equipment — one billing code for a piece of home equipment; the letter E and four digits
EHR: electronic health record — the hospital's or practice's patient-record software
EMG: electromyography — reading the electrical activity of a muscle
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
K######: an FDA 510(k) clearance number — the public record of one cleared device; the letter K and six digits
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
MAC: Medicare administrative contractor — a regional contractor that processes Medicare claims and writes local coverage rules
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
OIG: Office of Inspector General — the US health department's auditor; its reports on Medicare pricing are public
PMA: premarket approval — the FDA route for the highest-risk devices; years and clinical trials
PT: physical therapist — a physiotherapist
RCT: randomised controlled trial — the kind of clinical study that compares a treatment against an alternative by chance assignment
SUI: stress urinary incontinence — leaking urine on a cough, a laugh or a lift

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