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Section reference-products · Version 2026-09-30 · Cadence quarterly · Evidence class mixed · Sources 15 · Supersedes none
Domain: stress-urinary-incontinence · Scope: Public primary sources reachable by this repo's connectors, WebSearch and WebFetch — eCFR, CMS (Centers for Medicare & Medicaid Services) coverage memos and transmittals, DME MAC (durable medical equipment Medicare administrative contractor)/PDAC articles, HHS-OIG (Office of Inspector General) reports, SEC filings of the manufacturers named, PubMed. Excludes CPT (Current Procedural Terminology) descriptors (AMA-licensed), the DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) fee schedule dollar amounts (no local cache at data/dmepos_fee_schedule.csv or data/hcpcs_level_ii.csv), private manufacturer-to-supplier price lists, and jurisdictions other than US.
Sourcing: Rests mostly on manufacturers' own SEC filings (Empi/DJO, Zynex, Orthofix) and single CMS/OIG documents; no source gives a manufacturer-to-supplier acquisition price for any of these codes.
Medicare covers non-implantable pelvic floor electrical stimulators for stress and/or urge incontinence only after a failed documented trial of pelvic muscle exercise, and the code for them, E0740 (a HCPCS code for durable medical equipment), was built around predicate devices that pair stimulation with integrated muscle-contraction monitoring [3][4]. Among the home-electrotherapy manufacturers examined here, the ones that sold into this benefit did so by acting as their own DMEPOS supplier and billing payers directly, not by selling to independent suppliers [7][9]. Both such manufacturers found in this search either closed the business line (Empi, 2015) or went into Chapter 11 after a payer suspended payment (Zynex, 2025–2026) [7][10][11]. Neither source base discloses what Medicare specifically paid per beneficiary for these devices.
_Baseline (v1). No prior version; this establishes the starting point for future diffs._
Payment frame common to every case. Under 42 CFR 414.229(f), capped-rental items furnished on or after 2006-01-01 are paid "based on a monthly rental fee schedule amount during the period of medical need, but for no longer than a period of continuous use of 13 months", and "the supplier must transfer title to the item to the beneficiary on the first day that begins after the 13th continuous month" [1] [single-source]. The monthly amount "equals 10 percent of the purchase price recognized … for each of the first 3 months and 7.5 percent of the purchase price for each of the remaining months" [1] [single-source]. CMS Change Request 8566 (Transmittal 1445, dated 2014-12-05) moved E0740 "Incontinence treatment system" from the inexpensive-or-routinely-purchased category to capped rental, effective 2014-04-01 [2] [single-source]. HHS-OIG has audited supplier acquisition cost against Medicare payment for a home DMEPOS product before: for CGMs, July 2022–June 2023, "Medicare payments for CGMs and supplies exceeded suppliers' acquisition costs by $377 million (or 69 percent) in a year" [12] [single-source]. Round 1 competitive-bidding prices (2011–13 and 2014–16) were "comparable to those obtained, on average, by large commercial insurers" for the same item types, 2011–14 [15] [single-source].
Had to show: that a manufacturer of prescription home electrotherapy devices and supplies (TENS, and the Innova Feminine Incontinence Treatment System, one of the three predicate products PDAC (Pricing, Data Analysis and Coding contractor) names for E0740) could run its own third-party billing profitably; "Empi generally billed third party payors, either government payors such as Medicare and Medicaid, or private payors, on behalf of the patient" [4][7] [manufacturer].
What happened: 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 [7] [single-source · manufacturer]. In 2012 TENS entered competitive bidding in nine areas; Empi won in two but "did not enter into a contract", the rate there being "a 46% reduction to the Medicare fee schedule rate" [7] [single-source · manufacturer]. In Q4 2015 DJO "ceased manufacturing, selling and distributing products of our Empi business and the related insurance billing operations domestically", stating Empi "was facing a challenging regulatory and compliance environment, decreasing reimbursement rates and remained below the level needed to reach adequate profitability within an economically justified period of time"; the 2015 loss from discontinued operations was $157.6M [7] [single-source · manufacturer].
Transfers: the same benefit (DMEPOS), the same code (E0740, via Innova), prescription-only home use, and the vertically integrated manufacturer-plus-biller model [4][7] [manufacturer].
Does not transfer: Empi's revenue was dominated by TENS for pain, not incontinence, and the filing does not split out Innova or give a Medicare share; the exit came inside a large diversified parent that could absorb it [7] [manufacturer].
Had to show: that a manufacturer holding its own Medicare Supplier Number, submitting "a claim for payment directly to third-party payers", could make home electrotherapy pay; the filing states "A significant portion of our revenues are dependent upon our Medicare Supplier Number" [9] [single-source · manufacturer].
What happened: 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 [9] [single-source · manufacturer]. Its own E0740-type product, InWave ("in-home electrical stimulation device used to treat female urinary incontinence"), is described as "covered by most insurance plans and Medicare", yet "Zynex did not have material sales of this product in 2024 or 2023" [9] [single-source · manufacturer]. In 2025 the Defense Health Agency suspended Tricare payments (historically "approximately 20-25%" of revenue) over alleged misrepresented supply claims and diagnoses; nine-month 2025 revenue fell to $62.2M from $146.4M, and management disclosed "substantial doubt" about continuing as a going concern [10] [manufacturer]. On 2026-02-17 HHS-OIG reported a non-prosecution agreement in which Zynex admitted "participating in a conspiracy to commit health care fraud", paying $5–12.5M and forfeiting "more than $85 million billed to TRICARE during a suspension period", subject to approval in its "ongoing Chapter 11 proceedings" [11] [single-source].
Transfers: manufacturer-as-supplier, prescription home electrostimulation, and a recurring consumables line billed separately from the device; Zynex also held an E0740-type incontinence product in the same portfolio [9] [manufacturer].
Does not transfer: Zynex's revenue came from pain and rehabilitation devices, with a large Tricare and commercial component, not from Medicare incontinence patients; the filings give no Medicare share [9][10] [manufacturer].
Had to show: Class III (FDA device class III) PMA (premarket approval) approval for its regenerative stimulation devices, and DMEPOS supplier accreditation of Orthofix Inc. (ACHC), so that the manufacturer supplied patients directly [8] [single-source · manufacturer].
What happened: 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 81.3% in 2012 [8] [single-source · manufacturer]. A qui tam complaint alleged the defendants "improperly promoted the sale, as opposed to the rental, of regenerative stimulation devices" and waived "patients' insurance co-payments"; Orthofix paid $34.2M to settle, Orthofix Inc. pleaded guilty to one felony count of obstructing a June 2008 federal audit (fine $7.8M), and it signed a five-year Corporate Integrity Agreement in June 2012 [8] [single-source · manufacturer].
Transfers: a home electrical-stimulation device dispensed under the DMEPOS benefit by its own manufacturer, where the rental-versus-purchase choice was itself the focus of federal enforcement [8] [manufacturer].
Does not transfer: Class III PMA with a post-surgical, time-limited indication; exempt from competitive bidding; margin reported company-wide, not per device; not an incontinence or pelvic floor product [8] [manufacturer].
Had to show: under Medicare's 1980s guidelines, a one-month trial with monitored effectiveness; "The device may be rented during the assessment period and then purchased if beneficial" [6] [single-source].
What happened: 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 found 33% should not have been paid, and among purchasers, 53 of 55 with a trial period were helped against 14 of 30 without one [6] [single-source]. On 2012-06-08 CMS decided "TENS is not reasonable and necessary for the treatment of CLBP", leaving coverage only in approved studies under coverage with evidence development [5] [single-source].
Transfers: a home electrostimulation device whose Medicare payment depends on a short rental trial before longer-term use, and whose coverage was later narrowed by a national coverage decision [5][6].
Does not transfer: TENS is a low-cost pain device with far higher 1980s volume; the OIG data are from 1986 claims; the 2012 decision concerned chronic low back pain, and no pelvic floor indication [5][6].
Had to show: a payer case to commercial plans rather than to the Medicare fee schedule; a 24-month budget-impact model for "a 1-million-member US commercial health plan" estimated $11,267 per treated patient under current practice and $10,447 with Leva, assuming 15% Leva uptake [14] [single-source].
What happened: 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" [13] [single-source · manufacturer].
Transfers: a prescription home intravaginal pelvic floor device for female urinary incontinence, sold through DME (durable medical equipment) and pharmacy channels [13][14].
Does not transfer: Leva is a motion-sensor (accelerometer) training device without electrical stimulation, so it falls outside the stimulate-and-monitor devices PDAC describes as E0740; its payer case is commercial, not Medicare capped rental [4][14].
[1] 42 CFR 414.229, Other durable medical equipment—capped rental items — eCFR, Office of the Federal Register (issue 2026-08-13; accessed 2026-09-30). 42 CFR 414.229 — https://www.ecfr.gov/current/title-42/section-414.229 [federal-registry] [2] Rescind and Replace of CR 8409: Reclassification of Certain DME from the Inexpensive and Routinely Purchased Payment Category to the Capped Rental Payment Category, Pub 100-20 Transmittal 1445, CR 8566 — CMS (published 2014-12-05; accessed 2026-09-30). R1445OTN — https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R1445OTN.pdf [federal-registry] [3] Decision Memo, Pelvic Floor Electrical Stimulation for Urinary Incontinence (CAG-00021N) — CMS (published 2000-10-05; accessed 2026-09-30). NCD 230.8 (a Medicare national coverage determination number) — https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=61 [payer-policy] [4] PDAC Code Review – E0740 Non-Implantable Pelvic Floor Electrical Stimulator — Noridian JD DME (last updated 2023-11-10; accessed 2026-09-30). HCPCS E0740 — https://med.noridianmedicare.com/web/jddme/policies/dmd-articles/pdac-code-review-e0740-non-implantable-pelvic-floor-electrical-stimulator [payer-policy] [5] Decision Memo, Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain (CAG-00429N) — CMS (published 2012-06-08; accessed 2026-09-30). NCD (national coverage determination) 160.27 — https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=256 [payer-policy] [6] Transcutaneous Electrical Nerve Stimulation (TENS) Devices — HHS Office of Inspector General (published 1989-07, day not given on the report; accessed 2026-09-30). Report No. OAI-02-88-00060 — https://oig.hhs.gov/documents/evaluation/1435/OAI-02-88-00060-Complete%20Report.pdf [other] [7] DJO Finance LLC Form 10-K for fiscal year 2015 — US SEC EDGAR (filed 2016, day not captured; accessed 2026-09-30). [no-identifier] an SEC filing is named by its EDGAR accession number (SEC accession no. 0001564590-16-015274), which this tree's identifier vocabulary has no slot forhttps://www.sec.gov/Archives/edgar/data/1395317/000156459016015274/djo-10k_20151231.htm [manufacturer] [8] Orthofix International N.V. Form 10-K for fiscal year 2012 — US SEC EDGAR (filed 2013, day not captured; accessed 2026-09-30). [no-identifier] an SEC filing is named by its EDGAR accession number (SEC accession no. 0001193125-13-087561), which this tree's identifier vocabulary has no slot forhttps://www.sec.gov/Archives/edgar/data/884624/000119312513087561/d446479d10k.htm [manufacturer] [9] Zynex, Inc. Form 10-K for fiscal year 2024 — US SEC EDGAR (filed 2025, day not captured; accessed 2026-09-30). [no-identifier] an SEC filing is named by its EDGAR accession number (SEC accession no. 0001558370-25-002717), which this tree's identifier vocabulary has no slot forhttps://www.sec.gov/Archives/edgar/data/846475/000155837025002717/zyxi-20241231x10k.htm [manufacturer] [10] Zynex, Inc. Form 10-Q for the quarter ended 2025-09-30 — US SEC EDGAR (filed 2025, day not captured; accessed 2026-09-30). [no-identifier] an SEC filing is named by its EDGAR accession number (SEC accession no. 0001104659-25-113280), which this tree's identifier vocabulary has no slot forhttps://www.sec.gov/Archives/edgar/data/846475/000110465925113280/zyxi-20250930x10q.htm [manufacturer] [11] Zynex, Inc. Agrees to Criminal Resolution Addressing Claims of Millions of Dollars of Health Care Fraud, Securities Fraud and Related Offenses — HHS Office of Inspector General enforcement action page (published 2026-02-17; accessed 2026-09-30). [no-identifier] an agency enforcement web page carries no report or docket number on the page as retrieved — https://oig.hhs.gov/fraud/enforcement/zynex-inc-agrees-to-criminal-resolution-addressing-claims-of-millions-of-dollars-of-health-care-fraud-securities-fraud-and-related-offenses/ [other] [12] Medicare Payments for Continuous Glucose Monitors and Supplies Exceeded Supplier Costs and Retail Market Prices — HHS Office of Inspector General (published 2025-11-20; accessed 2026-09-30). Report No. OEI-04-23-00430 — https://oig.hhs.gov/reports/all/2025/medicare-payments-for-continuous-glucose-monitors-and-supplies-exceeded-supplier-costs-and-retail-market-prices-indicating-medicare-can-save-at-least-tens-of-millions-of-dollars-in-one-year/ [other] [13] Axena Health announces new HCPCS code supporting coverage for the Leva Pelvic Health System — Axena Health, Inc. (published 2024-03-04; accessed 2026-09-30). [no-identifier] a company press release; the release as retrieved does not state the code number itself — https://axenahealth.com/2024/03/axena-health-announces-new-hcpcs-code-supporting-coverage-for-the-leva-pelvic-health-system/ [manufacturer] [14] U.S. payer budget impact of the Leva Pelvic Health System to improve pelvic floor muscle training as first-line treatment of female urinary incontinence compare to real-world clinical practice — Journal of Medical Economics (published 2025-12, day not given in the PubMed record; accessed 2026-09-30). PMID (PubMed identifier) 40249373 — https://pubmed.ncbi.nlm.nih.gov/40249373/ [peer-reviewed] [15] Medicare Competitive Bidding Program Realized Price Savings For Durable Medical Equipment Purchases — Health Affairs (published 2017-08-01; accessed 2026-09-30). PMID 28784728 — https://pubmed.ncbi.nlm.nih.gov/28784728/ [peer-reviewed]
Well established: the E0740 coverage frame (failed pelvic muscle exercise trial; stimulate-and-monitor devices) rests on two CMS-side documents [3][4]. That the Empi and Zynex businesses billed payers directly as their own supplier rests on each company's own filing [7][9], and the Zynex collapse on its 10-Q plus an HHS-OIG page [10][11].
Thin: everything about per-company revenue, margin and exit reasons is [manufacturer] (SEC filings) [7][8][9][10]. The capped-rental rule [1], the E0740 reclassification [2], the TENS decision [5], the 1989 OIG findings [6], the CGM acquisition-cost audit [12] and the competitive-bidding comparison [15] are each [single-source]. Leva's code and channel are [single-source · manufacturer] [13]. The Leva budget-impact abstract [14] was read at abstract depth only; its funding disclosure was not in the abstract and the full text returned HTTP 403, so any Axena sponsorship is unknown. The 1989 OIG report was read from an OCR text layer with character errors; the figures quoted were legible.
Rescoped from class 3: none in this report. The row asks what manufacturers did (revealed behaviour in filings and enforcement records), not what suppliers or clinicians would do.
Out of scope: DMEPOS fee schedule dollar amounts for E0740, E0720/E0730, E0745/E0770 and E0747/E0748/E0760. The hcpcs, payment and coverage connectors returned unconfirmed because no local cache exists at data/hcpcs_level_ii.csv, data/dmepos_fee_schedule.csv or data/medicare_coverage_policies.csv. This is an unchecked gap, not an absence. The ncd connector could not read the NCD manual (pypdf not installed), so NCD text was read from the CMS decision memos instead. Private manufacturer-to-supplier price lists are not public and were not sought.
Not searched vs. not found:
[inference] In every case found, the manufacturer captured the supplier margin by being the supplier, rather than selling at an acquisition price below the fee schedule.
[inference] In the two electrotherapy cases [7][9], recurring consumables billed separately were a large share of revenue (69% at Zynex, FY2024). Those same supply lines were the subject of the Tricare enforcement against both companies [10][11].
[inference] No case found shows a manufacturer sustaining a business mainly on Medicare capped-rental E0740 revenue. Empi's Innova sat inside a TENS business, and Zynex's InWave had no material sales.
| Proposition | Evidence class | Resolvable identifier | Dossier section |
|---|---|---|---|
| 42 CFR 414.229(f) caps capped-rental payment at 13 continuous months, with title transferring to the beneficiary after the 13th month | 1 registry | 42 CFR 414.229 | reimbursement |
| CMS reclassified HCPCS E0740 from inexpensive/routinely purchased to capped rental, effective 2014-04-01 (CR 8566, Transmittal 1445) | 1 registry | R1445OTN | reimbursement |
| PDAC names Perry Vaginal, Perry Anal and Empi's Innova Feminine Incontinence Treatment System as the products establishing E0740 as stimulation with integrated monitoring | 1 registry | HCPCS E0740 | reference-products |
| DJO ceased Empi's manufacturing and insurance-billing operations in Q4 2015, citing decreasing reimbursement rates and inadequate profitability | 2 published | SEC accession no. 0001564590-16-015274 | market-players |
| Zynex reported no material sales of its InWave incontinence stimulator in 2023 or 2024 | 2 published | SEC accession no. 0001558370-25-002717 | market-players |
| Supplies were 69% of Zynex FY2024 net revenue of $192.4M | 2 published | SEC accession no. 0001558370-25-002717 | market-players |
| Zynex disclosed substantial doubt about continuing as a going concern in its Q3 2025 10-Q after a Tricare payment suspension | 2 published | SEC accession no. 0001104659-25-113280 | market-players |
| Orthofix paid $34.2M to settle allegations including promoting the sale rather than the rental of bone growth stimulators | 2 published | SEC accession no. 0001193125-13-087561 | reference-products |
| CMS decided in 2012 that TENS is not reasonable and necessary for chronic low back pain outside approved studies | 1 registry | NCD 160.27 | reference-products |
| HHS-OIG found Medicare CGM payments exceeded supplier acquisition costs by $377M (69%), July 2022–June 2023 | 2 published | Report No. OEI-04-23-00430 | reimbursement |
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