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The benefit manager the chronic wound has been missing

CMS capped the price of a skin substitute and walked away from the medical necessity. Someone has to manage what's left. The cost is real, but the number that matters is limbs kept.

Author Joe Nalley Audience Payer medical & pharmacy leadership Date June 2026 Figures Verified to primary source
The problem

A spigot opened, and no one is at the valve

Medicare Part B spending on skin substitutes went from $256 million in 2019 to more than $10 billion in 2024 — about 40-fold — while the number of patients treated only roughly doubled.1

That gap between dollars and patients is not biology. It is the signature of a payment incentive with no clinical guardrail behind it. The graft got applied more often, in larger sizes, on wounds that did not need it, because the rate rewarded volume and the payment itself never asked whether the wound was closing.

~40x
Part B skin-substitute spend growth, 2019–2024, against a patient count that only doubled1
$1.2B
Arizona wound-graft fraud scheme; guilty pleas, 15.5- and 14-year sentences, $309M civil5
$28.1B+
Annual chronic-wound burden in Medicare across 8.2M beneficiaries (~15%)8
Fig. 1
Dollars outran patients, 2019–2024

Medicare Part B skin-substitute spend, plotted against the patient count it was meant to track.1

PART B SPEND ($B) $0 $5B $10B 201920202021202220232024 $256M >$10B patients ~2× JAN 1, 2026 FLAT RATE $127.14/CM² Dollars outran patients ≈ 20 : 1
Each column is a year of spend; the gold line is the same population, indexed. The endpoints are the OIG figures: $256M in 2019 and more than $10B in 2024; the 2020–2023 columns are interpolated between them.1 The gap between the columns and the line is the overutilization a benefit manager exists to close.

CMS saw it. Effective January 1, 2026, it replaced ASP+6% with a single flat rate of $127.14 per square centimeter, paid as an incident-to supply at the same rate in office and hospital outpatient settings. That is roughly a 90% cut, about $19.6 billion saved in CY2026 alone.23 A clean fix to the price.

But CMS fixed the price, not the coverage. The seven MAC skin-substitute coverage policies that would have restricted which products and which wounds qualified were withdrawn on December 24, 2025.4

So which product, which indication, how many applications, how large a graft — all of it is still unguarded. A flat per-square-centimeter rate even rewards a larger graft. CMS capped dollars per unit and left medical necessity open. No regulator has stepped in to fix that side. That is the benefit manager's job, and the chronic wound is a major spend category with no dedicated one.

Why it lands on the patient

This is a clinical failure before it is a financial one

It would be easy to read the 40x chart as a fraud story and stop there. The harder truth is what happens to the patient when the wound is managed for the graft instead of for the limb.

Five-year mortality after a major diabetic-foot-ulcer amputation is roughly 56.6%, worse than breast, prostate, and colorectal cancer, and worse than the pooled all-cancer average.6 The burden falls unevenly: Black patients are amputated at two to four times the rate of white patients, with lower rates of limb-saving revascularization before the amputation.7

An amputation is rarely a single decision. It is the end of a chain of missed steps: an infection caught late, a vascular problem never worked up, an ulcer left under pressure. The graft is the loudest line on the invoice, but the limb is lost in the visits that didn't happen.

The model

Manage the episode, not the product. Be the brain and the scoreboard; rent the hands.

KEEP is a benefit manager for the chronic wound, the PBM-equivalent for a category that has no dedicated one. It is built to manage the whole wound episode through a credentialed home-care network it contracts and measures, with an evidence-based formulary and a closure-rate registry sitting inside it.

The episode, not a slide off a graft list

The skin substitute is the trigger, not the prize. It books the meeting, but it is a slice of the dollar. The bulk of the burden lives in hospitalizations, ED visits, surgery, and amputations, not the graft. A manager that touches only the formulary handles the loud 10% and leaves the real money, and the real outcomes, untouched. So KEEP manages the episode end to end:

  • Home nurse monitoring — the Tuesday visit that catches the infection early. This is the actual mechanism of keeping a limb.
  • Medications — the right antibiotic before it reaches bone; pain control; glycemic control, because a diabetic foot ulcer does not heal on a high A1c.
  • Labs and the vascular gate — wound cultures and vascular studies. No graft goes on a limb with no blood supply; the vascular workup is a hard gate before advanced product is approved.
  • Offloading and DME — total-contact casts and therapeutic footwear, because an ulcer under pressure does not close.
  • Acuity management — escalate to vascular, surgery, HBOT, or admission when the limb is threatened; step down to home maintenance as it closes. Levels of care are the lever; limbs kept is the result.
  • Nutrition, behavioral health, navigation, transportation — the supports a chronic-wound patient, often elderly, immobile, and diabetic, needs to actually heal.
Fig. 2
The wound episode, escalated up and stepped down

One managed pathway across levels of care. Ancillary services are the levers; the formulary and registry sit inside; everything is orchestrated to one number.

ESCALATE · LIMB THREATENED DE-ESCALATE · WOUND CLOSING LEVEL 4 · HIGHEST ACUITY Vascular & surgery · hospital admission · HBOT When the limb is threatened — revascularize, debride, admit. LEVEL 3 · SPECIALTY ESCALATION Vascular workup · infectious disease · advanced product VASCULAR GATE · ABI / studies HARD GATE → No graft on a limb with no blood supply. LEVEL 2 · HOME-BASED ACTIVE MANAGEMENT Tele-wound MD/NP supervision · the credentialed home network Evidence formulary Closure registry LEVEL 1 · HOME MAINTENANCE Closed wound, kept whole at home — monitor, prevent recurrence. THE LEVERS Home-nurse monitoring Medications · A1c Labs & cultures Vascular studies Offloading / DME Nutrition · behavioral Care coordination Transportation ORCHESTRATED TO Limbs kept closure rate, then cost — in that order, on purpose.
Levels of care are the lever; limbs kept is the result. The graft is one slice of a dollar — total wound burden runs $28B+ in Medicare alone8, most of it in visits, escalations, and avoided amputations. You cannot capitate a product; you capitate the episode.

A hybrid, aimed at capitation

KEEP owns the high-value control points and rents the hands. It owns the closure registry, the tele-wound MD and NP supervision, the formulary, and the steerage engine. Credentialed home-wound-care providers deliver the hands-on visits; KEEP does not employ a field workforce. A paperwork-only manager can't move outcomes, so it is stuck at thin fees. An own-and-operate provider is labor-bound and lowest-margin. The hybrid is the structure that reaches a capitated carve-out without being labor-bound. And you can only take a capitated rate if you can move the outcome, which means you must control measurement and supervision.

The risk model — CCOC, not TCOC

KEEP takes risk on the total cost of the wound episode — grafts, home nursing, wound meds, the vascular workup, offloading, and the big ones, wound-related hospitalizations and amputations. It does not take risk on the member's entire spend. Unrelated admissions, cardiac, renal, and diabetes pharmacy stay with the plan and the member's PCP or ACO. The boundary is adjudicable because the episode itself is defined: a trigger event opens it, only wound-attributable services live inside it, and a closure-or-escalation endpoint closes it. This is condition cost-of-care done thoroughly, the depth of one disease, the same boundary as kidney (Strive, Somatus), maternity (Maven), and oncology carve-outs.

KEEP climbs a risk ladder: an admin or PMPM management fee first (formulary, prior authorization aligned to evidence, network access, the diagnostic); then performance guarantees that put fees at risk against closure and limb-preservation targets; then a capitated wound carve-out, taking a per-member rate and keeping the spread it saves. The precedent that payers will capitate a young vendor for a carve-out is recent and real: Synapse Health and UnitedHealth, DME, 2026.

The moat

Claims data cannot see whether a wound closed

This is the gap every incumbent shares. A claim records that a graft was applied and paid for. It says nothing about whether the wound closed, whether the limb was kept, or whether a different product would have worked at a third of the cost.

KEEP makes photographic, measurement-based wound documentation a network-contracting requirement, producing a closure-rate dataset segmented by product, by provider, and by wound type — the record claims data can't supply. A utilization-management rule copies in a quarter. A longitudinal closure registry takes years to build. That registry is also the risk-enabler — it is what makes capitation possible — and the steerage engine, because it lets KEEP point volume to the providers and products with the best real closure rates.

Today the pieces sit apart. The US Wound Registry owns risk-stratified closure benchmarks. Net Health owns product utilization. Swift Medical owns objective imaging. None of them fuses closure-rate-by-product-and-provider into payer purchasing and steerage. That fusion is KEEP.

The economics

Where the exposed dollars actually are

The honest read on the market matters here, because it is also the strategy. Medicare Advantage already self-manages this category: MA accounted for only about 7% of fee-for-service skin-substitute spend despite holding more than half of the lives, because plans use prior authorization.9 MA is not a large unmanaged pool to rescue. It is a buyer for the home spine, the registry, and managed services.

The genuinely exposed dollars are commercial and Medicaid — the fee-for-service segments and weak-medical-policy states — plus the coverage gap everywhere, now that the LCDs are withdrawn. Same clinical wound burden, no CMS rate to cap it, and no public dataset even sizing it. That data vacuum is both the opportunity and the moat: the plan that can see its own exposure first has the advantage, and producing that view is exactly what KEEP's diagnostic does.

The economics follow from the model. Adding the right care — more nursing, the vascular gate, offloading, correct medications — while removing the wasteful care, mostly over-grafting, is what makes "savings follow the outcome" true rather than a slogan. A plan does not save money by denying grafts. It saves money by closing wounds and keeping limbs, because a kept limb is the avoided hospitalization, the avoided surgery, and the avoided amputation that drive the real spend.

Lead with limb preservation. The savings are downstream of the outcome, and they are larger when the outcome is real.

The operator

Built by someone who has run the delivery and the payer side

Joe Nalley
Joe Nalley · Operator

Care delivery, billing integrity, and payer growth — in that order

Joe built a 13-location integrated health system from the ground up — behavioral health, SUD and MAT, primary care, urgent care, lab, imaging, a surgical center, and a community hospital — and ran it as CEO through acquisition. He founded and sold ClearBill, a billing-integrity platform that returned $9.2M to payers in its first six months of full deployment.

Today he is Staff Vice President of Carelon Growth (Elevance Health's specialty health-services arm), where he owns six high-acuity clinical risk books — MSK, oncology, CHF, maternity, autoimmune, and dementia — across more than $50B in specialty medical spend. Across the lifetime of the companies he has led, more than 200,000 patients have been served.

KEEP is the benefit manager that work has been pointing toward: the home spine from delivery, the integrity discipline from ClearBill, and the carve-out mechanics from inside payer growth, aimed at one number — limbs kept.

Sources

  1. HHS-OIG, OEI-BL-24-00420 (September 2025). Medicare Part B skin-substitute spend $256M (2019) to over $10B (2024), ~40x; patient count roughly doubled.
  2. CMS-1832-F; Federal Register correction, November 28, 2025. Single flat rate of $127.14/sq cm, incident-to, office = hospital outpatient, effective January 1, 2026 (was $127.28 pre-correction).
  3. CMS press release / CY2026 Physician Fee Schedule. About a 90% cut; approximately $19.6B saved in CY2026, a single year.
  4. CMS LCD-withdrawal fact sheet. Seven MAC skin-substitute LCDs withdrawn December 24, 2025.
  5. U.S. Department of Justice (Apex Medical; Gehrke & King). $1.2B Arizona wound-graft scheme; guilty pleas; 15.5- and 14-year sentences; $309M civil.
  6. Armstrong et al., Journal of Foot and Ankle Research, 2020. Five-year mortality after major DFU amputation ~56.6% — exceeds the pooled all-cancer average (~31%) and is worse than breast, prostate, and colorectal cancer.
  7. Durazzo et al., Journal of Vascular Surgery, 2011; tctmd. Black patients amputated at 2–4x the rate of white patients; lower pre-amputation revascularization.
  8. Nussbaum et al., Value in Health, 2018. Chronic-wound burden $28.1B–$96.8B in Medicare; 8.2M beneficiaries (~15%).
  9. HHS-OIG, OEI-BL-24-00420. Medicare Advantage ~7% of FFS skin-substitute spend despite over half of lives, via prior authorization.