Skin Substitutes: How a Medicare Pricing Loophole Drove a $10 Billion Wound-Care Boom

ByEduardo Bacci

June 28, 2026
Sample United States Medicare cardA sample U.S. Medicare card. (Image: Centers for Medicare & Medicaid Services, public domain)Sample Medicare card, public domain (CMS). Used to illustrate reporting on Medicare Part B skin-substitute spending.

When the Justice Department unveiled the largest coordinated health care fraud enforcement action in its history on June 23, the number that led the announcement was $6.5 billion in alleged false claims spread across 455 defendants in 56 federal districts. But the most revealing figure in the entire takedown was far smaller and far stranger: $1,450. That was the price, per square centimeter, that one company allegedly charged Medicare for a sheet of relabeled human placental tissue it had bought from a tissue bank and marked up roughly 2,000 percent.

That single unit price — for a product category most Americans have never heard of — is the key to understanding how Medicare’s wound-care spending rocketed from a rounding error to one of the fastest-growing line items in the entire program. Federal records reviewed by The Investigative Journal show that spending on so-called skin substitutes climbed nearly fortyfold in five years, that the surge was driven less by sick patients than by a pricing formula that all but invited abuse, and that prosecutors and regulators did not move decisively to close the gap until billions had already gone out the door.

A product paid like a blockbuster drug

Skin substitutes are bioengineered wound coverings, many of them amniotic membrane allografts derived from donated human placental tissue, used to treat chronic wounds such as diabetic foot ulcers. Medicare Part B covers them when they are reasonable and necessary. The problem lies in how Medicare pays for them. According to the Department of Health and Human Services Office of Inspector General, CMS treats skin substitutes like approved prescription biologics, reimbursing them in non-institutional settings at 106 percent of a product’s average sales price (ASP).

That methodology works when a product has an established ASP. But when a new skin substitute enters the market with no reported sales history, Medicare must fall back on the manufacturer’s own list price — the wholesale acquisition cost — until real-world ASP data catches up. The result, the OIG found, is a window in which a manufacturer can set an extraordinarily high launch price, capture rich reimbursement, and offer providers the difference as profit. The watchdog identified two structural drivers: manufacturers’ ability to bring new products to market far faster than typical ASP-priced drugs, and “financial incentives such as spread pricing that make certain products more attractive to providers.” In plain terms, the bigger the gap between what a provider paid and what Medicare reimbursed, the more money the provider pocketed for applying it.

An OIG analysis the watchdog had issued back in March 2023 already warned that many manufacturers were not complying with ASP reporting requirements for these products. The pricing window stayed open anyway.

The data: a fortyfold spike

The scale of what followed is documented in the OIG’s September 2025 evaluation, report number OEI-BL-24-00420. Medicare Part B expenditures for skin substitutes, the report found, “skyrocketed over the last 2 years, surpassing $10 billion annually by the end of 2024.” Other federal data put the starting point in sharp relief: outside analyses of Medicare claims trace the climb from roughly $256 million in 2019 to more than $10 billion in 2024, a nearly fortyfold increase in five years. The Medicare Payment Advisory Commission, the independent body that advises Congress, noted in its 2025 comment letters to CMS that 2024 Part B spending on the products had more than doubled year over year, to roughly $10.2 billion.

The OIG’s findings point away from a sudden epidemic of wounds and toward the payment incentives themselves. Growth was fueled by both higher utilization and higher prices. Although Medicare Advantage plans — which negotiate prices and manage utilization — cover more than half of all Medicare enrollees, their spending on skin substitutes was a small fraction of spending under Original Medicare, where the ASP formula governs. And costs for patients reportedly treated at home were four times as high as those treated in an office. Skin substitutes, the OIG concluded, “seem particularly vulnerable to questionable billing and fraud schemes.”

The bust: kickbacks, hospice patients, and a Bulgari necklace

This year’s National Health Care Fraud Takedown made wound care a centerpiece. According to the Justice Department, charges were filed against 11 defendants — including a company executive and eight medical professionals — across six federal districts in connection with billions of dollars in fraudulent claims for amniotic wound allografts. In the U.S. Attorney’s Office for the Southern District of Florida alone, prosecutors said 12 defendants were charged in schemes involving more than $4 billion in claims for products including skin substitutes.

The marquee case, brought in the District of Arizona, targets the supply side. According to the Department, the vice president of sales for a company that sold allografts was charged in a nationwide kickback and health care fraud scheme. From approximately December 2021 through June 2024, prosecutors allege, providers billed Medicare more than $4 billion for that company’s allografts, resulting in over $2 billion in payments. The company, the Department says, did not manufacture the grafts at all: it acquired them from tissue banks and relabeled them for sale at a 2,000 percent markup, charging up to $1,450 per square centimeter, then allegedly paid kickbacks of roughly 40 percent of that amount — leaving marketers and providers $500 to $600 per square centimeter in spread. The executive is alleged to have received more than $24 million, which prosecutors say funded multimillion-dollar homes, life-insurance policies, a $135,000 Maserati, and luxury watches. The defendant has been charged but not convicted and is presumed innocent.

The human cost is what distinguishes these cases from ordinary billing disputes. The kickbacks, prosecutors allege, drove participants to target hospice patients and apply grafts without coordination with treating physicians, without proper treatment for infection, to superficial wounds that did not need them, and to areas far larger than the wounds themselves. In the Southern District of Texas, a nurse practitioner was charged in a $906 million scheme in which she allegedly billed Medicare more than $1 million per patient on average for medically unnecessary allografts. Investigators seized more than $30 million in bank accounts, a $594,000 Ferrari 296 GTS, seven other high-end vehicles, an $865,000 custom Bulgari necklace, and $1 million in other jewelry, and traced $4.6 million in alleged proceeds to the construction of a beach resort in the Philippines. In the Middle District of Florida, three defendants were charged in a $118 million allograft scheme in which a nurse practitioner allegedly spent the proceeds on a luxury box at an NFL stadium and more than $400,000 in fine art. All of these defendants are presumed innocent; the charges are allegations that have not been proven in court.

The precedent: a $1.2 billion scheme aimed at the dying

The Arizona charge did not come out of nowhere. The Justice Department noted it “follows” sentences of 15.5 and 14 years handed down last year “in connection with the scheme” — a reference to what the Department called the first prosecution of its kind. In that case, Alexandra Gehrke, 39, and her husband Jeffrey King, 46, both of Phoenix, were sentenced in October after pleading guilty to orchestrating a wound-graft scheme that ran from 2022 through 2024.

Court documents lay out a chain that maps the entire ecosystem. Gehrke owned companies that hired medically untrained “sales representatives” to find elderly Medicare beneficiaries — many in hospice care — with wounds of any kind. The representatives were directed to order the most expensive bioengineered skin substitutes available and, to maximize profit, only the largest graft sizes, whether or not the size or the treatment was appropriate. Gehrke’s companies, enrolled as Medicare providers, bought the grafts from a wholesale distributor and contracted nurse practitioners to apply them, instructing the clinicians to “suspend their medical judgment.” The result, prosecutors said, was large grafts applied to small wounds, multiple grafts on single wounds, grafts applied to non-existent wounds, and grafts applied to terminally ill patients in palliative care — some of whom died within days, or the same day, of the application.

The financial figures come straight from the government’s filings. Over just 18 months, from November 2022 through May 2024, the conspirators submitted approximately $1,212,005,778 in false and fraudulent claims, including more than $960 million to Medicare, TRICARE, and CHAMPVA; the programs paid out $614,945,420. Gehrke received more than $279 million in kickbacks from the wholesale graft distributor in exchange for ordering its grafts, while King’s company received an additional $130 million from the same distributor. Gehrke was ordered to pay more than $614 million in restitution and to forfeit nearly $280 million; she and her marketing company, Apex Medical LLC, separately agreed to a civil False Claims Act settlement of $279,912,916, and King agreed to pay $30 million. Investigators seized $97 million from 28 bank accounts, life-insurance annuities exceeding $21 million, a Ferrari 488 Spider, a G-Wagon, and gold and silver bars.

Read together, the two cases describe a complete supply chain: tissue banks at the top; a wholesale distributor that relabeled the tissue and, according to the government, paid out more than $400 million in kickbacks; marketing companies that recruited patients; sales representatives paid by the square centimeter; and nurse practitioners who applied whatever was ordered. The 2026 takedown reaches the distributor tier of that chain that the earlier prosecution had left for later — and court filings note the underlying whistleblower suits “remain under seal while the investigation of other parties continues.”

Prevention versus prosecution

The enforcement numbers are genuinely historic. The Department says that since the Health Care Fraud Strike Force program began in 2007, it has charged more than 6,200 defendants responsible for over $45 billion in fraudulent billing — and this year’s action outpaced even the 2025 takedown, which counted 324 defendants and $14.6 billion in intended loss. The Department’s data analysts say they flagged the allograft spike and built cases around it, and CMS moved to suspend 1,079 providers and revoke billing privileges for 1,403 more in conjunction with this year’s action, which the Criminal Division documented in case-by-case summaries and court records.

But the structural fix arrived only after the spending curve had already gone vertical. CMS realigned payment for skin substitutes, cutting Medicare’s reimbursement to $127 per square centimeter effective January 1, 2026 — a reduction of roughly 90 percent from the $1,450 ceiling at the center of the Arizona case, and part of a broader effort the agency has described as modernizing payment accuracy. The Department itself underscored how close the program came to passing the cost on to seniors: absent the change, it said, the premium impact of allograft spending alone would have cost every Medicare beneficiary in the country an extra $11 a month.

That sequence — a known pricing vulnerability, an early watchdog warning in 2023, a fortyfold spending increase, and a corrective rule that took effect only in 2026 — is the heart of the accountability question. Prosecutions recover pennies on the dollar after the fact; the OIG itself framed the lesson bluntly, writing that “action is urgently needed” and that the findings “illustrate the critical need for payment reforms that address fraud, waste, and abuse.” A formula designed for slow-moving prescription biologics proved a poor fit for a category of products that could reach the market quickly and be priced almost at will.

What to watch

Several threads remain open. The 2026 charges are allegations, and the defendants are entitled to the presumption of innocence; the cases will be tested in court. The sealed qui tam suits referenced in the Gehrke and King resolutions signal that additional parties — potentially including others in the distribution and manufacturing tiers — remain under investigation. And the durability of the new $127 reimbursement rate will determine whether the spending curve actually bends; industry groups have warned that an across-the-board cut could affect patient access, and the rate could be litigated or revised.

The skin-substitute episode is, in the end, less a story about a few bad actors than about how a payment rule can manufacture its own crime wave. The dollars were extracted not by hacking Medicare but by following its formulas to their logical conclusion. As CMS deploys data analytics to catch the next anomaly, the more durable safeguard may be the least glamorous one: pricing products in a way that does not reward selling a $70 graft for $1,450 — and applying it to patients who, in too many documented cases, were among the most vulnerable people the program is meant to protect.

This article is based on Department of Justice and HHS Office of Inspector General press releases, court filings, and federal payment data. Criminal charges described from the 2026 National Health Care Fraud Takedown are allegations; the defendants are presumed innocent unless and until proven guilty. Civil settlements resolve allegations without admissions of liability. Counsel for charged individuals could not immediately be identified; the publication will update this report with any response.

ByEduardo Bacci

Investigative journalist and founder of The Investigative Journal. Specializing in OSINT-driven reporting on corporate malfeasance, government accountability, and institutional corruption.