The Trump administration announced last week the first criminal charges against a skin substitute executive accused of committing Medicare fraud on an outrageous scale. Providers who exploit Medicare or endanger patients should be investigated and prosecuted to the fullest extent of the law. But holding bad actors accountable and preserving access to medically necessary wound care are not mutually exclusive goals.
A new Medicare policy change that took effect in January, also intended to curb abuse, has been catastrophic for patients and providers with legitimate reasons to use this life and limb-saving therapy.
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Across the U.S., doctors who provide wound care for seniors in their homes and assisted living facilities are reporting a surge in amputations and hospital stays. Still others have had to shutter their practices completely in just months since the new reimbursement policy went into effect, leaving patients who already struggled with access to care with nowhere to turn.
Each year, more than 10.5 million Medicare beneficiaries receive treatment for advanced chronic wounds. Skin substitutes — used when the body’s natural healing processes are inadequate — encompass a broad range of products, including allografts derived from human donors, xenografts sourced from animals such as pigs or fish, synthetic materials, and tissue-engineered constructs containing living cells.
These FDA-regulated products are used in burn care and certain reconstructive and dermatologic procedures, as well as in the management of chronic wounds such as lower extremity diabetic ulcers and venous leg ulcers. Skin substitutes play a critical clinical role by reducing infection risk and promoting tissue regeneration when standard therapies — such as dressings, compression, or offloading — are no longer sufficient. Chronic wounds already carry a significant clinical risk. When access to appropriate wound care therapies is reduced, patients experience higher rates of amputation, infection, hospitalization, ICU utilization, and death.
Importantly, these therapies are not first-line treatment. Medicare generally requires physicians to document at least four weeks of unsuccessful conventional wound care before skin substitutes can be used, reflecting strict clinical criteria designed to ensure appropriate use.
Their value has also been recognized across the federal government. The Department of Veterans Affairs has used these products for more than a decade, the Department of War has explored their use to treat battlefield burns, and certain products are maintained in the Strategic National Stockpile for emergency response.
However, the industry has drawn fraudsters who drove Medicare spending to nearly $15 billion last year. But rather than targeting the individuals responsible, the Centers for Medicare and Medicaid Services adopted an across-the-board reimbursement policy that has made it financially impossible for many providers to continue offering these therapies.
The 2026 CMS Physician Fee Schedule set a flat rate of $127.14/cm² for all skin substitutes, regardless of product, complexity, or where care is delivered. The result has been interrupted treatment, provider closures, increased hospitalizations, and, according to physicians across the country, a troubling rise in amputations.
Physicians’ reports are now reflected in new data. A national survey published by the Wound and Hyperbaric Association found that 61% of respondents reported authorization delays for clinically eligible patients, 58% reported reduced ability to deliver timely advanced wound care, and 45% reported actual or planned closure of a wound care practice or service line. Many of the affected practices serve patients outside hospital outpatient departments, including in homes, assisted living facilities, skilled nursing facilities, and mobile or community-based care settings.
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Older adults are particularly vulnerable to lower extremity diabetic ulcers and venous leg ulcers, which can lead to devastating complications, including amputation. A lower-limb amputation occurs every 20 seconds, and approximately 85% are preceded by a diabetic foot ulcer. Individuals with lower extremity diabetic ulcers have an estimated five-year mortality rate of 50-70%. The five-year mortality rate following a major amputation exceeds 50%, higher than that of breast cancer and all other cancers except lung cancer.
Fortunately, there is a reform effort underway in Congress that would eliminate incentives for abusive pricing while preserving patient access. Congress and the Trump administration have an opportunity to demonstrate that protecting taxpayer dollars and protecting patients can advance together. The appropriate response to fraud is stronger enforcement against those breaking the law, not policies that deny seniors timely access to medically necessary, limb-saving care. As the administration prepares to release its proposed rule for the next calendar year, it should take this unfolding patient access crisis into account.
Dr. William Tettelbach is a certified wound specialist who is actively board-certified in Undersea & Hyperbaric Medicine, Infectious Diseases and Internal Medicine with formal training in Biomedical Informatics. He currently serves as president of the American Professional Wound Care Association.
