Starting January 2026, Medicare will drastically restrict wound treatment coverage and slash reimbursement rates by up to 90%. If you have chronic wounds, the clock is ticking—but there’s still time to secure treatment under current rules.
Medicare beneficiaries with chronic wounds face significant challenges starting January 1, 2026, when new coverage restrictions take effect. These changes will impact the total population of Medicare beneficiaries with chronic wounds who depend on advanced wound care treatments for diabetic foot ulcers, venous leg ulcers, and pressure sores.
The Centers for Medicare and Medicaid Services (CMS) has finalized sweeping changes to its Local Coverage Determination (LCD) for Cellular and Tissue-Based Products (CTPs), commonly known as skin substitutes. These modifications represent the most significant shift in wound care coverage in nearly a decade, directly affecting how patients access life-changing treatments.
Medicare spending on skin substitutes has grown from $252 million in 2019 to over $10 billion in 2024. CMS cites this unprecedented growth and allegations of fraud as primary reasons for implementing stricter controls. However, wound care experts warn these cost-cutting measures may create dangerous barriers to needed treatments.
As Kure Care explained in recent coverage, these changes could impact tens of thousands of vulnerable patients, which is why they are encouraging those affected to get educated about these upcoming changes and to seek treatment as soon as possible.
The 2026 Medicare changes establish specific requirements for the three most common chronic wound conditions. Each wound type now faces unique barriers that could delay or prevent access to advanced treatments.
For diabetic foot ulcers, Medicare requires documentation of failure to achieve at least 50% ulcer area reduction after four weeks of standard care before approving skin substitute treatments. This requirement creates a problematic catch-22: patients need advanced treatments to achieve healing, but cannot access those treatments without first showing improvement.
Traditional wound care methods often prove insufficient for diabetic foot ulcers, which frequently stall in the inflammatory phase of healing. The documentation requirement may force patients to endure months of ineffective standard care before qualifying for treatments that could have accelerated their recovery from the start.
Medicare will now require detailed documentation proving standard care has been attempted and failed before approving skin substitutes for venous leg ulcers. This documentation must include detailed records of compression therapy, wound cleansing protocols, and debridement procedures.
The enhanced documentation requirements place significant administrative burdens on healthcare providers while potentially delaying patient access to effective treatments. Many venous leg ulcers respond poorly to standard care alone, making the documentation requirement a barrier rather than a medically sound practice.
While the LCD primarily focuses on diabetic foot ulcers and venous leg ulcers, pressure sore patients may also encounter coverage challenges. Services outside the scope of the LCD must adhere to Medicare's reasonable and necessary criteria, which may limit access to certain treatments.
The limited options particularly impact patients in skilled nursing facilities and long-term care settings, where pressure sores are most common. Facilities may struggle to provide continuity of care when preferred products face coverage restrictions.
The new Medicare rules establish a restrictive formulary system, where only products with peer-reviewed clinical evidence supporting efficacy in specific wound types receive coverage approval. This represents a fundamental shift from the previous system that covered most FDA-approved skin substitutes.
Several widely-used skin substitutes will lose Medicare coverage for diabetic foot ulcers and venous leg ulcers due to insufficient clinical evidence. Oasis Tri-Layer Wound was removed from coverage for these wound types, affecting thousands of patients who have experienced success with this treatment.
Healthcare providers must now navigate a complex approval process for non-formulary products, often requiring prior authorization and detailed documentation. The administrative burden may discourage providers from pursuing coverage for effective but non-preferred treatments.
Medicare will only reimburse skin substitutes with published, peer-reviewed clinical studies demonstrating efficacy for specific wound types. Products like Derma-Gide, Kerecis, and NuShield have gained approval for diabetic foot ulcer indications based on meeting these evidence standards.
The evidence-based approach sounds reasonable in theory but creates practical challenges. Many effective treatments lack specific studies for every wound type, potentially excluding beneficial options based on regulatory technicalities rather than clinical outcomes.
Perhaps the most dramatic change involves Medicare's payment restructuring for skin substitutes. The new system fundamentally alters how providers are reimbursed and may significantly impact patient access to care.
CMS is finalizing its proposal to pay separately for skin substitutes not licensed as biologicals under Section 351 of the Public Health Service Act, treating them as incident-to supplies when used during a covered application procedure. This establishes a single payment rate of approximately $127.28 per square centimeter for 2026, representing up to a 90% reduction in Medicare Part B expenditures for skin substitutes.
The dramatic reimbursement cut threatens the financial viability of wound care practices. Many providers may reduce or eliminate wound care services, creating access problems for Medicare beneficiaries in affected areas. Clinics that previously offered wound care may close their doors entirely.
The new payment structure requires detailed documentation including precise wound measurements, drainage assessments, and photographic evidence. Providers must maintain detailed records justifying each treatment decision and demonstrating medical necessity.
While thorough documentation supports quality care, the increased requirements create administrative overhead that many practices cannot sustain under reduced reimbursement rates. The documentation burden may force providers to limit the number of Medicare wound care patients they accept.
Reduced Medicare reimbursement often translates to higher patient costs through balance billing or the need for supplemental insurance coverage. Patients may face unexpected bills for treatments that were previously fully covered under Medicare.
Medicare beneficiaries should review their supplemental insurance policies to understand potential coverage gaps. Medicare Advantage plans may implement additional prior authorization requirements or coverage restrictions beyond those established by traditional Medicare.
Despite the significant changes to skin substitute coverage, Medicare continues to provide wound care benefits through its various parts. Understanding what remains covered helps patients plan their care strategy.
Medicare Part A continues covering wound care services provided in inpatient facilities, including hospitals, skilled nursing facilities, and rehabilitation centers. This coverage includes wound debridement surgeries, infection management, and wound care during facility stays.
Inpatient wound care often provides access to advanced treatments that may be restricted in outpatient settings under the new rules. Patients with severe wounds may benefit from facility-based care that bypasses some outpatient coverage limitations.
Medicare Part B maintains coverage for outpatient wound care services and basic supplies when healthcare professionals dress wounds. This includes primary dressings such as sterile gauze pads, hydrogel dressings, hydrocolloid dressings, alginate dressings, and foam dressings.
Standard wound care supplies and provider visits remain covered, ensuring patients can access basic care even when advanced treatments face restrictions. However, the quality and effectiveness of available treatments may be limited compared to previous options.
Medicare Advantage plans must cover everything traditional Medicare covers but often implement additional requirements like prior authorization for advanced treatments. These plans may create additional barriers beyond the new CMS restrictions.
Patients enrolled in Medicare Advantage should carefully review their plan's specific wound care policies and network restrictions. Some plans may offer enhanced wound care benefits, while others may be more restrictive than traditional Medicare.
The Medicare changes reflect broader healthcare policy trends emphasizing cost containment and evidence-based medicine. CMS implemented these restrictions in response to dramatic spending increases and concerns about inappropriate utilization of expensive wound care products.
The agency's efficiency adjustment reduces work relative value units (RVUs) and corresponding intraservice time by 2.5 percent for most non-time-based services, recognizing that some services become more efficient over time. Critics argue this approach fails to account for the complexity of chronic wound care. The policy prioritizes immediate cost savings while potentially ignoring long-term consequences like increased amputations and hospital readmissions.
Healthcare policy experts worry these changes represent a shift toward a "sick-care system" rather than true healthcare, where cost considerations override clinical judgment. The restrictions may ultimately increase overall healthcare costs by preventing early, effective interventions.
Medicare beneficiaries with chronic wounds should seek immediate evaluation and treatment to understand their coverage options and begin treatments before January 1, 2026, when new coverage rules take effect. Patients who begin treatment before the deadline may continue their established care plans without facing new restrictions.
Early intervention proves especially critical for patients with stalled wounds that have shown little improvement with standard care. Advanced treatments initiated before the deadline can continue under grandfather provisions, protecting patients from coverage disruptions.
Healthcare providers are encouraging eligible patients to schedule wound assessments immediately. The window for accessing unrestricted care is rapidly closing, and patients who delay may face significant barriers to effective treatment after the new year.
