Our Position on the CY2026 PFS and LCDs

The proposed changes to skin substitute reimbursement and coverage in the CY2026 Medicare Physician Fee Schedule (PFS) and Future Effective Local Coverage Determinations (LCDs) have sparked concern across the advanced wound care community—particularly among mobile and office-based providers. These products are widely used among advanced wound specialists and represent a key tool in the care of difficult to heal wounds. The current proposals will result in reduced access, disrupted clinical practice, and long-term harm to patients. At IWSS we seek to chart a course from the current unsustainable system to one which is rational and sustainable for patients, providers, industry and CMS.

Our Ideals and Recommendations For The Future:

Rescind the Future Effective LCDs

Originally designed to control cost, now redundant after CMS pricing reform.

  • Restrictive product selection harms access, limits clinician choice, and stifles innovation.

  • Sole reliance on RCTs ignores the value of real-world evidence (RWE) and other valid evidence.

  • Especially harmful for wounds like VLUs, PUs and surgical wounds where RCTs are limited or impractical.

  • Proposed update cycles span years—unworkable for a dynamic clinical field.

  • Arbitrary 8-application cap is not evidence-based and should be removed.

Call for a National, Uniform LCD Framework

  • Establish consistent rules and documentation standards across all wound types.

  • Avoid regional disparities and overly prescriptive policies—maximize clinical flexibility for providers.

Reimbursement Rate Must Sustain Access and Innovation

  • CMS used only HOPD data in setting its proposed rate—other sites of care should be included in rate calculations.

  • Accurate modeling supports a base rate of $550–$711/cm².

  • Raise non-facility physician application fees to >$500 for equity across care settings.

  • Overzealous audit activity threatens practice viability and patient access and must be curbed

Replace ASP Model with a Higher Fixed-Fee Rate

  • ASP-based pricing is highly variable ($7–$13,117/cm²), unpredictable, and misaligned with clinical value.

  • Tiered reimbursement would create artificial hierarchies not tied to comparative outcomes.

  • Preferred model for 2026: single flat rate per square cm.

  • Establish favorable payment enhancements for products which can demonstrate high comparative effectiveness via RCT or RWE – similar to pass-through concept.

Want To Help Save the Wound Care Industry?

Contact your local legislators and tell your story.