Final Call For Submitting Your Comments To CMS

Instructions for Submission

We urge you to submit comments to CMS on the proposed 2026 Physician Fee Schedule and to specifically address the deficiencies in the proposed skin substitute reimbursement. Comments are due by 5:00 PM Eastern Time on September 12, 2026.

Comments may be submitted electronically to CMS-2025-0304-0009 on https://www.regulations.gov/commenton/CMS-2025-0304-0009

Suggested Comment Template (Customize as Needed)

As a wound care clinician, I strongly oppose the CMS proposal of $125.38 per cm² rate for Skin substitutes under CMS–2025–0304–P. This rate in inadequate and will restrict patient access to advanced wound care and bring innovation in the space to a halt.

I support the consensus proposal developed by Dr. William Tettelbach and many other clinical, industry and reimbursement experts. Tettelbach et al., Safeguarding access, fiscal responsibility and innovation: a comprehensive reimbursement framework for CAMPs to preserve the Medicare Trust Fund, Journal of Wound Care, https://doi.org/10.12968/jowc.2025.0396.

I offer these additional comments:

The Methodology Used to Calculate The Proposed Reimbursement Rate is Improper.

To calculate the skin substitute reimbursement rate, CMS should take into account weighted product usage in all relevant settings of care, and should not restrict consideration only to the HOPD. Based on the work of Tettelbach and others, I suggest that a rate in the range of $700 per sq cm would be appropriate to ensure patient access to care and maintain innovation.

Application Fees Should Also Be Equal Between Sites of Care

If the PFS and OPPS systems are to be equilibrated, as CMS has indicated is its intent, the clinical fee paid under the physician fee schedule is far too low. Under the current proposal, the HOPD would receive a facility fee of $708 with independent and mobile providers only receiving about $150. These should be equalized.

Increased Reimbursement Should be Based on Clinical Evidence, Not FDA Status

CMS should equalize reimbursement for all skin substitute products for 2026, but continue to work with industry and the clinical community to develop a strategy to provide additional reimbursement to support innovation and clinically proven product effectiveness in future years. Rather than basing pricing differentiation on FDA classification, I suggest that comparative clinical evidence is the only appropriate basis of pricing differentiation.

The future effective LCDs are inappropriate

In light of the proposal that skin substitutes are considered “incident to” supplies under the PFS the requirements for randomized controlled trials and a covered list of products both countermands FDA requirements and is unmanageable. The future effective LCDs are nothing more than unnecessary regulation restricting clinical decisionmaking and effective patient care. They are no longer helpful since CMS is addressing the core problem of the reimbursement rate directly, and should be rescinded.

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