Hi Jennifer,

Cellular Tissue Products are definitely a hot topic for CMS right now. The implementation of the new 2025 LCD changes for VLUs and DFUs has been delayed until January 1, 2026, giving everyone a bit more time to prepare. As you noted, many wound care procedures are considered “high dollar,” so it’s crucial to approach them with careful attention to documentation and compliance. A great starting point is to thoroughly review your Medicare Administrative Contractor (MAC) and Local Coverage Determination (LCD) guidelines, as these outline what’s considered reasonable and necessary for coverage in your region.

While existing and future effective LCDs on CTP offer clear criteria for venous leg ulcers (VLU) and diabetic foot ulcers (DFU), they’re often less specific about other wound types. That doesn’t lessen the documentation requirements, it actually raises the bar for demonstrating medical necessity. Make sure the CTP the provider is planning to use is FDA-approved and indicated by the manufacturer for that specific wound type. It’s also important to back the provider's decision with clinical evidence supporting positive outcomes and to document why this product is necessary for this patient at this time. Be sure they track and document progress after application as well.

Keep in mind that not all CTPs are covered by Medicare, even if they’re FDA-approved and have a HCPCS code with an assigned payment rate. Some are only reimbursed in outpatient settings like hospital outpatient departments, ambulatory surgical centers, or physician offices—others may be restricted to inpatient use. Coverage varies by MAC, so checking the specific policy for your area is key. It's also important to check if the specified CTP “Q” or “A” product code is payable when performed in the intended place of service (POS). 

Since your LCD has informed you that it requires pre-authorization, setting up a standardized process—including a checklist with all the medical necessity elements—can really help ensure consistency and avoid denials.

WoundReference has some excellent tools to support you, including CTP guidance, documentation checklists, and coverage resources. Definitely worth exploring!

Please refer to the resources below:

Cellular and/or Tissue Based Products

Jump right to the Coding, Coverage, and Reimbursement section.

Checklist Request for Cellular and/or Tissue Based Products

Hope this helps!

Kim Simonson