CME ruling for dermal products 2025

Thank you for your guidance regarding dermal product approved list and indications. We do have the approved CMS list for VLU and DFU. Do you know if there is an option to apply dermal products not on this VLU/DFU approved list for wounds of other etiologies, such as radiation soft tissue injury, or traumatic wounds? Essentially, is there a known allowance for this based on the ruling? Or are the dermal product applications restricted to these etiologies. I wasn't sure if this was a grey area, or if there was something known and defined. Thanks.

Dec 4, 2024 by Bill Khoury,

1 replies

Elaine Horibe Song
MD, PhD, MBA

Hi Dr Khoury,

Hope you are doing well. Thank you for your question. Medicare Administrative Contractors (MAC)'s cellular and/or tissue based products (CTP) LCDs and Articles that will be effective on 2/12/2025 apply specifically to VLUs and DFUs. The application of CPTs for other conditions isn't explicitly addressed in these documents. However, Medicare may consider coverage if the treatment is deemed "reasonable and necessary" for the specific condition, and the product is used according to its FDA-approved indications.

For guidance on coverage pertaining to other ulcer etiologies, providers in California (Noridian) can seek direct clarification via email at medweb@noridian.com or through their provider portal. Please note that MACs may take up to 45 business days to respond to inquiries, so it's advisable to contact them well in advance of the planned treatment date. To increase chances of specific answers, it is important to list specific information such as ICD-10s, product Q or A code, application codes and place of service (e.g. Are applications of skin substitute HCPCS code [insert Q or A code] for [the specific conditions/etiologies of the ulcer] in POS [insert POS] covered? Provide specific ICD-10 codes)

Documentation to support medical necessity is essential, and providers might consider including at least the same elements required for CTP application for VLU or DFU (e.g. failure to respond to documented standard of care for least 4 weeks with documented compliance, ulcer characteristics and measurements at various timepoints, etc). Documentation checklists in topic 'Cellular and/or Tissue Based Products" are being updated and will be released in the next few days. In the meantime, documentation requirements for CTP application for DFU and VLU can be found in Noridian's LCD and Article.

Hope this helps!

Dec 4, 2024

* Information provided without clinical evaluation and is not intended as a replacement for in-person consultation with a medical professional. The information provided through Curbside Consult is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.

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