As I have already discussed, 3 Medicare Administrative Contractors (MACs) CGS, First Coast Service Option (FCSO) and Novitas issued their final Local Coverage Determinations (LCDs) for Cellular and/or tissue-based products (CTPs). These policies will go into effect on September 17. Links to the articles are provided below.

Here is just a partial list of the reasons why CTPs will NOT be considered medically reasonable and necessary:

  • Application of skin substitute grafts/CTPs in patients with inadequate control of underlying conditions or exacerbating factors, or other contraindications (e.g., uncontrolled diabetes, active infection, active Charcot arthropathy of the ulcer extremity, active vasculitis)
    • (I wonder what the definition of “uncontrolled” diabetes will be? CF)
  • Use of surgical preparation services (for example, debridement), in conjunction with routine, simple and/or repeat skin replacement surgery with a skin substitute graft/CTP.

(Did you read the above carefully?)


The medical record must clearly document that the criteria listed in the LCD has been met, as well as the appropriate diagnosis and response to treatment. Description of the ulcer(s) must be documented at baseline (prior to beginning standard of care treatment) relative to size, location, stage, duration, and presence of infection, in addition to the type of standard of care treatment given and the response. This information must be updated in the medical record throughout the patient’s treatment. It is expected that the response of the ulcer to treatment will be documented in the medical record at least once every 30 days. The ulcer description must also be documented pre- and post- treatment with the skin substitute graft/CTP being used. The reason(s) for any repeat application should be specifically addressed in the medical record…

That means that a LOT of documentation will be required to survive an audit – and not just in the procedure note.

There’s a lot in these LCDs, so definitely read them for yourself!