Three 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 are just a few of the many things to note in these LCDs:

  • There is a VERY long list of CTPs which will not be covered.
  • The LCDs increased the number of applications from 2 in the proposed policy to 4 applications over a 12-week period.
  • The number of applications will not “restart” because a different product is chosen.
  • The application of a skin substitute graft/CTP beyond the 12-week episode of skin replacement surgery will be denied.
  • 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.
  • Here is a partial list of what the medical record must contain:
    • 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
    • The type of standard of care treatment given and the response to treatment.
    • 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.
  •  EVERY page of the medical record must be legible.

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