1. FOR DFU:
    The 3 most common criteria for DFU are (this is not limited to only these bullets, Please read the entire LCD):

    • Chronic wounds always need to show treatments tried and failed at least 30 days SOC as per definition of “chronic”
    • Adequate blood flow (typically ABI above 0.60 in the last 60 days, however any form documenting blood flow to the wound is acceptable – example TBI (toe-brachial pressures) > 30 mmHg.)
    • Controlled diabetes (gold standard is A1C levels under 12% in the last 90 days), however any adequate medical management of the condition is acceptable.
  2. FOR VLU:

    3. 3 most common, (not all inclusive):

    • Presence of a venous stasis ulcer for at least 3 months
    • Unresponsive to appropriate wound care for at least 30 days with documented compliance.
    • Adequate Blood flow

DOCUMENTATION REQUIREMENTS FOR THE ACTUAL SKIN SUB USED:

The amount of utilized and wasted skin substitute must be clearly documented in the procedure note with the following minimum information:

  • Date, time and location of ulcer treated;
  • Name of skin substitute and how product supplied;
  • Amount of product unit used;
  • Amount of product unit discarded;
  • Reason for the wastage;
  • Manufacturer’s serial/lot/batch or other unit identification number of graft material. When manufacturer does not supply unit identification, record must document such.