The Devil in the Documentation Details of the Proposed Novitas LCD on “Skin Substitutes” – Part 3


Novitas has issued a draft Local Coverage Determination (LCD) for the use of “skin substitutes” (more accurately known as Cellular and/or Tissue Based Products  or CTPs) when used for treating Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs).  The proposed LCD has been posted to Novitas’ website for comments.

This is Part 3 of the list of what you need to document (per the proposed rule) if you want to use a skin substitute (CTP) for a DFU or VLU.

I am pointing out just a few interesting and important things about the way that documentation impacts coverage for CTPs in these two types of chronic ulcerations – based on the proposed rule.

The medical record has to include the following:

  • “Documentation that specifically addresses the circumstances regarding why the wound has failed to respond to standard wound care treatment of greater than four weeks”
  • The specific interventions that have failed
  • An updated medication history
  • A review of pertinent medical problems that may have arisen since the previous wound evaluation
  • An explanation of the planned skin replacement surgery
  • An explanation of the choice of skin substitute graft product (I take that to mean you have to provide an explanation of the reason you chose the specific CTP you are going to use)
  • The procedure risks and complications
  • Documentation that, “The patient is under the care of a qualified physician/NPP for their underlying chronic condition.”

The most intriguing part of the proposed policy is the list of what is NOT “medically reasonable and necessary”:

  • “Greater than two applications of a specific skin substitute graft product within the episode of skin replacement surgery for wound care (defined as 12 weeks from the first application of a skin substitute graft).”

Yes, you heard that right. Novitas is going to limit clinicians to 2 applications of a “specific skin substitute” over the 12-week period defined by the date of the first application. But there is a lot more I haven’t told you yet, because I am not even halfway through the details of the proposed policy.

If you want to present comments on any part of Novitas proposed LCD, sign up to attend the Open Meeting. Register by the August 24th deadline using the appropriate presenter or observer registration link provided at

Caroline Fife, MD

Dr. Fife is Co-Founder and Chief Medical Officer of Intellicure, Executive Director of the US Wound Registry, and Editor of Today’s Wound Clinic.

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