The Devil in the Documentation Details of the Proposed Novitas LCD on “Skin Substitutes” – Part 2


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.

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.

This is Part 2 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. The continuation of the list includes:

  • “Some form of offloading for DFUs and some form of compression for VLUs”
  • Infection control
  • Management of exudate (note that it states that moist saline gauze is OK along with “other  classic dressings” and “bioactive dressings”)
  • Regarding smoking:
    • Document that the patient is a nonsmoker, OR
    • The patient has refrained from smoking for at least 6 weeks prior to planned skin replacement surgery, OR
    • The patient has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation (watch out there, the way I read that, telling the patient smoking is bad for them is not enough – they need documentation of “treatment”)

Here’s what you have to document in order to show that the ulcer has “failed to respond to documented conservative wound care measures,” which means they qualify for a CTP.

Documentation of “response” requires:

  • Measurements of the initial ulcer AND
  • Measurements at the completion of at least four weeks of conservative wound care measures AND
  • Measurements immediately prior to placement of the skin substitute graft for a DFU or VLU
  • For VLUs, there must be documentation of no less than 4 weeks of on-going compression therapy

A “failed response” is defined as:

  • An ulcer that has increased in size or depth OR
  • An ulcer that has no change in baseline size or depth, OR
  • An ulcer with “no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closing)” (Note, the policy appears to say that there can be “no” granulation – which is odd since we usually put CTPs over granulation tissue)

I am not even halfway through the details of the proposed policy, so stay tuned for more. If you want to present comments on any of the above elements in the Novitas proposed LCD, sign up to attend the Open Meeting. Register by the August 24th deadline using the appropriate presenter or observer registration link.

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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