The Devil in the Documentation Details of the Proposed Novitas LCD on “Skin Substitutes” – Part 1


Novitas and First Coast have issued draft Local Coverage Determinations (LCDs) that are practically identical. We are seeing an increasing trend toward virtually identical LCDs across different regions. This is particularly interesting given that the Medicare Administrative Contractors (MACs) are actually completely different private healthcare companies.

I am not going to review all the details of the proposed Novitas/First Coast LCDs pertaining to “skin substitutes” (more accurately known as Cellular and/or Tissue Based Products  or CTPs) used for treating Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs). However, I am going to point out a few interesting and important things about the way that proposed documentation impacts coverage for CTPs in these two types of chronic ulcerations.

Remember that these are proposed rules, but honestly, most of the language looks like the existing LCD with the exception of the proposed limit on the total number of CTPs that can be applied to a wound per year.

  • Both VLUs and DFUs must be documented as having failed to respond to 4 weeks of conservative wound care measures.
    • Note they use the term “documented compliance” on the part of the patient
  • These conservative measures include (but are not limited to):
    • An ankle brachial index – ABI (I use skin perfusion pressure which is far more accurate but the policy says I have to get an ABI)
    • An “implemented treatment plan” (in other LCDs it says you need a “care plan” in the chart- but in any case, note that there has to be a “treatment plan” and you have to show you implemented it)
  • For DFUs, you must document:
    • The “management history” of the diabetes
    • Current blood glucose levels and Hemoglobin A1c
    • Diet and Nutritional status
    • Activity level
    • ABI
    • Off-loading device or assessment of appropriate footwear
    • Whether there is vascular disease
    • Whether there is neuropathy
    • Whether there is osteomyelitis
  • For VLUs, you must document:
    • Clinical history of prior ulcers
    • Thrombosis risks
    • ABI
    • “Venous diagnostic testing to verify superficial or deep venous reflux, perforator incompetence, and chronic (or acute) venous thrombosis.” (It goes on to require the CEAP classification – even though all patients with a venous ulcer are a CEAP 6 . . .)
    • “some form of compression”

There’s a lot more to talk about but if you want to present comments on any of the proposed policies in the Novitas 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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