I recently got a complicated patient healed with a cellular product. I’d have to pay money back if Medicare reviews my claim because I used it outside of the coverage criteria. Based on the analysis that Dr. Marissa Carter and I performed, here’s a description of the typical wound center patient:

  • Average patient age: 60.4 (1 – 104) years
  • Average wound duration at consultation: 189 days (6 months)
  • Average number of co-morbid conditions = 6
  • Top co-morbid conditions or problems:
    • 54% of wounds are considered “infected” (and patients placed on systemic antibiotics) during their course of care
    • 26% of wounds that were not specifically diabetic foot ulcers are in patients who have diabetes
    • 16% of patients have coronary artery disease
    • 10% are current smokers
    • 4% require systemic steroids
    • 5% have renal failure or have had a renal transplant

We keep doing trials of only healthy people so that coverage policies by payers can mandate that we use new products on only healthy people. What are we going to do about this ridiculous problem? The only solution is to have a risk stratification system to measure relative “sickness” in wound center patients. I am happy to report that we have one, although no one is talking about it. Why do we need a risk stratification system? Because:

  • We MUST HAVE generalizable trials
  • We HAVE to know if new products work in OUR patients
  • We MUST have coverage policies that allow us to use products on the patients who need them
  • We need a way to prioritize patients who most need expensive therapies in this time of limited resources
  • We must be able to report truthful outcomes to CMS and stop saying we heal everyone. You know we don’t.

Caroline Fife, MD
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