I completed my review of the Novitas LCD for “bioengineered skin” otherwise known as cellular and/or tissue based products (CTPs). The documentation required by the Novitas LCD requires clinicians to specifically address the circumstances as to why the wound has failed to respond to standard wound care treatments over the past 4 weeks and must reference the specific interventions that have failed. I need to document that there is no evidence of underlying osteomyelitis or cellulitis and any potential infection or bacterial colonization has been controlled. I must include an explanation of the planed skin replacement surgery with the choice of the skin substitute graft product. I must document adequate treatment of the underlying conditions that contributed to the ulcer and that the patient has been compliant with recommendations including that the patient is a non-smoker or has refrained from systemic tobacco intake for at least 4 weeks during conservative wound care and prior to the procedure. Those are just the highlights—there are other requirements.
Fortunately, Intellicure facilitates these notes with a unique “built-in intelligence” engine that fetches information from various places in the chart in order to help provide that documentation and leads me through a list of prompts to ensure that I don’t forget anything. That way I am not “cutting and pasting” or using templates that would sound like a “cookie cutter” procedure note.
There is one problem for which I can’t find a solution. The LCD says that CTPs can’t be placed over exposed muscle, tendon or bone, or necrotic tissue. It says that they ARE to be placed over granulation tissue. However, the LCD says that CTPs are not indicated if there is evidence of improvement over the 30 days prior to the procedure and one definition of “improvement” is an increase in granulation tissue. So, I can’t apply a CTP over muscle, tendon, bone, or necrotic tissue. I must apply it over granulation tissue BUT, the % of granulation tissue cannot have increased over the 4 weeks prior or that would constitute an improvement in the wound – negating the need for the CTP. Got it? That means that the wounds must be 100% granulated from the beginning of the 30 day period without any change in surface area because that, too would be an improvement. Strange, but true.