Every Tuesday this month we’ve been having some straight talk about a US Wound Registry Quality Measure. I’d like to talk about the measure “Appropriate use of hyperbaric oxygen therapy for diabetic foot ulcers”. This was the first HBOT measure the USWR asked CMS to approve and it is a very straightforward measure. To pass this measure—meaning, to use HBOT for a DFU, the ulcer has to be a Wagner grade 3 or greater, have been present at least 30 days, have undergone arterial screening and have undergone appropriate off-loading. Those are the most of the requirements of the National Coverage Determination (NCD) for HBOT in the diabetic foot ulcer.
It’s fair to ask why anyone would need a measure which seems that obvious. However, in 2013, David Margolis and colleagues published a paper in Diabetes Care entitled, “Lack of Effectiveness of Hyperbaric Oxygen Therapy for the Treatment of Diabetic Foot Ulcer and the Prevention of Amputation” (see link below). They showed that a very large percentage of patients undergoing HBOT had Wagner Grade 2 ulcers. It’s also not clear that they got proper vascular screening or off-loading (not to mention that one third of the HBOT patients got more than 40 treatments each). It’s hard to say if that’s the reason that HBOT was ineffective. I wish they had used US Wound Registry data since the USWR has most of the information they were missing from their dataset. But, given the findings, it’s no wonder that CMS is piloting a pre-authorization program for hyperbaric oxygen therapy in conditions like DFU. They have to act to stop inappropriate use of HBOT. If you want some straight talk, I’d rather see them pilot an “appropriate use” quality measure.