There’s a big focus on finding surrogate measures for wound outcome. I thought I could save anyone working in this area some wasted time by letting you know what outcomes CMS doesn’t care about. I can’t speak to what the FDA might care about. Under the Merit Based Incentive Payment System (MIPS), Qualified Clinical Data Registries (QCDRs) like the US Wound Registry (USWR) were empowered to develop specialty relevant quality measures. Truth be told, CMS doesn’t really WANT QCDR measures at all. I based that on the fact that they didn’t include them in the MIPS Value Pathways which are the way specialists are going to get paid (or NOT paid, in the case of wound management). I also base that on the fact that it’s darn near impossible to KEEP a QCDR measure. I have earned the right to say that, since I am the Army of One that goes to battle with CMS every year begging to keep them.

Healing Rate by Risk Category (This Works)

Every QCDR has to have at least one outcome measure. Outcome measures have to be risk-stratified so that physicians caring for the sickest patients do not appear to have worse outcomes than their peers whose patients are not as sick. That’s why we developed the Wound Healing Index (WHI) which includes both wound and patient factors to predict the likelihood of healing. The USWR has set national benchmark rates for diabetic foot ulcer (DFU) and venous leg ulcer (VLU) healing rate. This year, in 2020, we will start reporting pressure ulcer healing rate, stratified by the WHI. The WHI is holding up well for reporting healing rates to CMS and for creating matched cohorts for both prospective and retrospective studies.

Quality of Life (Busted…)

There’s one surrogate that seems totally logical, and that is wound-related quality of life (QOL). It seems like it ought to work and perhaps for patients with wounds who are not too sick, or who tend to have only one wound (like a dehisced surgical wound), QOL might work, if you use the right QOL assessment tool. I recently posted an article about why QOL failed miserably as a surrogate in a series of 500 patients.

I think I know how QOL COULD work as a surrogate for wound outcome, but I am not funding another QOL project out of my own pocket. Anyone ready to write a check for the next one can email me.

Major Amputation Rate (Busted…)

Amputation rate is an obvious wound outcome to measure. At least, you would think so. The USWR had a CMS recognized QCDR measure of major amputation rate among patients with DFUs. Seems logical, right? Wrong. To keep a quality measure, 20 doctors have to report it successfully with at least 20 patients. Major amputation happens “too rarely” (sic) for CMS to keep it as an outcome measure of quality of care, because we couldn’t find 20 doctors who had 20 of them in a reporting period (12 months). While everyone talks about amputation as an outcome that matters, the reason that major amputation is not part of any quality reporting program in any site of care is that it doesn’t happen OFTEN enough. Ironic, isn’t it?

CMS wanted us to include Minor amputations in the Major amputation outcome measure, which would mean that practitioners would be penalized when a patient loses a pinky toe – even if what really happened was that the practitioner diagnosed critical limb ischemia, got it corrected, and the patient lost a pinky toe rather requiring a below the knee amputation. That scenario is a WIN, but would be classified as a failure if all amputations counted “against” the practitioner. I could have saved an amputation quality measure by allowing practitioners to be penalized for minor amputations. I refused, so we lost the major amputation measure.

Maintaining Ambulatory Status (Busted…)

We HAD a quality measure that was focused on maintaining the patient’s ambulatory status even in the event of a MINOR amputation. If I had known then what I know now, I’d have approached this measure differently. My idea was to allow minor amputations to be reported, but keep the measure focused in the positive as long as ambulatory status was preserved. So, if the patient walked into the clinic, lost a few toes BUT walked out, the doctor passed this measure. When CMS told me to combine minor and major amputations into one measure, it would have meant that CMS would count minor amputations exactly the same as a BKA or AKA. I refused to do that, so the USWR lost BOTH the major amputation and the functional status measures. In truth, I MIGHT be able to get a new functional measure approved by CMS if the measure did not include any information about minor amputations. If anyone thinks ambulatory status is important as an outcome measure and is willing to make a tax deductible contribution to the USWR to pay for the cost of developing a new measure, we will at least try to get it approved by CMS.

Tracking ambulatory status or any functional assessment will likely require filling out one of those rather laborious functional assessment tools employed by physical therapists. And that brings up the final reason why surrogate measures fail. What we found with QOL project is that whenever the questionnaire or assessment is just “another darn thing” that the staff have to get done, but which has no impact on the care provided and is collected is “ONLY” for the purpose of assessing response to treatment – there is exactly ZERO incentive to do it. You can’t get paid for the time it takes, it’s a headache to collect the data, it’s a nightmare to report it, and hospitals can’t turn it into a marketing slogan. Somehow the slogan, “If you can walk IN, we make sure you walk OUT,” does not have the sex appeal as claiming that the program heals 95% of all wounds. I don’t have the answers, but I can tell you why my attempted solutions failed.