The Need for Real Venous Ulcer Data

On July 20, 2016, the Centers for Medicare & Medicaid Services (CMS) convened a Medicare Evidence Development and Coverage Advisory Committee (MedCAC) meeting to discuss recommendations regarding treatment strategies for patients living with lower extremity chronic venous disease. I represented the Alliance of Wound Care Stakeholders and its member organizations. The purpose of my brief presentation was to provide real-world data on venous ulcers, since a major argument for venous ablation is the relatively poor outcome of venous leg ulcers (VLUs).

I queried data from the U.S. Wound Registry (USWR), a 501 (c)(3) nonprofit organization recognized by CMS as a qualified clinical data registry (QCDR). As I’ve discussed before in this journal, the USWR provides data reporting services for advanced practitioners subject to the Merit-Based Incentive Payment System (MIPS). Eighteen months ago, when the MedCAC meeting was held, there were 59,116 VLUs documented in the USWR in 19,151 patients (an average of three VLUs per patient). The average VLU was 34 cm² at the initial visit and had already been present five months by the time the patient arrived to a wound center, after which the VLU took an average of three months to heal, if it healed at all. The average time in service was 29 weeks (7.2 months). Approximately 79% of VLUs healed after an average of 12 weeks, which means at least 21% of VLUs never heal. However, when including those patients lost to follow up or referred to other providers, the outcome numbers look much worse, with only about half of all VLUs documented as healing. VLU patients also have many comorbid conditions excluded from most prospective trials: 30% live with diabetes, 70% are obese or morbidly obese, 8% are on dialysis, and 8% take prednisone for a systemic autoimmune disease. VLUs are also more likely than not to have moderate to large amounts of drainage documented at clinic visits, so it’s no surprise that when venous ulcer patients are given an ulcer-related quality-of-life questionnaire (in 2016, a USWR quality measure), 90% express worry about their wound, more than 75% express frustration or unhappiness about their wound, and (contrary to conventional teaching) 68% say their wound hurts. More than 50% say their VLU affects their sleep.

When we looked at the consistency of VLU compression in 2010, we found that adequate compression was applied in only 17% of visits for a VLU. To improve the standard of venous care, the USWR partnered with the Alliance to develop a suite of wound care-relevant QCDR quality measures, six of which were specific to venous ulcer care, which CMS recognized in 2014 for reporting under the Physician Quality Reporting System. I’m pleased to report that since the USWR began focusing on quality measures, arterial screening, which previously was only documented in 24% of VLU patients, is now documented in 77.5% of VLU patients, and adequate compression of VLUs at every visit has improved to 80% of visits (at least among the practitioners who actually report these two measures).

In 2017, I announced the big news in Today’s Wound Clinic that the USWR had achieved “benchmark” rates for arterial screening of leg ulcers and venous ulcer compression¹ — a process that takes three years and a lot of work. Benchmarking matters because unbenchmarked quality measures are only worth three (out of 10) possible points, making it unlikely that anyone would select an unbenchmarked measure for MIPS reporting when monetary bonuses are at stake. But, not long after I announced this exciting news, CMS officials informed me that they intended to reject both of these measures, as well as diabetic foot ulcer offloading. I was dumbfounded. My voice started to shake. I reminded CMS folks that the USWR, which seeks to reduce amputation rates by noninvasive arterial screening and to improve venous ulcer care with low-cost interventions like compression, receives no monetary support. Because wound care practitioners usually don’t perform procedures with medical devices, device manufacturers don’t support the USWR. That means we can’t advertise our measures or analyze the impact of our work on patient outcomes. We don’t have a medical specialty society to support the reporting of wound care-relevant quality measures, nor have the wound care clinical associations gotten behind the concept of quality measure reporting. I told CMS that: 1) despite these barriers, the USWR was moving the needle on quality of venous care and that 2) someday I’d be able to demonstrate that we were reducing time in service for VLUs, and thus the cost to heal a VLU (and, therefore, Medicare spending per beneficiary). CMS agreed to let arterial screening and VLU compression stay for another year. Unfortunately, CMS did reject the wound-related quality-of-life measure we spent so much time and effort getting approved, a measure that from which, ironically, I obtained the data presented at the MedCAC meeting. Quality-of-life data from 400 wound care patients (many living with VLUs) will never be analyzed because there’s no funding to pay for it, although folks were surely anxious to have some data about quality of life for that MedCAC meeting.

DATA VS. REAL DATA

I’m tormented when I see data that I know we need to understand better. For example, we’ve noticed that African American patients who are living with VLUs actually get more cellular products per patient than their white counterparts, but the outcomes of their VLUs appear to be worse. We can create matched cohorts between African American and white patients using the Wound Healing Index so that we can properly evaluate whether this apparent difference is because their wounds are worse or due to some other factor, but no study like that will happen. Truthfully, I don’t know how valuable venous interventions are in the treatment of VLU patients. I do know that the majority of VLUs in real-world patients are not in the distribution of the greater saphenous vein. Surprisingly (and yes, we have the data), the majority of ulcers are anterior and lateral. We could evaluate the benefit of venous ablation on wound healing and recurrence by linking the many thousands of patients in the USWR to the Medicare data warehouse. Although it’s a shame that we don’t use the information we have (after all, we already have it), that’s not the real problem. The real problem is that CMS convenes MedCAC meetings when it’s deciding how it will limit coverage for treatments it thinks are overutilized. If we don’t figure out what is cost effective in venous disease and help CMS to make those decisions, then CMS will make them without our input. To make matters worse, if we don’t create and keep better quality measures, CMS will start to claw back from practitioners some of the money they have spent. The USWR’s QCDR has a mountain of structured data on VLUs that could improve our understanding of what works (and doesn’t work) to heal them. Sadly, despite the billions spent annually on VLUs by Medicare, it’s not possible to find a few hundred thousand dollars to analyze the data to identify what works best to treat the wounds. CMS has rejected the quality measure focused on wound-related quality of life, and I’m not sure I can hold on to the venous compression or arterial screening quality measures next year. I could use some help with this, folks.

Caroline E. Fife is chief medical officer at Intellicure Inc.; executive director of the U.S. Wound Registry; medical director of St. Luke’s Wound Clinic, The Woodlands, TX; and co-chair of the Alliance of Wound Care Stakeholders.

Reference

1. Fife, CE. From the Editor: wound care is the data underdog. TWC. 2017;11(8):4-32.