Fighting Peripheral Arterial Disease One Leg at a Time

To prevent amputation by screening for and treating peripheral arterial disease, this author notes CMS quality measures can aid clinicians in doing the right thing.

A few weeks ago, I saw an 82-year-old woman who with a non-healing wound on her right lateral leg, which had been present since the removal of a skin cancer two years prior. She has been cared for at another wound center in my town for over a year, treated with compression bandaging and the application of cellular- and/or tissue-based products (CTPs). Her son brought her to see me because he was frustrated with her lack of improvement after a year of treatment.

She weighed only 95 lbs. In fact, her body mass index (BMI) was only 16.3, lower than many patients I saw in Haiti. Yet, she had not undergone any type of nutritional evaluation or been recommended to take nutritional supplements. Failure to recognize malnutrition is the reason that the U.S. Wound Registry (USWR) has developed a nutritional screening quality measure for patients with chronic wounds and why in 2020, new nutritional evaluation quality measures were developed by the Academy of Nutrition and Dietetics.

At her initial visit, I screened her for arterial disease, according to a quality measure recognized by the Centers for Medicare and Medicaid Services (CMS). Although many different screening techniques are valid, my preferred method is skin perfusion pressure (SPP) with pulse volume recording (PVR). Her SPP was only 27 mmHg on the lateral leg near the wound. A value of 30 mmHg or less suggests that the wound is unlikely to heal due to inadequate tissue oxygenation. Low tissue oxygen levels can be due to a variety of causes. The PVR provides information regarding the arterial supply. The PVR of the right leg was biphasic and of low amplitude, suggesting the reason for the poor tissue oxygenation was arterial disease. Further evidence of arterial disease included the fact that she had ischemic rubor of her entire lower leg and extreme leg pain kept her awake at night. In addition, she had a significant risk factor for atherosclerosis because she is a longtime smoker.

Let me recap the situation: An elderly woman at high risk for vascular disease (longtime smoker), with a non-healing leg wound for two years and symptomatic arterial disease (nocturnal rest pain and ischemic rubor), had been treated for nearly a year at a wound center with compression bandaging and expensive CTPs without improvement. She had not undergone an arterial assessment, which would have found her peripheral arterial disease (PAD), and her malnutrition had not been addressed despite a BMI indicating she is starving. I am happy to report that she underwent a successful endovascular revascularization (after a cardiac workup was performed). You can see images of the successful procedure here: https://carolinefifemd.com/2020/05/29/fighting-peripheral-arterial-disease-pad-one-leg-at-a-time/.

Sadly, this situation is not unique. Every month, I see at least one patient with a non-healing wound caused by PAD that was not diagnosed at a hospital based wound center. Undiagnosed arterial disease is one of the primary reasons that patients end up with amputations, which is certainly how this story could have ended. We continue to have a problem “doing the right thing” for patients with chronic wounds.

Why Is It So Hard To Do The Right Thing In Wound Care?

A decade ago, I published a paper with Dr. Marissa Carter entitled, “Why Is It So Hard to Do the Right Thing in Wound Care?”¹ The paper explored how well practitioners implemented basic wound management interventions such as providing evidence-based compression of venous leg ulcers (VLUs). Using the database that later became the USWR, we analyzed 108,000 de-identified patient visits at 18 hospital-based outpatient wound centers in 16 states. Among the 2,139 patients with VLUs, adequate compression was performed in only 17% of patient visits. Part of the problem was the frequent use of Kerlix, simple elastic bandages, anti-embolism stockings, and other forms of inadequate compression. Furthermore, the vast majority of patients with diabetic foot ulcers (DFUs) were not adequately offloaded.

Although we didn’t discuss it in the paper, delays in performing arterial screening were another reason for failing to provide compression at any given visit. Many of the patients who were screened for peripheral arterial disease were sent to the hospital for arterial vascular evaluations rather than being screened in the wound center, incurring weeks of delay in initiating appropriate treatment. The good news was that at least some patients got an arterial assessment. Unfortunately, the majority of patients with non-healing lower extremity wounds did not undergo any type of arterial assessment. We concluded that there was a serious problem with regard to “doing the right thing” for patients with DFUs and VLUs in hospital-based outpatient wound centers.¹ I was determined to change that. The question was, “How do we get practitioners to do the right thing?”

Reporting and Measuring the Right Things with Quality Measures

Problems with quality of care are not unique to wound care practitioners. In 2008, the Medicare Improvements for Patients and Providers Act (MIPAA) was passed in the hopes of addressing serious quality deficits identified in all specialties by authorizing a 2% bonus for practitioners who reported quality data. Over past 12 years, Today’s Wound Clinic has published many articles discussing the evolution of the various quality programs implemented by the Centers for Medicare and Medicaid Services (CMS). Currently, most practitioners who see Medicare patients are subject to the Merit-based Incentive Payment System (MIPS). In 2020, practitioners can experience a 9% negative payment adjustment to their Medicare payment for failing to participate in MIPS, with 45% of the total MIPS score based on quality measure reporting. Unfortunately, of the hundreds of national quality measures (QMs) available for reporting, none are directly relevant to wound management.

CMS is beginning to implement the payment system it is calling MIPS Value Pathways (MVPs), which will require clinicians to report the suite of quality measures associated with their specialty board certification (e.g., family practice, internal medicine, general surgery, etc.). As a family practitioner who practices full time wound care, I will be unable to pass the quality measure portion of the MVP since my practice does not involve activities like screening for breast and colon cancer. It is increasingly vital that wound management practitioners have a suite of quality measures relevant to what they do.

That is the reason that in 2014, when CMS created Qualified Clinical Data Registries (QCDRs), the USWR became recognized by CMS as a QCDR and, in conjunction with the Alliance of Wound Care Stakeholder and its member organizations, developed a suite of quality measures relevant to wound management. Although in 2020, there are a total of 12 USWR QCDR measures for reporting under MIPS, the three measures that the USWR has continued to emphasize most are: Arterial screening of patients with lower extremity wounds and ulcers, Adequate compression of VLUs at each visit, and Adequate offloading of DFUs at each visit. Many hospitals and hospital-based outpatient wound centers have decided to internally report these 3 quality measures, even when their practitioners are not reporting data to CMS under MIPS.

The exciting news is that a decade after we wrote, “Why is it hard to do the right thing in wound care?” the data on VLU compression, DFU offloading and arterial screening look quite different. In 2019, USWR data show that DFU offloading occurs in 44.8% of visits (rather than 6%), adequate compression of VLUs occurs in 76% of visits (rather than 17), and 40.8% of patients with lower extremity wounds undergo a non-invasive arterial assessment at the first visit. If we are going to make a dent in the rate of major amputations and improve “honestly” reported healing rates, this is how we are going to do it, by enshrining the standards of care as quality measures and by publicly reporting them.

A Manifesto for Doing the Right Thing

To quote the endovascular cardiologist who revascularized the 82-year-old woman I mentioned earlier, “We fight peripheral vascular disease one leg at a time.” Here’s my manifesto when it comes to arterial screening, which may generate heated debate:
1. A wound center should be able to screen patients for arterial disease on site. It should not be necessary to send patients to a vascular lab for non-invasive screening.
2. Arterial screening should be done at the first wound center visit in patients with non-healing lower extremity wounds and ulcers.
3. While an ankle brachial index (ABI) can be used to determine whether compression can be applied safely, I do not think an ABI is sensitive enough to establish whether a wound will heal. To determine whether a wound will heal, you need a physiological test such as skin perfusion pressure or transcutaneous oximetry. It seems to me that a facility that calls itself a “wound center” should offer some type of physiological screening for healing potential and should perform it consistently.

Why Is It Still Hard To Do The Right Thing In Wound Care?

Although arterial screening is still a work in progress, the next big issue for us to tackle will be nutritional screening. I know it’s possible to have an esoteric argument about the details of nutritional evaluation and treatment, but basic things (including checking a Vitamin D-OH level) should not be controversial. I personally think nutritional supplements (e.g. L-arginine) should be universally recommended for patients with non-healing wounds.

USWR data prove that practitioners who report the 3 quality measures of arterial screening, diabetic foot ulcer offloading and venous ulcer compression have significantly higher healing rates of DFUs and VLUs than practitioners who don’t report those measures. Access to the programmatic specifications of QCDR measures (which is necessary to report the measures to CMS) has long been a barrier, but that barrier is about to fall with the advent of a “smart app” that enables the programming to be put inside any EHR.

Why is it still hard to do the right thing in wound care, particularly when it comes to arterial screening? I don’t know. Non-healing wounds are a symptom. Our job is to diagnose and treat the underlying disease(s) responsible for causing chronic wounds. To heal wounds and reduce the rate of major amputation, we must diagnose and treat peripheral arterial disease. I believe the best way to get clinicians to do that consistently is to measure and track their performance via CMS approved quality measures.

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

1. Fife CE, Carter MJ, Walker D. Why is it so hard to do the right thing in wound care? Wound Rep Reg. 2010; 18(2):154–158.