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Who Is to Blame for the Rampant Overtreatment of Peripheral Artery Disease?

— The loudest critics are the biggest offenders

MedpageToday
A photo of a surgeon holding a rotablator catheter.
Hicks is an associate professor of surgery and a director of clinical outcomes research.

The recent New York Times highlighting inappropriate treatment patterns among patients with peripheral artery disease (PAD) has made a serious but much needed impact on patients and physicians alike. The article is complemented by a of ProPublica articles that highlight similar issues. Together, these works have brought concerns about widespread overuse and overtreatment of PAD directly into the spotlight of public opinion.

The most common symptom of PAD is claudication, which manifests as pain in one or both legs that occurs with walking and is relieved at rest. Among persons affected by claudication, the risk of leg amputation is less than 1% over 5 years if managed correctly with appropriate medications (aspirin and statins) and lifestyle modifications (smoking cessation and exercise). In contrast, the risk of leg amputation following an invasive procedure to improve blood flow for claudication is approximately , representing a sixfold higher risk compared to medical management alone. As a result, the use of invasive interventions (such as atherectomies or use of metal stents) as the first-line treatment of claudication is by any major professional societies.

Many patients are appalled at the practices of the doctors highlighted in the New York Times and ProPublica articles, resulting in physician distrust and a reticence to seek care. Physician opinions about the articles are divided. Some physicians, including myself, applaud the public exposure of the darker side of procedural medicine, where financial incentives can outweigh the most basic physician oath of "primum non nocere" (first, do no harm). Other physicians have taken the reports as personal attacks, decrying the authors for writing one-sided "hit pieces" that selectively exaggerated a few bad outcomes for doctors such as Jihad Mustapha, MD, the self-proclaimed "leg saver."

Physician opinions about the articles are divided across very visible lines. There is a clear division of opinion not only between specialties, but also between physicians who perform procedures in hospital settings versus outpatient office-based laboratories (OBLs). The released a strong statement confirming that, "no procedure should be recommended or performed in any patient if it is not primarily and solely for the benefit and best interests of that patient." They also stated that vascular surgeons are largely practicing within the ethical boundaries of the profession, and that patients should seek out comprehensive vascular care from physicians that are specifically trained to provide all facets of that care. The released a statement criticizing the New York Times article for "virtue signaling," stating that their society, "is comprised of physicians who are dedicated to patient-centered, quality care and who are concerned about appropriateness, safety, and long-term outcomes." Other key societies with substantial representation in the treatment of PAD, including the American College of Cardiology and the Society of Interventional Radiology, have yet to release public statements on the issue. However, physicians from all specialties involved in the treatment of PAD have eagerly, and in many cases divisively, made their opinions known on social media.

There is some truth to every voice in the morass of the PAD treatment controversy. Vascular surgeons are the only specialists trained to perform both open and endovascular procedures to improve blood flow. However, there are many interventional radiologists and cardiologists who provide excellent care to their patients with PAD using a multidisciplinary approach. OBLs may offer an appealing advantage as they are easier to navigate for patients, and often have a spa-like environment rather than the forbidding environment of a hospital. However, financial incentives allure physicians to do more cases in the OBL setting, as many OBLs are physician-owned and supported by large loans. Reimbursement for cases performed in an OBL has to cover the overhead of the facility, facility staff, materials used for the case, and physician salaries. As a result, there is an inherent incentive not only to do more cases, but also to use technology that allows the physician to bill for higher reimbursement. This is where atherectomy comes into play.

Atherectomy is best described as a Roto-Rooter for blood vessels. A small device is inserted into an artery using a fine wire to shave plaque away and improve blood flow to the leg. While the concept of atherectomy makes logical sense, the data supporting its use in the treatment of PAD is equivocal, showing -- and in some cases -- compared to other technologies. Despite this, atherectomy is the most highly reimbursed treatment approach for PAD, adding thousands of dollars per intervention in reimbursement. These reimbursement rates were set by the Centers for Medicare & Medicaid Services (CMS) more than 15 years ago, and have only been adjusted marginally despite substantial reductions in the purchase cost of a device. This is the main problem. Physicians operating in locations where their livelihood is dependent on reimbursement are, not surprisingly, to use atherectomy than physicians who operate predominantly in hospitals. This is capitalism at is finest. Unfortunately, it's the patients who suffer as a result, undergoing multiple reinterventions in short periods of time, suffering progression of disease, and even ending up with .

Physicians criticizing the articles are quick to point out that patients with PAD need treatment, and that concerns around the inappropriate use of PAD treatments are unfounded. However, nearly all of these critics are providers who perform atherectomies for the majority of their PAD cases and practice predominantly in OBL settings themselves (see Figure; critics denoted as red markers). Importantly, the overuse of atherectomy in the treatment of PAD is not a specialty-specific problem; of the 200 outliers highlighted by the New York Times, 21% are vascular surgeons, 41% are cardiologists, 23% are interventional radiologists, and 15% are physicians from other specialties. Despite the finger-pointing, the vast majority of "bad apples" who have traded their ethics for profit have only one thing in common: performing most of their cases in OBLs.

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Figure. Scatterplot showing the connection between physician atherectomy use (Y-axis) and OBL use (X-axis) for the treatment of PAD. Individual markers represent individual physicians from cardiology (circles), interventional radiology (triangles), and vascular surgery (squares). Red dots represent the most vocal critics of the recent press highlighting overtreatment of PAD and overuse of atherectomy. Data represent mean percentages for individual physicians based on 100% fee-for-service Medicare claims data from 2017 through 2021. Physicians who billed Medicare for less than 10 cases per year are not shown. Original graphic from Hicks.

We are at a cross-roads for how we care for patients with PAD. Overtreatment of PAD is not a burden owned by one group of physicians or another. All physicians who claim to have expertise in treating the disease are complicit, and all are responsible for much-needed reform.

Reform can come in many ways. CMS could reduce reimbursement for expensive technologies that provide minimal benefit to alternative treatments. Insurance companies could start requiring preauthorization for procedures, where they evaluate medical records to ensure that patients have been treated with the necessary medical therapy (aspirin, statin, smoking cessation, exercise therapy), prior to intervention. Professional societies (or CMS) could implement a regulatory environment for OBLs, whereby practices providing high-quality care can receive a stamp of approval that will allow patients to know that they are safe to be treated there. Most importantly, physicians can start acknowledging that some of their fellow physicians are not doing the right thing. Outliers comprise a small number of physicians who practice PAD care, but the negative impact is huge. If we do not call out inappropriate behavior, the actions of a few will cast doubt on us all. It is time to stop putting our heads in the sand, and return to practicing medicine as intended. Medicine is not a business; it is a calling. Primum non nocere.

is an associate professor of surgery in the Division of Vascular Surgery at Johns Hopkins University School of Medicine in Baltimore.

Disclosures

Hicks is a consultant for Cook Medical and W.L. Gore, which manufacture products related to peripheral artery treatment and intervention.