Sunday, 14 April, 2024
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Profit drives over-treatment of peripheral artery disease

A recent report on widespread overuse and overtreatment of peripheral artery disease (PAD) has drawn strongly divided reaction.

The article in The New York Times and re-published in MedicalBrief, highlighting rampantly inappropriate over-treatment of patients with PAD, has made a serious but necessary impact on patients and physicians alike, with one expert saying “the loudest critics are the biggest offenders”.

In a MedPage Today report, Dr Caitlin Hicks said the most common symptom of PAD is claudication, manifesting as pain in one or both legs during walking, and which is relieved at rest. Among people affected by claudication, leg amputation risk is less than 1% over five years if managed correctly with appropriate medications (aspirin and statins) and lifestyle modifications (smoking cessation and exercise).

In contrast, the risk of leg amputation after an invasive procedure to improve blood flow for claudication is 6% over five years, representing a six-fold higher risk compared with medical management alone.

As a result, using invasive interventions (like atherectomies or metal stents) as the first-line treatment of claudication is not currently recommended 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, 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 doctors who perform procedures in hospital settings versus outpatient office-based laboratories (OBLs).

The Society for Vascular Surgery released a strong statement confirming “no procedure should be recommended or performed if it is not primarily and solely for the benefit and best interests of that patient”.

It also stated that vascular surgeons are largely practising within the ethical boundaries of the profession, and that patients should seek comprehensive vascular care from physicians specifically trained to provide all facets of that care.

The Outpatient Endovascular and Interventional Society also criticised The New York Times article for “virtue signalling”, saying its society, “comprises physicians dedicated to patient-centred, quality care… 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, expressed their opinions 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, 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, 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 allowing 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 away plaque 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 are equivocal, showing no benefit, and in some cases, harm, compared with other technologies.

Despite this, atherectomy is the most highly reimbursed treatment approach for PAD, adding thousands of dollars per intervention in reimbursement.

These rates were set by the Centres 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, more likely to use atherectomy than physicians who operate predominantly in hospitals.

This is capitalism at is finest.

Unfortunately, the patients who suffer as a result, undergoing multiple re-interventions in short periods, suffering progression of disease, and even ending up with amputations.

Physicians criticising 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 practise predominantly in OBL settings themselves.

Importantly, the overuse of atherectomy in the treatment of PAD is not a speciality-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.

We are at a crossroads for how we care for patients with PAD.

Over-treatment 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 pre-authorisation for procedures, where they evaluate medical records to ensure patients have been treated with the necessary medical therapy (aspirin, statin, smoking cessation, exercise therapy), before 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 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 behaviour, 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.

Caitlin Hicks, MD, MS,  is an associate professor of surgery in the Division of Vascular Surgery at Johns Hopkins University School of Medicine in Baltimore, USA.


ProPublica series (Open access)


Society for Vascular Surgery Vascular AGM article – Early peripheral vascular interventions for claudication are associated with higher rates of late interventions and progression to chronic limb threatening ischaemia


MedPage Today article – Who Is to Blame for the Rampant Overtreatment of Peripheral Artery Disease? (Open access)


See more from MedicalBrief archives:


US doctors rake in millions from unnecessary atherectomies


Increased fruit and veggies uptake reduces PAD risk


US doctors buy their way out of trouble


Cocoa may improve walking in people with peripheral artery disease — small study








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