American doctors are raking in billions of dollars for unnecessary, often reckless surgery – costing patients their limbs and risking their lives – in pursuit of kickbacks from device manufacturers and medical aid payouts.
People with peripheral artery disease are particularly vulnerable to the predatory targeting, according to The New York Times, with ruthless physicians performing numerous, needless operations that often result in the loss of limbs.
Kelly Hanna’s leg was amputated in 2020 after a Michigan doctor who called himself the “leg saver” had damaged her arteries by snaking metal wires through them to clear away plaque.
It started with a festering wound on her left foot. Her podiatrist referred her to Dr Jihad Mustapha. Over 18 months, he performed at least that many artery-opening procedures on her legs, telling her they would improve blood flow and prevent amputations.
They didn’t – for her or many of his other patients. Surgeons at nearby hospitals had seen so many of his patients with amputations and other problems that they complained to Michigan’s medical board. An insurance company told authorities 45 people had lost limbs after treatment at his clinics over four years.
Mustapha – with the financial backing of medical device manufacturers – has become a leader of a booming industry peddling risky procedures to millions of Americans, enriching doctors and device companies and sometimes costing patients their limbs.
The industry targets the roughly 12m Americans with peripheral artery disease, where plaque accumulates in the leg arteries. For a tiny portion of patients, the plaque can choke blood flow, leading to amputations or death.
But more than a decade of medical research has shown that most people with peripheral artery disease have mild or no symptoms and don’t require treatment, aside from more exercise and taking medication. Experts said even those with severe symptoms, like Hanna, shouldn’t undergo repeated procedures in a short period.
Many people with peripheral artery disease also have heart disease or diabetes, and already anxious about their health, are susceptible to warnings from doctors that, without intrusive medical procedures, they could lose their legs.
Some doctors insert metal stents or nylon balloons to push plaque to the sides of arteries. Others perform atherectomies, where a wire armed with a tiny blade or laser is deployed inside arteries to blast away plaque.
Rigorous medical research has found that atherectomies are especially risky: patients with peripheral artery disease who undergo the procedures are likelier to have amputations than those who do not.
The volume of these vascular procedures has surged. The use of atherectomies, particularly, has soared – more than doubling in the past decade, found a Times analysis of Medicare payment data.
The number of atherectomies billed to Medicare has risen significantly over the past decade for two reasons.
First, the government changed how it pays doctors for these procedures. In 2008, Medicare created incentives for doctors to perform various procedures outside hospitals, part of an effort to curb medical costs.
Then, it began paying doctors for outpatient atherectomies, transforming the procedure into a money-spinner. Doctors rushed to open outpatient clinics, where by 2021 they were billing $10 000 or more per atherectomy.
The second reason: companies that make equipment for vascular procedures pumped resources into a fledgling field of medicine to build a lucrative market.
When doctors open vascular clinics, major players are there to help with training and billing tips. Electronics giant Philips works with a finance company to offer loans for equipment and discounts to clinics that do more procedures.
A database of state loan filings for the 200 doctors who have billed Medicare the most for atherectomies since 2017 showed that at least three-quarters either received loans from the device industry or work at clinics that have.
The device industry rewards high-volume doctors with lucrative consulting and teaching opportunities.
This ecosystem is worth $2bn a year, analysts estimate. Insurers pay doctors per procedure. And because new equipment is needed each time, also profit from repeat customers.
The vascular industry faces minimal regulation. Many medical devices sail through the Food and Drug Administration’s clearance process without much data. The clinics are not subject to the same safety regulations as hospitals. Even when regulators determine that doctors have performed unnecessary procedures, they generally impose paltry fines and let them continue practicing.
Fifteen surgeons told the Times they were frequently called in to fix problems caused by doctors in vascular clinics.
‘A clear business motive’
Medicare’s decision to reimburse doctors for procedures performed outside hospitals led to a proliferation of outpatient clinics specialising in everything from orthopaedics to dermatology.
It also motivated doctors to perform more procedures, partly because private insurers tend to follow the federal agency’s lead. Before, doctors working in a hospital pocketed only a slice of what insurers paid, the hospital getting the rest to cover overhead costs. Doctors who owned clinics could now collect the entire payment.
A decade ago, there were virtually no clinics to treat peripheral artery disease. Today, there are about 800.
Atherectomy devices were first developed in the 1980s to clear artery blockages. Even then, they were controversial.
In the ensuing decades, several companies began selling the devices to treat blockages in the legs. The FDA sets a low bar for authorising atherectomy tools and other medical devices: companies just have to convince it their devices are similar to existing products.
In 2011, Medicare began paying for outpatient atherectomies, and that year, reimbursed doctors $86m for the procedures, and by 2021, $612m.
Yet research has found that for about 90% of people with peripheral artery disease, including those with the most common symptom, pain while walking, or who have no symptoms, recommended treatments are blood-thinning medications and lifestyle changes like more exercise or quitting smoking.
For some people with advanced peripheral artery disease, atherectomies can be useful. But even for them, studies have found atherectomies do not work better than less expensive methods of clearing blockages and restoring blood flow. Others have found that because atherectomies can further inflame patients’ arteries, they can lead to higher rates of amputations.
Some doctors who own their own clinics push patients to undergo screenings to catch peripheral artery disease in its early, asymptomatic stages, often encouraging patients to get repeat procedures, weeks apart.
From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4bn – went to 200 high-volume providers, the Times analysis found.
Device companies have also lent money to 153 of the 200 doctors or their clinics to finance the purchase of medical equipment, with at least one company, Philips, allowing doctors to reduce or eliminate their monthly payments if they use the company’s equipment to perform a minimum number of procedures.
See more from MedicalBrief archives:
Not enough night-time sleep linked to clogged arteries – Swedish study
Cocoa may improve walking in people with peripheral artery disease — small study
US doctors buy their way out of trouble