Facts have emerged that medical device manufacturers and doctors are feeding fat from about 12 million Americans with peripheral artery disease, a health condition in which plaque — a sticky slurry of fat, calcium and other materials accumulate in the arteries of the legs.
In some cases, the plaque can choke off blood flow, leading to amputations or death, the New York Times reports.
According to the report, 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.
New York Times says it started with a festering wound on her left foot. Her podiatrist referred Hanna to Dr. Jihad Mustapha.
Over 18 months, he performed at least that many artery-opening procedures on Hanna’s legs, telling her they would improve blood flow and prevent amputations, a claim that never worked.
Surgeons at nearby hospitals had seen so many of his patients with amputations and other problems that they complained to Michigan’s medical board about his conduct.
Mustapha is no back-alley operator working in the shadows of the medical establishment, an investigation by The New York Times has found.
With the financial backing of medical device manufacturers, he has become a leader of a booming cottage industry that peddles risky procedures to millions of Americans, the report added.
But more than a decade of medical research has shown that the vast majority of people with peripheral artery disease have mild or no symptoms and don’t require treatment, aside from getting more exercise and taking medication.
Experts said even those who do have severe symptoms, like Hanna, shouldn’t undergo repeated procedures in a short period of time.
The report says some doctors insert metal stents or nylon balloons to push plaque to the sides of arteries. Others perform atherectomies, in which 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 more likely to have amputations than those who do not.
The volume of these vascular procedures has been surging. The use of atherectomies, in particular, has soared — by one measure, more than doubling in the past decade, according to a Times analysis of Medicare payment data.
New York Times says there are two reasons. First, the government changed how it pays doctors for these procedures. In 2008, Medicare created incentives for doctors to perform all sorts of procedures outside hospitals, part of an effort to curb medical costs. A few years later, it began paying doctors for outpatient atherectomies, transforming the procedure into a surefire moneymaker.
Doctors rushed to capitalize on the opportunity by opening their own 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 their own vascular clinics, major players like Abbott Laboratories and Boston Scientific are there to help with training and billing tips. Electronics giant Philips works with a finance company to offer loans for equipment and dangles discounts to clinics that do more procedures.
Mustapha declined to comment on Hanna’s case, citing health care privacy law. But he strongly defended his treatment of the seriously ill patients who form the bulk of his practice. He said his clinics have “very low” rates of complications, including 1.3% of patients having “major amputations” within 30 days of treatment.
“The vast majority of the patients we serve have had exceptional outcomes,” Mustapha said. “We have saved countless limbs — and lives.”
Representatives of Philips, Abbott and Boston Scientific stood by their work with outpatient clinics, which they said cut costs and were better for patients. A Philips spokesperson said it was standard practice across industries to provide loans to finance large purchases.
The vascular industry faces minimal regulation. Many medical devices sail through the Food and Drug Administration’s clearance process without much data showing they work. 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.
“Someone who cuts or inserts something into a patient for unnecessary work is the same as someone stabbing you in the street and taking your wallet,” said Dr. Russell Samson, a vascular surgeon in Florida.
From 2017 to 2021, about half of Medicare’s atherectomy payments — $1.4 billion — have gone to 200 high-volume providers, the Times analysis found.
Many of the doctors who do the most vascular procedures receive payments — for consulting, speeches and other services — from the device industry that profits from their work.
For example, the top provider of Medicare-financed atherectomies in Louisiana, Dr. David Allie, received $2.8 million from drug and device makers between 2013, when the federal government began collecting such data, and 2022. He didn’t respond to requests for comment.
In addition to those payments, device companies have lent money to 153 of the 200 doctors or their clinics to finance the purchase of medical equipment, according to a Times review of loan filings.
At least one company, Philips, allows doctors to reduce or eliminate their monthly payments if they use the company’s equipment to perform a minimum number of procedures, according to current and former Philips employees.
The Philips spokesperson, Ken Peters, said the loans are issued by Philips Medical Capital, which Philips owns with a finance company. He said Philips Medical Capital made independent decisions about which doctors get loans.
