Kelly Hanna’s leg was amputated on a summer day 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 Ms. Hanna to Dr. Jihad Mustapha. Over 18 months, he performed at least that many artery-opening procedures on Ms. Hanna’s legs, telling her they would improve blood flow and prevent amputations.

They didn’t — for Ms. Hanna 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 about his conduct. An insurance company told state authorities that 45 people had lost limbs after treatment at his clinics in the past four years.

Dr. 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 — enriching doctors and device companies and sometimes costing patients their limbs.



The industry targets the roughly 12 million Americans with peripheral artery disease, in which plaque, a sticky slurry of fat, calcium and other materials, accumulates in the arteries of the legs. For a tiny portion of patients, the plaque can choke off blood flow, leading to amputations or death.

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 Ms. Hanna, shouldn’t undergo repeated procedures in a short period of time.

Many people with peripheral artery disease also have heart disease or diabetes, which present serious risks. Such patients, already anxious about their health, are susceptible to warnings from doctors that, absent 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, 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.

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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.

Atherectomies Have Soared
The number of atherectomies billed to Medicare has risen significantly over the past decade.

Breakdown of hospital vs. outpatient procedures not available.


Note: Hospitals include ambulatory surgical centers.Source: Centers for Medicare and Medicaid ServicesBy Ella Koeze
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 of 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. The electronics giant Philips works with a finance company to offer loans for equipment and dangles discounts to clinics that do more procedures.

The Times searched a database of state loan filings for the 200 doctors who have billed Medicare the most for atherectomies since 2017. At least three-quarters either received loans from the device industry or work at clinics that have. Some loans have gone to doctors with well-documented histories of endangering patients.



The device industry rewards high-volume doctors with lucrative consulting and teaching opportunities. And it sponsors medical conferences and academic journals to bolster a niche medical field that favors aggressive interventions.

This self-sustaining ecosystem is worth $2 billion a year, analysts estimate. Insurers pay doctors per procedure. And because new equipment is needed each time, the companies also profit from repeat customers.

Dr. Mustapha declined to comment on Ms. 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 percent of patients having “major amputations” within 30 days of treatment.

“The vast majority of the patients we serve have had exceptional outcomes,” Dr. Mustapha said. “We have saved countless limbs — and lives.”

ImageDr. Mustapha and Dr. Saab’s Lansing clinic.
Dr. Mustapha and Dr. Saab’s Lansing clinic.Credit...Cydni Elledge for The New York Times



Image
A scan shows a network of blood vessels.
Ms. Hanna shared an image of her arteries with Dr. Mustapha’s handwriting on it: “Excellent blood flow.”Credit...Cydni Elledge for The New York Times

Image
A cellphone screen displaying a photo of feet; one foot is a dark color.
She lost her job after her amputation. “Twenty-two years down the drain,” Ms. Hanna said.Credit...Cydni Elledge for The New York Times

Representatives of Philips, Abbott and Boston Scientific stood by their work with outpatient clinics, which they said cut costs and were better for patients. The Philips spokesman 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.

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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.



‘A Clear Business Motive’
Medicare’s decision to reimburse doctors for procedures performed outside hospitals led to a proliferation of outpatient clinics specializing in everything from orthopedics to dermatology.

The policy also motivated doctors to perform more procedures, in part 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, with 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, according to an industry trade group.

Atherectomy devices were first developed in the 1980s to clear blockages in arteries. Even then, they were controversial. Studies cast doubt on their safety and effectiveness in the heart.

In the ensuing decades, several companies began selling the devices to treat blockages in the legs. The F.D.A. sets a low bar for authorizing atherectomy tools and other medical devices: Companies just have to convince the agency that their devices are similar to existing products.



The turning point came in 2011, when Medicare began paying for outpatient atherectomies. That year, Medicare reimbursed doctors $86 million for the procedures, according to the Times analysis of Medicare data. By 2021, the most recent year for which data is available, the figure was $612 million.

The amount spent on atherectomies is far higher. Private insurers covered roughly three times as many procedures as Medicare did, according to Definitive Healthcare, a health analytics firm.

Yet a wide body of scientific research has found that for about 90 percent of people with peripheral artery disease — including those who experience the most common symptom, pain while walking, or have no symptoms — the recommended treatments are blood-thinning medications and lifestyle changes like getting more exercise or quitting smoking.

For some people with advanced forms of peripheral artery disease, atherectomies can be useful. But even for them, studies have found that 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. And atherectomies tend to beget more atherectomies.

Some doctors who own their own clinics push patients to undergo screenings to catch peripheral artery disease in its early, asymptomatic stages. Doctors often encourage patients to get repeat procedures, weeks apart.



“There is a clear business motive for treating people with no symptoms,” said Dr. Caitlin Hicks, an associate professor of surgery at Johns Hopkins University School of Medicine who has studied the overuse of atherectomies.

Millions in Payments
Image
Dr. Jihad Mustapha, in a suit and tie, standing and speaking.
Dr. Jihad Mustapha, in a screengrab from a video in which he talked about treating severe peripheral artery disease.Credit...NACCME, via YouTube

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 spokesman, 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.

Eva Gunasekera, who was the top lawyer in a health care fraud unit at the Justice Department from 2008 to 2017, said such incentives were problematic because they can prompt doctors to say, “Let’s use this procedure more.”

Some of the doctors who received the Philips loans had troubling professional histories.

Among them is Dr. Ralph Brookshire, a vascular surgeon in Texas. The state medical board found in 2016 that he had been abusing his medical license to prescribe himself opioids. The board said he was using the drugs during the same period that he performed a procedure that triggered hemorrhaging in a patient. (Dr. Brookshire said he was taking an opioid at night for migraines, not while he was treating patients. He is now in good standing with the board.)



In 2020, Dr. Brookshire opened his own outpatient clinic in the Rio Grande Valley. He needed at least $600,000. He approached lenders, which demanded high interest rates. He also balked at the terms offered by a venture capital firm.

So Dr. Brookshire turned to Philips, which lent him the funds to get his clinic running. Philips “can offer advantageous financing through this difficult hurdle in the process,” he said in a 2021 promotional brochure, “From Passion to Possible,” on the company’s website.

Philips Medical Capital also lent money to Dr. James McGuckin, a Pennsylvania radiologist, and the chain of clinics where he was chief executive, according to loan filings.

Image
Dr. James McGuckin, in bright blue scrubs, stands with one hand on a computer monitor.
In 2021 alone, Dr. James McGuckin earned $4 million from Medicare for atherectomies.

Dr. McGuckin has been among the most prolific providers of atherectomies, earning $4 million from Medicare for the procedures in 2021 alone.

LINK: https://www.nytimes.com/2023/0...-artery-disease.html

Give careful consideration before going to a doctor named Jihad.

Healthcare is an industry, like making cars. Or an airline.
It's all about profits. There's a few that are truly concerned with helping people.
The rest including insurance companies are banksters.

quote:

The industry targets the roughly 12 million Americans with peripheral artery disease, in which plaque, a sticky slurry of fat, calcium and other materials, accumulates in the arteries of the legs. For a tiny portion of patients, the plaque can choke off blood flow, leading to amputations or death.

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.

Diet and execise!
Who'd a thunk it?

I see a whirlwind of money in the triad. Healthcare, insurance, and lawyers. They all feed off of one another with the government on one side, and the people on the other pumping in huge amounts of cash. How can this be fixed? I have no idea. But, change just might be coming to healthcare with AI. For example.

https://www.mayoclinic.org/med...percent/mac-20536196

If AI can be trusted in the future to do much of the diagnosis healthcare just might get a whole lot cheaper. A big "if" I know. Its also said AI is going to wipe out lower tiered lawyers who do nothing but read contracts.