I now sport a shiny stainless steel stent implanted into my left anterior descending coronary artery that was 99% blocked when I survived a heart attack two years ago. Stents are like tiny chicken wire mesh tubes inserted inside the obstructed coronary arteries of your beating heart and then expanded using a small balloon to open blocked arteries that prevent blood flow to heart muscle.

But it appears that some cardiologists like these miraculous little devices so much that they are implanting stents into patients who don’t need them. A current U.S. investigation in Maryland involves Dr. Mark Midei, who has subsequently been relieved of his privileges* at St. Joseph Medical Center in Towson, MD. According to Heartwire, the hospital, following up on a patient complaint, discovered stenting rates high enough to bring them under scrutiny, and determined that hundreds of Midei’s patients received stents they didn’t need during his last two years at the hospital.

How could this happen?

One potential way to make this kind of health care fraud easier to pull off is the way this doctor was able to successfully sidestep his hospital’s peer review safety net. The veteran cardiologist accused of performing hundreds of unnecessary and potentially dangerous procedures was able to slip through this safety net because, as a department chair, he could personally select which of his cases would be evaluated, according to Maryland’s Office of Health Care Quality.

A subsequent review by the Maryland Medical Board led to administrative charges in June, accusing Midei of “gross overutilization of health care services” and “willfully making a false report or record in the practice of medicine,” according to a Board report.

In Midei’s defense, about 100 of his cases were reviewed by another interventional cardiologist, Dr. William O’Neill, of the University of Miami Miller School of Medicine, who told Heartwire:

“I concluded that (Dr. Midei) really was a good operator and there was really no reason to have an emergency suspension of his privileges.”

Quelle surprise. O’Neill had been hired by the legal team of this “good operator” and was reimbursed by these lawyers for his professional opinion of their client.

A U.S. Senate investigative report revealed that Midei was a favourite of device-maker Abbott Laboratories, the company that manufactured the stents. According to Maggie Mahar, author of the book, Money-Driven Medicine, Abbott even celebrated the fact that the handy doctor had inserted 30 of the company’s cardiac stents into trusting patients during a single day in August 2008: “Two days later, an Abbott sales representative spent $2,159 to buy a whole, slow-smoked pig, peach cobbler and other fixings for a barbecue dinner at Dr. Midei’s home.” Although St. Joseph’s Hospital has not admitted to any wrongdoing, it did agree to pay a $22 million fine to settle charges that it paid illegal kickbacks to Dr. Midei’s medical practice in exchange for patient referrals. In other words, it seems that the hospital encouraged the doctor to implant stents into his patients’ arteries. Certainly, hospital executives knew that they were making handsome profits on Midei’s stent procedures. As Maggie Mahar explains: “Midei was a rainmaker.”

Clinical guidelines require that a coronary artery must be at least 70% blocked before a stent is appropriate to open it up, and St. Joseph’s own rules consider anything less than 50% blockage to be “insignificant.” But court documents allege that some of Midei’s patients were told they had blockages in the 90% range, while a subsequent review of their records shows blockages closer to 10% or less. Yet even after being notified in writing by the authorities that their coronary arteries had actually been less than 50% blocked (clinically meaningless and not an indication for stenting), many of Midei’s stent patients appeared unfazed. One woman even told the Baltimore Sun: “No one can ever tell me that I didn’t need that stent. I feel like [Dr. Midei] saved my life!” Any patient who has undergone angioplasty and stent implantation is duly impressed by the number of nurses and technicians working alongside interventional cardiologists in the catheterization lab, a reality that certainly implies collusion on the part of Midei’s cath lab colleagues. As Dr. Bob Wachter of the University of California at San Francisco writes in his essay Badness In Baltimore: Can Peer Review Catch Rogue Doctors?: “It strains credibility to think that no one in the lab knew that inconsequential lesions were being read as tight stenoses and treated with stents.” A 2007 study in the New England Journal of Medicine, while stopping short of concluding that stents were not beneficial for some patients, rather reported that not implanting a stent can often be just as good, while avoiding the very real risks of complications or even death from the procedure. But as the Baltimore Sun pointed out: “Hospitals can’t bill $12,000 for deciding not to implant a stent, even if that’s the best thing for the patient.”

The disturbing revelations about the stent-happy Midei may be just the tip of the iceberg. The Sun also reported that the State of Maryland has now expanded its investigation to include other cardiologists and hospitals with stent-procedure rates significantly higher than the state average.

But as the New York Times has reported, stents are also big business, with powerful stent manufacturers like Johnson & Johnson and Boston Scientific selling over $3 billion worth of stents last year. They have invested heavily in expanding the use of these stents; stent implants have become more popular as rates for the more invasive open heart bypass surgery have dropped. According to the Times:

“The specialists who are most likely to diagnose coronary artery disease are in many cases also the doctors who implant stents. Cardiac surgeons have seen their annual incomes dwindle to an average $425,000 down from $1.02 million in 1990, after adjusting for inflation. Meanwhile, the average income of an interventional cardiologist, as a stent specialist is known, has risen to $550,000 from an inflation-adjusted $392,000 in 1990.”

Midei is not likely the only stent-happy interventionalist out there. As cardiologist Dr. Eric Topol reported last fall:

“A case report* in the Journal of the American College of Cardiology of a 56-year-old male patient with 67 stents and a history of 28 coronary angiograms is symbolic of a health care system that is barreling out of control fueled by outrageous costs and unbridled use of procedures. “

If I were Midei, I’d be very, very worried right about now. Last year, another U.S. interventional cardiologist who implanted stents in patients who didn’t need them was convicted on 51 counts of health care fraud. Dr. Mehmood Patel, a 64-year old Louisiana cardiologist, was sentenced to 10 years in federal prison, the maximum legal punishment allowed.

Patel’s former employer, Our Lady of Lourdes Hospital in Louisiana, also paid $7.4 million to settle a class-action lawsuit brought by his former patients. His 11-week trial included charges of fraud involving 75 patients. Medical experts testified that Patel had:

performed unnecessary tests and procedures in patients with little or no disease

falsified medical test results

falsified patient symptoms in medical records, including chest pain when patients had never complained of such pain

billed government health insurance and private insurance companies more $3 million, during a time when he was the top cardiology biller in the state

personally pocketed more than $500,000 in cash

And in perhaps the most celebrated cardiology case in recent memory, Drs. Chae Moon and Fidel Realyvasquez of Redding Medical Center in California remain the poster boys for dangerous health care fraud after it was found that 50% of the procedures conducted by the two physicians (diagnostic catheterization, angioplasty, and coronary bypass surgery procedures) were medically unnecessary. Evidence from one cardiologist who saw patients after they’d been to Moon claimed that in many instances, Moon’s first interaction with the patients was to perform a heart catheterization procedure. Two of Moon’s patients interviewed during FBI investigations stated that Moon had conducted “urgent” angiography procedures on them in the absence of any symptoms and a normal treadmill stress test. Realyvasquez had billed Medicare over $3.5 million and Moon almost $4 million. Redding Medical Center’s cardiac unit, home base to the two cardiologists, was described as a “cash cow”, generating over $3,000 in revenue per patient per day, or twice the hospital’s average. They and their hospital settled civil cases for $450 million. Moon and Realyvasquez left medicine. Their hospital also paid the U.S. government $900 million to settle claims regarding alleged improper financial activities. Former New York Times and Washington Post investigative reporter Stephen Klaidman wrote about this scandal in his book Coronary: A True Story of Medicine Gone Awry.

Convictions like health care fraud may make you wonder who is policing these guys – since their senior positions in hospitals can mean that they, like Midei, hand-pick cases for peer review.

Not surprisingly, many docs don’t like the idea of non-doctors looking over their shoulders.

Dr. Larry Dean at the University of Washington Regional Heart Center in Seattle, for example, insists that neither governments nor lawyers are capable of doing this policing job. He told Heartwire:

“This is our responsibility. If it’s done properly, it will work. I’ll be honest with you. I don’t think that the government or lawyers can do this. It comes down to the single individual patient-level decision, and the only people who understand that are the ones who are doing it every day.”

Earth to Dr. Dean: the “ones who are doing it everyday” include the very cardiologists accused of performing unnecessary and potentially dangerous procedures. Because such cardiologists are like foxes guarding the henhouse, independent regulators are the only secure protection that cardiac patients may have.

* NEWS UPDATE: July 14, 2011 – Baltimore, MD – “Cardiologist’s License Ordered Revoked In Stents Case” – A state medical panel has declined to reverse a judge’s order to revoke a cardiologist’s license on accusations he performed hundreds of medically unnecessary coronary stent procedures. The Maryland Board of Physicians ruled that Dr. Mark Midei violated five provisions of the Medical Practice Act, including provisions that prohibit unprofessional conduct, making false reports, keeping inadequate records and over-utilization of health care services. The board declined to reverse the ruling, calling Midei’s violations “repeated and serious”, and further writing that Midei “unnecessarily exposed his patients to the risk of harm” and “increased the costs of the patients’ medical care.”

NEWS UPDATE, October 15, 2015 – The U.S. Department of Justice has reached a $250 million settlement with 457 hospitals related to cardiac devices that were implanted in violation of Medicare rules. It’s one of the largest whistle-blower cases brought under the False Claims Act in terms of the number of defendants and the monetary recovery. It involved implantable cardioverter defibrillators (ICDs) which detect life-threatening heart rhythms and treat them by shocking the heart back to a normal beat.

MORE STENT INVESTIGATIONS:

March 3, 2011 – Medical reviews at Pittsburgh’s Westmoreland Hospital have determined two cardiologists there implanted coronary stents in at least 141 patients in 2010 who may not have had enough blockage in their arteries to need a stent. Letters to these patients do not provide a reason why the patients received the stents, but state their condition “may not have justified the placement of a coronary stent.” Hospital officials said the questionable stents were implanted by Drs. Ehab Morcos and George Bousamra , who voluntarily resigned their hospital privileges at Westmoreland on January 12, 2011 after being investigated. The two doctors performed more than 750 of the up to 2,000 stent procedures done at Westmoreland Hospital that year.

July 26, 2011 – A federal jury has convicted Maryland interventional cardiologist Dr. John R. McLean , 59, on six charges of health care fraud relating to insurance claims he’d filed for stents deemed to have been placed unnecessarily, as well as for ordering unnecessary tests and making false entries in patient medical records. A statement released by the Office of the Inspector General said: “The evidence shows that Dr. McLean egregiously violated the trust of his patients and made false entries in their medical records to justify implanting unneeded cardiac stents and billing for the surgery and follow-up care.” McLean faces a maximum sentence of 10 years in prison for health care fraud and five years in prison on each of five counts of making false statements. His sentencing is scheduled for November 10, 2011.

Read more about unnecessary stent implants in this article from Heartwire.

See also:

* Khouzam RN, Dahiya R, and Schwartz R. A heart with 67 stents. J Am Coll Cardiol. 2010;56;1605.

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