For over a year, The Baltimore Sun has been following the federal investigation of Dr. Mark Midei, a Maryland cardiologist who is charged with implanting unneeded heart stents after being influenced by the stent maker, Abbott Laboratories. The Maryland legislature is now considering a ban on gifts to all physicians from medical companies.

Here’s how The Sun summarizes the latest news  in this health care fraud case: 

“St. Joseph Medical Center in Towson, Maryland, whose cardiology business is a focus of a continuing federal health care fraud investigation, has notified hundreds of its heart patients that they may have received expensive and potentially dangerous coronary implants they didn’t need.

“An internal review, begun last May at the behest of federal investigators and in response to a patient complaint, has turned up 369 patients with stents that appear to have been implanted in their arteries unnecessarily, hospital CEO Jeffrey K. Norman said in an interview yesterday. Patients began receiving letters alerting them to the finding early last month, and more notifications are expected as the review continues. Norman said:

”We take our interaction and the care of our patients with the utmost seriousness, and so we wanted to alert patients and their physicians to what we found.”

“In several cases, patients who received coronary stents at St. Joseph – purportedly to open a clogged artery to correct a severe blockage – have since learned they had only minor blockage, if any. For example:

• One 69-year-old man was told that his artery had a 95% blockage, yet the new review suggests something closer to 10% , which is considered insignificant.

• A 55-year-old woman who agreed to receive a stent after being told that she had a 90% blockage has since learned she had virtually no problem and that she never suffered from the heart diagnosis that has consumed her life for the past 18 months.

“While Dr. Mark Midei was allegedly implanting unnecessary cardiac stents in hundreds of patients at a Towson hospital, stent manufacturer Abbott Laboratories was paying for crab and barbecue feasts at his Monkton home and building a business strategy around the Maryland cardiologist’s high output, according to a federal report being released today.

“Abbott, a $30 billion-a-year, Chicago-based pharmaceutical firm, ranked Midei among its top-volume doctors in the Northeast and made plying him with research money and “VIP trips” part of its business plan in late 2008 — about the time Midei’s usage of Abbott-brand stents soared, the report said.

“The 170-page document contains the findings of a months-long investigation by the U.S. Senate Committee on Finance into allegations of inappropriate and potentially harmful cardiac procedures performed by Midei at St. Joseph Medical Center. It calls the case “a clear example of potential fraud, waste and abuse,” noting that Midei’s employer, St. Joseph, billed government and private insurers more than $6.6 million for the procedures he performed.

“Maryland lawmakers are again considering legislation to bar gifts from companies to health care providers in the wake of allegations that Midei was “indirectly influenced” to perform unnecessary stent procedures by the device maker Abbott Laboratories.

“Vermont and Massachusetts have recently enacted similar laws, considered the most restrictive in the nation, that significantly limit the items that industry sales representatives can offer to physicians, prohibiting trinkets, trips and most meals. They also require public disclosure of certain financial transactions.

“The bans drew an outcry from drug and device industry officials, who tried unsuccessfully to repeal the Massachusetts law last year, saying it hurt business. Maryland has weighed such conflict-of-interest legislation before, though it’s never gotten very far. Last year’s stent scandal involving accusations against Midei has renewed interest in the proposed law.”

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As a heart attack survivor who now sports a shiny stainless steel stent in my left anterior descending coronary artery (which was 99% blocked before being propped open with a bare metal stent on May 6, 2008), I have a keen (some might say obsessive) interest in All Things Cardiac, and particularly, like most patients who’ve had stents implanted, in this growing controversy around stent-happy cardiologists.

This topic began to worry heart patients and their physicians after the COURAGE* trials were published the year before my own heart attack, suggesting that for elective (non-emergency) coronary artery disease cases, stents show no benefit compared to just taking recommended heart drugs in preventing cardiac events in stable patients.

Tell that to Dr. Mehmood Patel, a 64-year old stent-happy Louisiana cardiologist who was sentenced to 10 years in federal prison, the maximum legal punishment allowed. Patel’s former employer, Our Lady of Lourdes Hospital, also paid $7.4 million to settle a class-action lawsuit brought by his former patients who had had coronary stents unnecessarily implanted.  His 11-week trial included charges of fraud involving 75 patients.

Meanwhile, back in Baltimore, Midei has subsequently been relieved of his privileges at St. Joseph Medical Center after last May’s internal investigation revealed that his stenting rates over the past two years were alarming enough to bring them under scrutiny. And St. Joseph has repaid several million dollars in federal Medicare funds it received for Midei’s procedures in order to settle pending government legal claims.

Although St. Joseph 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.

A study of over 1,000 U.S. hospitals** led by Dr. Paul Chan reported in the Journal of the American Medical Association this year found that when cardiac catheterizations were done for acute indications like my own myocardial infarction (heart attack), the overwhelming majority of cases (98.6%) were performed for appropriate indications. Only 1.1% were done inappropriately (in the other cases, the benefit was uncertain).

But for elective procedures like the ones performed by Midei, however, Dr. Chan found that almost 12% of all such procedures were inappropriate, and an additional 38% were carried out for indications associated with unclear benefits.

Most of the procedures studied that were deemed to be inappropriate had been carried out on patients:

• with no angina (54%)
• with low-risk ischemia as determined by exercise testing (72%)
• who were not receiving ‘maximal’ medical therapy (96%).
• and 94% of these patients also did not have ‘high risk’ coronary anatomical findings.

Meanwhile, St. Joseph’s Hospital now claims it has revamped its internal review systems and has agreed to operate under increased federal oversight for the next five years.

Over 80 medical malpractice lawsuits have been filed so far by Midei’s former patients. Meanwhile, Midei himself has filed a $60 million lawsuit against St. Joseph Medical Center. His lawyer Stephen Snyder told The Sun:

“Midei was injured because city-based media published accounts of the allegations against him, which became known after St. Joseph began sending the warning letters to patients”.

And what do Midei’s own patients think of this scandal?

When one stent recipient, 66-year-old Peggy Lambdin, received the warning letter from St. Joseph’s indicating that her coronary artery had been less than 50% blocked when Midei implanted her stent (a blockage considered clinically meaningless and not an indication for stenting), she was unfazed, according to an interview in the Baltimore Sun:

“No one can ever tell me that I didn’t need that stent. I feel like [Dr. Midei] saved my life.”

NEWS UPDATE: July 14, 2011 – “Cardiologist’s License Ordered Revoked In Stents Case” 

Baltimore, MD  –  A Maryland 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.”

The judge had ordered Midei’s medical license be revoked and not reinstated for at least two years, to which the board agreed, adding that Midei had falsified the extent of blockages of patients’ coronary arteries by reporting them as being 80% blocked, when they were actually lower – and in most cases, much lower. In some patients, he had also falsely reported that they suffered from unstable angina when in fact they did not.

The Board found that he inserted cardiac stents into arteries that weren’t clogged enough to need them — likely because of “pressure to produce.” 

The Board’s report also noted that Midei was hired to run St. Joseph’s cardiac catheterization lab at a seven-figure salary that was triple his prior earnings, adding:

“Dr. Midei testified that he understood that he was a big generator of business for the hospital, that the hospital had lost many patients to competition, and that its goal was to hold onto the stent business that it saw slipping away.”

• Cardiologist Accused Of Implanting Cardiac Stents That Weren’t Necessary

• Do Patients Really Hear What Doctors Are Actually Telling Them? published on my other site, Heart Sisters

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.

• June 10, 2011 – The US Department of Justice will investigate charges by a Tennessee cardiologist against another cardiologist and two hospitals. Dr. Wood Deming of Jackson is accusing Dr. Elie Hage Korban (Heart and Vascular Center of West Tennessee, Jackson) of “blatant overutilization of cardiac medical services, including, but not limited to, cardiac sonography, scintigraphic stress imaging, angiography, angioplasty, and stenting” in order to defraud government insurance programs. Dr. Deming also alleges that the executives of Jackson-Madison County General Hospital and the Regional Hospital of Jackson and radiologist Dr. Joel Perchik condoned or assisted in Korban’s fraud in addition to engaging in a bilateral kickback and self-referral scheme. The US attorney’s office in Memphis will file its own complaint against Korban within the next two months.

• 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.”  UPDATE, November 10, 2011: Dr. John McLean was sentenced to eight years in prison followed by three years of supervised release. McLean has also been “ordered to pay $579,070 in restitution to Medicare and other health insurance programs and to forfeit $579,070 as proceeds of the crime.”  McLean had previously resigned his hospital privileges at Peninsula Regional Medical Center in Salisbury, MD in 2007, citing visual impairment as the reason. Hospital administrators, however,  had conducted internal and external reviews leading them to conclude that McLean had implanted as many as 25 stents in patients who did not meet the clinical criteria for PCI.

UPDATE April 12, 2012: Read Larry Husten’s interview with Mark Midei in Forbes: “Mark Midei Can’t Get a Job Taking Blood Pressure At A Walmart”

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* Boden WE, O’Rourke RA, Teo KK, et al. “Optimal medical therapy with or without PCI for stable coronary disease”.  New England Journal of Medicine 2007; DOI:10.1056/NEJMe070829.

** “Appropriateness of Percutaneous Coronary Intervention”. Journal of the American Medical Association,  2011;306(1):53-61.