Posts Tagged ‘overstenting’

As readers know, I recently gave a CME presentation on The Syntax Trial   and discussed the new Revascularization guidelines that were released last month.  I’ve posted the slides for anyone who wants to use them.  (It would be nice if you mentioned where you got them – but feel free to use them.)

Now – new criticisms of these revised guidelines are already emerging.  But before tackling these new criticisms, we should review the old controversies surrounding the previous guidelines.

In a interesting article (by one of my favorite summarists) Reed Miller over at The Heart.org reviews the issues behind the old (2009) guidelines..  It’s a good article that talks about many of the issues behind the 2012 revisions. I’ve re-posted the article below.

PCI appropriateness criteria draw criticism

(originally posted February 8th, 2012 at the Heart.org)

Kansas City, MO – The interminable controversy about appropriate use and overuse of PCI is being stirred up again [1].

Dr Steven P Marso (St Luke’s Mid-America Heart Institute, Kansas City, MO) and five other cardiologists have published a paper online February 8, 2012 in the Journal of the American College of Cardiology: Cardiovascular Interventions criticizing both the 2009 coronary revascularization appropriate-use criteria (AUC) and how those criteria have been applied to the study of contemporary practice patterns.

As reported by heartwire, the AUC were created by a technical committee representing six professional societies. Last summer, Marso’s colleague in Kansas City, Dr Paul Chan (St Luke’s Mid-America Heart Institute), led a study of PCI cases in the National Cardiovascular Data Registry (NCDR) that showed that only 50.4% of nonacute cases in the registry during the yearlong study period would be classified as appropriate under the AUC and that 11.6% of nonacute cases were classified as inappropriate.

“We are duty bound to evaluate appropriate use of PCI and other medical procedures,” Marso told heartwire. “The problem is that we are no closer to being able to identify overuse based upon these appropriate-use criteria than before they were created. The reason is that there are too many assumptions and too much variability that go into that 11.6% inappropriate rate.”

For example, Marso et al argue that the AUC put too much emphasis on stress testing without precise definitions to guide the interpretation of those tests. “The vast majority of AUC scenarios require knowledge of preprocedural stress-test findings . . . [but] the NCDR does not require interpreting physicians to determine this risk. Therefore, this data-collection burden falls onto the data abstractors, who are required to assign a risk category based on vague guidelines,” they say. “Essentially, they are required to interpret the interpretation.”

Chan told heartwire that the appropriateness criteria were never intended to be perfect, but they are the best effort to sort out which procedures are supported by evidence and which are not. They will evolve over several iterations, including the recent update, which provides more detail on patients with unstable angina. However, Chan does not expect any major changes from the 2009 version to be made soon.

Chan also pointed out that the purpose of the AUCs is to explain the existing evidence base, not pass judgment on each procedure, so nobody should interpret “inappropriate” in the AUCs to mean “fraudulent.”

“Ultimately, my main concern is that we don’t lose sight of the forest for the trees. Our profession of cardiology has taken an amazing leadership role in defining quality and appropriateness of care—in a way that no subspecialty has done to date. In so doing, we have moved the quality yardstick forward,” Chan said. “[But] we need to be humble as physicians to recognize that sometimes we may actually be doing procedures that have little evidence to support their use . . . and that not only are we not providing benefit but perhaps subjecting patients to unnecessary procedure risks and costs.”

Who decides which side is “right” and which side is “wrong?”

Marso et al are especially concerned with the AUC’s treatment of patients with one- or two-vessel disease, no proximal left anterior descending artery involvement or prior coronary artery bypass graft, class I or II symptoms, low-risk noninvasive findings, and on no or minimal medications. The AUC state that PCI in this scenario, labeled scenario 12b, is “inappropriate.” This scenario accounted for nearly 40% of the inappropriate nonacute procedures categorized by Chan et al as inappropriate, making it the most common type of procedure in this category.

Prior to the release of the 2009 AUCs, Chan et al surveyed 85 cardiologists—including 44 interventionalists and 41 noninterventional cardiologists—on the appropriateness of 68 coronary revascularization indications also addressed by the AUCs. That group classified scenario 12b as “uncertain.” Instead of assuming that the cardiologists in the survey need to be educated about the appropriateness of this procedure, Marso et al suggest it’s the technical panel that could learn something from the cardiologists in the survey. “These are 80 clinical cardiologists who answered questions about what they thought was appropriate, driven by medical decision-making, and they concluded that the technical panel just plain got it wrong,” Marso told heartwire.

In response to this specific point, Chan told heartwire, “The decision of the AUC technical panel to make this scenario inappropriate was based on the lack of available clinical evidence to support PCI in patients who have only mild to moderate symptoms with intermediate stress tests without a trial of medical therapy. This is, indeed, consistent with the COURAGE trial, wherein medical therapy was found to be comparable to PCI for patients with even greater symptoms and more severe ischemia.

“Although the COURAGE quality-of-life substudy did find that patients who underwent PCI, compared with medical therapy, had modestly improved angina relief during the first year, this benefit was likely concentrated in those COURAGE patients who had far greater symptoms than [Canadian Cardiovascular Society (CCS)] class I or II—eg, CCS class II or IV,” Chan said. “Dr Marso’s assertion that this indication should be uncertain, however, is not supported by any evidence to date.”

Who decides who gets to decide?

Marso et al also object to the composition of the technical panel, which included only four interventionalists out of 16 total members. The panel was put together according to the so-called Rand method to prevent conflicts of interest. Marso objects to the technical panel’s insinuation that “interventional cardiologists are inherently biased due a financial bias or an intellectual bias, that their ideas are preconceived, and that they are unwilling to evaluate data in an objective manner.” He points out that the FDA, which certainly has a vested interest in rooting out both financial and intellectual bias from its advisory panels, does not limit whole categories of experts from serving on these panels. Instead, it evaluates the background and potential conflicts of interest of each individual.

Dr John Spertus, the director of outcomes research at Saint Luke’s Mid America Heart Institute and senior author of the AUC writing group, does not agree that the AUC technical committee needs more interventionalists. “The benefits of revascularization should be very transparent. Clinicians caring for patients should all be on the same page with the same perspectives of revascularization of patients. That isn’t information that is uniquely known to the interventional community,” he said. “While they have extensive expertise and knowledge around the technical aspects of doing the procedure, whether it should be done or not is something that all clinicians caring for patients with coronary disease should know, appreciate, and be able to communicate to their patients.”

The missing voice: The patient

In an accompanying editorial [2], Dr James Blankenship (Geisinger Medical Center, Danville, PA) argues that the AUC “will never fully define the best treatment decision for a particular patient . . . because occasionally, patients will have exceptional circumstances that dictate treatment different from that recommended by AUC and guidelines; and different patients experience a given level of symptoms differently.

“Determinations of appropriateness by the AUC based on angina class fail to take patients’ perceptions and preferences into account. This is a fundamental flaw, because patients’ perceptions and preferences are a critical component of decision making,” Blankenship argues. However, he acknowledges that “factoring in patient preferences raises a host of new problems. Patients’ preferences are routinely based on incorrect perceptions and nonobjective factors; [they] routinely overestimate the benefits of PCI, underestimate its risks, and underestimate the efficacy of medical therapy [and] tend to discount the sometimes-superior benefits of one treatment (eg, CABG for very complex triple-vessel disease), because those benefits accrue later, and instead prefer the more immediate but lesser benefits of another treatment (eg, PCI) because they accrue sooner (temporal discounting).”

More data on the way

Chan said that a prospective study of 7000 to 8000 patients measuring the change in quality of life from baseline to six months among patients who have undergone PCI will soon be complete. Results of this study, intended to validate the ratings of the AUC, will probably be available this summer, he said.

“We anticipate that we will find that patients with inappropriate AUC ratings will have little to no improvement in quality of life at six months, appropriate AUC ratings will have substantial improvements in quality of life, and uncertain AUC ratings will have modest improvements in quality of life,” Chan said. “Once we have these results, we will be able to say with confidence whether indications such as 12b should be kept as inappropriate or changed to uncertain.”

Spertus said that the AUC will be updated when there are methodological or technical deficiencies in the current approach or if important new evidence on PCI is published. One of the goals of the AUC is to identify gaps in the scientific knowledge that need further study.

Marso reports no personal conflicts of interest during the previous 24 months.

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New allegations of gross medicare fraud from overstenting and unnecessary interventional procedures has been filed against surgeons in Pennsylvania, including the prestigious UPMC medical center.  This story, (based on cases dating back to 2001 and onwards), comes just as the dust in settling from an outbreak of unnecessary stent cases in neighboring Maryland.

What is overstenting?

Article by Michael R’iordan from the Heart.com re-posted below:

Cardiologists accused of defrauding Medicare by performing unnecessary cardiac procedures

Erie, PA – A new whistle-blower lawsuit filed in US District Court in Erie, PA claims that five cardiologists from two medical practices defrauded Medicare by performing unnecessary cardiac and vascular surgeries and interventional procedures between 2001 and 2005.

The suit, filed under the False Claims Act (FCA) and first reported January 22, 2012 in the Erie Times-News [1], states that as a result of the fraud, Medicare overpaid for these procedures, which wasted substantial public money, and patients were placed at significant and unnecessary risk of harm.

According to a copy of the lawsuit obtained by heartwire, the physicians named are Drs Richard Petrella, Robert Ferraro, Charles Furr, Timothy Trageser, and Donald Zone. The two medical practices named in the lawsuit are Medicor Associates Inc—and its affiliate Flagship Cardiac, Vascular, and Thoracic Surgery (CVTS)—and the University of Pittsburgh Medical Center (UPMC) Hamot (formerly known as Hamot Medical Center). The Medicor practice is the full-service cardiology center affiliated with UPMC Hamot.

The lawsuit states that from June 2001 and earlier, the defendants “knowingly, systematically, routinely, and repeatedly submitted false claims to and received reimbursements from Medicare and other federal healthcare programs for medically unnecessary cardiac catheterizations and cardiac and vascular surgical procedures, including but not limited to . . . PCI.”

As result of the false claims, the physicians received money to “which they were not entitled.”

Paid directorships and kickbacks

Dr Tullio Emanuele, who worked at Medicor and Hamot Medical Center from 2001 to 2005, filed the suit and claims that Medicor engaged in illegal “kickbacks” with Hamot Medical Center and referred cardiac patients to the hospital. In the lawsuit, it is alleged that Hamot signed contracts with Medicor and Flagship CVTS, valued at $75 000 per physician and as high as $525 000 per year, and the doctors would refer patients in need of medical procedures to Hamot Medical Center.

“Specifically, Hamot identified physicians who referred a high volume of patients and/or had potential to refer a high volume of patients for special treatment and offered remuneration to them in the guise of sham contracts for medical directorships or other similar personal service arrangements,” according to the lawsuit.

The claim states the physicians and the participating hospitals violated the federal Anti-Kickback Statute and the federal Stark Act, which says that a hospital is not allowed to submit a claim for reimbursement from Medicare if the procedure has been referred by a physician with improper financial ties to the hospital.

The suit also claims that Emanuele began to grow suspicious in 2004 when he noticed higher rates of intervention among certain physicians within the group. Between 2004 and 2005, 4408 catheterizations were performed, and Petrella, Trageser, and Ferraro had a “rate of surgical intervention following catheterization of double the junior members of the group.”

Emanuele, according to the lawsuit, believes that many of the procedures were performed unnecessarily. For example, Trageser is accused of performing a cardiac catheterization in a patient with chest pain, despite the symptomology being inconsistent with angina. Ferraro is accused of implanting a stent in an artery with moderate stenosis, even though Emanuele previously recommended medical therapy. Zone performed a cardiac catheterization and overstated the severity of stenosis, sending the patient on to CABG surgery, where he/she later died.

UPMC Hamot and the named physicians received copies of the lawsuit last week, according to the Erie Times-News, and have 20 days to respond. If they are found guilty, UPMC Hamot and the Medicor physicians would be required to reimburse Medicare at triple the cost of the original procedure. Emanuele, as the whistle-blower in the case, would be entitled to 30% of the reimbursed money.

More on similar stories here at Cartagena Surgery:

The Ethics of the Syntax Trial

Stent Scandal series:

Cardiology takes another hit

Mark Midei – or the man who started it all..

This is just a sample of the articles available here at Cartagena Surgery.. For more on this topic, look under the cardiology tab..

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In a disturbing story out of Maryland, the Heart.org reports that Dr.  John Chung Yee Wang, one of the doctors investigating claims of improper, and unnecessary stenting in the wake of the Mark Midei overstenting scandals has now been charged with unnecessary stenting.

Is this just a sign of how incredibly pervasive this practice is?  Is this an example of the widespread corruption of a specialty due to a lack of outside oversight or accountability – and the incredible ease of creating huge profits [by performing unneeded procedures?]

Or is it as some cardiologists suggest, a crazed witch hunt?   I don’t know – but angiography doesn’t lie, and there have been too many cases of 20% and even 10% lesions being ‘over-called’ and stented as critical disease.  This is particularly important now – as a recent study [the landmark Syntax trial] shows that stents are not the ‘miracle cure’ they’ve been touted as.  In fact – one in ten patients who receives a stent has to be re-hospitalized within 30 days.

Overstenting, stent fractures, sudden stent thrombosis* and stent deformities – in the wake of all of this – we need to stop and consider our other options; the ones that aren’t quite as easy..

* Please note that both of these sources are heavily biased in favor of interventional cardiologists.

Supervised exercise programs as effective as stents

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As I delve further into the Syntax trial, (in preparation for a presentation at work):

Mark Midei was charged with another 175 counts of unneccessary stenting this week..

The Syntax trial is a great example of the ‘big lie’ of the easy fix – and the publicity spin, as explained on this blog by (what appears to be ) one of the last honest cardiologists..  As I slosh through reams and reams of printed articles, as well as on-line stories, and links to journals on the Syntax trial and the results – it becomes readily apparent – that it is almost impossible to find an honest, and unbiased report of actual syntax results (particularly since cardiologists are doing most of the writing.)  Cardiac surgeons – listen up!!  You know the truth about outcomes with stents versus cabg (surgery) – you see it every single day.. But stop sitting there smugly, and self-assuredly, so certain that the truth will out..

The truth is out, but it’s so muddied as to be unrecognizable.  Start writing your own research papers and defend yourself (and your patients) from this watershed of biased reporting.. Stenting is EASY but it’s NOT effective, and bypass surgery remains the standard of practice and the best treatment for longevity.. No propaganda can change that – but surgeons can’t lie back and rest on their laurels..

Dr.  DeMaio escapes..

and the most infamous cardiologist in America.

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The FDA recently approved the first TAVI device for aortic stenosis.   Currently the device is only eligible for patients who are unable to withstand surgery.   But who will end up making that determination?  The cardiologist who will be implanting the device?  At present – the company manufacturing the Sapien aortic device is recommending that patients be evaluated by a heart surgeon – but if this follows the typical course, I am sure that this recommendation will be abandoned as a matter of course.

Hopefully, the industry (interventional cardiology) will proceed cautiously, after being ‘omce bitten, twice shy” in light of the epidemic overstenting catastrophies.

For more on Aortic stenosis, TAVI and the overstenting controversies – look under the cardiology and cardiac surgery tab.

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Update: 12 July 2011 :  Another kind of inappropriate stenting makes this news.  In the stories below, interventionalists are placing stents in patients after a heart attack (but days to weeks after – when the artery has already closed – tissue has died).  In these cases, stents are not advised because it’s too late to salvage any heart muscle, making stents in the culprit artery useless.  (However, some interventionalists may still be placing stents inappropriately in these cases not due to fraud but because they have failed to keep up with the most recent guidelines and recommendations for treatment, which is only mildly comforting.)

Guidelines don’t curb unnecessary treatment

Doctors overusing stents  – article quote

“Hochman’s findings apply to about 100,000 Americans a year, suggesting that
about 50,000 people are having the $20,000 procedure done unnecessarily every
year.”  [if you remember from a previous post – a prominent interventional cardiologist considered 50,000 “a rare event”.]  It’s also a billion dollars worth of unnecessary procedures..

From 13 June 2011

More cases of overstenting make the news – again.. This time it’s a cardiologist and a radiologist in Tennessee.  Both are accused of ordering unnecessary tests, including angiography (cardiac caths) and performing unnecessary stenting in a scheme to defraud insurance.. The radiologist received kick backs for his patient referrals..

Article by Reed Miller  (June 10, 2011) over at Heartwire.com re-posted here.

Unnecessary stenting cases grabs government attention in Tennessee

Jackson, TN – The US Department of Justice is looking into charges of fraudulent billing leveled by a Tennessee cardiologist against another cardiologist and two hospitals.

Dr Wood Deming (Regional Cardiology Consultants, Jackson, TN) 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, according to documents filed with the US District Court for Western Tennessee. Deming also alleges that the executives of Jackson-Madison County General Hospital and the Regional Hospital of Jackson and radiologist Dr Joel Perchik (Advanced Radiology, Jackson, TN) condoned or assisted in Korban’s fraud in addition to engaging in a bilateral kickback and self-referral scheme [1].

Deming is seeking to collect a portion of whatever fines the government collects from the defendants in this case, as provided for by the “whistleblower” provisions in federal antikickback and false-claims laws.

According to Deming’s complaint, from 2003 onward the hospitals’ executives allowed Korban to routinely order numerous unnecessary diagnostic studies at the hospitals, including transthoracic echocardiography, scintigraphic stress imaging, and transesophageal echocardiography, and then ordering that the patients be transported by ambulance to one of the hospitals for unnecessary catheterization, coronary angiography, and other coronary and peripheral intervention procedures. The complaint alleges that many of these patients underwent coronary angiography after a negative stress test on the premise that they were still having chest pain, but the records were fraudulently dictated to reflect symptoms that were not present. In many cases, Korban subsequently performed unnecessary interventional procedures including stenting, and patients were then admitted to one of the hospitals for recuperation, Deming alleges.

Deming also alleges that Perchik and the hospitals’ leadership “engaged in a pattern of bad-faith peer review of any physician who chose to oppose the hospitals’ drive for excess and inappropriately collected remuneration, such that such physicians were eliminated from the medical staff if they chose to speak out as whistleblowers concerning any aspect of the scheme,” according to the documents. He also accuses Jackson-Madison County General Hospital of paying for referrals from Medical Specialty Clinic, a group practice led at the time by the hospital’s chief of the medical staff, Dr Charles Hertz. Deming alleges that these illegal payments for referrals were concealed in a series of real-estate transactions.

A statement issued to heartwire from Jackson-Madison County General said that the hospital “is fully cooperating with government investigators and because this is an ongoing investigation we have no further comment.” In a prepared statement, the Regional Hospital of Jackson said it is “pleased that the United States chose not to intervene in the portion of the relator’s lawsuit that named the hospital and a former administrator.”

Likewise, staff at Korban’s office responded saying, “At this time, we have no comment,” and the lawyer for Deming did not return calls.

Deming filed his complaint in 2007, but it remained under seal until Assistant US Attorney William Siler notified the court in May that his office intends to pursue a case against Korban [2]. The US attorneys have agreed to investigate only Deming’s allegations against Korban for false and fraudulent billing for unnecessary cardiac stent procedures that caused the submission of false claims by the hospital. The US attorney’s office in Memphis will file its own complaint against Korban within the next two months.

However, the Department of Justice will not intervene on any of the other charges against any of the other defendants, including the hospitals, but charges against the other defendants cannot be dismissed without approval of the Department of Justice, which also reserves the right to intervene in those actions later.

As first reported in the Jackson Sun [3], last week, US District Judge Dernice Bouie Donald acknowledged the US Attorney’s plan to intervene and ordered that Deming’s complaint be unsealed and served on the defendants with 120 days [4].”

I still think this is only the tip of the iceberg.  If cardiology researchers themselves estimate that over 11% of stents were not ‘appropriate’ with another 38% being ‘undetermined’ (statistics from a previous post) – well, that’s a heck of a lot of folks that got stents that didn’t really need them.

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Here’s another re-post from Heartwire :

Midei and unnecessary stents—or lack thereof—make news again

April 25, 2011            |            Shelley Wood

Baltimore, MD and Greensburg, PA – “Unnecessary stents” and the people who place them have been back in the news this past week with a confusing twist of the tale in Pennsylvania, previously reported by heartwire, where two cardiologists stepped down on charges of unnecessary stenting [1], and a published Commentary, by Dr Mark Midei, in the Baltimore Sun [2].

The latest development in the Greenburg, PA case, reported Saturday in the Pittsburgh Tribune-Review, involves an admission by the hospital’s chief medical officer that at least six of 141 Westmoreland Hospital patients sent letters telling them they may have received “unnecessary stents” in fact never got stents in the first place. Instead, the hospital now says, these six patients underwent angioplasty procedures that appeared, on review, to not have been medically warranted, although no stents were placed.

The two cardiologists who treated the 141 patients—Drs Ehab Morcos and George Bousamra—voluntarily resigned after hospital administrators first questioned the medical necessity of the procedures. Those questions stemmed from the conclusions of eight independent cardiologists, as part of a review by the American Medical Foundation in Philadelphia. The hospital alerted patients to the situation via a letter, and 19 patients have since launched lawsuits against the two cardiologists and the parent health organization for the hospital, Excela Health.

The hospital has now sent new letters “of clarification,” the Tribune-Review reports, a move that has been slammed by lawyers handling the lawsuits and by outside observers.

“It is confusing,” Dr Gregory J Dehmer (Texas A&M University College of Medicine, Temple) is quoted in the article. “The bottom line is that it was an unnecessary procedure, whether they got a stent or not.”

Midei’s day in the Sun

Meanwhile, Dr Mark Midei, whose predicament in Baltimore is viewed by many as the catalyst for the stepped-up scrutiny of interventionalists around the US, once again lays out his side of the story—this time in the Baltimore Sun, the newspaper that has meticulously covered this saga. In the article, published Friday, Midei notes that he will soon be appearing before the Maryland Board of Physicians to “make the case for retaining my license to practice medicine” but in the meantime wants his voice heard.

Midei repeats an allegation he made when he first spoke out on the case, in an interview with heartwire, saying that St Joseph used him as a “decoy” when the hospital was embroiled in a federal investigation.  He has also, he says, been falsely portrayed as “manipulating” the peer-review process at the hospital, when in fact “any doctor, nurse, technologist, or physician assistant could suggest additional cases for review.” As well, he notes, he was not paid by the hospital based on the number of cases he performed, as press reports have suggested.

As for his relationship with stent manufacturers, he says he never accepted gifts or offers from companies, and any personal honoraria were donated to outside charities or foundations. He does not specifically address the now famous “appreciation pig roast” paid for by Abbott held for St Joseph’s cardiac staff in Midei’s backyard.

But he does, with some humility, acknowledge that may not “have been perfect in my practice of medicine; no doctor can make that claim.”

And he concludes: “I can say unequivocally that my decisions as a doctor have been motivated by one thing only: The well-being of my patients.”

As reported by heartwire, two cardiology organizations recently asked the state of Maryland to legislate cath lab oversight in an effort to avoid the tangles unraveling in Baltimore and Pittsburgh; that plan has since been nixed.

Update: 22 July 2011 – Dr. Midei’s medical license has been revoked. (article re-post – Heartwire.com in another report by Shelley Wood).

Dr Mark Midei’s medical license revoked

July 13, 2011            |            Shelley Wood

Baltimore, MD (updated) – The Maryland Medical Board has concluded its review of Dr Mark Midei, deciding to revoke his license, calling his violations of the Medical Practice Act “repeated and serious.”

The disciplinary actions alert published on the board’s website today notes that the board will not accept any application for reinstatement by Midei for at least two years. At that time, it is up to the board whether it will consider reinstatement of his license.

As previously reported by heartwire, Midei is alleged to have implanted hundreds of unneeded stents when he worked at St Joseph Medical Center in Towson, MD. The imbroglio was ultimately taken up by the US Senate Finance Committee, which issued a damning report back in December 2010.

For years, however, watchers have been waiting to hear what the Maryland Board of Physicians concluded, having charged Midei with violating the Medical Practice Act back in July 2010, focusing specifically on five patients it was alleged may have received stents unnecessarily. A subsequent seven-day hearing before an administrative law judge (ALJ) led to her issuing a 77-page “proposed decision” that Midei have his license revoked for having violated five provisions of the act, specifically those prohibiting:

  • Unprofessional conduct in the practice of medicine.
  • Willfully making a false report or record in the practice of medicine.
  • Gross overutilization of health care services.
  • Violations of the standard of quality care.
  • Failure to keep adequate records.

In its “findings of fact,” the board concluded that Midei implanted six cardiac stents unnecessarily in four out of the five cases reviewed and noted in his charts that the extent of the stenosis was 80%, when in fact it was lower “and in most cases much lower.” In three cases he falsely reported that patients had unstable angina, when in fact they didn’t, and in all five patients he failed to obtain the active coagulation time and instead administered heparin while inserting the catheter. In one of the patients, Midei “also failed to look at or disregarded the hospital’s note that the patient had already been given an anticoagulant and should not be given another.”

In June, Midei filed exceptions with the board in an oral hearing, which was considered in advance of today’s announcement. Those included a request by Midei that the board reverse the judge’s opinion on which expert reviewer to believe. The ALJ had used Dr Matthews Chacko (Johns Hopkins Hospital, Baltimore, MD) as expert reviewer, whereas Midei’s primary expert witness was Dr William O’Neill (University of Miami, FL). The board’s “consideration of exceptions” notes that all of the experts were “qualified” but that the ALJ “made her determination based on the consistency of Dr Chacko’s testimony and his clear presentation and demeanor” as well as her consideration of professional publications. By contrast, the ALJ “noted some inconsistencies or equivocations in the testimony” of O’Neill. Also at issue was the fact that Chacko was paid $1400 for his report and expert testimony—something Midei raised as problematic. The board report notes that O’Neill, Midei’s expert, was “paid more than 20 times that much.”

Asked to comment, O’Neill emailed heartwire to say: “I think it’s a tragedy that a fine doctor’s reputation and livelihood are ruined when there was never a single shred of proof that he harmed any patient. I stand by my [previous] comment that after reviewing all the records and films personally, I would have no problem letting Dr Midei treat me or a family member. I pity any interventional cardiologist practicing in Maryland today; if Dr Midei can lose his license, any of them could.”

The board agreed with the ALJ’s conclusions and, “using its own expertise,” agreed that Chacko’s testimony “represents an accurate statement of the standard of quality care.” The board clearly took exception to Midei’s suggestion that he sometimes wrote “80%” as a form of shorthand for blockages that in fact were less than 50%, calling that “a justification for a blatant falsehood that resulted in patients receiving unneeded stents as well as the creation of false records.”

The board also questioned the believability of Midei’s testimony that his decision to stent certain patients was on the basis of “remembered” symptoms not recorded in patients’ medical records. “The ALJ found it not credible that Dr Midei could remember these unrecorded symptoms in the cases of patients who were among thousands that he saw only once, for very brief period of time (from 20 to 37 minutes) three years previously.”

As reported by heartwire, Midei, who is being sued by hundreds of former patients believing they received unnecessary devices, is himself suing his former hospital, St Joseph, alleging in part that he was a scapegoat in “an epic campaign of corporate deception, trickery, and fraud” relating to past business deals and a federal investigation. In his medical-board hearing, Midei was permitted to present evidence to support this claim; the board, ultimately, agreed with the ALJ that “nothing St Joseph Medical Center did or failed to do is relevant to the issues of this case.”

The final decision and order, signed by board chair Dr Paul T Elder, contains a number of scalding conclusions about Midei’s conduct, stating that he failed to deal honestly with patients and colleagues and that his reports intentionally and nonaccidentally “exaggerated” patient symptoms and degree of stenosis.

“Dr Midei’s violations were repeated and serious. They unnecessarily exposed his patients to the risk of harm,” the decisions states. “They increased the cost of the patients’ medical care. Dr Midei’s willful creation of false percentage numbers for the degree of occlusion of coronary arteries is indefensible and amounts to a deliberate and willful fabrication of medical records.”

Requests for a reaction from Midei’s lawyers have not been returned. Midei has 30 days to ask for a judicial review of the decision.

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