Posts Tagged ‘fraud’

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..


Read Full Post »

There is an excellent article by Simon Wein, published in Oncology; “Cancer, unproven therapies and magicthat explores not just alternative and complimentary health – but also the taxonomy itself.  He also talks about the rationale behind these strategies (magical thinking) for patients – as coping mechanisms etc. and as a palliative care physician – he’s certainly has the experience to understand, and explain the behaviors of the dying and their families.

But here at Cartagena Surgery – we’re going to stick with the taxonomy or nomenclature for a minute.

One of the things the author asks is, “Is it fair to lump massage therapy, and palliative health practices under the same umbrella with shamanism, patent medicines, voodoo and faith-healing?*” [in fairness to the author – these are my examples, not his.]  This is, I feel a legitimate question – asked under circumstances (aggressive cancers) that certainly warrant closer investigation.  In his writings, he uses the term, “unproven therapies” which is descriptive, but not quite whole.  It does reveal a gap in our medical language for describing, and discussing these types of treatments.  Too negative a word such as ‘fakery’ or ‘quackery’ is just as unfair as misleading terms such as ‘miracle treatments’, ‘panaceas’ or the emotional laden term, “cure.”

Part of the problem is that currently, our language doesn’t differentiate between these therapies – the whole spectrum from massage, music, pet therapy, yoga to crystals, reiki, and new age spiritualism  and alchemy fall under the heading of “Alternative Therapies”.  This is a significant problem  – because by lumping all of these ‘treatments’ together, it makes it even harder for people / patients to distinguish which therapies have merit, and which ones don’t – (or which claims have validity – and which claims are out-and-out lies.)

As we’ve discussed in several previous postings – sadly – there are people (Frauds) everywhere who are happy to make money off of someone else’s misfortune or tragedy.  Not only that – but as part of an attempt to protect themselves from either discover or prosecution, these people will discourage patients from seeking legitimate medical care, often leading to dire consequences for the patients involved.

Then there are people, who may have earnest beliefs but no proof or clinical basis to promote their ‘therapies’ but use ‘anecdotal evidence’.  While these people may sincerely believe in the therapies they are touting, this too – should not be covered under the title of ‘alternative or complementary therapies.’

Using this umbrella terminology legitimizes practices that should never be legitimized.  It makes no discrimination between complementary therapies that have been clinically proven to provide benefits (such as massage, and physical therapies) and out and out ‘quackery’ that may even hasten a patient’s deterioration.

But thirdly, there are therapies ALL along this spectrum, that will never ever cure, or heal medical illness but do provide very real benefits to their practitioners/ adherents.  This is what Dr. Wein addresses when he talks about coping.  These therapies need to be recognized as well – without overemphasizing or estimating their effects.  This is where new terminology can help delineate these concepts in just a word or phrase..

Why is this important?

While I am one of the first people to argue for a person’s right to self-determination, and the right to choose your own treatment – it is important that people have accurate and truthful information.  This is particularly important when people are facing serious, or potentially terminal illnesses.  Also – using the umbrella term of ‘alternative’ therapies does not excuse these therapies or their practitioners of the burden of providing scientific or research based proof of their claims.  Too often – these practitioners use ‘faith’ as the basis of their claims, to excuse themselves from the scientific rigor that other treatments (chemotherapy, surgery) must undergo.  There is a very nice blog by a surgeon that discusses many of these issues in the context of the case mentioned above.  [I don’t usually promote so-called ‘anonymous’ blogs but the content of this particular post is very well-written.]

This ‘faith’ does not refer only to religious beliefs, though many practitioners use this guise to guilt believers (patients) into accepting (and paying for) otherwise questionable practices.  This ‘faith’ is often based on the practitioners (and patient’s) willingness to believe in the treatment itself.  Thus, a failure of the treatment is attributed in a failure of the patient to believe – (blaming the patient for treatment failure).

A good example of this is “The Secret” phenomenon that occurred a few years ago – based on a book touted by Oprah Winfrey.  In several cases, including one widely publicized case, people stopped conventional treatments to attempt to treat/ cure cancer based on principles from this book – mainly ‘positive thinking’.

While I may not believe in any/ all of these therapies – I do realize that others derive comfort from many of them – which leads to my proposal for a new terminology for many of these treatments.

As an alternative terminology, I propose the term, “Comfort therapies” as an umbrella for all of the practices and therapies that fall outside of legitimately and scientifically proven ‘alternative health’ practices.  This is not to say that these therapies are without merit – but that the merits of these therapies is better described with this new terminology, as more fully defined below.

Comfort Therapiesany health-related practices, treatments or therapies that give spiritual, emotional or physical comfort to its receiver, but are devoid of demonstrable, or valid clinical measures meeting scientific rigor to show clinical benefits. These therapies may rely on anecdotal ‘evidence’ as proof of effectiveness.  These therapies will not ‘cure’ patients or practitioners of any medical disease or condition but may provide recipients with varying measures of comfort.

This term acknowledges the very real spiritual and emotional benefits (namely comfort) that patients and their families may receive from these therapies without legitimizing claims of ‘cure’ that are unproven and unsupported by clinical evidence or scientific research.  Also the term ‘comfort’ very clearly does not imply healing/ fixing / or curing.  In medicine – particularly palliative medicine, “comfort care” is a concept that is already well-established – and these therapies fall well within palliative frameworks, when presented and accepted as such.

While it’s an imperfect definition – it fits many of the imperfect or poorly defined therapies out there which do provide some (if limited) benefits to our patients.  It also clearly delineates the degree of effectiveness that these therapies can legitimately claim, which is important.

*This is not about religion or religious beliefs – that is not up for discussion here.  This post is about people using a person’s beliefs to victimize patients, by making patients feel guilty, disloyal or unfaithful for questioning many of these (sometimes costly and harmful) practices.  This post is also about how imprecise language and terminology can contribute to the confusion and deceptive practices.

Read Full Post »

Here’s a link to another heartbreaking story, of a person who was taken in by a fraudulent medical practitioner. In this story, the patient initially began seeing this uncredentialled/ unlicensed ‘alternative healer’ for a chronic pain condition because she didn’t have insurance. We’ve talked about unlicensed / fraudulent practitioners before, (usually pretending to be surgeons) and how to research to make sure your doctor is a licensed surgeon. Today we are going to review a case and talk about the clues that may indicate that the practitioner  is not a legitimate, licensed health care provider.

(Read the article first – then come back here to discuss).

However, while reading this article – several warning bells should go off:

He claims to ‘intuitively’ know what is wrong with people just by looking at them.
This is extremely far fetched to begin with. Even the best doctors in the world use tests, and instruments to help them assess and evaluate patients. No one just ‘knows”.

He is not licensed.
Regardless of what you might think regarding the validity of different alternative health practices – most states have established regulatory boards to oversee practitioners of alternative health (acupuncture, massage, reiki etc.) The boards require practitioners to provide evidence of formalized education and training, and have been established to protect the public from
abuses similar to what is described in the attached article.

In this case, he claimed his license was being ‘processed’ yet he had been treating a number of
people the patient knew over the course of an extended period of time. Licenses don’t take years – and in many cases license boards issue temporary licenses almost immediately after application – so that should have been a red flag..

He does not have an ‘office’.

This person provided ‘treatments’ in the basement of a Chinese restaurant – similar to previously presented cases of patients having surgery in motel rooms, garages, and apartments. Legitimate practitioners have offices. Granted, the office may be small, or attached to their home but an official office nonetheless. The office should be well marked with a sign or
signs on the outside, and listed in the yellow pages. A hidden ‘office’ in an unmarked area of another business should make you suspicious. He later upgraded to a set of rooms, with a website but the website – breaks another rule we talked about in a previous post – Avoid anonymous blogs/ anonymous websites.

Prescribes “sketchy” treatments of dubious value – (particularly if involving exposure or manipulation of genitalia.)  You don’t need to have medical training to question the use of ‘rectal penetration’ for the treatment of ‘pre-diabetes’ like the patient
reported in the above mentioned article. In fact, I would advise anyone to question any ‘health’ provider that wants to manipulate or examine your genitals (outside of an OB/GYN office). This is often done because quack /fraudulent practitioners know that personal embarrassment will prevent many of their patients from complaining or reporting them once they realize they’ve been duped. (People are often too ashamed to admit that their trust was breeched in such an intimate and personal way.)

If the ‘doctor’ wants to touch you somewhere that makes you uncomfortable  – particularly for a seemingly unrelated complaint like diabetes, neuralgias or migraines – pull your pants up and get the heck out of there.

There is no definitive treatment plan (or it’s an endless treatment plan) – this is
more important when talking about physical treatments such as chiropractic or ‘adjustment’ therapies. There should be a planned amount of sessions (i.e. 10treatments, for example) not an endless cycle of treatments. This should be clear at the first or second visit. Part of legitimate therapy is adjusting the treatment plan to the person’s response – but if looks like it is endless –
consider seeking a second opinion.   Also – talk to other patients – are they all doing more than the original set of treatment? If everyone you know is still receiving on-going treatment, you should re-assess how it effective it really is.

It’s a panacea treatment – we talked about this a little in the paragraph above, but no one treatment cures all ailments, and very few treatments ‘cure’ systemic diseases. Any ‘cure’ claims should be specifically investigated.

Take diabetes for example – there is no non-surgical ‘cure’ for diabetes, and the existing surgical treatment is well-publicized, well documented and well researched (and reported in reputable medical journals). There are no ‘secret cures’ that are known to just a few select practitioners. If someone is advertising a ‘miracle cure’ or a ‘cure’ that only they have – a red flag should immediately go up… Legitimate / valid medical therapies are not advertised in the back of tabloid newspapers, or in small print.

Legitimate practices are backed by hard science** , clinical data and randomized control trials (RCTs).  (RCTs are the gold standard for evaluating and establishing a pattern of causality (A leads to B). Without this data -anything a provider presents as a claim, is suspect.

** Not chakras, ‘spiritual’ sources or mystical effects.

This isn’t to say that ‘alternative medicine’ doesn’t have a place in today’s health care system – but there is a huge difference between alicensed massage therapist / acupuncturist/ etc. and someone who sets out a shingle and suddenly claims to be an alternative health provider without the appropriate training / background.  Legitimate providers would want to prevent their specialty from quackery and frauds are among the most ardent supporters of government regulatory boards to protect their patients.

In other news – I have re-posted the article series on carotid stenosis to Yahoo! Associated Content – so if you get a minute – take a look – so the article gets some views..  (If I get enough views, I will write some more articles for Yahoo!)

Read Full Post »

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.

Read Full Post »

Now all of my long-term readers should be able to spot the flaws in the logic here. One study, funded by a drug company with results that are at odds with just about every other study ever published – and that’s the one the FDA uses to approve/ expand the indications for stenting? Guess it’s just another ‘easy’ solution to sell to patients / primary care providers who don’t have the time and resources to review the literature themselves.  No surprise, since I am guessing that cardiologists will be placing the majority of these stents..

From HeartWire:
FDA approves expanded indication for carotid stenting
May 6, 2011 | Susan Jeffrey

Adapted from Medscape Medical News—a professional news service of WebMD
Silver Spring, MD – The US Food and Drug Administration announced today it approved an expanded indication for the RX Acculink carotid stent system (Abbott Vascular, Santa Clara, CA) to include patients at standard surgical risk for carotid endarterectomy [1].

Previously, the RX Acculink stent, used in conjunction with Abbott’s Accunet or Emboshield embolic-protection devices, was approved for use only in patients requiring carotid revascularization who were at high surgical risk. These high-risk patients were also required to have a reference vessel diameter ranging from 4.0 mm to 9.0 mm at the target lesion and be symptomatic with a stenosis of the common or internal carotid artery of >50%.

The stent was also previously approved in high-risk patients without neurological symptoms but with a stenosis of the common or internal carotid artery >80%.

In January, the FDA’s Circulatory System Devices Panel voted 7 to 3 in favor of this expanded indication for the system, saying the benefits of carotid stenting in patients at standard risk for adverse events from endarterectomy outweighed the risks. wait – are you sure about that?? because most of the data shows that surgical risk is actually well under 1% – and that’s looking at VA studies involving tens of thousands of patients, with multi-year follow-up..

The panel also voted 6 to 4, with one abstention, in support of the safety of carotid stenting in standard-risk surgical patients and 8 to 2, again with one abstention, in a vote that asked about the effectiveness of therapy in this expanded patient population.

“Expanded access to RX Acculink means patients and their healthcare providers have another option for treating clogged neck arteries,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement.

The FDA based its approval on the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), a 10-year study of 2502 symptomatic and asymptomatic patients at 119 clinical sites in the US and Canada, funded by the National Institute of Neurological Disorders and Stroke with supplemental funding by Abbott.

Patients were treated and followed for at least one year. Results of that study, published in the New England Journal of Medicine, showed that patients treated with stenting had a similar combined rate of death, stroke, and MIs those who underwent surgery [2].

Those who underwent surgery, however, had fewer strokes, and those who had stenting had fewer MIs over follow-up. There was also an effect of age, where older patients had fewer events with surgery, while younger patients had slightly fewer events with stenting. Wait a minute – older patients – surgery is actually safer.. but remember, that’s the excuse we received from the beginning – ‘stents are for the frail old people’.. define ‘slightly fewer’ – does that mean ‘not statistically significant’ because that’s what it sounds like. [cartagena surgery]

The FDA advisory panel emphasized the need for additional long-term follow-up information and the importance of the stent’s use in conjunction with an embolic-protection device.

As a condition of the approval, Abbott is required to conduct a postapproval study that will follow new patients treated with the stent system for at least three years to confirm the results identified in CREST.

The postapproval study will also evaluate how patients age 80 years and older respond to treatment, whether treatment success is affected by operator experience, and whether symptomatic and asymptomatic patients have different outcomes.

“The study is consistent with recommendations made by the expert advisory panel,” the FDA statement notes

Read Full Post »

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.

Read Full Post »

Over at theheart.org they’ve published a whole series of video lectures, articles, and discussions on the phenomena of overstenting and inappropriate PCI.. Of course, you have to be a member to read any of it – which leaves a lot of my readers out in the cold. As longtime blog readers know, we’ve discussed this topic at length in previous posts:

What is overstenting?

The problems with stenting (USAToday report)

I have another re-post from Reed Miller on the topic – which I’ve pasted below.. It’s quite wordy, but I want you to remember while you are reading this – that they are discussing the percentage of inappropriate procedures according to cardiology guidelines – now that’s a particularly important point, because, if you recall – about a month ago: there was an article calling into question the validity and appropriateness of these very guidelines, since the majority of cardiologists that helped draft them were paid large sums of money by stent manufacturers and drug companies.

Also I have placed certain areas in italics.. Areas where I feel the commentary in the article is questionable, or open to debate – such as stenting the left main or three vessel stenting – just because interventional cardiologists have decided that they should perform this procedure doesn’t mean that it benefits the patient – or that the procedure isn’t still somewhat controversal.
So what does this mean to you – it means that we need to continue to focus a critical eye on cardiology, and the current use and indications for stent placement.

So, what should you do if you find yourself in this situation? you or a loved one has just had a cardiac catheterization, and you find yourself wondering about the best/ most appropriate treatment.. Ask to have a cardiac surgeon review your history and films.. A lot of good facilites already do this – to get a second opinion.. A cardiac surgeon is going to be looking at your films with a different perspective – we only want to do surgery once – when it benefits the patient the most, since surgery is nothing to be taken lightly.

NCDR shows 11.6% of nonacute PCIs and 1.1% of acute PCIs are “inappropriate” based on AUC
April 5, 2011 | Reed Miller

“New Orleans – A review of over 500 000 cases presented at the American College of Cardiology (ACC) 2011 Scientific Sessions shows that overuse of PCI is uncommon but that there is still plenty of room for improvement in the number of inappropriate elective PCI procedures.” Really? More than 1 out of ten – and they say it’s uncommon? Pretty darn frequent, you ask me (cartagenasurgery).

This morning, Dr Paul Chan (St Luke’s Mid-America Heart Institute, Kansas City, MO) presented results of a study of over 500 000 cases in the National Cardiovascular Data Registry (NCDR) from July 2009 to June 2010 that categorized each PCI as appropriate, inappropriate, or of uncertain value based on the 2009 coronary revascularization appropriate use criteria (AUC). The AUC writing committee included representatives of the ACC, Society for Cardiovascular Angiography and Interventions (SCAI), and several other cardiology organizations, including two surgical specialty groups.

Chan reported that overall, 84.6% of the procedures in the study that could be categorized were appropriate based on the AUC, while 4.1% were inappropriate and 11.2% were in categories that the AUC deems uncertain.
Former SCAI president and member of the AUC writing committee, Dr Gregory J Dehmer (Texas A&M University College of Medicine, Temple), told heartwire that the study by Chan and colleagues “really gives us our first biopsy of what is the level of appropriateness of PCI care in all of these NCDR hospitals, which include over 900 facilities.”

Dehmer proclaimed that the results are “great news, especially in today’s environment,” referring to the recent cases of interventionalists charged with routinely performing inappropriate PCIs. “It’s very comforting news for both patients and regulators,” he said.

Most of the problems in nonacute procedures

Of the cases that could be categorized by the AUC, 71% were acute patients, and 98.6% of these were deemed appropriate procedures while only 1.1% were inappropriate. Chan also pointed out that there was very little variation among hospitals in their rates of appropriate and inappropriate procedures for acute patients. The acute cases included were ST-elevated MIs (21.3%), non-STEMIs with documented troponin rises (20.5%), and patients with high-risk unstable angina (29%).

However, among the 29% of the categorizable elective PCIs for nonacute patients in the study, 50.4% were categorized as appropriate, 38% were of uncertain value, and 11.6% were inappropriate based on the AUC. About 71% of the inappropriate nonacute patients were low-risk according to their ischemia study results, and two-thirds were asymptomatic to very mildly symptomatic. More detail on the study will be provided when the results are published in a peer-reviewed journal. The paper is currently under review, Chan said.

The study showed wide variation from center to center in the rate of inappropriate intervention in nonacute patients, ranging from below 10% to over 30%, and the median was 10.7%, with an interquartile range of 6% to 16.7%. Some of these cases were appropriate due to special circumstances, Chan said. “However, it is unlikely that exceptions would explain this marked variation across sites” in the rate of inappropriate procedures in nonacute patients.

Mostly good news, but plenty of room to do better

Chan agreed that the study results show that “on the whole, the US angioplasty community is doing a decent job in ensuring that most procedures are appropriate when you look at the acute and nonacute procedures all together, but we do have some work to do in the nonacute setting.” He added that “no other subspecialty has taken the lead on self-regulation and self-reflection like cardiology has, and it’s a tribute to organizations like the ACC that are moving this field.”

Really? Didn’t several cardiologists have to be charged with malpractice for ‘the subspecialty to take the lead’?? Didn’t state legislature (maryland) have to become involved for an investigation to take place?? (cartagenasurgery)

Chan and Dehmer both emphasized that while there is plenty of room for reduction of unnecessary procedures, no center should expect to have a rate of 0% inappropriate procedures. There will be cases where patient characteristics not considered in the AUC make an otherwise inappropriate procedure appropriate for a particular patient. The AUC categorizes 198 clinical scenarios based on acuity of presentation, extent of coronary disease, the extent and magnitude of ischemia, the intensity of medical therapy, and the severity of symptoms, but the AUC do not consider potentially critical factors such as age, Dehmer pointed out. “For example, what you’d do for a 45-year-old guy who can’t hold down a job because of his coronary disease might be different from what you do for an 85-year-old grandmother who just sits and knits all day.”

Sounds like the 45 year old might need CABG or TMR versus 27 stents that will close in a year or two. (cartagenasurgery)

“But when you have some hospitals exceeding 17%, in the upper quartile, and others at 6%, we need to learn what the hospitals with lower rates are doing differently,” Chan said.

Chan also pointed that about 19% of the PCI cases that the investigators originally looked at for inclusion in the study could not be categorized by the AUC because the case record is missing some relevant information. For example, the study had to exclude patients who had stress tests but whose ischemia risk was not recorded by the referring physician. “That’s something that we can improve” by emphasizing to the NCDR sites and referring physicians the importance of collecting all of the information needed to show that a procedure is appropriate.

He also noted that the AUC will soon be updated to reflect more recent clinical trials on left main and three-vessel disease, although most of those procedures are already categorized as appropriate.

this wisdom of doing PCI on the above mentioned patients is still hotly under debate, but as we’ve discussed before- long term data favors CABG (in these patients with SEVERE disease.) The studies they mention only look at six month outcomes. (cartagenasurgery)

Interventionalists must use the data wisely

In the future, centers participating in the NCDR will receive quarterly reports detailing the rates of appropriate, uncertain, and inappropriate PCI procedures performed at their facility, with benchmark data on how other centers are performing. The centers will also receive a line-item list of all the cases that were classified as inappropriate for that quarter so that they can subsequently develop internal quality improvements to better understand why those procedures were performed. “Maybe there are all sorts of reasons to explain it, but we need to find out why. It causes the questions to be asked and then, hopefully, if there is a reason, those reasons can be rectified,” Dehmer said.

Dehmer also pointed out that the continued collection of these data will identify “gaps in our knowledge” and which types of procedures need more study. It may also help to stimulate more discussion among interventionalists about appropriateness. A recent survey by Chan et al found widespread variability of opinion among cardiologists on the appropriateness of some PCI indications.

“Hospitals should look at their rates in relationship to other hospitals and how far above or below the median they are and then look at the list of the inappropriate cases and go back and better understand if there were extenuating circumstances that made them [actually appropriate],” Chan said. “But if there is a pattern such that the majority of those inappropriate cases didn’t have exceptions, then it provides a red flag, and the interventional cardiologists should discuss how this should inform their future practice. Even hospitals with low rates of inappropriate cases can use that information to see if there is further improvement they can make.

“It will be interesting to see how hospitals and physicians work together to develop the quality-improvement effort to look at these questions,” he said. “The use of the reports will dictate how useful the information we’re providing to physicians will be. If the reports are just put on a shelf, they won’t provide hospitals any benefit.”

Also, it appears if you document poorly, when the cardiologists review the data – they will note any discrepancies as ‘uncertain’ instead of ‘inappropriate’ which saves them from admitting what the real incidence of inappropriate PCI is. In 1 out of 5 cases, the cardiologist couldn’t bother to chart completely, but I bet they were more diligent in the billing department…

Read Full Post »

Older Posts »