Maryland Mulls Midei Case as Cardiology Orgs Ask Legislators to Leave Policing Procedures to Doctors

Shelley Wood

September 01, 2010

September 1, 2010 (Baltimore, Maryland) — There is no word yet from the Maryland Medical Board as to what action, if any, it will be taking against former St Joseph's department of cardiology chair Dr Mark Midei, after a private meeting with him August 4, 2010, or against any other hospitals identified by the board has having conspicuously high stent-procedure volumes. Lawyers for Midei have told heartwire that their client can't tell his side of the story while a review of his cases is continuing. His medical license is listed as "active."

As previously reported by heartwire , Midei was removed of his privileges at St Joseph Medical Center in Towson, MD in 2009, after the hospital, following up on a patient complaint, determined that some of Midei's patients may have received stents they didn't need. The hospital subsequently sent letters to 585 of Midei's patients, as well as their primary-care physicians and cardiologists, informing them that patients may have received stents not supported by their angiograms.

A subsequent review by the Maryland Medical Board led to administrative charges in June, accusing Midei of "gross overutilization of healthcare services" and "willfully making a false report or record in the practice of medicine," according to a board report obtained by the media. The recent August 4 meeting is what's known as a case-resolution conference and can lead to a settlement or a formal hearing.

At the end, I concluded that he really was a good operator and there was really no reason to have an emergency suspension of his privileges.

The Baltimore Sun reported that the State of Maryland had expanded its investigation to include other cardiologists and hospitals with stent-procedure rates significantly higher than the state average; the Sun, citing data from the Health Services Cost Review Commission, notes that both Union Memorial Hospital in Baltimore and Washington Adventist Hospital in Takoma Park had stenting rates high enough to bring them under scrutiny.

In statements, however, Midei has said he denies any wrongdoing. A prominent interventional cardiologist, who says he's reviewed over 100 cases that were in question at the time the peer review was conducted at St Joseph, has also come to Midei's defense, first in's forum, then in interviews with heartwire .

"If you only look at angiograms, you can always find flaws, should you dilate that lesion or that lesion," Dr William O'Neill (University of Miami Miller School of Medicine, FL) explained. "We took a different approach, we looked at the patient as a whole and reviewed the clinical history and strategy for doing these procedures, and our conclusion was that there might have been one or two questionable cases, but the vast majority of the cases he did were very appropriate treatment of the patients, and his catheter technique, his angiographic technique, his stent technique is flawless. At the end, I concluded that he really was a good operator and there was really no reason to have an emergency suspension of his privileges."

O'Neill reviewed cases for Midei's legal team and was reimbursed for his work.

Maryland Weighs Changes to Oversight Procedures

Maryland legislators are now weighing what rules or oversight could be put in place to ensure physicians are stenting patients appropriately. The Baltimore Sun has reported that in the Midei case, he himself picked the cases that would undergo peer review.

Seeing the writing on the wall--and hoping to be holding a piece of the chalk--cardiologists representing the American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI) met with Maryland Secretary of Health and Mental Hygiene John Colmers and other state officials last week to discuss performance standards and review processes for cath labs, including guidelines, appropriateness criteria, and "optimal peer-review processes."

According to spokespeople from both ACC and SCAI, physicians who met with the secretary explained the societies' now-joint efforts to develop the Accreditation for Cardiovascular Excellence (ACE) organization, launched by SCAI earlier this year. While the first focus of ACE was carotid stenting, the societies are also proposing to accredit cath labs and outlined their approach to Secretary Colmers.

Dr Mark Turco, an interventionalist at Adventist--one of the hospitals now on the radar of the Maryland medical board because of its stent-procedure numbers--is also active in SCAI and was one of the physicians who met with the Maryland state officials last week.

"The state of Maryland announced in the middle of the St Joe's investigation that they were expanding their evaluation of [PCI] programs throughout the state . . . and what the state obviously is concerned about is whether St Joe's is an isolated phenomenon or [whether] overutilization of stents and inappropriate use are occurring at other institutions," he told heartwire . "And what they did was use [Centers for Medicare & Medicaid Services] payment records to look at stent use at different centers. At that point, all of us [at SCAI and ACC] became increasingly concerned at the direction the state was going: in our minds . . . while there are certainly variability and outliers and aberrations, the overall process works. And it was alarming when they used payment databases to determine appropriate use."

Turco continued: "What we proposed to the State of Maryland at that meeting was that Maryland act as a pilot program for the catheterization/PCI component of ACE."

It was alarming when they used payment databases to determine appropriate use.

Turco added that he was motivated not by the scrutiny his own hospital is under, but because he believes accreditation and review procedures should be managed by physicians, albeit through a third party--the ACE accreditation process would entail third-party peer review, conducted by ACC/SCAI physicians. "Processes that are set forth by outsiders may not provide us with the type of system that the public demands. We need to restore to patients the confidence that we as physicians are performing appropriate procedures and using expensive medical devices in an appropriate way."

According to Turco, Maryland officials have said they will announce a decision and possible legislation by mid-September on plans for monitoring appropriateness, accreditation, and peer review.

Oversight by Whom?

Cardiologists are closely watching the St Joseph/Midei stent situation, aware that whatever happens in Maryland may ultimately affect how they practice elsewhere.

O'Neill was frank, saying that while he believes Midei will be exonerated, he thinks "American operators have kind of brought this outside pressure on themselves--I do think that as a field, we're probably doing too many borderline lesions without having the proper indications for doing that."

And Dr Gregg Stone (Columbia University, New York, NY), who stressed that he didn't know details of the Midei case, turned the equation upside down, saying he has "evolved" his thinking in the wake of the COURAGE trial.

"We are doing probably too much PCI in certain types of lesions that don't need it, as a field, but I think on the other hand there are a lot of lesions out there that do need to be intervened on, that are 30% to 40% stenosed, that do have a positive fractional flow reserve [FFR], and that are ischemia-producing, but we can't tell that from the angiogram," Stone said. "We need to get smarter with our tools to interrogate lesions to treat the ischemia-producing lesions primarily, and not treat the ones that are not producing ischemia."

Indeed, more and more cath labs are investing in intravascular ultrasound or FFR to get a better idea of lesion morphology and function, something O'Neill agrees people should be using when in doubt.

According to SCAI president Dr Larry Dean (University of Washington Medicine Regional Heart Center, Seattle), stent procedures, after peaking in 2004, have been declining ever since. But both Dean and O'Neill cite the need for rigorous charting, since imaging technologies can't always capture the rationale for any given decision. And properly implemented external-review processes, conducted by physicians, at centers that are accredited as having appropriate procedures in place, will ideally remove variability and inconsistencies from the peer-review process and ultimately protect both physicians and patients, both Dean and Turco say.

I'll be honest with you. I don't think that the government or lawyers can do this.

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

O'Neill is blunter, calling some of the existing single-hospital peer-review processes "a morass."

"Many hospitals are trying to do a good job and trying to figure out if their operators are safe, but there are enormous hospital politics. You have one operator mad at another operator and then they level accusations, and the hospitals have no clue what to do about it. So they hire out to organizations, and there are some very good companies that can provide skilled interventionalists to do outside peer review, but that's an incredibly expensive process."

According to O'Neill, the ACC and SCAI "need to be more proactive," as, indeed, they seem to be doing by meeting with Maryland state officials. "Otherwise we'll let the plaintiff lawyers dictate how we're going to practice interventional cardiology."

And Speaking of Lawsuits

Case in point: lawsuits are piling up in the St Joseph case--Midei's lawyers have repeatedly told heartwire that he can't speak until the legal and medical board issues are settled. But in a curious twist, St Joseph Medical Center, which took the unusual step of informing patients of the investigation into Midei when it terminated his privileges in the first place, has now, in the face of lawsuits, said that the hospital itself "generally denies all allegations of liability."

Quoted in the Baltimore Sun [1], a lawyer representing some of Midei's former patients filed a document last week stating, "St Joseph Medical Center and its attorneys are [now] not only categorically denying any wrongdoing by Dr Midei--and fighting damages in every aspect--they are also employing tactics to delay and obstruct [evidence] discovery at every possible turn.

"If they're going to [now] stand by [Midei's] care and say what he did is not negligent and what he did is justified," lawyer H Briggs Bedigian said in an interview with the Sun, Midei should "be looking for an employment lawyer."

Indeed, as some observers have pointed out to heartwire , if Midei is ultimately cleared of wrongdoing, the letters sent by St Joseph to patients may be solid grounds for a lawsuit of his own. Neither his lawyers nor St Joseph responded to requests for comment on the latest legal wrangling.


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