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HCA Probe Reignites Questions Over Interventional Appropriateness

 |  By cclark@healthleadersmedia.com  
   August 27, 2012

Important questions remain in the wake of the federal inquiry into whether cardiologists at HCA, the largest hospital corporation in the nation, performed some 1,200 allegedly unnecessary cardiac procedures on patients—interventions that potentially exposed them to complications at a huge cost to the healthcare system.

Details of the investigations by the U.S. Attorney's Office in Miami of the for-profit chain's operations remain unclear. The public does not know at which hospitals these procedures were alleged to have taken place, with the exception of three Florida facilities: Lawnwood Regional Medical Center in Fort Pierce, Regional Medical Center Bayonet Point, and Cedars Medical Center in Miami, no longer an HCA facility.

It's also unknown whether the patients came through the emergency room with chest pain that turned out to be non-emergent—for example heartburn—rather than life-threatening artery occlusions, for example.

And it is not known whether patients were referred to cardiologists for an annual checkup or stress test and then needlessly ended up in a cath lab. It's also unclear when these unnecessary cases occurred, although there's some indication some were at least two years ago.

So it's too early to tell whether whatever is eventually discovered will ricochet in a way that prompts cardiology practitioners and hospitals around the country to change their appropriateness criteria.

But Gregg Fonarow, MD, director of the Ahmanson-UCLA Cardiomyopathy Center, says that cardiologists have been shifting to more conservative treatment strategies for the last five years, since March of 2007.

That's when researchers disclosed what he called the "pivotal" results of the COURAGE trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation). The surprising results from this multi-center study showed that in thousands of males who had at least one coronary artery stenosis of at least 70% and classic angina, percutaneous coronary intervention or stenting had the same impact on their outcomes as if they had simply taken appropriate medications for the following 2.5 to 7 years.

"There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke...hospitalization for acute coronary syndrome...or myocardial infarction," the researchers found.

That research project alone may have altered the clinical practice of many cardiologists, says Fonarow, a member of the steering committee for the American Heart Association's Get with the Guidelines program.

"This made either approach comparable, but obviously, the medication approach being less expensive and less invasive would be the preferable strategy for managing patients," Fonarow says. "And that has had an influence on some of the management approaches that have been utilized for many physicians."

The shift, however, has been modest, he emphasizes. "There are still some people who think there are still too many procedures being done in stable coronary disease patients, while others believe that it's corrected itself. But as with any medical or surgical circumstance, there's practice variation at different rates as you look across the country."

A few years later, a second development may have prompted some more aggressive cardiologists to get the message if they hadn't already done so.

Major federal investigations in at least five states resulted in accusations against at least seven cardiologists that they performed unnecessary coronary intervention procedures on patients who didn't need them in a fraudulent effort to bilk payers, especially Medicare.

A third development may have had some influence as well. Last July, a report in the Journal of the American Medical Association used the American College of Cardiology's PCI registry and found that only 50% of a sample of such procedures met necessity criteria, 12% were indisputably unnecessary, and another 38% were uncertain.

Fonarow says that over the last several years, perhaps in response to "some of the earlier cases that were under scrutiny," hospitals, cardiology practices and professional societies have become proactive to assure the necessity of all procedures.

Sometimes, he says, hospitals will have a second interventional cardiologist review the films before allowing an interventionalist to proceed. Or, cases will be subject to subsequent peer review.

Some hospitals have decided to regularly select a random set of cases to send to a committee "to see if there's any concern and provide feedback, to make sure they're providing high quality, but also appropriate, care."

"You're seeing lot of hospitals doing that," he says.

In Maryland, where two cardiologists were convicted in 2011 of having billed Medicare out of hundreds of thousands of dollars for unnecessary interventional procedures, the American College of Cardiology and the Society of Coronary Angiography are working to develop a program to conduct peer review for cardiologists and certification of catheterization labs.

Fonarow says he feels certain that today, most interventional procedures are done in patients who present with acute symptoms: they are having a heart attack and many will die unless a blockage is removed quickly.

"It is generally accepted that lesions that are less than 70%, unless there are mitigating circumstances, and certainly less than 50%, and which do not cause symptoms and aren't limiting flow... should not be intervened upon," he says.

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