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December 4, 2011 -- 5:05pm EST

Stents, Angioplasty and PCI: The Uncertainty Principle (MEDICARE Style)
Is This Stent Necessary?
The question of the day, regarding whether or not to stent a coronary artery, is now being brought to the forefront by the U.S. government in the form of a Medicare "Demonstration Project". And by "brought to the forefront", I mean MONEY! -- as in "we won't pay you if we determine that the stent procedure was inappropriate."

The bottom line is that, on November 15, CMS announced "New Demonstrations to Help Curb Improper Medicare, Medicaid Payments". These so-called "demonstrations" will occur in 11 states where claims "historically result in high rates of improper payments": Florida, California, Michigan, Texas, New York, Louisiana, Illinois, Pennsylvania, Ohio, North Carolina and Missouri.

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You can read their press release and not quite realize what this means, so here's the deal: according to preliminary publications, stenting and angioplasty in non-emergency cases are on the list for audits. CMS will review these cases and, only after the review, will CMS reimburse the providers. For cardiologists, this means that in these 11 states, if they perform a PCI, they and their hospitals will have to wait 30-60 days for a review of their decision -- and, if CMS decides they were wrong, and the stent procedure was "inappropriate", neither they nor their hospitals will be reimbursed. In fact, the hospital will wind up out-of-pocket for the entire incident, overnight stay, etc.

But don't worry -- it's just a "demo project" of only 11 states.... A very interesting "demo" indeed, since these 11 states constitute 54% of the entire U.S. population!! Perhaps "demo" stands for "demolition"!

Actually it's more like a "time-bomb". This announcement was made just as both the TCT and AHA annual meetings ended and the Veith vascular surgery symposium was just beginning in NYC. Most interventionalists were just getting their bearings back (am I in San Francisco or Orlando or NY and, oh yeah, how many people are coming to Thanksgiving?) and so the press release from CMS didn't get much play -- until the implications were revealed two weeks later in an analyst's letter and a Bloomberg News report on Friday in the San Francisco Chronicle, titled "Hospitals Tumble on Medicare Order for Heart Procedure Audit".

And tumble they did. Tenet Healthcare plunged 11%, and heart device manufacturer Medtronic was down 6%; Boston Scientific, Volcano and St. Jude all dropped 7%. Yesterday, Shelley Wood's article in detailed the issue for the cardiology community.

But the big big question that I have, the elephant in the cath lab, so to speak, is "what is an inappropriate procedure?" and "who makes that decision?" Welcome to the "Uncertainty Principle".

The issue of appropriateness of procedures has always been one of our prime concerns on Angioplasty.Org. Back in July, we posted several interviews and articles concerning the subject of "Appropriateness" for PCI (angioplasty and stenting) including an exclusive interview with Dr. Paul S. Chan, author of an extensive study of over a half-million patients that had just been published in JAMA.

Appropriateness is a topic that has always followed the field of interventional cardiology. The level of attention usually peaks with certain events, such as the COURAGE trial, which questioned the use of PCI in stable patients, or with the allegations against Dr. Mark Midei for "unnecessary stenting."

Paul Chan's review of a half-million PCIs from the NCDR database added a significant amount of data to this debate, but unfortunately the terminology that is used can be very confusing (the terminology comes from the Guidelines, not Chan's study). The categories are "appropriate", "uncertain" and "inappropriate". Here's how Dr. Chan explained them to me:

"Appropriate" procedures really suggest a definitive or probable benefit; "uncertain" procedures really suggest a possible benefit; and "inappropriate" procedures suggest that there's unlikely to be benefit. That doesn't mean that there's no circumstance when an inappropriate patient has no benefit; it means that, on a population average, patients who have inappropriate procedures are not going to gain as much in terms of symptom benefit or health status improvement as patients who had a clinical and appropriate procedure.

As for what is appropriate, there's a debate as to whether a 50% narrowing is a reason to do angioplasty; some say 70%. And, of course, these measurements are taken from standard angiography. Many cardiologists feel that angiography alone is not enough and that intravascular measurements, like intravascular ultrasound (IVUS) and fractional flow reserve (FFR) are really necessary to make this judgement.

We're also not sure what the massive problem is, because Chan's study showed that only 12% of non-emergency PCIs were "inappropriate" (virtually none of the emergency angioplasties were). So will CMS be equating "uncertain" with "inappropriate" -- because that would be, according to Dr. Chan, a misinterpretation. Or, as I like to think of it, "uncertainty about the uncertain" -- it has a much more quantum physics feel to it. But "uncertain" is definitely not the same as inappropriate. It just means that, in this particular situation, the patient's clinical situation is not addressed or covered by the various published studies and trials and that there is no consensus about treatment. It does not mean the doctor's decision to do the procedure was incorrect.

But back to the crux of the issue: who are these CMS people who will be auditing the decisions of cardiologists? And what criteria will they use? I mean there's a significant level of debate about this issue within the interventional cardiology community as it stands. Go to any interventional meeting and listen to the panel discussions. These are not a bunch of thieves trying to figure out how to gyp the government. These are respected scientists trying to digest and discern the vast amount of data generated by the hundreds of studies and presentations on display.

Yes, there are guidelines, but guidelines are NOT rules or laws. They address average populations, they give guidance to physicians (hence the name). And yes, there are definitely outliers...and liars. There are a very few physicians who are out to defraud, but they do exist -- one Maryland doc was recently sentenced to 8 years in prison for unnecessary stenting.

Again, regarding these audits, what measures will be used? An angiogram? A percentage stenosis? What about using FFR to determine if a narrowing is causing ischemia. The FAME study showed that stenting is best done when the FFR is .80 or lower -- but FFR is not fully reimbursed in the U.S. so we have a conundrum whereby CMS may not reimburse a stent procedure that they determine is inappropriate, but the very test that might answer the question of appropriateness is also not reimbursed.

You could call it a "no-win" situation; I call it a Cath-22!

You can read more about the FFR issue in our article, "FFR: Why Isn't Everyone Using It?" which brings me to another question: why would both Volcano and St. Jude's stocks fall so much on this news? Both companies manufacture FFR catheters which, one would think, should be a boom industry in a field where decision-making is so desperately looking for a threshold number to put down in the patient's chart and prove to CMS that, yes, this procedure was "appropriate"!

Go figure -- and by all means, send me your comments!

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