Actually, it's Fraud
It was a type of fraud that's difficult to prosecute.
Dr. Mark Medei ran a very profitable cardiology practice in the Baltimore Maryland area. Too profitable perhaps. He inserted way more cardiac stents than his peers and it took too long for the medical/industrial complex to stop it. Part of the problem was that Dr. Midei chaired the peer review committee that oversaw cardiac catheterization cases and he cherry picked which of his cases the committee reviewed. Medei effectively flew under the radar for over 10 years.
Monday, the story got more interesting as the Senate Finance Committee released a report that says Dr. Midei received a lot of money from Abbott Labs to insert those stents and Abbott Labs then hired Dr. Midei to promote stents to China and Japan when he lost his hospital privileges.
While policy makers are doing high fives over getting one bad apple out of the barrel, those of us who work in health care compliance.... Well, let's just say at least they got one bad apple, but there's a few more to find.
Dr. Midei's issue surrounded the "best practices" model. Without going too wonky on you, the standard of care is that cardiac stents are indicated when an artery is over 70% occluded. Over 500 of Dr. Midei's patients who received stents, didn't meet that criteria. How many were 55% occluded and how many were 35% occluded isn't quantified in the data I read. What is in the complaint is that Dr. Midei made operative reports stating more than one patient had an 80% occluded artery, while the cardiac images showed a 30-50% occlusion. That would be fraud. Cardiac stents have their own risks of up to a 5% complication rate and the metal in the artery can lead to blood clots. The thing is the patient with a 38% occluded artery would feel better after receiving a stent, so they wouldn't be likely to complain; but they aren't a candidate for a stent intervention under the current cardiac standards of care. Their insurer (including Tricare, Medicare, Medicaid and Medicare Advantage) would have the right to complain and get their money back, if they could detect the fraud.
I've written about over utilization and targeted cardiac stents before along with the absurdity of getting patients to be better consumers of health care. The idea that a patient could know when to turn down a heart procedure their physician recommends doesn't make a lot of sense and this case goes a long way toward proving that point. The cardiac angiogram that would detect the occlusion and the stent insertion is often done during the same operative session. The patient may be awake, but their decision making ability is compromised when they are on the table and their trusted physician is standing over them advising a stent. The informed consent is phrased to allow the doctor to exercise their best judgment.
Dr. Midei's patients had no clue they might not have needed the cardiac stent they received until St. Joseph's sent them a letter. Medicare didn't notice anything until 3 physicians who were losing business decided to fight for market share and contacted authorities. No other insurer has complained about Dr. Midei's out of whack stent insertion rates. It took St. Joseph's over a year to question Dr. Midei's stent insertion behavior, largely because they operated a kickback scheme with him from 1996 to 2006 prior to hiring him full time. If the external experts didn't catch on until a prosecutor told them to look for it, and hospital executives were complicit in the scheme; what chance did the patients have in figuring out they are being used and abused?
Dr. Mark Midei's patient's and supporters set up a web site where they can post their support. The patients focus on how they feel. The co-workers and students write about how easy the doctor is to work with. The comments are one long stream of thank god Dr. Midei treated my family/my friend/me and they/I would have died if Dr. Medei hadn't operated on me; or, Dr. Midei always was awesome as a supervisor/teacher. No doubt, Dr. Midei did a lot of good work. It's just that starting in 2007, Dr. Midei's cardiac stent insertion rate statistically went off the bell curve and by the 3rd quarter of 2008, he burrowed under the bell curve's tail. True, some outliers can be explained and some doctors do see sicker patients which would lead to higher procedure rates; but that wasn't the case for Dr. Midei. He is accused of inserting stents on patients who didn't need them and is under medical board review to retain his license.
The problem is three fold.
First, we don't use the right criteria to identify this type of fraud. Dr. Midei didn't trigger any of the known "trouble signs" that hospitals and medical directors look for like "low procedural volumes, unusual numbers of complications, and frequent patient complaints, unexpected deaths, and malpractice suits" - none of which are "trouble signs" indicating fraudulently performing unnecessary procedures. Dr. Midei had high procedure volumes (good for business), low complications (which is predictable if you do unnecessary procedures on healthier people), low patient complaints (the patients did feel better after their procedures) which resulted in low numbers of malpractice suits (until his over utilization habits came to light). Someone would have had to compare the images with the op reports to see the discrepancies. Then, someone would have had to tally up the discrepancies and noticed it was 3-4 out of 25-32 op reports. HIPAA actually impedes this type of investigation.
The second problem is more insidious, it's the seduction of money. Who's going to complain when the money's so good? At $15,000 per stent procedure, what hospital executive is going to complain about that kind of revenue? They would be more likely to put in another cath lab. Too bad St. Joseph's former CEO Tolmei didn't foresee the $22 million settlement with the feds over Medicare and Medicaid fraud. Ok, maybe the corner office didn't get a memo, but what about the other people working beside Dr. Midei? Cath lab nurses, techs and supervisors had to have noticed Dr. Midei was freezing out other cardiac surgeons. There's no doubt that hospital personnel had to have known or should have known some of those stents were inserted unnecessarily long before 3 whistle blowers came forward. Usually the mark is the last to see the con, but we're to believe the frozen out surgeons were the first to see the kickback scheme? Naw, I'm not buying that one. The greed of this case is overwhelming. Were the complaining physicians upset that they lost patients to Dr. Midei who was doing interventive treatments while they were still in the medication stage? It's reasonable to wonder if the whistle blowers are just doing the right thing, or if they were trying to get their piece of the pie back by taking out the competition. It's reasonable to ask if the complainers were more interested in restoring their incomes than looking out for the patients' best interest.
The second problem continues as the "authorities" that should have seen these stats and questioned them, didn't. My friends at the fiscal intermediaries have told me, "We don't have enough analysts at CMS that see and identify this stuff". I've been told by more than one fraud unit employee that they don't even look at a case until the fraud goes over $250,000. I can't believe a simple procedure report per physician couldn't be run, analyzed and then audited. Then again, looking at my home state of Florida with around 40,000 physicians; our AHCA requires facilities to send an electronic monthly report of every surgical procedure done. AHCA now has so much information, they can't wade through it. So, the procedure report needs to have parameters to exclude anyone under the bell curve.
Third, the U.S. health care system doesn't reward lower utilization, it punishes it. We reward meticulousness over effectiveness. Patients like it when they receive costly high tech interventions, especially if they feel a lot better after they are done. Patients don't like the idea of exercising more and eating less fat, salt and sugar; which would lead to better cardiovascular health. Furthermore, we are locked into a fee for service reimbursement structure that at best facilitates over utilization and at worst promotes fraud. With our multi-payer system, there's no way to determine when a physician's utilization is off the charts. (For instance, I briefly worked with a psychiatrist who was billing 35 patient therapy sessions per day which is near impossible to do in terms of clock hours. He kept it under wraps by using 3 different billing services and was very attentive to his patient/insurance mix, so no insurer received more than 5-7 claims per date of service. I would never have found out if I hadn't stumbled across it. Uh, yeah, he flunked my compliance audit.)
Medical Fraud and Waste vs ?
One argument Dr. Midei's legal team is sure to make is that he erred, but didn't commit fraud. They are likely to argue Dr. Midei made mistakes that favored the patient. That even if he did make the mistake of saying an artery was 80% occluded when it was only 30-50% occluded, it was still in the patient's best interest to receive the stent. They will point to low malpractice claims and high patient satisfaction. They will point to low readmission rates. All the metrics health care wonks care about. They will say that it was Dr. Midei's duty to insert these stents. That failure to insert them would be malpractice. They will say the guidelines aren't law and Dr. Midei had the right to override them.
The problem is that insurers have the right to specify when they will and will not pay for stents and they specify >70% occlusion as the benchmark. The problem is that Dr. Midei can't point to much charity care where uninsured people received stents. The problem is that insurers have the right to demand that the reports sent to them be accurate. The problem is that the current health care reporting laws specify that a clear pattern of abuse is fraud. That means Dr. Midei could insert the stents, but his informed consent with the patient needed to specify that they could be on the hook for the costs if he didn't follow the guidelines. He should have informed the insurers that he went off the guidelines, so they could make their reimbursement decision based upon accurate reporting. The problem was greed. Dr. Midei knew or should have known that his reporting was inaccurate and that continuing to make "mistakes" was actually fraud.
Fraud
Some of you may be surprised that I'm not attacking the insurers in this diary and yes, insurers are a huge problem. Some of you may be wondering why I'm not going after Abbott labs, the device maker who hired Dr. Midei after the shit hit the fan and I will in another diary, as Abbott had to have known statistically there weren't that many stent candidates in Dr. Midei's practice region. The heart of this case is about a physician systematically bilking the system. It's about a hospital rewarding over utilization and cardiac physician extenders not making waves. You can't say an artery is 80% occluded when it's only 40% occluded and not call that fraud, because it is fraud. The patient has no way of knowing they were the mark until someone in the know tells them about it. The defensive medicine defense doesn't hold up when you have hundreds of patients with cardiac images showing a <50% occlusion with corresponding op reports where the physician declares he saw 80% occlusions. It. doesn't. hold. up.</p>
If the doctor made that many mistakes he should lose his license due to incompetence. If the doctor lied, then it is fraud.
There are many physicians out there that faithfully follow treatment guidelines and would never, ever do what Dr. Midei is accused of doing, systematically reporting facts not supported by evidential images. Dr. Midei is the physician who is accused of gaming the system, but there are others who do the same thing. Our system sucks, yet again, at identifying and correcting the real problem: greed based medicine.