In early 2010, my administrative assistant, Barbara Raney, came into my office with a worried expression on her face. She told me that a lawyer from the Department of Justice (DOJ) in Washington, DC was on the phone and wanted to speak with me. My immediate thought was “What have I done that would raise the attention of the DOJ?” Fortunately, the topic that we subsequently discussed had nothing to do with my behavior! The lawyer and his associate asked if I would serve on a panel to review the appropriateness of placement of implantable cardioverter-defibrillators (ICDs) by hospitals and cardiologists throughout the country. I was informed that it had come to the attention of the DOJ that many ICDs were being implanted inappropriately, and that the government was initiating a study to see if some hospitals and cardiologists should be forced to repay Medicare/Centers for Medicare and Medicaid Services (CMS) for these allegedly fraudulent implantation procedures.
The lawyer then told me that the amount of money involved could eventually add up to a sum exceeding hundreds of millions dollars. At that time the cost for an ICD implantation, excluding physician and anesthesia fees, was approximately $37,000.1 I was further informed that the DOJ believed that hundreds and hundreds of ICDs had been inappropriately placed in patients according to Medicare guidelines. The two lawyers from the DOJ asked if I would be willing to serve on a panel of cardiologists that would review patient records to determine if an ICD implantation had been performed in a manner that violated the Medicare requirements. I was told that initially the panel would create a set of rules for appropriateness of implantation based on CMS regulations and that the members of the panel would then review a specific number of hospital records to decide if the billing was potentially improper and deemed to be possibly fraudulent by the government. Once a determination of incorrect billing had been established, the lawyers for the DOJ would take over and demand repayment from the erring hospital and cardiologist.
I told the DOJ lawyers that I was a general cardiologist with a particular expertise in acute myocardial infarction and not an expert in cardiac electrophysiology. They informed me that the panel would consist of a number of the best known electrophysiology cardiologists in the US, but that the DOJ also wanted a few general cardiologists on the panel for balance. Since I had done something similar in the past involving clinical guideline preparation for the Heart Rhythm Society, I agreed to serve on the panel. Over the next 5 years, I met repeatedly with the DOJ lawyers and the other empaneled cardiologists to prepare the guidelines for the chart reviews and to report the results of my own findings from those reviews. Eventually, I reviewed dozens of patient records involving individuals who had received ICDs following an acute myocardial infarction, coronary artery angioplasty (PCI), and/or coronary artery bypass surgery, (CABG).
The Medicare/CMS guidelines required that a waiting period of 40 days after a myocardial infarction or 90 days after a PCI or CABG was needed in a patient with reduced left ventricular function before a determination could be made that this particular patient required insertion of an ICD in order to prevent morbidity and/or mortality from ventricular tachycardia or ventricular fibrillation.2, 3 The reason for the waiting period was that many of these patients achieve substantial recovery of left ventricular function during that time period and hence do not require implantation of an ICD.
Unfortunately, many of the charts that I reviewed were in gross violation of the Medicare regulations: Patients with a reduced left ventricular ejection fraction by cardiac echo often developed some type of ventricular arrhythmia during the first few days following an acute myocardial infarction or PCI/CABG. The physician entry in the patient record at that time frequently consisted of just a brief one or two line note stating that the patient had had a “malignant” ventricular arrhythmia as well as reduced left ventricular function and was therefore being scheduled for an ICD implantation the next day. The records were disappointingly brief and uninformative about the patient’s clinical status and were often poorly legible. Reading these records left me with a deep sense of unhappiness concerning the documentation and presumably the quality of the patient care observed.
Eventually, following the chart reviews by the panel, the DOJ lawyers informed the various offending cardiologists and hospitals of our findings and demanded repayment for the ICD implantations. I do not know if the patients themselves were informed of these findings, nor do I know what the ultimate outcome was for these individuals with their presumably unnecessary ICDs. The government eventually recovered 280 million dollars from the offending hospitals and cardiologists. I do not remember clearly if the DOJ lawyers proceeded with criminal court cases against any of the cardiologists or institutions that were involved in the repayment process. My recollection was that if repayment was made, no criminal charges were forthcoming.
As noted above, my personal reaction throughout the 5 year process was one of repeated disappointment with the quality of the documentation and possibly also the medical care of the patients that I reviewed. Implantation of an ICD should not be taken lightly, not only because of the cost, but also because of possible complications downstream such as infection of the ICD pocket or the implanted electrode.
In my opinion, these patients did not receive the highest quality medical care. What was the reason for this poor level of medical care? Were the physicians involved sloppy in their practice? Were they greedy? Or, were they just overworked, stressed, and hurrying to get through a large patient load? Over my more than 40 years as a cardiologist, I have rarely encountered a physician who I felt practiced either sloppy or greedy medicine. Almost universally, I have felt that my colleagues and I went into medicine because we wanted to serve humanity in a profession that was both very demanding and very rewarding. We were told from our very first day in medical school that there would be constant new developments in diagnosis and therapy during the years that we practiced medicine. And, that if we did not keep ourselves current with respect to these new developments, we would soon become inadequate physicians. Almost all the doctors that I have encountered in my career have been dedicated to keeping current with new developments in diagnosis and therapy as well as with Medicare and insurance regulations. On a rare occasion, I have encountered a colleague who seemed more interested in money than in delivering excellent patient care, but fortunately, such individuals were very unusual. Rather, I have been repeatedly impressed by the level of professional excellence and concern for good patient care exhibited by my companions in medicine. So, in the end, I hope and believe that the mistakes made with respect to ICD implantation occurred because the physicians involved were overworked and overstressed and forced to make hasty clinical decisions. However, in the end, there is good news. It was recently reported that the number of ICDs implanted in the US has fallen significantly since the announcement of the results of the DOJ investigation and repayment process.4 I take this as a hopeful sign that cardiologists are following the guidelines and implanting these devices appropriately.
As always, I welcome responses to this commentary at jalpert@shc.arizona.edu or on our blog at amjmed.org.
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-Joseph S. Alpert, MD
This article originally appeared in the December issue of The American Journal of Medicine.
