The problem of regulatory oversight and ICD implantation

Slightly over a year ago, the Department of Justice (DOJ) launched an investigation of a large number of institutions regarding concerns that implantable cardiac defibrillator (ICD) procedures were performed for reasons outside of the criteria set forth in Medicare’s National Coverage Decision (NCD). This investigation occurred just after Al-Khatib and others published a report January 4, 2011 in JAMA that suggested as many as 22.5% of implantable defibrillators implanted for primary prevention of sudden death were not evidence-based.

While the physician community took issue with the Al-Khatib paper, the media firestorm it generated paired with the announcement to the Heart Rhythm Society physician community that a federal investigation was underway, had a chilling effect on ICD implantation nationwide. Drs. Jonathan S.Steinberg and Suneet Mittal report on their experience with DOJ investigators under this heavy regulatory oversight in the Journal of the American College of Cardiology.

Steinberg and Mittal’s diplomatic account carefully describes the challenges of retrospective audits performed by lawyers from the Department of Justice and those of their targeted health care facilities. The DOJ identified 229 cases as potentially inappropriate cases based on Medicare code criteria. (This represented 8.7% of the de novo non-resynchronization ICD implants done for primary prevention at their institutions). After determining that some of these targeted cases were actually for secondary prevention or other coding transgressions, the authors could medically justify all but thirty-four (15%) (or a very low 1.5% of all ICD’s implanted for primary prevention of sudden death) at their institution. As has been the case in most reports, the majority of outside NCD-directed ICD implants occurred because of timing violations—too close to the diagnosis of heart failure, heart attack and coronary intervention. These timing constraints constitute the primary issue before implanting doctors: their professional society guidelines do not–in all cases–recognize similar timing restrictions.

It is surprising that we are not told what sanctions, if any, were levied against their respective institutions. Perhaps the authors felt this detail was unimportant to disclose or perhaps they were prohibited from doing so. Perhaps their penalty is still being determined: after all, nothing drives behavior like fear. To this end, we found the authors’ compliments of the government’s legal team unusual to report in a scientific manuscript, as if the they were suffering from Stockholm Syndrome.

We should acknowledge that the authors have added much-needed clarity to the gray area of decision-making surrounding ICD implantation. Their explanations of timing violations highlight problems with coding, confusion around incidental PCI intervention in patients with dilated cardiomyopathy, and demonstrate the overlap decisions that must be made when bradycardia and tachycardia functions might be required for our patients. This kind of clinically relevant nuance was lacking in the impugnable Al-Khatib JAMA piece.

We can only speculate the large cost of the legal fees and man-hours devoted to this review process. We will never know how many patients died during, or now after, the course of this investigation because they were not offered ICDs because ICDs can only be offered to patients who meet Medicare’s rigid, outdated, and still-to-be-updated National Coverage Decision for implantable defibrillators. But perhaps this is the price of regulation that America is willing to pay in return for cost savings. Perhaps we should not be concerned that professional guidelines for care delivery should be second fiddle to government mandates for ICD implantation.

With this latest report, a new era for medical practice is now upon us – one where priorities of low-cost care and high quantity of care determined by non-medical personnel supersede the highest quality of medical care to our patients. For regulators, it is easy to be a Monday-morning armchair quarterback evaluating health care delivery. It is far harder, however, to decide prospectively who is likely to die (or not) when they sit before you with a newly-diagnosed cardiomyopathy and ejection fraction of 12%.

When government and legal officials who carry no responsibility for the long-term well-being of our patients have the authority to retrospectively impugn and penalize doctors (and their health care facilities) based merely on retrospective reviews of billing codes and outdated payment mandates, they risk irrevocable harm to patients who might qualify for devices according to updated professional guidelines. Doctors everywhere should stand up collectively to disown the practice of using NCD mandates, rather than updated professional guidelines, to determine appropriate care for patients.

After all, our patients are depending on us.

John Mandrola is a cardiologist who blogs at Dr John MWes Fisher is a cardiologist who blogs at Dr. Wes.

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