The Heart Rhythm Society has informed its members that it is “aware of an ongoing US Department of Justice (DOJ) civil investigation of Implantable Cardioverter Defibrillator (ICD) implants” and that it has “agreed to assist in an advisory role to lend expertise concerning proper guidelines for clinical decision making.”
HRS explained that its role involved “reviewing information that does not include either identifiable patient or facility level data. Rather, we are providing insight on the field of electrophysiology to the DOJ.”
At this point it appears there will not be more information from HRS: “Because this is an ongoing investigation, HRS Staff or Leadership is not available for further comment. HRS will communicate additional information to its membership when permitted to do so by the DOJ.”
Debate and Commentary: Two well-known electrophysiologists who are HRS members, Westby Fisher and John Mandrola, first reported the HRS notification on their blogs. Each expressed concern that the investigation would have an overall negative impact on public health. Mandrola described a “palpable fear in my community,” and said “the tone of the HRS statement” would result in people forgetting that “ICDs are therapy for sudden death, not back pain.”
Both EPs focus on the limitations of current guidelines and assume that the DOJ investigation will focus on clinicians and hospitals that deviate from the guidelines. Fisher writes that “there is no way a published document can cover every clinical circumstance a doctor might encounter when he or she is in the trenches with an individual patient.” He continues: “no one knows” what percentage of patients who fall outside the current guidelines may benefit from ICDs, but “that does not seem to be stopping the DOJ from investigating doctors for their criminal intent…”
I think Mandrola and Fisher make good points, but that they are missing a larger point. It is extremely unlikely that the DOJ, with the assistance of HRS, are investigating or are likely to prosecute the occasional or even moderately frequent use of “reasonable” off-guidelines cases. (In addition, although Fisher writes that the DOJ is “investigating doctors for their criminal intent” the HRS statement refers to a “civil investigation.”)
My guess is that, learning from the example of interventional cardiology and the well known cases of Mark Midei and the Redding Medical Center scandal, the DOJ is investigating egregious cases of abuse. Mandrola’s joke may prove prescient: the DOJ may well be focusing on a few bad apples who actually are implanting ICDs in people with bad backs.
Earlier this month a study in JAMA, based on a national registry run by the ACC and the HRS, found that 22.5% of ICD implants are performed without a proper evidence base. The study provoked a lot of controversy, and even prompted a statement from the HRS outlining the limitations of the study. It is extremely tempting to link these two events, but it seems unlikely that the wheels of justice are able to move quite so fast, and I doubt that the DOJ is gearing up to tackle the vast majority of “reasonable” off-guideline implants. I think they will be going for the real outliers, and when and if they reveal the details of their case there will be little sympathy for their targets.
Here is the text of the HRS notification:
Heart Rhythm Society Member Notification
The Heart Rhythm Society (HRS) is aware of an ongoing U.S. Department of Justice (DOJ) civil investigation of Implantable Cardioverter Defibrillator (ICD) implants and has agreed to assist in an advisory role to lend expertise concerning proper guidelines for clinical decision making. As an advisor to this investigation, HRS is reviewing information that does not include either identifiable patient or facility level data. Rather, we are providing insight on the field of electrophysiology to the DOJ. Because this is an ongoing investigation, HRS Staff or Leadership is not available for further comment. HRS will communicate additional information to its membership when permitted to do so by the DOJ.
For decades, HRS has issued consensus statements and clinical documents outlining guidelines and best practices for clinicians. We remain confident that adherence to these guidelines is critical to improve the safety of care provided to patients.
As nearly decade long ICD patient with a history of pure hell, it is about time the rotten underbelly of this money pit industry of bad design and lousy manufacturing received attention. What a joy to have a defective lead that may kill if left in or kill taking it out. Defective software that allows uncontrolled shocks, bad reed switches that don’t reliably disable the device, garbage algorithms that shock for all the wrong reasons even when the device is not doing that on its own. All stats point to this thing having reduced my all ready threatened life span by 100s of percent. In this witches brew, the Supreme court has stripped citizens the right to petition the courts of compensation (a fundamental function of an legal system) by claiming deference to an obviously less than capable FDA approval process. Guess what – that leaves medical malpractice as the main way to achieve justice for damages and wrongful death. Still want to remove regulations? Oh yes, and stop implanting these killer devices “prophetically” without good stats to justify it.
je suis éberlué par ce débat publique qui existe aux USA!!. Il existe des dérives préjudiciables à une bonne pratique de la médecine, c’est certain !!! mais delà à comparer la frilosité des instances décisionnelles médicales et institutionnelles dans certains pays , il y a un pas que je franchis aisément car l’immobilisme ne fait pas une décision, il la dénature et laisse les praticiens de terrain et les patients dans une situation de précarité impossible et de mauvaise pratique médicale car basée sur les seules recommandations de l’industrie des fabricants et autres laboratoires, sans avoir une clairvoyance apportée par une expertise indépendante et transparente!!.
There are some known misnomers with the design. I would suggest consulting with a specialist and attaining thorough understand of what ICD is being put into implementation as well as the ranges of diversities when it comes to choosing your various options.