Payments from device manufacturers to physicians are likely to have a bearing on device selection in patients receiving an implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy-defibrillator (CRT-D), a study published in the Journal of the American Medical Association (JAMA) has concluded.
The US cross-sectional study examined the association between payments to physicians from four major device manufacturers—which were not named in the study—and device selection for patients undergoing first-time implantation of an ICD or CRT-D. Study authors Amarnath Annapureddy (Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut) et al concluded that patients were substantially more likely to receive ICD or CRT-D devices from a manufacturer providing the highest payment to the physician performing the procedure.
The researchers used data from the National Cardiovascular Data Registry (NCDR) ICD Registry which was then linked with payment data from the Open Payments Program, taken from 1 January 2016 through to 31 December 2018.
Patients were categorised into four groups—A, B, C, and D—corresponding to the manufacturer from which the physician who performed the implantation received the largest payment. For each patient group, the proportion of patients who received a device from the manufacturer that provided the largest payment to the physician who performed implantation was determined by the research team. Within each group, the absolute difference in proportional use of devices between the manufacturer that made the highest payment and the proportion of devices from the same manufacturer in the entire study cohort (expected prevalence) was calculated.
The study found that over the three-year period, 145,900 patients (median age, 65 years; 29.6% women) received ICD or CRT-D devices from the four chosen manufacturers, implanted by 4,435 physicians at 1,763 facilities. Among these physicians, 4,152 (94%) had received payments from device manufacturers ranging from US$2 to US$323,559 with a median payment of US$1,211 (interquartile range, US$390‒US$3,702).
Between 38.5% and 54.7% of patients received devices from the manufacturers that had provided physicians with the largest payments, the study team reports. Patients were substantially more likely to receive devices made by the manufacturer that provided the largest payment to the physician who performed implantation than they were from each other individual manufacturer, they add.
Discussing the findings, the authors note that there are a number of factors that may drive device selection, including patient, device, hospital, and physician considerations. “Patients may express a preference for a device from a particular manufacturer based on experiences of family and friends,” they write. “Furthermore, there are clinical scenarios that may dictate the use of a particular manufacturer’s device. For example, a patient requiring a subcutaneous ICD could only receive a device by one manufacturer. Similarly, differences in device functionality, such as compatibility with magnetic resonance imaging, lead characteristics, and battery life may influence clinical decision-making. In addition, hospital contracting could restrict device choice. However, in this study, devices from a single manufacturer were used in 236 hospitals (13%).”
Annapureddy and colleagues suggest that it is likely that physician choice is also an important determinant of device selection. Futhermore, they state: “This study’s findings raise the possibility that payments from device manufacturers may influence the physician’s choice in selection of a manufacturer’s device.”
However, this may not be the only contributing factor, they add, noting that device experience and familiarity, are also important considerations.
The study team notes that there are several limitations to the findings, notably that it could not be ascertained whether implanting the devices preceded or followed a physician’s receipt of payments, while also noting that the study cannot exclude the possibility of unmeasured confounders, including patients’ preferences, patients’ clinical factors that may warrant one device over another, and differences in devices, such as battery life, that might play a role in the selection of an implant. Additionally they add that relatively little is known about the comparative effectiveness of devices from various manufacturers used between 2016 and 2018.