CHICAGO — New research shows $22.7 million changed hands between four major device manufacturers and roughly 3500 cardiologists in 2014 and 2015.
Physicians who received the highest payments from a particular manufacturer were nearly three to 12 times more likely to use an implantable cardioverter-defibrillator (ICD) made by that manufacturer. Procedure volume, notably, did not influence device selection.
"Our study suggests a strong association between payments from device manufacturers and device selection among patient undergoing ICD implantation," Amarnath Annapureddy, MD, Yale School of Medicine, New Haven, Connecticut, told theheart.org | Medscape Cardiology.
The study was presented during a poster session at the American Heart Association 2018 Scientific Sessions along with related work from the investigators showing similar complication rates among physicians who did and did not have financial ties with device companies.
Senior author of both studies, Jeptha P. Curtis, MD, also from Yale, said "it is certainly possible that these associations are not driven by any untoward intent. At the same time, I think it's our responsibility to make sure that's the case and not assume these are innocuous payments."
NCDR ICD Registry
To examine the potential influence of industry dollars, the investigators linked data from the National Cardiovascular Data Registry (NCDR) ICD registry with Dollars for Docs payment data using physician National Provider Identifier (NPI) numbers.
Between January 2014 and December 2015, 152,496 first-time ICD or cardiac resynchronization therapy defibrillator (CRT-D) devices from the four major manufacturers were implanted at 1687 facilities.
The 3474 physicians who performed the procedures received payments totaling $22,796,148 from the unnamed device makers. Electrophysiologists, a group that previous reports indicate receive the highest payments from industry, comprised 70% of physicians.
The average payment per physician per year was similar between manufacturers A, B, C, and D, at $8975, $5883, $4859, and $5524, respectively.
Among physicians who received three-fourths of their total payments from a specific manufacturer, the proportion of devices implanted from that company was 49.42% for manufacturer A, 55.03% for manufacturer B, 43.47% for manufacturer C, and 31.51% for manufacturer D (P <.001 for all).
Regression analysis showed that physicians who received the highest payments from a particular manufacturer were significantly more likely to implant devices made by that company (P < .001 for all). Specifically, the odds ratios (OR) were:
Manufacturer A (OR, 3.7; 95% CI, 3.7 - 3.8)
Manufacturer B (OR, 3.2; 95% CI, 3.1 - 3.2)
Manufacturer C (OR, 2.8; 95% CI, 2.7 - 2.8)
Manufacturer D (OR, 11.9; 95% CI, 11.4 - 12.5).
The analysis also revealed a dose–response relation between payments and device selection within each group, Annapureddy said. For example, odds ratios for implanting a device from manufacturer A were 2.2 for physicians receiving $100 to $999 in annual payments, 3.4 at the $1000 to $9999 level, and 6.4 when payments totaled $10,000 or more. For manufacturer D, the odds jumped from 5.8 to 10.3 to a whopping 37.1, respectively.
There was no dose–response relation between use of a specific device and annual procedure volume, even at more than 200 cases per year for physicians implanting devices from manufacturer D (OR, 0.68; 95% CI, 0.60 - 0.78).
"These findings highlight the need for hospitals to develop and enforce the policies and procedures needed to mitigate potential conflicts of interest," Annapureddy said. "At the end of the day, device selection should be made solely on the basis of what is best for the patient and without regard for the financial interests of providers."
No Harm, No Foul?
The second study used the same databases to compare outcomes between the 152,496 procedures performed by the 3474 physicians who received payments and 13,125 ICD or CRT-D procedures performed over the study period by 622 physicians who took no money or less than $100 from industry.
Patients treated by physicians who did or did not receive payments were well balanced in terms of the number who were older than 65 years (13.0% vs 13.1%), received Medicare (57.1% vs 57.0%), or had New York Heart Association class IV disease (both 2.6%), atrial fibrillation (both 30.1%), or diabetes (39.0% vs 39.1%).
Physicians who took payments, compared with those who did not, had similar rates of intra- or postprocedure complications (both 2.1%) and in-hospital death (0.32% vs 0.24%), according to the authors, led by Shady Henien MD, Brown University, Providence, Rhode Island.
Physicians who received payments were more likely to implant a CRT-D in eligible patients (24.4% vs 23.2%; P < .01), whereas those taking no payments were more likely to prescribe appropriate discharge medications (84.2% vs 85.3%; P < .001).
"I found it reassuring but it doesn't mean that we're off the hook," Curtis said. "We need to be certain that the decisions that we're making are being driven entirely by the patient's interest. That is the most important take-home."
"Anything that gives the appearance of undue influence really and fundamentally undermines the trust between patients and physicians, and that's a relationship that, quite frankly, has been increasingly strained over the years," he said.
Although fields such as oncology have recently gone very thorough public reckonings over undisclosed financial ties with industry, the issue is very pervasive across all medicine, and cardiology is no exception, Curtis said.
"I don't know that we've done a better job than other specialties on this, but we do need to understand we are going to be under the spotlight, particularly as these data are publicly available and increasingly used to examine individual conflicts," he said. "So we really need to make sure that we have our policies in place and that we are toeing the line."
One of the problems, observed Curtis, is that policies and procedures related to physician payments and conflict of interest disclosure often aren't resourced to the extent they could be. Yale University, he noted, has a conflicts of interest committee that performs a yearly review of all physicians who have relationships with industry and take care of patients, and in the course of that, are reviewing all potential conflicts and developing mitigation plans.
"I think my institution does a great job of that, but it is a very resource-intensive activity and one that's hard to make sure you do right," he said.
The Medical Device Manufacturers Association, a national trade association that represents the interests of more than 280 member companies, did not respond to requests for an interview by press time.
The research was supported by the American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR). Annapureddy and Henien report no relevant conflicts of interest. Curtis reports receiving salary support from the NCDR to provide analytical services; funding from the Centers for Medicare & Medicaid Services to develop and maintain performance measures used for public reporting, and equity interest in Medtronic.
American Heart Association (AHA) Scientific Sessions 2018: Abstracts Su1304 and Su1328. Both presented November 11, 2018.
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Medscape Medical News © 2018
Cite this: Industry Payments to Cardiologists Sway Device Selection - Medscape - Nov 19, 2018.