Payments to Docs Appear to Influence Implantable Device Selection

Physicians who receive money from manufacturers of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds)—for activities as diverse as consulting, speaking at a dinner engagement, or for travel and lodging—are more likely to implant those companies’ devices, a new analysis shows.  

In a study of more than 140,000 people who received an ICD or CRT-D device, anywhere from 38.5% to 54.7% received a device from a manufacturer that made the largest annual payment to the implanting physician, report investigators. If the total value of compensation to the physician exceeded $10,000 per year, anywhere from 51.2% to 60.8% of patients treated by the doctor received a device from the company that made the payment.

While there are numerous factors that guide device selection, the study raises the possibility that payments from device companies influence physician choices, Amarnath Annapureddy, MD (Yale-New Haven Hospital, CT), and colleagues write in the new paper published November 3, 2020, in JAMA.

To TCTMD, senior investigator Jeptha Curtis, MD (Yale-New Haven Hospital), said that one of the goals of their research is for physicians to acknowledge that these “financial entanglements” have consequences.

“We aren’t immune to influence,” he said, adding that physicians should also be prepared to justify these payments to their patients. “I hope that our patients will start to look at this a little more closely because it is public information. It can hopefully lead to a better conversation—‘Why are you using this device? What are the alternatives?’ That could be helpful in terms of shared decision-making vis-à-vis device choice.”

Four Big ICD Players

Several studies published to date have shown that payments to physicians influence prescribing patterns, and that some of the choices physicians make might not be in the best interests of patients. For example, studies have shown that payments were associated with a greater likelihood of prescribing branded medication instead of cheaper generic alternatives.

Decision-making for medical devices is quite different from outpatient clinical medicine, said Curtis, but there are limited data available as to whether these decisions are affected by industry payments. Part of the challenge, he said, has been obtaining detailed information regarding the implanted devices and linking those data to the corresponding information available through the Physician Payments Sunshine Act.

We aren’t immune to influence. Jeptha Curtis

In this cross-sectional study, the investigators obtained data from the American College of Cardiology (ACC)’s National Cardiovascular Data Registry (NCDR) ICD Registry and general payment data, which includes money for travel and lodging, food and drinks, consulting, and dinner speaking engagements, from the Sunshine Act’s Open Payments program reported to the Centers for Medicare & Medicaid Services. The study cohort consisted of 145,900 patients who received an ICD or CRT-D from 4,435 physicians between 2016 and 2018.

Annapureddy and colleagues say their study didn’t intent to focus on the practices of a specific device company, but rather to take a look at the association between industry payments and patterns of care, including device selection. As such, when the study was approved by the NCDR ICD Registry’s research and publications committee, it was agreed they would not disclose the names of specific device companies, instead classifying them as company A, B, C, and D. In the United States, the major players in the field are Boston Scientific, Medtronic, St. Jude Medical, and Biotronik.

“There’s nothing really unique about ICDs,” said Curtis. “It was simply the place where we had the data and the opportunity to do this. If we looked anywhere else in the device world, including outside cardiology, I’m sure we would see the exact same findings.”

Of the doctors included in the study, 94% received payments from the device manufacturers, with the total value of the annual payments north of $20 million. The median annual payment from the four companies to physicians ranged from a low of $978 to a high of $2,228 (median $1,211 for all companies). Overall, 43% of doctors received payments ranging between $1,000 to $10,000, and just 4% received an annual payment exceeding $25,000. More than 90% of physicians received payments from more than one company, with 17%, 38%, and 37% reporting payments from two, three, and four manufacturers, respectively.

Between 38.5% and 54.7% of patients were implanted with an ICD/CRT-D device from companies that made the largest payment to physicians. For example, among physicians who received the highest total payment from device manufacturer A, 45.4% of patients under their care received a device from that company. Among doctors who received the most money from company C, 47.7% of their patients received an ICD/CRT-D from that manufacturer.

When compared to patients treated by physicians who received no money from industry, those treated by doctors who received the most money from a particular company were significantly more likely to receive an ICD/CRT-D made by the same device company. When focusing only on those physicians who received more than $10,000 per year, there was a significant association—what Curtis called the “dose-response relationship”—between payment and likelihood of implanting that company’s device with company A and D, but not B and C.

“I’m not exactly sure how to explain that, but in terms of the overall relationship, it does seem to exist regardless of the payment value,” said Curtis.

The study, he added, suggests that these payment to doctors are “impacting decision-making more than we would like to admit.” Curtis also praised the ACC for allowing the researchers to perform the study, especially since it’s a controversial topic that doesn’t cast physicians in a glowing light. “But it is an important topic for us to understand,” he said.

’Eliminate or Severely Control‘ Payments

In an editorial, Carmel Shachar, JD, MPH (Harvard Medical School, Boston, MA), and Gregory Curfman, MD, a JAMA deputy editor, say the Sunshine Act attempts to curb financial incentives to physicians through public reporting but may not be enough to discourage “high-value relationships between physicians and industry,” as evidenced by a second study published in the journal.

Led by Deborah Marshall, MD (Icahn School of Medicine at Mount Sinai, New York, NY), researchers report that since the start of the Open Payments Program, the proportion of doctors receiving payments from industry declined from 52.2% in 2014 to 45.0% in 2018. However, the total value of payments remained stable (except in primary care, where the value declined).

They also found that while annual payment values decreased over time for physicians who received “lower-value” payments (≤ $50,000), they did not for doctors who received “higher-value” payments (> $50,000) did not. These high earners continued to receive the same or more money year-over-year from industry, “perhaps reflecting evolving industry strategy that concentrates payments, for which greater return on investment is anticipated,” Marshall et al note.

Regarding the study by Annapureddy and Curtis, the editorialists say that “the consistent correlation between the payments to physicians and the selection of the devices is striking.” The payments, they add, “often avoid triggering Anti-Kickback Statute liability because they may be nominally intended to cover speakers’ fees or travel costs.” Because these inducements run counter to improving the value of healthcare and are financed by ICD sales, thus artificially driving up device prices, current fraud and abuse statutes should be revised to address any payments that increase healthcare costs, they add.

To TCTMD, Curtis said he would like organizations to “eliminate or severely control” industry’s historically “unfettered access” to physicians. At Yale-New Haven Health, the approach is evolving, but physicians are not allowed to give sponsored dinner talks or be reimbursed for travel, said Curtis. “That wasn’t a popular decision, but I think it was the right one.”