Industry Payments Linked With Rheumatologists’ Prescribing

UPDATED FEBRUARY 28, 2022 // Editor’s note: This article, which originally attributed comments to Dr Karen Onel personally, has been updated to further emphasize that these comments were not on behalf of the committee that she leads.

Payments to rheumatologists by pharmaceutical companies, whether through food and beverages or consulting fees, are linked with a higher likelihood of prescribing drugs and higher Medicare spending, according to a new study published on February 2 in Mayo Clinic Proceedings.

Alí Duarte-García, MD, of the Division of Rheumatology in the Department of Medicine at the Mayo Clinic in Rochester, Minnesota, led the study.

Researchers conducted a cross-sectional analysis of Medicare Part B Public Use File, Medicare Part D Public Use File, and Open Payments data for 2013–2015. They included prescription drugs that accounted for 80% of the total Medicare pharmaceutical expenditures in rheumatology.

They then calculated annual average drug cost per beneficiary per year, the percentage of rheumatologists who received payments, and the average payment per physician per drug per year. Industry payments were categorized as either food/beverage or consulting/compensation.

Multivariable regression models were used to assess links between industry payments, prescribing patterns, and prescription drug spending.

“Directly Associated” With Prescribing Probability

The authors conclude, “pharmaceutical company payments to rheumatologists were directly associated with the probability of the physician’s prescribing a drug marketed by that company, the proportion of prescriptions that are for that drug, and the resulting Medicare expenditures.”

The authors note that food and beverage payments were associated with increased Medicare reimbursement amounts for all drugs except rituximab.

The article includes examples that help quantify the link between payments and prescribing.

The authors write that for each $100 in food/beverage payments, Medicare reimbursement increased 6% to 44%. The increases were particularly high for infliximab and rACTH (repository corticotropin injection), “whereby a payment of $100 to a prescriber of these drugs was associated with increases of approximately $72,000 and $30,000 in Medicare reimbursements, respectively. For most of the other drugs, for every $100 in payments, the Medicare reimbursement increased by $8000 to $13,000.”

The associations were strongest for food and beverage payments even though those were for lower dollar amounts.

The researchers found that every $100 in food and beverage payments, which also include gifts, entertainment, or educational materials, was linked with more than twofold higher probability of prescribing and higher Medicare reimbursements than for every $1000 paid in consulting fees and compensation.

That finding and findings from previous studies, they say, “suggest that the current approach to regulating industry influence, which focuses on disclosure of large payments, may be inadequate.”

Aaron Mitchell, MD, MPH, a medical oncologist and health services researcher with Memorial Sloan Kettering Cancer Center in New York City, told Medscape Medical News that the findings regarding rACTH show the potential harm of industry payments that are linked with prescribing.

The drug is a naturally produced hormone used for both rheumatologic and neurologic conditions. “Since it is an unpatentable drug ― really just a hormone ― it’s kind of grandfathered in and never had to get FDA approval for its current indications,” Mitchell said.

The drug, which costs nearly $230,000 per Medicare beneficiary, hasn’t been tested head to head in large randomized trials against much cheaper rheumatology drugs, such as prednisone.

In the case of infliximab, he notes, for every $100 in food/beverage payments, there was an increase of $72,000 in Medicare spending.

Mitchell studies industry influence in a variety of specialties and said rheumatology follows the universal pattern, although the drugs used in the specialty are more expensive than in many specialties.

He agrees with the authors that focusing on disclosures to address the problem is probably not enough.

“We’ve been in this period of full and open disclosure for going on 10 years, and we haven’t really seen a decline in these payments,” he said.

Results Won’t Surprise Rheumatologists

Karen Onel, MD, a pediatric rheumatologist and chair of the American College of Rheumatology’s (ACR’s) Ethics and Conflict of Interest Committee, who said she was speaking only for herself and not on behalf of the committee, told Medscape Medical News that the study will not be surprising to rheumatologists or to physicians in other specialties who are aware of the plethora of studies that concluded that industry payments influence prescribing.

Physicians are well aware of the problem, but “they all think it’s not them,” she said.

She said a shortcoming of this study is that it is unclear what the payments were for, because many things are lumped together in the categories. In the case of food and beverage payments, she said that could include payments physicians don’t realize are going on their open payments profile.

Onel gives a personal example. When she goes to a medical conference, she says, “I don’t eat on pharma’s dime.” But because badge numbers are scanned, it appears she accepted the food provided by the pharmaceutical sponsor when she enters a room where food or coffee is being served.

She said that although there are outliers like rACTH that often get highlighted, “the numbers are very low of the physicians who had [industry] money, and the change in prescribing patterns actually was very low.”

She pointed to an important limitation that the authors list: The study was limited to patients with fee-for-service Medicare coverage and did not include those with private insurance.

The authors write, “For example, Aetna, Cigna, and UnitedHealthcare have restricted reimbursement for rACTH in recent years, citing its lack of proven efficacy and the availability of more affordable options, and rACTH is not in the Veterans Affairs formulary.”

Rapid Development of Specialty Drugs

Still, the authors write, the associations described in this article are of high interest because even though rheumatologists make up a small proportion of the physician workforce, they have among the highest costs per prescription in Medicare drug claims.

“Rheumatology, second only to oncology, has entered an era of rapid development of specialty drugs, including biologic disease-modifying antirheumatic drugs (DMARDs),” the authors write.

The complex drugs are expensive to produce and require expertise in handling. Most are under patent with no generic or approved biosimilar equivalent.
 

Nearly half of all US rheumatologists received some payment from a pharmaceutical company in the study period, and most payments to rheumatologists were for low dollar amounts.

The highest per-year annual expenditures were attributed to etanercept ($741 million), adalimumab ($620 million), and infliximab ($539 million).

These drugs were both expensive per beneficiary ($20,728 for etanercept, $21,492 for adalimumab, and $15,941 for infliximab) and were also prescribed by a large number of rheumatologists (4068, 3872, and 1349, respectively).

Addressing the Problem

Mitchell says the leaders of individual societies need to fill the gaps that leave busy clinicians searching for easy ways to get up-to-date information on drugs.

He says in all specialties, “Industry should not be the most easily and readily available source of information.

“We’re in the age of Zoom now,” he said. “There’s no reason you have to be sitting for an hour at lunch with a sales rep and not a brown-bag lunch getting a 1-hour update from a society on a new drug indication.

“We will get higher-quality information if we’re doing the education ourselves, and we’d be removing the sense of obligation to pay back the industry gift givers,” Mitchell said.

Onel says among the most critical work is making sure that the leadership of ACR is free of conflicts of interest.

“They are making decisions for the entire organization. We need to feel safe and comfortable that they are acting in the best interest of the rheumatologists and patients vs corporate partners,” she said.

Additionally, guidelines must strictly follow the standards from the Institute of Medicine that fewer than 50% of the regular guideline committee members may have commercial conflicts, Onel said.

She added that training on real or apparent conflicts of interest must start in medical school, residency, and fellowship, before physicians start to think they know their own practice patterns and that the results don’t apply to them.

However, the reality is that the industry and physicians will always need each other, she said.

Onel describes a tension between rheumatologists needing industry’s help for research and education, especially when federal money for research can be difficult to get, and managing those relationships to avoid real or apparent conflicts.

“We want the public’s trust,” she said.

A study coauthor has served on advisory boards of Boehringer Ingelheim (>$10,000) and Gilead Sciences (>$10,000); has served on speakers bureaus for Simply Speaking (>$10,000) and Boehringer Ingelheim ($10,000). Mitchell and Onel reported no relevant financial relationships.

Mayo Clin Proc. Published online February 2, 2022. Abstract

Marcia Frellick is a freelance journalist based in Chicago. Follow her on Twitter at @mfrellick.

For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.