On April 1, the review and dispute period commenced prior to the annual publication of payments required by the Open Payments, or Sunshine Act. Physicians and advanced-practice providers may find this an opportune time in which to examine their personal prescribing practices and identify any possible payment-related biases.

A new Mayo Clinic-led study, published in Mayo Clinic Proceedings, shows that at least for rheumatologists, gifts and payments from pharmaceutical companies are associated with a greater probability of prescribing and Medicare spending.

What makes rheumatology different?

There are relatively few rheumatologists compared to overall numbers of physicians and advanced-practice providers. This internal medicine specialty treats patients with autoimmune and inflammatory diseases, most of which cause chronic pain and are disabling. Although rheumatic diseases are primarily disorders of the musculoskeletal system, they can affect multiple organs and systems in the body.

"Before the 2000s most of the treatments for rheumatic diseases consisted of non-steroidal anti-inflammatory medications, or NSAIDS, and glucocorticoids," says Ali Duarte Garcia, M.D., a rheumatologist at Mayo Clinic and the study's first author. "For the last two decades there has been a rapid development of effective medications in rheumatology, first for rheumatoid arthritis and more recently for other types of arthritis and autoimmune diseases.

Dr. Duarte Garcia says that rheumatology, much like oncology, is experiencing rapid development of specialty drugs, some of which use complex technology and require special expertise to administer. Because they are new, little or no head-to-head clinical trial data is available. All are costly. But because physicians and patients seek hope and healing in the face of debilitating conditions, they are often persuaded to try a new medication.

The researchers hoped to determine how much influence payments from pharmaceutical companies have in this decision-making process.

Findings and data sources

Dr. Duarte Garcia and his team identified 13 medications that collectively make up 80% of the costs of rheumatology prescriptions. Three of these have long been available to treat rheumatic diseases, and thus were almost universally provided as generic prescriptions. These three — methotrexate, hydroxychloroquine and prednisone — had almost no associated gifts or payments to physicians.

The investigators reviewed the records of 4,822 U.S. rheumatologists who had prescribed any of the 13 medications for Medicare beneficiaries during the years 2013 to 2015. On average, the cost for a beneficiary receiving prednisone — the lowest priced medication — was about $42 a year; whereas the most expensive medication, repository corticotropin, cost around $230,000 per year.

Payments were defined in two categories. The first — consulting and compensation — included speaker fees, consulting fees, honorariums, travel costs and nonresearch grants. The second type encompassed activities typical to physician audiences receiving information, and included food and beverages, gifts, education and entertainment.

The percentage of rheumatologists who prescribed a drug and received any pharmaceutical company payment for that drug ranged from 46.5% to 96.2%. In their paper, Dr. Duarte Garcia and his colleagues describe associations between receipt of payment and relative rates of prescribing and relative annual Medicare spending. They also identify the association between payments and probability of prescribing, noting, "For most drugs, every $100 in food and beverage payments was associated with an increase between 1.5% and 14% in the probability of prescribing." Consulting and compensation payments also increased likelihood, although in general the effect was not as great.

To reach these conclusions, the research team conducted a cross-sectional analysis of four publicly available data sets: Open Payments, Centers for Medicare and Medicaid Services (CMS) Physician Compare, Medicare Part B Provider Utilization and Payment Data: Physician and Other Practitioners Public Use File, and Medicare Part D Prescriber Public Use File.

Widespread effects

According to the Centers for Medicare and Medicaid Services (CMS), health care spending accounts for about 18% of the national economy. This amounted to $3,337.2 billion in 2016 — of which about 10%, or $328.6 billion, went for prescription drugs.

Pharmaceutical companies want patients to use their products. The various payments examined in this study help garner awareness of specific medications. As the investigators showed, these payments appear to have some influence in treatment decisions.

"Across the industry, payments are common, says Dr. Duarte Garcia. "Our research shows that small payments in particular, such as a meal during an education event, can have outsized effects on prescribing behavior."

And it's not unique to rheumatology, he says.

The specialty drug industry continues to grow. This leads to innovative drugs and new treatment options for patients with a variety of diseases or chronic conditions. Many of these patients are those who have not had success with currently available medications.

In 2021, the Food and Drug Administration approved 50 new drugs and biologics. Of these, approximately 40% are drugs used in rheumatology or oncology. The remainder are treatments for a range of rare and more common conditions including ADHD, HIV, diabetes and migraine.

Unique to Mayo

Mayo Clinic's Division of Rheumatology has a long history of exceptional care integrated with both Education and Research. In the 1920's, the first organized training program in rheumatic diseases for physicians was developed at Mayo Clinic. A few decades later, Mayo Clinic rheumatologist and division chair, Dr. Philip S. Hench, shared the Nobel Prize for helping discover the beneficial effects of cortisone in rheumatoid arthritis. Read more in Mayo Clinic Proceedings, Rheumatology Practice at Mayo Clinic: The First 40 Years – 1920 to 1960.

This study was made possible by the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. Dr. Duarte Garcia dedicates part of his time to health care delivery research such as this. He is a Kern Health Care Delivery Scholar, currently in a follow-on cycle of funding beyond his initial award.

The other authors from Mayo Clinic are:

• Cindy Crowson, Ph.D.
• Eric Matteson, M.D., emeritus faculty.
• Rozalina McCoy, M.D.
• Nilay Shah, Ph.D., who has since left Mayo Clinic.

External collaborators are:

• Jeph Herrin, Ph.D., Yale School of Medicine, New Haven, Conn.
• Veronica Lam, Flying Buttress Associates, Charlottesville, Va.
• Michael Putman, M.D., Medical College of Wisconsin, Milwaukee.
• Joseph Ross, M.D., Yale–New Haven Hospital, New Haven, Conn.

All authors full affiliations and research funding sources are described in the paper. For more on a related Yale and Mayo Clinic collaboration, visit the collaboration webpage for the Center for Excellence in Regulatory Science and Innovation (CERSI).

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