Research Letter
Health Policy
May 16, 2024
Trends in Industry-Sponsored Research Payments to Physician Principal Investigators
Zhuo T. Su, Zeyad Hammadeh, Joseph G. Cheaib, et al
JAMA Netw Open. 2024;7(5):e2412432.
doi:10.1001/jamanetworkopen.2024.12432
Introduction
After passage of the Physician Payments Sunshine Act (PPSA), the Open Payments program (OPP) was launched in 2013 to increase transparency of physician-industry financial relationships.1 Because research payments constitute the largest payment category in the OPP,2,3 we characterized trends in industry-sponsored research payments (ISRPs).
Methods
This cohort study follows the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline. We used OPP data4 to identify ISRPs inflation-adjusted to 2022 US $ values during 2015 to 2022. In the OPP, covered recipients include teaching hospitals, physicians, and advanced practice practitioners not employed by applicable organizations reporting payments. Noncovered entities (NCEs) are organizations that do not meet the OPP definition of covered recipients. ISRPs to NCEs are reportable if a covered physician is a principal investigator (PI).4 We analyzed ISPRs to NCEs with physician PIs because these constituted most ISRPs by value (>70%). Where multiple (up to 5 could be listed per ISRP) PIs were listed for an ISRP, we attributed the full amount of that ISRP to the primary PI given a lack of disclosure requirements about fund allocations within an ISRP. This attribution avoided double counting of the same ISRP. We tested trends in total values using linear regression and trends in per-physician ISRPs using generalized linear models with a γ distribution to account for physician effects, with a 2-sided α < .05 applied. We used Stata statistical software version 18.0 (StataCorp).
Results
Overall, ISRPs increased 20.0%, from $6.32 billion in 2015 to $7.58 billion in 2022 (P = .01). ISRPs to NCEs increased 19.1%, from $4.98 billion in 2015 to $5.93 billion in 2022 (P = .06), and the trend was not statistically significant; the total in 2022 accounted for 47.1% of all Open Payments ($12.58 billion) that year. In contrast, ISRPs paid directly to covered physicians decreased 61.7%, from $179.5 million to $68.8 million (P < .001) (Table 1).
ISRPs to NCEs with a physician PI increased 23.0%, from $4.52 billion in 2015 to $5.55 billion in 2022 (P = .03), accounting for 44.1% of all Open Payments. General internists had the highest annual median ISRPs per PI (Table 2). In 2022, ISRPs were made to NCEs with 21 518 physicians as primary PIs, accounting for 2.0% of US physicians. The maximum ISRP received by an NCE with a physician PI was $89.5 million.
Discussion
This cohort study found that between 2015 and 2022, ISRPs increased by 20.0% to reach $7.58 billion by 2022. In comparison, National Institutes of Health research grants increased by 24% over this period, to $31.3 billion by 2022.5 Most ISRPs were directed to NCEs rather than teaching hospitals or physicians. While direct ISRPs to physicians steadily declined over time, ISRPs to NCEs with physician PIs increased to $5.55 billion by 2022, accounting for almost half of all Open Payments. General internists had the highest ISRPs per PI, potentially reflecting their access to patients with chronic diseases of interest for industry-sponsored pharmaceutical research.
Reporting rules in the PPSA specify that only the research entity, affiliated physician PIs, and total amount of the research payment are mandated for disclosure.6 Consequently, the industry is not obligated to divulge specific research payment amounts allocated to individual physicians within NCEs vs payments for direct research expenses. It becomes imperative to disclose ISRPs to individual physicians in NCEs to promote transparency and accountability within the health care system, as intended by the PPSA.
Our study has several limitations, including potential data reporting errors to the OPP, attribution of an ISRP exclusively to the primary PI, and unmeasured confounding. Despite these limitations, our study reveals a substantial increase in ISRPs to NCEs, comprising nearly half of overall Open Payments. Further research is needed to investigate factors associated with these payments to NCEs and their association with regulatory oversight and financial conflicts of interest.
