Even though the federal Physician Payments Sunshine Act was enacted more than a decade ago, misconceptions persist as to its requirements. “In talking to colleagues and friends, the impression we got is that most people are not generally aware how publicly available the data are; and most physicians think that the reporting amount has to be significantly large,” reports Ajay Malhotra, MBBS, MD, MMM, a professor of radiology and biomedical imaging and of neurosurgery at Yale University School of Medicine.
Since the law was enacted in 2013, biotechnology, pharmaceutical, and medical device companies have been required to report all payments to physicians to the Centers for Medicare and Medicaid Services. The information then is made publicly available on the Open Payments database. “There is an overall lack of awareness of how low the reporting amounts are,” says Malhotra. The reporting threshold for 2024 is $13.07.1
Physicians use the American College of Radiology Appropriateness Criteria (ACR-AC) to make decisions on what diagnostic imaging to order. “It has become even more onerous on people who are writing the guidelines, which are dictating the clinical use of imaging, to be more transparent about their financial conflicts,” says Malhotra.
Malhotra and colleagues wanted to know if guideline authors were disclosing all their financial conflicts. Previously, the researchers looked at authors’ financial conflicts in a single radiology journal.2 They compared the payment reports in the Open Payments database to the financial disclosures made by guideline authors. The nondisclosure rate was very high.
“We decided to extend the study and look at the five main radiology journals,” says Malhotra. The researchers looked at financial disclosures that were provided by authors of all ACR-AC published in 2019, 2021, and 2023.3 They compared those with payment reports from the Open Payments database in the previous three years. “We found high nondisclosure rates for all of the journals,” says Malhotra. Of guideline authors in those journals who received industry payments, most of the payments were undisclosed. The proportion of the total value of nondisclosed payments was 86.1% in 2019, 88.6% in 2021, and 56.7% in 2023.
One issue is that many journals ask authors to report conflicts of interest that are “pertinent” to the research being submitted for publication. This is likely a reason for the undisclosed financial conflicts.
“It puts the onus on the person who is completing the form to determine what’s considered ‘pertinent,’” explains Malhotra. As it stands currently, guideline authors can choose not to report financial conflicts if they view those as not “pertinent.” For example, a clinician may be authoring guidelines on how to image patients with intracranial aneurysms and is not being paid by the specific device makers included in the guidelines. However, the clinician is being paid by the industry overall, which is making devices to treat various types of aneurysms. “Is it a conflict? Potentially, yes. But the authors might say they don’t think so. And most of those people are not disclosing it,” explains Malhotra.
Some journals now are emphasizing the need for guideline authors to disclose all their financial relationships, not just those specific to the paper being presented. As a board member of the American Journal of Neurology, Malhotra has seen increasing attention to this issue. The journal currently is considering providing authors access to the Open Payments website and asking them to cross-check their own names with what they have reported to the journal. This way, the author cannot claim that they did not know about a financial conflict. “There’s been an ongoing discussion about changing policies to have people disclose everything, and not just what they consider pertinent,” reports Malhotra.
REFERENCES
- Centers for Medicare and Medicaid Services. Data collection. https://www.cms.gov/openpayments/program-participants/reporting-entities/data-collection
- Futela D, Khunte M, Bajaj S, et al. Financial conflicts of interest among physician authors of ACR Appropriateness Criteria. Acad Radiol 2024; Mar 26. doi: 10.1016/j.acra.2024.02.038. [Online ahead of print].
- Futela D, Khunte M, Bajaj S, et al. Accuracy of financial disclosures in radiology journals. J Am Coll Radiol 2024; Mar 23. doi: 10.1016/j.jacr.2024.01.027.[Online ahead of print].
Even though the federal Physician Payments Sunshine Act was enacted more than a decade ago, misconceptions persist as to its requirements.
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