Open Payments—a program created by the Affordable Care Act—aims to provide transparency in the health care industry by publishing data on payments made to physicians and teaching hospitals by drug and medical device manufacturers for things such as meals, gifts, entertainment, and research. Open Payments does not prohibit such financial relationships. But it does provide the public with the information necessary to make informed decisions about them. And it provides transparency that “discourage[s] development of inappropriate relationships” that may “influence research, education, and clinical decision-making in ways that compromise clinical integrity and patient care and may potentially lead to increased healthcare costs.”[1]
Under current data collection requirements, manufacturer contributions to continuing education organizations for continuing medical education events are reportable if 1) the payment meets the definition of an “indirect payment” to a covered recipient[2] and 2) the manufacturer knows or can determine the identity of the covered recipient by the end of the second quarter of the following reporting year. Payments provided to physicians for both attending and speaking at continuing medical education events must be reported if these conditions are met.
Unsurprisingly, industry participants are now throwing their support behind a Senate bill that proposes to, inter alia, exempt from the transparency reporting requirements indirect payments to physicians for speaking at certain such events and indirect payments “that serve[ ] the sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event.”[3]These supporters claim the bill is necessary to ensure patients have access to the most up-to-date medical knowledge.
But the Open Payments program does not prevent medical manufacturers from contributing to continuing education organizations. Nor does it prohibit physicians from attending or speaking at events put on by such organizations. Open Payments simply requires that certain qualifying continuing education-related payments be made public. In a world in which the industry’s provision of even a less-than-$20 meal has been associated with higher prescription rates for the promoted drugs,[4] this hardly seems too much to ask.
[1] Centers for Medicare and Medicaid Services, Center for Program Integrity, Open Payments User Guide (January 2016), available at https://www.cms.gov/OpenPayments/Downloads/Open-Payments-User-Guide.pdf, at 4.
[2] An “indirect payment” is defined as a “payment[ ] or other transfer[ ] of value made by an applicable manufacturer . . . to a covered recipient . . . through a third party, where the applicable manufacturer . . . requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient(s).” 42 C.F.R. § 403.902.
[3] Protect Continuing Physician Education and Patient Care Act, S. 2978, 114th Cong. (2016).
[4] Tracy Staton, Hey, doc, how about a burger with a side of branded drug scripts?, FIERCE PHARMA (June 21, 2016), http://www.fiercepharma.com/pharma/hey-doc-about-about-a-burger-a-side-branded-drug-scripts.
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