Final Rule for the Open Payments Database (2012)

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Created Date

February 8, 2013 - 12:00am


Contributed date

February 21, 2024 - 7:44am

Critical Commentary

On February 8, 2013, the United States Center for Medicare and Medicaid Services published a final rule to the U.S. Federal Register, outlining standards and requirements for reporting data via a program known as Open Payments. Enacted via the Affordable Care Act, the Physician Payments Sunshine Act would require that pharmaceutical companies and medical device companies in the U.S. report "transfers of value" (or payments) they had distributed to physicians on an annual basis. These payments would be published in a public database, enabling patients to look up their doctors and determine how much they had been paid via manufacturuers. The original intention was to track conflicts of interest in prescribing in the U.S. 

While the Affordable Care Act was passed in 2010 and outlined the general scope of the reporting program, the final rule, which outlined the specifics of who would have to report payments and how took another three years to develop. During this interim time, CMS met with a number of stakeholder groups to discuss the definitions that should guide reporting, the categories that should classify types of payments, how certain kinds of payments (such as group meals) would be calculated, how different entities would be uniquely identifed in the system, and how "context" would be presented on the program's website. CMS collected a comments in a variety of ways - via oral testimonials, from pubilc stakeholder meetings, and via written commentary. Statutorily , they were required to address the bulk of these comments in drafting the final rule. 

The document that is attached here captures some of the provenance of the definitions undergirding Open Payments. The actual "rule" is summarized in the last 7 pages of the document. However, the first 65 pages of the document summarize comments that CMS received in relation to the final rule and then outline CMS's response to those comments. 

Because this is such a long document, I recommended focusing in on just one section B.1.a.(1) Definition of an Applicable Manufacturer, which starts on the third column on page 9460 and continues to 9462. In this section, CMS outlines comments that they received regarding the definition of industrial entities that would be required to report to Open Payments. 



Cite as

Center for Medicare and Medicaid Services, 8 February 2013, "Final Rule for the Open Payments Database (2012)", contributed by Lindsay Poirier, STS Infrastructures, Platform for Experimental Collaborative Ethnography, last modified 21 February 2024, accessed 22 July 2024.