Written by: Thomas S. Crane and Kimberly J. Gold
September 30th marked the launch of transparency reports under the Sunshine Act through a new Open Payments website hosted by the Centers for Medicare & Medicaid Services (CMS).
Mandated by the Affordable Care Act, the Sunshine Act creates a regulatory scheme requiring drug and device manufacturers and group purchasing organizations (GPOs) to report a variety of information about payments and other transfers of value to physicians and academic medical centers. The first data reporting period was for August 2013 through December 2013, and this data is now available on the Open Payments website.
Unlike last year’s launch of the federal health insurance exchange website, the Open Payments website appears to be working smoothly. CMS reported that the payment information includes over 4.4 million payments valued at nearly $3.5 billion. More than 26,000 physicians and 400 teaching hospitals registered through the Open Payments data system.
The website includes a useful “Explore the Data” tab, which takes viewers to 14 pre-packaged data sets and dataset downloads. The data sets include summary reports of categories of interest such as general payment data, research data, and by far the most viewed data set: “Physician Profile Data 2013 Reporting Year.” As the name indicates, the data set downloads provide various zip files of more detailed reports.
The Sunshine Act was heralded by lawmakers and policy advocates for making public vast amount of payment information physicians receive from drug and device companies and ownership information from GPOs. Promoters of the law advocated that having such information public could, alone, have the salutary effect of reducing payments, and at least would help allow consumers to make more informed choices about conflicts of interest. From a program integrity perspective, the requirement to disclose payment information likely caused many manufacturers to review all such payments for compliance with the anti-kickback statute.
As the regulatory process unfolded, practical data implementation issues overwhelmed small and large manufacturers. As a result, many compliance officers quietly voiced concerns at the level of accuracy in these first reports. Data inaccuracies have caused CMS to de-identify approximately 40% of the payment data. In turn, the American Medical Association has repeatedly called for delays in this data reporting in order to allow time to clean up the data and educate physicians on the meaning of all of this data.
It is certain that researchers, consumer advocates, and potential whistleblowers, among others, will be pouring over this data to find patterns and high levels of payments or ownership information, especially ownership interests in physician-owned distributorships, or PODs.
What does it mean to be listed as a recipient of payments or other transfers of value? In a CMS e-mail release, Shantanu Agrawal, CMS’s Center for Program Integrity Deputy Administrator and Director, stated: “Open Payments does not identify which financial relationships are beneficial and which could cause conflicts of interest.”
But he seemed to back away from this neutrality when he stated at a September 30th press conference: “There shouldn’t be too much presumption, just based on the fact of the data” - implying that apparently there is at least some type of presumption in his mind.
Presumption or not, as we wrote in an earlier post, this Open Payments data will surely be cross-matched with other available data sources, including the Medicare Provider Utilization and Payment Data: Physician and Other Supplier website, to yield powerful information that will be useful to journalists, researchers, and others to spot outlier payments.