Life Science Compliance Update

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June 23, 2014

Physician Payments Sunshine Act: PhRMA Urges CMS To Push Back June 30 Deadline For Phase 2 Data Submission

Last week, the Pharmaceutical Research and Manufacturers of America (PhRMA) wrote a letter to the Centers for Medicare and Medicaid Services (CMS) asking them to push back the June 30th deadline for Phase 2 data submission under the Physician Payments Sunshine Act. PhRMA stressed that many of their members have reported significant difficulty when attempting to register as applicable manufacturers and upload data to the Open Payments website. We have heard similar accounts from companies, and recently compiled a list of frequent issues to watch for here.

PhRMA notes that foreign manufacturers and foreign affiliates of US-based manufacturers have had an especially tough time. "Registration glitches appear particularly acute" for foreign entities, PhRMA notes, "and they are compounded by the fact that Open Payments helpdesk hours do not accommodate European or Asian time zones."

CMS' timeline for manufacturers to submit their data does not leave much room for error. From June 9 to June 30—16 business days—companies are required to finish the second step of Phase 2, which includes completing the final data submission and attesting to its accuracy. However, companies must successfully register with CMS before they are able to submit their data. Glitches in the Open Payments system have set companies back. The original window is "now substantially and meaningfully reduced for many manufacturers through no fault of their own," PhRMA states.

PhRMA requests CMS grant a 30-day extension of time for all manufacturers to complete the data submission process once CMS confirms Open Payments is "fully operational and the technical problems have been resolved."

Additionally, PhRMA highlights two issues with the data submission process that could affect the accuracy of the data that manufacturers submit. First, PhRMA addresses payment credits. Their letter states: "it is our understanding that manufacturers will not be permitted to list instances in which payments or transfers of value have been refunded by a covered recipient." These situations "routinely occur with research grants—after a clinical trial has been completed and a covered recipient completes a process to 'true up' the research grant with the expenses incurred, the covered recipients refunds any unused grant amounts."

Last year, we covered a study in which 43 percent of physicians said that inaccurate reporting would adversely affect their interactions with industry. Twenty-one percent said they would sever the relationship with the company that reported incorrect information. Physicians might be unhappy that their name gets attached to large research payments, but they will be more so if companies report money that physicians have refunded.

Second, PhRMA asks CMS to accept typographical characters, such as parentheses and certain symbols, in manufacturers' assumptions text box that will accompany the payment data. They are concerned that this restriction will diminish the accuracy of the data. For example, "with respect to research payments, manufacturers have attempted unsuccessfully to mirror descriptions of clinical trials identified on It would serve the goals of accuracy and consistency for manufacturers to be able to report the same information on both government websites."


AMA's request seems reasonable given that CMS announced last February that they would not be fining applicable manufacturers for data submitted before August 1, 2014.   The idea that the system is only open for 21 days is difficult to imagine given all the delays that have affected this program thus far.

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