CMS Delays Penalties for Missing Physician Payment Deadline

Are device manufacturers trying to report physician payments on the CMS Open Payments web site experiencing similar problems insurance enrollees experienced when they tried to sign up for Obamacare?

It appears there are problems as the Centers for Medicare and Medicaid Services (CMS) help desk announced the agency will not enforce penalties for non-compliance until after July 7, 2014. The deadline for manufacturers to submit data required under the Physician Payments Sunshine Act. Remains June 30, 2014.

AdvaMed Keeps Quiet

We’ve been hearing anecdotal stories from device makers that they are experiencing problems with the site and can’t complete their data submissions. AdvaMed, the device industry’s trade group told us they would have no comment about the delay.

Pharma Squawks

The Pharmaceutical Research and Manufacturers of America (PhRMA) asked for a delay for the Phase 2 data submission requirement in mid-June. PhRMA told CMS that many of their members have reported significant difficulty trying to register as applicable manufacturers and upload data to the Open Payments website. Thomas Sullivan of Policy and Medicine said he heard similar accounts from companies.

Registration Glitches

PhRMA notes that foreign manufacturers and foreign affiliates of U.S.-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.”

Sullivan reported that CMS’ timeline for manufacturers to submit their data did not leave much room for error. From June 9 to June 30, companies were 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, ” stated PhRMA.

PhRMA had requested 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.”

PhRMA also highlighted two issues with the process that could affect the accuracy of the data that manufacturers submit.

First, were payment credits “It is our understanding, ” wrote PhRMA, “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, their letter continued, “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 [sic] any unused grant amounts.”

Physician Concerns

Last year, Sullivan reported on a study in which 43% 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, ” write Sullivan.

PhRMA also asked CMS to accept typographical characters, such as parentheses and certain symbols, in manufacturers’ assumptions text box that accompany the payment data. They said they were concerned that this restriction will diminish the accuracy of the data. “With respect to research payments, manufacturers have attempted unsuccessfully to mirror descriptions of clinical trials identified on ClinicalTrials.gov. It would serve the goals of accuracy and consistency for manufacturers to be able to report the same information on both government websites, ” wrote PhRMA.

Docs Concerned

The American Medical Association (AMA) is also concerned the database might not function properly. During the Sunshine Act roll-out, “CMS has missed nearly every deadline laid out in the law and regulations to implement it, ” wrote AMA President Ardis Hoven, M.D., including the March 31 deadline by which companies were supposed to be able to submit aggregate reports.

These delays “raise serious concerns about whether the [Open Payments] database will function properly, ” wrote Hoven in a note to members recently reminding them to register. Thus, Hoven continued, “the AMA is still advocating for physicians to have more time to register and review the data.”

Sounds like the CMS help desk is busy.