The CMS has confirmed that it will withhold until next June about one-third of submitted records on drug and device industry payments to physicians and teaching hospitals because of suspected inaccuracies with data included on its Open Payments website. The decision comes as criticism of the agency's implementation of the Physician Payments Sunshine Act provision of the Patient Protection and Affordable Care Act from healthcare providers and manufacturers mounts.
But the CMS says it's sticking with its plan to make the website accessible to the general public Sept. 30, and has extended the review period for doctors and teaching hospitals to Sept. 8.
The problems, first reported by ProPublica, came to light in the past few weeks after Dr. David E. Mann of Kentucky registered
for the Open Payments website and found that data concerning his financial relationships with pharmaceutical and medical-device manufacturers had been commingled with data from Dr. David E. Mann of Florida. The error led the CMS to temporarily suspend registration and review the website while it hunted down the source of the problem.
The Open Payments review website is now back up and only accessible to healthcare providers to check the accuracy of their own data.
The CMS has found that about one-third of data is “intermingled”—meaning data on different doctors is mixed up—and therefore not appropriate for publication. While the precipitating issue was the name mix-up, that wasn't the root cause behind all of the withheld data, said CMS spokesman Tony Salters, though he declined to delve into the exact issues behind the inaccurate data.
The same-name problem is caused by manufacturers submitting the wrong national provider identifier or state license number. That error was “not accounted for in the system design,” Salters said. The agency, therefore, has created “more enhanced algorithms and validation checks” to weed out incorrectly attributed data.
“This enhanced matching process flagged current records within the system that were inaccurate,” he said. “These flagged records will need to be corrected and resubmitted to resolve data matching issues.”
The withheld data, Salter said, will appear in June 2015. Manufacturers and group purchasing organizations will have to correct and resubmit their data at a later date. The CMS has not released the deadline for the resubmission, though it will not be prior to the calendar year.
Users of the Open Payments website also have complained of an ambiguous “error” message, which states: “There are no results that match the specified search criteria.” As a large number of doctors will presumably have no records of relationships with manufacturers or group purchasing organizations, the ambiguity may cause more widespread confusion. But the CMS believes it has resolved the issue by changing the messaging.
The news that a large portion of records will be absent prompted dismay from one of the Sunshine Act's architects. “CMS needs to be transparent about what will be public and what won't be public Sept. 30,” said Sen. Charles Grassley (R-Iowa). “Incomplete information won't give the public a full picture of payment data. CMS and the companies have had plenty of time to work this out. It will be disappointing if the database is missing one-third of its data by the deadline.”
Heather Pierce, regulatory counsel for the Association of American Medical Colleges, said she sees the impending data release—minus the withheld incorrect data—as a “dry run.” It's not, she said, “a meaningful snapshot of physician interaction.”
When the data are released, she hopes that it will be clear to the viewer which data are from 2013 and which data are from 2014. And “we're still concerned about whether there's ample time and opportunity to review the information that's available,” she said.
The American Medical Association also has expressed concern about the adequacy of review time. It has called for a delay of the data release until March 31, 2015, because of to the “poor functionality” displayed by the websites. The organization released a survey to state and specialty societies to gather more information regarding physicians' experiences with the website. Though today was the original deadline for response, the AMA has decided to extend it until Friday due to the temporary shutdown.
Manufacturers also are concerned. In an op-ed published by the Morning Consult, John Castellani, CEO of the Pharmaceutical Research and Manufacturers of America, argued
the data release will be confusing to the public. Many physicians aren't aware of the impending data release and therefore won't have time to check the data, he cautioned.
If the data are released without context, he said, it won't give patients the opportunity to assess the circumstances under which the doctor received payment. “It's critical to note that the new database will include information on many different types of interactions,” he wrote. “For example, the data could reflect an oncologist partnering with a biopharmaceutical company to lead a clinical trial on an innovative cancer treatment.” Follow Darius Tahir on Twitter: @dariustahir