Pharmaceutical and device manufacturers spent several years and millions of dollars developing systems and processes to properly track the reams of data required to comply with the Physician Payments Sunshine Act. Two weeks ago, many manufacturers had to read ProPublica to figure out why much of their data was missing from the Open Payments system—in many cases data that both manufacturers and physicians knew to be correct. Late last week, again from a CMS source on ProPublica, companies learned that perhaps even more data would be kept off of the Open Payments website.
We are concerned with a number of aspects of both the Open Payments rollout, and the way CMS has been revealing the problematic aspects of the system.
When we covered CMS’s decision to withhold one-third of the Open Payments data, we noted that the inherent inaccuracies and constantly changing nature of the NPPES database—which formed the basis for CMS’s matching and verification of physician data—was likely to blame.
This reveals an inherent flaw in the way CMS has gone about verifying a manufacturer’s data submission: The "accuracy" of an Open Payments submission is only as good as CMS’s master data.
Unfortunately, the master data is not necessarily correct data.
Most obviously, the Office of the Inspector General for the US Department of Health and Human Services last year found that NPPES data “in at least one field were inaccurate in 48% of inspected records in the NPPES.” Physicians may have several NPI numbers, they may have entered the state license number incorrectly, they may have moved states, etc. Unless, there is a particular time stamped date that CMS will be matching a companies’ data with, even a completely identical transcription from NPPES to the Open Payments spreadsheet could be outdated and incorrect the very next day.
Another issue companies ran into was that teaching hospital addresses often didn’t quite match what CMS had put forth in their official teaching hospital list. The Open Payments system was unable to accept nearby office locations.
What this boils down to is that perhaps the only way for CMS to have a workable data validation strategy is for them to release a standardized list of the physicians and teaching hospital information it is using to match the manufacturers’ data. Robert Preston, Director, Strategic Alliance and Partnerships at Healthcare Data Solutions, notes that while this will not necessarily be the most accurate list, it may be the only way to prevent another situation like this one.
For example, during this reporting period, companies could have coded a doctor’s correct state license number—which, unlike an NPI number, is mandatory of all licensed practitioners—but still have their data rejected by CMS.
Last week, ProPublica reported:
“[A] source familiar with the matter tells ProPublica that CMS won't disclose another batch of payments: research grants made by pharmaceutical companies to doctors through intermediaries, such as contract research organizations. In these cases, doctors apparently have not been given a chance to verify and dispute payments attributed to them, as required by law.
“Officials at CMS have not publicly disclosed anything about this latest batch of withheld data and did not answer questions from ProPublica about how many records are involved.”
The problem in this case seems to be the Open Payments system's inability to match research payments made to principal investigators through third party organizations, such as contract research organizations (CROs) and site management organizations (SMOs). Propublica states that "doctors apparently have not been given a chance to verify and dispute payments attributed to them, as required by law.” However, we have heard from large CROs that they have received physician disputes based on research allocation. Thus, at least for now, much of this payment data is still available on Open Payments. We are still investigating the accuracy of this information. So far CMS has not responded to our inquiries, but companies should check their data to see if their research payments are showing up in the system.
As a background, many pharmaceutical companies contract with third party CROs and SMOs to conduct their clinical trials and engage in other research. The person responsible for the conduct of the clinical trial and in charge of the team at a trial site is known as the principal investigator (PIs), who are most often physicians. Open Payments requires reporting on the industry payment that covers the investigator's research costs and salaries of their team. In many cases, clinical research teams have multiple PIs. As you may imagine with a complex web of CROs, SMOs, and multiple PIs in the mix, the manufacturer's payments that eventually make its way to paying for research is anything but a straight line.
This issue appears separate from the matching issue that CMS previously announced. Again, we are awaiting an official CMS announcement on this new issue, but according to ProPublica, CMS is withholding this data specifically because physicians have been unable to dispute it. If there are, in fact, issues with research payments, we suspect the problem relates to field 7 in CMS’s research document, “Non-covered Recipient Entity Name.”
Click here for the CMS research document.
Much of the frustration that companies are facing in not being able to see their data is that CMS has avoided contact with the manufacturers who actually submitted the information. Some employees worked full-time this past year to ensure the aggregate spend information was complete and accurate. Now, the Open Payments system isn’t showing one-third of the data, and companies have to seek out the “Dollars for Docs” website to figure out what new information is going to be withheld.
The Pharmaceutical Research and Manufacturers of America (PhRMA) issued a statement regarding CMS's lack of outreach. “PhRMA supports the Sunshine Act and, since the law was enacted, biopharmaceutical companies have worked diligently to ensure that their data is accurate and submitted in a timely manner so that physicians have sufficient time to review and provide feedback,” stated John Murphy, assistant general counsel for PhRMA. “An analysis of the data that CMS removed from the database found that PhRMA member companies submitted their data in a manner consistent with the reporting rules outlined by the agency. To reconcile the existing data issues, additional guidance from CMS is needed clarifying the reporting regulations.”
It should not be the case where companies are left foraging for answers online instead of receiving information from the agency they are attempting to work with to submit data.
Open Payments Delays; Dispute Window Extended
Additionally, CMS recently extended the Open Payments review and dispute deadline and the 15-day corrections period deadline. The review and dispute period now ends September 8, and the correction period will run from September 9-23. The public website launch date remains September 30, 2014. These further delays accentuate the problematic roll-out of Open Payments, including the exclusion of millions of payment records. The American Medical Association and many other physician organizations have repeatedly called on CMS to delay the public release of this payment information. Given the inevitable news coverage Open Payment will receive and the fact that much of the data will actually be missing from the system, we would also urge CMS to reconsider their timeline.