On Tuesday, Pharmaceutical Research and Manufacturers of America (PhRMA) Assistant General Counsel, John Murphy, issued a statement regarding the announcement by the Centers for Medicare and Medicaid Services (CMS) to delay publication of a significant portion of data in the Open Payments database:
“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.
“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. We also ask CMS provide additional transparency around the decision to remove one-third of the data from the site.
“Our industry is committed to working with CMS and the physician community to ensure that all data is accurate, and that proper context is provided to explain how collaborations between companies and physicians can improve patient care and help promote medical innovation.”
Yesterday, the Wall Street Journal reported on PhRMA’s response to the data withholding.
“John Murphy says its members spent several years of ‘very tedious and difficult work’ to set up their systems for tracking and reporting the payment data” to CMS. ‘How is it the case that at the last minute CMS is telling us more than one-third of the data we submitted would be incorrect?’ he said.
“Murphy thinks he has one clue. One drug maker received an email response from a CMS helpdesk outlining how CMS determines when a payment record is considered invalid. Among the criteria: when a company-reported physician state license number fails to exactly match against a CMS data source.
“Murphy says there was nothing in CMS rules that specify a state license number had to match exactly with the data source used by CMS. And it turns out that there are different data sources for state medical license numbers, and the numerical formatting does not always match up. (The Policy and Medicine blog flagged this issue last week).”
We will continue to follow updates on the Open Payments website.