At a Food and Drug Law Institute webinar last week, Robin Usi, the Director for the Division of Data & Informatics (DDI), in the Data Sharing & Partnership Group of the CMS Center for Program Integrity, made clear that accuracy matters in the reporting of spend data to CMS pursuant to the Physician Payments Sunshine Act.
She further stated that CMS is working to identify inaccurate data reporters and that reporters of inaccurate data are prime targets for agency audit and/or compliance actions.
Government enforcers, private plaintiffs and even investigative reporters are mining this data to make the case that certain payments to physicians are nothing more than kickbacks. One company in particular – Insys Therapeutics, Inc. – has already witnessed the mining of its Open Payments data firsthand. The CMS Open Payments database shows that, during the last five months of 2013, Insys made over $2.7 million in general payments to physicians and teaching hospitals.
The class action complaint attached a 39-page spreadsheet that detailed the payments Insys made to physicians who spoke promotionally for the company. The payment data came straight from the CMS Open Payments database. According to the Complaint, Insys’ then-CEO noted during an earnings call that a small number of physicians write a large percentage of prescriptions for opioid drugs and that Insys “appeared to have targeted these doctors and rewarded them generously for writing Subsys prescriptions.”
The Insys case study clearly demonstrates that the mining of CMS Open Payments data can prove tremendously useful in supporting allegations that payments to physicians are kickbacks to induce the writing of prescriptions. Continued mining of this data may demonstrate that the penalties for what is being reported under the Sunshine Act are much more significant than any statutory penalties for failing to report or reporting inaccurately.
To read this article by Brian A. Dahl