Three weeks after the commencement of data collection under the Physician Payment Sunshine Act (the “Act”), the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance to assist applicable manufacturers and GPOs with compliance, to educate physicians and teaching hospitals about the reporting process, and to resolve ambiguities in the Act and the Final Rule.  

CMS recently published a User Guide to the Open Payments Program (the “Program”) for manufacturers and GPOs.  The User Guide does not provide new regulatory information, but may be a useful tool for manufacturers and GPOs to consult for an overview of the Program and as an educational tool for their workforces.  CMS has also created two short handouts—one aimed at physicians and one aimed at patients—to help explain the Program and the types of information being reported.  

On August 8th, CMS held its second National Provider call on Open Payments Program. The call was focused on third-party payments, indirect payments, and resources for physicians.  On the call, CMS addressed indirect payments and third-party payments, two issues that applicable manufacturers and covered recipients may still be struggling to define and track during the initial reporting period.  CMS provided examples of both types of payments in the presentation and clarified that, for indirect payments, information about the intermediary is not reported.  

Though CMS has issued a number of answers to frequently asked questions (“FAQs”) about the Sunshine Act and the Open Payments program, call attendees raised a number of issues that continue to concern manufacturers and covered recipients.  Among those questions were the definition of a “large group setting” for purposes of identifying payments that need not be tracked proper use of the “expenditure category” line item in the Research Payments Template.  On both issues, CMS stated that further guidance would be forthcoming in the FAQ section of the Open Payments website.  The slides from the presentation are available on CMS’s website.