Today at the Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (PCF), the audience heard from Anita Griner, Deputy Director at the Centers for Medicare & Medicaid Services (CMS) who has responsibility related to Open Payments.  In addition to providing an overview of Sunshine implementation, Ms. Griner provided a few key updates to attendees:

  • CMS has received over 1,000 questions to its Open Payments email address from industry related to the implementation of Sunshine reporting requirements.  CMS is trying to respond to questions as quickly as possible, sometimes after significant back-and-forth with the submitters. 
  • Another round of FAQs will be released shortly, possibly as early as this week.  Cooley will update its CMS Sunshine FAQ Tracker when these become available. 
  • CMS is looking to release additional resources to industry.  One notable resource will be teleconferences for IT professionals related to technical requirements for collecting and submitting data to CMS.

Additionally, Cegedim Relationship Management presented the results of its annual industry survey related to Sunshine.  One particularly interesting finding was that approximately 50% of companies are planning to provide a “pre-submission review” to covered recipients as recommended by the CMS Final Rule.  This percentage is down from over 60% of companies planning to do so in 2012.  The results of the Cegedim survey can be requested here.

Posted by Cooley

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