As Sunshine Act Reporting Deadline Looms, CMS Issues Additional Guidance

With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for Medicare and Medicaid Services (“CMS”) has issued additional guidance on Phase 2 reports. As is well known, the Sunshine Act (the “Act”) requires Applicable Manufacturers and GPOs to report certain financial relationships with physicians and teaching hospitals. The new guidance includes both technical guidance for preparing and uploading data submissions and an updated User Guide.

Phase 2 reporting will occur in two steps.  First, applicable manufacturers and GPOs must register for the Open Payments system, a separate system from the system used for Phase 1, and can perform test file uploads to the Open Payments system.  Second, applicable manufacturers and GPO will submit their final reports for 2013 and attest to the accuracy of the submission.  Both steps must be completed by the June 30 deadline.  CMS has issued two video tutorials to assist Applicable Manufacturers and GPOs with Phase 2 reporting; a third tutorial focused on data submission is expected shortly.  The tutorials are available through the Open Payments website.

In addition to the activities that Applicable Manufacturers and GPOs must complete during the month of June, physicians and teaching hospitals (“Covered Recipients”) can now register to view the data submitted about them by Applicable Manufacturers and GPOs. Covered Recipients begin by registering for an Enterprise Portal and will separately register for the Open Payments system beginning in July.  CMS will be hosting a national provider call for Covered Recipients on June 12, 2014.  Registration is available through the CMS website. 

Finally, Applicable Manufacturers, GPOs and Covered Recipients may wish to review and comment on the Notice of New System of Records regarding CMS’s recordkeeping requirements under the Act.  Notably, the Notice provides that the purposes for which CMS may use the information in the Open Payments system include (1) supporting litigation involving the agency and (2) assisting with fraud, waste and abuse detection and prevention activities.  Comments on the Notice are due July 7, 2014.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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