The Centers for Medicare and Medicaid Services (“CMS”) is charged with the implementation of the Physician Payments Sunshine Act. CMS developed the Open Payments Program to keep track of data on consulting fees, research grants, travel reimbursements and other gifts made by certain manufacturers and organizations to physicians and teaching hospitals. Since the implementation of the Open Payments Program in February 2013, CMS has encouraged and received feedback from the public regarding certain aspects of the reporting requirements set forth in the Open Payments regulations. Based on this feedback, CMS made the following revisions to the regulations as a part of the 2015 Medicare Physician Fee Schedule (see, Final Rule published November 13, 2014):
• Deleted the Continuing Education Exclusion in its entirety because it is redundant with the exclusion for indirect payments where the manufacturer does not know the identity of the recipient during the reporting year or by the end of the second quarter of the following reporting year (see, 42 C.F.R. 403.904(i)(r)). Therefore, if a continuing education payment meets the exclusion in § 403.904(i)(r), it will remain unnecessary to report the payment even in light of the deleted exclusion;
• Made the reporting of the marketed name of a covered drug, device, or biological required, as opposed to optional, even if the marketed name may not be recognizable to the general public;
• Required reporting of stocks, stock options, or any other ownership interest as distinct categories; and • Removed the definition of “covered device” because it is duplicative.
The revisions were effective as of October 31, 2014 and will be implemented for the 2016 program year, with reporting to CMS in 2017.
For more information, or for questions regarding the Sunshine Act and Open Payments Program, please contact Clinton Mikel, Esq., at (248) 996-8510 or firstname.lastname@example.org.