The Centers for Medicare & Medicaid Services (CMS) recently announced in the 2017 Physician Fee Schedule proposed rule that since publication and implementation of the Open Payments Final Rule and the 2015 Physician Fee Schedule, various stakeholders have provided feedback to CMS regarding aspects of the Open Payment program, including identification of certain areas that may benefit from revision. Thus, CMS is soliciting comments to inform future rulemaking, but made it clear that it was not intending to finalize any Open Payments requirements directly as a result of the 2017 Physician Fee Schedule.

To further discuss the topics listed in the 2017 Physician Fee Schedule, CMS held today a Special Open Door Forum for industry stakeholders “to inform future rulemaking and other enhancements” to the Open Payments program. CMS provided a presentation slide deck for the Open Door Forum, which outlined various topics in which it was soliciting stakeholder feedback, including:

  • Nature of payments used for reporting
  • Reports for prior years
  • Data retention and refreshes
  • Registration requirements for Applicable Manufacturers
  • Pre-vetting requirements for Applicable Manufacturers relevant to Payments and Transfers of Value provided to Covered Recipients
  • Definition of Teaching Hospitals
  • Ongoing/incremental reporting
  • Applicability of mergers, acquisitions, corporate reorganizations and similar changes
  • Ownership and Investment Interest changes
  • Reporting related to Physician Owned Distributors (PODs)

After providing a brief overview of these topics, CMS opened the teleconference lines to allow participants to provide comments related to these topics. Participants from life sciences companies, teaching hospitals, and service providers made comments to, and questions of, CMS. A transcript and audio recording of the Special Open Door Forum should be available shortly on the CMS website.

Industry stakeholders are encouraged to submit comments to CMS on these topics by September 6, 2016 to OpenPaymentsComments@cms.hhs.gov or electronically to www.regulations.gov. Additionally, industry stakeholders should consider submitting comments to any future CMS proposed rulemaking related to Open Payments.