CMS announced that the agency “will consider the public  comments received [on the Open Payments / Sunshine Act program] in the future through possible rulemaking or publication of subregulatory guidance” in the recently released “Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017.” But for now, CMS said: “No Open Payments program changes are being proposed or finalized within this final rule.”

In the final rule, CMS acknowledged that “areas of the [Open Payments final] rule that might benefit from revision or subregulatory clarification, and asked for public comments on a number of categories.  The agency stated that it received 95 timely comments deemed relevant to future rulemaking and system enhancements for the Open Payments / Sunshine Act program.

According to CMS, most of these comments focused on:

  • Expanding or clarifying the nature of payment categories enumerated in §403.904(e)(2).
  • Changing the continued reporting obligation to a specific period of time, such as 5 years after the payment or transfer of value was made.
  • Publishing or refreshing the Open Payments data so that it is accessible to stakeholders for an appropriate period of time, such as 5 years or the number of years in which an applicable manufacturer or GPO is required to report.
  • Streamlining the Open Payments registration process and maintaining voluntary registration for those applicable manufacturers or GPOs that do not report.
  • Requiring applicable manufacturers and GPOs to pre-vet financial information with physicians and teaching hospitals before it is reported to Open Payments
  • Clarifying the regulatory definition of a teaching hospital.
  • Adding non-public data elements that allow additional detail about the specific recipient or department of a teaching hospital that received a payment or transfer of value.
  • Expanding the timeframe in which the Open Payments program can accept data submissions from applicable manufacturers and GPOs, such as by implementing multiple submission windows.
  •  Implementing flexible reporting requirements so that applicable manufacturers and GPOs can properly and easily represent changes resulting from mergers, acquisitions, and other business dealings.
  • Clarifying the definition of PODs and how Open Payments requirements apply to PODs.

Stay tuned for possible rulemaking or publication of subregulatory guidance based on the agency’s consideration of these comments.