CMS Requirements for Life Sciences Companies in 2022

Starting off 2022, CMS has issued new updates in the Open Payments program that will be effective for data collection beginning in Calendar Year 2023 and applicable to data reported in Calendar Year 2024.

In the Calendar Year 2022, CMS has finalized the proposed changes to the Open Payments program to ensure adequate usability and integrity of the data for the public, researchers, and reporting entities; in short, for better transparency. So, what does it mean?

This means that after you’re done with 2021’s reporting by March 31st this year (which is just around the corner, so we hope you’re all set!), you have the following new aspects of Aggregate Spend Reporting to take care of. These are:

  • New mandatory payment context field for records attributed to teaching hospitals

  • New option for reporting entities to recertify annually even when no records are being reported by the reporting entity

  • No more record deletions without a substantiated reason

  • Updated definition for physician-owned distributorship(s) (PODs) as a subset of applicable manufacturers and group purchasing organizations and also a revised definition of ownership interest

  • Requirement for reporting entities to update their contact information

  • No more publication delays for general payment records

  • Clarification for the exception for short-term loans; explaining that the exception for short-term loans applies for 90 total days in a calendar year, regardless of whether the 90 days were consecutive or not

  • Removal of the option to submit and attest to general payment records with an “Ownership” Nature of Payment category.

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