All individual payments of $11.04 or more and aggregated payments of $110.40 or more must be reported in CY 2021 (these amounts started at $10 for individual payments and $100 for aggregated payments in 2013 but have increased over time).
Under the new proposed rule, CMS wishes to clarify Open Payments requirements and add new “provisions that program stakeholders have requested and we agree would improve the quality of the data.” The proposed changes would become effective for data collection beginning in CY 2023 and reporting in CY 2024.
The proposed changes include:
- Adding a mandatory payment context field for records to teaching hospitals;
- Adding the option to recertify annually even when no records are being reported;
- Disallowing record deletions without a substantiated reason;
- Updating the definition of ownership and investment interest;
- Adding a definition for physician-owned distributorships;
- Requiring reporting entities to disclose relationships they have with other companies for the purposes of transparent reporting;
- Disallowing publications delays for general payment records;
- Clarifying the exception for short-term loans applies for 90 total days in a calendar year, regardless of whether those days are consecutive; and
- Removing the option to submit and attest to general payment records with an “Ownership” Nature of Payment category.
According to the Federal Register notice, the definition for PODs would be a subset of applicable manufacturers and group purchasing organizations and would only apply to the Open Payments program reporting. The definition would not apply for the purposes of any other laws or regulations, including the federal Anti-Kickback Statute and the physician self-referral law. CMS has proposed this change because while PODs are a subset of GPOs, they are not specifically defined in the Open Payments regulations.
Additionally, CMS states that several thousand payments in the general payments category are flagged by reporting entities for publication delay each year, while it is only payments that are associated with research that should be delayed. To avoid this delay in the future, CMS is proposing language that will clarify the impermissibility of delaying general payments, and that research-related payments do not need to have been specifically outlined in the original research agreement to be reported as research payments. The research payment format allows CMS to verify that the payment is being delayed correctly.
With respect to recertification, the process is not currently available for companies that do not have records to report. Therefore, CMS proposed that companies be given the option to recertify and attest to the fact that they do not have any records to submit for a reporting year. The agency believes this will help simplify communication bout compliance between CMS and reporting entities.
Source: Policy and Medicine