On July 23, 2021, the Centers for Medicare and Medicaid Services (CMS) published a draft of the calendar year 2022 payment policies under the Medicare Physician Fee Schedule (PFS) in the Federal Register. The PFS includes a number of proposed changes to the Open Payments Program which would become effective for data gathered in 2023 and reported in 2024.
Several companies expressed to CMS that they would like the ability to attest that they do not have any reportable records for that year. Due to this, CMS is proposing to make it optional for a company that does not have reportable payments or transfers of value for the program year to recertify their registration in Open Payments and attest that it does not have any records to submit.
CMS is proposing to add a definition for physician-owned distributorships, a type of group purchasing organization, and make clear that physician-owned distributorships are required to report under the Open Payments Program. The definition would only apply for the Open Payments Program.
CMS is also seeking to clarify delayed publication for research payments. Currently, there are three distinct category reports due annually: general, research and ownership interest reports. CMS allows for payments associated with research to have their publication delayed using the research report delayed reporting indicator; however, CMS has found that companies are flagging delay for general payments. In the PFS, CMS emphasized that delayed reporting of general payments is not permitted and is suggesting clarifying language be included in the final rule.
According to CMS, information provided for payments related to teaching hospitals has not included enough information surrounding the nature of payments which has led to disputes from teaching hospitals requesting additional information. CMS is proposing that a mandatory “payment context” field be added to the reporting template for payments to teaching hospitals. "To reduce the burden created by disputes for both reporting entities and teaching hospitals, we are proposing a mandatory context field for payments or transfers of value attributed to teaching hospitals, which would contain information to better identify the payment as deemed appropriate by the applicable manufacturer or GPO. Examples of data that the reporting entity may choose to include are the check number or electronic wire number for the payment; related department of the hospital; or other pieces of relevant information." This field would only be visible to the teaching hospital disputing the reported information.
In addition to the above, the following proposed changes are also included:
- Disallowing record deletions without a substantiated reason
- Updating the definition of ownership and investment interest
- Requiring reporting entities to disclose relationships they have with other companies for the purposes of transparent reporting
- Clarifying that the exception for short-term loans applies for 90 days total in a calendar year, regardless of whether the days are consecutive.
The complete PFS can be found at https://public-inspection.federalregister.gov/2021-14973.pdf. Comments on the proposed rule are due by September 13, 2021.