Feds Extend Prescription Drug Filing Deadline, Announce Relaxed Enforcement

The Departments of Labor, Health and Human Services, and the Treasury (collectively, the Departments) last week issued an FAQ that relieved filing entities from the December 27, 2022, deadline for providing certain information.

The Departments understood many plans and carriers faced significant operational challenges in complying with the reporting requirements, including arranging and coordinating a plan’s submission across multiple reporting entities. The Departments also noted they were extending the deadline to allow filers to accurately classify, compile, and validate required submission data. The Departments will consider a plan or issuer to be compliant if they make a good faith submission of 2020 and 2021 data on or before January 31, 2023.

Many interested parties also had expressed fears that the new and complex reporting requirements would inevitably lead to errors and other failures despite good faith efforts to comply.  So, for the 2020 and 2021 data submissions that were to have been due by December 27, 2022, the Departments announced they will not take enforcement action against any plan or carrier that uses a good faith, reasonable interpretation of the regulations and the Prescription Drug Data Collection (RxDC) Reporting Instructions in making its initial submission.

In addition, to facilitate compliant submissions, the Departments clarified and simplified the reporting requirements for 2020 and 2021 data to allow:

• Multiple submissions by the same reporting entity; thus, a reporting entity submitting for more than one plan or carrier may create more than one submission for a reference year, instead of including the data of all clients within a single set of lists and files for the year.
• More than one reporting entity to submit the same data file type on behalf of the same plan or carrier, instead of having to consolidate all of the plan’s or carrier’s data into a single data file for each type of data.
• A reporting entity submitting the required data, within each state and market segment, to aggregate at a less granular level than that used by the reporting entity that is submitting the total annual spending data as would have been required under final rules.

The Departments also stated that reporting entities may, but will not be required to, include national drug codes for vaccines in their data files. Further, reporting entities will not have to report a value for amounts not applied to the deductible or out-of-pocket maximum or prescription amounts not applied to the deductible or out-of-pocket maximum. The FAQ notes that a reporting entity should not remove these columns from data files but rather may leave the data fields in these columns blank.

The immediate relief is welcome, albeit late, but plans should still be vigilant in working to ensure their RxDC requirements are met by no later than January 31, if not already submitted. The Departments also noted that further relief would be announced, as they deem necessary, prior to the next filing deadline.