The guidance states that the Departments will not take enforcement action with respect to group health plans that use a good-faith, reasonable interpretation of the regulations and RxDC Reporting Instructions in making its submission of the 2020 and 2021 data.

In addition, the Departments announced a submission grace period through January 31, 2023. Consequently, group health plans that make a good-faith submission of the 2020 and 2021 data by January 31, 2023, will not be considered out of compliance with RxDC reporting requirements.

The guidance

The guidance mentioned above was issued as FAQ 56.

The Departments also provided the following clarification and flexibility with respect to submitting the required 2020 and 2021 data:

1. Reporting entities that report data for more than one plan may create more than one submission, and do not have to include the data of all clients within a single list.
2. More than one reporting entity may submit the same data file type on behalf of the same plan.
3. For 2020 and 2021 data only, a reporting entity submitting the required data may, within each state and market segment, aggregate at a less granular level than that used by the reporting entity that is submitting the total annual spending data.
4. Sponsors of group health plans that are only submitting the plan list (P2 file), premium and life-years data (the D1 data file) and narrative response may submit the file by email to RxDCsubmissions@cms.hhs.gov instead submitting in HIOS.
5. A reporting entity may, but is not required, to submit Vaccine National Drug Codes in its data files.
6. Reporting entities do not have to report a value for amounts not applied to the deductible or out-of-pocket limit in the D2 and D6 files. A reporting entity may leave blank the data fields in these columns but should not remove these columns from the D2 and D6 files.

2022 data reporting

The Departments have not announced a good-faith rule for 2022 data, which must be filed by June 1, 2023. However, they stated that they will continue to review whether additional guidance is necessary.