Regulatory Resources

Feds Provide Non-Enforcement, Grace Period and More Flexibility for RX/Medical Data Reporting Under FAQ Part 56

The Consolidated Appropriations Act, 2021 requires data reporting on prescription drug and other health care expenditure data to federal regulators (Regulators) by group health plans and health insurers. November 2021 interim final rules (Rules) stated that Regulators would not initiate enforcement action if such data were submitted for 2020 and 2021 by December 27, 2022.

FAQ Part 56
On December 23, 2022, Regulators published FAQ Part 56, providing the following relief for the 2020 and 2021 data reports that are due by December 27, 2022:

  1. Regulators will not take enforcement action against any plan or insurer that uses a good faith, reasonable interpretation of the regulations and the Prescription Drug data Collection (RXDC) Reporting Instructions in making its submission; and
  2. Regulators are providing a submission grace period through January 31, 2023, and will not consider a plan or insurer to be out of compliance with these requirements if a good faith submission of 2020 and 2021 data is made on or before that date.
  3. Regulators are providing the following clarifications and flexibilities for the Health Insurance Oversight System (HIOS) reporting system for the 2020 and 2021 data submissions:
    1. Multiple submissions by the Same Reporting Entity Allowed – While a reporting entity generally should create only one submission in HIOS, when a reporting entity submits on behalf of more than one plan or insurer for a reference year, the reporting entity may create more than one submission for that reference year, instead of including the data of all clients within a single set of plan lists and data files for the year. These multiple submissions will be considered valid and not duplicate submissions.
    2. Submissions by Multiple Reporting Entities Allowed – More than one reporting entity may submit the same data file type on behalf of the same plan or insurer, instead of working together to consolidate all of the Plan’s or insurer’s data into a single data file for each type of data.
    3. Aggregation Restriction Suspended – 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. Submission of Premium and Life-Years Data by Email available for Certain Group Health Plans – If a group health plan or its reporting entity is submitting only the plan list, premium and life-years data, and narrative response and no other data, it may submit the file by email to instead of submitting in HIOS. See FAQ for more details.
    5. Reporting on Vaccines Optional – Plans and insurers were instructed to report information on drug names and codes using the CMS drug and therapeutic class crosswalk, which was updated October 3, 2022 to include National Drug Codes (NDCs) for vaccines. Reporting entities may, but are not required to, incorporate these vaccine NDCs in their data files.
    6. Reporting Amounts Not Applied to the Deductible or Out-of-Pocket Maximum Optional – Reporting entities do not have to report a value for “Amounts not applied to the deductible or out-of-pocket maximum” and the “RX Amounts not applied to the deductible or out-of-pocket maximum”. Reporting entities should not remove these columns from data files D2 and D6, but may leave blank the data fields in these columns.


Regulators state they will continue to monitor stakeholder efforts to comply to determine whether additional guidance is needed in advance of future reporting deadlines. As a reminder, the next submission for 2022 data is due by June 1, 2023.