While it wasn't the night before Christmas, on December 23, the Departments of Health and Human Services, Labor, and Treasury (the Departments) issued surprise relief from the inaugural deadline for the Prescription Drug Data Collection (RxDC) reports. The relief was set forth in FAQ 56,* which provides a grace period for the initial due date from December 27, 2022 to January 31, 2023, allowing plan sponsors of group health plans and their vendors a little more time to comply with the reporting hurdle. The Departments also provided enforcement relief for the data submissions for calendar years (also known as "reference" years) 2020 and 2021 as long as the reporting entity uses a good faith, reasonable interpretation of the requirements in making its submission.

Group health plans are required to submit RxDC reports to The Centers for Medicare and Medicaid Services (CMS). The RxDC reports include eight data files (D1-D8) and a plan file. For group health plans, the plan file is P2. The reports can also include a narrative file to provide explanations for specific calculations. The information reported to CMS includes the top 50 most frequently dispensed drugs, the costliest and those with the greatest spending increase, among many other data points, including plan spending, rebate information and average monthly premiums paid by the employer and participants.

The Departments issued the relief recognizing the significant challenges plan sponsors and their insurers, third-party administrators (TPAs) and pharmacy benefit managers (PBMs) were facing in coordinating, compiling and aggregating data among the various entities. The relief also came with numerous welcomed clarifications on the RxDC reports that reflect some of the difficulties reporting entities were facing.

  • Multiple submissions by one reporting entity will be considered valid. CMS prefers that entities create one submission when reporting on behalf of more than one plan; however, the clarification allows entities to create more than one submission instead of including data on all plans within a single set of files.
  • Submissions by multiple entities allowed. It's likely that multiple entities hold the information necessary to report to CMS on behalf of a single plan. Rather than share the data for one submission, separate parties may report the same data file for a plan.
  • No requirement to aggregate. For the 2020 and 2021 reference years only, reporting entities may aggregate at a less granular level than the level used to submit total annual spending data.
  • Email submission of premium and life years. If an entity is reporting only its plan list, premium and life-years data, and a narrative response, it may submit the information by email to rather than submitting through HIOS. The email must include the plan list file, premium and life-years data (file D1), and the narrative response. It may also include supplemental documents. When emailing, the name of each file should include the reference year, the plan list or data file type (e.g., P2, D1), and the name of the group health plan sponsor.
  • Vaccine information optional. Reporting entities are required to report information on drug names and codes using the CMS drug and therapeutic crosswalk. In October, the crosswalk was updated to include drug codes for vaccines. Entities may, but are not required to, report the vaccines in their data files.
  • Reporting amounts not applied to the deductible or out-of-pocket maximum. Files D2 and D6 include columns titled "amounts not applied to the deductible or out-of-pocket maximum" and "Rx amounts not applied to the deductible or out-of-pocket maximum." Reporting entities may leave those columns blank but should not remove or hide the columns from the files for submission.

This relief is late but welcome news from the Departments. While plan sponsors, insurers, TPAs and PBMs will be able to use this good faith relief and grace period for the 2020 and 2021 reference year, the next round of reports for the 2022 reference year are due June 1, 2023. The Departments have not extended the good faith relief to that set of submissions.



*Employee Benefits Security Administration. "Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 56," U.S. Department of Labor, 23 Dec 22.


The intent of this analysis is to provide general information regarding the provisions of current federal laws and regulation. It does not necessarily fully address all your organization's specific issues. It should not be construed as, nor is it intended to provide, legal advice. Your organization's general counsel or an attorney who specializes in this practice area should address questions regarding specific issues.