Departments Provide Prescription Drug Data Collection Enforcement Relief

On December 23, 2022, the DOL, HHS and IRS (the departments) provided relief for employer plan sponsors regarding the CAA 2021 prescription drug data collection (RxDC) reporting requirements. Specifically, for the 2020 and 2021 data submissions that were due by December 27, 2022, the departments provided a submission grace period through January 31, 2023, and will not consider a plan to be out of compliance with the requirements provided that a good faith submission of 2020 and 2021 data is made on or before that date. Additionally, the departments will not take enforcement action with respect to any plan that uses a good faith, reasonable interpretation of the regulations and the RxDC Reporting Instructions in making its submission. Future reports will be due on June 1 following the data year. For example, the 2022 report will be due June 1, 2023.

The guidance provided the following clarifications and flexibilities with respect to reporting requirements for the 2020 and 2021 data:

• Multiple reporting entities can submit the same data file type on behalf of the same plan or issuer, rather than consolidating all the plan’s or issuer’s data into a single data file for each type of data. This is a welcome relief for employers as some employers with more than one TPA or issuer have struggled to coordinate and compile the data from multiple entities into a single data file.
• Certain group health plans may email premium and life-years data instead of submitting it to the Health Insurance Oversight System (HIOS). Though plans and issuers were required to submit information using the HIOS RxDC module, if a group health plan or its reporting entity is submitting only the plan list, premium and life-years data, and narrative response and is not submitting any other data, it may submit the file by email to RxDCsubmissions@cms.hhs.gov instead of submitting in HIOS. In the email, it must include the plan list file, premium and life-years data (data file D1) and a narrative response. The submission may include optional supplemental documents. The name of each file should include the reference year of the submission, the plan list or data file type (e.g., P2, D1) and the name of the group health plan sponsor.
• Same reporting entity may make multiple submissions. The new guidance clarifies that when a reporting entity submits data on behalf of more than one plan or issuer for a reference year (calendar 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.
• Optional to report the amounts not applied to the deductible or out-of-pocket maximum. Reporting entities are not required 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 on vaccines is optional. Plans and issuers were required to report information on drug names and codes, including National Drug Codes for vaccines. However, the guidance makes vaccine reporting optional.
• Aggregation restriction is suspended. A reporting entity (e.g., issuer) can aggregate at a less granular level than the level used by the reporting entity that is submitting the total annual spending data.

With this relief, employers should review the guidance, particularly the latest clarifications and flexibilities with respect to reporting requirements, and work with their carriers, TPAs, PBMs and other vendors to ensure filings are completed by January 31, 2023.

For background of the RxDC reporting requirement, see the articles published in the December 9, 2021, and September 15, 2022, editions of Compliance Corner.

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