/>iOn December 23, 2022, the Departments of Labor, Health and Human Services and the Treasury (collectively, the “Departments”) provided welcome relief in the form of an FAQ regarding the Prescription Drug Data Collection (RxDC) reporting for the 2020 and 2021 reference years due December 27, 2022 (available here). For more information about the RxDC reporting requirements, see Foley’s prior articles available here and here. Most notably, the Departments adopted a good faith standard for the reporting submissions and implemented a grace period through January 31, 2023 for reporting entities to make these submissions. In addition, the FAQ provided flexibility on several other items in relation to the 2020 and 2021 RxDC reports.
Good Faith Standard
The Departments indicated that they will not take enforcement action against a plan or issuer that uses a good faith, reasonable interpretation of the regulations and reporting instructions in making its submissions. The interim final rules were released on November 23, 2021 (“Rules”), and the Departments most recently updated the reporting instructions on June 29, 2022 (“Instructions”). Though the Rules and Instructions are comprehensive, there are some gaps in the guidance and industry members have struggled with the newness and complexity of the requirements. This good faith standard is a welcome adoption by the Departments.
Grace Period
The FAQ also provided that if the submissions for the 2020 and 2021 reference years are made by January 31, 2023, the plan or issuer will not be considered to be out of compliance with the RxDC reporting requirements. A CMS representative had previously indicated in an informal training that the HIOS portal would remain open through January 31, 2023. The FAQ identified January 31, 2023 as the last date the RxDC reports for the 2020 and 2021 reference years may be submitted in HIOS without the applicable plan or issuer being subject to potential enforcement action by the Departments.
Alternative Means of Reporting
Unexpectedly, the FAQ provided an alternate means of reporting for entities submitting limited information. Though plans and issuers have been instructed to submit the RxDC reports through HIOS, the FAQ allows a group health plan or its reporting entity to submit RxDC reports by email, if the only reports being submitted by the plan or reporting entity are (1) the plan list (e.g. P2), (2) premium and life-years data (D1), and (3) a narrative response. The three items, plus any optional supplemental documents, may be submitted to RxDCsubmissions@cms.hhs.gov. File names must include the reference year, file type (e.g. D1) and the name of the group health plan sponsor.
This reporting option is a helpful alternative for employer plan sponsors who are submitting only the P2, D1 and narrative response reports in relation to their group health plan. However, given that this alternative reporting option is temporary and the time to submit has been extended, if an employer has already established a HIOS account, it may be beneficial for the employer to submit the 2020 and 2021 RxDC information through HIOS, so that they are familiar with the site prior to the June 1, 2023 due date for the 2022 reference year.
Relief for Multiple Reporting Entities
The Departments are temporarily relaxing the requirements regarding duplicative submissions for reporting entities, which will come as a welcome relief to plan service providers who are in the process of preparing and submitting RxDC reports for multiple plan or issuer clients. Contrary to the Rules and Instructions, the Departments will allow reporting entities to submit more than one submission for the 2020 and 2021 reference years rather than including the data of all clients within a single set of plan lists and data files for the year. Additionally, the FAQ indicated that more than one reporting entity may submit the same data file type on behalf of the same plan or issuer, instead of working with other reporting entities to consolidate data into a single data file for each type of data.
Finally, the Departments are suspending the requirement for reporting entities to aggregate data at the same level of aggregation used for submitting the total annual spending data in relation to the 2020 and 2021 reference years. As a reminder, the Rules require that if multiple reporting entities submit the required data on behalf of one or more plans or issuers in a state and market segment, the data submitted by each of these reporting entities must be aggregated to at least the aggregation level used by the reporting entity that submits data on the total annual spending on health care services on behalf of those plans or issuers. Total annual spending data is included in the D2 RxDC data file. Under this FAQ relief, a reporting entity submitting data may, within each state and market segment, aggregate the data at a less granular level than is used by the reporting entity submitting the total annual spending data. This relief means that if a different entity is submitting D2 than D3-D8, the entity submitting D3-D8 does not need to coordinate with the entity submitting D2 for the 2020 and 2021 reference years to ensure that the data is aggregated at the same level of detail.
Other Relief
The Departments provided relief on two other reporting elements in the FAQ. First, the Departments indicated that reporting entities may, but are not required to, incorporate National Drug Codes for vaccines included in the updated October 2, 2022 CMS drug name and therapeutic class crosswalk into the 2020 and 2021 RxDC reports. Second, the 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.” These columns can be left blank in files D2 and D6, but the Departments requested that the columns themselves not be deleted.
Conclusion
The Departments have provided welcome and useful relief for group health plans, issuers and plan service providers struggling to comply with the new RxDC reporting requirements.
