December 28, 2022
On December 23, 2022, federal agencies released ACA and CAA Implementation FAQ Part 56 which extends the December 27, 2022 deadline for Prescription Drug Data Collection Reporting (“RxDC Reporting”) through January 31, 2023, and provides relief for plans that use a good faith, reasonable interpretation of the regulations and RxDC Reporting Instructions when submitting their data for the 2020 and 2021 reference years Further, as discussed below, the FAQ offers guidance and provides additional flexibility to assist group health plans and health insurance issuers in accomplishing the reporting.
The Consolidated Appropriations Act, 2021 (“CAA, 2021”) included a provision that requires group health plans and health insurance issuers (collectively “plans and issuers”) to report certain specified data related to prescription drug and other health care spending, including, but not limited to: (1) general information regarding the plan or coverage; (2) the 50 most frequently dispensed brand prescription drugs; (3) the 50 most costly prescription drugs by total annual spending; (4) the 50 prescription drugs with the greatest increase in plan expenditures over the preceding plan year; (5) total spending by the plan or coverage broken down by the type of costs; (6) the average monthly premiums paid by participants, beneficiaries, and enrollees and paid by employers; and (7) the impact of premiums on rebates, fees, and other remuneration paid by drug manufacturers to the plan or coverage or its administrators or service providers, including the amount paid with respect to each therapeutic class of drugs and for each of the 25 drugs that yielded the highest amount of rebates and other remuneration under the plan or coverage from drug manufacturers during the plan year.
Pursuant to the CAA, 2021, initial reporting for the 2020 reference year was to be reported on December 27, 2021, and then each June 1st thereafter for future reference years, making the 2021 reference year reporting due June 1, 2022. However, when the agencies released final rules on November 23, 2021, which extended the statutory deadlines for plans and issuers to submit their 2020 and 2021 reference year reporting to December 27, 2022. Thereafter future reference year reporting will be due each June 1st.
Recognizing the operational challenges for coordinating data among multiple reporting entities and submitting data that is accurately classified, compiled, and validated, the agencies provided the following guidance, flexibility, and/or relief related to RxDC Reporting for the 2020 and 2021 reference years:
As set forth above, plans and issuers have until January 31, 2023 to submit the required RxDC Reporting and must use a good faith, reasonable interpretation of the regulation and RxDC Reporting Instructions when preparing their submissions. They should ensure any of their reporting entities are aware of the FAQs and are prepared to timely comply with all applicable regulations and guidance when completing their submissions. Plans and issuers who take advantage of alternative reporting (via email in lieu of the HIOS RxDC Module) must ensure they are only submitting data that is subject to the relief (P2, D1, and a narrative response) or optional supplemental documents, and that their data files comply with the required naming conventions. At this point, this relief is for the 2020 and 2021 reference years only. RxDC Reporting for the 2022 reference year is due on June 1, 2023, and all or part of this relief may not be available at that time.
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