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December 30, 2022

RxDC Reporting Enforcement Relief Announced: More Time to Comply!

Although they are cutting it a little close, the Departments of Labor, Health and Human Services, and Treasury (the “Departments”) have given us all a gift for the holidays: The Departments announced today that they are offering enforcement relief in connection with the Prescription Drug Data Collection (RxDC) Reporting mandate. For those who have been struggling to meet the December 27 compliance deadline – particularly those with self-funded plans – this is very good news, and may make your holiday season feel a bit more merry and bright.

Under existing rules, by December 27, 2022, plans and issuers are required to report prescription drug and health plan data for the 2020 and 2021 calendar (or “reference”) years. By June 1, 2023, plans and issuers are required to report for the 2022 reference year.

In a set of FAQs (Part 56) issued December 23, 2022, the Departments announced two forms of enforcement relief in connection with reporting for the 2020 and 2021 reference years. (The relief does not apply to the 2022 reference year reporting due June 1, 2023.)

First, “for the 2020 and 2021 data submissions that are due by December 27, 2022, the Departments will not take enforcement action with respect to any plan or issuer that uses a good faith, reasonable interpretation of the regulations and the Prescription Drug Data Collection (RxDC) Reporting Instructions in making its submission.” This will help many reporting entities that are struggled to interpret the available guidance and apply it to their existing data and administrative processes. The Departments had previously announced in the text of the Instructions some limited enforcement relief in connection with reporting average monthly premiums for the 2020 and 2021 reference years, but this new announcement has a broader application.

Second, the Departments are giving plans and issuers more time to comply, by announcing a grace period that will run through January 31, 2023: “The Departments are also providing a submission grace period through January 31, 2023, and will not consider a plan or issuer to be out of compliance with these requirements provided that a good faith submission of 2020 and 2021 data is made on or before that date.”

Why are they doing this? The Departments “recognize the significant operational challenges that plans and issuers may have encountered in complying with these reporting requirements.” They also recognize that “given the novelty and complexity of the requirements, there may be errors or other issues with the first round of data submissions, despite good faith efforts by plans and issuers.” Many of you will be able to echo these concerns.

After announcing the enforcement relief, the Departments then include in Part 56 a set of FAQs that answer some common questions and concerns about the data collection and submission process. The FAQs address such issues as multiple submissions by the same reporting entity or by multiple reporting entities, the ability to submit certain limited data by email rather than through the HIOS system (which some users find challenging), and reporting on vaccines.

Article Written By: Marilyn Monahan (Monahan Law Office)