Policy & Advocacy

Departments Provide Good Faith 2022 RxDC Compliance Relief as Advocacy for 2023 Relief Continues

Tri-Departments issue new FAQs providing good-faith compliance relief for 2020/2021 prescription drug data collection (RxDC) submissions. Business Group continues to work with the Departments for continued flexibility in 2023.

January 26, 2023

On December 23, 2022, the Departments of Labor (DOL), Health and Human Services (HHS), and Internal Revenue Service (IRS) (collectively the Departments) jointly issued Affordable Care Act (ACA) FAQs Part 56. The FAQ guidance provides enforcement relief and a submission grace period for employer plan sponsors who are working in good faith to comply with the prescription drug data collection (RxDC) reporting requirements under the Consolidated Appropriations Act, 2021 (CAA ’21).

Background

CAA ’21 established new requirements on group health plans (plans) and issuers of group or individual health insurance (issuers) to report specific prescription drug and plan spending data to the Departments, including general information regarding the plan or coverage, total spending by the plan or coverage broken down by type of costs, spending by therapeutic category, the top 50 most frequently dispensed and top 50 most costly drugs, among other data. The Departments will utilize the collected data to issue biannual reports on plan and issuers’ prescription drug reimbursements, pricing trends, and the impact on prescription drug costs on health plan premiums.

CAA ’21 initially imposed a December 27, 2021 deadline for plans and issuers to submit RxDC reports with 2020 data. However, the Departments issued FAQs on August 20, 2021 deferring enforcement for one year. Plans and issuers were required to submit data for both the 2020 and 2021 reference years by December 27, 2022. Beginning with the 2022 reference year reporting, plans and issuers must submit data by June 1, 2023, and by June 1 annually thereafter.

The Business Group has previously covered the RxDC submission requirements in detail, including recent FAQs and trainings from the Centers for Medicare and Medicaid Services (CMS). See our August 2022, December 2022 and January 2023 Regulatory & Compliance webinars for deeper dives into the RxDC requirements.

ACA FAQs Part 56 and Temporary Good-Faith Compliance Relief

The Departments note in FAQs Part 56 that plans and issuers have encountered operational challenges in complying with the RxDC reporting requirements, particularly with respect to coordinating the submission of a plan or issuer’s data across multiple reporting entities. Therefore, for the 2020 and 2021 data submissions that were due by December 27,2022 the Departments state they will not take enforcement action against any plan or issuer that uses a “good faith, reasonable interpretation” in making the RxDC submissions. The Departments are also providing a grace period through January 31, 2023 and will not consider a plan or issuer to be out-of-compliance if they make a good faith submission of 2020 and 2021 data on or before this date.

In addition to this temporary relief, the FAQs also include clarifications and flexibilities regarding the reporting requirements for 2020 and 2021 data submissions:

Reporting entities that report data for more than one plan or issuer will be allowed to submit multiple submissions, rather than having to include data for all clients on a single file.
Multiple reporting entities may submit the same data file type on behalf of the same plan or issuer, instead of having to work together to consolidate all of the plan or issuer’s data into a single file.
For 2020 and 2021 data only, a reporting entity may aggregate the data at a less granular level than used by the reporting entity that is submitting the total annual spending data.
Certain plans and issuers may submit premium and life-years data (D1 data file) and narrative responses via email to [email protected] instead of submitting via the Health Insurance Oversight System (HIOS) portal.
Reporting entities may, but are not required to, incorporate vaccine National Drug Codes (NDCs) into their data files.
Reporting of certain amounts not applied to the deductible or out-of-pocket maximum on the D2 and D6 data files is optional.

Employer plan sponsors should note that this temporary good faith relief is for the 2020 and 2021 reference year submissions only. FAQs Part 56 does not provide any good faith relief for the 2022 reference year submissions; those remain due by June 1, 2023. The FAQs note that the Departments will continue to monitor stakeholder compliance efforts and will determine whether additional guidance is needed.

Looking Ahead to 2022 Data Submissions

Business Group on Health continues to engage with the Departments and advocate for further guidance, compliance relief and resources for reporting entities. The Business Group and other stakeholders recently sent a letter to CMS encouraging technical and enforcement accommodations, particularly for employers with multiple reporting entities. We are pleased the Departments included some of the requests made by the Business Group in FAQs Part 56, such as providing plans and issuers with a grace period submissions and good faith compliance relief – albeit temporary – for 2020 and 2021 submissions.

Yet, there remain some key concerns for employers as they complete these initial submissions and turn their attention to the 2022 reference year submissions due by June 1. Although the Departments indicate they may issue additional guidance before the next submission deadline, the Business Group will continue to advocate for further support for reporting entities, including:

Technical assistance workshops, as well as making staff available, for reporting entities to ask questions and receive guidance directly;
Reporting instructions for 2022 data submissions, including the opportunity for plans and issuers to submit comments and feedback on updated draft instructions;
Continued ability to have multiple vendors file the same file type on behalf of the plan or issuer; and
Continued enforcement relief for plans and issuers who make good faith, reasonable interpretations in RxDC submissions.

Business Group on Health will continue to keep members informed of subsequent developments.

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If you have questions, comments, or concerns about these or other regulatory and compliance issues, please contact us.

We provide this material for informational purposes only; it is not a substitute for legal advice.

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