Last minute relief for prescription drug reporting

Section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 amended the Internal Revenue Code, the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to add rules governing prescription drug data collection (RxDC). The rules require group health plans, including plans offered to Federal Employees Health Benefits carriers, and health insurance issuers to report certain information related to prescription drug and other health care expenditures to the U.S. Departments of Labor, Health and Human Services and the Treasury (collectively, the Departments). Under the statute, the first RxDC reports were due to be filed by December 27, 2021. However, in response to concerns expressed by stakeholders, enforcement was pushed back a full year to December 27, 2022.

In an FAQ issued December 23, 2022 (FAQ About Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 56), the Departments provided relief to group health plans and health insurance issuers who are required to report information relating to prescription drug and health care spending.

According to the FAQ, “plans and issuers may encounter significant operational challenges” in complying with the RxDC requirements. The FAQ further recognizes that the need to coordinate submission of a plan or issuer’s data across multiple reporting entities — and to accurately classify, compile and validate the required data — will likely result in “errors or other issues [ ] despite good faith efforts by plans and issuers.” The FAQ advises that the Departments will not take enforcement action against any plan or issuer that makes a good faith effort to comply and establishes a submission grace period through January 31, 2023.

The FAQ also provides further “clarifications” to the RxDC rules, including:

• Multiple submissions by the same reporting entity is allowed. To prevent unnecessary duplication, the RxDC rules generally bar multiple submissions of the same data file. However, the FAQ waives this requirement. Reporting entities may now create more than one submission for the year, instead of including the data of all clients within a single set of plan lists and data files for the year.
• Submissions by multiple reporting entities is allowed. More than one reporting entity may submit the same data file type on behalf of the same plan or issuer, instead of working together to consolidate all of the plan or issuer’s data into a single data file for each type of data.
• Aggregation restriction is suspended. The RxDC rules require that reporting entities submitting the required data on behalf of one or more plans or issuers 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. This requirement is waived for 2020 and 2021 data only.
• Submission of premium and life-years data by email is available for certain group health plans. Email submissions are permitted where the reporting entity is only submitting plan lists, premium and life-years data and the narrative response (if no other data is submitted).
• Reporting on vaccines is optional. Reporting entities may — but are not required to — incorporate certain vaccines in their data files.
• Reporting amounts not applied to the deductible or out-of-pocket maximum are optional. 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.”

Read more: The data behind the drugs: New strategies for lower prescription drug costs

The relief provided by the FAQ is limited. The RxDC rules require the collection and organization of voluminous amounts of data from disparate sources and for different purposes, and reporting sometimes requires a heretofore unheard-of level of vendor-to-vendor cooperation. While a longer good faith compliance period might be more helpful particularly for group health plan sponsors, the FAQ is still very much welcome.

Alden J. Bianchi is counsel at international law firm McDermott Will & Emery. He advises corporate, not-for-profit, governmental and individual clients on a broad range of executive compensation and employee benefits matters.