June 11, 2025

The Departments of Labor (DOL), Health and Human Services (HHS) and Treasury (the Departments) recently signaled their intention to develop and implement a long-awaited file specification and enforce the prescription drug machine-readable file (MRF) requirement under the Transparency in Coverage (TiC) Final Rules. While the in-network and out-of-network MRFs have been required and enforced since 2022, enforcement of the prescription drug MRF was previously delayed indefinitely.

On June 2, the Departments of Labor, Health and Human Services, and Treasury issued a Request for Information (RFI) seeking stakeholder input on how best to structure the prescription drug MRF requirement. This move follows 2023 guidance which suggested that formal guidance or rulemaking could be on the horizon. In addition, a new FAQ document issued on May 22 outlines changes to the technical schema for the in-network and out-of-network files, confirming a technical shift to “schema version 2.0.”

Background and RFI

Finalized in late 2020 during President Trump’s first administration, the original Final TiC Rules require individual and group health plans and health insurance issuers offering non-ACA grandfathered health coverage to disclose the following information on a public website: (i) in-network rates for covered items and services, (ii) out-of-network allowed amounts and billed charges for covered items and services, and (iii) negotiated rates and historical net prices for covered prescription drugs. While the first two files have been required since 2022, the Rx MRF requirement was paused in 2021 due to stakeholder concerns and potential overlap with drug data reporting required by the Consolidated Appropriations Act of 2021 (CAA ’21).

In September 2023, however, the Departments rescinded that enforcement delay, clarifying that the Rx MRF would be required pending promised technical specifications and a compliance timeline. Then, earlier this year, the White House issued an executive order directing federal agencies to take all necessary steps to improve existing price transparency requirements and increase enforcement efforts – leading to the June 2025 RFI.

The RFI seeks input from stakeholders on how to make prescription drug pricing disclosures “meaningful,” technically feasible and consistent with existing reporting infrastructure. It focuses on questions such as which data elements are necessary (including options to streamline data formats and reduce unnecessary duplication), how prescription drug pricing should be represented and whether further alignment with other transparency initiatives (such as hospital price transparency) is warranted. While the RFI does not include a proposed timeline or enforcement date, it represents the most concrete step yet toward enforcing the long-dormant prescription drug MRF requirement.

The Departments indicate they are especially interested in data usability from the perspective of employers and other health care purchasers. Business Group on Health supports efforts to increase meaningful health care transparency – while emphasizing the need for clear guidance and practical implementation strategies that reflect the complexity of employer plan administration – and expects to submit comments to the Departments in response to the RFI.

FAQ Provides Guidance on Technical Shift to Schema Version 2.0

Separately, the Departments released a new FAQ confirming plans to upgrade the schema used for the in-network and out-of-network MRFs from version 1.0 to version 2.0. Final specifications are expected by October 1, 2025, with compliance assessed beginning February 2, 2026.

Schemas are technical frameworks that define how machine-readable data is structured and formatted for public disclosure. Since the TiC Final Rules took effect, plans and vendors have used schema version 1.0, originally published on GitHub in 2022, to post required MRFs. While this initial schema enabled compliance, the Departments received feedback that large file sizes, redundant data fields and limited navigability made the files difficult to utilize.

According to the Departments, schema version 2.0 is intended to address these concerns by streamlining file construction and improving accessibility. Planned improvements include eliminating duplicative provider listings, consolidating data using a standardized Table of Contents, clearly labeling provider network information and minimizing unnecessary file size. These changes apply only to the in-network and out-of-network files at this stage but could preview the technical direction for the forthcoming prescription drug file as well.

Next Steps

Taken together, the RFI and FAQ underscore that full implementation of the TiC framework, including the long-deferred prescription drug MRF, is in motion. While many plan sponsors may have already developed MRF infrastructure in partnership with TPAs and carriers, the introduction of schema version 2.0 and impending action on the Rx file signal a need to revisit existing processes and prepare for future changes.

Employers should continue working closely with vendors and legal counsel to monitor regulatory developments and understand how any new requirements may apply to their plan structure and compliance strategy. Business Group on Health will continue engaging with the Departments and will keep members informed as rulemaking and guidance are released.

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

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