Enforcement Back On: Departments Rescind Enforcement Relief for Machine Readable File Requirements under Transparency in Coverage Rules

Amberlee (Conley) Lapointe • October 6, 2023

On September 27th, the Departments released FAQs about Affordable Care Act Implementation Part 61 (“FAQ 61”), announcing that the Departments are rescinding prior-issued enforcement relief for certain machine-readable file requirements under the Transparency in Coverage (the “TiC”) regulations.

The final TiC regulations, published in the Federal Register on November 12, 2020, in part required group health plans to disclose on a public website three files regarding negotiated rates for covered items and services from in-network providers (the “In-Network Rate File”), historical payments to out-of-network providers (the “Out-of-Network Rate File”), and in-network negotiated rates and historical prices for covered prescription drugs (the “Prescription Drug File”), starting with plan years beginning on or after January 1, 2022.

Before the TiC machine-readable file requirements took effect, however, the Departments provided some limited enforcement relief for these requirements, including the relief described below:

  • In Q1 of FAQs About Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 49 (“FAQ 49”), the Departments announced their deferral of enforcement regarding the Prescription Drug File requirement.
  • In FAQs About Affordable Care Act Implementation Part 53 (“FAQ 53”), the Departments announced a limited enforcement safe harbor regarding the In-Network Rate File.  The enforcement safe harbor generally applied to plans that are unable to fully comply with the In-Network Rate File requirement due to having an alternative reimbursement arrangement that prevents the accurate reporting of certain dollar amounts, as required for the In-Network Rate File.  FAQ 53 provided such plans with technical alternatives for compliance.

FAQ 61 rescinds enforcement relief under FAQs 49 and 53 as follows:

  • FAQ 61 rescinds the deferred enforcement of Prescription Drug Files provided by Q1 of FAQ 49 and indicates that the Departments will address enforcement decisions related to the Prescription Drug Files on a case-by-case basis, as the facts and circumstances warrant.  FAQ 61 further notes that the Departments intend to develop technical requirements and an implementation timeline in future guidance regarding the Prescription Drug Files. 
  • FAQ 61 rescinds the enforcement safe harbor for In-Network Rate Files provided by FAQ 53 and indicates that the Departments intend to exercise enforcement discretion on a case-by-case basis, noting that the Departments are unlikely to pursue enforcement action if plans can demonstrate that compliance would have been extremely difficult or impossible.  

With enforcement back on, this may be a good time for group health plans to consider whether they are in compliance with the TiC regulations.  Keep in mind that the TiC machine-readable file requirements are in addition to group health plans’ requirements imposed by the Consolidated Appropriations Act, 2021 (the “CAA”).  For more information about the CAA compliance obligations, see our CAA chart .

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