PBMs, Chamber File Suits to Block Transparency Machine - Readable Files 

Aug 19 2021

A difficult burden in implementing transparency is the requirement of publishing 3 machine-readable files, effective on the first day of the 2022 plan year. Two lawsuits filed this month challenge the mandate, contained in last November’s Transparency in Coverage regulations.

Pharmacy Benefit Managers (PBMs) have told us that they object to disclosure of historical net prices in the prescription drug machine-readable file. In fact, two of the largest PBMs said they won’t provide historical net prices until July 2022. It is no surprise then that the Pharmaceutical Care Management Association – the national PBM association – filed a lawsuit last week challenging the machine-readable files. The lawsuit contends that these files exceed the authority of the Affordable Care Act transparency provisions. Historical net price objections featured prominently in the complaint. There is no objection to the self-service tool requirement in the regulations or any of the transparency provisions in the Consolidated Appropriations Act (CAA).

Additionally, the US Chamber of Commerce sued HHS and other agencies to stop the machine-readable file requirement. The Chamber argued that “specific provisions of the Rule that are not consumer-focused and that are in fact counterproductive, wasteful, and unlawful…threaten to reduce competition, and ultimately raise costs to consumers, by revealing confidential, commercially sensitive information that competitors currently do not share with each other.”

We’ll closely monitor this situation and provide updates as needed. It will take time for final resolution of legal challenges. For now, transparency compliance is a reality for employers who sponsor group health plans.

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