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Chris Cusimano Jan 11, 2023 1:30:00 PM 2 min read

District Court Rule January 10, 2023, to Allow HHS to Use Its Discretion to Determine How to Remedy the 340B Underpayments from January 1, 2018, through September 27, 2022

Tuesday, January 10, 2023, the District Court for the District of Columbia ruled to allow HHS to use its discretion to determine how to remedy the 340B underpayments resulting from their unlawful payment methodology as determined by the Supreme Court of the United States. Here are links to two relevant articles.
Here is a link to the Memorandum Opinion:
The court remanded to the agency without vacatur and without retaining jurisdiction. Regarding the when we should see details about a remedy from CMS, the Memorandum Opinion describes HHS' intention as follows:
Moreover, HHS has indicated that it plans to issue a detailed proposed remedy prior to issuing the CY 2024 OPPS Rule. 2023 OPPS Final Rule at 71,973; Def.’s Response to Pls.’ Suppl. Notice at 1–2 (“[HHS] has committed to announcing [a remedy for claims submitted 2018 through September 27, 2022] through special notice-and-comment rulemaking, which it intends to complete before the 2024 OPPS rulemaking cycle is complete.”). Although the Court declines to retain jurisdiction, it expects that HHS will act promptly to remediate its underpayments. (See, page 13 of the Memorandum Opinion)
The CY 2023 OPPS Proposed Rule was issued July 15, 2022. The CY 2023 OPPS Final Rule was issued November 1, 2022. The APA Notice and Comment period is 30 days minimum, but there are exceptions. It isn't clear what they mean by " special notice-and-comment rulemaking." Whether or not they provide notice and seek comments and take those comments into consideration according to the full APA process or treat this as exempt and bypass comments and consideration, they should issue their remedy by the end of October 2023, at latest.