In this episode, Greg and Rob are joined by returning guest, healthcare attorney Jeff Davis. They’ll be discussing the CMS provider-based rule changes coming out of the 2026 Consolidated Appropriations Act, including the impact that these changes will have on 340B hospitals. They’ll also share some initial reactions to the Albany Medical Health System v. HHS court ruling out of the DC District Court, which has resulted in the vacating of HRSA’s policy notice from October 2023 that addressed 340B child site eligibility timing.

In this episode, Greg and Rob are joined again by healthcare attorney Todd Nova to discuss the recent HRSA Request For Information (RFI) related to a potential future 340B rebate model pilot. They discuss the nature of the info requested by HRSA in the RFI, thoughts around including confidential/sensitive information in responses, and general strategies for providing constructive feedback to HRSA regarding an important potential change to the 340B Program.

In the intro, Greg and Rob discuss some challenges with MFP refund reconciliation, and also review recent manufacturer policies requiring claims submission for 340 pricing access.

In this episode, Greg and Rob catch up on various looming deadlines for 340B providers. That includes submitting responses to the HRSA 340B Rebate Request For Information (RFI), as well as submitting drug purchasing data for the CMS ODACS. Additionally, they talk about struggles with the 340B/MFP reconciliation process and manufacturer policies requiring claims submission.

As referenced in the episode, here is the CMS ODACS acquisition data template:

https://www.cms.gov/files/zip/odacs-acquisition-data-template.zip