Rob and Greg are joined by healthcare attorney Mark Ogunsusi to discuss 340B patient definition, including the 1996 HRSA guidance, key regulatory developments over the years, and the impact that recent litigation might have on enforcement of this standard. 

In this week’s episode, Greg and Rob discuss developments across the 340B community, including new manufacturer claims level data submission policies and ongoing discussion in Congress on 340B Program reform.

Questions or comments? Email us at [email protected]!

In this episode, Greg and Rob catch up on more recent developments across the 340B community. They discuss recent Congressional activity where 340B has been a focus, a shift in court rulings related to state contract pharmacy laws, and they catch up on recent litigation over 340B child site eligibility timing, GPO Prohibition policies, and patient definition. They round out the discussion by recapping developments with manufacturer contract pharmacy restrictions and claim-level data submission policies.

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In this episode, Greg and Rob catch up on various developments happening in the 340B community. Topics discussed include the proliferation of manufacturer claim submission requirements, notable court rulings and 340B-related lawsuits, and reactions to Congressional hearings that featured testimony related to 340B Program reform considerations.

Got questions?  Email us at [email protected]! 

In this episode, Greg and Rob discuss reports of 340B pricing removal from wholesaler accounts, which may be related to recent manufacturer claim submission requirement policies.  They also catch up on some developments in state-level contract pharmacy laws, including Washington’s newly passed state law that incorporates contract pharmacy provisions, as well as reporting requirements for both providers and manufacturers.

As a bonus, Nick Gnadt joins at the end to share an update on a recent court ruling (Premier v HHS) in which a judge vacated the 2013 HRSA GPO Prohibition Policy Notice.

Premier, Inc. v HRSA DC District Court Ruling:  https://cases.justia.com/federal/district-courts/district-of-columbia/dcdce/1:2024cv03116/274475/23…

Questions for us? Email us at [email protected]

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

In this episode, Greg and Rob are joined again by healthcare attorney Emily Cook. They discuss a recent HRSA Information Collection Request (ICR) that describes some changes being made to the 340B enrollment, registration and recertification processes. They also discuss recent industry observations around hospital disproportionate share percentage calculations and impact on 340B Program eligibility.

Going to 340B Coalition Winter Conference in San Diego? Come see the SpendMend team at booth #418!

In this episode, Rob and Greg are joined by guest Andy Ruskin, healthcare attorney and government payer expert from K&L Gates. They’ll be discussing the 2026 CMS OPPS Final Rule, focusing on the provision related to the ODACS, or Outpatient Drug Acquisition Cost Survey. They’ll review the statutory landscape surrounding the survey, recap past attempts by CMS to lower 340B hospital reimbursement, and discuss considerations for hospitals as they contemplate how to respond this time around.

In the intro, the guys review updates to manufacturer 340B policies. Specifically, they discuss a new policy from one manufacturer that conditions 340B pricing access for in-house pharmacies on claim submission requirements.