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Without much fanfare, Greg and Rob celebrate the 100th episode of the 340B Unscripted Podcast. They catch up on hot topics in the 340B space, including going through a rundown of key timelines for various 340B-related changes on the horizon. Email us at [email protected] with your questions! Register for our upcoming 340B CE Webinar on Thursday, October 1st: https://attendee.gotowebinar.com/register/2166173604735814495?source=340BUnscripted

In this episode, healthcare attorneys Joella Roland and Jason Reddish from Powers join to provide commentary on a variety of developments impacting 340B covered entities. They’ll discuss ongoing manufacturer activity, from contract pharmacy restrictions to claim data submission requirements, and how 340B providers have been responding. They’ll also share some opinions on how recent judicial rulings on HRSA policy, including child site eligibility timing and GPO Prohibition, have impacted regulatory enforcement of the 340B Program. They’ll also offer some thoughts on how recent proposed CMS rules related to Medicare Part B billing and Medicare Part D 340B data collection will impact covered entities in the future. In the intro, Greg and Rob recap changes that have been made to the HRSA Data Request List for FY27. Save the date for our upcoming 340B CE webinar on Tuesday, September 29th. Questions?  Email us at [email protected]

In this episode, Greg and Rob are joined by healthcare attorney Kyle Vasquez to discuss the recently released CMS 2027 OPPS proposed rule. They’ll review key provisions in the policy that could impact 340B hospitals, including significant changes to billing requirements, reimbursement rates, and changes to CMS implementation of provider-based criteria for offsite outpatient departments. Earlier in the episode, the guys catch up on 340B news. Questions for us? Email us at [email protected]

In this episode, Greg and Rob cover a couple of hot topics in the 340B community. First, they will discuss the recently published HRSA notice regarding a 340B Rebate Model Pilot Program, which is set to initiate in January 2027. They discuss what the operational changes might look like for covered entities, and identify key upcoming dates in HRSA’s implementation timeline. Then, they discuss the recently introduced SUSTAIN 340B Act, a bipartisan Senate bill that addresses extensive 340B Program reforms.  They debate the merits of various provisions in the bill from the perspective of the covered entity, and share opinions on how this might advance through the legislative process.  HRSA Notice Regarding 340B Rebate Model Pilot Program: https://public-inspection.federalregister.gov/2026-15633.pdf  List of Drugs Subject to 340B Rebate Model: 340B Rebate 2026 Chart.pdf SUSTAIN 340B Act: https://www.moran.senate.gov/public/_cache/files/1/6/169a3bd3-466d-43ee-a15a-2d1f7a3506ca/56EA0919A4EEBD88A3E23AF3E1F6ED76A051C57C7E9B30FB4D1CC9E15FC3FE32.340b.pdf   Questions, comments?  Email us at [email protected]

In this episode, Greg and Rob recap highlights from this year's 340B Coalition Summer Conference in Washington, D.C. Comments or questions?  Email us at [email protected]

In this episode, Greg and Rob are joined by Ted Slafsky and Will Newton of 340B Report. They recap major developments in the first half of 2026 that have impacted the 340B community. They’ll discuss recent Congressional activity, including a newly introduced 340B Program reform bill (SECURE 340B Act), trends in federal administrative agency policies from HRSA and CMS, and the evolution of various manufacturer actions within the 340B Program. In the intro, they discuss recent HRSA audit finding trends and highlight key provisions in the CMS 2027 OPPS proposed rule, including anticipated Medicare Part B reimbursement reductions for 340B hospitals.    Use “SPENDMEND25” to get a 25% discount on a subscription to 340B Report: https://340breport.com/subscribe/ Going to the 340B Coalition Summer Meeting? Come see us at booth #418.

In this episode, Greg and Rob are joined by returning guest, healthcare attorney Emily Cook. They discuss a recent court ruling (Premier v HHS) that vacated HRSA’s 2013 GPO Prohibition policy notice that addresses compliance with inventory replenishment models, covering insights into the court’s opinion, what it means in terms of potential process changes for covered entities, and compliance considerations given that GPO Prohibition is still a statutory requirement for hospital eligibility in the 340B Program. They’ll also touch on thoughts related to the process of reporting 340B pricing access issues to HRSA based on manufacturer actions.   Premier v. HHS court opinion:  https://law.justia.com/cases/federal/district-courts/district-of-columbia/dcdce/1:2024cv03116/27447…   340B Price Unavailability – How to Report to HRSA:  340B Price Unavailability - How to Report to HRSA | HRSA

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. Email us questions at [email protected]

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