340B Unscripted

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 consi...

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 340BUnscripted@spendmend.com!

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 recap...

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 340BUnscripted@spendmend.c...

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 prov...

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 Cou...

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...

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 th...

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 eligibilit...

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 reimbursemen...

In this episode, Greg and Rob share some initial reactions around the recent judicial activity affecting HRSA's 340B rebate model. They'll discuss thoughts on the federal court ruling that halted the rebate model from going into effect, and also debate what the fallout could be for manufacturers and covered entities given the lack of a regulated deduplication process for MFP and 340B prices. They'...

In this episode, Greg and Rob recap key developments in the 340B space from 2025.  They’ll discuss the flurry of activity in recent months related to 340B rebates, project the impact of the OBBB on DSH hospitals, share insights from HRSA audit trends over the last year, and offer commentary on one of the few high points for 340B providers this year – state legislative activity. Also, Rob offers a...

In this episode, Greg and Rob are joined by Katheryne Richardson of the Beacon team, to discuss frequently asked questions about the upcoming 340B rebate model.  They’ll cover the differences between Beacon applications, commonly asked questions regarding data submission, and tips for covered entities to consider as the implementation date approaches. Come see us at Booth #1545 during this year’s...

In this episode, Greg and Rob catch up on some clarifications gained around the upcoming 340B rebate model, including purchasing requirements and developments with select chain retail pharmacies updating their policies. Additionally, they discuss the CMS CY2026 OPPS final rule that was just published, including potential implications for 340B hospitals. CMS Hospital Drug Acquisition Cost Survey In...

In this episode, Greg and Rob share initial reactions to the HRSA update on 340B rebate model implementation. They’ll review the communication provided by HRSA on October 30th on their website, as well as discuss some of the manufacturer letters published on October 31st, that formally communicate rebate policies to 340B stakeholders.   HRSA 340B Rebate Website:  https://www.hrsa.gov/opa/340b-mode...

In this episode, Greg and Rob chat about what the government shutdown might mean for 340B Program oversight in the short-term. They’ll also discuss a flurry of developments from manufacturers recently. Specifically, they’ll highlight efforts to promote more direct-to-consumer (DTC) pathways for obtaining medications, all related to a recent Trump Administration executive order calling for “most fa...

In this episode, Greg and Rob are joined by SpendMend colleague Heather Lynch, to talk about how H.R.1 (i.e. One Big Beautiful Bill Act, or OBBBA) could impact 340B covered entities in the long run. They’ll discuss how federal Medicaid cuts projected from the bill could influence a trend in lower average DSH% for some hospitals, threatening 340B Program eligibility. They’ll also have a conversatio...

In this episode, Greg and Rob review recent changes made to the HRSA Audit Data Request List (DRL). They also discuss some of the comments provided by the public to HRSA regarding potential 340B rebate models, debate a recent change to a manufacturer’s contract pharmacy restrictions, and highlight some communication that has gone out to hospitals regarding a proposed CMS 340B drug acquisition cost...

In this episode, Greg and Rob catch up on insights gathered and lessons learned from various forums our team has attended over the last few weeks. Also, they discuss the recently posted FAQ page provided by HRSA in response to questions around the 340B Rebate Model Pilot Program. 340B Rebate HRSA FAQ:  https://www.hrsa.gov/opa/340b-model-pilot-program 340B Rebate Comments:  https://www.regulations...

In this episode, Greg and Rob discuss tips for completing the annual 340B hospital recertification process, which is occurring now through early September. They also recap a recent notice in the Federal Register that signals HRSA’s intent on modifying some elements of OPAIS and the 340B enrollment/registration/recertification process. The guys also can’t help themselves and wrap up with another de...

In this episode, Greg and Rob share initial thoughts on 340B Rebate Model Guidance released by HRSA on July 31st. They also catch up on some of the hot topics that were generating conversations at the recent 340B Coalition Summer Conference Meeting.

This week’s episode is a short one but a good one. Rob is out on vacation, so Greg is joined by SpendMend colleague Sabrina Allen to discuss the recent policy changes impacting FQHCs related to a Trump Administration executive order from earlier this year that address insulin and injectable epinephrine 340B pricing provisions. SpendMend is at Booth #413 this week at the 340B Coalition Summer Confe...

In this episode, Greg and Rob welcome back Ted Slafsky to recap what the first six months of 2025 have brought to the 340B landscape. They’ll talk about where we are at with 340B rebate model action, discuss how federal agency reorganization efforts could impact 340B regulatory oversight, recap state legislative wins for 340B providers and debate how Congress may address the call for 340B Program...

In this episode, Greg and Rob catch up on developments in the 340B space. They chat about new information provided by CMS for pharmacies related to the Medicare Drug Price Negotiation Program (some helpful links are below). Also, they debate about what might be coming with the widely anticipated 340B rebate model guidance. CMS Medicare Transaction Facilitator (MTF) User Guide: https://www.cms.gov/...