340B Unscripted

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 340BUnscripted@spendmend.com

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 340BUnscripted@spendmend.com

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 340BUnscripted@spendmend.com 

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 340BUnscripted@spendmend.com

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 340BUnscripted@spendmend.com!