340B Unscripted

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 favored nation (MFN)” pricing for drugs in the U.S.
SpendMend will be at the 340B Grantee Conference in Atlanta October 20 – 22.  Stop by our booth and also catch our presentation at the “Ask the Experts – Open Forum” while you are there!

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 conversation about things hospitals should consider, both in the short term and long term, to brace for the impact.
In the intro, they’ll also catch up on various manufacturer actions affecting 340B providers.
Email us at 340BUnscripted@spendmend.com with questions and comments!

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 survey expected in CY26.
SpendMend’s comments on HRSA’s proposed 340B rebate model: https://www.regulations.gov/comment/HRSA-2025-0001-1115
CMS proposed Medicare Part B 340B drug acquisition cost survey template: CMS-10931 | CMS
 
Got questions? Email us at 340BUnscripted@spendmend.com 

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.gov/document/HRSA-2025-0001-0001

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 debate around impending 340B rebate considerations.
Proposed OPAIS changes: https://www.federalregister.gov/documents/2025/08/07/2025-14955/agency-information-collection-activities-proposed-collection-public-comment-request-information
 
Register for our Trulla webinar on August 26th: https://attendee.gotowebinar.com/register/2844398547415085144?source=340B+Unscripted

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 Conference in National Harbor, MD. Come meet our team, eat some chocolate and discuss what’s happening in the 340B world.
Webinar Alert! Join us for a webinar on 340B Patient Definition on Thursday July 24 at 2PM ET. Register here: https://attendee.gotowebinar.com/register/1724500873792685151?source=340B+Unscripted

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 reform later in the year.
Come catch us at Booth #413 at the 2025 340B Coalition Summer Conference!
Listeners are welcome to use code “SpendMend25” to receive a 25% discount for new subscriptions to 340B Report. Visit https://340breport.com/