340B Unscripted

Ep 74 | Annual Hospital Recertification & Proposed Changes to OPAIS

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

Ep 73 | Coalition Recap & 340B Rebate Guidance Release

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.

Ep 72 | Insulin & EpiPen 340B Policy Changes for FQHCs

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

Ep 71 | 2025 Midyear 340B Review – Conversation with Ted Slafsky

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/

Ep 70 | 340B Updates – IRA Guidance and Rebate Models

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/files/document/negotiation-program-mtf-user-guide.pdf
CMS MTF Pharmacy FAQs: https://340breport.com/wp-content/uploads/2025/06/pharmacy-and-dispensing-entity-mtf-faq.pdf
 

Ep 69 | Quick 340B Update

This week's episode is a quick one. We pushed out this episode expecting to have HRSA guidance on rebate models to discuss, but we'll have to wait for that topic another day! Greg and Rob catch up on a few developments in the 340B news cycle, primarily recapping HRSA's first final agency action taken in the context of 340B ADR claims.  

Ep 68 | 340B Hot Topics Discussion

In this episode, Greg and Rob are joined by guest Peggy Tighe, healthcare attorney and government relations specialist. They catch up on lots of contemporary issues impacting 340B providers, including state legislative activity (19:44), the recent Trump Administration’s executive order on drug pricing (30:02), Senator Cassidy’s 340B investigation report (43:20), and movement in 340B rebate litigation (52:00).   Also, listen for Dave Chappelle and magic mushroom references – this one was a lively discussion!
Register for our upcoming Trulla Webinar: https://attendee.gotowebinar.com/register/7502684065481252181?source=340B+Unscripted
Attending the 340B Grantees Spring Conference in Kansas City May 27 - 30? Come say hello to our team – we’ll be at Booth #24 sharing our insights from our work with the 340B grantee community!

Ep 67 | 340B Location Issues – Webinar Follow Up

In this week’s episode, Greg and Rob are joined by colleague Heidi Larson to recap lots of questions that came out of a recent SpendMend webinar focused on 340B location issues. They’ll address issues like what is considered onsite vs. offsite for the purposes of OPAIS registration, when newly registered locations are eligible to use 340B and a variety of other issues pertaining to how entities need to address their locations from a 340B compliance perspective.
In the intro, the guys catch up on 340B hot topics in the news. They’ll hit highlights of lots of state level activity, discuss ongoing changes in D.C. with federal agency changes, and a new White House executive order with some 340B implications.
If you missed the webinar, you can catch it again on demand here: https://ww2.spendmend.com/webinar-all-about-locations-understanding-the-importance-of-location-considerations-in-340b-program-compliance/
If you have any question or topics to suggest, email us at 340BUnscripted@spendmend.com