340B Unscripted

In our first episode of 2025, Greg and Rob discuss the latest developments in 340B. They’ll recap HRSA audit trends, discuss how Congressional committee membership seems to be forming, and discuss a variety of 340B provisions being litigated in court.

In our last episode of 2024, Greg and Rob recap major developments in the 340B space from the last year.  They’ll start with trends in HRSA audit activity, including thoughts on patient definition. They’ll address a variety of manufacturer developments, from contract pharmacy restrictions to manufacturer audits to proposed 340B rebate models. They end with a forecast of what to watch for in 2025

Thank you for listening to our podcast! Email us at [email protected] if you have any questions or topics that you want us to address!

In this week’s episode, Greg and Rob cover the recent policy notice put out by Sanofi regarding a 340B credit model. They discuss how it compares to other proposed credit/rebate models, and more importantly how this one is unique.

In the intro, the guys recap developments in Washington D.C., as well as some updates in court action amongst HRSA, covered entities and manufacturers regarding audit activity.

In this episode, Greg and Rob are joined by Rodney Whitlock, healthcare policy expert, to discuss the recent 2024 election results.    They’ll discuss what the second Trump Administration might prioritize in terms of healthcare policy, how a Republican-controlled Congress will impact 340B legislation activity, and whether or not any developments coming out of the upcoming lame-duck session might be on the horizon for 340B providers.

In the intro, Greg and Rob catch up on a variety of topics, including J&J’s recently filed lawsuit against HRSA regarding rebate models, CMS final rules around inflation rebate penalties, and they share some anecdotes from recent HRSA audit activity.

Register for our upcoming webinars below:

340B Hidden Strategies: Mastering 340B Advocacy: https://attendee.gotowebinar.com/register/8182646241351674200?source=340B+Unscripted

The Power of Trulla: An Overview of Our Award-Winning Pharmacy Procurement Software: https://attendee.gotowebinar.com/register/8037692126057457751?source=340B+Unscripted

In this episode, Greg and Rob are joined by Mike Strazzella, government affairs expert from Buchanan Ingersoll & Rooney, to discuss the upcoming general election, and what races may be critical to future 340B policy developments. They’ll discuss Senate and House races that could precipitate leadership changes in Congressional committees that drive legislative work, debate what a future Harris or Trump administration means for health care policy in general, and they wrap up with some conversation around how stakeholders can successfully advocate for the importance of the 340B Program.

Have a 340B question or topic you want us to cover?  Email us at [email protected].

In this episode, Greg and Rob discuss the various uses of 340B billing modifiers. They’ll discuss some general considerations around what billing modifiers are used for, highlight differences between hospital/clinic and pharmacy billing in terms of applying correct modifiers, and debate different aspects of Medicaid and Medicare billing modifier requirements.  It’s another heavy duty 340B-operations focused episode. 

In this episode, Greg and Rob get back to 340B basics and have a conversation around the concept of “clean site” 340B-only locations.  They discuss what “clean site” means in the world of 340B, what the benefits of the approach are, what some of the risks and obstacles are from a compliance perspective, and share some anecdotes from past experiences working with these types of 340B universes.

In the intro, the guys discuss a couple of recent developments – most notably, J&J's response to HRSA's enforcement letter regarding the proposed rebate model.

Register for our upcoming webinar "Revolutionizing Pharmacy Procurement: Unlocking Savings with Automated NDC Selection": https://attendee.gotowebinar.com/register/1835792334721804630?source=340BUnscripted

In this episode, Greg and Rob get back to 340B basics and have a conversation around the concept of “clean site” 340B-only locations. They discuss what “clean site” means in the world of 340B, what the benefits of the approach are, what some of the risks and obstacles are from a compliance perspective, and share some anecdotes from past experiences working with these types of 340B universes.

In the intro, the guys discuss a couple of recent developments – CMS’s publication of the Medicaid Drug Rebate Program rule change and a revised Sanofi contract pharmacy policy impacting Arkansas covered entities. Also, they check in on developments around the impending J&J 340B rebate model.

Register for our upcoming webinar "Revolutionizing Pharmacy Procurement: Unlocking Savings with Automated NDC Selection": https://attendee.gotowebinar.com/register/1835792334721804630?source=340BUnscripted

In this episode, Greg and Rob catch up on developments surrounding the J&J 340B rebate proposal, including HRSA’s response. They’ll address some outstanding questions from the recent SpendMend webinar on the topic.

In the intro, they recap some updates regarding contract pharmacy litigation and thoughts on how DSCSA and product serialization data might impact 340B operations.

If you missed it before, you can watch our webinar on the J&J 340B rebate model here: https://ww2.spendmend.com/webinar-jj-340b-rebate-model-what-covered-entities-need-to-know/

In this episode, Greg and Rob are joined by healthcare attorney and 340B veteran Barbara Straub Williams.  They cover a variety of topics, including an update on litigation targeting state-level contract pharmacy laws (21:18), navigating manufacturer audits and ADR claim submissions (38:47), a recent court ruling related to exclusion of Section 1115 wavier days from DSH percentage calculations (50:53), and last but not least a recent policy notice by J&J to covered entities announcing a 340B rebate model for two of their products  (58:17).

In the intro, the guys offer some preliminary thoughts on the topics at hand this week.

SAVE THE DATE – September 12th 1PM ET

Register for our upcoming webinar on the J&J 340B Rebate Model - https://attendee.gotowebinar.com/register/1165611409822890584?source=340B+Unscripted