340B Unscripted

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

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.  

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!

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 [email protected]

In this episode, Rob and Greg review tips and tricks for maintaining a covered entity’s registration on the OPAIS database. Failure to keep an up-to-date and accurate listing on OPAIS can result in audit findings, and may warrant a corrective action plan with HRSA. The guys will cover some of the common compliance pitfalls with keeping an accurate record on this website. Megan from the team chimes in, too, with some tips for grantee covered entities.

Register for our webinar to get CE for pharmacists and technicians: https://attendee.gotowebinar.com/register/7740801999245853530?source=340B+Unscripted

In this episode, Greg and Rob are joined by Meetali Desai, a pharmacy business leader for a large health system in New England, to discuss thoughts around projecting the impact that IRA-mandated Medicare drug prices will have on 340B covered entities, which will go into effect in January 2026. Meetali shares her approach to quantifying the impact a 340B provider might feel from the intersection between these two federal programs. She’ll also offer her insights into other hot topics in the 340B space. In the intro, the guys will discuss updates in the news, including movement in current litigation between HHS and manufacturers attempting to implement 340B rebate models, as well as some concerns regarding cybersecurity risks in the vendor-space.

Email us your questions and topics recommendations – [email protected]

In this week’s episode, Greg and Rob recap lessons learned from the recent 340B Coalition Winter Conference in San Diego. They’ll share commentary that was circulating regarding HRSA audit trends, 340B rebate models, Inflation Reduction Act impact on budgets, contract pharmacy developments and some insights on what to watch for out of Washington D.C.

Email us your questions at [email protected]!

On this episode, Rob and Greg are joined again by healthcare attorney Emily Cook. Emily shares some insight into CMS Provider Based Rules and how 340B covered entities need to be thoughtful about where these rules intersect with various 340B Program initiatives, including new outpatient service implementation, referral capture and pharmacist-driven medication management models.

We are at 340B Coalition Winter Conference in San Diego, CA. Come visit us at booth #315 to talk with our team about hot topics in the 340B world, from patient definition to HRSA audits, to program optimization!

In this episode, Greg and Rob are joined again by Jeff Davis, healthcare attorney, to catch up on various court action impacting the 340B community. With so many 340B Program elements hung up in litigation, it's challenge to keep tabs on what has been happening. Jeff will recap key appellate court decisions on manufacturer-implemented restrictions of contract pharmacies, discuss the merits of litigation challenging state legislative efforts to protect contract pharmacy provisions, and share opinions on where 340B rebate models may go in the future. They'll also dive in to child site eligibility timing, HRSA-approved manufacturer, audits and recent threats to covered entities who receive in-kind funding. They'll also debate patient definition standards now that we are a year removed from the Genesis case. 

We can't wait to see you at 340B Coalition Winter Conference in San Diego. Catch up with the SpendMend team at Booth #315.   

In this week’s episode, Greg and Rob catch up on newsworthy developments in the 340B community. They’ll discuss various state and federal legislative developments, they’ll share how recent White House executive orders, including a pause on federal agency communications and grant funding freezes, may be impacting 340B providers, and they’ll offer some commentary on HHS Secretary confirmation hearing debate.

Catch us at the 340B Coalition Winter Conference in San Diego, CA! The SpendMend team will be at Booth 315