340B Unscripted

In this episode, Greg and Rob are joined by Katheryne Richardson of the Beacon team, to discuss frequently asked questions about the upcoming 340B rebate model.  They’ll cover the differences between Beacon applications, commonly asked questions regarding data submission, and tips for covered entities to consider as the implementation date approaches. Come see us at Booth #1545 during this year’s ASHP Midyear Clinical Meeting!

In this episode, Greg and Rob catch up on some clarifications gained around the upcoming 340B rebate model, including purchasing requirements and developments with select chain retail pharmacies updating their policies. Additionally, they discuss the CMS CY2026 OPPS final rule that was just published, including potential implications for 340B hospitals. CMS Hospital Drug Acquisition Cost Survey Info: https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient-pps/outpatient-prospective-payment-system-opps-drug-acquisition-cost-survey Come see us at booth #1545 at the ASHP Clinical Midyear Meeting December 8-11 in Las Vegas!

In this episode, Greg and Rob share initial reactions to the HRSA update on 340B rebate model implementation. They’ll review the communication provided by HRSA on October 30th on their website, as well as discuss some of the manufacturer letters published on October 31st, that formally communicate rebate policies to 340B stakeholders.   HRSA 340B Rebate Website: https://www.hrsa.gov/opa/340b-model-pilot-program Beacon Manufacturer Resources Website (includes letters): https://cm.beaconchannelmanagement.com/pages/resources   Email us at 340BUnscripted@spendmend.com with questions, comments and topic suggestions!

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/

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 340BUnscripted@spendmend.com

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 – 340BUnscripted@spendmend.com  

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 340BUnscripted@spendmend.com!

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.