340B Unscripted
Business og økonomiPharmacists and healthcare industry leaders Rob ‘Hoopi’ Nahoopii PharmD, MS, ACE and Greg Wilson PharmD, BCPS, ACE dive deeply into the complicated and contentious 340B Program as well as other pressing Pharmacy matters. Special guests and industry experts pop in frequently to add insights from all sides of the discussion. If you serve in the pharmacy sector, this podcast is a must-listen!
Siste episoder av 340B Unscripted podcast
- Ep 77 | DSH Hospital Threats (00:50:28)
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!
- Ep 76 | HRSA DRL Updates & 340B Rebate Comments (01:01:45)
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
- Ep 75 | 340B Rebate Guidance Update – HRSA FAQs (00:50:34)
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
- Ep 74 | Annual Hospital Recertification & Proposed Changes to OPAIS (00:30:34)
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 (00:43:21)
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 (00:20:31)
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 (01:00:52)
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 (00:32:13)
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 (00:24:29)
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 (01:11:37)
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 (01:09:15)
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
- Ep 66 | OPAIS Database Compliance Tips (01:17:58)
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
- Ep 65 | IRA Impact on 340B (01:01:05)
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
- Ep 64 | 340B Winter Coalition Conference Recap (00:43:40)
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!
- Ep 63 | Provider-Based Rules & 340B (01:00:56)
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!
- Ep 62 | Updates from Ongoing 340B Litigation (01:07:57)
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.
- Ep 61 | What Else is Happening in 340B to Start 2025 (00:34:04)
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
- Ep 60 | What’s Happening in 340B to Start 2025 (00:48:47)
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.
- Ep 59 | Recap of 340B Developments in 2024 (01:02:51)
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 340BUnscripted@spendmend.com if you have any questions or topics that you want us to address!
- Ep 58 | Sanofi 340B Credit Model (00:51:10)
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.
- Ep 57 | Post-Election Outcome & 340B Implications (00:54:35)
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
- Ep 56 | 2024 General Election Outlook & 340B (00:55:47)
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 340BUnscripted@spendmend.com.
- Ep 55 | All About 340B Modifiers (00:58:43)
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.
- Ep 54 | 340B Operations Discussion – “Clean Site” Locations (00:50:19)
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
- Ep 53 | J&J 340B Rebate Model Follow-Up Discussion (00:52:59)
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/