Pharmacists 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
Her er de nyeste episodene tilgjengelige via RSS-feeden:
Ep 82 | Recap of 340B Developments from 2025 (00:45:37)
In this episode, Greg and Rob recap key developments in the 340B space from 2025. They’ll discuss the flurry of activity in recent months related to 340B rebates, project the impact of the OBBB on DSH hospitals, share insights from HRSA audit trends over the last year, and offer commentary on one of the few high points for 340B providers this year – state legislative activity. Also, Rob offers a heartfelt pep talk for 340B folks at the end of the episode – so make sure you listen through to the end!
Medi-Cal Provider Guidance on 340B Rebates: https://mcweb.apps.prd.cammis.medi-cal.ca.gov/news/33779
Email us at 340BUnscripted@spendmend.com with your questions and comments!
Ep 81 | 340B Rebate Q&A with Beacon (01:19:54)
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!
Ep 80 | 340B Updates, including CMS CY26 OPPS Final Rule and Rebate Developments (00:47:45)
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!
Ep 79 | 340B Rebate Model Update (00:52:37)
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!
Ep 78 | Government Shutdown, Most Favored Nations Pricing and Direct-to-Consumer Pharmacy Supply Chain Discussion (00:33:05)
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!
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!
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
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
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.
