340B Unscripted

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 litigat...

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 ne...

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 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 be...

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@spend...

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 Coal...

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 liti...

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 hearin...

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 T...

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 ac...

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 b...

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...

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-operatio...

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 t...

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...

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...

In this episode, Greg and Rob are joined by healthcare attorney Todd Nova to discuss a proposed rule change put forth by CMS in 2023 regarding the Medicaid Drug Rebate Program (MDRP), which includes a potential change to the definition of “covered outpatient drug”. They’ll discuss how covered entities have historically interpreted the definition of covered outpatient drugs, and what impact might c...

This is our 50th episode, and it marks the 2 year anniversary of the 340B Unscripted Podcast. To mark the occasion, Greg asks Rob a hodgepodge of 340B-related questions including entity-owned vs contract pharmacy considerations, out-of-state Medicaid carve-out challenges, “class of trade”, referral capture documentation standards and how CEs should keep an eye on their OPAIS registration. Thanks e...

In this episode, Greg and Rob have another repeat guest!  Healthcare attorney Emily Cook shares some insights gained from the 340B Coalition Summer Conference around recent HRSA audit patterns (08:37) and a cluster of manufacturer audits of 340B covered entities (27:46). In the intro, the guys touch base on some 340B newsworthy developments in the contract pharmacy and legislative space. Email us...

In this episode, Greg and Rob gear up for the 340B Summer Coalition conference, and are joined again by Ted Slafsky to discuss various 340B developments from the first half of 2024.  They’ll discuss the ongoing contract pharmacy saga between entities and manufacturers, debate the future of proposed federal legislation addressing 340B Program reform, and recap pertinent court cases with both direct...

In this episode, Greg and Rob are joined by a new SpendMend team member – Nick Gnadt – to discuss considerations around the use of alternate distribution models (ADMs) in the 340B space. They discuss some of the practical considerations around implementing ADM, where there may be operational or regulatory challenges, and what the long-term outlook is for this more novel strategy. In the intro, the...

In this episode, Greg and Rob welcome back health care attorney Jeff Davis to catch up on the latest draft guidance published by CMS to address IRA-mandated Medicare drug pricing provisions and impact to 340B providers (15:25).   Additionally, they chat about the 340B ACCESS Act, a new piece of draft legislation introduced in the House with sweeping 340B Program reform considerations (41:28). In t...

In this episode, Greg and Rob are joined by healthcare attorney Ross Marguiles to discuss how a Supreme Court ruling on litigation in the fishing industry could have a major impact on the healthcare landscape.  Ross provides background on Chevron deference, a 40-year judicial doctrine that allows courts to defer ruling to federal administrative agencies, and ponders what the ripple effects could b...