340B Unscripted

Ep 52 | 340B Smorgasbord - Contract Pharmacy Legislation, ADR, Section 1115 Waiver Days & 340B Rebate Models

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 (50:53), and last but not least a recent policy notice by J&J to covered entities announcing a 340B rebate model for two of their products  (58:17).
 
In the intro, the guys offer some preliminary thoughts on the topics at hand this week.
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Ep 51 | CMS Medicaid Drug Rebate Program & “Covered Outpatient Drug” Definition

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 come from CMS’s proposed change in this definition. Greg and Rob also get Todd’s take on recent HRSA audit activity in a post-Genesis 340B environment.
In the intro, the guys discuss the recent announcement of Medicare prices on the first 10 drugs subject to IRA-mandated drug price negotiations, a court ruling in Texas over DSH% calculation and use of Section 1115 waiver days, and changes to claims submission via 340B ESP. 

Ep 50 | 340B Q&A with Hoopii

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 everyone for listening, and here’s to another 50 episodes!

Ep 49 | HRSA Audit Trends and Manufacturer Audit Activity – Conversation with Emily Cook

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 your 340B-related questions at 340BUnscripted@spendmend.com

Ep 48 | 2024 Midyear 340B Review - Conversation with Ted Slafsky

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 and indirect impact on 340B. In the intro, the guys catch up on updated contract pharmacy restrictions and recent audit experiences.  Come find us at Booth #717 at the 2024 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 47 | Alternate Distribution Models & 340B

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 guys recap a flurry of updates in contract pharmacy restrictions, and discuss a communication posted on OPA’s website that foreshadows what might be an increasing number of HRSA audit reports released over the next few months that have findings of non-compliance.
Catch us at 340B Coalition Summer Conference July 8th - 10th in National Harbor. We will be at booth 717! 

Ep 46 | Revisiting the Intersection of the IRA Medicare Drug Pricing Program & 340B – Conversation with Jeff Davis

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 the intro, the guys talk about the Congressional developments around legislation and an upcoming House Energy & Commerce subcommittee hearing called on the 340B Program, recap the D.C. Circuit Court of Appeals ruling related to manufacturer-implemented contract pharmacy restrictions, and make a case for why telling your 340B story is critical right now. Reach out to us at 340BUnscripted@spendmend.com with questions, comments or if you would give us the privilege of helping you share your 340B story!

Ep 45 | Chevron Doctrine & 340B

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 be to the 340B community if SCOTUS overturns this long-standing rule.
In the intro, the guys catch up on state-level contract pharmacy legislation and share thoughts on some recent data published around the 340B Program.