340B Unscripted

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. 

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!

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 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 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! 

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 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.

In this episode, SpendMend colleague Matt Parker joins Greg and Rob (14:00) to discuss pharmacotherapy services, and how pharmacist-driven care can help promote improved health outcomes in a community, as well as how these services might intersect with a covered entity’s 340B Program. They highlight the clinical and financial benefits that these services can provide, map out a typical workflow for how these services might be executed, and share thoughts on both operational and regulatory challenges that might be encountered when getting started.

In the intro, Rob and Greg briefly discuss some 340B news, including the recently published Administrative Dispute Resolution (ADR) Final Rule.

Register for our webinar on Tuesday, May 14th at 2 PM ET/11 AM PT, which offers pharmacist and pharmacy technician CE credits! https://attendee.gotowebinar.com/register/1001816060425009246?source=340BUnscripted

In this episode, Greg and Rob continue to provide insights on the HRSA data request list.   DRL #8 is self-disclosure documentation and DRL #9 is Medicaid billing information, which includes providing details regarding your CE’s listing on the Medicaid Exclusion File, as well as sample billing claim forms for physician-administered drugs and billing claim screenshots for retail dispenses.

In the intro, they recap state-level 340B legislation, discuss ongoing uncertainty around Medicare Advantage & Part B underpayment remedies, and also note some recent data published on drug shortages.

Rob and other folks from our team will be attending Asembia in Las Vegas from April 29 – May 2.  Reach out to us if you want to connect there! Email us at [email protected]

Also, save the date for our next webinar, which will be on May 14, 2024 – We’ll be sharing tips on what covered entities should be doing to effectively self-audit their 340B Program operations!

SpendMend colleagues Jasmine and Megan continue their conversation providing some grantee CE perspectives concerning the HRSA DRL.