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 expert
The 340B Unscripted podcast is a refreshing and engaging platform that tackles the complex and hot topics surrounding hospitals, clinics, and health systems. With its candid discussions and informative insights, this podcast is truly a gem for anyone interested in the intricacies of the 340B program.
One of the best aspects of The 340B Unscripted podcast is its ability to simplify and inform its listeners about an otherwise confusing and complicated topic. Rob and Greg, with their wealth of knowledge and experience in the field, are able to break down the various moving parts of the 340B program and provide valuable perspectives that help make sense of it all. This podcast goes beyond just scratching the surface and delves into deeper discussions that shed light on issues that many healthcare professionals face.
Moreover, the hosts' fun personalities and banter add a lighthearted touch to an otherwise serious subject matter. Their humor creates an enjoyable listening experience, making it easier for audiences to stay engaged throughout each episode. Additionally, The 340B Unscripted podcast draws from a diverse pool of clients who share their experiences related to 340B, offering real-world examples that are both relatable and applicable.
While it's difficult to find any significant drawbacks to this podcast, one potential downside may be that some episodes may delve too deeply into technical details for those who are seeking a more general overview. However, even for those listeners who may feel overwhelmed by the complexity at times, The 340B Unscripted podcast still manages to strike a balance between depth and accessibility.
In conclusion, The 340B Unscripted podcast is an invaluable resource for anyone interested in gaining a deeper understanding of the 340B program. Through its informative discussions, relatable experiences, and entertaining hosts, this podcast offers a unique blend of education and entertainment that keeps listeners coming back for more. Whether you're already familiar with 340B or just starting to explore the topic, this podcast is a must-listen for healthcare professionals seeking to stay informed and engaged in the ever-evolving landscape of healthcare.
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
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 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!
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
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
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
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!
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!
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.
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
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 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!
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.
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
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.
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.
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
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 – CMS's publication of the Medicaid Drug Rebate Program rule change and a revised Sanofi contract pharmacy policy impacting Arkansas covered entities. Also, they check in on developments around the impending J&J 340B rebate model. Register for our upcoming webinar "Revolutionizing Pharmacy Procurement: Unlocking Savings with Automated NDC Selection": https://attendee.gotowebinar.com/register/1835792334721804630?source=340BUnscripted
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/
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. SAVE THE DATE – September 12th 1PM ET Register for our upcoming webinar on the J&J 340B Rebate Model - https://attendee.gotowebinar.com/register/1165611409822890584?source=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 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
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/
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 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!
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 340Unscripted@spendmend.com 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.
In this episode, SpendMend colleagues Jasmine and Megan provide some grantee CE perspectives concerning the HRSA DRL. They have so much great insight, we are breaking this conversation up into two parts. Stay tuned for Part 2 next week! In the intro, Rob and Greg discuss thoughts around responding to manufacturer 340B inquiries.
In this episode, Rob and Greg catch up on a cluster of developments in the 340B space, including updates to manufacturer contract pharmacy restrictions, thoughts on a federal appellate court ruling on Arkansas' contract pharmacy law, a preliminary take on the 340B PATIENTS Act recently introduced by Rep. Doris Matsui (D-CA), and an update on ongoing litigation between hospitals and HRSA over child site eligibility guidance. Email us at 340BUnscripted@spendmend.com with comments, questions, or topic suggestions!
In this episode, Greg and Rob continue reviewing data solicited by HRSA during an audit. DRL #5 is purchasing documentation, including a list of accounts, sample invoices, and 340B purchase order details. This ends up being a labor-intensive section to complete for HRSA, especially for larger organizations with a variety of purchasing practices. DRL #7 is an entity-owned pharmacy documentation, which includes demonstrating ownership of pharmacies that are dispensing 340B drugs but are not registered as contract pharmacies. In the intro, the guys catch up on new manufacturer restrictions in the contract pharmacy space and share thoughts on other items in the news, including the Change Healthcare cyberattack and a political ad recently published targeting the 340B Program. Contact us at 340BUnscripted@spendmend.com if you have any questions or comments on what we've discussed, or have a topic that you think we should address on the podcast!
In this episode, Greg and Rob are once again joined by SpendMend team member Riley Protz, to catch up on the current state of ongoing manufacturer restrictions on 340B contract pharmacy operations, as well as to offer insights on various mitigation strategies, like the opportunity for grantee CEs to make associated site contract pharmacy designations in 340B ESP. If you have questions about this topic or have other topics that you want us to address on the podcast, email us at 340BUnscripted@spendmend.com. Pharmacy technicians and Pharmacists looking for CE credits? Please register to attend our upcoming webinar: https://attendee.gotowebinar.com/register/8340831873822502743?source=340BUnscripted
In this episode, Greg and Rob continue their review of items from the HRSA audit data request list (DRL). They'll cover DRL #4, the provider list, as well as DRL #6, contract pharmacy documentation. Don't worry – they'll come back to DRL #5 (purchasing documentation) in an upcoming episode! In the intro, Rob shares a few insights from the recent 340B Coalition Winter Meeting in San Diego, and then the guys catch up on some 340B related news. They'll share a quick reminder on grantee 340B annual recertification (starting now through 2/26/2024) and describe communication HRSA has been sending to hospitals that were granted eligibility extensions last year under the Consolidated Appropriations Act. Finally, they'll discuss some developments from the Senate “Gang of 6” and their newly released 340B legislative draft and request for information on 340B Program reform.
In this episode, Greg and Rob continue to cover the HRSA data request list, focusing this week on DRL item #3, probably the most complex of all of the sections – 340B universe data. They'll talk about tips for organizing your 340B utilization data for an HRSA audit, and share insights regarding what the HRSA audit experience might be like when reviewing this data. In the intro, the guys catch up on state-level 340B legislative updates, discuss CMS's upcoming process for Medicare Part B repayments, and talk about a new Medicaid rebate policy change that might impact 340B providers in the future. We are at the 340B Coalition Winter Conference in San Diego this week! Stop by and see the team at booth 611!
In Episode 36, Greg and Rob provide updates on recent 340B news around state legislation, manufacturer restrictions, and HRSA's decision to not appeal the Genesis case court ruling. They also provide insight and thoughts around the HRSA data request list item 2, the covered entity eligibility documentation. Also, if you are at 340B Winter Coalition, make sure to come see the team at Booth 611.
For our last episode of 2023, Greg and Rob reviewed hot topics impacting 340B covered entities from the past year.
In this episode, Greg and Rob are joined by Spendmend colleague Cat Eriksen (16:11) to discuss the importance of self-auditing as part of a 340B covered entity's overall compliance strategy. They'll talk about HRSA standards around self-auditing, how some hospitals and clinics struggle to prioritize this effort, and why seeking external support to address self-auditing needs might be a good approach for some. But first, the guys share additional thoughts on the recent Genesis case. SpendMend is at ASHP Midyear, stop by and see some members of our team at Booth 1500. Also, don't forget to register for our next webinar: https://attendee.gotowebinar.com/register/6765415327956894816?source=340B+Unscripted
In this episode, Rob and Greg share thoughts from the recent federal court ruling on the Genesis v Becerra case, which focuses on patient definition. Additionally, they catch up on manufacturer restriction changes and some developments from recent Senate HELP Committee 340B inquiries. If you are attending the ASHP Clinical Midyear meeting in Anaheim, make sure to stop by booth 1500 to see us!
This episode is the first part of a series of recordings we are putting together to review the HRSA data request list (DRL). Rob and Greg discuss DRL item #1 – 340B Policies and Procedures. They'll review the types of operations that HRSA expects to see outlined in a covered entity's 340B policies and share some insights into how to manage these documents. HRSA audit readiness and a detailed overview of the DRL will be the subject of our next SpendMend Pharmacy Webinar in December 2023. Look for more information on registering for this webinar on our social media pages. Have a suggested podcast topic? Email us at 340BUnscripted@spendmend.com with your ideas.
In this bonus episode, Rob and Greg review the HRSA notice published on October 27 that addresses the immediate use of 340B drugs in unregistered locations and some hospital considerations in response to the update.
In this episode, Rob is pitted against ChatGPT to answer 340B-related FAQs, including topics like child site registration, GPO prohibition, and HRSA audit findings (17:29). In the intro, Greg and Rob catch up on revised contract pharmacy restrictions and thoughts on recent manufacturer inquiries that 340B entities have been receiving. Email us questions, comments, or suggested podcast topics at 340BUnscripted@spendmend.com!
Rich Bucher, one of the co-founders of Turnkey Pharmacy Solutions, makes a long-awaited appearance on the podcast with Greg and Rob. Rich and Rob share anecdotes from their early days getting involved in external 340B support (23:26). Rich also shares some thoughts on 340B topics like GPO Prohibition mitigation strategies (39:13), what to make of the FAQ 4301 developments earlier this year (49:58) and opinions on recent state-enacted laws addressing contract pharmacy provisions (57:49). In the intro, Greg, Rob, and Rich get caught up on manufacturer restrictions and react to inquiries sent to 340B hospitals from the Senate HELP Committee. Please email us with questions or suggested podcast topics at 340BUnscripted@spendmend.com. Also, don't forget to register for an upcoming SpendMend webinar focusing on innovative pharmacy supply chain management: https://attendee.gotowebinar.com/register/677788879648187232?source=340B+Unscripted
In this episode, Greg and Rob are joined by healthcare attorney Jeff Davis, to discuss how the Medicare drug pricing provisions in the IRA will impact 340B providers. They'll go over CMS billing modifier requirements (15:27), share opinions on the financial impact covered entities might experience (38:02), and how various legal challenges to the IRA by the pharma industry may play out (56:29). They also add some insights around CMS's proposed Part B payment remedy (1:01:03). In the intro, Rob catches Greg up on new manufacturer restrictions, and some recent HRSA audit experience related to interpreting data request list (DRL) revisions, and shares some commentary on the current House E&C subcommittee hearing on proposed drug shortage legislation. Email us questions, thoughts, and ideas for podcast topics at 340BUnscripted@spendmend.com!
Rob and Greg continue their conversation with health care attorney and 340B expert Emily Cook (21:05). They discuss thoughts on the CMS Medicare Part B remedy, provide some commentary on the Inflation Reduction Act (IRA) and its intersection with 340B covered entities, and address an issue that could impact hospital DSH eligibility in the future. In the intro, Greg and Rob are joined by SpendMend colleague Jennifer Hagen and catch up on recent 340B developments, including updates on manufacturer restrictions, follow-up from a prior question about CAR-T therapy, as well as Spendmend's reference within an amicus brief filed in the Genesis case. Finally, the team recaps recent changes discovered in the HRSA audit data request list (DRL). If you have any questions or topic suggestions, please email 340BUnscripted@spendmend.com.
Rob and Greg are joined by Emily Cook (20:15), an attorney in the health care and 340B space. They discuss a number of 340B topics, including ongoing manufacturer restrictions of contract pharmacies (24:52) as well as legal challenges to HRSA's patient definition (42:16). This is part one of a two-part series, so look for a future podcast episode with more conversation among Rob, Greg, and Emily. In the intro, the guys catch up on some news and noteworthy 340B items, including drug shortage legislation, state-level 340B developments, tips on addressing manufacturer repayment notifications, and reminders about hospital-CE recertification.
Aiden shares the 340B questions sent in by our listeners, and there are some good ones. Questions include opening an in-house retail pharmacy, CAR-T therapy, continuum of care and 190 clinics, the IRA, and a couple of other fun ones. On our one-year anniversary, we want to thank everyone for listening and for all the encouragement we have received.
Rob and Greg continue to unpack all the great information gathered from the 2023 340B Coalition Summer Conference in Washington D.C. They chat with coworkers, clients, and friends in the 340B community to share insights from sessions at the Conference. Guests include SpendMend colleagues Jennifer Hagen (16:54) and Shakita Carter (38:12), as well as 340B hospital experts Erin Leigh (47:12), Nan Kempadoo (1:00:14) and Pooja Shah (1:14:08). Submit your questions for Rob and Greg here: https://ww2.spendmend.com/340b-unscripted-qa/
Greg and Rob share highlights from the 340B Coalition Conference in DC. Topics covered include proposed CMS repayment for affected hospitals, Inflation Reduction Act updates, legislative updates, and other worthy conference discussions.
Greg and Rob break down the ins and outs of the Medicare Cost Report and the dos and don'ts of child site registrations. They also provide an update on contract pharmacy manufacturer restrictions and information on the upcoming 340B Coalition Conference. We also hear from our Producer Aiden and provide the secret password for your free 340B Unscripted t-shirt at the conference.