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!
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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…
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Ep 49 | HRSA Audit Trends and Manufacturer Audit Activity – Conversation with Emily Cook
1:05:53
1:05:53
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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 c…
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Ep 48 | 2024 Midyear 340B Review - Conversation with Ted Slafsky
1:14:37
1:14:37
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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,…
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Ep 47 | Alternate Distribution Models & 340B
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55:07
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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 …
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Ep 46 | Revisiting the Intersection of the IRA Medicare Drug Pricing Program & 340B – Conversation with Jeff Davis
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53:12
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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 …
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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 agen…
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Ep 44 | Pharmacotherapy Clinic Services & 340B
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53:22
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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 se…
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Ep 43 | Getting to Know the HRSA DRL – DRL 8 Self-Disclosure Documentation and DRL 9 Medicaid Billing Information
51:10
51:10
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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 …
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Ep 42 | Getting to Know the HRSA DRL – Grantee Considerations Part 2
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44:43
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SpendMend colleagues Jasmine and Megan continue their conversation providing some grantee CE perspectives concerning the HRSA DRL.By SpendMend Pharmacy
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Ep 42 | Getting to Know the HRSA DRL – Grantee Considerations Part 1
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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.…
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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 ongoin…
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Ep 40 | Getting to Know the HRSA DRL: DRL 5 Purchasing Documentation and DRL 7 Entity-Owned Pharmacy Documentation
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48:20
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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. DR…
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Ep 39 | A Revisit of Ongoing Contract Pharmacy Restrictions
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32:39
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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 designatio…
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Ep 38 | Getting to Know the HRSA DRL: DRL 4 Provider List and DRL 6 Contract Pharmacy Documentation
1:04:50
1:04:50
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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 34…
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Ep 37 | Getting to Know HRSA DRL: Part 3 - 340B Universe Data
1:06:51
1:06:51
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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 revi…
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Ep 36 | Getting to Know HRSA DRL: Part 2 - CE Eligibility Documentation
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43:32
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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…
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Ep 35 | Top 10 Developments in 340B for 2023
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1:05:01
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For our last episode of 2023, Greg and Rob reviewed hot topics impacting 340B covered entities from the past year.By SpendMend Pharmacy
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Ep 34 | Maintaining 340B Compliance: The Importance of Self-Auditing
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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 …
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Ep 33 | Thoughts on the Genesis v. Becerra Court Ruling
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38:53
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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 Anahei…
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Ep 32 | Getting to Know the HRSA DRL: Part 1 – Policies & Procedures
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58:56
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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 do…
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Bonus Ep 2 | HRSA Notice Addressing 340B Registration Requirements
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24:47
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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.By SpendMend Pharmacy
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Ep 31 | Answering 340B FAQs - Rob vs. ChatGPT
1:02:37
1:02:37
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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 ques…
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Ep 30 | Turnkey Pharmacy Solutions, Whiteboards & 340B Stuff
1:07:46
1:07:46
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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 t…
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Ep 29 | The Intersection Between the Inflation Reduction Act (IRA) & 340B – Conversation with Jeff Davis
1:09:11
1:09:11
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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 IR…
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Ep 28 | 340B Conversation with Emily Cook - Part 2
50:13
50:13
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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. I…
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Ep 27 | 340B Conversation with Emily Cook - Part 1
1:08:21
1:08:21
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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 w…
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Ep 26 | First Year Anniversary of the 340B Unscripted Podcast - Q & A Session
1:05:31
1:05:31
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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.…
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Ep 25 | 340B Coalition Summer Conference Recap - Part 2
1:33:30
1:33:30
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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…
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Ep 24 | 340B Coalition Summer Conference Recap
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54:19
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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.By SpendMend Pharmacy
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Ep 23 | 340B and the Medicare Cost Report
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57:38
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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 Unscrip…
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Ep 22 | Maintaining 340B Compliance: Medicaid Duplicate Discount Prevention
1:04:33
1:04:33
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In this episode, Greg and Rob talk about an important 340B Program compliance element – preventing Medicaid duplicate discounts. They discuss the importance of maintaining the Medicaid Exclusion File (MEF), challenges with managing state-specific billing requirements, and strategies for managing out-of-state Medicaid. In the intro, the guys review …
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Ep 21 | Thoughts on 340B & Biosimilar Uptake
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40:00
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In this episode, Greg and Rob discuss a recent publication regarding how 340B Program participation may impact the degree of biosimilar utilization. Additionally, the guys recap recent legislative proposals with 340B impact that were advanced by the House Energy & Commerce Committee. Article citation: Health Affairs 42, NO. 5 (2023): 632–641…
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Ep 20 | 340B History Lesson – The Morford Letter
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54:16
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In this episode, Rob and Greg discuss an interesting piece of 340B history – the Morford letter (25:31). Rob shares his understanding of the origins of the letter and contemporary application of the letter as it relates to the recent debate around the 340B-eligible patient definition. But first, the guys catch up on 340B news, including: -A reminde…
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Bonus Ep 1 | New 340B Location Qualification and FAQ 4301 Update
16:39
16:39
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Greg and Rob provide a quick update on FAQ 4301 and where we are with HRSA removing language around the immediate use of new 340B locations.By SpendMend Pharmacy
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Ep 19 | 340B D.C. Update – Conversation with Ted Slafsky
1:09:27
1:09:27
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In this episode, Rob and Greg are joined by guest Ted Slafsky, of 340B Report and Wexford Solutions (13:20). Ted shares his thoughts on the ongoing contract pharmacy impasse, updates on legislative developments coming out of D.C., and highlights some of the emerging advocacy groups as the debate over 340B Program reform heats up. But first, Greg an…
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Ep 18 | 340B Program Reform – A Conversation with NACHC
1:11:32
1:11:32
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This week, Rob and Greg connected with Vacheria Keys, Director of Policy & Regulatory Affairs at NACHC. Vacheria will talk about her role at NACHC and how the health centers she represents have been impacted by a number of ongoing 340B developments (23:05). She’ll also share her thoughts on where things may go in terms of ongoing litigation related…
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Ep 17 | 2023 Winter Coalition Recap and More!
1:03:28
1:03:28
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Rob is back from San Diego, and he and Greg have a lot to catch up on, including a recap of notable events and sessions from the 340B Coalition 2023 Winter Conference (27:37). But first, They’ll discuss recent changes to manufacturer-related contract pharmacy restrictions (1:03), share insights from recent Congressional hearings where 340B has been…
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Ep 16 | Dissecting Recent 340B Program Reform Proposals
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44:26
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In this episode, Rob and Greg dissect some of the finer details of the ASAP 340B policy principles. They’ll address the merits of proposed reform around topics like patient definition, hospital and child site eligibility, contract pharmacy provisions, and 340B savings transparency, among other targeted policy areas. Also, with the 340B Coalition Wi…
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In this episode, Rob and Greg are joined by pharmacist leader and 340B expert Leah Marcelin (22:32) to share thoughts and ideas about building out an expert staff to manage your 340B program. They’ll debate strategies for right-sizing and organizing your team, share tips on recruiting 340B talent, and offer ideas on how to provide training and enri…
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Ep 14 | All About 340B Grantees (Part 2)
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1:00:37
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This is part two of our two-part series focusing on 340B grantee-covered entities. The team talks about the importance of maintaining auditable records (15:34) and the challenges that many grantees face in meeting this 340B eligibility requirement. Also, they cover important billing considerations related to Medicaid Duplicate Discount prevention (…
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This episode is the first part of a two-part series focusing on 340B grantee-covered entities. Rob and Greg are joined by SpendMend pharmacy experts (19:43) who bring their FQHC and Ryan White experience to share insights into 340B Program participation from the grantee perspective. They’ll discuss what to look out for regarding OPAIS registrations…
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Ep 13 | Update on Manufacturer Restrictions for 340B Contract Pharmacies
1:04:37
1:04:37
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In this episode, Rob and Greg catch up on recent 340B developments, including the 3rd Circuit Court ruling on one of the contract pharmacy cases and the subsequent changes to some manufacturer's policies (1:36), how the new shape of the Senate HELP Committee may influence 340B legislative debate, and why a renewed focus on advocacy might be helpful…
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Ep 12 | Pharmacy Benefit Optimization for 340B Covered Entities
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53:45
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Rob and Greg kick off the episode with some discussion around news and noteworthy items across the 340B landscape, including more dialogue around CMS guidance on “JG”/”TB” modifiers (1:01), 340B in the news media (4:31), grantee recertification tips (14:13) and ongoing challenges working 340B ESP (18:39). Later in the episode, they are joined by Vi…
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Ep 11 | Trends in Direct Order Procurement
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32:51
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Ep 10 | Top 10 Developments in 340B for 2022
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47:39
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For our last episode of 2022 Rob and Greg are joined again by SpendMend colleague Matt Parker and debate the top developments in the 340B space over the last year.By SpendMend Pharmacy
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In this episode, we have podcast guests Anna Bulochnik, and Chelsea Violette to discuss the challenging task of switching third-party administrators (TPAs). Great tips and recommendations on how to make the transition as smooth as possible.By SpendMend Pharmacy
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Ep 8 | Trulla - Modernizing Pharmacy Procurement
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44:27
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On this episode, Rob and Greg welcome a few new SpendMend colleagues - Curtis McEntire and Angela Whitney– to talk about Trulla, a state-of-the-art pharmacy procurement solution now offered by SpendMend. They’ll talk about the challenges of today’s pharmacy buyer, common untapped opportunities for drug savings, and how Trulla can bring your pharmac…
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Ep 7 | Don’t be Haunted by a HRSA Audit!
1:16:03
1:16:03
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It’s Halloween, and in this episode, Greg and Rob invite guests from the field to discuss “tricks and treats” from recent HRSA audit experiences! They’ll review strategies for gathering audit data, the coaching staff for the onsite visit, and what you need to consider when you eventually receive your final audit report. HRSA audits can be a “fright…
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In this episode, Rob and Gren welcome William Mayhood to the Pod and get into the New York Times article on Bon Secours’ 340B program. We shift gears and get into what covered entities should be doing in preparation for a similar media article, or congressional inquiry, and bring back the 340B Impact Statement. You never know, your CE could be next…
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