340B Pulse

NorthArcHealth

340B Pulse is a NorthArc Health podcast powered by PureLogics. Built on nearly two decades of experience developing healthcare systems, data platforms, and compliance-driven environments, this podcast focuses on the real operational side of 340B including claims validation, reporting gaps, manufacturer requirements like ESP and Beacon, and program defensibility. This is not about noise or high-level theory. It’s about operator-level conversations — how 340B programs actually function, where friction shows up, and what it takes to run them effectively in the real world.

  1. 22h ago

    What Do the 2027 340B Changes Mean for Your Program? | Joella Roland

    340B regulatory changes are the new rules, guidance and court decisions that change what a covered entity must do. Joella Roland, counsel at Powers Pyles Sutter & Verville and former lead compliance officer at HRSA, explains how to read each one before acting and how to prepare for what's coming in 2027. When a new 340B rule comes out, who on your team reads it first? Joella Roland used to read them before anyone else: she reviewed agency rules for compliance at CMS and HRSA before they went out.Joella spent more than a decade in federal service, from the Presidential Management Fellowship at CMS to lead compliance officer and information collection clearance officer at HRSA. Today she is counsel at Powers Pyles Sutter & Verville, which represents safety net providers only. She walks host Muhammad Atif through how to read a 340B development past its headline, why even a change that doesn't apply deserves a written note, and how a federal reporting requirement actually gets approved.She also covers practicing on the voluntary CMS Part D repository, what the rebate pilot demands before day one, the HRSA-to-CMS oversight debate, where AI helps and why a human still checks it, and what to prioritize over the next 30 days.Recorded 1 October 2026. How to tell whether a new 340B development applies to you, and what to check firstWhy every development needs a documented response, even when it has no impactWho should own regulatory tracking on a short-staffed teamHow the Paperwork Reduction Act and OMB approval shape new reporting requirementsWhy your comment on reporting burden mattersHow to use the voluntary CMS Part D repository period as practiceWhat to have in place before the rebate pilot: cash, a TPA, a denial plan and manufacturer trackingWhere AI helps a 340B team, and why a human has to review it00:00 Cold open: can AI help short-staffed covered entities? 01:18 Welcome to 340B Pulse 01:37 From law school to the Presidential Management Fellowship at CMS 04:01 Moving to HRSA: compliance and information collection clearance 05:05 Joining Powers Pyles Sutter & Verville06:17 CMS and HRSA: who oversees what 07:31 Should 340B oversight move from HRSA to CMS? 09:33 When a new 340B development lands: what to check first 11:37 How short-staffed covered entities keep up 13:40 Trusted sources for 340B updates 15:34 Inside the agency: how a reporting requirement gets approved 20:04 The CMS Part D repository: practice in the voluntary period 22:36 The rebate pilot: cash, TPA, denials and manufacturer policies 26:19 When a proposal needs an operational response 27:20 AI with a human in the loop 29:01 The next 30 days: what to prioritize 31:31 Closing Does every 340B regulatory change need a response? Joella Roland says almost every development needs some response, from a public comment to an operational change. Even when guidance has no impact, someone should read it and document why it doesn't apply. Who should track 340B regulatory changes at a small covered entity? One dedicated person, or outside counsel or a consultant, who knows both the covered entity and the 340B program. Apexus's 340B ACE certification is one way to find people with that knowledge. Should 340B oversight move from HRSA to CMS? Lawmakers have discussed moving the Office of Pharmacy Affairs to CMS since at least 2018, because CMS has more experience regulating programs. The counterargument is that HRSA has run 340B since 1992 and CMS, as the nation's largest insurer, could face a conflict of interest.

  2. Oct 26

    340B Policy vs Practice: Where Audits Find the Gaps | Joshua Free

    A 340B policy is the written description of how a covered entity runs its program. Joshua Free, PharmD, MBA, founder and president of Nelco Advisory, audits those programs every year, and explains where the policy and daily operations drift apart and how to close the gap. What does your 340B policy say that your team isn't actually doing? Joshua Free audits 340B programs for a living, and the first contradiction he usually finds is a steering committee the policy describes and nobody has ever convened.Joshua has sat in the operator, advisor and builder seats: retail and long-term care pharmacy, a health system where 340B reported up to him, chief pharmacy officer, and now Nelco Advisory and RxFusion. He walks host Muhammad Atif through why every entity should have an annual independent audit, why a TPA's yes on a claim is not proof, and why a policy written at procedure level is guaranteed to fall out of date.He also covers the CMS Part D repository, the 2027 rebate pilot, where AI helps and where it confidently gets things wrong, and the one control to test this quarter.Recorded 1 October 2026. The three places 340B policy and practice most often drift apartWhy every covered entity should have an annual independent auditWhat "independent" should mean for a 340B auditHow to design internal audits around your known weak spotsWhy a TPA's qualification logic is not an auditWhy policy and procedure belong in separate documentsWhat to build for the CMS Part D repository and the 2027 rebate pilotHow to use AI in 340B without creating another black box 00:00 Cold open: where policy and practice first contradict 01:22 Welcome to 340B Pulse 01:50 Joshua's path: retail, long-term care and health system 340B 03:35 RxFusion and provider office dispensing 04:11 Nelco Advisory: audit, strategy and compliance support 06:06 Is RxFusion a TPA? How office dispensing works in the clinic 07:40 PrEP at the point of care 08:50 The first contradiction: a steering committee that never met 10:17 Why the gap exists: change, staffing or governance 11:53 What an annual independent audit should cover 13:34 Mock HRSA audits and choosing your risk position 15:08 Multi-site and multi-entity programs 17:09 Keeping TPA and EHR logic in line with policy 19:07 What proof to ask your TPA for 21:41 What changes should trigger a policy review 23:39 The CMS Part D repository and the 2027 rebate pilot 26:26 Where AI helps without becoming a black box 28:52 Rapid fire round31:02 Closing Where do 340B policies and operations most often disagree? According to Joshua Free, the most common gaps are a policy that references a 340B steering committee that never meets, training standards that are missing or impossible to meet, and Medicaid carve-in or carve-out status that doesn't match practice. Should 340B policy and procedure be in the same document? Joshua Free recommends keeping them separate. The policy sets governance and controls, while procedure documents change with daily operations, so a TPA interface update doesn't require going back to the policy committee. What one 340B control should a covered entity test this quarter? Duplicate discount prevention. Joshua Free calls it one of the harder things to get right, one of the easier things to test, and an area that both HRSA and manufacturers look at closely.

  3. Oct 19

    340B Rebate Model 2027: Legal Risks & Cash Flow | Jesse Dresser

    Will the 340B Rebate Model Launch in January 2027? | Jesse C. Dresser Will the 340B rebate model launch in January 2027? What happens to covered entities' cash flow when rebates are delayed or denied? In this episode of 340B Pulse, host Muhammad Atif speaks with Jesse C. Dresser of Frier Levitt, a pharmacy and drug supply attorney with over 15 years of experience representing 340B covered entities, hospitals, contract pharmacies, and specialty pharmacies. They explore the legal and operational challenges surrounding HRSA's proposed 340B rebate pilot, including the October 1 announcement, manufacturer participation, data submission requirements, rebate payment timelines, and the legal challenges that could affect implementation. Topics discussed: The history of the 340B program and manufacturer restrictions The Inflation Reduction Act and HRSA's rebate pilot The proposed 45-day data submission window and 10-day rebate payment timeline The potential impact of delayed or denied rebates on covered entities' cash flow The role of TPAs, 340B ESP, Beacon, and claims-level data Manufacturer audits, patient eligibility documentation, and compliance risks How AI and automation could support 340B workflows Preparing for the evolving 340B landscape? NorthArc Health supports covered entities with 340B program health checks, ESP and Beacon readiness, ongoing monitoring, and HRSA audit preparation working alongside existing TPAs and internal teams. Learn more: https://northarchealth.com/ 340B Pulse is a NorthArc Health podcast. Recorded in October 2026. The rebate model and its implementation remain subject to evolving legal and legislative developments. Consult official HRSA sources for current information. This episode is for educational purposes only and does not constitute legal advice.

  4. Oct 12

    340B Rebate Pilot 2027: How Hospitals Should Prepare | Holly Herring

    340B rebate cash flow is the money a covered entity has tied up between buying an in-scope drug at WAC and receiving the manufacturer's rebate. Holly Herring, Vice President of Client Services at Clearway Health, explains why the 45-day submission window under the 2027 pilot is a safety net rather than a target, and what to do now so rebate cash does not get stuck. What happens to a hospital's cash when a discount becomes a rebate? Holly Herring recorded this episode the day after HRSA approved ten manufacturers for the 2027 340B rebate pilot, and she went straight to the money. From 1 January, covered entities pay full WAC for the selected drugs and wait for the rebate. They have 45 days from dispense to submit. Manufacturers have 10 days to pay once a claim is complete, and every correction restarts that clock. Holly, who oversaw 12 340B programs at SSM Health, puts it simply: 45 days is a safety net, not a target date. Submit on day 40 and you have five days to fix a denial. She walks host Muhammad Atif through her first call after the announcement (her TPA configurations), the Beacon setup step that catches teams registered for MFP, how a CFO should size the cash at stake, why oncology-heavy entities feel it first, and how to judge the pilot after 90 days. Recorded 2 October 2026. On 9 October the AHA and others sued to block the pilot; as of 12 October there is no ruling. Why the 45-day submission window is a safety net, not a target dateHow a correction restarts the manufacturer's 10-day payment clockWhy entities registered in Beacon for MFP must re-verify their bank credentialsHow TPA data lags can cost a rebate under a fixed 45-day windowHow to estimate the cash at stake from your own NDC-level utilizationWhy extending wholesaler payment terms can protect cash flowWhy oncology-heavy covered entities face the sharpest patient impactThe four measures that show whether the pilot is working after 90 days 00:00 Cold open: the risk hospitals are underestimating 01:08 Introduction to 340B Pulse 02:13 Holly Herring's path from the ICU to 340B 03:52 Clearway Health and specialty pharmacy access 07:47 Where pharmacy finance meets patient access 09:17 One purchase under the rebate model, step by step 11:18 Setting up Beacon and re-verifying bank credentials 12:56 What HRSA's 1 October announcement said 14:54 How to avoid denials: complete data on the first pass 17:51 What happens when the 45-day window closes 19:55 Her first call: reviewing TPA configurations 21:21 What hospitals are underestimating right now 24:09 How much cash is at stake 25:29 What a CFO should model 27:50 Is the 10-day payment rule protection or pressure?30:25 How to judge the pilot after 90 days 33:45 Advice for covered entities short on staff 35:12 Where AI can help: good faith inquiries3 9:17 Rapid fire round 43:01 One piece of advice for this week Why is the 45-day rebate window a safety net and not a target? Because manufacturers have 10 days to pay once a claim is complete, and a correction restarts that clock. A claim submitted early leaves weeks to fix a denial; one submitted on day 40 leaves about five days before the window closes. Do covered entities have to set up Beacon again if they used it for MFP? According to Holly Herring, yes for banking: entities registered in Beacon for MFP have to re-verify their bank credentials before they can receive rebate payments under the 2027 pilot. Who should own 340B rebate readiness, pharmacy or finance? Both. Holly Herring says it has to be collaborative, with clear ownership of each preparedness item, or it will not succeed for the covered entity.

  5. Sep 14

    Inside FQHC 340B Data Submission: Zero Ticket Numbers, $200K a Year | Jason Bilyj

    340B claims data submission is the process of reporting individual, transaction-level prescription data to a manufacturer's platform within a fixed window, usually 45 days, to keep a claim's 340B pricing intact. In this episode of 340B Pulse, Jason Bilyj, PharmD, ACE, Director of Pharmacy at Third Street Family Health Services, an FQHC in north central Ohio, explains why that process breaks down across four mismatched TPA platforms, what it costs when it does — roughly $200,000 a year — and what changes for covered entities when the 340B rebate pilot moves to a per-claim vendor model in 2027. In this episode, Jason — Director of Pharmacy at Third Street Family Health Services, an FQHC in north central Ohio that opened its own in-house pharmacy in 2023 — walks host Muhammad Atif through what claims-level submission actually costs: roughly $200,000 a year lost to manufacturer restrictions and errors, a support system that won't even give him a ticket number when something breaks, and a rejected claim for a prescription a patient had already paid for and picked up, thirteen days after it was filled.He grounds all of it in the patients on the other end — about 30 percent with transportation issues, half without reliable internet access, and 12 percent who are homeless — including the story of a patient buying insulin off Craigslist because her copay was too high, until Jason found her a year of free medication instead. He closes on what changes for covered entities when the 340B rebate pilot moves to a per-claim vendor model in 2027, and his direct advice for FQHC pharmacy leaders preparing for it now. 00:00 Cold open: "just upload the claims-level data" 01:37 Welcome to 340B Pulse 02:48 Meet Jason Bilyj, Director of Pharmacy at Third Street 04:01 From Giant Eagle retail to FQHC pharmacy 06:30 Inheriting a 340B program and the staff turnover problem 08:26 Why Third Street opened its own pharmacy in 2023 08:34 Transportation, connectivity, and homelessness in the patient population 12:25 Retail habits Third Street deliberately left behind 14:26 The insulin black market story and patient assistance funds1 6:16 The $200,000-a-year cost of manufacturer restrictions 17:03 Becoming a data detective inside claims-level submission 17:28 Four TPAs, four different reports1 8:58 A claim rejected after the patient already paid 23:17 Manufacturer transparency claims versus the ESP and TRUSO reality 26:44 No ticket number: accountability on a support portal 33:16 Proving you acted on time when the delay wasn't yours 37:25 A fair claims transparency model and the road to 2027 38:47 The 2027 per-claim vendor model and the 10-day WAC risk 43:23 Where AI and automation could help small FQHC teams 47:15 Rapid fire round 48:46 Jason's advice for new FQHC pharmacy leaders 50:30 Closing thoughts and thank youWhy do rural and safety-net covered entities depend on multiple TPAs for 340B claims submission? Because different contract pharmacy networks and platforms each use their own identifiers and report formats, so a covered entity working across several networks ends up manually reconciling data from every TPA to satisfy manufacturer submission portals. Why would a covered entity lose 340B pricing on a claim it submitted correctly? Because the 45-day submission window starts at the date the prescription was dispensed, not the date the covered entity can act on it — patient pickup delays, wholesaler pricing corrections, and TPA processing time can all push a valid claim past the deadline. What does Jason Bilyj want FQHC pharmacy leaders to do before the 2027 rebate pilot takes effect? Confirm which manufacturers are actually participating, model the cash-flow impact of fronting full drug cost for roughly 10 days before a rebate check arrives, vet a claims-tracking vendor on more than price, and start tracking capture rate weekly now. #340BProgram #FQHC #PharmacyOperations #CoveredEntity

  6. Sep 7

    It Takes a Village: 340B Lessons From 10 HRSA Audits | Mark Capuano

    HRSA audit readiness is the ability to explain, with evidence, why a 340B program operated the way it did on an ordinary day, not simply the ability to assemble documents quickly once an audit letter arrives. Mark Capuano, PharmD, MBA, who leads 340B and supply chain work in corporate pharmacy at NYC Health + Hospitals, draws on 10 HRSA audits to explain what actually creates risk long before an auditor ever arrives.What do you understand after your tenth HRSA audit that you couldn't have known after your first? For Mark Capuano, the answer isn't a bigger checklist. It's knowing exactly where small things go unchecked long enough to become findings. He explains why Medicaid billing and location eligibility are the two areas auditors probe hardest, why a location crosswalk connecting OPAIS, the Medicare cost report, the EHR, and the TPA has to be rechecked every single year, and why the real cause of most findings is small, unmonitored logic drift rather than a missing document.He's candid about where he draws the line with vendors, too: "the TPA handled that" is never the end of the conversation for his team, and where he sees Agentic AI actually helping today versus where a human still has to validate the final answer before it reaches an auditor. He closes with the advice he'd give any 340B leader about to face their first audit, and the one line that sums up how his team gets through every single one. Why Medicaid billing and location eligibility are the two areas HRSA auditors probe hardestHow a defensible location crosswalk connects OPAIS, the Medicare cost report, the EHR, billing, and the TPA Why small, unmonitored logic drift causes more findings than any missing documentThe exact sequence a strong team checks when HRSA traces a single transaction from six months agoWhere Agentic AI can genuinely help an audit command center today, and where human validation still has to stay in the loopWhy "the TPA handled that" is never a complete answer on its ownWhat Mark believes 340B audit readiness will require as the program moves toward a claims-based rebate model 00:00 Introduction to 340B Pulse00:03:18 Mark Capuano's path from NYU Langone to NYC Health + Hospitals00:06:13 What repeatedly catches 340B programs off guard00:08:57 The split-billing blind spot in mixed-use settings00:10:58 Why the HRSA data request list barely changes year to year00:13:06 Small logic drift: the real cause of most findings00:15:11 The location crosswalk and HRSA child sites00:17:38 Where Agentic AI helps in an audit command center00:19:58 What belongs on a 340B audit dashboard00:22:07 Would he trust AI to prepare the evidence package00:23:11 Following one 340B transaction end to end00:26:11 When to stop investigating claims and start investigating the process00:27:35 Why "the TPA handled that" isn't good enough00:29:36 The future of 340B: not going away, but harder00:31:44 Why covered entities will need more software, not less00:33:23 Rapid fire round00:36:42 Final advice: you can't do it alone00:37:52 Closing thoughts Why is location eligibility so hard for HRSA audits to defend?  Location eligibility is hard to defend because a single clinic can carry a different name or ID in OPAIS, the Medicare cost report, the EHR, billing, and the TPA, and those records have to be actively reconciled or they quietly drift apart. What should a covered entity do when it can't answer an auditor's question immediately?  The strongest move is to tell the auditor the question needs proper investigation and come back with a validated answer after a break, rather than guessing on the spot and risking a wrong answer on the record. Is 340B going away?  No. 340B is not going away, since federal law requires manufacturers participating in Medicare and Medicaid to offer 340B pricing, though generating the same level of savings is expected to keep getting harder.

  7. Aug 31

    You Are Not Getting Ready 340B Audit Readiness Across 50 Hospitals | Dr. Darra M. Edwards

    340B audit readiness is what your control systems are doing during an ordinary month when no audit is expected. Audit preparation is what happens after the HRSA letter arrives. Dr. Darra M. Edwards, who oversees 340B compliance across covered entities in 15 states and more than 50 hospitals, explains how to tell which one your program actually has.In this conversation she separates audit preparation from audit readiness and gives a test any program can run today. From there the episode builds out the operating discipline underneath it.Which controls belong on a daily cycle rather than a monthly one. Why a monthly review should be targeted at your highest-risk points instead of sampling randomly. Why a clean TPA report is the end of the evidence chain rather than the source of it. The specific scenario where Medicare observation rules reclassify a patient to inpatient days after your TPA correctly qualified the claim as outpatient, and what that does to an eligibility decision you thought was settled.She also covers what the rebate model adds to all of this, why she considers it an extension of audit readiness rather than a new discipline, and the three capabilities to test before the workflow becomes operational in January 2027.The rapid-fire round closes with the metric she would watch above total savings or claim value.00:00 Cold open01:17 Welcome to 340B Pulse and the question behind this episode03:10 Dr. Darra M. Edwards on her path from frontline pharmacist to corporate 340B leadership05:36 Overseeing 340B across 15 states and more than 50 hospitals06:16 What audit ready looks like on an ordinary Tuesday07:18 Audit preparation versus audit readiness, and the test that separates them09:15 The first signs a team is reacting to problems instead of preventing them11:16 Designing the monthly 340B operating rhythm11:56 Which controls are genuinely non-negotiable15:36 The one manual activity to automate first17:37 The evidence chain behind a single 340B claim20:04 When Medicare rules reclassify a patient after the dispense21:31 Why a covered entity cannot rely entirely on its TPA22:20 From audit ready to rebate ready26:51 What to test before the rebate workflow becomes operational29:15 AI, automation, and where human judgment still decides33:31 Three to five years out: what should still be manual35:25 Rapid-fire round38:57 Final advice before January 2027 What is the difference between 340B audit readiness and audit preparation? Audit preparation is the work performed after a HRSA notice arrives: collecting files, pulling reports, briefing the team. Audit readiness is the condition of your control systems beforehand. The practical test is whether the letter changes how your team practices.Can a covered entity rely on its TPA for 340B compliance? No. A TPA provides information, but the covered entity remains accountable to HRSA for whether a transaction was genuinely eligible. Readiness means being able to independently explain and validate how the TPA reached its determination.What single metric best indicates 340B program control? Exception ageing. How long open exceptions have gone unresolved says more about whether the underlying system works than total savings or claim value does.#340B #340BPulse #AuditReadiness #HRSA #CoveredEntity #PharmacyOperations #HealthcareCompliance #NorthArcHealth

  8. Aug 24

    Trust No One: What HRSA Really Means for Your TPA | Thomasyna Sweed

    LifeSpring Health Systems, the FQHC in Jeffersonville, Indiana where she serves as Program Manager, has no entity-owned pharmacy. Every 340B dollar it captures moves through a pharmacy it does not own. She runs that across four separate TPAs, by herself. When a manufacturer publishes a new restriction, it does not narrow a channel for her. It threatens the program. Her sharpest moment is her answer on whether a covered entity can lean on its TPA. Because HRSA holds the covered entity 100 percent responsible for compliance, her rule is to trust no one. Delegate, yes. Have faith in your vendor, absolutely. Blindly trust the output, never. Why contract pharmacy becomes the whole 340B program when there is no in-house pharmacyWhat actually happens inside a covered entity after a manufacturer restriction is publishedWhy the administrative burden compounds with each restricted manufacturer while headcount stays flatThe three facts every covered entity should know cold about its own pharmacy networkWhy your highest-volume contract pharmacy is usually not your highest-savings pharmacyHow to plan manufacturer by manufacturer instead of trying to solve every policy at onceWhat HRSA's 100 percent responsibility standard means for how you treat TPA outputHow state-level Medicaid rules, PBM provisions, and distance requirements reshape a pharmacy networkWhere AI genuinely helps a team of one, and the trust problem that has to be solved firstThe 12 items HRSA requires in a Pharmacy Services AgreementThomasyna's six rules for 340B leaders00:00:00 Cold open 00:01:42 Welcome and why contract pharmacy is the pressure point 00:03:26 From high school pharmacy intern to 340B program manager 00:04:43 What contract pharmacy pressure looks like inside a covered entity 00:07:17 The biggest risks when contract pharmacy access is restricted 00:08:47 The signs a covered entity does not understand its own exposure 00:10:30 AbbVie as an example of where restrictions are heading 00:12:27 Keeping the original purpose of 340B at the center 00:13:24 How to stop being reactive every time a policy changes 00:15:16 Balancing compliance, transparency, and patient access 00:17:28 Claims data, 340B ESP, and who carries the internal burden 00:20:49 When one or two manufacturers becomes ten, then twenty, then fifty 00:22:01 Can a covered entity rely on its vendor 00:22:48 Evaluating pharmacy dependency before disruption happens 00:25:53 State-by-state variation and Medicaid billing requirements 00:29:19 How state differences affect patient access 00:31:21 Staying proactive when the rules keep changing 00:34:30 Where AI helps in 340B, and where trust has to come first 00:37:31 Rapid fire takeaways 00:39:30 Six things every 340B leader should know 00:40:43 Close Q: Who is responsible for 340B compliance when a TPA submits claims data?  A: The covered entity is. HRSA holds covered entities 100 percent responsible for program compliance regardless of which vendor, consultant, or platform performed the work. A TPA can submit on your behalf, but you still own whether those claims were complete, correct, and compliant. Q: What data should a 340B program review regularly?  A: 340B savings is the single metric Thomasyna names. Underneath it: claim volume by contract pharmacy, savings by contract pharmacy, the top 15 to 30 drugs driving savings and the manufacturers behind them, and TPA-to-pharmacy relationships, all trended week over week and month over month. Q: What is the first step when a new manufacturer restriction is published?  A: Read the policy fully and determine what actually applies to your covered entity type, because some contract pharmacy policies apply to FQHCs and some do not. Then build the requirement into the system you already have rather than standing up a parallel process. #FQHC#CommunityHealth#PatientAccess#HealthcareLeadership#PharmacyLeadership#HealthcareAI

About

340B Pulse is a NorthArc Health podcast powered by PureLogics. Built on nearly two decades of experience developing healthcare systems, data platforms, and compliance-driven environments, this podcast focuses on the real operational side of 340B including claims validation, reporting gaps, manufacturer requirements like ESP and Beacon, and program defensibility. This is not about noise or high-level theory. It’s about operator-level conversations — how 340B programs actually function, where friction shows up, and what it takes to run them effectively in the real world.

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