340B Pulse

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.

340B Pulse is a health podcast hosted by NorthArcHealth, with 23 episodes on record and a Required Pod Score of 80.

NorthArcHealth hosts 340B Pulse, a health show with 23 episodes published.

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  340B Pulse

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

  Sep 14, 202651 min

  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 you Why 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

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  340B Pulse

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

  Sep 7, 202638 min

  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.

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  340B Pulse

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

  Aug 31, 202641 min

  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

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  340B Pulse

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

  Aug 24, 202641 min

  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 pharmacy What actually happens inside a covered entity after a manufacturer restriction is published Why the administrative burden compounds with each restricted manufacturer while headcount stays flat The three facts every covered entity should know cold about its own pharmacy network Why your highest-volume contract pharmacy is usually not your highest-savings pharmacy How to plan manufacturer by manufacturer instead of trying to solve every policy at once What HRSA's 100 percent responsibility standard means for how you treat TPA output How state-level Medicaid rules, PBM provisions, and distance requirements reshape a pharmacy network Where AI genuinely helps a team of one, and the trust problem that has to be solved first The 12 items HRSA requires in a Pharmacy Services Agreement Thomasyna's six rules for 340B leaders 00:00:00 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

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  340B Pulse

  Ask for the Fees Back: Real Vendor Accountability in Multi-State 340B | Dr. Maria Campanella

  Aug 17, 202633 min

  A multi-state 340B program is a single covered-entity operating model applied across hospitals, clinics, pharmacies, vendors, and state regulatory environments that do not match each other. Dr. Maria Campanella, who leads 340B operations and compliance across a multi-state nonprofit health system, explains what such a program must standardize, what state law forces it to localize, and how to govern vendors on outcomes rather than service levels. At a single site, the question is whether a claim was processed correctly. Across a dozen states, that question stops being the one that matters. In this episode, Dr. Maria Campanella walks host Muhammad Atif through the operating model behind a large multi-state 340B program. She has managed a Ryan White clinic in Atlanta, directed 340B operations and compliance at a nonprofit health system, and now leads the function across hospitals and clinics in markets throughout the U.S. She is direct about what scales and what does not. TPAs, policies, procedures, SOPs, and the compliance core stay standardized everywhere. Legal contracting cannot be, because state law dictates it. Every local market feeds one centralized dashboard so a missing-claims error in one state can be checked against every other. Support tickets get consolidated specifically so a repeating pattern becomes visible and a team can conclude that a vendor's fix is not working. She is equally candid about the rebate model, the PHI question nobody has answered, and exactly where she thinks AI helps a 340B team and where it does not. 00:00 Cold open 01:22 Introduction to 340B Pulse 03:01 Dr. Maria's journey into 340B 03:53 When site-by-site management stops working 05:36 Does centralization create bottlenecks or efficiency 06:52 Justified local variation vs a normalized control weakness 08:25 A controlled inventory of variations and drug procurement 09:25 Internal audits: site-level, centralized, or both 10:19 Why more reports do not mean more control11:14 Building one centralized dashboard 13:19 Document management across multi-site programs 14:44 Vendor accountability: administering a contract vs governing it 16:34 What to validate independently of vendor reports 17:27 When a vendor meets the SLA but misses the outcome 18:33 Today's pressure: HRSA rebate model, 340B ESP, Truzo 21:44 Keeping manufacturer policy change consistent across sites 23:16 The rebate model, advocacy in DC, and patient impact 25:19 Administrative burden and the PHI question 26:23 Where AI actually helps a 340B team 27:30 Rapid fire round 30:51 One principle for scaling without losing control 32:15 How to connect with Dr. Maria What should a multi-state 340B program standardize first? The compliance core comes first: diversion prevention, duplicate discount prevention, and high WAC spend monitoring, along with policies, procedures, and SOPs. Dr. Maria calls these the core heartbeat of the program, and they should look identical at every site. Which 340B metric tells a leader more than total savings? A monthly report comparing WAC spend against 340B spend. Total savings and claim volume both rise with growth even when a program is drifting, but the WAC-to-340B comparison shows whether the program is actually becoming more efficient. Can a covered entity recover money from an underperforming vendor? Yes, where the shortfall relates to contracted work. If accumulations covered in the contract are being missed, the covered entity can request that the vendor credit back the administration fees paid for that service. Does AI replace 340B compliance staff? No. Dr. Maria's line is that AI helps with reporting and analytics, including tracking which manufacturer paid a rebate and which did not, but the hands-on submission, monitoring, and appeal work still requires a person. #340BProgram#HealthSystems#VendorManagement#HealthcareCompliance#PharmacyOperations

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