340B Pulse

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.

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.

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

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.

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

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

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

Every quarter brings another pricing impact, another piece of state legislation, another manufacturer restriction. Most covered entities have settled into bracing for the next hit.
Kaitlyn Weckhorst Wood argues that the work which actually protects a program is smaller and duller than the headlines, and it is available right now. She has seen it from both sides: pharmacy analyst at Oklahoma Medicaid, then 340B program manager at an academic health center, and now a 340B Pharmacy Account Executive at SunRx working with covered entities from single-site clinics to large health systems.
She asks a question that reliably exposes the gap. Can your team run an eRx report from your EMR, and do you run it regularly? About half cannot answer, and that report is what shows where prescriptions actually go after a patient leaves. Rural programs in particular discover their scripts are filled thirty miles away rather than at the pharmacy they contracted with next door.
She is also unusually direct for someone who works at a TPA, stating plainly that the program belongs to the covered entity and that vendors are a small piece of the puzzle. Her illustration is a covered entity that changed its EMR without telling anyone, and found six months later that the program savings had simply stopped.

00:00 Cold open: what strong 340B operations actually look like

02:11 Welcome to 340B Pulse

02:25 Why practical 340B operations, and why now

03:16 Introducing Kaitlyn Weckhorst Wood

04:24 From Oklahoma Medicaid to academic health center to the vendor side

05:28 Why operational tips resonate: playing offense instead of defense

06:46 The daily habits behind well-managed programs

07:49 Asking vendors questions: "you have not because you've asked not"

09:15 The biggest gap Kaitlyn sees in covered entities

09:21 The eRx report, and why it's her "number one lethal weapon"

10:04 Where prescriptions actually go, and rural leakage

11:06 Why there is no 340B operational playbook

12:06 What better operations mean for patients

13:16 The patient who was 39 weeks pregnant and paid nothing

14:24 Visibility gaps and early warning signs

14:57 Capture reports, and why fallout reports matter more

16:21 Checking wholesaler invoices against the 340B price

17:30 Building a review cadence that holds

18:58 What TPA software does well, and where oversight is still needed

20:34 Why the program belongs to the covered entity, not the TPA

21:16 Evaluating a TPA: what to look for

22:56 The partnership question most evaluations skip

24:00 Vendor accountability without friction

26:05 The EMR change that erased six months of savings

27:16 Small covered entities wearing multiple hats

29:05 Documentation as a habit, not an audit response

31:54 Kaitlyn's view on the rebate model

33:15 Where AI helps in 340B, and where it doesn't

34:42 Summer Coalition takeaways: state laws, IRA, MFP

36:17 Rapid fire round

38:03 The one practical takeaway

39:16 Closing

What is an eRx report in 340B? An eRx report is pulled from a covered entity's EMR and shows where prescriptions are sent after a patient leaves. It matters because it reveals whether the contract pharmacy network matches actual patient behaviour, and covered entities frequently find their prescriptions filled far from the pharmacies they contracted with.

Why does the fallout report matter more than the capture report? Because the capture report only confirms what already worked. The fallout report lists what should have captured and did not, which is where recoverable savings sit and where configuration problems become visible.

What is the earliest warning sign a 340B program is losing control? Decreasing program savings. If the benefit coming in starts falling, something upstream has broken, and it is worth investigating before the cause compounds across months.

#340BOperations#PharmacyLeadership#HealthcareOperations#340BSavings#NorthArcHeal

Duplicate discount prevention is the process of ensuring a covered entity never claims both a 340B discount and a Medicaid rebate on the same drug unit. Vinson Tran, founder of Pharmacy Operation Solutions, explains why it's straightforward for retail pharmacy and genuinely hard for hospital mixed-use operations, and why he built his career around one rule: don't trust the system, trust the workflow you build to catch it when something's wrong.

In this episode, Vinson who holds a core TPA role at a hospital and founded Pharmacy Operation Solutions after watching an early 340B program get misused and shut down walks host Muhammad Atif through what actually prevents duplicate discounts in practice, why hospital mixed-use operations are a fundamentally harder problem than retail pharmacy, and how he manually isolates duplicate claims when hospital systems don't agree with each other.
He shares a concrete reimbursement example a $1,300 wholesale drug paid back at roughly $11 that makes the case for watching program revenue as closely as compliance, what to actually expect (and not expect) from TPA and split-billing software, and his honest, 50/50 take on HRSA's reproposed rebate model and the cash-flow risk it could create for small, thin-staffed covered entities.

What You'll Learn in This Episode

Why duplicate discount prevention requires at minimum two data sets, always The one file every hospital 340B program depends on, and why it's the most common point of failure How to build a temporary fix when hospital transaction IDs don't match across systems Why a $1,300 drug reimbursed at $11 isn't a compliance failure it's a revenue-visibility problem What to ask a TPA or software vendor before accepting any new feature Vinson's honest take on where AI helps in 340B today, and where it still falls short What actually happens during an HRSA audit, and how to prepare before one is ever announced

00:00 Introduction to 340B Pulse

00:33 Guest introduction: Vinson Tran

02:48 Vinson's journey into 340B

04:37 His experience with two HRSA audits

06:35 What duplicate discount prevention actually requires

11:09 Medicaid carve-in vs. carve-out decisions

13:10 The most common mistake covered entities make

14:24 Mixed-use hospital operations, explained

17:20 What hospitals should monitor regularly

19:25 Data, reporting, and review rooms

21:16 The KPIs that show whether a program is healthy

23:56 TPA software and vendor accountability

29:42 Questions to ask your TPA regularly

31:06 Where AI fits (and doesn't) in 340B

34:54 The reproposed HRSA rebate model

38:17 How to prepare for an HRSA audit

40:56 Rapid-fire round43:28 Final takeaway and closing

What is duplicate discount prevention in 340B? 

Duplicate discount prevention is the process that ensures a covered entity never claims both a 340B discount and a Medicaid rebate on the same drug unit, verified by matching pharmacy claims data against 340B software data and confirming the correct Medicaid modifier.

Why is duplicate discount prevention harder for hospitals than retail pharmacies?

 Because hospital claims pass through the EMR, IT, billing, inpatient, and outpatient systems before reaching the 340B splitter, while retail pharmacy owns the entire process end to end, making the hospital's charge file the critical point to monitor.

What should covered entities ask their TPA or software vendor regularly? 

One core question before accepting any new feature or enhancement: how does this actually impact my covered entity?

#HealthSystemPharmacy#HealthcareLeadership#HealthTech#340BPulse#NorthArcHealth

340B rebate readiness is the operational work of identifying, validating, submitting, and reconciling 340B claims under a rebate-based model, then confirming that the rebate a covered entity is owed is the rebate it actually receives. Celeste Fowler, Executive Director of Pharmacy 340B at Piedmont Healthcare, joins 340B Pulse to explain why that work is far bigger than the "five-hour myth" suggests.
Everyone's talking about 340B rebate model litigation and manufacturer policy. Almost nobody's talking about who actually checks whether the rebate check that comes back is correct.

On this episode of 340B Pulse, host Muhammad Atif sits down with Celeste Fowler, Executive Director of Pharmacy 340B at Piedmont Healthcare, to get past the policy headlines and into what a rebate-based 340B model actually demands operationally. Celeste has spent her career building this kind of program from the ground up, starting as what she calls a "one-woman show" at a single community hospital and now leading a health-system program across multiple facilities.

She explains why the widely repeated "five-hour myth" undersells the real work, why more submitted data doesn't automatically create more transparency, why standardization has to be the fixed recipe underneath every program's unique implementation, where AI genuinely earns its place versus where clinical judgment can't be replaced, and what it takes to "check the checker" on a manufacturer's rebate payment before a covered entity can trust it.

• Why the "five-hour myth" may actually describe five hours a day, not five hours a month, if rebate readiness is done correctly
• Why data integrity and security, not policy uncertainty, is the operational risk healthcare leaders are missing
• What it actually takes to reconcile pharmacy, revenue-cycle, and EMR data that was never built to talk to each other
• Why standardization is the fixed compliance foundation underneath every covered entity's unique 340B program
• Where AI and automation genuinely help in 340B operations, and where human clinical judgment has to stay in the loop
• What "checking the checker" means for a covered entity's cash flow and financial sustainability
• How to build cross-departmental governance and vendor accountability across a health system

00:00 — Cold open: the real cost of rebate readiness

00:30 — Welcome to 340B Pulse

03:35 — Celeste Fowler's path into 340B leadership

07:34 — What healthcare leaders are missing operationally 12:34 — The five-hour myth, explained

14:16 — Mapping the real data gaps behind every claim

18:02 — Why standardization is the core of a defensible program

20:02 — Where AI and automation actually help

25:45 — Data security, AI vendors, and patient trust

28:35 — Financial sustainability and checking the checker 35:18 — Governance and vendor accountability at health-system scale

37:47 — Rapid fire: what rebate readiness actually takes

41:47 — 340B training, coalitions, and building a support network

45:11 — Celeste's final perspective for healthcare leaders 46:03 — Connect with Celeste Fowler

What is the five-hour myth in 340B rebate readiness? It's the idea that preparing for a rebate-based 340B model only takes a few extra hours a month. Celeste says that number really only covers uploading a file, and that doing the work behind it properly could take closer to five hours a day.

What does "checking the checker" mean? It means a covered entity has to independently confirm that the rebate a manufacturer pays back actually matches what was owed, instead of just trusting the number that comes in.

Why does standardization matter so much for 340B programs? Because it gives every site the same compliance baseline, so when something looks off, a team can actually trace it back to the cause instead of guessing whether it's a real problem or just normal variation.

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