340B claims-level data is the patient- and claim-level information covered entities must reconcile across split billing, contract pharmacy, TPAs, EHR outputs, and wholesaler feeds to defend eligibility and program performance. Bryan McCormick explains that most organizations do not have one source of truth, because retail partner mandates can force multiple TPAs, split billing and contract pharmacy remain separate operational worlds, and compliance accountability still rests with the covered entity even when vendors process claims.

340B Pulse is a NorthArc Health podcast powered by PureLogics, built for operator-level conversations about how the 340B program actually runs day to day.

In this episode, host Muhammad Atif is joined by Bryan McCormick, Corporate Director of the 340B Program at RWJBarnabas Health. Bryan unpacks claims-level data challenges across pharmacy and medical-related 340B workflows, including TPA configuration accountability, multi-TPA aggregation burden, split billing versus contract pharmacy separation, garbage-in/garage-out feed discipline, EHR governance, real-world connectivity failures, reconciliation and root-cause expectations, staffing realities for safety-net hospitals, manufacturer portal fragmentation (ESP and related channels), and a practical view of AI and vendor sprawl.

If your organization needs stronger claims validation, reporting visibility, and custom agentic automation with compliance guardrails, NorthArc Health helps covered entities modernize 340B operations without losing operator control.

0:00:00 TPA configuration is a covered-entity compliance decision

0:01:08 Multi-TPA reality: Walgreens, CVS, and aggregation burden

0:03:25 Why leadership reports must be 100% accurate

0:04:18 Pharmacy vs medical claims fragmentation in 340B

0:04:38 Split billing vs contract pharmacy: two separate worlds

0:07:15 Garbage in, garbage out and roster discipline

0:09:27 PBMs, TPAs, EHR: volume, variability, and fragmentation

0:10:20 Stakeholder forums and EHR as source of truth

0:12:19 Compliance accountability always on the covered entity

0:13:30 Where data breakdowns occur in handoffs

0:14:21 Pharmacy switch outage case (2024 backlog impact)

0:16:21 Operational impact on eligibility, accumulation, and reporting

0:17:33 Monitoring volume and vendor value

0:19:57 Identification, tracking, and read-only access

0:21:21 Reconciliation, escalation, and self-disclosure thresholds

0:23:29 Scaling, Epic + Verity integration, and KISS operations

0:27:19 Dedicated 340B FTEs and policy volatility

0:28:34 Manufacturer portals: ESP, restrictions, no global playbook

0:30:09 Human review before external manufacturer submissions

0:31:27 AI potential vs integration and PHI risk

0:33:22 More vendors means more integration to police

0:34:36 Practical advice: plug-and-play is over

0:38:05 Stakeholder meetings and how to connect with Bryan

What is 340B claims-level data?

340B claims-level data is the detailed claim, eligibility, and feed information covered entities use to run split billing and contract pharmacy workflows, validate vendor outputs, and support compliance, financial reporting, and audit defensibility.

Why do covered entities use multiple TPAs?

Covered entities often use multiple TPAs because major retail contract pharmacy partners may require their own systems while a primary TPA still supports split billing and other contract relationships, which forces manual aggregation before holistic reporting.

Who owns 340B data accuracy when vendors process claims?

The covered entity owns compliance and performance accountability in most vendor relationships, which means teams must validate what they send to TPAs and what vendors return before leadership or external reporting.

#340B program,#claims data, #pharmacy operations, #healthcare compliance, #split billing,#contract pharmacy, #TPA, #EHR integration, #healthcare data

340B operational control is the covered entity’s ability to maintain audit-ready compliance while also sequencing cross-functional work across pharmacy, finance, informatics, and legal when policies and reimbursement mechanics change quickly. Katy Felice Lees frames this as a leadership and operating discipline problem, not a single-policy problem, because the same compliance words on paper can require different workflows in inpatient, outpatient, mixed-use, and contract pharmacy settings. Strong programs pair transparency with defensible documentation, keep government and internal relationships warm before emergencies, and use data to avoid reactive decision-making.340B Pulse is a NorthArc Health podcast powered by PureLogics, built for operator-level conversations about how the 340B program actually runs day to day.In this episode, hosts Muhammad Atif and Nadia are joined by Katy Felice Lees, Director of 340B Policy and Business Strategy at the University of Rochester Medical Center and Principal 340B Compliance Advisor with Virtue 340B. Katy discusses what changed as 340B work expanded beyond traditional compliance priorities, why teams describe the current environment as relentlessly urgent, and what “control” means when organizations must prepare for policy paths that may pivot late.

0:01:12 Opening: why 340B Pulse exists and today’s topic 0:04:22 Katy’s journey from pharmacy technician to leading a 14-person 340B team 0:06:43 What feels most different operationally versus a few years ago

0:08:50 The current operational reality: urgency without pause 0:09:31 Defining control: what you can manage versus what you cannot

0:11:01 Leadership control: stewardship, narrative, relationships, budget cycles 0:13:02 Overreacting vs under-preparing when information is still forming

0:15:50 Compliance vs operational control: duplicate discounts in the real world 0:18:27 Child-site developments: opportunity, mindfulness, transparency

0:21:09 GPO prohibition: constraints embedded in daily infrastructure

0:23:44 Rebate model noise: what leaders should focus on underneath

0:26:11 Internal discipline: cross-functional cadence and ownership 0:29:22 Signals of strong control vs slipping control 0:31:01 Data access, informatics, and realistic AI expectations 0:32:21 Staying current: trusted sources and conferences 0:35:39 Advice for covered entity leaders for the next 6 to 12 months

0:36:49 How to connect with Katy Felice Lees and Virtue 340BWhat is 340B operational control? 340B operational control is the organization’s combined ability to keep core compliance stable, validate workflows in real settings, and coordinate pharmacy, finance, informatics, and legal decisions when external requirements change quickly, without losing sight of cash flow, documentation, and accountability.Why does “compliance on paper” fail teams during audits and manufacturer interactions?Compliance language fails when it does not match tested workflows, because duplicate discount prevention and similar obligations become configuration, modifiers, carve logic, and continuous monitoring that differ by site type and vendor setup.How should leaders prepare for rebate-model mechanics even when policy timing shifts? Leaders should prepare by clarifying upfront purchase and rebate timing impacts on cash flow, assigning ownership for data submission and reconciliation, learning from MFP and manufacturer data-policy experiences, and building cross-functional runbooks rather than assuming a single vendor will interpret organizational risk.#340B, #340B program, #covered entity, #hospital pharmacy, #pharmacy operations, healthcare compliance, duplicate discounts, #GPO prohibition, 340B policy, drug pricing, Medicare, #MFP

340B operational readiness is the practical ability of a covered entity to execute 340B compliance, data visibility, and cross-team workflow ownership continuously, even as MFP and rebate-related responsibilities increase, without relying on last-minute scrambles. In this episode of 340B Pulse, Eric Mitchell explains why most failures are not caused by policy confusion, but by ownership, work design, handoffs, and low-quality inputs that technology cannot fix.In this episode of 340B Pulse, NorthArc’s Muhammad Atif and Hassaan sit down with Eric Mitchell to unpack a reality covered entity teams are living every day: more complexity, more data requirements, and more platforms, but the same staffing and the same operational bandwidth.We break down what has changed operationally inside covered entities as Medicare Maximum Fair Price (MFP) becomes an operational reality and rebate-related workflows push new responsibilities downstream. Eric shares a practical prioritization sequence for leaders who know change is coming but have limited capacity: protect irreversible risk first, identify leakage in process or revenue second, and then decide what to solve long-term so you are not perpetually firefighting.We also discuss where technology genuinely removes burden through visibility and data aggregation, where expectations become unrealistic, and why “garbage in, garbage out” still governs analytics, models, and AI. Finally, we cover why HIPAA and privacy guardrails are shaping how healthcare organizations adopt AI, often through controlled internal approaches.NorthArc helps covered entities strengthen visibility, improve ESP and Beacon readiness, reduce operational burden, and enhance audit defensibility without disrupting existing TPAs or workflows. 00:00 - Cold open on flexibility, complexity, and MFP01:19 - 340B Pulse introduction and why operator-level conversations matter03:09 - Guest introduction: Eric Mitchell and his 340B journey08:05 - What changed for covered entities: workload, flexibility, and interconnected work09:41 - Where execution breaks down: ownership and work design11:01 - MFP as operational reality and what teams underestimate12:36 - Prioritization under pressure: risk, leakage, and capability15:09 - Technology, AI, and the limits of tools without process discipline17:03 - Trusting calculators and models: validate assumptions and pressure test18:20 - Leadership and change: supporting people so strategy works23:58 - Where leaders should start: networks, SWOT, and not doing it alone27:11 - Wrap up Q: What is 340B operational readiness? A: 340B operational readiness is the continuous ability to execute patient eligibility, claim validation, audit defensibility, and stakeholder ownership with reliable data and disciplined workflows, even as MFP and rebate responsibilities add operational load.Q: Why do 340B programs break down operationally even when policies are understood? A: 340B programs often break down because ownership and work design are unclear, cross-team handoffs are fragile, and data inputs are inconsistent, which creates execution gaps that tools and platforms cannot automatically correct.Q: How should a covered entity prioritize work when bandwidth is limited? A: A covered entity should prioritize by protecting irreversible risk first, then identifying leakage in process or revenue second, and finally investing in long-term capability so recurring problems are solved once instead of repeatedly firefought.#340B, #340B Program, #MFP, Medicare Maximum Fair Price, #340B Operations, #Healthcare Compliance, #Pharmacy Operations,# Healthcare Operations, #Audit Readiness,# Data Governance, #Healthcare AI, #NorthArc Health,, #Eric Mitchell

340B operations management is the continuous tracking and execution of contract pharmacy claims, duplicate discount prevention, and inventory replenishment to maintain HRSA eligibility. In this episode of 340B Pulse, we break down exactly how leading covered entities manage operational complexity.

Is your 340B program rapidly expanding while your compliance oversight lags behind? You are putting your entire savings margin at risk.
In this episode of 340B Pulse, NorthArc's Muhammad Atif and Salman Asif sit down with Robert Ferraro, CEO of Ravin Consultants. Robert manages 340B operations for nearly 80 covered entities and drops a masterclass on navigating the increasing pressure of 340B transparency reporting and rebate pilot models. We dive deep into the specific operational bottlenecks holding programs back, including how inexpensive EMR setups stifle your ability to validate claims and how failing to perform a 10% monthly claims check can lead to devastating HRSA findings.

NorthArc helps covered entities establish custom backend data infrastructure and Agentic AI controls to ensure your 340B operations remain tightly governed, highly visible, and perfectly audit-ready without disrupting your existing TPA relationships.

- 00:00 - Introduction to 340B Pulse & NorthArc

- 03:57 - Robert Ferraro's 340B Operator Journey

- 08:02 - How the 340B Rebate Pilot Forces Traceability

- 12:12 - Approaching 340B Transparency & State Reporting

- 15:28 - Creative 340B Savings Utilization (Food Banks & Mobile Clinics)

- 19:43 - The Biggest Bottlenecks to Scaling: EMRs & Personnel

- 24:49 - Day-to-Day 340B Compliance and Audit Checkpoints

- 28:11 - Preventing Drug Diversion through Closed-Loop Referrals

- 33:25 - The Most Devastating Avoidable Leadership Mistakes

- 36:26 - How to Reach Out to Ravin Consultants & NorthArc

What is a 340B closed-loop referral?

A 340B closed-loop referral is a documented workflow where a covered entity refers a patient to an outside specialist and subsequently receives and files the specialist's clinical progress notes back into their EMR to prove continuous ownership of care.
How do covered entities use 340B savings?

Covered entities use 340B savings by aggressively expanding local healthcare access through fully funded community food banks, free transportation programs (like bus or Lyft vouchers), and specialized mobile mental health clinics.

What is the biggest operational bottleneck in 340B scaling?The biggest operational bottleneck in 340B scaling is utilizing an inexpensive or rigid EMR platform that lacks deep technological integration abilities, slowing down the extraction of ICD-10 codes needed to accurately evaluate patient eligibility.

#340B #340BProgram #HealthcareCompliance #PharmacyOperations #HealthcareTech #HealthTech #NorthArcHealth #DataEngineering #PharmacyDirector

What is a 340B contract pharmacy program? A 340B contract pharmacy program is an operational partnership where a covered entity utilizes an external pharmacy to dispense discounted outpatient drugs to eligible patients. To maintain compliance and profitability, entities must rigorously manage inventory, dispensing fees, and TPA audits.

The friction between covered entities and contract pharmacies is costing the 340B ecosystem millions. In this episode of 340B Pulse, Mohammad Atif and Hassan sit down with Lyssa Limbrecht-Mosh, founder of Optimal340B, to expose the operational realities of 340B pharmacy management. Lyssa breaks down why TPA auto-ordering systems trigger catastrophic inventory swell, how to structure fair dispensing fees, and why auditing uncaptured claims is the fastest way to recover lost revenue. We also discuss the looming threat of the Maximum Fair Price (MFP) regulations and the controversial shift toward a rebate model.

00:00 - Introduction to 340B Pulse

04:49 - Lyssa's Journey into 340B Compliance

06:41 - What Defines a Healthy Contract Pharmacy?

08:19 - The Disconnect in Healthcare Reimbursement

11:34 - The Danger of TPA Auto-Ordering & Inventory Swell

18:22 - Structuring Fair Pharmacy Dispensing Fees

21:32 - Real Example: Recovering $1.3 Million Through Audits 23:19 - 3 Immediate Steps to Improve Your 340B Program

25:03 - The Role of AI and Custom Technology in 340B

27:24 - Future Threats: MFP and the 340B Rebate Model

29:20 - How to Connect with Optimal340B

How do you prevent 340B inventory swell?

To prevent 340B inventory swell, covered entities must communicate with their contract pharmacies, avoid rigid auto-ordering for low-volume specialty drugs, and allow pharmacies visibility into replenishment schedules.

Why are 340B dispensing fees important?

340B dispensing fees compensate the contract pharmacy for the operational burden of managing dual inventories and processing complex 340B claims, ensuring the partnership remains financially viable for the pharmacy.

What is the 340B rebate model?

The 340B rebate model is a proposed system where covered entities purchase drugs at full wholesale acquisition cost (WAC) and subsequently request a rebate from the manufacturer, significantly impacting cash flow.

340B #HealthcareCompliance #PharmacyOperations #ContractPharmacy #NorthArc #HealthcareTechnology #340BAudits #Optimal340B #HealthTech

340B audit readiness is the operational ability of a covered entity to maintain explicit, trackable evidence of patient eligibility, pharmacy dispensation, and drug accumulation logic, proving immediate HRSA compliance on any given day.

Are you relying on end-of-year mock audits to save your 340B program from HRSA scrutiny?
This week on *340B Pulse*, host Muhammad Atif stands alongside Salman Asif to explore the realities of operational compliance with Carrie Yannarella. With decades of outpatient clinical operations experience, Carrie breaks down why relying on reactive tracking guarantees an audit failure. Rather than scrambling to find missing referral logs and unmapped Medicaid modifiers hours before an external audit, Carrie teaches program managers how to establish a continuous, frictionless monthly rhythm.
If you are a covered entity executive or a pharmacy leader exhausted by compliance burnout, this episode offers a practical, step-by-step masterclass on how to deploy TPA platforms efficiently, sample the right claims, and force cross-functional accountability without overwhelming your staff.

What You’ll Learn in This Episode

- The definition of true 340B audit readiness and why reactive models fail.

- How to efficiently identify drug diversion through monthly purchasing variance reviews.- The precise methodology required for targeted 10% claim sampling.

- How to structure reporting handoffs between Pharmacy, Clinics, and Finance correctly.- Essential project management strategies for defeating compliance burnout.

[00:00] – Intro to 340B Pulse and NorthArc Health

[04:49] – Understanding the Mindset Behind Daily Audit Readiness

[06:24] – How to Actively Monitor High-Risk Dispensations

[07:48] – The Danger of Random Sampling vs. Targeted Sampling

[10:50] – Breaking Down Departmental Silos for Perfect Traceability

[14:55] – The Crucial Artifacts You Must Keep Ready for HRSA

[16:33] – Preventing Burnout Using Basic Technology Tools

[18:00] – Closing Notes and the Importance of Agentic AI

Q: What exactly is 340B audit readiness?

A: Audit readiness is a proactive operational philosophy ensuring that a covered entity tracks and documents every step of their 340B workflow so perfectly that they could successfully pass an unannounced HRSA compliance audit immediately.

Q: Who is responsible for 340B program compliance?

A: Program compliance is a deeply cross-functional responsibility requiring Pharmacy to control drug builds, Clinics to control referral documentation, and Finance to manage the ultimate auditing and claims retrieval.

Q: Why do covered entities fail HRSA audits?

A: Covered entities typically fail HRSA audits due to systemic drug diversion, meaning they lack the concrete internal clinical systems, like EMR data interoperability, needed to prove they actively maintained medical responsibility for the patients receiving discounted medications.

Brought to you by NorthArc Health. We engineer intelligent Agentic AI software that drives unshakeable administrative visibility. Reach out for a consultation today.

Are your 340B operations fully optimized, or are you secretly missing massive savings? In this episode of 340B Pulse, Lisa Nezneski, Founder of 340B Orphan Drug Solutions, explains the "Orphan Drug Blind Spot." Many rural and community hospitals mistakenly assume orphan drugs are strictly excluded from their programs, but discretionary manufacturer pricing can unlock $200K to $450K in hidden revenue for your hospital every year.

If an executive asked you right now if your hospital was fully maximizing its 340B savings, your answer would probably be "Yes." But if you operate a Critical Access Hospital (CAH), a Sole Community Hospital (SCH), or a Rural Referral Center (RRC), your program might still be leaving hundreds of thousands of dollars on the table.

Join hosts Mohamed Atif and Salman Asif as they sit down with 340B veteran Lisa Rizenki to unpack this massive, widely misunderstood opportunity. This operational deep-dive reveals why orphan drugs routinely make up 50% to 75% of your total drug budget, the truth about discretionary manufacturer discounts, and why your Third-Party Administrator (TPA) might be automatically blocking these life-changing accumulations.
Discover how to safely run a "first-pass" validation without disrupting operations, reframe the discovery of missing savings for hospital administration, and ultimately turn regulatory complexity into a predictable strategy that funds vital community health programs.

Subscribe to 340B Pulse for more operator-level conversations on program compliance, hospital finance, and healthcare technology!
00:00 - Introduction to 340B Pulse & Today's Topic

01:45 - What is the 340B Orphan Drug Blind Spot?

06:43 - The Discretionary Pricing Misconception Explained

13:35 - The 50% Rule & Avoiding The $75,000 Weekend Mistake

18:10 - Identifying TPA Bottlenecks & Accumulator Setup Issues

26:57 - The Secret to Pitching Administrators & The CFO

28:05 - Why Pharmacists Must Learn to Sell

32:19 - The "Bless Your Heart" TPA Software Blocker Story

38:50 - The $450,000 Success Story (Case Study)

49:04 - The $200 vs. $2 Gleevec Pricing Reality

50:37 - Overcoming the Fear of Finding "Missed" Savings (Becoming the Hero)

53:30 - Final Thoughts & Closing Actions

What is the 340B Orphan Drug Blind Spot?

Many Critical Access and Sole Community Hospitals mistakenly assume orphan drugs are strictly excluded from their 340B programs and cannot receive discounts. In reality, manufacturers often offer discretionary discounts that hospitals fail to claim, leaving significant money on the table.

How much in savings are hospitals missing from orphan drugs?

On average, audits reveal that hospitals frequently miss between $200,000 and $450,000 annually due to misconfigured TPA setups and blocked accumulations regarding orphan drug claims.

How can a hospital fix missed orphan drug savings?

Covered Entities can recapture these savings by utilizing tracking tools like the 340B Orphan Drug Estimator, directly managing IT communication queues with TPAs, and properly routing NDCs to align with discretionary manufacturer pricing.

#340B #OrphanDrugs #HospitalFinance #HealthcareOperations #PharmacyBenefitManager #HealthcareTech #RuralHealth #CriticalAccessHospital #340BPulse #NorthArcHealth

Are Pharmacy Benefit Managers (PBMs) saving your healthcare organization money, or are they a hidden operational cost driver?

In this episode of 340B Pulse, hosts Muhammad Atif and Hassaan sit down with Dr. Jonathon Harrison, President and CEO of Wellyfe, to expose the realities of traditional PBM contracts. Dr. Harrison pulls back the curtain on how vertical integration has shifted the PBM model away from saving employers money and towards retaining multiple hidden margin layers.
Tune in to learn how shifting to a Direct Pharmacy Care model can immediately recover up to 60% in savings for 340B operations, and why health systems must rely on custom AI-driven reporting to truly audit their pharmacy expenditures.

What You’ll Learn in This Episode:

- The truth behind arbitrary $8,000 "specialty drug" markups.

- The 15 hidden revenue streams PBMs use to collect your margins.- Why the incoming 340B rebate pilot programs will overwhelmingly punish small FQHCs.- The top 5 non-negotiable questions every CFO must ask before their next PBM contract renewal.- How leveraging custom Agentic AI eliminates dashboard fatigue and returns actionable, CFO-grade analytics.

Future-Proof Your Program with NorthArc Health

Navigating PBM contracts and mitigating operational burdens requires a sophisticated, technological approach. Explore how NorthArc's custom Agentic AI solutions can strengthen your program visibility and streamline your workflows: 🌐 [NorthArc Health](https://northarchealth.com)

## Interactive Timestamps / Chapters

(00:00) - Introduction to 340B Pulse & Today’s Topic

(02:50) - Who is Dr. Jonathon Harrison?

(06:20) - The True Intended Motive of Modern PBMs

(07:39) - Why the 340B Rebate Model is Failing

(09:43) - Minimum Operational Controls for Covered Entities

(11:30) - Can PBMs Actually Cut Hospital Costs?

(15:20) - Exposing the 15 Hidden PBM Revenue Streams

(18:00) - How Rebates Distort Formulary Placement

(20:13) - The Specialty Drug Markups Secret

(23:20) - Why You Shouldn't Rely on "Standard Transparency"(25:00) - Top 5 Questions Every CFO Must Ask Their PBM

(30:11) - Debunking the PBM "Transparency" Myth

(32:00) - Defeating Dashboard Fatigue with AI

(34:06) - How Organizations Recover 60% of Pharmacy Margins(35:42) - Restoring the Community Pharmacy Model