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Robert Ferraro

What is 340B Compliance Audit Readiness? How Operations Keep Programs Safe

340B compliance audit readiness is the continuous, proactive state of maintaining perfect documentation, precise patient eligibility tracking, and exact claims-to-purchase traceability, ensuring a healthcare organization is perpetually prepared to pass an HRSA or manufacturer audit on any given day. If you are a covered entity executive or a pharmacy director, achieving flawless 340B compliance audit […]

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340B Contract Pharmacy Program Optimization: The Definitive Guide to Eradicating Operational Friction

What is a 340B Contract Pharmacy Program? A 340B contract pharmacy program is an operational partnership where a covered entity utilizes an external, independent pharmacy to dispense discounted outpatient drugs to eligible patients, expanding access to care while generating savings for the health center. This arrangement requires rigorous compliance, inventory management, and oversight to ensure

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340B Audit Readiness

What Are the Best Practices for 340B Audit Readiness? Creating a Monthly Rhythm

340B audit readiness is the continuous operational state wherein a covered entity maintains perfectly trackable pharmacy claims, exact patient eligibility logic, and up-to-date compliance documentation securely, allowing them to pass a sudden HRSA or manufacturer audit on any given day. In the complex world of the 340B prescription drug program, the days of scrambling to

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Orphan drug blind spot in 340B

What Is the Orphan Drug Blind Spot in 340B and How Can Hospitals Find Missing Savings?

The orphan drug blind spot in 340B refers to the missed financial savings, often ranging from $200,000 to $450,000 annually, by rural and expansion hospitals that fail to capture discretionary pricing on orphan medications. Because of complex exclusions established under the Affordable Care Act, many hospital pharmacy teams mistakenly believe these high-cost specialty drugs are

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Decoding the PBM Equation: Strategies for 340B Operations and Financial Transparency

Decoding the PBM Equation: Strategies for 340B Operations and Financial Transparency

Pharmacy Benefit Managers (PBMs) act as intermediaries between health systems, pharmacies, and drug manufacturers, intended to control drug costs through negotiated discounts. However, misaligned incentives, hidden spread pricing, and opaque rebate structures often transform them into significant cost drivers, draining financial resources from 340B Covered Entities and communities. This article examines the systemic issues embedded

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Data Sovereignty in 340B Programs

How AI Solves Data Sovereignty and Compliance Challenges in 340B Programs

Data sovereignty in 340B programs refers to the ability of healthcare covered entities to maintain absolute control, privacy, and ownership over their patient and pharmacy claims data while navigating an increasingly complex web of manufacturer restrictions and federal compliance tracking requirements. As pharmaceutical manufacturers demand more granular data, and as state and federal regulations continuously

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340B Eligibility Requirements

340B Eligibility Requirements Explained for Covered Entities

340B eligibility requirements for covered entities are designed to ensure that only specific healthcare providers serving vulnerable populations can access discounted drugs. To qualify, an entity must be a federally qualified health center (FQHC), certain hospitals such as disproportionate share hospitals (DSH), children’s hospitals, or other HRSA-recognized safety-net providers. The entity must be officially registered

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340B Drug Pricing Program

The Ultimate Guide to the 340B Drug Pricing Program

The 340B Drug Pricing Program is a U.S. federal program that allows eligible healthcare organizations to purchase outpatient drugs at significantly reduced prices. Because the program involves complex compliance and operational requirements, many hospitals conduct a 340B Program Health Check to evaluate risks, strengthen controls, and ensure their program is operating correctly. The program matters

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