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HRSA’s 2026 oversight of 340B contract pharmacy profit retention exposes gaps in pricing transparency, rebate practices, and covered entity accountability.
HRSA’s 2026 oversight of 340B shortage substitutions is catching covered entities that swap NDCs in contract pharmacies without proper tracking.
HRSA’s 2026 audits target 340B duplicate discounts in contract pharmacies, focusing on state Medicaid mismatches and manufacturer rebate exposure.
HRSA’s 2026 audits emphasize 340B compliance for hematology and transplant infusion drugs, demanding airtight inventory tracking and audit-proof records.
How HRSA’s 2026 oversight priorities are reshaping 340B compliance for specialty pharmacies and limited-distribution drugs.
HRSA is tightening oversight on 340B insulin discounts for FQHC Look-Alikes and contract pharmacies facing manufacturer access conditions in 2025.
HRSA’s 2025 enforcement push on child site registration and Medicaid carve-in rules will upend how hospitals handle off-campus clinics under 340B.
How covered entities should train pharmacy residents on 340B compliance and HRSA documentation standards in 2025 amid tighter oversight.
HRSA is focusing 2025 340B audits on pediatric-use formulations. Children’s hospitals need airtight compliance documentation for outpatient prescribing.
How oncology infusion sites can align 340B split-billing controls with HRSA’s 2025 audit priorities and avoid diversion or duplicate discounts.
Behavioral health drugs create unique 340B compliance risks. Here’s how covered entities should handle HRSA oversight, billing, and coordination in 2025.
How to build a 340B infusion center inventory reconciliation process that stands up to HRSA’s 2025 audit priorities and stops diversion at the source.
HRSA’s 2025 ceiling price enforcement rule raises the stakes for manufacturers and covered entities in 340B pricing and inflationary penalties.
HRSA’s 2025 audits show orphan drug exclusion errors remain a top compliance risk for Rural Referral Centers and Critical Access Hospitals.
Detailed 2025 HRSA 340B recertification instructions to prevent data mismatches, account lockouts, or program termination for hospitals and grantees.
How to correct 340B eligibility documentation errors after a HRSA audit finding in 2025, with step-by-step context from real covered entity experiences.
How telehealth prescribing intersects with 340B patient definition, HRSA audits, and covered entity oversight in 2025.
HRSA’s 2025 crackdown on child site registration ties 340B eligibility to how hospitals bill for offsite clinics, forcing system-level compliance overhauls.
HRSA’s 2025 audits show rising duplicate discount findings in Managed Medicaid carve-ins, forcing hospitals and states to overhaul rebate exclusion protocols.
Many FQHCs lose 6-10% of 340B savings each year from wrong Medicaid Exclusion File reporting. Here’s how to fix it heading into 2025.
HRSA’s 2025 guidance tightened 340B mixed-use oversight. Here’s how to implement split-billing software that actually survives audit scrutiny.
How hospitals and grantees can stay compliant with 340B contract pharmacy limits after 2024 court rulings weakened HRSA’s enforcement powers.
HRSA’s 2024 contract pharmacy oversight is forcing covered entities to rethink diversion prevention, patient documentation, and audit defense.
HRSA’s 2024 340B audits are tougher on mixed-use areas, duplicate discounts, and patient eligibility, here’s what FQHCs and DSHs should check now.
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This half-day workshop includes a series of expert-lead presentations and audience Q&A sessions focused on the latest advancements and regulatory considerations in the evolving field of Model-Inte
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This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in t
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Rare Disease Regulatory Framework
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