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The U.S. drug pricing infrastructure is entering a transformative era. On August 1, 2025, the Health Resources and Services Administration (HRSA) announced a voluntary 340B Rebate Model Pilot, aligned with the Inflation Reduction Act’s Maximum Fair Price (MFP) provisions
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Federally Qualified Health Centers (FQHCs) play a critical role in delivering accessible and affordable healthcare to underserved communities. However, they are facing mounting challenges that threaten their ability to maintain operations and meet growing community needs. With limited infrastructure, evolving regulations, upcoming Medicaid cuts, drops in the insured
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The 340B program has morphed into a battlefield of rules, audits, and reporting. For smaller covered entities (CEs), especially rural hospitals and community clinics, keeping pace feels like a losing race. While large health systems deploy entire
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TIP: When a covered entity participates with 340B ESP™ to obtain 340B pricing restoration, it is critical to monitor manufacturer policies, ESP eligibility,
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Since this article was published, HRSA released new guidance on a proposed pilot rebate model. This pilot would permit manufacturers to offer 340B rebates for a limited set of drugs under defined conditions. Read more in 340B
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The regulatory landscape for the 340B drug pricing program is evolving rapidly. As scrutiny from the Health Resources and Services Administration (HRSA) and drug manufacturers intensifies, healthcare leaders and 340B teams face growing pressure to maintain airtight
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AI is everywhere—chatbots, smart assistants, predictive tools. But in 340B? The line between what’s useful and what’s just marketing is getting blurrier by the day.
We’ve seen AI do
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As the 2025 political season heats up, federally qualified health centers (FQHCs), hospitals, STD clinics, Ryan White grantees, and other covered entities must brace for another round of uncertainty. With renewed debates around entitlement spending,
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Let’s be honest. 340B compliance is demanding. It takes time, coordination, and precision. After more than a decade working in 340B compliance and auditing, I’ve learned it always comes back to one thing: the data.
Where does the data come from? How accurate is it? How quickly
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Location: Gaylord National Resort & Convention Center, Fort Washington, MD
340B stakeholders headed to the 340B Coalition Summer Conference 2025 can start their week learning the latest developments in
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