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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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Introduction: Navigating Political Headwinds
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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Q: Where did you grow up?
I grew up in Argyle, NY, a small rural community in upstate New York. When I say small, picture the graduating class being 39 students! And the cows outnumber the people by a large margin.
Q: Where did you go to college/graduate school?
Albany College of Pharmacy and Health Sciences
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The 340B program is facing a period of unprecedented change. With the Inflation Reduction Act (IRA) and Medicare’s Maximum Fair Price (MFP) provisions set to take effect in 2026, covered entities can expect significant shifts—most notably, reduced drug reimbursement and
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Whether it’s new manufacturer restrictions affecting script and data qualification, amended state laws or regulations, or updated audit guidelines, the 340B landscape is constantly evolving. So, it’s no surprise that managing an organization’s 340B program is not easy
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In today’s 340B environment, every claim counts. With increased oversight, tighter margins, and growing manufacturer restrictions, covered entities need to maximize their 340B savings by capturing every eligible claim. One often-overlooked opportunity lies in understanding and monitoring disqualified claims.
These are
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