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Consider the following scenario: A recent change in electronic health record billing at one of your outpatient clinics has led to accumulation errors in your 340B split-billing software, resulting in overpurchasing of 340B drugs. Although hypothetical, this scenario illustrates just one of many inventory-related situations
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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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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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When it comes to doing more with less, Community Health Centers (CHCs) and Federally Qualified Health Centers (FQHCs) are unmatched. These mission-driven organizations are lifelines in underserved communities, delivering critical care where it’s needed most. And for many, the 340B program has become
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Drug manufacturers defend their unrelenting campaign to reform the 340B program by citing, among other things, the need to protect themselves from the problem of duplicate discounts. Federal law affords such protection for drugs dispensed or administered to Medicaid
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The 340B program has been bombarded with threats over the past five years. 340B professionals have had their hands full defending the safety net program from contract pharmacy restrictions, state-level reporting, proposed legislative changes, the IRA, rebate models, 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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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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