Like many health care programs, the 340B program, created in 1992, continues to receive many updates as the landscape evolves. As many covered entities struggle to fully comprehend the program’s complex rules and updates, it is important to gain a full understanding of all program developments to properly comply with requirements of the program.
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This volume of the Regulatory Advisor will discuss some of the recent updates that have been seen within the program.
Issues discussed in this volume include:
- Health Resources and Services Administration (HRSA) regulatory updates on the 340B Drug Pricing Program Omnibus Guidance (the Mega-Guidance) and the 340B Drug Pricing Program Celling Price and Manufacturer Civil Monetary Penalties Regulation
- HRSA program integrity updates and audit processes
- How impending legislation and the upcoming presidential and congressional elections will impact the 340B program
- The impact of the average manufacturer price (AMP) final rule, published by the Centers for Medicare and Medicaid Services (CMS)
CliftonLarsonAllen’s Regulatory Advisor is a reference tool that offers a summary of the key 340B provisions. We translated these complex updates into understandable terms to help hospital leadership prepare for the future.
Download the Regulatory Advisor.