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May 17, 2022

340B Program Compliance in a Shifting Landscape: What Challenges Do Stakeholders Face?

This Briefing is brought to you by AHLA’s Fraud and Abuse Practice Group.
  • May 17, 2022
  • Brenda Shafer , Quarles & Brady LLP
  • Richard Davis , Quarles & Brady LLP
  • Michael French , Quarles & Brady LLP

The federal 340B Drug Pricing Program (340B Program) allows certain qualifying health care providers such as hospitals and clinics (Covered Entities) to purchase outpatient medications at significant discounts. The 340B Program has long had an expansive reach that significantly impacts a wide variety of stakeholders in the health care space. According to the Covered Entities, the 340B Program provides crucial funds to safety net providers that help them better serve at-risk patient populations. Drug manufacturers and associated advocacy groups disagree, claiming the 340B Program has little oversight and is rife with non-compliance that unfairly impacts those selling medications. These disagreements have only intensified over the last couple of years, as the enforcement of the 340B Program’s sub-regulatory guidance has come into question. This uncertainty has unleashed new interpretations of applicable obligations and triggered numerous lawsuits that could change the 340B Program as we know it.


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