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The 2016 election season is over, and discussion regarding the future of the 340B program is heating up. In the face of this uncertainty, supporters are wondering how the nation’s new leadership will oversee caring for our most vulnerable — patients who face major health problems.

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Since the enactment of the Affordable Care Act in 2010, the 340B Drug Pricing Program has expanded in size, complexity, and risk due to changes to the regulation. The evolution of the 340B Program has driven increased interest from policymakers and stakeholders alike, as they continue to assess both the design and the financial impact of the program for all participants.

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The 340B industry has undergone significant changes since HRSA’s 2010 Contract Pharmacy Guidance, which paved the way for the expansion of retail contract pharmacy networks as part of the 340B program. Although these changes have provided significant expansion opportunities for Covered Entities, the complexity, cost, and regulatory risk has increased, as well.

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Now is time for all Covered Entities participating in the 340B Drug Pricing Program – the key stakeholders – to pay close attention to the November elections.

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Being aware of the complex and ever-changing 340B Drug Pricing Program rules helps covered entities maintain integrity and drive program value. Successful 340B programs focus on three fundamental objectives; ensuring compliance, optimizing savings and controlling skyrocketing costs of pharmaceuticals. It’s a three-legged stool analogy, where all of the legs must be in balance in order to stand solidly over time.