On May 11, 2018, President Donald Trump and Secretary of Health and Human Services Alex Azar announced “American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs” (the “Blueprint”) in televised speeches to an audience in the White House Rose Garden.1
Immediately following the speeches by the President and the Secretary, the Department of Health and Human Services (HHS) released a 39-page document containing the Blueprint.2 However, rather than laying out a comprehensive set of new policy changes the Administration will implement or is proposing, the Blueprint largely repeats proposals previously made in the President’s fiscal year (FY) 2019 Budget proposal,3 coupled with a wide-ranging list of issues on which the Administration is seeking public input before determining any additional reforms it will implement or propose. In contrast to Secretary Azar’s comments suggesting immediate action, the Blueprint is in large part a very open-ended invitation for additional discussion on what should be done.
Moreover, despite the President’s remarks indicating the Blueprint will result in prices at the pharmacy counter starting to come down very soon, nearly all of the most significant changes contemplated would require congressional action, and would likely be fiercely opposed by affected industry participants. Even the steps that the Administration could potentially take on its own would typically require notice-and-comment rulemaking, and in many cases may be subject to challenge on statutory or constitutional grounds. Most of the changes would normally require a period of years to implement.
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Client Alert 2018-114