On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug Pricing Program (the “340B Program”) and civil monetary penalties (“CMPs”) against manufacturers that “knowingly and intentionally” fail to provide such pricing to 340B covered entities. [1] The final rule follows the release of a proposed rule in June 2015 and HRSA’s reopening of the comment period in April 2016 and covers issues that Congress directed the HHS Secretary to address through regulation as part of the Patient Protection and Affordable Care Act (“ACA”). Our alert on the proposed rule is available here.

The final rule comes at a time of great uncertainty for the 340B Program and the ACA more broadly. The 340B Program has come under scrutiny in recent months as drug manufacturers, hospitals, and other stakeholders debate potential changes to the 340B Program, including legislative changes and the policies contained in HRSA’s proposed 340B Omnibus Guidance. In addition, the ACA is entering a period of turmoil as the Republican-controlled Congress and President-elect Donald J. Trump vow to repeal and replace the law.

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