The Health Resources and Services Administration (HRSA) is once again delaying the effective date of its January 5, 2017 rule on 340B drug pricing program ceiling price calculation and civil monetary penalties (CMPs). Specifically, under a final rule published June 5, 2018, HRSA is pushing back the 340B ceiling price/CMP rule's effective date for an additional year, to July 1, 2019. In addition to providing regulated entities with more time to implement the 2017 rule, HRSA states that the Department of Health and Human Services "intends to engage in additional or alternative rulemaking on these issues." HRSA also points out that the Trump Administration is "developing new comprehensive policies to address the rising costs of prescription drugs," which will address the 340B program and other government drug pricing policies.
This article is presented for informational purposes only and is not intended to constitute legal advice.
