Coming Proposed Rule Could Shed Light on HRSA’s 340B Enforcement Power

A forthcoming HHS proposed rule could more shed light on the Trump administration’s thinking about HRSA’s ability to enforce 340B program policy. | Source: Shutterstock

Coming Proposed Rule Could Shed Light on HRSA’s 340B Enforcement Power

The U.S. Health and Human Services Department (HHS) has signaled it is going publish a proposed rule soon setting standards for HHS administrative enforcement actions and adjudication.

With just 50 days left until President-elect Joe Biden’s inauguration, it’s unclear whether HHS under President Trump has enough time to publish a final rule. A proposed rule, however, could shed light on current HHS leadership’s thinking about civil enforcement and final agency determinations—a hot topic now in 340B circles. What HHS might do about pharmaceutical manufacturers’ denials of 340B pricing on drugs shipped to contract pharmacies is an example of a civil enforcement action. Also, the 340B administrative dispute resolution (ADR) process that HHS is preparing to launch is an example of civil administrative adjudication. (Although HHS says the 340B ADR process isn’t intended to be “trial-like,” its decisions will be final, binding, and appealable to a court.) HHS last month asked the White House to sign off on a 340B ADR final rule.


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