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December 17, 2020

HRSA Issues Rule on 340B Dispute Resolution

The Health Resources and Services Administration issued a final rule on December 14 setting out the administrative dispute resolution process for certain claims arising under the 340B program.  The rule is applicable to all drug manufacturers and covered entities participating in the 340B program. This final rule is effective January 13, 2021 and replaces guidelines published in December, 1996.