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On December 10, 2020, the U.S. Department of Health and Human
Services ( HHS ), Health Resources and Services
Administration ( HRSA ) issued a long-anticipated
regulation of interest to drug makers and providers: the 340B Drug
Pricing Program Alternative Dispute Resolution Final Rule
( ADR Final Rule ).
1 The ADR Final Rule
establishes an alternative dispute resolution ( ADR )
process that offers manufacturers and 340B covered
entities a means of negotiating certain disputes in a more
formal setting without resorting to litigation or private
arbitration. In the ADR Final Rule, HRSA notes that its intention