Lexology April 19, 2024
On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative dispute resolution (ADR) process under the 340B Drug Pricing Program (340B Program). The Final Rule largely finalizes the policies in the proposed rule, dated November 30, 2022. The Final Rule arrives a little over three years after HRSA issued its 2020 final rule governing the current ADR process (2020 Final Rule).
As a general matter, the Final Rule places access to and the results of the ADR process more squarely in the control of the HRSA Office of Pharmacy Affairs (OPA), as compared to the current process under which claims are submitted...
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