After a 10-Year Odyssey, HRSA Finally Releases 340B Dispute Resolution Rule (Updated)

Today, more than a decade after Congress ordered that it be done, HRSA released a final rule establishing a binding 340B administrative dispute resolution process. The rule takes effect Jan. 14. | Source: Shutterstock

After a 10-Year Odyssey, HRSA Finally Releases 340B Dispute Resolution Rule

CORRECTION, Dec. 11, 2020—We reported incorrectly yesterday that the U.S. Health Resources and Services Administration (HRSA), in the preamble to its 340B program administrative dispute resolution final rule, “rejected recommendations that manufacturers be required to first to audit covered entities before bringing claims against entities.” The opposite is true. HHS rejected recommendations that manufacturers not be required to first audit covered entities before bringing claims against entities.


UPDATED, Dec. 11, 2020, 2:00 p.m. EST—Pharmaceutical Research and Manufacturers of America (PhRMA) this afternoon provided 340B Report with the following statement about HRSA’s 340B program administrative dispute resolution final rule:

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