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The Biden administration wants major changes to the 340B program administrative dispute resolution process, including giving OPA the only votes on ADR panels.

340B Dispute Resolution Proposed Rule Would Eject CMS Staff and HHS Lawyers from Process and Put OPA in Charge

As we were the first to report on Tuesday morning, the Biden administration has proposed major changes to the 340B program administrative dispute resolution process, including stripping the Centers for Medicare & Medicaid Services and the Department of Health and Human Services Office of General Counsel of their roles on ADR panels and giving the Health Resources and Services Administration’s Office of Pharmacy Affairs the only votes. 

HRSA released the proposed rule to the public on Nov. 29 and formally published it in the Federal Register yesterday. Comments are due Jan. 30. HRSA would have to publish a final rule for the changes to take effect. There is no deadline for it to do so.

As we were the first to report on Tuesday morning, the Biden administration has proposed major changes to the 340B program administrative dispute resolution process, including stripping the Centers for Medicare & Medicaid Services and the Department of Health and Human Services Office of General Counsel of their roles on ADR panels and giving the Health Resources and Services Administration’s Office of Pharmacy Affairs the only votes.

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