A federal appeals court says South Carolina health center Genesis Healthcare has the right to challenge the 340B patient definition's legality in a lower federal court.

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In Important Ruling, Federal Appeals Court Says Health Center May Challenge 340B Patient Definition’s Legality

A federal appeals court ruled unanimously this morning that a South Carolina health center has the right to challenge the legality of the government’s 340B patient definition in a lower federal court. The case ultimately could have profound implications for access to 340B drug discounts.

The U.S. Fourth Circuit Court of Appeals in Richmond, Va., held that a federal district court in December 2019 incorrectly dismissed as moot Genesis Healthcare’s lawsuit over its brief expulsion from 340B in 2018. The U.S. Health Resources and Services Administration expelled it after an audit found that Genesis dispensed 340B drugs to ineligible patients. HRSA reinstated Genesis on the same day the health center sued over its expulsion, and about two weeks later HRSA voided its audit findings, all without explanation.

A federal appeals court ruled unanimously this morning that a South Carolina health center has the right to challenge the legality of the government’s 340B patient definition in a lower federal court.

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