A recent U.S. Supreme Court ruling confirms that the 340B administrative dispute resolution process is constitutional, government lawyers told a federal district judge this month.

340B Dispute Resolution Process is Constitutional, Feds Tell Court

A recent U.S. Supreme Court ruling about administrative law judges who hear patent disputes confirms that rules establishing the 340B program’s administrative dispute resolution (ADR) process are constitutional, government lawyers told a federal district judge this month.

Under the 340B ADR final rule and the 340B statute, the U.S. Health and Human Services (HHS) secretary “may freely exercise discretionary review” of ADR panel decisions, even though the rule didn’t establish a formal mechanism for appeals to the secretary, the U.S. Justice Department (DOJ) said in a Sept. 9 brief in a drug industry lawsuit challenging both the ADR rule and 340B program guidance governing drug company audits of 340B covered entities.

A recent U.S. Supreme Court ruling about administrative law judges who hear patent disputes confirms that rules establishing the 340B program’s administrative dispute resolution (ADR) process are constitutional, government lawyers told a federal district judge this month.

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