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.

Please Login or Become a Paid Subscriber to View this Content

If you are already a paid subscriber, please follow the steps below.
If you are not yet a paid subscriber, please Subscribe now.
For questions about subscriptions or technical assistance, please contact Reshma Eggleston at reshma.eggleston@340breport.com.
« Read Previous Read Next »
Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
×

×

*Sign up for news summaries and alerts from 340B Report

Site Footer