Federal judge blocks HHS final rule on 340B program

A federal judge has blocked HHS from implementing its administration dispute resolution final rule, released in December, ruling that the department didn’t follow proper protocols when finalizing the rule.

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The decision, released March 16 by Judge Sarah Evans Barker of U.S. District Court for the Southern District of Indiana, states that HHS messaging around the final rule was “ambiguous, confusing, duplicitous and misleading.” 

The judge added that because HHS issued the final rule without additional notice or a comment period, it violated Eli Lilly’s rights. The drugmaker sued HHS over the final rule. 

The blocked rule created a panel to settle disputes between hospitals and drugmakers on issues related to the 340B drug discount program. Shortly after the rule was released, HHS also released an advisory opinion stating that 340B drug discounts apply to community pharmacies contracted to dispense drugs for hospitals participating in the 340B program. 

Read the full decision here

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