A federal court today denied the Department of Health and Human Services’ motion for a stay in a lawsuit brought by the AHA, Association of American Medical Colleges, America’s Essential Hospitals, 340B Health and three hospital systems challenging the excessive delay in the effective date for the 340B price transparency rule. The judge ordered HHS to file by Nov. 13 its opposition to the plaintiffs’ motion for summary judgment and any cross motion and motion to dismiss. AHA and the other plaintiffs last month urged the court to reject HHS’s motion for a stay in the case.
 
The AHA and other groups in September asked a federal court to order HHS to make effective within 30 days a final rule requiring drug companies to disclose the ceiling price for 340B outpatient drugs. To ensure accuracy and compliance with the 340B drug savings program, the rule also describes how ceiling prices must be calculated and would allow the federal government to levy civil monetary penalties against drug companies that intentionally overcharge 340B providers.
 
Facing deadlines for responding to the lawsuit, HHS this week published a proposed rule to move up to Jan. 1 the effective date of the final rule. HHS will accept comments through Nov. 21 on its proposal. Today’s decision puts more pressure on HHS to stick to the Jan. 1 deadline for making the final rule effective.

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