AMERICAN HOSPITAL ASSOCIATION et al v. KENNEDY et al

UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
AMERICAN HOSPITAL 	)
ASSOCIATION, et al., 	)
)
Plaintiffs 	)
)
v. 	) 	No. 2:25-cv-00600-LEW
)
ROBERT F. KENNEDY, JR., 	)
SECRETARY of the U.S. Department 	)
of Health and Human Services, et al., 	)
)
Defendants 	)
ORDER
This matter is before the Court on the parties’ Joint Motion for Vacatur and Remand
(ECF No. 114). 	On December 1, 2025, Plaintiffs filed their Complaint alleging that the
340B Rebate Model Pilot Program violated the Administrative Procedure Act (APA) and
moved for a Temporary Restraining Order1 to prevent the Rebate Program from taking
effect on January 1, 2026. 	See Compl. (ECF No. 1), Mot. for TRO (ECF No. 3). 	On
December 29, 2025, I preliminarily enjoined Defendants from implementing the Program.
See Order on Mot. for Prelim. Inj. (ECF No. 90). In so doing, I concluded that Plaintiffs’
were likely to succeed on the merits of their claims that Defendants were required to but
did not consider significant reliance interests and costs, based on Defendants’ preview of
the administrative record. 	Id. at 9-18. 	Defendants requested a stay of the preliminary
1 Plaintiffs’ request was converted into a motion for a preliminary injunction.
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injunction pending appeal, which the First Circuit denied. Defendants’ have since
dismissed their appeal.
Defendants now represent that, following the decisions of both this Court and the
First Circuit, they do not believe the full administrative record would change the outcome
of this litigation at summary judgment. See J. Mot. for Vacatur & Remand ¶ 7. The parties
agree that the agency actions comprising the Rebate Program should be vacated and
remanded to the Department of Health and Human Services, to “allow [the agency] to
correct [its] own mistakes without expending the resources of the court in reviewing a
record that is admittedly incomplete or incorrect.” 	Bennett v. Murphy, No. 14-cv-10275,
2016 WL 1449571, at *1 (D. Mass. Apr. 13, 2016).
It is therefore ORDERED that the 340B Rebate Model Pilot Program Application
Notice, 90 Fed. Reg. 36,163 (Aug. 1, 2025), the Corrected 340B Rebate Model Pilot
Program Application Notice, 90 Fed. Reg. 38,165 (Aug. 7, 2025), and the approvals of
applications from drug manufacturers submitted pursuant to those notices (announced
between October 30 and November 14, 2025) are VACATED and REMANDED to the
agency. The Joint Motion for Vacatur and Remand (ECF No. 114) is GRANTED.
SO ORDERED.
Dated this 10th day of February, 2026.
/S / Lance E. Walker
Chief U.S. District Judge
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