In a highly unusual filing, Defendants seek to defend the 2019 OPPS Rule with arguments that Defendants forthrightly acknowledge the Court has already rejected. See Gov’t Mem. in Supp. of Mot to Dismiss New Claim & Opp’n to Mot. for Perm. Inj. With Respect to 2019 OPPS Rule (“Gov’t Mot.”), ECF No. 42 at 2 (“Defendants recognize that the Court has rejected those arguments in the context of the 2018 OPPS Rule . . . .”). Although Defendants ask the Court to “reconsider its conclusion in the context of the 2019 OPPS Rule,” id., Defendants recite exactly the exact same arguments that they raised in defense of the 2018 OPPS Rule and give no reason whatsoever that the result should be different for the 2019 OPPS Rule. Plaintiffs respectfully ask the Court to issue a permanent injunction holding the 2019 OPPS Rule unlawful under 42 U.S.C. § 1395l(t)(14)(A)(iii), just as the Court did with respect to the 2018 OPPS Rule.
340B Drug Pricing Program Legal Resources
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The Court concluded that the defendants – the U.S. Department of Health and Human Services and its Secretary (referred to collectively throughout as “the Agency”) – acted in an ultra vires fashion by reducing the payment rate for drugs purchased through the 340B Program in the 2018 Outpatient Prospective Payment System (“OPPS”) Rule, 82 Fed. Reg. at 52, 362. Memorandum Opinion (“Op.”), Dec. 27, 2018, ECF No. 25. Plaintiffs have supplemented their complaint to challenge the analogous payment reduction in the 2019 OPPS Rule, Supplemental Compl., Feb. 8, 2019, ECF No. 34-3, and have filed a motion for a permanent injunction with respect to that rule, Motion for A Permanent Injunction Covering the 2019 OPPS Rule, Feb. 11, 2019, ECF No. 35.
In November 2018, Defendants issued a regulation requiring that, for calendar year 2019, the Centers for Medicare & Medicaid Services (CMS) reimburse drugs purchased under section 340B of the Public Health Services Act ("340B drugs") by using a methodology based on Average Sales Price minus 22.5%, just as they had done for calendar year 2018. CMS, Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, 83 Fed. Reg. 58,818, 58,979-81 (Nov. 21, 2018) ("2019 OPPS Rule"). Defendants explained that they were "continuing the 340B Program policies that were implemented in [calendar year] 2018"-i.e., the policy of "pay[ing] for separately payable Medicare Part B drugs ... that are acquired through the 340B Program at ASP minus 22.5 percent." Id. at 58,980-81.
The Court determined that the U.S. Department of Health and Human Services ("Agency") acted in an ultra vires fashion when it reduced the payment, in the 2018 Medicare Outpatient Prospective Payment System Rule ("OPPS Rule"), 82 Fed. Reg. at 52, 362, for drugs purchased through the 340B Program. Memorandum Opinion ("Op."), Dec. 27, 2018, ECF No. 25. The Court, however, declined to issue a remedy without further briefing, as it recognized that the remedy in this case could potentially wreak havoc on the vast and complex Medicare payment system.
This Court should reject Defendants’ attempt to re-litigate the merits of the case or, alternatively, to decide on their own if the 340B hospitals are entitled to relief and if so what that relief might be. Defendants’ proposal is nothing more than an attempt to further delay resolution of this matter, which Plaintiffs have been attempting to resolve since the illegal reductions in reimbursements for 340B drugs were first proposed 19 months ago. Instead this Court should direct Defendants to make 340B hospitals whole in the simple and expeditious manner proposed in Plaintiffs’ opening brief.
Re: 340B Payment Reductions in the CY2018 Final OPPS Rule.
Re: 340B Payment Reductions in the CY2018 Final OPPS Rule
Re: 340B Payment Reductions in the CY2018 Final OPPS Rule.
In a status conference held on December 17, 2018, the parties agreed that, with respect to plaintiffs' principal claims relating to the final 340B Rule, the case is now MOOT.
Notice of Administrative Decisions, Exhibit 1 - Declaration of Krista Pedley and Defendant's reply
Memorandum in Opposition to Defendants' Motion to Dismiss and Reply in Support of Summary Judgment