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Govt. Motion to Stay Case Proceedings in Light of Appropriations Lapse (Jan. 6, 2019)
Re: 340B Payment Reductions in the CY2018 Final OPPS Rule.
Status Report
Following a December 17, 2018 status conference, the Court issued a minute order requiring defendants to "file [a] status report[] pertaining to their progress in publishing pricing data by not later than February 28, 2019 . . . ." Minute Order, Dec. 18, 2018. Consistent with their representations at the status conference, Defendants anticipate that covered entities will have access to ceiling prices via the Office of Pharmacy Affairs Information System pricing system on April 1, 2019. The attached declaration from Krista Pedley, Director of the Office of Pharmacy Affairs, Healthcare Systems Bureau, Health Resources and Services Administration, U.S. Department of Health and Human Services, provides additional details on Defendants' progress.
AHA, Associations, Hospitals’ Motion for an Injunction for 2019
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.
Memorandum in Support of Motion to Dismiss New Claim with Respect to 2019 OPPS Rule
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.
Opposition to Government’s Motion to Dismiss and Reply in Support of Motion for a Permanent Injunction Covering the 2019 OPPS Rule
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 Delay: Order denying the Government's motion to stay
Plaintiffs, a collection of hospitals, hospital associations, and healthcare providers, have brought this action against the Department of Health and Human Services (“HHS”) and Secretary of HHS Ale
340B Reg Delay: Briefing schedule proposed order (Nov. 7, 2018)
In a November 2, 2018 Order, the Court instructed the parties to file, by no later than November 8, 2018, a joint proposed schedule for briefing, plaintiffs' motion for summary judgment and de
340B Delay: Memorandum in Opposition to Defendants' Motion to Dismiss and Reply in Support of Summary Judgment
Memorandum in Opposition to Defendants' Motion to Dismiss and Reply in Support of Summary Judgment
340B Payment Reduction Suit: Notice of ALJ Rulings
Notice of Administrative Decisions, Exhibit 1 - Declaration of Krista Pedley and Defendant's reply