Government's reply in support of their motion to dismiss (October 10, 2018)

Plaintiffs essentially allege that they have a statutory entitlement to a government-funded windfall with every drug purchase they make through the 340B Program, and that the Secretary erred by decreasing the amount of the windfall in the final 2018 OPPS Rule. See, e.g., Plaintiffs' Reply in Support of Their Motion for Preliminary and Permanent Injunction and Opposition to Defendants' Motion to Dismiss ("MTD Opp."),1 Sept. 26, 2018, ECF No. 16, at 21-22. It is a startling claim. And it is wrong.

But the Court need not - indeed, cannot - reach the merits of the claim because Congress has precluded judicial review of the Secretary's decision to reduce the payment rate for drugs purchased through the 340B Program. See Memorandum in Support of Defendants' Motion to Dismiss and in Opposition to Plaintiffs' Motion for a Preliminary Injunction ("MTD"), Sept. 14, 2018, ECF No. 14, at 16-24. In fact, Congress has broadly precluded review of the Secretary's decisions regarding the establishment and adjustment of the components of the outpatient prospective payment system. The reason for this is simple enough: Adjustments by the Secretary are made in a budget neutral fashion, meaning that a decrease in the payment rate for one component is offset by an increase for the payment rate of another, and a post hoc, court­ordered change to a component could have significant effects throughout a system that handles over 100 million outpatient claims every year. See Ex. 1 to MTD.

Read the full reply brief below.