Biotechnology Innovation Organization v. Alex M. Azar, II

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF CALIFORNIA

CALIFORNIA LIFE SCIENCES Case No. 20-cv-08603-VC ASSOCIATION, et al.,

Plaintiffs, ORDER GRANTING MOTION FOR

PRELIMINARY INJUNCTION

v. Re: Dkt. No.

CENTER FOR MEDICARE AND

MEDICAID SERVICES, et al., Defendants.

The motion for a preliminary injunction is granted based on the government’s failure to complete the notice and comment procedures required by the Administrative Procedure Act. The government is enjoined from implementing the rule pending completion of those procedures. The recent ruling by Judge Catherine Blake thoroughly explains why the rule should be temporarily enjoined, and her reasoning is largely adopted here. See Association of Community Cancer Centers v. Azar, 2020 WL 7640818 (D. Md. Dec. 23, 2020). This ruling will highlight a few specific points: 1. Judicial review. As Judge Blake explains, the bars on judicial review contained in 42 U.S.C. §§ 405(g), (h) do not apply to this case. The defendants cite 42 U.S.C. § 1395ff(b), which incorporates the bars in section 405 into the Medicare statute, but that provision applies to appeals of initial determinations of benefits under…