American Clinical Laboratory Assoc. v. Azar, No. 18-5312 (D.C. Cir. 2019)Annotate this Case
ACLA filed suit alleging that the Secretary's final ruling implementing the Protecting Access to Medicare Act's (PAMA) definition of "applicable laboratory" unlawfully excluded most hospital laboratories from PAMA's reporting requirements. The district court dismissed the complaint for lack of subject matter jurisdiction. As a preliminary matter, the DC Circuit held that ACLA had standing.
In view of PAMA's text, its structure, and the distinct nature of the processes of data collection and establishment of payment rates, the court could not conclude that the bar against reviewing the "establishment of payment amounts" also prevents its review of the rule setting up a new and detailed process for collecting data on market rates that private insurers pay to laboratories. Because the statute is "reasonably susceptible" to this interpretation, the court held that it does not bar judicial review of the Secretary's rule establishing the parameters of data collection under 42 U.S.C. 1395m-1(a). Finally, the court rejected ACLA's claim that the Secretary's rule was ultra vires. Accordingly, the court reversed the district court's holding on subject matter jurisdiction and remanded for further proceedings.