On July 30, 2019, the D.C. Circuit issued a favorable jurisdictional decision on behalf of King & Spalding client the American Clinical Laboratory Association (ACLA), reversing the district court. Accepting ACLA’s arguments, the Court found that, while the Protecting Access to Medicare Act of 2014 precludes judicial review of the setting of laboratory reimbursement rates, it does not preclude review of CMS’s implementation of the statute’s separate data-collection provision, as the government had argued.

This is a significant procedural win affecting clinical laboratories across the country and is precedent-setting for important principles of administrative law around statutory preclusion of review provisions. The case now returns to the district court for further proceedings on the question of whether CMS acted in an arbitrary and capricious manner in collecting private payor data from only a small number of laboratories before setting national Medicare reimbursement rates. The case is American Clinical Laboratory v. Azar, and the Court’s decision is available here.