Shalala

The Secretary of Health and Human Services appeals the district court’s summary judgment in favor of Cedars-Sinai Medical Center and twenty-four other hospitals (“the Hospitals”) in the Hospitals’ declaratory judgment action challenging a 1986 Health Care Financing Administration (“HCFA”) policy. The challenged policy provides that Medicare will not cover investigational medical devices that have not been approved for marketing by the Food and Drug Administration. The Hospitals claim, and the district court held, that the policy is invalid because it was not issued in accordance with the rulemaking requirements of the Administrative Procedure Act (“APA”), 5 U.S.C. § 553 .

A qui tam relator (“the Relator”), who is the plaintiff in a False Claims Act ( 31 U.S.C. § 3729 ) case in the federal district court in Seattle, appeals the district court’s denial of his motion to intervene and dismiss this action. In the qui tam action, which is under seal, the Relator alleges that 130 hospitals knowingly submitted false claims for payment to Medicare and Medicaid seeking reimbursement for non-FDA-approved medical devices, which are barred from Medicare coverage under the 1986 HCFA policy.…