Hospitals and Laboratory Seek to Enjoin Clinical Laboratory Competitive Bidding

On January 29, 2007, Sharp Healthcare, Scripps Health and Internist Laboratory filed a Complaint for Injunctive Relief (Complaint) in the U.S. District Court for the Southern District of California. 

The Complaint seeks to enjoin the Secretary of the Department of Health and Human Services (Secretary) from implementing the Medicare clinical laboratory services competitive bidding demonstration project (and its February 15, 2008 bid date) in the San Diego-Carlsbad-San Marcos, California area or any other area.

In the Complaint, the plaintiffs allege that, among other things, the Secretary is implementing the demonstration project without abiding by the notice and comment rule making requirements of the Administrative Procedure Act, and that the project would dramatically change and irreparably harm and damage the system for delivering clinical laboratory services to Medicare beneficiaries in the San Diego-Carlsbad-San Marcos area.

The demonstration project is authorized by the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA).  On October 17, 2007, the Centers for Medicare & Medicaid Services (CMS) announced that the first site for the Medicare clinical laboratory services competitive bidding demonstration project would be the San Diego-Carlsbad-San Marcos, California metropolitan statistical area. 

For more information, see Sharp Healthcare et al. v. Leavitt, Case No. 3:08-cv-00170-W-POR.