California Clinical Laboratory Association 1127 Eleventh Street, Suite 820 l Sacramento, CA 95814 l (916) 446-2646

FOR IMMEDIATE RELEASE: April 22, 2014

CONTACT: Michael Arnold, Executive Director

California Clinical Laboratory Association Suit To Prevent Medicare from Denying Coverage for Vital Laboratory Tests Needed by Medicare Patients Accepted by the Federal District Court in the District of Columbia

(Sacramento, CA.) – Today, the federal district court in the District of Columbia officially accepted a complaint filed by the national law firm of Hooper, Lundy & Bookman, PC, on behalf of the California Clinical Laboratory Association (CCLA) and a Medicare beneficiary against the U.S. Department of Health & Human Services. This precedent setting suit charges that Medicare Administrative Contractors (MACs) are adopting Local Coverage Determinations (LCDs) that deprive Medicare beneficiaries throughout the country of critical clinical laboratory tests.

At issue is Medicare coverage for various clinical laboratory tests ordered by physicians to obtain information needed to make medical decisions regarding the diagnosis, treatment or management of patients. Importantly, many of these tests can save money for the Medicare system by enabling medical decisions which can accomplish the following:

  • l Avoidance of costly invasive procedures and debilitating therapies
  • l Utilization of prescription drugs which are properly metabolized by the patient to provide more effective therapeutic results
  • l Appropriate monitoring of pain management drugs to avoid overutilization and potentially life threatening drug interactions

Included are molecular diagnostic tests that enable personalized treatments designed to meet the precise needs of the patient and urine drug testing to monitor pain management therapies. When weighed against the costs and side effects of treatment decisions that may not be ideal nor appropriate for a particular patient, these tests are both economical and quality of life enhancing.

The complaint, filed in federal district court in the District of Columbia, asserts that:

  • l Congress has unlawfully delegated regulatory power to the MACs
  • l MACs have implemented Medicare policy without following required federal rulemaking requirements
  • l MACs have developed LCDs based on criteria they are not permitted to consider
  • l HHS has eliminated any meaningful opportunity for laboratories to administratively appeal the application of LCDs and has not established a required mediation process
  • l HHS has not developed an effective plan to evaluate the appropriateness of adopting new LCDs nationally, as noted recently by the Office of Inspector General Jean Amos Wilson, President of the CCLA, states: “This law suit is being filed as a last resort. The input provided by the clinical laboratory industry, speaking on behalf of the patients we serve, has been virtually ignored by the Medicare Administrative Contractors. These MACs have been granted unilateral authority by Medicare and HHS to use the LCD process to make coverage decisions which deny access to vital laboratory testing needed by Medicare patients.”

The positions taken by CCLA in this action do not necessarily reflect the positions of all of its member organizations.