Hooper, Lundy & Bookman Files Suit on Behalf of California Clinical Labs and Medicare Patient to Prevent Medicare From Denying Patients Coverage for Vital Laboratory Tests

The national law firm of Hooper, Lundy & Bookman, PC, on April 18, 2014 filed a complaint on behalf of the California Clinical Laboratory Association (CCLA) and a Medicare beneficiary against the U.S. Department of Health & Human Services, charging that Medicare Administrative Contractors (MACs) continue to develop and apply Local Coverage Determinations (LCDs) that result in policies depriving Medicare beneficiaries throughout the country of critically necessary clinical laboratory services.

“Today, the MACS have a stranglehold on critical, cost-effective innovation,” said Hooper, Lundy & Bookman attorney Patric Hooper, lead attorney for the plaintiffs. “Our clients have been forced to bring this lawsuit to bring attention to, and change, the current practice of denying coverage for critically important laboratory services. In addition, the same private insurers who make determinations for Medicare, also make determinations in the private market, so the entire population is affected.”

At issue is Medicare coverage for various clinical laboratory tests ordered by patients’ physicians, including molecular diagnostic tests, advanced testing that enables personalized protocols for treatments such as chemotherapy, rather than the “one-size-fits-all” treatment protocols based on population averages. When weighed against the costs of treating complications and other side effects of treatments that may not be ideal for a particular patient, the costs of the tests are considered both economical and quality-of-life enhancing.

“With the rate of speed at which health care reform is moving in other sectors, it is time to catch up with respect to innovative, patient-centered care from a clinical perspective,” said Hooper. “With this complaint, our clients hope to make strides toward that end.”

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

• Congress has unlawfully delegated regulatory power to the MACs;
• MACs have implemented Medicare policy without following required federal rulemaking requirements;
• MACs have developed LCDs based on criteria they are not permitted to consider;

• HHS has eliminated any meaningful opportunity for laboratories to administratively appeal the application of LCDs and has not established a required mediation process;
• 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.

“Each MAC makes LCDs for a specific geographic portion of the country,” explained Mr. Hooper. “By eliminating any chance that clinical labs have to promote progress in patient care, and expand that care nationally, the MACs have overstepped their authority, as has Congress, and HHS has not fulfilled its promises to beneficiaries.”

CCLA is a membership organization and the position of independent members may differ from that of the Association.

About Hooper, Lundy & Bookman: Founded in 1987, Hooper, Lundy & Bookman, P.C., is the largest full service law practice in the country dedicated solely to the representation of health care providers and suppliers. With offices in Los Angeles, San Francisco, San Diego and Washington, D.C., and clients in all 50 States, we meet the business, litigation, regulatory and government relations needs of a broad array of health care providers--ranging from the largest national health care organizations to community hospitals and individual physician practices. For more information, please visit our website at www.health-law.com.