Frustrated by Medicare local coverage determinations (LCDs) that effectively deny patients access to critical lab testing, the California Clinical Laboratory Association (CCLA) on April 18 filed a lawsuit against the Department of Health and Human Services (HHS) asking that the LCD process and resulting LCDs for laboratory services to be declared invalid and unenforceable. The complaint, filed by the law firm of Hooper, Lundy, and Bookman PC (Los Angeles) on behalf of CCLA and an unnamed beneficiary, charges that Medicare Administrative Contractors (MACs) continue to develop and apply local coverage determinations 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 Patric Hooper, the 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 are coverage policies determined by MACs without any input from the laboratory community or beneficiaries. In many instances, lab tests are denied…

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