California Clinical Laboratory Association sues HHS over local coverage determinations

The California Clinical Laboratory Association (CCLA) and an unnamed Medicare recipient have filed a lawsuit against the secretary of the Department of Health and Human Services (HHS), alleging the local coverage determinations (LCDs) adopted by Medicare Administrative Contractors (MACs) are unconstitutional and “deprive Medicare beneficiaries throughout the country of critical clinical laboratory tests.” The complaint states the delegation of rule-making authority to private entities violates Article I, Section 1 of the US Constitution, which says all legislative powers shall be vested in the Congress. The plaintiffs also argue MACs are promulgating LCDs outside of the normal rule-making process as codified in the Administrative Procedure Act, and are using criteria to formulate LCDs that are not supposed to be considered. In addition, it is alleged the Secretary of HHS is not ensuring nationwide consistency in the treatment of Medicare beneficiaries, as is required by Congress. Finally, HHS has made it so that laboratories are not allowed to appeal these LCDs .