ACLA sues HHS over clinical laboratory fee schedule rule

The American Clinical Laboratory Association today filed a federal lawsuit claiming the Department of Health and Human Services ignored congressional intent and instituted a “highly flawed” data reporting process in advance of setting market rates under the Protecting Access to Medicare Act, and asking the court to force the agency to comply with the statutory requirements. The Centers for Medicare & Medicaid Services last month issued final Medicare payment rates for clinical diagnostic laboratory tests and advanced diagnostic laboratory tests in calendar year 2018. The rates are based on the weighted median of private insurer payment rates, as required by a 2016 final rule implementing changes to the Medicare clinical laboratory fee schedule under PAMA. “Contrary to Congress’s intent, instead of reforming Medicare reimbursement rates to reflect the broad scope of the laboratory market, the Secretary’s final rule will disrupt the market and prevent beneficiaries from having access to the essential laboratory services they need,” said ACLA President Julie Khani. Twenty-three organizations, including the AHA, had urged CMS to suspend implementation of new payment rates, citing significant concerns with the data collection process used to establish the rates.