ACLA Files Notice of Appeal in ACLA v. Becerra

Washington, D.C. –  The American Clinical Laboratory Association (ACLA) today filed a notice of appeal in its lawsuit against the U.S. Department of Health and Human Services (HHS) challenging the agency’s implementation of the Protecting Access to Medicare Act (PAMA), which requires HHS to establish a market-based data collection process for clinical laboratory diagnostic services. 

“In ACLA’s previous appeal, the court ruled that ACLA is indeed entitled to challenge the harmful regulatory overreach by the HHS Secretary in his implementation of PAMA,” said Julie Khani, president of ACLA. “On behalf of the millions of patients we serve, we’ll continue to fight for the opportunity to do so.”

The lawsuit, first filed by ACLA in December 2017, was dismissed in September of 2018 after the U.S. District Court for the District of Columbia concluded that despite the fact that ACLA’s “arguments on the merits raise important questions,” ruling on “the establishment of payment amounts” under PAMA was barred by the statute. In 2019, the U.S. Court of Appeals for the D.C. Circuit overturned that dismissal, sending it back to the lower court “to address in the first instance the merits of petitioner’s arbitrary-and-capricious challenge.” After an extended delay, the federal district court again dismissed the lawsuit on March 30, 2021, relying on the same conclusions that the D.C. Circuit rejected. 

“While we continue our advocacy in the courts, it is even more critical for Congress to take legislative action on PAMA reform,” said Khani. “ACLA will continue to work with policymakers to establish a Medicare Clinical Laboratory Fee Schedule that is truly representative of the market and supports continued innovation and access to vital laboratory services, as Congress originally intended.  Now is the time to strengthen our laboratory infrastructure and support continued access to the high-quality lab services that seniors depend on.” 

To view FAQs on the lawsuit, click here. For additional background on ACLA’s litigation timeline, click here.


The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.

Print page / Save as PDF