WASHINGTON, D.C. – As litigation continues in the American Clinical Laboratory Association’s legal challenge against the U.S. Department of Health and Human Services (HHS), ACLA has filed a new reply brief in response to HHS’s cross-motion for summary judgment.
The latest brief in ACLA v. Azar reinforces the association’s argument that HHS failed to implement the Protecting Access to Medicare Act (PAMA) as Congress intended.
In July, a favorable ruling from the U.S. Court of Appeals for the District of Columbia recognized that ACLA is entitled to challenge the harmful regulatory overreach by the HHS Secretary in his implementation of PAMA. To view the decision from the D.C. Circuit, click here.
ACLA’s latest brief further explains that the Secretary has failed to comply with his statutory obligations. As ACLA’s brief explains, “The Secretary’s final rule impermissibly and unreasonably redefines ‘applicable laboratory’ in contradiction of PAMA, exempting almost all hospital laboratories from the statute’s data-collection requirements. To make matters worse, the Secretary failed to justify or even acknowledge his departure from the statutory text. Accordingly, the rule fails as both an unreasonable interpretation of the statute and an arbitrary and capricious exercise of administrative authority.”
HHS has until January 10 to file its reply in support of its cross-motion for summary judgment.
“There’s been growing acknowledgement, most recently from Congress, that HHS’s actions undermined the intent of PAMA,” said ACLA President Julie Khani. “As our legal challenge advances through the courts, we will continue to work to protect seniors’ access to vital laboratory services on behalf of our members and the millions of patients they serve.”