ACLA Statement on District Court Opinion in Lawsuit Against HHS

Lawsuit targeted HHS’ unlawful implementation of 2014 Medicare legislation, regulatory guidance that would jeopardize beneficiaries’ access to critical lab services

Washington, D.C. – Following the opinion from the U.S. District Court for the District of Columbia in ACLA v. Azar, Julie Khani, ACLA President, issued the following statement:

“This is an extremely disappointing outcome for ACLA’s members and the millions of seniors they serve – including the most vulnerable Medicare beneficiaries – who rely on clinical laboratory tests for their most basic health needs. While the District Court’s opinion acknowledges that ACLA’s ‘arguments on the merits raise important questions,’ the District Court refused to consider those arguments, because it erroneously concluded that Congress had stripped it of jurisdiction to do so. The Court’s decision that it is powerless to require HHS to comply with the statutory requirements sets a harmful precedent that allows agencies to circumvent Congress’ express directions at the expense of patient care.”

“HHS’ continued assertion that collecting data from less than one percent of laboratories nationwide meets the standards for a market-based system is indefensible.  By intentionally omitting data from more than 99 percent of laboratories, HHS is undermining Congress’ goal of protecting beneficiaries and supporting value-based care delivery.”

“ACLA and its members are reviewing further legal options. In the meantime, it’s imperative that Congressional leaders take immediate action to mitigate the harm facing millions of seniors as a result of year-over-year cuts to essential lab services. Because the District Court declined to step in to address the ‘important questions’ the lawsuit raises about HHS’ misconduct, Congress must reform and modernize the clinical lab fee schedule to ensure that beneficiaries can continue to access the lab services and diagnostics they need.”

# # #

ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly, and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.


Print page / Save as PDF