ACLA Statement on Notice of Appeal in ACLA v. Azar

HHS’s continued reliance on faulty data collection process jeopardizes access to critical lab tests for millions of beneficiaries; ACLA files appeal following District Court decision

 Washington, D.C. – Today, the American Clinical Laboratory Association (ACLA) filed its notice of appeal in its lawsuit against the U.S. Department of Health and Human Services (HHS) challenging its 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. ACLA President Julie Khani issued the following statement:

“HHS’s continued assertion that collecting data from less than one percent of laboratories nationwide meets the standards for a representative market-based system is indefensible.  HHS’s failure to collect data from more than 99 percent of laboratories undermines Congress’s goal of ensuring patients benefit from a market-based system for critical laboratory services.”

“HHS’s misguided and flawed data collection process continues to threaten access to lifesaving lab services and ultimately the health outcomes of millions of seniors across the country—a reality that is clear for those serving on the front lines of our health care system and one that will have increasing ramifications for beneficiaries if not addressed.”

“While the District Court ruled on narrow procedural grounds, its opinion acknowledges that ACLA’s ‘arguments on the merits raise important questions,’ about HHS’s actions. We believe it is critically important for ACLA to be able to address these issues in court. While ACLA continues to pursue legal action, we also call on Congress to reform and modernize the Clinical Laboratory Fee Schedule to ensure that beneficiaries can continue to access the lab services and diagnostics they need.”

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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.


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