All posts by Clare Krusing

ACLA Files Appeal in ACLA v. Azar, Asks U.S. Court of Appeals to Address HHS’s Overreach in Data Reporting

HHS’s continued flawed implementation of PAMA threatens beneficiaries’ access to critical lab services

Washington, D.C. – Today, the American Clinical Laboratory Association (ACLA) advanced its case against the U.S. Department of Health and Human Services’ (HHS) flawed and harmful implementation of the Protecting Access to Medicare Act (PAMA). ACLA’s opening brief argues that HHS has exceeded its statutory authority, circumventing Congress’ stated directive of establishing a market-based reimbursement model for laboratory services.

ACLA initially filed its lawsuit against HHS in 2017. Since then, ACLA and various stakeholders—including organizations representing patients, health care professionals, laboratories and diagnostic manufacturers—have reiterated the ongoing harm caused by the Department’s attempt to exempt nearly 99 percent of the laboratory market from the data reporting requirements under PAMA.

As ACLA’s brief notes, the Secretary’s final rule ” violates Congress’s unambiguous statutory directive to collect data from any ‘laboratory’ that receives a majority of its Medicare revenues from the relevant fee schedules. Instead, the Secretary’s rule rewrites the statute’s majority-of-revenues test to take into account non-laboratory revenue and, through this rewrite, exempts virtually all hospital laboratories from the data-reporting requirements. Because hospital laboratories are significant participants in Medicare and compete with independent laboratories and physician office laboratories in the private market, the Secretary’s rule guarantees that the data collected does not reliably represent the private market as Congress intended.”

HHS’ statutory violation has serious consequences for millions of Medicare beneficiaries, particularly the most vulnerable, who rely on essential lab services to monitor and manage a range of chronic diseases. Laboratories, including those serving rural communities and homebound seniors, have been forced to reduce services and care for Medicare beneficiaries as a result of the flawed data collection process.

“It’s imperative that the Court puts a stop to the Secretary’s regulatory overreach,” Julie Khani, President of ACLA, said. “Seniors are bearing the direct harm from the Department’s continued reliance on a failed process that directly contradicts the stated goals of Congress in protecting beneficiaries’ Medicare lab benefits.”

While the Court reviews the appeal, it is imperative that Congress take immediate action to address the harm facing millions of seniors and their access to essential lab services. Congress must reform and modernize the Clinical Laboratory Fee Schedule to ensure that all patients can continue to access the lab services upon which they depend.

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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.

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.

 

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.”

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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.