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ACLA Files A Motion for Summary Judgment Against HHS In ACLA v. Azar

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Washington, D.C. — Following a favorable decision on a jurisdictional question issued by the U.S. Court of Appeals for the D.C. Circuit, the American Clinical Laboratory Association (ACLA) has filed a motion for summary judgment before the U.S. District Court for the District of Columbia challenging the flawed implementation of the Protecting Access to Medicare Act (PAMA) in the final rule promulgated by the U.S. Department of Health and Human Services (HHS). ACLA’s motion asks the District Court to strike down HHS’s final rule as unreasonable and contrary to PAMA’s requirements.

ACLA v. Azar returns to the District Court after the U.S. Court of Appeals ruled in favor of ACLA and remanded the case in late July for the District Court to rule on the merits of ACLA’s challenge. To view the decision from the U.S. Court of Appeals, click here.

ACLA’s motion argues that HHS ignored congressional intent and instituted a flawed data collection process in advance of setting rates under PAMA, failing to protect access to laboratory services for Medicare beneficiaries.

The lingering consequences of PAMA’s flawed implementation are severe. As ACLA notes in the motion, “Because the data-collection parameters imposed by the final rule have resulted in the Secretary establishing payment rates that are far below private-sector rates, some laboratories face a serious threat of being forced out of business, others are being forced to scale back essential services, and patients are being deprived of the services they need.”

“We appreciate the District Court’s review of the flawed implementation of PAMA, and the resulting harm to laboratories and the patients they serve,” ACLA President Julie Khani said. “While we continue our advocacy in the courts, it’s even more critical that Congressional leaders advance bipartisan reform and pass the Laboratory Access for Beneficiaries Act, which would delay data reporting for 2020 and provide the necessary time to address the flaws in PAMA that undermine senior’s care.”

To view the original complaint and release, click here. For ACLA’s motion for summary judgment, click here.

ACLA Statement in Response to U.S. Court of Appeals Ruling in ACLA v. Azar

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Court of Appeals Says ACLA is Entitled to Challenge HHS’s Harmful Regulatory Overreach 

Washington, D.C. — In response to today’s ruling from the U.S. Court of Appeals for the District of Columbia in favor of the American Clinical Laboratory Association (ACLA) in its lawsuit against the Department of Health and Human Services (HHS), ACLA President Julie Khani issued the following statement:

“We strongly commend the Court of Appeals’ decision and are very encouraged that it recognizes that ACLA is entitled to challenge the harmful regulatory overreach by the HHS Secretary in his implementation of the Protecting Access to Medicare Act (PAMA). HHS’s continued flawed data collection process poses a direct challenge to the rule of law and PAMA’s intent to support a sustainable, market-based laboratory market for millions of seniors. On behalf of those who have already seen the consequences of this painful overreach, we urge the District Court to act quickly to rule on the merits of ACLA’s case.”

In its brief, ACLA argued that “Congress precluded judicial review of only ‘the establishment of payment amounts.’ It did not bar review of the Secretary’s final regulations establishing the parameters for collecting confidential data from laboratories.” The Court of Appeals upheld this distinction and noted that, “PAMA’s data collection provision…is distinct from its rate-estimation provisions.”

“For data collection, the statute obligates clinical laboratories that participate in the Medicare program to report distinct reimbursement rates they receive from private insurers and requires the Secretary to establish the rules governing that reporting through notice and comment rulemaking. To be sure, the results of that data collection process are used to establish Medicare payment amounts. But the statute’s bifurcated structure supports ACLA’s view that the two provisions and the processes they require are distinct…That the statutory scheme requires private laboratories to report non-Medicare and generally confidential business information (private market rates) to the government on pain of monetary penalties further stands this statutory scheme in sharp contrast to others where the challenged action was found to be intertwined with other agency actions regarding which Congress had barred judicial review.”

The Court’s decision sends the case back to the U.S. District Court for the District of Columbia for review to ensure the Department’s continued regulatory implementation of the law adheres to Congressional intent in establishing clear, market-based parameters for data collection and calculation of rates in accordance with those guidelines.

While ACLA v. Azar continues to be under judicial review, it’s even more critical that Congressional leaders continue to advance bipartisan reforms that would provide a one-year delay of upcoming PAMA reporting activities. The Laboratory Access for Beneficiaries (LAB) Act would suspend data reporting for 2020, providing HHS and Congress the necessary time to address flaws in the current reporting process that continue to undermine seniors’ care.

“While today’s decision is an important moment for millions of beneficiaries, we urge Congressional leaders to immediately halt the data reporting process and allow time to ensure that HHS is implementing PAMA in the right way.”

New Report Highlights Value of Clinical Labs to U.S. Economy

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Washington, D.C. – The American Clinical Laboratory Association (ACLA) today released new economic data highlighting the contributions of clinical laboratories to the economy and the job market in the United States.

The findings provide a snapshot of the benefits clinical labs provide to the national economy as well as states and local communities. Clinical laboratories support more than 688,000 jobs in the workforce, bringing $44.75 billion in wages to American workers. The industry pays more than $9.81 billion in federal taxes.

The report, sponsored by ACLA and conducted by John Dunham & Associates, used public data and ACLA member data to draw its conclusions, examining records from more than 53,600 laboratories nationwide.

“Providers and patients know that in addition to delivering valuable health information, labs also drive significant savings for the health system—helping identify and diagnose diseases in earlier stages before costly interventions are necessary,” Julie Khani, ACLA President, said. “This new report examines the value of clinical laboratories through a different lens—focusing on the industry’s important economic contributions to communities all across the country.”

At a time when the very existence of some local laboratories is being threatened by the government’s flawed implementation of the Protecting Access to Medicare Act (PAMA), this new analysis reinforces the important human and economic costs at stake if senseless cuts to Medicare reimbursement for lab services continue.

“Now more than ever, we must fight to protect seniors’ access to their essential lab benefits which continue to be threatened under the flawed implementation of PAMA,” said Khani.

To explore the findings of this year’s economic report, click here.

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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 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.

ACLA Files Reply Brief Ahead of Oral Arguments in ACLA v. Azar Appeal

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HHS’ data collection process under PAMA disregards Congressional intent, jeopardizing lab access for millions of seniors

Washington, D.C. – The American Clinical Laboratory Association (ACLA) filed a reply brief today ahead of oral arguments in the ACLA v. Azar appeal which has been scheduled for April 23, 2019. The brief reinforces ACLA’s argument that the U.S. Department of Health and Human Services (HHS) failed to implement the Protecting Access to Medicare Act (PAMA) as Congress intended. It urges the appellate court to reverse the district court’s decision dismissing the lawsuit.

The lawsuit, 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. ACLA filed an appeal arguing that, “The act of promulgating a legislative rule requiring private parties to report confidential data does not itself establish payment amounts.”

As ACLA’s brief notes, “PAMA’s text and structure show that Congress directed the Secretary to undertake two separate and logically distinct actions,” the first being establishing parameters for data collection and the second being establishment of payment amounts. “Congress precluded judicial review of only ‘the establishment of payment amounts.’ It did not bar review of the Secretary’s final regulations establishing the parameters for collecting confidential data from laboratories.” HHS’ response brief filed February 25, 2019 offered no meaningful answers to these important distinctions.

“Throughout this process, HHS has advanced a data collection process that is not only flawed and incomplete in its own right but also stands to directly harm the health of millions of seniors who rely on the Medicare lab services being jeopardized,” said ACLA President, Julie Khani. “Congress intended to protect seniors’ access to care. HHS’ implementation has turned that intent on its head and puts seniors at risk, particularly the most vulnerable seniors and those who suffer from chronic disease.”

To read ACLA’s full reply brief click here. To read its opening brief, click here. To view the original complaint, click here.

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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.