ACLA Member Labs Surpass 100 Million COVID-19 Tests Performed
Association Outlines Key Priorities to Address Next Phase of the Pandemic
WASHINGTON, D.C. – Members of the American Clinical Laboratory Association (ACLA) today surpassed 100 million PCR tests performed for COVID-19.
“I am incredibly proud of the dedicated lab professionals who have worked around the clock since March to perform more than one hundred million PCR tests for COVID-19,” said Julie Khani, president of ACLA. “ACLA member laboratories were among the first to validate and scale novel tests for the virus following the FDA’s guidance in February of 2020 and as we pass this milestone today, we remain focused on expanding access to accurate and reliable testing for the patients who are counting on us.”
For months, laboratory professionals have stepped up to meet an unprecedented challenge – adapting platforms and workflows, navigating supply constraints and working creatively and collaboratively to meet patients’ evolving health needs. These unsung heroes, who often work behind the scenes, moved into hotels to remain closer to the labs, pulled all-nighters to bring high-throughput platforms online and prioritized innovation and efficiency every step of the way. Because of their hard work, ACLA member laboratories have continued to perform tests with quick turnaround times and increased capacity, and today they stand ready to perform more diagnostic testing, serology testing and genomic sequencing.
Despite our collective progress, fundamental challenges still exist and access to accurate and reliable testing remains critical. As the country enters the next phase of the pandemic, ACLA released the following roadmap to protect access to the testing patients need, now and in the future:
Expand access to, and coverage of, accurate and reliable testing for every American. We know uncertainty about coverage and costs creates unnecessary barriers for patients. According to a recent survey of a small subset of ACLA members, health plans have denied at least 1,000,000 claims for COVID-19 PCR tests since June 2020. Insurers continue to deny claims even in cases when the patient is suspected of having COVID-19 or has been exposed to it. On January 21, 2021, as part of a set of executive orders to expand access to accurate and reliable testing for all Americans, President Biden directed federal agencies to clarify insurers’ obligation to cover COVID-19 testing. That important directive aligns with the policy mandate in the Families First Coronavirus Response Act (later affirmed by the Coronavirus Aid, Relief, and Economic Security (CARES) Act), which set forth a promise to all Americans that testing for COVID-19 would be broadly covered by insurance and available to anyone that needed it. We’re pleased to see the Biden Administration’s national testing strategy recognize the need to clarify health insurers’ responsibilities to cover and pay for COVID-19 testing, and we look forward to working together to ensure all Americans can access the testing they need without the added burden of paying any out of pocket costs.
Track emerging variants and expand sequencing efforts. ACLA member laboratories are armed with the personnel, scientific expertise and experience necessary to support sequencing emerging SARS-CoV-2 variants. Genetic sequencing of SARS-CoV-2 variants helps public health partners monitor how the virus changes over time, assess characteristics of different strains and inform response efforts at the national and local levels. ACLA members stand ready to expand our ongoing efforts in coordination with the CDC and state and local public health labs.
Increase the number of specimen collection sites in underserved areas and fix our flawed data reporting systems. Like vaccination sites, there have been significant disparities in access to specimen collection sites. The government must prioritize working with pharmacies, faith-based organizations, community centers and other locations to expand access to testing. President Biden’s response plan proposes several important steps to address these disparities and ACLA members stand ready to build on our ongoing initiatives to realize this goal. As a key tool in that effort, we must work together to improve the current data reporting systems. Public health officials need clear, reliable data points to contain this devastating virus and protect our most vulnerable communities. ACLA and our members have been working with other stakeholders on how best to communicate with ordering providers on the need to gather and report expanded demographic data to laboratories and public health authorities. A successful effort will also require additional federal investment in public health IT systems, adequate time for providers to successfully implement these new tools and a robust education effort that incentivizes this reporting. To better understand and mitigate disparities in access, it’s critical that we make capturing more comprehensive data a core priority.
Apply learnings from the current pandemic and prepare for the next one. The first COVID-19 tests available in the United States, beyond the CDC kits, were highly-accurate and reliable laboratory developed tests (LDTs), and ACLA members were among the first to bring these tests to market. That’s why we remain focused on working with leaders in Congress to advance a modernized regulatory framework to protect access to innovative tests, including those required during a future public health emergency, and to support the next generation of diagnostic breakthroughs for patients. In addition, private-sector clinical laboratories – particularly CLIA-certified, high-complexity laboratories with the technical expertise and infrastructure to rapidly expand capacity at a national scale – are uniquely qualified to support public health laboratories and develop, validate and perform high-quality diagnostic tests that are necessary for managing a pandemic response. The current public health framework does not adequately recognize or leverage the power of the private laboratory community to respond to a pandemic, particularly in the earliest phases, and this must change moving forward. Finally, despite the pre-pandemic evidence illustrating how cost effective and critical lab services are to diagnosing and managing disease, lab services are facing another round of Medicare payment cuts again in 2022. It’s critical that Congress delay those cuts and amend the Protecting Access to Medicare Act of 2014 (PAMA) by establishing a clinical laboratory fee schedule that supports continued innovation and access. Now is the time to strengthen our laboratory infrastructure, eliminate year-over-year payment cuts and support continued access to the high-quality lab services that the nation depends on.
The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.