Last Updated April 2, 2020
ACLA and our members are committed to working with Congress, the Trump Administration and public health partners across the country to ensure that Americans receive the testing they need.
ACLA members, including ARUP, BioReference Laboratories, LabCorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare have developed and validated novel COVID-19 tests and continue to scale up testing capacity.
On Saturday, February 29, the FDA issued new guidance that provided an accelerated path for high-complexity laboratories (including commercial laboratories) to support additional testing capacity in response to the COVID-19 outbreak. Prior to this announcement, ACLA members were already working to develop novel tests for COVID-19.
ACLA members that have had their tests validated, including Quest Diagnostics, LabCorp, ARUP, BioReference Laboratories, Mayo Clinic Laboratories and Sonic Healthcareare now in the process of scaling up capacity and providing ongoing support to physicians and other healthcare providers, and to state and local health authorities across the country.
ACLA has consistently advocated for clear guidelines around screening that ensure high-risk patients are quickly identified and tested as soon as possible. While we support expanded access to testing services, we must ensure that those patients who are particularly at high-risk for COVID-19 are prioritized for testing and that we are able to ensure accurate, reliable results as additional tests begin to go “live” in the coming weeks.
Testing guidelines and recommendations must also account for repeat or secondary testing in cases where public health officials may require a second validating test for quarantine status.
Since commercial tests first went live during the first week of March, we’ve been working closely with the CDC and other federal agencies to help anticipate any potential supply shortages laboratories may face down the line.
The FDA has recently taken several positive steps to make additional platforms and instruments available to provide accelerated access to diagnostic tests for patients. For example, the March 13 updated guidance expanding eligible swabs was an important step forward, as it allowed commercial laboratories to work with additional suppliers to access necessary specimen collection tools.
We continue to closely monitor the status of certain supplies necessary for commercial labs to expand testing capacity. Any one link in the chain of supply and demand could suddenly cause a bottleneck. We need the continued commitment from HHS and the administration to work with us to maintain the necessary volume of those supplies, so that we can remain proactive in the face of these expected challenges.
Given the ongoing risk of exposure for technicians handling specimens, clinical labs must have a stable supply of protective medical equipment and clothing (including gloves, marks, etc.) for handling infectious disease specimens. There also must be clear processes for providers on how to prepare specimens for shipping and transport.
Laboratory staff are rising to the challenges of the growing demand for increased testing capacity, and it’s essential that we do everything possible to prioritize their health and safety, including the support to procure necessary resources and supplies to safely and properly run patient tests.
ACLA is committed to supporting our public health partners and rapid response efforts. We’re working closely with our members—and in close coordination with state and local public health labs, hospitals, the CDC and the FDA—to increase overall national capacity. On March 4, 2020, ACLA and several of our members met with Vice President Pence and members of the White House’s Coronavirus Task Force.
Commercial laboratories have been in close communication with public health agencies since mid-January as part of our existing memorandum of understanding (MOU) with the CDC, the Association of Public Health Laboratories, and the Council of State and Territorial Epidemiologists. The CDC has been actively utilizing ACLA and the MOU to keep ACLA member laboratories with infectious disease expertise informed on the progression of the current outbreak, the government response, and how our member laboratories can best be prepared to support those efforts.
In any outbreak, Centers for Disease Control and Prevention (CDC) laboratories, supported by state public health laboratories, have primary responsibility for providing guidance to healthcare providers, including criteria for diagnosing patients and determining when diagnostic testing would be appropriate. In recent public health emergencies, including the SARS and Zika outbreaks, commercial laboratories have supported public response and expanded test capacity.
While there is agreement that consumers won’t have to pay for tests, what is less clear is who will pay. That’s an important detail. Without sustainable funding, there is simply no way to have sustainable testing. When a laboratory receives a specimen for a test ordered by a physician, we run the test, regardless of whether insurance information has been collected. The hard truth? This means laboratories are being set up to perform COVID-19 testing at a loss. We currently have no protection if payers seek to compensate us below cost or require laboratories to cover a patient’s copay, and we have already seen some state Medicaid programs establish reimbursement at a fraction of our costs.
This strain on laboratories is coming at a time the industry has endured year-over-year cuts to Medicare reimbursement to common lab tests. We will not be able to make necessary investments to meet future demand without more support from the U.S. Government. Labs need additional resources. We need equipment, supplies and personnel. We have asked Congress to support the continued availability of these lab tests – now and into the future.
For the most up-to-date information on COVID-19, including proper preventative measures, please visit the Centers for Disease Control and Prevention.
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.