WASHINGTON, D.C. – As ACLA member laboratories continue to navigate unprecedented demand and significant supply challenges, ACLA President Julie Khani issued the following statement:

“In light of the ongoing spread of COVID-19 in states across the country, many labs are now receiving more test orders than they are able to process in a single day. We have urged ordering providers to prioritize testing for those most in need, especially hospitalized and symptomatic patients. That will help better manage demand for testing while labs continue to perform COVID-19 testing and increase their capacity, which will require adequate supplies and additional equipment.

Since the federal government first cleared regulatory hurdles to expand testing on February 29, ACLA member laboratories have performed over 20 million molecular tests for COVID-19.  We have made significant strides in expanding capacity, which has tripled since early April, and ACLA labs are now performing more than 300,000 tests each day. Our members have been committed from the earliest stages of this pandemic to do everything possible to increase access to testing and have pioneered a wide range of innovative approaches to meet testing demand. From developing and bringing to market new tests to diagnose this evolving virus, to engaging physicians and public health partners around the importance of ordering guidelines and data that must be collected at the point of care, to closely monitoring supplies with diagnostic manufacturers and the federal government, ACLA members have responded with actionable solutions to facilitate patient access to testing.

But we can’t do it alone.  Laboratories, diagnostic manufacturers, ordering providers, public health officials, states and importantly, the federal government – including Congress and the Administration – all have a role to play in addressing the challenges hampering our nation’s response to this public health crisis.

In collaboration with the broader diagnostics community, we are exploring new technologies and testing strategies to maximize capacity for COVID-19 molecular testing, including targeting the use of antibody testing, expanding antigen and other point-of-care testing, and implementing specimen pooling in low-prevalence areas and populations.  ACLA laboratories will continue to bring forward novel approaches to expand testing capacity and work closely with regulatory agencies to maximize their use.

Accurate and reliable testing is one of the most important tools we have to combat this crisis, but what we do with the information yielded by these tests is just as important. Testing is a critical component of a comprehensive and coordinated public health strategy within each community, which also must include other elements such as adherence to mask protocols and social distancing recommendations.

As we work to mitigate the spread of the virus and meet the range of needs facing the country, including the reopening of schools and workplaces, now is the time for the federal government to outline a clear action plan to guide us through this pandemic.  ACLA members will continue to do our part in expanding COVID-19 testing capacity to support the public health needs our nation faces now and in the future.”

WASHINGTON, D.C. – Following additional guidance released today from the Department of Labor, the Department of Treasury, and the Department of Health and Human Services regarding the coverage and payment requirements for testing in the Families First Coronavirus Response Act and the CARES Act, ACLA President Julie Khani released the following statement:

“As leading government officials outlined in congressional testimony today, testing is a critical component of our nation’s response to the COVID-19 pandemic. In addition to helping inform care for an individual patient, information derived from broadly available testing allows us to understand and triage the spread of the disease, and help Americans return to work and school safely.

However, the tri-agency guidance released today creates widespread gaps in coverage for COVID-19 testing and ends the clear coverage mandates passed by Congress that required comprehensive health plans to cover molecular and serologic COVID-19 testing without cost sharing or prior authorization.

Today’s reversal creates gaps in coverage that, if left unfilled, pose a direct threat to the public health and undermine state and national efforts to reopen the economy. For employees of nursing homes, meatpacking facilities, restaurants and others who rely on regular testing to keep their families and workplaces safe, for schools hoping to welcome students back to school in the fall, and for communities anxious to limit asymptomatic spread of the virus, coverage for COVID-19 testing is now in doubt.

While there is widespread agreement that this testing is necessary, the issue of how these tests will be paid for remains unclear. Laboratories cannot – and should not be expected to – absorb the costs for return to work and surveillance testing.

We call on Congress to immediately designate funding to close the gaps created by the tri-agency guidance, ensuring access to testing and fair reimbursement for laboratories for tests performed. We must give public health officials the data points and tools they need to contain this devastating virus.”

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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.