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ACLA President Julie Khani Outlines Key Challenges Facing Testing Capacity
WASHINGTON, D.C. – Today, ACLA President Julie Khani released the following statement:
“One month ago today, the FDA cleared the regulatory barriers preventing commercial labs from performing COVID-19 testing. Since then, ACLA member laboratories have steadily increased COVID-19 testing capacity each week. In total, ACLA members have performed approximately 650,000 COVID-19 tests to date, including 84,000 tests completed just yesterday. We currently have six ACLA members testing for COVID-19, and other members are working to bring additional tests online.
Although ACLA members are rapidly expanding testing capacity nationwide, demand for testing is also growing significantly each day. As labs continue to extend resources to expand capacity, the most immediate action we can all take is to prioritize who gets tested. ACLA greatly appreciates recent efforts by the federal government to reinforce clear guidelines to ensure that testing remains readily available for those who need it most. It is essential that doctors and hospitals order COVID-19 tests in accordance with the CDC recommendations and adhere to these guidelines when identifying samples to be prioritized.
This crisis demands the full force of the clinical laboratory industry. We’re in uncharted territory, and our ability to make headway against this pandemic hinges on the availability of testing. In order to continue to increase capacity, all laboratories must have predictable and consistent access to swabs, personal protective equipment, test kits, reagents and other supplies necessary for testing. We are also working closely with our manufacturing partners who produce the high-throughput platforms that are essential to further expand testing capacity. For laboratories processing thousands of specimens a day, having additional platforms available can help boost daily capacity, a shared goal for our industry and our public health partners.
We must remain proactive in response to these anticipated challenges. Any constriction or disruption in the supply chain could suddenly create a bottle neck, and we continue to work closely with the administration to address the obstacles we face.”
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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 Statement on CARES Act
WASHINGTON, D.C. – Following the release the Coronavirus Aid, Relief, and Economic Security Act this evening, ACLA President Julie Khani released the following statement:
“For the third time, Congress has failed to provide the necessary funds to support ‘free testing’ for all Americans. Our members remain in an untenable situation, absorbing growing, uncompensated costs for testing specimens with no assurance that they will be appropriately or fairly reimbursed for all the tests they are performing.
This emergency requires the full force of laboratories nationwide, and Americans are counting on us to deliver. As labs continue to extend tremendous resources to rapidly expand testing capacity, the most immediate action we can all take is to prioritize who gets tested. ACLA greatly appreciates efforts this week by the federal government and several states to reinforce clear guidelines and provide new guidance to ensure that testing is performed where and for whom it is most needed. It is essential that doctors order COVID-19 tests in accordance with recommendations from the CDC, HHS and local health authorities, and that hospitals adhere to guidelines when identifying the samples to be prioritized.
In a moment when labs have been asked to make unprecedented investments to meet surge capacity, we were encouraged to see the inclusion of one particular provision in this bill. Over the past several years, labs have sustained significant year-over-year cuts to Medicare reimbursement for common lab tests, which will average about 30% when fully implemented. As part of this third stimulus package, most Medicare lab rates will freeze for one year—an important step for seniors and our most vulnerable patients who rely on vital, routine tests for their health.
Our ability to make headway against this pandemic hinges on the availability of testing. If Congress fails to designate essential emergency funding for clinical laboratories to support our efforts, labs will be soon be forced to make difficult decisions about whether they can keep building the capacity our nation needs.”
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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.
With Congress on its third financial relief package, policymakers fail to recognize critical role of labs
WASHINGTON, D.C. — As policymakers close in on a third financial relief package, ACLA President Julie Khani issued the following statement:
“We are on the cusp of the U.S. Congress finalizing a third legislative financial relief package to address the coronavirus response. It is disappointing and alarming that Congress has not yet recognized the contributions of the lab industry and its response during this public health crisis. None of these packages to date contain a single provision to designate resources and support to the commercial laboratories who have stepped up to provide critical testing for health care workers, emergency responders, patients at high risk, and others in need. In a matter of weeks, ACLA laboratories went from a standing start to performing more than 50,000 COVID-19 tests a day. Collectively, these labs have completed over 234,000 tests to date, and nearly quadrupled our daily test capacity over the past week.
Laboratories perform testing first, and worry about being paid later. They are still waiting for reimbursement for tests performed. In many cases, labs are receiving specimens with incomplete or no insurance information, and are burdened with absorbing the cost. This isn’t theoretical. This is happening at drive thru sites across the country. The strain on laboratories is also coming at a time when the industry has endured year-over-year cuts to Medicare reimbursement to common lab tests.
Laboratories have not received the necessary support from the federal government as they extend significant resources to expand capacity, such as purchasing equipment, personal protective gear and testing supplies. If the urgent funding and supply challenges aren’t resolved now, America’s commercial laboratories could be forced to retrench rather than keep building the capacity that is needed. We implore Congress to recognize the critical role that labs have played on the front lines since day one, and be the partner we need as we support our nation’s response to this public health crisis.”
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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.
National Demand for COVID-19 Testing Requires Congress to Act, Approve Funding & Reimbursement for Testing Capacity
There is broad recognition among public health experts, the White House and congressional leaders that COVID-19 testing is the most critical element of our national response to this public health emergency. Our ability to assess every intervention – health or economic – depends on the availability of testing; yet, dedicated funding for testing is notably missing from current Congressional funding packages. Testing should be accessible for all who need it. But to deliver on that promise, Congress needs to take immediate action to ensure that there is sufficient funding to support the testing itself. Read ACLA’s latest statements and updates on clinical labs’ COVID-19 response at https://www.acla.com/covid-19/.
- “For God’s sake, just get us more tests.” – Dr. Rob Davidson, executive director of the Committee to Protect Medicare, March 20
- “Without readily available coronavirus tests, hospitals are ‘simply burning up [personal protective equipment] at unsustainable rates. If we had the tests and got the results quickly, we can free up PPE and hospital beds for those that really need the care.’” – Rick Pollack, American Hospital Association President, March 21
- “As primary-care physicians, we’re the canaries in the coal mine. But we’re not canaries who want to die because we don’t have the appropriate protections or appropriate testing.” – Gary LeRoy, President of the American Academy of Family Physicians, March 11
- “The three most important parts…are testing, testing, testing…We can only defeat this outbreak if we have an accurate determination of its scale and scope, so that we can pursue the precise, science-based response that is necessary.” – House Speaker Nancy Pelosi, March 13
- “…The most important thing that we need is data. We should be testing everyone who can — who comes in so that we can really understand if there clusters, are there geographic areas that we need to make priorities, are there lessons to be learned, how many people are being hospitalized of those that test positive.” – Gov. Gretchen Whitmer, March 22
- “Our highest priority is keeping Marylanders safe, and having the capability to test quickly for potential COVID-19 cases is an important part of that.” – Gov. Larry Hogan, March 3
- “…Let’s increase as quickly as possible our testing capacity so we can identify the positive people.” – Gov. Andrew Cuomo, March 7
- “The pace of testing has to increase in Louisiana and this order will allow more laboratories in Louisiana to process COVID-19 tests, which is critical as our state fights the spread of this illness.” – Gov. John Bel Edwards, March 19
- “Hopefully we will get these tests going very soon, because ideally, everyone should have access to a test if they need it and want it. But unfortunately, that’s not what we have now… But the most important thing is we need to know who currently has the disease because we need to know who is actively infectious and therefore able to transmit the disease to others.” – Dr. Leana Wen, emergency physician and public health professor at George Washington University, March 18
- “Until we get test results, we’re working in the blind.” – Dr. Michael Baden, forensic pathologist and FOX News contributor, March 13
- “Testing is crucially important to find when the virus is spreading, control outbreaks in health facilities, care for people with pneumonia, and understand the virus better.” – Dr. Thomas Frieden, former head of the CDC, March 15
- “We must make sure we are testing more people so we can start to respond to this epidemic with our eyes open.” – Caroline Buckee, Harvard T.H. Chan School of Public Health, March 11
- “The testing capacity remains extraordinarily limited compared to where we should be. And in many ways we are absolutely flying blind at the moment.” – Dr. Michael Mina, Harvard T.H. Chan School of Public Health, March 18
- “Get the capacity, and test, test, test…If you don’t know you’ve got a fire, you can’t put it out.” – Dr. Margaret Harris, member of the WHO Coronavirus response team, March 18
- “Access to testing is the No. 1 issue right now. People who need and want to be tested are being turned away. In the nation with the best and most developed health care system in the world, that is absolutely ridiculous.” – Sen. Rick Scott, March 13
- “Frankly, having testing would have given us a much better view as to how many people have the virus and what kind of social distancing actions we should be taking to prevent the spread of the virus.” – Sen. Mitt Romney, March 12
- “Members of our delegation have come forward to say this is not acceptable for Minnesota not to have the capacity to process our tests in large numbers right now. Let’s get the testing capacity to the point where we know what the numbers are, when we know community spread is occurring, so our state can have the ability to act as quickly as possible.” – Rep. Angie Craig, March 16
- “…As legislators, we need to ensure that this bipartisan bill provides the support for testing. That is the number one priority to make sure that we are able to do this in a timely way.” – Rep. Elise Stefanik, March 12
- “We’re the boots on the ground. We know what’s available. Some of the commercial labs do not have the materials they need…We’re getting reagents wherever we can get them. The bottom line is our lab has been using several different testing methodologies in an attempt to maximize the testing we can do, and if the supplies for that are running out, we move to the next methodology…” – Kris Ehressman, infectious disease division director for the Minnesota Health Department, March 20
- “Key to using screening as a tool to blunt epidemic spread is the delivery systems, and supplies, to allow widespread testing.” – Dr. Scott Gottlieb, former FDA commissioner, March 16
ACLA Statement on Senate COVID-19 Response Effort
WASHINGTON, D.C — Following the release of the latest Senate legislation in response to the COVID-19 pandemic, ACLA President Julie Khani released the following statement:
“We are alarmed by the latest Senate proposal – it fails to clearly designate essential emergency funding for expanded testing capacity and laboratory operations. If this legislation moves forward, it would set up commercial laboratories to perform COVID-19 testing at a loss, putting at risk the private sector efforts that the country is relying on for national testing.
Free testing is an empty promise if labs do not have the resources to process specimens. Without immediate certainty on testing reimbursement and funding for supplies, clinical labs will face growing capacity challenges that could lead to disruptions in test processing time and availability. Without testing, doctors cannot adequately treat patients. Without testing, health care workers will not know if they are contagious or if they can continue to serve on the frontlines. Without testing, individuals will not know if they are sick and should quarantine. Without testing, our economy will struggle to recover.
This strain on laboratories is coming at a time the industry has endured year-over-year cuts for testing from the federal government. Now more than ever, it’s time for Congress and the administration to make the necessary investments to meet demand. We have urged Congress to immediately set aside funding to support our efforts, to provide clear guidelines on fair reimbursement, and to delay scheduled cuts to reimbursement for laboratory services that continue to undermine our members’ ability to respond to this national crisis. Absent these changes, this legislation will jeopardize the progress clinical labs have made to stop the spread of COVID-19 across the country.”
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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.
Without sustainable funding, there is simply no way to have sustainable testing
WASHINGTON, D.C. – Following today’s White House briefing, ACLA President Julie Khani released the following statement:
“As the White House pointed out today, commercial labs are rapidly ramping up testing capacity. Since the FDA first provided an accelerated path for commercial labs to respond to the COVID-19 outbreak, ACLA laboratories have collectively reported out approximately 129,000 tests to date, including 41,000 tests performed just yesterday.
The current stimulus bill being considered by Congress does not provide the adequate support to keep up this pace. What the bill does include is billions of dollars in aid for affected industries—restaurants, airlines, and manufacturers who have started to shut their doors. But for those industries to make a comeback, it will require the availability of reliable, accurate and accessible testing. As Congress considers additional provisions to this bill, it would be a grave mistake to overlook the fundamental resources needed to continue and expand testing.
We will not be able to make necessary investments to meet future demand without more support from the U.S. Government. We have asked Congress to set aside five billion dollars to support the continued availability of these lab tests – now and into the future. Like other providers, labs need to know that resources will be available to support our expanded efforts. Our laboratories are the front line of the fight against this pandemic. But without sustainable funding, there is simply no way to have sustainable testing. While we wait for Congress to act, it’s essential that we prioritize testing so those most in need or at high-risk for COVID-19 are able to access tests as quickly as possible.”
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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 Statement on Stimulus Bill
WASHINGTON, D.C. — ACLA President Julie Khani today issued the following statement regarding the current stimulus bill under consideration in the Senate:
“ACLA members have collectively reported out approximately 88,000 COVID-19 tests to date, including 25,000 tests performed just yesterday. As we continue to scale up capacity, the current stimulus bill under consideration in the Senate would not provide the sufficient backing for our members to continue this robust effort. We will not be able to make necessary investments to meet future demand without more support from the U.S. Government.
As it stands now, the current stimulus package has tens of billions of dollars in aid for affected industries—restaurants, airlines, and manufacturers who have started to shut their doors. The availability of reliable, accurate and accessible testing is a requirement for those industries to make a comeback. As Congress considers additional provisions to this bill, it would be dangerous to overlook this fact.
Without swift action by Congress, our laboratories are being set up to perform COVID-19 testing at a loss. While we support the patient coverage provisions already enacted, laboratories are unable to absorb the costs that will be pushed onto us. We currently have no protection if payers seek to compensate us below cost or require laboratories to cover a patient’s copay. We have already seen some state Medicaid programs establish reimbursement at a fraction of our costs.
This national emergency demands the full force of the clinical laboratory industry and the rest of the health care community. Congress must act now to include our $5 billion emergency fund in the stimulus package to help cover the cost of uncompensated COVID-19 testing, support continued surge capacity, and ensure government buyback for necessary equipment and supplies, such as high-capacity platforms that are being used to significantly expand testing throughput.
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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 Comments Federal Health IT Strategic Plan
Facing Unprecedented Demand for Testing, Clinical Labs Ask Congress for Surge Capacity Fund
WASHINGTON, D.C. — As commercial laboratories rapidly extend considerable resources to meet demand for COVID-19 testing, ACLA President Julie Khani sent a letter to congressional leadership seeking support from the federal government.
“We are growing increasingly concerned that the federal government is not recognizing the strain on the laboratory industry to meet the demand for testing for COVID-19,” writes Khani.
As policymakers consider measures to support the public health response to COVID-19, ACLA has asked Congress to support an emergency laboratory surge capacity fund of $5 billion. These funds would help ensure that the clinical laboratory industry has the equipment, supplies, labor and resources necessary to sustain robust testing capacity for millions of Americans.
“Free testing for COVID-19 has now been promised to the American people,” said Khani. “The laboratory industry wholeheartedly supports no-cost testing but is in critical need of additional support from Congress to ensure we have the necessary staffing, supplies and equipment to fulfill that vital promise.”
Highlights from the letter are included below:
- Since the FDA’s February 29 guidance provided an accelerated path for commercial laboratories to perform COVID-19 testing, labs within ACLA’s membership have performed approximately 43,000 tests for COVID-19. Notably, these tests have been performed absent assurances about the payment for these necessary services.
- We are growing increasingly concerned that the federal government is not recognizing the strain on the laboratory industry to meet the demand for testing for COVID-19. Free testing for COVID-19 has now been promised to the American people. Laboratories should not bear the cost of “free” testing. Clinical laboratories need additional support from Congress to ensure we have the necessary staffing, supplies and equipment to fulfill that vital promise.
- In the coming weeks and months, maintaining the full force of a robust lab industry will be necessary to enable other industries (e.g. airlines, cruise lines, hospitality) to recover from this crisis. As our industry extends considerable resources to meet demand, we seek support from the federal government so that we can continue our vital work for many months to come.
To view the full letter, 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.
