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With Congress on its third financial relief package, policymakers fail to recognize critical role of labs

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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

ACLA Blog

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/.

 

  • “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

 

 

  • “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

 

 

 

 

 

 

 

  • “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

 

 

 

ACLA Statement on Senate COVID-19 Response Effort

Public Health Preparedness and Infrastructure, ACLA News, All News, Featured News, ACLA Press Releases

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

Public Health Preparedness and Infrastructure, ACLA Press Releases

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

ACLA Press Releases

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.

Facing Unprecedented Demand for Testing, Clinical Labs Ask Congress for Surge Capacity Fund

Public Health Preparedness and Infrastructure, ACLA News, All News, ACLA Press Releases

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.

Statement on Recent FDA Actions To Expand COVID-19 Testing

Public Health Preparedness and Infrastructure, ACLA News, All News, Featured News, ACLA Press Releases

WASHINGTON, D.C. – Following the FDA’s actions announced on March 16, ACLA President Julie Khani released the following statement:

“The FDA’s guidance released on Saturday, February 29th cleared the regulatory hurdles to allow commercial labs to immediately begin testing patients as soon as test validation was complete, and our members began accepting specimens for testing less than a week later.

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. In addition, the recent FDA approval of large automated platforms for testing is expected to dramatically increase testing capacity. Assuming there are no delays or shortages of necessary materials and supplies, commercial capacity is expected to exceed 280,000 tests per week by April 1.

ACLA is reviewing the FDA’s actions announced last night. While New York State Dept of Health has a long-established and experienced oversight program for Lab Developed Tests (LDTs), this is not the case for every state. To maintain specimen integrity and deliver the clear and reliable results that patients and clinicians depend on, it is essential that all laboratories conducting testing for COVID-19, regardless of location or state, have the appropriate expertise, equipment and training to do so.”

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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.