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ACLA Responds to New Tri-Agency Guidance, Calls on Federal Government to Address Newly-Created Coverage Gaps
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.
ACLA Letter to CDC on Antibody Guidance
Amid Growing Demand For Testing, Lawmakers Call On HHS To Designate Resources For Clinical Laboratories
In a bipartisan letter to Secretary Azar, 30 lawmakers urge HHS to designate funds to help clinical laboratories expand capacity
WASHINGTON, D.C. – As clinical laboratories continue to work around the clock to expand access to high-quality testing across the country, a bipartisan group of lawmakers today urged Health and Human Services Secretary Alex Azar to direct funds from the Public Health and Social Services Emergency Fund (PHSSEF) to support the expanded efforts of clinical laboratories.
“Funding for lab capacity through the PHSSEF can help ensure that these labs have the supplies, equipment, workforce, and other resources necessary to continue expanding COVID testing in our districts and throughout the U.S.,” the lawmakers wrote.
Today’s action follows a letter sent by ACLA on April 29, which requested designated funding be made available for clinical laboratories performing COVID-19 testing.
To date, ACLA members have performed more than 10 million molecular PCR tests for COVID-19 and are investing in new platforms, driving forward innovative solutions to meet the evolving needs of workers, patients and their families, and developing new technology to expand access.
“As the demand for testing continues to grow, clinical laboratories need dedicated funding to plan for challenges that lie ahead,” said ACLA President Julie Khani. “Strong federal coordination and leadership is essential, and we’re looking forward to working with HHS to ensure that laboratories have the resources necessary to continue to expand our role at the forefront of the nation’s response.”
Highlights from the letter are included below:
- “Laboratories have invested significant resources in equipment, supplies, and staffing to meet the very specific needs of COVID-19 testing demands, while simultaneously facing steep revenue declines for their usual work due to the public health emergency.”
- “There have been no federal funds specifically designated for the laboratories that have stepped up in this public health crisis and have made significant investments to expand access to COVID-19 testing despite 40-60 percent reductions in regular commercial volume due to the economic lockdowns.”
- “As laboratories work to maintain their investments in critical resources for testing platforms, reagents, swabs, and PPE, as well as hiring, training, and overtime pay for the laboratory workforce, we urge HHS to direct a portion of funding that has not already been allocated towards these efforts.”
To view the full letter, click here. To view ACLA’s letter from April 29, 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.
ACLA Statement on New Data Reporting Guidance
WASHINGTON, D.C. – As ACLA reviews the new data reporting guidance released today by the Department of Health and Human Services (HHS), ACLA President Julie Khani released the following statement:
“Information is power. This simple truth drives our mission and purpose as clinical laboratories, and it’s why, since the start of this public health emergency, ACLA members have made every effort to report the information that is provided by the ordering clinician with each test order as quickly as possible, while navigating multiple, overlapping data requests at different levels of government.
ACLA recognizes how vital having this data is, particularly to help address the persistent health disparities across the communities we serve. Public health officials need clear, reliable data points to address the effects of this devastating virus effectively and protect our most vulnerable communities, and we are hopeful that the actions announced today with give clarity to providers about what information needs to be collected at the point of care.
Over the last several months, ACLA members have faced obstacles tracking down missing information not reported by the provider when a specimen is collected. That’s why we’ve been engaged with providers, the CDC, public health agencies and others since the beginning of this public health emergency to ensure we are working collaboratively to address these problems. Clinical laboratories do not typically interact directly with the patient, and they are not always able to collect information that is missing from a test order.
Fixing the current patchwork reporting system will require strong federal coordination and leadership. ACLA is committed to helping HHS gather as much data as possible to respond to the COVID-19 pandemic effectively.”
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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.
COVID-19 Frequently Asked Questions
Last Updated August 17, 2020
1. What is molecular PCR testing and when is it used?
Molecular testing is the gold standard of diagnostic testing for COVID-19. This highly accurate testing method uses “PCR” (polymerase chain reaction) to detect the presence of a virus. For COVID-19 testing, this method typically uses upper and lower respiratory specimens.
Molecular testing was the first kind of testing for COVID-19 available in the United States. A dozen ACLA member laboratories currently perform molecular testing for COVID-19. Since February 29, when FDA guidance first allowed high-complexity laboratories, including academic, hospital and commercial labs, to step forward with novel tests for COVID-19, ACLA members have performed millions of these diagnostic tests. For the latest number of tests performed, including daily totals, click here.
2. What is antibody testing and when is it used?
Serologic testing, also referred to as antibody testing, is used to analyze blood specimens for the presence of proteins, called antibodies, made in response to an infection. The presence of specific antibodies indicates that an individual has been infected by that specific pathogen. When used appropriately, high-quality serologic testing may help determine the number of individuals who have been infected with SARS-CoV-2 and inform public health strategies.
Serologic testing should not be used as a primary method of diagnosing COVID-19 in an acutely ill patient. However, accurate and reliable serologic testing is a valuable tool in a comprehensive response to the COVID-19 pandemic. Several ACLA member laboratories are currently performing serologic testing and continue to scale up capacity nationwide. To read more about ACLA’s position on the role of serologic testing, view our recent white paper on the subject.
3. If someone has been exposed to COVID-19 and believe they may be immune, will the antibody test reliably confirm this?
The presence of antibodies in a patient’s blood demonstrates an immune response to infection – no one is debating that point. What we don’t know yet is the level or the duration of immunity against reinfection that these antibodies provide. The science and research continues to progress each day, and clinical laboratories are working closely with researchers and public health experts to piece together the complete picture of this evolving virus.
The value of antibody tests for COVID-19 is significant. High-quality serologic testing can help determine the number of individuals who have been infected with SARS-CoV-2 and inform broader public health strategies.
Antibody testing also has a vital role in supporting ongoing development of vital COVID-19 treatments and vaccines, and preliminary reports indicate that convalescent plasma transfusions from patients who have tested positive for these antibodies are providing relief to some of the sickest patients.
4. What is antigen testing and when is it used?
Patients may be most familiar with antigen testing as an initial diagnostic tool used at a hospital or doctor’s office to deliver rapid results for flu or strep throat. This test typically is performed at the point-of-care.
Antigen testing for COVID-19 can be used to quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity. While antigen tests deliver rapid results, these tests are not as sensitive as molecular PCR tests, and as a result, the FDA has cautioned that “negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.”
5. What does point-of-care testing mean?
Rapid or point-of-care testing refers to testing that is done at or near where patients receive care, such as physician offices and ambulatory care centers. Point-of-care testing plays a vital role in our nation’s response to the pandemic, but this type of testing does have limitations. In general, point-of-care testing is less accurate than molecular PCR testing performed in laboratories. Another difference between point-of-care platforms and instruments that ACLA members typically use is volume; laboratory-based testing utilizes high-throughput platforms that process several thousand specimens a day.
6. What kinds of tests are available in a provider’s office or testing site? Are there at-home specimen collection options available?
Molecular PCR tests are both the most accurate and the most widely available diagnostic tests for COVID-19 in the United States. In physician offices, hospital settings and drive through sites, patient specimens are collected and sent to a laboratory where highly accurate results are typically reported within a few days. Rapid point-of-care tests also can be available in many of these settings. In addition, the FDA has authorized several at-home specimen collection kits for laboratory-based molecular tests. This method allows patients to collect their own nasal specimens, which then are sent to a laboratory for testing. At-home specimen collection is not currently available in all states due to local restrictions.
Currently, the FDA has not approved at-home specimen collection for serologic (antibody) testing or for antigen testing. Antibody testing, which requires a blood sample, is offered through many patient service centers, physician offices and other health care settings. The first antigen test was recently approved by the FDA. In addition, ACLA members are also working on innovative approaches to assist employers with return to work strategies, including on site specimen collection support.
7. Why does testing access vary by state?
Guidelines communicated to clinicians about who should be tested vary state to state. ACLA members are working closely with governors to deliver accurate, highly scalable testing through our 24/7 national network. ACLA members do not reserve testing capacity by state or region, but direct available capacity based on need so we can remain flexible to respond to outbreaks and hotspots.
8. Do Medicare and Medicaid cover COVID-19 testing?
Yes. Medicare Part B covers molecular and serologic COVID-19 tests with no cost sharing for beneficiaries. Medicaid programs are required to cover COVID-19 testing for beneficiaries, though some state programs have taken concerning actions to restrict coverage for certain tests.
9. How are patients prioritized for testing?
Guidelines communicated to clinicians about who should be tested is determined at the state-level and therefore varies state-to-state. The CDC recommends that clinicians use their judgment to determine whether a patient should be tested for COVID-19. The agency has also released guidelines to help inform these decisions and prioritize testing for patients who need it most.
10. What are labs doing to minimize disruption to non-COVID testing?
ACLA members are committed to providing patients with the essential tools they rely on to identify, manage and treat a range of health conditions. Laboratories are making adjustments to maintain predictable access to laboratory services for patients, and many ACLA member laboratories with patient service centers are designating special hours for routine testing for high-risk populations, such as seniors and those living with chronic health conditions.
11. What is test pooling and how does it work?
Pooled testing allows a laboratory to combine samples from multiple patients together and test them as a pool rather than individually to detect the SARS-CoV-2 virus. If the result of the pooled test is negative, all individual samples in the pool are reported as negative. If the result of the pooled test is positive, one or more samples in the pool may be positive. A laboratory then seeks to identify which specimen(s) contains the virus.
Pooling allows for more specimens to be tested at once, maximizing capacity and reducing the use of some supplies (e.g., reagents) that are in short supply. Pooled molecular diagnostic COVID-19 testing can be used efficiently in areas and populations of low prevalence where most results are expected to be negative. However, pooling is not an appropriate methodology to use in communities or populations with high rates of infection. If a high number of specimens are positive, a lab has to run more tests to determine which sample(s) contain the virus, consuming more reagents and other supplies that are already scarce.
Additionally, pooled testing requires changes in laboratory workflow and extra steps, many of them manual steps that disrupt standard operations for non-pooled testing. In pooling, extraction of the specimens to be tested involves the creation of a separate pooled assay from a number of different patient samples. The samples selected for pooling must be retained for further analysis, if needed. Moreover, because pooling can be used only in populations with low disease prevalence, a lab must sort specimens by site of collection or zip code to determine if pooling is feasible. Creating the pools and retesting individual samples if a pooled test is positive and the individual positive sample(s) cannot otherwise be identified requires added manual labor.
12. Is pooled molecular COVID-19 testing billed in the same way as individual testing?
Yes. Since the same molecular COVID-19 testing is ordered, performed and reported, pooled testing is billed in the same way using the same codes as non-pooled testing. While pooling can consume fewer reagents, it is not always the case that fewer tests will be performed with pooling. The efficiencies that arise from pooling are dependent upon identifying low prevalence populations and are offset by increased labor outlined above (e.g., changes in workflow and extra steps including specimen extraction and retention for further analysis; sorting specimens by site of origin to determine low prevalence and whether pooling is feasible; and retesting, as applicable where the pool is positive). Pooled testing is recognized as a means to significantly expand COVID-19 testing capacity and throughput and should be reimbursed no differently than the same tests performed individually.
13. What is multiplex testing and how is it used?
Multiplex testing helps providers detect multiple respiratory viral pathogens (e.g. SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus [RSV]) at the same time, using one specimen sample and the same instrument. Leading public health experts have noted the significance and importance of broad access to multiplex testing as a critical part of the country’s response to the upcoming flu season and the ongoing health challenges from the COVID-19 pandemic. Following the FDA’s authorization of the CDC’s Flu SC2 Multiplex Assay in July, several ACLA member laboratories have pioneered new multiplex tests to support our nation’s public health goals.
The distinction between SARS-CoV-2, influenza A, influenza B and RSV can be significant as they do not share the same treatment or public health implications. COVID-19, influenza and RSV are spread through respiratory droplets and can cause similar symptoms, including fever, cough and loss of smell. According to the Centers for Disease Control (CDC), patients may also experience concurrent respiratory infections, making our ability to identify these viruses in a single patient sample even more important.
Multiplex testing also helps laboratories conserve important testing supplies, such as pipettes, swabs and reagents, all of which remain in high demand. Moreover, multiplex testing decreases the need for single-use tests and allows labs to provide more comprehensive results in a given time period.
ACLA Statement on Medicare Reimbursement Rate For Serologic Testing
WASHINGTON, D.C. – Following the release by the Centers for Medicare and Medicaid Services (CMS) of a reimbursement rate of $42.13 for the most commonly-performed COVID-19 serologic tests, ACLA President Julie Khani released the following statement:
“We applaud CMS’ release of a Medicare reimbursement rate that will encourage a broad cross section of laboratories to rapidly scale up capacity for accurate and reliable serologic testing for SARS-CoV-2.
Serologic testing is one of many valuable tools used to inform broader prevention, containment and mitigation strategies in our fight against COVID-19. To meet unprecedented demand, we must encourage every laboratory, including commercial, public, academic and hospital labs with the necessary expertise, to expand testing capacity. Today’s decision is an important step forward to achieve that goal.
This announcement also reflects one of the important lessons learned from the roll out of COVID-19 molecular tests. We know that the lack of sufficient reimbursement for tests performed was a barrier to entry for many laboratories, and we have seen the positive outcomes from increasing the Medicare reimbursement rate for the molecular test. Laboratories across the country are bringing on additional testing platforms and increasing testing for high-risk populations, such as nursing home residents.
To help give public health officials the data points they need to contain this virus, the federal government must dedicate financial resources to ensure that accurate and reliable COVID-19 testing is widely available when and where it is needed. As congressional leaders consider additional legislative packages to address this unprecedented public health crisis, robust federal funding is still needed to ensure that all patients – regardless of insurance status – have access to accurate and reliable serologic and molecular tests.”
To read ACLA’s recent white paper, Supporting a Comprehensive, Nationwide Response to COVID-19: The Role of Serologic Testing, 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.
ACLA Statement on HEROES Act
WASHINGTON, D.C. — Following the introduction of the ‘‘Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act” ACLA President Julie Khani issued the following statement:
“ACLA is currently reviewing the HEROES Act. As noted in our letter to Secretary Azar last month, direct federal funding for laboratories performing COVID-19 testing is critical to achieve our nation’s testing goals. As labs across the country plan for the large capital expenses that will be necessary to meet the needs of communities in the weeks and months ahead, we need clarity from policymakers about how resources designated for testing will be allocated.
Today, leaders from both the House of Representatives and the Senate once again signaled a shared commitment to expand access to high-quality testing. Meeting this need will require consistent access to supplies, adequate and predictable funding for laboratories performing the testing, and clear guidance to clinicians about who should be tested. These core needs were outlined during our first meeting with the White House Coronavirus Task Force on March 4, just days after FDA guidance allowed our members to begin testing. Today, ACLA members have performed nearly five million tests for COVID-19, and these needs remain unchanged.”
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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 Expanding Access to Testing
WASHINGTON, D.C. — Following the Trump Administration’s announcements today on expanding access to testing, ACLA President Julie Khani released the following statement:
“After scaling up to meet an unprecedented demand for testing, ACLA members have performed nearly five million tests for COVID-19. By expanding the availability of specimen collection materials, such as swabs and transport media, the actions announced by the White House today will help states take full advantage of the capacity available through the robust national network of ACLA member laboratories.
We are also encouraged by the administration’s actions to dedicate additional resources to the states and expand access in underserved communities. However, as noted in our letter to Secretary Azar last month, direct federal funding for laboratories performing COVID-19 testing is critical to meet the continued demand for testing.
Across the country, laboratories have made significant investments to expand capacity, including purchasing new platforms, retraining staff, and managing the skyrocketing cost of supplies. To continue to make these investments and expand patient access to high-quality testing in every community, laboratories will need designated resources. Without sustainable funding, we cannot achieve sustainable testing.”
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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 Support Necessary For Laboratories
WASHINGTON, D.C. — Following ongoing developments related to COVID-19 testing and response, ACLA President Julie Khani issued the following statement:
“Labs are not scaling back. We’re ramping up. ACLA members are investing in additional high-throughput testing platforms, retraining staff, and working to anticipate the supply challenges we’ll face down the road.
During ACLA’s first meeting with the White House Coronavirus Task Force on March 4, we discussed what was needed to help labs rapidly scale up capacity and accelerate access to high-quality testing for patients across the country. Those three areas included ready access to supplies, adequate funding for labs performing the tests, and clear guidance to providers about who should be tested. ACLA members have now performed more than four million tests for COVID-19, and while the landscape of testing has changed, these three core needs remain unchanged.
The White House Coronavirus Task Force isn’t the only tool we have to address these challenges, but as we look to the levels of testing that will be needed in the weeks and months ahead, strong, clear, and nimble federal leadership is not optional.”
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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.