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ACLA Comments on MedPAC CLFS Session – September 2020
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Maintaining and Expanding Access to COVID-19 Testing: The Critical Need for Sustainable Reimbursement
Since the start of the pandemic, ACLA laboratories have focused on developing and offering a range of new tests and techniques to directly support patients in need, including the first at-home specimen collection kits, COVID-19 specimen pooling and the launch of novel RNA extraction methods. All of these innovative testing methods are designed to speed up turnaround times and maximize the use of supplies needed to run each test. At the same time, laboratories have been working around the clock to handle the unprecedented demand for PCR tests, processing more than 37 million tests to date.
We are acutely aware of the serious nature of this pandemic and the responsibility of our industry in supporting nationwide efforts to prevent and mitigate the spread of COVID-19. Yet, as the U.S. faces a staggering and growing death toll from COVID-19, we are deeply concerned some experts are pushing drastic proposals, including slashing reimbursement for labs that do not meet certain turnaround deadlines. Penalizing labs for extended turn-around times fails to acknowledge the range of factors that impact testing and would do nothing to improve the supply chain.
Proposals that penalize labs for factors outside of their control – including the global demand for testing supplies and the uncontrolled spread of the virus – would have an immediate and chilling effect on patients’ access to COVID-19 testing. These plans would also do nothing to address the fundamental supply and demand challenges that limit labs’ ability to expand and speed up testing nationwide.
Labs’ turnaround times are significantly impacted by demand, which fluctuates based on the continued spread of the virus. ACLA has long encouraged strict accordance to public health recommendations, including social distancing and mask wearing, in every community as the best way to address this problem. Further, since labs do not order tests, they are unable to control the ongoing influx of patient specimens for testing. ACLA has called for robust adherence to clear ordering guidelines for clinicians so those providing COVID-19 testing can better manage demand and prepare for potential surges in testing needs and ensure high-risk patients can access the testing they need.
In addition, the global demand for testing supplies, including reagents and pipette tips, remains a challenge. Indeed, over the past several months the supply scarcity has periodically limited labs’ ability to use the full scope of their testing capacity.
Finally, if labs are forced to absorb the full costs of tests performed, some laboratories will need to make difficult decisions about whether they can sustain their capacity, continue to develop new testing methods or perform testing at all. For example, the initial low Medicare reimbursement rate was a major barrier to entry for some laboratories in the early stages of the pandemic. Sustainable reimbursement allows labs that otherwise may be sidelined due to cost to bring COVID-19 testing online and further expand capacity. Notably, CMS’s April decision to increase reimbursement for high-throughput PCR testing helped enable a near immediate uptick in capacity.
While turnaround times have been significantly reduced, it’s important to acknowledge a test result’s value is its accurate and reliable diagnosis – information that expands our knowledge of the disease, informs our pandemic response and supports safe return-to-work efforts.
As we continue to respond to the changing testing environment, ACLA encourages every lab with the appropriate expertise to increase COVID-19 testing capacity. To do so, it’s critical that sustainable and predictable reimbursement for COVID-19 testing remain in place and that policymakers continue to prioritize federal funding to expand testing to millions of Americans.
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Collaboration and Teamwork – Key Components of Nation-wide COVID-19 Testing
Every day, clinical laboratory professionals use their depth of knowledge and expertise to perform complex diagnostic tests and empower clinicians, patients and families with the information they need to save lives build healthier communities. In the midst of this pandemic, lab professionals are more essential than ever. More than 47,000 Quest Diagnostics’ employees nationwide are hard at work developing accurate and reliable COVID-19 testing to help reach patients in all communities.
Carlene Wong and Marzena Galdzicka, Ph.D. have dedicated the past few months to combatting the COVID-19 pandemic. At Quest’s state of the art laboratory in Marlborough, Massachusetts, both Carlene and Marzena have worked around the clock to ensure that accurate, reliable testing is available to those who need it.
As the manager of the molecular department at Quest’s laboratory, Carlene Wong has been an indispensable member of the team. Her leadership and innovative approach to molecular biology has helped Quest’s lab professionals provide millions of patients with life-changing diagnostic results. With Carlene’s help, Quest has pushed the limits on PCR testing methods for COVID-19 to increase capacity and access for those who need it most.
Scientific director of molecular biology Dr. Marzena Galdzicka and her team have been focused on the quality of the tests performed, working alongside Carlene to ensure that all tests are accurate and precise. “It’s very important for me and for everyone in the lab to do the analysis of the results and to report correctly. It is very important for the physicians to get the right results and as soon as possible,” explained Marzena.
Successful coordination between lab professionals, clinicians and public health professionals ultimately allows patients to receive the best care possible. For lab professionals like Carlene and Marzena, collaboration and teamwork are essential to their everyday work.
And even after performing COVID-19 tests with their colleagues, lab professionals like Carlene and Marzena are driven to serve patients, and the individual behind each and every test order.
“We treat each patient, not as a sample sitting in front of us, but a person, a patient, a grandmother, a grandfather, because we heard those stories, and we lived those stories as well,” said Carlene.
As the country moves forward during the COVID-19 pandemic, Carlene and Marzena at Quest Diagnostics are continuing their efforts to ensure all COVID-19 patients have access to testing.
Watch below for highlights from the interviews with Marzena and Carlene.
ACLA Statement on Recent HHS Announcement Regarding Regulation of Laboratory Developed Tests
Washington, D.C. – Following the recent announcement from the U.S. Department of Health and Human Services (HHS) that the U.S. Food and Drug Administration (FDA) will not require premarket review of laboratory developed tests (LDTs) without first going through notice and comment rulemaking, ACLA President Julie Khani released the following statement:
“We agree that labs providing vital testing services during the pandemic need clarity and certainty about how those services are regulated. We appreciate that HHS recognizes the importance of flexibility to innovate for laboratories bringing quality testing services to the market. We also believe it is critical that all laboratories developing and performing testing for COVID-19—irrespective of the regulatory authorities under which they operate—have the appropriate expertise, equipment and training to develop valid tests and deliver the accurate and reliable results that patients and clinicians depend on.
As a key source of diagnostic quality and innovation, laboratory developed tests play a critical role in our healthcare system, especially during a pandemic. These tests are often developed to address unmet clinical needs and are critical tools in the fight against cancer, rare diseases, and emerging outbreaks. Indeed, in the case of COVID-19, many of the first widely available tests in the U.S. were LDTs developed by ACLA members.
Since the start of this pandemic, ACLA member laboratories have made significant investments in automation and quality checks to maintain the accuracy and reliability of test results while dedicating resources to meet the extraordinary and often unpredictable demand for testing.
To date, ACLA member laboratories collectively have performed nearly 35 million molecular tests for COVID-19 and are actively developing new tests and methods, adapting workflows, bringing on new platforms and retraining workers. We remain laser focused on continuing to innovate, scale up capacity, and perform tests with quick turnaround time for the patients and clinicians who are counting on us.”
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The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.
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A lab professional’s dedication to urgent, accurate COVID-19 testing
Suzanne Dale, who serves as the technical director of molecular biology at LabCorp, has been on the frontlines of the COVID-19 pandemic since the very start. In her role at LabCorp’s Center for Esoteric Testing in North Carolina, Suzanne has been an essential member of the COVID-19 response team – working to make sure that all COVID-19 diagnostic tests that run through her lab are performed accurately and efficiently, and then transitioning to help develop and process LabCorp’s at-home collection option for COVID-19 testing.
Like many of the passionate lab professionals responding to COVID-19, Suzanne and her colleagues have been leading an around-the-clock effort to bring new diagnostic tests online in record time, increase test capacity and offer expanded testing options to meet the needs of patients across the country.
“The clinical laboratories in the United States were able to mobilize quickly and effectively and with a depth of expertise that’s unparalleled,” Suzanne said. That expertise and experience helped inform LabCorp’s response to the growing access challenges facing patients in need of COVID-19 testing.
In May, LabCorp received the first EUA to permit nasal swab specimens to be collected at home and sent to LabCorp for testing. The launch of this at-home collection kit was an important step to increasing access to COVID-19 testing for many Americans who are home-bound or have limited access to traditional specimen collection methods.
Clinical testing and diagnoses are essential to informing treatment plans and medical decisions – during a pandemic and every day. While LabCorp is processing hundreds of thousands of tests each day, Suzanne and her team never lose sight of the individual patients relying on them for their health. “We see the [specimen] tube, but behind that tube is a patient and a doctor waiting on the result. So, we need to act with urgency and accuracy. Because a single test result could potentially change that person’s life,” Suzanne said.
In times of uncertainty, and especially during a public health crisis like COVID-19, doctors and experts rely heavily on the clinical testing results that laboratory professionals provide. “The testing that we perform is going to be used to determine if a patient may be able to go back to work or back to school or to screen for an operation,” Suzanne said.
As the country moves forward during the COVID-19 pandemic, Suzanne and her team at LabCorp are continuing to work around the clock to provide accurate and reliable testing for patients across the country. With the contributions from the staff at LabCorp, ACLA member laboratories have run more than 28 million tests to date.
Watch highlights from the interview with LabCorp’s Suzanne Dale.
With the help of clinical labs, “The Fight Is In Us” aims to boost convalescent plasma donations nationwide
ACLA member laboratories have been committed from the earliest stages of this pandemic to do everything possible to support the fight against COVID-19, performing nearly 27 million molecular tests for the virus while pioneering a wide range of innovative approaches to meet testing demand.
As part of our ongoing work to support public health partners, ACLA is proud to support efforts to significantly increase donations of convalescent plasma, which has the potential to combat the virus and help save lives.
Patients infected with COVID-19 develop antibodies – proteins developed by the immune system to help fight infections. These antibodies are found in a survivor’s blood plasma. COVID-19 Convalescent Plasma, or CCP, can then be collected from a recovered patient and then transfused into the blood of a sick patient, or used to help develop another potential treatment.
Participating ACLA member laboratories will send communications to targeted individuals encouraging them to donate their plasma and directing them to The Fight Is In Us, where they can confirm eligibility and find a donation center.
To be eligible to donate, individuals need to have had a previous COVID-19 infection as documented by a laboratory test, an antibody test, or clinical diagnosis, be fully recovered, and meet other donor criteria as specified by the collection facility.
For more information on how to donate, visit The Fight Is In Us.
ACLA Statement on Senate Republicans’ Coronavirus Relief Package
WASHINGTON, D.C. — Following the release of Senate Republicans’ coronavirus relief package, ACLA President Julie Khani issued the following statement:
“ACLA is currently reviewing the Senate Republicans’ coronavirus relief package. At a time when the country is focused on protecting millions of people who are returning to work and school, Americans need a clear federal standard on coverage for testing performed for return-to-work, return-to-school, or public health purposes. Without this guarantee, Americans will continue to face a patchwork system of coverage that undermines our shared goal of safely reopening local economies.
As noted in a letter from nearly 50 leading organizations representing patients, employers and other key stakeholders sent to congressional leaders last week, policymakers must prioritize the creation of a federal fund for this testing. Employees of meatpacking facilities and restaurants, nursing homes, as well as other essential workers, first responders, students and teachers hoping to return to school this fall are critical to our nation’s recovery. These groups need certainty that their tests will be covered.
The federal government’s stake in ensuring reliable coverage for testing is considerable, and Congress should invest the resources to support this critical need. Policymakers must immediately establish a dedicated federal fund to pay for testing not otherwise covered by insurance. As a nation, we can’t afford to have testing be left in limbo.”
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The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.
Data Reporting for COVID-19 Testing
Information and Resources for Providers
Overview
Since the start of the COVID-19 public health emergency, clinical laboratories have worked closely with the provider community and public health officials to ensure relevant patient information is included in COVID-19 test orders.
This critical data helps inform prevention, surveillance and mitigation efforts across the country, including identifying patients at higher risk for infection, hospitalization and death from COVID-19. Further, this information provides important insight to better understand the disproportionate impact of COVID-19 on older Americans, people of color and other marginalized and minoritized communities to ensure that these high-risk populations are protected.
Recent guidance released by the U.S. Department of Health and Human Services (HHS) takes an important step in setting a national standard for data elements and patient demographic information that must be collected and reported for COVID-19 testing. Clinical laboratories rely on physicians, nurse practitioners, pharmacists, physician assistants and other health care providers to include demographic information from patients on every test order. Clinical labs do not typically interact directly with patients, making their ability to collect patient information limited to the data they receive from the ordering provider.
If we are to make progress on addressing the disproportionate impact of COVID-19 on marginalized and minoritized communities, we must work collaboratively to address gaps in our data reporting system. First and foremost, providers and laboratories must be committed to adhering to their respective reporting requirements and work together to close any data gaps in the least burdensome way possible. Furthermore, it is critical that we modernize our country’s health IT systems to provide clinicians and laboratories with the tools and information they need to accurately and efficiently capture data on testing orders, not just for COVID-19, but for public health surveillance broadly.
Addressing the current patchwork reporting system across the states as well as the ongoing technical challenges will require strong federal coordination and leadership, and clinical labs are committed to supporting these important reporting efforts as part of our robust response to the COVID-19 pandemic.
Below are Frequently Asked Questions regarding COVID-19 data reporting. For additional questions, please reach out to Liz Thomas (lthomas@acla.com).
Frequently Asked Questions
- Why has HHS expanded the kinds of information that must be reported by laboratories and other entities that conduct COVID-19 testing?
HHS developed this guidance in response to the recently enacted CARES Act, which requires that “every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19” reports the results from each such test in a manner determined by HHS. Although state and local public health departments have required testing results reporting since the beginning of the COVID-19 public health emergency, the requirements for patient information and other data elements have varied across states. The recent HHS guidance creates a national standard for the data fields required so that this critical information can inform real-time clinical interventions and mitigation strategies across the U.S. - What information must be collected and reported for COVID-19 testing?
Beginning August 1, 2020, HHS will require that laboratories and other entities that conduct COVID-19 testing immediately begin reporting the following information:- Test ordered
- Use harmonized LOINC codes provided by CDC.
- Device Identifier
- Test result
- Use appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC.
- Test Result date (date format)
- Accession #/Specimen ID
- Patient age or DOB
- Patient race
- Patient ethnicity
- Patient sex
- Patient Street address
- Patient residence zip code
- Patient residence county
- Ordering provider name and NPI (as applicable)
- Ordering provider zip
- Ordering Provider phone number
- This is a critical element to assist public health authorities in follow up.
- Performing facility name and/or CLIA number, if known
- Performing facility zip code
- Specimen Source
- Use appropriate LOINC, SNOMED-CT, or SPM4 codes, or equivalently detailed alternative codes.
- Date test ordered (date format)
- Date specimen collected (date format)
- First test (Y/N/U)
- Indicates whether this is the patient’s first test for the condition of interest.
- Employed in healthcare? (Y/N/U)
- Indicates whether patient is employed in a healthcare setting, particularly those who work in a high-risk setting with patients.
- Symptomatic? (Y/N/U)
- This is defined per current CDC guidance at time of order for the reportable condition/illness.
- If yes, then Date of Symptom Onset (mm/dd/yyyy).
- Hospitalized? (Y/N/U)
- Indicates whether the patient has been hospitalized for the reportable illness/condition that this order has been placed for (suspected or diagnosed).
- ICU? (Y/N/U)
- Indicates if patient has been admitted/transferred to the ICU at any time during the encounter for the reportable illness/condition that the order has been placed for (suspected or diagnosed).
- Resident in a congregate care setting? (Y/N/U)
- This includes nursing homes, residential care for people with intellectual and developmental disabilities, psychiatric treatment facilities, group homes, board and care homes, homeless shelter, foster care or other setting at time of exposure where they normally live.
- Pregnant?
- If the patient is female, expected answers are: Patient currently pregnant or possibly pregnant (Y); Not pregnant (N); or Unknown (U).
- Test ordered
- For which kinds of tests is public health reporting required?
Federal guidance and state laws require public health reporting of patient information for all COVID-19 tests conducted at a lab or other entity with a certificate under the Clinical Laboratory Improvement Amendments (CLIA). Reporting is required for all diagnostic tests to detect infection with SARS-CoV-2 and antibody tests to detect immune response, regardless of the outcome of the test. It is critical that clinicians collect patient demographic information when ordering a COVID-19 test and include that information when the specimen and test order are sent to a lab. Laboratories are then required to report the patient data they receive from the clinician for each individual tested for COVID-19 within 24 hours of receiving results. In the case of point-of-care (POC) testing, clinicians performing POC tests are also required to report required patient data with all test results to public health departments beginning August 1. Reporting must happen on a daily basis to the appropriate state or local public health department based on where the individual resides or where the provider is located if the patient is out-of-state. - Who is obligated to participate in public health reporting for COVID-19 test results, and how should patient information be collected?
Laboratories and other entities with CLIA certificates that conduct COVID-19 testing are required to report test results and patient information to local or state public health departments. Clinicians that order COVID-19 tests are required to collect all required patient information (noted in Question 2 and listed here) when ordering the test. Clinicians must share this information with laboratories when submitting the test order, or in the case of POC testing, clinicians conducting POC tests must report results with patient information, including the expanded data elements to the local and/or state public health department directly.Federal guidance specifies that entities conducting testing should utilize one of the following methods of submission:- Submission of laboratory testing data directly to state or local public health departments, as required by state and/or local law or policy, followed by submission of de-identified data to the CDC, as the HHS designee, on a daily basis using either Health Level 7 (HL7) messaging or the CDC-provided CSV format.
- Submission of laboratory testing data to state and local public health departments through a centralized platform (such as the Association of Public Health Laboratories’ AIMS platform) where such data will then be routed to the appropriate state and local authorities and routed to CDC after removal of elements to achieve de-identification according to applicable rules and regulations.
- Submission of laboratory testing data through a state or regional Health Information Exchange (HIE) to the appropriate state or local public health department or to CDC as directed by the state.
- To which state public health departments should clinicians and labs report patient information and test results, and where can providers find more information about reporting requirements?
The reporting obligation is based on the patient’s residence or the provider location for cases when a patient is out-of-state. Clinicians and labs should contact their local and/or state departments of health directly for more information on reporting requirements and the method for reporting. - What happens if the provider who is caring for the patient being tested does not provide the required patient information – how can the laboratory secure the necessary information?
Ordering providers should make every effort to collect this critical information from patients during ordering and/or the specimen collection process. If ordering providers do not collect this information from patients, labs lose the opportunity to provide robust data to public health authorities to inform COVID-19 response efforts.
To download a sharable copy of these FAQs, click here.
Patients, Employers, Labs and Health Insurance Providers Call on Congress to Dedicate Funding for COVID-19 Testing to Get America Back to Work and School
WASHINGTON, D.C. – The National Consumers League, the American Clinical Laboratory Association (ACLA) and America’s Health Insurance Plans (AHIP) joined nearly 50 leading stakeholders representing patients, employers, clinical laboratories, health insurance providers and other leaders from across health care community yesterday in sending a letter to congressional leadership requesting dedicated federal funding for the critical testing needed to reopen the country.
“Every American, especially essential workers, clinicians and physicians on the front lines of health care, should have access to the COVID-19 tests they need,” said NCL Executive Director Sally Greenberg. “To reduce transmission of the virus, improve public health, increase surveillance capacity and help Americans return to work, school and other activities, Congress must provide robust dedicated funding for testing.”
“Testing is one of the most important tools we have to combat this crisis, both for identifying the virus and also for preventing its spread in communities across the country,” said ACLA President Julie Khani. “It’s vital that the federal government designate the resources to support expanded access to testing.”
The letter was signed by a 49 organizations from across health care community, including 1in9 L.I. Breast Cancer Organization/Hewlett House, Academy of Managed Care Pharmacy, ACLA, ADAP Advocacy Association, AdvaMedDx, AHIP, AMDA-The Society for Post-Acute and Long-Term Care Medicine, American Association for Respiratory Care, American Association of Neurological Surgeons, American Association of Nurse Practitioners, American College of Physicians, American Geriatrics Society, American Health Care Association, American Society for Microbiology, America’s Physician Groups, APS Foundation of America, Inc, Arizona Bioindustry Association, Inc. (AZBio), BioKansas, Black Women’s Health Imperative, Blue Cross Blue Shield Association, Business Group on Health, Business Roundtable, California Hepatitis C Task Force, California Life Sciences Association (CLSA), Community Access National Network (CANN), Congress of Neurological Surgeons, Cutaneous Lymphoma Foundation, Healthcare Leadership Council, ICAN, International Cancer Advocacy Network, Infectious Disease Society for America (IDSA), International Association of Hepatitis Task Forces, International Pemphigus Pemphigoid Foundation, Johns Hopkins Center for Health Security, LeadingAge, Lupus and Allied Diseases Association, Inc., March of Dimes, Michigan Biosciences Industry Association (MichBio), National Association of Area Agencies on Aging (n4a), National Association of Manufacturers, National Consumers League, National Health Council, National Hispanic Medical Association, National Retail Federation, New Jersey Rheumatology Association, Oncology Managers of Florida, the Gerontological Society of America, the Society for Healthcare Epidemiology of America, U.S. Chamber of Commerce and the Virginia Public Health Association.
Highlights of the letter are included below. To read the full letter, click here.
- “Swift action is needed to ensure that every American, especially essential workers, frontline healthcare physicians and other clinicians and those at disproportionate risk for COVID-19 have access to vital COVID-19 testing, whether for diagnostic, occupational, return-to-school, public health or virus monitoring purposes.”
- “Expanded access to COVID-19 testing for all individuals, regardless of their coverage status or purpose for receiving the test (i.e. diagnostic, public health or return-to-office), will require additional dedicated and robust federal funding. Without such funding, and with demand increasing, Americans will only see a reduction in access to testing, as well disruptions in clinician, hospital, and laboratory payments, diminished public health surveillance capacity, and higher insurance premiums – all while millions of Americans begin to seek testing in exponential numbers to facilitate return to work, school and other normal activities.
- “We share the goal of safely reopening the economy and returning to normal business, but this will require a sustained federal investment in testing facilitated by the public health and existing health care delivery system. Such a commitment will serve to support reopening and help to prevent and mitigate the spread of COVID-19. Dedicated federal funding, and clear coverage guidelines are critical for the scale and degree of testing that is needed to reopen, to reduce the risk of transmission, and to understand the progression of the disease and aid in development of better treatments and vaccines.”
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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
About the American Clinical Laboratory Association (ACLA)
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.