All posts by aclasuperadmin
ACLA Statement on CMS Policy: Cutting lab reimbursement won’t address the root causes of delayed turnaround times
Washington, D.C. – Following today’s announcement by Centers for Medicare & Medicaid Services (CMS) on Medicare reimbursement rates for COVID-19 testing, ACLA President Julie Khani issued the following statement:
“We are currently reviewing how this policy change will impact laboratories and the patients we serve.
ACLA member laboratories have already implemented innovative solutions and reworked operations to support increased COVID-19 testing capacity and faster turnaround times.
We’re concerned this policy could create a domino effect where patient access to testing is severely reduced. Cutting laboratory reimbursement won’t address the root causes of delayed turnaround times. Turnaround time is driven largely by fluctuations in demand and access to critical supplies. As states across the country experience a surge in new cases, the global demand for testing supplies remains high.”
###
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.
ACLA Statement on FDA Announcement Regarding EUA Reviews
Washington, D.C. – Following the recent FDA decision to no longer review emergency use authorizations (EUAs) for lab-developed COVID-19 testing, ACLA President Julie Khani released the following statement:
“Many of the tests that have been granted EUAs for COVID-19 testing are innovative, high-throughput LDTs that have reduced reliance on supplies and been integral to expanding testing capacity. These are exactly the kinds of tests that FDA has stated it wants to prioritize. ACLA believes the FDA should continue to allow labs to voluntarily submit EUAs for FDA review and authorization. Today’s announcement by the FDA creates unnecessary confusion.”
###
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.
ACLA Letter to Bill Gates
ACLA Comments on MedPAC CLFS Session – September 2020
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.
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.”
###
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.
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.
