All posts by gstrong

Congress Must Fix PAMA, Protecting Patient Access to Laboratory Testing Services 

America’s clinical laboratories deliver screening and diagnostic test results that serve as the foundation for early diagnosis, disease prevention, and personalized care for millions of patients each day. From routine blood tests to innovations resulting in ground-breaking genetic testing, clinical laboratories foster improved patient outcomes and quality of life while delivering value to the health care system, including by often reducing costs. Further, the nation’s clinical laboratory infrastructure is essential to protecting public health when regional, national and global emergencies arise, from COVID-19 to other pathogens of concern. But Medicare beneficiaries and all patients across the country could soon face a preventable risk: compromised access to these critical laboratory tests.  

Without congressional intervention, come January 2023, laboratories across the country will face a fourth round of Medicare reimbursement cuts authorized by the Protecting Access to Medicare Act (PAMA). PAMA was enacted in 2014 to establish a uniform reimbursement system for laboratories nationwide. However, due to an inadequate data reporting system, which only collected rates from less than 1 percent of the nation’s laboratories, clinical laboratories have already faced three years of compounding cuts to the most common tests, including the top 25 tests most used by seniors.  

This next round of Medicare reductions would cut reimbursement up to 15 percent for over 800 lab tests. These cuts would undermine our nation’s clinical diagnostic infrastructure and could jeopardize access for seniors and all patients who rely on laboratory tests to diagnose, treat, and monitor their health on a regular basis, all while chilling innovation. Rather than weaken the health care system with further PAMA cuts, the nation’s clinical laboratory infrastructure should be strengthened, ensuring laboratories have the tools and resources necessary to continue serving patients, innovate, and prepare for and respond to future public health challenges.  

Thanks to the leadership of longstanding bipartisan champions, this year Congress is poised to permanently improve implementation of the PAMA reimbursement model and protect the more than 50 million seniors and all patients who rely on screening and diagnostic tests to manage their health through the Saving Access to Laboratory Services Act. The bill, introduced by Sens. Sherrod Brown (D-OH) and Richard Burr (R-NC), along with Reps. Bill Pascrell (D-NJ), Scott Peters (D-CA), Richard Hudson (R-NC), Gus Bilirakis (R-FL), and Kurt Schrader (D-OR), would permanently ease Medicare cuts, addressing the consequences of PAMA by collecting representative private market data to achieve accurate and sustainable rates for laboratory services. 

Because of the leadership of the Saving Access to Laboratory Services Act sponsors, Congress has previously come together three times to deliver bipartisan short-term relief that has delayed further implementation of PAMA. Most recently in 2021, Congress passed the Protecting Medicare and American Farmers from Sequester Cuts Act, which provided relief from another year of laboratory reimbursement cuts and received praise from leading organizations representing patients, health care professionals, hospitals, public health, laboratories, and diagnostic manufacturers.  

By alleviating the PAMA cuts, setting Medicare reimbursement for laboratories on a sustainable pathway, Congress can protect seniors and all patients from potentially losing access to critical tests and support innovation for the next generation of screening and diagnostics while keeping our nation’s laboratory infrastructure healthy. Congress must pass the Saving Access to Laboratory Services Act. 

ACLA Response to WSJ’s Op-Ed on The High Cost of Constant Covid Testing

The following is ACLA’s submitted response to the Wall Street Journal’s June 6, 2022 op-ed on the high cost of constant COVID-19 testing.

The June 6 op-ed paints a misleading picture of the clinical laboratory industry amid a once-in-a-generation public health crisis, and glosses over the instrumental role lab professionals continue to play in ensuring Americans have the critical health information only a lab test can provide.

A strong bipartisan commitment early on from Congress and the Administration for test coverage without cost-sharing was critical to broad patient access and the industry’s ability to scale testing while continuing routine non-pandemic testing. Contrary to what the op-ed suggests, levels of Medicare reimbursement are typically a ceiling – and not a floor – for commercial payers, and Medicaid rates are often lower. 

Clinical labs have long been the backbone of our public health response. The simple swab of a patient’s nasal passages belies the complexity of developing and validating a new diagnostic test for a previously unknown pathogen and rapidly scaling a system – ensuring a stable workforce, procuring materials, running millions of tests, and delivering results. Clinical labs mobilized and grew capacity, responding to repeated COVID-19 surges. And they did this while processing routine tests for patients with diabetes, heart disease, and cancer – tests that inform many of life’s most important health care decisions. 

Dismissing the importance of this reimbursement only undermines the commonsense need to maintain the nation’s diagnostic testing infrastructure and the importance of a diagnosis for healthcare decision making.

Susan Van Meter, President of the American Clinical Laboratory Association (ACLA)

ACLA and 15 Leading National Health Care Organizations Urge Extension of COVID-19 Public Health Emergency Declaration

Washington, D.C. – The American Clinical Laboratory Association (ACLA) today joined 15 national health care organizations in a letter to the U.S. Department of Health and Human Services (HHS) urging an extension of the COVID-19 public health emergency.

Citing both the ongoing risk of new COVID-19 variants and the uptick in case rates across the country, ACLA and the other organizations, including AARP, American Cancer Society Cancer Action Network, the American Hospital Association, and the American Medical Association, stressed vigilance. The letter states, “Advancements in surveillance have observed rapid variant mutations and while public health experts acknowledge that current variants are not leading to excessive hospitalizations at this time, they also assert that new variants absolutely could.”

The letter goes on to highlight some of the flexibilities under the public health emergency that have been central to supporting patient care and helping the health system adapt as the pandemic evolves, including protecting Americans’ access to vaccines, testing, and treatments, and the ability for health care providers to quickly increase capacity to test and treat patients.

“As we continue to navigate the COVID-19 pandemic, the public health emergency declaration is key to ensuring the health system as a whole remains prepared to help all Americans navigate the ongoing pandemic including through robust access to tests, treatments, and vaccines, and that those on the frontlines are able to swiftly respond to meet patient needs,” said Susan Van Meter, ACLA President.

To view the full letter, click here.

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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.

Prioritizing Actionable Data to Help Clinicians Care for Patients and Improve Their Outcomes 

This Laboratory Professionals Week, we honor the innovators, collaborators and colleagues who have gone above and beyond behind the scenes to meet patient need. Today, ACLA is celebrating Josh Corbin, Director of Clinical Operations at Precision Diagnostics, who attributes robotic process improvement as a key factor in achieving more accurate and reliable data to improve patient care. 

In the nine years since Josh Corbin joined Precision Diagnostics as a laboratory technician, he’s seen a variety of advancements in the technology laboratory professionals rely on daily. Today, as Precision Diagnostics’ Director of Clinical Operations, Josh cites robotic process improvement as the most impactful advancement he’s seen during those years. 

“Before using robotics, it was difficult and time consuming to process a sample because the required tools needed for sample processing often could not communicate with each other,” explains Josh. “Now, robotic process improvement helps us communicate across all systems and allows clinical lab professionals to access more accurate and reliable data to improve patient outcomes.” 

From urine drug testing to oral fluid testing, everything at Precision Diagnostics requires, well, precision. And as the opioid crisis continues to ravage communities across the country, the focus on precision is on display. High-sensitivity technology and rapid results allow Precision Diagnostics to paint a more complete picture of a patient’s health status – something that health care providers and drug monitoring programs depend on every day. 

“We strive to provide actionable data that gives clinicians the information they need to showcase what’s going on with a patient. Ensuring that information is accurate and reliable is our top priority and robotic process improvement has made that a reality while also enabling us to serve more patients,” adds Josh. 

Kevin Krock, Precision Diagnostics’ Director of Business Operations & Associate Laboratory Director says it’s business as usual for Josh and his team. 

“Josh leads the entire lab by example,” says Kevin. “Whether it’s accessioning samples on a busy Saturday or going back to school to qualify for his state license, his dedication to the employees and the important work they do here at Precision is always on display.” 

Embracing Innovation to Provide Complex Diagnoses with Greater Ease 

This Laboratory Professionals Week, we honor the innovators, collaborators and colleagues who have gone above and beyond behind the scenes to meet patients’ needs. Today, ACLA is featuring Vanessa Moelius, a clinical laboratory technologist at NeoGenomics who is at the forefront of innovative process developments that help improve patient care. 

Vanessa Moelius has always had a passion for patient care. After graduating from Stockton University with a Bachelor of Science degree in Biology, Vanessa first worked as a phlebotomist before joining the NeoGenomics team in 2009.  

In her current position, Vanessa works as a clinical laboratory technologist on NeoGenomics’ Fluorescence in Situ Hybridization (FISH) team. FISH testing is used to identify hematologic diseases and solid tumors and to map the genetic material in a patient’s cells. Vanessa and her colleagues apply their expertise to aid in the diagnosis and treatment of specific forms of cancer, including leukemia, lymphoma and breast cancer, as well as conditions involving chromosomal abnormalities.  

Over time, Vanessa started to increase her focus on process improvement and efficiency in the laboratory setting. When automation began making its way into Vanessa’s work, she jumped at an opportunity to work on validating NeoGenomics’ first Plasma Cell Separator instrument. Less than two years later, Vanessa transitioned full-time into the FISH analysis department where she was introduced to NeoGenomics’ first automated microscope.   

“An avid multi-tasker motivated by the opportunity to participate in process improvements, I was quickly given multiple validation projects that paved the way for automated analysis on blood, bone marrow, bladder and paraffin-embedded samples,” explains Vanessa. “Our organization’s focus on automated innovation has contributed to the expansion of our uniquely-unified national network of analysis resources and I am very proud to have been a part of that success.” 

Most recently, Vanessa’s drive has propelled her from NeoGenomics headquarters in Florida to a facility in California to lead the automation of its FISH testing systems. By utilizing her unmatched level of technical expertise in system automation, Vanessa has made FISH testing more accessible to her peers at NeoGenomics – and ultimately, to patients. 

“NeoGenomics has given me an outlet for my passion for process improvement, where I feel my contributions can truly make an impact on improving patient care,” explains Vanessa.  

Never satisfied with “good enough,” Vanessa holds herself and the rest of her NeoGenomics team to the highest standard. Two weeks after her initial trip to California to train technicians, she returned to improve processes with the automated platform and fully validate the systems to introduce a new type of scanning to the NeoGenomics FISH network.  

As a testament to her work on NeoGenomics’ FISH team, Vanessa was nominated and selected by her peers as the recipient of the NeoGenomics 2021 Living Our Values Award for her integrity on the job. Vanessa earned this award through her efforts as a key driver for better collaboration across the NeoGenomics FISH network and her leadership connecting clinical lab testing sites and lab professionals across the country.  

“Vanessa has drawn on her vast technical knowledge of automated platforms to help shepherd NeoGenomics’ FISH into a more streamlined automated future, allowing us to perform all testing seamlessly across the country,” says Peter Ortegel (ASCP)CG, Clinical Laboratory Supervisor, FISH. “I’m excited by the potential of the new technologies we are looking to leverage, and I know Vanessa will be at the forefront of implementing those improvements.” 

Operational Efficiency is Essential Amid Growing Demand for Routine and Specialty Testing 

This Laboratory Professionals Week, we honor the innovators, collaborators and colleagues who have gone above and beyond behind the scenes to meet patient need. Today, ACLA is featuring Brian Hatcher, Director of Laboratory Services at McLaren Health Care, who was quick to roll up his sleeves and lead the facility’s efforts to take on additional testing needs related to the pandemic – all while maintaining prompt turnaround times and training the next generation of leaders in the laboratory. 

Throughout the pandemic, laboratory leaders have had to adapt and take on new roles to maintain quality patient care.  Brian Hatcher, Director of Laboratory Services at McLaren Health’s corporate laboratory in Michigan, is one such laboratory professional who moved outside of his comfort zone to take on new responsibilities. Pivoting from the management of McLaren’s microbiology lab to learning all facets of core lab operations, Brian quickly immersed himself in departments he hadn’t worked in since his clinical rotations. 

“During the early days of the pandemic we faced a lot of uncertainty, but our commitment to serve patients with the laboratory services they need never wavered,” says Brian. “This meant our team, myself included, had to think outside the box and take on additional roles to ensure we could continue providing high-quality, convenient and cost-efficient services to our patients and their providers.” 

McLaren’s corporate facility is one of many laboratories that are part of the Joint Venture Hospital Laboratories (JVHL). Together, JVHL’s laboratories perform approximately 70 million tests annually and have a network that serves about 34,000 physician clients with more than 450 patient services. Despite workforce gaps and staffing shortages during the height of the COVID-19 pandemic, leaders at McLaren’s corporate laboratory decided to take on non-urgent testing requests from hospital laboratories.  

“This was done to ease the burden on hospitals so they could focus on their urgent testing needs in addition to COVID-19 testing,” explains Brian. 

To support the additional workload, McLaren’s corporate laboratory incorporated the Roche Chemistry platform into its processes to improve efficiencies and accelerate diagnostic turnaround times. Brian was quick to dive into the effort – first by observing the setup of the equipment and second by participating in the validation and testing of the platform to ensure the three lines of analyzers, the two input modules and the storage unit were all communicating properly. In addition to managing the operational components, Brian also trained lab technical assistants to become “super users,” equipping them with the expertise to help him with system maintenance and troubleshooting.  

“Setting up the Roche Chemistry automated line was rewarding because it meant our laboratory would become more efficient and better equipped to support our patients and providers with their testing needs,” adds Brian. 

Ensuring that the automation line was functional required a rapid and successful “Go Live” plan. This plan was essential for Brian and his team and continues to be important for McLaren’s broader health system.  

“By adapting to a new role and adopting new skills critical to lab operations, Brian was able to facilitate his lab’s fast turnaround times to ultimately deliver high quality results for patients and providers,” says RoseAnn Carlsen, Vice President of Corporate Laboratory Services at McLaren Health Care. “During the past two years, all of us have had to step up, learn new skills and work in very challenging times. Brian, along with our entire team of laboratory professionals, have proven themselves to be true leaders, who often go far beyond the call of duty to optimize diagnostic value.” 

ACLA Statement on the HRSA COVID-19 Uninsured Relief Fund

Washington, D.C. ACLA issued the following statement in response to delayed Congressional action to replenish the depleted COVID-19 Uninsured Relief Fund:

“ACLA is committed to ensuring all Americans have access to COVID-19 testing amid the ongoing pandemic, regardless of health insurance status. Providing additional resources for the Health Resources and Services Administration (HRSA) COVID-19 Uninsured Relief Fund is required to fulfill this commitment, and we urge Congress to take action to replenish the fund when it reconvenes later this month.

The COVID-19 Uninsured Relief Fund was established to cover testing, treatment and vaccinations for uninsured individuals throughout the pandemic. That fund has been depleted and, as a result, stopped accepting claims for testing and treatment on March 23 and for vaccinations on April 6. If Congress does not replenish this fund, millions of uninsured Americans may forgo testing and ultimately delay care for COVID infections and place others at risk of infection.

Broad access to COVID-19 testing has been a cornerstone of our pandemic response, ensuring that all Americans could access a test when needed, regardless of insurance status. Replenishing the COVID-19 Uninsured Relief Fund is critical to our efforts and to fulfilling Congress’ promise to provide access to testing, treatment and vaccinations without cost-sharing to all Americans. We strongly urge Congress to support the Administration’s request to fund all aspects of our national pandemic response immediately and not prematurely dismantle critical elements of our public health response.”

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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.

An Emerging Crisis of Undiagnosed Diseases and Delayed Treatment

As we enter the third year of the COVID-19 pandemic, we are beginning to see some of the longer-term impacts of the virus on our health care system. COVID-19 has impacted the access to and delivery of routine care for millions across the country. When it comes to diagnostic tests and services, a preliminary Braid Forbes Health Research analysis of the 2020 Medicare Clinical Laboratory Fee Schedule (CLFS) utilization data indicates alarming declines for routine screenings and chronic disease testing during the first year of the pandemic.

Findings from this analysis reveal that clinical lab test utilization overall fell by nearly 18% from 2019 to 2020, even when accounting for the large volume of COVID-19 tests that were conducted in 2020. What’s more, utilization of critical diagnostic tools often used for routine screenings, such as chemistry panels, fell by 22% in that same time period.

The impact of this decline for patients with common chronic conditions like cancer, cardiovascular disease and diabetes can be severe. The Braid Forbes analysis shows that there was a 31% drop in cancer testing on average across key tests conducted in 2020 as compared to 2019. The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) has also observed significant declines in test volumes, finding that the total number of NBCCEDP-funded breast and cervical cancer screening tests declined by 87% and 84%, respectively, during April 2020 compared with the previous 5-year averages for that month. Recent data from the American Association for Cancer Research supports these findings as well, reporting that from January to July of 2020, the pandemic led to nearly 10 million missed cancer screenings.

This decline in testing can have serious consequences for seniors who rely on lab tests to diagnose, monitor and treat chronic diseases. Left unchecked, many of these diseases can progress from manageable chronic conditions to life changing illnesses. In fact, the National Cancer Institute now predicts that there will be almost 10,000 excess deaths over the next decade from breast and colorectal cancer alone due to pandemic-related delays in patient diagnosis and treatment.

While we remain committed to doing our part to end the pandemic and provide the diagnostic tools necessary to detect and monitor the SARS-CoV-2 virus, we must not forget the importance of routine screenings and testing for diagnosis, treatment and management medical conditions. Medical professionals, policymakers and advocates must work together to raise awareness of this downward trend to ensure that seniors do not face additional obstacles in better managing their health care.

Clinical Labs’ Role in Identifying and Sequencing Variants During the COVID-19 Pandemic

Genetic variations in viruses are a common occurrence that naturally take place over time and can lead to the emergence of new variants with different characteristics. Understanding these variants, including the genetic makeup of the virus itself, is essential for public health efforts and is particularly important amid the current COVID-19 pandemic.

The key to identifying a virus starts with its genome, which is the set of genetic instructions used to build the virus. From there, scientists use a process called genomic sequencing to decode the genes and learn more about the virus, including how the virus mutates over time and which characteristics are present in different strains.

While scientists can use genetic sequencing to study everyday viruses, such as cancers, to help inform treatment plans for doctors and certain patients, sequencing to track the SARS-CoV-2 virus is a public health effort. In the United States, the Centers for Disease Control (CDC) uses genomic surveillance to track emerging SARS-CoV-2 variants, such as the most recent Delta and Omicron variants. By identifying different variants, public health experts can determine which variants produce the most severe symptoms as well as how the different variants may respond to vaccines. Through these efforts, public health partners can better inform pandemic response strategies, such as determining where testing is most needed at the national and local levels.

Utilizing this critical surveillance tool requires a level of collaboration across the entire health care continuum. In this era of unprecedented innovation and collaboration, several ACLA member labs are working in close coordination with the FDA, CDC and state and local public health labs to identify and sequence SARS-CoV-2 variants. ACLA members are armed with the personnel, scientific expertise and experience necessary to support sequencing efforts for emerging infectious disease variants.

Continuing this work is essential to better understanding the COVID-19 pandemic and ensuring a quick and nimble public health response as the virus evolves. Sequencing will remain a critical tool, particularly as scientists study the long-term impacts of the virus.