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ACLA Response to the New York Times’ Article on NIPT

Comments and Letters, ACLA News

The following is ACLA’s submitted response to the New York Times’ January 1, 2022 Article on Non-Invasive Prenatal Testing (NIPT).

The Times’ Jan. 1 article presents a misleading picture of the role prenatal genetic screening tests play in the full scope of care patients may receive under the direction of their doctors and in consultation with genetic counselors. It also excludes any mention of the comprehensive regulatory requirements and patient protections CLIA-certified labs follow to ensure the reliability of these screening tests.

These tests, like all screening tests, are optional and intended to provide a preliminary assessment of potential risk for certain health issues and are not equivalent to, nor intended to be used as, diagnostic tests for specific fetal conditions. Additionally, screening tests are an important precursor to identify individuals with elevated risk who are most suitable for subsequent diagnostic testing, which is typically more invasive and more expensive.

Ignoring the safeguards in place and failing to tell the full story paints an incomplete picture for patients.

Tom Sparkman, Senior Vice President, Government Affairs and Policy, American Clinical Laboratory Association (ACLA)

Congress Passes PAMA Relief, Safeguards Seniors’ Access to Critical Lab Tests Ahead of January Deadline

PAMA Reform, ACLA News, All News, Featured News, ACLA Press Releases

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) applauds the passage of S. 610, the Protecting Medicare and American Farmers from Sequester Cuts Act, paving the way for renewed protections for seniors accessing vital lab tests and services. Among the bill’s Medicare provisions was relief from another year of reimbursement cuts to many of the most commonly ordered clinical laboratory tests. Nearly 600 tests were scheduled to see cuts of up to 15% beginning January 1, 2022. Once signed into law, these cuts and reporting requirements will be delayed one full year.

“America’s 56 million seniors can breathe a sigh of relief,” said Tom Sparkman, ACLA Senior Vice President, Government Affairs and Policy. “The pandemic has had a profound impact on seniors and has made it ever more challenging for many to receive the routine care and treatment they rely on to stay healthy. We applaud Congress for taking decisive action before the new year to support clinical laboratories on the front lines and to protect the health of seniors. We look forward to continuing to work on a long-term fix to both the payment cuts and burdensome reporting.”

Earlier this month, nearly 30 leading health organizations representing patients, seniors, laboratories and diagnostic manufacturers called on Congress to take immediate action to address the pending harm to seniors’ access to lab tests and services as a result of the flawed implementation of the 2014 Protecting Access to Medicare Act (PAMA).

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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.

ACLA Applauds Inclusion of PAMA Relief in Year-End Medicare Package

PAMA Reform, ACLA News, All News, Featured News, ACLA Press Releases

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) today welcomed the bipartisan and bicameral agreement to safeguard seniors’ access to lifesaving clinical laboratory services in the new year. The year-end package provides relief from yet another year of cuts to many of the most commonly ordered clinical laboratory tests (cumulatively a 27.1% cut to date). Specifically, nearly 600 tests are scheduled to see up to 15% cuts beginning January 1, 2022 absent Congressional action.

“This is welcome news for seniors across the country, but our work is not yet done. We urge Members of Congress to support this measure – delaying both the payment cut and burdensome reporting – so we can ensure seniors have access to the critical testing they need to make informed health decisions,” said Tom Sparkman, ACLA Senior Vice President, Government Affairs and Policy. “We’re grateful to Sen. Sherrod Brown (D-OH), Sen. Richard Burr (R-NC), Rep. Bill Pascrell (D-NJ), Rep. Scott Peters (D-CA), Rep. Kurt Schrader (D-OR), Rep. Richard Hudson (R-NC) and Rep. Gus Bilirakis (R-FL) for standing up for America’s seniors and for public health more broadly.”

This bipartisan agreement comes after nearly 30 leading health organizations representing patients, seniors, laboratories and diagnostic manufacturers called on Congress to take immediate action to address the pending harm to seniors’ access to lab tests and services as a result of the flawed implementation of the 2014 Protecting Access to Medicare Act (PAMA).

The letter signatories wrote, “Without action by Congress, Medicare patients could lose access to essential laboratory services. Without ready access to lab tests, patients risk missed or delayed diagnoses, increased barriers to maintaining their health, and forgoing the opportunity to prevent even worse health outcomes or disease. In a medical age where technology is pushing health care closer to patients, the bureaucratic policies implemented through PAMA will drive care and the promise of better health further away from patients.” 

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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.

Leading Organizations Representing Seniors, Health Care Professionals, Laboratories and Diagnostic Manufacturers Call on Congress to Take Immediate Action to Delay Pending Cuts to Lab Tests, Flawed Reporting Requirements to Protect Seniors’ Access to Lifesaving Lab Testing

PAMA Reform, ACLA News, All News, ACLA Press Releases

WASHINGTON, D.C. – With millions of seniors facing decreased access to lab services as a result of cuts to nearly 600 lab tests, nearly 30 leading health organizations representing patients, seniors, laboratories and diagnostic manufacturers called on Congressional leaders to delay scheduled Medicare cuts to laboratory services and flawed reporting requirements taking effect in January 2022. 

The groups, including the American Clinical Laboratory Association (ACLA), National Independent Laboratory Association (NILA), American Academy of Family Physicians, American Hospital Association, AdvaMedDx, Cancer Support Community, National Consumers League and key voices across the health system, urged Congress to take immediate action to address the looming harm to seniors’ access to care as a result of the flawed implementation of the Protecting Access to Medicare Act (PAMA).

Since 2018, PAMA has resulted in three years of 10 percent annual cuts to many of the most commonly ordered clinical laboratory tests (cumulatively a 27.1 percent cut to date), with up to 15 percent cuts for nearly 600 tests scheduled to resume on January 1st. Congress has twice responded in a bipartisan fashion to mitigate PAMA’s harmful impact – first through passage of the Laboratory Access for Beneficiaries (LAB) Act in 2019 and again by providing relief in the Coronavirus Aid, Relief and Economic Security (CARES) Act in 2020.  

Delaying both the next round of cuts and the scheduled data reporting in 2022 will help ensure labs can continue to serve the millions of Americans who are managing diabetes, heart disease, cancer and other chronic conditions, while also maintaining a nimble diagnostic infrastructure to rapidly respond to evolving COVID-19 testing demands. 

Highlights from the letter are included below:

  • “As we approach the end of the second year of the COVID-19 pandemic, our nation’s clinical laboratories continue to work tirelessly on the front lines of the response. However, the flawed implementation of the Protecting Access to Medicare Act (PAMA) has resulted in drastic cuts to some of the most frequently ordered clinical laboratory tests. In just a few weeks, laboratories are scheduled to see cuts as large as 15 percent to some of the most common tests on their menus—basic clinical laboratory tests that are essential to the health and wellbeing of Americans.”
  • “Reducing access to clinical laboratory services drives up the cost of care for patients and taxpayers. Millions of Americans who are managing diabetes, heart disease, liver disease, kidney disease, prostate and colon cancers, anemia, infections, opioid dependency, and countless other common diseases and conditions rely heavily on access to these routine lab tests to prevent costly interventions. Worse, these cuts will undermine the basic public health and clinical laboratory infrastructure that is needed to quickly respond to emerging and future public health threats.”  
  • “PAMA cuts have had a detrimental impact on clinical laboratory infrastructure, particularly labs who serve rural and underserved communities. In addition, laboratories are not immune to general market conditions. As supplies and labor costs continue to grow, laboratories struggle to maintain and hire essential personnel. Further cuts will continue to damage the nation’s laboratory infrastructure at a time when it is needed most.”
  • “Without action by Congress, Medicare patients could lose access to essential laboratory services. Without ready access to lab tests, patients risk missed or delayed diagnoses, increased barriers to maintaining their health, and forgoing the opportunity to prevent even worse health outcomes or disease. In a medical age where technology is pushing health care closer to patients, the bureaucratic policies implemented through PAMA will drive care and the promise of better health further away from patients.” 
  • “We urge you to include a one-year delay to the 2022 Medicare CLFS cuts and private payer data reporting period in the continuing resolution that is currently being negotiated.”

Groups signing include: AdvaMedDx, American Academy of Family Physicians, American Association for Clinical Chemistry, American Association of Bioanalysts, ACLA, American Hospital Association, American Medical Group Association (AMGA), American Medical Technologists, American Society for Clinical Laboratory Science, American Society for Clinical Pathology, American Society for Microbiology, Association of Public Health Laboratories, Association for Molecular Pathology, Association of Public Health Laboratories, California Clinical Laboratory Association, Cancer Support Community, Caregiver Action Network, Caregiver Voices United, FORCE: Facing Our Risk of Cancer Empowerment, Infectious Diseases Society of America, Medical Group Management Association, National Association for the Support of Long Term Care (NASL), National Black Nurses Association, National Consumers League, National Independent Laboratory Association, New York State Clinical Laboratory Association, Personalized Medicine Coalition, Point of Care Testing Association and RetireSafe.

To view the 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.

Preventive Screenings and Routine Testing Are Essential for Protecting Seniors’ Health

ACLA Blog, PAMA Reform, ACLA News, All News

With Medicare reimbursement for nearly 600 laboratory tests scheduled for significant cuts in a matter of weeks, 56 million seniors are at risk of losing access to vital lab tests and diagnostics that help them stay healthy and manage existing conditions. The culprit? The poorly implemented 2014 Protecting Access to Medicare Act (PAMA).

Though PAMA was meant to establish a uniform reimbursement system for lab tests and services under Medicare, the U.S. Department of Health and Human Services’ (HHS) misguided implementation of the law has led to 3 years of draconian cuts to the tests Americans rely on. By drastically cutting rates, including for many of the most commonly performed lab tests, PAMA may threaten access to critical lab services for diagnosing and treating beneficiaries with diabetes, heart disease, liver disease, kidney disease, prostate and colon cancers, anemia, infections, opioid dependency and countless other common health conditions. 

This comes at a time where many of America’s seniors are already struggling to access these essential laboratory services due to the COVID-19 pandemic. According to recent public health studies, roughly 1 in 5 Medicare beneficiaries avoided or missed necessary medical care last year as a result of the pandemic. Of those, more than one-third (32%) skipped vital laboratory testing and diagnostics, which are critical to early detection and prevention of serious diseases. 

As the foundation for early diagnosis, prevention and personalized care for millions of patients, the value of clinical laboratories remains unmatched. Protecting access to these vital laboratory services should remain a top priority. Even more, a dedicated focus on both prevention and early detection can drive savings across the health system by helping to identify diseases and risk factors for diseases at an early stage. Undiagnosed diabetes alone, for example, is associated with $31.7 billion in annual spending that could have been avoided through earlier diagnosis and better disease management. 

In order to continue providing value to patients, we must first protect access to quality care, including high quality clinical laboratory services. As the COVID-19 pandemic has proved, we must continue to advocate for widespread access to laboratory services for the early detection and prevention of other serious diseases that disproportionately impact seniors and vulnerable populations.  

We shouldn’t make it harder for seniors to stay healthy – Congress needs to protect seniors’ access to laboratory tests and diagnostic services. Congress has already recognized this threat and delayed PAMA cuts and a second round of flawed PAMA data reporting for one-year in Section 3718 the bipartisan Coronavirus Aid, Relief, and Economic Security Act in 2020. Congress needs to act immediately and delay the cuts and data reporting for clinical labs another year. 

For 56 Million Seniors, New Cuts to Lab Tests Makes the Road to Better Health Much Harder

ACLA Blog, PAMA Reform, ACLA News, All News

Millions of seniors weathered the worst of the pandemic – the uncertainty of COVID-19, the disruptions to family life and the ongoing risks to their health. As a result of many factors throughout the pandemic, seniors have faced a drastic, and concerning, drop in routine testing and diagnostic screenings for cancer and other chronic conditions. Now seniors across the country could face a new risk: losing access to the critical lab services that are essential for diagnosing and treating chronic and severe conditions at their earliest stages.

In 2014, Congress passed the Protecting Access to Medicare Act (PAMA) to establish a uniform reimbursement system for labs across the country. However, as a result of flawed implementation, laboratories have faced three years of 10 percent cuts to the most common laboratory tests, including the top 25 tests most used by seniors. Fast forward to January 2022, the U.S. Department of Health and Human Services is set to further cut Medicare reimbursement for nearly 600 clinical laboratory tests.

Previous Medicare cuts to lab tests have already forced specialized labs serving nursing homes, skilled nursing and long-term care facilities to significantly reduce services, and in some cases, stop operations or lay off staff. These cuts have a disproportionate impact on seniors in rural communities who already face shortages of medical care and staffing within their communities.  

Congress has recognized the direct harm to patients as a result of these cuts. Over the last two years, policymakers have passed bipartisan legislation, including the 2019 Laboratory Access for Beneficiaries (LAB) Act and the 2020 Coronavirus Aid, Relief, and Economic Security Act, to make sure seniors’ access to lab testing was maintained.  

However, without Congress taking immediate steps to delay the upcoming cuts and flawed reporting requirements, seniors could face new challenges in accessing the testing they need. 

Congress acted in the darkest days of the pandemic to make sure America’s seniors wouldn’t lose access to vital lab services. As we approach the 11th hour, policymakers must do everything possible to ensure Medicare beneficiaries get the care they need.  

Seniors’ return to health could be jeopardized by upcoming lab cuts

ACLA Blog, PAMA Reform, ACLA News

Over the past two years, seniors have had to be extra vigilant when it comes to protecting their health, especially those with existing health issues or those who are immunocompromised. Just as we’re turning a corner on another wave of the pandemic, looming cuts to Medicare lab services send the wrong message to millions of Medicare beneficiaries who depend on lifesaving diagnostics for their health. 

The National Council on Aging reports that approximately 80% of older adults have at least one chronic condition, and approximately 50% have at least two chronic conditions. Access to lab tests and services is a key component in coordinating their comprehensive care – be it prevention or maintenance.

Data consistently show that timely access to clinical testing can help stop the progression of chronic conditions like cancer, diabetes and heart disease in their earliest stages and protect patients from serious and costly interventions in the future. For example, high blood pressure, high cholesterol and smoking are key risk factors for the leading cause of death in the U.S., heart disease, which can be controlled by lifestyle changes and medications when caught early through routine and recommended lab testing. 

Despite the vital role that lab tests play, more than 56 million seniors across the country are at risk of losing access to critical lab services as a result of the misguided implementation of the 2014 Protecting Access to Medicare Act (PAMA). The U.S. Department of Health and Human Services (HHS) has routinely cut reimbursement rates for some of the most common lab tests that seniors rely on. In fact, with the new year, nearly 600 clinical laboratory tests and diagnostic services – including the top 25 tests most used by America’s seniors – will see their Medicare reimbursement cut. These tests screen for and monitor common conditions like diabetes, heart disease, liver disease, kidney disease, prostate cancer, anemia and hypothyroidism. Early diagnosis is key for any disease, and losing access to these important tests can have a devastating impact on patient health. In the wake of the pandemic, where routine care was put on hold for so many vulnerable Americans, these tests are even more important. 

Collectively, these cuts can have a drastic impact on labs across the country and their ability to perform the routine testing that seniors need. According to the Centers for Medicare & Medicaid Services (CMS), hundreds of routine low-cost tests have been cut by 10% per year, every year, from 2018 through 2020 and face up to an additional 15% cut on January 1st, 2022.  These extreme reductions in reimbursement also limit the types of tests a provider can offer. For example, a 2018 survey of laboratories by the Infectious Disease Society of America (IDSA) showed that more than 79% of respondents reported they would be unable to provide the full range of testing needed to rapidly diagnose infectious diseases following the 2018-2019 PAMA cuts.

Congress acted last year in the throes of the pandemic to ensure seniors wouldn’t face access issues, but they have yet to address this next cliff. America’s seniors deserve better. 

ACLA Statement on Changes to LDT Regulation and Review

ACLA News, All News, Featured News, ACLA Press Releases

Following the announcement from U.S. Department of Health and Human Services Secretary Xavier Becerra regarding regulation and review of laboratory developed tests (LDTs), ACLA President Julie Khani issued the following statement: 

“Laboratory developed tests (LDTs) are a vital tool in our fight against complex and often devastating diseases facing patients and their families. Clinical experts rely on LDTs to fill emerging gaps in medical care for which a test may not currently exist, such as for cancers and rare diseases. In the case of COVID-19, many of the first tests available were LDTs developed by ACLA member companies. As this pandemic has illustrated, a clear and nimble regulatory framework with appropriate and clear pathways for test development is essential to public health and patient care. 

Today’s announcement from the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) marks another shift in federal policy regarding the regulation of LDTs. While we appreciate the Administration’s focus on the need for high-quality testing, continually shifting regulatory policies creates uncertainty and undermines patient access to lifesaving diagnostics. This underscores the clear need for comprehensive diagnostic reform legislation that can provide long-term clarity and continuity for clinical labs and their work to support medical breakthroughs moving forward. We remain focused on the continuing pandemic response and our continued work with stakeholders and congressional leaders to advance meaningful comprehensive diagnostic reform and achieve this shared goal.”

To view ACLA’s previous letter to Secretary Becerra on LDT regulation, 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.

ACLA Statement on Release of OSHA and CMS Rules

ACLA News, ACLA Press Releases

Following the Biden Administration’s announcement regarding two new federal rules on COVID-19 vaccination, ACLA President Julie Khani released the following statement: 

“We welcome the Biden Administration’s focus on two key strategies to put the COVID-19 pandemic behind us – vaccination and testing. As we make great strides in broad vaccination uptake, we know that testing must remain a core component of our national response. With a standardized date for implementation, we believe these policies will advance our goal to increase vaccination rates while also providing employers time to establish and implement their testing policies. 

As we approach the January 4, 2022 deadline, clinical laboratories need predictability and continued support in order to respond quickly to the evolving pandemic. ACLA member labs have ample testing capacity and stand ready to meet the nation’s testing needs.”

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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.