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Reflecting on Healthy Aging Month and the Importance of Routine Laboratory Services in Informing Care

September marks Healthy Aging Month, a vital opportunity for patients, providers, and caregivers to reflect on the importance of accessible care for America’s seniors. It also serves as a reminder to seniors to prioritize their physical and mental health as they age. 

The National Council on Aging reports that 80 percent of adults over the age of 65 have at least one chronic condition, and that more than two-thirds have multiple chronic conditions. Disease management can become more challenging in older age, which makes continued access to the laboratory services that inform routine care critical for seniors. 

The diagnostic tests performed by our nation’s clinical laboratories each day are central to disease management. Results from laboratory tests guide many of life’s most important health care decisions, like whether a patient’s medication is working or if a new condition identified needs to be treated. Results from laboratory tests also help providers develop more personalized care plans that improve patient outcomes. It’s no wonder that results from laboratory tests inform 70 percent of clinical decision-making.

Unfortunately, a 2014 law has led to three years of compounding cuts to Medicare reimbursement, compromising seniors’ access to routine laboratory tests, including the top 25 most commonly ordered tests. These tests are used to help diagnose, monitor, and treat seniors with a wide range of conditions, including diabetes, heart disease, liver disease, kidney disease, prostate and colon cancers, and anemia, among others. The solution to this problem is simple: Congress must act now and pass the Saving Access to Laboratory Services Act (S. 4449/H.R. 8188), a bicameral, bipartisan bill that would ease these harmful cuts and help protect patients’ access to the tests they depend on. 

The Saving Access to Laboratory Services Act offers a straightforward solution to achieving accurate and sustainable Medicare rates for laboratory services. If enacted, this legislation would simplify the current data reporting process by directing the Centers for Medicare & Medicaid Services (CMS) to collect data for widely available laboratory tests via statistical sampling of all major types of laboratories that provide services to seniors, including independent, hospital, and physician office laboratories.  The end result is a framework that helps support a strong clinical laboratory infrastructure and innovation in the next generation of diagnostic tests, while also protecting robust access to care for patients. 

Without strong clinical laboratories, the nation’s response to COVID-19 would have been severely hampered. It’s imperative our nation’s clinical laboratories have the infrastructure to respond to emerging public health needs, as well as the standard screening and diagnostic tests we need to inform routine care.

This Healthy Aging Month, we urge patients, providers, and caregivers to call on Congress to pass the Saving Access to Laboratory Services Act. As we encourage seniors to take charge of their health, we must also encourage our legislators to protect their access to the vital laboratory services that inform their care. Learn more at StopLabCuts.org

ACLA and 25 Provider Organizations Urge Congress to Protect Access to Critical Laboratory Tests for Seniors and All Patients 

Washington, D.C.— The American Clinical Laboratory Association (ACLA) today sent a letter with more than 20 leading organizations representing laboratories, laboratory professionals, providers including hospitals, health systems, and physicians, and diagnostic manufacturers, urging Senate and House leaders to protect patient access to clinical laboratory services by enacting the Saving Access to Laboratory Services Act (SALSA / S. 4449 / H.R. 8188) this year. The bill would help ensure that America’s seniors maintain access to lifesaving clinical laboratory tests and services in the face of pending Medicare cuts in January 2023.

“A fourth round of harmful Medicare cuts to clinical laboratories could reduce access to essential testing for patients, stifle innovation, and weaken our national clinical laboratory infrastructure,” said Susan Van Meter, ACLA President. “Passage of the Saving Access to Laboratory Services Act would reform current Medicare rate-setting that has led to years of harmful laboratory cuts and, instead, set reimbursement for widely available laboratory services on a sustainable path forward. This reform will allow laboratories to focus on providing timely, high quality clinical services for patients and providers and, also, invest in innovation in future diagnostics and the infrastructure necessary to protect public health.” 

SALSA seeks to address the consequences of incomplete and unrepresentative payment data collected under the 2014 Protecting Access to Medicare Act (PAMA), which has led to significant cuts to payments for routine laboratory tests that guide clinical decision-making. At the time PAMA was enacted, the Congressional Budget Office (CBO) projected $2.5 billion in cuts to reimbursement for labs over 10 years. However, PAMA has already cut nearly $4 billion from the Medicare Clinical Laboratory Fee Schedule (CLFS) from 2018 to 2021, which has a total annual spending of only $8 billion, or roughly 3 percent of overall Medicare Part B spending. 

Absent congressional intervention, more than 800 tests will receive up to 15 percent cuts on January 1, 2023. Collectively, these cuts may compromise access to laboratory services for diagnosing and treating seniors with a wide range of conditions, including diabetes, heart disease, liver disease, kidney disease, prostate and colon cancers, anemia, viral and bacterial infections, and opioid dependency, among others. SALSA is a long-term policy that would set Medicare reimbursement for laboratory services on a sustainable path forward.

To view the full letter, click here.  

Click here to learn more about how America’s seniors could be impacted by further cuts to laboratory services.

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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 Monkeypox Testing

Washington, D.C. – In response to the growing cases of monkeypox infections and the expanded testing capacity from the public-private response, the American Clinical Laboratory Association (ACLA) released the following statement about clinical testing: 

“Five leading clinical laboratory members of the ACLA are partnering with the CDC to strengthen the U.S. response to the monkeypox emergency through the dramatic scaling up of monkeypox testing capacity. Collectively, these laboratories now have in place the capacity to test up to 70K patient samples per week, above current demand. This public-private partnership is essential for a robust testing response to meet the needs of patients throughout the country. 

In partnership with the CDC, these laboratories offer monkeypox testing to physicians and health care providers nationwide. Based on medical and CDC guidelines, testing for monkeypox requires a specimen collected from suspected monkeypox lesions using a swab of a skin lesion. The laboratories can pick up patient specimens or arrange for their transport to laboratories for testing. 

Patients suspected of having monkeypox may need additional diagnostic tests for other diseases or conditions. CDC’s revised guidance clarifies that laboratory patient-collection sites can provide these additional test services to individuals who have, or are suspected of having, monkeypox, subject to the requirements in the CDC’s Infection Prevention and Control of Monkeypox in Healthcare Settings.

ACLA member laboratories employ thousands of trained phlebotomists who safely perform test services for patients including through the collection of blood from patients who may have different communicable diseases including, but not limited to, HIV, hepatitis, COVID-19, and now monkeypox.  

ACLA, the five laboratories, Aegis Sciences, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare USA, and additional ACLA members bringing monkeypox testing online will continue to collaborate with federal and state governments and the FDA and CDC as this public health emergency evolves to provide high quality, reliable diagnostic testing to all patients as the demand for testing grows, while protecting the safety of laboratory workers and the patients they serve.”

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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 Introduction of Bipartisan Bill to Protect Seniors’ Access to Critical Diagnostic Tests

Washington, D.C. – The American Clinical Laboratory Association (ACLA) today welcomed the bipartisan introduction of the Saving Access to Laboratory Services Act (SALSA) to ensure America’s seniors maintain access to lifesaving clinical laboratory tests and services in the face of pending Medicare cuts next year.

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), seeks to address the consequences of the flawed implementation of the 2014 Protecting Access to Medicare Act (PAMA), which has led to significant cuts to payments for routine laboratory tests that guide clinical decision-making.   

“Over the past several years, we have achieved strong bipartisan and bicameral support to delay these anticipated cuts, but it is time to permanently fix this problem. Medicare cuts to clinical laboratories could reduce access to essential testing for all patients, stifle innovation, and weaken the laboratory infrastructure, which is essential for emergency resonse. Seniors and all patients need to know if they are at risk for certain cancers, if their diabetes is under control, or if their heart medication is working. Now is the time to set laboratories on a sustainable path once and for all,” said Susan Van Meter, ACLA President.

At the time PAMA was enacted, the Congressional Budget Office (CBO) projected $2.5 billion in cuts to reimbursement rates over 10 years if PAMA was implemented as Congress intended. However, PAMA has already led to nearly $4 billion in cuts to laboratories since 2018 (after only three years of cuts). 

Absent congressional intervention, more than 800 tests will receive up to 15 percent cuts on January 1, 2023. Collectively, these cuts may threaten access to laboratory services for diagnosing and treating seniors with a wide range of conditions, including diabetes, heart disease, liver disease, kidney disease, prostate and colon cancers, anemia, infections, and opioid dependency, among others. Additionally, these cuts would come as clinical laboratories across the country face continued inflationary pressure on costs, labor, and supply shortages, as well as the ongoing demands of the pandemic. 

“ACLA is grateful for Sens. Brown and Burr and Reps. Pascrell, Peters, Hudson, Bilirakis, and Schrader for introducing the Saving Access to Laboratory Services Act, and for fighting for our seniors’ access to clinical laboratory services and keeping the clinical laboratory infrastructure healthy,” said Van Meter. “Congress must act to permanently end these senseless cuts. Patients and their health care providers depend on accessible, high quality laboratory testing to prevent, diagnose, and manage illness. They are counting on Congress to act.”

Click here to learn more about how America’s more than 56 million seniors could be impacted by cuts to laboratory services.

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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 Updated VALID Act Introduced as Part of Senate FDA User Fee Package

Washington, D.C. – In response to the Senate Committee on Health, Education, Labor and Pensions’ (HELP) release of a bipartisan, updated version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, as part of a legislative package that would renew various FDA user fee programs, ACLA President, Susan Van Meter, issued the following statement:  

“We commend Senate HELP Committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) for their leadership and commitment to a bipartisan legislative process. Today’s release of the updated VALID Act, which aims to establish a diagnostics-specific regulatory framework for all diagnostic tests, represents a pivotal moment in the multi-year effort on diagnostic regulatory reform.  

ACLA and our members are moving swiftly to review the discussion draft and will submit comments to the HELP Committee outlining our position on the policies included in the updated legislation. ACLA remains focused on ensuring that the new regulatory paradigm would fully recognize the critical role of clinical laboratories in public health and patient health, preserve and foster innovation in clinical laboratories, while maintaining access to empower providers and patients in health care decisions.  

ACLA members are high-complexity, CLIA-certified and CAP-accredited clinical laboratories and leaders on the forefront of medical innovation across virtually all areas of patient care and public health. Through the development and validation of laboratory developed tests (LDTs), ACLA members address unmet medical needs, aid diagnoses and guide treatment and prevention, which, taken together, reduce the cost and increase the quality of care available to patients. While laboratories have been driving innovation for decades across common and rare diseases alike, the pandemic has made the public acutely aware of the value of clinical laboratories and laboratory tests in facilitating informed and quality health care decisions. Laboratories need clarity and certainty in the regulatory environment to respond to public health emergencies, encourage innovation and develop the next generation of breakthrough technologies.”    

ACLA’s comments on the VALID Act, as introduced in the U.S. House of Representatives in 2021, are available 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 and NACDS, 65 Patient Groups, Provider and Public Health Organizations Urge Congress to Replenish the HRSA COVID-19 Uninsured Relief Fund

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) and the National Association of Chain Drug Stores (NACDS) today sent a letter with over 60 leading organizations representing patients, health care professionals, hospitals, public health, laboratories, and diagnostic manufacturers urging Senate and House leaders to replenish the Health Resources and Services Administration (HRSA) COVID-19 Uninsured Relief Fund. In the letter, the organizations urged Congress to take immediate action and replenish the fund to protect Americans’ ability to access testing, treatments and vaccinations without cost-sharing. 

“Throughout the pandemic, federal COVID-19 funding supporting access to testing has been essential to our nation’s pandemic response,” said Tom Sparkman, ACLA Senior Vice President, Government Affairs and Policy. “As a result of the COVID-19 Uninsured Relief Fund, ACLA members have performed more than 8 million tests for uninsured individuals in 2021 alone. We must continue to support access to testing for all Americans, regardless of their insurance status, as testing remains a critical need to fight the pandemic.” 

HRSA, which administers the program, has been unable to reimburse providers for testing and treatment since March 22 and stopped accepting claims for vaccinations on April 5. The letter emphasizes that without Congressional action, providers across the country will be “left without recourse to handle the influx of demand from uninsured Americans, forcing them to make decisions about the long-term sustainability of providing COVID-19 tests and services.” 

The COVID-19 Uninsured Relief Fund originally was established by the Families First Coronavirus Response Act and has been replenished as needed throughout the pandemic, most recently through the 2021 American Rescue Plan Act. The COVID-19 Uninsured Relief Fund has successfully provided life-saving access to COVID-19 testing for uninsured individuals and ensured that all Americans could access testing, treatments and vaccinations when needed.

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.