All posts by dapfel

ACLA Statement on CDC Clinical Practice Guideline for Opioid Treatment

ACLA News, All News, ACLA Press Releases

Washington D.C. – In response to newly released CDC guidance on prescribing opioids for pain, the American Clinical Laboratory Association (ACLA) released the following statement:

“ACLA commends the CDC for developing evidence-based guidelines on opioid treatment that include recommendations on appropriate utilization of drug testing to assess use of prescribed medications as well as other prescribed and nonprescribed controlled substances. ACLA previously commented on the draft guidelines to recommend the CDC further clarify when and how clinicians should utilize clinical toxicology drug testing to ensure the responsible and effective use of prescribed opioids and other controlled medications and to reference the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for select opioid therapy to ensure that patients receive individualized care.

ACLA supports implementation of the new CDC guideline as testing performed as a part of a well-developed treatment plan for an individual with subacute and chronic pain vastly improves providers’ abilities to characterize risk for adverse events, including overdose, medication diversion, medication adherence, and/or therapeutic failures. The new guidelines also account for the proliferation of new psychoactive substances (e.g., fentanyl analogs, designer benzodiazepines) and illicit counterfeit tablets containing highly potent opioids, which require definitive testing methodologies to allow for specific identification of use of these compounds. 

ACLA also supports the guideline’s focus on vigilance in attending to health inequities through a multimodal and multidisciplinary approach to pain management. The comparison of available methodologies for testing included within the guideline will assist clinicians in making appropriate treatment decisions as they seek to provide care to all individuals at risk for adverse events, including those in underserved communities, amid the ongoing opioid epidemic.”

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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 Leads #StopLabCuts Twitter Day of Advocacy Urging Congress to Pass the Saving Access to Laboratory Services Act

ACLA Blog, PAMA Reform, All News

The American Clinical Laboratory Association (ACLA) recently led a Twitter Day of Advocacy to raise awareness of the Saving Access to Laboratory Services Act (SALSA / S. 4449 / H.R. 8188) and to demonstrate widespread support for this bipartisan legislation among ACLA members, physician and patient groups, and laboratory professionals.  

The effort was part of ACLA’s comprehensive Stop Lab Cuts campaign, which urges Congress to protect patients’ access to routine testing and laboratory services from impending cuts in 2023. The campaign includes advertising, media outreach, grassroots engagement, and stakeholder education and activation to urge Congress to enact SALSA this year.

The Twitter Day of Advocacy generated more than 100 tweets and retweets sharing the #StopLabCuts hashtag, reaching close to 12,000 Twitter users. Throughout the week, 500,000 Twitter users were reached via our #StopLabCuts efforts. Many individuals across the country took the opportunity to engage directly with members of Congress, calling on them to co-sponsor this important legislation. 

SALSA would reform the 2014 Protecting Access to Medicare Act (PAMA), which has led to years of significant cuts to Medicare payments for routine laboratory tests that guide clinical decision-making. If enacted, SALSA would set Medicare reimbursement for widely available laboratory services on a sustainable path forward.

Advocates on Twitter helped make clear that Congress must act now to protect access to routine testing for patients, encourage innovation in next generation of clinical laboratory tests, and strengthen the national clinical laboratory infrastructure to ensure we are prepared to manage future public health crises.

Visit StopLabCuts.org to learn more and see below for additional highlights from the #StopLabCuts Twitter Day of Advocacy.

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

ACLA Blog, All News

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 

PAMA Reform, ACLA News, ACLA Press Releases

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

ACLA News, All News, ACLA Press Releases

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

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

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.