All posts by dlemle
ACLA and 33 Provider Organizations Urge Congress to Protect Americans’ Access to Essential Laboratory Tests
Washington, D.C. – The American Clinical Laboratory Association has joined with more than 30 health care provider organizations to urge House and Senate leadership to protect patient access to clinical laboratory services by passing the Saving Access to Laboratory Services Act (SALSA / H.R. 2377 / S. 1000) this year.
In a letter to House and Senate leaders sent today, the provider organizations make the case that “without congressional action, Medicare reimbursement cuts – a fourth round scheduled to begin January 1, 2024 – could jeopardize access to many clinical laboratory tests that are used to diagnose, monitor, prevent, and manage common diseases for Medicare beneficiaries.” The letter states further that repeated payment cuts undermine the nation’s laboratory infrastructure essential for day-to-day care and in times of emergency, while dampening innovation in advanced diagnostics, which has not only led to earlier detection of disease but has also become a crucial tool in how care is delivered.
The broad group of signers includes AdvaMedDx, American Academy of Family Physicians, American Hospital Association, American Medical Association, College of American Pathologists, Infectious Disease Society of America, and the National Independent Laboratory Association. The letter and full list of signatories are included below.
“ACLA is grateful for the strong collaboration from across the health care provider community, from hospitals, laboratories, physicians, and medical specialties organizations, to press Congress to act to pass SALSA this year,” said Susan Van Meter, ACLA President. “SALSA is the bipartisan, bicameral, straightforward solution for sustainable reimbursement that would protect patient access to laboratory services, bolster clinical laboratory infrastructure, and foster innovation in the next generation of laboratory testing.”
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). Congress has previously delayed additional rounds of cuts three times.
Absent congressional intervention, about 800 tests will receive up to 15 percent cuts on January 1, 2024. 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.
Learn more about the Stop Lab Cuts campaign and how Americans could be harmed by further cuts to laboratory services here.
The letter is here and the complete list of signatories is below:
AdvaMedDx
ADVION (Formerly the National Association for the Support of Long Term Care (NASL))
American Academy of Family Physicians
American Association for Clinical Chemistry
American Association of Bioanalysts
American Clinical Laboratory Association
American College of Osteopathic Family Physicians
American Hospital Association
American Medical Association
American Medical Technologists
American Society for Clinical Laboratory Science
American Society for Clinical Pathology
American Society for Histocompatibility and Immunogenetics
American Society for Microbiology
American Society of Nephrology
AMGA
Association for Molecular Pathology
Association of American Medical Colleges
Association of Pathology Chairs
Association of Public Health Laboratories
California Clinical Laboratory Association
COLA Inc.
College of American Pathologists
Federation of American Hospitals
Infectious Diseases Society of America (IDSA)
Medical Group Management Association (MGMA)
National Independent Laboratory Association
National Rural Health Association
New Jersey Association of Mental Health and Addiction Agencies, Inc.
New York State Clinical Laboratory Association
Personalized Medicine Coalition
Point of Care Testing Association
The Gerontological Society of America
American College of Medical Genetics and Genomics
*Updated on 5/22/23.
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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 by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.
ACLA Affirms Laboratories’ Commitment to Patient Access to COVID-19 Diagnostic Testing; Reflects on Industry Response as Formal Public Health Emergency Ends
Washington, D.C. – The American Clinical Laboratory Association (ACLA) today issued the following statement as the federal government’s formal declaration of a Public Health Emergency (PHE) for COVID-19 ends:
“Since the outset of the COVID-19 pandemic in early 2020, ACLA member laboratories led the way developing, scaling, and performing hundreds of millions of tests for SARS-CoV-2 in communities in every state across the country, serving as an essential element of the nation’s health infrastructure, supporting the U.S. response to the pandemic. ACLA is grateful for the expertise and tireless dedication of our nation’s laboratory professionals.
Though the COVID-19 Public Health Emergency may be officially ending today, the need for quality SARS-CoV-2 testing remains. ACLA members will continue to provide patients and clinicians throughout the country with robust access to testing services, including molecular laboratory testing, which is the gold standard for detection of the virus. ACLA encourages public and private insurers to provide broad coverage for testing now and throughout any potential surges of the virus we may face in the future.
As Congress works to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) this year, ACLA – informed by the experiences and expertise of its members – is engaging with policymakers to advocate for meaningful improvements to the nation’s health emergency preparedness and response efforts, ensuring enhanced readiness to provide quality testing for future pathogens of concern.”
Read more about ACLA’s efforts supporting public health preparedness and infrastructure 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 by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.
Clinical Laboratory Testing Crucial for Women Across Many Life Stages
May is Women’s Health Month – a perfect opportunity to focus on the value clinical laboratories bring to supporting women and their clinicians in evaluating and optimizing their overall health, including testing for diseases and conditions that either disproportionately or solely affect women, which include:
Heart Disease
Heart disease is the leading cause of death for women in the United States, accounting for about 1 in every 5 female deaths.[1] Routine blood tests performed by clinical laboratories[2] measure cholesterol (both HDL, “good” and LDL “bad” cholesterol), triglycerides, and C-reactive protein (CRP), which can be indicators of coronary artery disease. An A1C test blood test measures average blood sugar levels over 3-month periods and is commonly used to diagnose prediabetes and diabetes, which are closely associated with heart disease. Test results can help women and their clinicians make decisions about how best to optimize their health, including through diet, medication, and physical activity. Of course, it is important for women to recognize the signs and symptoms of heart attack, which may not look the same in women as in men. When experiencing a heart attack, chest pain is a warning, but it does not occur in everyone. Women are more likely than men to experience nausea, light-headedness, or unusual fatigue. [3] As about 1 in 5 heart attacks are silent, knowing the signs and symptoms is critical to getting timely care.[4]
Cancer
Innovation in clinical laboratory testing has dramatically improved cancer detection in women, allowing for earlier interventions and tailoring of new therapies that can extend life. For example, genetic testing for higher-risk patients can reveal early warnings of gene mutations that could increase the risk of breast cancer, cervical cancer, and others, with early detection improving survival rates. Biomarker testing[5] looks for genes, proteins, and other substances that can identify the characteristics of cancer, allowing a doctor to customize the course of treatment. Pap and HPV tests screen for cervical cancer. Along with HPV vaccination and treatments, screening through laboratory testing has helped reduce incidence and deaths from cervical cancer, once one of the most common causes of cancer death in women,[6] by 50 percent since the 1970s.
Thyroid Disease
Thyroid disease is up to eight times more likely in women, and of the overall estimated 20 million people in the U.S. who have thyroid disease,[7] about 60 percent of those affected do not know it, making laboratory screening for the disease critically important. Clinical laboratories perform a routine blood test that measures levels of key hormones, including thyroid stimulating hormone (TSH) and thyroxine (T4). Test results may prompt further investigation or medication to manage thyroid disease, which, if undiagnosed, raises the risk for osteoporosis, cardiovascular disease, and infertility.
Reproductive Health
Clinical laboratory tests can help inform important stages of women’s reproductive lives, from fertility treatment and prenatal care throughout pregnancy and childbirth. At the outset of fertility testing, anti-müllerian hormone (AMH) tests[8] estimate the number of follicles in the ovaries, helping assess reproductive health. Other tests, including follicle stimulating hormone (FSH), estradiol, prolactin and hyperprolactinemia,[9] determine levels of hormones that support development of the eggs, embryo, and the production of breast milk. Blood typing checks for Rh factor status[10] and the potential need for treatment to address anemia in a fetus and newborn or jaundice in a newborn. Non-invasive prenatal screening can indicate the possibility of fetal abnormalities and assess whether additional definitive diagnostic testing is needed.
Throughout a woman’s life, clinical laboratory tests provide important and actionable insights that can improve and save lives. This Women’s Health Month, ACLA encourages women to prioritize their health and self-care, and in consultation with your clinician, follow recommended testing guidelines.
For more information about women’s health, visit https://www.cdc.gov/women/index.htm.
[1] Centers for Disease Control and Prevention, National Center for Health Statistics. Underlying Cause of Death 1999-2019 on CDC Wonder Online Database, released in 2020. Data are from Multiple Cause of Death Files, 1999-2019, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Accessed Jan 7, 2021.
[2] Mayo Clinic, https://www.mayoclinic.org/diseases-conditions/heart-disease/in-depth/heart-disease/art-20049357
[3] Centers for Disease Control and Prevention, https://www.cdc.gov/heartdisease/heart_attack.htm
[4] Centers for Disease Control and Prevention, https://www.cdc.gov/heartdisease/facts.htm
[5] National Cancer Institute, https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment
[6] American Society of Clinical Oncology (ASCO), https://www.cancer.net/cancer-types/cervical-cancer/statistics#:~:text=It%20is%20estimated%20that%204%2C310,earlier%20detection%20of%20cervical%20cancer
[7] American Thyroid Association, https://www.thyroid.org/media-main/press-room/
[8] Yale Medicine, https://www.yalemedicine.org/news/fertility-test#:~:text=The%20AMH%20Test&text=The%20level%20of%20AMH%20in,better%20her%20chances%20of%20pregnancy.%5D
[9] Kaiser Permanente Centers for Reproductive Health, https://www.kpivf.com/fertility-101/female-fertility/
[10] The American College of Obstetricians & Gynecologists, https://www.acog.org/womens-health/faqs/the-rh-factor-how-it-can-affect-your-pregnancy
Celebrating Medical Laboratory Professionals Week
The below blog was written by ACLA President Susan Van Meter.
The American Clinical Laboratory Association (ACLA) is grateful to represent the nation’s leading clinical laboratories and during Medical Laboratory Professionals Week, to celebrate the dedication and expertise of laboratory professionals across the country whose work is foundational to informed clinical care for millions of patients.
As I have travelled the country visiting member laboratories in my first year as president of ACLA, I have been fortunate to see first-hand the expertise, commitment, and compassion of America’s laboratory professionals. I think often of one recent visit when I had the opportunity to speak with a cytotechnologist about his work. He has a great many years of experience and told me that over the course of a day he might review 100 slides, and every time he looks at a sample, he reflects on the person behind it, recognizing he has been entrusted with a vital part of their health care.
These demonstrations of expertise and expressions of compassion take place in laboratories across the country each day, where thousands of laboratory professionals deliver critical insights and data essential to patient care. In fact, 70 percent of health care decisions are based on the seven billion lab tests performed each year by laboratorians. The screening and diagnostic tests span from the routine to the cutting edge. On any given day, laboratorians are identifying cervical abnormalities that may turn into cancer without treatment, generating data to predict whether a patient’s kidney transplant will be successful, determining whether certain genes are causing a heart rhythm disorder, and so much more. Ongoing innovations in diagnostics are expanding the capabilities of laboratorians to help improve and save patient lives.
Beyond providing test results each day to clinicians and patients, laboratory professionals are also a central pillar of America’s health infrastructure, critical in times of public health emergency. In just the last several years, these dedicated professionals have worked around the clock to rapidly develop, validate, and test for novel pathogens while scaling capacity that allows access to communities across the country. They also do the critical work of providing surveillance on burden of disease, in addition to other efforts that support public health.
This Medical Laboratory Professionals Week, ACLA thanks America’s laboratorians, whose work every day improves and saves lives.
ACLA Applauds Administration’s Designation of Fentanyl-Xylazine Combination as Emerging Threat
Washington, D.C. – The American Clinical Laboratory Association (ACLA) released the following statement in response to the Biden-Harris Administration designating fentanyl-xylazine as an emerging threat:
“The American Clinical Laboratory Association (ACLA) thanks the Biden-Harris Administration’s Office of National Drug Control Policy (ONDCP), led by Dr. Rahul Gupta, for recognizing the significant health risks associated with the combination of fentanyl and xylazine. Identifying this threat as a national health risk will help reduce the ongoing negative impact that this substance combination has on the current overdose crisis and should aid in reducing unnecessary deaths. ACLA applauds the Administration’s plans to develop a national response plan that includes an emphasis on testing for these substances. Tackling this issue will require a significant coordination of public and private sector efforts to protect Americans across the country.
Clinical laboratory-developed definitive drug testing for fentanyl, xylazine, and many other illicitly-manufactured compounds that are currently in circulation can and should be employed to assist with early identification of use of these substances. Early identification of these compounds via this necessary testing modality is key to appropriate treatment and reduction of overdose risk.
ACLA strongly encourages public and private payers to employ appropriately robust payment and coverage policies for definitive drug testing to ensure widespread and equitable patient access to these essential 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 Welcomes Sarah Thibault-Sennett, PhD, as Senior Director of Reimbursement Policy
Washington, D.C. – The American Clinical Laboratory Association (ACLA) has welcomed Sarah Thibault-Sennett, PhD, as Senior Director of Reimbursement Policy.
“Sarah’s deep knowledge of reimbursement and regulatory policy issues and her experience as a laboratory scientist will enhance ACLA’s work to advance policy that fosters innovation and expands patient access to quality laboratory testing services being delivered every day by ACLA members across the country,” said Susan Van Meter, President of ACLA. “We are gratified to have Sarah join ACLA.”
At ACLA, Sarah will serve a key role in the association’s work supporting innovation in laboratory services that deliver life-saving results for patients and pave the access pathway for future clinical laboratory advancements. She will focus on ensuring that reimbursement policies provide appropriate access to testing for patients and the health care providers who detect, prevent, manage, and diagnose acute, chronic, and infectious diseases through the power of clinical laboratory testing.
Sarah was previously the Director of Public Policy & Advocacy at the Association for Molecular Pathology (AMP). She has a strong background in patient engagement and regulatory issues affecting molecular pathology, as well as molecular genetics and developmental biology. She transitioned into public policy with the goal of increasing patient access to appropriate diagnostic testing.
Sarah holds a PhD in Molecular and Cell Biology from the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD, as well as a Bachelor of Science degree in Biology from Bucknell University.
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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 Response to Senate HELP RFI on PAHPA
Screening, Diagnosis and Treatment are Key to Addressing Nationwide Spike in STIs
April is Sexually Transmitted Infections (STI) Awareness Month, a time to encourage conversation and education around the importance of sexual health in promoting overall wellness. When undiagnosed and left untreated, STIs can lead to irreversible health outcomes such as chronic pelvic pain, infertility, adverse pregnancy outcomes, neonatal death, and congenital abnormalities, and can facilitate human immunodeficiency virus (HIV) acquisition. Human papillomavirus (HPV) can cause numerous forms of cancer, although most HPV types associated with cancer are preventable through vaccination. What’s more, the U.S. Centers for Disease Control and Prevention (CDC) reports a continued and alarming increase in the spread of STIs, driven partly by reduced screenings early in the COVID-19 pandemic.[1] Screening, early diagnosis and treatment are essential to maintaining overall health.
Amid this worrisome increase, ACLA is highlighting the vital role of clinical laboratories in accurately identifying STIs so health care providers can treat or cure these infections and help stem their spread.
Sexually transmitted infections impact millions of Americans each year, with the overall reported number of STIs increasing since 2014. In fact, the CDC reports that between 2016 and 2020, cases of gonorrhea increased 45 percent; syphilis increased 52 percent; and congenital syphilis (mother-to-baby) increased by a staggering 235 percent.[2] While the prevalence of these infections has increased as a whole, young people, racial and ethnic minorities, and gay and bisexual men have been disproportionately impacted.
Given the continued prevalence of STIs, the CDC and U.S. Preventive Services Task Force (USPSTF) recommend regular screenings for most adolescents and adults. For example, USPSTF recommends screening for gonorrhea and chlamydia in all sexually active women ages 24 years or younger and women ages 25 years or older who are at increased risk for infection.[3] Clinical laboratory tests accurately identify patients with gonorrhea and chlamydia by utilizing swab tests collected by a patient’s clinician, which can then be easily treated.[4]
STI detection through clinical laboratory testing can save lives. When used for cervical cancer screening, research has shown that testing for HPV reduces a woman’s likelihood of developing ovarian cancer when compared to those who have not been tested for HPV.[5] Also, research has highlighted that clinical laboratory tests can predict the risk of serious complications resulting from syphilis.[6]
Sexual health is an important component of an individual’s overall health and wellness. With a continued increase of STI prevalence across the country, there’s an urgent need for timely screening and clinical testing. America’s clinical laboratories take seriously their role in providing clear insights to bolster health across the nation.
For more information on screening for sexually transmitted infections, visit https://www.cdc.gov/std/prevention/screeningreccs.htm.
[1] Centers for Disease Control & Prevention, https://www.cdc.gov/nchhstp/newsroom/fact-sheets/std/std-us-2020.html.
[2] Centers for Disease Control & Prevention, https://www.cdc.gov/nchhstp/newsroom/fact-sheets/std/std-us-2020.html.
[3] U.S. Preventive Services Task Force, https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/chlamydia-and-gonorrhea-screening
[4] Martin, D H, et al. “Multicenter Evaluation of AMPLICOR and Automated Cobas AMPLICOR CT/NG Tests for Neisseria Gonorrhoeae.” Journal of Clinical Microbiology, U.S. National Library of Medicine, Oct. 2000, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC87434/.
[5] Ogilvie, Gina Suzanne, et al. “Effect of Screening with Primary Cervical HPV Testing vs Cytology Testing on High-Grade Cervical Intraepithelial Neoplasia at 48 Months.” JAMA, vol. 320, no. 1, 2018, p. 43., https://doi.org/10.1001/jama.2018.7464.
[6] Marra, Christina M., et al. “Cerebrospinal Fluid Abnormalities in Patients with Syphilis: Association with Clinical and Laboratory Features.” The Journal of Infectious Diseases, vol. 189, no. 3, 2004, pp. 369–376., https://doi.org/10.1086/381227.
ACLA Statement on Texas Court Ruling on Preventive Screening Coverage
Washington D.C. – The American Clinical Laboratory Association (ACLA) released the following statement in response to a Texas court striking down an Affordable Care Act (ACA) provision requiring coverage of certain medical screenings at no cost to patients:
“The American Clinical Laboratory Association (ACLA) is deeply concerned by the decision of a Texas federal court to strike a critical Affordable Care Act provision requiring insurers and health plans to cover preventive services at no cost to patients, including routine screenings used to detect common diseases like cancer, diabetes, and heart disease. Millions of Americans and their health care professionals rely on these essential screenings, including through clinical laboratory services, to provide accurate and reliable information to manage health and guide treatment plans. This ruling will jeopardize access to clinical laboratory and other screening services central to health care delivery that improve and save lives. Further, by eliminating the coverage requirement, this ruling will reduce access to critical screening services for underserved populations, who already bear an outsized burden of disease for many illnesses for which screening is recommended.”
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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.
