All posts by dlemle

ACLA, Key Stakeholders Urge Medicare Administrative Contractors to Ensure Access to Genetic Testing for Oncology

Reimbursement and Coverage, ACLA Press Releases, Regulatory Issues

Washington, D.C. – The American Clinical Laboratory Association (ACLA), along with 44 stakeholders, sent a letter to Medicare Administrative Contractors (MACS), Novitas Solutions Medical Affairs and First Coast Service Options, Inc. (FCSO), raising significant concerns with their draft local coverage determinations (LCDs) that, within their jurisdictions, would harm access to clinically appropriate genetic testing for Medicare beneficiaries with cancer. The signatories united in opposition to the draft LCDs include the nation’s leading cancer-related provider groups and patient advocates. The concerns raised by the broad group echoed those detailed in a separate letter ACLA sent to the MACs on the same date.

As it currently stands, the draft LCDs, entitled “Genetic Testing for Oncology,” would automatically deny coverage for any genetic tests not currently included within at least one of three identified third-party “knowledgebases.” ACLA and fellow signatories note that this approach does not comport with the requirements of the Social Security Act and implementing guidance, nor does it give stakeholders sufficient information to evaluate the contractors’ coverage decisions through the required notice-and-comment procedures and process.

Under the draft LCDs, if a genetic test is not included in the “knowledgebases” and non-covered, a provider, organization, or Medicare beneficiary may submit a reconsideration request. However, this process is not transparent, can take years and would delay patient access to testing.

All patients, especially those with cancer, require timely access to diagnostics that inform their treatment. ACLA and stakeholders believe there is broader concern that the draft LCDs’ presumptive non-coverage approach will create additional barriers for Medicare beneficiaries seeking access to newer, and often more innovative, diagnostics.

“Medicare beneficiaries with cancer should have robust and timely access to valuable, appropriate genetic tests used to guide their treatment,” said Susan Van Meter, ACLA President. “We urge Novitas and FCSO not to finalize this LCD as drafted and instead work with stakeholders to address our significant concerns.”

The letter is available here and the appendix can be found here. A complete list of signatories is below:

Advanced Practitioner Society for Hematology and Oncology

AliveAndKickn

American Cancer Society Cancer Action Network

American Clinical Laboratory Association

American College of Medical Genetics and Genomics

American Gastroenterological Association

American Society for Clinical Pathology

American Society for Radiation Oncology

Association for Molecular Pathology

Association of Community Cancer Centers

Biomarker Collaborative

Bladder Cancer Advocacy Network (BCAN)

Blood Profiling Atlas in Cancer (BLOODPAC)

Cancer Support Community

Cancer Support Community Delaware

Cancer Support Community Greater Lehigh Valley

CancerCare

Caregiver Action Network

Cholangiocarcinoma Foundation

College of American Pathologists

Community Liver Alliance

FORCE: Facing Our Risk of Cancer Empowered

Free ME from Lung Cancer

GI Cancers Alliance

Gilda’s Club South Florida, Inc.

GO2 for Lung Cancer

ICAN, International Cancer Advocacy Network

Living Beyond Breast Cancer

Lung Cancer Research Foundation

LUNGevity Foundation

MET Crusaders

National Alliance of State Prostate Cancer Coalitions

National Marrow Donor Program/Be The Match

National Ovarian Cancer Coalition

Patient Advocates In Research (PAIR)

Patient Empowerment Network

PD-L1 Amplifieds

Raymond Foundation

Sharsheret

The Clearity Foundation

The Exon 20 Group

The Life Raft Group

The White Ribbon Project

Triage Cancer

Upstage Lung Cancer

###

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.

Routine Health Checkups – Including Recommended Laboratory Tests – Improve and Save Men’s Lives

ACLA Blog, ACLA News

June is Men’s Health Month, an opportunity to focus on the many ways that recommended clinical laboratory testing is essential in assessing, addressing and managing men’s health. In what has been called a “silent health crisis,’’[1] research shows that, compared to women, men are less likely to see the doctor, and are at greater risk of death[2] from a variety of health issues. According to a recent survey,[3] more than half of men say they do not get regular health checkups, which means they are missing out on recommended routine clinical laboratory tests that are key to maintaining optimal health and diagnosing many conditions.

These missed regular checkups contribute to higher death rates and a significant lifetime longevity gap between men and women. In 2021, men’s life expectancy[4] was nearly 6 years shorter than women’s, with an average of 73.2 years for men and 79.1 years for women. This difference in expected lifespan is the largest seen in the United States since 1996.

A lack of regular checkups means reduced opportunities for men and their providers to help prevent, identify and treat adverse health outcomes that can lead to reduced quality of life and earlier morbidity and mortality from conditions like diabetes, heart disease and prostate cancer.

Men should also be screened at regular wellness visits through laboratory tests for levels of cholesterol and blood glucose. Diabetes and high levels of cholesterol increase the risk of heart disease, the leading killer of men in the United States,[5] accounting for about a quarter of male deaths. An A1C test[6] can help diagnose prediabetes and diabetes, and a lipid panel can identify abnormalities with cholesterol and triglycerides that determine approximate risk of cardiovascular disease.

Clinical laboratory testing is also a critical tool in cancer detection, including for those that are specific to or more commonly diagnosed in men. Prostate cancer, the second-most common cancer in men, can be flagged by the prostate-specific antigen (PSA) blood test, which may prompt further testing to confirm a diagnosis and lead to better outcomes in the 1 in 8 men[7] likely to have prostate cancer in their lifetime. Another kind of blood test measures levels of serum tumor markers for testicular cancer, helping clinicians more accurately define the cancer stage and plan treatment accordingly.

Colorectal cancer has higher incidence and mortality rates in men. However, partly because colorectal cancer screening guideines have led to earlier detection and treatment, the death rate from this form of cancer has been dropping for decades.[8] Advancements in clinical laboratory screenings for colorectal cancer, including the guaiac-based fecal occult blood test (gFOBT), fecal immunochemical test (FIT) and stool DNA test, help identify the disease earlier,[9] prompting earlier intervention and treatment. Additionally, while most often associated with breast cancer in women, mutations in the BRCA1 and BRCA2 genes can increase the risk[10] of breast cancer, high-grade prostate cancer, and pancreatic cancer in men. Clinical laboratory tests help identify genetic mutations that increase these risks.

Clinical laboratories are vital in assessing and managing men’s health, providing insights and guidance that improve health and save the lives of fathers, brothers, husbands, sons, and friends. This Men’s Health Month, ACLA urges men to proactively engage in their health care management, talk to their providers and follow through on recommended clinical laboratory testing.

[1] Men’s Health Network, https://menshealthnetwork.org/lib.php?d=silenthealthcrisis.pdf

[2] Washington Post, https://www.washingtonpost.com/wellness/2023/04/17/mens-health-longevity-gap/

[3] Cleveland Clinic, https://newsroom.clevelandclinic.org/2022/09/07/cleveland-clinic-survey-reveals-mens-top-health-concerns-as-they-age/

[4] Centers for Disease Control & Prevention, https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/20220831.htm

[5] Centers for Disease Control & Prevention, https://www.cdc.gov/heartdisease/men.htm#:~:text=How%20does%20heart%20disease%20affect,in%20every%204%20male%20deaths

[6] Centers for Disease Control & Prevention, https://www.cdc.gov/diabetes/managing/managing-blood-sugar/a1c.html#:~:text=The%20A1C%20test%E2%80%94also%20known,care%20team%20manage%20your%20diabetes.

[7] American Cancer Society, https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html

[8] American Cancer Society, https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html

[9] WebMD, https://www.webmd.com/cancer/cancer-screenings-men

[10] Centers for Disease Control & Prevention, https://www.cdc.gov/cancer/breast/men/index.htm

ACLA and 33 Provider Organizations Urge Congress to Protect Americans’ Access to Essential Laboratory Tests

Public Health Preparedness and Infrastructure, Saving Access to Laboratory Services Act, ACLA News, All News, Reimbursement and Coverage, ACLA Press Releases, Regulatory Issues

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.

###

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 

Public Health Preparedness and Infrastructure, ACLA News, All News, ACLA Press Releases, Regulatory Issues, , ,

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.

# # #

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

ACLA Blog, ACLA News

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

Laboratory Professionals Week, Public Health Preparedness and Infrastructure, ACLA Blog, ACLA News, All News

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

ACLA News, ACLA Press Releases, Regulatory Issues

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.”

###

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.