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Screening, Diagnosis and Treatment are Key to Addressing Nationwide Spike in STIs

ACLA Blog, ACLA News

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

ACLA News, Reimbursement and Coverage, ACLA Press Releases, Regulatory Issues

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.

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

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

Association Relaunches ‘Stop Lab Cuts’ Campaign

Washington, D.C. – The American Clinical Laboratory Association (ACLA) today welcomed the bipartisan and bicameral introduction of the Saving Access to Laboratory Services Act (SALSA). The bipartisan bill would ensure that America’s seniors’ access to lifesaving clinical laboratory tests and services would be maintained by alleviating deep Medicare payment cuts next year.

The bill was introduced by Sens. Sherrod Brown (D-OH) and Thom Tillis (R-NC), along with Reps. Richard Hudson (R-NC), Bill Pascrell, Jr. (D-NJ), Gus Bilirakis (R-FL), Scott Peters (D-CA), and Brian Fitzpatrick (R-PA). The legislation seeks to address the consequences of the flawed implementation of the 2014 Protecting Access to Medicare Act (PAMA), which has led to repeated, significant payment cuts for routine laboratory tests that guide clinical decision-making.  

“It’s time for a permanent legislative solution that preserves and sustains critical clinical laboratory services for seniors,” said Susan Van Meter, president of ACLA. “With strong bipartisan and bicameral support of SALSA, Congress has the opportunity to fix the flawed PAMA framework and prevent reduced access to essential testing, stifled innovation, and weakened laboratory infrastructure essential to public health preparedness. Congress must pass SALSA now.”

At the time PAMA was enacted, the Congressional Budget Office (CBO) projected $2.5 billion in cuts to reimbursement rates over 10 years. However, PAMA has already led to nearly $4 billion in payment cuts to laboratories after three years of reductions. 

Absent congressional intervention, payment for about 800 tests will be cut up to 15 percent on January 1, 2024. Collectively, these cuts may threaten access to laboratory services that help diagnose and treat 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 workforce shortages and inflationary pressure on costs.

“ACLA thanks Sens. Brown and Tillis, and Reps. Hudson, Pascrell, Bilirakis, Peters, and Fitzpatrick for introducing SALSA, fighting for seniors’ access to clinical laboratory services, and keeping the clinical laboratory infrastructure healthy,” said Van Meter. “Patients are counting on Congress to act.”

ACLA has also re-launched the “Stop Lab Cuts” advocacy campaign, mobilizing broad SALSA support from organizations serving providers, hospitals, and patients. The campaign serves as a central advocacy hub and resource for information on the need for PAMA reform. Visit StopLabCuts.org to learn more.

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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.

Clinical Laboratories’ Role in Informing Kidney Health

ACLA Blog, ACLA News, All News

During March’s National Kidney Month, ACLA is highlighting the essential role that clinical laboratories serve in the diagnosis and management of kidney health. In the United States, diabetes and high blood pressure are the leading causes of kidney failure, accounting for three out of four new cases.[1] Also, chronic kidney disease (CKD) is a leading cause of death in the United States. Experts have noted that with appropriate kidney screening, patients at high risk for CKD have seen a 34 percent reduction in risk of death and an 80 percent reduction in their risk of end-stage renal disease.[2]

The kidneys have a number of functions, including filtering waste from blood. When kidney function declines, waste builds up, leading to an array of potential complications. Fortunately, routinely performed clinical laboratory tests can help determine if kidneys are functioning normally. For example:

  • Blood urea nitrogen (BUN) and creatinine A levels, measured from a comprehensive metabolic panel blood test, can be indicators for early signs of kidney disease.
  • Cystatin C (sCysC) tests have improved the accuracy of risk categorization for patients who may develop CKD or reduced kidney function in the future.[3]  These same tests can also help predict with high accuracy the likelihood of at-risk patients developing acute kidney complications after COVID-19 infections.[4]  
  • Innovative diagnostic laboratory tests can help kidney transplant patients avoid unnecessary biopsies or identify potential transplant rejection prior to symptoms.

ACLA and its members will continue to collaborate with providers, policymakers, patient advocates, and public health leaders to demonstrate the value of clinical laboratory testing and champion diagnostic innovations that promote kidney health and reduce the impact of CKD.

For more information about kidney disease, visit https://www.cdc.gov/kidneydisease/basics.html

[1] Centers for Disease Control & Prevention, https://www.cdc.gov/kidneydisease/basics.html

[2] Centers for Disease Control & Prevention, https://www.cdc.gov/kidneydisease/basics.html

[3] Shlipak, M. G., Matsushita, K., Ärnlöv, J., Inker, L. A., Katz, R., Polkinghorne, K. R., … & Gansevoort, R. T. (2013). Cystatin C versus creatinine in determining risk based on kidney function. New England Journal of Medicine, 369(10), 932-943.

[4] Shlipak, M. G., Matsushita, K., Ärnlöv, J., Inker, L. A., Katz, R., Polkinghorne, K. R., … & Gansevoort, R. T. (2013). Cystatin C versus creatinine in determining risk based on kidney function. New England Journal of Medicine, 369(10), 932-943.

Clinical Laboratory Tests Offer Line of Defense Against Colorectal Cancer

ACLA Blog, ACLA News, All News

America’s clinical laboratories play a critical role in the prevention and detection of colorectal cancer, as well as in the identification and monitoring of appropriate therapies. Colorectal cancer is the second deadliest cancer in the United States affecting both men and women. This Colorectal Cancer (CRC) Awareness Month, ACLA adds its voice to those raising awareness of CRC and is highlighting the value of non-invasive screening and diagnostic tests performed by clinical laboratories.

In 2019, the U.S. Centers for Disease Control and Prevention (CDC) reported 142,462 new cases of CRC in the United States alone.[1] Fortunately, increased screening has led to a 25.5 percent reduction in CRC incidence and a 52.4 percent reduction in CRC deaths between 2000 and 2015.[2]  

It is estimated that one in three adults are not up to date with the CDC’s recommended screening guidelines for CRC. In fact, over 75 percent of people who died from CRC did not receive a recommended screening test. Most people should begin screening for CRC at age 45, then continue screening at regular intervals. Some individuals should be screened earlier, especially if they have an inflammatory bowel disease, family history of CRC, or a genetic syndrome such as familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (Lynch syndrome).[3]

Colorectal cancer screening through clinical laboratory tests is very effective and paramount to determining patient care pathways. For patients diagnosed with CRC, laboratory-run genetic tests can help identify the right medication and guide disease management decisions. Identification of disease-causing genetic variants can guide further testing and diagnosis of individuals with a family history of certain inherited disorders leading to CRC.

Clinical laboratory tests, including recent innovations such as DNA-based stool or blood sample tests, help identify CRC in its earliest stages, when it is most treatable. Laboratory tests work to detect the disease in different ways:

  • The fecal immunochemical test (FIT) looks for blood hidden in the stool
  • The guaiac-based fecal occult blood test (gFOBT) generates a chemical reaction to find blood hidden in the stool
  • A stool DNA test looks for abnormal sections of DNA from cancer or polyp cells as well as for hidden blood
  • A test can detect signs of CRC via molecular material in a blood sample.

Patients should follow the screening interval recommendations for the type of test they use. 

Clinical laboratories are making a difference saving and improving lives. By encouraging patients to receive their recommended screenings — either through non-invasive laboratory tests or endoscopic methods — and enabling clinicians to personalize CRC treatment through specialized laboratory testing, we can make strides toward significantly reducing incidence and death from CRC.

For more information about colorectal cancer, visit https://www.cdc.gov/cancer/colorectal/index.htm.

[1] Centers for Disease Control & Prevention, https://gis.cdc.gov/Cancer/USCS/#/AtAGlance/

[2] Levin, T. R., Corley, D. A., Jensen, C. D., Schottinger, J. E., Quinn, V. P., Zauber, A. G., … & Doubeni, C. A. (2018). Effects of organized colorectal cancer screening on cancer incidence and mortality in a large community-based population. Gastroenterology, 155(5), 1383-1391.

https://www.sciencedirect.com/science/article/abs/pii/S0016508518347838

[3] Centers for Disease Control & Prevention, https://www.cdc.gov/cancer/colorectal/index.htm.

American Clinical Laboratory Association Elects Officers for 2023-2024 Board of Directors

ACLA News, ACLA Press Releases

Washington, D.C. – The American Clinical Laboratory Association (ACLA)  announced the election of its Board officers for 2023-2024, confirmed by a membership vote today at the Association’s annual meeting.

William Morice II, M.D., Ph.D., president and CEO of  Mayo Clinic Laboratories, was re-elected ACLA Board Chair for a second term. Jerry Hussong, M.D.,M.B.A., CEO of Sonic Healthcare USA, and Adam Schechter, president, chairman and CEO of Labcorp, were re-elected Vice Chairs. Kevin Conroy, chairman and CEO of Exact Sciences Corporation, was elected Treasurer.

“Dr. Morice’s leadership and depth of expertise have been invaluable assets to the ACLA team and our membership as a whole,” said Susan Van Meter, president of ACLA. “It is a privilege to work in collaboration with him and board officers Dr. Hussong and Messrs. Schechter and Conroy to advance advocacy priorities on behalf of the clinical laboratory industry and the patients and providers we serve. Together, we are committed to achieving our advocacy priorities that include securing long term Medicare payment reform for clinical laboratories through passage of the Saving Access to Laboratory Services Act (SALSA) this year. We are also focused on advancing reimbursement, regulatory and preparedness policies that support innovation and bolster both the nation’s clinical laboratory infrastructure and workforce to ensure access to laboratory testing services that improve and save lives.”

To view the full list of ACLA’s board members, 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.

Clinical Laboratory Tests: Essential Tools for Detecting and Managing Heart Disease

ACLA Blog, ACLA News, All News

This American Heart Month, we are reminded of the vital role that clinical laboratory testing services play in the prevention, detection, and management of heart disease.

For decades, providers have relied on certain clinical laboratory tests to assess their patients’ heart health. Test results can help identify risks for developing heart disease or reveal critical data informing how diagnosed heart disease is being managed. With one in every five deaths in the United States linked to heart disease, it is the single biggest killer of adults in this country. While many have knowns risks – such as high blood pressure, diabetes, high cholesterol, or a history of smoking – even those without obvious risk factors can have underlying heart issues.

Routine physicals that include clinical laboratory blood testing can provide early warning signs of cardiac issues, giving providers and patients an intervention opportunity to help lessen the chance of serious heart problems down the road.

For example, health care providers use cholesterol screening to assess whether a patient has high levels of LDL cholesterol. This so called “bad” cholesterol can create plaque in the arteries – known as atherosclerosis – that can lead to a heart attack or stroke. 

In addition to high cholesterol, researchers have become increasingly focused on the role of chronic inflammation in arterial plaque buildup caused by injury, infection, or chronic disease.[1] Blood tests run by clinical laboratories can measure levels of C-reactive protein (CRP), which is produced by the liver when there is inflammation in the body. Studies have shown that elevated levels of CRP may predict risk of a first heart attack up to eight years in advance.

Blood glucose tests help assess the risk of developing insulin resistance, prediabetes, and type 2 diabetes. Those with diabetes are two to four times more likely than others to develop heart disease. Another blood test measures for the thyroid-stimulating hormone (TSH) and thyroid function. TSH influences the force and speed of the heartbeat and blood pressure as well as cholesterol levels.

For more information about heart disease, visit https://www.cdc.gov/heartdisease/index.htm.

[1] Sorriento D, Iaccarino G. Inflammation and Cardiovascular Diseases: The Most Recent Findings. Int J Mol Sci. 2019 Aug 9;20(16):3879. doi: 10.3390/ijms20163879. PMID: 31395800; PMCID: PMC6719998.

Clinical Laboratories’ Role in Eradicating Cervical Cancer

ACLA Blog, All News, ACLA News

Clinical laboratory services play a critical role in evaluating womens’ cervical health. The utilization of screening tools, made possible by the ever-advancing capabilities of clinical laboratories, helps diagnose about 13,000 new cases of cervical cancer annually and, just as importantly, helps identify risk factors for hundreds of thousands of women.[1] Early detection and diagnosis can help reduce the more than 4,000 annual deaths in the US from cervical cancer.[2] 

Two common diagnostic laboratory tests screen for and monitor cervical cancer risk. The Pap test looks for precancers, or cell changes on the cervix that might become cervical cancer if not addressed. The human papillomavirus (HPV) test looks for the virus that can cause these precancer cell changes. Vaccination against HPV is another important addition to cervical cancer prevention.  

The US Centers for Disease Control and Prevention (CDC) recommends that women begin screening for cervical cancer at age 21, starting with a routine Pap test. Between the ages of 30 and 65, women are advised to consult with their provider to determine which testing option is most beneficial: HPV testing only, HPV testing along with a Pap test, or a Pap test only.[3] Research has shown that cervical cancer tests performed within a 3-year period reduced the odds of cancer spreading beyond the cervix by 83 percent and reduced the risk of Stage 1 cervical cancer by 48 percent compared to women not screened in the previous 5 years.[4]

Despite strong clinical laboratory capacity to provide cervical cancer diagnostic screening services, data shows they are significantly underutilized, and disproportionately so among Black and Hispanic women.  According to the CDC, Hispanic women face the highest rates of developing cervical cancer, while Black women face the highest mortality rates.[5]

A recent Harris Poll survey reports that about one in 10 Hispanic and Black women say they have never had an OB/GYN visit for routine care (12 percent of Hispanic women and 8 percent of Black women vs. 3 percent of non-Hispanic white women) and similar proportions say they have never had a Pap test (12 percent of Hispanic women and 13 percent of Black women vs. 6 percent of non-Hispanic white women).[6] Moreover, CDC statistics reveal that more than 50 percent of new cervical cancers are in women who have never been screened or have not been screened in the previous 5 years of their life.[7] 

ACLA joins the chorus of voices raising awareness during Cervical Cancer Awareness Month to highlight the value of laboratory-enabled screening and prevention tools. We will continue to work with providers, policymakers, patient advocates and public health leaders in promoting the use of vaccines, preventative screenings, early diagnoses, and treatments. Together, we can continue to make progress toward eradicating cervical cancer in the US and globally.

For more information about cervical cancer, including causes, risk factors, screening and prevention, visit https://www.cancer.gov/types/cervical.

[1] American Cancer Society, https://www.cancer.org/cancer/cervical-cancer/about/key-statistics.html

[2] American Cancer Society, https://www.cancer.org/cancer/cervical-cancer/about/key-statistics.html

[3] Centers for Disease Control & Prevention, https://www.cdc.gov/cancer/cervical/basic_info/screening.htm

[4] Landy, R., Sasieni, P. D., Mathews, C., Wiggins, C. L., Robertson, M., McDonald, Y. J., … & New Mexico HPV Pap Registry Steering Committee. (2020). Impact of screening on cervical cancer incidence: a population‐based case–control study in the United States. International journal of cancer, 147(3), 887-896.

[5] Centers for Disease Control & Prevention, https://www.cdc.gov/cancer/cervical/statistics/index.htm

[6] The Harris Poll, https://www.prnewswire.com/news-releases/new-harris-poll-reveals-significant-gaps-in-womens-knowledge-about-cervical-cancer-301714162.html

[7] Centers for Disease Control & Prevention, https://www.cdc.gov/vitalsigns/cervical-cancer/index.html

ACLA Commends the 2023 Omnibus Appropriations Bill

Saving Access to Laboratory Services Act, ACLA News, All News, Featured News, ACLA Press Releases, Regulatory Issues

The 2023 Omnibus provides critical relief for labs and patients

Washington, D.C. – The American Clinical Laboratory Association (ACLA) commends inclusion in the 2023 Omnibus Appropriations Bill of critically needed relief from Medicare payment cuts to clinical laboratory services. The bill would provide a one-year reprieve from Medicare cuts of up to 15 percent for over 800 laboratory services that would have gone into effect January 2023. Further, ACLA appreciates the inclusion of provisions that would mitigate Medicare payment cuts to physician services over the next two years, lift the 4 percent statutory Pay-As-You-Go (PAYGO) payment cuts to Medicare in 2023, and extend, until 2025, Medicare coverage for telehealth services. ACLA urges swift passage of the Omnibus bill.

“ACLA commends Congress for prioritizing a reprieve from deep Medicare laboratory payment cuts and data reporting, acknowledging that these repeated cuts are an unsustainable risk for patient access to quality clinical laboratory services, undermining innovation in the next generation of diagnostics and the nation’s clinical laboratory infrastructure,” stated ACLA President, Susan Van Meter. “ACLA is grateful to Senators Sherrod Brown and Richard Burr, and Representatives Bill Pascrell, Scott Peters, Richard Hudson, Gus Bilirakis, and Kurt Schrader, the bipartisan champions of the Saving Access to Laboratory Services Act (SALSA), who ensured temporary relief from cuts and reporting was included in the Omnibus. We look forward to working with returning SALSA champions to carry forward the strong support for SALSA this year to advance a long-term PAMA fix in 2023.”

Notably excluded from the Omnibus is the Verifying Accurate Leading-Edge IVCT Development Act of 2021 (the VALID Act), which would have established a regulatory framework specifically for diagnostics. Throughout this Congress, ACLA has constructively engaged with the VALID Act sponsors, key congressional leaders, FDA, patient groups, and other stakeholders. Our engagement was focused on advancing improvements to the bill to recognize the critical role that clinical laboratories perform in supporting public health and to foster innovation in diagnostics while maintaining access to critical testing services that physicians and patients rely on every day. ACLA maintains that clarity and certainty on the regulatory requirements for clinical laboratories is needed and only through legislation to create a diagnostics-specific framework should new regulation of laboratory developed tests move forward.

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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.