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ACLA Statement on One-Year Delay to Clinical Laboratory Payment Cuts Being Included in Congressional Spending Package
Washington, D.C.– The American Clinical Laboratory Association (ACLA) commends the inclusion of critically needed relief from looming Medicare payment cuts to clinical laboratory services in the short-term spending package passed by Congress on Wednesday, November 15.
The bill provides a one-year reprieve from Medicare cuts of up to 15 percent for approximately 800 laboratory services that would have gone into effect in January 2024. ACLA remains focused on securing passage of the Saving Access to Laboratory Services Act (SALSA), which would mitigate years of pending reductions, setting Medicare payment for clinical laboratory services on sustainable pathway.
“ACLA is grateful to Congress for including a short-term reprieve from Medicare laboratory payment cuts and data reporting as part of the stopgap funding bill. Resumption of year-over-year cuts would threaten patient access to quality clinical laboratory services, reduce investment in innovation for the next generation of diagnostics, and weaken the nation’s clinical laboratory infrastructure,” said ACLA President Susan Van Meter. “We are thankful to Senators Sherrod Brown (D-OH) and Thom Tillis (R-NC), and Representatives Richard Hudson (R-NC), Bill Pascrell, Jr. (D-NJ), Gus Bilirakis (R-FL), Scott Peters (D-CA), Brian Fitzpatrick (R-PA), Larry Bucshon (R-IN), Ann Kuster (D-NH), and Dan Crenshaw (R-TX), the bipartisan champions of the Saving Access to Laboratory Services Act (SALSA), and the dozens of co-sponsors across both chambers for ensuring cuts will not resume in January. The one-year delay is essential and in 2024 we will continue partnering with the 70 patient and provider organizations and the bipartisan and bicameral SALSA champions in Congress to advance SALSA as a sustainable, long-term solution to this problem.”
Medicare reimbursement for clinical laboratory services has been set on an unsustainable path of multi-year, double-digit reimbursement cuts resulting from the Protecting Access to Medicare Act of 2014 (PAMA), which relied on a narrow and unrepresentative sample to set Medicare reimbursement rates for hundreds of common laboratory tests. Since the enactment of PAMA, there have been three rounds of payment cuts of up to 10 percent that have impacted 72 percent of tests on Medicare’s Clinical Laboratory Fee Schedule.
Learn about ACLA’s “Stop Lab Cuts” campaign here, which seeks Congressional action on planned Medicare payment cuts to clinical laboratories and features broad support from organizations serving patients, providers, and hospitals.
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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 Laboratories Empower Patients to Take Charge of Diabetes
November is American Diabetes Month, a chance to bring awareness to the fundamental role of clinical laboratories in diagnosing and managing this chronic, progressive health condition. Diabetes affects more than 37 million Americans, yet more than 20% people who have it are unaware.[1]
One of the main tests used in both diagnosis and treatment of diabetes is the A1C, also known as the hemoglobin A1C or HbA1c.[2] It is an important tool that measures average blood sugar levels over the prior three months, and is relied upon to manage diabetes and detect chronic high-glucose levels that correlate with a risk of long-term complications.[3]
Other tests include:
- Blood tests such as a fasting blood test, which measures the level of glucose after an overnight fast; glucose tolerance test, which measures levels before and after drinking a liquid that contains glucose, and random blood sugar tests, which show blood glucose levels at the time of testing.[4]
- Genetic testing, done by specialized clinical laboratories to identify genetic risk factors for diabetes and to help develop appropriate treatments and pregnancy planning in families affected by rare forms of diabetes associated with gene mutations.[5]
- Urine testing, used to check levels of blood sugar and ketones, is another tool in diabetes management. Ketones are chemicals produced in the liver that can build to dangerous levels when there is not enough insulin to allow blood sugar into cells for energy. This can cause diabetic ketoacidosis, which can be life-threatening.[6]
- C-peptide tests to assess the level of this hormone, which is produced in the pancreas and helps glucose get into cells to produce energy. Measuring C-peptide in a sample of blood or urine is a way to measure how much insulin is being produced in the body.[7]
Annual recommended blood testing can detect prediabetes, a treatable condition in which glucose levels are elevated but have not yet progressed to diabetes. As with other diseases, early detection allows prompt treatment that can delay or prevent serious complications associated with later stages of the disease. Clinical laboratory tests inform patients and their caregivers when glucose levels are too high or too low, guiding treatment toward better control of the disease.
There was a time when diabetes inevitably led to a life of illness. But today, thanks to advances in clinical testing that allows for earlier detection and tighter control of blood glucose levels, people with diabetes can reduce their risk of life-limiting complications and live longer, healthier lives.
[1] American Diabetes Association, https://diabetes.org/about-diabetes/statistics/about-diabetes#:~:text=Prevalence%3A%20In%202019%2C%2037.3%20million,of%20the%20population%2C%20had%20diabetes.&text=Diagnosed%20and%20undiagnosed%3A%20Of%20the,and%208.5%20million%20were%20undiagnosed.
[2] https://www.cdc.gov/diabetes/managing/managing-blood-sugar/a1c.html#:~:text=The%20A1C%20test%E2%80%94also%20known,care%20team%20manage%20your%20diabetes.
[3] The United States National Library of Medicine, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4933534/#:~:text=HbA1c%20is%20an%20important%20indicator,of%20long%2Dterm%20diabetes%20complications.
[4] Centers for Disease Control & Prevention, https://www.cdc.gov/diabetes/basics/getting-tested.html.
[5] National Institute of Diabetes and Digestive and Kidney Diseases, https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/monogenic-neonatal-mellitus-mody#:~:text=Some%20rare%20forms%20of%20diabetes,from%20one%20or%20both%20parents.
[6] Centers for Disease Control & Prevention, https://www.cdc.gov/diabetes/basics/diabetic-ketoacidosis.html#:~:text=People%20with%20type%202%20diabetes,that%20produces%20acids%20called%20ketones.
[7] MedlinePlus, https://medlineplus.gov/lab-tests/c-peptide-test/#:~:text=This%20test%20measures%20the%20level,can%20be%20used%20for%20energy.
ACLA Statement on House Energy and Commerce Subcommittee Hearing on Medicare Legislation
Washington, D.C. – The American Clinical Laboratory Association’s (ACLA) President, Susan Van Meter, issued the following statement after the House Energy and Commerce Committee’s Health Subcommittee hearing examining Medicare reforms to improve patient access to care.
“ACLA is grateful for the Health Subcommittee’s consideration of legislation to provide relief for yet another wave of scheduled Medicare payment cuts. Set to resume on January 1, 2024, these anticipated cuts once again threaten access to critical clinical laboratory services that America’s seniors depend on. The Saving Access to Laboratory Services Act (SALSA) is a bipartisan and bicameral long-term solution that will help protect patient access to testing, support investment in diagnostics innovation, and strengthen the nation’s public health infrastructure. ACLA is deeply appreciative of subcommittee members who have co-sponsored SALSA and urges Congress to Stop Lab Cuts this year.”
Learn more about ACLA’s “Stop Lab Cuts” campaign here, which features broad support from organizations serving patients, providers, and hospitals.
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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 Laboratories Key to Breast Cancer Diagnosis and Treatment
In the United States, a woman’s average risk of developing breast cancer at some time during her life is about 13%, meaning women face a one in eight chance of developing the disease.[1] October, National Breast Cancer Awareness Month, highlights the burden of this disease to increase patient knowledge and to highlight the critical importance of regular screenings to improve survival rates.
Clinical laboratories play a vital role in all aspects of breast cancer care, including identifying the disease, describing, and understanding its traits, and providing critical information that can guide decisions on individualized treatment.
While breast cancer accounts for 30% of all new female cancers each year,[2] men are affected, too, though at a much lower rate of about one in every 833 men.
The causes of breast cancer are complex, with some types related to hereditary genetics and others linked to gene changes in cancer cells. The most well-known genetic determinants are inherited mutations in the BRCA 1 and BRCA 2 genes (BReast CAncer genes 1 and 2), which can be passed from either parent to child. When present, these mutations significantly increase the risk of breast cancer in women. For instance, among women who inherit a harmful BRCA 1 variant, 55% to 72% will develop breast cancer by age 70-80 years. Of those with the harmful BRCA 2 variant, 45% to 69% will develop breast cancer by that age.[3]
However, the risk for any one woman may involve many factors. Clinical laboratories conduct multi-gene biomarker testing, which helps identify patients at risk and those who are likely to benefit from a given therapy.
Genetic testing performed by clinical laboratories helps recognize whether someone has an inherited gene that could increase the chance of developing breast cancer. Those who have received a diagnosis of breast cancer are offered clinical laboratory tests to identify and characterize cancerous cells through the examination of biopsy samples. These tests reveal the type of breast cancer, the stage or extent of the cancer, and help guide a patient’s treatment plan.
Clinical laboratories also analyze the size of a tumor, determine whether there is possible lymph node involvement, and describe microscopic characteristics of tumors. This information helps to predict the likelihood of cancer recurrence and helps patients and oncologists to design long-term treatment strategies, which may include breast surgery, chemotherapy, hormone therapy, radiation, or other options.
Once surgery or other treatments have been completed, clinical laboratory tests can, by examining surgical margins and lymph nodes, detect any remaining cancer cells, which can suggest the need for further treatment. Biomarker testing on cancer tissue or fluid helps determine the most effective treatment options in individual cases.
Clinical laboratories also can perform advanced genomic and molecular testing to help pinpoint changes in DNA that may spur the growth of an individual’s tumor. This information can help oncologists make decisions regarding targeted drug therapies or immunotherapy drugs for treatment.
Adjuvant chemotherapy after breast surgery has been shown to reduce the recurrence of cancer, leading a National Institutes of Health panel to recommend it in most patients, but in some cases, it may be unnecessary. Gene assay tests can help predict the possible benefits of chemotherapy treatment, identifying patients with early breast cancer who may be spared adjuvant chemotherapy.[4] Gene expression tests provide more information about the cancer cells and help tailor personalized treatment, predicting which patients are most likely to benefit from chemotherapy to reduce the risk of recurrence of cancer after breast surgery.
Other clinical laboratory tests, such as a complete blood count (CBC), blood chemistry tests, and tumor markers, can help determine if a patient is well enough to undergo surgery, chemotherapy, or immunotherapy as part of treatment.
Breast cancer is the most common cancer in women, with more than 2 million cases diagnosed worldwide in 2018,[5] and nearly 300,000 new cases expected in the U.S. this year.[6] But over the years, the prognosis for long-term survival has improved dramatically. Currently, five-year survival rates for women with non-metastatic breast cancer are 91%, and the 10-year survival rate is 85%.[7]
This hopeful trend is attributed in large part to widespread use of screening programs that lead to early diagnosis, when treatment is most effective, and to advances in molecular understanding of tumors, and subtype classification that leads to treatment personalization.[8] Clinical laboratories play an essential role in this progress, resulting in better outcomes for all people with breast cancer.
For additional information on breast cancer, visit https://www.cdc.gov/cancer/breast/basic_info/what-is-breast-cancer.htm.
[1] American Cancer Society, https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html#:~:text=Overall%2C%20the%20average%20risk%20of,will%20never%20have%20the%20disease.
[2] American Cancer Society, https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html#:~:text=Overall%2C%20the%20average%20risk%20of,will%20never%20have%20the%20disease.
[3] National Cancer Institute, https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet.
[4] The New England Journal of Medicine, https://www.nejm.org/doi/full/10.1056/nejmoa1804710.
[5] National Institutes of Health (NIH), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7308500/.
[6] American Cancer Society, https://www.cancer.org/cancer/types/breast-cancer/about/how-common-is-breast-cancer.html#:~:text=Overall%2C%20the%20average%20risk%20of,will%20never%20have%20the%20disease.
[7] American Society of Clinical Oncology (ASCO), https://www.cancer.net/cancer-types/breast-cancer/statistics#:~:text=The%205%2Dyear%20relative%20survival%20rate%20for%20women%20in%20the,vary%20based%20on%20several%20factors.
[8] National Institutes of Health (NIH), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7308500/.
ACLA Opposes Unilateral FDA Action to Regulate Laboratory Developed Tests Under Medical Device Authority
Washington, D.C. – The American Clinical Laboratory Association (ACLA) today issued the following statement after the U.S. Food and Drug Administration (FDA) released a proposed rule that would seek to regulate Laboratory Developed Tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. ACLA does not believe that FDA’s actions are in the best interest of patients or our nation’s health care system. Because the proposed rule exceeds FDA’s existing authority, ACLA plans to submit comments urging FDA to withdraw the proposed rule and resume work with Congress, the laboratory community, patient groups, and other stakeholders toward a legislative solution that provides a framework that is appropriate for the unique attributes of LDTs.
“ACLA has long taken the position that FDA does not have statutory authority to regulate LDTs under its medical device authority and strongly opposes unilateral action that exceeds the Agency’s current authority. LDTs are not medical devices. To the extent that FDA secures legislative authority to regulate LDTs, it must be through a regulatory framework that works with, not against, the LDT regulation already in place through the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA).
Any expansion of FDA’s role in this framework should be tailored by Congress to fit LDTs, just as has been done for food, supplements, drugs, and cosmetics – each of which has a distinct framework suited to the unique characteristics of its category. We also are concerned that FDA is already under resourced and not prepared to complete all of the new work the Agency has now proposed to undertake. FDA seriously risks falling behind on its current public health priorities.
ACLA strongly believes FDA regulation of LDTs could only be done through legislation that establishes a diagnostic-specific, risk-based framework that recognizes the essential role of clinical laboratories in advancing public health, preserving and fostering innovation, and maintaining access to critical testing services that physicians and patients rely on every day.
During the last Congress, ACLA worked collaboratively with bipartisan co-sponsors of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, committees of jurisdiction, FDA, and private sector stakeholders to provide expertise around key provisions of the legislation that resulted in significant improvements in the bill to help protect access and innovation for patients. While VALID was not enacted by Congress last December, ACLA remains committed to working productively with Congress on diagnostic-specific legislation.
Clinical laboratory testing is an essential part of health care that informs 70 percent of health care decisions. Billions of tests are run each year by ACLA member laboratories that are certified under CLIA and accredited by the College of American Pathologists (CAP). These include tests developed during health emergencies like COVID-19 and MPX and for unmet needs. For example, the only clinical tests currently available to detect fentanyl with xylazine are LDTs.
The current system works well for patients and significant changes to the regulatory structure should be done carefully and thoughtfully to avoid unintended consequences that could reduce access to testing, undermine innovation in next generation diagnostics, and increase health care costs.
ACLA believes there remains bipartisan interest in Congress and among key stakeholders to establish a pathway tailored to the dynamic nature of laboratory diagnostics, rather than applying a framework that Congress never intended for this purpose. ACLA urges FDA to resume its work toward a legislative solution. Pursuing a significant change in the regulatory framework without congressional authorization does not benefit patients and risks FDA falling behind on its current public health priorities.”
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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, Key Stakeholders Urge Medicare Administrative Contractors to Ensure Access to Genetic Testing for Oncology
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
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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.
Letter to ONDCP on NCCI Edits for Drug Testing
Letter from Leading Patient Advocacy Organizations on Passing the Saving Access to Laboratory Services Act
Routine Health Checkups – Including Recommended Laboratory Tests – Improve and Save Men’s Lives
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
