ACLA and 30+ Leading Provider Organizations Urge Congress to Pass RESULTS Act to Protect Access to Clinical Laboratory Services
Without Congressional action in 2025, cuts threaten patient access to timely, innovative clinical laboratory tests
Washington, D.C. – The American Clinical Laboratory Association (ACLA) joined with more than 30 leading provider organizations in a unified call for Congress to protect patient access to clinical laboratory services by enacting the bipartisan, bicameral Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act (H.R. 5269 / S. 2761) before deep Medicare payment cuts take effect on January 1, 2026.
In a letter sent to congressional leadership today, the diverse coalition, including laboratory, physician, hospital and health system, health care provider, laboratory professional, and diagnostic manufacturer organizations, emphasized the critical role laboratory tests serve in the U.S. health care system. Clinical laboratory tests inform 70 percent of medical decisions, yet the Medicare Clinical Laboratory Fee Schedule (CLFS) represents less than one percent of total Medicare spending.
“Without Congressional action, Medicare reimbursement cuts of up to 15 percent on about 800 clinical laboratory tests are set to take effect on January 1, 2026,” said ACLA President Susan Van Meter. “The RESULTS Act provides the permanent, market-based reform needed to prevent destabilizing cuts, reduce administrative burdens, and ensure patients have access to essential laboratory diagnostic services.”
Originally intended to determine CLFS rates based on private payor rates, the Protecting Access to Medicare Act (PAMA) of 2014 failed to capture representative data from all laboratory segments. Since 2018, CLFS rates have been based on 2016 commercial market data reported by less than one percent of all laboratories, resulting in artificially low payment rates and cutting nearly $4 billion from the CLFS between 2018 and 2020. Payment rates for 2026 will continue to be based on that unrepresentative 2016 data.
While Congress has acted repeatedly to delay further cuts and data reporting, stakeholders agree that now is the time for permanent reform.
The RESULTS Act would protect patient access to laboratory services by:
- Directing the Centers for Medicare & Medicaid Services (CMS) to contract with an independent, not-for-profit commercial claims database with robust private payor claims data across all laboratory segments to determine CLFS rates for widely available tests
- Requiring clinical laboratories to report commercial rate data directly to CMS for non-widely available tests, such as proprietary diagnostics and those for rare diseases
- Extending the rate-setting cycle to every four years, reducing administrative burden on laboratories and CMS
- Establishing guardrails to limit annual payment reductions and prevent destabilizing cuts to CLFS rates
- Excluding artificially low Medicaid managed care payment rates from the data used to set CLFS reimbursement levels
“On behalf of clinical laboratories, laboratory professionals, physicians, hospitals and health systems, health care providers, and stakeholders across the country, the signatories urge Congress to enact the RESULTS Act to provide long-term stability to the Medicare Clinical Laboratory Fee Schedule and protect access to routine and innovative diagnostic testing for millions of patients,” the letter states.
ACLA also recently re-launched the Stop Lab Cuts campaign, which has garnered support from individuals across the country—generating more than 100,000 messages to Congress—urging action to protect access to innovative clinical laboratory testing services. The campaign serves as a central advocacy hub and resource for information on the need for long-term payment reform. Visit StopLabCuts.org to learn more.
The letter is here and the complete list of signatories is below:
AdvaMed
ADVION
American Academy of Family Physicians
American Association of Bioanalysts
American Clinical Laboratory Association
American Hospital Association
American Medical Association
American Medical Group Association
American Medical Technologists
American Osteopathic Association
American Society for Clinical Laboratory Science
American Society for Clinical Pathology
American Society for Microbiology
Association for Molecular Pathology
American Society for Histocompatibility and Immunogenetics
Association of American Medical Colleges
Association for Academic Pathology
Association for Diagnostics & Laboratory Medicine
Association of Public Health Laboratories
California Clinical Laboratory Association
College of American Pathologists
COLA Inc.
GreatLakes Laboratory Network
Healthcare Leadership Council
Infectious Diseases Society of America
Medical Group Management Association
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
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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.