Advocacy - Comment Letter
Dear Senate Majority Leader Thune, Senate Minority Leader Schumer, Speaker of the House Johnson, and House Minority Leader Jeffries:
As organizations representing laboratories, physicians, hospitals and health systems, health care providers, laboratory professionals, and diagnostic manufacturers, we respectfully urge Congress to protect patient access to clinical laboratory services by enacting needed reforms to the Medicare Clinical Laboratory Fee Schedule (CLFS). The CLFS represents less than one percent of total Medicare spending, while clinical laboratory services inform 70 percent of clinical decision making. Timely access to innovative clinical laboratory tests is critical to the prevention, early detection, therapy selection, and effective management of chronic and life- threatening diseases.
CLFS reform can be achieved through the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act (S. 2761 / H.R. 5269), bipartisan, bicameral legislation that would:
Importantly, action by Congress on the RESULTS Act would prevent deep pending payment cuts for clinical laboratory services. Without action, around 800 laboratory tests will be subject to payment cuts of up to 15 percent on January 1, 2026, threatening patient access to routine and life-saving diagnostics.
In 2014, Congress passed The Protecting Access to Medicare Act (Pub. L. 113-93) (PAMA), which established a single national fee schedule based on private market data from all types of laboratories that service Medicare beneficiaries, including independent laboratories, hospital outreach laboratories, and POLs. Unfortunately, the first round of data reporting in 2017 did not produce data that was reflective of the entire laboratory market serving Medicare beneficiaries. In fact, less than one percent of clinical laboratories’ private payor data was used to determine CLFS rates, resulting in artificially low payment rates and cutting nearly $4 billion from the CLFS in the first three years alone.
Because of the serious implications for patients who rely on both routine and advanced diagnostic laboratory services, Congress has acted to delay payment cuts for the last five years in a row and to delay data reporting for the last six years. We are grateful for that relief. Now is the time for the permanent relief offered by the RESULTS Act.
On behalf of clinical laboratories, laboratory professionals, physicians, hospitals and health systems, health care providers and stakeholders across the country, we urge you to act on permanent reform that will provide long-term stability for clinical laboratories and for the millions of Medicare beneficiaries and patients across the country whose health decisions rely on clinical laboratory results.
We welcome the opportunity to discuss this critical issue with you and your staff, and we stand ready to help advance the RESULTS Act to achieve fundamental reform of the flawed Medicare clinical laboratory payment system.
Sincerely,
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