Securing Your Assay's CPT Code: A Guide to US Reimbursement and the CLFS

This episode details the process of obtaining a unique CPT or PLA code for a diagnostic assay in the U.S. and its direct impact on reimbursement under the Medicare Clinical Laboratory Fee Schedule (CLFS). We cover the application steps with the American Medical Association (AMA), the role of the PAMA Act, and recent legislative updates affecting payment rates and reporting deadlines. • What is a Proprietary Laboratory Analyses (PLA) code and why is it crucial for my new assay? • What is the step-by-step process for submitting a PLA code application to the AMA? • Who are the CPT Editorial Panel and the PLA-TAG, and what role do they play? • What are the key deadlines and timelines I need to be aware of, including the September 9, 2025 application deadline? • How does the Protecting Access to Medicare Act (PAMA) of 2014 influence my test's payment rate? • What is the Clinical Laboratory Fee Schedule (CLFS) and how are rates determined? • How did the legislation on September 26, 2024, change the data reporting requirements and payment reductions? • What is the next data reporting period and what data collection period is it based on? • How does having a unique PLA code ultimately lead to a specific payment rate for my assay? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.