November 13, 11:00 AM ET
2024 has been a busy year for legal, legislative, and regulatory developments affecting the laboratory industry. Following the FDA’s introduction of its final rule on regulation of laboratory-developed tests (LDTs) as medical devices, both the American Clinical Laboratory Association and the Association for Molecular Pathology filed lawsuits against the FDA, challenging the agency’s authority to regulate LDTs. In addition, as it has done for the past few years, Congress again passed legislation to delay scheduled Medicare payment cuts to clinical lab services by another year. These cuts, authorized under the Protecting Access to Medicare Act (PAMA), would have reduced reimbursements for around 800 lab tests.
What is likely to be in store for labs in the coming months? This presentation will provide updates on where the LDTs lawsuits currently stand, as well as on legislative efforts to regulate LDTs and provide a permanent solution to PAMA.
Attendees will learn:
- What legislation may be on the horizon for regulating LDTs—including the Verifying Accurate Leading-edge IVCT Development (VALID) Act
- How PAMA could be reformed and what hurdles would need to be overcome
- What Congress may do at the end of this year and how that could affect the laboratory industry
Speaker:
Joyce Gresko
Partner
Alston & Bird
Note: You only need to register once to be signed up for all of the November 2024 Lab Institute talks. View the full event agenda at https://www.g2intelligence.com/lab-institute-virtual-event-advancing-the-profession-of-diagnostic-medicine-2024/.