Device Week, Feb. 22, 2019 – The Latest On Lab Reimbursement And Possible LDT Regulatory Reform
Executive Summary
In this week’s podcast, senior reporter Sue Darcey talks about troubling developments for US laboratories and diagnostic test-makers that say the Government Accountability Office was mistaken in conclusions it reached in a recent report about how much labs will be billing Medicare for clinical tests. Also discussed are comments lab associations sent to US legislators, who have been trying to win industry and stakeholder consensus on a regulatory reform proposal for laboratory developed tests (LDTs) that they call the VALID Act.
Listen to the podcast via the player below:
Medtech Insight article addressing topics discussed in this episode:
- Lab Groups Disagree With GAO That Medicare Will Be Overbilled For PAMA Test Payments
- ACLA Rejects FDA As A ‘Clinical Validity’ Judge, While AdvaMedDx Seeks Tweaks To VALID Act