Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests

Feb 27, 2023 | Compliance, Legal, and Malpractice, Laboratory Pathology, Laboratory Resources, Laboratory Sales and Marketing, Laboratory Testing

Supporters of the VALID Act say lobbying blitz by academic medical centers prevented its passage In 2022, a bill before Congress titled the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) sought to change the current regulatory scheme for clinical laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). But even though the College of American Pathologists (CAP) and nine other organizations signed a December 12 stakeholder letter to leaders of key House and Senate...

Four Regulatory Developments Coming This Fall That Are Relevant for Clinical Laboratory Leaders and Pathology Group Managers

Oct 31, 2022 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing, Molecular Diagnostics, Genetic Testing, Whole Gene Sequencing

Regulators and lawmakers are considering proposed changes to CLIA and PAMA involving medical laboratory services Clinical laboratories and pathology groups should monitor a series of federal regulatory developments underway this fall. The proposals and documents will potentially affect how lab managers and staff do their jobs and how much Medicare reimbursement medical laboratories receive for certain diagnostic tests next year. Among the initiatives under consideration are the following:...
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