The Diagnostics Pipeline: FDA Proceeds without Congress Over LDTs Reform
The agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
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The Diagnostics Pipeline: FDA Launches Pilot for Cancer Companion Diagnostic LDTs
New program aims to provide greater transparency on the recommended performance characteristics of such tests.
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Congress Moves to Require Medicare Coverage of Multi-Cancer Early Detection Tests
Federal lawmakers have renewed efforts to pass legislation ensuring Medicare coverage of multi-cancer early detection (MCED) tests.
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Could SALSA Pass This Year?
Lab industry insiders say they’re confident the Saving Access to Laboratory Services Act (SALSA) will pass in 2023.
Congress Moves to Permanently Restore Medicare Coverage of Pharmacy Lab Tests
Congress is renewing its previous efforts to make Medicare reimbursement of pharmacy testing permanent—here’s what that could mean for labs.
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