CMS
Banner Year for Blood-Based Cancer Screening in 2021, but Reimbursement and Utility Hurdles Loom
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New companies claimed stakes during the year, established firms solidified their plans and data, and Grail launched the first genomic multi-cancer early detection test.
Nearly 600 clinical laboratory tests could have their reimbursement from Medicare slashed starting in 2023, which would disproportionately affect small, rural labs.
CMS Repeals Rule Aimed at Expediting Medicare Coverage for FDA Breakthrough Devices
The rule would have granted quicker Medicare coverage for up to four years for tests that had received breakthrough device designation from the FDA.
Palmetto Finalizes Medicare Coverage for MRD Cancer Testing
To receive coverage, the patient must have a personal history of cancer where the type and staging are within the intended use of the test.
The company has slightly extended its timeline for launching a Lyme disease test to focus on marketing its COVID assay for immunocompromised individuals.