High payment rates for tests for rare disorders in regions covered by two Medicare Administrative Contractors could spark debate about genetic testing fraud.
Despite some stumbles by firms that it supported, RADx may serve as a template for other federally funded programs for diagnostics development moving forward.
Through $1.15B NIH Project, Researchers Look for Markers of Long COVID for Potential Dx Tests
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The four-year National Institutes of Health-funded project is coordinating hundreds of researchers with goals of determining the causes and effects of long COVID.
Despite a few less successful elements, the overall portfolio increased test availability and RADx is now becoming a model for federal investing.
The AACC representative said that, as written, the exemption would not apply to large portions of laboratory-developed testing done at academic medical centers.
HHS Report Identifies Labs Billing for Unusually High Amounts of COVID-19 Add-on Testing
The report found that 378 labs out of 19,577 billed Medicare Part B for large amounts of add-on respiratory and other testing with their COVID-19 tests.
Roche Alzheimer's Disease Assays Obtain FDA 510(k) Clearance
The two cerebrospinal fluid-based Elecsys tests will be available on Roche's Cobas immunoassay analyzers.