LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
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Articles and Reports
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
New CMS TCET Rule Likely Won’t Hasten Medicare Coverage of Breakthrough Devices
Recently proposed rule seems too stringent to reduce the lag between FDA approval and Medicare coverage.
Proposed Rule Puts Labs at Greater Risk of FCA Liability
CMS recently proposed a rule that would make the False Claims Act rule the standard for overpayments under the Affordable Care Act regulations.
CMS Proposes Modest Increase to Hospital IPPS Rates
Unsurprisingly, the American Hospital Association and other industry groups don’t think that increase is anywhere near adequate.
CMS Launches Free Medicare Coverage of OTC COVID-19 Rapid Antigen Tests
Starting April 4, Medicare beneficiaries can get eight free tests per month for each month the public health emergency remains in effect.
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CMS Delays Payer-to-Payer Data Exchange but Prior Authorization Rules Remain on Track
On Sept. 17,...
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