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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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.
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Congress Moves to Limit Prior Authorization Protocols of Medicare Advantage Plans
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CMS Proposes to Ease, but Not End Hospital Price Transparency
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MCIT Medicare Coverage Rule Could Be Reimbursement “Breakthrough” for Makers of LDTs
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CMS Delays New Rule Providing Automatic Medicare Coverage of Breakthrough Devices
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MedPAC Explores Simplified PAMA Reporting to Cut Burdens & Restore Lab Prices
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New Federal Regulations Streamline and Speed Up Payor Prior Authorization
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