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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August 2023 FDA Watch
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.
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Using the IQCP Process to Improve CLIA Compliance and Lab Testing System Quality
Individualized quality control plans offer flexibility and the capacity to seamlessly adopt new nonwaived tests, practices, and technologies.
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CMS Provides New Guidance on When International Labs Must Seek CLIA Certification
Recently released Centers for Medicare and Medicaid Services guidance shares when CLIA regulations apply to international labs.
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Billing & Coding Alert: CMS Adds 15 New PLA Codes to Medicare Clinical Laboratory Fee Schedule
Here’s what to know about the new codes that CMS recently added to the national HCPCS table as well as which ones were removed.
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