Archive for: CLIA

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Payment Innovation: COVID-19

COVID-19 Activities and Actions Update

As part of the ongoing White House Coronavirus Task Force efforts, CMS and other agencies have issued several resource documents, refocused activities related to state survey agencies and accrediting organizations, and taken other related actions.

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Diagnostics

FDA Posts a Number of New Items Related to Coronavirus

On February 29, 2020, the FDA issued a new guidance document (immediately in effect) on its policy for diagnostic testing in laboratories certified to perform high complexity testing under CLIA prior to EUA for COVID-19 during the public health emergency.

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Diagnostics

FDA Issues Two CLIA-Related Final Guidance Documents

The FDA issued two final guidance documents.

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Diagnostics: Other

CMS Releases List of New CLIA-Waived Tests

CMS releases list of 12 new CLIA-waived tests

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Diagnostics: Regulation

CMS Extends Comment Period on Proposed Changes to Proficiency Testing

The Centers for Medicare and Medicaid Services has extended the comment period on proposed changes to proficiency testing to June 4.

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Diagnostics: Regulation

CMS Proposes Rule on Proficiency Testing

On February 4, 2019 CMS released the “Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance” proposed rule on.

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Diagnostics: Guidance

CMS Publishes CLIA User Fee Update

On December 28, 2018 CMS published its CLIA User Fee Update.

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Diagnostics: Guidance

FDA Releases Draft Guidance and Announces Webinar on CLIA Waiver Applications

The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.

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