Archive for: Laboratory

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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: PAMA

CMS Releases Laboratory Data Collection FAQ

CMS has released a new set of frequently asked questions addressing lab data collection.

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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: Payment Rates

CMS Releases CY 2019 CLFS Payment Rates

CMS has released the final CY 2019 payment rates for clinical diagnostic services along with supporting instructional materials.

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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FDA Releases Draft Guidance and Announces Webinar on CLIA Waiver Applications

The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.

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Diagnostics: OIG

Medicare Payments for Clinical Diagnostic Laboratory Tests in 2017: Year 4 of Baseline Data

OIG releases the fourth in a series of data briefs looking at Medicare spending under the Clinical Laboratory Fee Schedule.

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