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FDA Releases Draft Guidance and Announces Webinar on CLIA Waiver Applications

The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.

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• CLIA /
• Diagnostics /
• FDA /
• Laboratory

Diagnostics: Guidance

CMS releases April CLFS pricing file

EXTERNAL LINK

• Final Rates

Diagnostics: Guidance

CMS Releases Final CY 2018 Crosswalk and Gapfill Determinations

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• Final Rates

Diagnostics: Guidance

CMS instructs contractors to stop applying Automated Test Panel edits to claims effective January 1, 2018

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• Lab Reimbursement

Diagnostics: Guidance

CMS Instruction to Contractors to Report Claims Data for “Not-OtherwiseClassified” Lab Codes

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• Lab Reimbursement

Diagnostics: Guidance

OIG releases report on Medicare payments for Lab Tests

EXTERNAL LINK

• OIG

Diagnostics: Guidance

CMS solicitation of comments on 60 codes without reported data

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• Lab Reporting

Diagnostics: Guidance

CMS Presentation on Data Reporting Required by PAMA

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• Lab Reporting

Diagnostics: Guidance

Changing How Medicare Pays for Clinical Diagnostic Laboratory Tests: An Update on CMS’s Progress (OEI-09-16-00100)

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• OIG

Diagnostics: Guidance

Medicare Payments for Clinical Diagnostic Laboratory Tests in 2015: Year 2 of Baseline data (OEI-09-16-00040)

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• OIG

Diagnostics: Guidance

Shape the CPT® Proprietary Lab Analyses Code Set

EXTERNAL LINK

• MedPAC

Diagnostics: Guidance

Clinical Laboratory Payment System

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• MedPAC

Diagnostics: Guidance

Medicare Payments for Clinical Laboratory Tests in 2014: Baseline Data

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• OIG

Diagnostics: Guidance

Comparing Lab Test Payment Rates: Medicare Could Achieve Substantial Savings

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• OIG

Diagnostics: Guidance

Report on Variation in the Clinical Laboratory Fee Schedule

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• OIG