The Gapfill worksheet(XLSX, 11 KB) is part of a required process for tests that must be priced by Palmetto GBA. This includes tests described by PLA codes or those that are not defined by current CPT codes in the CLFS. Labs must submit this form to Palmetto GBA as part of this process and it must be transparent and easy for them to do so. The MolDX website is the best location to store this for providers.

INDUSTRY NEWS TAGS:Molecular Diagnostics

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The claim line for molecular diagnostic tests must contain the appropriate CPT code and test identifier (DEX Z-Code) associated with the test. Once DEX assigns a Z-Code, it is not effective until the MolDX team has reviewed your test application to determine coverage and assigned a CPT code. The CPT code you submit with your application is not necessarily the CPT code that MolDX will assign to your test. You must submit the correct combination of Z-Code, CPT code and NPI in order for claims to be paid.

INDUSTRY NEWS TAGS:Molecular Diagnostics

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The National Institutes of Health is investing $248.7 million in new technologies to address challenges associated with COVID-19 testing (which detects SARS-CoV-2 coronavirus). NIH’s Rapid Acceleration of Diagnostics (RADx) initiative has awarded contracts to seven biomedical diagnostic companies to support a range of new lab-based and point-of-care tests that could significantly increase the number, type and availability of tests by millions per week as early as September 2020.

INDUSTRY NEWS TAGS:Molecular Diagnostics

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Medicare Administrative Contractor Noridian Health Solutions recently issued a final local coverage determination aligning its coverage with Palmetto's earlier decision to cover molecular diagnostic laboratory tests as predictive classifiers for non-small cell lung cancer.

INDUSTRY NEWS TAGS:Molecular Diagnostics

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Medicare Administrative Contractor Noridian Healthcare Solutions aligned its coverage decision with Palmetto GBA's recently announced limited coverage determination for single-gene and multi-gene pharmacogenomics tests. 

INDUSTRY NEWS TAGS:Molecular Diagnostics

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The US Food and Drug Administration on Thursday granted Emergency Use Authorization to a molecular diagnostic test from the US Centers for Disease Control and Prevention that can detect and differentiate the viruses that cause COVID-19 and flu.

INDUSTRY NEWS TAGS:Molecular Diagnostics

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The American Medical Association (AMA) recently updated Current Procedural Terminology (CPT) to enable proper COVID-19 coding and billing of antigen tests performed on patients suspected of being infected with the novel coronavirus.

Unveiled on Friday, 87426 is a Category I CPT code approved by the CPT Editorial Panel late last week during a special meeting. The long descriptor is:

INDUSTRY NEWS TAGS:Molecular Diagnostics

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In a keynote address to begin a virtual American Society for Microbiology Microbe conference on Monday, Deborah Birx, the response coordinator for the White House coronavirus task force, urged labs to expand SARS-CoV-2 diagnostic testing in the US through sample pooling and community engagement.

Expanding testing through pooling could enable more frequent testing, and a surveillance strategy could, in turn, allow people to more safely return to schools and work, Birx suggested.

INDUSTRY NEWS TAGS:Molecular Diagnostics

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In a move it described as a step forward in getting more COVID-19 tests to more Americans more quickly, the US Food and Drug Administration on Tuesday provided developers with new Emergency Use Authorization guidance on the validation processes it expects for pooling samples and for screening of asymptomatic people.

In the updated template for molecular diagnostic tests, there are two pathways to the asymptomatic and pooling indications – one for a previously unauthorized test, and one for a test that already has an EUA.

INDUSTRY NEWS TAGS:Molecular Diagnostics

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The US Food and Drug Administration said it has added a template to its website intended to facilitate submission of requests for Emergency Use Authorization of at-home sample collection kits for molecular diagnostic testing to detect SARS-CoV-2.

The template describes the data and information that labs and commercial manufacturers should submit for EUA of collection kits or tests with a home self-collection component.

INDUSTRY NEWS TAGS:Molecular Diagnostics

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