Novitas Tracking Sheet (L39365)

 

Tracking Sheet

Genetic Testing for Oncology

DL39365

Issue

Issue Description

Multiple reconsideration requests have been received regarding a variety of molecular pathology services. 

This is a rapidly evolving field and area of study; therefore this LCD addresses testing of DNA and RNA in the context of oncology through the use of multiple evidence-based third-party databases.

Issue - Explanation of Change Between Proposed LCD and Final LCD

L39365

In response to stakeholder comments that were received during the Open Meeting and subsequent Comment Period, several changes were made to the LCD:

• Update to the Issue Description.
• Updates to the Introduction Citations.
• Minor text changes to the History/Background and/or General Information.
• Updates to the Definitions including 25 additional terms.
• Updates to the Covered Indications including the addition of a note regarding cell-free DNA and NCD 90.2, the addition of score tables for Items 2, 3 and 4, and a note regarding reconsideration requests.
• Added a new section: Additional Requirements for Next Generation Sequencing (NGS) tests.
• Updates to the Limitations including revised text for Items 1, 2, and 3, and the addition of 13 specific laboratory tests.
• Updates to the Summary of Evidence including Technology Assessment of knowledge bases, addition of a reference to the National Comprehensive Cancer Network’s (NCCN’s) summary, and literature reviews added for 13 specific tests (Cxbladder, ThyroSeq® CRC, PancraGEN®, DecisionDX-Melanoma, DecisionDX-SCC, UroVysion® FISH, Colvera™, PancreaSeq® Genomic Classifier).