Billing and Coding: MolDX: Breast Cancer Assay: Prosigna - R2 - Effective April 22, 2021

This coverage article has been revised and published for notice under contract numbers: 02101 (AK), 02201 (ID), 02301(OR), 02401 (WA), 03101 (AZ), 03201 (MT), 03301 (ND), 03401 (SD), 03501 (UT), and 03601.

Effective Date: April 22, 2021
Summary of Changes:

Under Article Title added a registered mark to Prosigna®.

Under CMS National Coverage Policy revised regulation CMS Internet-Only Manual, Pub 100-02, Chapter 15 from §80.2 to §80.1.2 and moved CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15 §80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests and §80.1.1 Certification Changes to the related LCD.

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes deleted C50.019, C50.119, C50.219, C50.319, C50.419, C50.519, C50.619, C50.819, C50.919, D05.00, D05.10, D05.80, and D05.90.

Prosigna® was inserted throughout the article where applicable.

Visit the Molecular Diagnostic Services (MolDX) webpage to access the locally hosted MolDX Medicare Coverage Article from the “Covered Tests” or the “Excluded Tests” webpage.

To view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD, visit the Medicare Coverage Articles webpage.

            Last Updated Wed, 21 Apr 2021 17:19:28 +0000