This coverage article has been revised and published for notice under contract numbers: 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, NMI), and 01312 (NV).

Effective Date: July 22, 2021
Summary of Article Changes:

• Under Article Title revised to MDS FISH.
• Under CMS National Coverage Policy removed regulation 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 and §80.2 Clinical Laboratory Services. Added regulation CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15 §80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories.
• Under Article Text revised title to MDS FISH. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes deleted D46.4 and D46.9.

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.