Article Detail - JE Part A

Date Posted: July 31, 2025

This Billing and Coding Article has been revised under contract numbers: 01111 (CA), 01211 (AS, GU, HI, NMI), 01311 (NV), and 01911 (CA, HI & Territories).

Effective Date: July 31, 2025

Summary of Changes:

Under Article Text revised Table 1 row 3 to remove "Whole Exome" and replaced with "Bespoke Assay Design" to Signatera and RaDaR test names. Revised row 4 to read "Guardant360 Response (Guardant, Inc)". Revised row 5 to add "in accordance with NCD 90.2". Revised row 9 to remove "Whole Exome Design" and replaced with "Bespoke Assay Design" to Signatera and RaDaR test names. Revised row 11 to read "NavDX single Plasma Test (Naveris, Inc)" and "Guardant Reveal single Plasma Test (Guardant, Inc)". Under subheading Additional Test-specific Indications, Limitations and Instructions revised first sentence to remove "Natera" and replaced with "Signatera". Revised "Guardant" to read "Guardant Reveal". Revised second sentence to remove "Natera" and "Naveris" and replaced with "Signatera" and "NavDX". Revised third sentence to read "Guardant Response". Removed "Natera" and replaced with "Signatera". Formatting and punctuation errors were corrected throughout the article. This revision is effective 7/31/2025.

Under Article Text revised Table 1 row 3 to add "Oncodetect Bespoke Assay Design + Plasma Test Bundle (Exact Sciences Corp)". Revised row 6 to add "Oncodetect Plasma Test Bundle (Exact Sciences Corp)". Revised row 9 to add "Oncodetect Bespoke Assay Design + single Plasma Test (Exact Sciences Corp)". Revised row 10 to add "Oncodetect single Plasma Test (Exact Sciences Corp)". Under subheading Additional Test-specific Indications, Limitations and Instructions revised first sentence to add "Oncodetect". This revision is due to a new covered test that has successfully completed a TA and is effective for 4/18/2025.

Visit the Noridian Molecular Diagnostic Services webpage to view the Active MolDX LCDs or access it via the CMS MCD.