Article Detail - JF Part A

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 (WY).

Effective Date: January 1, 2024

Date Posted: January 11, 2024

Summary of Article Changes:

Under CPT/HCPCS Group 1: Codes the description was revised for 81445. Under CPT/HCPCS Group 2: Codes added 0422U. This revision is due to the 2024 Annual/Q1 CPT/HCPCS Code Update and is effective 1/1/2024.

Under Article Text below the table first subsection revised first sentence to read "Intended uses that have met clinical validity (CV) criteria under the policy include: (1) the diagnosis of disease progression, recurrence, or relapse for advanced colorectal (Natera and Guardant), bladder and breast cancers (Natera) (2) the diagnosis of disease recurrence or relapse for advanced breast (RaDaR) and HPV-driven oropharyngeal cancer (Naveris) (3) the monitoring of response to immune-checkpoint inhibitor therapy for colorectal cancer (Guardant) or any solid tumor (Natera)." Under subheading Regarding NGS panels removed "DEX™" and replaced with "DEX Z-Code®". Under subheading Billing Instructions revised second sentence to remove "DEX™" and replace with "DEX®". Revised 3rd and 6th bullets to remove "DEX Z-Code™" and replaced with "DEX Z-Code®". Added "NOTE: When entering the DEX Z-Code® on the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line". Formatting and punctuation errors were corrected throughout the article. This revision is effective 1/1/2024.

Under Article Text revised Table 1 row 9 to add "RaDaR Recurrence Monitoring Whole Exome Design + single Plasma Test (NeoGenomics Laboratories, Inc)". Revised row 10 to add "RaDaR Recurrence Monitoring single Plasma Test (NeoGenomics Laboratories, Inc)". This revision is due to new covered test that has successfully complete a TA and is effective for 3/24/2023.

Under Article Text revised Table 1 to add new row for Tumor Naïve Test for NavDX. Under CPT/HPCS Codes Group 3: Paragraph added "This group includes MRD tests that do not use NGS for the purpose of diagnosing disease progression, recurrence, or relapse.". Under CPT/HCPCS Group 3: Codes added 0356U. Under ICD-10 Codes that Support Medical Necessity Group 3: Paragraph added "The following ICD-10 codes can be used with MRD tests that do not use NGS for the purpose of diagnosing disease recurrence." Under ICD-10 Codes that Support Medical Necessity Group 3: Codes added Z85.810, Z85.818, and Z85.819. This revision is due to new covered test that has successfully completed a TA and is effective for 6/26/2023.

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

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