Billing and Coding: MolDX: Minimal Residual Disease Testing for Solid Tumor Cancers

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 3^rd and 6^th 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.

Updated to indicate this article is an LCD Reference Article.

Under Article Text revised table one to add “Guardant360 Response”. This revision is effective on 4/6/2023.

Under Article Text below the table first subsection deleted first and second paragraphs. Added verbiage, “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, bladder and breast cancers and (2) the monitoring of response to immune-checkpoint inhibitor therapy for any solid tumor. However, the tests listed in the table may have only been approved for one or more (but not necessarily all) of these indications”. Under subsection heading “Additional process requirements for coverage” third paragraph added “NOTE: Prophylactic therapeutic interventions in patients with a history of cancer are excluded from the definition of a patient "with cancer"”. This revision is effective on 7/6/2023.

Under CPT/HCPCS Codes Group 1: Codes the description was revised for 81445. This is due to the 2023 Annual/Q1 CPT/HCPCS Code Update and is effective for dates of services on or after 1/1/2023.

Under Article Text revised table one and under table added verbiage, “Guardant Test - Coverage criteria under the policy have been met for the diagnosis of disease progression, recurrence, or relapse for colon cancer.” This revision is retroactive effective for dates of service on or after 10/01/2022.

Under Article Text revised verbiage in first sentence under table to include “bladder cancer”. This revision is effective for dates of service on or after 10/01/2022.

Under Article Text, first paragraph under the table removed last sentence and revised fourth sentence under table. Under Article Text under billing instructions added verbiage, “When submitting claims for the specific indicated use of monitoring response to ICI therapy, the ICI drug name must be included on the claim in the applicable detail line 2400 loop.” Under CPT/HCPCS Codes Group1: Paragraph revised verbiage. Under CPT/HCPCS Codes Group 2: Paragraph deleted verbiage. Under CPT/HCPCS Codes Group 2: Codes deleted 81479. Under CPT/HCPCS Codes moved Group 3 Paragraph and code to become Group 2 and revised verbiage. Under ICD-10 Codes that Support Medical Necessity Group 2: Paragraph deleted verbiage. Under ICD-10 Codes that Support Medical Necessity Group 2: Codes deleted all codes. Under ICD-10 Codes that Support Medical Necessity moved Group 3 Paragraph and codes to become Group 2 and revised verbiage. This revision is effective for dates of service on or after 10/01/2022.

Under CPT/HCPCS Codes Group1: Codes added 0340U. This revision is due to the Q4 2022 CPT/HCPCS Code Update and is effective for dates of service on or after 10/01/2022.

Under Article Title revised the title from, “Billing and Coding: MolDX: Minimal Residual Disease Testing for Cancer” to “Billing and Coding: MolDX: Minimal Residual Disease Testing for Solid Tumor Cancers”.

Under Article Text deleted the verbiage, “Relevant Articles regarding single-gene and panel testing of genes” and the 2 bullet points that followed. The table heading was revised to read, “The following tests have met the criteria for coverage under the policy”. The table was deleted, and 2 new tables were added. The sentence after the table was revised to read, “These Tables will be updated to reflect revisions and additions of newly covered tests” and the verbiage, “With the exception of single-gene PCR tests, tests not listed in this table have not established they meet the coverage criteria in the associated policy” was deleted. ClonoSeq^® was removed from the third paragraph. Deleted the subheading, Single-gene PCR tests and the verbiage that followed. The subheading, Other tests (i.e., Signatera, ClonoSeq®) was deleted. ClonoSeq^® was removed from the fifth paragraph. The following verbiage was added to the sixth paragraph, “Testing in these patients will be accompanied by the appropriate ‘Personal history of cancer’ ICD-10 code”.

Under subheading, Billing instructions the first bullet point was revised to add the verbiage, “If no specific CPT code exists for the test submitted, bill with the NOC code 81479”.

Under CPT/HCPCS Codes Group 1: Codes deleted 81450. Deleted CPT/HCPCS Codes Group 4: Paragraph, CPT/HCPCS Codes Group 4: Codes, CPT/HCPCS Codes Group 5: Paragraph, CPT/HCPCS Codes Group 5: Codes, CPT/HCPCS Codes Group 6: Paragraph, CPT/HCPCS Codes Group 6: Codes. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C46.0, C46.1, C46.2, C46.3, C46.4, C46.50, C46.51, C46.52, C46.7, C46.9 and deleted C82.00, C82.01, C82.02, C82.03, C82.04, C82.05, C82.06, C82.07, C82.08, C82.09, C82.10, C82.11, C82.12, C82.13, C82.14, C82.15, C82.16, C82.17, C82.18, C82.19, C82.20, C82.21, C82.22, C82.23, C82.24, C82.25, C82.26, C82.27, C82.28, C82.29, C82.30, C82.31, C82.32, C82.33, C82.34, C82.35, C82.36, C82.37, C82.38, C82.39, C82.40, C82.41, C82.42, C82.43, C82.44, C82.45, C82.46, C82.47, C82.48, C82.49, C82.50, C82.51, C82.52, C82.53, C82.54, C82.55, C82.56, C82.57, C82.58, C82.59, C82.80, C82.81, C82.82, C82.83, C82.84, C82.85, C82.86, C82.87, C82.88, C82.89, C82.90, C82.91, C82.92, C82.93, C82.94, C82.95, C82.96, C82.97, C82.98, C82.99, C83.10, C83.11, C83.12, C83.13, C83.14, C83.15, C83.16, C83.17, C83.18, C83.19, C83.30, C83.31, C83.32, C83.33, C83.34, C83.35, C83.36, C83.37, C83.38, C83.39, C84.7A, C85.10, C85.11, C85.12, C85.13, C85.14, C85.15, C85.16, C85.17, C85.18, C85.19, C85.20, C85.21, C85.22, C85.23, C85.24, C85.25, C85.26, C85.27, C85.28, C85.29, C85.80, C85.81, C85.82, C85.83, C85.84, C85.85, C85.86, C85.87, C85.88, C85.89, C85.90, C85.91, C85.92, C85.93, C85.94, C85.95, C85.96, C85.97, C85.98, C85.99, C90.00, C90.01, C90.02, C90.11, C91.00, C91.01, C91.02, C91.10, C91.11, C91.12, C92.00, C92.01, C92.02, C92.10, C92.11, C92.12, C92.20, C92.21, C92.22, C92.30, C92.31, C92.32, C92.40, C92.41, C92.42, C92.50, C92.51, C92.52, C92.60, C92.61, C92.62, C92.A0, C92.A1, C92.A2, C92.Z0, C92.Z1, C92.Z2, C92.90, C92.91, C92.92, C93.00, C93.01, C93.02, C93.10, C93.12, C93.Z0, C93.Z2, C93.90, C93.92, C94.00, C94.01, C94.02, C94.20, C94.21, C94.22, C94.30, C94.31, C94.32, C94.40, C94.41, C94.42, C94.6, C94.80, C94.81, C94.82, D45, D46.0, D46.1, D46.20, D46.21, D46.22, D46.A, D46.B, D46.C, D46.4, D46.Z, D46.9, D47.02, D47.1, D47.3, D47.4, D47.Z9, D47.9, D61.09, D61.3, D61.818, D61.89, D61.9, D75.81, Z85.6, Z85.71, Z85.72, Z85.79. Under ICD-10 Codes that Support Medical Necessity Group 2: Paragraph deleted the word only from the first sentence and all verbiage that followed in this section. Under ICD-10 Codes that Support Medical Necessity Group 3: Paragraph deleted the subheading, In patients with cancer and all verbiage that followed this subheading.

Under ICD-10 Codes that Support Medical Necessity Group 3: Codes added C46.0, C46.1, C46.2, C46.3, C46.4, C46.50, C46.51, C46.52, C46.7, and C46.9. Deleted ICD-10 Codes that Support Medical Necessity Group 4: Paragraph, ICD-10 Codes that Support Medical Necessity Group 4: Codes, ICD-10 Codes that Support Medical Necessity Group 5: Paragraph, ICD-10 Codes that Support Medical Necessity Group 5: Codes, ICD-10 Codes that Support Medical Necessity Group 6: Paragraph, and ICD-10 Codes that Support Medical Necessity Group 6: Codes. This revision is retroactive effective for dates of service on or after 01/01/2022.