Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A56333 (Billing and Coding: MolDX: Inivata™, InVisionFirst®, Liquid Biopsy for Patients with Lung Cancer) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A56333: Billing and Coding: MolDX: Inivata™, InVisionFirst®, Liquid Biopsy for Patients with Lung Cancer (Billing and Coding, effective 2023-07-01)
- Covered ICD-10-CM codes
- 17
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 2
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| C33 | Malignant neoplasm of trachea |
| C34.01 | — |
| C34.02 | — |
| C34.11 | — |
| C34.12 | — |
| C34.2 | — |
| C34.31 | — |
| C34.32 | — |
| C34.81 | — |
| C34.82 | — |
| C34.90 | — |
| C34.91 | — |
| C34.92 | — |
| C38.1 | — |
| C38.2 | — |
| C38.4 | — |
| C38.8 | — |
Procedure codes: 0388U, 81479.
Coverage indications, limitations and medical necessity
This test is a “liquid biopsy”. It is intended to assist physicians caring for patients who suffer from a common form of lung cancer and who have advanced disease.
This policy provides limited coverage for InvisionFirst ® - Lung (Inivata™, Research Triangle Park, NC) (hereafter InVision ® ) a plasma-based, somatic comprehensive genomic profiling (CGP) test for patients with advanced (Stage IIIB/IV) non-small cell lung cancer (NSCLC)
• At diagnosis –
• When results for EGFR single nucleotide variants (SNVs) and insertions and deletions (indels); rearrangements in ALK and ROS1; and SNVs for BRAF are not available AND when tissue-based CGP is infeasible [i.e., quantity not sufficient (QNS) for tissue-based CGP or invasive biopsy is medically contraindicated],
or
• At progression –
• For patients progressing on or after chemotherapy or immunotherapy who have not been tested for EGFR SNVs and indels; rearrangements in ALK and ROS1; and SNVs for BRAFs, and for whom tissue-based CGP is infeasible;
or
• For patients progressing on EGFR tyrosine kinase inhibitors (TKIs),
If no genetic alteration is detected by InVision ® or if circulating tumor DNA (ctDNA) is insufficient/not detected, tissue-based genotyping should be considered.
Summary of evidence (opening)
Background
It is estimated that more than 222,500 new cases of lung cancer will be diagnosed in the United States (US) this year. 1 This represents roughly 13% of all new cancer diagnoses and 26% of cancer deaths. 1 At least 87% of lung cancer is NSCLC. 2 The estimated 5-year survival rate for all NSCLC cancer patients is 17%, and only 4% for patients with advanced (stage IIIB/IV) disease. 3
The pathophysiological development of lung cancer is complicated, with several known genomic alterations found individually or in combination in many patients. These alterations may be due to toxic exposure or underlying genetic factors, and not all alterations have the same impact on disease development or prognosis. Some alterations appear to be integral to the transformation and ongoing growth of the tumor (driver alterations).
Among the best-studied genomic alterations are EGFR SNVs and indels and EML4-ALK rearrangements/fusions. EGFR-mutated NSCLC comprises up to 15% of all NSCLC patients in the US, with higher prevalence in certain ethnic groups (e.g., 40% in Asian Americans and 26% in Latin Americans). 4 These mutations convey a more favorable prognosis and predict response to treatment with oral EGFR inhibitors such as erlotinib, gefitinib, osimertinib or afatinib. Rearrangements of ALK and EML4, or with other less common fusion partners, occur in approximately 4% of all NSCLC patients and predict response to treatment with oral ALK-targeted inhibitors such as crizotinib, ceritinib, or alectinib. 5 Recently, dabrafenib in combination with trametinib has been approved for BRAF V600E positive metastatic NSCLC. 6
The contractor cites 36 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2019-04-15
- Current revision effective
- 2025-11-27
- Last reviewed by the contractor
- 2025-11-01
- MCD version
- 18
The contractor lists one National Coverage Determination as related: NCD 90.2 Next Generation Sequencing (NGS). Where an NCD speaks, it controls; the LCD can only address what the NCD leaves open.
Other related documents: A56336 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Wisconsin Physicians Service Insurance Corporation hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L37921 cover?
This test is a “liquid biopsy”. It is intended to assist physicians caring for patients who suffer from a common form of lung cancer and who have advanced disease. The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L37921 apply to?
Wisconsin Physicians Service Insurance Corporation applies it to Medicare claims in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L37921?
The companion billing and coding article A56333 lists 17 ICD-10-CM codes in 1 group that support medical necessity; the first 17 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L37921?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.