TL;DR: Aetna, a CVS Health company, modified CPB 1085 for telisotuzumab vedotin-tllv (Emrelis), effective February 27, 2026. Here's what billing teams need to know before submitting claims.

Aetna's updated Emrelis coverage policy now defines strict medical necessity criteria for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The policy requires precertification for all claims and covers administration under chemotherapy administration CPT codes in the 96401 range. If your oncology or infusion team treats NSCLC patients and bills Aetna commercial plans, this policy is live and the criteria are narrow.


Quick-Reference Table

Field Detail
Payer Aetna, a CVS Health company
Policy Telisotuzumab Vedotin-tllv (Emrelis) — CPB 1085
Policy Code CPB 1085
Change Type Modified
Effective Date February 27, 2026
Impact Level High
Specialties Affected Medical oncology, hematology-oncology, infusion therapy, hospital outpatient
Key Action Confirm c-Met overexpression documentation and prior authorization before submitting claims

Aetna Telisotuzumab Vedotin Coverage Criteria and Medical Necessity Requirements 2026

The CPB 1085 Aetna coverage policy for Emrelis is tight. Aetna covers telisotuzumab vedotin-tllv for one specific population, and if your patient doesn't meet all three conditions, you're looking at a claim denial.

Here's exactly what Aetna requires for initial approval:

Diagnosis: Locally advanced or metastatic non-squamous NSCLC only. Squamous cell histology is explicitly excluded. Make sure your ICD-10-CM coding reflects non-squamous histology.

Biomarker threshold: High c-Met protein overexpression, defined as 50% or more of tumor cells with strong (3+) staining. This is not a "c-Met positive" checkbox — the pathology report must document that specific threshold. If the report says "c-Met overexpression" without quantifying the staining level, Aetna has grounds to deny.

Prior treatment: The member must have received at least one prior systemic therapy. Document the prior regimen clearly in the medical record. Aetna will ask for it during precertification.

This is a classic Aetna coverage policy structure — narrow biomarker gating with a prior therapy requirement. The c-Met staining threshold (≥50% of tumor cells at 3+) is the hardest gate. Generic pathology notes won't clear it. Your team needs the actual immunohistochemistry (IHC) report in the chart before you call for precertification.

Prior Authorization Requirements

Precertification is required for all Aetna participating providers and members in applicable plan designs. There are no exceptions for urgent cases or in-network facilities.

Call (866) 752-7021 or fax (888) 267-3277 to start the precertification process. For Statement of Medical Necessity (SMN) forms, go to Aetna's Specialty Pharmacy Precertification page directly. Don't send a generic prior auth form — use the SMN form specific to this drug.

Build precertification into your workflow before the first infusion. Telisotuzumab vedotin billing fails fast when precertification is skipped or submitted after administration.

Continuation of Therapy

Aetna considers reauthorization for continuation of therapy medically necessary when two conditions are met: no unacceptable toxicity and no disease progression on the current regimen. Your clinical team needs to document both at each reauthorization cycle. Absence of documentation on either point gives the prior auth reviewer a reason to deny.


Aetna Telisotuzumab Vedotin Exclusions and Non-Covered Indications

Aetna considers all indications outside of the NSCLC criteria above to be experimental, investigational, or unproven. That language carries real weight in appeals — it's harder to overturn than a simple "not medically necessary" denial.

Specific exclusions include:

#Excluded Procedure
1Squamous NSCLC — the policy specifies non-squamous histology. Squamous cell carcinoma of the lung is not covered, full stop.
2Small cell lung cancer — not mentioned as a covered indication, and falls under the "all other indications" exclusion.
3c-Met overexpression below threshold — if the IHC result shows fewer than 50% of tumor cells at 3+ staining, the patient does not meet medical necessity criteria under this policy.
+ 1 more exclusions

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If you're treating a patient whose c-Met result is borderline or whose report uses different quantification language, loop in your compliance officer or billing consultant before submitting. Aetna's standard on this biomarker is specific enough that ambiguous pathology reports create real denial risk.


Coverage Indications at a Glance

Indication Status Histology Requirement Biomarker Requirement Prior Therapy Notes
Locally advanced or metastatic non-squamous NSCLC Covered Non-squamous only c-Met ≥50% tumor cells, 3+ staining At least one prior systemic therapy required Precertification required; continuation requires no toxicity/progression
Squamous NSCLC Not Covered Excluded N/A N/A Falls under experimental/investigational designation
Small cell lung cancer Not Covered / Experimental N/A N/A N/A Not listed as covered indication
+ 2 more indications

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This policy is now in effect (since 2026-02-27). Verify your claims match the updated criteria above.

Aetna Telisotuzumab Vedotin Billing Guidelines and Action Items 2026

The effective date of February 27, 2026 means this policy is already active. If your team has been billing Emrelis claims without these criteria locked in, audit your recent submissions now.

#Action Item
1

Verify IHC documentation before every precertification request. The pathology report must show c-Met ≥50% of tumor cells with 3+ staining. Pull the actual IHC report, not a summary note. If the report uses non-standard language, get a pathologist to clarify before you call Aetna at (866) 752-7021.

2

Confirm non-squamous histology in the chart and on the claim. Your ICD-10-CM code must reflect non-squamous NSCLC. Squamous histology codes will not match the covered indication and will trigger a denial. Review your charge capture templates to make sure coders aren't defaulting to a generic lung cancer code.

3

Document prior systemic therapy explicitly in the medical record. List the regimen, dates, and reason for discontinuation. Aetna's prior authorization reviewers will look for this. A note that says "patient has received prior chemotherapy" is not enough — name the drug(s).

+ 4 more action items

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Sample Version Diff Line-by-line changes
Previous VersionCurrent Version
Coverage is considered experimental and investigational for all indicationsCoverage is considered medically necessary when specific criteria are met
Prior authorization is not requiredPrior authorization is required for initial treatment
Documentation must include clinical historyDocumentation must include clinical history
+ 1 more action items

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CPT, HCPCS, and ICD-10 Codes for Telisotuzumab Vedotin Under CPB 1085

Covered CPT Codes (When Medical Necessity Criteria Are Met)

The policy lists chemotherapy and biologic agent administration CPT codes in the 96401–96480 range as applicable codes. These cover the infusion administration component of Emrelis treatment. The drug itself requires a separate HCPCS J-code for the drug product — confirm the correct J-code for telisotuzumab vedotin-tllv with your payer contract or drug reference, as the policy data does not list a specific HCPCS code.

Code Type Description
96401 CPT Chemotherapy and other highly complex drug or highly complex biologic agent administration
96402 CPT Chemotherapy and other highly complex drug or highly complex biologic agent administration
96403 CPT Chemotherapy and other highly complex drug or highly complex biologic agent administration
+ 77 more codes

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The policy data notes 148 total CPT codes in the 96401 series. The codes above represent the full list provided in the policy data through 96480. The policy did not provide distinct descriptions for individual codes beyond the shared chemotherapy administration description.

Key ICD-10-CM Diagnosis Codes

The policy data references 93 ICD-10-CM codes total but did not include the specific codes or descriptions in the data provided. Use ICD-10-CM codes that accurately reflect locally advanced or metastatic non-squamous NSCLC for your patient's specific presentation. Work with your coding team to select from the C34 category codes that match non-squamous histology and stage. Do not use squamous cell carcinoma codes — those histology codes will not align with the covered indication and will contribute to claim denial.

If you're not sure which ICD-10 codes Aetna expects on these claims, request the full code list directly from Aetna or through your provider relations contact.


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