TL;DR: Aetna, a CVS Health company, modified CPB 0341 governing infliximab coverage policy, effective January 9, 2026. Here's what billing teams need to know before submitting another claim.
This update to CPB 0341 Aetna system covers all five infliximab products — Remicade, Renflexis, Avsola, Inflectra, and Zymfentra — across a wide range of inflammatory conditions. The policy affects infliximab billing for CPT codes 96365–96368 (IV infusion), 96372 (subcutaneous injection), and 96374–96375 (IV push), along with a cluster of diagnostic codes that are explicitly excluded from coverage. If your practice manages rheumatology, gastroenterology, or dermatology patients on Aetna commercial plans, this policy touches nearly every infliximab claim you submit.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Infliximab — CPB 0341 |
| Policy Code | CPB 0341 |
| Change Type | Modified |
| Effective Date | January 9, 2026 |
| Impact Level | High |
| Specialties Affected | Gastroenterology, Rheumatology, Dermatology, Pulmonology, Ophthalmology, Oncology/Hematology |
| Key Action | Verify prescriber specialty matches the approved list for each indication before submitting precertification requests |
Aetna Infliximab Coverage Criteria and Medical Necessity Requirements 2026
Aetna's coverage policy for infliximab requires precertification for every product, every time. Call (866) 752-7021 or fax (888) 267-3277 to initiate. There are no exceptions for participating providers.
The first gate is prescriber specialty. Aetna won't approve infliximab for Crohn's disease or ulcerative colitis unless a gastroenterologist prescribes or co-signs. Rheumatoid arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, Behcet's disease, Takayasu's arteritis, and reactive arthritis require a rheumatologist. Psoriatic arthritis and hidradenitis suppurativa accept either a rheumatologist or dermatologist. Plaque psoriasis and pyoderma gangrenosum require a dermatologist specifically.
That prescriber requirement is a hard stop. If the ordering provider doesn't match the approved specialty for the stated diagnosis, the prior authorization will be denied before Aetna even looks at clinical criteria.
Rheumatoid Arthritis: The Most Complex Pathway
RA has two routes to initial approval, and they work very differently.
Route one is simpler: the member received a biologic or targeted synthetic DMARD (like Rinvoq or Xeljanz) for moderately to severely active RA within the past 120 days. If that's the case, infliximab (Avsola, Inflectra, Remicade, or Renflexis — not Zymfentra) is approvable when combined with methotrexate or leflunomide, unless a documented clinical reason prevents those combinations.
Route two requires biomarker testing. Aetna requires either a positive rheumatoid factor (RF — CPT 86430 or 86431) or a positive anti-CCP (CPT 86200). If both are negative, the member must have documented testing for RF, anti-CCP, and CRP/ESR (CPT 86140, 86141, 85651, or 85652) before Aetna considers the medical necessity case. Missing that lab documentation is one of the most common reasons RA infliximab claims fail on initial prior auth.
The combination requirement with methotrexate or leflunomide is also non-negotiable unless you document a clinical exception. Pull that documentation before you submit, not after.
Crohn's Disease and Ulcerative Colitis
For CD and UC, coverage applies to moderately to severely active disease. The clinical bar is consistent with FDA labeling — this isn't a new restriction. But Aetna's site-of-care policy applies to IV products (Avsola, Inflectra, Remicade, Renflexis). Your infliximab billing for these IV products may be denied if the service site doesn't meet Aetna's Utilization Management Policy on Site of Care for Specialty Drug Infusions.
Zymfentra (infliximab-dyyb subcutaneous) is the exception — it doesn't go through IV site-of-care review. If your practice is seeing site-of-care denials on IV infliximab, that subcutaneous option may open a different path for appropriate patients.
TB Screening Is a Prerequisite
Before any infliximab product gets approved, members need TB screening. CPT 86480 and 86481 (QuantiFERON and T-SPOT.TB) and CPT 86580 (tuberculin skin test) are all listed as related codes under this policy. A missing TB test result is a common prior auth deficiency. Include it in your precertification package.
Chest X-ray codes 71045–71048 are also listed as related — relevant when TB screening is positive or indeterminate.
Aetna Infliximab Exclusions and Non-Covered Indications
Aetna explicitly excludes several lab tests from coverage under this policy. These are worth knowing because they show up in drug monitoring workflows and can generate unexpected denials.
CPT 80230 (infliximab drug level) is not covered for indications listed in CPB 0341. Same for CPT 83516 and 83520, which cover immunoassays for anti-drug antibody testing (including human anti-chimeric antibodies/HACA and infliximab trough levels).
The two newer MAAA codes — 0514U (quantitative adalimumab level for IBD) and 0515U (quantitative infliximab level for IBD) — are also not covered. 0350U (drug metabolism DNA analysis) is excluded as well.
The real issue here is that therapeutic drug monitoring for infliximab — checking trough levels and anti-drug antibodies to guide dosing — is a standard clinical practice. Aetna's position is that the evidence doesn't support routine monitoring under this CPB. If your GI or rheumatology practice bills these codes for infliximab management, expect denials on Aetna commercial plans. That's not a billing error — it's a coverage policy decision. But your patients need to know before the test runs.
CPT 86235 (extractable nuclear antigen/ANA panel) is also excluded. That's relevant for practices that run autoimmune panels as part of workup — it won't be reimbursed under this CPB.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Crohn's disease (moderately to severely active) | Covered | 96365–96368, 96372, 96374 | All five products; gastroenterologist required; site-of-care applies to IV |
| Ulcerative colitis (moderately to severely active) | Covered | 96365–96368, 96372, 96374 | All five products; gastroenterologist required; site-of-care applies to IV |
| Rheumatoid arthritis | Covered (IV products only — not Zymfentra) | 96365–96368, 96374; labs: 86200, 86430, 86431, 86140, 85651 | Requires methotrexate/leflunomide combination; biomarker testing required unless step-through pathway |
| Ankylosing spondylitis | Covered | 96365–96368, 96374 | Rheumatologist required |
| Non-radiographic axial spondyloarthritis | Covered | 96365–96368, 96374 | Rheumatologist required |
| Psoriatic arthritis | Covered | 96365–96368, 96374 | Rheumatologist or dermatologist |
| Plaque psoriasis | Covered | 96365–96368, 96374 | Dermatologist required |
| Hidradenitis suppurativa | Covered | 96365–96368, 96374 | Rheumatologist or dermatologist |
| Uveitis | Covered | 96365–96368, 96374 | Ophthalmologist or rheumatologist |
| Sarcoidosis | Covered | 96365–96368, 96374 | Dermatologist, pulmonologist, rheumatologist, cardiologist, neurologist, or ophthalmologist |
| Behcet's disease | Covered | 96365–96368, 96374 | Rheumatologist required |
| Takayasu's arteritis | Covered | 96365–96368, 96374 | Rheumatologist required |
| Reactive arthritis | Covered | 96365–96368, 96374 | Rheumatologist required |
| Pyoderma gangrenosum | Covered | 96365–96368, 96374 | Dermatologist required |
| Immune checkpoint inhibitor-related inflammatory arthritis | Covered | 96365–96368, 96374 | Oncologist, hematologist, or rheumatologist |
| Immune checkpoint inhibitor-related toxicity | Covered | 96365–96368, 96374 | Gastroenterologist, oncologist, or hematologist |
| Acute graft versus host disease | Covered | 96365–96368, 96374 | Oncologist or hematologist |
| Infliximab drug level monitoring (CPT 80230, 83516, 83520) | Not Covered | 80230, 83516, 83520 | Not covered under CPB 0341 for any listed indication |
| Therapeutic drug monitoring — MAAA (CPT 0514U, 0515U) | Not Covered | 0514U, 0515U | Excluded regardless of clinical context |
| Drug metabolism DNA analysis (CPT 0350U) | Not Covered | 0350U | Not covered under this CPB |
| ANA/extractable nuclear antigen panel (CPT 86235) | Not Covered | 86235 | Not covered under this CPB |
Aetna Infliximab Billing Guidelines and Action Items 2026
| # | Action Item |
|---|---|
| 1 | Verify prescriber specialty against the indication before submitting precertification. This is a hard stop in the policy. If your ordering provider is an internist co-managing a rheumatology patient, you need a rheumatologist to prescribe or formally consult before January 9, 2026. Retroactive fixes don't work here. |
| 2 | Pull biomarker lab results before submitting RA prior auth. CPT 86200 (anti-CCP), 86430/86431 (RF), 86140/86141 (CRP/hsCRP), and 85651/85652 (ESR) all need to be in the authorization package. A positive RF or anti-CCP satisfies the requirement. If both are negative, you need all three documented. Don't submit without them. |
| 3 | Document methotrexate or leflunomide use — or the clinical exception — for every RA claim. Aetna requires combination therapy for RA. If your patient can't tolerate methotrexate or leflunomide, you need the clinical rationale in the chart and the prior auth request. "Patient declined" is not sufficient — document the clinical reason. |
| 4 | Remove CPT 80230, 0514U, 0515U, 83516, and 83520 from your infliximab monitoring order sets for Aetna commercial patients. These codes will deny. If your practice routinely monitors trough levels or anti-drug antibodies, flag these patients before ordering. The denial won't come at prior auth — it will come as a claim denial after the test is already resulted. That's a harder conversation with the patient. |
| 5 | Check your infliximab billing site-of-care against Aetna's infusion policy for IV products. Avsola, Inflectra, Remicade, and Renflexis are subject to Aetna's Site of Care Utilization Management Policy. If you're billing CPT 96365–96368 or 96374–96375 for these products in a hospital outpatient setting, verify that setting meets Aetna's criteria. Office-based infusion or home infusion may be required depending on the member's plan. |
| 6 | Include TB screening results in every new-start precertification package. Use CPT 86480 or 86481 for IGRA testing, or 86580 for TST. A missing TB test is one of the most common deficiencies in infliximab prior auth requests. Don't leave it out. |
If your panel includes a high volume of Aetna commercial lives across rheumatology and GI, the RA biomarker and combination therapy requirements represent the highest financial exposure here. Talk to your compliance officer before the effective date if you're unsure how your current documentation practices hold up against the updated criteria.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Infliximab Under CPB 0341
Administration CPT Codes (Covered When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| 96360 | CPT | Intravenous infusion, hydration |
| 96361 | CPT | Intravenous infusion, hydration, each additional hour |
| 96365 | CPT | IV infusion, therapy/prophylaxis/diagnosis — initial |
| 96366 | CPT | IV infusion, therapy/prophylaxis/diagnosis — each additional hour |
| 96367 | CPT | IV infusion, additional sequential infusion, new drug/substance |
| 96368 | CPT | IV infusion, concurrent infusion |
| 96372 | CPT | Therapeutic/prophylactic/diagnostic injection — subcutaneous or intramuscular |
| 96374 | CPT | IV push, single or initial substance/drug |
| 96375 | CPT | IV push, each additional sequential new substance/drug |
| 96379 | CPT | Unlisted therapeutic/prophylactic/diagnostic IV or intra-arterial injection |
| 96401–96448 | CPT | Chemotherapy administration (range) |
Not Covered / Excluded CPT Codes
| Code | Type | Description | Reason |
|---|---|---|---|
| 0350U | CPT | Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis | Not covered for indications listed in CPB 0341 |
| 0514U | CPT | Gastroenterology (IBD), immunoassay — quantitative adalimumab level | Not covered for indications listed in CPB 0341 |
| 0515U | CPT | Gastroenterology (IBD), immunoassay — quantitative infliximab level | Not covered for indications listed in CPB 0341 |
| 80230 | CPT | Infliximab drug level | Not covered for indications listed in CPB 0341 |
| 83516 | CPT | Immunoassay for analyte other than infectious agent — qualitative | Not covered for indications listed in CPB 0341 |
| 83520 | CPT | Immunoassay, analyte, quantitative (HACA, infliximab-related) | Not covered for indications listed in CPB 0341 |
| 86235 | CPT | Extractable nuclear antigen (ANA panel), antibody | Not covered for indications listed in CPB 0341 |
Note: The policy lists 378 ICD-10-CM codes. The full code set is available in the complete CPB 0341 policy document at app.payerpolicy.org/p/aetna/0341.
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