Ravulizumab-cwvz (Ultomiris) — CPB 0946 | AETNA Coverage Update

TL;DR: Aetna, a CVS Health company, modified CPB 0946 covering ravulizumab-cwvz (Ultomiris) billing, effective December 20, 2025. Here's what changes for billing teams.

This update to the Aetna ravulizumab-cwvz coverage policy affects claims billed under HCPCS J1303 (injection, ravulizumab-cwvz, 10 mg) across four approved indications. The policy sets specific medical necessity thresholds for each condition—and the complement inhibitor combination restrictions are the part most likely to trigger a claim denial if your documentation isn't tight. If you bill CPB 0946 Aetna charges for any of the four covered indications, read this before your next claim goes out.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Ravulizumab-cwvz (Ultomiris) — CPB 0946
Policy Code	CPB 0946
Change Type	Modified
Effective Date	December 20, 2025
Impact Level	High
Specialties Affected	Hematology, Nephrology, Neurology, Pulmonology
Key Action	Audit all active Ultomiris authorizations against updated indication-specific criteria before submitting new prior auth requests

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Aetna Ravulizumab-cwvz Coverage Criteria and Medical Necessity Requirements 2025

Aetna considers ravulizumab-cwvz (Ultomiris) medically necessary for four indications: paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD). Each has its own set of hard criteria. Miss one element and you're looking at a denial.

Precertification is required. Call (866) 752-7021 or fax (888) 267-3277. This is not a soft requirement — every Aetna participating provider must precertify before billing J1303. The site of care utilization management policy also applies, so confirm the infusion setting meets Aetna's site-of-care rules before the first dose.

The coverage policy also enforces a strict rule across all four indications: Ultomiris cannot be used with another complement inhibitor. For PNH, that list includes Empaveli, Fabhalta, PiaSky, and Soliris. The one exception is Voydeya — concomitant use with Voydeya is allowed for PNH. For gMG, the restriction also covers neonatal Fc receptor blockers: Vyvgart, Vyvgart Hytrulo, and Rystiggo are all off the table in combination with Ultomiris.

Paroxysmal Nocturnal Hemoglobinuria (PNH) — ICD-10 D59.5

All four of these must be documented:

If your patient file shows GPI-AP deficiency but lacks LDH values or documented clinical manifestations, that prior authorization request will stall.

Atypical Hemolytic Uremic Syndrome (aHUS) — ICD-10 D59.30–D59.39

Three criteria, all required:

#	Covered Indication Copy
1	Shiga toxin absent
2	ADAMTS 13 activity above 5%
3	No concurrent complement inhibitor (e.g., Soliris)

The Shiga toxin and ADAMTS 13 results need to be in the record. Aetna isn't going to take your word for it.

Generalized Myasthenia Gravis (gMG) — ICD-10 G70.0, G70.1

This is the most complex indication. Five criteria, with one being a three-part sub-criterion:

That 12-month trial requirement is the biggest documentation burden here. Make sure your clinical team captures therapy start dates, response assessments, and adverse event notes in the record before submitting. Lack of that timeline is a common reason reimbursement gets delayed or denied.

Neuromyelitis Optica Spectrum Disorder (NMOSD) — ICD-10 G36.0

The policy summary included the AQP4 antibody requirement — anti-aquaporin-4 (AQP4) antibody positive — as the first criterion. CPT codes 86051, 86052, and 86053 (aquaporin-4 antibody testing by ELISA, cell-based immunofluorescence, and flow cytometry, respectively) are listed in the policy as related codes. Document the specific test method used — the policy lists three distinct test types, each with its own CPT code, and your record should match.

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Aetna Ravulizumab-cwvz Exclusions and Non-Covered Indications

The combination restrictions are the practical exclusions here. Billing J1303 when the patient is also receiving a complement inhibitor — Soliris (eculizumab, J1299), Empaveli, Fabhalta, or PiaSky — will result in a denial for all four indications. The policy is explicit.

For gMG, adding a neonatal Fc receptor blocker like efgartigimod alfa-fcab (J9332) or rozanolixizumab-noli (J9333) alongside Ultomiris also disqualifies the claim. These aren't soft contraindications — they're hard coverage policy exclusions.

The ICD-10 codes G12.21 (ALS), J12.82 (COVID-19 pneumonia), and U07.1 (COVID-19) appear in the policy's code set, but those indications have no documented approval criteria in the policy summary. Don't bill J1303 against those codes expecting coverage without explicit documented medical necessity and prior authorization.

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Coverage Indications at a Glance

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Aetna Ravulizumab-cwvz Billing Guidelines and Action Items 2025

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Ravulizumab-cwvz Under CPB 0946

Covered HCPCS Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
J1303	HCPCS	Injection, ravulizumab-cwvz, 10 mg

Combination Therapy / Comparator HCPCS Codes (No Specific Coverage Criteria — Exclusion Context)

Key ICD-10-CM Diagnosis Codes

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