TL;DR: Aetna, a CVS Health company, modified CPB 1002 — its coverage policy for efgartigimod alfa-fcab (Vyvgart) and efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) — effective December 10, 2025. Here's what billing teams need to know before submitting claims under HCPCS J9332 and J9334.
Aetna's updated Vyvgart coverage policy tightens medical necessity criteria for two approved indications: generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). The primary billing codes are J9332 (efgartigimod alfa-fcab, 2 mg) and J9334 (efgartigimod alfa and hyaluronidase-qvfc, 2 mg). Both require precertification, and the CIDP indication for Vyvgart Hytrulo carries an additional site-of-care utilization management requirement. If your practice bills either of these drugs to Aetna commercial plans, this update changes how you document and submit.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Efgartigimod Alfa-fcab (Vyvgart) and Efgartigimod Alfa and Hyaluronidase-qvfc (Vyvgart Hytrulo) |
| Policy Code | CPB 1002 |
| Change Type | Modified |
| Effective Date | December 10, 2025 |
| Impact Level | High |
| Specialties Affected | Neurology, Infusion Centers, Specialty Pharmacy |
| Key Action | Verify AChR antibody status and step therapy documentation before submitting precertification for J9332 or J9334 |
Aetna Vyvgart Coverage Criteria and Medical Necessity Requirements 2025
The Aetna Vyvgart coverage policy under CPB 1002 covers two drugs for two indications. The rules are different for each combination. Get this wrong, and you'll get a claim denial before the drug even ships.
Generalized Myasthenia Gravis (gMG)
Aetna considers J9332 (Vyvgart IV) or J9334 (Vyvgart Hytrulo subcutaneous) medically necessary for gMG when all of the following are met:
| # | Covered Indication |
|---|---|
| 1 | The member is anti-acetylcholine receptor (AChR) antibody positive |
| 2 | MGFA clinical classification is II through IV |
| 3 | MG activities of daily living (MG-ADL) total score is ≥ 5 |
| 4 | Step therapy is satisfied — one of:
|
| 5 | Inadequate response or intolerable adverse event to at least one immunosuppressive therapy and IVIG over at least 12 months |
| 6 | Documented clinical reason to avoid both immunosuppressive agents and IVIG |
That AChR antibody requirement is the gate. If the chart doesn't document antibody-positive status, the prior authorization will be denied. Pull the lab results before you submit — not after.
The combination exclusion is the other hard stop. Aetna will not cover Vyvgart alongside Rystiggo or complement inhibitors like eculizumab (J1300/Soliris) or ravulizumab (Ultomiris). If a patient is on any of those agents, you'll need to document a transition plan or the prior auth will fail.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
For CIDP, only Vyvgart Hytrulo (J9334) is covered — not the IV formulation (J9332). Aetna considers it medically necessary when all of the following are met:
| # | Covered Indication |
|---|---|
| 1 | Disease course is progressive or relapsing/remitting for 2 months or longer |
| 2 | Diagnosis confirmed by electrodiagnostic testing consistent with EFNS/PNS guidelines — this means nerve conduction studies (CPT 95907–95913) and/or needle EMG (CPT 95860–95872) are in the chart |
| 3 | Step therapy satisfied — one of:
|
| 4 | Documented clinical reason to avoid all three |
The electrodiagnostic testing requirement is specific. Aetna explicitly references EFNS/PNS guidelines. Nerve conduction studies and needle EMG aren't optional supporting documentation here — they're required for the diagnosis to count. If the neurologist ordered only range-of-motion measurements (CPT 95851, 95852), that's not sufficient.
CIDP also carries a site-of-care utilization management requirement under Aetna's drug infusion site-of-care policy. For Vyvgart Hytrulo in CIDP, Aetna will review where the drug is being administered. Infusion centers and hospital outpatient departments should expect scrutiny. Home administration or lower-cost sites may be preferred.
Prior Authorization Requirements
Both drugs require precertification for all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277. Submit the Statement of Medical Necessity form through Aetna's Specialty Pharmacy Precertification portal before administering either drug.
There's no grace period here. Administering either drug before prior authorization is approved puts full reimbursement at risk.
Aetna Vyvgart Exclusions and Non-Covered Indications
Aetna considers all indications for Vyvgart and Vyvgart Hytrulo experimental, investigational, or unproven except gMG and CIDP. That's a short list of covered uses for two drugs with expanding clinical trial programs.
If you're billing J9332 or J9334 for anything other than gMG or CIDP — Lambert-Eaton myasthenic syndrome, pemphigus vulgaris, immune thrombocytopenia, or any other off-label use — Aetna will deny it under CPB 1002. Don't submit without a documented peer-to-peer plan or an appeals strategy ready.
Coverage Indications at a Glance
| Indication | Drug Covered | Status | Key Codes | Notes |
|---|---|---|---|---|
| Generalized myasthenia gravis (gMG) | Vyvgart IV or Vyvgart Hytrulo | Covered | J9332, J9334 | AChR antibody positive required; MG-ADL ≥ 5; MGFA Class II–IV; step therapy required; no combo with FcRn blockers or complement inhibitors |
| Chronic inflammatory demyelinating polyneuropathy (CIDP) | Vyvgart Hytrulo only | Covered | J9334 | Electrodiagnostic confirmation required; step therapy required; site-of-care UM applies |
| All other indications | Either drug | Not Covered | J9332, J9334 | Considered experimental, investigational, or unproven |
Aetna Vyvgart Billing Guidelines and Action Items 2025
The effective date for this modified coverage policy is December 10, 2025. If you're already billing J9332 or J9334, these actions are overdue. If you're about to start, do these before the first claim goes out.
| # | Action Item |
|---|---|
| 1 | Confirm AChR antibody documentation for every gMG patient. Aetna's coverage policy is explicit: antibody-negative or antibody-unknown patients don't qualify. Pull the lab report and attach it to the prior authorization submission. Don't assume the ordering neurologist's notes are enough. |
| 2 | Audit step therapy records before submitting precertification. For gMG, you need 12 months of documented therapy with at least two immunosuppressives, or one immunosuppressive plus IVIG, or a clinical contraindication to both. For CIDP, you need documented failure or contraindication for immunoglobulins, corticosteroids, or plasma exchange. If those records aren't in the chart, the PA will be denied. |
| 3 | Verify electrodiagnostic testing for every CIDP patient. Nerve conduction studies (CPT 95907–95913) and needle EMG (CPT 95860–95872, 95885–95887) must be in the record and must meet EFNS/PNS diagnostic guidelines. If the neurologist's workup is incomplete, the prior auth request will fail at review. |
| 4 | Check the combination drug list for every gMG patient on Vyvgart. Aetna will not approve J9332 or J9334 for any patient currently on an FcRn blocker (Rystiggo) or complement inhibitor (eculizumab/J1300, ravulizumab, zilucoplan). Review the active medication list before submitting. Combination therapy is a hard denial — no appeal will fix a contraindicated combination. |
| 5 | Address the site-of-care requirement for CIDP claims. Vyvgart Hytrulo billing for CIDP goes through Aetna's site-of-care utilization management review. If you're billing CPT 96372 (subcutaneous injection) in a hospital outpatient or infusion center setting, document medical necessity for that site specifically. Home administration may reduce prior authorization friction. |
| 6 | Set up reauthorization tracking now. CPB 1002 includes continuation-of-therapy criteria — patients don't get indefinite authorization. Build a reauthorization workflow that flags patients 30–45 days before authorization expiration. Letting auth lapse and billing without it is a clean path to denied claims. |
| 7 | Submit precertification requests through the correct channel. Call (866) 752-7021 or fax (888) 267-3277. Use the SMN precertification form from Aetna's Specialty Pharmacy Precertification portal. Submitting through a standard PA channel can cause delays that create billing gaps. |
If you're managing a high-volume neurology or infusion practice with significant Aetna commercial exposure on these drugs, loop in your billing consultant or compliance officer before December 10, 2025 to review your existing authorizations under the modified 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 Vyvgart Under CPB 1002
HCPCS Codes Covered When Selection Criteria Are Met
| Code | Type | Description |
|---|---|---|
| J9332 | HCPCS | Injection, efgartigimod alfa-fcab, 2 mg (Vyvgart IV) |
| J9334 | HCPCS | Injection, efgartigimod alfa and hyaluronidase-qvfc, 2 mg (Vyvgart Hytrulo) |
CPT Codes Related to This Policy
These codes appear in CPB 1002 as supporting procedures — diagnostic testing, infusion administration, and related services. They establish medical necessity documentation and support the clinical record for prior authorization and claim submission.
| Code | Type | Description |
|---|---|---|
| 36514 | CPT | Therapeutic apheresis; for plasma pheresis |
| 90283 | CPT | Immune globulin (IgIV), human, for intravenous use |
| 95851 | CPT | Range of motion measurements and report; each extremity (excluding hand) |
| 95852 | CPT | Range of motion measurements and report; hand, with or without comparison |
| 95860 | CPT | Needle electromyography |
| 95861 | CPT | Needle electromyography |
| 95862 | CPT | Needle electromyography |
| 95863 | CPT | Needle electromyography |
| 95864 | CPT | Needle electromyography |
| 95865 | CPT | Needle electromyography |
| 95866 | CPT | Needle electromyography |
| 95867 | CPT | Needle electromyography |
| 95868 | CPT | Needle electromyography |
| 95869 | CPT | Needle electromyography |
| 95870 | CPT | Needle electromyography |
| 95871 | CPT | Needle electromyography |
| 95872 | CPT | Needle electromyography |
| 95885 | CPT | Needle electromyography, each extremity, with related paraspinal areas (with nerve conduction studies) |
| 95886 | CPT | Needle electromyography, each extremity, with related paraspinal areas (with nerve conduction studies) |
| 95887 | CPT | Needle electromyography, each extremity, with related paraspinal areas (with nerve conduction studies) |
| 95905 | CPT | Motor and/or sensory nerve conduction, using preconfigured electrode array(s) |
| 95907 | CPT | Nerve conduction studies |
| 95908 | CPT | Nerve conduction studies |
| 95909 | CPT | Nerve conduction studies |
| 95910 | CPT | Nerve conduction studies |
| 95911 | CPT | Nerve conduction studies |
| 95912 | CPT | Nerve conduction studies |
| 95913 | CPT | Nerve conduction studies |
| 96360 | CPT | Intravenous infusion, hydration; initial, 31 minutes to 1 hour |
| 96361 | CPT | Intravenous infusion, hydration; each additional hour |
| 96365 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour |
| 96366 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis; each additional hour |
| 96367 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis; additional sequential infusion |
| 96368 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis; concurrent infusion |
| 96372 | CPT | Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular |
Selected HCPCS Codes Referenced in CPB 1002 (Comparator and Related Drugs)
These HCPCS codes appear in CPB 1002 as reference codes for drugs mentioned in the criteria — including excluded combination drugs and step therapy agents.
| Code | Type | Description |
|---|---|---|
| J0702 | HCPCS | Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg |
| J1094 | HCPCS | Injection, dexamethasone acetate, 1 mg |
| J1100 | HCPCS | Injection, dexamethasone sodium phosphate, 1 mg |
| J1300 | HCPCS | Injection, eculizumab, 10 mg (Soliris — excluded combination drug) |
| J1459–J1496 | HCPCS | Immune globulin injections, various formulations (step therapy reference agents) |
The full HCPCS code list in CPB 1002 includes 162 codes. The codes above are the primary billing and reference codes most relevant to Vyvgart billing.
Note: No ICD-10-CM codes are listed in the CPB 1002 policy data. Document the clinical diagnosis using the appropriate ICD-10 code for gMG or CIDP based on your standard coding workflow.
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