Mitomycin Intravesical Solution (Zusduri) — CPB 1086 | AETNA Coverage Update

Aetna modified CPB 1086 to add coverage criteria for mitomycin (Zusduri) intravesical solution, effective December 4, 2025. Here's what billing teams need to know.

Aetna, a CVS Health company, updated Clinical Policy Bulletin 1086 to establish medical necessity criteria for mitomycin (Zusduri) — the FDA-approved intravesical formulation used to treat recurrent low-grade non-muscle invasive bladder cancer. This coverage policy applies to commercial plans and requires precertification before treatment begins. The primary billing codes affected are HCPCS J9282 (mitomycin, intravesical instillation, 1 mg) and CPT 51720 (bladder instillation of anticarcinogenic agent).

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna
Policy	Mitomycin Intravesical Solution (Zusduri)
Policy Code	CPB 1086
Change Type	Modified
Effective Date	December 4, 2025
Impact Level	High
Specialties Affected	Urology, Oncology, Urogynecology
Key Action	Obtain precertification before billing J9282 or CPT 51720 for Zusduri administration

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Aetna Mitomycin Zusduri Coverage Criteria and Medical Necessity Requirements 2025

The Aetna mitomycin (Zusduri) coverage policy is narrow. Aetna covers this drug for one specific indication — and everything else is experimental by default.

To meet medical necessity under CPB 1086 Aetna system, your patient must have recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). That intermediate-risk classification matters. Aetna defines it as the presence of multiple tumors, a solitary tumor greater than 3 cm, and/or early or frequent recurrence. If your patient's chart doesn't document at least one of those risk factors, you don't have a clean claim.

Two additional criteria must both be satisfied:

#	Covered Indication Copy
1	The drug must be given via intravesical instillation — not systemic delivery.
2	It must be administered once weekly for six weeks (six doses total).

Both conditions must be met simultaneously. This isn't an either/or. Document the delivery route and the planned dosing schedule explicitly in the treatment notes before you submit for prior authorization.

Prior Authorization Requirements

Precertification is mandatory. Aetna requires prior authorization for mitomycin (Zusduri) across all participating providers and members in applicable plan designs. Don't assume an exception exists for your plan — it doesn't.

Call (866) 752-7021 or fax (888) 267-3277 to request precertification. For Statement of Medical Necessity (SMN) forms, go to Aetna's Specialty Pharmacy Precertification page on the Aetna provider site. Missing this step before administration will cost you the claim.

Continuation of Therapy

Aetna's continuation criteria mirror the initial approval criteria exactly. Any member — including new members switching plans mid-treatment — must meet all the same selection requirements to continue authorization. If your patient changes insurance mid-cycle, don't assume their prior auth transfers. Start the precertification process again.

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Aetna Mitomycin Zusduri Exclusions and Non-Covered Indications

Aetna's position here is blunt: all other indications are experimental, investigational, or unproven.

That's not a soft exclusion. It means if a physician wants to use Zusduri for anything other than LG-IR-NMIBC — high-grade bladder cancer, upper tract urothelial carcinoma, muscle-invasive disease, or any off-label use — Aetna will deny the claim. No gray area, no case-by-case review pathway mentioned in CPB 1086.

The real issue here is that mitomycin itself is not new. Older mitomycin formulations have been used intravesically for years across a range of urothelial conditions. But Zusduri is a distinct drug product, and Aetna is treating it that way. Don't assume coverage from a prior mitomycin authorization carries over to Zusduri billing. It won't.

If your urologist is using Zusduri in a broader clinical context, loop in your compliance officer before billing. The financial exposure from a wrongly coded claim on a specialty drug at this price point is not small.

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Coverage Indications at a Glance

Indication	Status	Relevant Codes	Notes Copy
Recurrent LG-IR-NMIBC — intravesical, once weekly × 6 weeks	Covered	J9282, CPT 51720, C67.0–C67.9 / D09.0	Precertification required; both delivery and dosing criteria must be met
All other indications (including off-label use)	Not Covered — Experimental/Investigational	—	Applies to all indications not explicitly listed above

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Aetna Mitomycin Zusduri Billing Guidelines and Action Items 2025

The effective date is December 4, 2025. If your team has been waiting on coverage clarity for Zusduri, that date is your starting gun. Here's what to do now.

Copy Action Items

The mitomycin intravesical billing process under this policy is manageable — but it rewards teams that prep the chart before authorization, not after denial.

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CPT, HCPCS, and ICD-10 Codes for Mitomycin Zusduri Under CPB 1086

Covered Procedure Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
J9282	HCPCS	Mitomycin, intravesical instillation, 1 mg
51720	CPT	Bladder instillation of anticarcinogenic agent (including retention time)

Note on J9282: This code is per milligram. Confirm the prescribed dose with the ordering physician and document the total milligrams administered per session. Undercoding or overcoding milligram units is a common reimbursement error on per-unit drug codes.

Note on CPT 51720: This code is listed under "Other CPT codes related to the CPB" in the policy — meaning it's the procedural code associated with the administration, not a separately covered drug code. Bill it alongside J9282, not instead of it.

Key ICD-10-CM Diagnosis Codes

Use the most specific C67 subsite code your documentation supports. Don't default to C67.9 (unspecified) when the operative or pathology report names the tumor location. Payers scrutinize unspecified codes, and specificity strengthens medical necessity alignment. D09.0 applies for carcinoma in situ cases that might also meet LG-IR-NMIBC criteria — confirm with your physician before using it, since staging nuance matters for coverage policy alignment.

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