Padcev (J9177): Medicare coverage & FDA-indicated diagnoses

Padcev (Enfortumab vedotin) · Medicare Part B (physician-administered) · 12 FDA-indicated ICD-10 codes

Medicare pays for Padcev (J9177) under Part B per medical necessity. There is no drug-specific Medicare LCD, so the 12 ICD-10 codes below are the FDA-approved indications — the labeled uses Medicare generally pays for — grouped by condition. Coverage is judged by your MAC. Page reviewed Aug 23, 2026.

Page reviewed Aug 23, 2026 · from FDA-approved labeling (Drugs@FDA) — no drug-specific Medicare LCD

Quick answer

Medicare benefit
Part B (physician-administered)
FDA-indicated diagnoses
12 ICD-10 codes
Governing policy
FDA indications (no LCD)
Contractor (MAC)
Per medical necessity
Source
FDA labeling
Page reviewed
Aug 23, 2026
HCPCS codes covered:
J9177
No drug-specific Medicare coverage article exists for Padcev. Coverage is decided per medical necessity by your MAC. The FDA-approved indications below are the labeled uses Medicare generally pays for; an off-label use may be covered if supported by an approved compendium. Find your MAC by state →

What Medicare pays for Padcev (2026 Q3)

Once a claim carries a covered diagnosis, Medicare Part B reimburses the drug at the ASP + 6% payment limit. Current allowed amounts per billing unit:

HCPCSDescriptionPer unitAllowed (ASP + 6%)
J9177Inj enfort vedo-ejfv 0.25mg0.25 mg$36.658

Source: CMS ASP Drug Pricing File, 2026 Q3. Payment = ASP + 6% per unit; multiply by units billed (watch JZ/JW wastage). Your patient's share is typically 20% after the deductible. Estimate the full cost & patient out-of-pocket →

Padcev is a physician-administered biologic billed under Medicare Part B (not the Part D pharmacy benefit). Under Part B, Medicare pays the practice for the drug (HCPCS J9177) plus its administration — but only when the claim's diagnosis (ICD-10) code supports medical necessity. Each MAC publishes the specific covered diagnoses in a Billing & Coding Article; a claim with a diagnosis outside that list is typically denied as not medically necessary (CO-50).

Covered ICD-10 diagnoses for Padcev

The 12 FDA-approved indications for J9177, grouped by condition — filter to find a code.

Urothelial Carcinoma — 3 diagnoses (applies to J9177)

Neoplasms (3)

ICD-10Covered diagnosis
C65.9Malignant neoplasm of unspecified renal pelvis
C67.0Malignant neoplasm of trigone of bladder
C67.9Malignant neoplasm of bladder, unspecified

Encounter — 1 diagnoses (applies to J9177)

Factors influencing health status (1)

ICD-10Covered diagnosis
Z51.11Encounter for antineoplastic chemotherapy

Bladder Cancer — 8 diagnoses (applies to J9177)

Neoplasms (8)

ICD-10Covered diagnosis
C67.1Malignant neoplasm of dome of bladder
C67.2Malignant neoplasm of lateral wall of bladder
C67.3Malignant neoplasm of anterior wall of bladder
C67.4Malignant neoplasm of posterior wall of bladder
C67.5Malignant neoplasm of bladder neck
C67.6Malignant neoplasm of ureteric orifice
C67.7Malignant neoplasm of urachus
C67.8Malignant neoplasm of overlapping sites of bladder

How to bill Padcev

Put a medically necessary, FDA-indicated diagnosis from the list above on the claim line with J9177. Matching codes, units and JZ/JW wastage →

Which policy governs Padcev

No drug-specific LCD or Article — see the note at the top of this page. Find your MAC → What an LCD, an Article and an NCD each govern →

If a claim for Padcev is denied

With no drug-specific Article, the usual cause is a diagnosis the MAC does not accept as medically necessary for J9177, or an off-label use with no compendium support. The five denial patterns and how to fix each →

Frequently asked questions

Is Padcev covered by Medicare?
Yes. Padcev (J9177) is covered under Medicare Part B as a physician-administered drug when billed for a medically necessary indication. There is no drug-specific Local Coverage Determination (LCD) for it, so coverage is determined per medical necessity by your MAC; the FDA-approved indications below are the starting point.
What diagnoses are covered for Padcev (J9177)?
Medicare publishes no drug-specific covered-diagnosis list for J9177. The 12 ICD-10 codes here are the FDA-approved indications; an off-label use needs approved-compendium support (DrugDex, NCCN) to be payable.
Which Medicare policy covers Padcev?
No drug-specific LCD or Billing & Coding Article exists for Padcev. It's covered under the general Medicare Part B drug benefit per medical necessity, as judged by your Medicare Administrative Contractor (MAC).
Why was my Padcev claim denied as not medically necessary?
The most common cause is a diagnosis the MAC doesn't consider medically necessary for J9177. Bill a covered/FDA-approved indication from the list below, document medical necessity, and confirm any local guidance with your MAC.

Related references

Covered is only half the answer.

You know the diagnosis is payable. Now quote the patient before the visit and catch underpayments: get Padcev's exact Medicare allowed amount, your payer's rate vs. ASP+6%, and the patient's out-of-pocket — in about 30 seconds, free.

Estimate Padcev cost & patient owe →

Source & verification

Source
FDA-approved indications (Drugs@FDA labeling) mapped to ICD-10-CM. No drug-specific Medicare LCD/Article exists for Padcev — Part B coverage is determined per medical necessity by your MAC.
Primary sources
DailyMed — Padcev prescribing information · CMS Part B Drug ASP Pricing File — the quarterly payment limit quoted above · CMS Medicare Coverage Database — searched for “Padcev”; no drug-specific NCD, LCD or Billing & Coding Article exists, which is why the FDA-indicated codes above are the working list
Page last reviewed by CareCost
Aug 23, 2026 (coverage data retrieved 2026-08-26; we re-verify against CMS quarterly).
Code licensing
ICD-10-CM codes are public domain (CMS/CDC). CPT® codes are AMA-copyrighted and are intentionally not listed here — see the administration-code reference for those.
Not advice
This is general billing reference, not legal or billing advice. Always verify against the LCD/Article that applies to your MAC and patient.
How we build this
Compiled programmatically from the CMS Coverage API under a founder-led methodology maintained by Erin Rose (Founder), and reviewed against the source article with a practitioner-correction loop. See our methodology and editorial policy.
Spotted an error?
Email editorial@carecostestimate.com.