Trodelvy (J9317): Medicare coverage & FDA-indicated diagnoses

Trodelvy (Sacituzumab govitecan-hziy) · Medicare Part B (physician-administered) · 6 FDA-indicated ICD-10 codes

Medicare pays for Trodelvy (J9317) under Part B per medical necessity. There is no drug-specific Medicare LCD, so the 6 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
6 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:
J9317
No drug-specific Medicare coverage article exists for Trodelvy. 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 Trodelvy (2026 Q4)

2026 Q4 payment limit per billing unit for Trodelvy’s HCPCS code (how ASP + 6% works):

HCPCSDescriptionPer unitAllowed (ASP + 6%)
J9317Sacituzumab govitecan-hziy2.5 mg$37.536

CMS ASP Drug Pricing File, 2026 Q4. Trodelvy patient out-of-pocket estimate →

Worked billing example for Trodelvy

A concrete, paste-checkable example using J9317’s own billing-unit basis and vial sizes — not a hypothetical.

Scenario800 mg dose — 10 mg/kg IV for an 80 kg reference patient
Dose administered800 mg
Billing unit basis1 unit = 2.5 mg
Billing units (dose ÷ unit basis, rounded up)320 units of J9317
Vial combination drawn (min-waste plan)5 × 180 mg vials
Discarded (waste)100 mg
Wastage modifier (JW / JZ)Bill the 320 administered units on one claim line (no wastage modifier), and the 40 discarded units on a separate line with JW. Do not add JZ — JW and JZ are never billed together for the same drug on the same date of service. JW vs JZ, with examples →
Medicare allowable (ASP + 6%, 2026 Q4)360 units × $37.536/unit = $13512.96

Allowable, not paid: sequestration and the covered diagnosis still apply.

Dose source: drugs/trodelvy.html — "Worked example — 80 kg patient, 800 mg dose". Different dose or drug? Compute your own dose → or estimate the full cost & patient out-of-pocket →.

Trodelvy (HCPCS J9317) is paid under Part B only when the claim’s ICD-10 code is one the MAC accepts; otherwise expect a CO-50 denial. How Part B drug coverage is decided →

Covered ICD-10 diagnoses for Trodelvy

The 6 FDA-approved indications for J9317, grouped by condition — filter to find a code.

Triple-Negative Breast — 2 diagnoses (applies to J9317)

Neoplasms (2)

ICD-10Covered diagnosis
C50.911Malignant neoplasm of unspecified site of right female breast
C50.919Malignant neoplasm of unspecified site of unspecified female breast

Urothelial Carcinoma — 1 diagnoses (applies to J9317)

Neoplasms (1)

ICD-10Covered diagnosis
C67.9Malignant neoplasm of bladder, unspecified

Encounter — 1 diagnoses (applies to J9317)

Factors influencing health status (1)

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

Breast Cancer — 2 diagnoses (applies to J9317)

Neoplasms (2)

ICD-10Covered diagnosis
C50.912Malignant neoplasm of unspecified site of left female breast
C50.921Malignant neoplasm of unspecified site of right male breast

How to bill Trodelvy

Put a medically necessary, FDA-indicated diagnosis from the list above on the claim line with J9317. Matching codes, units and JZ/JW wastage →

Which policy governs Trodelvy

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 Trodelvy is denied

With no drug-specific Article, the usual cause is a diagnosis the MAC does not accept as medically necessary for J9317, or an off-label use with no compendium support. The five denial patterns and how to fix each →

Frequently asked questions

Is Trodelvy covered by Medicare?
Yes. Trodelvy (J9317) 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. None of the 8 Medicare Administrative Contractors lists J9317 as self-administered.
What diagnoses are covered for Trodelvy (J9317)?
Medicare publishes no drug-specific covered-diagnosis list for J9317. The 6 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 Trodelvy?
No drug-specific LCD or Billing & Coding Article exists for Trodelvy. 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 Trodelvy claim denied as not medically necessary?
The most common cause is a diagnosis the MAC doesn't consider medically necessary for J9317. 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 Trodelvy'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 Trodelvy 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 Trodelvy — Part B coverage is determined per medical necessity by your MAC.
Primary sources
DailyMed — Trodelvy prescribing information · CMS Part B Drug ASP Pricing File — the quarterly payment limit quoted above · CMS Medicare Coverage Database — searched for “Trodelvy”; 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 2026-09-21; we re-verify against CMS quarterly).
Notes
ICD-10-CM is public domain; CPT® (AMA) is intentionally not listed. Reference, not billing advice — built from the CMS Coverage API per our methodology; corrections to editorial@carecostestimate.com.