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

Trodelvy (Sacituzumab govitecan-hziy) · Medicare Part B (physician-administered) · 5 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 5 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 Jun 29, 2026.

Page reviewed Jun 29, 2026 · from FDA-approved labeling (Drugs@FDA) — no drug-specific Medicare LCD

Quick answer

Medicare benefit
Part B (physician-administered)
FDA-indicated diagnoses
5 ICD-10 codes
Governing policy
FDA indications (no LCD)
Contractor (MAC)
Per medical necessity
Source
FDA labeling
Page reviewed
Jun 29, 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 Q2)

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%)
J9317Sacituzumab govitecan-hziy2.5 mg$36.797

Source: CMS ASP Drug Pricing File, 2026 Q2. 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 →

Trodelvy 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 J9317) 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 Trodelvy

The 5 ICD-10 codes below are the FDA-approved indications for J9317 — the labeled uses Medicare generally pays for under medical necessity — grouped by condition. Use the filter to find a specific code or condition.

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 — 1 diagnoses (applies to J9317)

Neoplasms (1)

ICD-10Covered diagnosis
C50.9Malignant neoplasm of breast of unspecified site

How to use this list when billing

Put a medically necessary, FDA-indicated diagnosis from the list above on the claim line with J9317, match the correct product code and units (check JZ/JW wastage), and document medical necessity. Because there's no drug-specific LCD, coverage is judged per medical necessity by your MAC; an off-label use can still be covered if supported by an approved drug compendium.

LCD vs. Billing & Coding Article vs. NCD

An LCD (Local Coverage Determination) is a MAC's policy on whether a service is reasonable and necessary in its region, and its companion Billing & Coding Article holds the covered ICD-10 and HCPCS code lists. A NCD (National Coverage Determination), where one exists, applies nationwide. Trodelvy has no drug-specific LCD or Article, so there is no published covered-code list — it's covered under the general Part B drug benefit per medical necessity, and the FDA-approved indications above are the practical starting point.

Common Trodelvy denial reasons

What you seeWhyFix
CO-50 — not medically necessaryDiagnosis the MAC doesn’t accept as medically necessaryBill a medically necessary FDA-indicated diagnosis from the list above; document necessity (compendium cite for off-label)
Diagnosis/units mismatchRight dx but wrong product code or unit countMatch the J/Q code and units to the drug actually given (check JZ/JW wastage)
Off-label denialIndication isn't FDA-labeled and isn't compendium-supportedCite an approved compendium (e.g. DrugDex/NCCN) or appeal with literature
Self-administered (SAD) denialDrug is on your MAC's self-administered exclusion listCheck the SAD list — it may be Part D, not Part B

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.
What diagnoses are covered for Trodelvy (J9317)?
Medicare does not publish a drug-specific covered-diagnosis list for J9317. The 5 ICD-10 codes on this page are the FDA-approved indications — the labeled uses Medicare will generally pay for under medical necessity. Off-label uses may be covered if supported by an approved compendium.
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.
CMS article last revised
n/a — the most recent revision CMS has published for this article.
Page last reviewed by CareCost
Jun 29, 2026 (coverage data retrieved 2026-06-28; 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 and reviewed by the CareCost Estimate editorial team against the source article. See our methodology and editorial policy.
Spotted an error?
Email editorial@carecostestimate.com.