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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 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
5 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 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%)
J9317Sacituzumab govitecan-hziy2.5 mg$37.640

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 →

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. What JZ/JW mean →
Medicare allowable (ASP + 6%, 2026 Q3)360 units × $37.640/unit = $13550.40

This is Medicare’s allowable payment limit (ASP + 6%, 2026 Q3) — not a promise of what you will be paid. Actual paid amount depends on sequestration and whether the claim carries a covered diagnosis.

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 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 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 — 1 diagnoses (applies to J9317)

Neoplasms (1)

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

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.
What diagnoses are covered for Trodelvy (J9317)?
Medicare publishes no drug-specific covered-diagnosis list for J9317. The 5 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

Trodelvy billing & units guideJ-code, NDC, units, JZ/JW wastage Medicare coverage hubCovered diagnoses for more drugs Estimate patient costReimbursement & patient out-of-pocket Neulasta coverage1270 covered ICD-10 codesAvastin coverage458 covered ICD-10 codesDenosumab (Prolia, Xgeva) coverage434 covered ICD-10 codes

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 2026-08-26; 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.