Opdivo (nivolumab) · Medicare Part B (physician-administered) · 44 FDA-indicated ICD-10 codes
Medicare pays for Opdivo (J9299) under Part B per medical necessity. There is no drug-specific Medicare LCD, so the 44 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
44 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: J9299
No drug-specific Medicare coverage article exists for Opdivo. 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 Opdivo (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:
HCPCS
Description
Per unit
Allowed (ASP + 6%)
J9299
Injection, nivolumab
1 mg
$33.624
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 →
Opdivo 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 J9299) 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 Opdivo
The 44 ICD-10 codes below are the FDA-approved indications for J9299 — the labeled uses Medicare generally pays for under medical necessity — grouped by condition. Use the filter to find a specific code or condition.
NSCLC — 2 diagnoses (applies to J9299)
Neoplasms (2)
ICD-10
Covered diagnosis
C34.10
Malignant neoplasm of upper lobe, unspecified bronchus or lung
C34.90
Malignant neoplasm of unspecified part of bronchus or lung
Melanoma — 8 diagnoses (applies to J9299)
Neoplasms (8)
ICD-10
Covered diagnosis
C43.0
Malignant melanoma of lip
C43.10
Malignant melanoma of unspecified eyelid
C43.20
Malignant melanoma of unspecified ear
C43.30
Malignant melanoma of unspecified part of face
C43.59
Malignant melanoma of other part of trunk
C43.71
Malignant melanoma of right lower limb, including hip
C43.72
Malignant melanoma of left lower limb, including hip
C43.9
Malignant melanoma of skin, unspecified
Renal Cell — 1 diagnoses (applies to J9299)
Neoplasms (1)
ICD-10
Covered diagnosis
C64.9
Malignant neoplasm of unspecified kidney, except renal pelvis
Urothelial Carcinoma — 1 diagnoses (applies to J9299)
Neoplasms (1)
ICD-10
Covered diagnosis
C67.9
Malignant neoplasm of bladder, unspecified
Hodgkin Lymphoma — 7 diagnoses (applies to J9299)
Neoplasms (7)
ICD-10
Covered diagnosis
C81.00
Nodular lymphocyte predominant Hodgkin lymphoma, unspecified site
C81.10
Nodular sclerosis Hodgkin lymphoma, unspecified site
C81.20
Mixed cellularity Hodgkin lymphoma, unspecified site
C81.30
Lymphocyte depleted Hodgkin lymphoma, unspecified site
C81.40
Lymphocyte-rich Hodgkin lymphoma, unspecified site
C81.70
Other Hodgkin lymphoma, unspecified site
C81.90
Hodgkin lymphoma, unspecified, unspecified site
Head and Neck — 2 diagnoses (applies to J9299)
Neoplasms (2)
ICD-10
Covered diagnosis
C00.9
Malignant neoplasm of lip, unspecified
C10.9
Malignant neoplasm of oropharynx, unspecified
Hepatocellular — 1 diagnoses (applies to J9299)
Neoplasms (1)
ICD-10
Covered diagnosis
C22.0
Liver cell carcinoma
Gastric/GEJ — 1 diagnoses (applies to J9299)
Neoplasms (1)
ICD-10
Covered diagnosis
C16.9
Malignant neoplasm of stomach, unspecified
Esophageal — 1 diagnoses (applies to J9299)
Neoplasms (1)
ICD-10
Covered diagnosis
C15.9
Malignant neoplasm of esophagus, unspecified
Mesothelioma — 2 diagnoses (applies to J9299)
Neoplasms (2)
ICD-10
Covered diagnosis
C45.0
Mesothelioma of pleura
C45.9
Mesothelioma, unspecified
Encounter — 1 diagnoses (applies to J9299)
Factors influencing health status (1)
ICD-10
Covered diagnosis
Z51.12
Encounter for antineoplastic immunotherapy
Lung Cancer — 2 diagnoses (applies to J9299)
Neoplasms (2)
ICD-10
Covered diagnosis
C34.00
Malignant neoplasm of unspecified main bronchus
C34.30
Malignant neoplasm of lower lobe, unspecified bronchus or lung
Head and Neck Cancer — 7 diagnoses (applies to J9299)
Neoplasms (7)
ICD-10
Covered diagnosis
C00.0
Malignant neoplasm of external upper lip
C01
Malignant neoplasm of base of tongue
C02.0
Malignant neoplasm of dorsal surface of tongue
C09.0
Malignant neoplasm of tonsillar fossa
C10.0
Malignant neoplasm of vallecula
C13.0
Malignant neoplasm of postcricoid region
C14.0
Malignant neoplasm of pharynx, unspecified
Bladder Cancer — 1 diagnoses (applies to J9299)
Neoplasms (1)
ICD-10
Covered diagnosis
C67.0
Malignant neoplasm of trigone of bladder
Colorectal Cancer — 4 diagnoses (applies to J9299)
Neoplasms (4)
ICD-10
Covered diagnosis
C18.0
Malignant neoplasm of cecum
C18.9
Malignant neoplasm of colon, unspecified
C19
Malignant neoplasm of rectosigmoid junction
C20
Malignant neoplasm of rectum
Renal Cell Carcinoma — 1 diagnoses (applies to J9299)
Neoplasms (1)
ICD-10
Covered diagnosis
C64.1
Malignant neoplasm of right kidney
Esophageal Cancer — 1 diagnoses (applies to J9299)
Neoplasms (1)
ICD-10
Covered diagnosis
C15.5
Malignant neoplasm of lower third of esophagus
Gastric Cancer — 1 diagnoses (applies to J9299)
Neoplasms (1)
ICD-10
Covered diagnosis
C16.0
Malignant neoplasm of cardia
How to use this list when billing
Put a medically necessary, FDA-indicated diagnosis from the list above on the claim line with J9299, 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. Opdivo 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 Opdivo denial reasons
What you see
Why
Fix
CO-50 — not medically necessary
Diagnosis the MAC doesn’t accept as medically necessary
Bill a medically necessary FDA-indicated diagnosis from the list above; document necessity (compendium cite for off-label)
Diagnosis/units mismatch
Right dx but wrong product code or unit count
Match the J/Q code and units to the drug actually given (check JZ/JW wastage)
Off-label denial
Indication isn't FDA-labeled and isn't compendium-supported
Cite an approved compendium (e.g. DrugDex/NCCN) or appeal with literature
Self-administered (SAD) denial
Drug is on your MAC's self-administered exclusion list
Yes. Opdivo (J9299) 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 Opdivo (J9299)?
Medicare does not publish a drug-specific covered-diagnosis list for J9299. The 44 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 Opdivo?
No drug-specific LCD or Billing & Coding Article exists for Opdivo. 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 Opdivo claim denied as not medically necessary?
The most common cause is a diagnosis the MAC doesn't consider medically necessary for J9299. Bill a covered/FDA-approved indication from the list below, document medical necessity, and confirm any local guidance with your MAC.
You know the diagnosis is payable. Now quote the patient before the visit and catch underpayments: get Opdivo's exact Medicare allowed amount, your payer's rate vs. ASP+6%, and the patient's out-of-pocket — in about 30 seconds, free.
FDA-approved indications (Drugs@FDA labeling) mapped to ICD-10-CM. No drug-specific Medicare LCD/Article exists for Opdivo — 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.