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
44 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:
J9299
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 Q4)
2026 Q4 payment limit per billing unit for Opdivo’s HCPCS code (how ASP + 6% works):
| HCPCS | Description | Per unit | Allowed (ASP + 6%) |
|---|---|---|---|
| J9299 | Injection, nivolumab | 1 mg | $34.191 |
CMS ASP Drug Pricing File, 2026 Q4. Opdivo patient out-of-pocket estimate →
Opdivo (HCPCS J9299) 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 Opdivo
The 44 FDA-approved indications for J9299, grouped by condition — filter to find a code.
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 bill Opdivo
Put a medically necessary, FDA-indicated diagnosis from the list above on the claim line with J9299. Matching codes, units and JZ/JW wastage →
Which policy governs Opdivo
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 Opdivo is denied
With no drug-specific Article, the usual cause is a diagnosis the MAC does not accept as medically necessary for J9299, or an off-label use with no compendium support. The five denial patterns and how to fix each →
Frequently asked questions
- Is Opdivo covered by Medicare?
- 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. None of the 8 Medicare Administrative Contractors lists J9299 as self-administered.
- What diagnoses are covered for Opdivo (J9299)?
- Medicare publishes no drug-specific covered-diagnosis list for J9299. The 44 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 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.
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 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.
Estimate Opdivo 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 Opdivo — Part B coverage is determined per medical necessity by your MAC.
- Primary sources
- DailyMed — Opdivo prescribing information · CMS Part B Drug ASP Pricing File — the quarterly payment limit quoted above · CMS Medicare Coverage Database — searched for “Opdivo”; 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.