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
50 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:
J9271
J9271
No drug-specific Medicare coverage article exists for Keytruda. 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 Keytruda (2026 Q4)
2026 Q4 payment limit per billing unit for Keytruda’s HCPCS code (how ASP + 6% works):
| HCPCS | Description | Per unit | Allowed (ASP + 6%) |
|---|---|---|---|
| J9271 | Inj pembrolizumab | 1 mg | $62.253 |
CMS ASP Drug Pricing File, 2026 Q4. Keytruda patient out-of-pocket estimate →
Keytruda (HCPCS J9271) 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 Keytruda
The 50 FDA-approved indications for J9271, grouped by condition — filter to find a code.
NSCLC — 3 diagnoses (applies to J9271)
Neoplasms (3)
| ICD-10 | Covered diagnosis |
|---|---|
| C34.10 | Malignant neoplasm of upper lobe, unspecified bronchus or lung |
| C34.30 | Malignant neoplasm of lower lobe, unspecified bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified part of bronchus or lung |
Melanoma — 8 diagnoses (applies to J9271)
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 |
Urothelial Carcinoma — 1 diagnoses (applies to J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C67.9 | Malignant neoplasm of bladder, unspecified |
Gastric/GEJ — 2 diagnoses (applies to J9271)
Neoplasms (2)
| ICD-10 | Covered diagnosis |
|---|---|
| C16.0 | Malignant neoplasm of cardia |
| C16.9 | Malignant neoplasm of stomach, unspecified |
Esophageal — 1 diagnoses (applies to J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C15.9 | Malignant neoplasm of esophagus, unspecified |
Endometrial — 2 diagnoses (applies to J9271)
Neoplasms (2)
| ICD-10 | Covered diagnosis |
|---|---|
| C54.1 | Malignant neoplasm of endometrium |
| C55 | Malignant neoplasm of uterus, part unspecified |
Cervical — 1 diagnoses (applies to J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C53.9 | Malignant neoplasm of cervix uteri, unspecified |
Hepatocellular — 1 diagnoses (applies to J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C22.0 | Liver cell carcinoma |
Hodgkin Lymphoma — 7 diagnoses (applies to J9271)
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 |
DLBCL — 1 diagnoses (applies to J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C83.30 | Diffuse large B-cell lymphoma, unspecified site |
Renal Cell — 1 diagnoses (applies to J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C64.9 | Malignant neoplasm of unspecified kidney, except renal pelvis |
Head and Neck — 2 diagnoses (applies to J9271)
Neoplasms (2)
| ICD-10 | Covered diagnosis |
|---|---|
| C00.9 | Malignant neoplasm of lip, unspecified |
| C10.9 | Malignant neoplasm of oropharynx, unspecified |
Triple-Negative Breast — 1 diagnoses (applies to J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C50.919 | Malignant neoplasm of unspecified site of unspecified female breast |
Encounter — 2 diagnoses (applies to J9271)
Factors influencing health status (2)
| ICD-10 | Covered diagnosis |
|---|---|
| Z51.11 | Encounter for antineoplastic chemotherapy |
| Z51.12 | Encounter for antineoplastic immunotherapy |
Lung Cancer — 1 diagnoses (applies to J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C34.00 | Malignant neoplasm of unspecified main bronchus |
Head and Neck Cancer — 9 diagnoses (applies to J9271)
Neoplasms (9)
| 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 |
| C03.0 | Malignant neoplasm of upper gum |
| C04.0 | Malignant neoplasm of anterior floor of mouth |
| 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 J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C67.0 | Malignant neoplasm of trigone of bladder |
Cervical Cancer — 1 diagnoses (applies to J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C53.0 | Malignant neoplasm of endocervix |
Skin Cancer — 1 diagnoses (applies to J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C44.40 | Unspecified malignant neoplasm of skin of scalp and neck |
Renal Cell Carcinoma — 1 diagnoses (applies to J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C64.1 | Malignant neoplasm of right kidney |
Breast Cancer — 2 diagnoses (applies to J9271)
Neoplasms (2)
| ICD-10 | Covered diagnosis |
|---|---|
| C50.011 | Malignant neoplasm of nipple and areola, right female breast |
| C50.911 | Malignant neoplasm of unspecified site of right female breast |
Esophageal Cancer — 1 diagnoses (applies to J9271)
Neoplasms (1)
| ICD-10 | Covered diagnosis |
|---|---|
| C15.5 | Malignant neoplasm of lower third of esophagus |
How to bill Keytruda
Put a medically necessary, FDA-indicated diagnosis from the list above on the claim line with J9271. Matching codes, units and JZ/JW wastage →
Which policy governs Keytruda
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 Keytruda is denied
With no drug-specific Article, the usual cause is a diagnosis the MAC does not accept as medically necessary for J9271, or an off-label use with no compendium support. The five denial patterns and how to fix each →
Frequently asked questions
- Is Keytruda covered by Medicare?
- Yes. Keytruda (J9271) 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 J9271 as self-administered.
- What diagnoses are covered for Keytruda (J9271)?
- Medicare publishes no drug-specific covered-diagnosis list for J9271. The 50 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 Keytruda?
- No drug-specific LCD or Billing & Coding Article exists for Keytruda. 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 Keytruda claim denied as not medically necessary?
- The most common cause is a diagnosis the MAC doesn't consider medically necessary for J9271. 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 Keytruda'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 Keytruda 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 Keytruda — Part B coverage is determined per medical necessity by your MAC.
- Primary sources
- DailyMed — Keytruda prescribing information · CMS Part B Drug ASP Pricing File — the quarterly payment limit quoted above · CMS Medicare Coverage Database — searched for “Keytruda”; 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.