Keytruda (J9271): Medicare coverage & FDA-indicated diagnoses

Keytruda (Pembrolizumab) · Medicare Part B (physician-administered) · 50 FDA-indicated ICD-10 codes

Medicare pays for Keytruda (J9271) under Part B per medical necessity. There is no drug-specific Medicare LCD, so the 50 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
50 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:
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 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%)
J9271Inj pembrolizumab1 mg$61.251

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 →

Keytruda 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 J9271) 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 Keytruda

The 50 ICD-10 codes below are the FDA-approved indications for J9271 — the labeled uses Medicare generally pays for under medical necessity — grouped by condition. Use the filter to find a specific code or condition.

NSCLC — 3 diagnoses (applies to J9271)

Neoplasms (3)

ICD-10Covered diagnosis
C34.10Malignant neoplasm of upper lobe, unspecified bronchus or lung
C34.30Malignant neoplasm of lower lobe, unspecified bronchus or lung
C34.90Malignant neoplasm of unspecified part of bronchus or lung

Melanoma — 8 diagnoses (applies to J9271)

Neoplasms (8)

ICD-10Covered diagnosis
C43.0Malignant melanoma of lip
C43.10Malignant melanoma of unspecified eyelid
C43.20Malignant melanoma of unspecified ear
C43.30Malignant melanoma of unspecified part of face
C43.59Malignant melanoma of other part of trunk
C43.71Malignant melanoma of right lower limb, including hip
C43.72Malignant melanoma of left lower limb, including hip
C43.9Malignant melanoma of skin, unspecified

Urothelial Carcinoma — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C67.9Malignant neoplasm of bladder, unspecified

Gastric/GEJ — 2 diagnoses (applies to J9271)

Neoplasms (2)

ICD-10Covered diagnosis
C16.0Malignant neoplasm of cardia
C16.9Malignant neoplasm of stomach, unspecified

Esophageal — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C15.9Malignant neoplasm of esophagus, unspecified

Endometrial — 2 diagnoses (applies to J9271)

Neoplasms (2)

ICD-10Covered diagnosis
C54.1Malignant neoplasm of endometrium
C55Malignant neoplasm of uterus, part unspecified

Cervical — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C53.9Malignant neoplasm of cervix uteri, unspecified

Hepatocellular — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C22.0Liver cell carcinoma

Hodgkin Lymphoma — 7 diagnoses (applies to J9271)

Neoplasms (7)

ICD-10Covered diagnosis
C81.00Nodular lymphocyte predominant Hodgkin lymphoma, unspecified site
C81.10Nodular sclerosis Hodgkin lymphoma, unspecified site
C81.20Mixed cellularity Hodgkin lymphoma, unspecified site
C81.30Lymphocyte depleted Hodgkin lymphoma, unspecified site
C81.40Lymphocyte-rich Hodgkin lymphoma, unspecified site
C81.70Other Hodgkin lymphoma, unspecified site
C81.90Hodgkin lymphoma, unspecified, unspecified site

DLBCL — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C83.30Diffuse large B-cell lymphoma, unspecified site

Renal Cell — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C64.9Malignant neoplasm of unspecified kidney, except renal pelvis

Head and Neck — 2 diagnoses (applies to J9271)

Neoplasms (2)

ICD-10Covered diagnosis
C00.9Malignant neoplasm of lip, unspecified
C10.9Malignant neoplasm of oropharynx, unspecified

Triple-Negative Breast — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C50.919Malignant neoplasm of unspecified site of unspecified female breast

Encounter — 2 diagnoses (applies to J9271)

Factors influencing health status (2)

ICD-10Covered diagnosis
Z51.11Encounter for antineoplastic chemotherapy
Z51.12Encounter for antineoplastic immunotherapy

Lung Cancer — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C34.00Malignant neoplasm of unspecified main bronchus

Head and Neck Cancer — 9 diagnoses (applies to J9271)

Neoplasms (9)

ICD-10Covered diagnosis
C00.0Malignant neoplasm of external upper lip
C01Malignant neoplasm of base of tongue
C02.0Malignant neoplasm of dorsal surface of tongue
C03.0Malignant neoplasm of upper gum
C04.0Malignant neoplasm of anterior floor of mouth
C09.0Malignant neoplasm of tonsillar fossa
C10.0Malignant neoplasm of vallecula
C13.0Malignant neoplasm of postcricoid region
C14.0Malignant neoplasm of pharynx, unspecified

Bladder Cancer — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C67.0Malignant neoplasm of trigone of bladder

Cervical Cancer — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C53.0Malignant neoplasm of endocervix

Skin Cancer — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C44.40Unspecified malignant neoplasm of skin of scalp and neck

Renal Cell Carcinoma — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C64.1Malignant neoplasm of right kidney

Breast Cancer — 2 diagnoses (applies to J9271)

Neoplasms (2)

ICD-10Covered diagnosis
C50.011Malignant neoplasm of nipple and areola, right female breast
C50.911Malignant neoplasm of unspecified site of right female breast

Esophageal Cancer — 1 diagnoses (applies to J9271)

Neoplasms (1)

ICD-10Covered diagnosis
C15.5Malignant neoplasm of lower third of esophagus

How to use this list when billing

Put a medically necessary, FDA-indicated diagnosis from the list above on the claim line with J9271, 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. Keytruda 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 Keytruda 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 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.
What diagnoses are covered for Keytruda (J9271)?
Medicare does not publish a drug-specific covered-diagnosis list for J9271. The 50 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 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.

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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.
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.