KEYTRUDA FOR ADVANCED UROTHELIAL CARCINOMA

The following codes as of September 2023 are provided as a reference and may be relevant when billing for KEYTRUDA and its administration. Consult the relevant manual and/or other guidelines for a description of each code to determine the appropriateness of its use and for information on additional codes. Diagnosis codes should be selected only by a health care professional. You are solely responsible for determining the appropriate codes and for any action you take in billing.

When submitting a claim for KEYTRUDA, always verify coding requirements with the relevant payer. Coding requirements may vary by insurer or plan; please refer to the payer-specific policies to understand what may be covered.

Check with the relevant payer regarding guidance on which diagnoses they will recognize and the applicability of secondary codes. Health care professionals are solely responsible for selecting codes that appropriately reflect the patient’s diagnosis, the services rendered, and the applicable payers’ guidelines.

Providers should document the diagnosis with a sufficiently high degree of specificity based on the information available to enable the identification of the most appropriate code. Although CMS has said that an unspecified code may be appropriate in some cases, CMS has advised that you should always code with as much specificity as possible consistent with the clinical documentation.

Merck and its agents make no warranties concerning the accuracy or appropriateness of this information for your particular use given the frequent changes in public and private payer billing. Merck cautions that payer-coding requirements vary and can frequently change, so it is important to regularly check with each payer or, where applicable, the Medicare Administrative Contractor as to payer-specific requirements. The use of this information does not guarantee payment or that any payment received will cover your costs.

Indication

KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or mUC:

  • who are not eligible for any platinum-containing chemotherapy, or
  • who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

FDA-Approved Dosing

The FDA-approved dose of KEYTRUDA is either 200 mg administered after dilution as an intravenous infusion over 30 minutes every 3 weeks or 400 mg administered after dilution as an intravenous infusion over 30 minutes every 6 weeks, until disease progression or unacceptable toxicity, or up to 24 months.

When administering KEYTRUDA in combination with enfortumab vedotin, administer KEYTRUDA after enfortumab vedotin when given on the same day. Refer to the Prescribing Information for enfortumab vedotin for recommended dosing information, as appropriate.

See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions.

Possible relevant diagnosis codes for urothelial carcinoma

Learn more about each diagnosis code and descriptor by selecting from the series options below.

 

C65: Malignant Neoplasm of Renal Pelvis4

The C65 series:

  • Includes: malignant neoplasm of pelviureteric junction, malignant neoplasm of renal calyces
ICD-10-CM CODE DESCRIPTOR
C65.1 Malignant neoplasm of right renal pelvis
C65.2 Malignant neoplasm of left renal pelvis

C66: Malignant Neoplasm of Ureter4

The C66 series:

  • Excludes: malignant neoplasm of ureteric orifice of bladder
ICD-10-CM CODE DESCRIPTOR
C66.1 Malignant neoplasm of right ureter
C66.2 Malignant neoplasm of left ureter

C67: Malignant Neoplasm of Bladder4

ICD-10-CM CODE DESCRIPTOR
C67.0 Malignant neoplasm of trigone of bladder
C67.1 Malignant neoplasm of dome of bladder
C67.2 Malignant neoplasm of lateral wall of bladder
C67.3 Malignant neoplasm of anterior wall of bladder
C67.4 Malignant neoplasm of posterior wall of bladder
C67.5 Malignant neoplasm of bladder neck
  • Malignant neoplasm of internal urethral orifice
C67.6 Malignant neoplasm of ureteric orifice
C67.8 Malignant neoplasm of overlapping sites of bladder
C67.9 Malignant neoplasm of bladder, unspecified

C68: Malignant Neoplasm of Other and Unspecified Urinary Organs4

The C68 series:

  • Excludes: malignant neoplasm of female genitourinary tract not otherwise specified (NOS), malignant neoplasm of male genitourinary tract NOS
ICD-10-CM CODE DESCRIPTOR
C68.0 Malignant neoplasm of urethra
  • Excludes: malignant neoplasm of urethral orifice of bladder (C67.5)
C68.8 Malignant neoplasm of overlapping sites of urinary organs
  • Primary malignant neoplasm of two or more contiguous sites of urinary organs whose point of origin cannot be determined