The following codes as of August 2020 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 is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 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. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

FDA-Approved Dosing

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

The FDA-approved dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months.

KEYTRUDA is indicated for use at an additional recommended dosage of 400 mg every 6 weeks for all approved adult indications. This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Possible relevant diagnosis codes for advanced TMB-H cancers

When assigning ICD-10-CM for TMB-H advanced tumors treated with KEYTRUDA, identify the appropriate ICD-10-CM category for the advanced malignant solid neoplasm of the body part under treatment and select the code based on the specific site. For example: C34.01 malignant neoplasm of right main bronchus.