The following codes as of July 2021 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.
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test.
The FDA-approved dose of KEYTRUDA in adults with locally recurrent unresectable or metastatic TNBC 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.
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.
Learn more about each diagnosis code and descriptor by selecting from the series options below.