Billing and Coding: The Routine Costs of Investigational Chemotherapy Drugs Studied In a Qualifying Clinical Trial

Palmetto GBA has been receiving claims for chemotherapy drugs billed as if the drug is a covered charge, when the drug is utilized as the investigational item in a qualifying clinical trial. Generally the investigational item, in this case chemotherapy drugs, used in a qualifying clinical trial is provided free of charge by research sponsors and may not be billed to be paid by Medicare, and providers are not required to submit the charge to Medicare. Refer to the CMS Internet-Only Manual (IOM), Pub 100-04, Medicare Claims Processing Manual, Chapter 32, §69.5 for general billing requirements for qualifying clinical trials. If the chemotherapy drug(s) is administered for an investigational indication and is billed to Medicare in the course of an outpatient clinical trial, the drug(s) should be billed as a noncovered service (even if the drug is covered by Medicare for other indications) with condition code 30, the Q0 (zero) modifier and diagnosis code Z00.6 ( examination of participant or control in clinical research program ) included on the claim. Routine costs of clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials are covered by Medicare. The CMS Internet-Only Manual (IOM), Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §310.1 includes a description of covered routine costs that are included in a qualifying clinical trial.