Q&A: Billing for separate, unrelated items in a clinical trial

Q: How do we bill for items provided to a patient participating in a clinical trial that are not listed on the billing intention?

A: Items provided to the patient that are not listed on the billing intention would be considered separate, unrelated services. Consider the following scenario:

Patient Mary Smith presents to the hospital to receive chemotherapy. Mary has been enrolled in a clinical trial that is determining whether a new cocktail of two drugs will produce a better outcome for her type of cancer. The two drugs are both FDA approved and commercially available. The sponsor of the trial is the manufacturer of one of the drugs, Drug A, and this drug will be provided free of charge to those participating in the study. Drug B will be billed to the patient’s insurance along with various other related services, such as the anti-emetic regimen, lab work to ensure that patients can withstand the chemotherapy, and the infusion administration service. The billing intention would read as follows:

• Drug A: Bill to sponsor — This drug is provided by the sponsor free of charge and thus should not be billed to the patient’s insurance even if medically necessary.
• Drug B: Bill to insurance — This drug is medically necessary for the patient to treat the cancer.
• Anti-emetic: Bill to insurance — This supportive care service is medically necessary even though this product is connected to the clinical trial.
• Lab work: Bill to insurance — This supportive care service is medically necessary even though this service is performed in conjunction with the clinical trial.
• Infusion administration: Bill to insurance — This supportive care service is medically necessary even though this service is performed in conjunction with the clinical trial.

The study calendar accompanies the billing intention and forms the road map or schedule of the trial events. The billing intention answers the questions “what” and “who,” whereas the study calendar answers the “when.”

Editor's note: For more information, see The Practical Guide to Clinical Trials Billing.

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