Money provided by a sponsor to pay for patient‐specific billable items and services must be used to cover these services and should not be reallocated to cover study team effort. You must read the clinical trial agreement and review the sponsor’s budget incorporated in that agreement to determine how the sponsor wants the funds spent. Do not assume that the sponsor is providing money for any purpose. Many sponsors will specifically indicate how funds must be spent. If the sponsor has agreed to pay for certain items or services or provides items/supplies for free, do not bill a health plan or the patient for those items/supplies or services.
Medicare generally covers reasonable and necessary items and services used to diagnose and treat complications arising from participation in clinical trials in qualifying clinical trials. Medicare Secondary Payer regulations, however, have been interpreted by Medicare to prevent the Medicare program from covering services related to these complications when another party has assumed responsibility for payment. Most commercial health plans will not cover items and services that are the responsibility of another party, often called “third party” or “other party” payment exclusions.
It is the responsibility of the study team to ensure that sponsors are billed for adverse events and/or complications for industry‐sponsored clinical trials. For one‐on‐one counseling on completing the subject injury sections of your consent, contact the CRAO Dept. at CR2firstname.lastname@example.org.