“Clinically proven!” It is a phrase we hear used – and abused – so often in advertising that we tend to forget the real, important work that inspired its entry into our lexicon. Clinical trials are voluntary research studies designed to answer specific questions about the safety and effectiveness of drugs, vaccines, and other therapies. They are the cornerstone of medical progress.
But clinical trials are expensive, and determining who pays can be tricky – especially for health insurers. Insurance claims professionals do not always understand what should be paid or where coverage stops. Digging deeper into the trial is often the only way to uncover what an insurance company needs to know.
Routine Costs vs. Investigational Services
With trial participants, the process of establishing which medical services are to be billed to insurance and which are to be covered by the study requires categorizing treatments as either routine costs or investigational services.
Routine costs apply to drugs, tests, and services that a subject would likely receive even if not part of the study. This includes items or services typically provided as part of conventional care. It also includes medical care needed in order to administer the study drug, such as premeds or adjunct therapies; clinical monitoring; and prevention and management of complications and side effects.
Investigational services, on the other hand, are the specific drugs, devices, and interventions being studied and should therefore be covered by the trial. Other costs considered investigational include:
- Items and services provided solely to determine eligibility
- Professional visits required by protocol that would not otherwise be part of standard treatment
- Study-related labs or tests
- Data collection and analysis
- Any items or services listed as free in the subject’s informed consent document
How to Avoid Overpaying
Far too often, insurers pay for investigational services that should be billed to the study. While intentional fraud may be at work in a very small percentage of cases, the usual culprits are unfamiliarity of how clinical trials work, inadequate billing practices, and lack of awareness of available resources. Fortunately, all are relatively simple to remedy.Read More +