HB 09-1059: Clinical Trials
By: Aubrey Hill
Many people in Colorado, especially those who have MS, participate in clinical trials, sometimes as a last resort for disease control/treatment. Some insurance companies could deny coverage to a client for seemingly unrelated illnesses, i.e. strep throat or mono, by claiming a connection between the illness and the clinical trial participation.
This bill would impede insurance companies from denying routine coverage despite the patient participation in a clinical trial. Insurance companies are required to cover the client as if the client were not participating in a clinical trial and if the illness is unrelated to the clinical trial. The coverage does not have to include any extraneous expenses, i.e. travel expenses incurred to and from the clinical trial.
Additionally, the clinical trial is required to meet certain standards of approval in the health and research community. The clinical trial must be approved or recommended by the patient’s treating physician who is covered under said insurance policy. The approval or recommendation must be based on the trial’s potential to provide a therapeutic health benefit to the patient. The clinical trial must also be approved under the Medicare National Coverage Decision regarding clinical trials and must be implemented by a qualified and licensed health provider. The patient also needs to sign a consent form and must be suffering from a condition that is disabling, progressive, or life-threatening.