2025 Blue Cross and Blue Shield Service Benefit Plan - FEP Blue Focus
Section 9. Coordinating Benefits With Medicare and Other Coverage
Clinical trials
Section 9. Coordinating Benefits With Medicare and Other Coverage
Clinical trials
Clinical trials
If you are a participant in an approved clinical trial, this health Plan will provide benefits for covered related care as follows, if it is not provided by the clinical trial:
An approved clinical trial includes a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition, and is either Federally funded; conducted under an investigational new drug application reviewed by the Food and Drug Administration (U.S. FDA); or is a drug trial that is exempt from the requirement of an investigational new drug application.
If you are a participant in an approved clinical trial, this health Plan will provide benefits for covered related care as follows, if it is not provided by the clinical trial:
- Routine care costs – costs for medically necessary services such as doctor visits, lab tests, X-rays and scans, and hospitalizations related to treating the patient’s condition, whether the patient is in a clinical trial or is receiving standard therapy. We provide benefits for these types of costs at the benefit levels described in Section 5 (Benefits) when the services are covered under the Plan and we determine that they are medically necessary.
- Extra care costs – costs of covered services related to taking part in a clinical trial such as additional tests that a patient may need as part of the trial, but not as part of the patient’s routine care. This Plan covers extra care costs related to taking part in an approved clinical trial for a covered stem cell transplant such as additional tests that a patient may need as part of the clinical trial protocol, but not as part of the patient’s routine care. For more information about approved clinical trials for covered stem cell transplants, see Section 5(b). Extra care costs related to taking part in any other type of clinical trial are not covered. We encourage you to contact us at the customer service phone number on the back of your ID card to discuss specific services if you participate in a clinical trial.
- Research costs – costs related to conducting the clinical trial such as research physician and nurse time, analysis of results, and clinical tests performed only for research purposes. These costs are generally covered by the clinical trials. This Plan does not cover these costs.
An approved clinical trial includes a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition, and is either Federally funded; conducted under an investigational new drug application reviewed by the Food and Drug Administration (U.S. FDA); or is a drug trial that is exempt from the requirement of an investigational new drug application.