The Member receives the Service at a facility accredited by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). 6. Services Provided in Connection with Clinical Trials We cover Services you receive in connection with a clinical trial if all of the following conditions are met: We would have covered the Services if they were not related to a clinical trial. You are eligible to participate in the clinical trial according to the trial protocol with respect to treatment of cancer or other life-threatening condition (a condition from which the likelihood of death is probable unless the course of the condition is interrupted), as determined in one of the following ways: • A Participating Provider makes this determination. • You provide us with medical and scientific information establishing this determination. • If any Participating Providers participate in the clinical trial and will accept you as a participant in the clinical trial, you must participate in the clinical trial through a Participating Provider unless the clinical trial is outside the state where you live. The clinical trial is a phase I, phase II, phase III, or phase IV clinical trial related to the prevention, detection, or treatment of cancer or other life-threatening condition and it meets one of the following requirements: • The study or investigation is conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration (FDA). • The study or investigation is a drug trial that is exempt from having an investigational new drug application. • The study or investigation is approved or funded by at least one of the following: o The National Institutes of Health. o The Centers for Disease Control and Prevention. o The Agency for Health Care Research and Quality. o The Centers for Medicare & Medicaid Services. o A cooperative group or center of any of the above entities or of the Department of Defense or the Department of Veterans Affairs. o A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. o The Department of Veterans Affairs or the Department of Defense or the Department of Energy, but only if the study or investigation has been reviewed and approved through a system of peer review that the U.S. Secretary of Health and Human Services determines meets all of the following requirements: It is comparable to the National Institutes of Health system of peer review of studies and investigations. It assures unbiased review of the highest scientific standards by qualified people who have no interest in the outcome of the review. For covered Services related to a clinical trial, you will pay the Cost Share you would pay if the Services were not related to a clinical trial. For example, see “Hospital Services” in the “Benefit Summary” for the Cost Share that applies to hospital inpatient care. EWCLGHDHP1983ACT0124 42 WAPEBB-CD-ACT
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