• Centers for Disease Control and Prevention (CDC). • Agency for Health Care Research and Quality (AHRQ). • Centers for Medicare and Medicaid Services (CMS). • a cooperative group or center of any of the entities described above or the Department of Defense (DOD) or the Department of Veterans Affairs (VA). • a qualified non-governmental research entity identified in NIH guidelines for center support grants. • any of the following: Department of Energy, Department of Defense, Department of Veterans Affairs, if both of the following conditions are met: • the study or investigation has been reviewed and approved through a system of peer review comparable to the system of peer review of studies and investigations used by the National Institutes of Health (NIH); and • the study or investigation assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review. • 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 such an investigational new drug application. The plan does not cover any of the following services associated with a clinical trial: • services that are not considered routine patient care costs and services, including the following: • the investigational drug, device, item, or service that is provided solely to satisfy data collection and analysis needs. • an item or service that is not used in the direct clinical management of the individual. • a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis. • an item or service provided by the research sponsors free of charge for any person enrolled in the trial. • travel and transportation expenses, unless otherwise covered under the plan, including but not limited to the following: • fees for personal vehicle, rental car, taxi, medical van, ambulance, commercial airline, train. • mileage reimbursement for driving a personal vehicle. • lodging. • meals.
• routine patient costs obtained out-of-network when Out-of- Network benefits do not exist under the plan. Examples of routine patient care costs and services include: • radiological services. • laboratory services. • intravenous therapy. • anesthesia services. • Physician services. • office services. • Hospital services. • Room and Board, and medical supplies that typically would be covered under the plan for an individual who is not enrolled in a clinical trial. Clinical trials conducted by Out-of-Network providers will be covered only when the following conditions are met: • In-Network providers are not participating in the clinical trial; or • the clinical trial is conducted outside the individual’s state of residence.
HC-COV1128
01-22
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