ROUTINE COSTS
As used in this policy, routine costs include items and services covered under the benefit contract that would typically be provided according to the standard of care for the diagnosed disease in the absence of the qualifying clinical trial (Benefit language).
In addition, routine costs may include the following, unless covered by the study Sponsor:
- Items and services and supplies required solely for the provision of the biological product, device, drug, medical treatment, procedure, or therapy under investigation in the clinical trial investigational item or service.
- The clinically appropriate monitoring of the effects of the biological product, device, drug, medical treatment, procedure, or therapy under investigation investigational item or service in the clinical trial that is required for the prevention of complications during the clinical trial
- Items or services and supplies required for the diagnosis or treatment of medical complications arising from the provision of the biological product, device, drug, medical treatment, procedure, or therapy under investigation investigational item or service in the qualifying clinical trial
- Office/outpatient visits
- Routine laboratory tests
- Imaging studies
- Echocardiography
- Electrocardiogram
CLINICAL TRIAL
A clinical trial, also referred to as clinical research or a clinical study, is a research study with human volunteers to test new methods of screening, prevention, diagnosis, or treatment of disease. These studies are conducted by physicians and other health professionals in a controlled environment to help determine the safety and efficacy of biological products, devices, drugs, medical treatments, procedures, or therapies to improve health.
A qualifying clinical trial, as defined by the Company, is the systematic, intensive investigation or evaluation of a biological product, device, drug, medical treatment, procedure, or therapy that meets all of the following requirements:
- It investigates a service that falls within a benefit category of a Company benefit contract.
- It is not a benefit contract exclusion.
- It does not unjustifiably duplicate existing studies.
- It is designed to collect and disseminate reliable evidence and answer specific questions being researched in the trial.
- It is designed and conducted according to appropriate standards of scientific integrity.
- It complies with federal regulations relating to the protection of human subjects.
- It is conducted by a participating provider in a participating facility, unless otherwise pre-approved by the Company.
- It is being studied in a Phase I, II, III, or IV clinical trial in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. (
In addition, the qualifying clinical trial must meet one of the following requirements:
- It is funded by, or supported by, centers or cooperative groups that are funded by one of the following:
- National Institutes of Health (NIH)
- Centers for Disease Control and Prevention (CDC)
- Agency for Healthcare Research and Quality (AHRQ)
- Centers for Medicare and Medicaid Services (CMS)
- Department of Defense (DOD), Department of Veterans Affairs (VA) or Department of Energy
- It is being conducted under an IND application reviewed by the FDA or is an IND exemption as defined by the FDA.
- It is being conducted under an Investigational Device Exemption (IDE).
Clinical trials involving drugs or biological products are classified by the US Food and Drug Administration (FDA) and are designated by the following terms:- Phase 0 (zero): Preliminary exploration of an investigational new drug (IND) clinical study that involves limited human exposure and no therapeutic or diagnostic intent (e.g., screening studies, microdose studies)
- Phase I: Initial clinical studies to determine the metabolism and pharmacologic actions of drugs in individuals, the side effects associated with increasing doses, and the early evidence of effectiveness; may include healthy participants and/or individuals with the disease or condition under study
- Phase II: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication(s) in individuals with the disease or condition under study and to determine the common short-term side effects and risks of the drug
- Phase III: Expanded controlled and uncontrolled clinical trials conducted after preliminary evidence has been obtained to suggest the effectiveness of the drug; also intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for labeling
- Phase IV: Post-marketing clinical studies to delineate additional information, including the drug's risks, benefits, and optimal use
Reliable evidence is classified as any of the following:
- Reports and articles published in the authoritative medical and scientific literature
- Written protocol(s) used by the treating facility or the protocol(s) of another facility studying substantially the same biological product, device, drug, medical treatment, procedure, or therapy
- Written informed consent used by the treating facility or by another facility studying the same biological product, device, drug, medical treatment, procedure, or therapy
The term experimental/investigational (E/I) is defined by the individual's product or plan. 
