Common use of Investigative Clause in Contracts

Investigative. As determined by us, a drug, device or medical treatment or procedure is investigative if reliable evidence does not permit conclusions concerning its safety, effectiveness, or positive effect on health outcomes. We will consider the following categories of reliable evidence, none of which shall be determinative by itself: • There is final approval from the appropriate government regulatory agency, if required. This includes whether a drug or device can be lawfully marketed for its proposed use by the United States Food and Drug Administration (FDA); and • The drug or device or medical, behavioral health or dental treatment or procedure is not the subject or ongoing Phase I, II or III clinical trials; and • Whether there are consensus opinions or recommendations in relevant scientific and medical literature, peer-reviewed journals, or reports of clinical trial committees and other technology assessment bodies. This includes consideration of whether a drug is included in any authoritative compendia as identified by the Medicare program for use in the determination of a medically necessary accepted indication of drugs and biologicals used off-label, as appropriate for its proposed use; and • Whether there are consensus opinions of national and local health care providers in the applicable specialty as determined by a sampling of providers, including whether there are protocols used by the treating facility or another facility studying the same drug, device, medical treatment or procedure. Medically Necessary Care. This is health care services appropriate, in terms of type, frequency, level, setting and duration, to the enrollee’s diagnosis or condition, and diagnostic testing and preventive services. Medically necessary care must be consistent with generally accepted practice parameters as determined by health care providers in the same or similar general specialty as typically manages the condition, procedure, or treatment at issue, and must: • help restore or maintain your health; or • prevent deterioration of your condition The fact that an authorized network, or non-network, provider prescribes treatment does not necessarily mean the treatment is covered under this Contract.

Investigative. As determined by us, a drug, device or medical or dental treatment or procedure is investigative if reliable evidence does not permit conclusions concerning its safety, effectiveness, or positive effect on health outcomes. We will consider the following categories of reliable evidence, none of which shall be determinative by itself: • There is final approval from the appropriate government regulatory agency, if required. This includes whether a drug or device can be lawfully marketed for its proposed use by the United States Food and Drug Administration (FDA); and • The drug or device or medical, behavioral health or dental treatment or procedure is not the subject or ongoing Phase I, II or III clinical trials; and • Whether there are consensus opinions or recommendations in relevant scientific and medical and/or dental literature, peer-peer- reviewed journals, or reports of clinical trial committees and other technology assessment bodies. This includes consideration of whether a drug is included in any authoritative compendia as identified by the Medicare program for use in the determination of a medically necessary accepted indication of drugs and biologicals used off-label, as appropriate for its proposed use; and • Whether there are consensus opinions of national and local health care providers in the applicable specialty as determined by a sampling of providers, including whether there are protocols used by the treating facility or another facility studying the same drug, device, medical or dental treatment or procedure. Medically Necessary Care. This is health care services appropriate, in terms of type, frequency, level, setting and duration, to the enrollee’s diagnosis or condition, and diagnostic testing and preventive services. Medically necessary care must be consistent with generally accepted practice parameters as determined by health care providers in the same or similar general specialty as typically manages the condition, procedure, or treatment at issue, and must: • help restore or maintain your health; or • prevent deterioration of your condition The fact that an authorized network, or non-network, provider prescribes treatment does not necessarily mean the treatment is covered under this Contract.

Investigative. As determined by us, a drug, device or medical or dental treatment or procedure is investigative if reliable evidence does not permit conclusions concerning its safety, effectiveness, or positive effect on health outcomes. We will consider the following categories of reliable evidence, none of which shall be determinative by itself: • There is final approval from the appropriate government regulatory agency, if required. This includes whether a drug or device can be lawfully marketed for its proposed use by the United States Food and Drug Administration (FDA); and • The drug or device or medical, behavioral health or dental treatment or procedure is not the subject or ongoing Phase I, II or III clinical trials; and • Whether there are consensus opinions or recommendations in relevant scientific and medical and/or dental literature, peer-peer- reviewed journals, or reports of clinical trial committees and other technology assessment bodies. This includes consideration of whether a drug is included in any authoritative compendia as identified by the Medicare program for use in the determination of a medically necessary accepted indication of drugs and biologicals used off-label, as appropriate for its proposed use; and • Whether there are consensus opinions of national and local health care providers in the applicable specialty as determined by a sampling of providers, including whether there are protocols used by the treating facility or another facility studying the same drug, device, medical or dental treatment or procedure. Medically Necessary Care. This is health care services appropriate, in terms of type, frequency, level, setting and duration, to the enrollee’s diagnosis or condition, and diagnostic testing and medical treatment and prescription drug use which is medically appropriate to the member's physical or mental diagnosis for an injury or illness, and preventive servicesservices covered in this Contract. Medically necessary care must be consistent with generally meet the following criteria: • it meets clinically accepted medical services and practice parameters as determined by health of the general medical community; and • it meets the most appropriate and cost-effective level of medical services, prescription drugs or supplies that can be safely provided. When applied to inpatient care, if further means that the medical symptoms or conditions require that the medical services or supplies cannot be safely provided in a lower level of care providers in the same setting; and • it restores or similar general specialty as typically manages the condition, procedure, or treatment at issue, and must: • help restore or maintain your maintains health; or • prevent it prevents deterioration of your condition The fact that the member's condition; or • it prevents the reasonably likely onset of a health problem or detects an authorized network, or non-network, provider prescribes treatment does not necessarily mean the treatment is covered under this Contractincipient problem.

Investigative. As determined by us, a drug, device or medical treatment or procedure is investigative if reliable evidence does not permit conclusions concerning its safety, effectiveness, or positive effect on health outcomes. We will consider the following categories of reliable evidence, none of which shall be determinative by itself: • There is final approval from the appropriate government regulatory agency, if required. This includes whether a drug or device can be lawfully marketed for its proposed use by the United States Food and Drug Administration (FDA); and • The drug or device or medical, behavioral health or dental treatment or procedure is not the subject or ongoing Phase I, II or III clinical trials; and • Whether there are consensus opinions or recommendations in relevant scientific and medical literature, peer-reviewed journals, or reports of clinical trial committees and other technology assessment bodies. This includes consideration of whether a drug is included in any authoritative compendia as identified by the Medicare program for use in the determination of a medically necessary accepted indication of drugs and biologicals used off-label, as appropriate for its proposed use; and • Whether there are consensus opinions of national and local health care providers in the applicable specialty as determined by a sampling of providers, including whether there are protocols used by the treating facility or another facility studying the same drug, device, medical treatment or procedure. Medically Necessary Care. This is health care services appropriate, in terms of type, frequency, level, setting and duration, to the enrollee’s diagnosis or condition, and diagnostic testing and medical treatment and prescription drug use which is medically appropriate to the member's physical or mental diagnosis for an injury or illness, and preventive servicesservices covered in this Contract. Medically necessary care must be consistent with generally meet the following criteria: • it meets clinically accepted medical services and practice parameters as determined by health of the general medical community; and • it meets the most appropriate and cost-effective level of medical services, prescription drugs or supplies that can be safely provided. When applied to inpatient care, if further means that the medical symptoms or conditions require that the medical services or supplies cannot be safely provided in a lower level of care providers in the same setting; and • it restores or similar general specialty as typically manages the condition, procedure, or treatment at issue, and must: • help restore or maintain your maintains health; or • prevent it prevents deterioration of your condition The fact that the member's condition; or • it prevents the reasonably likely onset of a health problem or detects an authorized network, or non-network, provider prescribes treatment does not necessarily mean the treatment is covered under this Contractincipient problem.