Common use of Related Exclusions Clause in Contracts

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; • demonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this Section 3.11); • sound scientific studies published in authoritative, peer reviewed medical journals that: • show statistically significant outcomes about the effectiveness of the service, and • permit a consensus of opinion that the service improves the member’s net health outcome, and • show it is as beneficial as any established alternatives, and • show that the improvement is attainable outside the investigational setting; or • the determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, if one or more of the following circumstances are true: • The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, except as described above. • Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. • The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. • The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: • Published reports in authoritative, peer-reviewed medical literature; and • Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. • If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: • it has not received FDA approval; • it has limited FDA approval under regulations such as Treatment Investigational New Drugs; • it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: •  final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; •  demonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this Section 3.11); •  sound scientific studies published in authoritative, peer reviewed medical journals that: •  show statistically significant outcomes about the effectiveness of the service, and •  permit a consensus of opinion that the service improves the member’s net health outcome, and •  show it is as beneficial as any established alternatives, and •  show that the improvement is attainable outside the investigational setting; or •  the determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, if one or more of the following circumstances are true: •  The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, except as described above. •  Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. •  The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. •  The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: •  Published reports in authoritative, peer-reviewed medical literature; and •  Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. •  If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: •  it has not received FDA approval; •  it has limited FDA approval under regulations such as Treatment Investigational New Drugs; •  it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final Final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; OR • demonstratedDemonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this Section 3.113.12); OR • sound Sound scientific studies published in authoritative, peer reviewed medical journals that: • show statistically significant outcomes about the effectiveness of the service, and • permit a consensus of opinion that the service improves the member’s net health outcome, and • show it is as beneficial as any established alternatives, and • show that the improvement is attainable outside the investigational setting; or OR • the The determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, excluded if one or more of the following circumstances are true: • The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, except as described above. • Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. ; or • The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. ; or • The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: • Published reports in authoritative, peer-reviewed medical literature; and AND • Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. ; or • If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: • it has not received FDA approval; or • it has limited FDA approval under regulations such as Treatment Investigational New Drugs; or • it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final  Final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; • demonstratedOR  Demonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this Section 3.113.12); • sound OR  Sound scientific studies published in authoritative, peer reviewed medical journals that: •  show statistically significant outcomes about the effectiveness of the service, and •  permit a consensus of opinion that the service improves the member’s net health outcome, and •  show it is as beneficial as any established alternatives, and •  show that the improvement is attainable outside the investigational setting; or • the OR  The determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, excluded if one or more of the following circumstances are true: • The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, except as described above. •  Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. • ; or  The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. • ; or  The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: •  Published reports in authoritative, peer-reviewed medical literature; and • AND  Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. • ; or  If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: •  it has not received FDA approval; • or  it has limited FDA approval under regulations such as Treatment Investigational New Drugs; • or  it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final Final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; OR • demonstratedDemonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this Section 3.11); OR • sound Sound scientific studies published in authoritative, peer reviewed medical journals that: • show statistically significant outcomes about the effectiveness of the service, and • permit a consensus of opinion that the service improves the member’s net health outcome, and • show it is as beneficial as any established alternatives, and • show that the improvement is attainable outside the investigational setting; or OR • the The determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, if one or more of the following circumstances are true: • The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, trial ,except as described above. ; • Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. ; or- • The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. ; or • The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: • Published reports in authoritative, peer-reviewed medical literature; and AND • Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. ; or • If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: • it has not received FDA approval; or • it has limited FDA approval under regulations such as Treatment Investigational New Drugs; or • it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final  Final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; • demonstratedOR  Demonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this Section 3.113.12); • sound OR  Sound scientific studies published in authoritative, peer reviewed medical journals that: •  show statistically significant outcomes about the effectiveness of the service, and •  permit a consensus of opinion that the service improves the member’s net health outcome, and •  show it is as beneficial as any established alternatives, and •  show that the improvement is attainable outside the investigational setting; or • the OR  The determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, excluded if one or more of the following circumstances are true: •  The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, trial except as described above. • ;  Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. • ; or  The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. • ; or  The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: •  Published reports in authoritative, peer-reviewed medical literature; and • AND  Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. • ; or  If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: •  it has not received FDA approval; • or  it has limited FDA approval under regulations such as Treatment Investigational New Drugs; • or  it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final  Final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; • demonstratedOR  Demonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this subsection Section 3.113.12); • sound OR  Sound scientific studies published in authoritative, peer reviewed medical journals that: •  show statistically significant outcomes about the effectiveness of the service, and •  permit a consensus of opinion that the service improves the member’s net health outcome, and •  show it is as beneficial as any established alternatives, and •  show that the improvement is attainable outside the investigational setting; or • the OR  The determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, excluded if one or more of the following circumstances are true: • The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, except as described above. •  Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. • ; or  The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. • ; or  The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We This agreement will determine the applicability of this criterion based on: •  Published reports in authoritative, peer-reviewed medical literature; and • AND  Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. • ; or  If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: •  it has not received FDA approval; • or  it has limited FDA approval under regulations such as Treatment Investigational New Drugs; • or  it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We This agreement will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described aboveinvestigative. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final Final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; OR • demonstratedDemonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in subsection 4 (c) of this Section 3.11); OR • sound Sound scientific studies published in authoritative, peer reviewed medical journals that: • o show statistically significant outcomes about the effectiveness of the service, and • o permit a consensus of opinion that the service improves the member’s net health outcome, and • o show it is as beneficial as any established alternatives, and • o show that the improvement is attainable outside the investigational setting; or OR • the The determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, if one or more of the following circumstances are true: • The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, except as described above. • Is trial or is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. ; or • The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. ; or • The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: • o Published reports in authoritative, peer-reviewed medical literature; and • AND o Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. ; or • If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria will apply: • o it has not received FDA approval; • or o it has limited FDA approval under regulations such as Treatment Investigational New Drugs; • or o it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative investigational except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; • demonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this Section 3.113.13); • sound scientific studies published in authoritative, peer reviewed medical journals that: • show statistically significant outcomes about the effectiveness of the service, and • permit a consensus of opinion that the service improves the member’s net health outcome, and • show it is as beneficial as any established alternatives, and • show that the improvement is attainable outside the investigational setting; or • the determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, if one or more of the following circumstances are true: • The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, except as described above. • Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. • The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. • The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: • Published reports in authoritative, peer-reviewed medical literature; and • Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. • If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: • it has not received FDA approval; • it has limited FDA approval under regulations such as Treatment Investigational New Drugs; • it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final  Final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; • demonstratedOR  Demonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this subsection Section 3.113.12); • sound OR  Sound scientific studies published in authoritative, peer reviewed medical journals that: •  show statistically significant outcomes about the effectiveness of the service, and •  permit a consensus of opinion that the service improves the member’s net health outcome, and •  show it is as beneficial as any established alternatives, and •  show that the improvement is attainable outside the investigational setting; or • the OR  The determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, excluded if one or more of the following circumstances are true: •  The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, trial except as described above. • ;  Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. • ; or  The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. • ; or  The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We This agreement will determine the applicability of this criterion based on: •  Published reports in authoritative, peer-reviewed medical literature; and • AND  Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. • ; or  If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: •  it has not received FDA approval; • or  it has limited FDA approval under regulations such as Treatment Investigational New Drugs; • or  it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We This agreement will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative investigational except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: •  final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; •  demonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this Section 3.11); •  sound scientific studies published in authoritative, peer reviewed medical journals that: •  show statistically significant outcomes about the effectiveness of the service, and •  permit a consensus of opinion that the service improves the member’s net health outcome, and •  show it is as beneficial as any established alternatives, and •  show that the improvement is attainable outside the investigational setting; or •  the determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, if one or more of the following circumstances are true: •  The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, except as described above. •  Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. •  The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. •  The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: •  Published reports in authoritative, peer-reviewed medical literature; and •  Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. •  If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: •  it has not received FDA approval; •  it has limited FDA approval under regulations such as Treatment Investigational New Drugs; •  it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described aboveinvestigative. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final Final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; OR • demonstratedDemonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in subsection 4 (c) of this Section 3.113.12); OR • sound Sound scientific studies published in authoritative, peer reviewed medical journals that: • show statistically significant outcomes about the effectiveness of the service, and • permit a consensus of opinion that the service improves the member’s net health outcome, and • show it is as beneficial as any established alternatives, and • show that the improvement is attainable outside the investigational setting; or OR • the The determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, if one or more of the following circumstances are true: • The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, except as described above. • Is trial or is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. ; or • The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. ; or • The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: • Published reports in authoritative, peer-reviewed medical literature; and AND • Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. ; or • If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria will apply: • it has not received FDA approval; or • it has limited FDA approval under regulations such as Treatment Investigational New Drugs; or • it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final Final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; OR • demonstratedDemonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this subsection Section 3.113.12); OR • sound Sound scientific studies published in authoritative, peer reviewed medical journals that: • show statistically significant outcomes about the effectiveness of the service, and • permit a consensus of opinion that the service improves the member’s net health outcome, and • show it is as beneficial as any established alternatives, and • show that the improvement is attainable outside the investigational setting; or OR • the The determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, excluded if one or more of the following circumstances are true: • The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, except as described above. • Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. ; or • The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. ; or • The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We This agreement will determine the applicability of this criterion based on: • Published reports in authoritative, peer-reviewed medical literature; and AND • Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. ; or • If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: • it has not received FDA approval; or • it has limited FDA approval under regulations such as Treatment Investigational New Drugs; or • it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We This agreement will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final  Final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; • demonstratedOR  Demonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this Section 3.113.13); • sound OR  Sound scientific studies published in authoritative, peer reviewed medical journals that: •  show statistically significant outcomes about the effectiveness of the service, and •  permit a consensus of opinion that the service improves the member’s net health outcome, and •  show it is as beneficial as any established alternatives, and •  show that the improvement is attainable outside the investigational setting; or • the OR  The determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, excluded if one or more of the following circumstances are true: • The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, except as described above. •  Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. • ; or  The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. • ; or  The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: •  Published reports in authoritative, peer-reviewed medical literature; and • AND  Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. • ; or  If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: •  it has not received FDA approval; • or  it has limited FDA approval under regulations such as Treatment Investigational New Drugs; • or  it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final Final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; OR • demonstratedDemonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this Section 3.113.12); OR • sound Sound scientific studies published in authoritative, peer reviewed medical journals that: • show statistically significant outcomes about the effectiveness of the service, and • permit a consensus of opinion that the service improves the member’s net health outcome, and • show it is as beneficial as any established alternatives, and • show that the improvement is attainable outside the investigational setting; or OR • the The determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, excluded if one or more of the following circumstances are true: • The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, trial except as described above. ; • Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. ; or • The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. ; or • The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: • Published reports in authoritative, peer-reviewed medical literature; and AND • Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. ; or • If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: • it has not received FDA approval; or • it has limited FDA approval under regulations such as Treatment Investigational New Drugs; or • it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia:

Related Exclusions. This agreement does NOT cover any treatments, procedures, facilities, equipment, drugs, devices, supplies, or services that are experimental or investigative except as described above. Treatments, procedures, facilities, equipment, drugs, devices, supplies, or services will be recognized as having been proven effective in clinical medicine only if one of the following apply: • final approval for the use of a specific service for a specific condition from the appropriate governmental regulatory body; • demonstrated, reliable evidence based upon an entry in at least one of the three standard reference compendia (shown in this Section 3.113.13); • sound scientific studies published in authoritative, peer reviewed medical journals that: • show statistically significant outcomes about the effectiveness of the service, and • permit a consensus of opinion that the service improves the member’s net health outcome, and • show it is as beneficial as any established alternatives, and • show that the improvement is attainable outside the investigational setting; or • the determination by an expert medical consultant retained by us, for the purpose of reviewing a particular service, that the service is not experimental/investigational for that particular member’s case. A service is considered experimental/investigational, and therefore excluded, if one or more of the following circumstances are true: • The service is the subject of ongoing Phase I or Phase II clinical trial or is the experimental arm of Phase III clinical trial, except as described above. • Is under study to determine the maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with a standard means of treatment or diagnosis. • The prevailing opinion among experts about the service is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. • The current belief in the pertinent specialty of the medical profession in the United States is that the service or supply should not be used for the diagnosis or indications being requested outside of clinical trials or other research settings because it requires further evaluation for that diagnosis or indications. We will determine the applicability of this criterion based on: • Published reports in authoritative, peer-reviewed medical literature; and • Reports, publications, evaluations, and other sources published by government agencies, such as the National Institutes of Health, the FDA, and the Agency for Healthcare Research and Quality. • If the benefit in question is a drug, a device, or other supply that is subject to approval by the FDA, and at least one of the following criteria apply: • it has not received FDA approval; • it has limited FDA approval under regulations such as Treatment Investigational New Drugs; • it has FDA approval but the indication for the drug or device, or the dosage, is not an accepted off-label use. We will judge this criterion through review of reports published in authoritative peer-reviewed United States medical literature OR entries in one or more of the following drug compendia: