Common use of Clinical Trials Clause in Contracts

Clinical Trials. Routine patient care costs incurred while taking part in a qualifying clinical trial for the treatment of: • Cancer or other life-threatening disease or condition. For purposes of this Benefit, a life-threatening disease or condition is one which is likely to cause death unless the course of the disease or condition is interrupted. • Cardiovascular disease (cardiac/stroke) which is not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Surgical musculoskeletal disorders of the spine, hip and knees, which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Other diseases or disorders which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from taking part in a qualifying clinical trial. Benefits are available only when you are clinically eligible, as determined by the researcher, to take part in the qualifying clinical trial. Routine patient care costs for qualifying clinical trials include: • Covered Health Care Services for which Benefits are typically provided absent a clinical trial. • Covered Health Care Services required solely for the following: ▪ The provision of the Experimental or Investigational Service(s) or item. ▪ The clinically appropriate monitoring of the effects of the service or item, or ▪ The prevention of complications. • Covered Health Care Services needed for reasonable and necessary care arising from the receipt of an Experimental or Investigational Service(s) or item. Routine costs for clinical trials do not include: • The Experimental or Investigational Service(s) or item. The only exceptions to this are: ▪ Certain Category B devices. ▪ Certain promising interventions for patients with Terminal Illnesses. ▪ Other items and services that meet specified criteria in accordance with our medical and drug policies. • Items and services provided solely to meet data collection and analysis needs and that are not used in the direct clinical management of the patient. • A service that clearly does not meet widely accepted and established standards of care for a particular diagnosis. • Items and services provided by the research sponsors free of charge for any person taking part in the trial. With respect to cancer or other life-threatening diseases or conditions, a qualifying clinical trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial. It takes place in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. It meets any of the following criteria in the bulleted list below. With respect to cardiovascular disease, musculoskeletal disorders of the spine, hip and knees and other diseases or disorders which are not life-threatening, a qualifying clinical trial is a Phase I, Phase II, or Phase III clinical trial. It takes place in relation to the detection or treatment of such non-life-threatening disease or disorder. It meets any of the following criteria in the bulleted list below. • Federally funded trials. The study or investigation is approved or funded (which may include funding through in- kind contributions) by one or more of the following: ▪ National Institutes of Health (NIH). (Includes National Cancer Institute (NCI).) ▪ Centers for Disease Control and Prevention (CDC).

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Samples: www.uhc.com, www.uhc.com, www.uhc.com

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Clinical Trials. Routine patient care costs incurred while taking part in a qualifying clinical trial for the treatment of: • Cancer or other life-threatening disease or condition. For purposes of this Benefit, a life-threatening disease or condition is one which is likely to cause death unless the course of the disease or condition is interrupted. • Cardiovascular disease (cardiac/stroke) which is not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Surgical musculoskeletal disorders of the spine, hip and knees, which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Other diseases or disorders which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from taking part in a qualifying clinical trial. Benefits are available only when you are clinically eligible, as determined by the researcher, to take part in the qualifying clinical trial. Routine patient care costs for qualifying clinical trials include: • Covered Health Care Services for which Benefits are typically provided absent a clinical trial. • Covered Health Care Services required solely for the following: ▪ The provision of the Experimental or Investigational Service(s) or item. ▪ The clinically appropriate monitoring of the effects of the service or item, or ▪ The prevention of complications. • Covered Health Care Services needed for reasonable and necessary care arising from the receipt of an Experimental or Investigational Service(s) or item. Routine costs for clinical trials do not include: • The Experimental or Investigational Service(s) or item. The only exceptions to this are: ▪ Certain Category B devices. ▪ Certain promising interventions for patients with Terminal Illnesses. ▪ Other items and services that meet specified criteria in accordance with our medical and drug policies. • Items and services provided solely to meet data collection and analysis needs and that are not used in the direct clinical management of the patient. • A service that clearly does not meet widely accepted and established standards of care for a particular diagnosis. • Items and services provided by the research sponsors free of charge for any person taking part in the trial. With respect to cancer or other life-threatening diseases or conditions, a qualifying clinical trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial. It takes place in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. It meets any of the following criteria in the bulleted list below. With respect to cardiovascular disease, musculoskeletal disorders of the spine, hip and knees and other diseases or disorders which are not life-threatening, a qualifying clinical trial is a Phase I, Phase II, or Phase III clinical trial. It takes place in relation to the detection or treatment of such non-life-threatening disease or disorder. It meets any of the following criteria in the bulleted list below. • Federally funded trials. The study or investigation is approved or funded (which may include funding through in- kind contributions) by one or more of the following: ▪ National Institutes of Health (NIH). (Includes National Cancer Institute (NCI).) ▪ Centers for Disease Control and Prevention (CDC). ▪ Agency for Healthcare 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 Veterans Administration (VA). ▪ A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. ▪ The Department of Veterans Affairs, the Department of Defense or the Department of Energy if the study or investigation has been reviewed and approved through a system of peer review. The peer review system is determined by the Secretary of Health and Human Services to meet both of the following criteria: ♦ Comparable to the system of peer review of studies and investigations used by the National Institutes of Health. ♦ Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

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Samples: www.uhc.com, www.uhc.com, www.uhc.com

Clinical Trials. Routine patient care costs incurred while taking part in a qualifying clinical trial for the treatment of: • Cancer or other life-threatening disease or condition. For purposes of this Benefit, a life-threatening disease or condition is one which is likely to cause death unless the course of the disease or condition is interrupted. • Cardiovascular disease (cardiac/stroke) which is not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Surgical musculoskeletal disorders of the spine, hip and knees, which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Other diseases or disorders which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from taking part in a qualifying clinical trial. Benefits are available only when you are clinically eligible, as determined by the researcher, to take part in the qualifying clinical trial. Routine patient care costs for qualifying clinical trials include: • Covered Health Care Services for which Benefits are typically provided absent a clinical trial. • Covered Health Care Services required solely for the following: ▪ The provision of the Experimental or Investigational Service(s) or item. ▪ The clinically appropriate monitoring of the effects of the service or item, or ▪ The prevention of complications. SAMPLE • Covered Health Care Services needed for reasonable and necessary care arising from the receipt of an Experimental or Investigational Service(s) or item. Routine costs for clinical trials do not include: • The Experimental or Investigational Service(s) or item. The only exceptions to this are: ▪ Certain Category B devices. A Category B device is known to be safe and effective due to Food and Drug Administration premarket approval for that device type. ▪ Certain promising interventions for patients with Terminal Illnessesterminal illnesses. ▪ Other items and services that meet specified criteria in accordance with our medical and drug policies. • Items and services provided solely to meet data collection and analysis needs and that are not used in the direct clinical management of the patient. • A service that clearly does not meet widely accepted and established standards of care for a particular diagnosis. • Items and services provided by the research sponsors free of charge for any person taking part in the trial. With respect to cancer or other life-threatening diseases or conditions, a qualifying clinical trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial. It takes place in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. It meets any of the following criteria in the bulleted list below. With respect to cardiovascular disease, musculoskeletal disorders of the spine, hip and knees and other diseases or disorders which are not life-threatening, a qualifying clinical trial is a Phase I, Phase II, or Phase III clinical trial. It takes place in relation to the detection or treatment of such non-life-threatening disease or disorder. It meets any of the following criteria in the bulleted list below. • Federally funded trials. The study or investigation is approved or funded (which may include funding through in- kind contributions) by one or more of the following: ▪ National Institutes of Health (NIH). (Includes National Cancer Institute (NCI).) ▪ Centers for Disease Control and Prevention (CDC). ▪ Agency for Healthcare 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 Veterans Administration (VA). ▪ A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. ▪ The Department of Veterans Affairs, the Department of Defense or the Department of Energy if the study or investigation has been reviewed and approved through a system of peer review. The peer review system is determined by the Secretary of Health and Human Services to meet both of the following criteria: ♦ Comparable to the system of peer review of studies and investigations used by the National Institutes of Health. ♦ Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

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Samples: www.uhc.com

Clinical Trials. Routine patient care costs incurred while taking part in a qualifying clinical trial for the treatment of: • Cancer or other life-threatening disease or condition. For purposes of this Benefit, a life-threatening disease or condition is one which is likely to cause death unless the course of the disease or condition is interrupted. • Cardiovascular disease (cardiac/stroke) which is not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Surgical musculoskeletal disorders of the spine, hip and knees, which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Other diseases or disorders which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from taking part in a qualifying clinical trial. Benefits are available only when you are clinically eligible, as determined by the researcher, to take part in the qualifying clinical trial. Routine patient care costs for qualifying clinical trials include: • Covered Health Care Services for which Benefits are typically provided absent a clinical trial. • Covered Health Care Services required solely for the following: The provision of the Experimental or Investigational Service(s) or item. The clinically appropriate monitoring of the effects of the service or item, or The prevention of complications. • Covered Health Care Services needed for reasonable and necessary care arising from the receipt of an Experimental or Investigational Service(s) or item. Routine costs for clinical trials do not include: • The Experimental or Investigational Service(s) or item. The only exceptions to this are: Certain Category B devices. Certain promising interventions for patients with Terminal Illnessesterminal illnesses. Other items and services that meet specified criteria in accordance with our medical and drug policies. • Items and services provided solely to meet data collection and analysis needs and that are not used in the direct clinical management of the patientthepatient. • A service that clearly does not meet widely accepted and established standards of care for a particular diagnosis. • Items and services provided by the research sponsors free of charge for any person taking part in the trial. With respect to cancer or other life-threatening diseases or conditions, a qualifying clinical trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial. It takes place in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. It meets any of the following criteria in the bulleted list below. With respect to cardiovascular disease, musculoskeletal disorders of the spine, hip and knees and other diseases or disorders which are not life-threatening, a qualifying clinical trial is a Phase I, Phase II, or Phase III clinical trial. It takes place in relation to the detection or treatment of such non-life-threatening disease or disorder. It meets any of the following criteria in the bulleted list below. • Federally funded trials. The study or investigation is approved or funded (which may include funding through in- in-kind contributions) by one or more of the following: National Institutes of Health (NIH). (Includes National Cancer Institute (NCI).) Centers for Disease Control and Prevention (CDC).  Agency for Healthcare 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 Veterans Administration (VA).  A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.  The Department of Veterans Affairs, the Department of Defense or the Department of Energy if the study or investigation has been reviewed and approved through a system of peer review. The peer review system is determined by the Secretary of Health and Human Services to meet both of the following criteria: ◆ Comparable to the system of peer review of studies and investigations used by the National Institutes of Health. ◆ Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

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Samples: www.uhc.com

Clinical Trials. Routine patient care costs incurred while taking part in a qualifying clinical trial for the treatment of: • Cancer or other life-threatening disease or condition. For purposes of this Benefit, a life-threatening disease or condition is one which is likely to cause death unless the course of the disease or condition is interrupted. • Cardiovascular disease (cardiac/stroke) which is not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Surgical musculoskeletal disorders of the spine, hip and knees, which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Other diseases or disorders which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from taking part in a qualifying clinical trial. SAMPLE Benefits are available only when you are clinically eligible, as determined by the researcher, to take part in the qualifying clinical trial. Routine patient care costs for qualifying clinical trials include: • Covered Health Care Services for which Benefits are typically provided absent a clinical trial. • Covered Health Care Services required solely for the following: ▪ The provision of the Experimental or Investigational Service(s) or item. ▪ The clinically appropriate monitoring of the effects of the service or item, or ▪ The prevention of complications. • Covered Health Care Services needed for reasonable and necessary care arising from the receipt of an Experimental or Investigational Service(s) or item. Routine costs for clinical trials do not include: • The Experimental or Investigational Service(s) or item. The only exceptions to this are: ▪ Certain Category B devices. ▪ Certain promising interventions for patients with Terminal Illnessesterminal illnesses. ▪ Other items and services that meet specified criteria in accordance with our medical and drug policies. • Items and services provided solely to meet data collection and analysis needs and that are not used in the direct clinical management of the patient. • A service that clearly does not meet widely accepted and established standards of care for a particular diagnosis. • Items and services provided by the research sponsors free of charge for any person taking part in the trial. With respect to cancer or other life-threatening diseases or conditions, a qualifying clinical trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial. It takes place in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. It meets any of the following criteria in the bulleted list below. With respect to cardiovascular disease, musculoskeletal disorders of the spine, hip and knees and other diseases or disorders which are not life-threatening, a qualifying clinical trial is a Phase I, Phase II, or Phase III clinical trial. It takes place in relation to the detection or treatment of such non-life-threatening disease or disorder. It meets any of the following criteria in the bulleted list below. • Federally funded trials. The study or investigation is approved or funded (which may include funding through in- kind contributions) by one or more of the following: ▪ National Institutes of Health (NIH). (Includes National Cancer Institute (NCI).) ▪ Centers for Disease Control and Prevention (CDC).. ▪ Agency for Healthcare 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 Veterans Administration (VA). ▪ A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. ▪ The Department of Veterans Affairs, the Department of Defense or the Department of Energy if the study or investigation has been reviewed and approved through a system of peer review. The peer review system is determined by the Secretary of Health and Human Services to meet both of the following criteria: ♦ Comparable to the system of peer review of studies and investigations used by the National Institutes of Health. ♦ Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review. SAMPLE

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Clinical Trials. Routine patient care costs incurred while taking part in a qualifying clinical trial for the treatment of: • Cancer or other life-threatening disease or condition. For purposes of this Benefit, a life-threatening disease or condition is one which is likely to cause death unless the course of the disease or condition is interrupted. • Cardiovascular disease (cardiac/stroke) which is not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Surgical musculoskeletal disorders of the spine, hip and knees, which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Other diseases or disorders which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from taking part in a qualifying clinical trial. Benefits are available only when you are clinically eligible, as determined by the researcher, to take part in the qualifying clinical trial. Routine patient care costs for qualifying clinical trials include: • Covered Health Care Services for which Benefits are typically provided absent a clinical trial. • Covered Health Care Services required solely for the following: ▪ The provision of the Experimental or Investigational Service(s) or item. ▪ The clinically appropriate monitoring of the effects of the service or item, or ▪ The prevention of complications. SAMPLE • Covered Health Care Services needed for reasonable and necessary care arising from the receipt of an Experimental or Investigational Service(s) or item. Routine costs for clinical trials do not include: • The Experimental or Investigational Service(s) or item. The only exceptions to this are: ▪ Certain Category B devices. ▪ Certain promising interventions for patients with Terminal Illnessesterminal illnesses. ▪ Other items and services that meet specified criteria in accordance with our medical and drug policies. • Items and services provided solely to meet data collection and analysis needs and that are not used in the direct clinical management of the patient. • A service that clearly does not meet widely accepted and established standards of care for a particular diagnosis. • Items and services provided by the research sponsors free of charge for any person taking part in the trial. With respect to cancer or other life-threatening diseases or conditions, a qualifying clinical trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial. It takes place in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. It meets any of the following criteria in the bulleted list below. With respect to cardiovascular disease, musculoskeletal disorders of the spine, hip and knees and other diseases or disorders which are not life-threatening, a qualifying clinical trial is a Phase I, Phase II, or Phase III clinical trial. It takes place in relation to the detection or treatment of such non-life-threatening disease or disorder. It meets any of the following criteria in the bulleted list below. • Federally funded trials. The study or investigation is approved or funded (which may include funding through in- kind contributions) by one or more of the following: ▪ National Institutes of Health (NIH). (Includes National Cancer Institute (NCI).) ▪ Centers for Disease Control and Prevention (CDC). ▪ Agency for Healthcare 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 Veterans Administration (VA). ▪ A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. ▪ The Department of Veterans Affairs, the Department of Defense or the Department of Energy if the study or investigation has been reviewed and approved through a system of peer review. The peer review system is determined by the Secretary of Health and Human Services to meet both of the following criteria: ♦ Comparable to the system of peer review of studies and investigations used by the National Institutes of Health. ♦ Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

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Samples: www.uhc.com

Clinical Trials. Routine patient care costs incurred while taking part in a qualifying clinical trial for the treatment of: • Cancer or other life-threatening disease or condition. For purposes of this Benefit, a life-threatening disease or condition is one which is likely to cause death unless the course of the disease or condition is interrupted. • Cardiovascular disease (cardiac/stroke) which is not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Surgical musculoskeletal disorders of the spine, hip and knees, which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Other diseases or disorders which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from taking part in a qualifying clinical trial. Benefits are available only when you are clinically eligible, as determined by the researcher, to take part in the qualifying clinical trial. SAMPLE Routine patient care costs for qualifying clinical trials include: • Covered Health Care Services for which Benefits are typically provided absent a clinical trial. • Covered Health Care Services required solely for the following: ▪ The provision of the Experimental or Investigational Service(s) or item. ▪ The clinically appropriate monitoring of the effects of the service or item, or ▪ The prevention of complications. • Covered Health Care Services needed for reasonable and necessary care arising from the receipt of an Experimental or Investigational Service(s) or item. Routine costs for clinical trials do not include: • The Experimental or Investigational Service(s) or item. The only exceptions to this are: ▪ Certain Category B devices. ▪ Certain promising interventions for patients with Terminal Illnesses. ▪ Other items and services that meet specified criteria in accordance with our medical and drug policies. • Items and services provided solely to meet data collection and analysis needs and that are not used in the direct clinical management of the patient. • A service that clearly does not meet widely accepted and established standards of care for a particular diagnosis. • Items and services provided by the research sponsors free of charge for any person taking part in the trial. With respect to cancer or other life-threatening diseases or conditions, a qualifying clinical trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial. It takes place in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. It meets any of the following criteria in the bulleted list below. With respect to cardiovascular disease, musculoskeletal disorders of the spine, hip and knees and other diseases or disorders which are not life-threatening, a qualifying clinical trial is a Phase I, Phase II, or Phase III clinical trial. It takes place in relation to the detection or treatment of such non-life-threatening disease or disorder. It meets any of the following criteria in the bulleted list below. • Federally funded trials. The study or investigation is approved or funded (which may include funding through in- kind contributions) by one or more of the following: ▪ National Institutes of Health (NIH). (Includes National Cancer Institute (NCI).) ▪ Centers for Disease Control and Prevention (CDC). ▪ Agency for Healthcare 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 Veterans Administration (VA). ▪ A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. ▪ The Department of Veterans Affairs, the Department of Defense or the Department of Energy if the study or investigation has been reviewed and approved through a system of peer review. The peer review system is determined by the Secretary of Health and Human Services to meet both of the following criteria: ♦ Comparable to the system of peer review of studies and investigations used by the National Institutes of Health. ♦ Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

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Samples: www.uhc.com

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Clinical Trials. Routine patient care costs incurred while taking part in a qualifying clinical trial for the treatment of: Cancer or other life-threatening disease or condition. For purposes of this Benefit, a life-threatening disease or condition is one which is likely to cause death unless the course of the disease or condition is interrupted. Sample  Cardiovascular disease (cardiac/stroke) which is not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Surgical musculoskeletal disorders of the spine, hip and knees, which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Other diseases or disorders which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from taking part in a qualifying clinical trial. Benefits are available only when you are clinically eligible, as determined by the researcher, to take part in the qualifying clinical trial. Routine patient care costs for qualifying clinical trials include: Covered Health Care Services for which Benefits are typically provided absent a clinical trial. Covered Health Care Services required solely for the following: The provision of the Experimental or Investigational Service(s) or item. The clinically appropriate monitoring of the effects of the service or item, or The prevention of complications. Covered Health Care Services needed for reasonable and necessary care arising from the receipt of an Experimental or Investigational Service(s) or item. Routine costs for clinical trials do not include: The Experimental or Investigational Service(s) or item. The only exceptions to this are: Certain Category B devices. Certain promising interventions for patients with Terminal Illnessesterminal illnesses. Other items and services that meet specified criteria in accordance with our medical and drug policies. Items and services provided solely to meet data collection and analysis needs and that are not used in the direct clinical management of the patient. A service that clearly does not meet widely accepted and established standards of care for a particular diagnosis. Items and services provided by the research sponsors free of charge for any person taking part in the trial. With respect to cancer or other life-threatening diseases or conditions, a qualifying clinical trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial. It takes place in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. It meets any of the following criteria in the bulleted list below. With respect to cardiovascular disease, musculoskeletal disorders of the spine, hip and knees and other diseases or disorders which are not life-threatening, a qualifying clinical trial is a Phase I, Phase II, or Phase III clinical trial. It takes place in relation to the detection or treatment of such non-life-threatening disease or disorder. It meets any of the following criteria in the bulleted list below. Federally funded trials. The study or investigation is approved or funded (which may include funding through in- in-kind contributions) by one or more of the following: National Institutes of Health (NIH). (Includes National Cancer Institute (NCI).) Sample  Centers for Disease Control and Prevention (CDC).  Agency for Healthcare 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 Veterans Administration (VA).  A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.  The Department of Veterans Affairs, the Department of Defense or the Department of Energy if the study or investigation has been reviewed and approved through a system of peer review. The peer review system is determined by the Secretary of Health and Human Services to meet both of the following criteria: ♦ Comparable to the system of peer review of studies and investigations used by the National Institutes of Health. ♦ Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

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Samples: www.uhc.com

Clinical Trials. Sample Routine patient care costs incurred while taking part in a qualifying clinical trial for the treatment of: • Cancer or other life-threatening disease or condition. For purposes of this Benefit, a life-threatening disease or condition is one which is likely to cause death unless the course of the disease or condition is interrupted. • Cardiovascular disease (cardiac/stroke) which is not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Surgical musculoskeletal disorders of the spine, hip and knees, which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Other diseases or disorders which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from taking part in a qualifying clinical trial. Benefits are available only when you are clinically eligible, as determined by the researcher, to take part in the qualifying clinical trial. Routine patient care costs for qualifying clinical trials include: • Covered Health Care Services for which Benefits are typically provided absent a clinical trial. • Covered Health Care Services required solely for the following: The provision of the Experimental or Investigational Service(s) or item. The clinically appropriate monitoring of the effects of the service or item, or The prevention of complications. • Covered Health Care Services needed for reasonable and necessary care arising from the receipt of an Experimental or Investigational Service(s) or item. Routine costs for clinical trials do not include: • The Experimental or Investigational Service(s) or item. The only exceptions to this are: Certain Category B devices. Certain promising interventions for patients with Terminal Illnessesterminal illnesses. Other items and services that meet specified criteria in accordance with our medical and drug policies. • Items and services provided solely to meet data collection and analysis needs and that are not used in the direct clinical management of the patient. • A service that clearly does not meet widely accepted and established standards of care for a particular diagnosis. • Items and services provided by the research sponsors free of charge for any person taking part in the trial. With respect to cancer or other life-threatening diseases or conditions, a qualifying clinical trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial. It takes place in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. It meets any of the following criteria in the bulleted list below. With respect to cardiovascular disease, musculoskeletal disorders of the spine, hip and knees and other diseases or disorders which are not life-threatening, a qualifying clinical trial is a Phase I, Phase II, or Phase III clinical trial. It takes place in relation to the detection or treatment of such non-life-threatening disease or disorder. It meets any of the following criteria in the bulleted list below. Sample • Federally funded trials. The study or investigation is approved or funded (which may include funding through in- in-kind contributions) by one or more of the following: National Institutes of Health (NIH). (Includes National Cancer Institute (NCI).) Centers for Disease Control and Prevention (CDC).  Agency for Healthcare 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 Veterans Administration (VA).  A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.  The Department of Veterans Affairs, the Department of Defense or the Department of Energy if the study or investigation has been reviewed and approved through a system of peer review. The peer review system is determined by the Secretary of Health and Human Services to meet both of the following criteria: ♦ Comparable to the system of peer review of studies and investigations used by the National Institutes of Health. ♦ Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

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Clinical Trials. Routine patient care costs incurred while taking part in a qualifying clinical trial for the treatment of: • Cancer or other life-threatening disease or condition. For purposes of this Benefit, a life-threatening disease or condition is one which is likely to cause death unless the course of the disease or condition is interrupted. • Cardiovascular disease (cardiac/stroke) which is not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Surgical musculoskeletal disorders of the spine, hip and knees, which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Other diseases or disorders which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from taking part in a qualifying clinical trial. Benefits are available only when you are clinically eligible, as determined by the researcher, to take part in the qualifying clinical trial. Routine patient care costs for qualifying clinical trials include: • Covered Health Care Services for which Benefits are typically provided absent a clinical trial. • Covered Health Care Services required solely for the following: ▪ The provision of the Experimental or Investigational Service(s) or item. ▪ The clinically appropriate monitoring of the effects of the service or item, or ▪ The prevention of complications. • Covered Health Care Services needed for reasonable and necessary care arising from the receipt of an Experimental or Investigational Service(s) or item. Routine costs for clinical trials do not include: • The Experimental or Investigational Service(s) or item. The only exceptions to this are: ▪ Certain Category B devices. ▪ Certain promising interventions for patients with Terminal Illnessesterminal illnesses. ▪ Other items and services that meet specified criteria in accordance with our medical and drug policies. • Items and services provided solely to meet data collection and analysis needs and that are not used in the direct clinical management of the patient. • A service that clearly does not meet widely accepted and established standards of care for a particular diagnosis. • Items and services provided by the research sponsors free of charge for any person taking part in the trial. With respect to cancer or other life-threatening diseases or conditions, a qualifying clinical trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial. It takes place in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. It meets any of the following criteria in the bulleted list below. SAMPLE With respect to cardiovascular disease, musculoskeletal disorders of the spine, hip and knees and other diseases or disorders which are not life-threatening, a qualifying clinical trial is a Phase I, Phase II, or Phase III clinical trial. It takes place in relation to the detection or treatment of such non-life-threatening disease or disorder. It meets any of the following criteria in the bulleted list below. • Federally funded trials. The study or investigation is approved or funded (which may include funding through in- in-kind contributions) by one or more of the following: ▪ National Institutes of Health (NIH). (Includes National Cancer Institute (NCI).) ▪ Centers for Disease Control and Prevention (CDC). ▪ Agency for Healthcare 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 Veterans Administration (VA). ▪ A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. ▪ The Department of Veterans Affairs, the Department of Defense or the Department of Energy if the study or investigation has been reviewed and approved through a system of peer review. The peer review system is determined by the Secretary of Health and Human Services to meet both of the following criteria: ♦ Comparable to the system of peer review of studies and investigations used by the National Institutes of Health. ♦ Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

Appears in 1 contract

Samples: www.uhc.com

Clinical Trials. Routine patient care costs incurred while taking part in a qualifying clinical trial for the treatment of: • Cancer or other life-threatening disease or condition. For purposes of this Benefit, a life-threatening disease or condition is one which is likely to cause death unless the course of the disease or condition is interrupted. • Cardiovascular disease (cardiac/stroke) which is not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Surgical musculoskeletal disorders of the spine, hip and knees, which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. • Other diseases or disorders which are not life threatening, when we determine the clinical trial meets the qualifying clinical trial criteria stated below. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from taking part in a qualifying clinical trial. Benefits are available only when you are clinically eligible, as determined by the researcher, to take part in the qualifying clinical trial. Routine patient care costs for qualifying clinical trials include: • Covered Health Care Services for which Benefits are typically provided absent a clinical trial. • Covered Health Care Services required solely for the following: SAMPLE ▪ The provision of the Experimental or Investigational Service(s) or item. ▪ The clinically appropriate monitoring of the effects of the service or item, or ▪ The prevention of complications. • Covered Health Care Services needed for reasonable and necessary care arising from the receipt of an Experimental or Investigational Service(s) or item. Routine costs for clinical trials do not include: • The Experimental or Investigational Service(s) or item. The only exceptions to this are: ▪ Certain Category B devices. ▪ Certain promising interventions for patients with Terminal Illnessesterminal illnesses. ▪ Other items and services that meet specified criteria in accordance with our medical and drug policies. • Items and services provided solely to meet data collection and analysis needs and that are not used in the direct clinical management of the patient. • A service that clearly does not meet widely accepted and established standards of care for a particular diagnosis. • Items and services provided by the research sponsors free of charge for any person taking part in the trial. With respect to cancer or other life-threatening diseases or conditions, a qualifying clinical trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial. It takes place in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. It meets any of the following criteria in the bulleted list below. With respect to cardiovascular disease, musculoskeletal disorders of the spine, hip and knees and other diseases or disorders which are not life-threatening, a qualifying clinical trial is a Phase I, Phase II, or Phase III clinical trial. It takes place in relation to the detection or treatment of such non-life-threatening disease or disorder. It meets any of the following criteria in the bulleted list below. • Federally funded trials. The study or investigation is approved or funded (which may include funding through in- kind contributions) by one or more of the following: ▪ National Institutes of Health (NIH). (Includes National Cancer Institute (NCI).) ▪ Centers for Disease Control and Prevention (CDC). ▪ Agency for Healthcare 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 Veterans Administration (VA). ▪ A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants. ▪ The Department of Veterans Affairs, the Department of Defense or the Department of Energy if the study or investigation has been reviewed and approved through a system of peer review. The peer review system is determined by the Secretary of Health and Human Services to meet both of the following criteria: ♦ Comparable to the system of peer review of studies and investigations used by the National Institutes of Health. ♦ Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

Appears in 1 contract

Samples: www.uhc.com

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