Clinical Trial Participation. 1. This Contract shall provide coverage for patient costs incurred as a result of a treatment being provided in accordance with a clinical trial for cancer. Coverage will be subject to any applicable Copayment, Deductible, or Coinsurance amounts shown in the Schedule of Benefits. 2. The following services are not covered: a. Non-health care services provided as part of the clinical trial; b. Costs for managing research data associated with the clinical trial; c. Investigational drugs or devices; and/or d. Services, treatment or supplies not otherwise covered under this Contract. 3. Investigational treatments and associated protocol related patient care not excluded in this paragraph shall be covered if all of the following criteria are met: a. The treatment is being provided with a therapeutic or palliative intent for patients with cancer or for the prevention or early detection of cancer. b. The treatment is being provided or the studies are being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer. c. The treatment is being provided in accordance with a clinical trial approved by one of the following entities: (1) One of the United States National Institutes of Health. (2) A cooperative Group funded by one of the National Institutes of Health. (3) The FDA in the form of an Investigational new drug application. (4) The United States Department of Veterans Affairs. (5) The United States Department of Defense. (6) A federally funded general clinical research center. (7) The Coalition of National Cancer Cooperative Groups. d. The proposed protocol must have been reviewed and approved by a qualified institutional review board which operates in this state and, which has a multiple project assurance contract approved by the office of protection from research risks. e. The facility and personnel providing the protocol must provide the treatment within their scope of practice, experience, and training and are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise. f. There must be no clearly superior, non-investigational approach. g. The available clinical or pre-clinical data provide a reasonable expectation that the treatment will be at least as efficacious as the non-investigational alternative. h. The patient has a signed institutional review board approved consent form.
Appears in 1 contract
Clinical Trial Participation. 1. This Contract shall provide coverage for patient costs incurred as a result of a treatment being provided in accordance with a clinical trial for cancer. Coverage will be subject to any applicable Copayment, Deductible, Deductible or Coinsurance amounts shown in the Schedule of Benefits.
2. The following services are not covered:
a. Non-health care services provided as part of the clinical trial;
b. Costs for managing research data associated with the clinical trial;
c. Investigational drugs or devices; and/or
d. Services, treatment or supplies not otherwise covered under this Contract.
3. Investigational treatments and associated protocol related patient care not excluded in this paragraph shall be covered if all of the following criteria are met:
a. The treatment Treatment is being provided with a therapeutic or palliative intent for patients with cancer or for the prevention or early detection of cancer.
b. The treatment Treatment is being provided or the studies are being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer.
c. The treatment Treatment is being provided in accordance with a clinical trial approved by one of the following entitiesby:
(1) One of the United States National Institutes of Health.
(2) A cooperative Group funded by one of the National Institutes of Health.Health.
(3) The FDA in the form of an Investigational new drug application.
(4) The United States Department of Veterans Affairs.
(5) The United States Department of Defense.
(6) A federally funded general clinical research center.
(7) The Coalition of National Cancer Cooperative Groups.
d. The proposed protocol must have been reviewed and approved by a qualified institutional review board which operates in this state and, and which has a multiple project assurance contract approved by the office of protection from research risks.
e. The facility and personnel providing the protocol must provide the treatment within their scope of practice, experience, and training and are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise.
f. There must be no clearly superior, non-investigational approach.
g. The available clinical or pre-clinical data provide a reasonable expectation that the treatment will be at least as efficacious as the non-investigational alternative.
h. The patient has a signed an institutional review board approved consent form.
Appears in 1 contract
Samples: Comprehensive Major Medical Contract
Clinical Trial Participation. 1. This Contract shall provide coverage for patient costs incurred as a result of a treatment being provided in accordance with a clinical trial for cancer. Coverage will be subject to any applicable Copayment, Deductible, or Coinsurance amounts shown in the Schedule of Benefits.
2. The following services are not covered:
a. Non-health care services provided as part of the clinical trial;
b. Costs for managing research data associated with the clinical trial;
c. Investigational drugs or devices; and/or
d. Services, treatment or supplies not otherwise covered under this Contract.
3. Investigational treatments and associated protocol related patient care not excluded in this paragraph shall be covered if all of the following criteria are met:
a. The treatment is being provided with a therapeutic or palliative intent for patients with cancer or for the prevention or early detection of cancer.
b. The treatment is being provided or the studies are being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer.
c. The treatment is being provided in accordance with a clinical trial approved by one of the following entities:
(1) One of the United States National Institutes of Health.
(2) A cooperative Group funded by one of the National Institutes of Health.
(3) The FDA in the form of an Investigational new drug application.
(4) The United States Department of Veterans Affairs.
(5) The United States Department of Defense.
(6) A federally funded general clinical research center.
(7) The Coalition of National Cancer Cooperative Groups.
d. The proposed protocol must have been reviewed and approved by a qualified institutional review board which operates in this state and, which has a multiple project assurance contract approved by the office of protection from research risks.
e. The facility and personnel providing the protocol must provide the treatment within their scope of practice, experience, and training and are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise.
f. There must be no clearly superior, non-investigational approach.
g. The available clinical or pre-clinical data provide a reasonable expectation that the treatment will be at least as efficacious as the non-investigational alternative.alternative.
h. The patient has a signed institutional review board approved consent form.
Appears in 1 contract
Clinical Trial Participation. 1. This Contract shall provide coverage for patient costs incurred as a result of a treatment being provided in accordance with a clinical trial for cancer. Coverage will be subject to any applicable Copayment, Deductible, or Coinsurance amounts shown in the Schedule of Benefits.
2. The following services are not covered:
a. Non-health care services provided as part of the clinical trial;
b. Costs for managing research data associated with the clinical trial;
c. Investigational drugs or devices; and/or;
d. Services, treatment or supplies not otherwise covered under this the Contract; and/or
e. Physician’s office visits.
3. Investigational treatments and associated protocol related -related patient care not excluded in this paragraph shall be covered if all of the following criteria are met:
a. The treatment is being provided with a therapeutic or palliative intent for patients with cancer or for the prevention or early detection of cancer.
b. The treatment is being provided or the studies are being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer.
c. The treatment is being provided in accordance with a clinical trial approved by one of the following entities:
(1) One of the United States National Institutes of Health.
(2) A cooperative Group funded by one of the National Institutes of Health.
(3) The FDA in the form of an Investigational new drug application.
(4) The United States Department of Veterans Affairs.
(5) The United States Department of Defense.
(6) A federally funded general clinical research center.
(7) The Coalition of National Cancer Cooperative Groups.
d. The proposed protocol must have been reviewed and approved by a qualified institutional review board which operates in this state and, which has a multiple project assurance contract approved by the office of protection from research risks.
e. The facility and personnel providing the protocol must provide the treatment within their scope of practice, experience, and training and are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise.
f. There must be no clearly superior, non-investigational Investigational approach.
g. The available clinical or pre-clinical data provide a reasonable expectation that the treatment will be at least as efficacious as the non-investigational Investigational alternative.
h. The patient has a signed institutional review board approved consent form.
Appears in 1 contract
