Common use of Agreement of Coverage Clause in Contracts

Agreement of Coverage.  The Member has signed a statement of consent before his participation in the clinical trial or study indicating that he has been informed of:  The procedure to be undertaken;  Alternative methods of treatment; and  The risks associated with participation in the clinical trial or study. Benefit coverage for medical treatment received during a clinical trial or study is limited to the following Covered Services:  The initial consultation to determine whether the Member is eligible to participate in the clinical trial or study;  Any drug or device that is approved for sale by the FDA without regard to whether the approved drug or device has been approved for use in the medical treatment of the Member, if the drug or device is not paid for by the manufacturer, distributor, or Provider:  Services normally covered under this Plan that are required as a result of the medical treatment or related complications provided in the clinical trial or study when not provided by the sponsor of the clinical trial or study;  Services required for the clinically appropriate monitoring of the Member during the clinical trial or study when not provided by the sponsor of the clinical trial or study. Benefits for Covered Services in connection with a clinical trial or study are payable under this Plan to the same extent as any other Illness or Injury. Services must be provided by an HPN Plan Provider. In the event an HPN Plan Provider does not offer a clinical trial with the same protocol as the one the Member’s Plan Provider recommended, the Member may select a Non-Plan Provider performing a clinical trial with that protocol within the State of Nevada. If there is no Provider offering the clinical trial with the same protocol as the one the Member’s Plan Provider recommended in Nevada, the Member may select a clinical trial outside of Nevada but within the United States of America. In no event will HPN pay more than the maximum payment allowance established in the HPN Reimbursement Schedule. HPN will require a copy of the clinical trial or study certification approval, the Member’s signed statement of consent and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment.

Agreement of Coverage.  The Member has signed a statement of consent before his participation in the clinical trial or study indicating that he has been informed of:  ▪ The procedure to be undertaken;  ▪ Alternative methods of treatment; and  ▪ The risks associated with participation in the clinical trial or study. Benefit coverage for medical treatment received during a clinical trial or study is limited to the following Covered Services:  • The initial consultation to determine whether the Member is eligible to participate in the clinical trial or study;  • Any drug or device that is approved for sale by the FDA without regard to whether the approved drug or device has been approved for use in the medical treatment of the Member, if the drug or device is not paid for by the manufacturer, distributor, or Provider:  • Services normally covered under this Plan that are required as a result of the medical treatment or related complications provided in the clinical trial or study when not provided by the sponsor of the clinical trial or study;  • Services required for the clinically appropriate monitoring of the Member during the clinical trial or study when not provided by the sponsor of the clinical trial or study. Benefits for Covered Services in connection with a clinical trial or study are payable under this Plan to the same extent as any other Illness or Injury. Services must be provided by an HPN Plan Provider. In the event an HPN Plan Provider does not offer a clinical trial with the same protocol as the one the Member’s Plan Provider recommended, the Member may select a Non-Plan Provider performing a clinical trial with that protocol within the State of Nevada. If there is no Provider offering the clinical trial with the same protocol as the one the Member’s Plan Provider recommended in Nevada, the Member may select a clinical trial outside of Nevada but within the United States of America. In no event will HPN pay more than the maximum payment allowance established in the HPN Reimbursement Schedule. HPN will require a copy of the clinical trial or study certification approval, the Member’s signed statement of consent and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment.