coverage. Plan must receive written certification by a treating physician that states the child is suffering from a serious illness or injury and the leave of absence is medically necessary. 42 USC § If the plan provides coverage to individuals”: “qualified Coverage for Cannot deny participation in an clinical trial” for treatment of cancer or another “approved individuals disease or condition; participating Cannot deny, limit, or impose additional conditions on the coverage of routine patient costs for in approved items and services furnished in connection with participation in the trial; clinical trials Cannot discriminate on the basis of participation in the trial. 42 USC § This includes an enrollee participating in an approved clinical conducted outside the state in which the enrollee resides. individual” means enrollee who is eligible to participate in the according to “Qualified 42 USC § 300gg-8(b) protocol, and either: (1) referring provider is a participating provider and has concluded that the would be appropriate for individual, or (2) individual provides medical or scientific information establishing that the would be appropriate. clinical trial” means a phase I, II, III, or IV clinical conducted in relation to the “Approved prevention, detection, or treatment of cancer or other life-threatening disease or condition, and it is either: (1) federally funded or approved, (2) conducted under FDA investigational new drug application, or (3) drug exempt from FDA investigational new drug application. patient costs” includes all items/services that would be typically covered if not enrolled in “Routine 42 USC but not: (1) the investigational item, device, or service, (2) items solely for data collection or § analysis needs, and (3) service clearly inconsistent with widely accepted standards of care. If an in-network provider is participating in a clinical trial, the issuer may require participation in the 42 USC § through the participating provider if the provider will accept the individual as a participant. ; ; Resources:
coverage. Plan must receive written certification by a treating physician that states the child is suffering from a serious illness or injury and the leave of absence is medically necessary. Coverage for individuals participating in approved clinical trials 42 USC § 42 USC § 42 USC § 300gg-8(b) 42 USC § 42 USC § If the plan provides coverage to “qualified individuals”: Cannot deny participation in an “approved clinical trial” for treatment of cancer or another disease or condition; Cannot deny, limit, or impose additional conditions on the coverage of routine patient costs for items and services furnished in connection with participation in the trial; Cannot discriminate on the basis of participation in the trial. This includes an enrollee participating in an approved clinical conducted outside the state in which the enrollee resides. “Qualified individual” means enrollee who is eligible to participate in the according to protocol, and either: (1) referring provider is a participating provider and has concluded that the would be appropriate for individual, or (2) individual provides medical or scientific information establishing that the would be appropriate. “Approved clinical trial” means a phase I, II, III, or IV clinical conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition, and it is either: (1) federally funded or approved, (2) conducted under FDA investigational new drug application, or (3) drug exempt from FDA investigational new drug application. “Routine patient costs” includes all items/services that would be typically covered if not enrolled in but not: (1) the investigational item, device, or service, (2) items solely for data collection or analysis needs, and (3) service clearly inconsistent with widely accepted standards of care. If an in-network provider is participating in a clinical trial, the issuer may require participation in the through the participating provider if the provider will accept the individual as a participant. Resources: ; ;
checklist-forms-disability-large-group.docx