Approved Clinical Trial
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Health Net covers routine patient care costs for members participating in an approved clinical trial including items and services furnished in connection with participation by members in a qualifying clinical trial. An approved clinical trial is a phase I, phase II, phase III, or phase IV clinical trial conducted in relation to the prevention, detection or treatment of cancer or another life-threatening disease or condition that meets at least one of the following:
- The study or investigation is approved or funded, which may include funding through in-kind donations, by one or more of the following:
- The National Institutes of Health.
- The federal Centers for Disease Control and Prevention.
- The Agency for Healthcare Research and Quality.
- A cooperative group or center of the National Institutes of Health, the federal Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, the federal Centers for Medicare and Medicaid Services, the Department of Defense, or the United States Department of Veterans Affairs.
- A qualified nongovernmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.
- One of the following departments, if the study or investigation has been reviewed and approved through a system of peer review that the Secretary of the United States Department of Health and Human Services determines is comparable to the system of peer review used by the National Institutes of Health and ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review:
- The United States Department of Veterans Affairs.
- The United States Department of Defense.
- The United States Department of Energy.
- The study or investigation is conducted under an investigational new drug application reviewed by the United States Food and Drug Administration.
- The study or investigation is a drug trial that is exempt from an investigational new drug application reviewed by the United States Food and Drug Administration.
Routine patient care costs are costs associated with the provision of health care services, including drugs, items, devices, and services that would otherwise be covered under the Medi-Cal program if those drugs, items, devices, and services were not provided in connection with an approved clinical trial program.
Coverage of routine patient care costs is to be provided regardless of geographic location or if the treating provider or principal investigator of the qualifying clinical trial is a network provider. Coverage of routine patient care costs must be based on provider’s and principal investigator’s approval regarding the member’s appropriateness for the qualifying clinical trial.
Authorizations for items and services furnished in connection with participation by members in a qualifying clinical trial are expedited and completed within 72 hours.
Health Net requires the submission of the “Medicaid Attestation Form on the Appropriateness of the Qualifying Clinical Trial” for approval of the clinical trial. The attestation form must include the following information:
- The member’s name and client identification number;
- The national clinical trial number;
- A statement signed by the principal investigator attesting to the appropriateness of the qualified clinical trial; and
- A statement signed by the provider attesting to the appropriateness of the qualified clinical trial.