Clinical Trials
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Health Net covers routine patient care costs for members participating in a qualifying clinical trial including items and services furnished in connection with participation by members in a qualifying clinical trial. A qualifying clinical trial is a clinical trial in any clinical phase of development that is conducted in relation to the prevention, detection, or treatment of any serious or life-threatening disease or condition.
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.