Original Medicare Coverage for Qualified Clinical Trials

Original Medicare provides coverage for routine costs of qualifying clinical trials, as well as reasonable and necessary items and services to diagnose and treat complications arising from participating in all qualifying clinical trials. Medicare's clinical trial National Coverage Determination (NCD) defines routine costs and also clarifies when items and services are reasonable and necessary. Costs directly related to the experimental portion of the clinical trial are the responsibility of the institution conducting the research. If a Health Net Medicare Advantage (MA) member joins a clinical trial, the member is responsible for any coinsurance under Original Medicare.

Health Net pays the MA member the difference between Original Medicare cost-sharing incurred for qualified clinical trials and services and Health Net's in-network cost-sharing for the same category of items and services. This cost-sharing reduction applies to all qualified clinical trials.

To be eligible for reimbursement, the MA member (or provider acting on behalf of the member) must notify Health Net that they have received qualified clinical trial services and provide documentation of the cost-sharing incurred, such as the Medicare Summary Notice (MSN). If necessary, Health Net may seek the MA member's Original Medicare cost-sharing information directly from the clinical trial provider.

Health Net does not require prior authorization for a qualified clinical trial; however, Health Net should be notified prior to when a MA enrollee is participating in a clinical trial.

Clinical trial providers are not required to be Health Net MA participating providers. MA members continue to receive care for MA-covered services unrelated to clinical trials through their Health Net MA plan.

For specific information related to coverage for clinical trials, refer to Coverage of Clinical Trials on the Centers for Medicare and Medicaid Services' (CMS').

Investigational Device Exception (IDE)

CMS determines Medicare device coverage based on Food and Drug Administration (FDA) category. FDA-designated Category A investigational device exception (IDE) (IDEs that are experimental/investigational) studies are not covered by Medicare unless they are part of a qualifying clinical trial as described in the preceding section. Category B IDE (non-experimental/investigational) studies may be covered through local determinations made by the Medical Advisory Council (MAC). Health Net is responsible for payment of claims related to Category B IDE studies covered by the local MAC with jurisdiction over the MA plan's service area.