Health plans or delegated participating physician groups (PPGs) must cover all medically necessary routine patient care costs related to a clinical trial for a member diagnosed with cancer whose physician has recommended participation in the clinical trial, and who has been accepted for participation in a nationally recognized phase I, II, III, or IV clinical trial for cancer. Routine patient care costs refers the costs associated with the provision of health care services, including drugs, items, devices, and services that would otherwise be covered under the plan or contract if those drugs, items, devices, and services were not provided in connection with an approved clinical trial program.

The California Department of Health Care Services (DHCS) has not contracted with Health Net to provide managed health care services or treatment for a member with a California Children's Services (CCS)-eligible condition; such coverage is carved out from Health Net coverage responsibilities and must be authorized by and provided through the CCS Program. Medi-Cal members under age 21 are eligible for participation in cancer clinical trials when authorized by the CCS program. Members under age 21 who are candidates for cancer clinical trials can be referred to the county CCS office for authorization to participate in the cancer clinical trial. Health Net's care managers assist primary care physicians (PCPs) , specialists and members in ensuring timely referral to the CCS program.

CCS coverage is dependent on the timeliness of referral to CCS. Refer to the CCS Program Description for information on participating provider responsibilities for referring potential eligible members to CCS and for identifying CCS-eligible conditions.

The Health Net prior authorization letter for a cancer clinical trial identifies items and services, which are considered part of the cancer clinical trial to the extent they are known at the time of the initial review. These items and services are covered by the study entity.

Services rendered as part of a cancer clinical trial may be provided by a Health Net-participating providers or by a non-participating provider when the protocol for the trial is not available through a participating provider. The provider's recommendation for participation must be based on a determination that participation in the clinical trial has a "meaningful potential to benefit the member." Members participating in cancer clinical trials must continue to obtain primary and specialty health care services from or through their PCPs. Authorization requirements that would apply to services were they are not performed in relation to a clinical trial continue to apply to routine services provided in relation to a clinical trial. PPGs and PCPs should authorize the services of, and refer members to, in-network providers whenever it is medically appropriate.

Refer to definition of clinical trials for more information.

Coverage for cancer clinical trials does not include health care services that would not normally be covered and are provided only as a result of a member's participation in the clinical trial. Coverage for clinical trials does not include:

When a referral to a non-participating provider is necessary because a cancer clinical trial is not available through a participating provider, Health Net or the PPG may condition the referral to the non-participating provider on its acceptance of a negotiated rate that Health Net or the PPG would otherwise pay to a participating provider for the same services, less any applicable copayments and deductibles or for the clinical trial to work with the PPG to have the routine services done within the network.

The following information applies only to participating physician groups (PPGs) and physicians.

Participating physician groups (PPGs) or directly contracting physicians should use the following process when requesting that Health Net provide prior authorization for a Health Net member to participate in a cancer clinical trial:

All prior authorization requests for cancer clinical trials are considered urgent prior authorization requests, unless otherwise noted.

When Health Net receives a direct communication from a provider requesting authorization to allow a member to participate in a cancer clinical trial, Health Net alerts the PPG of such a request in order to better ensure that the member is appropriately case managed.

A member in a group health plan who meets the following criteria is considered a qualified individual for a clinical trial:

For information n Medi-Cal members under 21 years of age, refer to Coverage Explanation - Cancer Clinical Trial in this section.