Clinical Trials Support Program

Reimbursement Policy:
Clinical Trials Support Program

Effective Date:
September 24, 2018

Purpose:
To more clearly define the parameters of Horizon BCBSNJ’s Clinical Trials Support Programs (CTSP), including outlining how trials are selected, how the reimbursement of services under the CTSP are determined, and what specific services are eligible for reimbursement.

Scope:
All products are included, except

• Products where Horizon BCBSNJ is secondary to Medicare (e.g. Medigap).
• COB

All Insured plans/products are included in the scope of this policy. Administrative Services Only (ASO) accounts can opt-in.

Policy:
In recognition of medical technology’s evolving knowledge-base and to promote the further accumulation of scientific evidence through well-designed clinical trials, Horizon BCBSNJ has developed the Clinical Trials Support Program (CTSP). A Horizon member’s medical circumstances and treatment, which may be outside of current medical policy and the medical necessity criteria included therein, may be eligible for coverage under the CTSP program, if all of the requirements listed below are satisfied:

1. The provider must be located in the New Jersey geographic area.
2. Cancer-related treatments are performed at an NCI-designated Comprehensive Cancer Center.
3. Horizon members must be afforded a consultation with a participating physician in the corresponding specialty; that physician reviews all treatment alternatives with the member and offers treatment with alternate techniques that make up the accepted standard of care in the community.
4. Any facility’s clinical trial study program being considered for participation by the member must comply with the following research requirements:

1. The primary purpose of the study is to investigate the comparative effectiveness of the new treatment versus current standard techniques that do not employ the new treatment. (Registry studies will not answer questions regarding appropriateness/advantages/benefits of new treatments in comparison with community standard accepted techniques).
2. The study is registered with the appropriate national organization (e.g., clinicaltrials.gov) in order to ensure transparency of enrollment criteria and outcomes.
3. The study is led by a nationally-recognized academic center or a government institution, such as the NCI, with the knowledge and experience to execute the study.
4. The study operates in compliance with federal regulations relating to the protection of human subjects. The study occurs within a setting in which there is a pre-specified process for gathering additional data, and in which that process provides additional protections and safety measures for an individual study participant and has been approved by the facility’s institutional review board (IRB).

Procedure:
Horizon BCBSNJ shall only consider treatment outside of current medical policy criteria under a CTSP program if all of the requirements listed above have been satisfied. Specific CTSP program details may be found on Horizon BCBSNJ’s website.

Horizon BCBSNJ shall have absolute discretion is determining whether any specific clinical trial study program will be approved for inclusion under the CTSP and the parameters of coverage that Horizon BCBSNJ affords any study participants in any trials approved for inclusion within the CTSP. Coverage afforded an approved program under the CTSP may include not only the “routine patient costs” as defined under the ACA mandate, but also the cost of the treatment or investigational item involved in the clinical trial. Further, Horizon BCBSNJ’s coverage may be withdrawn at any time for any clinical trial study program’s material failure to comply with any of Horizon BCBSNJ's requests for this information or upon Horizon BCBSNJ's evaluation and finding that demonstration of treatment effectiveness is absent or inadequate to support continued coverage.

All other coverage is subject to the terms and conditions of the members Benefit Plan.

Limitations and Exclusions:
While reimbursement is considered, payment determination is subject to, but not limited to:

• Group or Individual benefit
• Provider Participation Agreement
• Routine claim editing logic, including but not limited to incidental or mutually exclusive logic, and medical necessity
• Mandated or legislative required criteria will always supersede.

History:
09/24/2018: Policy approved

Policy121_v1_09242018