Medical Policy

THESE CRITERIA ARE USED IN THE DEVELOPMENT AND UPDATING OF MEDICAL POLICIES. AS THESE CRITERIA MAY NOT BE THE CRITERIA USED IN THE DEFINITION OF INVESTIGATIONAL WITHIN THE COVERED INDIVIDUAL'S PLAN DOCUMENT, THE DEFINITION IN THE COVERED INDIVIDUAL’S PLAN DOCUMENT IS TO BE USED FOR BENEFIT DETERMINATIONS. (SEE COVERED INDIVIDUAL’S BENEFIT PLAN FOR SPECIFIC CONTRACT LANGUAGE).

Note: For a high-level overview of this document, please see “Summary for Members and Families” below. 

"Investigational" means that the procedure, treatment, supply, device, equipment, facility or drug (all services) does not meet the Company Technology Evaluation Criteria because it does not meet one or more of the following criteria:

• have final approval from the appropriate government regulatory body; or
• have the credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community which permits reasonable conclusions concerning the effect of the procedure, treatment, supply, device, equipment, facility or drug (all services) on health outcomes; or
• be proven materially to improve the net health outcome; or
• be as beneficial as any established alternative; or
• show improvement outside the investigational settings.

In addition to the above criteria, the Medical Policy & Technology Assessment Committee (MPTAC) will consider recommendations of national physician specialty societies, nationally recognized professional healthcare organizations and public health agencies, and in its sole discretion, may consider other relevant factors, including information from the practicing community.

This document explains how “investigational” health services are defined. A service may include a procedure, treatment, supply, device, equipment, facility, or drug. A service is called investigational if it does not meet specific standards, such as government approval, scientific evidence, and whether the service improves health outcomes compared to other options.

Why Investigational services are not clinically appropriate

A service is not clinically appropriate if it is considered investigational. This means it does not meet one or more of the required standards listed above in the Definitions section. For example, it may lack final government approval, or there may not be enough published research to show that it improves health outcomes.

When services have not been proven to improve health, better studies are needed to know if the service improves health, or use of that service should be discontinued. Using services that are not proven to help can lead to care, including use of a treatment that does not help, or results in harm. For this reason, investigational services are not considered clinically appropriate.

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“Investigational” Criteria
Investigational

Applicable to Commercial HMO members in California: When a medical policy states a procedure or treatment is investigational, PMGs should not approve or deny the request. Instead, please fax the request to Anthem Blue Cross Grievance and Appeals at fax # 818-234-2767 or 818-234-3824. For questions, call G&A at 1-800-365-0609 and ask to speak with the Investigational Review Nurse.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

© CPT Only – American Medical Association