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).

"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.

“Investigational” Criteria
Investigational

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

The requirements below are specific to the Florida Medicaid Managed Care Plan and are not a part of the Medical Policy or Clinical UM guideline approved by Elevance Health's Medical Policy and Technology Assessment Committee.
 
If the Florida Medicaid Managed Care Plan intends to deny coverage on the basis that a diagnostic test, therapeutic procedure, or medical device or technology is experimental or investigational, the Managed Care Plan shall submit a request for coverage determination to the Agency in accordance with rule 59G-1.035, F.A.C and Core SMMC Contract, Attachment II, Section VI.G.4.d.
 
Below is a list of the materials the plans are required to submit when they deny coverage as experimental/investigational: 

1. Include the CPT or HCPCS code(s)  
2. Include a list of other state Medicaid agencies and private insurers who cover the service  
3. Include information about the health service from the U.S. Food and Drug Administration  
4. Include known risks of the service and health outcomes of others who have received it  
5. Include a list of covered alternative services, if any, that could be used to treat the condition  
6. Identify a specific recipient needing the service  
7. Include the recipient’s health history  
8. Include the disease information necessitating the requested service  
9. Include a rationale for the immediacy of the review  

1. Submit the rationale used to preliminarily indicate the service is experimental/investigational
   1. Include peer-reviewed journal articles in PDF format with links to the online articles  
   2. Include evidence-based clinical guidelines reviewed by the plan  
2. Submit direct contact information (name, phone number, & email address) for the Medical Director