Medical Policy

D-1050-003

Policy Id

HHO-DE-MP-1050

Topic

Experimental/Investigational Services

Section

All Policies

Effective Date

Jun 16, 2025

Issued Date

May 16, 2025

Last Revision Date

05/2025

Annual Review

05/2026

Prepared By

J Fletcher

DISCLAIMER

Highmark medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions.

POLICY STATEMENT

This policy provides information regarding the coverage of, as determined by applicable federal and/or state legislation. 

This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records.

The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the Delaware Department of Health and Social Services (DHSS) and all applicable state and federal regulations. 

PROCEDURES

Services meeting ANY of the following criteria are considered experimental/investigational:

·         The intervention does not have FDA approval to be marketed for the specified indication(s); or

·         Available scientific evidence does not permit conclusions concerning the effect of the intervention on health outcomes; or

·         The intervention is not proven to be safe or effective in achieving an outcome equal to or exceeding the outcome of alternative therapies; or

·         The intervention does not improve health outcomes; or

·         The intervention is not proven to be applicable outside the research setting.