Experimental/Investigational Services
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Defines Highmark Pennsylvania's position that specified treatments, procedures, equipment, drugs, services or supplies determined to be experimental or investigational are typically non-covered for commercial members; describes application to professional and facility claims and billing/consent expectations for members.
No material clinical or coverage changes in this revision.
Coverage Criteria
Experimental/Investigational Determination
Charges for services are denied as experimental/investigational when ONE OR MORE of the following reasons apply:
Policies apply across professional and facility claims
Policies apply across professional and facility claims
Policies apply across professional and facility claims
Policies apply across professional and facility claims
Policies apply across professional and facility claims
This medical policy may not apply to the Federal Employee Program (FEP). Benefits for FEP members are determined by the Federal Employee Program and may differ from the coverage indicated in this policy.
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I) and are therefore non-covered. When a service is deemed E/I, a network provider may bill the member only after providing advance written notice, a cost estimate, and obtaining the member's written agreement to assume financial responsibility, with the signed agreement retained in the provider’s records.
Procedure and Billing Codes
| No codes listed |
Provider Actions and Billing Requirements
Pre-payment application (professional & facility claims)
This policy is applied on a pre-payment basis for both professional and facility claims; experimental/investigational services are considered non-covered.
Provider-impact summary (commercial lines; limited inpatient exceptions)
The policy position applies to all commercial lines of business; experimental/investigational services are typically non-covered and may only be eligible in limited inpatient circumstances.
Billing and member consent requirements for E/I services
If a network provider elects to bill a member for an experimental/investigational service, the provider must give advance written notice, provide a cost estimate, obtain the member’s written agreement to assume financial responsibility before the service, and retain the signed agreement in the provider’s records.
Denial triggers for E/I determination
Charges for services listed in this policy are denied as experimental/investigational when one or more of the listed conditions apply, including lack of FDA approval for the specific indication, insufficient scientific evidence of effect on health outcomes, not proven as safe/effective versus alternatives, failure to improve health outcomes, or applicability only in research settings.
- Denied when intervention lacks FDA approval for the relevant indication.
- Denied when available scientific evidence does not permit conclusions about effects on health outcomes.
- Denied when not proven as safe or effective compared with alternatives.
- Denied when the intervention does not improve health outcomes.
- Denied when the intervention is not proven applicable outside research settings.
Background
Experimental/Investigational services are interventions—such as a treatment, procedure, facility, equipment, drug, service or supply—that have been determined not to be medically effective for the condition being treated. Charges for services listed on this policy are denied as experimental/investigational when ONE OR MORE of the following apply: the intervention lacks FDA approval for the specific indication; available scientific evidence is insufficient to conclude an effect on health outcomes; the intervention is not proven as safe or effective compared with alternatives; the intervention does not improve health outcomes; or the intervention is applicable only in a research setting.
Definitions
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