Clinical Guideline

The services, products, drugs, and biologicals referenced in this Clinical Guideline are considered experimental or investigational and are therefore not covered by the Plan. This Clinical Guideline may not encompass all services, products, drugs, and biologicals; specific benefit plan documents (e.g., Evidence of Coverage, Schedule of Benefits) and federal or state mandated health benefits and laws supersede this Clinical Guideline. The member's benefit plan documents specify the services that are covered, excluded, or subject to limitations.

A service, product, drug, or biological is considered experimental or investigational when its safety and efficacy have not been established. These interventions may yield outcomes that are inferior to standard medical treatments with proven long-term clinical utility. To determine whether a service, device, treatment, or procedure has proven safety and efficacy, a thorough review of the available reliable evidence is conducted. This evidence may include, but is not limited to, the following sources (listed in order of decreasing reliability):

1. Published technology assessments and/or high-quality meta-analyses
2. Randomized, controlled trials (RCTs)
3. Other controlled studies, such as non-randomized controlled trials, and cohort studies
4. Case reports or case series1
5. Reports of expert opinion and consensus statements from professional organizations

Definitions

Experimental, Investigational, and Unproven Services

"Experimental, Investigational, and Unproven Services" include any drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply used in or directly related to the diagnosis, evaluation, or treatment of a disease, injury, illness, or other health condition for which one or more of the following criteria apply when the service is rendered with respect to the use for which benefits are sought:

• The drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply cannot be legally marketed in the United States without the final approval of the Food and Drug Administration ("FDA"), or other licensing or regulatory agency, and such final approval has not been granted;
• The FDA has determined the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply to be contraindicated for the specific use;
• The drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply is provided as part of a clinical research protocol or clinical trial or is provided in any other manner that is intended to evaluate the safety, toxicity, or efficacy of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply;
• The drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply is subject to review and approval of an Institutional Review Board ("IRB") or other body serving a similar function;
• The drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply is provided pursuant to informed consent documents that describe the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply as Experimental/Investigational, or otherwise indicate that the safety, toxicity, or efficacy of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply is under evaluation.

Off-Label Use

"Off-Label Use" refers to the use of an FDA-approved drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply for a purpose, condition, or patient population other than those for which it has received FDA approval. Off-label use may be considered experimental or investigational, depending on the available evidence supporting its safety and efficacy for the specific use in question.

Peer Review

"Peer Review" refers to the evaluation process in which experts in a relevant field critically assess the quality, validity, and reliability of a research study or publication. Peer review helps ensure that only scientifically sound and credible evidence is considered in the development of clinical policies and guidelines.2

Standard Medical Treatment

"Standard Medical Treatment" refers to any healthcare service, treatment, procedure, facility, equipment, drug, device, or supply that is in general use in the medical community in the United States, and:

• Has been demonstrated through reliable evidence in peer-reviewed medical literature to have scientifically established medical value for diagnosing, curing or alleviating the condition being treated; and
• Is appropriate for the hospital or other facility provider in which it is performed; and
• The performing physician or other professional provider has had the appropriate training and experience to provide the service, treatment or procedure.

Reliable Evidence

"Reliable Evidence" means reports and articles with scientifically valid data published in authoritative, peer-reviewed medical and scientific literature.

Reports, articles, or statements by providers or groups of providers that only contain abstracts, anecdotal evidence or personal professional opinions are not considered reliable evidence.

Coverage Exclusions

The following services are considered experimental, investigational, or unproven and are therefore NOT covered:

• Code 0002M: Insertion Date 10/11/2017 | Last Review Date 5/2/2023
• Code 0003M: Insertion Date 10/11/2017 | Last Review Date 5/2/2023
• Code 0004M: Insertion Date 10/11/2017 | Last Review Date 5/2/2023
• Code 0015M: Insertion Date 5/2/2023
• Code 0016M: Insertion Date 5/2/2023 | Last Review Date 5/2/2023

Note: Additional codes and dates follow the same format, but are not listed here for brevity.

Some services may have specific criteria or notes indicating the context in which they are considered non-covered.

Clinical Guideline Revision / History Information

Original Date: 4/11/2017
Reviewed/Revised: 10/11/2017, 1/18/2018, 4/15/2019, 5/5/2020, 7/21/2020, 04/21/2021, 12/01/2021, 04/25/2022, 05/2/2023