Medical Policy Bulletin

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Title:

Experimental/Investigational Services

Policy #:

12.01.01f

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The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service. This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.

Intent

The intent of this policy is to communicate services that are considered experimental/investigational.

For information on policies related to this topic, refer to Attachment A in this policy.

Description

The following is a summary of the definition of the term experimental/investigational and experimental/investigative as found in various benefit contracts. For the purposes of this policy, both terms are referred to as experimental/investigational throughout this document. This summary is provided for illustrative purposes only. Please consult the applicable health benefit plan contract for the specific definition of experimental/investigational.

The terms experimental/investigational are used to describe services that address a drug, biological product, device, medical treatment, or procedure that is not recognized by the Company as standard medical care for a medically diagnosed condition, illness, disease, or injury.

A service is considered experimental/investigational if it meets any of the following criteria:

• Reliable evidence demonstrates that the inherent nature of the drug, biological product, device, medical treatment, or procedure necessitates further basic scientific research, laboratory-based clinical studies, clinical outcomes research, or clinical trials to determine the safety and efficacy of anticipated outcomes as compared with the standard means of treatment or diagnosis.
• There is insufficient or inconclusive medical and scientific evidence to permit the Company to evaluate the therapeutic value of the drug, biological product, device, medical treatment, or procedure.
• The drug, biological product, device, medical treatment, or procedure in question requiring clearance from a federal, governmental regulatory body, or other governmental agency (eg, US Food and Drug Administration [FDA]) has not obtained final and unrestricted market approval for use in the treatment of a specified condition. Approvals that are granted as an interim step in the regulatory process (eg, an Investigational Device Exemption [IDE] or an Investigational New Drug [IND] Exemption) are not a substitute for final or unrestricted market approval.
• There is inconclusive medical and scientific evidence in published peer-reviewed medical literature that the drug, biological product, device, medical treatment, or procedure has a beneficial effect on health outcomes. Evaluations and clinical recommendations are assessed according to the scientific quality of the supporting evidence and rationale (eg, national medical associations, independent panels, or technology assessment organizations).
• The drug, biological product, device, medical treatment, or procedure under consideration is not as beneficial as any established medical-based alternatives and has not been incorporated into standard medical practice.
• There is insufficient information or inconclusive scientific evidence that, when used in a non-investigational setting, the drug, biological product, device, medical treatment, or procedure has a beneficial effect on health outcomes or is as beneficial as any established alternative.

Policy

This policy addresses those specific services that are determined by the Company to be experimental/investigational based on the definition in the Company's benefit contracts. The services that are listed in Attachment A are considered experimental/investigational and, therefore, not covered because the safety and/or efficacy of these services cannot be established by review of the available published peer-reviewed literature.

The services listed in Attachment A are not all-inclusive. Additions and deletions will be made as changes occur or if the experimental/investigational status of a service changes. The services that are listed do not include services that have split coverage decisions based on criteria.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, services listed in Attachment A are not eligible for payment under the medical benefits of the Company’s products because the services are considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

MEDICARE

There is no comprehensive Medicare coverage policy addressing this service; therefore, the Company policy is applicable.

References

Company Benefit Contracts.

Coding Table

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply. The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates. In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

Code System	Code Number(s) and Narrative(s)
CPT	See Attachment A
ICD Procedure	N/A
ICD Diagnosis	N/A
HCPCS Level II	See Attachment A
Revenue Codes	N/A

Cross References

Version Effective Date: 07/01/2010