CurrentExcellus Health Plan IncPolicy 11.01.03

Experimental or Investigational Services

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This policy determines whether services, devices, delivery systems, drugs, biological products, and procedures are experimental or investigational for a requested indication. Such services are excluded from coverage unless coverage is required by state or federal law.

Policy Summary

PayerExcellus Health Plan Inc

PolicyExperimental or Investigational Services

Policy CodePolicy 11.01.03

Change TypeAdministrative and clarifying revisionno material change

Effective DateAugust 7, 2026

Next Review DateMarch 1, 2027

Key ActionFor Medicare products, refer to the procedure- or technology-specific Medicare policy when determining whether a service is experimental or investigational.

SourceLink

POLICY UPDATE CHANGES

The policy statements were revised for clarity during the March 19, 2026 annual review without changing policy intent.

Policy guidelines were moved to policy statements on February 20, 2025 without changing policy intent.

6Evidence-based criteria for experimental or investigational determinations

3Related Excellus policies

1New York statutory exception described

FDA

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CurrentExcellus Health Plan IncPolicy 11.01.03

Experimental or Investigational Services

Customize your policy alerts

Sign up for excellus_health_plan_inc Policy 11.01.03 alerts

Get alerted when Policy 11.01.03 changes without checking for updates manually.

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Policy Summary

PayerExcellus Health Plan Inc

PolicyExperimental or Investigational Services

Policy CodePolicy 11.01.03

Change TypeAdministrative and clarifying revisionno material change

Effective DateAugust 7, 2026

Next Review DateMarch 1, 2027

Key ActionFor Medicare products, refer to the procedure- or technology-specific Medicare policy when determining whether a service is experimental or investigational.

SourceLink

POLICY UPDATE CHANGES

The policy statements were revised for clarity during the March 19, 2026 annual review without changing policy intent.

Policy guidelines were moved to policy statements on February 20, 2025 without changing policy intent.

6Evidence-based criteria for experimental or investigational determinations

3Related Excellus policies

1New York statutory exception described

FDA

Experimental or Investigational Determination

A service, device, delivery system, drug, or biological product is experimental or investigational when there is insufficient peer-reviewed scientific evidence to support all of the following for the requested indication:

All of the following criteria must be supported

Standard medical care: It is recognized by the Health Plan, in accordance with its standard policies and procedures, as standard medical care.
Governmental approval: It has final approval by applicable governmental agencies, such as the U.S. Food and Drug Administration.
Safety and effectiveness: Its safety and effectiveness have been proven.
Net health outcome: It improves the net health outcome.
Non-investigational setting: The health outcome improvements can be achieved outside the clinical investigational setting.
Established alternatives: It is at least as beneficial as any established service or technology alternatives.

Experimental or investigational procedures and services are excluded from coverage under Health Plan contracts unless coverage is mandated by state or federal law.

Coverage is product dependent. If the member’s product does not cover a specific service, medical policy criteria do not apply. When the applicable product does cover the service, medical policy criteria apply subject to product-specific requirements and any controlling Medicaid or Medicare coverage guidance.

Applicable Coding Information

CPT CodesCPT

No codes listed

HCPCS CodesHCPCS

No codes listed

ICD10 CodesICD-10

No codes listed

Provider Coverage Guidance

Denial Risk

Experimental or Investigational Services May Be Excluded

Coverage may be denied when the Health Plan determines that a requested service, device, delivery system, drug, biological product, or procedure is experimental or investigational. These services are excluded under Health Plan contracts unless coverage is mandated by state or federal law.

For the requested indication, insufficient peer-reviewed scientific evidence may support an experimental/investigational determination when the item is not recognized as standard medical care.
The item does not have final approval from applicable governmental agencies, such as the U.S. Food and Drug Administration.
Safety and effectiveness have not been proven.
The item does not improve the net health outcome.
Health outcome improvements cannot be achieved outside the clinical investigational setting.
The item is not at least as beneficial as established service or technology alternatives.

Note

Policy Scope and Application

This policy applies broadly to treatments, procedures—including organ transplantation—drugs, biological products, medical devices, delivery systems, and other services. It addresses whether these items are experimental or investigational for the requested indication.

Key Terms and Abbreviations

Experimental or Investigational Services

DefinitionTreatments, procedures (including organ transplantation), drugs, biological products, or medical devices that, in the judgment of the Health Plan, are experimental or investigational in nature.

Experimental or Investigational Determination

DeterminationA service, device, delivery system, drug, or biological product is considered experimental or investigational when there is insufficient peer-reviewed scientific evidence to support all required criteria for the requested indication.

Abbreviation

E/IExperimental/Investigational

Billing Rule

Product Benefit Controls Coverage

Coverage is contract- and product-dependent. If the applicable product does not cover the service, medical policy criteria do not apply; when the product does cover the service, the applicable medical policy criteria apply to that benefit.

Commercial products, including Essential Plan and Child Health Plus products: if the product covers the service, medical policy criteria apply.
Medicaid products: if the product covers the service and no New York State Medicaid (eMedNY) criteria exist, medical policy criteria apply.
Medicare products, including Medicare HMO-Dual Special Needs Program (DSNP) products: if the product covers the service and no national or local Medicare coverage decision exists, medical policy criteria apply.
If a Medicare HMO-Dual Special Needs Program (DSNP) product does not cover the service, refer to the Medicaid Product coverage line.
Codes may not be covered under all circumstances.