Medical Policy

Effective Date:08/16/2013 Title:Review of Experimental Surgical Devices
Revision Date:10/01/2020 Document:BI426:00
CPT Code(s):None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

QualChoice permits a surgeon, before utilizing a specific surgical product or medical device that QualChoice deems experimental or investigational, to obtain a review for coverage of the product or device.

EOC Statement:


See “Experimental or Investigational Procedures” in the Exclusions section.

Medical Statement

1)    Some products or devices approved for marketing by the United States Food and Drug Administration are considered by QualChoice to be experimental and/or investigational.

2)    A surgeon desiring to use a specific surgical product or medical device in a specific member may request a review for coverage before utilizing the device or product. 

a)    To be considered, the surgeon must present medical evidence that would support such use in the individual member.

b)    QualChoice retains the final decision as to whether the product or device will be covered. For details, please refer to BI024 Medical Necessity Determinations.

c)    Review may be obtained by following the process for pre-authorization as detailed in the provider manual.

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Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.