Medical Review

Experimental/Investigational Services

Introduction

Locally underwritten Blue Cross and Blue Shield of Kansas (BCBSKS) member contracts include a general exclusion for any drug, device or medical treatment or procedure and related services that are experimental or investigational. (The definition of experimental or investigational as defined in the member contract appears below - view definition.)

The BCBSKS provider contract prohibits the provider from billing a member for experimental or investigational services unless the provider issued a written notice in advance stating that a specific service was not covered and why.

Providers are responsible to know if services offered at their facility are experimental or investigational. While it is not the responsibility of BCBSKS to keep providers informed of medical protocols and approvals, we may become aware of information about services through communications with providers and other medical resources.

This notice includes a list of experimental or investigational services. The list:

• Is not all-inclusive.
• Includes information that's valid as of the update date.
• Is subject to change without notice.
• Does not relieve the provider of their responsibility to monitor medical protocols and approvals.
• Is intended only as a method to share information with providers.

Experimental/Investigational Defined

The following definition appears in the locally underwritten BCBSKS member contract.

Experimental or Investigational refers to the status of a drug, device, medical treatment or procedure:

• If the drug or device cannot be lawfully marketed without approval of the of the U.S. Food and Drug Administration and approval for marketing has not been given at the time the drug or device is furnished and the drug or device is not research-urgent as defined by the BCBSKS member contract; or

• If Credible Evidence shows that the drug, device, medical treatment or procedure is the subject of ongoing phase I, II or III clinical trials or under study to determine its maximum tolerated dose, its toxicity, its safety, its efficacy, or its efficacy as compared with the standard means of treatment or diagnosis and the trials are not research-urgent as defined by the BCBSKS member contract; or

• If Credible Evidence shows that the consensus among experts regarding the drug, device, medical treatment or procedure is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, its efficacy or its efficacy as compared with the standard means of treatment or diagnosis and the trials are not research-urgent as defined by the BCBSKS member contract; or

• If there is no credible evidence available that would support the use of the drug, device, medical treatment or procedure compared to the standard means of treatment or diagnosis.

Credible Evidence means only published reports and articles in the authoritative medical and scientific literature; the written protocol or protocols used by the treating eligible provider or the protocol of another eligible provider providing or studying substantially the same drug, device, medical treatment or procedure; or the written informed consent used by the treating eligible provider or by another eligible provider providing or studying substantially the same drug, device, medical treatment or procedure.
(updated 2/2005)

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