Experimental and Investigational Procedures
Experimental and investigational procedures are any medications, treatments or devices which are still part of an ongoing clinical trial. You may find yourself in a position where the standard treatment or therapy has been unable to help you. Either you or your physician may stumble upon something that is still in the investigational/experimental phase of development and ask your insurance carrier cover the cost.
Most insurance policies exclude coverage of anything considered to be experimental and investigational, however under certain circumstances they may make an exception. If you have been approved to participate in a clinical trial by the organization running the trial, that organization will submit a request to your insurance carrier.
Your insurance carrier will review the request for the experimental and investigational procedure to insure the trial meets regulatory guidelines, and also that you meet the criteria to participate in the trial. If you have failed all other standard approved forms of treatment and you meet the criteria for the study, your insurance carrier may approve your request.
You may have seen advertisements searching for participants for clinical trials. The ads may say "insurance is not necessary." If this is true, then why do such organizations contact your insurance carrier?
While the organization running the study may cover the cost of the experimental medication or device, it may not cover the cost of blood work, x-rays or other diagnostic tests/procedures required to insure your safety during the study. Your insurance carrier will be asked to cover these costs and the costs will be applied to your lifetime maximum.
Here’s an example:
You have completed treatment for cancer. Unfortunately, the cancer has not responded to any of the current therapies. Your physician has informed you of a clinical trial being conducted and feels you would be an excellent candidate to participate in the trial. He/she forwards your information to the pharmaceutical company performing the study.
After careful review, the pharmaceutical company agrees that you meet their subject requirements. They will cover the cost of the experimental medication but will need you to have period scans, x-rays and blood work for your safety.
The pharmaceutical company submits the request to your insurance carrier, accompanied by the specifics of the study and confirmation that the study has met all regulatory requirements.
Specialists within your insurance carrier will review your request. If it is approved, charges received by your carrier will be applied against your lifetime maximum.
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