1. The intervention does not have FDA approval to be marketed for the specific relevant indication(s); or
2. Available scientific evidence does not permit conclusions concerning the effect of the intervention on health outcomes; or
3. The intervention is not proven to be as safe or effective in achieving an outcome equal to or exceeding the outcome of alternative therapies; or
4. The intervention does not improve health outcomes; or
5. The intervention is not proven to be applicable outside the research setting.

These criteria apply even if there is no available alternative to treat an injury, ailment, condition, disease, disorder, or illness. This determination will be made by MSBCBS, in its sole discretion, and will be conclusive.

Services performed in connection with research or investigational/experimental procedures are excluded from payment. Therefore, when the same physician who is performing an experimental procedure or treatment requests payment for services that are considered to be incidental to the research or experimental/investigational procedure, such payment should be denied as noncovered. A participating, preferred, or network provider can bill the member for the denied experimenal/investigational item or service.

A service is considered investigational (experimental) if any of the following criteria are met:

1. The services or supplies requiring Federal or other Governmental body approval, such as drugs and devices, do not have unrestricted market approval from the Food and Drug Administration (FDA) for use in treatment of a specified condition. Any approval that is granted as an interim step in the regulatory process is not a substitute for unrestrictive market approval. The state of the FDA approval may be obtained by contacting the Project Manager, Medical Information Services at the BCBSA at 888-832-4321.
2. There is insufficient or inconclusive *evidence in peer-reviewed medical literature to permit the Plan to evaluate the therapeutic value of the service or supply.
3. There is insufficient or inconclusive *evidence in peer-reviewed medical literature that the service or supply has a beneficial effect on health outcomes.
4. The service or supply under consideration is not as beneficial as any established alternatives.
5. There is insufficient or inconclusive evidence that, when used in a non-investigational setting, the service or supply has a beneficial effect on health outcomes or is as beneficial as any established alternatives.

* Evidence as noted above is defined as at least two peer-reviewed documents of medical/scientific evidence that treatment is likely to be beneficial.

Opinions of experts in a particular field and opinions and assessments of nationally recognized review organizations may also be considered by the Plan but are not determinative nor conclusive. All services or procedures determined as or potentially considered Investigational (Experimental) would be referred to the Medical Director/Physician Advisor for review (Refer to Policy CM 02 – Medical Director/Physician Advisor Referral).

See Medical Policy Bulletin B-41 for information on coverage for medically and otherwise covered patient care costs associated with qualifying/approved clinical trials.

State or federal mandates may dictate that all FDA approved devices/procedures may not be considered investigational and thus coverage eligibility may be assessed only on the basis of medical necessity.