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How are Medical and Behavioral Health Policies developed?
Medical and behavioral health policies are developed by the Blue Cross and Blue Shield of Minnesota (Blue Cross) Medical and Behavioral Health Policy Committee which is comprised of practicing physicians and providers representing a variety of specialties in the local community and one Blue Cross representative.
Blue cross makes its determination of experimental, investigative, unproven based upon a preponderance of evidence after the examination of the following reliable evidence, none of which shall be determinative in and of itself:
1. Whether there is final approval from the appropriate government regulatory agency, if approval is required;
2. Whether there are consensus opinions and recommendations reported in relevant scientific and medical literature, peer-reviewed journals, or the reports of clinical trial committees and other assessment bodies; and
3. Whether there are consensus opinions of national and local health care providers in the applicable specialty or subspecialty that typically manages the condition as determined by a survey or poll of a representative sampling of these providers.
The Committee considers a number of additional factors when evaluating each of the criteria. These factors include, but are not limited to: Quality of the available peer-reviewed medical literature; safety, effectiveness, appropriateness of technology; Blue Cross and Blue Shield Association requirements and Medical Policies; and the relevant impact and consequences of coverage for the technology (for example, patient, Blue Cross, ethical, societal, legal).
If Blue Cross determines a technology to be investigative, the following definition of Investigative applies:
A drug, device, medical treatment, diagnostic procedure, technology, or procedure for which reliable evidence does not permit conclusions concerning its safety, effectiveness, or effect on health outcomes. Blue Cross bases its decision upon an examination of the following reliable evidence, none of which is determinative in and of itself.
Drugs and devices cannot be lawfully marketed without the approval 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;
The drug, device, diagnostic procedure, technology, or medical treatment or procedure is the subject of ongoing phase I, II, or III clinical trials:
Phase I clinical trials determine the safe dosages of medication for Phase II trials and define acute effects on normal tissue.
Phase II clinical trials determine clinical response in a defined patient setting. If significant activity is observed in any disease during Phase II, further clinical trials usually study a comparison of the experimental treatment with the standard treatment in Phase III trials. Phase III trials are typically quite large and require many patients to determine if a treatment improves outcomes in a large population of patients); or
Medically reasonable conclusions establishing its safety, effectiveness or effect on health outcomes have not been established. For purposes of this subparagraph, a drug, device, diagnostic procedure, technology, or medical treatment or procedure shall not be considered investigative if reliable evidence shows that it is safe and effective for the treatment of a particular patient.