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How are Medical and Behavioral Health Policies developed?
Medical and behavioral health policies are developed by the Blue Cross Blue Shield of Minnesota (BCBSM) Medical and Behavioral Health Policy Committee which is comprised of 14 voting members who are practicing physicians and providers representing a variety of specialties in the local community and one voting member who is a BCBSM care management representative. An ethicist and employer benefits manager from the community serve as consultants in a non-voting capacity.
The Medical and Behavioral Health Policy Committee reviews technologies and services according to the following technology assessment criteria which have been established by the national Blue Cross Blue Shield Association and endorsed by BCBSM:
1. The technology must have final approval from the appropriate government regulatory bodies.
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
3. The technology must improve the net health outcome.
4. The technology must be as beneficial as any established alternatives.
5. The improvement must be attainable outside the investigational settings.
The Committee considers each of these criteria when evaluating new technologies or services for coverage by BCBSM. A number of factors are considered when evaluating each of the criteria including, but not limited to: quality of the available peer-reviewed medical literature; safety, effectiveness, and appropriateness of the technology; Blue Cross Blue Shield Association recommendations; and relevant impact and consequences of coverage for the technology (e.g., patient, provider, BCBSM, ethical, societal, legal). Based on this evaluation, the Committee determines the policy position for each technology being considered.
Investigative technologies
If BCBSM determines a technology to be investigative, the following definition of Investigative applies:
A drug, device, diagnostic procedure, technology, or medical treatment or procedure is investigative if reliable evidence* does not permit conclusions concerning its safety, effectiveness, or effect on health outcomes. We base our decision upon and examination of the following reliable evidence, none of which is determinative in and of itself:
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The drug or device cannot be lawfully marked without 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;
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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
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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.
*Reliable evidence shall mean consensus opinions and recommendations reported in the relevant medical and scientific literature, peer-reviewed journals, reports of clinical trial committees, or technology assessment bodies, and professional expert consensus opinions of local and national health care providers.