Part 2 – Explanation of Terms (continued) WORDS IN ITALICS ARE EXPLAINED IN PART 2. Page 18 Medical Policy To receive your health plan coverage, your health care services and supplies must meet the criteria for coverage that are defined in each Blue Cross Blue Shield HMO Blue medical policy that applies. Each health care service or supply must also meet the Blue Cross Blue Shield HMO Blue medical technology assessment criteria. (See below.) The policies and criteria that will apply are those that are in effect at the time you receive the health care service or supply. These policies are based upon Blue Cross Blue Shield HMO Blue’s assessment of the quality of the scientific and clinical evidence that is published in peer reviewed journals. Blue Cross Blue Shield HMO Blue may also consider other clinical sources that are generally accepted and credible. (These sources may include specialty society guidelines, textbooks, and expert opinion.) These medical policies explain Blue Cross Blue Shield HMO Blue’s criteria for when a health care service or supply is medically necessary, or is not medically necessary, or is investigational. These policies form the basis of coverage decisions. A policy may not exist for each health care service or supply. If this is the case for a certain health care service or supply, Blue Cross Blue Shield HMO Blue may apply its medical technology assessment criteria and its medical necessity criteria to determine if the health care service or supply is medically necessary or if it is not medically necessary or if it is investigational. To check for a Blue Cross Blue Shield HMO Blue medical policy, you can go online and log on to the Blue Cross Blue Shield HMO Blue Web site at www.bluecrossma.org. (Your health care provider can also access a policy by using the Blue Cross Blue Shield HMO Blue provider Web site.) Or, you can call the Blue Cross Blue Shield HMO Blue customer service office. You can ask them to mail a copy to you. Medical Technology Assessment Criteria To receive your health plan coverage, all of your health care services and supplies must conform to Blue Cross Blue Shield HMO Blue medical technology assessment criteria. These criteria assess whether a technology improves health outcomes such as length of life or ability to function when performing everyday tasks. The medical technology assessment criteria that apply are those that are in effect at the time you receive a health care service or supply. These criteria are:  The technology must have final approval from the appropriate government regulatory bodies. This criterion applies to drugs, biological products, devices (such as durable medical equipment), and diagnostic services. A drug, biological product, or device must have final approval from the U.S. Food and Drug Administration (FDA). Any approval granted as an interim step in the FDA regulatory process is not sufficient. (The FDA Humanitarian Device Exemption is one example of an interim step.) Except as required by law, Blue Cross Blue Shield HMO Blue may limit coverage for drugs, biological products, and devices to those specific indications, conditions, and methods of use approved by the FDA.  The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. The evidence should consist of well-designed and well-conducted investigations published in peer-reviewed English-language journals. The qualities of the body of studies and the consistency of the results are considered in evaluating the evidence. The evidence should demonstrate that the technology can measurably alter the physiological changes related to a disease, injury, illness, or condition. In addition, there should be evidence or a convincing argument based on established medical facts that the measured alterations affect health outcomes. Opinions and evaluations by national medical associations, consensus panels, and other technology evaluation bodies are evaluated according to the scientific quality of the supporting evidence upon which they are based.  The technology must improve the net health outcome. The technology’s beneficial effects on health outcomes should outweigh any harmful effects on health outcomes.  The technology must be as beneficial as any established alternatives. The technology should improve the net outcome as much as or more than established alternatives. The technology must be as cost effective as any established alternative that achieves a similar health outcome.