Section 16.03.09.443 - INVESTIGATIONAL PROCEDURES OR TREATMENTS: PROCEDURAL REQUIREMENTSThe Department may consider Medicaid coverage for investigational procedures or treatments on a case-by-case basis for life-threatening medical illnesses when no other treatment options are available. For these cases, a focused case review is completed by a professional medical review organization to determine if an investigational procedure would be beneficial to the participant. The Department will perform a cost-benefit analysis on the procedure or treatment in question. The Department will determine coverage based on this review and analysis.
01.Focused Case Review. A focused case review consists of assessment of the following: a. Health benefit to the participant of the proposed procedure or treatment;b. Risk to the participant associated with the proposed procedure or treatment;c. Result of standard treatment for the participant's condition, including alternative treatments other than the requested procedure or treatment;d. Specific inclusion or exclusion by Medicare national coverage guidelines of the proposed procedure or treatment;e. Phase of the clinical trial of the proposed procedure or treatment;f. Guidance regarding the proposed procedure or treatment by national organizations;g. Clinical data and peer-reviewed literature pertaining to the proposed procedure or treatment; andh. Ethics Committee review, if appropriate.02.Additional Clinical Information. For cases in which the Department determines that there is insufficient information from the focused case review to render a coverage decision, the Department may, at its discretion, seek an independent professional opinion.03.Cost-Benefit Analysis. The Department will perform a cost-benefit analysis that will include at least the following:a. Estimated costs of the procedure or treatment in question.b. Estimated long-term medical costs if this procedure or treatment is allowed.c. Estimated long-term medical costs if this procedure is not allowed.d. Potential long-term impacts approval of this procedure or treatment may have on the Medical Assistance Program.04.Coverage Determination. The Department will make a decision about coverage of the investigational procedure or treatment after consideration of the focused case review, cost-benefit analysis, and any additional information received during the review process.Idaho Admin. Code r. 16.03.09.443