(1) This rule provides the requirements for Medicaid coverage of organ and tissue transplantations. The requirements in this rule are in addition to those contained in ARM 37.85.401, 37.85.402, 37.85.406, 37.85.407, 37.85.410, 37.85.412, 37.85.413, 37.85.414, and 37.85.415.

(2) General requirements for Medicaid coverage of transplantations are as follows:

(a) Medicaid will only cover medically necessary organ or tissue transplants.

(i) Services must comply with Medicare coverage guidelines for organ or tissue transplant service.

(ii) If Medicare coverage guidelines are not available, the department or the department's designated review organization will review the requested transplant surgery to determine whether the surgery is medically necessary and is not experimental or investigational.

(b) All cases presented for organ or tissue transplantation require prior authorization from the department's designated review organization, with the exception of corneal transplantation.

(c) Organ transplants must be performed in a Medicare certified center. If Medicare has not designated a certified center, the transplant must be performed by a program that is located in a hospital or parts of a hospital certified by the Organ Procurement and Transplantation Network (OPTN) for the specific organ being transplanted.

(3) Services considered experimental and/or investigational are not a benefit of the Montana Medicaid Program.

(a) Experimental and/or investigational services include:

(i) Procedures and items including prescription drugs, considered experimental and/or investigational by the U.S. Department of Health and Human Services or any other appropriate federal agency.

(ii) Procedures and items, including prescribed drugs, provided as part of a control study, approved by the Department of Health and Human Services or any other appropriate federal agency to demonstrate whether the item, prescribed drug, or procedure is safe and effective in caring, preventing, correcting, or alleviating the effects of certain medical conditions.

(iii) Procedures and items, including prescribed drugs, which may be subject to question, but are not covered in (3)(a)(i) and (ii), will be evaluated by the department or the department's designated medical review organization to determine whether they are experimental and/or investigational.