(1) The requirements and restrictions in these rules apply for purposes of coverage and reimbursement of home infusion therapy services under the Montana Medicaid program.

(2) Medicaid coverage and reimbursement of home infusion therapy services is available, subject to applicable requirements, for services provided to recipients that are residing in their own home, a nursing facility or any setting other than a hospital. Medicaid coverage and reimbursement of home infusion therapy services is not available to recipients who are receiving infusion therapy as a hospital inpatient or outpatient service.

(3) Except as otherwise provided by these rules, home infusion therapy services must be provided within the scope of practice permitted by applicable state law.

(4) For those services subject to prior authorization, the Montana Medicaid program will not cover or reimburse home infusion therapy services unless the department or its designated agent has approved a prior authorization request. The department will determine the specific home infusion therapy services that require prior authorization in consultation with the department's Drug Use Review Board established pursuant to 42 USCA 1396r-8(g). A list of the specific services subject to prior authorization will be provided upon request made to the Department of Public Health and Human Services, Health Resources Division, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951.

(5) The Montana Medicaid program will not cover or reimburse home infusion therapy services for the following:

(a) medications which can be appropriately administered orally, through intramuscular or subcutaneous injection, or through inhalation; and

(b) drug products that are not FDA approved or whose use in the nonhospital setting presents an unreasonable health risk to the patient.

(6) The department will determine the specific therapies that are not allowable as home infusion therapy services under (5)(a) or (b) in consultation with the department's Drug Use Review Board established pursuant to 42 USCA 1396r-8(g). A list of the specific therapies determined not allowable under this rule will be provided upon request made to the Department of Public Health and Human Services, Health Resources Division, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951.