Section 20-77-143 - Products and label expansions approved by the United States Food and Drug Administration(a) The General Assembly finds that: (1) The Arkansas Medicaid Program has historically delayed or denied access to new products and label expansions approved by the United States Food and Drug Administration during the time period after the products or label expansions have been approved by the United States Food and Drug Administration but before the Arkansas Medicaid Drug Utilization Review Board has conducted a formal clinical review;(2) This practice: (A) Unnecessarily delays patient access to innovative products which can be particularly harmful for citizens of Arkansas who are living with life-shortening or life-threatening conditions; and(B) May result in irreversible harm to the health of citizens of Arkansas;(3) Other state Medicaid programs provide immediate access to new products and label expansions approved by the United States Food and Drug Administration prior to a formal clinical review; and(4) It is in the best interest of the citizens of this state to provide immediate access to new products and label expansions approved by the United States Food and Drug Administration prior to a formal clinical review.(b) Consistent with federal laws and regulations, the Arkansas Medicaid Program shall: (1) Provide immediate access to and reimbursement for new products and label expansions approved by the United States Food and Drug Administration, or outpatient drugs with a federal rebate agreement in place, if the product is prescribed according to approved indications or medically accepted indications; and(2) Not deny or delay coverage or reimbursement for new products and label expansions for an existing covered product approved by the United States Food and Drug Administration for an existing covered product, including denying or delaying access to a product solely because the Arkansas Medicaid Drug Utilization Review Board or any other advisory body has not conducted a formal clinical review of the product or label expansion.(c)(1) The Department of Human Services shall appoint two (2) individuals to the Arkansas Medicaid Drug Utilization Review Board.(2) The individuals appointed under subdivision (c)(1) of this section shall be: (A) Either physicians or advanced practice registered nurses;(B) Licensed and practicing in this state; and(C) Currently treating rare diseases or conditions.(3) The department shall amend any rules or bylaws of the Arkansas Medicaid Drug Utilization Review Board to implement this section.Added by Act 2021, No. 745,§ 1, eff. 7/28/2021.