A. The provider shall obtain preauthorization from the Department or its designee for any prescription for:
(1) Antibiotic liquids requiring reconstitution for amounts exceeding a 14-day supply;
(2) Nonmaintenance drugs for more than a 34 day supply;
(3) A usual and customary charge exceeding $2,500;
(4) Female hormones for biologic males when used for treating sexual aggression;
(5) Enteral nutritional products and vitamin and mineral products when given by nasogastric, jejunostomy, or gastrostomy tube in the home;
(6) Drugs rejected by the point-of-sale system because of edits established by the Program to ensure appropriate utilization of medication before the prescription is dispensed, if the Department does not allow provider level overrides;
(7) Where a prescriber has filed an official report of an adverse event or product problem with the Program or the United States Food and Drug Administration regarding a generic drug, the brand name drug used as an alternative to that generic drug;
(8) Drugs identified by the Program that are subject to fraud or abuse; or
(9) Drugs not on the preferred drug list developed under Regulation .12 of this chapter except for:
(a) Antiretrovirals; or
(b) Any other drugs or classes of drugs as determined by the Department.
B. Off-Label Uses of Drugs.
(1) The Department may require preauthorization for an off-label use of a drug.
(2) Except as provided in §B(3) of this regulation, the Department or its designee may not grant preauthorization for an off-label use of the drug if:
(a) The off-label use is inconsistent with generally accepted standards of care;
(b) The drug is prescribed for a non-medically accepted indication;
(c) The drug is prescribed in a manner not approved by the U.S. Food and Drug Administration; or
(d) The off-label use is not documented in and supported by the latest edition of:
(i) The American Hospital Formulary Service Drug Information (AHFS-DI);
(ii) The Thompson Micromedex Drugdex; or
(iii) The United States Pharmacopeia.
(3) The Department or its designee may grant preauthorization for the off-label use of mental health drugs for individuals 18 years old and younger within the limits established by the Program.
C. Preauthorization is not required for:
(1) Prescriptions for oral contraceptive drug products;
(2) Drugs dispensed in unit dose form to patients in a nursing facility by a provider using an approved unit dose system.
D. Preauthorization Process.
(1) The provider or the prescriber, if appropriate, ordering a drug subject to preauthorization, shall:
(a) Contact the Department or its designee through an established 24-hour hot-line to request preauthorization; and
(b) Provide required information and documentation.
(2) The Department or its designee shall respond to a request for preauthorization by telephone or facsimile request within 24 hours of receipt of a request for preauthorization.
(3) A 72-hour supply of the prescribed drug shall be allowed:
(a) In an emergency as determined by the prescriber;
(b) In an emergency as determined by the pharmacist, if possible in consultation with the prescriber; or
(c) If the Department does not provide a response to a preauthorization request within 24 hours.
(4) A preauthorization granted by the Department or its designee under this Regulation may not be used by any person as indicating that the individual for whom the prescription was ordered is eligible for Program benefits on the day the prescription is filled or that the Department will guarantee reimbursement for the prescription. All Program restrictions and requirements on eligibility, covered services, and limitations on reimbursement remain in effect.
(5) A 30-day emergency supply of atypical antipsychotic drugs not on the preferred drug list shall be:
(a) Immediately authorized by the Department or its designee in an emergency as determined by the:
(i) Prescriber; or
(ii) Pharmacist, if unable to contact the prescriber; and
(b) Limited to a one-time 30-day period.
E. Reconsideration of Adverse Decisions.
(1) The Department or its designee shall respond within 48 hours of receiving all necessary documentation of a written request from a participant or provider for reconsideration of an adverse decision on a preauthorization request.
(2) The Department or its designee shall ensure that all adverse decisions of reconsiderations are reviewed and issued by a physician.
(3) Appeals of adverse decisions of reconsideration requests shall be filed in accordance with Regulation .10 of this chapter.
F. The Department or its designee may:
(1) Require preauthorization for more than ten prescriptions including refills per 30-day period per noninstitutionalized participant; and
(2) May exclude certain drugs such as antibiotics from the limit as appropriate.