HAR §17-1737-71. Drugs

(a) Medical assistance payments shall be made for drugs when dispensed to eligible recipients within the following guidelines: (1) When prescribed by a practitioner licensed in the United States; (2) The drug has been approved by the U.S. Food and Drug Administration for the purpose for which it is prescribed; (3) The drug can be expected to be of therapeutic value for the disease or condition under treatment; and (4) The drug complies with the Medicaid drug formulary or prior authorization has been obtained from the department's medical consultant or designee or there is compliance with the prior authorization requirements set forth in section 17-1739.1-4.1. (b) A drug formulary may be maintained as follows: (1) An advisory formulary committee shall be appointed by the director of the department, and shall consist of: (A) A committee consisting of physicians, pharmacists, and other individuals deemed appropriate by the director; or (B) At the option of the State, the State's drug use review (DUR) board; (2) The formulary committee's secretary or drug use review coordinator shall be representatives of the department and selected by the director; (3) The duties of the advisory drug formulary committee shall be to: (A) Meet when called by the chairperson; (B) Develop and maintain a current and effective drug formulary; (C) Advise the department of suggested changes; and (D) Recommend the criteria under which prior authorization may be appropriate; (4) Actions of the advisory drug formulary committee shall be: (A) Subject to the approval of the department; (B) Circulated to appropriate providers; and (C) Effective upon receipt by providers unless otherwise stated; and The term of each formulary committee member shall be not more than two years UNOFFICIAL 1737-78 and overlapped in such a way that expiration of term does not cause a total membership change, or subject to the bylaws of the drug use review board. (c) The drug formulary shall contain: (1) Drugs approved by the U.S. Food and Drug Administration for human use and whose manufacturers' have entered into rebate agreement with the Centers for Medicare and Medicaid Services; (2) Drug products which are safe, economical, and effective; (3) Drugs that are not experimental; and (4) The following categories of drugs, subject to restriction under section 1927 of the Act, are not covered: (A) Used for cosmetic purposes or hair growth; (B) With associated tests or monitoring purchased exclusively from the manufacturer or designee as a condition of sale; (C) Which are classed as “less than effective” as described in Section 107(c)(3) of the Drug Amendments of 1962 or are identical, similar or related; and (D) Used to promote fertility. (d) A recipient eligible for medical assistance, who is eligible for Medicare, shall not be covered for prescription drugs that are covered under the Medicare Part D Prescription Drug Program effective January 1, 2006. (e) Selected drugs that are excluded from the Medicare Part D Prescription Drug Program or otherwise restricted drugs or classes of drugs, may be covered and available with prior authorization. They are as follows: (1) Agents when used for anorexia, weight loss, weight gain; (2) Agents when used for the symptomatic relief cough and colds; (3) Prescription vitamins and mineral products, except prenatal vitamins and fluoride; (4) Nonprescription drugs; (5) Barbiturates; and (6) Benzodiazepines. [Eff 08/01/94; am 11/13/95; am 03/30/96; am 03/11/04; UNOFFICIAL 1737-79 am 12/26/05 ] (Auth: HRS §346-14) (Imp: 42 C.F.R. §440.120; P. L. No. 103-66; 42 U.S.C. §§ 1396r(8)(d)(4) and (5), 1927(d)(2), 1935(d)(2)) §17-1737-71.1 Supplemental rebate agreement for a drug. (a) The department may enter into an agreement with a pharmaceutical manufacturer to obtain a rebate(s) in addition to the rebates pursuant to 42 U.S.C. Section 1396r-8(a). (b) Participation by a pharmaceutical manufacturer in a supplemental rebate agreement with the department is voluntary. (c) A supplemental rebate agreement may be a factor in the placement of a drug on a preferred drug list pursuant to section 17-1739.1-4.1(b). [Eff 03/11/04 ] (Auth: HRS §346-14) (Imp: 42 C.F.R. §440.120; 42 U.S.C. §1396r(8))