Okla. Admin. Code § 317:30-5-72.1

Current through Vol. 42, No. 4, November 1, 2024

Section 317:30-5-72.1 - Drug benefit

The Oklahoma Health Care Authority (OHCA) administers and maintains an Open Formulary subject to the provisions of 42 U.S.C. § 1396r-8. The OHCA covers a drug that has been approved by the Food and Drug Administration (FDA) and whose manufacturers have entered into a drug rebate agreement with the Centers for Medicare and Medicaid Services (CMS), subject to the following exclusions and limitations.

(1) The following drugs, classes of drugs, or their medical uses are excluded from coverage:

(A) Agents used to promote fertility.

(B) Agents primarily used to promote hair growth.

(C) Agents used for cosmetic purposes.

(D) Agents used primarily for the treatment of anorexia or weight gain. Drugs used primarily for the treatment of obesity, such as appetite suppressants are not covered. Drugs used primarily to increase weight are not covered unless otherwise specified.

(E) Agents that are investigational, experimental or whose side effects make usage controversial including agents that have been approved by the FDA but are being investigated for additional indications. For more information regarding experimental or investigational including clinical trials see, OAC 317:30-3-57.1.

(F) Covered outpatient drugs which the manufacturer seeks to require as a condition of sale that associated tests or monitoring services be purchased exclusively from the manufacturer or designee.

(G) Agents when used for the treatment of sexual or erectile dysfunction, unless such agents are used to treat a condition, other than sexual or erectile dysfunction, for which the agents have been approved by the FDA.

(H) Agents used for the symptomatic relief of cough and colds.

(2) The drug categories listed in (A) through (D) of this paragraph are covered at the option of the state and are subject to restrictions and limitations. An updated list of products in each of these drug categories is included on the OHCA's public website.

(A) Vitamins and Minerals. Vitamins and minerals are not covered except under the following conditions:

(i) Prenatal vitamins are covered for pregnant women;

(ii) Fluoride preparations are covered for persons under sixteen (16) years of age or pregnant;

(iii) Vitamin D, metabolites, and analogs when used to treat chronic kidney disease or end stage renal disease are covered;

(iv) Iron supplements may be covered for pregnant women if determined to be medically necessary;

(v) Vitamin preparations may be covered for children less than twenty-one (21) years of age when medically necessary and furnished pursuant to EPSDT protocol; and

(vi) Some vitamins are covered for a specific diagnosis when the FDA has approved the use of that vitamin for a specific indication.

(B) Coverage of non-prescription or over the counter drugs is limited to:

(i) Insulin;

(ii) Certain smoking cessation products;

(iii) Family planning products;

(iv) OTC products may be covered for children if the particular product is both cost-effective and clinically appropriate; and

(v) Prescription and non-prescription products which do not meet the definition of outpatient covered drugs, but are determined to be medically necessary.

(C) Coverage of food supplements is limited to PKU formula and amino acid bars for members diagnosed with PKU, other certain nutritional formulas and bars for children diagnosed with certain rare metabolic conditions when medically necessary and prior authorized.

(3) All covered outpatient drugs are subject to prior authorization as provided in OAC 317:30-5-77.2 and 317:30-5-77.3.

(4) All covered drugs may be excluded or coverage limited if:

(A) The prescribed use is not for a medically accepted indication as provided under 42 U.S.C. § 1396r-8; or

(B) The drug is subject to such restriction pursuant to the rebate agreement between the manufacturer and CMS.

Okla. Admin. Code § 317:30-5-72.1

Added at 17 Ok Reg 2383, eff 6-26-00; Amended at 19 Ok Reg 2773, eff 4-24-02 (emergency); Amended at 20 Ok Reg 1193, eff 5-27-03; Amended at 20 Ok Reg 2771, eff 7-1-03 (emergency); Amended at 21 Ok Reg 419, eff 1-1-04 (emergency); Amended at 21 Ok Reg 2176, eff 6-25-04; Amended at 25 Ok Reg 119, eff 8-1-07 (emergency); Amended at 25 Ok Reg 1192, eff 5-25-08; Amended at 27 Ok Reg 306, eff 11-3-09 (emergency); Amended at 27 Ok Reg 949, eff 5-13-10; Amended at 28 Ok Reg 266, eff 11-15-10 (emergency); Amended at 28 Ok Reg 1448, eff 6-25-11

Amended by Oklahome Register, Volume 33, Issue 23, August 15, 2016, eff. 9/1/2016

Amended by Oklahoma Register, Volume 34, Issue 23, August 15, 2017, eff. 9/1/2017

Amended by Oklahoma Register, Volume 35, Issue 24, September 4, 2018, eff. 9/14/2018

Amended by Oklahoma Register, Volume 38, Issue 23, August 16, 2021, eff. 9/1/2021