Current through Vol. 42, No. 1, September 16, 2024
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.
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
