Ohio Administrative Code
Title 5160 - Ohio Department of Medicaid
Chapter 5160-9 - Pharmacy Services
Section 5160-9-01 - Pharmacy services: definitions
Universal Citation: OH Admin Code 5160-9-01
Current through all regulations passed and filed through September 16, 2024
(A) Covered drugs.
(1)
"Compounded prescriptions" are prescription drugs made by
combining two or more drugs. Active pharmaceutical ingredients (API) and
excipients are listed on the ODM pharmacy program website at
https://pharmacy.medicaid.ohio.gov.
(2)
"Covered prescribed drug" means a drug covered by the
Ohio department of medicaid (ODM) pharmacy program, or a managed care plan
entity as defined in rule
5160-26-01 of the Administrative
Code. Covered prescribed drugs are prescribed drugs that are dispensed to an
eligible recipient for use in the recipient's residence, including a nursing
facility (NF), as defined in section
5165.01 of the Revised Code, or
intermediate care facility for individuals with intellectual disabilities
(ICF/IID), as defined in section
5124.01 of the Revised Code, and
fall into one of the following categories:
(a)
"Dangerous drugs"
as defined in section
4729.01 of the Revised Code that
meet the definition of a "covered outpatient drug (COD)" as defined in
42 C.F.R.
447.502 (November 19, 2021) that are not
non-covered drugs.
(b)
Over-the-counter (OTC) drugs listed on the "OH PBM OTC
List" located on the ODM pharmacy website at
https://pharmacy.medicaid.ohio.gov. The list is updated regularly and is recorded with the
effective date included in each new version.
(B) "Noncovered drugs" are drugs that fall into one of the following categories for which coverage is not available through the Ohio medicaid pharmacy program as described in rule 5160-9-03 of the Administrative Code.
(C) Pricing.
(1)
"340B ceiling price" means the highest price allowed to
be charged by a manufacturer to a 340B covered entity as described in section
340B(a)(4) of the "Public Health Service Act,"42 U.S.C.
256b(a)(4) (in effect as of
June 25, 2020).
(2)
"Actual acquisition cost (AAC) means the best
determination by the Ohio department of medicaid (ODM) of the actual amount the
provider paid to purchase the prescribed drug. ODM acquires AAC data through
one or more of the following: national survey of retail pharmacy providers,
e.g., national average drug acquisition cost (NADAC) rate process, states'
surveys of retail pharmacy providers e.g.,Ohio average acquisition cost (OAAC),
and published compendia prices, e.g., wholesale acquisition cost
(WAC).
(3)
"Administration fee" means the maximum amount payable
to a provider to administer a vaccine or injectable drug that is payable under
this chapter and authorized to be administered by a pharmacist or pharmacy
intern in accordance with sections
4729.41 and
4729.45 of the Revised Code and
the rules promulgated thereunder.
(4)
"Equivalent drug
product" means drug products with the same active ingredient, strength, and
dosage form.
(5)
"Equivalent generic drug products" means equivalent
drug products that are identified by the medicaid drug rebate program (MDRP)
drug product data files as non-innovator products. MDRP files are available on
the federal centers for medicare and medicaid services (CMS) website at
https://www.medicaid.gov .
(6)
"Ingredient cost" means the portion of the total
medicaid payment amount attributable to the cost of the drug product, or in the
case of a compound drug, the sum of the cost of the ingredients that are
covered in accordance with rule
5160-9-03 of the Administrative
Code.
(7)
"Long-term care facility (LTCF)" means a nursing
facility as defined in section
5165.01 of the Revised Code or
intermediate care facility for individuals with intellectual disabilities as
defined in section 5124.01 of the Revised
Code.
(8)
"NADAC" means the rate determined by the CMS to be the
average AAC for retail community pharmacies. NADAC rates are on the CMS website
at
https://www.medicaid.gov .
(9)
"Ohio average acquistion cost (OAAC)" means pricing
that more accurately reflects the actual acquisition cost for drugs for
pharmacy providers in Ohio and is based on actual costs for the provider to
purchase a drug.
(10)
"Pharmacy pricing and audit consultant (PPAC)" means an
organization which is responsible for pharmacy reimbursement calculation,
benefit design, and pharmacy benefits management oversight and
auditing.
(11)
"Prescribed drug" has the same meaning as in section
5164.01 of the Revised
Code.
(12)
"Professional dispensing fee (PDF)" means the fee or
fees determined pursuant to section
5164.753 of the Revised Code and
set forth in this rule.
(13)
"Single pharmacy benefits manager (SPBM)" means the
pharmacy benefit manager selected by and under contract with the medicaid
director under section
5167.24 of the Revised
Code.
(14)
"State maximum allowable cost (SMAC)" means the maximum
amount determined by ODM, based upon an estimate of the statewide average
acquisition cost (AAC) for a particular equivalent generic drug group, to be
paid to Ohio medicaid providers for an equivalent generic drug
group.
(15)
"WAC" means the amount reported by a pharmaceutical
manufacturer to pharmacy pricing compendia as the list price for a drug and may
not represent the actual price of a particular transaction.
(D) Provider types eligible for payment for pharmacy services.
(1)
"Clinic" providers with valid medicaid provider agreements
and meet the criteria under the Revised Code to personally furnish
pharmaceuticals, but are not eligible to become a "pharmacy provider" are
eligible to apply for a "pharmacy" specialty designation and bill for
self-administered take-home drugs.
(2)
A "pharmacy
provider" designation and provider number can be obtained by a "terminal
distributor of dangerous drugs," as defined in section
4729.01 of the Revised Code,
who:
(a)
Has a
valid drug enforcement agency (DEA) registration;
(b)
Has a pharmacist
as the "responsible person," as defined in rule
4729:5-2-01 of the
Administrative Code; and,
(c)
Complies with eligible provider rules
5160-1-17 to
5160-1-17.9 of the
Administrative Code and signs a provider agreement with the Ohio department of
medicaid (ODM).
(3)
A "hospital"
provider acting as a pharmacy can obtain a "pharmacy" specialty designation and
bill for self-administered take-home drugs.
Replaces: 5160-9-01, 5160-9-06
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