(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 January 7,
(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, and published
compendia prices, e.g., wholesale acquisition cost (WAC).
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 section
4729.45 of the Revised Code and the rules promulgated thereunder.
allowable" means the sum of the ingredient cost plus any applicable
administration fee or professional dispensing fee.
(5) "Equivalent drug
product" means drug products with the same active ingredient, strength,
and dosage form.
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) web site at
(7) "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
(8) "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
(9) "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.
drug" has the same meaning as in section 5164.01 of the Revised
(11) "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.
(12) "State maximum allowable cost
(SMAC)" means the maximum amount determined by ODM, based upon an estimate
of the statewide AAC for a particular equivalent generic drug group, to be paid
to Ohio medicaid providers for an equivalent generic drug group.
(13) "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
(B) Payment for prescribed drugs is the
lesser of the provider's billed charges or the calculated allowable, after
any coordination of benefits is applied as described in paragraph (F) of this
rule. For prescribed drugs that are subject to a co-payment, the amount paid by
ODM will be decreased by the amount equal to the co-payment that is to be
billed to the individual in accordance with rules 5160-1-09 and 5160-9-09 of
the Administrative Code.
(C) The ingredient cost portion of the
calculated allowable shall be determined in accordance with the following
(1) No ingredient cost
shall be allowed for a pandemic vaccine that is provided by the Ohio department
of health or other government entity at no cost to the provider.
(2) For dates of service
on or after April 1, 2017, for any drug purchased under the 340B program, the
ingredient cost is the 340B ceiling price. If the 340B ceiling price is not
available, the ingredient cost shall be fifty per cent of WAC.
(3) For dates of service
on or after April 1, 2017, for a clotting factor, the ingredient cost shall be
the payment limit shown in the current medicare part B drug pricing file, minus
the furnishing fee assigned by medicare part B. The medicare part B pricing
file is available at https://www.cms.gov.
(4) For all other ingredients not
captured in paragraphs (C)(1) to (C)(3) of this rule:
(a) For dates of service prior to April 1, 2017, including drugs
purchased under the 340B program and clotting factors:
(i) Maximum allowable
cost (MAC) pharmaceuticals.
(a) Maximum allowable
costs have been determined by the federal department of health and human
services for selected drugs. ODM shall not make payment for these products, in
the aggregate, at a rate higher than the federal upper limit
(b) ODM established a
SMAC for additional selected drugs where either bio-equivalency of the drugs
has been established or bio-inequivalency of the drugs has not been
established. Payment for SMAC drugs shall be based on the sixty-fifth
percentile of the estimated acquisition cost of all readily available
equivalent generic drug products.
acquisition cost (EAC) pharmaceuticals. All products, other than those
designated as MAC drugs, will be considered EAC drugs. Reimbursement will be
based on the estimate of WAC determined by periodic review of pricing
information from Ohio drug wholesalers, pharmaceutical manufacturers and a
pharmacy pricing update service. Maximum reimbursement for these drugs will be
WAC plus seven per cent.
(b) For dates of service on or after April 1, 2017, the
ingredient cost shall be the NADAC. If CMS has not published a NADAC for the
ingredient for the date of service, the ingredient cost shall be the lesser of
WAC or SMAC.
(D) For dates of service on or after
April 1, 2017, the administration fee portion of the calculated allowable for a
vaccine, except for a vaccine for COVID-19, or other injectable drug
administered at the pharmacy shall be nineteen dollars thirty-five cents. The
administration fee for a vaccine for COVID-19 equals the medicare rate. For
dates of service prior to April 1, 2017, the administration fee shall be ten
dollars. A vaccine, except for a vaccine for COVID-19, or other drug that is
dispensed by a pharmacy to be administered outside the pharmacy, for example at
a LTCF, is not eligible for a pharmacy administration fee but may be eligible
for a professional dispensing fee.
(E) The PDF portion of the calculated
allowable shall be determined in accordance with the following
(a) For dates of service prior to April 1, 2017, only pharmacy
and hospital providers as defined in rule 5160-9-01 of the Administrative Code
are eligible to receive a dispensing or administration fee. The dispensing fee
shall be one dollar eighty cents.
(b) For dates of service on or after April 1, 2017, the PDF paid
to a provider for dispensing a non-compounded drug shall be assigned based on
the total number of prescriptions filled by the provider during the
provider's last completed fiscal year prior to completing the survey
required by rule 5160-9-01 of the Administrative Code and reported on the
survey. The PDF shall be assigned in accordance with the following
(i) For providers reporting fewer than fifty thousand
prescriptions, thirteen dollars and sixty-four cents.
(ii) For providers reporting between fifty thousand and
seventy-four thousand nine hundred ninety-nine prescriptions, ten dollars and
(iii) For providers reporting between seventy-five thousand and
ninety-nine thousand nine hundred ninety-nine prescriptions, nine dollars and
(iv) For providers reporting one hundred thousand or more
prescriptions, eight dollars and thirty cents.
(v) For a provider that failed to submit a complete response to
the cost of dispensing survey required by rule 5160-9-01 of the Administrative
Code for the previous reporting period, eight dollars and thirty
(vi) For providers newly enrolled as medicaid providers as
described in rule 5160-9-01 of the Administrative Code, the PDF shall be as
(a) For a new provider located in Ohio, the provider shall be
assigned a PDF of thirteen dollars and sixty-four cents.
(b) For a new provider located outside of Ohio, the provider
shall be assigned a PDF of eight dollars and thirty cents.
(2) Compounded drugs. The
PDF paid to a provider for dispensing compounded drugs shall be paid in
accordance with the following criteria:
(a) The PDF for claims for dispensing total parenteral nutrition
(TPN) shall be fifteen dollars per one-day supply on the claim, with a maximum
total PDF of one hundred fifty dollars for the claim. To qualify for the TPN
PDF, the TPN compound must be mixed by the pharmacy to the final form under
sterile conditions. If the products are mixed or activated at the point of
administration by connecting components or breaking seals without the need for
sterile conditions, the dispensing does not qualify for payment of the
(b) For dates of service prior to April 1, 2017, claims submitted
for infusion compounds will receive a dispensing fee of ten dollars per day,
with a maximum dispensing fee of seventy dollars. Infusion compounds include
intravenous (IV) therapy for chemotherapy, pain management and
(c) For dates of service on or after April 1, 2017, the PDF for
dispensing sterile compounds, other than TPN, that are required to be sterile
for a route of administration including inhaled, infused, instilled, implanted
or injected, shall be ten dollars per days supply, with a minimum PDF of twenty
dollars and a maximum of seventy dollars for the claim. To qualify for payment
of the sterile compound PDF, the sterile compound must be mixed by the pharmacy
to the final form under sterile conditions. Products that are mixed or
activated at the point of administration by connecting components or breaking
seals without the need for sterile conditions are not eligible for a sterile
(d) Compounded drugs other than TPN or sterile
(i) For dates of service
prior to April 1, 2017, compounded drugs that are not infusion compounds or TPN
claims will receive a single six dollar dispensing fee per prescription.
(ii) For dates of service on or after April 1, 2017, compounded
drugs that are not eligible for the TPN or sterile compound PDF will receive
the PDF determined under paragraph (E)(1)(b) of this rule.
(3) Vaccine or injectable
drug dispensing that qualifies for payment of an administration fee shall not
qualify for medicaid payment of a PDF.
paragraph (E)(1) of this rule, prescribed drugs, other than compounded drugs,
dispensed to patients residing in LTCFs shall be limited to one PDF per
patient, per equivalent product, per rolling twenty-five days. In the event
that multiple supplies of an equivalent product are dispensed within
twenty-five days, only the ingredient cost shall be paid. Exceptions to the one
PDF per patient, per product rule are:
(a) Situations where the prescriber has ordered a second round of
medication for an acute condition within the twenty-five day
(b) Situations where the prescriber has changed the
(c) Situations where the drug has been compromised by accident,
for example contaminated or destroyed.
(d) Dispensing of controlled substances, which is limited to two
PDFs per twenty-five days.
(F) Coordination of
(1) Claims for medicare
part B cost sharing as described in rule 5160-1-05 of the Administrative Code
shall be submitted using the medical claim format and shall not be payable
under this chapter.
(2) No payment shall be
made under this chapter for any drug that may be covered by medicare part D for
an individual who is eligible for coverage by medicare part D, regardless of
whether the individual is actually enrolled in a part D plan or the particular
drug is covered by the individual's part D plan.
(3) Cost-sharing for
claims involving neither medicare part B nor medicare part D is determined in
accordance with rule 5160-1-08 of the Administrative Code.