Current through all regulations passed and filed through September 16, 2024
(A) Covered
prescribed drugs
Drugs covered by the Ohio department of medicaid (ODM) pharmacy
program, or a managed care
entity as defined in rule
5160-26-01 of the Administrative
Code, are prescribed drugs as defined in rule
5160-9-05 of the Administrative
Code 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:
(1) "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 as described in paragraph (B) of this rule.
(2) 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.
(3) Compounded prescriptions in accordance
with paragraph (E) of this rule, when compounded with ingredients described in
paragraphs (A)(1) to (A)(2) of this rule or with active pharmaceutical
ingredients (API) and excipients listed on the ODM pharmacy program
website at
https://pharmacy.medicaid.ohio.gov.
(4)
Vaccines, inoculations, and
immunizations, other than influenza and coronavirus
vaccines, are covered under fee-for-service by the ODM pharmacy program only
for residents of a NF or ICF/IID; otherwise these services
should
be billed as physician services in accordance with Chapter 5160-4 of the
Administrative Code.
Influenza and coronavirus
vaccines may be billed by the pharmacy for
a
recipient who is not a resident of a NF or ICF/IID if the vaccine will be
administered at the pharmacy, or for
a recipient who is a resident
of a NF or ICF/IID to be administered by facility staff.
(B) Non-covered drugs
Drugs that fall into one of the following categories are
non-covered by the Ohio medicaid pharmacy program:
(1) Drugs for the treatment of
obesity.
(2) Drugs for the
treatment of infertility.
(3) Drugs
for the treatment of erectile dysfunction.
(4)
Drug efficacy
study implementation ( DESI) drugs or drugs
that are determined to be identical, similar, or
related.
(5) Drugs that are covered
or are eligible to be covered by medicare part D, when prescribed for
a
recipient who is eligible for medicare.
(6) Over-the-counter
drugs that are not listed
on the "OH PBM OTC
List" located on the ODM pharmacy program website.
(7) Drugs being used for indications not
approved by the food and drug administration unless there is compelling
clinical evidence to support the experimental use.
(C) The prescribed drugs covered under the
ODM pharmacy program without prior authorization are specified on the ODM
website at
https://pharmacy.medicaid.ohio.gov.
This list indicates the drugs
for which copayments are
necessary in accordance with rule
5160-9-09 of the Administrative
Code, and specifies whether the drug is covered for a dual eligible as
described in rule
5160-1-05 of the Administrative
Code. Drugs not listed that meet the requirements of paragraph (A)(1) of this
rule and are antidepressants or antipsychotics
are exempted from prior
authorization if the pharmacy claim indicates that the
prescription meets the criteria listed in section
5167.12 of the Revised
Code.
(D) Prior authorization
Dangerous drugs not listed in accordance with paragraph (C) of
this rule that are medically necessary for treatment require prior
authorization; however, noncovered drugs listed in paragraphs (B)(1) to
(B)(5)
of this rule and APIs and excipients not on the list described in paragraph
(A)(3) of this rule are not eligible for prior authorization.
(1) Prior authorization of pharmacy services
is
administered in compliance with section 1927 of the Social Security Act
(January 1, 2020), including a response by telephone or other telecommunication
device within twenty-four hours of receipt of a request for prior
authorization, and provisions for the dispensing of a seventy-two-hour supply
of a COD in an emergency situation.
(2) Drugs not listed in accordance with
paragraph (C) of this rule may be covered with prior authorization if medical
necessity is documented, the drug is not excluded per paragraphs (B)(1) to
(B)(5)
of this rule, and a drug that does not require prior authorization cannot be
used.
(3) Prior authorization must
be obtained from ODM or its designee before the drug claim may be paid. All
requests must be submitted in accordance with instructions issued by ODM or its
designee.
(a) Only the prescribing provider or
a member of the prescribing provider's staff may request prior authorization
except as described in paragraph (D)(3)(b) of this rule.
(b) A pharmacist may request prior
authorization for an alternative dosage form of a drug to be administered
through a tube for
recipients who are tube fed, if no comparable
drugs that do not require prior authorization can be administered through a
tube. A pharmacist may also request prior authorization of a seventy-two-hour
supply of a dangerous drug that is a COD in an emergency situation if the
prescribing provider or prescribing provider's staff is not available to
request prior authorization. A pharmacist may also
request prior authorization for a recipient resident in long term
care.
(4) Drugs in
therapeutic classes that are covered or are eligible to be covered under
medicare part D are not available for prior authorization for
a
recipient who is eligible for medicare. Prior authorization may be
requested for drugs in drug classes that may be covered by medicaid for a dual
eligible as indicated in the list described in paragraph (C) of this rule and
are subject to any stated limits.
(5) When a request for prior authorization is
denied, the
recipient
is informed in writing of the denial
and the right to a state hearing.
(E) Compounded drugs
(1) Compounded drugs
are
covered if
the recipient's medical need cannot be met by a covered
product that is a COD and at least one ingredient meets the requirements of
paragraph (A) of this rule.
(2) Compounded drug claims must be submitted
to ODM or its designee using the national drug code (NDC) for each ingredient
that is a part of the compound.
(3)
An ingredient in a compounded drug that is both a COD and a dangerous drug, not
listed in accordance with paragraph (C) of this rule, will require prior
authorization. If a prior authorization is not approved or if an ingredient is
not eligible for authorization (i.e., not covered as described in paragraph (A)
of this rule, excluded from coverage as described in paragraph (B) of this
rule, or excluded from separate payment as described in paragraph (I) of this
rule), the pharmacy provider may elect to receive payment only for those
ingredients in the compound that are directly payable by ODM, in accordance
with billing instructions issued by ODM or its designee.
(F) Dispensing limitations
(1) Days'
supply limits
(a) Acute medications are
limited to a thirty-four-day supply.
(b)
Select
chronic maintenance medications
and select durable medical equipment (DME) products
covered under the pharmacy benefit are limited to a one-hundred-two-day
supply.
(2) Maximum
quantity limits
Maximum prescription quantities are listed on the ODM pharmacy
program
website and represent the largest number of units per
drug that may be dispensed at any one time for a single prescription or the
largest number of units per drug per day (or other time period) of
therapy.
(3) Maximum
equivalent daily dose limits
Maximum equivalent daily doses are listed on the ODM pharmacy
program
website and establish the highest equivalent dose of
certain therapeutic classes that may be dispensed when
equivalent doses of all drugs in the therapeutic class are summed.
(4) Maximum prescription claim
limits
Maximum prescription claim limits are listed on the ODM
pharmacy program
website and establish the maximum number of
claims for drugs that are therapeutic duplicates that
are
paid within specified time limits .
(5) Claims submitted that exceed
the limits described in paragraphs (F)(1) to (F)(4) of this rule
are
denied. Denials may be overridden by ODM or its designee in cases where medical
necessity
was determined through the prior authorization
process.
(G) Refill
prescriptions
(1) Unless the pharmacy is
submitting an early refill for a shortened days'
supply to support medication synchronization described in section
5164.7511 of the Revised Code
and the claim is submitted pursuant to billing instructions for medication
synchronization issued by ODM or its designee, the following limitations apply:
(a) Refills of drugs not scheduled by the
federal drug enforcement administration (DEA) requested before eighty per cent
of the days' supply
was utilized
will be denied.
(b) Refills of
drugs scheduled by the DEA requested before ninety per cent of the days supply
was
utilized will be denied.
(2) If a new prescription
was
issued by the prescriber that requires increased dosing frequency, the existing
prescription must be utilized until the days supply per cent threshold
was
met, calculated using the increased dosing frequency.
(3) Denials may be overridden by ODM or its
designee for the following documented reasons:
(a) Previous supply was lost, stolen, or
destroyed. ODM or its designee may limit the number of instances denials may be
overridden in cases of suspected fraud, waste, or
abuse, and may request additional documentation before an override is
authorized.
(b) Previous claim was
submitted with wrong days' supply.
(c) Vacation or travel, for not more than three total months during a twelve month
period.
(d) Multiple supplies
of the same medication are needed, for example in a school or workshop setting.
Multiple supplies are limited to products that cannot be broken into multiple
containers, such as inhalers or other unit-of-use containers.
(e) Hospital or police kept the
medication.
(f) Brand or generic
was ineffective and the
recipient was switched to generic or
brand.
(g)
The recipient is in the custody of the public children's
services agency (PCSA) or other Title IV-E agency.
(H) Selected pharmaceuticals,
including injectable drugs, are not covered under the pharmacy program if they
are administered by a healthcare provider as defined in
rule 4123-6-01 of the Administrative
Code
other
than in a NF, ICF/IID, or pharmacy.
(1) Long-acting injectable pharmaceuticals
used for substance use disorder or mental health conditions may be billed by
the pharmacy for administration in a provider setting under the following
circumstances:
(a) The pharmaceutical is
dispensed pursuant to a valid prescription; and
(b) The pharmaceutical is labeled with the
recipient name; and
(c) The pharmaceutical will be administered
by a qualified healthcare professional in a provider setting; and
(d) The pharmacy and administering provider
follow any special handling requirements in the package labeling; and
(e) The pharmacy releases the pharmaceutical
only to the administering provider or member of the provider's staff, and
followed all regulations for a
prescription pick-up station required by the Ohio state board of pharmacy. The
pharmacy
cannot dispense the pharmaceutical directly to the
recipient, caregiver, or
recipient's
representative.
(2)
Pharmaceuticals not described in paragraph (H)(1) of this rule administered in
the physician's office must be purchased by the physician's office and billed
as a professional service claim.
(I) Selected over-the-counter drugs are not
separately payable when prescribed for
a recipient residing in a NF.
Such drugs are the responsibility of the NF and are included in the facility
per diem payment. The over-the-counter drugs not separately payable are those
that are classified into the following drug classes:
(1) Analgesics, including urinary
analgesics;
(2) APIs and excipients
used in compounded prescriptions;
(3) Cough and cold preparations and
antihistamines;
(4) Ear
preparations;
(5) Gastrointestinal
agents, except histamine-2 receptor antagonists, proton pump inhibitors, and
loperamide;
(6) Hemorrhoidal
preparations;
(7) Nasal
preparations, except nasal corticosteroids;
(8) Ophthalmic agents, except
antihistamines;
(9) Saliva
substitutes;
(10)
Sedatives;
(11) Topical agents,
except antifungal and acne preparations; or
(12) Vitamins and minerals, except prenatal
vitamins and fluoride.
