(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 co-payments 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.
