Current through all regulations passed and filed through September 16, 2024
(A) Except as otherwise provided in rule
4123-6-21.6 of the
Administrative Code, medication must be for the treatment of a work related
injury or occupational disease in a claim either allowed by an order of the
bureau or the industrial commission, or recognized by a self-insuring employer.
The bureau may deny a drug or therapeutic class of drugs as not being
reasonably related to or medically necessary for treatment of the allowed
conditions in a claim.
(B)
Medication may be prescribed by any treating provider authorized by law to
prescribe such medication; however, reimbursement for medication shall be
denied under the following circumstances:
(1)
Reimbursement for prescriptions written by providers who are not enrolled with
the bureau and who refuse to become enrolled shall be denied.
(2) Reimbursement for prescriptions written
by providers who are enrolled but noncertified shall be denied except in the
following situations:
(a) The prescription is
written by a non-bureau certified provider during initial or emergency
treatment of the injured worker if the injured worker's claim and treated
conditions are subsequently allowed.
(b) The prescription is written by a
non-bureau certified provider who is outside the state or within the state
where no or an inadequate number of bureau certified providers exist and the
MCO has determined that the treatment to be provided by the non-bureau
certified provider is not reasonably available through a like bureau certified
provider and has authorized the non-bureau certified provider to continue to
provide the treatment.
(c) The
prescription is written by a non-bureau certified provider for an injured
worker with a date of injury prior to October 20, 1993, the provider was the
injured worker's physician of record prior to October 20, 1993, and the injured
worker has continued treatment with that non-bureau-certified
provider.
(C)
Drugs covered are limited to those that are approved for human use in the
United States by the food and drug administration (FDA) and that are dispensed
by a registered pharmacist from an enrolled pharmacy provider.
(D) The bureau may require prior
authorization of certain drugs or therapeutic classes of drugs, drugs above a
certain cost threshold, drugs submitted outside a certain time frame from the
date of injury or the last prescription submitted. or drugs being prescribed
for a condition or in a manner not approved by the FDA. The bureau will publish
a list of all such drugs or therapeutic classes of drugs, cost thresholds, or
time frames for which prior authorization is required.
(E) Prescriptions for compounded drug
products:
(1) Prior authorization may be
required for compounded sterile drug products.
(2) Compounded non-sterile prescriptions.
(a) Reimbursement for non-sterile compounded
prescriptions will be denied, except when a commercially available
formulary product becomes unavailable (listed on the "Food & Drug
Administration Drug Shortages List," or "American Society of HealthSystem
Pharmacists Drug Shortages List").
(b) Reimbursement for non-sterile compounded
prescriptions shall only be considered upon the submission of both:
(i) A prior authorization request,
and
(ii) A copy of the signed
prescription that lists all active pharmaceutical ingredients. The prescription
must comply with the Ohio state board of pharmacy requirements for a valid
prescription set forth in rules
4729-5-13 and
4729-5-30 of the Administrative
Code.
(c) Approval for
reimbursement of non-sterile compounded prescriptions will be for an initial
period of
thirty days with subsequent approvals contingent upon
commercial product
availability. Not more than one prescription for a non-sterile compounded
prescription will be approved for reimbursement in any thirty day period.
(F) Drugs which fall into one of the
following categories may be approved and reimbursed by an MCO as part of a
comprehensive treatment plan submitted by the physician of record or treating
physician:
(1) Drugs for the treatment of
obesity;
(2) Drugs for the
treatment of infertility;
(3)
Non-compounded parenteral drugs not intended for self-administration;
(4) Drugs used to aid in smoking
cessation;
(5) Drugs dispensed to a
injured worker while the injured worker is admitted to a hospital during an
approved inpatient admission or during the course of an outpatient visit in a
hospital.
(G) Payment
for medications to pharmacy providers shall include both a product cost
component and a dispensing fee component.
(1)
Except as provided in this paragraph, product cost component shall be the
lesser of the following: maximum allowable cost, if applicable, or the average
wholesale price (AWP) of the commonly stocked package size minus fifteen per
cent.
(a) For repackaged brand name
medications, the product cost component shall be calculated using the AWP of
the original labeler.
(b) For
compounded prescriptions, the product cost component shall be limited to the
lesser of the maximum allowable cost, if applicable, for each ingredient, or
the AWP of the commonly stocked package size minus fifteen per cent for each
ingredient.
(c) The maximum
reimbursement for any one non-sterile compounded prescription will be
one
hundred dollars.
(2) The
dispensing fee component for non-compounded prescriptions shall be three
dollars and fifty cents. Only pharmacy providers are eligible to receive a
dispensing fee.
(3) The dispensing
fee component for non-sterile compounded prescriptions shall be eighteen
dollars and seventy-five cents.
(4)
The dispensing fee component for sterile compounded prescriptions shall be
thirty-seven dollars and fifty cents.
(H) The pharmacy provider is required to bill
medication at their usual and customary charge. The amount paid to the provider
will be the lesser of the provider's usual and customary charge or the
reimbursement allowed as determined by the bureau under paragraph (G) of this
rule. The bureau shall not reimburse any third-party pharmacy biller that
submits pharmacy bills on behalf of a pharmacy provider or that has purchased
pharmacy bills from a pharmacy provider for subsequent submission to the bureau
for payment. Pharmacy providers are required to submit for billing the NDC
number of the stock bottle from which the dispensed medication is obtained.
Drugs may be dispensed in unit dose packaging, but the NDC number of the
closest comparable bulk package listed in the bureau or the bureau's pharmacy
benefit manager's payment system must be used for billing purposes. The
pharmacy provider shall:
(1) Include
prescriber information within bills submitted electronically to the bureau or
the bureau's pharmacy benefits manager for payment. The prescriber information
must include the national provider identifier (NPI) or the drug enforcement
administration (DEA) number;
(2)
Not pay, allow, or give, or offer to pay, allow, or give, any consideration,
money, or other thing of value to an injured worker, or to any other person,
firm, or corporation (including but not limited to free or discounted
medications or other goods or services) as an inducement to or in return for
the injured worker ordering or receiving from the provider any medications or
other goods or services for which payment may be made by the bureau, the
bureau's pharmacy benefits manager, or MCO under Chapter 4121., 4123., 4127.,
or 4131. of the Revised Code;
(3)
Comply with all applicable billing instructions contained in the bureau's
provider billing and reimbursement manual in effect on the billed date(s) of
service.
(I) The bureau
may establish a maximum allowable cost for single source or multisource
medications which are pharmaceutically and therapeutically equivalent, that is,
contain identical doses of the active ingredient and have the same biological
effects as determined by the FDA and designated by an "A" code value in the FDA
publication, "Approved Drug Products With Therapeutic Equivalence Evaluations"
in effect on the billed date(s) of service. The methodology used to determine a
maximum allowable cost for a qualified drug product shall be determined by the
bureau. The bureau may choose to utilize the maximum allowable cost list of a
vendor or develop its own maximum allowable cost list.
(J) Injured workers who request a brand name
drug or whose physician specifies a brand name drug designated by "dispense as
written" on the prescription for a medication for which pharmaceutically and
therapeutically equivalent medication exist, as defined in paragraph (I) of
this rule, shall be liable for the product cost difference between the AWP of
the dispensed brand name drug minus fifteen percent and the established maximum
allowable cost price of the drug product. However, the bureau may approve
reimbursement of the dispensed brand name drug at the AWP of the drug minus
fifteen per cent if the following circumstances are met:
(1) The injured worker has a documented,
systemic allergic reaction as a result of taking the generic equivalent which
is consistent with known symptoms or clinical findings of a medication allergy;
or
(2) The injured worker has been
prescribed, and has tried, another generic equivalent and the intended
therapeutic benefit has not been achieved or an unacceptable adverse event has
occurred.
(K) The
following dispensing limitations may be adopted by the bureau:
(1) The bureau may publish supply limitations
for drugs which represent the maximum number of days supply that may be
dispensed at any one time for a single prescription.
(2) The bureau may publish maximum
prescription quantities which represent the largest number of units per drug
that may be dispensed at any one time for a single prescription.
(3) Requests submitted that exceed any
published days supply limit or maximum quantity limit shall be denied. Denials
may be overridden by the bureau in cases where medical necessity and
appropriateness have been determined.
(4) Refills of drugs not scheduled by the DEA
requested before eighty per cent of any published days supply limit has been
utilized will be denied.
(5)
Refills of drugs scheduled by the DEA requested before ninety per cent of any
published days supply limit has been utilized will be denied.
(6) Denials may be overridden by the bureau
for the following reasons with supporting documentation:
(a) The injured worker's pharmacy is
submitting an early refill for a shortened days supply to support synchronizing
the filling or refilling of the prescription in a manner that allows the
dispensed drug to be obtained on the same date each month;
(b) The injured worker is traveling out of
the country and will be unable to refill medications during that
time;
(c) The injured worker's
pharmacy will be closed for more than two days.
(d) An emergency or disaster, as defined in
division (O) of section
4123.511 of the Revised Code, is
declared by the governor of Ohio or the president of the United
States.
(L)
Except as otherwise provided in paragraph (F) of this rule, outpatient
medications shall be billed to and reimbursed through the bureau's pharmacy
benefits manager. Pharmacy providers must submit bills for medication by an
on-line point-of-service authorization terminal or a host-to-host link with the
bureau's pharmacy benefits manager's established bill processing system as a
condition of provider enrollment or reimbursement. Submission by paper or by
tape-to-tape will not be accepted by the bureau or the bureau's pharmacy
benefits manager.
(M) A claimant
may request outpatient medication reimbursement in accordance with rule
4123-6-26 of the Administrative
Code using form C-17 or equivalent. Claimant reimbursement may be limited to
the following situations:
(1) Claimants whose
medication is not payable under division (I) of section
4123.511 of the Revised Code on
the date of service, but later becomes payable;
(2) Emergency situations where an enrolled
pharmacy provider is not available;
(3) Claimants who reside out of the
country.
(N) A "pharmacy
provider" designation and provider number can be obtained by a provider who
meets all the following criteria:
(1) Has a
valid "terminal distributor of dangerous drugs" as defined in section
4729.01 of the Revised Code if
located within Ohio; or an equivalent state license if located outside of Ohio;
and,
(2) Has a valid DEA number;
and,
(3) Has a licensed registered
pharmacist in full and actual charge of a pharmacy; and,
(4) Has the ability and agrees to submit
bills at the point of service.
All state and federal laws and regulations relating to the
practice of pharmacy and the dispensing of medication by a duly licensed
pharmacist must be observed.
(O) The bureau may contract with a pharmacy
benefit manager to perform drug utilization review and on-line bill processing,
maintain a pharmacy provider network and prior authorization program for
medications, and provide management reports. The bureau or its vendor may also
contract rebate agreements with drug manufacturers. The bureau may utilize
other services or established procedures of the pharmacy benefits manager which
may enable the bureau to control costs and utilization and detect
fraud.
(P) The bureau may identify
circumstances under which it may consider reimbursement for pharmacist
professional services (also known as cognitive services) when payment for such
services results in a measurable, positive outcome. The bureau shall be
responsible for developing the criteria which will be used to assess the
compensability of billed pharmacist professional services. The bureau shall be
responsible for developing the structure of the reporting of the measurable
outcomes used to justify the payment of pharmacist professional services, which
may include reimbursement for the dispensing fee component. The amount that
could be reimbursed for pharmacist professional services shall be determined by
the bureau.
(Q) The bureau shall
retain a registered pharmacist licensed in the state of Ohio to act as the
full-time pharmacy program director to assist the bureau in the review of drug
bills. The pharmacy program director may assist the bureau in determining the
appropriateness, eligibility, and reasonableness of compensation payments for
drug services. The bureau may adopt a drug formulary with the recommendation of
the bureau's pharmacy and therapeutics committee established by rule
4123-6-21.2 of the
Administrative Code, and may consult with the committee on the development and
ongoing annual review of the drug formulary and other issues regarding
medications.
