(A) All of the following shall apply to the step therapy exemption process established and implemented by the department of medicaid pursuant to division (B)(2) of section 5164.7512 of the Revised Code:

(1) The process shall be clear and convenient.

(2) The process shall be easily accessible on the department's web site.

(3) The process shall require that a medicaid provider initiate a step therapy exemption request on behalf of a medicaid recipient.

(4) The process shall require supporting documentation and rationale be submitted with each request for a step therapy exemption.

(5) The process shall, pursuant to a step therapy exemption request made under division (B)(2) of section 5164.7512 of the Revised Code or an appeal made under division (B)(2) of this section, require the department to grant a step therapy exemption if either of the following applies:

(a) Either of the following apply to the prescribed drug that would otherwise have to be used under the step therapy protocol:

(i) The required prescription drug is contraindicated for that specific medicaid recipient, pursuant to the drug's United States food and drug administration prescribing information.

(ii) The medicaid recipient tried the required prescription drug while enrolled in medicaid or other health care coverage, or another United States food and drug administration approved AB-rated prescription drug, and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event.

(b) The medicaid recipient is stable on the prescribed drug selected by the recipient's medicaid provider for the medical condition under consideration, regardless of whether or not the drug was prescribed while the individual in question was a medicaid recipient, or has already gone through a step therapy protocol. However, the department may require a stable medicaid recipient to try a pharmaceutical alternative, per the federal food and drug administration's orange book, purple book, or their successors, prior to providing coverage for the prescribed drug.

(6) On granting a step therapy exemption, the department shall authorize payment for the prescribed drug prescribed by the medicaid recipient's medicaid provider.

(B)

(1) From the time a step therapy exemption request is received, the department shall either grant or deny the request within the following time frames:

(a) Forty-eight hours for requests related to urgent care services;

(b) Ten calendar days for all other requests.

(2)

(a) If an exemption request is denied, a medicaid provider may appeal the denial on behalf of the medicaid recipient.

(b) From the time a step therapy appeal is received, the department shall either grant or deny the appeal within the following time frames:

(i) Forty-eight hours for appeals related to urgent care services;

(ii) Ten calendar days for all other appeals.

(3) The appeal shall be between the medicaid provider making the appeal and a clinical peer appointed by or contracted by the department or the department's designee.

(4) If the department does not either grant or deny an exemption request or an appeal within the time frames prescribed in division (B)(1) or (2) of this section, then such an exemption request or appeal shall be deemed to be granted.

(C) If an appeal is rejected, the medicaid recipient in question may make a further appeal in accordance with section 5160.31 of the Revised Code.

(D) This section shall not be construed to prevent either of the following:

(1) The department from requiring a medicaid recipient to try any new or existing pharmaceutical alternative, per the federal food and drug administration's orange book, purple book, or their successors, before authorizing a medicaid payment for the prescribed drug;

(2) A medicaid provider from prescribing a prescribed drug that is determined to be consistent with medical or scientific evidence.

Added by 132nd General Assembly File No. TBD, SB 265, §1, eff. 4/5/2019.