(A) As used in sections 5164.7512 to 5164.7514 of the Revised Code:

(1) "Clinical practice guidelines" means a systematically developed statement to assist providers and medicaid recipients in making decisions about appropriate health care for specific clinical circumstances and conditions.

(2) "Clinical review criteria" means the written screening procedures, decision abstracts, clinical protocols, and clinical practice guidelines used by the medicaid program to determine whether or not a health care service or drug is appropriate and consistent with medical or scientific evidence.

(3) "Medical or scientific evidence" has the same meaning as in section 3922.01 of the Revised Code.

(4) "Step therapy exemption" means an overriding of a step therapy protocol in favor of immediate coverage of a medicaid provider's selected prescription drug.

(5) "Step therapy protocol" means a protocol under which it is determined through a specific sequence whether the medicaid program, under either a pharmacy or medical benefit, will pay for a prescribed drug that a medicaid provider, consistent with medical or scientific evidence, prescribes for a medicaid recipient's specified medical condition, including both self-administered and physician-administered drugs.

(6) "Urgent care services" has the same meaning as in section 3922.041 of the Revised Code.

(B) If the department of medicaid utilizes a step therapy protocol for the medicaid program under which it is recommended that prescribed drugs be taken in a specific sequence, the department shall do all of the following:

(1) Implement that step therapy protocol using clinical review criteria that are based on clinical practice guidelines or medical or scientific evidence. The department shall take into account the needs of atypical patient populations and diagnoses when establishing clinical review criteria.

(2) In a manner consistent with section 5164.7514 of the Revised Code, establish and implement a step therapy exemption process under which medicaid recipients and medicaid providers who prescribe prescribed drugs for medicaid recipients may request and receive a step therapy exemption;

(3)

(a) Make available, to all medicaid providers, a list of all drugs covered by the medicaid program that are subject to a step therapy protocol;

(b) Along with the information required under division (B)(3)(a) of this section, the department of medicaid shall indicate what information or documentation must be provided to the department for a step therapy exemption request to be considered complete. Such information shall be provided for each drug, if the requirements vary according to the drug or protocol in question.

(c) The list required under division (B)(3)(a) of this section, along with all of the required information or documentation described in division (B)(3)(b) of this section, shall be made available on the department of medicaid's web site or provider portal.

(C) This section shall not be construed as requiring the department to set up a new entity to develop clinical review criteria for step therapy protocols.

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