{"data":{"id":"us-ky/krs-304.17a-163","jurisdiction":"us-ky","citation":"KRS 304.17A-163","heading":"Definitions for KRS 304.17A -163 and 304.17A -1631 -- Establishment","body":"of clinical review criteria -- Override of restrictions on medication sequence in\nstep therapy or fail-first protocol.\n(1) As used in this section and KRS 304.17A -1631, unless the context requires\notherwise:\n(a) \"Clinical practice guidelines\" means a systematically developed statement to\nassist decision making by health care providers and patients about appropriate\nhealthcare for specific clinical circumstances and conditions;\n(b) \"Clinical review criteria\" means the written screening procedures, decision\nabstracts, clinical protocols, and clinical practice guidelines used by the\ninsurer, health plan, pharmacy benefit manager, or private review agent to\ndetermine the medical necessity and appropriateness of health care services;\n(c) \"Health plan\":\n1. Means any state-regulated policy, certificate, contract, or plan that offers\nor provides coverage in this state, by direct payment, reimbursement, or\notherwise, for prescrip tion drugs pursuant to a step therapy protocol,\nregardless of whether the protocol is described as a step therapy\nprotocol; and\n2. Shall include but not be limited to a health benefit plan;\n(d) \"Pharmacy benefit manager\" has the same meaning as in KRS 304.9-020;\n(e) \"Private review agent\" has the same meaning as in KRS 304.17A-600;\n(f) \"Step therapy exception\" means a determination that a step therapy protocol\nshould be overridden in favor of immediate coverage of the health care\nprovider's selected prescription drug; and\n(g) \"Step therapy protocol\" means a protocol, policy, or program t hat establishes\nthe specific sequence in which prescription drugs that are for a specified\nmedical condition and medically appropriate for a particular insured are\ncovered by an insurer or health plan.\n(2) (a) Except as provided in paragraph (b) of this su bsection, clinical review criteria\ndeveloped by an insurer, health plan, pharmacy benefit manager, or private\nreview agent to establish a step therapy protocol shall be based on clinical\npractice guidelines that:\n1. Recommend that prescription drugs be tak en in the specific sequence\nrequired by the step therapy protocol;\n2. Are developed and endorsed by a multidisciplinary panel of experts that\nmanages conflicts of interest among the members of the writing and\nreview groups by:\na. Requiring members to:\ni. Disclose any potential conflict of interests with entities,\nincluding insurers, health plans, and pharmaceutical\nmanufacturers; and\nii. Recuse himself or herself from voting if the member has a\nconflict of interest;\nb. Using a methodologist to work with wri ting groups to provide\nobjectivity in data analysis and ranking of evidence through the\npreparation of evidence tables and facilitating consensus; and\nc. Offering opportunities for public review and comments;\n3. Are based on high quality studies, research, and medical practice;\n4. Are created by an explicit and transparent process that:\na. Minimizes biases and conflicts of interest;\nb. Explains the relationship between treatment options and outcomes;\nc. Rates the quality of the evidence supporting recommend ations;\nand\nd. Considers relevant patient subgroups and preferences; and\n5. Are continually updated through a review of new evidence, research,\nand newly developed treatments.\n(b) In the absence of clinical practice guidelines that meet the requirements of\nparagraph (a) of this subsection, an insurer, health plan, pharmacy benefit\nmanager, or private review agent may use peer -reviewed publications to\nestablish step therapy protocols.\n(c) When establishing clinical review criteria for a step therapy protocol , an\ninsurer, health plan, pharmacy benefit manager, or private review agent shall\ntake into account the needs of atypical patient populations and diagnoses.\n(d) 1. An insurer, health plan, pharmacy benefit manager, or private review\nagent shall, upon writ ten request, provide all specific written clinical\nreview criteria relating to a particular condition or disease, including\nclinical review criteria relating to a step therapy exception\ndetermination.\n2. The clinical review criteria and other clinical info rmation shall be made\navailable:\na. On the insurer's, health plan's, pharmacy benefit manager's, or\nprivate review agent's website; and\nb. To a health care professional on behalf of an insured upon written\nrequest.\n(e) Nothing in this subsection shall be construed to require an insurer, health plan,\npharmacy benefit manager, or private review agent to establish a new entity to\ndevelop clinical review criteria used for step therapy protocols.\n(3) (a) When coverage of a prescription drug for the treatment of any medical\ncondition is restricted for use by an insurer, health plan, private review agent,\nor a pharmacy benefit manager by a step therapy protocol, the insured and\nprescribing provider shall hav e access to a clear, readily accessible, and\nconvenient process to request a step therapy exception.\n(b) An insurer, health plan, private review agent, or pharmacy benefit manager:\n1. May use its existing medical exceptions process to satisfy the\nrequirements of paragraph (a) of this subsection;\n2. Shall make the step therapy protocol easily accessible on its website;\nand\n3. Shall, upon request, disclose all rules and criteria related to the step\ntherapy protocol to all prescribing providers, including the specific\ninformation and documentation that must be submitted by a prescribing\nprovider or insured to be considered a complete request for a step\ntherapy exception.\n(4) (a) A step therapy exception request, or an internal appeal under KRS 304.17A -\n617 of a step therapy exception request denial, shall be granted by the insurer,\nhealth plan, private review agent, or the pharmacy benefit manager within\nforty-eight (48) hours if:\n1. All necessary information to perform the step therapy exception review,\nor make the appeal determination, has been provided; and\n2. One (1) of the following apply:\na. The required prescription drug is:\ni. Contraindicated or will likely cause an adverse reaction by\nphysical or mental harm to the insured; or\nii. Expected to be ineffecti ve based on the known clinical\ncharacteristics of the insured and the prescription drug\nregimen;\nb. Based on clinical appropriateness, the required prescription drug is\nnot in the best interest of the insured because the insured's use of\nthe required prescription drug is expected to:\ni. Cause a significant barrier to the insured's adherence to or\ncompliance with the insured's plan of care;\nii. Worsen a comorbid condition of the insured; or\niii. Decrease the insured's ability to achieve or maintain\nreasonable functional ability in performing daily activities;\nc. The insured has tried the required prescription drug while under\nthe insured's current or a previous health plan, or another\nprescription drug in the same pharmacologic class or with the\nsame mechanis m of action, and the prescription drug was\ndiscontinued due to lack of efficacy or effectiveness, diminished\neffect, or an adverse event; or\nd. The insured is stable on the prescription drug selected by the\ninsured's health care provider for the medical co ndition under\nconsideration while under a current or previous health plan.\n(b) If a request for a step therapy exception, or an internal appeal under KRS\n304.17A-617 of a step therapy exception request denial, is incomplete or\nadditional clinically relevan t information is required, the insurer, health plan,\npharmacy benefit manager, or private review agent shall notify the prescribing\nprovider within forty-eight (48) hours of submission of the request or appeal:\n1. That the request or appeal is incomplete; and\n2. What additional or clinically relevant information is required in order to\napprove or deny the step therapy exception.\n(5) If a step therapy exception request determination, notification under subsection\n(4)(b) of this section, or internal appeal determination under KRS 304.17A-617 of a\nstep therapy exception request denial by an insurer, health plan, pharmacy benefit\nmanager, or private review agent is not received by the prescribing provider within\nthe time period specified in subsection (4) of this section, the step therapy exception\nrequest or internal appeal shall be deemed granted.\n(6) An insured or a provider may:\n(a) Initiate an internal appeal under KRS 304.17A -617 upon the denial of a step\ntherapy exception request under this section; and\n(b) Request an external review under KRS 304.17A -623 upon the denial of an\ninternal appeal under paragraph (a) of this subsection.\n(7) An insurer, health plan, pharmacy benefit manager, or private review agent shall:\n(a) Upon the granting of a step therapy exception request, internal appeal, or\nexternal review, authorize coverage for the prescription drug selected by the\ninsured's health care provider; or\n(b) Upon the denial of a step therapy exception request or internal appeal, inform\nthe insured of the internal appeal or external review process, as applicable.\n(8) (a) Except as provided in paragraph (b) of this subsection, the duration of any\nstep therapy protocol shall not be longer than a period of thirty (30) days if the\ntreatment is deemed and documented as clinically ineffective by the\nprescribing provider.\n(b) When the prescribing provider can demonstrate, through sound clinical\nevidence, that the originally prescribed medication is likely to require more\nthan thirty (30) days to provide any relief or an amelioration to the insured,\nthe step therapy protocol may be extended up to seven (7) additional days.\n(9) Nothing in this section shall be construed to prevent:\n(a) An insurer, health plan, pharmacy benefit manager, or private review agent\nfrom requiring an insured to try:\n1. An AB -rated generic equivalent prior to providing coverage for the\nreference listed drug;\n2. An interchange able biological product, as defined in 42 U.S.C. sec.\n262(i)(3), prior to providing coverage for the reference product; or\n3. A biosimilar biological product, as defined in 42 U.S.C. sec. 262(i)(2),\nprior to providing coverage for the reference product;\nunless the requirement meets any of the criteria set forth in subsection (4)(a)2.\nof this section pursuant to a step therapy exception request submitted under\nsubsection (4) of this section;\n(b) An insurer, health plan, pharmacy benefit manager, or private review agent\nfrom requiring a pharmacist to effect substitutions of prescription drugs\nconsistent with KRS 217.814 to 217.896 and 304.17A-535; or\n(c) A health care provider from prescribing a prescription drug that is determined\nto be medically appropriate.","path":[],"source_url":"https://apps.legislature.ky.gov/law/statutes/statute.aspx?id=54758","current_through":"Includes enactments through the 2026 Regular Session","vintage":"09/05/2026","retrieved_at":"2026-09-05T20:57:46Z","sha256":"f12c0e441e29f67e8a9e4f2a5c9b5dcd0d54bc4c030155b9c652ef82a6189c55","source_id":"us-ky","stale":false,"prev":"us-ky/krs-304.17a-162","next":"us-ky/krs-304.17a-1631"},"notice":"GroundRules: Original legal text. Not legal advice."}