(a)(1) If coverage of a prescription drug for the treatment of any medical condition is restricted for use by a healthcare insurer, health benefit plan, or utilization review organization through the use of a step therapy protocol, a patient and prescribing healthcare provider shall have access to a clear, readily accessible, and convenient process to request a step therapy protocol exception.
(2)(A) A healthcare insurer, health benefit plan, or utilization review organization may use its existing medical exceptions process to satisfy the requirement under subdivision (a)(1) of this section.
(B)The existing medical exceptions process shall be made easily accessible on the website of the healthcare insurer, health benefit plan, or utilization review organization.
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(a) (1) If coverage of a prescription drug for the treatment of any medical condition is restricted for use by a healthcare insurer, health benefit plan, or utilization review organization through the use of a step therapy protocol, a patient and prescribing healthcare provider shall have access to a clear, readily accessible, and convenient process to request a step therapy protocol exception. (2) (A) A healthcare insurer, health benefit plan, or utilization review organization may use its existing medical exceptions process to satisfy the requirement under subdivision (a)(1) of this section. (B) The existing medical exceptions process shall be made easily accessible on the website of the healthcare insurer, health benefit plan, or utilization review organization. (C) Upon request, a healthcare insurer, health benefit plan, or utilization review organization shall disclose to a prescribing healthcare provider all rules and clinical review criteria related to the step therapy protocol, including without limitation the specific information and documentation that is required to be submitted by a prescribing healthcare provider or patient to the healthcare insurer, health benefit plan, or utilization review organization to be considered a complete step therapy protocol exception request. (b) A step therapy protocol exception shall be expeditiously granted if: (1) A required prescription drug is contraindicated or will likely cause an adverse reaction or physical or mental harm to the patient; (2) A required prescription drug is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen; (3) A patient has tried the required prescription drug while under the patient's current or previous health benefit plan, or another prescription drug in the same pharmacologic class or with the same mechanism of action and the prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event; (4) A required prescription drug is not in the best interest of the patient, based on medical necessity; or (5) A patient is stable on a prescription drug selected by the patient's healthcare provider for the medical condition under consideration while on a current or previous health benefit plan. (c) (1) The healthcare insurer, health benefit plan, or utilization review organization shall grant or deny a request for a step therapy protocol exception within seventy-two (72) hours of receiving the request. (2) In cases in which exigent circumstances exist, the healthcare insurer, health benefit plan, or utilization review organization shall grant or deny the request within twenty-four (24) hours of receiving the request. (d) (1) A patient covered by a healthcare insurer under a health benefit plan may appeal the denial of a request for a step therapy protocol exception. (2) The health benefit plan shall grant or deny the appeal within seventy-two (72) hours of receiving the appeal. (3) In cases in which exigent circumstances exist, the health benefit plan shall grant or deny the appeal within twenty-four (24) hours of receiving the appeal. (e) If a response by a healthcare insurer, health benefit plan, or utilization review organization is not received within the time allotted under this section, the request for a step therapy protocol exception or the appeal of a denial of such a request shall be deemed granted. (f) (1) If a request for a step therapy protocol exception is incomplete or additional clinically relevant information is required, a healthcare insurer, health benefit plan, or utilization review organization shall notify the prescribing healthcare provider within seventy-two (72) hours of submission, or twenty-four (24) hours in exigent circumstances, of the additional or clinically relevant information that is required in order to approve or deny the step therapy protocol exception request or appeal as described under subdivision (a)(1) of this section. (2) Once the requested information is submitted, the applicable time period to grant or deny a step therapy protocol exception request or appeal shall apply. (3) If a determination or notice of incomplete or clinically relevant information by a healthcare insurer, health benefit plan, or utilization review organization is not received by the prescribing healthcare provider within the time allotted, the step therapy protocol exception or appeal shall be deemed granted. (4) In the event of a denial, a healthcare insurer, health benefit plan, or utilization review organization shall inform the patient of a potential appeal process. (g) Upon the granting of a step therapy protocol exception, a healthcare insurer, health benefit plan, or utilization review organization shall authorize coverage for the prescription drug prescribed by the patient's treating healthcare provider. (h) This section shall not be construed to prevent: (1) A healthcare insurer, a health benefit plan, or a utilization review organization from requiring: (A) A patient to try a generic equivalent, interchangeable biological product, or biosimilar medical product unless such a requirement meets subsection (b) of this section pursuant to a step therapy protocol exception request submitted under subsection (b) of this section; or (B) A pharmacist to effect substitutions of prescription drugs consistent with § 17-92-503 ; or (2) A healthcare provider from prescribing a prescription drug that is determined to be medically necessary.