(a) If a health carrier, health benefit plan, or utilization review organization denies coverage of a prescription drug for the treatment of a medical condition through the use of a step therapy protocol, then the health carrier, health benefit plan, or utilization review organization must provide access to a clear, readily accessible, and convenient process for a patient or prescribing practitioner to request a step therapy exception. The process must be easily accessible on the website of the health carrier, health benefit plan, or utilization review organization. A health carrier, health benefit plan, or utilization review organization may use its existing medical exceptions process to satisfy this subsection (a).
(b) A health carrier, health benefit plan, or utilization review organization shall grant a step therapy exception if one (1) of the following applies:(1) The required prescription drug is contraindicated or will likely cause an adverse reaction to, or physical or mental harm to, the patient due to a documented adverse event with a previous use of the required prescription drug or a documented medical condition, including a comorbid condition;(2) The 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) The required prescription drug is not in the best interest of the patient, based on clinical appropriateness, because the patient's use of the drug is expected to:(A) Cause a significant barrier to the patient's adherence to or compliance with the patient's plan of care;(B) Worsen a comorbid condition of the patient; or(C) Decrease the patient's ability to achieve or maintain reasonable functional ability in performing daily activities; or(4) The patient is currently receiving a positive therapeutic outcome on a prescription drug selected by the patient's healthcare provider for the medical condition under consideration while on a current or previous health insurance or health benefit plan, and the patient's healthcare provider gives documentation to the health insurance, health benefit plan, or utilization review organization that the change in prescription drug required by the step therapy protocol is expected to be ineffective or cause harm to the patient based on the known characteristics of the specific enrollee and the known characteristics of the required prescription drug.
(1) The required prescription drug is contraindicated or will likely cause an adverse reaction to, or physical or mental harm to, the patient due to a documented adverse event with a previous use of the required prescription drug or a documented medical condition, including a comorbid condition;
(2) The 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) The required prescription drug is not in the best interest of the patient, based on clinical appropriateness, because the patient's use of the drug is expected to:(A) Cause a significant barrier to the patient's adherence to or compliance with the patient's plan of care;(B) Worsen a comorbid condition of the patient; or(C) Decrease the patient's ability to achieve or maintain reasonable functional ability in performing daily activities; or
(A) Cause a significant barrier to the patient's adherence to or compliance with the patient's plan of care;
(B) Worsen a comorbid condition of the patient; or
(C) Decrease the patient's ability to achieve or maintain reasonable functional ability in performing daily activities; or
(4) The patient is currently receiving a positive therapeutic outcome on a prescription drug selected by the patient's healthcare provider for the medical condition under consideration while on a current or previous health insurance or health benefit plan, and the patient's healthcare provider gives documentation to the health insurance, health benefit plan, or utilization review organization that the change in prescription drug required by the step therapy protocol is expected to be ineffective or cause harm to the patient based on the known characteristics of the specific enrollee and the known characteristics of the required prescription drug.
(c) Upon granting a step therapy exception, the health carrier, health benefit plan, or utilization review organization shall authorize coverage for the prescription drug prescribed by the patient's treating healthcare provider if the prescription drug is covered under the current health insurance, health benefit plan, or utilization review organization.
(d) The health carrier, health benefit plan, or utilization review organization shall grant or deny a step therapy exception request or an appeal within the turnaround times established pursuant to § 56-6-705. If a response by a health carrier, health benefit plan, or utilization review organization is not received within that time period, then the exception is granted.
(e) A step therapy exception is eligible for appeal by an insured.
(f) This section does not prevent:(1) A health carrier, health benefit plan, or utilization review organization from requiring a patient to try an AB-rated generic equivalent product, interchangeable biological product, or biosimilar product prior to providing coverage for the equivalent branded prescription drug;(2) A health carrier, health benefit plan, or utilization review organization from requiring a pharmacist to substitute a prescription drug consistent with the laws of this state; or(3) A healthcare provider from prescribing a prescription drug that is determined to be medically appropriate.
(1) A health carrier, health benefit plan, or utilization review organization from requiring a patient to try an AB-rated generic equivalent product, interchangeable biological product, or biosimilar product prior to providing coverage for the equivalent branded prescription drug;
(2) A health carrier, health benefit plan, or utilization review organization from requiring a pharmacist to substitute a prescription drug consistent with the laws of this state; or
(3) A healthcare provider from prescribing a prescription drug that is determined to be medically appropriate.
(g) The use of pharmaceutical samples of a required prescription drug is not considered a trial of the required prescription drug as part of a step therapy protocol.
(h) (1) Notwithstanding this section, and except as provided in subdivision (h)(3), a health benefit plan that provides coverage for stage 4 advanced metastatic cancer, metastatic blood cancer, and associated conditions shall not require use of a step therapy protocol before the health benefit plan provides coverage of an approved prescription drug to an enrollee who has received a diagnosis of stage 4 advanced metastatic cancer or metastatic blood cancer.(2) For an approved prescription drug prescribed for an associated condition in this section, the treating healthcare provider shall inform the health benefit plan that the condition is an associated condition of stage 4 advanced metastatic cancer or metastatic blood cancer when requesting authorization.(3) This subsection (h) does not apply to the group insurance plans offered under title 8, chapter 27.(4) This subsection (h) does not prevent a health carrier, health benefit plan, or utilization review organization from requiring a patient to try an AB-rated generic equivalent product, interchangeable biological product, or biosimilar product prior to providing coverage for the equivalent branded prescription drug.(5) Each treating healthcare provider who prescribes an approved prescription drug to a patient pursuant to this section shall submit an annual report to the department of health by such date and in such manner as the commissioner of health may prescribe by rule, that includes the number of stage 4 advanced metastatic cancer and metastatic blood cancer cases treated, the approved prescription drug involved in treatment, and the overall six-month survival rate for the cases treated.(6) As used in this subsection (h), “approved prescription drug” means a prescription drug that is:(A) Approved by the United States food and drug administration;(B) Consistent with best practices for the treatment of stage 4 advanced metastatic cancer or metastatic blood cancer;(C) Supported by peer-reviewed, evidence-based literature consistent with the National Comprehensive Cancer Network Drugs and Biologics Compendium for the treatment of stage 4 advanced metastatic cancer or metastatic blood cancer; and(D) On the health benefit plan's prescription drug formulary.
(1) Notwithstanding this section, and except as provided in subdivision (h)(3), a health benefit plan that provides coverage for stage 4 advanced metastatic cancer, metastatic blood cancer, and associated conditions shall not require use of a step therapy protocol before the health benefit plan provides coverage of an approved prescription drug to an enrollee who has received a diagnosis of stage 4 advanced metastatic cancer or metastatic blood cancer.
(2) For an approved prescription drug prescribed for an associated condition in this section, the treating healthcare provider shall inform the health benefit plan that the condition is an associated condition of stage 4 advanced metastatic cancer or metastatic blood cancer when requesting authorization.
(3) This subsection (h) does not apply to the group insurance plans offered under title 8, chapter 27.
(4) This subsection (h) does not prevent a health carrier, health benefit plan, or utilization review organization from requiring a patient to try an AB-rated generic equivalent product, interchangeable biological product, or biosimilar product prior to providing coverage for the equivalent branded prescription drug.
(5) Each treating healthcare provider who prescribes an approved prescription drug to a patient pursuant to this section shall submit an annual report to the department of health by such date and in such manner as the commissioner of health may prescribe by rule, that includes the number of stage 4 advanced metastatic cancer and metastatic blood cancer cases treated, the approved prescription drug involved in treatment, and the overall six-month survival rate for the cases treated.
(6) As used in this subsection (h), “approved prescription drug” means a prescription drug that is:(A) Approved by the United States food and drug administration;(B) Consistent with best practices for the treatment of stage 4 advanced metastatic cancer or metastatic blood cancer;(C) Supported by peer-reviewed, evidence-based literature consistent with the National Comprehensive Cancer Network Drugs and Biologics Compendium for the treatment of stage 4 advanced metastatic cancer or metastatic blood cancer; and(D) On the health benefit plan's prescription drug formulary.
(A) Approved by the United States food and drug administration;
(B) Consistent with best practices for the treatment of stage 4 advanced metastatic cancer or metastatic blood cancer;
(C) Supported by peer-reviewed, evidence-based literature consistent with the National Comprehensive Cancer Network Drugs and Biologics Compendium for the treatment of stage 4 advanced metastatic cancer or metastatic blood cancer; and
(D) On the health benefit plan's prescription drug formulary.