Amends TCA Title 8; Title 33; Title 53; Title 56; Title 63 and Title 71.

This bill establishes clinical review criteria requirements in regard to an insurer's step therapy protocols for prescription drug coverage, as discussed below. This bill will apply to a group health plan or health insurance coverage offered in connection with a group health plan that provides coverage for a prescription drug pursuant to a policy that meets the definition of a medication step therapy protocol, regardless of whether the policy is described as a step therapy protocol, and includes a state or local insurance program and a managed care organization contracting with the state to provide insurance through the TennCare program. "Step therapy protocol" means a protocol, policy, or program that establishes a specific sequence in which prescription drugs for a specified medical condition, and is medically appropriate for a particular patient, are covered by an insurer or health plan. "Clinical review criteria" means the written screening procedures, decision abstracts, clinical protocols, and clinical practice guidelines used by an insurer, health plan, or utilization review organization to determine the medical necessity and appropriateness of healthcare services. This bill requires that clinical review criteria used to establish a step therapy protocol must be based on clinical practice guidelines that: (1) Recommend that the prescription drugs be taken in the specific sequence required by the step therapy protocol; (2) Are developed and endorsed by a multidisciplinary panel of experts that manages conflicts of interest among the members of the writing and review groups by: (A) Requiring members to disclose any potential conflict of interest with an entity, including an insurer, a health plan, and a pharmaceutical manufacturer, and recuse themselves from voting if the member has a conflict of interest; (B) Using a methodologist to work with writing and review groups to provide objectivity in data analysis and ranking of evidence through the preparation of evidence tables and facilitating consensus; and (C) Offering opportunities for public review and comment; (3) Are based on high quality studies, research, and medical practice; (4) Are created by an explicit and transparent process that minimizes biases and conflicts of interest, explains the relationship between treatment options and outcomes, rates the quality of the evidence supporting recommendations, and considers relevant patient subgroups and preferences; and (5) Are continually updated through a review of new evidence, research, and newly developed treatments. This bill provides that in the absence of clinical practice guidelines that meet the above requirements, peer-reviewed publications may be substituted. This bill requires utilization review agents to take into account, when establishing clinical review criteria for a step therapy protocol, the needs of atypical patient populations and diagnoses. This bill specifies that it does not require an insurer, a health plan, or this state to establish a new entity to develop clinical review criteria used for step therapy protocols. This bill requires, in situations where coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer, health plan, or utilization review organization through the use of a step therapy protocol, that the patient and prescribing practitioner have access to a process to request a step therapy exception. An insurer, health plan, or utilization review organization will grant a step therapy exception if: (1) The required prescription drug is contraindicated or will likely cause an adverse reaction by, or physical or mental harm to, the patient; (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 patient, while under the current or a previous health insurance or health plan, has previously tried: the required prescription drug or another prescription drug in the same pharmacologic class or with the same mechanism of action as the required prescription drug, and the other prescription drug was discontinued due to a lack of efficacy or effectiveness, a diminished effect, or an adverse event; (4) The required prescription drug is not in the best interest of the patient, based on medical necessity; or (5) The 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 insurance or health plan. This bill requires the insurer, health plan, or utilization review organization to grant or deny a step therapy exception request or an appeal within 72 hours of receipt. However, if an emergency medical condition exists, then an insurer, health plan, or utilization review organization must respond within 24 hours of receipt. If a response by an insurer, health plan, or utilization review organization is not received within the time period required, then the exception will be granted. For the purpose of promulgating rules, this bill will take effect upon becoming a law. For all other purposes, this bill will take effect January 1, 2022, and apply to agreements for health insurance or health plans entered into, issued, delivered, amended, or renewed on or after that date. ON MARCH 31, 2022, THE SENATE ADOPTED AMENDMENT #1 AND PASSED SENATE BILL 1310, AS AMENDED. AMENDMENT #1 rewrites this bill to require a health carrier, health benefit plan, or utilization review organization that denies coverage of a prescription drug for the treatment of a medical condition through the use of a step therapy protocol to provide access to a clear, readily accessible, and convenient process for a patient or prescribing practitioner to request a step therapy exception. This amendment provides that "step therapy exception" occurs when a step therapy protocol is overridden in favor of immediate coverage of the healthcare provider's selected prescription drug. This amendment provides that a health carrier, health benefit plan, or utilization review organization may use its existing medical exceptions process to satisfy this requirement. This amendment requires a health carrier, health benefit plan, or utilization review organization to grant a step therapy exception if: (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. Under this amendment, upon granting a step therapy exception, the health carrier, health benefit plan, or utilization review organization will 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. This amendment requires a health carrier, health benefit plan, or utilization review organization to grant or deny a step therapy exception request or an appeal within the turnaround times established pursuant to the Health Care Service Utilization Review Act. If a response by a health carrier, health benefit plan, or utilization review organization is not received within that time period, then the exception will be granted. A step therapy exception is eligible for appeal by an insured. This amendment specifies that the use of pharmaceutical samples of a required prescription drug will not be considered a trial of the required prescription drug as part of a step therapy protocol. ON APRIL 18, 2022, THE HOUSE SUBSTITUTED SENATE BILL 1310 FOR HOUSE BILL 677, ADOPTED AMENDMENT #3, AND PASSED SENATE BILL 1310, AS AMENDED. AMENDMENT #3 clarifies that the grant therapy exception will be granted if one of the circumstances described above in items (1)-(4) of the summary for Senate Amendment #1 applies.