(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).
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Terms Used In Tennessee Code 56-7-3502

  • Appeal: A request made after a trial, asking another court (usually the court of appeals) to decide whether the trial was conducted properly. To make such a request is "to appeal" or "to take an appeal." One who appeals is called the appellant.
  • Interchangeable biological product: means a biological product licensed by the federal food and drug administration and determined to meet the safety standards for determining interchangeability pursuant to 42 U. See Tennessee Code 56-7-3501
  • Prescription drug: means a drug that under federal or state law is required to be dispensed only pursuant to a prescription order or is restricted to use by individuals authorized by law to prescribe drugs. See Tennessee Code 56-7-3501
  • Required prescription drug: means a medication that is required as part of a step therapy protocol. See Tennessee Code 56-7-3501
  • State: when applied to the different parts of the United States, includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
  • Step therapy protocol: means a protocol, policy, or program that establishes a specific sequence in which prescription drugs for a specified medical condition, and medically appropriate for a particular patient, are covered by a health carrier or health benefit plan. See Tennessee Code 56-7-3501
  • Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
  • Utilization review organization: means an entity that conducts utilization review, as defined in §. See Tennessee Code 56-7-3501
(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.
(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 or interchangeable biological 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.
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