Limitations on Step Therapy
(a) If a utilization review entity has required a healthcare provider to utilize step therapy for a specific prescription drug for a subscriber, the utilization review entity shall not require the healthcare provider to utilize step therapy a second time for that same prescription drug, even though the utilization review entity or healthcare insurer may change its prescribed drug formulary or change to a new or different pharmacy benefits manager or utilization review entity.
(b) In order to ensure compliance with this section, if a healthcare insurer or utilization review entity changes its pharmacy benefits manager, the healthcare insurer or utilization review entity shall provide the new pharmacy benefits manager with adequate historical claims data to identify all subscribers who have been required to utilize step therapy and the results of that step therapy.
(c) Except as provided in subsection (d) of this section, notwithstanding subsection (a) of this section, a utilization review entity may require the utilization of step therapy if:
(1) A new drug has been introduced to treat the patient’s condition or an existing therapy is considered clinically appropriate for treatment of the patient’s condition; or
(2) The patient’s medical or physical condition has changed substantially since the step therapy was required that makes the use of repeat step therapy appropriate.
(1) An insurance policy that provides coverage for the treatment of metastatic cancer shall not limit or exclude coverage under the health benefit plan for a drug approved by the United States Food and Drug Administration that is on the prescription drug formulary of the insurance policy by mandating that a covered person with metastatic cancer undergo step therapy unless the preferred drug is consistent with best practices that:
(A) Are used for the treatment of metastatic cancer or associated conditions under:
(i) The United States Food and Drug Administration-approved indication; or
(ii) The National Comprehensive Cancer Network Drugs and Biologics Compendium indication; or
(B) Use evidence-based, peer-reviewed, recognized medical literature.
(2) As used in subdivision (d)(1) of this section, “metastatic cancer” means cancer that has spread from a primary or original site of the cancer to surrounding or nearby tissues, lymph nodes, or other parts of the body.