DIGEST The digest printed below was prepared by House Legislative Services. It constitutes no part of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)] HB 263 Engrossed 2020 Regular Session Huval Abstract: Provides for clinical review criteria and use of clinical practice guidelines to be used as minimum standards in developing a step therapy or fail first protocol and a process to request an override of step therapy or fail first protocol requirements. Present law establishes certain requirements for implementation of step therapy or fail first protocols used by any health coverage plan. Proposed law retains present law and further requires the development of the step therapy or fail first protocol to be based on clinical review criteria and clinical practice guidelines that are developed and endorsed by a multidisciplinary panel of experts based on certain identified criteria. Proposed law does not require the health coverage plan to establish a new entity to develop clinical review criteria. Present law provides for a step therapy or fail first protocol override process to be used by prescribing physicians. Proposed law retains present law but adds the requirement that the override process be accessible on the health coverage plan's website and expands the permitted prescriber class from a physician to a practitioner. Present law provides for an opportunity for the prescriber to demonstrate to the health coverage plan that the preferred treatment has been ineffective in treating the disease or mental condition of the insured. Proposed law retains present law and provides additional criteria in which a prescriber can demonstrate that the patient tried the required prescription drug under a current or prior health coverage plan, or another drug in the same drug class, and it was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event. Present law provides the prescriber with an opportunity to demonstrate to the health coverage plan that the preferred treatment will cause or will likely cause an adverse reaction or other physical harm to the patient. Proposed law retains present law and further allows the prescriber to demonstrate that the preferred treatment is contraindicated or will cause mental harm to the patient, that the patient is stable on a certain prescription drug, or that the preferred drug is not in the best interest of the patient based on medical necessity. Proposed law requires for a drug deemed not in the best interest of the patient, based on medical necessity, to be evidenced by valid documentation submitted by the prescriber. Proposed law requires a health coverage plan to approve or deny a step therapy or fail first protocol override request within 72 hours of receipt, except, in exigent circumstances, the health coverage plan shall approve or deny a step therapy or fail first protocol override request within 24 hours of receipt. Proposed law provides that failure by a health coverage plan to comply with the timelines in proposed law shall cause the override request to be considered approved. Proposed law requires a practitioner or healthcare provider, in the case of an appeal, to consider atypical diagnoses and the needs of atypical patient populations when deciding on appeals. Proposed law requires a health coverage plan, if the plan denies an override request, to provide the prescribing practitioner and the patient with the reason for the denial, an alternative covered medication, and information regarding the procedure for submitting an appeal of the denial. Proposed law updates definitions for "health coverage plan" and "stage-four advanced, metastatic cancer". (Amends R.S. 22:1053) Summary of Amendments Adopted by House The Committee Amendments Proposed by House Committee on Insurance to the original bill: 1. Clarify that a multidisciplinary panel of experts will review and research certain treatments to update clinical review criteria and clinical practice guidelines. 2. Require for a drug deemed not in the best interest of the patient, based on medical necessity, to be evidenced by valid documentation submitted by the prescriber. 3. Require a practitioner or healthcare provider, in the case of an appeal, to consider atypical diagnoses and the needs of atypical patient populations when deciding on appeals. 4. Make technical changes.