RÉSUMÉ DIGEST
ACT 181 (HB 263) 2020 Regular Session Huval
Existing law establishes certain requirements for implementation of step therapy or fail first
protocols used by any health coverage plan.
New law requires the development of a step therapy or fail first protocol to be based on
certain identified clinical review criteria and clinical practice guidelines developed and
endorsed by a multidisciplinary panel of experts. New law does not require health coverage
plans to establish a new entity to develop clinical review criteria and does not prohibit the
substitution of an AB-rated generic equivalent or interchangeable biological product as
designated by the federal Food and Drug Administration (FDA).
Existing law provides for a step therapy or fail first protocol override process to be used by
prescribing physicians.
New law requires the override process to be accessible on a health coverage plan's website
and expands the prescriber class to include practitioners. Further requires a health coverage
plan to grant an override restriction if the prescriber, using sound clinical evidence, can
demonstrate certain patient outcomes to treatment.
Existing law requires the prescriber to demonstrate to a health coverage plan that the
preferred treatment under the step therapy or fail first protocol has been ineffective in treating
the disease or mental condition of the insured.
New law requires the prescriber to demonstrate that a patient tried a current or prior health
coverage plan's required prescribed drug, 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.
Existing law requires the prescriber to demonstrate to a health coverage plan that the
preferred treatment under the step therapy or fail first protocol will likely cause an adverse
reaction or other physical harm to the patient.
New law further requires the prescriber to demonstrate that the preferred treatment is
contraindicated or will cause mental harm to the patient, that the patient has a positive
therapeutic outcome on a certain prescription drug, or that the preferred drug is not in the
best interest of the patient based on medical necessity as evidenced by valid documentation
submitted by the prescriber.
New law requires a health coverage plan's approval of a step therapy or fail first override
request to include clear authorization of coverage for the drug prescribed by the patient's
practitioner, provided the drug is covered by the health coverage plan.
New 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 must approve or deny the override request within 24 hours of receipt.
Further provides that an override request is considered approved if the health coverage plan
fails to comply with the timelines provided in new law.
New law requires a health coverage plan, if the plan denies an override request, to provide
the prescribing practitioner and the patient with reason for the denial, an alternative covered
medication, and information regarding the procedure for submitting an appeal of the denial.
New 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.
New law modifies the definition of "health coverage plan" and "stage-four advanced,
metastatic cancer".
Effective upon signature of governor (June 11, 2020).
(Amends R.S. 22:1053)