Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Nuedexta 20-10 mg, #60 per 30 days. The Plan did not grant this request. We received this case to conduct an independent review. Your appeal also involves a grievance.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Nuedexta 20-10 mg capsule 60/30.Nuedexta 20-10 mg capsule 60/30 is requested for ongoing treatment of pseudobulbar affect (PBA) associated with Lewy body dementia. The Plan has indicated in the case file that there is a previous authorization on file for the requested drug; however, they have denied coverage because they state in their denial letter that the following coverage criteria was not met: Documented improvement in CNS-LS score or inappropriate behavior episodes from baseline.The prescriber has submitted information that indicates that the enrollee has satisfied the noted criterion. It is noted that Nuedexta was started in December 12, 2016, at which time his CNS-LS score was 19. The prescriber has indicated that family reported improvement of mood lability at follow up and has reported improvement subsequently. CNS-LS score November 9, 2017, was 12. The test was not formally repeated since that time. Medical records from November 2019 do not indicate that symptoms of PBA/inappropriate behavior were an issue at that time. The enrollee satisfies the Plan's coverage criteria.Our Physician Reviewer's opinion is that prior authorization criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Nuedexta.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.Your appeal also involves a grievance. Your complaint regarding the Plan's denial of coverage for a long-term (up to 90-day) supply for Nuedexta is a grievance. A grievance is any complaint or dispute, other than one that involves a coverage determination or at-risk determination, expressing dissatisfaction with any aspect of the operations, activities, or behavior of a Part D plan. Grievance procedures are separate and distinct from appeal procedures. Medicare defines a coverage determination as (1) a decision not to provide or pay for a Part D drug, (2) failure to provide a coverage determination in a timely manner, when a delay would adversely affect the health of the enrollee, (3) a decision concerning an exceptions request, or (4) a decision on the amount of cost-sharing for a drug. (42 CFR ??423.560, 423.564(b), 423.566(b)).Since your complaint regarding a long-term (up to 90-day) supply for Nuedexta involves a grievance, the Part D Plan must review this complaint under the Plan's grievance procedures. Each Part D Plan must provide meaningful procedures for timely hearing and resolving grievances between enrollees and the Part D Plan (or any other entity or individual through whom the Part D Plan provides covered benefits under any Part D Plan it offers). At this time, you should contact the Plan for information on how to proceed with having this complaint reviewed under the Plan's grievance procedures. 42 CFR Section 423.564(a).