Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to provide reimbursement for Gentamicin-Nifedipine-Typsin-Polymyxin B-Urea compound gel claims. The Plan did not grant this request. We received this case to conduct an independent review.A written request for Reconsideration must be filed within 60 days from the date of the Plan's Redetermination Letter. This request was not filed within the required 60-day time limit. However, the case record reflects there is good cause for the late filing. Therefore, the Reconsideration request is being processed.Our decision is that the Plan is not required to cover or provide reimbursement for Gentamicin-Nifedipine-Typsin-Polymyxin B-Urea compound gel.Medicare law requires that Part D Plans coordinate benefits with SPAPs, other entities providing prescription drug coverage, beneficiaries, and others paying on the beneficiaries' behalf for a period of 3 years from the date on which the prescription for a covered Part D drug was filled. This means that claims for coverage and reimbursement must be submitted to the Plan within 3 years from the date of purchase. In this case, the record shows that the purchase(s) in dispute were made. A request for coverage/reimbursement was not submitted to the Plan. As a result, the claim was not submitted within the Medicare required timeframe of 3 years or less from the date the drug was filled. Therefore, our decision is that the Plan is not required to cover or provide reimbursement for Gentamicin-Nifedipine-Typsin-Polymyxin B-Urea compound gel.Our decision is also that the Plan is not required to cover or provide reimbursement for Gentamicin-Nifedipine-Typsin-Polymyxin B-Urea compound gel.Medicare does not cover drugs that are not FDA approved. Bulk powders used in pharmacy compounding are not reviewed and approved for safety and efficacy by the FDA. We attempted to contact the pharmacy where this drug was compounded. We were unable to obtain sufficient information confirming that the Compound drug purchased from the Pharmacy are FDA approved and compounded using Part D eligible ingredients. We then checked the Centers for Medicare & Medicaid Services (CMS) published list of excluded bulk powder products. Each active ingredient used to compound the prescription is included on this list. Therefore, the Plan is not required to provide reimbursement for Gentamicin-Nifedipine-Typsin-Polymyxin B-Urea compound gel.Please note that sterile water was not included in the list of ingredients in the information provided. There is no proof of purchase of sterile water and the Pharmacy was unable to verify that it was included in the product(s) dispensed on the dates at issue. Therefore, the Plan is not required to cover or provide reimbursement for sterile water. This decision does not address the medical necessity or appropriateness of the requested drug. It only establishes that payment cannot be made under the Medicare Part D benefit.Please note: Your complaint regarding the 36-month date for submitting claims, payment regarding sterile water, and difficulty obtaining information from the Plan are grievances. 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 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).