Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D plan must have enough contracted retail pharmacies in its network to ensure that enrollees have adequate access to covered prescription drugs. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1.For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The Social Security Act generally defines a Part D drug as a drug product that meets the following requirements:-It requires a prescription for dispensing; and-It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and-It is prescribed for a medically accepted indication; and-It is not otherwise excluded from coverage under Part D law and rules.See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1.The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2.If a plan sponsor does not have all of the information it needs to make a decision, the plan sponsor should make reasonable and diligent efforts to obtain the missing information within the standard timeframe for making a decision and notifying the enrollee of the decision (i.e., within 72 hours after receiving the request or physician's or other prescriber's supporting statement). When a plan sponsor could acquire missing information, such as a National Drug Code (NDC) number, by contacting the enrollee's pharmacist, physician, or other prescriber, it should do so instead of relying on the enrollee to provide the information. Prescription Drug Benefit Manual, Chapter 18, ?30.3.2.Occasionally, a plan sponsor will have enough information to determine that a reimbursement request is payable, but not enough to determine the exact amount. When this situation occurs, the plan sponsor could issue a favorable decision within the 72-hour timeframe (the plan sponsor is not required to say how much the payment will be in its notice to the enrollee), and utilize the remainder of the 30-day payment period described in ??40.2 and 130.1 of this chapter to determine how much the enrollee should be reimbursed and make payment. If a plan sponsor chooses to send the payment within the 30-day timeframe after notifying the enrollee of the favorable decision within the 72-hour timeframe, the initial notice to the enrollee must include the following information: 1) the plan sponsor is approving the request; 2) payment will be sent within 30 days after the request was received; 3) if the enrollee does not agree with the amount received, he or she can request an appeal with the plan sponsor; and 4) briefly explain that the member may not receive the entire amount he or she paid out-of-pocket because certain items (e.g., co-payment amounts) are not reimbursable, and include a brief summary of items that are generally subtracted. Prescription Drug Benefit Manual, Chapter 18, ?30.3.2.The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage.