Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will findabbreviated 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 haveadequate access to covered prescription drugs. Access to covered drugs from an out-of-network pharmacyis required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacyand (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required toestablish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42CFR ?423.120 and ?423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, ?60.1.If a plan sponsor does not have all of the information it needs to make a decision, the plan sponsor shouldmake reasonable and diligent efforts to obtain the missing information within the standard timeframe formaking a decision and notifying the enrollee of the decision (i.e., within 72 hours after receiving therequest or physician's or other prescriber's supporting statement). When a plan sponsor could acquiremissing information, such as a National Provider Identifier (NPI) number, by contacting the enrollee'spharmacist, physician, or other prescriber, it should do so instead of relying on the enrollee to provide theinformation. Prescription Drug Benefit Manual, Chapter 18, ?30.3.2.Occasionally, a plan sponsor will have enough information to determine that a reimbursement request ispayable, but not enough to determine the exact amount. When this situation occurs, the plan sponsor couldissue a favorable decision within the 72-hour timeframe (the plan sponsor is not required to say how muchthe payment will be in its notice to the enrollee), and utilize the remainder of the 30-day payment perioddescribed in ??40.2 and 130.1 of this chapter to determine how much the enrollee should be reimbursedand make payment. If a plan sponsor chooses to send the payment within the 30-day timeframe afternotifying the enrollee of the favorable decision within the 72-hour timeframe, the initial notice to theenrollee must include the following information: 1) the plan sponsor is approving the request; 2) paymentwill be sent within 30 days after the request was received; 3) if the enrollee does not agree with the amountreceived, he or she can request an appeal with the plan sponsor; and 4) briefly explain that the member maynot receive the entire amount he or she paid out-of-pocket because certain items (e.g., co-paymentamounts) are not reimbursable, and include a brief summary of items that are generally subtracted.Prescription Drug Benefit Manual, Chapter 18, ?30.3.2.]A Part D plan is permitted to use a number of different tools to manage its formulary, including priorauthorization, step therapy and dose restriction, or quantity limits. 70 Federal Register No. 18, issuedJanuary 28, 2005 (Preamble to Final Rule); 42 CFR ?423.578(b)(5)(ii).For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The SocialSecurity 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 PrescriptionDrug 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 arethose drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluationand Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. MedicarePart D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug BenefitManual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2.The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptionsfilled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. ThePlan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for amedical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonabledriving distance or when the prescription is for a drug that is out of stock at an accessible networkpharmacy. If an enrollee must use an out-of-network pharmacy, the enrollee will generally have to pay thefull cost when the prescription is filled. The enrollee may submit a request for reimbursement with proof ofpayment to ask the Plan to pay its share of the cost. The Plan does not cover drugs/items excluded fromMedicare 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 (EOC).