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 Plan may exclude from qualified prescription drug coverage any covered part D drug--(A) for whichpayment would not be made if Section 1862(a) applied to this part; or (B) which is not prescribed inaccordance with the plan or this part. Such exclusions are determinations subject to reconsideration andappeal pursuant to subsections (g) and (h), respectively, of Section 1860D-4. Social Security Act, Section1860D-2(e)(3)(A).Notwithstanding any other provision of this title, no payment may be made under part A or part B for anyexpenses incurred for items or services--(1)(A) which, except for items and services described in asucceeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness orinjury or to improve the functioning of a malformed body member,... Social Security Act, Section1862(a)(1)(A).The following actions by a Part D plan are coverage determinations: (1) A decision not to provide or payfor a Part D drug (including a decision not to pay because the drug is not on the plan's formulary, becausethe drug is determined not to be medically necessary, because the drug is furnished by an out-of-networkpharmacy, or because the Part D plan sponsor determines that the drug is otherwise excludable undersection 1862(a) of the Act if applied to Medicare Part D) that the enrollee believes may be covered by theplan. 42 CFR Section 423.566(b)(1).Each Part D plan must have established, for covered Part D drugs furnished through a Part D plan, a drugutilization management program, quality assurance measures and systems, and a Medication TherapyManagement Program (MTMP). 42 CFR Section 423.153(a).A Part D plan must have established a reasonable and appropriate drug utilization management programthat addresses the following: incentives to reduce costs when medically appropriate; policies and systems toassist in preventing over-utilization and under-utilization of prescribed medications; providing CMS withinformation concerning the procedures and performance of its drug utilization management program,according to guidelines specified by CMS. 42 CFR Section 423.153(b).A Part D plan must have established quality assurance measures and systems to reduce medication errorsand adverse drug interactions and improve medication use that include all of the following--(1)Representation that network providers are required to comply with minimum standards for pharmacypractice as established by the States. (2) Concurrent drug utilization review systems, policies, andprocedures designed to ensure that a review of the prescribed drug therapy is performed before eachprescription is dispensed to an enrollee in a sponsor's Part D plan, typically at the point-of-sale or point ofdistribution. The review must include, but not be limited to: Screening for potential drug therapy problemsdue to therapeutic duplication; Age/gender-related contraindications; Over-utilization and under-utilization;Drug-drug interactions; Incorrect drug dosage or duration of drug therapy; Drug-allergy contraindications;Clinical abuse/misuse. 42 CFR Section 423.153(c).A Part D sponsor must have established a MTMP that--(i) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries described in paragraph (d)(2) of this section are appropriately used to optimize therapeutic outcomes through improved medication use. (ii) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries described in paragraph (d)(2) of this section. (iii) May be furnished by a pharmacist or other qualified provider. (iv) May distinguish between services in ambulatory and institutional settings. (v) Must enroll targeted beneficiaries using an opt-out method of enrollment only. (vi) Must target beneficiaries for enrollment in the MTMP at least quarterly during each plan year. (vii) Must offer a minimum level of medication therapy management services for each beneficiary enrolled in the MTMP... 42 CFR Section 423.153(d). In accordance with Section 1860D-2(e)(3) of the Act, a Part D plan may exclude from qualified prescription drug coverage any Part D drug: 1) For which payment would not be made if items and services are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (except for Part D vaccines); or 2) Which is not prescribed in accordance with the Part D plan. Such exclusions are coverage determinations subject to reconsideration and appeal. Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.4.Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must be used for a medically accepted indication. A medically accepted indication means a use that is approved by the Food and Drug Administration (FDA), or a use supported by one or more citations in the drug compendia approved by Medicare. Medically accepted indications do not include uses in research or uses described in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(6); and 42 CFR Section 423.100.The Plan conducts drug use reviews for enrollees to help make sure that they are getting safe and appropriate care. These reviews are especially important for enrollees who have more than one provider who prescribes their drugs. The Plan does a review each time an enrollee fills a prescription. During these reviews, the Plan looks for potential problems such as possible medication errors, drugs that may not be necessary because the enrollee is taking another drug to treat the same medical condition, drugs that may not be safe or appropriate due to the enrollee's age or gender, certain combinations of drugs that could harm the enrollee if taken at the same time, prescriptions written for drugs that have ingredients the enrollee is allergic to, or possible errors in the amount (dosage) of a drug the enrollee is taking. Please refer to Chapter 3 of the Plan's Evidence of Coverage (EOC).The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).