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 is permitted to use a number of different tools to manage its formulary. One of these tools is known as prior authorization. This process requires an enrollee to obtain coverage approval for a drug before the drug is dispensed and covered by the plan. 70 Federal Register No. 18, issued January 28, 2005 (Preamble to Final Rule). Formulary use includes the application of cost utilization tools, including step-therapy, dosage limitations and therapeutic substitution. 42 CFR Section 423.578(b)(iii). The exceptions process extends to coverage requests to set aside cost utilization rules for non-formulary drugs. A Part D plan must grant an exception whenever it determines that the drug is medically necessary, consistent with the prescriber's statement, and that the drug would be covered but for the fact that it is subject to cost utilization rules. 42 CFR Section 423.578(b). The statement must show that all of the covered drugs on any tier of the plan's formulary for treatment of the enrollee's condition would not be as effective as the drug at issue, or would have adverse effects for the enrollee. Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance Manual, Section 40.5.3.A plan may exclude from qualified prescription drug coverage any covered part D drug--(A) for which payment would not be made if Section 1862(a) applied to this part; or (B) which is not prescribed in accordance with the plan or this part. Such exclusions are determinations subject to reconsideration and appeal pursuant to subsections (g) and (h), respectively, of Section 1860D-4. Social Security Act, Section 1860D-2(e)(3)(A). Notwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services--(1)(A) which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,... Social Security Act, Section 1862(a)(1)(A). The following actions by a Part D plan are coverage determinations: (1) A decision not to provide or pay for a Part D drug (including a decision not to pay because the drug is not on the plan's formulary, because the drug is determined not to be medically necessary, because the drug is furnished by an out-of-network pharmacy, or because the Part D plan sponsor determines that the drug is otherwise excludable under section 1862(a) of the Act if applied to Medicare Part D) that the enrollee believes may be covered by the plan. 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 drug utilization management program, quality assurance measures and systems, and a Medication Therapy Management Program (MTMP). 42 CFR Section 423.153(a). A Part D plan must have established a reasonable and appropriate drug utilization management program that addresses the following: incentives to reduce costs when medically appropriate; policies and systems to assist in preventing over-utilization and under-utilization of prescribed medications; providing CMS with information 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 errors and 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 pharmacy practice as established by the States. (2) Concurrent drug utilization review systems, policies, and procedures designed to ensure that a review of the prescribed drug therapy is performed before each prescription is dispensed to an enrollee in a sponsor's Part D plan, typically at the point-of-sale or point of distribution. The review must include, but not be limited to: Screening for potential drug therapy problems due 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.The Part D Plan can only cover drugs prescribed for a medically accepted indication. The Plan requires prior approval (also called prior authorization) before covering some prescription drugs. If prior approval is not obtained, the Plan may not cover the drug. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence of Coverage (EOC).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).