Appeal type: unknown
Decision: unknown

Under Medicare rules, 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. A Part D plan must also 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; and providing the Centers for Medicare & Medicaid Services with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by the Centers for Medicare & Medicaid Services. 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; and 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; and clinical abuse/misuse.A Part D sponsor must have established a Medication Therapy Management Program that: 1) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries previously described are appropriately used to optimize therapeutic outcomes through improved medication use; 2) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries previously described; 3) May be furnished by a pharmacist or other qualified provider; 4) May distinguish between services in ambulatory and institutional settings; 5) Must enroll targeted beneficiaries using an opt-out method of enrollment only; 6) Must target beneficiaries for enrollment in the Medication Therapy Management Program at least quarterly during each plan year; and 7) Must offer a minimum level of medication therapy management services for each beneficiary enrolled in the Medication Therapy Management Program. [42 Code of Federal Regulations Section 423.153(a)-(d)]A Part D Plan sponsor is required to grant an exception whenever it determines that the requested non-preferred drug for treatment of the enrollee's condition is medically necessary, consistent with the physician's or other prescriber's statement. A prescribing physician or other prescriber must provide an oral or written supporting statement that the preferred drug(s) for the treatment of the enrollee's condition would not be as effective for the enrollee as the requested drug and/or would have adverse effects for the enrollee. [42 Code of Federal Regulations Sections 423.578(a)(4) and 423.578(a)(6); the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication  100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.4]A Part D sponsor is responsible for ensuring that covered Part D drugs are prescribed for medically accepted indications using the tools and data available to them to make such determinations. Part D sponsors must reference all the Centers for Medicare & Medicaid Services recognized compendia to determine whether there are any supportive citations, prior to determining that a drug is not being used for a medically accepted indication. Part D sponsors may rely on utilization management policies and procedures, approved by the Centers for Medicare & Medicaid Services where required (see the Centers for Medicare & Medicaid Services Internet Only Manual Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.2.1), to make such determinations. A medically accepted indication is defined in part by reference to Section 1927(k)(6) of the Social Security Act, to any use of a covered Part D drug which is approved under the Federal Food, Drug, and Cosmetic Act, or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in Section 1927(g)(1)(B)(i) of the Act. The recognized compendia are: 1) American Hospital Formulary Service Drug Information, and 2) DRUGDEX Information System. [Section 1860D-2(e)(4) of the Social Security Act and 42  Code of Federal Regulations Section 423.100]