[Code of Federal Regulations] [Title 42, Volume 3] [Revised as of October 1, 2006] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR423.153] [Page 372-373] TITLE 42--PUBLIC HEALTH CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 423_VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT--Table of Contents Subpart D_Cost Control and Quality Improvement Requirements Sec. 423.153 Drug utilization management, quality assurance, and medication therapy management programs (MTMPs). (a) General rule. Each Part D sponsor 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 an MTMP as described in paragraphs (b), (c), and (d) of this section. (b) Drug utilization management. A Part D sponsor must have established a reasonable and appropriate drug utilization management program that-- (1) Includes incentives to reduce costs when medically appropriate; (2) Maintains policies and systems to assist in preventing over- utilization and under-utilization of prescribed medications; and (3) Provides CMS with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by CMS. (c) Quality assurance. A Part D sponsor 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, (i) Screening for potential drug therapy problems due to therapeutic duplication. (ii) Age/gender-related contraindications. (iii) Over-utilization and under-utilization. (iv) Drug-drug interactions. (v) Incorrect drug dosage or duration of drug therapy. (vi) Drug- allergy contraindications. (vii) Clinical abuse/misuse. (3) Retrospective drug utilization review systems, policies, and procedures designed to ensure ongoing periodic examination of claims data and other records, through computerized drug claims processing and information retrieval systems, in order to identify patterns of inappropriate or medically unnecessary care among enrollees in a [[Page 373]] sponsor's Part D plan, or associated with specific drugs or groups of drugs. (4) Internal medication error identification and reduction systems. (5) Provision of information to CMS regarding its quality assurance measures and systems, according to guidelines specified by CMS. (d) Medication therapy management program (MTMP)--(1) General rule. 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; and (iv) May distinguish between services in ambulatory and institutional settings. (2) Targeted beneficiaries. Targeted beneficiaries for the MTMP described in paragraph (d)(1) of this section are enrollees in the sponsor's Part D plan who-- (i) Have multiple chronic diseases; (ii) Are taking multiple Part D drugs; and (iii) Are likely to incur annual costs for covered Part D drugs that exceed a predetermined level as specified by the Secretary. (3) Use of experts. The MTMP must be developed in cooperation with licensed and practicing pharmacists and physicians. (4) Coordination with care management plans. The MTMP must be coordinated with any care management plan established for a targeted individual under a chronic care improvement program (CCIP) under section 1807 of the Act. A Part D sponsor must provide drug claims data to CCIPs for those beneficiaries that are enrolled in CCIPs in a manner specified by CMS. (5) Considerations in pharmacy fees. An applicant to become a Part D sponsor must-- (i) Describe in its application how it takes into account the resources used and time required to implement the MTMP it chooses to adopt in establishing fees for pharmacists or others providing MTMP services for covered Part D drugs under a Part D plan. (ii) Disclose to CMS upon request the amount of the management and dispensing fees and the portion paid for MTMP services to pharmacists and others upon request. Reports of these amounts are protected under the provisions of section 1927(b)(3)(D) of the Act. (6) MTMP reporting. A Part D sponsor must provide CMS with information regarding the procedures and performance of its MTMP, according to guidelines specified by CMS. (e) Exception for private fee-for-service MA plans offering qualified prescription drug coverage. In the case of an MA plan described in Sec. 422.4(a)(3) of this chapter providing qualified prescription drug coverage, the requirements under paragraphs (b) and (d) of this section do not apply.