Evolution of the Medicare Part D Medication Therapy Management Program from Inception in 2006 to the Present.

Background: In 2006, the Centers for Medicare & Medicaid Services (CMS) implemented the newly established Medicare Part D program that required plan sponsors to offer a medication therapy management (MTM) program. The MTM program requirements have become more prescriptive over the past decade in the attempt to address low beneficiary enrollment rates, improve the quality of services provided, and address gaps in meeting the needs of enrollees.

Objective: To describe changes to the requirements for the Medicare Part D MTM program since its inception in 2006 and the impact of these changes to inform future program enhancements.

Methods: We obtained publicly available information extracted from the Medicare Part D MTM program fact sheets for the years 2008 through 2018, in addition to searching indexed literature through PubMed and additional literature through Internet searches. We then categorized the program's requirement changes annually, and described the Part D MTM program characteristics and reported statistics.

Discussion: Significant changes to the Part D MTM program requirements occurred in 2010, 2013, and 2016 regarding eligibility criteria, MTM services, and reporting requirements. Thresholds to determine beneficiary eligibility have been lowered. Specific MTM services now include an annual comprehensive medication review, followed by a written summary using the Standardized Format. Quarterly targeted medication reviews are also required. Reporting requirements now include comprehensive medication review completion rates and the number of prescriber interventions, among others. Despite more prescriptive MTM program requirements, the low utilization of the MTM program continues.

Conclusion: Low beneficiary enrollment rates in the Medicare Part D MTM program led CMS to lower thresholds required for eligibility to expand the beneficiary pool. More prescriptive MTM service requirements enhanced service standardization. Despite these changes, MTM enrollment and comprehensive medication review rates remain low, likely, in part, from a lack of financial incentives. The Enhanced MTM program is a 5-year test model that is providing participating Part D plans regulatory flexibility and financial incentives to design their own MTM programs, to evaluate the impact of different program designs on beneficiary engagement and outcomes.