Validation of a Patient-Level Medication Regimen Complexity Index as a Possible Tool to Identify Patients for Medication Therapy Management Intervention

Currently in the United States, health care systems are being asked to increase the volume of patients who receive medication therapy management (MTM) services and to improve quality indicators that have a heavy emphasis on appropriate medication use. MTM services include comprehensive assessment and evaluation of a patient's complete medication therapy regimen.1 The Centers for Medicare and Medicaid Services (CMS) 2014 guidelines for MTM programs added requirements for health plan sponsors to have a dedicated MTM information page linked to their website and to actively promote available MTM services to beneficiaries in an effort to increase awareness of MTM service availability and ultimately utilization.2 A similar medication focus can be found in the recent CMS star rating system for health plans that implemented incentive quality-based payments based on number of stars earned, where some star rating criteria are related directly to medication use and could be improved through MTM programs.3 For example, star ratings are earned through direct medication targets, such as medication adherence rates (e.g., diabetes, hypertension), percentage of members receiving medications with a high risk of side effects, or other criteria that depend on appropriate medication use (e.g., percentage of patients with diabetes with controlled levels of blood sugar). A screening tool that reliably identifies patients with greater medication regimen complexity could be useful for health plans (e.g., CMS ratings) and for practicing clinicians. A literature review of measures of medication regimen complexity and associated outcomes found that medication regimen complexity is related to patient nonadherence, caregiver burden, quality of life, and medical resource utilization.4 Many different methods were used to quantify the complexity of medication regimens. The medication regimen complexity index (MRCI) was the most frequently used method. The MRCI is a tool that quantifies medication regimen complexity beyond the number of medications to include weighted scores for types of prescribed dosage forms, dosing frequency, and additional administration directions.5 The MRCI has been used to quantify medication regimen complexity in several studies.6–21 Results of MRCI studies describe medication regimen complexity for general groups of patients8,10–13,15–18 and for defined cohorts based on specific disease management (e.g., diabetes, hypertension).6,7,9,14,19–21 Two studies assessed the relationship of MRCI scores with medication adherence and found that increased MRCI scores were related to lower medication adherence levels.6,12 Earlier MRCI studies included only prescription medications for specific target diseases of interest (e.g., prescribed diabetes medications) and ignored other prescription and over-the-counter (OTC) medications for comorbidities (e.g., hypertension, pain management). In contrast, recent studies broadened the MRCI score to include all prescription and OTC medications used for all comorbidities, thus reporting a patient-level MRCI score.11,18,20,21 Patient-level MRCI scores have been shown to differentiate between high, medium, and low medical complexity as determined by other accepted measures of patient complexity, hospital readmission rates, medication count, comorbidity count, and Charlson comorbidity scores (a method of predicting mortality risk based on presence of comorbidities).11,20,21 The potential for the MRCI to be used as a tool in clinical practice and by health plans to identify patients who may benefit from subsequent interventions (e.g., comprehensive medication review) is limited by the original narrowly defined scope for the tool and the associated validation evidence. Although the MRCI was judged to be a reliable and valid tool from the original expert panel validation, the process was conducted using a single cohort of patients (chronic obstructive pulmonary disease) and only included prescription medications in the assessment of medication regimen complexity.5 Also, concordance of MRCI score ranking versus five expert clinician rankings was conducted by asking five experts from different fields (academic, research nurse, adherence expert, clinical pharmacist, and home medication review expert) to judge “the difficulty in coping with the provided regimens without taking into account any drug-, clinical-, or patient-related factors.”5 Considering the number of studies conducted since this initial validation, there appears to be a desire to use the MRCI as a risk assessment tool, along with other patient data, across disease states to identify patients for subsequent interventions.6–21 Thus, there is a need to validate the MRCI to identify patients for subsequent MTM interventions using commonly available drug- and patient-related data across multiple disease states.