Published Online: February 25, 2014
Rita L. Hui, PharmD, MS; Brian D. Yamada, PharmD; Michele M. Spence, PhD; Erwin W. Jeong, PharmD; and James Chan, PharmD, PhD
Objectives: To assess the impact of a Medicare Medication Therapy Management (MTM) program in a large integrated health plan on patient mortality, hospitalization and emergency department (ED) utilization, and daily prescription costs.
Study Design: Retrospective matched cohort study.
Methods: Patients who received MTM services between 2006 and 2010 were matched to control patients who were enrolled in Medicare but did not receive MTM services. They were matched in a 1:4 ratio based on age, gender, geographic location, and prospective diagnostic-cost-group (DxCG) risk score. Multivariate regressions were used to analyze the outcomes. Subgroup analyses were conducted for patients enrolled in 2010 because the Centers for Medicare & Medicaid Services lowered the drug-cost threshold for MTM eligibility and changed from opt-in to optout participation.
Results: We identified 34,532 members who received MTM services and 138,128 control members. The MTM group was found to have a significantly reduced mortality (hazard ratio 0.86, 95% confidence interval [CI], 0.84-0.88; P <.001), lower odds for hospitalization (odds ratio [OR] = 0.97, 95% CI, 0.94-0.99; P = .018), higher odds for emergency department visits (OR = 1.17, 95% CI, 1.14-1.20; P <.001), and no differences in change in daily medication costs when compared to the matched group. The subgroup analysis of the 2010 cohort found similar results with better outcomes than the overall cohort.
Conclusions: Medicare MTM services resulted in lower mortality and odds for hospitalization for enrolled patients compared with matched controls. This study observed an increase in ED visits and no differences in change in daily medication costs in MTM services.
Am J Manag Care. 2014;20(2):e43-e51
Medicare Medication Therapy Management (MTM) programs are mandated by the Centers for Medicare & Medicaid Services to be provided by any health plans that have a Medicare Part D (MPD) drug plan.
A pharmacy-led MTM program is useful in improving clinical outcomes in Medicare beneficiaries but it may not decrease medication costs.
Medicare Part D (MPD) is a prescription drug benefit for seniors and individuals with disabilities, which began in 2006 after enactment of the 2004 Medicare Modernization Act.1 Along with the establishment of MPD, there was a mandate for the participating plans to provide medication therapy management (MTM) services to MPD beneficiaries who met specific eligibility requirements. 2 The goal of the Medicare MTM program is to improve health outcomes. Although MTM services can be provided by a variety of healthcare professionals, pharmacists—with their extensive knowledge of medications—are the most common providers.3-5
The Centers for Medicare & Medicaid Services (CMS) mandates provision of MTM services, targeted at MPD beneficiaries with multiple chronic conditions who are taking multiple Part D medications and likely to exceed a preset annual cost for covered Part D medications.2 The eligibility criteria for MTM services have changed since the inception of the program for MPD beneficiaries, with the most significant updates imposed by CMS in 2010. The major changes included: (1) standardizing the minimum number of chronic conditions and Part D medications required; (2) decreasing the annual threshold for medication costs from $4000 in 2006 to $3000 in 2010; and (3) requiring all participating plans to enroll eligible Part D beneficiaries in an opt-out manner, versus the previous opt-in or opt-out option that MTM programs could offer at their discretion between 2006 and 2009. These changes resulted in a substantial increase in eligible beneficiaries for MTM programs in 2010.
Several small studies have evaluated various outcomes of MTM services in various settings.6-19 These studies were limited in that they were either limited to specific disease states, lacked a comparison group or used patients who opted out of MTM services as the comparison group. The purpose of our study was to evaluate the impact of pharmacist-run telephone based Medicare MTM services on health-related outcomes for enrolled patients compared with a matched control group from January 2006 to December 2010 in the Kaiser Permanente (KP) California Regions. Our aim was to evaluate if there was any impact that our MTM program had on hospitalization utilization, emergency department (ED) visits, change in daily prescription costs, and mortality rate.
MATERIALS AND METHODS
KP California is an integrated healthcare delivery system caring for 6.6 million members in California. Medicare beneficiaries comprise approximately 10% of the total membership, with over 90% of those members having purchased the MPD benefit. Over 40% of our MPD beneficiaries have employer-sponsored retiree benefits. KP California’s Medicare MTM program started in 2006 and was initially staffed by 16 full time (FT) clinical pharmacists and 10 FT support staff. By 2010, the number had grown to approximately 40 FT pharmacists and 22 FT support staff to meet the increased demand for services.
From 2006 to 2009, the KP California MTM program identified members that were likely to incur annual drug costs of $4000 or more, who were taking at least 2 medications covered by MPD and had at least 2 or more chronic conditions, such as diabetes, cardiovascular diseases, hypertension, hyperlipidemia, or stroke. MTM services were offered to these patients, and participation in the program was voluntary. In 2010, in addition to the changes in eligible requirements made by CMS, KP California MTM increased the number of chronic conditions from 2 to 3 and the number of required medications from 2 to 5. It was estimated that approximately 3% of MPD enrollees were eligible for the MTM program during the period from 2006 to 2009, while 5% of the MPD enrollees were eligible for MTM program during 2010.
Potential participants meeting the above criteria were identified several times per year during the study period by a computerized system and letters outlining the MTM program were mailed to the members. During 2006 to 2009, only patients who agreed to participate were contacted by the MTM staff, while in 2010, all patients who did not opt out were contacted by the MTM staff. All contacts were made by phone. The initial encounter consisted of the pharmacist or a support staff member obtaining a list of current medications, followed by the pharmacist performing a comprehensive medication review. Follow-up encounters generally focused on identifying opportunities to improve medication therapy. All encounters and interventions made by the MTM staff were documented in each patient's electronic medical record.
The MTM pharmacists worked under collaborative practice agreements with physicians from the Permanente Medical Group and Southern California Permanente Medical Group. Interventions may have included: performing or obtaining necessary assessments of the patient’s health status; initiating and adjusting doses of medications and ordering medication-associated laboratory tests; reviewing and adjusting medications to reduce the likelihood of adverse drug events, interactions, or duplication of therapy; ensuring optimal dosing; improving medication adherence; providing education to enhance each patient’s understanding and to encourage appropriate use of medications; simplifying drug therapy and reducing drug therapy costs; and ensuring therapies are in concordance with clinical practice guidelines. Any recommendations falling outside of the protocol were communicated to the primary care physician for approval. Coordination of services was performed with local population care management services, as well as ambulatory care pharmacist-managed services (eg, anticoagulation, oncology, etc).
This study was a retrospective, matched-control cohort study. The study group consisted of KP members participating in the Medicare MTM program who had a comprehensive medication review and as-needed follow-ups conducted by an MTM pharmacist. The matched-control group consisted of KP members who were Medicare beneficiaries, who may or may not have been enrolled in MPD, and were not eligible for MTM. Since patients that qualified for MTM (1) were enrolled in MPD, (2) had higher medication costs, and (3) had high disease burden, a likely control patient did not have all 3 conditions and hence may have had less spending in medications and less disease burden. Both the study and the control groups received the usual care, with scheduled visits with their primary care physician or other healthcare providers. Each study group member was matched to 4 control group members based on geographic location, age (same birth year), gender, and prospective diagnostic-cost-group (DxCG) score (within ± 0.01).20 The DxCG score predicts an individual’s total healthcare cost in the next year relative to the population mean using a model based on age, gender, diagnoses, and drug codes. This relative score is calculated at the individual level. DxCG scores for Medicare beneficiaries ranged from .05 to 15.59 in the national population. Individuals with a score of 1.0 have a relative risk that is equivalent to that of the national Medicare reference population.
The study group was enrolled in MTM during the 5-year period between January 2006 and December 2010. They were followed from their enrollment date for 365 days, or until death, or disenrollment from the health plan, whichever came first. If members were enrolled in the MTM program for multiple years, only the first year of enrollment was included in the study. The matched controls for each MTM member were assigned the same enrollment date as the MTM member and were followed in the same way as the patients enrolled in the study group. Each study and control group member was unique and was only used once in this study. All subjects must have had continuous health plan membership with drug benefits during the 12 months prior to the study period to ensure complete pre-period data.
Exclusions included subjects with a cancer diagnosis within 1 year of study entry and nursing home residents. This was because cancer patients were being followed by the specialized oncology team, which included physicians, pharmacists, nurses and social workers at KP and patients residing in the nursing homes did not obtain prescription drugs from our internal KP outpatient pharmacies.
All data were obtained from KP’s integrated electronic medical, pharmacy, and administrative databases. Other covariables included: age, gender, Charlson Comorbidity Index (CCI),21 and pre-period utilization, including hospitalization, ED visits, and daily medication costs during the 12-month period prior to enrollment.
This study was approved by Kaiser Permanente Institutional Review Boards of both Northern and Southern California regions.
The primary outcome of this study was all-cause mortality within 365 days of study enrollment. Deaths were identified using several administrative and clinical data sources within KP, including records indicating discharge status after hospitalization. Deaths that occurred outside of the health plan were identified from California vital statistics death tapes. Secondary outcomes included percentage of hospitalization and ED visits within each group, and median change in prescription cost per day for the same period. Since some patients did not have 365 days of follow-up records due to death or termination of membership, prescription cost were assessed on a cost-per-day metric. Daily medication costs were calculated by dividing total medication costs by the length of follow up time during study period.
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