Significant Research on MTM and its Associated Cost Savings

Chapter 13: Significant Research on MTM and its Associated Cost Savings

Medication therapy management (MTM) is a healthcare resource that is internationally recognized and utilized across multiple care settings. The body of research surrounding MTM is continuously growing as more institutions integrate it to improve the quality of health care. Current MTM research focuses on evaluating the benefit to patients, the benefit to the healthcare system, and the benefits in various healthcare settings.

The following studies were gathered by PubMed and Google Scholar searches. Only studies from 2013 or later were included since MTM practice needed time to mature after CMS began mandating payment for the service in 2003.

MTM researchers utilize a variety of study protocol, and the results are mixed or slightly in favor of MTM. None of the studies included in this review demonstrated adverse effects of MTM, but several did not find a significant benefit either.

In general, the research outlined below falls into three broad categories:

1. Transition of Care
2. Outpatient Care
3. Cost Benefits

Transition Of Care

Complications associated with chronic disease states are often associated with hospitalizations and can represent a significant burden in cases where frequent readmissions occur.

Tuttle et al. conducted a single-blind, randomized, controlled study¹ to measure the incidence of acute care utilization in patients with Chronic Kidney Disease (CKD) who were recently discharged from a hospital visit. The study was conducted at Providence Health Care in Spokane, Washington. Enrollment lasted from February 2012 until February 2015 and only included subjects who were discharged to home. The usual care (control) group received a medication list derived from their electronic health record and clinical education from the nursing staff of the hospital, including a teach-back session to verify the understanding of the information presented. The intervention group received the usual care plus a 1-2 hour home visit from a pharmacist who conducted an MTM session with the patient. The MTM session included a CMR, a MAP, and a PMR. The pharmacists who conducted the MTM sessions were CKD clinical experts.

One hundred and forty-one study subjects enrolled in the study, and 120 of them completed a 90-day follow-up after their hospitalization. The primary outcome was the utilization of acute care following discharge, including hospital admissions, emergency room visits, or urgent care visits. At the end of 90 days, the results showed no significant difference in the primary outcome between the intervention group and the usual care group. Acute care events occurred in 44% of the intervention group and 41% of the usual care group.

The investigators mentioned that the study had several limitations. Notably, the study was conducted at a single center and included predominately Caucasian adults with moderate to severe CKD. Additionally, the intervention included only a single visit from a pharmacist who conducted an MTM session with the patient within seven days of the transition from the hospital to home. Pharmacists documented and resolved medication-related problems during the MTM visit, but the effects did not translate to a meaningful difference in the primary outcome. The authors stated that CKD is a complicated disease state and recommended that future studies include a more diverse patient population across multiple settings.

Patients who utilize home health services have a high risk of re-hospitalization despite the specialized care they receive from their home health nurses. Zillich et al. conducted a two-stage, randomized, controlled trial² to evaluate the effectiveness of telephonic MTM at reducing hospitalizations in home health patients. The process for selecting study participants included two steps. First, researchers identified a random sample of 40 home health centers with specific census criteria, and then they used block randomization to enroll 28 patients from each site. The enrollment period lasted from February 2012 through April 2012.

Researched recruited a pharmacist to deliver telephonic MTM services to the intervention group in addition to the usual care provided by the home health nurses. The MTM service was aligned with the core elements of MTM, as defined by the APhA. The pharmacist completed a CMR and MAP for each patient. The pharmacist intervention time was approximately 60 minutes: 15 minutes preparing for the appointment, 30 minutes during the appointment, and 15 minutes for post-appointment documentation. The pharmacist called each patient seven days later to resolve any remaining medication-related problems or document newly discovered problems.

A total of 961 patients were randomized, but only 895 were included in the final analysis. Overall, the MTM intervention did not reduce the incidence of hospitalization at the 30-day and 60-day time points compared to the usual care group. However, the subgroup analysis revealed that patients in the lowest risk quartile had three times fewer hospitalizations at the 60-day time point and six times fewer hospitalizations at the 30-day time point. Additionally, the time to the first hospitalization was significantly longer for MTM patients in the lowest risk quartile compared to the usual care group.

The authors noted that their study was the first to examine the effects of MTM in Medicare patients who were recently admitted to home health care. They implied that the data could be useful for accountable care organizations that are challenged by the rising costs of healthcare in this population. They mentioned that the sample size was small due to the enrollment period ending early and that the study may have been underpowered to detect a difference in the overall group. The authors conclude that the MTM intervention might not be efficacious for all home health patients; however, for patients with the lowest risk profile, MTM intervention significantly prevented hospitalization at 60 days.

Patients who transition from the hospital setting back into the community are often sent home with multiple new prescriptions. In those circumstances, MTM providers have the opportunity to engage in medication reconciliation and utilization reviews to improve the quality of care during the transition. Haag et al. conducted a prospective, randomized, controlled study³ to evaluate the impact of pharmacist-provided telephonic MTM services on care quality in a care transition program (CTP) for high-risk older adults. The study lasted from December 2011 through October 2012 and randomized 25 high-risk elderly patients to the intervention or control group. The intervention consisted of a single telephone call conducted by a pharmacist to provide MTM services to elderly patients enrolled in a CTP program who were at a high risk of emergency service utilization or hospital readmission. The primary outcome used the Screening Tool to Alert Doctors to the Right Treatment (START) and the Screening Tool of Older Persons’ Prescriptions (STOPP) scores to evaluate the quality of medication prescribing and utilization. Secondary outcomes included medication utilization, hospital resource utilization within 30 days of discharge, and drug therapy problems.

The study did not find a difference in the START or STOPP criteria between the two groups. At the 30-day follow up point, three patients were found to have had an emergency department visit or hospitalization. The researchers found 20 cases of medication underuse per the START criteria and 55 drug therapy problems at baseline. 43.65% of the drug therapy problems remained unresolved after 30 days.

The authors concluded that the MTM program did not achieve a difference compared to the usual-care group. However, the findings demonstrated an ability to identify frequent medication misuse and underuse. They commented that the small size of the study could have limited its ability to detect a significant difference between the two groups. The authors also noted that the 43.65% of drug therapy problems that remained unresolved at the 30-day follow up represented a suboptimal rate of acceptance of pharmacist recommendations and could be partially responsible for the statistically insignificant results.

Every patient who leaves a hospital must transition to their next phase of care, and MTM services are being utilized to improve that process. Miller, Roane, and McLin conducted a retrospective chart analysis⁴ on patients who received MTM services following hospital discharge to home. They evaluated the effectiveness of the pharmacist-facilitated telephonic MTM services on reducing re-hospitalizations within 30 days of discharge. The secondary outcomes included identification and recommendations related to medication-related problems and discrepancies between the patients’ reported medication list compared to the hospital discharge medication list.

The final analysis included 267 patients and showed no statistically significant difference in readmission rates between the patients who received MTM services and those who did not; however, the pharmacists performing the MTM services identified 212 medication-related problems. The most common issues were gaps in therapy, drug-drug interactions, and non-adherence concerns. Additionally, the pharmacists identified 823 total discrepancies in the patients’ medication histories.

The authors noted several limitations to their study that may have impacted their findings, including patient selection, lack of risk stratification, lack of involvement of the pharmacist before the initial admission to the hospital, and competition from other transition of care programs at the time of the study conduct. In their conclusion, the authors noted that the intervention did not have an impact on hospital readmission rates in the study population. However, the data was still useful for designing and enhancing telephone-based MTM programs.

Outpatient Care

The outpatient setting is full of opportunities for pharmacists to interact with patients utilizing a variety of communication media, including telemedicine, telephone appointments, and other tools. Erku et al. (2017) conducted a prospective, randomized, controlled trial⁵ to examine the effects of a pharmacist-led MTM program on medication adherence and rates of hospitalization in patients with type 2 diabetes. The study lasted six months and was conducted at a single site in Ethiopia. The site was a large hospital that provided diabetes care services for more than 10,000 patients annually on an outpatient basis. The researchers received approval by an ethics committee, and all patients consented to participate in the trial.

The control group received the usual care, consisting of a short discussion with their physician regarding their diagnosis and the importance of medication adherence. Patients allocated to the intervention group received the usual care plus an MTM visit with a pharmacist. The MTM visit included a review of medications, education about the proper way to use the medications, and a teach-back style session to confirm the understanding of the information conveyed. The pharmacist provided and a follow-up call to patients after the initial intervention and patients were allowed to call the pharmacist at any time during the study period. The primary outcome of the study was the change of medication adherence from baseline to three months and from three months to six months. Researchers also compared the number of hospitalizations between the two groups.

The final analysis included 107 patients who completed the trial. From the baseline to the three-month and from the three- to six-month period, a statistically significant improvement in medication adherence was measured in the intervention group while the control group saw no change. At the six-month follow-up, there was a 52% difference in hospitalizations between the intervention group and the control group.

The authors noted that both groups had a high rate of hospitalization and non-adherence at baseline, which they attribute to the socioeconomic and educational status of their patient population. They concluded that the addition of MTM services from a pharmacist might improve medication adherence and reduce hospitalizations in patients with type 2 diabetes.

The authors noted that the study had several limitations, including the sample size, the duration of follow-up, the number of sites, and the self-reporting of medication adherence. Nonetheless, they argued that policies and guidelines should be put in place to allow clinical pharmacists to engage in MTM services. Chronic diseases like type 2 diabetes present significant challenges in the outpatient setting, due to the likelihood of co-morbidities that can arise.

Skinner et al. conducted a retrospective case-control study⁶ using the medical records of 100 subjects from a community clinic healthcare database. The goal was to determine the effects of pharmacist-led MTM on the outcomes of patients with poorly controlled type 2 diabetes. The investigators characterized the control group as those who did not receive any documented MTM services. Outcomes measured included hemoglobin A1c, blood pressure, lipid levels (HDL, LDL, and triglycerides), creatinine, and medication adherence.

The investigators matched the included subjects according to age, race, ethnicity, and body mass index (BMI) for outcome comparisons. The results demonstrated an improvement in hemoglobin A1c and medication adherence in the group who received MTM services compared to the control group. The other outcomes measured showed no difference between the groups, but the authors noted that the MTM group had a statistically significant improvement in LDL before the match.

This study is limited in scope because the patient population is from a single community clinic. Additionally, the retrospective design did not allow for blinding or randomization. Despite the limitations, the study shows that patients with poorly controlled diabetes may benefit from MTM services. The authors recommended that additional prospective studies should be conducted to assess the outcomes of pharmacist-led MTM interventions on patients with type 2 diabetes.

MTM programs often target cases of chronic illness that are not well controlled because they are opportunities to improve outcomes and quality of care. Rodis et al. (2017) conducted a multi-site prospective study⁷ at three Federally Qualified Health Centers (FQHC) to examine the effects of pharmacist-provided MTM services on patients with uncontrolled diabetes or hypertension.

A pharmacist from each site presented their site’s model of MTM delivery at a formal orientation. The MTM protocols varied between sites but all aligned with the core elements of MTM, as described by the APhA. The enrolled patients received MTM services per the respective site’s procedures. Data were reported in aggregate every month during the reporting period.

The reporting period lasted 22 months and enrolled 706 patients. Of the 422 participants with uncontrolled diabetes, 52% were brought into the goal range (A1c less than 9%). Of the 434 participants with uncontrolled hypertension, 65% were brought into the goal range (blood pressure less than 140/90 mmHg). The sites reported a total of 169 potential adverse drug events and 84 adverse drug events. Additionally, the pharmacists conducting the study identified and resolved more than 1400 medication-related problems by the end of the reporting period.

The authors concluded that MTM services provided by pharmacists in the FQHC setting have a positive impact on patients with uncontrolled diabetes or hypertension. While the study had a considerable sample size, the authors did note some limitations in the design. A critical consideration is the lack of a control group and randomization scheme. Additionally, the reporting of medication-related problems and other adverse event data may have been impacted by the subjectivity of the pharmacists conducting the MTM. Nonetheless, the authors encouraged public health practitioners and pharmacists to seize the opportunity to use sustainable MTM models to improve the quality of care for patients with chronic conditions.

Specialty care populations of patients are often required to use multiple expensive medications to manage their condition and could benefit from MTM services, which means pharmacists have the opportunity to limit or ease the burden for complex medication regimens. Chisholm-Burns et al. (2016) conducted cross-sectional analyses⁸ on Medicare claims and transplant follow-up data reported in the United States Renal Data System to examine the impact of Medicare Part D MTM eligibility on immunosuppressant therapy (IST) adherence.

The researchers included adult renal transplant recipients (RTR) who received a transplant between 2006 and 2011, had a graft survival of one year, were enrolled in a Medicare Part D plan, and were prescribed tacrolimus. The IST was measured using a possession ratio, MTM eligibility was determined using the criteria established by CMS, and adherence was modeled using multiple logistic regression.

The study examined 17,181 RTRs and found a mean medication possession ratio of 0.91. The modeling showed that MTM RTRs were more likely to be adherent to their tacrolimus medication than those who were ineligible (odds ratio 1.13 [1.02-1.26, 95% CI, p=0.02]). In their discussion, the authors state that these data were consistent with the findings of other similar studies and provided evidence to the basic premise of MTM. Based on this study, the authors concluded that access to MTM increased IST adherence among RTRs.

Oncology patients represent another high-risk patient population whose medication regimens are often complex with a high potential for adverse effects. Bertsch et al. conducted a retrospective analysis⁹ of data collected from patients receiving oral chemotherapy therapy that were provided MTM services. The outcomes examined in the study included the number of medication errors identified in the electronic medical records, the number of interventions performed by the pharmacist, time spent on the MTM process, and patient satisfaction.

Fifteen patients received MTM services throughout the study period. The results showed an average of six medication changes performed by a clinical pharmacist and three pharmacist-led medical interventions per patient. Additionally, there were multiple correlations identified between the variables, including the total number of prescriptions taken, the total number of medication errors identified, time spent on the MTM process, and the total number of interventions performed by the pharmacist. The satisfaction survey showed that patients were satisfied with the program.

Although the study was limited in size, scope, and the lack of a control group, the authors noted that the correlations identified in their results indicated a potentially positive impact of MTM services on patients who received oral chemotherapeutic agents. The results of this study led to a departmental change on the scheduling of pharmacists in the oncology clinic to allow pharmacists to perform more MTM services. They saw a 6-fold increase in MTM visits per month and began exploring the option of moving the program into other specialty areas.

Medicare patients have complicated cases and are at high risk of adverse events when they transition from the outpatient setting to an inpatient care facility. Gernant et al. conducted a secondary analysis¹⁰ of data from a cluster randomized controlled trial that assessed the hospitalization of patients insured by Medicare in the home health setting. Data from 656 patients were selected and split into an intervention MTM group and a usual care group with the primary outcome being all-cause emergency department utilization 60 days after a home health care episode.

The intervention consisted of MTM services conducted by a pharmacist and pharmacy technician approximately three days after the home health care visit. Study subjects were first contacted by the pharmacy technician who performed a medication reconciliation. A pharmacist then conducted a CMR and provided a 30-minute telephonic consultation with the patient to review and resolve medication-related problems. An action plan was created for each patient to assist the patient, caregiver, and pharmacist in resolving the issues identified. Follow up was conducted by the pharmacist via phone or fax.

The researchers used an existing logistic regression model to calculate a risk score for each patient that determined their overall likelihood of emergency department utilization. Overall, there was no difference in emergency department utilization between the groups. However, patients in the lowest quartile of risk did appreciate a statistically significant reduction in emergency department visits.

The authors noted that those in the highest risk category were much sicker than those in the lowest quartile and were likely more reliant upon their home care nurse for their basic health needs. They proposed that this difference in the independence of the study participants could account for the lack of significant results in the higher risk category subjects because their trained nurse or caregiver played a more substantial role in their medication adherence and basic care. Lower risk patients were more independent and able to take action on the knowledge gained by their telephonic intervention with the pharmacy team.

Cost Savings

Hospitalizations are an enormous contributor to the overall cost endured by the healthcare system. Pellegrin et al. (2016) conducted a quasi-experimental study¹¹ to evaluate the association between MTM services provided by trained hospital pharmacists and trained community pharmacists and the rates and costs of medication-related hospitalization in older adults. The intervention (Pharm2Pharm) was conducted across six non-federal hospitals in Hawaii. Five other hospitals served as a quasi-experimental comparison group. Hospitalizations due to medication-related problems were identified by evaluating the ICD-9 codes of the patients admitted.

The researchers utilized a three-year baseline data period to determine the rate of medication-related hospitalizations in the intervention and non-intervention hospitals. The intervention was implemented at the six study hospitals sequentially. They used mixed-effects modeling to demonstrate that the intervention hospitals saw a significant difference in the rate of hospitalization compared to the non-intervention hospitals. In the final analysis, the modeling predicted a 36.5% difference in the rate of hospitalization between the intervention hospitals and non-intervention hospitals during the final quarter of the study period. This decrease in hospitalization rates accounted for an estimated annualized cost difference of $6.6 million due to admissions. The annual cost of performing the intervention was estimated at $1.8 million.

The authors concluded that the Pharm2Pharm intervention model was associated with a 36% reduction in medication-related hospitalization for older adults and resulted in a 2.6:1 return on investment. The authors acknowledge that there was no randomization schedule followed for the study at the personal or hospital level, which means factors other than the Pharm2Pharm intervention could be partially responsible for the results reported in this trial. Another limitation is that the cost savings associated with the intervention only considered medication-related hospitalizations and did not include emergency department visits, nursing facilities, outpatient care, or prescription medications. The authors implied that the savings were potentially higher than reported, based on previous research.

Some researchers have found it useful to review multiple sources of data to get a broader view of the overall benefits of MTM services. Kahwati et al. (2015) conducted a systematic review¹² and meta-analysis to assess the effect of MTM on outpatients with chronic illnesses. Two reviewers accessed the Cochrane Library and International Pharmaceutical Abstracts database to identify comparable studies that measured medication-related problems, morbidity, mortality, quality of life, health care use, costs, and harms. The inclusion criteria allowed for studies that addressed ambulatory patients who received a CMR, patient-directed education, care coordination, and opportunities to follow up. The authors excluded studies of MTM services provided in an inpatient setting. The authors identified 44 studies that met the criteria.

The results of the meta-analysis revealed a decrease in health care use and costs compared to the control, but the strength of evidence was low. Most of the evaluated outcomes were found to have evidence that was insufficient to determine an effect. The authors noted that this meta-analysis was unable to determine how well resolving drug problems translated into consistent, measurable improvements in the outcomes assessed by the studies included.

Concerning healthcare costs, the authors discussed that the goal of MTM is to improve the effectiveness of pharmacotherapy and not to lower healthcare costs. Ideally, the results would be the reduction of unnecessary healthcare use, but in cases where the patients were under-treated, optimization of pharmacotherapy could increase the cost of care.

The authors noted that their findings were often weak in strength. They attributed this to the overall heterogeneity of the studies they found in their review and recommended that researchers and program directors work to improve the consistency of their intervention reporting, including following appropriate consensus guidelines and reporting of usual care practices. The authors believed improvements on these fronts would enable future systematic reviewers to more accurately differentiate between the types of services offered, the fidelity of the interventions, and the heterogeneity of the comparison groups.

While the cost savings for patients are an essential consideration, some researchers have turned their focus to the potential benefits appreciated by institutions that adopt MTM services. Pinto et al. (2013) conducted a prospective pre-post longitudinal study¹³ to determine the cost savings of a pharmacist-led employer-sponsored MTM program for diabetic patients. The authors also assessed the changes in patient satisfaction and self-reported medication adherence. Participants were enrolled at five community pharmacies that were part of a coalition known as the Toledo Area Coalition of Independent Pharmacies in Northwest Ohio. The enrollment period lasted from January of 2008 until September of 2010, and pharmacies incentivized patients by providing 90-day medications at the same cost of their mail-order pharmacies and 100 free glucometer testing strips and lancets per month.

All participants received a baseline visit followed by a two- to four-week visit, a three-month visit, a six-month visit, a nine-month visit, and a 12-month visit. At the first visit after baseline, pharmacists conducted a full medication review, suggested lifestyle and clinical interventions, and formulated a MAP for the patient. The subsequent visits were used to perform follow-up medication reviews and assess goal achievement. The pharmacists conducting the visits also contacted the patients’ physicians to recommend interventions. Outcomes measured included economic costs, patient satisfaction, and self-reported medication adherence.

One hundred and one patients were enrolled in the study. The pre-joining economic costs were collected by reviewing health care utilizations for one year leading up to enrollment, and the post-joining costs were collected by following the enrolled patient for one year. Upon completion of the study, the authors found that the mean number of visits to physicians’ offices decreased from 10.22 to 7.07, but the mean cost of the visits increased from $47.70 to $66.41. Despite the increase in the cost of visits, the use of emergency rooms and inpatient care decreased by more than 50%. The resultant cost to the employer decreased by $24,214.17 for emergency room visits and $166,610.84 for inpatient treatment. Overall, the study measured a cost savings of $179,047.80, and significant improvements were seen in patient satisfaction and medication adherence.

The authors concluded that pharmacist interventions provided through an employer-sponsored MTM program led to substantial cost savings for the employer and improved medication adherence and patient satisfaction. In their discussion, the authors explain that the pharmacists encouraged patients to seek specialized physician care whenever warranted, which could explain the increased cost of physician visits measured by the study. The authors noted that the decreased expense of emergency visits and hospitalizations could indicate improved management of the disease by patients as a result of the interventions provided by pharmacists and could also indicate a reduction in complications and an improvement in overall health outcomes. The study did not consider the cost of implementing the MTM interventions or the indirect cost savings associated with the improvement of quality of life. The authors believed that the actual cost savings are possibly higher than what was reported by this study and recommend future studies to determine the return on investment for employers.

The USA is not the only country to recognize MTM as a beneficial tool in the health care system. Research abroad is beginning to show the benefits to large foreign health care systems. Lin et al. (2017) conducted a prospective, randomized, controlled trial¹⁴ to economic differences and clinical outcomes associated with MTM services offered to older adults with multiple chronic conditions compared to those who were given usual care with follow up assessments.

The study was conducted at an academic medical center in Taiwan with more than 2000 beds and approximately 5000 outpatient visits daily. A single pharmacist was trained to provide direct patient care services and worked in a pharmacist-physician collaborative clinic located near the physician clinics in the outpatient areas of the medical center. The pharmacist followed the enrolled patients for 12 months and provided MTM services including, CMR, face to face consultation, and telephonic consultation. Direct physician contact was also included as part of the intervention.

One hundred seventy-eight patients were enrolled from November 2009 to March 2010 and randomized into the intervention group or usual care group. An estimated cost savings difference of $127,015 US dollars was found between the intervention group and the usual care group. This calculation represented a savings of roughly $1000 per patient per year. The benefit-to-cost ratio for the MTM program was 3.53:1. There were also improvements in some of the humanistic outcomes measured, though they were not statistically significant.

The authors concluded that a pharmacist-physician collaborative MTM program for older adults with multiple medications showed a significant difference in cost savings and a non-significant improvement in humanistic measures.

The authors noted that economic differences between countries might make their data challenging to extrapolate. While the MTM program included a collaborative effort between the pharmacist and physicians, the physicians’ time was not included in the economic assessments. However, the time spent by physicians on the interventions was minimal compared to the pharmacist. Some of the medical expenditures were calculated using a self-reporting model, but there was no difference in the reports from the intervention group and the usual care group. Despite the limitations of the study, the authors found this evidence to be in line with similar studies conducted in the United States.

Summary of the Literature

The evidence for MTM is mixed but generally leans towards positive outcomes in terms of cost savings and patient outcomes. In many cases, MTM benefits patients directly and can decrease the burden of healthcare costs, but results are not consistent across the board. Researchers have noted multiple factors that explain the inconsistency of results, including study size, study quality, and consistency MTM delivery methods. Several of the studies in this review had a relatively small sample size, sometimes including less than one hundred study subjects, and some were at a single site. Future studies should consider increasing study size and incorporating multiple sites to bolster the reliability of the results.

The overall quality of studies was non-homogenous. Some were robust and included randomization with blinding, but several studies lacked these elements. In some cases, the researchers noted their limitations and recommended the conduction of future studies.

Finally, the methods of delivering MTM varied. Most studies included a CMR, but there was a lack of consistency in the utilization of follow-up visits or phone calls. In multiple instances, the study subjects only received a single interaction with a pharmacist. MTM may require repeated exposure to the practitioner to reinforce action plans and help to identify new medication-related problems.

The body of evidence related to the impact of MTM on patient health outcomes and cost savings is generally positive, but somewhat inconsistent. Several of the studies discussed showed significantly positive effects, and some showed no effect on outcomes. None had negative impacts on patient outcomes or cost.