Assessing Evidence for MTM Quality Measure Development: A Scoping Review

ABSTRACT

Objectives: Performance measures for health care quality programs should rely on a strong evidence base, given their impact on patients, providers, and payers. The purpose of this review was to assess the literature on the association between medication therapy management (MTM) services and outcomes to substantiate a new quality measure.

Study Design: Scoping review.

Methods: We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews. The search included articles published between January 2006 and October 2024. Studies were included if they assessed the impact of Medicare Part D MTM service outcomes, followed Part D program MTM eligibility requirements, and were Medicare beneficiary specific. The search strategy was adapted for use in PubMed and grey literature. Reviewers extracted data using a screening tool developed for this study and used the Grading of Recommendations Assessment, Development, and Evaluation Evidence to Decision framework to determine the certainty of the evidence for risk of bias, indirectness, inconsistency, and imprecision.

Results: Of 424 screened articles, 27 studies met the inclusion criteria and were reviewed for certainty. Of these, 6 (22%) assessed for risk of bias had high levels of certainty that the true effect was similar to the estimated effect, whereas the levels of certainty for directness, consistency, and precision were rated low for all 6 studies.

Conclusions: The association between Part D MTM services and outcomes exists but is not sufficient to support recommendations for a new MTM quality measure. Future research with stronger study designs is warranted to support future measure development.

Am J Manag Care. 2026;32(3):172-180. https://doi.org/10.37765/ajmc.2026.89896

Takeaway Points

Quality evidence is needed to substantiate the development of a new health care performance measure in the Medicare Part D medication therapy management (MTM) program. The lack of clinical practice guidelines specific to the provision of MTM services necessitated a scoping review to assess the association between MTM services and outcomes.

• Although evidence exists to assess the association between MTM services and outcomes, findings are inconsistent due to variations in studied populations, interventions, and changes to the Part D MTM program.
• Sufficient evidence is lacking to support recommendations for a new quality measure for the Part D MTM program.

CMS requires Part D plan sponsors to offer medication therapy management (MTM) services to eligible beneficiaries, including those at risk for misuse or abuse of frequently abused drugs.¹ MTM services assess and prioritize medication-related problems to enhance patient health outcomes while reducing the risk of adverse drug events for patients taking multiple medications.² Interventions are made for both beneficiaries and prescribers. In 2009, the Part D MTM program included a combination of interventions (eg, medication review, refill reminders, letters, educational newsletters, drug interaction screening, or prescriber consultations).³

The program has evolved, and in 2026, beneficiaries are offered MTM interventions through an annual comprehensive medication review (CMR), which includes an interactive consultation with an MTM provider, and are provided an MTM Program Standardized Format written summary that includes recommendations. MTM providers may conduct the CMR with the prescriber or caregiver if the beneficiary is unable to participate. Part D plans have the flexibility to conduct CMRs either in person or via telephone, video conferencing, or another real-time method.⁴ Part D MTM programs must also offer quarterly targeted medication review (TMR) follow-up interventions to beneficiaries and prescribers to optimize medication use and resolve medication-related problems.⁵ Prescriber TMR consultations can be interactive, faxed, or mailed.⁴

Quality measures gauge the quality of care and are built upon principles established in clinical practice guidelines and scientific evidence.⁶ They are intended to reflect, but not set, the standard of care.⁷ The quality measure “MTM Program Completion Rate for CMR” was incorporated into the Part D Star Ratings program in 2016, encouraging plan sponsors to actively engage with their members who are eligible for services. The measure assesses the percentage of MTM program enrollees who received a CMR within a specified period.⁴ Stand-alone Medicare prescription drug plans’ performance rates increased from 16% to 56% between 2016 and 2024. Similarly, Medicare Advantage prescription drug plans’ rates increased from 31% to 84% between 2016 and 2024.⁸ Although this increase is positive, there is demand for a new MTM measure focused on the quality—rather than the quantity—of services provided.⁹

New measure concepts rely heavily on evidence-based clinical practice guidelines that use a rigorous systematic method to assess the scientific literature and inform health care recommendations used in practice.¹⁰ However, the deficit of evidence-based clinical practice guidelines specific to the provision of MTM services is a barrier to the development of new quality measures. Despite previous research demonstrating the negative effects of inappropriate prescription use^11,12 and the benefits of medication reviews on health outcomes,¹³ data from a study in 2014 showed the quality of evidence of MTM intervention impact on health outcomes to be insufficient.¹⁴ The 2014 study was not limited to the Part D MTM program, and a decade later, a number of additional publications have been produced examining outcomes associated with the Part D MTM program. Therefore, a thorough and transparent review of the quality of the evidence on the impact of Part D MTM services on outcomes is warranted to support the development of a new quality measure. The purpose of this scoping literature review was to assess the quality of MTM evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Evidence to Decision (EtD) framework.¹⁵

METHODS

Study Design and Eligibility Criteria

To be included, studies had to be published in English between January 2006 (Part D MTM program launch) and October 2024, assess the impact of any Part D MTM service on an outcome, follow the Part D program MTM eligibility requirements, and be specific to Medicare beneficiaries. Studies were excluded if they solely focused on inpatient settings, were not an original research article, did not investigate an MTM service outcome, or were not reflective of the standard Part D MTM program (ie, the Enhanced MTM model).

Search Strategy

This scoping review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) criteria listed in eAppendix A (eAppendices available at ajmc.com).¹⁶ A systematic literature search strategy was developed using a combination of Medical Subject Headings and was adapted for use in PubMed. The following keywords were used: Medicare with medication therapy management, comprehensive medication review, or targeted medication review (see eAppendix B).

Study Selection

Two independent reviewers (J.M.B. and C.E.V.) evaluated titles and abstracts, then reviewed the full text of all studies identified for potential inclusion. One discordance reviewer (M.C.-B.) reviewed studies in cases of disagreement. A screening and data extraction tool was developed in Excel version 16.0.18129.20158 (Microsoft) to extract relevant data including study author(s), year, mode of delivery, MTM intervention, comparison group, outcomes, and MTM eligibility criteria (eg, minimum number of chronic conditions, number of Part D drugs, and annual Part D drug cost).

Outcomes Categorization

Outcomes associated with MTM interventions were categorized into 4 medication-related need subgroups, as defined by the Pharmacy Quality Alliance (PQA) Medication Therapy Problem (MTP) Categories Framework, including medication (1) indication, (2) effectiveness, (3) safety, and (4) adherence.¹⁷ Items were included in the indication subgroup if reported outcomes were related to unnecessary medication therapy or the need for additional medication therapy; the effectiveness subgroup if reported outcomes were related to ineffective medications, subtherapeutic dosages, or the need for additional effectiveness monitoring; the safety subgroup if reported outcomes were related to adverse medication events, supratherapeutic dosages, or the need for additional safety monitoring; or the adherence subgroup if reported outcomes were specific to medication adherence.

Non–medication-specific outcomes were also categorized into prescription cost (ie, both plan and patient costs or total costs), out-of-pocket patient cost, medical cost (as defined by each article), health care resource use (ie, inpatient and emergency department [ED] use), and mortality.

Evidence Base Assessment

The quality of included studies for level of certainty was assessed using domains in the GRADE EtD framework to (1) determine risk of bias, indirectness, inconsistency, and imprecision, and (2) ensure systematic evaluation of the evidence.¹⁵ The EtD framework can be applied to measure development when clinical practice guidelines are not available, as it encourages measure developers to parallel their approach to scientific evidence assessment with the method used by guideline developers.¹⁵ Certainty, or confidence in the estimated effect, was ranked as either very low, low, moderate, or high after assessing the risk of bias, indirectness, inconsistency, and imprecision. A very low level of certainty was assigned when the available evidence was insufficient to support conclusions about the true effect, whereas a high level of certainty was assigned to well-conducted studies with minimal bias, direct evidence, and consistent and precise results indicating a high level of confidence that the estimated effect is similar to the true effect.¹⁵

Risk of bias. Studies were first reviewed to determine whether biases, or the potential for systematic errors in the design or conduct of the study, were present. Bias (eg, loss to follow-up, study design limitations, selective reporting) can under- or overestimate the effect of MTM services on outcomes.¹⁸ Hence, only studies that had a low risk of bias proceeded to the directness assessment because they were found to have higher internal validity.

Directness. Next, studies were reviewed to determine whether the studied populations, interventions, outcomes, and settings aligned with the Part D MTM program and eligible populations. Studies reviewed for directness were then assessed for consistency.

Consistency. The consistency of the direction and magnitude of the results was assessed to determine clinical or methodological heterogeneity. Studies reviewed for consistency proceeded to the precision assessment.

Precision. Finally, studies were reviewed for imprecision by assessing CIs and point estimates.

Taken together, the risk of bias, indirectness, inconsistency, and imprecision of the body of evidence was used to determine the level of certainty, or confidence, in MTM service impact on outcomes.

RESULTS

Identified Articles

A total of 424 studies were screened. After title and abstract review, 74 studies remained for full-text review. Of these, 47 were excluded in accordance with the predefined criteria, and 27 studies met eligibility criteria and were included (Figure¹³).

Characteristics of Included Articles

Of the 27 included studies, 6 did not specify the type of MTM intervention.^19-24 Of the 21 studies that provided such specification, the most common type of intervention was a CMR (17 of 21; 81%).^25-41 Twelve studies (44%) did not specify the mode of MTM service delivery.^{19,20,22-25,30-32,37,41,42} The most specified mode of delivery was telephonic (9 of 15; 60%).^{26-28,33-36,39,40} Of the studies that noted the number of chronic conditions as part of their MTM eligibility criteria (21 of 27; 78%), 14 (67%) specified the use of at least 3 chronic conditions.^{19,22-25,27-29,31,33,37,41-43} For studies that specified their Part D drug eligibility criteria (22 of 27; 81%), 10 (45%) required at least 8 Part D drugs.^{19,22-25,31,37,39,41,42} Twenty-two studies (81%) specified their minimum required annual Part D drug cost. See Table 1.^19-45

Of the 27 included studies, variability was observed in reported outcomes related to medication-related needs.¹⁷ Only 15 (56%) examined medication adherence,^{19-22,24,25,29,31,32,35,36,38,40-42} 9 (33%) examined medication effectiveness,^{22,23,26,29,33,35,36,38,40} 10 (37%) examined medication indication,^{21,22,26,29,35,36,38,40,43,44} and 14 (52%) examined medication safety.^{20-22,24,26-29,35-38,40,45} See Table 2.^17,19-45

For the non–medication-specific outcome categories, 4 studies (15%) examined ED use,^21,34,40,42 4 (15%) examined inpatient use,^21,34,40,42 6 (22%) examined medical costs,^{21-23,29,36,39} 2 (7%) examined mortality,^34,40 3 (11%) examined patient out-of-pocket costs,^30,33,36 and 9 (33%) examined prescription costs.^{21-23,33-36,39,40}

Risk of Bias Assessment

Of 27 studies, 20 included a comparison group and 7 did not.^{20,23,29,30,38,44,45} One study was labeled as not including a comparison group because it did not employ the group to compare outcomes of interest.²³ Of the studies that employed a comparison group, 14 (70%) had differences at baseline between control and intervention groups.^{19,21,25-28,31-36,40,43} Six (30%) of the 20 studies used propensity score matching to balance comparison groups at baseline to reduce the risk of bias and were considered to have low risk of bias.^{22,24,37,39,41,42} See Table 3 [part A and part B].^19-45

Directness Assessment

Of the 6 studies deemed to have low risk of bias,^{22,24,37,39,41,42} 8 outcomes were identified for directness assessment. Of these outcomes, 4 (ie, medication indication,²² medication effectiveness,²² inpatient use,⁴² and ED use⁴²) had only 1 associated study and were not deemed appropriate for directness assessment given that a single study should not be used to change health care practice.⁴⁶ The 4 remaining outcomes (ie, medication safety, prescription costs, medication adherence, medical costs) were assessed for directness.

Medication safety. Three studies examined medication safety.^22,24,37 One examined safety as part of a composite outcome and was not further assessed due to the inability to separate individual outcomes from the composite.²² Two assessed concurrent use of opioids and benzodiazepines and had the same inclusion criteria for their samples related to number of chronic conditions, number of drugs, and cost of medications, although intervention specifics were unclear.^24,37 One study specified the CMR intervention but did not specify the mode of delivery.³⁷ The other study did not specify the type of MTM intervention.²⁴

Prescription costs. Two studies examined the impact of MTM interventions on prescription costs.^22,39 In both, the samples were required to take at least 8 drugs and have a similar expected annual cost of medications, but one study required at least 2 chronic conditions³⁹ and the other required at least 3 chronic conditions.²² One study did not specify the type or mode of MTM intervention²² and the other focused on telephonic CMRs.³⁹

Medication adherence. Four studies examined medication adherence.^22,24,41,42 One examined adherence as part of a composite outcome and was not further assessed.²² One focused on TMRs,⁴² whereas another focused on the receipt of CMRs but did not specify the mode of delivery.⁴¹ The other studies did not specify the type of MTM intervention.^22,24 The intervention group among all 4 studies required 3 or more chronic conditions, 8 or more Part D medications, and annual drug costs between $3000 and $4000.^22,24,41,42

Medical costs. Two studies examined medical cost outcomes.^22,39 Similar to other outcomes, studies lacked specificity, and intervention groups had similar, but not the same, requirements for MTM eligibility.

All studies assessed for directness limited the ability to conclude that there was a direct body of evidence to support the effects of a specific intervention on an outcome either due to gaps in the availability of information reported or variability between populations, interventions, and outcomes.

Consistency Assessment

Two studies assessed concurrent use of opioids and benzodiazepines and both found favorable results for the intervention group.^24,37 Two studies examined the impact of MTM interventions on prescription costs, and findings were inconsistent.^22,39 One study found favorable results for prescription costs,²² whereas the other found no difference between intervention and comparison groups related to prescription costs.³⁹ Of the 4 studies that assessed medication adherence as an individual outcome,^22,24,41,42 no 2 studies found similar results for the same medication class. Lastly, 2 studies examined medical cost outcomes and found favorable results for the intervention groups.^22,39

Precision Assessment

Given the significant limitations identified in the bias, directness, and consistency assessments, precision assessment was not performed.

Overall, the evidence base had significant gaps and variation. There were at most 2 studies per outcome that reported consistent results, but at least 1 of the 2 studies for each outcome did not adequately report the details of the intervention. Only 1 study included a sufficient description of the MTM intervention to replicate implementation (eg, mode of delivery, MTM intervention, comparison group, outcomes, and MTM eligibility criteria).³⁹ Therefore, the level of certainty of the body of evidence describing the effects of MTM services on outcomes was rated as low, indicating the evidence was limited.

DISCUSSION

The key findings from this scoping review of MTM evidence were that (1) a high level of bias exists in the evidence based on study designs, (2) studied populations and interventions varied leading to inconsistent results, and (3) inconsistent reporting of study details, medication-related needs, and respective outcomes exists in the evidence. Due to these limitations, there was insufficient evidence to support the rationale for a new MTM quality measure.

Bias was indicated because many studies did not employ a comparison group or did not report balanced baseline characteristics between intervention and comparison groups, making it difficult to assert that MTM services impacted the studied outcomes.

Relatedly, individuals who declined MTM services and were used as comparisons^{26,33,34,36,40} may systematically differ from those who accepted services. These differences may have influenced how patients perceived or accepted the MTM service. The observed healthy-user effect, a known MTM evaluation limitation,²¹ may have limited accurate conclusions regarding the impact of services on outcomes.

This scoping review observed variation in populations, interventions, and outcomes assessed. Despite an additional 19 studies published since 2014, the results here are consistent with previous findings¹⁴ that concluded that variation in the populations and interventions resulted in inconsistency and imprecision for most outcomes and deemed the evidence base insufficient to assess the effect of MTM interventions on health outcome improvement.¹⁴ This review updated the assessment of evidence and limited the scope of the prior review to focus only on the Part D MTM program.

The directness of the evidence observed did not support conclusions about the relationship between Part D MTM services and outcomes. Some of the inconsistency in the populations stems from changes to the Part D program per CMS. Moreover, plan sponsors were able to apply additional targeting criteria beyond what CMS required, which created further variation in the studied populations. In addition, the process of providing and documenting MTM services did not use standardized approaches.¹⁴ This further complicated the ability to evaluate the impact of MTM services on outcomes and resulted in variation at both the service and plan sponsor level. Future research with homogeneous studies is warranted to strengthen the evidence and establish direct evidence with consistent target populations, interventions, and outcomes.

In addition to prioritizing rigorous research, a number of actions are required to enable a new quality measure.⁹ MTM stakeholders should promote a standard of care delivery for MTM. To support consistent reporting of MTM interventions and strengthen data collection and analysis, MTM stakeholders should promote the use of standardized health information technology to document MTM services, including reporting of MTM interventions that both address medication-related needs and resolve MTPs.⁹ Two PQA tools are available for the delivery and reporting of MTM services: the MTP Categories Framework and the Medication Therapy Problem Resolution monitoring measure. These efforts will improve service delivery, documentation, and enable data to cultivate high-quality evidence, all of which can enable measure development.

Limitations

This review was part of a larger effort to understand the landscape of literature related to Part D MTM, which may limit generalizability to evidence supporting broader medication management services.

CONCLUSIONS

The findings from this scoping review indicate that some evidence exists describing the association between MTM services and certain outcomes, but the overall body of evidence is insufficient to support recommendations for a new quality measure for the Part D MTM program. This conclusion should not undermine the value or evidence of pharmacist-provided care or medication management services but instead supports the position that a new quality outcome measure for the Part D MTM program is premature. Additional research that consistently reports intervention details and mitigates the risk of bias, indirectness, imprecision, and inconsistency is warranted to assess the impact of MTM services on outcomes.

Acknowledgments

The authors would like to acknowledge Dr Nicole Brandt for her contributions to this project.

Author Affiliations: Pharmacy Quality Alliance (JMB, CEV, MC-B), Alexandria, VA; University of Maryland School of Pharmacy (CEC), Baltimore, MD.

Source of Funding: None.

Author Disclosures: The authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (JMB, CEV, MC-B); acquisition of data (JMB, CEV, MC-B); analysis and interpretation of data (CEV, CEC, MC-B); drafting of the manuscript (JMB, CEV, MC-B); critical revision of the manuscript for important intellectual content (JMB, CEV, CEC, MC-B); administrative, technical, or logistic support (MC-B); and supervision (MC-B).

Address Correspondence to: Melissa Castora-Binkley, PhD, MA, Pharmacy Quality Alliance, 5911 Kingstowne Village Pkwy, Ste 130, Alexandria, VA 22315. Email: mcastora-binkley@pqa.org.

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