A checklist for a consistent, comprehensive medication review.

INTRODUCTION: Medicare Advantage Part D plans and stand-alone Part D prescription drug plans are required by the Centers for Medicare and Medicaid Services to have qualified providers, including pharmacists, and offer annual comprehensive medication reviews (CMRs) for eligible Medicare beneficiaries. Although guidance on the components of a CMR is available, providers have flexibility in how to deliver the CMR to patients and which content to cover. With the variety of patient needs, CMR content is not always consistently delivered in practice. Our research group performed an extensive evaluation to create and test an ideal CMR content coverage checklist for CMR provision. CMR CONTENT CHECKLIST: The CMR Content Checklist can be used for quality improvement purposes to evaluate the comprehensiveness of pharmacist services-to assess either within pharmacist variation across patients or within organization variations between pharmacists or sites. INCORPORATING THE CMR CONTENT CHECKLIST INTO PRACTICE: Testing in a real-world setting demonstrated where gaps in service coverage existed. The CMR Content Checklist could be used as the first step for quality improvement given that it provides details on the key aspects of the service that can inform quality measure development.

Qualitative analysis of telephonic comprehensive medication review content and delivery.

BACKGROUND: Comprehensive medication reviews (CMRs) are offered to eligible Medicare beneficiaries to improve patient medication knowledge, identify, and address medication concerns, and empower medication self-management. However, the specific content of real-world CMRs is unclear. OBJECTIVE: To qualitatively assess CMR content and delivery among telephonic CMR providers. METHODS: This qualitative thematic analysis used transcriptions of audio-recorded patient interactions during CMRs from 3 telephonic medication therapy management provider organizations. Data were qualitatively analyzed using the inductive saturation model to code emergent themes by independent reviewers who met to agree themes through consensus. Intercoder reliability was calculated using Krippendorf alpha. RESULTS: Overall, 32 CMR transcripts from 3 organizations were analyzed in 13 rounds of coding. Intercoder reliability was >95%. A total of 21 themes were identified across 4 stages: call opening (4 themes), medication reconciliation (5 themes), clinical assessments and guidance (8 themes), and call closing (4 themes). The call opening stage included: service explanation; insurance coverage/cost; identity/privacy/recording; and patient's medication management. Medication reconciliation included: drug name, dose, frequency, and indication; medication deletion and addition; over-the-counter and vaccination assessment; drug efficacy assessment; and prescribing provider assessment. Clinical assessments and guidance included 4 core clinical assessments: allergy assessment; drug therapy problem assessment; drug-related adverse events; and medication modification; and 4 additional assessments: clinical/therapeutic guidance; cost savings guidance; diet/exercise/lifestyle guidance; and optional clinical and behavioral assessments. Call closing included: documentation; primary care provider confirmation; patient satisfaction; and call transfer. There were variations among organizations in the depth that CMR components were covered. CONCLUSION: These findings suggest provider organizations are including components that meet Centers for Medicare and Medicaid Services goals for CMRs. Yet, variations among organizations indicate a need for standardization and patient-centered measures to ensure appropriate CMR components are covered, while maintaining flexibility for pharmacists to provide patient-oriented CMRs that meet patients' clinical needs.

Comparison of the properties of the English and Spanish versions of the Patient Satisfaction with Pharmacist Services Questionnaire 2.0.

BACKGROUND: Pharmacists provide direct patient care services such as chronic disease management and medication therapy management services. Patient satisfaction measures are valuable tools to assess outcomes. Therefore, measuring patient satisfaction with pharmacist services, using tools such as the Patient Satisfaction with Pharmacist Services Questionnaire 2.0 (PSPSQ 2.0), is important to ensure service quality. OBJECTIVE: The objective of the study was to evaluate the descriptive properties and reliability of the original English and newly translated Spanish versions of the PSPSQ 2.0 in a larger sample. METHODS: This project evaluated the functioning of the Spanish translation of the PSPSQ 2.0 compared to the English version. Demographic characteristics were analyzed to determine whether the instrument functioned differently for English- and Spanish-speaking groups. Psychometric properties were analyzed. RESULTS: Completed data for both PSPSQ 2.0 versions were available for 337 patients (English, n = 187; Spanish, n = 150) enrolled. In the English data set, no items had a ceiling or a floor effect, while in the Spanish data set, all items had a ceiling effect, but no items had a floor effect. In both the English and Spanish versions, nearly all the items had a strong, positive correlation with one another (greater than 0.30), indicating the measure was unidimensional. The pattern of the estimated loading indicated the items were assigned as expected. The items functioned differently in the English and Spanish instruments, and there was a statistically significant difference in Wald values between the 2 versions (P > 0.05). CONCLUSION: The PSPSQ 2.0 demonstrated reliability for this setting and population. However, regarding demonstration of validity, the response categories in the instrument seem not to capture the views of the Spanish-speaking respondents. Further work may focus on uncovering the preferences for use of Likert scale response categories by Spanish speakers to ensure greater cultural fidelity in the translation.

Trends in telephonic comprehensive medication review in the United States from 2000 to present: a scoping literature review.

BACKGROUND: Although comprehensive medication review (CMR) services have been shown to provide value to patients and payers, the extent of uniformity in service delivery is unknown. A variety of standards and recommendations are available from academic and professional sources, but variation in service provision is an important consideration when attempting to measure or compare service quality nationally. OBJECTIVE: This study aimed to identify and summarize trends in the peer-reviewed and gray literature describing telephonic CMR delivery and content. METHODS: A scoping review of peer-reviewed and gray literature was conducted to quantify and qualify trends in CMR service. Two independent reviewers screened abstracts from 9 bibliographic databases and selected gray literature sources in accordance with the Joanna Briggs Institute guidelines and an internally developed protocol. Inclusion criteria for the review were English language; discussion of telephonic CMR service in the United States; research, legislation, or guidelines that describe CMR content coverage requirements for payment; and publication from the year 2000 to the present. Data relating to publication type, study design, setting, region, and themes of CMR content were collated into a Microsoft Excel data extraction form. Qualitative thematic analysis was conducted, and key findings and concepts were reported contextually. RESULTS: Of 374 identified documents screened, 15 were included in this scoping review and thematic analysis. The following characteristics of CMRs were identified: content, coverage, eligibility, frequency, process, and responsiveness. All published documents (n = 15, 100%) included a discussion of CMR content, and 14 sources (93%) addressed process elements of providing a CMR. Discussion of other themes varied in frequency across documents, ranging from 3 articles (20%) addressing organizational goals for CMR to 12 articles (80%) including elements of responsiveness. Within-theme variation was also observed for several CMR content areas. CMR process was the most heterogeneous theme with topics ranging from access to patient health records to pharmacist training. CONCLUSIONS: Assessment of telephonic CMR comprised a small but steadily increasing portion of the medication therapy management literature. Publications since 2015 have shown an increasing consensus of CMR content and purpose. Per the identified literature, there is an ongoing demand for higher-quality, more holistic CMRs, but there is no consensus on how to measure CMR quality. Future work should include engaging with CMR experts to understand variability in measures of CMR success.

Key informant perspectives about telephonic comprehensive medication review services in the United States.

BACKGROUND: Comprehensive medication reviews (CMRs) are provided by providers such as pharmacists to eligible beneficiaries. Although CMRs have been shown to provide value to patients, little is known about the service uniformity, quality, and content of CMRs. OBJECTIVE: This study aimed to characterize the current state of CMR services from diverse stakeholder perspectives and describe variation in responses to content and delivery of telephonic CMR services. METHODS: Semistructured interviews were conducted with 10 key informants. The interview guide contained 6 key questions with additional probing questions. Transcripts were analyzed using the inductive saturation model and phenomenological approach to code emergent themes, which were iteratively refined until saturation was achieved. RESULTS: Key informants included CMR payers (n = 3), providers (n = 5), and standards-setting organizations (n = 2). Ten themes about CMRs emerged from qualitative analysis: (1) definition, (2) organizational goals, (3) content, (4) eligibility, (5) frequency, (6) acceptance and completion, (7) process and personnel, (8) quality assurance, (9) preparation, and (10) future directions. CMR content descriptions were consistent across perspectives. Key informants described scenarios appropriate for expanded CMR eligibility criteria, although none were consistently reported. Providers emphasized patient CMR acceptance rates whereas payers and standard-setting organizations emphasized completion rates. Completion rates and adherence to Centers for Medicare and Medicaid Services standards were characterized as core organizational goals (n = 8), whereas patient satisfaction was less frequently identified (n = 4). A lack of incentive for CMR providers to follow-up with patients was a barrier to expanded services. Overall, key informants were dissatisfied with the CMR completion rate measure and would prefer measures focused on service quality and outcomes. CONCLUSIONS: CMR services largely met perceived guidelines, with variation in value-added services. Key informants desired adoption of an actionable measure that is focused on quality rather than completion rate. To inform a quality measure, future research should analyze completed CMRs to determine the extent of variation in content and delivery.

A conceptual framework for evaluation of community pharmacy pay-for-performance programs.

BACKGROUND: Recent interest in initiating pay-for-performance (P4P) programs indicates an underlying belief that economic incentives will have a direct impact on health care quality and efficiency. Evaluations of the impact of P4P programs on health care organizations and providers have been presented in the literature; however, none have focused on the impact of an incentive targeting community pharmacies. OBJECTIVE: To propose a theory-derived conceptual framework of how a financial incentive might work in a community pharmacy. METHODS: Studies from the fields of economics (agency theory), psychology (intrinsic and extrinsic motivators; expectancy theory), and organizational theory (ownership, institutional layers, organizational culture, and change management; quality improvement) were reviewed to inform the framework's components. This proposed conceptual framework also integrated and expanded on previous health care-related P4P models. RESULTS: P4P programs inherently use financial incentives to catalyze change; however, elements from psychology and organizational theories along with economic theory were identified as important considerations in how a financial incentive may operate when targeting a community pharmacy. Through the incorporation of these theories along with other P4P frameworks in health care, a conceptual framework was derived comprising 4 domains: incentive, pharmacy, other influencing factors, and P4P program measures. Hypothesized relationships among these domains were depicted. CONCLUSION: As focus on improving the quality of health care provision develops, opportunities for pharmacists to provide patient care services beyond dispensing will continue to advance, along with expanded reimbursement mechanisms extending beyond traditional product dispensing. The proposed theory-derived conceptual framework serves to depict how the integration of P4P and other factors may affect the pharmacy environment and subsequently affect a pharmacy's capability to perform well on medication-related quality measures. This framework may be used as a foundation on which to design studies to investigate the association between community pharmacy factors and performance in a P4P program.

Evaluating the role and value of a clinical pharmacist in a concierge primary care clinic.

OBJECTIVE: To understand the perceived role and value of the clinical pharmacist in a southern Arizona concierge primary care practice (CPCP) by employees. METHODS: Semistructured face-to-face interviews were conducted with health care team members employed by the CPCP site in December 2019 and January 2020 for this study. The interviews were audio recorded, transcribed, and thematically analyzed using an inductive approach with ATLAS.ti (version 7). A qualitative assessment was performed by 2 independent reviewers to identify the themes, which included clinical, economic, and humanistic outcomes. RESULTS: Eleven CPCP employees were interviewed: physicians (n = 2), a nurse practitioner (n = 1), medical assistants (n = 4), and administrative staff (n = 4). The perceived role and value of the clinical pharmacist in this CPCP varied by employee position; yet, all expressed the pharmacist's positive impact on patient care. Five themes were identified. The most common pharmacist roles identified included providing medication knowledge to providers, preventing abuse of controlled substances, monitoring clinical response to medications and adverse drug events, aiding in prior authorizations, educating patients, and providing patient-centered care. CONCLUSION: These results demonstrate that the integration of a clinical pharmacist into a CPCP can be valuable. This study highlights that the pharmacist was positively received by the physicians and staff. This further supports the value of the pharmacist as a key interprofessional health care team member. Further study is warranted to assess the longitudinal impact of pharmacists' services in a CPCP.

Features of Cancer mHealth Apps and Evidence for Patient Preferences: Scoping Literature Review.

BACKGROUND: Cancer is increasingly being treated as a chronic disease rather than an acute one-time illness. Additionally, oral anticancer therapies, as opposed to intravenous chemotherapy, are now available for an increasing number of cancer indications. Mobile health (mHealth) apps for use on mobile devices (eg, smartphones or tablets) are designed to help patients with medication adherence, symptom tracking, and disease management. Several previous literature reviews have been conducted regarding mHealth apps for cancer. However, these studies did not address patient preferences for the features of cancer mHealth apps. OBJECTIVE: The primary aim was to review the scientific literature that describes the features and functions of mHealth apps designed for cancer self-management. METHODS: As the purpose of this review was to explore the depth and breadth of research on mHealth app features for cancer self-management, a scoping review methodology was adopted. Four databases were used for this review: PubMed/MEDLINE, Embase, CINAHL, and PsycINFO. Citation and reference searches were conducted for manuscripts meeting the inclusion criteria. A gray literature search was also conducted. Data extracted from manuscripts included author, title, publication date, study type, sampling type, cancer type, treatment, age of participants, features, availability (free or subscription), design input, and patient preferences. Finally, the features listed for each app were compared, highlighting similarities across platforms as well as features unique to each app. RESULTS: After the removal of duplicates, 522 manuscripts remained for the title and abstract review, with 51 undergoing full-text review. A total of 7 manuscripts (referred to as studies hereafter) were included in the final scoping review. App features described in each study varied from 2 to 11, with a median of 4 features per app. The most reported feature was a symptom or side effect tracker, which was reported in 6 studies. Two apps specified the inclusion of patients and health care providers during the design, while 1 app noted that IT and communications experts provided design input. The utility of the apps for end users was measured in several ways, including acceptability (measuring the end users' experience), usability (assessing the functionality and performance by observing real users completing tasks), or qualitative data (reports from end users collected from interviews or focus groups). CONCLUSIONS: This review explored the literature on cancer mHealth apps. Popular features within these mHealth apps include symptom trackers, cancer education, and medication trackers. However, these apps and features are often developed with little input from patients. Additionally, there is little information regarding patient preferences for the features of existing apps. While the number of cancer-related apps available for download continues to increase, further exploration of patient preferences for app features could result in apps that better meet patient disease self-management needs.

It is time for a new comprehensive medication review quality measure.

Medication therapy management (MTM) services include comprehensive medication reviews (CMRs), which have been completed with millions of patients since their inception in the United States. The current MTM quality measure focuses on whether CMRs were completed (ie, the CMR completion rate). However, this process measure does not assess quality of care, or patient-reported or other outcomes of CMRs, and, therefore, does not reward MTM providers for improving health outcomes. In this viewpoint article, we present 3 reasons that shape our argument for new MTM quality measures and offer recommendations on next steps to achieve this. DISCLOSURES: Dr Vaffis is an employee of Clinical Outcomes Solutions and discloses this was work was completed previously during her employment at the University of Arizona. Dr Dhatt is an employee of Janssen and discloses this was work was completed previously during her employment at the University of Arizona. Dr Anderson is an employee of The Freedom Fund and discloses this was work was completed previously during her employment at the University of Arizona. Dr Black is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Dr Campbell received funding from Pharmacy Quality Alliance, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and SinfoniaRx and discloses this work was completed previously during his employment at the University of Arizona. Dr Kolobova is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Dr Hines is an employee of Pharmacy Quality Alliance. Dr Castora-Binkley is an employee of Pharmacy Quality Alliance. Dr Nelson is an employee of Pharmacy Quality Alliance. Dr Axon received funding from Pharmacy Quality Alliance, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and SinfoniaRx. Dr Warholak received funding from Pharmacy Quality Alliance, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and SinfoniaRx and discloses this was work was completed previously during her employment at the University of Arizona.

Cost-Effectiveness of PD-L1 Testing in Non-Small Cell Lung Cancer (NSCLC) Using In Vitro Diagnostic (IVD) Versus Laboratory-Developed Test (LDT).

INTRODUCTION: Accurate PD-L1 testing for non-small cell lung cancer (NSCLC) maximizes the benefits of immune checkpoint inhibitor (ICI) drugs like pembrolizumab. False negative test results deny ICI treatments to eligible patients, worsening clinical and economic outcomes, while false positives increase costs by using ICI treatments without their benefits. This study evaluates the cost-effectiveness of PD-L1 testing with an in vitro diagnostic (IVD) compared to a laboratory-developed test (LDT) for allocating patients with NSCLC to treatment with either pembrolizumab or chemotherapy using the German healthcare system as a model. METHODS: We developed a decision analytical model to evaluate the cost-effectiveness of PD-L1 testing with a regulatory body approved IVD compared to an LDT from the national German healthcare payer (statutory health insurance system) perspective. Accuracy of PD-L1 testing was based on data from two independent proficiency testing programs. The 1-year model was based on outcomes data from the KEYNOTE-024 clinical trial and treatment patterns reflecting current German practices. RESULTS: IVDs produced accurate PD-L1 testing results in 93% (752/811) of tested cases compared to 73% (492/672) with LDTs. Most misclassifications concerned false negatives, occurring in 21% of LDTs vs 7% of IVDs. Total costs of the IVD group (48,878 €) were 196 € higher than the LDT group (48,682 €). These costs incorporate testing, first- and second-line therapy, managing treatment-related grade 3+ adverse events (AEs), and end-of-life costs for those who died within the year. Total effectiveness (percentage of patients successfully diagnosed and prescribed the correct therapy per German treatment guidelines) was 19 percentage points higher for the IVD group (88%) compared to the LDT group (69%). These differences in costs and effects lead to an incremental cost-effectiveness ratio (ICER) of 1057 €. CONCLUSION: Compared to LDT technology, on-label IVD use for PD-L1 testing is only slightly more costly and substantially more effective for aligning patients with PD-L1-positive NSCLC with ICI therapy according to German practice guidelines. Given these findings, changes to testing and reimbursement policies may be considered to maximize patient outcomes in NSCLC.

Health Costs of Older Opioid Users with Pain and Comorbid Hypercholesterolemia or Hypertension in the United States.

This retrospective cross-sectional database study used 2018 Medical Expenditure Panel Survey data to quantify and assess differences in healthcare expenditures between opioid users and non-users among a non-institutionalized sample of older (≥50 years) United States adults with pain in the past four weeks and a diagnosis of comorbid hypercholesterolemia (pain-hypercholesterolemia group) or hypertension (pain-hypertension group). Hierarchical multivariable linear regression models were constructed by using logarithmically transformed positive cost data and adjusting for relevant factors to assess cost differences between groups. Percent difference between opioid users and non-users was calculated by using semi-logarithmic equations. Healthcare costs included inpatient, outpatient, office-based, emergency room, prescription medication, other, and total costs. In adjusted analyses, compared to non-users, opioid users in the pain-hypercholesterolemia and pain-hypertension groups respectively had 66% and 60% greater inpatient expenditure, 46% and 55% greater outpatient expenditure, 67% and 72% greater office-based expenditure, 50% and 60% greater prescription medication expenditure, 24% and 22% greater other healthcare expenditure, and 85% and 93% greater total healthcare expenditure. In conclusion, adjusted total healthcare expenditures were 85-93% greater among opioid users versus non-users in older United States adults with pain and comorbid hypercholesterolemia or hypertension. Future research is needed to identify opioid use predictors among these populations and reduce expenditures.

Validation of a pre-/post-survey to measure change in student social justice attitudes and empathy.

INTRODUCTION: Despite endorsement by the Center for the Advancement of Pharmacy Education (CAPE), doctor of pharmacy (PharmD) students are infrequently taught concepts related to social justice and empathy in a formal capacity. In addition, no validated measure exists to examine changes in these attitudes. Therefore, we tested the ability of a survey to predict changes in social justice and professional empathy attitudes in PharmD students. METHODS: Retrospective pre-/post-data collected from PharmD students who completed a population health course at two schools of pharmacy were used to assess validity and reliability of the Social Justice and Empathy Assessment (SJEA) survey. A partial-credit Rasch model was used to test for uni-dimensionality, person and item fit, and rating scale functioning, as well as construct and content validity. Multiple linear regression was used to assess the effect of demographic covariates on the extent of pre-/post-change. RESULTS: Of 396 participating students, 60% were non-Hispanic White and 57% were male. The scale demonstrated evidence of uni-dimensionality of a construct designated "social justice self-efficacy." The rating scale functioned best as a three-option scale. Four items were removed to optimize person-item distribution, though few items were difficult to endorse. Attending the private school was significantly associated with increased pre-/post-change. CONCLUSIONS: The SJEA is functional as a criterion-referenced assessment to determine whether minimum competency in social justice self-efficacy is experienced before or after participation in a CAPE-informed educational program. Further research should explore contextual predictors of change in social justice self-efficacy.

Identifying Predictive Characteristics of Opioid Medication Use among a Nationally Representative Sample of United States Older Adults with Pain and Comorbid Hypertension or Hypercholesterolemia.

The prevalence of older adults with pain and comorbid cardiovascular conditions is increasing in the United States (U.S.). This retrospective, cross-sectional database study used 2017 Medical Expenditure Panel Survey data and hierarchical logistic regression models to identify predictive characteristics of opioid use among a nationally representative sample of older U.S. adults (aged ≥50 years) with pain in the past four weeks and comorbid hypertension (pain-hypertension group) or hypercholesterolemia (pain-hypercholesterolemia group). The pain-hypertension group included 2733 subjects (n = 803 opioid users) and the pain-hypercholesterolemia group included 2796 subjects (n = 795 opioid users). In both groups, predictors of opioid use included: White race versus others, Hispanic versus non-Hispanic ethnicity, 1 versus ≥5 chronic conditions, little/moderate versus quite a bit/extreme pain, good versus fair/poor perceived mental health, functional limitation versus no functional limitation, smoker versus non-smoker, and Northeast versus West census region. In addition, Midwest versus West census region was a predictor in the pain-hypertension group, and 4 versus ≥5 chronic conditions was a predictor in the pain-hypercholesterolemia group. In conclusion, several characteristics of older U.S. adults with pain and comorbid hypertension or hypercholesterolemia were predictive of opioid use. These characteristics could be addressed to optimize individuals' pain management and help address the opioid overdose epidemic.

Perceptions and experiences of promotoras and pharmacists in an academic-community partnership providing telephonic MTM services to a Spanish-speaking, rural population: a focus group study.

BACKGROUND: The literature is limited concerning the collaboration between pharmacists and promotoras in the delivery of medication therapy management (MTM) services. Yet, this information could help address a practice gap while improving MTM collaborative care approaches. OBJECTIVE: To identify the knowledge, attitudes, and barriers of clinical call center health professionals (pharmacists, nurses, pharmacy interns) and promotoras towards MTM collaborative care in implementing the Rural Arizona Medication Therapy Management (RAzMTM) program. METHODS: A descriptive, qualitative study using semistructured focus groups was conducted with call center health professionals and promotoras who participated in the RAzMTM program to improve pharmaceutical care for patients with diabetes and/or hypertension in rural Arizona. Recruitment and consent letters, a demographic questionnaire, and a focus group guide were designed specifically for this project. Three facilitators participated in each focus group-one guided the discussion while the others took notes. Focus groups were audio recorded to verify all responses and transcribed verbatim with omission of participant identifiers. Thematic analysis was conducted by 2 independent researchers who reviewed the transcripts to identify codes, seek consensus, and agree on themes, with negotiation from a third independent researcher. RESULTS: Nine participants took part in 2 focus groups. Participants were predominantly female (89%), college graduates and/or had postgraduate/professional degrees (78%), and were Hispanic or Latino (89%). Five themes were identified: (1) roles and responsibilities of RAzMTM participants; (2) benefits unique to the RAzMTM program; (3) interprofessional experience of RAzMTM participants; (4) professional growth for RAzMTM participants; and (5) opportunities for future improvement. Perceptions of the participants in the RAzMTM program were consistent-experiences of health professionals and promotoras were positive; they recognized the benefit of each other's involvement in the program; and they learned how to work together to improve patient care. Future recommended program improvements include improving ease of scheduling (e.g., extending pharmacist availability to provide MTM services). CONCLUSIONS: These focus group results suggest that provision of telephonic MTM services, using an academic-community partnership, was positively received by participating pharmacists and promotoras. However, future work is needed for continued improvement of strategies to enhance interprofessional relationships in patient chronic disease management. DISCLOSURES: This project was supported by the Grant or Cooperative Agreement Number DP004793, funded by the Centers for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention or the Department of Health and Human Services. This work also was supported, in part, by SinfoniaRx. Axon, Taylor, and Warholak received funding from SinfoniaRx. Axon reports grants from Tabula Rasa Op-Co, Merck & Co, Pharmacy Quality Alliance, Arizona Department of Health, and American Association of Colleges of Pharmacy, outside the submitted work. Warholak and Taylor received funding from Arizona Department of Health Services as part of a contract, outside the submitted work. Vaffis reports funding from Merck and Pharmacy Quality Alliance. This study was presented as a poster at the American Society of Health-System Pharmacists Summer Meetings & Exhibition (June 10-12, 2019, Boston, MA) and as a podium presentation at the Arizona Pharmacy Association Southwestern States Residency Conference (June 14, 2019, Phoenix, AZ).

Assessing the association between medication adherence, as defined in quality measures, and disease-state control, health care utilization, and costs in a retrospective database analysis of Medicare supplemental beneficiaries using statin medications.

BACKGROUND: Adherence to medication, and related health and economic outcomes, is becoming increasingly important as populations age and as the number of Americans managing chronic conditions increases. The Pharmacy Quality Alliance (PQA) statin medication adherence measure is used in Medicare star ratings to evaluate health plan performance. Yet, limited evidence exists that investigates the association between statin medication adherence, as specified in the PQA adherence quality measure, and disease-state control, health care utilization, and costs. OBJECTIVE: To determine the association between adherence (≥80% proportion of days covered) and disease-state control, health care utilization, and health care costs for Medicare supplemental beneficiaries using statin medications eligible for inclusion in the PQA statin adherence quality measure. METHODS: This retrospective study used a cohort of eligible beneficiaries for inclusion in the PQA statin adherence measure with low-density lipoprotein (LDL) laboratory values from IBM MarketScan Medicare Supplemental Research Databases (2009-2015). A logistic regression model assessed the association between adherence and LDL control (controlled individuals had LDL levels ≤ 100 mg/dL). Health care utilization and costs during a 1-year period, from first statin medication claim, were compared between adherent and nonadherent groups using generalized linear models with log link and negative binomial distribution (utilization) or gamma distribution (costs), adjusting for covariates. Beta coefficients were used to compute cost ratios (CR) and rate ratios (RR). Cohort characteristics were assessed using t-tests, Wilcoxon rank sum tests, or chi-square tests. An a priori alpha level of 0.001 was used. RESULTS: The study cohort consisted of 77,174 beneficiaries, of whom 58,668 (76.0%) were classified as adherent to their statin medications. After controlling for other factors, odds of disease-state control were approximately 2 times higher among medication adherent beneficiaries compared with their nonadherent counterparts (OR = 2.192; 95% CI = 2.109-2.278). Multivariable analyses showed adherers experienced 4.7% fewer outpatient (RR = 0.953; 95% CI = 0.940-0.965) and 27.5% fewer inpatient (RR = 0.725; 95% CI = 0.687-0.766) visits; had 9.9% lower outpatient (CR = 0.901; 95% CI = 0.885-0.916) and 28.3% lower inpatient (CR = 0.717; 95% CI = 0.705-0.729) costs; 14.7% lower total costs (CR = 0.853; 95% CI =0.838-0.868); and 7.0% higher prescription drug costs (CR = 1.070; 95% CI = 1.052-1.089) than nonadherers. Adherence to statin medications was associated with a reduction in total costs of $157.32 per member per month. CONCLUSIONS: This retrospective database analysis demonstrated that statin adherence was associated with approximately twice the odds of having a controlled disease state compared with nonadherence in a large Medicare sample. Adherent beneficiaries had fewer outpatient and inpatient visits (lower utilization), lower outpatient and inpatient costs, and lower total costs, a calculated savings of $157.32 per member per month, despite having higher prescription drug costs. Finally, these results provide important new information by demonstrating that adherence (≥ 80%) is associated with lower health care costs in a short (1-year) time frame. DISCLOSURES: Funding for this study was provided by Pharmacy Quality Alliance; Merck & Co. (Kenilworth, NJ); and SinfoniaRx. All authors except Pickering and Black were employed by the University of Arizona College of Pharmacy or the Mel & Enid Zuckerman College of Public Health at the time of this study. Pickering is employed by the Pharmacy Quality Alliance, and Black is employed by Merck & Co. Chinthammit also reports employment with Eli Lilly and Company, and Campbell reports employment with the Pharmacy Quality Alliance. Axon reports grants from Arizona Department of Health Services, unrelated to this work. Warholak reports grants from Novartis and the Arizona Department of Health Services, unrelated to this work. This research was presented as a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting 2019, May 18-22, 2019, in New Orleans, LA.