Graphical Depiction of Longitudinal Study Designs in Health Care Databases.

Pharmacoepidemiologic and pharmacoeconomic analysis of health care databases has become a vital source of evidence to support health care decision making and efficient management of health care organizations. However, decision makers often consider studies done in nonrandomized health care databases more difficult to review than randomized trials because many design choices need to be considered. This is perceived as an important barrier to decision making about the effectiveness and safety of medical products. Design flaws in longitudinal database studies are avoidable but can be unintentionally obscured in the convoluted prose of methods sections, which often lack specificity. We propose a simple framework of graphical representation that visualizes study design implementations in a comprehensive, unambiguous, and intuitive way; contains a level of detail that enables reproduction of key study design variables; and uses standardized structure and terminology to simplify review and communication to a broad audience of decision makers. Visualization of design details will make database studies more reproducible, quicker to review, and easier to communicate to a broad audience of decision makers.

A primer on managed care pharmacy.

This primer defines the practice of managed care pharmacy and introduces key competencies of managed care pharmacy organizations, including pharmacy benefit design and implementation, formulary and medication utilization management, clinical program development and implementation, quality and safety program management, and promotion of affordability.

Meeting report: an exploration into the scientific and regulatory aspects of pharmaceutical drug quality in the United States.

INTRODUCTION: The University of Florida College of Pharmacy, Department of Pharmaceutical Outcomes and Policy hosted a seminar 6-7 March 2021, on the quality of pharmaceutical products in the United States. This meeting report summarizes the topics presented at the seminar and highlights the expert opinions offered by the presenters. AREAS COVERED: The seminar, held virtually due to the COVID-19 pandemic, included slide presentations and faculty-moderated panel discussions from experts in the field. These experts from regulatory, academic, and private sectors discussed bioequivalence standards, existing and emerging efforts to promote quality in brand and generic manufacturing, as well as market-based solutions throughout the drug supply chain. EXPERT OPINION: The time spent understanding bioequivalence standards during the seminar felt especially important and relevant in our current pandemic environment, given the present need to have confidence in the science of drug development and to advocate for the safety of pharmaceuticals. Also an important point to emphasize from the seminar, was that every stakeholder along the drug supply chain has a responsibility to do their part to maintain its quality. And those in attendance, many of whom were students of healthcare sciences, were encouraged to be leaders in their fields and develop strategies to advance innovative improvements.

Distinguishing Predatory from Reputable Publishing Practices.

The preponderance of journals with dubious publishing practices has resulted in a new term in academic publishing: predatory journals. Although there is no standard definition, predatory journals generally subvert the traditional peer-reviewed system for financial gain. Common practices of predatory journals include publishing almost all submissions, a lack of transparency about publication fees, aggressive solicitation of contributors irrespective of relevant expertise and credentials, and even closely mimicking names of reputable journals-effectively acting as a decoy to attract authors and readers. Left unchecked, these journals have the potential to threaten the evidence base relied on by managed care pharmacists. Given the importance of peer-reviewed literature to managed care pharmacy practice, how is one to discern between a predatory journal and a reputable one? There are 5 key practices that distinguish reputable journals. First, reputable journals rely on peer reviewers who are experts in their respective fields to carefully review submitted manuscripts for suitability to publish. Second, reputable journals have a board of experts in relevant areas that serve in an advisory capacity to the editorial staff. Third, reputable journals follow recognized publishing standards to guide their policies, which range from determining authorship, to journal management, to handling allegations of misconduct. Fourth, reputable journals are transparent and fair about their levied fees, avoiding any real or perceived conflict of interest. Finally, reputable journals are indexed in searchable databases that have quality selection criteria for inclusion. These 5 criteria should be used by managed care authors and researchers when determining where to publish their papers and whether to serve as an editorial board member or peer reviewer when requested. Studies published in journals meeting these criteria can be deemed as reputable and suitable for review by managed care and health policymakers. It is essential that everyone involved in producing and using peer-reviewed literature is informed about the threat of predatory publishing and avoids engaging in any activities with these journals. DISCLOSURES: No funding was received for the writing of this article. The author is editor-in-chief of the Journal of Managed Care & Specialty Pharmacy and has nothing to disclose.

Managed Care Pharmacy Research on Inappropriate Opioid Use Interventions.

DISCLOSURES: No funding contributed to the writing of this commentary. The authors have nothing to disclose.

Application of a Graphical Depiction of Longitudinal Study Designs to Managed Care Pharmacy Research.

Managed care pharmacists apply real-world evidence (RWE) to support activities such as pipeline forecasting, clinical policy development, and contracting for pharmaceutical products. Managed care pharmacy researchers strive to produce studies that can be applied in practice. While asking the right research question is necessary, it is not sufficient. As with all studies, consumers of RWE look for internal and external validity, as well as sources of bias, to determine how the study findings can be applied in their work. To date, however, some of the safeguards that exist for clinical trials-such as public registration of study protocols-are lacking for RWE. Several leading professional organizations have initiatives dedicated to improving the credibility and reliability of such research. One component common to these initiatives is enhanced transparency and completeness of methodologic reporting. Graphical representations of study designs can improve the reporting and design of research conducted in health care databases, specifically by enhancing the transparency and clarity of often complex studies. As such, Schneeweiss et al. (2019) proposed a graphical framework for longitudinal study designs in health care databases. Herein, we apply this framework to 2 studies published in the Journal of Managed Care & Specialty Pharmacy that represent common research designs and report how application of the framework revealed deficiencies in reporting. We advocate for adoption of this framework in the effort to increase the usability of RWE studies using health care databases by managed care pharmacy. DISCLOSURES: No funding was provided for this work. Gatwood has received research funding from Merck & Co., AstraZeneca, and GlaxoSmithKline, unrelated to this work. Schneeweiss is a consultant to Aetion, of which he also owns equity. He is the principal investigator of investigator-initiated grants to the Brigham and Women's Hospital from Bayer, Genentech, Boehringer Ingelheim, and Vertex. Wang reports support from investigator-initiated grants from Novartis, Boehringer Ingelheim, and Johnson & Johnson to Brigham and Women's Hospital, unrelated to this work. Happe and Brown have nothing to disclose.

Impact of a pentavalent combination vaccine on immunization timeliness in a state Medicaid population.

BACKGROUND: Use of combination vaccines has been associated with improved coverage rates, but their effect on timeliness remains to be explored. This study assessed the effect of diphtheria-tetanus-acellular pertussis/hepatitis B/inactivated polio vaccine (DTaP/HepB/IPV) on the timeliness of vaccine administration. METHODS: This retrospective cohort study used administrative claims data from the Georgia Medicaid program. Children with 24 months of continuous enrollment and at least 4 vaccine-related office visits were stratified into 2 cohorts: those with at least 3 DTaP/HepB/IPV doses (DTaP/HepB/IPV cohort) and those with at least 3 doses of DTaP but no doses of DTaP/HepB/IPV (reference cohort). Children who received any dose of HepB/Hib were excluded to isolate the effect of the study vaccine. Timeliness was measured as the percentage of children who received their vaccines on time and the cumulative days undervaccinated. RESULTS: There were 2880 children in the DTaP/HepB/IPV cohort and 2672 in the reference cohort. After controlling for covariates, receipt of DTaP/HepB/IPV was associated with significantly improved timeliness for 3 doses of DTaP (on-time rates: 66.3% vs. 60.8%, P < 0.0001; cumulative days undervaccinated: 29.5 vs. 70.4 days, P < 0.0001). Significantly improved timeliness was also observed in the DTaP/HepB/IPV cohort for IPV, HepB, Hib, 4 DTaPs, and the combination series assessed (P < 0.001 for all comparisons). CONCLUSIONS: Use of DTaP/HepB/IPV in this Medicaid population was associated with improved on-time vaccination and fewer undervaccinated days. These findings, along with previous research associating combination vaccines with improved coverage rates, provide quantitative data to support the ACIP, AAP, and AAFP preference for combination vaccines.

Primary Care Provider Encounter Cadence and HbA1c Control in Older Patients With Diabetes.

INTRODUCTION: Primary care provider encounters are associated with health and well-being; however, limited evidence guides optimal primary care provider rate of visit, referred to as encounter cadence. This study measures associations between primary care provider encounter cadence and diabetes outcomes among individuals newly diagnosed with type 2 diabetes mellitus. METHODS: In this retrospective cohort study, 7,106 people enrolled in Medicare Advantage and newly diagnosed with type 2 diabetes mellitus between July 1, 2012 and June 30, 2013 were identified and followed for 36 months. Two methods measured primary care provider encounter cadence: total primary care provider encounters (frequency) and quarters with primary care provider encounter (regularity). Logistic regression measured relationships between primary care provider encounter cadence and non-insulin diabetes medication adherence, HbA1c control, emergency department visits, and inpatient admissions. Non-insulin diabetes medication adherence was defined according to the National Committee for Quality Assurance, Healthcare Effectiveness Data and Information Set specifications and measured using healthcare claims data. Post-hoc models examined adherence and diabetes control among those nonadherent (n=5,212) and with noncontrolled HbA1c (n=326) during the encounter/cadence period. Data were extracted and analyzed in 2017. RESULTS: Adjusted models indicated that both frequency (AOR=1.08, 95% CI=1.06, 1.10) and regularity (AOR=1.18, 95% CI=1.13, 1.22) of primary care provider encounters were associated with increased odds of adherence. Post-hoc analyses indicated that more frequent (AOR=1.12, 95% CI=1.10, 1.15) and regular (AOR=1.27, 95% CI=1.22, 1.33) primary care provider encounters were associated significantly with adherence and were associated directionally with HbA1c control. CONCLUSIONS: More frequent and regular primary care provider encounters are associated with an increased likelihood of non-insulin diabetes medication adherence. These findings contribute to data needed to establish evidence-based guidelines for primary care provider encounter cadence for those newly diagnosed with type 2 diabetes mellitus.

Postdischarge oral versus injectable anticoagulation following major orthopedic surgery.

BACKGROUND: Multiple clinical studies have shown postdischarge anticoagulation to be beneficial following major orthopedic surgery (MOS); however, outpatient prophylaxis is not widely practiced. OBJECTIVE: To quantify, from a third-party payer perspective, real-world clinical and economic outcomes for patients receiving injectable or oral anticoagulation as prophylaxis for venous thromboembolism (VTE) following discharge after MOS. METHODS: A retrospective database analysis was conducted using outpatient medical and pharmacy data from the PharMetrics Patient-Centric Database (January 1, 2002, to March 31, 2006). Patients greater than 18 years of age with 9 months of continuous eligibility who received an anticoagulant in the outpatient setting following MOS were eligible. Patients were stratified into 2 cohorts: injectable (dalteparin, enoxaparin, fondaparinux) and oral (warfarin), and were matched 1:1 on demographic and clinical characteristics. RESULTS: A total of 12,724 patients were included (injectable, 6362; oral, 6362). At 90 days, patients receiving oral anticoagulation were 20% more likely to experience a VTE than were those receiving an injectable agent (7.4% vs 6.3%; p = 0.02, OR 1.18; 95% CI 1.03 to 1.36). No significant differences in bleeding were observed (<0.4%). The average adjusted total 6-month costs were significantly (p < 0.001) higher for the oral versus injectable cohort ($18,039 vs $16,429). Medical costs in the oral cohort offset the higher pharmacy costs in the injectable cohort. CONCLUSIONS: This study demonstrates that the risk of VTE extends to the outpatient setting following MOS, even with postdischarge anticoagulation. Injectable agents used in the outpatient setting may result in fewer clinical VTEs without increasing the risk for major bleeding. These findings support the data from controlled clinical studies and expand the evidence to the real-world setting. Despite higher pharmacy acquisition costs for injectable anticoagulants, injectable agents may offer significant per patient savings to third party payers.

Burden of deep vein thrombosis in the outpatient setting following major orthopedic surgery.

BACKGROUND: Venous thromboembolism (VTE) is a known complication of major orthopedic surgery (MOS) with important clinical and economic consequences. Recently published orthopedic guidelines have focused on prevention of pulmonary embolism as a primary outcome, but deep vein thrombosis (DVT) occurrence should not be readily dismissed. OBJECTIVE: To describe the burden of DVT following hospital discharge for MOS by assessing the impact of DVT on costs and resource utilization from the third-party payer perspective. METHODS: Retrospective analysis used outpatient medical and pharmacy data from the PharMetrics Patient-Centric Database (January 1, 2002-March 31, 2006). Patients 18 years of age or older with a record of MOS were eligible for inclusion. Included patients were stratified based on the presence of a DVT during the first month after hospital discharge. Characteristics of the samples were described. The impact of DVT on total 6-month costs and resource utilization (readmissions, outpatient, emergency department visits) was assessed through statistical models. RESULTS: Of the 32,899 patients in the analysis, 1221 (3.71%) had a record of DVT during the first month following discharge for MOS. Compared with patients who did not develop DVT, patients who developed DVT postdischarge were slightly older (56.5 vs 55.8 y; p = 0.0127), had a higher occurrence of prior VTE (26.2% vs 3.4%; p < 0.0001), and had undergone recent surgical procedures other than MOS (73.0% vs 69.6%; p = 0.0116). After controlling for potential confounders, DVT was associated with a 22% and 74% increase in the average number of expected outpatient and emergency department visits, respectively, during the 6-month postdischarge period but did not significantly impact the number of readmissions. Furthermore, total 6-month costs were significantly higher for patients who developed DVT, with an incremental increase of over $2000. CONCLUSIONS: The burden of DVT following hospital discharge for MOS is substantial. Specifically, DVT increases total costs and outpatient and emergency department visits.

Decreased venous thromboembolism with injectable vs oral anticoagulation after discharge for major orthopedic surgery.

The use of outpatient anticoagulation after major orthopedic surgery with oral or injectable anticoagulants is recommended by national guidelines. A retrospective analysis of medical and pharmacy claims data using the PharMetrics Patient-Centric Database Inc, Watertown, Mass, was conducted. After adjusting for covariates, patients receiving warfarin were approximately 30% more likely to experience a venous thromboembolism than those receiving an injectable anticoagulant (6.3% vs 4.8%; adjusted odds ratio, 1.3; 95% confidence interval, 1.1-1.5) by 30 days. The data at 90 days showed similar results. No significant differences in the incidence of major bleeding events between the cohorts were observed (incidence of major bleed <0.4%). These findings support the randomized controlled studies and expand the data to the real-world perspective. Clinicians should evaluate these data alongside the clinical trial data when selecting the safest and most effective prophylactic therapy for postdischarge anticoagulation.

Outcomes at Bariatric Surgery Centers of Excellence and Non-Designated Centers: A Retrospective Cohort Study in a TRICARE Population.

In 2013, the Centers for Medicare and Medicaid Services reversed their coverage policy that limited bariatric operations to Centers of Excellence (COE). Data from Centers for Medicare and Medicaid Services may not be generalizable to younger, healthier populations; additional data are needed to inform coverage policies for other plans. This retrospective cohort study used the 2010 to 2011 administrative claims data from the TRICARE military healthcare program to evaluate readmission rates, readmission length of stay, and postoperative healthcare costs among patients who had bariatric surgery at a COE versus non-designated centers. Outcomes were reported at 30, 60, and 90 days, and compared using logistic and linear regression models while controlling for age, gender, and military status. A total of 3027 patients underwent bariatric operations (mean age 44.16, 84.11% female). At 30 days, there were no significant differences between patients in COEs (n = 2413) and non-designated centers (n = 614), in readmission rates (4.77%, 4.40%, P = 0.70), mean length of stay (5.5 days, 6.7 days, P = 0.41), or mean postoperative healthcare costs ($754, $962, P = 0.398). There were no significant differences in any outcomes at 60 or 90 days. Combined with concerns related to COE patient access barriers, these findings strengthen the evidence that reject the requirement for bariatric surgeries to be performed at COEs.

Alternative Payment Models in Medical Oncology: Assessing Quality-of-Care Outcomes Under Partial Capitation.

BACKGROUND: Alternative payment models (APMs) in healthcare are emerging that reward quality of care over quantity of services. Most bundled payment programs that are described in published studies are related to episodes for a surgical inpatient hospital stay. With outpatient services, monthly capitated payments are an alternative to bundled payments for specialty services. OBJECTIVE: To assess the association of a capitated contractual arrangement between a primary care physician group and an oncology clinic group with the quality of care received. METHODS: We evaluated the effect of an oncology group's transition from a fee-for-service (FFS) arrangement to a partial-capitated-payment model with a primary care group. We compared outcomes for patients who received treatment after implementation of the new arrangement (ie, postcontract capitated group) with outcomes of patients receiving treatment before the change (ie, precontract capitated group). In addition, we conducted a parallel analysis of patients from a population that was not affected by the contract to assess temporal effects (ie, postcontract FFS group vs precontract FFS group). All patients were enrolled in Medicare Advantage plans of a single health plan (ie, Humana), and outcomes were measured using claims data provided by that company. Patients in the 2 precontract groups received treatment between July 1, 2010, and June 30, 2011; patients in the 2 postcontract groups received treatment between January 1, 2013, and December 31, 2013. Age- and sex-adjusted all-cause hospitalization, complications from cancer treatment, and ambulance transfers during 6 months of follow-up were evaluated. RESULTS: In the population subject to the partial-capitated-payment model, the postcontract group (N = 305) was younger than the precontract group (N = 165). In a subset of patients in the 2 capitated groups who had Deyo-Charlson Comorbidity Index (CCI) RxRisk scores, the postcontract capitated group had significantly higher CCI scores. Adjusted odds ratios for the postcontract capitated group versus the precontract capitated group showed no difference in the likelihood that any of the outcomes would occur. However, the mean number of chemotherapy-related complications and ambulance transports were greater postcontract. In the parallel analysis of the population not affected by the new payment arrangement, no differences were found between the pre- and postcontract groups. This suggests that temporal changes potentially affecting patients in the capitated and FFS populations would not have influenced postcontract outcomes. CONCLUSIONS: After the implementation of partial-capitated payments for medical oncology services in the oncology practice, the likelihood of a patient experiencing at least 1 event of a specific adverse outcome did not change; however, the average number of some adverse events did increase, which may in part be explained by a higher level of underlying morbidity in the postcontract group. The overall findings of this study suggest that quality of care was not compromised in this APM.

Outcomes of a Digital Health Program With Human Coaching for Diabetes Risk Reduction in a Medicare Population.

OBJECTIVE: To examine the outcomes of a Medicare population who participated in a program combining digital health with human coaching for diabetes risk reduction. METHOD: People at risk for diabetes enrolled in a program combining digital health with human coaching. Participation and health outcomes were examined at 16 weeks and 6 and 12 months. RESULTS: A total of 501 participants enrolled; 92% completed at least nine of 16 core lessons. Participants averaged 19 of 31 possible opportunities for weekly program engagement. At 12 months, participants lost 7.5% ( SD = 7.8%) of initial body weight; among participants with clinical data, glucose control improved (glycosylated hemoglobin [HbA1c] change = -0.14%, p = .001) and total cholesterol decreased (-7.08 mg/dL, p = .008). Self-reported well-being, depression, and self-care improved ( p < .0001). DISCUSSION: This Medicare population demonstrated sustained program engagement and improved weight, health, and well-being. The findings support digital programs with human coaching for reducing chronic disease risk among older adults.

Use of combination vaccines is associated with improved coverage rates.

BACKGROUND: The number of shots represented by the routine childhood immunization schedule poses a logistical challenge for providers and a potential deterrent for parents. By reducing the number of injections, use of combination vaccines could lead to fewer deferred doses and improved coverage rates. OBJECTIVE: To determine the effect of combination vaccines on coverage rates. METHODS: This was a retrospective study of administrative claims data from the Georgia Department of Community Health Medicaid program conducted from January through September of 2003. Coverage rates were compared between children who received at least 1 dose of HepB/Hib (COMVAX) or DTaP/HepB/IPV (PEDIARIX) (the combination cohort) and children who received no doses of either combination (the reference cohort). Infants with fewer than 4 vaccination visits were excluded from the analysis. Multivariate logistic regression was performed on the whole study population to assess the effect of combination vaccines while controlling for potential confounders. Hepatitis B and pneumococcal conjugate vaccine coverage rates were not included as outcomes. RESULTS: The study population consisted of 18,821 infants, 16,007 in the combination cohort and 2814 in the reference cohort. Unadjusted coverage rates for DTaP, IPV and the 4 DTaP:3 IPV:1 MMR, 4 DTaP: 3 IPV: 1 MMR: 3 Hib: 1 varicella, and 3 DTaP:3 IPV: 3 Hib series were higher in the combination cohort. Receipt of at least 1 dose of a combination vaccine was independently associated with increased coverage for each of these vaccines and vaccine series when controlling for gender, birth quarter, race, rural versus urban residence and historical provider immunization quality. CONCLUSIONS: Use of combination vaccines in this Medicaid population was associated with improved coverage rates. Additional studies are warranted, including those examining private sector populations and outcomes such as timeliness and cost.

Venous thromboembolism after orthopedic surgery: implications of the choice for prophylaxis.

INTRODUCTION: Venous thromboembolism (VTE) is an important cause of morbidity and mortality following major orthopedic surgeries. In clinical trials, fondaparinux and low molecular weight heparins have been shown to be more effective than unfractionated heparin (UFH) in preventing VTE. We retrospectively analyzed a large hospital discharge database to assess the occurrence of clinically detected VTE as a function of the injectable antithrombotic agent used for VTE prophylaxis in orthopedic surgery. METHODS: The Premier's Perspective database, representing over 500 hospitals across the US, was utilized to identify patients receiving dalteparin, enoxaparin, fondaparinux, or UFH following hip or knee replacement or hip fracture surgery between January 2003 and March 2005. The primary outcome was the proportion of patients in each cohort with a VTE, while secondary outcomes included VTE occurrence during index hospitalization, and proportion of patients with a VTE-associated hospital readmission. RESULTS: A total of 144,806 patients were included in the study. Significantly fewer fondaparinux patients experienced a VTE event (1.5%) compared to enoxaparin (2.3%), dalteparin (2.1%), and UFH (4.2%). After controlling for baseline covariates, the odds of experiencing a VTE was significantly higher for other treatments when compared to fondaparinux (odds ratios: dalteparin=1.22 [95% CI: 1.01 to 1.46] p=0.0370; enoxaparin=1.39 [1.19 to 1.62], p<0.0001; UFH=1.98 [1.67 to 2.34], p<0.0001). Significantly fewer fondaparinux-treated patients experienced an event during the index hospitalization or were readmitted for a VTE compared to other treatments. CONCLUSIONS: Similar to clinical trial findings, patients receiving fondaparinux in this study experienced fewer VTE events following orthopedic surgeries.

Family Physician Readiness for Value-Based Payments: Does Ownership Status Matter?

Value-based payments are rapidly replacing fee-for-service arrangements, necessitating advancements in physician practice capabilities and functions. The objective of this study was to examine potential differences among family physicians who are owners versus employed with respect to their readiness for value-based payment models. The authors surveyed more than 550 family physicians from the American Academy of Family Physician's membership; nearly 75% had made changes to participate in value-based payments. However, owners were significantly more likely to report that their practices had made no changes in value-based payment capabilities than employed physicians (owners 35.2% vs. employed 18.1%, P < 0.05). This study identified 3 key areas in which physician owners' value-based practice capabilities were not as advanced as the employed physician group: (1) quality improvement strategies, (2) human capital investment, and (3) identification of high-risk patients. Specifically, the employed physician group reported more quality improvement strategies, including quality measures, Plan-Do-Study-Act, root cause analysis, and Lean Six Sigma (P < 0.05 for all). More employed physicians reported that their practices had full-time care management staff (19.8% owners vs. 30.8% employed, P < 0.05), while owners were more likely to report that they had no resources/capacity to hire care managers or care coordinators (31.4% owners vs. 19.4% employed, P < 0.05). Owners were significantly more likely to respond that they do not have the resources/capacity to identify high-risk patients (23.1% owners vs. 19.3% employed, P < 0.05). As public and private payers transition to value-based payments, consideration of different population health management needs according to ownership status has the potential to support the adoption of value-based care delivery for family physicians.