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Summary Background Seasonal influenza vaccine (SIV) uptake among US adults aged 65 years or older remains suboptimal and stagnant. Further, there is growing concern around racial and ethnic disparities in uptake. We aimed to assess racial and ethnic disparities in overall SIV and in high-dose vaccine (HDV) uptake among Medicare beneficiaries during the 2015–16 influenza season and sought to identify possible mediators for observed disparities. Methods We did a historical record-linkage cohort study using Medicare (a US national health insurance programme) databases, which included all older adults (≥65 years) enrolled in Medicare during the study period (July 1, 2015, to June 30, 2016). We excluded beneficiaries of Medicare Part C (managed care offered by private companies), and residents of long-term care facilities. The primary outcome was SIV receipt during the study period, classified into receipt of HDV and standard-dose vaccines (SDVs, representing all other SIVs). SIV uptake probabilities were estimated using competing-risk survival analysis methods. Mediation analyses were done to investigate potential mediators of the association between race and ethnicity and uptake. Findings During the study period, of 26·5 million beneficiaries in the study cohort, 47·4% received a SIV, 52·7% of whom received HDV. Compared with white beneficiaries (49·4%), Hispanic (29·1%), Black (32·6%), and Asian (47·6%) beneficiaries were less likely to be vaccinated and, when vaccinated, were less likely to receive HDV (37·8% for Hispanic people, 41·1% for Black people, and 40·3% for Asian people, compared with 53·8% of white people who received HDV). Among those vaccinated, after accounting for region, income, chronic conditions, and health-care use, minority groups were 26–32% less likely to receive HDV, relative to white people (odds ratio [OR] 0·68 [95% CI 0·68–0·69] for Black people; OR 0·71 [0·71–0·72] for Asian people; and OR 0·74 [0·73–0·74] for Hispanic people). Interpretation Substantial racial and ethnic disparities in SIV uptake among Medicare beneficiaries aged 65 years or older are evident. New legislative, fiscal, and educational strategies are urgently needed to address these inequities. Funding Sanofi Pasteur.

Aim: To characterize vaso-occlusive crises (VOCs) and describe healthcare costs among commercially-insured, Medicaid-insured, and Medicare-insured patients with sickle cell disease (SCD). Materials and Methods: The IBM Truven Health MarketScan Commercial (2000-2018), Medicaid Analytic eXtract (2008–2014), and Medicare Research Identifiable Files (2012–2016) databases were used to identify patients with ≥2 SCD diagnoses. Study measures were evaluated during a 12-month follow-up period, stratified by annual number of VOCs (i.e., 0, 1, and ≥2). Results: Among 16,092 commercially-insured patients (mean age =36.7 years), 35.3% had 1+ VOCs. Mean annual total all-cause healthcare costs were $15,747, $27,194, and $64,555 for patients with 0, 1, and 2+ VOCs, respectively. Total all-cause healthcare costs were mainly driven by inpatient (0 VOC =31.0%, 1 VOC =53.1%, 2+ VOCs =65.4%) and SCD-related costs (0 VOC =56.4%, 1 VOC =78.4%, 2+ VOCs =93.9%). Among 18,287 Medicaid-insured patients (mean age =28.5 years, fee-for-service =50.2%), 63.9% had 1+ VOCs. Mean annual total all-cause healthcare costs were $16,750, $29,880, and $64,566 for patients with 0, 1, and 2+ VOCs, respectively. Inpatient costs (0 VOC =37.2%, 1 VOC =64.3%, 2+ VOCs =72.9%) and SCD-related costs (0 VOC =60.9%, 1 VOC =73.8%, 2+ VOCs =92.2%) accounted for a significant proportion of total all-cause healthcare costs. Among 15,431 Medicare-insured patients (mean age =48.2 years), 55.1% had 1+ VOCs. Mean annual total all-cause healthcare costs were $21,877, $29,250, and $58,308 for patients with 0, 1, and ≥2 VOCs, respectively. Total all-cause healthcare costs were mainly driven by inpatient (0 VOC =47.9%, 1 VOC =54.9%, 2+ VOCs =67.5%) and SCD-related costs (0 VOC =74.9%, 1 VOC =84.4%, 2+ VOCs =95.3%). Limitations: VOCs managed at home were not captured. Analyses were descriptive in an observational setting; thus, no causal relationships can be inferred. Conclusions: A high proportion of patients experienced VOCs across payers. Furthermore, inpatient and SCD-related costs accounted for a significant proportion of total all-cause healthcare costs, which increased with VOC frequency.

Introduction Despite improved understanding of the risks of influenza and better vaccines for older patients, influenza vaccination rates remain subpar, including in high-risk groups such as older adults, and demonstrate significant racial and ethnic disparities. Methods This study considers demographic, clinical, and geographic correlates of influenza vaccination among Medicare Fee-for-Service (FFS) beneficiaries in 2015–2016 and maps the data on a geographic information system (GIS) at the zip code level. Results Analyses confirm that only half of the senior beneficiaries evidenced a claim for receiving an inactivated influenza vaccine (IIV), with significant disparities observed among black, Hispanic, rural, and poorer beneficiaries. More extensive disparities were observed for the high-dose (HD) vaccine, with its added protection for older populations and confirmed economic benefit. Most white beneficiaries received HD; no non-white subgroup did so. Mapping of the data confirmed subpar vaccination in vulnerable populations with wide variations at the zip code level. Conclusion Urgent and targeted efforts are needed to equitably increase IIV rates, thus protecting the most vulnerable populations from the negative health impact of influenza as well as the tax-paying public from the Medicare costs from failing to do so. Electronic supplementary material The online version of this article (10.1007/s12325-020-01324-y) contains supplementary material, which is available to authorized users.

ImportanceRacial and ethnic minority populations have been disproportionately affected in terms of hospitalizations and deaths during the COVID-19 pandemic. Vaccine uptake remains a barrier to full population inoculation against this highly infectious disease.ObjectiveThe purpose of this report is to describe SARS-CoV-2 vaccine interest rates in a racially, geographically, and ethnically diverse study cohort and characterize vaccine interest across a racially, ethnically, and geographically diverse study population.DesignThis report describes responses to a survey administered between November 2020 and May 2021 using a community convenience sample through a partnership between the National Minority Quality Forum (NMQF) and Federally Qualified Health Centers (FQHCs) as part of the Minority and Rural Coronavirus Insights Study (MRCIS). Analysis of survey responses from 3,624 participants are provided.ResultsEarly data from the MRCIS cohort suggest that “SARS-CoV-2 vaccine hesitancy” is more prevalent in Black versus Non-Hispanic Whites survey respondents, and the Hispanic community has positive interest in the vaccine, to a similar degree as Whites. The persistent presence of “vaccine undecideds” across different sites and racial/ethnic groups uncovers the need for more public health efforts to influence positive views about vaccination.ConclusionThese findings highlights the urgent need for interventional educational campaigns targeted at populations at risk of low vaccine interest. Focused efforts are needed to combat misinformation and explain the vaccine’s safety and effectiveness to promote its uptake and avoid low inoculation rates. Public health communication must consider differences in population groups, regions, and social determinants of health to fully address vaccine uptake disparities and overcome alleged hesitancy.Key PointsWillingness to receive the SARS CoV-2 varies among minority populations.“SARS-CoV-2 vaccine hesitancy” is more prevalent in the non-Hispanic Black population than the non-Hispanic White and Hispanic populations.Public health infrastructure is needed in underserved communities for efficient assessment and targeted communication of public health priorities such as the SARS CoV-2 vaccination.

Background: Recent inpatient data abstracted from the National Inpatient Sample and/or National Readmissions Database have shown higher than expected (0.46%) 30-day mortality rates of AF ablation prior to 2016. AF ablation has been increasingly coded as an outpatient procedure and primarily as of late 2015. Prior studies did not include some of these outpatient ablation cases. As such, more complete data on mortality and health-disparity outcomes for combined inpatient and outpatient-coded AF ablation is lacking. The purpose of our study was to assess updated 30-day mortality rates following inpatient or outpatient AF ablation following coding changes with ICD-10. Patients were also stratified by demographics and geographic region. Method: Data were abstracted from the 2017 inpatient and outpatient Medicare institutional claims files. AF was identified based on primary or secondary ICD-10 diagnosis codes. Inpatient procedures were identified by matching a CPT code for AF ablation that occurred on the same day as a primary or secondary ICD-10-PCS code for AF ablation. Outpatient AF ablation was identified using the CPT code. AV nodal ablation or a pacemaker procedure on the same day as AF ablation were excluded. AF ablation had to occur within the first 11 months of the calendar year to allow 30-day mortality data for all patients. We used the Medicare Master Beneficiary Summary File to further stratify beneficiaries by sex, race, and ethnicity, and geographic region. Mortality rates are shown as frequency and percent, compared using the chi-square test. Results: In 2017, a total of 40,373 AF ablations (58% men) were identified, of which 30,539 (75.6%) were coded as outpatient. The mean age in years was 71.5 (SD = 7.1), and median age was 71 (21 to 100). In total, 294 patients died within 30 days of procedure (0.73%, 95% CI: 0.65% to 0.82%). The 30-day mortality rate was higher following inpatient coded procedures compared to outpatient coded procedures (2.34% vs. 0.21%, p < .001). Further, higher 30-day mortality rates were observed for male patients compared to female patients (0.83% vs. 0.59%, p = .006) as well as in non-white patients compared to white patients (1.32% vs. 0.69%, p < .001). Finally, 30-day mortality rates differed by region (South: 0.85%, Midwest: 0.81%, Northeast: 0.56%, and West: 0.51%; p = .007). Conclusion: Overall 30-day mortality post-AF ablation appears high, particularly following inpatient coded AF ablation. Most notably, it is significantly higher than the recent estimate of 0.46% mortality risk following AF ablation from primarily inpatient data. The findings of higher mortality in males, in the non-white population, and in certain regions of the US are notable. Further studies are needed to understand the factors impacting mortality.

Anticoagulants are effective for stroke prevention in atrial fibrillation (AF). Data on population health-related cardiovascular outcomes by race/ethnicity and gender are not well described. The aim was to assess the impact of patient diversity on associated cardiovascular outcomes related to warfarin anticoagulation in Medicare beneficiaries with AF.Medicare administrative claims data for years 2000-2010 were used to calculate AF prevalence and rates of new AF cases. Three 20% sample cohorts of new AF beneficiaries for years 2000, 2005, and 2007 were extracted and analyzed in a longitudinal study design. The impact of warfarin on associated cardiovascular outcomes was measured with respect to race/ethnicity and gender. Measured outcomes included the risk of stroke, mortality and hospitalization after adjusting for age, gender, race/ethnicity, CHADS2 score and warfarin.AF prevalence and warfarin use increased while stroke and mortality rates declined across race/ethnicity and gender from 2000 to 2010. Analyses comparing Whites to non-Whites highlighted several disparities: (1) Blacks were 40% (p 0.0001) more likely to have a stroke even after adjustment for warfarin; (2) in 2007, Hispanics had a 35% (p 0.01) higher prevalence of stroke and warfarin did not reduce the risk; and (3) Asians had better outcomes. Warfarin reduced stroke less well in women who had a lower risk of death and hospitalization. Despite a 70% (p 0.0001) reduction in mortality for warfarin users, Blacks had a 25% (p 0.0001) higher mortality risk than Whites.Differences in population health metrics across race/ethnicity and gender exist in AF. Across all metrics, Blacks had comparatively worse outcomes. Patient diversity should be a focus for future investigations in AF to improve outcomes in the whole population.National Minority Quality Forum.

Introduction Nonadherence to antihyperglycemic agents (AHAs) increases the incidence of morbidity and mortality, as well as healthcare-related costs, in patients with type 2 diabetes (T2D). This study examined the association between medication copayment and adherence and discontinuation among elderly patients with T2D who use generic versus branded AHAs. Methods A retrospective, observational cohort study used Medicare administrative claims data (index period: 1 June 2012 to 31 December 2013). Drug copayments were measured as the copayment of the index medication for a 30-day supply after patients met their plan deductible. Patients were stratified into a branded or generic cohort based on the index medication. Adherence was measured by the proportion of days covered (≥ 80%) and discontinuation by a treatment gap of > 60 days in 10 months during the follow-up period. Poisson regressions were conducted for medication adherence and discontinuation, while controlling for demographic, clinical, and comorbid conditions. Results Overall, 160,250 patients on AHA monotherapy were included in the analysis; 131,594 (82%) were prescribed a generic and 28,656 (18%) a branded AHA with a mean copay of $6 and $41, respectively. Increases in copayment increased nonadherence and discontinuation for branded medications but not for generic AHA medications. In both cohorts, elderly patients (≥ 75 years of age) had a lower risk of nonadherence and discontinuation. Black patients had a higher risk of nonadherence or discontinuing medication. Patients having more frequent inpatient, emergency room, and/or physician visits were at higher risk of nonadherence or discontinuing therapy in the branded and generic cohorts (P

OBJECTIVE Use of glucose monitoring is essential to the safety of individuals with insulin-treated diabetes. In 2011, the Centers for Medicare & Medicaid Services (CMS) implemented the Medicare Competitive Bidding Program (CBP) in nine test markets. This resulted in a substantial disruption of beneficiary access to self-monitoring of blood glucose (SMBG) supplies and significant increases in the percentage of beneficiaries with either reduced or no acquisition of supplies. These reductions were significantly associated with increased mortality, hospitalizations, and costs. The CBP was implemented nationally in July 2013. We evaluated the impact of this rollout to determine if the adverse outcomes seen in 2011 persisted. RESEARCH DESIGN AND METHODS This longitudinal study followed 529,627 insulin-treated beneficiaries from 2009 through 2013 to assess changes in beneficiary acquisition of testing supplies in the initial nine test markets (TEST, n = 43,939) and beneficiaries not affected by the 2011 rollout (NONTEST, n = 485,688). All Medicare beneficiary records for analysis were obtained from CMS. RESULTS The percentages of beneficiaries with partial/no SMBG acquisition were significantly higher in both the TEST (37.4%) and NONTEST (37.6%) groups after the first 6 months of the national CBP rollout, showing increases of 48.1% and 60.0%, respectively (both P < 0.0001). The percentage of beneficiaries with no record for SMBG acquisition increased from 54.1% in January 2013 to 62.5% by December 2013. CONCLUSIONS Disruption of beneficiary access to their prescribed SMBG supplies has persisted and worsened. Diabetes testing supplies should be excluded from the CBP until transparent, science-based methodologies for safety monitoring are adopted and implemented.

Racial and ethnic minority groups have low rates of inclusion in cancer clinical trials (CCTs). For example, African American patients comprise 5% of patients enrolled in CCTs that support US Food and Drug Administration approval of new drugs but represent 13.3% of the general US population. Though cancer is the leading cause of death for Asian Americans, only 3% of CCTs is composed of Asian American participants. With the promise and rise of precision medicine, it is critical that study populations in clinical research reflect the changing US demographics. Expanding access to health data and analytics empower stakeholders to better understand and advocate for equitable research and treatment access in cancer. Research question: To what extent does the current US CCT site placement for non-small cell lung cancer (NCSLC) and small cell lung cancer (SCLC) reflect the reality of lung cancer patient prevalence and demographics in the US? Methods: Researchers used the following two primary data sources: (1) Medicare Fee-for-Service (FFS) patient-level claims data from 2016, including the following data elements: prevalence, co-morbidities, hospital encounters, and costs for patients with ICD-10 codes for NCSLC and SCLC, by demographic (age, gender, race, and ethnicity). Locations were designated as high (greater than 0.87%) or low (less than 0.87%) prevalence, based on national average prevalence. (2) CCT placement data was sourced from 2018 Clinical Trials.gov to determine ongoing NCLSC and SCLC studies where there are US study sites. Data were mapped on the Lung Cancer Index™, a National Minority Quality Forum (NMQF) geographic information system (GIS) with an interactive data warehouse and data visualization system, including geomapping. Preliminary data conclusions: 1) Of the 2812 interventional CCTs, the study team mapped 495 therapeutic, interventional, currently enrolling CCTs (after excluding trials for behavioral interventions and palliative care). 2) Of the 10015 zip codes mapped, 58.8% of those were designated as zones of high prevalence (HP) of lung cancer. Of the 5888 HP zip codes, only 10.5% had NSCLC trials and 5.6% percent had SCLC trials. 3) When analyzed by counties, of the 59% of counties with high prevalence of African American patients, only 3% and 1% of counties had more than 10 NSCLC trials and 10 SCLC trials respectively. Similarly, of the 24% of counties with high prevalence of Asian American lung cancer patients, only 3% and 1% of counties had more than 10 NSCLC and 10 SCLC trials respectively. Implications: While additional analyses are ongoing, preliminary findings suggest that there is a major disconnect between US lung CCT placement and where patients live. The advent of precision medicine creates urgency to improve CCT enrollment of racial and ethnic minority groups, for equitable benefit of resulting innovation and access to optimal treatment. Lung cancer prevalence, including by population demographics, at the zip code and county level can be a critical guide to CCT site placement. Citation Format: Upal Basu Roy, Liou Xu, Laura Lee Hall, Gary Puckrein, Andrea Ferris, Jeanne Regnante. Geographic relationship between lung cancer clinical trial sites and patient prevalence and demographics in the Medicare Fee-for-service program [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr D081.

Prior studies have shown that higher drug copay may be associated with a lower medication adherence and higher healthcare resource utilization in type 2 diabetes (T2D) patients but mostly in younger commercially insured population. Hence the current study examined this association in elderly T2D patients. This retrospective database study using Medicare claims database included T2D patients on branded non-insulin anti-hyperglycemic agent (AHA) monotherapy during index period (1/1/2013-2/28/2013). Drug copay was calculated for a 30-day supply of the index AHA. Hospitalization was assessed during 10-month follow-up period. Poisson regression model was used to control for baseline characteristics to evaluate the association between copay and hospitalization. A total of 28,656 T2D elderly patients met the inclusion criteria (mean age 78 years, 53% female, and 90% white). Mean branded drug copay was of $40. Higher drug copay was associated with increase in the risk of hospitalization [(e.g., Compared to patients with Disclosure L. Xu: None. M. Pawaskar: Employee; Self; Merck & Co., Inc. Y. Tang: Employee; Self; Merck & Co., Inc.. Stock/Shareholder; Self; Merck & Co., Inc.. Employee; Spouse/Partner; GlaxoSmithKline plc.. Stock/Shareholder; Spouse/Partner; GlaxoSmithKline plc.. G. Puckrein: None. S. Rajpathak: Employee; Self; Merck & Co., Inc. B.C. Stuart: Consultant; Self; Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation.

A multidimensional approach involving consideration of available resources, individual patient characteristics, patient preferences, and cost of treatment is often required to optimize clinical decision making in the management of atrial fibrillation (AF). In order to bring together varying perspectives on effective tactics and to formulate innovative strategies to improve the management of AF, a think tank consortium of advisors was assembled from across the spectrum of health care stakeholders. Focus groups were conducted and facilitated by a moderator and a notetaker. Participants were asked to comment on preliminary data for the increased prevalence of AF, patterns of treatment, impact of adherence with anticoagulants on clinical and economic outcomes, and opportunities for optimizing treatment.Several recommendations to reach short- and long-term goals in improving AF management emerged from the focus group discussions. These recommendations specifically targeted 3 stakeholder groups--patients/caregivers, physicians, and payers--and addressed the need for better understanding of determinants of undertreatment and nonadherence for those on anticoagulation therapy. Recommendations included the use of real-world data studies to understand regional and demographic patterns of treatment and outcomes, the development of an enhanced national quality standard for anticoagulation, and engaging patients in shared decision making to optimize satisfaction with treatment. Actionable strategies were presented to address gaps related to anticoagulation management. Balancing new anticoagulants' higher prescription costs and safety concerns with their superior effectiveness and convenience of administration for at-risk individuals would require a concerted effort involving patients and their caregivers, physicians, and payers.

Introduction Based upon the findings of the African-American Heart Failure Trial, the US Food and Drug Administration approved the fixed-dose combination of isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD) (FDC-ISDN/HYD) as a new drug for treatment of heart failure (HF) in self-identified African Americans. According to the FDA, FDC-ISDN/HYD has no therapeutic equivalent. However, off-label combinations of the separate generic drugs ISDN and HYD (OLC-ISDN+HYD) or isosorbide mononitrate (ISMN) and HYD (OLC-ISMN+HYD) are routinely substituted without any supporting outcome data. We conducted an exploratory retrospective propensity-matched cohort study using Medicare data to determine whether a survival difference exists between these treatments in medication-adherent patients. Methods Black Medicare beneficiaries with HF were matched with Medicare Part D data to identify patients with prescriptions to FDC-ISDN/HYD or the off-label combinations. Only patients with 1-year adherence levels ≥80% were included in the analysis. Propensity-matched scoring created two sets of matched cohort pairs on a 1:1 basis, each set comparing FDC-ISDN/HYD with one of the off-label combinations. Kaplan-Meier (KM) survival curves with the log-rank test were then calculated for each pair for the year of medication adherence. Results The analysis population was relatively older (77 years) and mainly female (66.7%), with a high burden of comorbid disease. The KM estimates of 1-year survival were 87.9% (95% CI 85.6–89.9%) and 83.0% (95% CI 80.3–85.3%) (log rank p = 0.0024), respectively, for the matched cohorts FDC-ISDN/HYD and OLC-ISDN+HYD (n = 886 in each group) and 88.2% (95% CI 85.9–90.2%) and 84.8% (95% CI 82.2–87.0%) (log rank p = 0.0320), respectively, for the matched cohorts FDC-ISDN/HYD and OLC-ISMN+HYD (n = 868 in each group). Conclusion The 1-year survival advantage for FDC-ISDN/HYD compared with off-label combinations in adherent black Medicare beneficiaries with HF suggests a genuine difference between these medications and warrants prospective investigation.

This study evaluates the effect of death as a competing event to the development of dementia in a longitudinal study of the cognitive status of elderly subjects. A multi-state Markov model with three transient states: intact cognition, mild cognitive impairment (M.C.I.) and global impairment (G.I.) and one absorbing state: dementia is used to model the cognitive panel data; transitions among states depend on four covariates age, education, prior state (intact cognition, or M.C.I., or G.I.) and the presence/absence of an apolipoprotein E-4 allele (APOE4). A Weibull model and a Cox proportional hazards (Cox PH) model are used to fit the survival from death based on age at entry and the APOE4 status. A shared random effect correlates this survival time with the transition model. Simulation studies determine the sensitivity of the maximum likelihood estimates to the violations of the Weibull and Cox PH model assumptions. Results are illustrated with an application to the Nun Study, a longitudinal cohort of 672 participants 75+ years of age at baseline and followed longitudinally with up to ten cognitive assessments per nun.

Background : Atrial fibrillation (AF) is the most common chronic cardiac arrhythmia. Predicting the risk of complications, or associated increases in healthcare costs, among AF patients is important for effective health care management. Methods : A bivariate regression model including a latent morbidity index is used to predict both risk of transition to higher health costs, and mortality risk over a single year. A risk scoring algorithm for predicting transition to higher cost levels is then set out which incorporates the most significant risk factors from the regression. Results : The regression analysis shows that in addition to age and comorbidities, baseline consumption category, ethnic group, metropolitan residence and Warfarin adherence are also significant influences on progression to increased health consumption, and relevant to assessing risk. The resulting risk scoring algorithm produces a higher AUC than the widely applied CHADS2 score. Conclusions : The utility of a bivariate regression method with a latent morbidity index for predicting transition to worsening health status among AF patients is demonstrated. A risk scoring system based on this method outperforms an established risk score.

Objectives: To determine current and future prevalence of overactive bladder (OAB) among Medicare fee-for-service beneficiaries in the United States. Methods: Prevalence of OAB in US adults ⩾ 65 years was determined using the 2013 Medicare Beneficiary Part B Carrier Claims File, Part D Drug Event File, and Medicare Beneficiary Annual Summary File. Prevalence for 2027 was forecasted with US Census population projections. Regional projections were based on applying national OAB rates by age, sex, and race/ethnicity to zip code tabulation area beneficiary populations. Results: In the 2013 dataset, the prevalence of OAB was 7.2% (male: 7.7%; female: 6.7%). Across demographic categories, prevalence was the highest among those aged more than 74 years (9.3%), identifying as White (7.4%), and residing in urban areas (7.5%). By 2027, OAB is projected to increase by 48.1%. Discussion: OAB affects a substantial proportion of the US fee-for-service beneficiary population, with the prevalent population projected to rise substantially by 2027.

Warfarin reduces atrial fibrillation (AF)-related strokes and may impact mortality, hospitalizations, and costs. This study investigated the possibility that patterns of warfarin consumption are associated with the frequency of acute events. Annual cost profiles of 9.2 million Medicare beneficiaries with AF were analyzed to identify patterns of benefits consumption from 2000 through 2010. Beneficiaries were divided into five consumption clusters based upon their annual cost profiles, ranging from crisis consumers at the high end to low consumers. Resource-utilization patterns and outcome differences were calculated between AF beneficiaries who received warfarin and those who did not. Propensity score-matched analysis was performed to reduce selection bias. The annual percentages of beneficiaries and expenditures that differentiated each cluster showed stable patterns. Warfarin use influenced consumption patterns and outcomes. The most important financial difference between higher and lower consumers was inpatient cost. AF beneficiaries on warfarin had lower annual cost profiles and had a higher propensity to persist in or migrate to consumption clusters with comparatively small reimbursement claims and lower hospitalization risks. AF beneficiaries not on warfarin had higher cost and mortality. These data signal that a nontrivial portion of acute events (hospitalization and mortality) are amenable to medical intervention (warfarin). When acute events are amenable to medical intervention and occur at a higher frequency because guidelines have not been applied evenly across affected populations, it is appropriate to define those occurrences as disparities associated with systemic failure in evidence-based medicine. Quality-improvement initiatives that reduce therapeutic disparities may result in lower cost and improved outcomes. No funding or sponsorship was received for this study or publication of this article.

140 Background: G-CSFs are utilized to lower the incidence of febrile neutropenia (FN) in patients with cancers treated with chemotherapy. In 2015 filgrastim-sndz was the first biosimilar to be approved and launched in the US. Limited data exists on the impact of biosimilars on patient out-of-pocket (OOP) expenditures. The objective of this simulation model is to estimate potential OOP cost savings through use of filgrastim-sndz (FIL-S) over reference filgrastim (FIL-REF) from a Medicare lung cancer patient perspective. Methods: An Excel simulation analysis was conducted among lung cancer patients treated with biosimilar FIL-S or FIL-REF (identified through HCPCS codes). Data from the 2016 Medicare Limited Data Set was used to populate the model. Average Medicare payment to the provider and beneficiary OOP responsibility per claim of either FIL-S or FIL-REF were calculated. The average OOP reduction per claim for a FIL-S beneficiary relative to a FIL-REF beneficiary was multiplied to a hypothetical FN prevalent population of 100,000 beneficiaries (average of 10 claims per beneficiary) to estimate the potential OOP savings. Results: Data from 525 FIL-S and 621 FIL-REF claims were analyzed. The average Medicare allowed charge amount per claim for a FIL-S beneficiary was $381.7 versus $419.1 for a FIL-REF beneficiary, while corresponding average Medicare payments to the provider were $299.3 and $327.4, respectively. On an average, OOP responsibility for a FIL-S beneficiary was lower compared to a FIL-REF beneficiary ($76.4 vs. $85.0) leading to a cost saving per claim of approximately $8.60. When extrapolated to 100,000 beneficiaries (1,000,000 claims), the overall cost saving was projected to be around $8.6 million. Conclusions: Our simulation model estimated potential OOP Medicare lung cancer beneficiary savings of around $8.6 million, based on a hypothetical population of 100,000 FN beneficiaries, with the use of biosimilar FIL-S over FIL-REF. Further real-world analyses are required to evaluate the true cost savings potential with the use of biosimilars over reference biologics.

OBJECTIVE In 2011, the Centers for Medicare & Medicaid Services (CMS) launched the Competitive Bidding Program (CBP) in nine markets for diabetes supplies. The intent was to lower costs to consumers. Medicare claims data (2009–2012) were used to confirm the CMS report (2012) that there were no disruptions in acquisition caused by CBP and no changes in health outcomes. RESEARCH DESIGN AND METHODS The study population consisted of insulin users: 43,939 beneficiaries in the nine test markets (TEST) and 485,688 beneficiaries in the nontest markets (NONTEST). TEST and NONTEST were subdivided: those with full self-monitoring of blood glucose (SMBG) supply acquisition (full SMBG) according to prescription and those with partial/no acquisition (partial/no SMBG). Propensity score–matched analysis was performed to reduce selection bias. Outcomes were impact of partial/no SMBG acquisition on mortality, inpatient admissions, and inpatient costs. RESULTS Survival was negatively associated with partial/no SMBG acquisition in both cohorts (P < 0.0001). Coterminous with CBP (2010–2011), there was a 23.0% (P < 0.0001) increase in partial/no SMBG acquisition in TEST vs. 1.7% (P = 0.0002) in NONTEST. Propensity score–matched analysis showed beneficiary migration from full to partial/no SMBG acquisition in 2011 (1,163 TEST vs. 605 NONTEST) was associated with more deaths within the TEST cohort (102 vs. 60), with higher inpatient hospital admissions and associated costs. CONCLUSIONS SMBG supply acquisition was disrupted in the TEST population, leading to increased migration to partial/no SMBG acquisition with associated increases in mortality, inpatient admissions, and costs. Based on our findings, more effective monitoring protocols are needed to protect beneficiary safety.

Previous epidemiologic studies suggest that antihypertensive drugs may be protective against cognitive decline. To determine if subjects enrolled in the University of Kentucky longitudinal aging study who used antihypertensive drugs showed diminished progression to dementia, we used a 3-parameter logistic regression model to compare the rate of progression to dementia for subjects who used any of the five common categories of antihypertensive drugs to those with similar demographic characteristics but who did not use antihypertensives. Regression modeling showed that subjects who used calcium channel blockers (CCBs) but not the other classes of antihypertensives showed a significant decrease in the rate of progression to dementia. Significantly, use of CCBs ameliorated the negative effects of the presence of APOE-4 alleles on cognitive decline. To determine if CCBs could minimize amyloid beta peptide (Aβ1–42) production, H4 neuroglioma cultures transfected to overexpress APP were treated with various CCBs and Aβ1–42levels and levels of proteins involved in Aβproduction were quantified. Results show that treatment with nifedipine led to a significant decrease in levels of Aβ1–42, with no significant decrease in cell viability. Collectively, these data suggest that use of CCBs significantly diminishes the rate of progression to dementia and may minimize formation of Aβ1–42.

Background: Anticoagulants are effective in stroke prevention in patients with atrial fibrillation (AF). Warfarin’s comparative effectiveness in AF Medicare beneficiaries by race/ethnicity and gender is not well described. Methods: Medicare claims data for years 2000-2010 were used to calculate: 1) AF per annum prevalence (N > 1.9 million); and 2) rates of new AF cases (first Medicare reimbursement for AF), hospitalization, and mortality. Three 20 % samples of AF beneficiaries for years 2000 (n=266K), 2005 (n=316K), and 2007 (n=311K) were used to calculate warfarin use and stroke (ischemic) rates. Consistent with prior study methods, INR test claims were used as a surrogate for warfarin use with a greater than 95 % precision rate and specificity. New AF cases were extracted from each of the three sample cohorts (mean 72K cases each) and continuous survival analyses conducted to assess warfarin’s relationship to stroke, mortality, and hospitalization after adjustment for CHADS2 score, age, gender, and race/ethnicity. Results: AF prevalence and warfarin use increased while stroke and mortality rates declined across gender and race/ethnicity from 2000 to 2010. Survival analysis comparing Blacks, Hispanics, and Asians to Whites showed: 1) even when adjusted for warfarin use, Blacks were 40 % (p70% (p Conclusions: Significant differences in key metrics between race/ethnicity and gender exist. Across all metrics, Blacks had worse outcomes with less warfarin use and comparatively worse outcomes even when on warfarin. Patient diversity should be a focus for future trials in AF-related cardiovascular outcomes.