Vitamin D Levels and SARS-CoV-2 Infection among Medically Underserved Populations in the Minority and Rural Coronavirus Insights Study.

BACKGROUND: Extant literature presents contradictory findings on the role of vitamin D on SARS-CoV-2 infection. Our study included an examination of the relationship between vitamin D levels and SARS-CoV-2 infection among the Minority and Rural Coronavirus Insights Study (MRCIS) cohort, a diverse population of medically underserved persons presenting at five Federally qualified health centers in the United States. METHODS: We conducted a descriptive analysis to explore the relationship between vitamin D levels and SARS-CoV-2 infection among medically underserved participants. A combined molecular and serologic assessment was used to determine the prevalence of SARS-CoV-2 infection. Vitamin D was examined as both a categorical (vitamin D status: deficient, insufficient, optimal) and continuous (vitamin D level) variable. Chi-squared testing, polynomial regression models, and logistic regression models were used to assess the relationship between vitamin D and SARS-CoV-2 infection. RESULTS: The overall SARS-CoV-2 infection rate among participants was 25.9%. Most participants were either vitamin D deficient (46.5%) or insufficient (29.7%), and 23.8% had an optimal level. Vitamin D status was significantly associated with key SARS-CoV-2 infection risk factors. As mean vitamin D levels increased, the proportion of participants with SARS-CoV-2 infection decreased. For every 10 ng/mL increase in vitamin D levels the odds of SARS-CoV-2 infection decreased by 12% when adjusting for race/ethnicity and age (main effect model). Participants who identified as Hispanic/Latino or Black non-Hispanic had approximately two times increased odds of SARS-CoV-2 infection when adjusting for age and vitamin D levels compared to white non-Hispanics. However, when additional factors were added to the main effect model, the relationship between vitamin D levels and SARS-CoV-2 infection did not remain significant. CONCLUSION: Vitamin D levels were associated with an increased risk of SARS-CoV-2 infection. Hispanic/Latino and Black, non-Hispanic compared to White, non-Hispanic participants were at increased odds for infection, after adjusting for race/ethnicity and age.

Nucleocapsid and Spike Protein-Based Anti-SARS-CoV-2 Assay Performance in the Minority and Rural Coronavirus Insights Study: Characteristics of Socioeconomically Disadvantaged Populations with Health Disparities.

BACKGROUND: COVID-19 has had a devastating impact on Black, Hispanic, and other underserved, disadvantaged populations. Here anti-SARS-CoV-2 tests are characterized in disadvantaged patients to examine equivalence in US populations. METHODS: Underserved participant adults (age > 18 years) were enrolled before the availability of SARS-CoV-2 vaccines in Federal Qualified Health Centers in California, Florida, Louisiana, Illinois, and Ohio and contributed samples to the Minority and Rural Coronavirus Insights Study (MRCIS). A subset coined the MRCIS SARS-CoV-2 Antibody Cohort of 2365 participants was tested with the Roche Anti-SARS-CoV-2 assay (Cobas e601). Five hundred ninety-five of these were also tested with the Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 IgG assay (VITROS-5600); 1770 were also tested with the Abbott ARCHITECT SARS-CoV-2 IgG assay (ARCHITECT-2000). Assay-specific cutoffs classified negative/positive results. RESULTS: Eight point four percent (199/2365) of the MRCIS SARS-CoV-2 Antibody Cohort was SARS-CoV-2 RNA positive at enrollment. Agreement between the Ortho/Roche and the Abbott/Roche antibody testing did not vary by enrollment RNA status. The Ortho (anti-spike protein) vs Roche (anti-nucleocapsid protein) comparison agreed substantially: kappa = 0.63 (95% CI: 0.57-0.69); overall agreement, 83%. However, agreement was even better for the Abbott vs Roche assays (both anti-nucleocapsid protein tests): kappa = 0.85 (95% CI: 0.81-0.87); overall agreement, 95%. Anti-SARS-CoV-2 comparisons stratified by demographic criteria demonstrated no significant variability in agreement by sex, race/ethnicity, or age. CONCLUSIONS: Analytical agreement is 96.4% for anti-spike-protein vs anti-nucleocapsid-protein comparisons. Physiologically, seroreversion of anti-nucleocapsid reactivity after infection occurred in the disadvantaged population similarly to general populations. No anti-SARS-CoV-2 assays included demonstrated a clinically significant difference due to the demographics of the disadvantaged MRCIS SARS-CoV-2 Antibody Cohort.

The Minority and Rural Coronavirus Insights Study: Design and Baseline Characteristics of a Minority Cohort.

The Minority and Rural Coronavirus Insights Study (MRCIS) is an ongoing prospective cohort study examining health disparities associated with SARS-CoV-2 infection among medically underserved populations. This report describes procedures implemented to establish the MRCIS cohort and examines the factors associated with the molecular and serological assessment of SARS-CoV-2 infection status at participant enrollment. Participants were recruited from 5 geographically dispersed federally qualified health centers between November 2020 and April 2021. At baseline, participants completed a detailed demographic survey and biological samples were collected for testing. SARS-CoV-2 infection status was determined based on the combined molecular and serological test results. Chi-squared and logistic regression analyses were conducted to examine associations between sociodemographic factors, COVID-19 safety measures, existing comorbidities, and SARS-CoV-2 infection status. The final cohort included 3238 participants. The mean age of participants was 50.2 ± 15.8 years. Most participants identified as female (60.0%), heterosexual or straight (93.0%), White (47.6%), and Hispanic or Latino (49.1%). Approximately 26.1% of participants had at least one positive SARS-CoV-2 test result. The main effect model included age, sex, and race/ethnicity. Compared with adults ≥65 years, participants in all other age groups had ∼2 times increased odds of a positive SARS-CoV-2 test result. In addition, racial/ethnic minorities had ∼2 times increased odds of a positive SARS-CoV-2 infection status compared with non-Hispanic Whites. A unique cohort of a traditionally medically underserved minority population was established. Significant racial and ethnic disparities in SARS-CoV-2 infection status at baseline were discovered.

Geographic Variation in Racial Disparities in Receipt of High-Dose Influenza Vaccine Among US Older Adults.

BACKGROUND: Racial disparities in receipt of high-dose influenza vaccine (HDV) have been documented nationally, but whether small-area geographic variation in such disparities exists remains unknown. We assessed the distribution of disparities in HDV receipt between Black and White traditional Medicare beneficiaries vaccinated against influenza within states and hospital referral regions (HRRs). METHODS: We conducted a nationally representative retrospective cohort study of 11,768,724 community-dwelling traditional Medicare beneficiaries vaccinated against influenza during the 2015-2016 influenza season (94.3% White and 5.7% Black). Our comparison was marginalized versus privileged racial group measured as Black versus White race. Vaccination and type of vaccine were obtained from Medicare Carrier and Outpatient files. Differences in the proportions of individuals who received HDV between Black and White beneficiaries within states and HRRs were used to measure age- and sex-standardized disparities in HDV receipt. We restricted to states and HRRs with ≥ 100 beneficiaries per age-sex strata per racial group. RESULTS: We detected a national disparity in HDV receipt of 12.8 percentage points (pps). At the state level, the median standardized HDV receipt disparity was 10.7 pps (minimum, maximum: 2.9, 25.6; n = 30 states). The median standardized HDV receipt disparity among HRRs was 11.6 pps (minimum, maximum: 0.4, 24.7; n = 54 HRRs). CONCLUSION: Black beneficiaries were less likely to receive HDV compared to White beneficiaries in almost every state and HRR in our analysis. The magnitudes of disparities varied substantially across states and HRRs. Local interventions and policies are needed to target geographic areas with the largest disparities to address these inequities.

Demographic Determinants and Geographical Variability of COVID-19 Vaccine Hesitancy in Underserved Communities: Cross-sectional Study.

BACKGROUND: COVID-19 hospitalizations and deaths disproportionately affect underserved and minority populations, emphasizing that vaccine hesitancy can be an especially important public health risk factor in these populations. OBJECTIVE: This study aims to characterize COVID-19 vaccine hesitancy in underserved diverse populations. METHODS: The Minority and Rural Coronavirus Insights Study (MRCIS) recruited a convenience sample of adults (age≥18, N=3735) from federally qualified health centers (FQHCs) in California, the Midwest (Illinois/Ohio), Florida, and Louisiana and collected baseline data in November 2020-April 2021. Vaccine hesitancy status was defined as a response of "no" or "undecided" to the question "Would you get a coronavirus vaccine if it was available?" ("yes" categorized as not hesitant). Cross-sectional descriptive analyses and logistic regression models examined vaccine hesitancy prevalence by age, gender, race/ethnicity, and geography. The expected vaccine hesitancy estimates for the general population were calculated for the study counties using published county-level data. Crude associations with demographic characteristics within each region were assessed using the chi-square test. The main effect model included age, gender, race/ethnicity, and geographical region to estimate adjusted odds ratios (ORs) and 95% CIs. Interactions between geography and each demographic characteristic were evaluated in separate models. RESULTS: The strongest vaccine hesitancy variability was by geographic region: California, 27.8% (range 25.0%-30.6%); the Midwest, 31.4% (range 27.3%-35.4%); Louisiana, 59.1% (range 56.1%-62.1%); and Florida, 67.3% (range 64.3%-70.2%). The expected estimates for the general population were lower: 9.7% (California), 15.3% (Midwest), 18.2% (Florida), and 27.0% (Louisiana). The demographic patterns also varied by geography. An inverted U-shaped age pattern was found, with the highest prevalence among ages 25-34 years in Florida (n=88, 80.0%,) and Louisiana (n=54, 79.4%; P<.05). Females were more hesitant than males in the Midwest (n= 110, 36.4% vs n= 48, 23.5%), Florida (n=458, 71.6% vs n=195, 59.3%), and Louisiana (n= 425, 66.5% vs. n=172, 46.5%; P<.05). Racial/ethnic differences were found in California, with the highest prevalence among non-Hispanic Black participants (n=86, 45.5%), and in Florida, with the highest among Hispanic (n=567, 69.3%) participants (P<.05), but not in the Midwest and Louisiana. The main effect model confirmed the U-shaped association with age: strongest association with age 25-34 years (OR 2.29, 95% CI 1.74-3.01). Statistical interactions of gender and race/ethnicity with the region were significant, following the pattern found by the crude analysis. Compared to males in California, the associations with the female gender were strongest in Florida (OR=7.88, 95% CI 5.96-10.41) and Louisiana (OR=6.09, 95% CI 4.55-8.14). Compared to non-Hispanic White participants in California, the strongest associations were found with being Hispanic in Florida (OR=11.18, 95% CI 7.01-17.85) and Black in Louisiana (OR=8.94, 95% CI 5.53-14.47). However, the strongest race/ethnicity variability was observed within California and Florida: the ORs varied 4.6- and 2-fold between racial/ethnic groups in these regions, respectively. CONCLUSIONS: These findings highlight the role of local contextual factors in driving vaccine hesitancy and its demographic patterns.

Assessment of Glucose Monitoring Adherence in Medicare Beneficiaries with Insulin-Treated Diabetes.

Background: We investigated the potential associations between race/ethnicity and adherence to prescribed glucose monitoring in a sample of Medicare beneficiaries with diabetes and how adherence to the method used impacted diabetes-related inpatient hospitalizations and associated costs among beneficiaries with intensive insulin-treated diabetes. Methods: This 12-month retrospective analysis utilized Centers for Medicare & Medicaid Services data to identify Medicare beneficiaries who used intensive insulin therapy from January through December 2018 and classified them into four groups: (1) persons using real-time continuous glucose monitoring (rtCGM), (2) persons using any method of blood glucose monitoring (BGM) who followed prescribed use patterns (adherent), (3) persons who were prescribed BGM but were nonadherent in its use, and (4) no record of any form of BGM. Analyses compared these groups and the role that comorbidities (Charlson Comorbidity Index [CCI]), and race/ethnicity played on group assignment, diabetes-related inpatient hospitalizations, and costs. Results: Among the 1,329,061 persons assessed, 38.14% had no record of glucose monitoring and 35.42% were BGM nonadherent. Similarly, among the 629,514 beneficiaries with a CCI risk score of ≥2, 466,646 (74.13%) were either nonadherent to BGM or had no monitoring record. The percentage of White (3.65%) rtCGM adherent beneficiaries was significantly larger than Black (1.58%) and Hispanic (1.28%) beneficiaries, both P < 0.0001. Hospitalizations and costs were higher for Black and Hispanic beneficiaries versus Whites within the risk score ≥ 2 group regardless of glucose monitoring method. Conclusions: Race is associated with increased hospitalizations and costs associated with diabetes care and absence of any form of BGM was associated with higher rates of comorbidities. Persons of color were less likely to use rtCGM despite Medicare coverage. New initiatives that promote diabetes self-management education and support services are needed to improve utilization of glucose monitoring within the Medicare diabetes population.

Effect of race and ethnicity on influenza vaccine uptake among older US Medicare beneficiaries: a record-linkage cohort study.

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.

Vaso-occlusive crises and costs of sickle cell disease in patients with commercial, Medicaid, and Medicare insurance - the perspective of private and public payers.

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.

A Map of Racial and Ethnic Disparities in Influenza Vaccine Uptake in the Medicare Fee-for-Service Program.

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.

Reducing Health Care Disparities in Sickle Cell Disease: A Review.

Sickle cell disease (SCD) is an inherited blood disorder most common among African American and Hispanic American persons. The disease can cause substantial, long-term, and costly health problems, including infections, stroke, and kidney failure, many of which can reduce life expectancy. Disparities in receiving health care among African Americans and other racial/ethnic minority groups in the United States are well known and directly related to poor outcomes associated with SCD. As an orphan disease-one that affects <200 000 persons nationwide-SCD does not receive the research funding and pharmaceutical investment directed to other orphan diseases. For example, cystic fibrosis affects fewer than half the number of persons but receives 3.5 times the funding from the National Institutes of Health and 440 times the funding from national foundations. In this review, we discuss the health inequities affecting persons with SCD, describe programs intended to improve their care, and identify actions that could be taken to further reduce these inequities, improve care, control treatment costs, and ease the burden of disease.

Increasing Diversity in Clinical Trials: Overcoming Critical Barriers.

Clinical trial results provide the critical evidence base for evaluating the safety and efficacy of new medicines and medical products. Efficacy and safety may differ among population subgroups depending on intrinsic/extrinsic factors, including sex, age, race, ethnicity, lifestyle, and genetic background. Racial and ethnic minorities continue to be underrepresented in cardiovascular and other clinical trials. Although barriers to diversity in trials are well recognized, sustainable solutions for overcoming them have proved elusive. We investigated barriers impacting minority patients' willingness to participate in trials and-based on literature review and evaluation, and input from key stakeholders, including minority patients, referring physicians, investigators who were minority-serving physicians, and trial coordinators-formulated potential solutions and tested them across stakeholder groups. We identified key themes from solutions that resonated with stakeholders using a transtheoretical model of behavior change and created a communications message map to support a multistakeholder approach for overcoming critical participant barriers.

Patient Diversity and Population Health-Related Cardiovascular Outcomes Associated with Warfarin Use in Atrial Fibrillation: An Analysis Using Administrative Claims Data.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. FUNDING: National Minority Quality Forum.

Effect of Medication Copayment on Adherence and Discontinuation in Medicare Beneficiaries with Type 2 Diabetes: A Retrospective Administrative Claims Database Analysis.

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 < 0.001). CONCLUSION: The impact of drug copayment on adherence and discontinuation varied considerably between branded and generic AHAs. Medicare patients taking branded AHAs had a higher risk of nonadherence with increasing copayment and were more likely to discontinue medication, whereas this association was not observed in patients taking generic medications. FUNDING: Merck & Co, Inc., Kenilworth, NJ, USA. Plain language summary available for this article.

Impact of the 2013 National Rollout of CMS Competitive Bidding Program: The Disruption Continues.

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.

Fixed-Dose Versus Off-Label Combination of Isosorbide Dinitrate Plus Hydralazine Hydrochloride: Retrospective Propensity-Matched Analysis in Black Medicare Patients with Heart Failure.

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.

Improving adult immunization equity: Where do the published research literature and existing resources lead?

Evidence suggests that disparities in adult immunization (AI) rates are growing. Providers need adequate patient resources and information about successful interventions to help them engage in effective practices to reduce AI disparities. The primary purposes of this paper were to review and summarize the evidence base regarding interventions to reduce AI disparities and to scan for relevant resources that could support providers in their AI efforts to specifically target disparities. First, building on a literature review conducted by the U.S. Centers for Disease Control and Prevention, we searched the peer-reviewed literature to identify articles that either discussed interventions to reduce AI disparities or provided reasons and associations for disparities. We scanned the articles and conducted an internet search to identify tools and resources to support efforts to improve AI rates. We limited both searches to resources that addressed influenza, pneumococcal, hepatitis B, Tdap, and/or herpes zoster vaccinations. We found that most articles characterized AI disparities, but several discussed strategies for reducing AI disparities, including practice-based changes, communication and health literacy approaches, and partnering with community-based organizations. The resources we identified were largely fact sheets and handouts for patients and journal articles for providers. Most resources pertain to influenza vaccination and Spanish was the most prevalent language after English. More evaluation is needed to assess the health literacy levels of the materials. We conclude that additional research is needed to identify effective ways to reduce AI disparities and more resources are needed to support providers in their efforts. We recommend identifying best practices of high performers, further reviewing the appropriateness and usefulness of available resources, and prioritizing which gaps should be addressed.