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Background Guidelines recommend adults who discontinue statin therapy because of statin-associated symptoms be reinitiated. Low-density lipoprotein cholesterol (LDL-C) levels achieved after statin reinitiation are unknown. Objective The objective of this study was to determine LDL-C levels after statin reinitiation. Methods We analyzed data from 5498 participants in the REasons for Geographic And Racial Differences in Stroke study who reported ever taking a statin. We categorized participants according to their pattern of statin use including those taking a statin who did not experience statin-associated symptoms and continued treatment, and those who discontinued statins because of statin-associated symptoms and were not reinitiated, reinitiated and remained on treatment, and discontinued treatment after being reinitiated. Mortality and vascular event reduction with statin reinitiation was estimated using data from the Cholesterol-Lowering Treatment Trialists Collaboration. Results After multivariable adjustment, LDL-C was 14.1 (95% CI: 9.9–18.3) mg/dL higher among participants reinitiated and taking a statin compared with those without statin-associated symptoms who continued statin therapy. Mean LDL-C was 18.1 mg/dL (95% CI: 13.0–23.1) and 27.5 mg/dL (95% CI: 20.7–34.4) lower among participants reinitiated and taking a statin compared with those who discontinued statin therapy and were not reinitiated and those who discontinued statins after being reinitiated, respectively. An LDL-C reduction of 18.1 mg/dL with statin reinitiation was projected to reduce all-cause and coronary heart disease mortality by 5.6% and 8.9%, respectively, and myocardial infarction or coronary heart disease death and major vascular events by 10.7% and 9.8%, respectively, over 5 years. Conclusion Reinitiating individuals who discontinue statin therapy may reduce LDL-C and cardiovascular risk.

Background The evidence-based beta-blockers carvedilol, bisoprolol, and metoprolol succinate reduce mortality and hospitalizations among patients with heart failure with reduced ejection fraction (HFrEF). Use of these medications is not well described in the general population of patients with HFrEF, especially among patients with potential contraindications. Objectives Our goal was to describe the patterns of prescription fills for carvedilol, bisoprolol, and metoprolol succinate among Medicare beneficiaries hospitalized for HFrEF, as well as to estimate the associations between specific contraindications for beta-blocker therapy and those patterns. Methods and Results With the use of the cohort of 15,205 Medicare beneficiaries hospitalized for HFrEF from 2007 to 2013 in the 5% Medicare random sample, we described prescription fills (30 days after discharge) and dosage patterns (1 year after discharge) for beta-blockers. By means of of Fine and Gray competing risk models, we estimated the associations between potential contraindications (hypotension, chronic obstructive pulmonary disease [COPD], asthma, and syncope) and prescription fill and dosing patterns while adjusting for demographics, comorbidities, and health care utilization. For beneficiaries who did not die or readmitted to the hospital, 38% of hospitalizations were followed by a prescription fill for an evidence-based beta-blocker within 30 days, 12% were followed by prescription fills for at least 50% of the recommended dose of an evidence-based beta-blocker within 1 year, and 9% were followed by a prescription fill for an up-titrated dose of an evidence-based beta-blocker within 1 year. The prevalence of the contraindications were 21% for hypotension, 48% for COPD, 15% for asthma, and 12% for syncope. Among beneficiaries who did not fill a prescription for an evidence-based beta-blocker within 30 days, 67% had at least 1 of these contraindications. Hypotension, COPD, and syncope were each associated with a ∼10% lower risk of filling a prescription for an evidence-based beta-blocker. Conclusions Prescription fill and up-titration rates for evidence-based beta-blockers are low among Medicare beneficiaries with HFrEF, but contraindications explain only a minor part of these low rates.

Supplemental Digital Content is Available in the Text., Among nonelderly adults with diabetes, we compared hospitalizations for ambulatory care–sensitive conditions from 2013 (pre-Medicaid expansion) and 2014 (post-Medicaid expansion) for 13 expansion and 4 nonexpansion states using State Inpatient Databases. Medicaid expansion was associated with decreases in proportions of hospitalizations for chronic conditions (difference between 2014 and 2013 −0.17 percentage points in expansion and 0.37 in nonexpansion states, P = .04), specifically diabetes short-term complications (difference between 2014 and 2013 −0.05 percentage points in expansion and 0.21 in nonexpansion states, P = .04). Increased access to care through Medicaid expansion may improve disease management in nonelderly adults with diabetes.

Background HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa despite increased antenatal care attendance and provision of antiretroviral therapy to pregnant women. In the Jamii Bora (“Better Family” in Swahili) Study, we seek to test the efficacy of an interdependence theory-based couple intervention. The intervention reaches pregnant women and male partners through home visits by male-female pairs of lay health workers. The aim is to increase access to home-based couples’ HIV testing and counseling services to improve family health. Methods This is a three-arm randomized control trial among 1080 pregnant women 15 years of age or older, living with their male partners, and who have not undergone couples’ HIV testing and counseling in Kisumu and Migori Counties in Kenya. Couples will be randomized into three groups: home-based couple visits, HIV self-testing kits for couple use, or standard care (male partner clinic invitation letters). Participants will be followed up to 18 months postpartum. The study has three aims: in aim 1, we will determine the effects of the intervention on our primary outcome of couple HIV testing, compared to HIV self-testing kits and standard care; in aim 2, we will examine the intervention impact on HIV prevention behaviors, facility delivery, and postnatal healthcare utilization, as well as secondary health outcomes of maternal viral suppression and HIV-free child survival up to 18 months for couples living with HIV; and in aim 3, we will compare the cost-effectiveness of the home-based couple intervention to the less resource-intensive strategies used in the other two study arms. Assessments with couples are conducted at baseline, late pregnancy, and at months 3, 6, 12, and 18 after birth. Discussion The results from this study will inform decision-makers about the cost-effective strategies to engage pregnant couples in the prevention of mother-to-child transmission and family health, with important downstream benefits for maternal, paternal, and infant health. Trial registration ClinicalTrials.gov NCT03547739. Registered on May 9, 2018

Background To the authors' knowledge, there is limited information regarding the long-term risk of congestive heart failure (CHF) among patients with follicular lymphoma, a prevalent non-Hodgkin lymphoma diagnosis among those aged >65 years, especially within the context of therapeutic exposures and preexisting comorbidities. Methods Using Surveillance, Epidemiology, and End Results-Medicare data from 1999 through 2013, the authors identified 6109 patients with follicular lymphoma who were diagnosed at age ≥66 years between January 1, 2000 and December 31, 2011, and a frequency-matched Medicare noncancer sample. Subdistribution hazards models assessed risks associated with new-onset CHF through December 31, 2013. Propensity score-matched models examined CHF risk in patients receiving anthracyclines when compared with matched noncancer controls. Results When compared with matched controls, patients with follicular lymphoma receiving anthracyclines at ages 66 to 75 years had a 1.7-fold (95% confidence interval, 1.4-fold to 2.1-fold) higher risk of new-onset CHF; patients diagnosed at age >75 years did not differ from noncancer controls with regard to CHF risk. Preexisting hypertension was associated with a 1.7-fold and 1.35-fold, respectively, increased hazard of CHF for each age group, independent of anthracycline exposure. Preexisting diabetes was associated with 1.5-fold increased hazard of CHF only in those patients aged 66 to 75 years. Patients with new-onset CHF had a 18% lower 10-year survival compared with those without CHF. Conclusions Patients with follicular lymphoma who were exposed to anthracyclines between the ages of 66 years and 75 years were found to be at an increased risk of new-onset CHF; preexisting hypertension and diabetes appeared to increase this risk. The findings of the current study support and inform the risk-based follow-up of vulnerable populations.

Annually in the United States, over 6,000 healthy individuals undergo living donor nephrectomy for the purposes of kidney transplantation.1,2 Living kidney donors gain no medical benefit from donation, exposing themselves to health risks associated with major surgery and reduced renal mass, including chronic kidney disease (CKD), entirely for the benefit of another individual.3,4 Essential to this process is proper medical evaluation and informed consent to promote donor autonomy in medical decision-making, requirements that mandate accurate quantification and communication of donor candidate risk for CKD. This is particularly crucial for young potential living kidney donors, who have the lengthiest remaining risk exposure, and African Americans (AA), who are at enhanced risk of CKD.5 Recently, an online risk tool was developed using population-based data that quantified the combined effect of 10 health characteristics to estimate the risk of end-stage renal disease (ESRD) among living kidney donor candidates.6 While informative, this study of seven cohorts was limited by short follow-up (median 4 to 16 years), heterogeneity of cohort design (incorporating both longitudinal and cross-sectional cohorts), no data on family history, and older age of potential living kidney donors (40–63 years-old). These limitations compromise the accuracy of lifetime estimates for ESRD among young living kidney donors and do not address the risk of the more proximate endpoint of CKD. Beyond the predictive value of baseline health characteristics is the rapidly evolving understanding of an individual’s genetic-risk profile.7–9 Recently, apolipoprotein L1 gene (APOL1) variants have been associated with nondiabetic CKD in AAs.10,11 About 40% of AAs have one of these renal-risk variants, with 13% of AAs demonstrating two.10,12,13 Previous work indicates that odds of CKD among individuals with one renal-risk variant were 1.3-fold higher and 7.3-fold higher among individuals with two variants compared to individuals without a variant allele.14 Independent of other risk factors, it is hypothesized that AA potential living kidney donors with APOL1 variants may be at particularly high risk of CKD;15 however, incorporation of APOL1 genotype into risk prediction models has not been done. The goal of this study was to develop a novel CKD risk prediction tool for young potential living kidney donors by leveraging data from a longitudinal cohort of adults ages 18–30 with more than 25 years of follow-up and availability of APOL1 genotyping.

Background Less intensive treatment for heart failure with reduced ejection fraction (HFrEF) may be appropriate for patients in long-term care settings because of limited life expectancy, frailty, comorbidities, and emphasis on quality of life. Methods We compared treatment patterns between REasons for Geographic And Racial Differences in Stroke (REGARDS) study participants discharged to long-term care versus home following HFrEF hospitalizations. We examined medical records and Medicare pharmacy claims for 147 HFrEF hospitalizations among 80 participants to obtain information about discharge disposition and medication prescriptions and fills. Results Discharge to long-term care followed 22 of 147 HFrEF hospitalizations (15%). Participants discharged to long-term care were more likely to be prescribed beta-blockers and less likely to be prescribed aldosterone receptor antagonists and hydralazine/isosorbide dinitrate (96%, 14%, and 5%, respectively) compared to participants discharged home (81%, 22%, and 23%, respectively). The percentages of participants discharged to long-term care and home who had claims for filled prescriptions were similar for beta-blockers (68% versus 66%) and angiotensin converting enzyme inhibitors or angiotensin receptor blockers (ACEI/ARBs) (45% versus 47%) after 1 year. Smaller percentages of participants discharged to long-term care had claims for filled prescriptions of other medications compared to participants discharged home (diuretics: long-term care-50%, home-72%; hydralazine/isosorbide dinitrate: long-term care-5%, home-23%; aldosterone receptor antagonists: long-term care-5%, home-23%). Conclusions Differences in medication prescriptions and fills among individuals with HFrEF discharged to long-term care versus home may reflect prioritization of some medical therapies over others for patients in long-term care.

To compare the costs associated with adjunctive azithromycin compared with standard cefazolin antibiotic prophylaxis alone for unscheduled and scheduled cesarean deliveries.A decision analytic model was created to compare cefazolin alone with azithromycin plus cefazolin. Published incidences of surgical site infection after cesarean delivery were used to estimate the baseline incidence of surgical site infection in scheduled and unscheduled cesarean delivery using standard antibiotic prophylaxis. The effectiveness of adjunctive azithromycin prophylaxis was obtained from published randomized controlled trials for unscheduled cesarean deliveries. No randomized study of its use in scheduled procedures has been completed. Cost estimates were obtained from published literature, hospital estimates, and the Healthcare Cost and Utilization Project and considered costs of azithromycin and surgical site infections. A series of sensitivity analyses were conducted by varying parameters in the model based on observed distributions for probabilities and costs. The outcome was cost per cesarean delivery from a health system perspective.For unscheduled cesarean deliveries, cefazolin prophylaxis alone would cost $695 compared with $335 for adjunctive azithromycin prophylaxis, resulting in a savings of $360 (95% CI $155-451) per cesarean delivery. In scheduled cesarean deliveries, cefazolin prophylaxis alone would cost $254 compared with $111 for adjunctive azithromycin prophylaxis, resulting in a savings of $143 (95% CI 98-157) per cesarean delivery, if proven effective. These findings were robust to a multitude of inputs; as long as adjunctive azithromycin prevented as few as seven additional surgical site infections per 1,000 unscheduled cesarean deliveries and nine additional surgical site infections per 10,000 scheduled cesarean deliveries, adjunctive azithromycin prophylaxis was cost-saving.Adjunctive azithromycin prophylaxis is a cost-saving strategy in both unscheduled and scheduled cesarean deliveries.

Background This study examines effects of mobility and multimorbidity on hospitalization and inpatient and postacute care (PAC) facility days among older men. Methods Prospective study of 1,701 men (mean age 79.3 years) participating in Osteoporotic Fractures in Men (MrOS) Study Year 7 (Y7) examination (2007-2008) linked with their Medicare claims. At Y7, mobility ascertained by usual gait speed and categorized as poor, intermediate, or good. Multimorbidity quantified by applying Elixhauser algorithm to inpatient and outpatient claims and categorized as none, mild-moderate, or high. Hospitalizations and PAC facility stays ascertained during 12 months following Y7. Results Reduced mobility and greater multimorbidity burden were independently associated with a higher risk of inpatient and PAC facility utilization, after accounting for each other and traditional indicators. Adjusted mean total facility days per year were 1.13 (95% confidence interval [CI] = 0.74-1.40) among men with good mobility increasing to 2.43 (95% CI = 1.17-3.84) among men with poor mobility, and 0.67 (95% CI = 0.38-0.91) among men without multimorbidity increasing to 2.70 (95% CI = 1.58-3.77) among men with high multimorbidity. Men with poor mobility and high multimorbidity had a ninefold increase in mean total facility days per year (5.50, 95% CI = 2.78-10.87) compared with men with good mobility without multimorbidity (0.59, 95% CI = 0.37-0.95). Conclusions Among older men, mobility limitations and multimorbidity were independent predictors of higher inpatient and PAC utilization after considering each other and conventional predictors. Marked combined effects of reduced mobility and multimorbidity burden may be important to consider in clinical decision-making and planning health care delivery strategies for the growing aged population.

The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide “drug holiday” clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow. The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question. We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization. Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study. Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.

Meredith Kilgore,1 Harshali K Patel,2 Adrian Kielhorn,2 Juan F Maya,2 Pradeep Sharma1 1Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, 2Amgen, Inc., Thousand Oaks, CA,USA Objective: The objective of this study was to assess the costs associated with the hospitalization and the cumulative 30-, 60-, and 90-day readmission rates in a cohort of Medicare beneficiaries with heart failure (HF).Methods: This was a retrospective, observational study based on data from the national 5% sample of Medicare beneficiaries. Inpatient data were gathered for Medicare beneficiaries with at least one HF-related hospitalization between July 1, 2005, and December 31, 2011. The primary end point was the average per-patient cost of hospitalization for individuals with HF. Secondary end points included the cumulative rate of hospitalization, the average length of hospital stay, and the cumulative 30-, 60-, and 90-day readmission rates.Results: Data from 63,678 patients with a mean age of 81.8 years were included in the analysis. All costs were inflated to $2,015 based on the medical care component of the Consumer Price Index. The mean per-patient cost of an HF-related hospitalization was $14,631. The mean per-patient cost of a cardiovascular (CV)-related or all-cause hospitalization was $16,000 and $15,924, respectively. The cumulative rate of all-cause hospitalization was 218.8 admissions per 100 person-years, and the median length of stay for HF-related, CV-related, and all-cause hospitalizations was 5 days. Also, 22.3% of patients were readmitted within 30 days, 33.3% were readmitted within 60 days, and 40.2% were readmitted within 90 days.Conclusion: The costs associated with hospitalization for Medicare beneficiaries with HF are substantial and are compounded by a high rate of readmission. Keywords: heart failure, Medicare, health economics, hospitalization, costs

Background After older adults experience episodes of poor health or are hospitalized, they may not return to premorbid or prehospitalization eating behaviors. Furthermore, poor nutrition increases hospital readmission risk, but evidence-based interventions addressing these risks are limited. Objective This pilot study's objective was to evaluate the feasibility of conducting a randomized controlled trial assessing a post-discharge home-delivered meal program's impact on older adults' nutritional intake and hospital readmissions and to assess patient acceptability and satisfaction with the program. The aims of the study were to evaluate successful recruitment, randomization, and retention of at least 80% of the 24 participants sought; to compare the outcomes of hospital readmission and total daily caloric intake between participants in the intervention and control groups; and to assess patient acceptability and satisfaction with the program. Design This study used a two-arm randomized controlled trial design, and baseline data were collected at enrollment; three 24-hour food recalls were collected during the intervention period; and health services utilization and intervention satisfaction was evaluated 45 days post-discharge. Participants/setting Twenty-four patients from the University of Alabama at Birmingham Hospital's Acute Care for Elders (ACE) Unit were enrolled from May 2014 to June 2015. They were 65 years or older; at risk for malnutrition; cognitively intact; able to communicate; discharged to a place where the patient or family was responsible for preparing meals; and diagnosed with congestive heart failure, chronic obstructive pulmonary disease, acute myocardial infarction, or pneumonia. Final analysis included 21 participants. Intervention The intervention group received 10 days of home-delivered meals and nutrition education; the control group received usual care and nutrition education. Main outcome measures The main outcome was intervention feasibility, measured by recruitment and retention goals. Hospital readmissions, caloric intake, and satisfaction with the intervention were also evaluated. Statistical analyses performed Univariate and bivariate parametric statistics were used to evaluate differences between groups. Goals for success were identified to assess feasibility of conducting a full-scale study and outcomes were measured against the goals. Results Of the randomized participants, 87.5% were retained for final data collection, indicating that this intervention study is feasible. There were no significant differences between groups for hospital readmissions; however, caloric intake during the intervention period was greater for intervention vs control participants (1,595 vs 1,235; P =0.03). Participants were overwhelmingly satisfied (82% to 100% satisfied or very satisfied) with staff performance, meal quality, and delivery processes. Conclusions Conducting a randomized controlled trial to assess outcomes of providing home-delivered meals to older adults after hospital discharge in partnership with a small nonprofit organization is feasible and warrants future research.

Importance High-intensity statin use after myocardial infarction (MI) varies by patient characteristics, but little is known about differences in use by hospital or region. Objective To explore the relative strength of associations of region and hospital and patient characteristics with high-intensity statin use after MI. Design, Setting, and Participants This retrospective cohort analysis used Medicare administrative claims and enrollment data to evaluate fee-for-service Medicare beneficiaries 66 years or older who were hospitalized for MI from January 1, 2011, through June 30, 2015, with a statin prescription claim within 30 days of discharge. Data were analyzed from January 4, 2017, through May 12, 2019. Exposures Beneficiary characteristics were abstracted from Medicare data. Hospital characteristics were obtained from the 2014 American Hospital Association Survey and Hospital Compare quality metrics. Nine regions were defined according to the US Census. Main Outcomes and Measures Intensity of the first statin claim after discharge characterized as high (atorvastatin calcium, 40-80 mg, or rosuvastatin calcium, 20-40 mg/d) vs low to moderate (all other statin types and doses). Trends in high-intensity statins were examined from 2011 through 2015. Associations of region and beneficiary and hospital characteristics with high-intensity statin use from January 1, 2014, to June 15, 2015, were examined using Poisson distribution mixed models. Results Among the 139 643 fee-for-service beneficiaries included (69 968 men [50.1%] and 69 675 women [49.9%]; mean [SD] age, 76.7 [7.5] years), high-intensity statin use overall increased from 23.4% in 2011 to 55.6% in 2015, but treatment gaps persisted across regions. In models considering region and beneficiary and hospital characteristics, region was the strongest correlate of high-intensity statin use, with 66% higher use in New England than in the West South Central region (risk ratio [RR], 1.66; 95% CI, 1.47-1.87). Hospital size of at least 500 beds (RR, 1.15; 95% CI, 1.07-1.23), medical school affiliation (RR, 1.11; 95% CI, 1.05-1.17), male sex (RR, 1.10; 95% CI, 1.07-1.13), and patient receipt of a stent (RR, 1.35; 95% CI, 1.31-1.39) were associated with greater high-intensity statin use. For-profit hospital ownership, patient age older than 75 years, prior coronary disease, and other comorbidities were associated with lower use. Conclusions and Relevance This study’s findings suggest that geographic region is the strongest correlate of high-intensity statin use after MI, leading to large treatment disparities.

Introduction Treat to target guidelines recommend achieving remission or low disease activity in rheumatoid arthritis (RA). However, the reduction in adverse events and costs associated with lower disease activity is unclear. Methods We used Corrona linked to Medicare data to identify RA patients. Time varying disease activity was measured using Clinical Disease Activity Index (CDAI); outcomes included all-cause hospitalization, a composite of hospitalization or emergency department (ED) visits, mortality, and medical costs. Outcome-specific Cox proportional models evaluated the adjusted hazard ratios between disease activity and outcomes, controlling for potential confounders including comorbidities grouped into four patient phenotypes. Costs were analyzed with mixed models using a Gaussian distribution with log transformation. Results Depending on outcome, 4593 RA patients contributed up to 12 001 person years. Median age was 71 years, 75% women. At baseline, approximately 50–60% of patients were in remission or low disease activity. There was a dose-response relationship between RA disease activity (remission, low, moderate, and high) and the incidence of hospitalizations (13.1, 17.8, 21.2, 27.5 per 100 py, respectively); all adjusted hazard ratios were significant: 0.68 (remission), 0.87 (low), and 1.24 (high) compared with moderate disease activity. Similar trends were observed for ED visits and mortality. The crude difference in annual medical costs between remission ($11 145) and moderate disease activity ($17 646) was $−6 500; the adjusted difference (95%CI) was $−3133 (−4737.72, −1528.43). Conclusion Leveraging the benefits of linking registry and administrative data together, lower disease activity in RA was associated with incrementally reduced risks of all-cause hospitalization, ED visits, mortality, and medical costs in a dose-dependent fashion. Copyright © 2016 John Wiley & Sons, Ltd.

Objective Methods to improve informed consent efficiency and effectiveness are needed for pragmatic clinical trials. We compared informed consent using a tablet computer to a paper approach to assess comprehension and satisfaction of patients and clinic staff for a future osteoporosis clinical trial. Methods Nine community-based practices identified and recruited patients to compare the informed consent processes (tablet vs. paper) in a mock osteoporosis clinical trial. The tablet informed consent included an animation summarizing the trial, complete informed consent document, and questions to assess and reinforce comprehension of the study. Participants were women age ≥55 years with ≥1 year of alendronate use. We surveyed participants to assess comprehension and satisfaction and office staff for satisfaction and perceived time demands. Results The nine practices enrolled 33 participants. There was not a significant difference in comprehension between the tablet vs. paper informed consent [mean (SD) tablet: 12.2 (1.0) vs. paper: 11.4 (1.7)]. Office staff preferred the tablet to the paper informed consent for identifying potential study participants (two-sided t-test p = 0.02) despite an increased perceived time spent to complete the tablet process [tablet: 28.3 min (SD 16.3) vs. paper: 19.0 min (SD 6.9); p = 0.08]. Conclusions Although, there were no significant differences in participant satisfaction and comprehension with the tablet informed consent compared to a paper informed consent, patients and office staff trended towards greater satisfaction with the tablet informed consent. Larger studies are needed to further evaluate the utility of electronic informed consent in pragmatic clinical trials.

This study examined whether access to and use of patient-centered medical home (PCMH) practices is associated with reduced nonurgent emergency department (ED) use, especially among the uninsured population. This retrospective study used 2010-2011 Medical Expenditure Panel Survey data. Difference-in-difference methods, multivariate logit model, marginal effect, and survey procedures were employed. A total of 1287 adults had any ED visit in 2011, which represented weighted 29 463 684 people in the population. Reductions in odds of nonurgent ED use between the full PCMH group and the “no regular provider” group was significantly larger for the uninsured group than publicly and privately insured groups (β = −1.70, P = .009, and β = −1.04, P = .040, respectively). Similar results were found between the partial PCMH group and the “no regular provider” group for the uninsured group compared to the public group (β = −1.67, P = .019). PCMH models demonstrate higher odds of reduced nonurgent ED use among uninsured individuals compared to public and private enrollees nationwide.

Background Medicare claims have been used to study lipid-lowering medication (LLM) use among US adults. Methods We analyzed the agreement between Medicare claims for LLM and LLM use indicated by self-report during a telephone interview and, separately, by a medication inventory performed during an in-home study visit upon enrollment into the REasons for Geographic And Racial Differences in Stroke (REGARDS) study. We included REGARDS participants ≥65 years enrolled in 2006–2007 with Medicare pharmacy benefits (Part D) from 120 days before their telephone interview through their medication inventory (n = 899). Results Overall, 39.2% and 39.5% of participants had a Medicare claim for an LLM within 120 days prior to their interview and medication inventory, respectively. Also, 42.7% of participants self-reported using LLMs, and 41.8% had an LLM in their medication inventory. The Kappa statistic (95% confidence interval [CI]) for agreement of Medicare claims with self-report and medication inventory was 0.68 (0.63–0.73) and 0.72 (0.68–0.77), respectively. No Medicare claims for LLMs were present for 22.1% (95%CI: 18.1–26.6%) of participants who self-reported taking LLMs and 18.9% (15.1–23.3%) with LLMs in their medication inventory. Agreement between Medicare claims and self-report was lower among Black male individuals (Kappa = 0.34 [95%CI: 0.14–0.54]) compared with Black female individuals (0.70 [0.61–0.79]), White male individuals (0.65 [0.56–0.75]), and White female individuals (0.79 [0.72–0.86]). Agreement between Medicare claims and the medication inventory was also low among Black male individuals (Kappa = 0.48 [95%CI: 0.29–0.66]). Conclusions Although substantial agreement exists, many Medicare beneficiaries who self-report LLM use or have LLMs in a medication inventory have no claims for these medications. Copyright © 2016 John Wiley & Sons, Ltd.

OBJECTIVES Assess the validity of Medicare claims for identifying myocardial infarction (MI). METHODS We used data from 9951 Medicare beneficiaries 65 years and above in the Reasons for Geographic And Racial Differences in Stroke study. Between 2003 and 2012, 669 participants had an MI identified and adjudicated through study procedures (ie, the gold standard), and 552 had an overnight inpatient claim with a code for MI (ICD-9 code 410.x0 or 410.x1) in any discharge diagnosis position. RESULTS Using Medicare claims with a discharge diagnosis code for MI in any position, the positive predictive value (PPV) was 84.3% [95% confidence interval (CI), 80.9%-87.3%] and the sensitivity was 49.0% (95% CI, 44.9%-53.1%). Sensitivity was lower for men (45.8%) versus women (55.1%), microsize MIs (13.7%) versus other MIs (64.7%), type 2 (30.9%), and 4-5 MIs (11.1%) versus type 1 MIs (76.6%), and MIs occurring in-hospital (28.8%) versus out-of-hospital (66.7%). Using Medicare claims with a code for MI in the primary discharge diagnosis position, the PPV was 89.7% (95% CI, 86.3%-92.5%) and sensitivity was 40.1% (95% CI, 36.1%-44.2%). The sensitivity of claims with a code for MI in the primary discharge diagnosis position was lower for microsize versus other MIs, type 2 and 4-5 MIs versus type 1 MIs and MIs occurring in-hospital versus out-of-hospital. Hazard ratios for MI associated with participant characteristics were similar using adjudicated MIs identified through study procedures or claims for MI without further adjudication. CONCLUSIONS Medicare claims have a high PPV but low sensitivity for identifying MI and can be used to investigate individual-level characteristics associated with MI.

Compare medical expenditures among adults with statin-associated adverse effects (SAAE) and high statin adherence (HSA) following myocardial infarction (MI). We analyzed expenditures in 2016 US dollars among Medicare beneficiaries with SAAE (n = 1741) and HSA (n = 55,567) who were ≥ 66 years of age and initiated moderate/high-intensity statins following an MI in 2007–2013. SAAE were identified through a claims-based algorithm, which included down-titrating statins and initiating ezetimibe, switching to ezetimibe monotherapy, having a rhabdomyolysis or antihyperlipidemic adverse event followed by statin down-titration or discontinuation, or switching between ≥ 3 statin types within 365 days following MI. HSA was defined by having a statin available to take for ≥ 80% of the days in the 365 days following MI. Expenditures among beneficiaries with SAAE and HSA were $40,776 (95% CI $38,329–$43,223) and $26,728 ($26,482–$26,974), respectively, in the 365 days following MI, and $34,238 ($31,396–$37,080) and $29,053 ($28,605–$29,500), respectively, for every year after the first 365 days. Multivariable-adjusted ratios comparing expenditures among beneficiaries with SAAE versus HSA in the first 365 days and after the first 365 days following MI were 1.51 (95% CI 1.43–1.59) and 1.23 (1.12–1.34), respectively. Inpatient and outpatient expenditures were higher among beneficiaries with SAAE versus HSA during and after the first 365 days following MI. Compared to beneficiaries with HSA, medication expenditures among those with SAAE were similar in the 365 days following MI, but higher afterwards. Other medical expenditures were higher among beneficiaries with SAAE versus HSA. SAAE are associated with increased expenditures following MI compared with HSA.

OBJECTIVE: To identify hospital/county characteristics and sources of regional heterogeneity associated with readmission penalties. DATA SOURCES/STUDY SETTING: Acute care hospitals under the Hospital Readmissions Reduction Program from fiscal years 2013 to 2018 were linked to data from the Annual Hospital Association, Centers for Medicare and Medicaid Services, Medicare claims, Hospital Compare, Nursing Home Compare, Area Resource File, Health Inequity Project, and Long‐term Care Focus. The final sample contained 3,156 hospitals in 1,504 counties. DATA COLLECTION/EXTRACTION METHODS: Data sources were combined using Medicare hospital identifiers or Federal Information Processing Standard codes. STUDY DESIGN: A two‐level hierarchical model with correlated random effects, also known as the Mundlak correction, was employed with hospitals nested within counties. PRINCIPAL FINDINGS: Over a third of the variation in readmission penalties was attributed to the county level. Patient sociodemographics and the surrounding access to and quality of care were significantly associated with penalties. Hospital measures of Medicare volume, percentage dual‐eligible and Black patients, and patient experience were correlated with unobserved area‐level factors that also impact penalties. CONCLUSIONS: As the readmission risk adjustment does not include any community‐level characteristics or geographic controls, the resulting endogeneity bias has the potential to disparately penalize certain hospitals.

Background Claims data from Medicare or other payers might not generalize to other populations regarding service use after stroke especially among younger patients. However, high agreement between self-report and Medicare claims data would support the use of self-reported healthcare utilization data in these populations. Methods A population-based sample of 147 stroke participants with traditional fee-for service Medicare and their family caregivers was examined. Concordance with Medicare claims was examined for stroke participant self-report for Emergency Room visits, hospitalizations, and physician visits for a six-month period after stroke, and for both stroke participant and caregiver reports of receipt of Physical Therapy (PT), Speech and Language Pathology (SLP), or Home Health Agency (HHA) visits. Results Agreement was good for Emergency Room visits (kappa 0.75), hospitalization (kappa 0.70), and physician visits (Prevalence Adjusted Bias Adjusted Kappa [PABAK] 0.69) but more moderate for physical therapy, speech and language therapy, and home health agency visits (kappa 0.56-0.63). Caregiver agreement with Medicare claims was similar to stroke participant agreement. African Americans were less likely to self-report therapy compared to whites (OR 0.32 PT, 0.38 SLP, 0.29 HHA, p < 0.03). Younger stroke participants reported lower levels of Emergency Room visits than claims (OR 0.81, p = 0.001). Conclusion Healthcare utilization after stroke can be reliably assessed from Medicare claims, Stroke participant, or Caregiver report for salient events such as hospitalizations and Emergency Room visits. Self-report and caregiver report appear to be less reliable for identifying use of therapy or home health services. Caution should be used when interpreting disparities based on self-report data alone in these areas.

Background Given FDA warnings, drug holidays (temporary or permanent discontinuation) of bisphosphonates (BPs) after long-term (3–5 years) continuous therapy is becoming increasingly common in the United States (US). However, the benefits and risks of stopping BPs, and the optimal timing to restart, remain unclear. Objectives We conducted a population-based cohort study of women on long term BP therapy to evaluate the rate of hip fracture following a drug holiday. Methods We used Medicare data (2006–2014) to identify all women with medical and pharmacy coverage who initiated a BP and were at least 80% adherent for ≥3 years (‘baseline’), at which follow-up time began. Patients using other bone therapies (e.g. denosumab, oestrogen, teriparatide, calcitonin) were excluded or censored if they started after follow-up began. We calculated crude rates of hip fracture for continuing BP therapy and among those who discontinued, for categories of time since discontinuing (i.e., length of drug holiday), extending up to 3 years. We used Cox proportional hazards models to evaluate the risk of discontinuing per the length of the drug holiday, using age as the time axis and controlling for potentially confounding factors, with and without adjusting for death as a competing risk. Results We identified 1 56 236 women who were highly adherent, long-term BP users. The mean (SD) age was 78.5 (7.5) years. The most commonly used BPs were alendronate (71.7% ever use, 52% exclusive use) and zoledronic acid (16.2% ever use, 8.9% exclusive use). During a median (IQR) followup of 2.1 (1.0, 3.3) years, 62 676 (40.1%) of women stopped BP therapy for at least 6 months or more. Among these women, 7947 (12.7%) subsequently restarted any BP. Overall, 16 904 (10.8%) died. A total of 3745 hip fractures occurred during follow-up. Hip fracture rates were lowest among women who were current users, and gradually increased as the length of the drug holiday increased, achieving their maximum with a drug holiday >2 years (table 1). Conclusions In a large cohort of U.S. women, a BP drug holiday greater than 2 years was associated with a significantly increased risk for hip fracture of up to 39% compared to continued BP use. Disclosure of Interest J. Curtis Grant/research support from: AbbVie, Amgen, BMS, Corrona, Janssen, Lilly, Myriad, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Amgen, BMS, Corrona, Janssen, Lilly, Myriad, Pfizer, Roche/Genentech, UCB, R. Chen Grant/research support from: Amgen, Z. Li Grant/research support from: Amgen, T. Arora Grant/research support from: Amgen, K. Saag Grant/research support from: Amgen, Merck, Consultant for: Amgen, Merck, Radius, N. Wright: None declared, S. Daigle: None declared, M. Kilgore Grant/research support from: Amgen, E. Delzell: None declared

A 9-point risk assessment identified persons with a history of injection drug use who were safe for discharge. "Low-risk" patients were discharged with outpatient antibiotics; others continued inpatient treatment. Use of the assessment reduced the mean length of stay by 20 days and total direct cost by 33%, creating capacity for an additional 333 patients.

Background Contact with the healthcare system represents an opportunity for individuals who discontinue statins to re‐initiate treatment. To help identify opportunities for healthcare providers to emphasize the risk‐lowering benefits accrued through restarting statins, we determined the types of healthcare utilization associated with statin re‐initiation among patients with history of a myocardial infarction. Methods and Results Medicare beneficiaries with a statin pharmacy fill claim within 30 days of hospital discharge for a myocardial infarction in 2007 to 2012 (n=158 795) were followed for 182 days postdischarge to identify treatment discontinuation, defined as 60 continuous days without statins (n=24 461). Re‐initiation was defined as a statin fill within 365 days of the discontinuation date (n=13 136). Using a case‐crossover study design and each beneficiary as their own control, healthcare utilization during 0 to 14 days before statin re‐initiation (case period) was compared with healthcare utilization 30 to 44 days before statin re‐initiation (control period). The mean age of beneficiaries was 75.4 years; 52.8% were women and 81.9% were white. For routine healthcare utilization, the odds ratio (95% confidence interval) for statin re‐initiation associated with lipid panel testing was 2.65 (1.93–3.65), outpatient primary care was 1.31 (1.23–1.40), and outpatient cardiologist care was 1.38 (1.28–1.50). For acute healthcare utilization, the odds ratio (95% confidence interval) for statin re‐initiation associated with emergency department visits was 1.77 (1.31–2.40), coronary heart disease ( CHD ) hospitalizations was 3.16 (2.41–4.14) and non–coronary heart disease hospitalizations was 1.73 (1.49–2.01). Conclusions The weaker association of routine versus acute healthcare utilization with statin re‐initiation suggests missed opportunities to reinforce the importance of statin therapy for secondary prevention.

State Medicaid programs increasingly use case management to manage enrollees with chronic conditions who may become cost intensive for the program. The authors examined the impact of Alabama Department of Public Health (ADPH)'s case management on care expenditures for Medicaid enrollees with various chronic diseases, over 2011 to 2014. The authors matched case-managed enrollees with three controls per case using health conditions and sociodemographics. Thereafter, the authors used a quasi-experimental approach to estimate how per-member-per-month costs changed following case management. Case -management appeared to result in program savings, driven largely by inpatient and emergency department cost-savings. There was noticeable variation in savings for members with different chronic conditions.

Purpose Intensity modulated radiation therapy (IMRT) is widely used in the treatment of head and neck cancers (HNC). There is not enough evidence to suggest that some radiation oncologists (ROs) are associated with better outcomes in patients with HNC. We conducted a cross-sectional analysis to evaluate the effect of ROs' characteristics on outcomes in patients with HNC treated with IMRT. Methods and materials The study used the Surveillance Epidemiology and End Results-Medicare linked database to identify patient characteristics. Physician records were obtained from the American Medical Association. Logistic regression models with propensity scores were analyzed to look for an association between RO characteristics and patient outcomes. Results RO characteristics showed that approximately 30% of ROS completed their training in or after the year 2000 (recently trained), and 17% were in top decile of treatment volume (high volume). Less than 3% of ROs work in academic settings. We found that ROs who were recently trained have higher odds (odds ratio [OR]: 1.10; 95% confidence interval [CI], 1.011-1.191) compared with those who were not. In addition, ROs who were treating high volumes of patients have higher odds (OR: 1.08; 95% CI, 1.010-1.165) compared with those treating low volumes of an event of adverse effect of IMRT or death among patients. ROs who work in academic settings have a protective effect (OR: 0.72; 95% CI, 0.569-0.925). Conclusions ROs who were recently trained and had a high treatment volume are associated with poorer outcomes among patients with HNC who receive IMRT treatment.

BackgroundChronic pain is a common, disabling, and costly comorbidity, particularly in people living with HIV (PLWH). This study developed and pilot tested a pain self-management intervention for chronic pain tailored to PLWH called Skills TO Manage Pain (STOMP).ObjectivesGiven the additional resources needed to deliver STOMP in HIV clinical settings, an important objective of the pilot study was to assess not only STOMP's preliminary efficacy, but also its cost-effectiveness.Research design and subjectsThe present study draws from a 44-participant, 2-arm randomized pilot trial of the STOMP intervention vs usual care among PLWH and at least moderate chronic pain (Clinicaltrials.gov: NCT02824562). Cost-effectiveness is presented as the incremental cost-effectiveness ratio (ICER). Costs were considered from the clinic perspective over a 1-year time horizon using real costs from the pilot trial. It was conservatively assumed there would be no costs savings. The Standard Gamble (SG) method was used to directly measure utilities.ResultsThirty-six participants met inclusion criteria for the present analyses. Mean age was 52 years; 61% were female and 86% were black. The total cost of STOMP was $483.83 per person. Using the SG method, the change in QALYs was 0.15, corresponding to an ICER of $3,225.ConclusionsSTOMP's cost/QALY is substantially lower than the $50,000 to $100,000/QALY benchmark often used to indicate cost-effectiveness. Although based on a pilot trial and, therefore, preliminary, these findings are promising, and suggest the importance of cost analyses in future STOMP trials.

Chronic pain is an important and understudied comorbidity in people living with HIV (PLWH). We conducted a pilot trial of Skills TO Manage Pain (STOMP), an innovative social cognitive theory-based pain self-management intervention tailored to PLWH, to assess feasibility, acceptability, and preliminary efficacy. Eligibility criteria included being HIV+, ≥ moderate pain for ≥ 3 months and a score of ≥ 4 on the three-item PEG pain severity and interference scale. Participants were randomized in a 1:1 fashion to STOMP or a usual care comparison. Among 22 participants randomized to STOMP, median session attendance was 9/12 (75%). Of 19 STOMP participants surveyed, 13 reported being "much better" overall since beginning treatment. Brief pain inventory-total scores decreased by 2 points in the intervention group and 0.9 in the control group (p = 0.11). STOMP is feasible, acceptable, and shows preliminary evidence of efficacy and promise for a full-scale trial.

Purpose We sought to determine the long-term risk of cardiovascular disease (CVD)—stroke and myocardial infarction—and congestive heart failure (CHF) in older patients with colorectal cancer, as well as to understand the roles that preexisting comorbidities and cancer therapy play in increasing this risk. Patients and Methods We evaluated individuals from the SEER-Medicare database with incident stage I to III colorectal cancer at age older than 65 years between January 1, 2000, and December 31, 2011 (n = 72,408) and compared these patients with a matched cohort of Medicare patients without cancer (n = 72,408). Results Median age at diagnosis of colorectal cancer was 78 years (range, 66 years to 106 years), and median follow-up was 8 years since diagnosis. The 10-year cumulative incidence of new-onset CVD and CHF were 57.4% and 54.5% compared with 22% and 18% for control, respectively ( P < .001). The interaction between hypertension and chemotherapy was significant ( P < .001) for CVD, and that between diabetes and chemotherapy was significant ( P < .001) for CHF. Within the first 2 years since diagnosis, exposure to capecitabine alone increased CHF hazard (hazard ratio [HR], 3.6; 95% CI, 12.76 to 4.38) compared with exposure to fluorouracil alone. Conversely, patients who were treated with fluorouracil alone had a higher CVD hazard at < 2 years and > 2 years since diagnosis compared with patients who received capecitabine alone (< 2 years HR, 0.63; 95% CI, 0.53 to 0.75; > 2 years HR, 0.72; 95% CI, 0.62 to 0.84). Conclusion Older patients with colorectal cancer are at increased risk of developing CVD and CHF. Diabetes and hypertension interact with chemotherapy to increase the risk of cardiovascular morbidity. Future studies should assess the potential for personalized therapeutic options for those with preexisting morbidities and for structured monitoring for patients with a history of exposure to chemotherapy regimens, as well as explore the management of preexisting comorbidities to address long-term cardiovascular morbidity.

We examined claims-based approaches for identifying a study population free of coronary heart disease (CHD) using data from 8,937 US blacks and whites enrolled during 2003–2007 in a prospective cohort study linked to Medicare claims. Our goal was to minimize the percentage of persons at study entry with self-reported CHD (previous myocardial infarction or coronary revascularization). We assembled 6 cohorts without CHD claims by requiring 6 months, 1 year, or 2 years of continuous Medicare fee-for-service insurance coverage prior to study entry and using either a fixed-window or all-available look-back period. We examined adding CHD-related claims to our “base algorithm,” which included claims for myocardial infarction and coronary revascularization. Using a 6-month fixed-window look-back period, 17.8% of participants without claims in the base algorithm reported having CHD. This was reduced to 3.6% using an all-available look-back period and adding other CHD claims to the base algorithm. Among cohorts using all-available look-back periods, increasing the length of continuous coverage from 6 months to 1 or 2 years reduced the sample size available without lowering the percentage of persons with self-reported CHD. This analysis demonstrates approaches for developing a CHD-free cohort using Medicare claims.

Background A well-functioning primary care system has the capacity to provide effective care for patients to avoid nonurgent emergency department (ED) use and related costs. Objective This study examined how patients' perceived deficiency in ambulatory care is associated with nonurgent ED care costs nationwide. Methods This retrospective cohort study used data from the 2010–2011 Medical Expenditure Panel Survey. This study chose usual source of care, convenience of needed medical care, and patient evaluation of care quality as the main independent variables. The marginal effect following a multivariate logit model was employed to analyze the urgent vs. nonurgent ED care costs in 2011, after controlling for covariates in 2010. The endogeneity was accounted for by the time lag effect and controlling for education levels. Sample weights and variance were adjusted with the survey procedures to make results nationally representative. Results Patient-perceived poor and intermediate levels of primary care quality had higher odds of nonurgent ED care costs (odds ratio [OR] = 2.22, p = 0.035, and OR = 2.05, p = 0.011, respectively) compared to high-quality care, with a marginal effect (at means) of 13.0% and 11.5% higher predicted probability of nonurgent ED care costs. Costs related to these ambulatory care quality deficiencies amounted to $229 million for private plans (95% confidence interval [CI] $100 million–$358 million), $58.5 million for public plans (95% CI $33.9 million–$83.1 million), and an overall of $379 million (95% CI $229 million–$529 million) nationally. Conclusions These findings highlight the improvement in ambulatory care quality as the potential target area to effectively reduce nonurgent ED care costs.

Background Health care claims data may provide a cost-efficient approach for studying chronic kidney disease (CKD). Study Design Prospective cohort study. Setting & Participants We compared characteristics and outcomes for individuals with CKD defined using laboratory measurements versus claims data from 6,982 REGARDS (Reasons for Geographic and Racial Differences in Stroke) Study participants who had Medicare fee-for-service coverage. Predictors Presence of CKD as defined by both the REGARDS Study (CKD REGARDS ) and Medicare data (CKD Medicare ), presence of CKD REGARDS but not CKD Medicare , and presence of CKD Medicare but not CKD REGARDS , and absence of both CKD REGARDS and CKD Medicare . Outcomes Mortality and incident end-stage renal disease (ESRD). Measurements The research study definition of CKD (CKD REGARDS ) included estimated glomerular filtration rate (eGFR) 2 or albumin-creatinine ratio > 30mg/g at the REGARDS Study visit. CKD in Medicare (CKD Medicare ) was identified during the 2 years before each participant's REGARDS visit using a claims-based algorithm. Results Overall, 32% of participants had CKD REGARDS and 6% had CKD Medicare . Sensitivity, specificity, and positive and negative predictive values of CKD Medicare for identifying CKD REGARDS were 15.5% (95% CI, 14.0%-17.1%), 97.7% (95% CI, 97.2%-98.1%), 75.6% (95% CI, 71.4%-79.5%), and 71.5% (95% CI, 70.4%-72.6%), respectively. Mortality and ESRD incidence rates, expressed per 1,000 person-years, were higher for participants with versus without CKD Medicare (mortality: 72.5 [95% CI, 61.3-83.7] vs 33.3 [95% CI, 31.5-35.2]; ESRD: 16.4 [95% CI, 11.2-21.6] vs 1.3 [95% CI, 0.9-1.6]) and with versus without CKD REGARDS (mortality: 59.9 [95% CI, 55.4-64.4] vs 25.5 [95% CI, 23.6-27.4]; ESRD: 6.8 [95% CI, 5.4-8.3] vs 0.1 [95% CI, 0.0-0.3]). Among participants with CKD REGARDS , those with abdominal obesity, diabetes, anemia, lower eGFR, more outpatient visits, hospitalization, and a nephrologist visit in the 2 years before their REGARDS visit were more likely to have CKD Medicare . Limitations CKD REGARDS relied on eGFR and albuminuria assessed at a single visit. Conclusions CKD, whether defined in claims or through research study measurements, was associated with increased mortality and ESRD. However, individuals with CKD identified in claims may represent a select high-risk population.

Background National guidelines recommend use of high-intensity statins after hospitalization for coronary heart disease (CHD) events. Objectives This study sought to estimate the proportion of Medicare beneficiaries filling prescriptions for high-intensity statins after hospital discharge for a CHD event and to analyze whether statin intensity before hospitalization is associated with statin intensity after discharge. Methods We conducted a retrospective cohort study using a 5% random sample of Medicare beneficiaries between 65 and 74 years old. Beneficiaries were included in the analysis if they filled a statin prescription after a CHD event (myocardial infarction or coronary revascularization) in 2007, 2008, or 2009. High-intensity statins included atorvastatin 40 to 80 mg, rosuvastatin 20 to 40 mg, and simvastatin 80 mg. Results Among 8,762 Medicare beneficiaries filling a statin prescription after a CHD event, 27% of first post-discharge fills were for a high-intensity statin. The percent filling a high-intensity statin post-discharge was 23.1%, 9.4%, and 80.7%, for beneficiaries not taking statins pre-hospitalization, taking low/moderate-intensity statins, and taking high-intensity statins before their CHD event, respectively. Compared with beneficiaries not on statin therapy pre-hospitalization, multivariable adjusted risk ratios for filling a high-intensity statin were 4.01 (3.58–4.49) and 0.45 (0.40–0.52) for participants taking high-intensity and low/moderate-intensity statins before their CHD event, respectively. Only 11.5% of beneficiaries whose first post-discharge statin fill was for a low/moderate-intensity statin filled a high-intensity statin within 365 days of discharge. Conclusions The majority of Medicare beneficiaries do not fill high-intensity statins after hospitalization for CHD.

Although the reverse syphilis screening algorithm is more efficient than the traditional algorithm, it may lead to exorbitant costs for health systems serving persons living with HIV needing annual syphilis screening. Alternatively, the traditional screening algorithm is cost saving in many scenarios.

AIM To identify the costs of replacing an entire malfunctioning AUS device versus an individual component at the time of device malfunction. METHODS Decision analysis was performed by analyzing the costs associated with revising a malfunctioning artificial urinary sphincter using one of two techniques: either individual or entire device replacement. Costs were determined by including actual institutional costs. Model assumptions were based on a summary of published literature and were created based on a time horizon of 0-5 years since the original, primary AUS was placed, and models were created for malfunction of each individual component. Sensitivity analysis was done adjusting for costs of the device and failure rates. RESULTS Total costs to replace an individual component were $8330 for the pump, $7611 for the cuff, and $5599 for the balloon, while entire device replacement cost $15 069. Over a 5-year time horizon the cost per patient for replacement of a balloon, pump, or cuff were $14 407, $17 491, and $15 212, respectively, versus $18 001 if the entire device was replaced. To be less costly to replace the entire device, balloon, pump, and cuff failure rates would need to be >55%, >25%, or >37.5% during the first 2 years after placement. CONCLUSION In the event of failure of the artificial urinary sphincter, cost analysis demonstrates that removal and replacement of the entire device is more expensive than replacement of a malfunctioning component at any point up to 5 years after initial AUS placement.

Background/Objectives Social support can prevent or delay long-term nursing home placement (NHP). The purpose of our study was to understand how the availability of a caregiver can affect NHP after ischemic stroke and how this affects different subgroups differently. Design Nested cohort study. Setting Nationally based REasons for Geographic and Racial Differences in Stroke (REGARDS) study. Participants Stroke survivors aged 65 to 100 (256 men, 304 women). Measurements Data were from Medicare claims from January 2003 to December 2013 and REGARDS baseline interviews conducted from January 2003 to October 2007. Caregiver support was measured by asking, “If you had a serious illness or became disabled, do you have someone who would be able to provide care for you on an on-going basis?” Diagnosis of ischemic stroke was derived from inpatient claims. NHP was determined using a validated claims algorithm for stays of 100 days and longer. Risk was estimated using Cox regression. Results Within 5 years of stroke, 119 (21.3%) participants had been placed in a nursing home. Risk of NHP was greater in those lacking available caregivers (log-rank P = .006). After adjustment for covariates, lacking an available caregiver increased the risk of NHP after stroke within 1 year by 70% (hazard ratio (HR) = 1.70, 95% confidence interval (CI) = 0.97–2.99) and within 5 years by 68% (HR = 1.68, 95% CI = 1.10–2.58). The effect of caregiver availability on NHP within 5 years was limited to men (HR = 3.15, 95% CI = 1.49–6.67). Conclusion In men aged 65 and older who have survived an ischemic stroke, the lack of an available caregiver is associated with triple the risk of NHP within 5 years.

BackgroundMeta-analyses of general population studies report mean low-density lipoprotein cholesterol (LDL-C) reductions of 30% to

Background— Although the benefits of statins accrue over time, treatment discontinuation is common. Examining the patterns of statin discontinuation, reinitiation, and persistence after reinitiation among Medicare beneficiaries after hospital discharge for a myocardial infarction may help increase statin use in high-risk patients. Methods and Results— Medicare beneficiaries with a statin fill claim within 30 days after hospital discharge for myocardial infarction in 2007 to 2012 (n=158 795) were followed for 182 days post-discharge to identify discontinuation, defined as 60 continuous days without statins available. Reinitiation, defined by a statin fill, was identified in the 365 days post-discontinuation. High persistence was defined as proportion of days covered ≥80% with ≥1 day of statin supply 182 days after reinitiation. Follow-up ended on December 31, 2014. In the 182 days after myocardial infarction hospital discharge, 15.4% of beneficiaries discontinued statins. Of this group, 53.7% reinitiated statins. On reinitiation, 27.1% changed statin type, 6.9% up-titrated intensity, 14.4% down-titrated intensity, and 66.0% had the same statin and intensity. In the 182 days after reinitiation, 45.8% had high persistence. Moderate- and high- versus low-intensity statins were associated with a lower risk for statin discontinuation (moderate intensity: relative risk [RR], 0.93; 95% confidence interval [CI], 0.89–0.96; high-intensity: RR, 0.95; 95% CI, 0.91–0.99). High persistence was less common after reinitiating high- versus low-intensity statins (RR, 0.80; 95% CI, 0.75–0.86), but no association was present for those reinitiating a moderate- versus low-intensity statin (RR, 0.95; 95% CI, 0.90–1.01). Down-titrating versus reinitiating the same statin intensity (RR, 1.10; 95% CI, 1.05–1.16) and reinitiating a different versus the same statin (RR, 1.10; 95% CI, 1.06–1.14) were associated with high persistence after treatment reinitiation. Conclusions— Although many people who discontinue a statin reinitiate treatment, statin persistence after reinitiation was low. Reinitiating therapy with moderate-intensity statins, down-titration, and using a different statin may promote persistence.

Background: American College of Cardiology/American Heart Association guidelines published in 2013 recommend high-intensity statins (atorvastatin 40 or 80 mg or rosuvastatin 20 or 40 mg) for most adults ≤75 years of age with atherosclerotic cardiovascular disease (ASCVD). For adults >75 years of age with ASCVD, the guidelines recommend continuation of tolerated statins or initiation of moderate intensity statins for most patients. Objective: To examine whether guideline concordant use of high-intensity statins following myocardial infarction (MI) among Medicare beneficiaries differed by hospital size, medical school affiliation, and region of the US in 2014 (after publication of the guidelines). Methods: We identified 28,086 Medicare beneficiaries with fee-for-service and pharmacy coverage who filled a statin within 30 days following hospital discharge for MI in 2014. The analyses were restricted to 731 hospitals with at least 20 beneficiaries discharged for MI in 2014. Hospital size and medical school affiliation were determined from the American Hospital Association survey. In subgroups ≤75 and >75 years of age, we calculated the proportion of beneficiaries whose first statin fill after MI was a high-intensity statin by hospital, hospital size, medical school affiliation, and region. Results: Among statin users ≤75 years of age, 10,696 (55%) beneficiaries filled a prescription for a high-intensity statin following MI. The percentage filling high-intensity statins range from 0-100% (25 th percentile 39%, 75 th percentile 69%) across hospitals. High-intensity statin use was more common following hospitalization at larger hospitals, hospitals with medical school affiliations, and those in New England ( Figure ). A lower percentage of Medicare beneficiaries >75 years of age filled high-intensity statins (n = 8,441, 44%), but patterns were similar across hospital characteristics and region. Conclusions: Similar patterns of high-intensity statin use were present among individuals ≤75 years of age, in whom high-intensity statin use is guideline concordant, and individuals >75 years of age, in whom high-intensity statin use is not necessarily guideline concordant, suggesting that variation in high-intensity statin prescriptions may not be directly related to close adherence to guidelines.

Background Better cardiovascular health is associated with lower cardiovascular disease risk. Methods and Results We determined the association between cardiovascular health and healthcare utilization and expenditures in the RE asons for Geographic And Racial Differences in Stroke (REGARDS) study. We included 6262 participants ≥65 years with Medicare fee‐for‐service coverage for the year after their baseline study visit in 2003‐2007. Cardiovascular health at baseline was assessed using the American Heart Association's Life's Simple 7 ( LS 7) metric, which includes 7 factors: cigarette smoking, physical activity, diet, body mass index, blood pressure, cholesterol, and glucose. Healthcare utilization and expenditures were ascertained using Medicare claims in the year following baseline. Overall, 17.2%, 31.1%, 29.0%, 16.4% and 6.4% of participants had 0 to 1, 2, 3, 4, and 5 to 7 ideal LS 7 factors, respectively. The multivariable‐adjusted relative risk (95% confidence interval [ CI ]) for having any inpatient and outpatient encounters comparing participants with 5 to 7 versus 0 to 1 ideal LS 7 factors were 0.55 (0.39, 0.76) and 1.00 (0.98, 1.02), respectively. Among participants with 0 to 1 and 5 to 7 ideal LS 7 factors, mean inpatient expenditures were $3995 and $1250, respectively, mean outpatient expenditures were $5166 and $2853, respectively, and mean total expenditures were $9147 and $4111, respectively. After multivariable adjustment, the mean (95% CI ) cost difference comparing participants with 5 to 7 versus 0 to 1 ideal LS 7 factors was −$2551 (−$3667, −$1435) for inpatient, −$2410 (−$3089, −$1731) for outpatient, and −$5016 (−$6577, −$3454) for total expenditures. Conclusions Better cardiovascular health is associated with lower risk for inpatient encounters and lower inpatient and outpatient healthcare expenditures.

Background— Little is known about associations of calcium channel blockers (CCBs) with outcomes in patients with heart failure and preserved ejection fraction (EF). Methods and Results— Of the 10 570 hospitalized patients with heart failure and preserved EF, ≥65 years, EF ≥40%, in the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF; 2003–2004), linked to Medicare data (through December 31, 2008), 7514 had no prior history of CCB use. Of these, 815 (11%) patients received new discharge prescriptions for CCBs. Propensity scores for CCB initiation, calculated for each of the 7514 patients, were used to assemble a matched cohort of 1620 (810 pairs) patients (mean age, 80 years; mean EF, 56%; 65% women; 10% black) receiving and not receiving CCBs, balanced on 114 baseline characteristics. The primary composite end point of all-cause mortality or heart failure hospitalization occurred in 82% and 81% of patients receiving and not receiving CCBs (hazard ratio for CCBs, 1.03; 95% confidence interval, 0.92–1.14). Hazard ratios (95% confidence intervals) for all-cause mortality, heart failure hospitalization, and all-cause hospitalization were 1.05 (0.94–1.18), 1.05 (0.91–1.21), and 1.03 (0.93–1.14), respectively. Similar associations were observed when we categorized patients into those receiving amlodipine and nonamlodipine CCBs. Among 7514 prematch patients, multivariable-adjusted and propensity-adjusted hazard ratios (95% confidence interval) for primary composite end point were 1.03 (0.95–1.12) and 1.02 (0.94–1.11), respectively. Conclusions— In hospitalized older patients with heart failure, new discharge prescriptions for CCBs had no associations with composite or individual end points of mortality or heart failure hospitalization, regardless of the class of CCBs.

Objectives/Hypothesis Recent reviews of laryngeal cancer have detected a trend toward reduced survival, linked temporally to an abrupt change in treatment of these patients during the 1990s to nonsurgical regimens. Because organ preservation also is an important goal for hypopharyngeal cancer, we sought to determine treatment trends and survival data for patients with hypopharyngeal squamous cell carcinoma (SCC). Study Design Retrospective cohort. Methods Records of 6,647 patients with SCC of the hypopharynx between 1973 and 2003 were selected for review from the Surveillance, Epidemiology and End Results database, with comparison of 1973 to 1989 and 1990 to 2003 cohorts. Results Overall 5-year survival rates for hypopharyngeal cancer have improved. Average survival of hypopharyngeal cancer patients increased to 41.3% in those diagnosed 1990 to 2003 from 37.5% in those diagnosed 1973 to 1989 (P < 0.0001). Since 1990, there is a trend toward treatment using radiation without surgery (43.1% increased to 52.1%), combined surgical and radiation therapy is relatively unchanged (43.6% to 41.8%), and fewer patients underwent surgery alone (14% reduced to 7.3%). Conclusion There has been a trend away from surgical therapy for hypopharyngeal SCC. In contrast to laryngeal cancer, survival for hypopharyngeal cancer has improved since 1990. Level of Evidence 2b. Laryngoscope, 125:624–629, 2015

Objective The patient-centered medical home has emerged as an innovative healthcare delivery model that holds the conceptual promise to improve healthcare quality while reducing costs. This study is among the first to examine how patient perceived patient-centered medical home is related to utilization and costs for emergency department and inpatient care nationwide in the U.S. Methods This retrospective cohort study used data from the 2007–2010 Medical Expenditure Panel Survey. This study focused upon insured individuals aged 18 and older. In each two-year cohort, we measured and identified a full patient-centered medical home group, a partial patient-centered medical home group (with a usual source of care but not a patient-centered medical home), and an unknown patient-centered medical home group. Using negative binomial regression and generalized linear models, we conducted the analysis while controlling for covariates at baseline. Given the nature of the complex survey design, we adjusted weights and variance. Results The study sample consisted of 15,595 individuals, representing a total of 368 million people in the U.S. In the trend of outcome changes from the baseline to the follow-up year, the full and partial patient-centered medical home groups demonstrated reduced efficiency for the 2007–2008 cohort, but increased efficiency for the 2009–2010 cohort, as compared to the no regular provider group. Conclusions Overall, the empirical evidence does not indicate whether patient-centered medical home models reduce healthcare utilization and costs, but it does suggest their potential as mechanisms for achieving healthcare system efficiency, when primary care practices have grown from early to middle stage of patient-centered medical home transformation. A longer observation window and holistic view on all stages of patient-centered medical home growth may be more informative on patient-centered medical home’s efficiency.

The strategy of evaluating every donation opportunity warrants an investigation into the financial feasibility of this practice. The purpose of this investigation is to measure resource utilization required for procurement of transplantable organs in an organ procurement organization (OPO).Donors were stratified into those that met OPTN-defined eligible death criteria (ED donors, n=589) and those that did not (NED donors, n=703). Variable direct costs and time utilization by OPO staff for organ procurement were measured and amortized per organ transplanted using permutation methods and statistical bootstrapping/resampling approaches.More organs per donor were procured (3.66±1.2 vs. 2.34±0.8, P0.0001) and transplanted (3.51±1.2 vs. 2.08±0.8, P0.0001) in ED donors compared with NED donors. The variable direct costs were significantly lower in the NED donors ($29,879.4±11590.1 vs. $19,019.6±7599.60, P0.0001). In contrast, the amortized variable direct costs per organ transplanted were significantly higher in the NED donors ($8,414.5±138.29 vs. $9,272.04±344.56, P0.0001). The ED donors where thoracic organ procurement occurred were 67% more expensive than in abdominal-only organ procurement. The total time allocated per donor was significantly shorter in the NED donors (91.2±44.9 hr vs. 86.8±78.6 hr, P=0.01). In contrast, the amortized time per organ transplanted was significantly longer in the NED donors (23.1±0.8 hr vs. 36.9±3.2 hr, P0.001).The variable direct costs and time allocated per organ transplanted is significantly higher in donors that do not meet the eligible death criteria.

Objective: This study examines temporal trends in hip fracture related utilization and outcomes among elderly fee-for-service Medicare beneficiaries. Method: The study uses claims data for a 5% sample of Medicare beneficiaries with an incident hip fracture hospitalization between 2000 and 2008. We present annual mean patient characteristics, health services utilization, and outcomes and use ordinary least squares regressions to examine adjusted trends in utilization and outcomes after controlling for changes in patient characteristics. Results: We observe a statistically significant temporal decline in inpatient acute days and a statistically significant increase in inpatient post-acute days following hip fractures. In models that control for patient characteristics, we observe statistically significant declines in 1-year hip fracture readmission and mortality rates. Rates of nursing home residence 1-year following fracture were unchanged and remain high. Discussion: Hip fractures remain highly debilitating events and pose significant challenges for the financing of public health insurance programs.

Background Although low-density lipoprotein cholesterol (LDL-C) is recommended as the primary marker to guide lipid-lowering therapy, some data suggest non–high-density lipoprotein cholesterol (non–HDL-C) may better reflect coronary heart disease risk. Discordance between these measures has not been evaluated. Methods We used data from the National Health and Nutrition Examination Surveys 2005–2010 (n = 4986) to examine the discordance between these lipid parameters. Elevated levels of non–HDL-C and LDL-C were defined by using the 2004 Adult Treatment Panel III guidelines. Results The prevalence of high non–HDL-C and LDL-C was 22.7% and 24.5%, respectively. Of participants with high non–HDL-C, 9.7% had normal LDL-C, whereas 15.7% of participants with high LDL-C had normal non–HDL-C. We estimate 3.9 million US adults had high non–HDL-C and normal LDL-C, whereas 6.8 million US adults had high LDL-C and normal non–HDL-C. Persons with high non–HDL-C and normal LDL-C were older, more likely to be men, Hispanic, and have impaired fasting glucose, diabetes metabolic syndrome, and more risk factors for coronary heart disease. Conclusions Substantial discordance exists between high non–HDL-C and high LDL-C among US adults. Reliance on either single measure could result in failure to classify cardiovascular heart disease risks appropriately.

Background We implemented an Intravenous Antibiotics and Addiction Team (IVAT) intervention to identify hospitalized persons with a history of injection drug use (IDU) that are safe for discharge with IV antibiotics based on a 9-point risk assessment. IVAT has been shown to reduce average length of stay (ALOS) without increasing readmissions. We analyzed the cost savings of the IVAT to the health system. Methods PWID at the University of Alabama at Birmingham (UAB) hospital with indications for prolonged IV antibiotics received IVAT to determine risk of continued IDU. “Low-risk” patients were discharged for outpatient antibiotics and addiction care; others continued inpatient antibiotics, group therapy, opioid agonist therapy (if applicable), and weekly assessment for discharge readiness. Cost of care was defined by direct costs and was obtained by querying financial accounts. Results A total of 37 pre-IVAT and 111 post-IVAT admissions (including 25 “low risk”) met study criteria. IVAT reduced ALOS by 20 days. Total direct costs per admission in the post-IVAT period were 33% lower: $26,014 versus $38,716 (Table 1). Because ALOS at UAB for all patients is 6.58 days, a 20-day ALOS reduction following IVAT creates capacity for an additional 333 patients (n = 20/6.58 × 111). Conclusion IVAT for PWID allows health systems to focus inpatient resources on those at greatest risk of ongoing IVDU, creates additional inpatient capacity, and may cut hospital direct costs by one-third. Table 1: Hospital Utilization Before and After IVAT Implementation Inpatient Costs Pre-Intervention January 2015–February 2016 Post-Intervention October 2016–January 2018 Number of admissions N = 37 N = 111 Risk group Low N/A 25 (27%) Medium 56 (61%) High 56 (61%) 11 (12%) Total direct costs $1,432,497 $2,887,515 Average LOS 42 22 Uninsured patients 20 (54%) 53 (48%) Medicaid beneficiaries 13 (35%) 31 (28%) Medicare beneficiaries 3 (8%) 9 (8%) Commercially insured patients 1 (3%) 18 (16%) Inpatient costs per admission Total direct costs $38,716 $26,014 Direct costs/day $922 $1,182 Inpatient costs per admission categorized by service Nursing costs $16,305 $9,139 Pharmacy costs $8,829 $5,720 Surgery costs $4,986 $3,474 ICU costs $2,568 $2,081 Disclosures J. M. Rodriguez, finch: Research Contractor, Research support. seres: Research Contractor, Research support.

Objective Self-injectable biologic agents have been covered by Medicare Part D since 2006. We hypothesized that this coverage benefit and related financial considerations would lead to increased use of self-injectable biologic agents over time and would be influential in determining which rheumatoid arthritis (RA) patients received infusion versus self-injected biologic agents. Methods We used 100% of US Medicare data (2006–2009) to calculate the prevalence of use of different RA biologic agents and evaluated factors associated with receipt of infliximab versus etanercept or adalimumab among patients starting their first anti–tumor necrosis factor (anti-TNF) agent. Results Through 2009, the prevalence of biologic agent use overall (∼27%) and via infusion (16–17%) or self-injection (10–11%) remained unchanged among Medicare beneficiaries with RA. After adjusting for patient characteristics, stronger physician preference for infused biologic agents was related to physician reimbursement and associated with an increased likelihood of using infliximab as the first anti-TNF agent (odds ratio [OR] comparing the highest to lowest quartile of physician preference 7.3, 95% confidence interval [95% CI] 6.4–8.3). Lower-income patients who received state assistance for Medicare coverage had lower out-of-pocket payments for injectable biologic agents ($4.10/prescription) and were less likely to use infliximab (OR 0.41, 95% CI 0.37–0.45) compared with etanercept or adalimumab. Conclusion The prevalence of injection and infusion biologic agents in RA remained stable in the Medicare program through 2009. The choice between an intravenous infusion versus an injectable anti-TNF agent as first-line treatment appeared to be strongly influenced by financial considerations affecting both patients and physicians.

Background After U.S. licensure, parenterally administered medications are identified using non-specific drug codes. Accurately identifying these medications is critical to safety and effectiveness research. Methods to identify medications prior to assignment of specific drug codes have not been well described. Objectives To describe a generalized approach using non-specific drug codes to identify parenteral therapies in Medicare claims and to assess the ability of that approach to identify tocilizumab (TCZ), a new biologic agent approved in 2010. Methods We used 2008–2010 Medicare data for a cohort of rheumatoid arthritis patients for algorithm development. Our algorithm classified non-specific drug codes based upon: 1) ICD9 codes; 2) unit values (i.e. dose); 3) codes for infusion/injection procedures; 4) expected versus observed total reimbursement amount and reimbursement per unit. We assessed algorithm performance by linking to an arthritis registry to examine external validity. Results Of 472 803 claims with non-specific drug codes, 9762 claims satisfied the TCZ algorithm. 74.3% of 9762 claims were classified as TCZ by exact unit price or allowed amount, 4.4% by unique doses, 21.3% by diagnosis code and small deviation from unit price or allowed amount. The algorithm demonstrated good performance characteristics: sensitivity 94% (95% CI 80–99), specificity 100% (99–100) and PPV 97% (84–100). Conclusion Claims-based algorithms in Medicare or similar data systems can accurately identify newly approved biologics administered parenterally prior to the assignment of specific drug codes. Copyright © 2013 John Wiley & Sons, Ltd.

Marked increases in the awareness, treatment, and control of high low-density lipoprotein (LDL) cholesterol occurred among United States (US) adults from 1988-1994 to 1999-2004. An update to the Third Adult Treatment Panel guidelines was published in 2004, and it is unknown if these improvements have continued since the publication of these revised treatment recommendations. The aim of this study was to determine trends in the awareness, treatment, and control of high LDL cholesterol among US adults from 1999-2000 to 2009-2010 using nationally representative samples of US adults aged ≥20 years from 6 consecutive National Health and Nutrition Examination Surveys (NHANES) in 1999-2000 (n = 1,659), 2001-2002 (n = 1,897), 2003-2004 (n = 1,698), 2005-2006 (n = 1,692), 2007-2008 (n = 2,044), and 2009-2010 (n = 2,318). LDL cholesterol was measured after an overnight fast, and high LDL cholesterol and controlled LDL cholesterol were defined using the 2004 updated Third Adult Treatment Panel guidelines. Awareness and treatment of high cholesterol were defined using self-report. Among US adults, the prevalence of high LDL cholesterol did not change from 1999-2000 (37.2%) to 2009-2010 (37.8%). Awareness of high LDL cholesterol increased from 48.9% in 1999-2000 to 62.8% in 2003-2004 but did not increase further through 2009-2010 (61.5%). Among those aware of having high LDL cholesterol, treatment increased from 41.3% in 1999-2000 to 72.6% in 2007-2008 and was 70.0% in 2009-2010. Among US adults receiving treatment for high LDL cholesterol, the percentage with controlled LDL cholesterol increased from 45.0% in 1999-2000 to 65.3% in 2005-2006 and had decreased slightly by 2009-2010 (63.6%). In conclusion, high LDL cholesterol remains common among US adults. Additional efforts are needed to prevent high LDL cholesterol and increase the awareness, treatment, and control of high LDL cholesterol among US adults.