Amy J. Graves

Cost-related medication nonadherence and spending on basic needs following implementation of Medicare Part D.

CONTEXT Cost-related medication nonadherence (CRN) has been a persistent problem for individuals who are elderly and disabled in the United States. The impact of Medicare prescription drug coverage (Part D) on CRN is unknown. OBJECTIVE To estimate changes in CRN and forgoing basic needs to pay for drugs following Part D implementation. DESIGN, SETTING, AND PARTICIPANTS In a population-level study design, changes in study outcomes between 2005 and 2006 before and after Medicare Part D implementation were compared with historical changes between 2004 and 2005. The community-dwelling sample of the nationally representative Medicare Current Beneficiary Survey (unweighted unique n = 24,234; response rate, 72.3%) was used, and logistic regression analyses were controlled for demographic characteristics, health status, and historical trends. MAIN OUTCOME MEASURES Self-reports of CRN (skipping or reducing doses, not obtaining prescriptions) and spending less on basic needs to afford medicines. RESULTS The unadjusted, weighted prevalence of CRN was 15.2% in 2004, 14.1% in 2005, and 11.5% after Part D implementation in 2006. The prevalence of spending less on basic needs was 10.6% in 2004, 11.1% in 2005, and 7.6% in 2006. Adjusted analyses comparing 2006 with 2005 and controlling for historical changes (2005 vs 2004) demonstrated significant decreases in the odds of CRN (ratio of odds ratios [ORs], 0.85; 95% confidence interval [CI], 0.74-0.98; P = .03) and spending less on basic needs (ratio of ORs, 0.59; 95% CI, 0.48-0.72; P < .001). No significant changes in CRN were observed among beneficiaries with fair to poor health (ratio of ORs, 1.00; 95% CI, 0.82-1.21; P = .97), despite high baseline CRN prevalence for this group (22.2% in 2005) and significant decreases among beneficiaries with good to excellent health (ratio of ORs, 0.77; 95% CI, 0.63-0.95; P = .02). However, significant reductions in spending less on basic needs were observed in both groups (fair to poor health: ratio of ORs, 0.60; 95% CI, 0.47-0.75; P < .001; and good to excellent health: ratio of ORs, 0.57; 95% CI, 0.44-0.75; P < .001). CONCLUSIONS In this survey population, there was evidence for a small but significant overall decrease in CRN and forgoing basic needs following Part D implementation. However, no net decrease in CRN after Part D was observed among the sickest beneficiaries, who continued to experience higher rates of CRN.

Diagnosing delirium in older emergency department patients: validity and reliability of the delirium triage screen and the brief confusion assessment method.

STUDY OBJECTIVE Delirium is a common form of acute brain dysfunction with prognostic significance. Health care professionals caring for older emergency department (ED) patients miss delirium in approximately 75% of cases. This error results from a lack of available measures that can be performed rapidly enough to be incorporated into clinical practice. Therefore, we developed and evaluated a novel 2-step approach to delirium surveillance for the ED. METHODS This prospective observational study was conducted at an academic ED in patients aged 65 years or older. A research assistant and physician performed the Delirium Triage Screen (DTS), designed to be a highly sensitive rule-out test, and the Brief Confusion Assessment Method (bCAM), designed to be a highly specific rule-in test for delirium. The reference standard for delirium was a comprehensive psychiatrist assessment using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria. All assessments were independently conducted within 3 hours of one another. Sensitivities, specificities, and likelihood ratios with their 95% confidence intervals (95% CIs) were calculated. RESULTS Of 406 enrolled patients, 50 (12.3%) had delirium diagnosed by the psychiatrist reference standard. The DTS was 98.0% sensitive (95% CI 89.5% to 99.5%), with an expected specificity of approximately 55% for both raters. The DTSs negative likelihood ratio was 0.04 (95% CI 0.01 to 0.25) for both raters. As the complement, the bCAM had a specificity of 95.8% (95% CI 93.2% to 97.4%) and 96.9% (95% CI 94.6% to 98.3%) and a sensitivity of 84.0% (95% CI 71.5% to 91.7%) and 78.0% (95% CI 64.8% to 87.2%) when performed by the physician and research assistant, respectively. The positive likelihood ratios for the bCAM were 19.9 (95% CI 12.0 to 33.2) and 25.2 (95% CI 13.9 to 46.0), respectively. If the research assistant DTS was followed by the physician bCAM, the sensitivity of this combination was 84.0% (95% CI 71.5% to 91.7%) and specificity was 95.8% (95% CI 93.2% to 97.4%). If the research assistant performed both the DTS and bCAM, this combination was 78.0% sensitive (95% CI 64.8% to 87.2%) and 97.2% specific (95% CI 94.9% to 98.5%). If the physician performed both the DTS and bCAM, this combination was 82.0% sensitive (95% CI 69.2% to 90.2%) and 95.8% specific (95% CI 93.2% to 97.4%). CONCLUSION In older ED patients, this 2-step approach (highly sensitive DTS followed by highly specific bCAM) may enable health care professionals, regardless of clinical background, to efficiently screen for delirium. Larger, multicenter trials are needed to confirm these findings and to determine the effect of these assessments on delirium recognition in the ED.

Access to care and medicines, burden of health care expenditures, and risk protection: Results from the World Health Survey

OBJECTIVES We assessed the contribution of health insurance and a functioning public sector to access to care and medicines and household economic burden. METHODS We used descriptive and logistic regression analyses on 2002/3 World Health Survey data in 70 countries. RESULTS Across countries, 286,803 households and 276,362 respondents contributed data. More than 90% of households had access to acute care. However, less than half of respondents with a chronic condition reported access. In 51 low and middle income countries (LMIC), health care expenditures accounted for 13-32% of total 4-week household expenditures. One in four poor households in low income countries incurred potentially catastrophic health care expenses and more than 40% used savings, borrowed money, or sold assets to pay for care. Between 41% and 56% of households in LMIC spent 100% of health care expenditures on medicines. Health insurance and a functioning public sector were both associated with better access to care and lower risk of economic burden. CONCLUSION To improve access, policy makers should improve public sector provision of care, increase health insurance coverage, and expand medicines benefit policies in health insurance systems.

Effect of the USPSTF Grade D Recommendation against Screening for Prostate Cancer on Incident Prostate Cancer Diagnoses in the United States.

PURPOSE In October 2011 the USPSTF (U.S. Preventive Services Task Force) issued a draft guideline discouraging prostate specific antigen based screening for prostate cancer (grade D recommendation). We evaluated the effect of the USPSTF guideline on the number and distribution of new prostate cancer diagnoses in the United States. MATERIALS AND METHODS We identified incident cancers diagnosed between January 2010 and December 2012 in NCDB (National Cancer Database). We performed an interrupted time series to evaluate the trend of new prostate cancers diagnosed each month before and after the draft guideline with colon cancer as a comparator. RESULTS Incident monthly prostate cancer diagnoses decreased by -1,363 cases (12.2%, p<0.01) in the month after the USPSTF draft guideline and continued to decrease by 164 cases per month relative to baseline (-1.8%, p<0.01). In contrast monthly colon cancer diagnoses remained stable. Diagnoses of low, intermediate and high risk prostate cancers decreased significantly but new diagnoses of nonlocalized disease did not change. Subgroups of age, comorbidity, race, income and insurance showed comparable decreases in incident prostate cancer following the draft guideline. CONCLUSIONS There was a 28% decrease in incident diagnoses of prostate cancer in the year after the USPSTF draft recommendation against prostate specific antigen screening. This study helps quantify the potential benefits (reduced harms of over diagnosis and overtreatment of low risk disease and disease found in elderly men) and potential harms (missed opportunities to diagnose important cancers in men who may benefit from treatment) of this guideline.

Cost-related medication nonadherence after implementation of Medicare Part D, 2006-2007.

To the Editor: High drug costs cause some elderly or disabled patients to take less medication than prescribed or forgo basic needs to pay for medicines.1,2,3 The 2006 Medicare Part D drug benefit was intended to increase economic access to medicines.4 Data from 2006 indicated modest nationwide decreases in cost-related medication non-adherence (CRN) and forgoing basic needs following Part D implementation, but no decline in high rates of CRN among the sickest beneficiaries.5 We analyzed more recent data to determine whether the reductions remained stable in 2007.

Increasing Use of Observation among Men at Low Risk for Prostate Cancer Mortality

PURPOSE There are growing concerns regarding the overtreatment of localized prostate cancer. It is also relatively unknown whether there has been increased uptake of observational strategies for disease management. We assessed the temporal trend in observation of clinically localized prostate cancer, particularly in men with low risk disease, who were young and healthy enough to undergo treatment. MATERIALS AND METHODS We performed a retrospective cohort study using the SEER-Medicare database in 66,499 men with localized prostate cancer between 2004 and 2009. The main study outcome was observation within 1 year after diagnosis. We performed multivariable analysis to develop a predictive model of observation adjusting for diagnosis year, age, risk and comorbidity. RESULTS Observation was performed in 12,007 men (18%) with a slight increase with time from 17% to 20%. However, there was marked increase in observation from 18% in 2004 to 29% in 2009 in men with low risk disease. Men 66 to 69 years old with low risk disease and no comorbidities had twice the odds of undergoing observation in 2009 vs 2004 (OR 2.12, 95% CI 1.73-2.59). Age, risk group, comorbidity and race were independent predictors of observation (each p <0.001), in addition to diagnosis year. CONCLUSIONS We identified increasing use of observation for low risk prostate cancer between 2004 and 2009 even in men young and healthy enough for treatment. This suggests growing acceptance of surveillance in this group of patients.

Cost-related medication nonadherence among beneficiaries with depression following Medicare Part D.

CONTEXT Cost-related medication nonadherence (CRN) was problematic for Medicare beneficiaries with depressive symptoms before Medicare Part D. OBJECTIVE To estimate changes in CRN and forgoing basic needs to pay for drugs among Medicare beneficiaries with and without depressive symptoms following Part D implementation. DESIGN AND SETTING The authors compared changes in outcomes between 2005 and 2006 before and after Part D with changes between 2004 and 2005 using logistic regression to control for demographic characteristics, health status, and historical trends. PARTICIPANTS The community-dwelling sample of the Medicare Current Beneficiary Survey (N = 24,234). MAIN OUTCOME MEASURES Self-reports of CRN (skipping or reducing doses and not obtaining prescriptions) and spending less on basic needs to afford medicines. RESULTS The unadjusted annual prevalence of CRN among beneficiaries with depressive symptoms was 27% (2004), 27% (2005), and 24% (2006), compared with 13%, 12%, and 9% among beneficiaries without depressive symptoms. The annual prevalence of spending less on basic needs was 22% (2004), 23% (2005), and 19% (2006), compared with 8%, 9%, and 5% among beneficiaries without depressive symptoms. Controlling for historical changes and demographic characteristics, CRN did not decline among beneficiaries with depressive symptoms compared with beneficiaries without depressive symptoms (ratio of Part D changes 0.98; 95% confidence interval [CI], 0.73-1.32). Respondents with depressive symptoms seemed less likely to spend less on basic needs compared with individuals without depressive symptoms (0.70; 95% CI, 0.49-1.01); however, this difference was not statistically significant. CONCLUSIONS Despite a Medicare Part D goal to improve medication adherence among mentally ill beneficiaries, the disparity in economic access to medications between beneficiaries with and without depressive symptoms did not improve after the start of Part D.

Prior Authorization for Antidepressants in Medicaid : Effects Among Disabled Dual Enrollees

BACKGROUND Prior authorization is a popular, but understudied, strategy for reducing medication costs. We evaluated the impact of a controversial prior authorization policy in Michigan Medicaid on antidepressant use and health outcomes among dual Medicaid and Medicare enrollees with a Social Security Disability Insurance designation of permanent disability. METHODS We linked Medicaid and Medicare (2000-2003) claims for dual enrollees in Michigan and a comparison state, Indiana. Using interrupted time-series and longitudinal data analysis, we estimated the impact of the policy on antidepressant medication use, treatment initiation, disruptions in therapy, and adverse health events among continuously enrolled (Michigan, n = 28 798; Indiana, n = 21 769) and newly treated (Michigan, n = 3671; Indiana, n = 2400) patients. RESULTS In Michigan, the proportion of patients starting nonpreferred agents declined from 53% prepolicy to 20% postpolicy. The prior authorization policy was associated with a small sustained decrease in therapy initiation overall (9 per 10,000 population; P = .007). We also observed a short-term increase in switching among established users of nonpreferred agents overall (risk ratio, 2.88; 95% confidence interval, 1.87-4.42) and among those with depression (2.04; 1.22-3.42). However, we found no evidence of increased disruptions in treatment or adverse events (ie, hospitalization, emergency department use) among newly treated patients. CONCLUSIONS Prior authorization was associated with increased use of preferred agents with no evidence of disruptions in therapy or adverse health events among new users. However, unintended effects on treatment initiation and switching among patients already taking the drug were also observed, lending support to the states previous decision to discontinue prior approval for antidepressants in 2003.

Cost-Related Medication Nonadherence and Cost-Saving Strategies Used by Elderly Medicare Cancer Survivors

ObjectivesThis study was conducted to compare cost-related medication nonadherence among elderly Medicare enrollees with and without cancer and to describe the strategies cancer survivors used to offset the costs of medications.MethodsUsing the 2005 Medicare Current Beneficiary Survey and Medicare claims, we compared self-reported cost-related medication nonadherence (CRN), spending less on basic needs to afford medicines, and cost reduction strategies among elderly beneficiaries with and without cancer. Descriptive statistics and logistic regression models were used to characterize and compare these populations.ResultsIn a nationally representative sample of 9,818 non-institutionalized elderly Medicare enrollees, 1,392 (14%) were classified as cancer survivors based on Medicare claims. Cancer survivors were older, more highly educated, more likely to be male and non-Hispanic, and more likely to have multiple comorbidities, poorer health status, and employer-paid medication coverage. While 10% of cancer survivors and 11% without cancer reported CRN, about 6% and 9% (p = 0.004) of those with and without cancer, respectively, reported spending less on basic needs to offset the costs of medications. Cancer survivors who reported CRN (n = 143) had lower income (62.2% versus 48.6%, p = 0.11) and were more likely to be African-American (13.0% versus 6.4%, p = 0.033) and have non-employer-based medication insurance (p = 0.002) compared to those who did not report CRN. In adjusted analyses, CRN among the two groups was similar, but with some subgroup differences noted by gender and cancer type. Use of cost reduction strategies was mostly similar among cancer survivors and those without cancer.ConclusionCost-related medication nonadherence medication is common among elderly Medicare beneficiaries, but appears to be similar among those with and without cancer.

Emergence from general anaesthesia and evolution of delirium signs in the post-anaesthesia care unit

BACKGROUND Emergence from anaesthesia is often accompanied by signs of delirium, including fluctuating mental status and inattention. The evolution of these signs of delirium requires investigation since delirium in the post-anaesthesia care unit (PACU) may be associated with worse outcomes. METHODS Adult patients emerging from anaesthesia were assessed for agitated emergence in the operating room using the Richmond Agitation-Sedation Scale (RASS). The Confusion Assessment Method for the Intensive Care Unit was then used to evaluate delirium signs at PACU admission and during PACU stay at 30 min, 1 h, and discharge. Signs consistent with delirium were classified as hyperactive vs hypoactive based upon a positive CAM-ICU assessment and the concomitant RASS score. Multivariable logistic regression was utilized to assess potential risk factors for delirium during PACU stay including age, American Society of Anesthesiologists classification, and opioid and benzodiazepine exposure. RESULTS Among 400 patients enrolled, 19% had agitated emergence. Delirium signs were present at PACU admission, 30 min, 1 h, and PACU discharge in 124 (31%), 59 (15%), 32 (8%), and 15 (4%) patients, respectively. In patients with delirium signs, hypoactive signs were present in 56% at PACU admission and in 92% during PACU stay. Perioperative opioids were associated with delirium signs during PACU stay (P=0.02). CONCLUSIONS A significant proportion of patients develop delirium signs in the immediate postoperative period, primarily manifesting with a hypoactive subtype. These signs often persist to PACU discharge, suggesting the need for structured delirium monitoring in the PACU to identify patients potentially at risk for worse outcomes in the postoperative period.