Randomized trial of four financial-incentive programs for smoking cessation.

BACKGROUND: Financial incentives promote many health behaviors, but effective ways to deliver health incentives remain uncertain. METHODS: We randomly assigned CVS Caremark employees and their relatives and friends to one of four incentive programs or to usual care for smoking cessation. Two of the incentive programs targeted individuals, and two targeted groups of six participants. One of the individual-oriented programs and one of the group-oriented programs entailed rewards of approximately $800 for smoking cessation; the others entailed refundable deposits of $150 plus $650 in reward payments for successful participants. Usual care included informational resources and free smoking-cessation aids. RESULTS: Overall, 2538 participants were enrolled. Of those assigned to reward-based programs, 90.0% accepted the assignment, as compared with 13.7% of those assigned to deposit-based programs (P<0.001). In intention-to-treat analyses, rates of sustained abstinence from smoking through 6 months were higher with each of the four incentive programs (range, 9.4 to 16.0%) than with usual care (6.0%) (P<0.05 for all comparisons); the superiority of reward-based programs was sustained through 12 months. Group-oriented and individual-oriented programs were associated with similar 6-month abstinence rates (13.7% and 12.1%, respectively; P=0.29). Reward-based programs were associated with higher abstinence rates than deposit-based programs (15.7% vs. 10.2%, P<0.001). However, in instrumental-variable analyses that accounted for differential acceptance, the rate of abstinence at 6 months was 13.2 percentage points (95% confidence interval, 3.1 to 22.8) higher in the deposit-based programs than in the reward-based programs among the estimated 13.7% of the participants who would accept participation in either type of program. CONCLUSIONS: Reward-based programs were much more commonly accepted than deposit-based programs, leading to higher rates of sustained abstinence from smoking. Group-oriented incentive programs were no more effective than individual-oriented programs. (Funded by the National Institutes of Health and CVS Caremark; ClinicalTrials.gov number, NCT01526265.).

Longitudinal Patterns of Spending Enhance the Ability to Predict Costly Patients: A Novel Approach to Identify Patients for Cost Containment.

BACKGROUND: With rising health spending, predicting costs is essential to identify patients for interventions. Many of the existing approaches have moderate predictive ability, which may result, in part, from not considering potentially meaningful changes in spending over time. Group-based trajectory modeling could be used to classify patients into dynamic long-term spending patterns. OBJECTIVES: To classify patients by their spending patterns over a 1-year period and to assess the ability of models to predict patients in the highest spending trajectory and the top 5% of annual spending using prior-year predictors. SUBJECTS: We identified all fully insured adult members enrolled in a large US nationwide insurer and used medical and prescription data from 2009 to 2011. RESEARCH DESIGN: Group-based trajectory modeling was used to classify patients by their spending patterns over a 1-year period. We assessed the predictive ability of models that categorized patients in the top fifth percentile of annual spending and in the highest spending trajectory, using logistic regression and split-sample validation. Models were estimated using investigator-specified variables and a proprietary risk-adjustment method. RESULTS: Among 998,651 patients, in the best-performing model, prediction was strong for patients in the highest trajectory group (C-statistic: 0.86; R: 0.47). The C-statistic of being in the top fifth percentile of spending in the best-performing model was 0.82 (R: 0.26). Approaches using nonproprietary investigator-specified methods performed almost as well as other risk-adjustment methods (C-statistic: 0.81 vs. 0.82). CONCLUSIONS: Trajectory modeling may be a useful way to predict costly patients that could be implementable by payers to improve cost-containment efforts.

Impact of CVS Pharmacy's Discontinuance of Tobacco Sales on Cigarette Purchasing (2012-2014).

OBJECTIVES: To assess the impact of CVS Health's discontinuation of tobacco sales on cigarette purchasing. METHODS: We used households' purchasing data to assess rates at which households stopped cigarette purchasing for at least 6 months during September 2014 to August 2015 among 3 baseline groups: CVS-exclusive cigarette purchasers, CVS+ (CVS and other retailers), and other-exclusive (only non-CVS retailers). In state-level analyses using retailers' point-of-sale purchase data, an interrupted time series compared cigarette purchasing before (January 2012 to August 2014) and after (September 2014 to April 2015) tobacco removal in 13 intervention states with CVS market share of at least 15% versus 3 control states with no CVS stores. RESULTS: Compared with other-exclusive purchasers, CVS-exclusive purchasers were 38% likelier (95% confidence interval = 1.06, 1.81) to stop cigarette purchasing after tobacco removal. Compared with control states, intervention states had a significant mean decrease of 0.14 (95% confidence interval = 0.06, 0.22) in packs per smoker per month. CONCLUSIONS: After CVS's tobacco removal, household- and population-level cigarette purchasing declined significantly. Private retailers can play a meaningful role in restricting access to tobacco. This highlights one approach to reducing tobacco use and improving public health.

Patients' Satisfaction with and Preference for Telehealth Visits.

BACKGROUND: One-quarter of U.S. patients do not have a primary care provider or do not have complete access to one. Work and personal responsibilities also compete with finding convenient, accessible care. Telehealth services facilitate patients' access to care, but whether patients are satisfied with telehealth is unclear. OBJECTIVE: We assessed patients' satisfaction with and preference for telehealth visits in a telehealth program at CVS MinuteClinics. DESIGN: Cross-sectional patient satisfaction survey. PARTICIPANTS: Patients were aged ≥18 years, presented at a MinuteClinic offering telehealth in January-September 2014, had symptoms suitable for telehealth consultation, and agreed to a telehealth visit when the on-site practitioner was busy. MAIN MEASURES: Patients reported their age, gender, and whether they had health insurance and/or a primary care provider. Patients rated their satisfaction with seeing diagnostic images, hearing and seeing the remote practitioner, the assisting on-site nurse's capability, quality of care, convenience, and overall understanding. Patients ranked telehealth visits compared to traditional ones: better (defined as preferring telehealth), just as good (defined as liking telehealth), or worse. Predictors of preferring or liking telehealth were assessed via multivariate logistic regression. KEY RESULTS: In total, 1734 (54 %) of 3303 patients completed the survey: 70 % were women, and 41 % had no usual place of care. Between 94 and 99 % reported being "very satisfied" with all telehealth attributes. One-third preferred a telehealth visit to a traditional in-person visit. An additional 57 % liked telehealth. Lack of medical insurance increased the odds of preferring telehealth (OR = 0.83, 95 % CI, 0.72-0.97). Predictors of liking telehealth were female gender (OR = 1.68, 1.04-2.72) and being very satisfied with their overall understanding of telehealth (OR = 2.76, 1.84-4.15), quality of care received (OR = 2.34, 1.42-3.87), and telehealth's convenience (OR = 2.87, 1.09-7.94) CONCLUSIONS: Patients reported high satisfaction with their telehealth experience. Convenience and perceived quality of care were important to patients, suggesting that telehealth may facilitate access to care.

Patient Use of Email, Facebook, and Physician Websites to Communicate with Physicians: A National Online Survey of Retail Pharmacy Users.

BACKGROUND: Patient-physician communication often occurs outside the clinic setting; many institutions discourage electronic communication outside of established electronic health record systems. Little empirical data are available on patient interest in electronic communication and Web-based health tools that are technically feasible but not widely available. RESEARCH OBJECTIVE: To explore patient behavior and interest in using the Internet to contact physicians. DESIGN: National cross-sectional online survey. PARTICIPANTS: A sample of 4,510 CVS customers with at least one chronic condition in the household was used to target patients with chronic conditions and their caregivers. Subjects were identified from a national panel of over 100,000 retail pharmacy customers. Of those sampled, 2,252 responded (50.0 % response rate). MAIN MEASURES: Survey measures included demographic and health information, patient use of email and Facebook to contact physicians, and patient interest in and use of Web-based tools for health. KEY RESULTS: A total of 37 % of patients reported contacting their physicians via email within the last six months, and 18 % via Facebook. Older age was negatively associated with contacting physicians using email (OR 0.57 [95 % CI 0.41-0.78]) or Facebook (OR 0.28 [0.17-0.45]). Non-white race (OR 1.61 [1.18-2.18] and OR 1.82 [1.24-2.67]) and caregiver status (OR 1.58 [1.27-1.96] and OR 1.71 [1.31- 2.23]) were positively associated with using email and Facebook, respectively. Patients were interested in using Web-based tools to fill prescriptions, track their own health, and access health information (37-57 %), but few were currently doing so (4-8 %). CONCLUSIONS: In this population of retail pharmacy users, there is strong interest among patients in the use of email and Facebook to communicate with their physicians. The findings highlight the gap between patient interest for online communication and what physicians may currently provide. Improving and accelerating the adoption of secure Web messaging systems is a possible solution that addresses both institutional concerns and patient demand.

Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naïve women.

BACKGROUND: The incidence of opioid-related death in women has increased 5-fold over the past decade. For many women, their initial opioid exposure will occur in the setting of routine medical care. Approximately 1 in 3 deliveries in the United States is by cesarean, and opioids are commonly prescribed for postsurgical pain management. OBJECTIVE: The objective of this study was to determine the risk that opioid-naïve women prescribed opioids after cesarean delivery will subsequently become consistent prescription opioid users in the year following delivery and to identify predictors for this behavior. STUDY DESIGN: We identified women in a database of commercial insurance beneficiaries who underwent cesarean delivery and who were opioid naïve in the year prior to delivery. To identify persistent users of opioids, we used trajectory models, which group together patients with similar patterns of medication filling during follow-up, based on patterns of opioid dispensing in the year following cesarean delivery. We then constructed a multivariable logistic regression model to identify independent risk factors for membership in the persistent user group. RESULTS: A total of 285 of 80,127 (0.36%, 95% confidence interval, 0.32-0.40), opioid-naïve women became persistent opioid users (identified using trajectory models based on monthly patterns of opioid dispensing) following cesarean delivery. Demographics and baseline comorbidity predicted such use with moderate discrimination (c statistic = 0.73). Significant predictors included a history of cocaine abuse (risk, 7.41%; adjusted odds ratio, 6.11, 95% confidence interval, 1.03-36.31) and other illicit substance abuse (2.36%; adjusted odds ratio, 2.78, 95% confidence interval, 1.12-6.91), tobacco use (1.45%; adjusted odds ratio, 3.04, 95% confidence interval, 2.03-4.55), back pain (0.69%; adjusted odds ratio, 1.74, 95% confidence interval, 1.33-2.29), migraines (0.91%; adjusted odds ratio, 2.14, 95% confidence interval, 1.58-2.90), antidepressant use (1.34%; adjusted odds ratio, 3.19, 95% confidence interval, 2.41-4.23), and benzodiazepine use (1.99%; adjusted odds ratio, 3.72, 95% confidence interval, 2.64-5.26) in the year prior to the cesarean delivery. CONCLUSION: A very small proportion of opioid-naïve women (approximately 1 in 300) become persistent prescription opioid users following cesarean delivery. Preexisting psychiatric comorbidity, certain pain conditions, and substance use/abuse conditions identifiable at the time of initial opioid prescribing were predictors of persistent use.

The adherence impact of a program offering specialty pharmacy services to patients using retail pharmacies.

BACKGROUND: A new service model integrates the specialty pharmacy's comprehensive service with the retail pharmacy's patient contact, giving patients options for medication delivery to home, pharmacy, or doctor's office. OBJECTIVE: Evaluate the impact of the new service model on medication adherence. DESIGN: Retrospective cohort study SETTINGS: One hundred fifteen CVS retail stores in Philadelphia participated in a pilot from May 2012 to October 2013, and 115 matched CVS retail stores from around the nation served as controls. PATIENTS: All eligible patients from the intervention and control stores received specialty medications through CVS retail pharmacies prior to implementation of the new service model. INTERVENTION: The intervention patients were transitioned from retail pharmacy service to the specialty pharmacy with delivery options. The control patients received standard retail pharmacy services. MAIN OUTCOME MEASURES: Proportion of days covered and first fill persistence were tracked for 12 months before and after program implementation. RESULTS: Under the new service model, 228 patients new to therapy in the post period had a 17.5% increase in the rate of obtaining a second fill as compared to matched controls. Patients on therapy in both the pre- and the post-periods had a pre-post increase of 6.6% in average adherence rates and a pre-post increase of 10.8% in optimal adherence rates as compared to 326 matched controls. CONCLUSION: The study demonstrated significant improvement in both adherence to therapy and first-fill persistence among patients in the new service model integrating specialty pharmacy's comprehensive services with the retail pharmacy's patient contact and medication delivery choices.

Prescription drug insurance coverage and patient health outcomes: a systematic review.

Previous reviews have shown that changes in prescription drug insurance benefits can affect medication use and adherence. We conducted a systematic review of the literature to identify studies addressing the association between prescription drug coverage and health outcomes. Studies were included if they collected empirical data on expansions or restrictions of prescription drug coverage and if they reported clinical outcomes. We found 23 studies demonstrating that broader prescription drug insurance reduces use of other health care services and has a positive impact on patient outcomes. Coverage gaps or caps on drug insurance generally led to worse outcomes. States should consider implementing the Affordable Care Act expansions in drug coverage to improve the health of low-income patients receiving state-based health insurance.

Comparative effectiveness of generic versus brand-name antiepileptic medications.

OBJECTIVE: The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a brand-name product. METHODS: We used linked electronic medical and pharmacy claims data to identify Medicare beneficiaries who initiated one of five AEDs (clonazepam, gabapentin, oxcarbazepine, phenytoin, zonisamide). We matched initiators of generic versus brand-name versions of these drugs using a propensity score that accounted for demographic, clinical, and health service utilization variables. We used a Cox proportional hazards model to compare rates of seizure-related emergency room (ER) visit or hospitalization (primary outcome) and ER visit for bone fracture or head injury (secondary outcome) between the matched generic and brand-name initiators. We also compared treatment persistence, measured as time to first 14-day treatment gap, between generic and brand-name initiators. RESULTS: We identified 19,760 AED initiators who met study eligibility criteria; 18,306 (93%) initiated a generic AED. In the matched cohort, we observed 47 seizure-related hospitalizations and ER visits among brand-name initiators and 31 events among generic initiators, corresponding to a hazard ratio of 0.53 (95% confidence interval, 0.30 to 0.96). Similar results were observed for the secondary clinical endpoint and across sensitivity analyses. Mean time to first treatment gap was 124.2 days (standard deviation [sd], 125.8) for brand-name initiators and 137.9 (sd, 148.6) for generic initiators. SIGNIFICANCE: Patients who initiated generic AEDs had fewer adverse seizure-related clinical outcomes and longer continuous treatment periods before experiencing a gap than those who initiated brand-name versions.

Association between trajectories of statin adherence and subsequent cardiovascular events.

PURPOSE: Trajectory models have been shown to (1) identify groups of patients with similar patterns of medication filling behavior and (2) summarize the trajectory, the average adherence in each group over time. However, the association between adherence trajectories and clinical outcomes remains unclear. This study investigated the association between 12-month statin trajectories and subsequent cardiovascular events. METHODS: We identified patients with insurance coverage from a large national insurer who initiated a statin during January 1, 2007 to December 31, 2010. We assessed medication adherence during the 360 days following initiation and grouped patients based on the proportion of days covered (PDC) and trajectory models. We then measured cardiovascular events during the year after adherence assessment. Cox proportional hazards models were used to evaluate the association between adherence measures and cardiovascular outcomes; strength of association was quantified by the hazard ratio, the increase in model C-statistic, and the net reclassification index (NRI). RESULTS: Among 519 842 statin initiators, 8777 (1.7%) had a cardiovascular event during follow-up. More consistent medication use was associated with a lower likelihood of clinical events, whether adherence was measured through trajectory groups or PDC. When evaluating the prediction of future cardiovascular events by including a measure of adherence in the model, the best model reclassification was observed when adherence was measured using three or four trajectory groups (NRI = 0.189; 95% confidence interval: [0.171, 0.210]). CONCLUSIONS: Statin adherence trajectory predicted future cardiovascular events better than measures categorizing PDC. Thus, adherence trajectories may be useful for targeting adherence interventions.

Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study.

BACKGROUND: Statins are effective in preventing cardiovascular events, but patients do not fully adhere to them. OBJECTIVE: To determine whether patients are more adherent to generic statins versus brand-name statins (lovastatin, pravastatin, or simvastatin) and whether greater adherence improves health outcomes. DESIGN: Observational, propensity score-matched, new-user cohort study. SETTING: Linked electronic data from medical and pharmacy claims. PARTICIPANTS: Medicare beneficiaries aged 65 years or older with prescription drug coverage between 2006 and 2008. INTERVENTION: Initiation of a generic or brand-name statin. MEASUREMENTS: Adherence to statin therapy (measured as the proportion of days covered [PDC] up to 1 year) and a composite outcome comprising hospitalization for an acute coronary syndrome or stroke and all-cause mortality. Hazard ratios (HRs) and absolute rate differences were estimated. RESULTS: A total of 90,111 patients who initiated a statin during the study was identified; 83,731 (93%) initiated a generic drug, and 6380 (7%) initiated a brand-name drug. The mean age of patients was 75.6 years, and most (61%) were female. The average PDC was 77% for patients in the generic group and 71% for those in the brand-name group (P<0.001). An 8% reduction in the rate of the clinical outcome was observed among patients in the generic group versus those in the brand-name group (HR, 0.92 [95% CI, 0.86 to 0.99]). The absolute difference was -1.53 events per 100 person-years (CI, -2.69 to -0.19 events per 100 person-years). LIMITATION: Results may not be generalizable to other populations with different incomes or drug benefit structures. CONCLUSION: Compared with those initiating brand-name statins, patients initiating generic statins were more likely to adhere and had a lower rate of a composite clinical outcome. PRIMARY FUNDING SOURCE: Teva Pharmaceuticals.

Untangling the relationship between medication adherence and post-myocardial infarction outcomes: medication adherence and clinical outcomes.

BACKGROUND: Patients who adhere to medications experience better outcomes than their nonadherent counterparts. However, these observations may be confounded by patient behaviors. The level of adherence necessary for patients to derive benefit and whether adherence to all agents is important for diseases that require multiple drugs remain unclear. This study quantifies the relationship between medication adherence and post-myocardial infarction (MI) adverse coronary events. METHODS: This is a secondary analysis of the randomized MI FREEE trial. Patients who received full prescription coverage were classified as adherent (proportion of days covered ≥80%) or not based upon achieved adherence in the 6 months after randomization. First major vascular event or revascularization rates were compared using multivariable Cox models adjusting for comorbidity and health-seeking behavior. RESULTS: Compared with patients randomized to usual care, full coverage patients adherent to statin, ß-blocker, or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker were significantly less likely to experience the study's primary outcome (hazard ratio [HR] range 0.64-0.81). In contrast, nonadherent patients derived no benefit (HR range 0.98-1.04, P ≤ .01 for the difference in HRs between adherent and nonadherent patients). Partially adherent patients had no reduction in clinical outcomes for any of the drugs evaluated, although their achieved adherence was higher than that among controls. CONCLUSION: Achieving high levels of adherence to each and all guideline-recommended post-MI secondary prevention medication is associated with improved event-free survival. Lower levels of adherence appear less protective.

Did HEDIS get it right? Evaluating the quality of a quality measure: adherence to ß-blockers and cardiovascular outcomes after myocardial infarction.

BACKGROUND: As an example of the process that could be used to evaluate and optimize the performance of quality measures in routine practice, we evaluated whether the Healthcare Effectiveness Data and Information Set (HEDIS) measure assessing the "persistence of ß-blocker treatment after a heart attack" correlates with post-myocardial infarction (MI) outcomes and whether or not there are alternative specifications of this construct which are better predictors and/or may be more easily applied. RESEARCH DESIGN: The study included a retrospective cohort of 8672 post-MI patients 18 years old and above. We assessed the strength of the association between the different adherence measures and the composite clinical outcome using multivariable Cox models. We compared the predictive capacity of each adherence definition model to one that did not contain adherence by computing the change in C-statistics and the continuous net reclassification improvement indices (NRIs). RESULTS: Adherence was associated with clinical outcome reductions, with hazard ratios ranging from 0.48 (95% CI, 0.27-0.85) to 0.81 (95% CI, 0.67-0.99). None of the adherence measures, including the HEDIS definition, significantly changed the C-statistic relative to a model that did not include adherence. However, the short-term adherence measure (having 72 d covered during the first 90 d postdischarge) showed a large change in NRI (correctly reclassifying 12% of cases and 16% of noncases; NRI: 28%; 95% CI, 22%-38%), although did not significantly differ from the change in NRI with the HEDIS measure. CONCLUSIONS: We identified an adherence measure that showed a predictive ability as good as that of the HEDIS definition to measure ß-blocker use after MI, halving the time of assessment required, and thus, allowing for the implementation of quality improvement interventions in a more timely manner.

Equity in the receipt of oseltamivir in the United States during the H1N1 pandemic.

OBJECTIVES: We assessed the relationship between individual characteristics and receipt of oseltamivir (Tamiflu) in the United States during the H1N1 pandemic and other flu seasons. METHODS: In a cohort of individuals enrolled in pharmacy benefit plans, we used a multivariate logistic regression model to measure associations between subscriber characteristics and filling a prescription for oseltamivir during 3 flu seasons (October 2006-May 2007, October 2007-May 2008, and October 2008-May 2010). In 19 states with county-level influenza rates reported, we controlled for disease burden. RESULTS: Approximately 56 million subscribers throughout the United States were included in 1 or more study periods. During pandemic flu, beneficiaries in the highest income category had 97% greater odds of receiving oseltamivir than those in the lowest category (P < .001). After we controlled for disease burden, subscribers in the 2 highest income categories had 2.18 and 1.72 times the odds of receiving oseltamivir compared with those in the lowest category (P < .001 for both). CONCLUSIONS: Income was a stronger predictor of oseltamivir receipt than prevalence of influenza. These findings corroborate concerns about equity of treatment in pandemics, and they call for improved approaches to distributing potentially life-saving treatments.

Gender and racial disparities in adherence to statin therapy: a meta-analysis.

BACKGROUND: Significant disparities exist in cardiovascular outcomes based on race/ethnicity and gender. Rates of evidence-based medication use and long-term medication adherence also appear to be lower in racial subgroups and women but have been subject to little attention. Our objective was to evaluate the effect of race/ethnicity and gender on adherence to statin therapy for primary or secondary prevention. METHODS AND RESULTS: Studies were identified through a systematic search of MEDLINE, EMBASE, ClinicalTrials.gov, and the Cochrane Database of Systematic Reviews (through April 1, 2010) and manual examination of references in selected articles. Studies reporting on adherence to statins by men and women or patients of white and nonwhite race were included. Information on study design, adherence measurement, duration, geographic location, sample size, and patient demographics was extracted using a standardized protocol. From 3,022 potentially relevant publications, 53 studies were included. Compared with men, women had a 10% greater odds of nonadherence (odds ratio 1.10, 95% confidence interval [CI], 1.07-1.13). Nonwhite race patients had a 53% greater odds of nonadherence than white race patients (odds ratio 1.53, 95% CI 1.25-1.87). There was significant heterogeneity in the pooled estimate for gender (I(2) 0.95, P value for heterogeneity <.001) and race (I(2) 0.98, P value for heterogeneity <.001). The overall results remained unchanged in those subgroups that had significantly less heterogeneity. CONCLUSIONS: Among patients prescribed statins, women and nonwhite patients are at increased risk for nonadherence. Further research is needed to identify interventions best suited to improve adherence in these populations.

Group-based trajectory models: a new approach to classifying and predicting long-term medication adherence.

BACKGROUND: Classifying medication adherence is important for efficiently targeting adherence improvement interventions. The purpose of this study was to evaluate the use of a novel method, group-based trajectory models, for classifying patients by their long-term adherence. RESEARCH DESIGN: We identified patients who initiated a statin between June 1, 2006 and May 30, 2007 in prescription claims from CVS Caremark and evaluated adherence over the subsequent 15 months. We compared several adherence summary measures, including proportion of days covered (PDC) and trajectory models with 2-6 groups, with the observed adherence pattern, defined by monthly indicators of full adherence (defined as having ≥24 d covered of 30). We also compared the accuracy of adherence prediction based on patient characteristics when adherence was defined by either a trajectory model or PDC. RESULTS: In 264,789 statin initiators, the 6-group trajectory model summarized long-term adherence best (C=0.938), whereas PDC summarized less well (C=0.881). The accuracy of adherence predictions was similar whether adherence was classified by PDC or by trajectory model. CONCLUSIONS: Trajectory models summarized adherence patterns better than traditional approaches and were similarly predicted by covariates. Group-based trajectory models may facilitate targeting of interventions and may be useful to adjust for confounding by health-seeking behavior.

Use and overuse of left ventriculography.

BACKGROUND: Left ventriculography provided the first imaging of left ventricular function and was historically performed as part of coronary angiography despite a small but significant risk of complications. Because modern noninvasive imaging techniques are more accurate and carry smaller risks, the routine use of left ventriculography is of questionable utility. We sought to analyze the frequency that left ventriculography was performed during coronary angiography in patients with and without a recent alternative assessment of left ventricular function. METHODS: We performed a retrospective analysis of insurance claims data from the Aetna health care benefits database including all adults who underwent coronary angiography in 2007. The primary outcome was the concomitant use of left ventriculography during coronary angiography. RESULTS: Of 96,235 patients who underwent coronary angiography, left ventriculography was performed in 78,705 (81.8%). Use of left ventriculography was high in all subgroups, with greatest use in younger patients, those with a diagnosis of coronary disease, and those in the Southern United States. In the population who had undergone a very recent ejection fraction assessment by another modality (within 30 days) and who had had no intervening diagnosis of new heart failure, myocardial infarction, hypotension, or shock (37,149 patients), left ventriculography was performed in 32,798 patients (88%)-a rate higher than in the overall cohort. CONCLUSIONS: Left ventriculography was performed in most coronary angiography cases and often when an alternative imaging modality had been recently completed. New clinical practice guidelines should be considered to decrease the overuse of this invasive test.

Warnings without guidance: patient responses to an FDA warning about ezetimibe.

BACKGROUND: In January 2008, the Food and Drug Administration (FDA) communicated concerns about the efficacy of ezetimibe, but did not provide clear clinical guidance, and substantial media attention ensued. We investigated the proportion of patients who discontinued therapy and switched to a clinically appropriate alternative after the FDA communication. METHODS: Using claims data from a national pharmacy benefits manager, we created a rolling cohort of new users of ezetimibe between January 2006 and August 2008 and created a supply diary for each patient in the year after cohort entry. A patient was identified as nonpersistent if a gap of 90 days was seen in the diary. Using segmented linear regression, we compared rates of nonpersistence before and after the FDA communication and assessed patient-level characteristics associated with discontinuation. Among nonpersistent patients, we determined whether a patient made a clinically appropriate switch in the subsequent 90 days by adding a new cholesterol-lowering medication or by increasing the dose of an existing one. We used a weighted t test to compare the rates of appropriate switching before and after the communication. RESULTS: Among 867,027 new ezetimibe users, 407,006 (46.9%) were nonpersistent in the first year. After the FDA communication, the monthly level of ezetimibe nonpersistence increased by 5.7 percentage points (P<0.0001). Younger patients, those who lived in low-income zip codes, and female patients were less likely to discontinue therapy (P<0.0001 for all). Among nonpersistent patients, rates of clinically appropriate switching increased from 10.8% before to 16.5% after the FDA warning (P = 0.004). CONCLUSIONS: A substantial increase in ezetimibe nonpersistence rates was seen after an FDA communication regarding its efficacy and following associated media attention, and a small proportion of patients made a clinically appropriate switch after discontinuation. Further consideration is needed to deliver messages that promote appropriate use of chronic therapy rather than simply reduce use.

Targeting cardiovascular medication adherence interventions.

OBJECTIVES: To determine whether adherence interventions should be administered to all medication takers or targeted to nonadherers. DATA SOURCES AND STUDY SELECTION: Systematic search (Medline and Embase, 1966-2009) of randomized controlled trials of interventions to improve adherence to medications for preventing or treating cardiovascular disease or diabetes. DATA EXTRACTION: Articles were classified as (1) broad interventions (targeted all medication takers), (2) focused interventions (targeted nonadherers), or (3) dynamic interventions (administered to all medication takers; real-time adherence information targets nonadherers as intervention proceeds). Cohen's d effect sizes were calculated. DATA SYNTHESIS: We identified 7,190 articles; 59 met inclusion criteria. Broad interventions were less likely (18%) to show medium or large effects compared with focused (25%) or dynamic (32%) interventions. Of the 33 dynamic interventions, 6 used externally generated adherence data to target nonadherers. Those with externally generated data were less likely to have a medium or large effect (20% vs. 34.8% self-generated data). CONCLUSION: Adherence interventions targeting nonadherers are heterogeneous but may have advantages over broad interventions. Dynamic interventions show promise and require further study.

Coverage Denials: Government And Private Insurer Policies For Medical Necessity In Medicare.

Little is publicly known about coverage denials for medical services that do not meet medical necessity criteria. We characterized the extent of these denials and their key features, using Medicare Advantage claims for a large insurer from the period 2014-19. In this setting, claims could be denied because of traditional Medicare's coverage rules or additional Medicare Advantage private insurer rules. We observed $416 million in denied spending, with 0.81 denials and $60 of denied spending per beneficiary annually. We found that 1.40 percent of services were denied and 0.68 percent of total spending was denied, with rates rising over time. Traditional Medicare's coverage rules accounted for 85 percent of denied services and 64 percent of denied spending; the remaining denials were due to additional Medicare Advantage insurer rules. Denial rates varied greatly across service type and provider type, with the most denials being for laboratory services and hospital outpatient providers. Traditional Medicare and Medicare Advantage insurer coverage policies each addressed different sources of medical spending; together they contributed to the denial of a modest but nontrivial portion of payments.