Insights into insurance coverage for digital therapeutics: A qualitative study of US payer perspectives.

BACKGROUND: In the last decade there has been an increase in the development and marketing of digital therapeutic (DTx) products aiming to prevent, manage, or treat a medical disorder or disease. Health insurance coverage for these products is not well established, and payers are facing increasing pressure to include these products as a covered benefit. OBJECTIVE: To examine factors and characteristics that could drive health insurance coverage of DTx products from US payers' and coverage decision-makers' perspectives. METHODS: This was a qualitative noninterventional, cross-sectional study conducted from August 2022 to October 2022. Virtual focus group meetings with pharmacy benefit managers/directors or medical directors representing a range of health insurance organizations were held following a semistructured interview guide. Convenience and snowball sampling techniques were used to identify participants. Transcripts were coded and analyzed with Atlas.ti software to identify common themes and subthemes. RESULTS: Five focus group meetings and 1 individual interview were held from August to October 2022. Participants (n = 22) were mostly pharmacists (n = 18, 85%) with more than 15 years of experience (n = 18, 85%). Some participants indicated that DTx products for diabetes (n = 6, 29%), mental/behavioral health (n = 3, 14%), and substance abuse disorders (n = 3, 14%) were already covered by their organizations. The topics generating the most comments grouped by code were issues around the evidence for DTx (67 unique comments) and barriers for coverage (60 unique comments). Participants indicated they want to have evidence of effectiveness that is similar to traditional pharmaceutical products. Barriers for coverage included a need to revise benefit policies, exclusion of nonprescription products, and mechanisms for billing. DTx products with an indication for mental/behavioral health were viewed as most likely to be reimbursed. Coverage of DTx products may occur under either the pharmacy or medical benefit. CONCLUSIONS: Health care payers stated that evidence of effectiveness was a necessary condition for health insurance coverage of DTx products. Given these are relatively new in health care, payers had more questions than answers regarding how these products will be integrated into health benefits.

Assessment of Disruptive Life Events for Individuals Diagnosed With Schizophrenia or Bipolar I Disorder Using Data From a Consumer Credit Reporting Agency.

Importance: There is a dearth of population-level data on major disruptive life events (defined here as arrests by a legal authority, address changes, bankruptcy, lien, and judgment filings) for patients with bipolar I disorder (BPI) or schizophrenia, which has limited studies on mental health and treatment outcomes. Objective: To conduct a population-level study on disruptive life events by using publicly available data on disruptive life events, aggregated by a consumer credit reporting agency in conjunction with electronic health record (EHR) data. Design, Setting, and Participants: This study used EHR data from 2 large, integrated health care systems, Kaiser Permanente Southern California and Henry Ford Health. Cohorts of patients diagnosed from 2007 to 2019 with BPI or schizophrenia were matched 1:1 by age at analysis, age at diagnosis (if applicable), sex, race and ethnicity, and Medicaid status to (1) an active comparison group with diagnoses of major depressive disorder (MDD) and (2) a general health (GH) cohort without diagnoses of BPI, schizophrenia, or MDD. Patients with diagnoses of BPI or schizophrenia and their respective comparison cohorts were matched to public records data aggregated by a consumer credit reporting agency (98% match rate). Analysis took place between November 2020 and December 2022. Main Outcomes and Measures: The differences in the occurrence of disruptive life events among patients with BPI or schizophrenia and their comparison groups. Results: Of 46 167 patients, 30 008 (65%) had BPI (mean [SD] age, 42.6 [14.2] years) and 16 159 (35%) had schizophrenia (mean [SD], 41.4 [15.1] years). The majoriy of patients were White (30 167 [65%]). In addition, 18 500 patients with BPI (62%) and 6552 patients with schizophrenia (41%) were female. Patients with BPI were more likely to change addresses than patients in either comparison cohort (with the incidence ratio being as high as 1.25 [95% CI, 1.23-1.28]) when compared with GH cohort. Patients with BPI were also more likely to experience any of the financial disruptive life events with odds ratio ranging from 1.15 [95% CI, 1.07-1.24] to 1.50 [95% CI, 1.42-1.58]). The largest differences in disruptive life events were seen in arrests of patients with either BPI or schizophrenia compared with GH peers (3.27 [95% CI, 2.84-3.78] and 3.04 [95% CI, 2.57-3.59], respectively). Patients with schizophrenia had fewer address changes and were less likely to experience a financial event than their matched comparison cohorts. Conclusions and Relevance: This study demonstrated that data aggregated by a consumer credit reporting agency can support population-level studies on disruptive life events among patients with BPI or schizophrenia.

The effects of early initiation of aripiprazole once-monthly on healthcare resource utilization and healthcare costs in individuals with schizophrenia: real-world evidence from US claims data.

AIM: To evaluate the impact of timing of aripiprazole once-monthly (AOM) initiation on healthcare resource utilization (HCRU), risk of hospitalization, and healthcare costs in patients with schizophrenia. METHODS: A retrospective cohort study was conducted using data from the Merative MarketScan database (01/01/2013-12/31/2019). Adults aged ≥18 years with a new episode of care for schizophrenia and an AOM claim were included. Patients were classified into two cohorts based on the time between the first schizophrenia diagnosis and the first AOM claim (early cohort: ≤1 year; late cohort: >1 year). All-cause and psychiatric-specific HCRU, risk of hospitalization, and healthcare costs were evaluated over 1-year post-AOM initiation. The relationship between the timing of AOM initiation and HCRU was evaluated using negative binomial regression, and healthcare costs using generalized linear models (log-link with gamma distribution). Logistic regression was used to estimate the likelihood of hospitalization during the follow up period for both all-cause and psychiatric-specific hospitalization. RESULTS: A total of 945 patients were included (early cohort: n = 525; late cohort: n = 420). At baseline, the early cohort had lower mean age, a greater proportion of males, and a lower mean Charlson Comorbidity Index score than the late cohort (all p < .05). After adjusting for baseline demographic and clinical characteristics, all-cause and psychiatric-specific hospitalization during the 1-year follow-up period were statistically significantly higher for the late cohort versus the early cohort (all-cause: incident rate ratio [IRR] = 1.63, 95% confidence interval [CI]: 1.28-2.07, p < .01; psychiatric-specific: IRR = 1.93, 95% CI: 1.46-2.55, p < .01). The early cohort had statistically significantly lower adjusted all-cause ($21,686 versus $29,033; p = .0002) and psychiatric-specific ($24,414 versus $32,461; p = .0002) healthcare costs versus the late cohort. LIMITATIONS: This study utilized claims data, which are intended for administrative purposes rather than for research. CONCLUSIONS: This analysis extends previous evidence for the benefits of AOM in patients with new episodes of schizophrenia, by demonstrating lower HCRU, risk of hospitalization, and healthcare costs with early AOM initiation compared with later initiation.

Schizophrenia is a costly disease that impacts patients, caregivers, and the healthcare system. Antipsychotic medications are an important component of schizophrenia treatment. These medications reduce symptom severity, improve functioning and reduce costs. Aripiprazole once-monthly (AOM) is a long-acting injectable antipsychotic used to treat schizophrenia. This study evaluates whether starting AOM early in the disease course improves outcomes for people with schizophrenia. Outcomes include healthcare resource utilization, risk of hospitalization, and healthcare costs. The study team found that hospitalization and costs were lower for people who started AOM early in the disease course as opposed to later. This study points to the importance of early treatment to improve outcomes for people with schizophrenia.

Treatment patterns and clinical outcomes among Medicare beneficiaries using antipsychotic medications for FDA-approved indications before and after transitioning from the community to a nursing home.

OBJECTIVES: This study examines the relationships between changes in antipsychotic medication (AP) use and acute clinical events (identified with administrative claims data) for patients with FDA-approved indications for APs following transition from the community (e.g. home) to a nursing home (NH) in a Medicare population. METHODS: A retrospective analysis was conducted using 100% Medicare fee-for-service (FFS) research identifiable files (RIF) claims data (2016-2018). Medicare beneficiaries with a condition for which APs are approved by the FDA were examined using logistic regression models to determine whether changes in AP use following transition from community to NHs were correlated with the likelihood of experiencing acute clinical events. RESULTS: We identified 38,448 Medicare FFS beneficiaries meeting our study criteria. A change in AP use after transition to a NH did not have a statistically significant association with acute skeletal events, coronary artery events, or cerebrovascular events (p = .55, p = .69, and p = .59, respectively). CONCLUSIONS: Between 2016 and 2018, Medicare FFS patients with approved-use indications for APs had lower average AP use following transition to a NH. Changes in the use of other medications of interest largely followed a similar pattern, indicating that these medications did not tend to be used as substitutions for APs. No clear relationship exists between increases or decreases in AP use and adverse events among NH residents who used APs and had FDA-approved conditions in the community setting.

Readmissions, costs, and duration to subsequent outpatient visit after hospital discharge among Medicaid beneficiaries utilizing oral versus long-acting injectable antipsychotics in bipolar disorder or schizophrenia.

BACKGROUND: Long-acting injectable antipsychotics (LAIs) may reduce hospitalizations versus oral formulations (OAP) in bipolar disorder (BP) and schizophrenia/schizoaffective disorder (SCZ), but the impact on time to outpatient follow-up is less understood. OBJECTIVES: To assess hospital readmissions and medical costs among Medicaid beneficiaries with BP or SCZ utilizing OAP or LAI SGAs. METHODS: Cross-sectional and longitudinal analyses utilized comprehensive administrative claims of Oklahoma Medicaid beneficiaries (≥18 years) with BP or SCZ between 1 January 2013 and 31 December 2017. Readmissions, total direct medical costs, and psychiatry-related outpatient visits were assessed via generalized linear models and generalized estimating equations, controlling for demographic and clinical covariates. RESULTS: Among 2523 included members, LAI utilization was associated with 1.50 and 1.73 times higher odds of any hospitalization and any readmission, respectively (p < .05). Cases involving both BP and SCZ were associated with a 2.40 times higher odds of any readmission, 2.26 times higher number of readmissions, and 24.5% higher costs (p < .001). Of the 468 members with a subsequent psychiatry-related outpatient visit, LAIs were associated with a 23.9% shorter duration to outpatient visit and 16.4% lower costs (p < .05). CONCLUSION: In contrast to prior studies, this real-world investigation noted higher hospitalizations and readmissions among LAIs relative to OAP medications, but among members with a hospitalization or ED visit, LAIs were associated with shorter durations to outpatient visits and lower costs. Those with diagnoses of both BP with SCZ had higher odds of any readmission, number of readmissions, and costs relative to those with bipolar disorder alone and may be a key target for interventions.

This study compared long-acting antipsychotics that were administered by injection (LAIs) to antipsychotic agents taken orally (OAPs) among Medicaid members with bipolar disorder and/or schizophrenia. Readmission to the emergency department (ED) or hospital (within 30 days of a previous visit) and costs were observed to be similar with LAIs relative to OAPs. Among members who went to the hospital, a shorter time to psychiatric follow-up outpatient visit and lower costs were observed among those taking LAIs relative to OAPs.

An Integrated Pharmacokinetic-Pharmacodynamic-Pharmacoeconomic Modeling Method to Evaluate Treatments for Adults with Schizophrenia.

INTRODUCTION: Schizophrenia is a chronic mental disorder that worsens with each relapse. Long-acting injectable (LAI) antipsychotics may prevent the exacerbation of symptoms and occurrence of relapses through improved continuity of care. Different dose regimens are available for the LAIs aripiprazole monohydrate (AM) and aripiprazole lauroxil (AL), but their cost effectiveness is unclear. OBJECTIVES: The study aim was to compare costs and effects (relapses) of the different aripiprazole LAI dose regimens to inform clinical and US payer decisions. METHODS: A state-transition model calculated the outcomes of eight LAI dose regimens based on their relapse rates. As effectiveness data from randomized controlled trials were unavailable, relapse rates were modeled using pharmacokinetic and pharmacodynamic evidence. These described blood plasma levels of aripiprazole as a function of AM and AL dose regimens and described the probability of relapse as a function of aripiprazole blood plasma levels. The analysis had a time horizon of 1 year and took the US healthcare payer perspective. The incremental cost per relapse avoided and the probability of cost effectiveness were calculated in deterministic and probabilistic analyses. Scenario analyses explored the model's main assumptions, and results were validated against external data and other cost-effectiveness analyses. RESULTS: Monthly administration of AM 400 mg consistently yielded the lowest predicted number of relapses across deterministic, probabilistic, and scenario analyses. The costs of treatment and relapses were projected to be the lowest with a monthly administration of AL 441 mg. The incremental cost per relapse avoided with AM 400 mg ranged from AM 400 mg being dominant to $US83,300. From willingness-to-pay thresholds of $US30,000 per relapse avoided, the probability of cost effectiveness was highest for AM 400 mg. The validation showed alignment with external data. CONCLUSION: The analysis highlighted the robustness of the novel framework based on pharmacokinetic and pharmacodynamic evidence and demonstrated an application in a postmarketing setting.

Impact of treatment-related discussions on healthcare resource use and costs among patients with severe mental illness.

OBJECTIVE: Serious mental illnesses (SMIs), including schizophrenia, bipolar disorder, and major depressive disorder (MDD), are often treated with antipsychotic medications. Unfortunately, medication non-adherence is widespread and is associated with serious adverse outcomes. However, little real-world data are available describing adherence, compliance, or other medication-taking-related discussions between providers and patients. This study described these communications in ambulatory care. METHODS: Commercially insured patients having acute (emergency or inpatient) behavioral health (BH) events were included by specific criteria: age 18-65 years; diagnoses of schizophrenia, bipolar disorder, or MDD; continuous health insurance coverage 6 months before to 12 months after the first claim (index) date during 01/01/2014‒12/31/2015; and prescribed antipsychotic medication. Medical charts were abstracted for ambulatory visits with a BH diagnosis through 12 months after the acute event, describing any treatment compliance discussions that occurred. BH-related healthcare utilization and costs were measured via insurance claims. Results were analyzed by observation of an antipsychotic medication taking-related (i.e. compliance or adherence) discussion at the initial abstracted visit. RESULTS: Ninety patients were included: 62% female, mean age 41 years. Only 58% had antipsychotic compliance discussions during the first abstracted ambulatory visit. A total of 680 BH-related visits were abstracted for the 90 patients. Providers frequently discussed any psychotropic medication use (97% of all visits abstracted); however, discussion of compliance with BH talk therapies was less common (49% of visits among patients with a first visit antipsychotic discussion and 23% without, p < .001). Follow-up BH-related healthcare utilization and costs were not significantly different by cohort. Patients with ≥2 compliance discussions had a significantly lower risk of follow-up acute events, which are the costliest components of healthcare for SMI (p = .023). CONCLUSION: Increasing the frequency of antipsychotic treatment-related adherence/compliance discussions may represent an opportunity to improve the quality of care for these vulnerable patients and reduce the overall economic burden associated with the treatment of SMI diagnosis.

Health Care Cost in Patients With Schizophrenia Treated With Brexpiprazole Versus Other Oral Atypical Antipsychotic Therapy.

PURPOSE: Brexpiprazole is an oral atypical antipsychotic (OAA) for the treatment of schizophrenia (SCZ). This study compared all-cause and psychiatric inpatient hospitalization and medical costs in adult patients with SCZ newly treated with brexpiprazole versus other US Food and Drug Administration-approved OAAs in a real-world setting. METHODS: This retrospective cohort study analyzed data from: (1) the IBM MarketScan Commercial and Medicare Supplemental databases, and the MarketScan Multi-State Medicaid database; and (2) the de-identified Optum Clinformatics Datamart. Adult patients were identified if they had SCZ and initiated either brexpiprazole or another OAA during the study identification period (July 1, 2015, to September 30, 2016, for MarketScan Commercial and Medicare Supplemental and for Optum; July 1, 2015, to June 30, 2016, for MarketScan Multi-State Medicaid) and had ≥12 months of continuous enrollment before (baseline) and after (follow-up) the first treatment date. Linear regression analyses were performed to test associations between treatment groups (brexpiprazole vs another OAA) and costs (total and medical); negative binomial regression models were used to estimate number of hospitalizations per year, adjusting for baseline characteristics and medication adherence to index treatment during the 12-month follow-up. FINDINGS: The final study sample consisted of 6254 patients with SCZ: 176 initiated brexpiprazole; 391, ziprasidone; 453, paliperidone; 523, lurasidone; 786, aripiprazole; 1234, quetiapine; 1264, olanzapine; and 1427, risperidone. Controlling for baseline characteristics and medication adherence, the adjusted number of hospitalizations (both all-cause and psychiatric), all-cause total costs, and all-cause medical costs did not differ across groups. Brexpiprazole users had the lowest mean psychiatric costs among all OAA users ($12,013; 95% bootstrap CI, 7488-16,538). Compared with brexpiprazole users, paliperidone (incidence rate ratio [95% CI], 1.52 [1.05-2.19]; P = 0.027) and quetiapine (incidence rate ratio [95% CI], 1.47 [1.04-2.07]; P = 0.029) users had more psychiatric hospitalizations per year. Paliperidone had higher psychiatric costs than brexpiprazole (total, $32,066 [95% bootstrap CI, 28,779-35,353] vs $23,851 [18,907-28,795]; medical, $19,343 [16,294-22,392] vs $12,013 [7488-16,538]). Psychiatric medical costs were also $6744 higher in olanzapine users (95% bootstrap CI, 1694-11,795; P = 0.009) than in brexpiprazole users. IMPLICATIONS: Patients with SCZ treated with brexpiprazole had fewer psychiatric hospitalizations and lower psychiatric costs than those treated with paliperidone. Differences in the number of all-cause hospitalizations and medical costs among treatments were not statistically significant. Although treatment decisions are driven by a number of factors (eg, clinical circumstances and drug costs), choice of OAA may affect health care costs.

A claims-based algorithm to reduce relapse and cost in schizophrenia.

OBJECTIVES: To refine a payer algorithm identifying patients with schizophrenia at high risk of relapse within a managed Medicaid population and evaluate its effectiveness in a case management (CM) program. STUDY DESIGN: Cross-sectional and longitudinal study design. METHODS: The algorithm used a single payer's Medicaid medical and pharmacy claims (August 1, 2009, to July 31, 2014) for patients with schizophrenia (N = 12,353) to predict those at high risk for hospitalization. The final algorithm was used in a CM program (outbound communication to providers) at 3 payer service centers in 3 states. Based on the algorithm, 60 patients (20 from each site) with the highest risk scores were targeted for CM (CM group) and 60 (those patients ranked 21st-40th most at-risk at each site) comprised the control group. Chi-square tests compared groups on frequency measures (hospitalizations, emergency department [ED] visits). Pre- to postimplementation differences were tested using McNemar's test. A pre-post analysis of variance assessed mean numbers of inpatient admissions, inpatient days, and ED visits for both groups. RESULTS: The algorithm had good positive predictive power (64.0%), negative predictive power (94.7%), sensitivity (40.2%), and specificity (97.9%). Following CM, the proportion of patients with at least 1 inpatient admission in the CM group decreased (23.3% to 13.3%), as did the rate of ED visits per month (by approximately 15%), whereas increases were observed in the control group. CONCLUSIONS: Although not all of these differences were statistically significant, they suggest that the algorithm may be an effective case-finding tool for plans attempting to mitigate hospitalizations among high-risk patients with schizophrenia.

Budget impact analysis of long-acting injectable aripiprazole once-monthly 400 mg in bipolar I disorder in the USA.

AIM: To estimate the budget impact (BI) of introducing aripiprazole once-monthly 400 mg/300 mg (AOM 400) in the maintenance monotherapy treatment of bipolar I disorder versus long-acting injectables, oral antipsychotics and best supportive care. METHODS: A BI model was developed from a US-payer perspective using treatment-related, hospitalization and adverse event management cost estimates for a hypothetical 1,000,000-member health plan over a 5-year period. RESULTS: Market share of AOM 400 was predicted to increase from 0.6% in Year 1 (current scenario) to 1.3% in Year 5 (predicted scenario), with predicted increases for paliperidone palmitate, asenapine and cariprazine. Treatment-related costs explained the BI increase, while adverse event and hospitalization costs were reduced. The per member per month incremental cost ranged from US$0.06 to US$0.26 in Years 1-5. The largest increases were predicted for paliperidone palmitate. CONCLUSION: As market shares of atypical antipsychotics are predicted to increase, payers may wish to re-evaluate their use.

Cost-effectiveness of long-acting injectable aripiprazole once-monthly 400 mg in bipolar I disorder in the USA.

AIM: To evaluate the cost-effectiveness of aripiprazole once-monthly 400/300 mg (AOM 400) in maintenance monotherapy treatment of bipolar I disorder (BP-I). METHODS: A de novo lifetime Markov model was developed for BP-I using available data for AOM 400 and relevant comparators. Base-case analysis considered costs and outcomes from the US payer perspective. RESULTS: The cost per quality-adjusted life year gained with AOM 400 versus comparators ranged from US$2007 versus oral asenapine to dominance (i.e., lower cost with quality-adjusted life gain) versus long-acting injectable risperidone, paliperidone palmitate, oral cariprazine and best supportive care. Patients treated with AOM 400 were estimated to have fewer mood episodes and hospitalizations per patient (5.37) than comparators (6.33, asenapine or cariprazine; 6.54, risperidone long-acting injectable; 7.64, paliperidone palmitate; and 8.93, best supportive care). Sensitivity analyses showed results were robust to parameter uncertainty. CONCLUSION: AOM 400 may be considered cost effective in the maintenance monotherapy treatment of BP-I in adults.

Relapse Risk Assessment for Schizophrenia Patients (RASP): A New Self-Report Screening Tool.

OBJECTIVES: The Relapse Assessment for Schizophrenia Patients (RASP) was developed as a six-question self-report screener that measures indicators of Increased Anxiety and Social Isolation to assess patient stability and predict imminent relapse. This paper describes the development and psychometric characteristics of the RASP. METHODS: The RASP and Positive and Negative Syndrome Scale (PANSS) were administered to patients with schizophrenia (n=166) three separate times. Chart data were collected on a subsample of patients (n=81). Psychometric analyses of RASP included tests of reliability, construct validity, and concurrent validity of items. Factors from RASP were correlated with subscales from PANSS (sensitivity to change and criterion validity [agreement between RASP and evidence of relapse]). RESULTS: Test-retest reliability returned modest to strong agreement at the item level and strong agreement at the questionnaire level. RASP showed good item response curves and internal consistency for the total instrument and within each of the two subscales (Increased Anxiety and Social Isolation). RASP Total Score and subscales showed good concurrent validity when correlated with PANSS Total Score, Positive, Excitement, and Anxiety subscales. RASP correctly predicted relapse in 67% of cases, with good specificity and negative predictive power and acceptable positive predictive power and sensitivity. CONCLUSIONS: The reliability and validity data presented support the use of RASP in settings where addition of a brief self-report assessment of relapse risk among patients with schizophrenia may be of benefit. Ease of use and scoring, and the ability to administer without clinical supervision allows for routine administration and assessment of relapse risk.

Managing to low-density lipoprotein particles compared with low-density lipoprotein cholesterol: a cost-effectiveness analysis.

BACKGROUND: Meta-analyses of clinical trials have shown that using statins to lower low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular events, and more intensive lowering of LDL-C further decreases the risk of occlusive vascular events. Lipoprotein studies suggest treating patients more aggressively when low-density lipoprotein particle (LDL-P) number is discordantly high in the presence of normal LDL-C levels. Failure to manage LDL-P numbers may lead to additional direct and indirect costs. OBJECTIVE: This analysis modeled direct and indirect costs associated with cardiovascular events due to suboptimal treatment resulting from discordance between LDL-C and LDL-P levels. METHODS: The analysis was conducted from the payer perspective and the employer perspective, respectively, over a 3-year time period. Clinical data were obtained from the Multi-Ethnic Study of Atherosclerosis, a community-based population study. The employer perspective included indirect costs and quality-adjusted life years in addition to the direct costs and cardiovascular disease events considered in the payer analysis. All costs are reported in 2011 dollars. RESULTS: From the payer perspective, managing LDL-C and LDL-P in comparison with LDL-C alone reduced costs ($21,212) and cardiovascular events (9 events). Similar patterns were observed for managing LDL-P alone in comparison with LDL-C. From the employer perspective, managing both LDL-P alone or in combination with LDL-C also resulted in lower costs, fewer cardiovascular disease events, and increased quality-adjusted life years in comparison with LDL-C. CONCLUSION: This analysis indicates that the benefits of additional testing to optimally manage LDL-P levels outweigh the costs of more aggressive treatment. These favorable results depended on the cost of drug therapy.

Economic measurement of medical errors using a hospital claims database.

OBJECTIVE: The primary objective of this study was to estimate the occurrence and costs of medical errors from the hospital perspective. METHODS: Methods from a recent actuarial study of medical errors were used to identify medical injuries. A visit qualified as an injury visit if at least 1 of 97 injury groupings occurred at that visit, and the percentage of injuries caused by medical error was estimated. Visits with more than four injuries were removed from the population to avoid overestimation of cost. Population estimates were extrapolated from the Premier hospital database to all US acute care hospitals. RESULTS: There were an estimated 161,655 medical errors in 2008 and 170,201 medical errors in 2009. Extrapolated to the entire US population, there were more than 4 million unique injury visits containing more than 1 million unique medical errors each year. This analysis estimated that the total annual cost of measurable medical errors in the United States was $985 million in 2008 and just over $1 billion in 2009. The median cost per error to hospitals was $892 for 2008 and rose to $939 in 2009. Nearly one third of all medical injuries were due to error in each year. CONCLUSIONS: Medical errors directly impact patient outcomes and hospitals' profitability, especially since 2008 when Medicare stopped reimbursing hospitals for care related to certain preventable medical errors. Hospitals must rigorously analyze causes of medical errors and implement comprehensive preventative programs to reduce their occurrence as the financial burden of medical errors shifts to hospitals.

A real-world comparative assessment of complications following various mid-urethral sling procedures for the treatment of stress urinary incontinence.

Stress urinary incontinence affects a significant proportion of the adult female population in the United States with prevalence increasing with growing age. Mid-urethral slings are among surgical options offering important improvement in the condition. The aim of this study was to evaluate clinical outcomes of different mid-urethral sling products with respect to postsurgery complications. This retrospective study utilized data from the Premier Perspective Database for mid-urethral sling procedures between 2005 and 2009. Patients were grouped into retropubic or transobturator cohorts, and these cohorts were further divided by the sling utilized during the procedure. Surgical outcomes and 12-month complication rates were assessed. In general, there were fewer complications noted for transobturator procedures than for retropubic procedures. In the retropubic category, Gynecare TVT had significantly lower rates of urinary obstruction/retention than other retropubic procedures. In the transobturator category, lower rates of overall pelvic complications as well as urologic complications, including urgency incontinence and urinary tract infections, were observed in the Gynecare TVTO subgroup than other transobturator procedures. Results of this study confirm the low overall rate of complications for midurethral sling procedures while at the same time suggesting that product choice may also have an impact on complication rates.

Impact of infliximab adherence on Crohn's disease-related healthcare utilization and inpatient costs.

INTRODUCTION: Few published reports have described the impact of adherence with biologic agents on hospitalizations and inpatient costs in Crohn's disease (CD). METHODS: A retrospective claims analysis using the IMS LifeLink Health Plan Claims Database between September 1, 2004 and June 30, 2009 was conducted. Continuous enrollment for 12 months before and 12 months after the index date was required. Patients were required to have ≥2 claims with an International Classification of Diseases, 9th Edition, Clinical Modification diagnosis code for CD (555.xx) preindex, be ≥18 years of age at index, and have ≥4 infliximab infusions with a gap no greater than 12 weeks between each infusion. Patients with 7-9 infliximab infusions (12 months postindex) were considered adherent; patients with 4-6 infliximab infusions were considered nonadherent. RESULTS: In total, 638 patients were included in the analyses (mean age, 43 years; 58% female in the adherent group and 53% in the nonadherent group). The number of patients who met the definition of adherence was 466 (73%). A smaller proportion of adherent patients had a CD-related emergency room visit, compared with nonadherent patients (11% vs. 17%, P=0.029). A smaller proportion of adherent patients required CD-related hospitalization, compared with nonadherent patients (8% vs. 12%, P=0.117). Among those hospitalized, adherent patients had fewer mean [median] days in the hospital (5.9 [5] days), compared with nonadherent patients (12.8 [8] days, P=0.015). Mean [median] hospital costs were significantly lower for adherent patients ($13,427 [$9,352]), compared with nonadherent patients ($37,783 [$28,864], P=0.001). Multivariate analyses confirmed lower inpatient (P<0.001) costs for adherent versus nonadherent patients. CONCLUSION: Adherence with infliximab therapy during the first year of treatment in patients with CD was associated with a shorter hospital length of stay and lower inpatient costs compared with nonadherent patients. Strategies for increasing adherence rates to infliximab maintenance therapy may be valuable in reducing hospitalizations and inpatient costs in patients with CD.

Impact of persistence with infliximab on hospitalizations in ulcerative colitis.

OBJECTIVES: To assess infliximab infusion patterns in ulcerative colitis (UC) and assess the impact of persistence with infliximab maintenance therapy on UC-related hospitalizations, lengths of stay, and inpatient costs. STUDY DESIGN: Retrospective analysis of medical claims for UC patients newly initiating infliximab treatment. METHODS: Patients were aged >18 years and had 2 UC diagnosis codes, an infliximab index date between September 1, 2005, and January 31, 2008, and continuous enrollment for >12 months before and >14 months after the index date. Infliximab induction (first 56 days postindex) and maintenance (>56 days and <12 months postinduction) patterns were evaluated. Of patients with maintenance treatment, persistence was defined as a medication possession ratio (MPR) of >80%, and this group was compared with those without persistence (<80% MPR). RESULTS: Overall, 420 patients were included in the analysis; 84.3% (n = 354) continued to maintenance therapy. Maintenance infusion patterns were consistent with recommended prescribing information. A smaller proportion of patients with maintenance therapy persistence required hospitalization compared with patients without persistence (3.0% vs 20.4%; P <.001). Hospitalized patients with maintenance therapy persistence had significantly lower mean inpatient costs ($14,243 vs $32,745; P = .046), with a trend toward shorter mean lengths of stay (6.67 vs 9.71 days; P = .147) than patients without persistence. CONCLUSIONS: Infliximab maintenance therapy persistence in UC was associated with significantly fewer hospitalizations. Once hospitalized, patients with therapeutic persistence had significantly decreased inpatient costs.

Laparoscopic supracervical hysterectomy versus laparoscopic-assisted vaginal hysterectomy.

OBJECTIVES: To compare the incidence of perioperative complications and postoperative healthcare utilization and costs in laparoscopic supracervical hysterectomy (LSH) versus laparoscopic-assisted vaginal hysterectomy (LAVH) patients. METHODS: Women 18 years with LSH or LAVH were extracted using a large national commercial claims database from 1/1/2007 through 9/30/2008. Outcome was perioperative complications and gynecologic-related postoperative resource use and costs. Multivariate analysis was performed to compare postsurgical outcomes between the cohorts. RESULTS: The final sample consisted of 6,198 LSH patients and 14,181 LAVH patients. LSH patients were significantly more likely to have dysfunctional uterine bleeding and leiomyomas and less likely to have endometriosis and prolapse as the primary diagnosis, and also significantly more likely to have a uterus that weighed 250 grams than LAVH patients. Compared with LAVH patients, LSH patients had significantly lower overall infection rates (7.4% versus 6.2%, P .002) and lower total gynecologic related postoperative costs ($252 versus $385, P .001, within 30 days of follow-up and $350 versus $569, P .001, within 180 days of follow-up). Significant cost differences remained following multivariate adjustment for patient characteristics. CONCLUSIONS: LSH patients demonstrated fewer perioperative complications and lower GYN-related postoperative costs compared to LAVH patients.

An exploratory analysis of healthcare costs and utilization of pediatric patients with Crohn's disease.

OBJECTIVE: To evaluate the healthcare costs and resource utilization associated with pediatric Crohn's disease (PCD) from a payer perspective. METHODS: A retrospective analysis was conducted using claims from 1 January 2003 through 31 December 2006 from the HealthCare Partners database. Patients were younger than 18 years of age, had a new diagnosis of PCD, and continuous health plan eligibility 6 months before and 12 months after the disease index date (the date of the first claim with a PCD diagnosis). For comparison, a non-PCD cohort was matched on age, sex, and birthday (within 30 days). RESULTS: Data from 30 patients with PCD and 10,864 non-PCD controls were included. The total cost per member per month (PMPM) for the PCD cohort was $2,547 compared with $101 for the non-PCD cohort. Inpatient admissions accounted for the largest portion (54%) of the total cost PMPM for PCD patients. There were 500 admissions per thousand members per year (PTMPY) for the PCD cohort and 11 admissions PTMPY for the non-PCD cohort. The average lengths of stay were 7.6 and 4.4 days for the PCD cohort and the non-PCD cohort, respectively, and the inpatient costs PMPM were $1,409 and $18, respectively. Costs and resource utilization were also higher for PCD patients treated with systemic therapies. CONCLUSION: PCD was associated with higher costs and resource utilization, compared with non-PCD controls, primarily driven by inpatient stays. Treating PCD appropriately before the disease progresses to a level requiring hospitalization may help reduce the costs associated with this disease.