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Adverse clinical events among medicare beneficiaries using antipsychotic drugs: linking health insurance benefits and clinical needs.

ABSTRACT: Medicare Part D provides formulary protections for antipsychotics but does not exempt these drugs from cost-sharing. We investigated the impact of Part D coverage on antipsychotic drug spending, adherence, and clinical outcomes among beneficiaries with varying indications for use.We conducted a historical cohort study of Medicare Advantage beneficiaries who received antipsychotic drugs, with diagnoses of schizophrenia or bipolar disorder or with no mental health diagnoses (N=10,190). Half had a coverage gap; half had no gap because of low-income subsidies. Using fixed effects regression models, we examined changes in spending and adherence as beneficiaries experienced cost-sharing increases after reaching the gap. We examined changes in hospitalizations and emergency department visits using proportional hazard models.Across all diagnostic groups, total monthly expenditure on antipsychotic drugs decreased with cost-sharing increases in the gap compared with those with no gap (eg, schizophrenia: -$123 95% confidence interval [-$138, -$108]), and out-of-pocket spending increased (eg, schizophrenia: $104 [$98, $110]). Adherence similarly decreased, with the largest declines among those with schizophrenia (-20.6 percentage points [-22.3, -18.9] in proportion of days covered). Among beneficiaries with schizophrenia and bipolar disorder, hospitalizations and emergency department visit rates increased with cost-sharing increases (eg, schizophrenia: hazard ratio=1.32 [1.06, 1.65] for all hospitalizations), but did not among subjects without mental health diagnoses. Clinical event rates did not change among beneficiaries with low-income subsidies without gaps.There is evidence of interruptions in antipsychotic use attributable to Part D cost-sharing. Adverse events increased among beneficiaries with approved indications for use, but not among beneficiaries without such indications.

SUBMITTER: Fung V

PROVIDER: S-EPMC3687515 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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Adverse clinical events among medicare beneficiaries using antipsychotic drugs: linking health insurance benefits and clinical needs.

Fung Vicki V Price Mary M Busch Alisa B AB Landrum Mary Beth MB Fireman Bruce B Nierenberg Andrew A Dow William H WH Hui Rita R Frank Richard R Newhouse Joseph P JP Hsu John J

Medical care 20130701 7

<h4>Objective</h4>Medicare Part D provides formulary protections for antipsychotics but does not exempt these drugs from cost-sharing. We investigated the impact of Part D coverage on antipsychotic drug spending, adherence, and clinical outcomes among beneficiaries with varying indications for use.<h4>Methods</h4>We conducted a historical cohort study of Medicare Advantage beneficiaries who received antipsychotic drugs, with diagnoses of schizophrenia or bipolar disorder or with no mental health ...[more]

PMID: 23752219

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Project description:ObjectivesTo investigate the consequences of endogeneity bias on the estimated effect of having health insurance on health at age 63 or 64, just before most people qualify for Medicare, and to simulate the implications for total and public insurance (Medicare and Medicaid) spending on newly enrolled beneficiaries in their first years of Medicare coverage.DataThe longitudinal Health and Retirement Survey of people who were 55-61 years old in 1992, followed through biannual surveys to age 63-64 or until 2000 (whichever came first), and those who were 66-70 years olds from the Medicare Current Beneficiary Surveys, 1992-1998.Study designInstrumental variable (IV) estimation of a simultaneous equation model of insurance choice and health at age 63-64 as a function of baseline health and sociodemographic characteristics in 1992 and endogenous insurance coverage over the observation period.FindingsContinuous insurance coverage is associated with significantly fewer deaths prior to age 65 and, among those who survive, a significant upward shift in the distribution of health states from fair and poor health with disabilities to good to excellent health. Treating insurance coverage as endogenous increases the magnitude of the estimated effect of having insurance on improved health prior to age 65. The medical spending simulations suggest that if the near-elderly had continuous insurance coverage, average annual medical spending per capita for new Medicare beneficiaries in their first few years of coverage would be slightly lower because of the improvement in health status. In addition, total Medicare and Medicaid spending for new beneficiaries over their first few years of coverage would be about the same or slightly lower, even though more people survive to age 65.ConclusionsExtending insurance coverage to all Americans between the ages of 55 and 64 would improve health (increase survival and shift people from good-fair-poor health to excellent-very good health) at age 65, and possibly reduce total short-term spending by Medicare and Medicaid for newly eligible Medicare beneficiaries, even though more people would enter the program because of increased survival.

Project description:ObjectiveTo test the hypothesis that health systems provide better care to patients with high needs by comparing differences in quality between system-affiliated and nonaffiliated physician organizations (POs) and to examine variability in quality across health systems.Data sources2015 Medicare Data on Provider Practice and Specialty linked physicians to POs. Medicare Provider Enrollment, Chain, and Ownership System (PECOS) and IRS Form 990 data identified health system affiliations. Fee-for-service Medicare enrollment and claims data were used to examine quality.Study designThis cross-sectional analysis of beneficiaries with high needs, defined as having more than twice the expected spending of an average beneficiary, examined six quality measures: continuity of care, follow-up visits after hospitalizations and emergency department (ED) visits, ED visits, all-cause readmissions, and ambulatory care-sensitive hospitalizations. Using a matched-pair design, we estimated beneficiary-level regression models with PO random effects to compare quality of care in system-affiliated and nonaffiliated POs. We then limited the sample to system-affiliated POs and estimated models with system random effects to examine variability in quality across systems.Principal findingsAmong 2 323 301 beneficiaries with high needs, 52.3% received care from system-affiliated POs. Rates of ED visits were statistically significantly different in system-affiliated POs (117.5 per 100) and nonaffiliated POs (106.8 per 100, P < .0001). Small differences in the other five quality measures were observed across a range of sensitivity analyses. Among systems, substantial variation was observed for rates of continuity of care (90% of systems had rates between 70.8% and 89.4%) and follow-up after ED visits (90% of systems had rates between 56.9% and 73.5%).ConclusionsSmall differences in quality of care were observed among beneficiaries with high needs receiving care from system POs and nonsystem POs. Health systems may not confer hypothesized quality advantages to patients with high needs.

Project description:ImportanceA lack of generalizability of pivotal cancer clinical trial data to treatment of older adults with Medicare could affect therapeutic decision-making in clinical practice.ObjectiveTo evaluate the differences in survival, duration of therapy, and treatment patterns between clinical trial patients and older adults with Medicare receiving cancer drugs for metastatic solid cancers in usual practice.Design, setting, and participantsThis retrospective cohort study, performed from May 1, 2018, to August 30, 2020, used the linked Surveillance, Epidemiology, and End Results (SEER) program and Medicare database to examine sequential US Food and Drug Administration (FDA)-approved cancer drug indications (2008-2013) for locally advanced or metastatic solid tumors to assess whether pivotal trials reflect the outcomes of Medicare patients with cancer treated in usual practice.ExposuresTreatment with FDA-approved cancer drugs for metastatic solid cancers in pivotal clinical trials and in the SEER-Medicare database.Main outcomes and measuresOverall survival, duration of treatment, and dose reductions among trial participants and treated Medicare patients.ResultsA total of 11 828 trial participants (mean age, 61.8 years; 6718 [56.8%] male; and 7605 [64.3%] White) and 9178 SEER-Medicare patients (mean age, 72.7 years; 4800 [52.3%] male; and 7437 [81.0% White]) were compared. Twenty-nine indications for 22 cancer drugs were included. Median overall survival among Medicare patients was shorter than among patients in the clinical trial intervention arm for 28 of 29 indications (median difference, -6.3 months; range, -28.7 to 2.7 months). Median duration of therapy among Medicare patients was shorter for 23 of the 27 indications with data available (median difference, -1.9 months; range, -12.4 to 1.4 months). For 9 indications, there was information available regarding dose reductions in the package insert or trial publication. In all but 1 instance, dose reductions or single prescriptions were more common in the Medicare population compared with dose reductions among the clinical trial patients; for example, in the Medicare patients, 600 of 1032 (58.1%) received dose reduction or a single prescription and 172 of 1032 (16.7%) received a single prescription vs 734 of 3416 (21.5%) in the trial intervention arm. The exception was afatinib for non-small cell lung cancer: 34 of 71 (47.9%) received dose reduction or a single prescription and 15 of 71 (21.1%) received a single prescription among the Medicare patients vs 120 of 230 (52.2%) receiving dose reductions among the trial intervention group.Conclusions and relevanceIn this cohort study, patients receiving Medicare who were treated with FDA-approved cancer drugs did not live as long as treated clinical trial participants and commonly received treatment modifications. This study suggests that cancer clinical data relevant to newly approved drugs lack generalizability to Medicare beneficiaries with cancer; therefore, these agents should be used with caution.

Project description:Importance:Meta-analyses of randomized clinical trials suggest that the advantages and risks of surgery compared with conservative management as the initial treatment for proximal humerus fracture (PHF) vary, or are heterogeneous across patients. Substantial geographic variation in surgery rates for PHF suggests that the optimal rate of surgery across the population of patients with PHF is unknown. Objective:To use geographic variation in treatment rates to assess the outcomes associated with higher rates of surgery for patients with PHF. Design, Setting, and Participants:This comparative effectiveness research study analyzed all fee-for-service Medicare beneficiaries with proximal humerus fracture in 2011 who were continuously enrolled in Medicare Parts A and B for the 365-day period before and immediately after their index fracture. Data analysis was performed January through June 2019. Exposure:Undergoing 1 of the commonly used surgical procedures in the 60 days after an index fracture diagnosis. Main Outcomes and Measures:Risk-adjusted area surgery ratios were created for each hospital referral region as a measure of local area practice styles. Instrumental variable approaches were used to assess the association between higher surgery rates and adverse events, mortality risk, and cost at 1 year from Medicare's perspective for patients with PHF in 2011. Instrumental variable models were stratified by age, comorbidities, and frailty. Instrumental variable estimates were compared with estimates from risk-adjusted regression models. Results:The final cohort included 72?823 patients (mean [SD] age, 80.0 [7.9] years; 13?958 [19.2%] men). The proportion of patients treated surgically ranged from 1.8% to 33.3% across hospital referral regions in the United States. Compared with conservatively managed patients, surgical patients were younger (mean [SD] age, 80.4 [8.1] years vs 78.0 [7.2] years; P?<?.001) and healthier (Charlson Comorbidity Index score of 0, 14?863 [24.4%] patients vs 3468 [29.1%] patients; Function-Related Indicator score of 0, 20?720 [34.0%] patients vs 4980 [41.8%] patients; P?<?.001 for both), and a larger proportion were women (49?030 [80.5%] patients vs 9835 [82.5%] patients; P?<?.001). Instrumental variable analysis showed that higher rates of surgery were associated with increased total costs ($8913) during the treatment period, increased adverse event rates (a 1-percentage point increase in the surgery rate was associated with a 0.19-percentage point increase in the 1-year adverse event rate; ??=?0.19; 95% CI, 0.09-0.27; P?<?.001), and increased mortality risk (a 1-percentage point increase in the surgery rate was associated with a 0.09-percentage point increase in the 1-year mortality rate; ??=?0.09; 95% CI, 0.04-0.15; P?<?.01). Instrumental variable mortality results were even more striking for older patients and those with higher comorbidity burdens and greater frailty. Risk-adjusted estimates suggested that surgical patients had higher costs (increase of $17?278) and more adverse events (a 1-percentage point increase in the surgery rate was associated with a 0.12-percentage point increase in the 1-year adverse event rate; ??=?0.12; 95% CI, 0.11 to 0.13; P?<?.001) but lower risk of mortality after PHF (a 1-percentage point increase in the surgery rate was associated with a 0.01-percentage point decrease in the 1-year mortality rate; ??=?-0.01; 95% CI, -0.015 to -0.005; P?<?.001). Conclusions and Relevance:This study found that higher rates of surgery for treatment of patients with PHF were associated with increased costs, adverse event rates, and risk of mortality. Orthopedic surgeons should be aware of the harms of extending the use of surgery to more clinically vulnerable patient subgroups.

Dataset Information

Adverse clinical events among medicare beneficiaries using antipsychotic drugs: linking health insurance benefits and clinical needs.

Publications

Adverse clinical events among medicare beneficiaries using antipsychotic drugs: linking health insurance benefits and clinical needs.

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