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Showing papers in "The American Journal of Managed Care in 2020"


Journal ArticleDOI
TL;DR: Healthcare providers should revisit disaster response policies to incorporate telemedicine systems to address some of the unique challenges posed by infectious disease outbreaks such as coronavirus disease 2019 (COVID-19).
Abstract: Healthcare providers should revisit disaster response policies to incorporate telemedicine systems to address some of the unique challenges posed by infectious disease outbreaks such as coronavirus disease 2019 (COVID-19).

200 citations


Journal ArticleDOI
TL;DR: Managed care organizations are in a unique position to develop utilization strategies that would positively impact early diagnosis and treatment to lead to better outcomes and lower costs for patients, caregivers, and the healthcare system.
Abstract: Alzheimer disease is the most common cause of dementia and the fifth leading cause of death in adults older than 65 years. The estimated total healthcare costs for the treatment of Alzheimer disease in 2020 is estimated at $305 billion, with the cost expected to increase to more than $1 trillion as the population ages. Most of the direct costs of care for Alzheimer disease are attributed to skilled nursing care, home healthcare, and hospice care. Indirect costs of care, including quality of life and informal caregiving, are likely underestimated and are associated with significant negative societal and personal burden. Managed care organizations are in a unique position to develop utilization strategies that would positively impact early diagnosis and treatment to lead to better outcomes and lower costs for patients, caregivers, and the healthcare system. Additionally, the recent inclusion of Alzheimer disease diagnoses into risk corridor calculations by the Centers for Medicare & Medicaid Services may encourage Medicare Advantage organizations to invest in programs that aid in its early detection and diagnosis.

172 citations


Journal ArticleDOI
TL;DR: The underlying concepts and supporting evidence for CBTI and dCBTI are presented, including their utility in vulnerable patient groups, and the rapidly evolving landscape of nondrug therapy for insomnia is explored.
Abstract: Insomnia, whether short-term or chronic, is a common condition. It has a negative impact on vulnerable patient groups, including active military personnel and veterans, patients with coexisting psychiatric and medical disorders, those in life transitions such as menopause, and elderly persons. Although cognitive behavioral therapy for insomnia (CBTI) is first-line treatment for insomnia, its high cost and a lack of trained providers has prevented widespread uptake. Now, digital CBTI (dCBTI) is emerging as a scalable option with the potential to overcome these barriers in managed care. The first part of this article reviews the epidemiology and pathophysiology of insomnia with a focus on vulnerable patient groups. The second part explores the rapidly evolving landscape of nondrug therapy for insomnia. The underlying concepts and supporting evidence for CBTI and dCBTI are presented, including their utility in vulnerable patient groups.

89 citations


Journal ArticleDOI
TL;DR: Daily admission rates during the COVID-19 pandemic were lower for these acute medical conditions, and public awareness campaigns are urgently needed to reassure the public about the safety of presenting for care.
Abstract: Objectives To determine whether patients are deferring necessary care for urgent conditions during the coronavirus disease 2019 (COVID-19) pandemic and, if so, to what extent. Study design Cross-sectional study. Methods Using billing data from 8 acute care hospitals, we identified 9 principal medical diagnoses from International Classification of Diseases, Tenth Revision codes across 4 medical specialties (cardiology, gastroenterology, neurology, and urology). In addition, we defined a combined obstetrical falsification end point. We compared daily admission rates during the pandemic period (3/1/2020-4/30/2020) with the same dates in 2019 (3/1/2019-4/30/2019). As a reference, we also compared a prepandemic period in the same years (1/1/2019-2/28/2019 and 1/1/2020-2/29/2020). We compared admission rates between years using t tests. Results There were 3219 admissions for the conditions of interest during the study period in 2019 and 2661 in 2020. There was no difference in prepandemic daily admission rates in 2020 compared with 2019 (29.04 vs 27.63 admissions per day; -4.9%; P = .50). During the pandemic period, there was a 33.7% decrease in admission rates for all conditions combined in 2020 compared with 2019 (24.68 vs 16.37; -33.7%; P = .03). By specialty, the combined gastroenterology (10.22 vs 7.20; -29.6%; P = .02) and cardiovascular (2.34 vs 1.29; -44.7%; P = .05) end points demonstrated reduction in daily admission rates. Conclusions Daily admission rates during the COVID-19 pandemic were lower for these acute medical conditions. Public awareness campaigns are urgently needed to reassure the public about the safety of presenting for care.

57 citations


Journal ArticleDOI
TL;DR: Factors worsening the opioid epidemic during the coronavirus disease 2019 pandemic provide valuable insight for strategy change where the country has historically suffered great loss, bodily and financially.
Abstract: Factors worsening the opioid epidemic during the coronavirus disease 2019 (COVID-19) pandemic provide valuable insight for strategy change where we have historically suffered great loss, bodily and financially.

48 citations


Journal ArticleDOI
TL;DR: A significant economic burden associated with fractures is suggested, including a high total all-cause cost of care, in a population of managed care enrollees who experienced an osteoporotic fracture.
Abstract: Objectives To examine healthcare resource utilization (HRU) and costs in a population of managed care enrollees who experienced an osteoporotic fracture. Study design Retrospective cohort study using the Optum Research Database (January 2007 to May 2017). Methods All-cause and osteoporosis-related HRU and costs were analyzed in patients 50 years and older with a qualifying index fracture and continuous enrollment with medical and pharmacy benefits for 12 months preindex (baseline period). Results Of 1,841,263 patients with fractures during the identification period, 302,772 met eligibility criteria. Two-thirds (66.6%) were 65 years and older, 71.6% were women, and 41.2% were commercial (not Medicare Advantage) enrollees. The most common fracture sites were spine (21.9%), radius/ulna (19.5%), and hip (13.7%). Mean (SD) total all-cause healthcare cost was $34,855 ($56,094), with most paid by health plans ($31,863 [$55,025]) versus patients ($2992 [$2935]). Most healthcare costs were for medical ($31,766 [$54,943]) versus pharmacy ($3089 [$6799]) services. Approximately 75% of patients received rehabilitation services (mean [SD] cost = $18,025 [$41,318]). Diagnosis of index fracture during an inpatient stay versus an outpatient visit (cost ratio, 2.16; 95% CI, 2.13-2.19) and fractures at multiple sites (cost ratio, 1.23; 95% CI, 1.21-1.26) were the leading predictors of cost. Kaplan-Meier estimated cumulative second-fracture rates were 6.6% at 1 year, 12.3% at 2 years, 16.9% at 3 years, and 20.9% at 4 years after index fracture. Conclusions These findings suggest a significant economic burden associated with fractures, including a high total all-cause cost of care. Early identification and treatment of patients at high risk of fractures are of paramount importance to reduce fracture risk and associated healthcare costs.

40 citations


Journal ArticleDOI
TL;DR: Carefully designed and targeted complex care management programs may be an effective approach to caring for high-need, high-cost Medicaid patients.
Abstract: OBJECTIVES Complex care management programs have emerged as a promising model to better care for high-need, high-cost patients. Despite their widespread use, relatively little is known about the impact of these programs in Medicaid populations. This study evaluated the impact of a complex care management program on spending and utilization for high-need, high-cost Medicaid patients. STUDY DESIGN Randomized quality improvement trial conducted at CareMore Health in Memphis, Tennessee. A total of 253 high-need, high-cost Medicaid patients were randomized in a 1:2 ratio to complex care management or usual care. METHODS Intention-to-treat analysis compared regression-adjusted rates of spending and utilization between patients randomized to the complex care program (n = 71) and those randomized to usual care (n = 127) over the 12 months following randomization. Primary outcomes included total medical expenditures (TME) and inpatient (IP) days. Secondary outcomes included IP admission, emergency department (ED) visits, care center visits, and specialist visits. RESULTS Compared with patients randomized to usual care, patients randomized to complex care management had lower TME (adjusted difference, -$7732 per member per year [PMPY]; 95% CI, -$14,914 to -$550; P = .036), fewer IP bed days (adjusted difference, -3.46 PMPY; 95% CI, -4.03 to -2.89; P <.001), fewer IP admissions (adjusted difference, -0.32 PMPY; 95% CI, -0.54 to -0.11; P = .014), and fewer specialist visits (adjusted difference, -1.35 PMPY; 95% CI, -1.98 to -0.73; P <.001). There was no significant impact on care center or ED visits. CONCLUSIONS Carefully designed and targeted complex care management programs may be an effective approach to caring for high-need, high-cost Medicaid patients.

32 citations


Journal ArticleDOI
TL;DR: Managed care organizations must evaluate clinical considerations, including safety profiles and the negative impact of disease on patients' QOL, to develop strategies for cost-effective treatment plans for patients with insomnia and to ensure appropriate use of these medications.
Abstract: Insomnia is a common sleep disorder in adults that can have many negative health impacts. The aggregate total of direct and indirect insomnia healthcare costs has been estimated to be as high as $100 billion US dollars per year. In addition to the societal cost burden, insomnia also negatively affects patients' quality of life (QOL), including social and occupational functioning or productivity as well as impaired cognition or mood. Insomnia may also exacerbate and increase morbidity and complications from psychological disorders, such as depression, as well as have serious consequences, such as increased risk of suicide. Comorbidities, medications, and/or psychosocial contributors may negatively influence QOL. Many medications for the treatment of insomnia have adverse effect (AE) profiles that increase the risk of falls and related injuries, cognitive impairment, and motor vehicle accidents. These AEs place additional burden on the already vulnerable older adult population and those with comorbidities. Managed care organizations must evaluate clinical considerations, including safety profiles and the negative impact of disease on patients' QOL, to develop strategies for cost-effective treatment plans for patients with insomnia and to ensure appropriate use of these medications.

32 citations


Journal ArticleDOI
TL;DR: RATKA was associated with shorter length of stay, reduced utilization of services, and reduced 90-day payer costs compared with MTKA, a retrospective longitudinal analysis of a commercial claims data set.
Abstract: OBJECTIVES Previous studies on Medicare populations have shown improved outcomes and decreased 90-day episode-of-care costs with robotic arm-assisted total knee arthroplasty (RATKA). The purpose of this study was to evaluate expenditures and utilization following RATKA in the population younger than 65 years. STUDY DESIGN This is a retrospective longitudinal analysis of a commercial claims data set. METHODS TKA procedures were identified using the OptumInsight Inc database. The procedures were stratified in 2 groups: the RATKA and manual TKA (MTKA) cohorts. Propensity score matching was performed at 1:5. Utilization and associated costs were analyzed for 90 days following the index procedure. A total of 357 RATKA and 1785 MTKA procedures were included in this analysis. RESULTS Within 90 days post surgery, patients who had RATKA were less likely to utilize inpatient services (2.24% vs 4.37%; P = .0444) and skilled nursing facilities (1.68% vs 6.05%; P < .0001). No patients in the RATKA group went to inpatient rehabilitation, whereas 0.90% of the MTKA arm went to an inpatient rehabilitation facility. Patients who utilized home health aides in the RATKA arm utilized significantly fewer home health days (5.33 vs 6.36 days; P = .0037). Costs associated with overall postsurgery expenditures were $1332 less in the RATKA arm ($6857 vs $8189; P = .0018). The 90-day global expenditures (index plus post surgery) were $4049 less in the RATKA arm ($28,204 vs $32,253; P < .0001). Length of stay after surgery was nearly a day less for the RATKA arm (1.80 vs 2.72 days; P < .0001). CONCLUSIONS RATKA was associated with shorter length of stay, reduced utilization of services, and reduced 90-day payer costs compared with MTKA.

31 citations


Journal ArticleDOI
TL;DR: This study indicates that it is possible to risk-stratify patients' risk of utilization without interacting with the patient or collecting information beyond the patient's age, gender, race, and address.
Abstract: Objectives To determine if it is possible to risk-stratify avoidable utilization without clinical data and with limited patient-level data. Study design The aim of this study was to demonstrate the influences of socioeconomic determinants of health (SDH) with regard to avoidable patient-level healthcare utilization. The study investigated the ability of machine learning models to predict risk using only publicly available and purchasable SDH data. A total of 138,115 patients were analyzed from a deidentified database representing 3 health systems in the United States. Methods A hold-out methodology was used to ensure that the model's performance could be tested on a completely independent set of subjects. A proprietary decision tree methodology was used to make the predictions. Only the socioeconomic features-age group, gender, and race-were used in the prediction of a patient's risk of admission. Results The decision tree-based machine learning approach analyzed in this study was able to predict inpatient and emergency department utilization with a high degree of discrimination using only purchasable and publicly available data on SDH. Conclusions This study indicates that it is possible to risk-stratify patients' risk of utilization without interacting with the patient or collecting information beyond the patient's age, gender, race, and address. The implications of this application are wide and have the potential to positively affect health systems by facilitating targeted patient outreach with specific, individualized interventions to tackle detrimental SDH at not only the individual level but also the neighborhood level.

28 citations


Journal ArticleDOI
TL;DR: The addition of self-reported SDOH data has a dose effect on CVD risk factors and future studies should address how to intervene to address social factors.
Abstract: OBJECTIVES Cardiovascular disease (CVD) continues to disproportionately affect disadvantaged populations, leading to calls to address social determinants of health (SDOH) as a preventive strategy. Our aim is to create a weighed SDOH score and to test the impact of each SDOH factor on the Framingham risk score (FRS) and on individual traditional CVD risk factors. STUDY DESIGN We conducted a retrospective cohort study. METHODS We included patients seen at a primary care clinic at UHealth/University of Miami Health System who answered a SDOH survey between September 16, 2016, and September 10, 2017. The survey included SDOH domains recommended by the American Heart Association position statement and by the National Academy of Medicine. We selected the FRS as well as all traditional CVD risk factors as our outcome metrics. RESULTS We included 2876 patients. The mean (SD) age of our cohort was 53.8 (15.8) years, 61% were female, 9% were Black, 38% were Hispanic, and 87% reported speaking English. The statistically significant β coefficients in the FRS model corresponded to being born outside of the United States, being a racial minority, living alone, having a high social isolation score, and having a low geocoded median household income (P < .01). Increasing quartile of SDOH score was significantly associated with higher systolic blood pressure, FRS, glycated hemoglobin, and smoking pack-years (P < .05). It was also associated with fewer minutes spent exercising weekly (P < .01). CONCLUSIONS The addition of self-reported SDOH data has a dose effect on CVD risk factors. Future studies should address how to intervene to address social factors.

Journal ArticleDOI
TL;DR: The current state of biomarker-driven drug development across the AD continuum is explored and investigational drugs in phase 2/3 clinical development for AD are reviewed.
Abstract: The burden of Alzheimer disease (AD) on the US healthcare system is substantial and increasing. AD progresses along a continuum from preclinical disease characterized by normal cognition and abnormal brain biomarkers to mild cognitive impairment and then clinically apparent dementia. Diagnosis early in the AD continuum has benefits for patients and caregivers and appears cost-effective, but often, the clinical diagnosis of AD may be delayed. Currently available biomarkers include β-amyloid positron emission tomography and cerebrospinal fluid tests. Collectively, they are expensive, may lead to adverse effects, are not widely available, and are not suited for primary care. Currently available treatment options, cholinesterase inhibitors and memantine, do not alter disease progression, but can help with some symptoms. Benefits of currently available treatments on cognition are difficult to quantify and are offset by a burden of adverse effects that often go unrecognized. More accurate diagnostic biomarkers and disease-modifying drug therapies are critical unmet needs of patients with AD despite decades of clinical research. Because many phase 3 clinical trials that enrolled patients with symptomatic AD have failed, researchers believe that disease-modifying treatment is more likely to demonstrate benefit when utilized early in the disease continuum. Within the past few years, significant achievements that will advance clinical trials in early AD include the Research Framework to define and stage the AD continuum, FDA guidance on study design in early AD, and development of scales to measure cognition that are suitable for early AD. In October 2019, the AD community was re-invigorated by unexpected news that a Biologics License Application will be submitted for aducanumab to treat AD. This article explores the current state of biomarker-driven drug development across the AD continuum and reviews investigational drugs in phase 2/3 clinical development for AD.

Journal ArticleDOI
TL;DR: No significant racial/ethnic disparities in the use of either palliative care or hospice at the end of life were found within hospitals.
Abstract: OBJECTIVES Prior research has demonstrated differences across race and ethnicity, as well as across geographic location, in palliative care and hospice use for patients near the end of life. However, there remains inconsistent evidence regarding whether these disparities are explained by hospital-level practice variation. The goals of this study were to evaluate whether inpatient palliative care consultation use and discharge to hospice differed by race/ethnicity and whether hospital-level variations explained these differences. STUDY DESIGN Retrospective, cross-sectional study. METHODS This study evaluated 5613 patients who were discharged to hospice or died during their hospital stay between 2012 and 2014 in 4 urban hospitals with an inpatient palliative care service. The main outcomes were receipt of an inpatient palliative care consultation and discharge to hospice. RESULTS The sample was 43% white, 44% African American, and 13% Hispanic. After adjusting for patient characteristics and hospital site, race/ethnicity was not significantly associated with receipt of inpatient palliative care consultation. Hispanic race/ethnicity was associated with a higher likelihood of discharge to hospice (odds ratio, 1.22; P = .036), and inpatient palliative care consultation was associated with 4 times higher likelihood of discharge to hospice (P <.001). Hospital site was also associated with both receipt of inpatient palliative care consultation and discharge to hospice. CONCLUSIONS Our results illustrate significant variation across hospitals in palliative care consultation use and discharge to hospice. No significant racial/ethnic disparities in the use of either palliative care or hospice at the end of life were found within hospitals.

Journal ArticleDOI
TL;DR: HCHN care management programs should consider systematic drug allergy evaluations to optimize antibiotic use in these fragile patients, with a high burden of reported drug allergy.
Abstract: Objectives More than 90% of patients who report a penicillin allergy have the allergy disproved when tested. Unnecessary use of alternative (non-beta-lactam) antibiotics can result in more treatment failures and adverse reactions. We described the prevalence and impact of a reported penicillin allergy in high-cost, high-need (HCHN) patients. Study design Retrospective cohort. Methods We identified HCHN patients in a care management program of an urban academic medical center (January 1, 2014, to December 31, 2016). We used multivariable logistic regression models to determine the association between a reported penicillin allergy and antibiotic use. We used multivariable Poisson regression models to determine the association between a reported penicillin allergy, with or without multiple drug intolerance syndrome (MDIS; ≥3 reported drug allergies), and healthcare resource utilization (HRU). Results Of 1870 HCHN patients, 383 (20%) reported penicillin allergy, 835 (45%) had MDIS, and 290 (16%) had both. HCHN patients reporting penicillin allergy had an increased odds of beta-lactam alternative antibiotic use (adjusted odds ratio, 3.84; 95% CI, 2.17-6.80). HRU was significantly higher for patients reporting a penicillin allergy alone (adjusted relative risk [aRR], 1.13; 95% CI, 1.03-1.25) and with concurrent MDIS (aRR, 1.20; 95% CI, 1.08-1.34). Conclusions HCHN patients had a high burden of reported drug allergy. A reported penicillin allergy conferred a 4-fold increased odds of beta-lactam alternative antibiotic use. Reporting penicillin allergy, with and without MDIS, was associated with significantly more HRU. HCHN care management programs should consider systematic drug allergy evaluations to optimize antibiotic use in these fragile patients.

Journal ArticleDOI
TL;DR: Imminent fracture risk can be assessed using 6 easily quantified factors and recent fracture, older age, female sex, white race, falls, and antidepressant/antipsychotic/sedative hypnotic/muscle relaxant medications predict imminent fracture risk in an older-adult Medicare Advantage population.
Abstract: OBJECTIVES To develop and validate predictive models for imminent fracture risk in a Medicare population. STUDY DESIGN This retrospective administrative claims (Humana Research Database) study assessed imminent risk in Humana's Medicare Advantage and Prescription Drug plan members. METHODS Individuals (aged 67-87 years on January 1, 2015 [index]) with 1 year or more of history were followed for 3 months to up to 2 years, with censoring at death/disenrollment. The cohort was split into training and validation samples (1:1). Cox regression models assessed demographics, fracture history, medically significant falls, osteoporosis-related factors, frailty markers, and selected medications and comorbidities for independent predictors (P <.001) of incident nontraumatic clinical fractures in 12 and 24 months. A 6-variable model of 12-month risk used a published method for the risk-scoring point system. RESULTS Of 1,287,354 individuals (mean age, 74.3 years; 56% female; 84% white), 3.8% had at least 1 fragility fracture at 12-month follow-up; 6.6% experienced fracture at 24 months (women vs men: 12 months, 4.8% vs 2.5%; 24 months, 8.3% vs 4.4%; both P <.01). At 12 months, recent fracture conferred approximately 3-fold-higher fracture risk (vs no recent fracture). Older age, white race, female sex, osteoporosis-related screening/diagnosis/medication, antidepressant/antipsychotic/sedative hypnotic/muscle relaxant medications, history of falls, fracture history, and respiratory conditions also increased risk (all P <.0001). The simplified model (recent fracture, age, sex, race, falls, antidepressant/antipsychotic/sedative hypnotic/muscle relaxant medications) performed well (C statistic = 0.71). CONCLUSIONS Recent fracture, older age, female sex, white race, falls, and antidepressant/antipsychotic/sedative hypnotic/muscle relaxant medications predict imminent fracture risk in an older-adult Medicare Advantage population. Imminent fracture risk can be assessed using 6 easily quantified factors.

Journal ArticleDOI
TL;DR: The oral tyrosine kinase inhibitor masitinib; the antisense drug tofersen; the humanized monoclonal antibody C5 complement inhibitor ravulizumab-cwvz; and mesenchymal stem cell-neurotrophic factor (NTF) cells, a proprietary platform that induces autologous bone marrow-derived MSCs to secrete high levels of NTFs are highlighted.
Abstract: Amyotrophic lateral sclerosis (ALS) is a devastating, fatal neuromuscular disease. Most patients die within 2 to 5 years of diagnosis. The disease stems from death of upper and lower motor neurons leading to degeneration of motor pathways and the paralytic effects of the disease. The economic cost of the disease is not clear, with estimates ranging from about $64,000 per year to $200,000. Two drugs, riluzole and edaravone, are currently FDA approved for the treatment of ALS, and each provides modest benefits in mortality and/or function. Recent developments in the understanding of the underlying pathophysiologic processes that contribute to ALS have led to the development of numerous investigational therapies, with several now in phase 3 trials. This article highlights the oral tyrosine kinase inhibitor masitinib; the antisense drug tofersen; the humanized monoclonal antibody C5 complement inhibitor ravulizumab-cwvz; and mesenchymal stem cell (MSC)-neurotrophic factor (NTF) cells, a proprietary platform that induces autologous bone marrow-derived MSCs to secrete high levels of NTFs.

Journal ArticleDOI
TL;DR: In the coronavirus disease 2019 (COVID-19) era, clinical registries and innovative virtual care delivery tools should be leveraged to engage populations in effective chronic disease management.
Abstract: In the coronavirus disease 2019 (COVID-19) era, clinical registries and innovative virtual care delivery tools should be leveraged to engage populations in effective chronic disease management.

Journal ArticleDOI
Megan Maroney1
TL;DR: The schizophrenia treatment guidelines, current treatment strategies, and emerging agents for the management of schizophrenia are summarized.
Abstract: Schizophrenia is a chronic neuropsychiatric disorder that has a significant impact on the functioning and quality of life of individuals affected by the disease. It affects 0.6% to 1.9% of individuals within the United States, and currently there is no cure. Guidelines recommend a combined treatment approach with both pharmacologic agents and psychological interventions for first-episode psychosis, acute exacerbations, and relapse prevention. Presently, multiple agents are available for the treatment of schizophrenia; however, the majority do not address negative symptoms and cognitive dysfunction, with many patients having debilitating residual symptoms, difficulties with adherence, and drug-related adverse effects. To address these concerns, new research evaluating investigational therapies has been undertaken to examine novel treatment strategies. This review summarizes the schizophrenia treatment guidelines, current treatment strategies, and emerging agents for the management of schizophrenia.

Journal ArticleDOI
TL;DR: Managed care clinicians are provided with an up-to-date assessment of currently available agents, followed by a preview of some investigational agents that could alter the future treatment landscape.
Abstract: The burden of age-related macular degeneration (AMD), a leading cause of vision loss in the elderly population, is poised to increase dramatically as the baby boomer generation ages. Fortunately, the prognosis of neovascular AMD has improved dramatically since anti-vascular endothelial growth factor (VEGF) agents reached the market 15 years ago. In large-scale clinical trials, anti-VEGF utilization maintained visual acuity in more than 90% of patients. However, providing anti-VEGF treatment requires the specialized expertise of retina specialists and is labor intensive and costly. Further, results in clinical practice do not always measure up to those obtained in rigorous phase 3 trials. Undertreatment and the burden on patients and caregivers from frequent anti-VEGF injections contribute to suboptimal visual acuity results in the real world. As a consequence, retinal specialists are focused on finding effective strategies to extend the dosing interval. These include individualized optical coherence tomography-guided dosing regimens, longer acting new agents with similar or new mechanisms of action, and sustained release delivery devices. With the recent approval of brolucizumab, the neovascular AMD armamentarium has expanded to 4 anti-VEGF agents, and more are in development. Understanding the treatment landscape is a key issue in managed care due to the substantial cost of anti-VEGF medications. The goal of this article is to provide managed care clinicians with an up-to-date assessment of currently available agents, followed by a preview of some investigational agents that could alter the future treatment landscape. These agents include abicipar pegol, faricimab, the ranibizumab port delivery system, an intravitreal bevacizumab formulation, and anti-VEGF biosimilars.

Journal ArticleDOI
TL;DR: This article provides an overview of the epidemiology, pathophysiology, clinical manifestations, and current management approaches for the diagnosis and management of LC-FAODs and provides the most recent clinical safety and efficacy data for triheptanoin and other therapies under investigation.
Abstract: Long-chain fatty acid oxidation disorders (LC-FAODs) are rare, life-threatening, autosomal recessive genetic disorders characterized by acute crises of energy production and chronic energy deficiency. Patients may present with rhabdomyolysis induced by exercise; fasting or illness; hepatic dysfunction, including severe hypoglycemia and hyperammonemia; and cardiomyopathy. These clinical manifestations can lead to frequent hospitalizations and premature death. LC-FAODs are caused by mutations in nuclear genes encoding mitochondrial enzymes involved in the conversion of dietary long-chain fatty acids (LCFAs) into energy during times of fasting and physiologic stress. Despite newborn screening, current management options leave many patients continuing to experience major clinical events, and mortality rates remain elevated. The current standard therapy for LC-FAODs is avoidance of fasting and supplementation of medium-chain triglyceride oil, an even, medium-chain fatty acid that does not require the typical steps of LC-FAOD for metabolism. Despite this therapy, patients with LC-FAODs continue to experience recurring hospitalizations, and high morbidity and mortality rates. In recent years, the use of medium, odd-chain fatty acids, such as triheptanoin, have been studied as a treatment of LC-FAODs due to its anaplerotic properties. Due to favorable safety and efficacy data from clinical trials, this novel agent has the potential to transform the treatment of LC-FAODs and improve patient outcomes in this patient population. This article provides an overview of the epidemiology, pathophysiology, clinical manifestations, and current management approaches for the diagnosis and management of LC-FAODs. It also provides the most recent clinical safety and efficacy data for triheptanoin and other therapies under investigation.

Journal ArticleDOI
TL;DR: Managed care professionals are positioned to improve adherence and outcomes through various drug utilization strategies and Clinicians may also empower patients with schizophrenia through shared decision making and the creation of a therapeutic alliance.
Abstract: Schizophrenia is a complicated chronic disease affecting approximately 3.5 million people in the United States, and its annual healthcare costs exceed $155 billion. People living with schizophrenia often experience a reduced quality of life (QOL) and are more likely to be homeless, unemployed, or living in poverty compared with the general population. Life expectancy for patients with schizophrenia is 15 to 20 years below the average and is complicated by numerous comorbidities, such as weight gain, increased cardiovascular risk, and changes in mood and cognition. Treatment nonadherence can increase the risk of relapse, rehospitalization, and self-harm, leading to a reduced QOL and increased economic burden. Managed care professionals are positioned to improve adherence and outcomes through various drug utilization strategies. Clinicians may also empower patients with schizophrenia through shared decision making and the creation of a therapeutic alliance. Careful monitoring of medication-related adverse effects and offering potential medication alternatives and routes of administration when indicated may also improve adherence to treatment regimens, resulting in improved outcomes and reduced healthcare costs.

Journal ArticleDOI
TL;DR: In this paper, the authors assess whether hospitals in states requiring explicit patient consent ("opt-in") for health information exchange (HIE) are more likely to report regulatory barriers to HIE and analyze whether these policies correlate with hospital volume of HIE.
Abstract: Objectives To (1) assess whether hospitals in states requiring explicit patient consent ("opt-in") for health information exchange (HIE) are more likely to report regulatory barriers to HIE and (2) analyze whether these policies correlate with hospital volume of HIE. Study design Cross-sectional analysis of US nonfederal acute care hospitals in 2016. Methods We combined legal scholarship surveying HIE-relevant state laws with the American Hospital Association Annual Information Technology Supplement for regulatory barriers and hospital characteristics. Data from CMS reports for hospitals attesting to Meaningful Use stage 2 (MU2; renamed "Promoting Interoperability" in 2018) in 2016 captured hospital HIE volume. We used multivariate logistic regression and linear regression to estimate the association of opt-in state consent policies with reported regulatory barriers and HIE volume, respectively. Results Hospitals in states with opt-in consent policies were 7.8 percentage points more likely than hospitals in opt-out states to report regulatory barriers to HIE (P = .03). In subgroup analyses, this finding held among hospitals that did not attest to MU2 (7.7 percentage points; P = .02). Among hospitals attesting, we did not find a relationship between opt-in policies and regulatory barriers (8.0 percentage points; P = .13) or evidence of a relationship between opt-in policies and HIE volume (β = 0.56; P = .76). Conclusions Our findings suggest that opt-in consent laws may carry greater administrative burdens compared with opt-out policies. However, less technologically advanced hospitals may bear more of this burden. Furthermore, opt-in policies may not affect HIE volume for hospitals that have already achieved a degree of technological sophistication. Policy makers should carefully consider the incidence of administrative burdens when crafting laws pertaining to HIE.

Journal ArticleDOI
TL;DR: The advent of liquid biopsy tests that could screen for dozens of cancers holds promise for identifying more cancers early, but the cost, the potential for overdiagnosis and false positives, and a lack of evidence demonstrating clinical utility or an improvement in health outcomes call into question their potential use for widespread screening.
Abstract: Despite significant improvements in mortality over the past 20 years, cancer remains the second leading cause of death in the United States. One reason for the improvement in mortality is screening for several common cancers in people at average risk for breast, cervical, colorectal, and prostate cancers, and screening for lung cancer in those with a 20-plus pack-year history. Such screening may result in earlier diagnosis when the cancer is most likely to respond to treatment. However, there are no population-based screening recommendations for the majority of cancers in average-risk patients, most of which are not diagnosed until the later stages. One question is whether earlier diagnosis could not only reduce mortality rates but also reduce medical costs. Screening comes with several potential risks, including false positives and overdiagnosis, both of which can affect patients' mental health, increase morbidity and mortality, and lead to excess spending. Additionally, certain cancers can evade traditional screening tests and lead to false-negative results, which delays cancer detection, treatment, and may affect treatment efficacy. The advent of liquid biopsy tests that could screen for dozens of cancers holds promise for identifying more cancers early. However, the cost, the potential for overdiagnosis and false positives, and a lack of evidence demonstrating clinical utility or an improvement in health outcomes call into question their potential use for widespread screening. Government and managed care organizations will need to consider the risks and benefits of these assays in determining coverage.

Journal ArticleDOI
TL;DR: Liver transplant candidates covered by Medicare or Medicaid have poorer wait-list outcomes and higher posttransplant mortality.
Abstract: Objectives The outcomes of liver transplantation may vary according to socioeconomic factors such as insurance coverage. The aim of this study was to assess the association between the type of insurance payer and outcomes of liver transplant candidates and recipients in the United States. Study design This was a retrospective cohort study of a national database. Methods The US Scientific Registry of Transplant Recipients was used to select adults (≥18 years) wait-listed for liver transplantation in the United States (2001-2017); patients were followed until March 2018. Results There were 177,862 liver transplant candidates with payer and outcomes data: The mean (SD) age was 54.1 (10.4) years, 64% were male, 39% had chronic hepatitis C with or without alcoholic liver disease (ALD), 19% had ALD alone, 17% had nonalcoholic steatohepatitis, and 16% had hepatocellular carcinoma. Fifty-nine percent were primarily covered by private insurance, 21% by Medicare, and 16% by Medicaid. After listing, 56% eventually received transplants (mean wait time of 229 days) and 22% dropped off the list. In multivariate analysis, adjusted for demographic and clinical factors, being covered by Medicare (odds ratio [OR], 0.81; 95% CI, 0.78-0.84) or Medicaid (OR, 0.76; 95% CI, 0.73-0.79) was independently associated with a lower chance of receiving a transplant (reference: private insurance). Posttransplant mortality was 11.6% at 1 year, 20.1% at 3 years, 26.8% at 5 years, and 41.6% at 10 years. Having Medicare (adjusted hazard ratio [aHR], 1.24; 95% CI, 1.17-1.31) or Medicaid (aHR, 1.14; 95% CI, 1.06-1.21) was independently associated with higher posttransplant mortality (P .05). Conclusions Liver transplant candidates covered by Medicare or Medicaid have poorer wait-list outcomes and higher posttransplant mortality.

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TL;DR: Insurance claims data was evaluated as a source for monitoring progression along the CHB care cascade and identified gaps in linkage to care and treatment in commercially insured adults with CHB.
Abstract: Objectives Monitoring care and treatment for persons with chronic hepatitis B (CHB) is essential for demonstrating progress in achieving national elimination goals. We sought to evaluate insurance claims data as a source for monitoring progression along the CHB care cascade. Study design Longitudinal evaluation from diagnosis to treatment among commercially insured enrollees with CHB. Methods We used standardized procedure and diagnosis codes to identify enrollees (≥ 18 years) with CHB in large insurance claims databases to describe the CHB care cascade from 2008 to 2016. Linkage to care was defined as procedure codes for liver fibrosis assessment (alanine aminotransferase in conjunction with either hepatitis B virus DNA or hepatitis B e-antigen) more than 12 months after CHB diagnosis. Treatment was defined as a claim for any CHB prescription. We analyzed factors associated with linkage to care and treatment using unadjusted logistic regression and evaluated rates of diagnosis, linkage to care, and treatment over time. Results Of 16,644 individuals with CHB, 6004 (36%) were linked to care and 2926 (18%) were treated. Persons coinfected with HIV (odds ratio [OR], 0.46; 95% CI, 0.36-0.59) or hepatitis C (OR, 0.50; 95% CI, 0.34-0.73) were less likely to be linked to care, and persons coinfected with HIV (OR, 0.29; 95% CI, 0.19-0.44) were less likely to be treated. From 2009 to 2015, there was a significant decrease in CHB diagnoses but no change in the proportion linked to care and treatment. Conclusions We identified gaps in linkage to care and treatment in commercially insured adults with CHB.

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TL;DR: With a "new normal" level of care going forward post coronavirus disease 2019 (COVID-19), the key will be to invest in high-value services while deterring a resurgence of low-value care.
Abstract: With a "new normal" level of care going forward post coronavirus disease 2019 (COVID-19), the key will be to invest in high-value services while deterring a resurgence of low-value care.

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TL;DR: It is important that all stakeholders, including managed care professionals, pharmacists, and practice administrators, understand how to incorporate trastuzumab biosimilars into formulary discussions, clinical care plans and processes, and educational initiatives for healthcare providers and patients.
Abstract: The approval of the humanized monoclonal antibody trastuzumab in 1998 changed the trajectory of treatment and subsequent outcomes for patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer and is now the standard of care in the neoadjuvant, adjuvant, and metastatic settings. However, as with most biologic drugs, trastuzumab comes with a relatively high price tag compared with traditional cytotoxic chemotherapy and contributes to healthcare budgets. Three engineered products related to trastuzumab-2 antibody-drug conjugates, ado-trastuzumab emtansine and fam-trastuzumab deruxtecan-nxki, as well as the subcutaneous trastuzumab/hyaluronidase-have since been approved and have expanded the treatment options for this patient population. The approval of 5 trastuzumab biosimilars as of the end of 2019 holds the promise of considerable cost savings, but challenges to integrating their use into patient care must be addressed. Barriers to their use, including physician uncertainty to switch patients from the reference drug to the therapeutic biosimilar and patients' lack of understanding about biosimilars, are common in the United States. It is also important that all stakeholders, including managed care professionals, pharmacists, and practice administrators, understand how to incorporate trastuzumab biosimilars into formulary discussions, clinical care plans and processes, and educational initiatives for healthcare providers and patients.

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TL;DR: Reforming the United States' outdated system of state-based medical licensure can help meet patient demand for virtual care services and improve access to care in rural and medically underserved areas.
Abstract: Telemedicine offers a promising solution to the growing physician shortage, but state-based medical licensing poses a significant barrier to the widespread adoption of telemedicine services. We thus recommend a mutual recognition scheme whereby states honor each other's medical licenses. Successfully implementing mutual recognition requires policy, technological, and administrative changes, including a federal mandate for states to participate in mutual recognition, consistent standards for using and regulating telemedicine, a mechanism to enable interstate data sharing, financial support for states, and a "state of principal license" requirement for physicians. Reforming the United States' outdated system of state-based medical licensure can help meet patient demand for virtual care services and improve access to care in rural and medically underserved areas.

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TL;DR: Findings show inadequate MDPP access, with relatively few suppliers and locations where beneficiaries can receive services, and strategies to facilitate access are urgently needed.
Abstract: Objectives The Medicare Diabetes Prevention Program (MDPP) launched in April 2018, offering an unprecedented opportunity to reach the estimated 483% of older adults with prediabetes Success of the innovative policy is likely to depend on adequate supplier availability We examined supplier data from CMS to assess beneficiaries' potential access to MDPP services Study design We conducted a descriptive analysis of MDPP suppliers using data extracted from the CMS registry of suppliers as of July 2019 and data about beneficiary populations Methods Identifying the location, type, and number of MDPP suppliers and their respective sites, including within states, US territories, and the District of Columbia (hereafter, states), we mapped geographic coverage of MDPP access Results There are 126 unique supplier organizations that offer the MDPP across 601 sites, equating to only 1 site per 100,000 Medicare beneficiaries Seventy-five percent of states have no MDPP sites, fewer than 1 site per 100,000 beneficiaries, and/or availability limited to a single municipality Although only 103% of MDPP suppliers are community-based organizations, they represent more than half (557%) of sites where beneficiaries can access the program Conclusions Findings show inadequate MDPP access, with relatively few suppliers and locations where beneficiaries can receive services Insufficient reimbursement relative to costs for suppliers may largely account for limited availability Strategies to facilitate access are urgently needed, which may include partnering with large organizations for greater per capita reach and rural organizations for broader geographic coverage, along with setting fiscally sustainable rates based on refined program implementation and cost analysis

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TL;DR: Policy makers need to create programs and policies that facilitate physician-led ACOs' success by helping them develop the capacity to take on risk, finance investments in high-value healthcare, and partner with other organizations to provide the full spectrum of care.
Abstract: Because hospitals and health systems sponsored the majority of new accountable care organizations (ACOs) from 2010 to 2015, they influenced priorities and strategies of the policies designed to drive ACO adoption. In recent years, however, the majority of new ACOs have been sponsored by physician groups. This shift means that policies need to be developed with the characteristic strengths and weaknesses of physician-led ACOs in mind. Using data from the Leavitt Partners ACO database, we analyzed the types of providers becoming ACOs over time to look at their numbers and market potential. Because the market potential for further growth of physician group-led ACOs is much stronger than for hospital- or health system-led ACOs, policy makers need to create programs and policies that facilitate physician-led ACOs' success by helping them develop the capacity to take on risk, finance investments in high-value healthcare, and partner with other organizations to provide the full spectrum of care.