Department of Medical Ethics and Health Policy
Now showing 1 - 10 of 13
PublicationA Pragmatic Analysis of the Regulation of Consumer Transcranial Direct Current Stimulation (TDCS) Devices in the United States(2015-10-01) Wexler, AnnaSeveral recent articles have called for the regulation of consumer transcranial direct current stimulation (tDCS) devices, which provide low levels of electrical current to the brain. However, most of the discussion to-date has focused on ethical or normative considerations; there has been a notable absence of scholarship regarding the actual legal framework in the United States. This article aims to fill that gap by providing a pragmatic analysis of the consumer tDCS market and relevant laws and regulations. In the five main sections of this manuscript, I take into account (a) the history of the do-it-yourself tDCS movement and the subsequent emergence of direct-to-consumer devices; (b) the statutory language of the Federal Food, Drug and Cosmetic Act and how the definition of a medical device—which focuses on the intended use of the device rather than its mechanism of action—is of paramount importance for discussions of consumer tDCS device regulation; (c) how both the Food and Drug Administration (FDA) and courts have understood the FDA's jurisdiction over medical devices in cases where the meaning of ‘intended use’ has been challenged; (d) an analysis of consumer tDCS regulatory enforcement action to-date; and (e) the multiple US authorities, other than the FDA, that can regulate consumer brain stimulation devices. Taken together, this paper demonstrates that rather than a ‘regulatory gap,’ there are multiple, distinct pathways by which consumer tDCS can be regulated in the United States. PublicationA Comprehensive Measure of the Costs of Caring for a Parent: Differences According to Functional Status(2018-10-01) Coe, Norma B; Skira, Meghan M; Larson, Eric BApproximately 34 million family and friends provided unpaid care to individuals aged 50 and older in 2015. It is difficult to place a value on that time, because no payment is made to the caregiver, and multiplying caregiving hours by a wage does not account for the value of lost leisure time, implications for future employability and wages, or any intrinsic benefits accrued to the care provider. This study used a dynamic discrete choice model to estimate the costs of informal care provided by a daughter to her mother, including these other costs and benefits not typically accounted for, and compared these cost estimates for 4 categories of the mother's functional status: doctor-diagnosed memory-related disease, limitations in activities of daily living (ADLs), combination of both, cannot be left alone for 1 hour or more. We studied women aged 40 to 70 with a living mother at the start of the sample period (N=3,427 adult daughters) using data from the Health and Retirement Study (1998-2012). The primary outcome was the monetized change in well-being due to caregiving, what economists call "welfare costs." We estimate that the median cost to the daughter's well-being of providing care to an elderly mother ranged from $144,302 to $201,896 over 2 years, depending on the mother's functional status. These estimates suggest that informal care cost $277 billion in 2011, 20% more than estimates that account only for current foregone wages. PublicationPatterns of Cost for Patients Dying in the Intensive Care Unit and Implications for Cost Savings of Palliative Care Interventions.(2016-11-01) Khandelwal, Nita; Benkeser, David; Coe, Norma B; Engelberg, Ruth A; Teno, Joan M; Curtis, J RandallBACKGROUND: Terminal intensive care unit (ICU) stays represent an important target to increase value of care. OBJECTIVE: To characterize patterns of daily costs of ICU care at the end of life and, based on these patterns, examine the role for palliative care interventions in enhancing value. DESIGN: Secondary analysis of an intervention study to improve quality of care for critically ill patients. SETTING/PATIENTS: 572 patients who died in the ICU between 2003 and 2005 at a Level-1 trauma center. METHODS: Data were linked with hospital financial records. Costs were categorized into direct fixed, direct variable, and indirect costs. Patterns of daily costs were explored using generalized estimating equations stratified by length of stay, cause of death, ICU type, and insurance status. Estimates from the literature of effects of palliative care interventions on ICU utilization were used to simulate potential cost savings under different time horizons and reimbursement models. MAIN RESULTS: Mean cost for a terminal ICU stay was 39.3K ± 45.1K. Direct fixed costs represented 45% of total hospital costs, direct variable costs 20%, and indirect costs 34%. Day of admission was most expensive (mean 9.6K ± 7.6K); average cost for subsequent days was 4.8K ± 3.4K and stable over time and patient characteristics. CONCLUSIONS: Terminal ICU stays display consistent cost patterns across patient characteristics. Savings can be realized with interventions that align care with patient preferences, helping to prevent unwanted ICU utilization at end of life. Cost modeling suggests that implications vary depending on time horizon and reimbursement models. PublicationEstimating the Effect of Palliative Care Interventions and Advance Care Planning on ICU Utilization: A Systematic Review(2015-05-01) Khandelwal, Nita; Kross, Erin K; Engelberg, Ruth A; Coe, Norma B; Long, Ann C; Curtis, J RandallOBJECTIVE: We conducted a systematic review to answer three questions: 1) Do advance care planning and palliative care interventions lead to a reduction in ICU admissions for adult patients with life-limiting illnesses? 2) Do these interventions reduce ICU length of stay? and 3) Is it possible to provide estimates of the magnitude of these effects? DATA SOURCES: We searched MEDLINE, EMBASE, Cochrane Controlled Clinical Trials, and Cumulative Index to Nursing and Allied Health Literature databases from 1995 through March 2014. STUDY SELECTION: We included studies that reported controlled trials (randomized and nonrandomized) assessing the impact of advance care planning and both primary and specialty palliative care interventions on ICU admissions and ICU length of stay for critically ill adult patients. DATA EXTRACTION: Nine randomized controlled trials and 13 nonrandomized controlled trials were selected from 216 references. DATA SYNTHESIS: Nineteen of these studies were used to provide estimates of the magnitude of effect of palliative care interventions and advance care planning on ICU admission and length of stay. Three studies reporting on ICU admissions suggest that advance care planning interventions reduce the relative risk of ICU admission for patients at high risk of death by 37% (SD, 23%). For trials evaluating palliative care interventions in the ICU setting, we found a 26% (SD, 23%) relative risk reduction in length of stay with these interventions. CONCLUSIONS: Despite wide variation in study type and quality, patients who received advance care planning or palliative care interventions consistently showed a pattern toward decreased ICU admissions and reduced ICU length of stay. Although SDs are wide and study quality varied, the magnitude of the effect is possible to estimate and provides a basis for modeling impact on healthcare costs. PublicationThe Social Context of “Do-It-Yourself” Brain Stimulation: Neurohackers, Biohackers, and Lifehackers(2017-05-01) Wexler, AnnaThe “do-it-yourself” (DIY) brain stimulation movement began in earnest in late 2011, when lay individuals began building stimulation devices and applying low levels of electricity to their heads for self-improvement purposes. To date, scholarship on the home use of brain stimulation has focused on characterizing the practices of users via quantitative and qualitative studies, and on analyzing related ethical and regulatory issues. In this perspective piece, however, I take the opposite approach: rather than viewing the home use of brain stimulation on its own, I argue that it must be understood within the context of other DIY and citizen science movements. Seen in this light, the home use of brain stimulation is only a small part of the “neurohacking” movement, which is comprised of individuals attempting to optimize their brains to achieve enhanced performance. Neurohacking itself is an offshoot of the “life hacking” (or “quantified self”) movement, in which individuals self-track minute aspects of their daily lives in order to enhance productivity or performance. Additionally, the home or DIY use of brain stimulation is in many ways parallel to the DIY Biology (or “biohacking”) movement, which seeks to democratize tools of scientific experimentation. Here, I describe the place of the home use of brain stimulation with regard to neurohackers, lifehackers, and biohackers, and suggest that a policy approach for the home use of brain stimulation should have an appreciation both of individual motivations as well as the broader social context of the movement itself. PublicationEvaluating the Economic Impact of Palliative and End-of-Life Care Interventions on Intensive Care Unit Utilization and Costs from the Hospital and Healthcare System Perspective.(2017-12-01) Khandelwal, Nita; Brumback, Lyndia C; Halpern, Scott D; Coe, Norma B; Brumback, Babette; Curtis, J RandallPurpose of report: Understanding the impact of palliative care interventions on intensive care unit (ICU) costs and utilization is critical for demonstrating the value of palliative care. Performing these economic assessments, however, can be challenging. The purpose of this special report is to highlight and discuss important considerations when assessing ICU utilization and costs from the hospital perspective, with the goal of providing recommendations on methods to consider for future analyses. FINDINGS: ICU length of stay (LOS) and associated costs of care are common and important outcome measures, but must be analyzed properly to yield valid conclusions. There is significant variation in costs by day of stay in the ICU with only modest differences between an ICU day at the end of a stay and the first day on the acute care floor; this variation must be appropriately accounted for analytically. Furthermore, reporting direct variable costs, in addition to total ICU costs, is needed to understand short-term and long-term impact of a reduction in LOS. Importantly, incentives for the hospital to realize savings vary depending on reimbursement policies. SUMMARY: ICU utilization and costs are common outcomes in studies evaluating palliative care interventions. Accurate estimation and interpretation are key to understanding the economic implications of palliative care interventions. PublicationLong-Term Care Insurance: Does Experience Matter?(2015-03-01) Coe, Norma B; Skira, Meghan M; Van Houtven, Courtney HaroldWe examine whether long-term care (LTC) experience helps explain the low demand for long-term care insurance (LTCI). We test if expectations about future informal care receipt, expectations about inheritance receipt, and LTCI purchase decisions vary between individuals whose parents or in-laws have used LTC versus those who have not. We find parental use of a nursing home decreases expectations that one's children will provide informal care, consistent with the demonstration effect. Nursing home use by in-laws does not have the same impact, suggesting that individuals are responding to information gained about their own aging trajectory. Nursing home use by either a parent or in-law increases LTCI purchase probability by 0.8 percentage points, with no significant difference in response between parents' and in-laws' use. The estimated increase in purchase probability from experience with LTC is about half the previously estimated increase from tax policy-induced price decreases. PublicationRetirement Effects on Health in Europe(2011-01-01) Coe, Norma B; Zamarro, GemaWhat are the health impacts of retirement? As talk of raising retirement ages in pensions and social security schemes continues around the world, it is important to know both the costs and benefits for the individual, as well as the governments' budgets. In this paper we use the Survey of Health, Ageing and Retirement in Europe (SHARE) dataset to address this question in a multi-country setting. We use country-specific early and full retirement ages as instruments for retirement behavior. These statutory retirement ages clearly induce retirement, but are not related to an individual's health. Exploiting the discontinuities in retirement behavior across countries, we find significant evidence that retirement has a health-preserving effect on overall general health. Our estimates indicate that retirement leads to a 35 percent decrease in the probability of reporting to be in fair, bad, or very bad health, and an almost one standard deviation improvement in the health index. While the self-reported health seems to be a temporary impact, the health index indicates there are long-lasting health differences. PublicationPotential Influence of Advance Care Planning and Palliative Care Consultation on ICU Costs for Patients With Chronic and Serious Illness.(2016-08-01) Khandelwal, Nita; Benkeser, David C; Coe, Norma B; Curtis, J RandallOBJECTIVES: To estimate the potential ICU-related cost savings if in-hospital advance care planning and ICU-based palliative care consultation became standard of care for patients with chronic and serious illness. DESIGN AND SETTING: Decision analysis using literature estimates and inpatient administrative data from Premier. PATIENTS: Patients with chronic, life-limiting illness admitted to a hospital within the Premier network. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Using Premier data (2008-2012), ICU resource utilization and costs were tracked over a 1-year time horizon for 2,097,563 patients with chronic life-limiting illness. Using a Markov microsimulation model, we explored the potential cost savings from the hospital system perspective under a variety of scenarios by varying the interventions' efficacies and availabilities. Of 2,097,563 patients, 657,825 (31%) used the ICU during the 1-year time horizon; mean ICU spending per patient was 11.3k (SD, 17.6k). In the base-case analysis, if in-hospital advance care planning and ICU-based palliative care consultation were systematically provided, we estimated a mean reduction in ICU costs of 2.8k (SD, 14.5k) per patient and an ICU cost saving of 25%. Among the simulated patients who used the ICU, the receipt of both interventions could have resulted in ICU cost savings of 1.9 billion, representing a 6% reduction in total hospital costs for these patients. CONCLUSIONS: In-hospital advance care planning and palliative care consultation have the potential to result in significant cost savings. Studies are needed to confirm these findings, but our results provide guidance for hospitals and policymakers. PublicationFamily Structure and Long-Term Care Insurance Purchase(2015-03-01) Van Houtven, Courtney Harold; Coe, Norma B; Konetzka, R TamaraWhile it has long been assumed that family structure and potential sources of informal care play a large role in the purchase decisions for long-term care insurance (LTCI), current empirical evidence is inconclusive. Our study examines the relationship between family structure and LTCI purchase and addresses several major limitations of the prior literature by using a long panel of data and considering modern family relationships, such as the presence of stepchildren. We find that family structure characteristics from one's own generation, particularly about one's spouse, are associated with purchase, but that few family structure attributes from the younger generation have an influence. Family factors that may indicate future caregiver supply are negatively associated with purchase: having a coresidential child, signaling close proximity, and having a currently working spouse, signaling a healthy and able spouse, that long-term care planning has not occurred yet or that there is less need for asset protection afforded by LTCI. Dynamic factors, such as increasing wealth or turning 65, are associated with higher likelihood of LTCI purchase.