In the midst of the pandemic, many companies have started marketing diagnostic and serological COVID-19 tests directly to consumers. Such direct-to-consumer (DTC) tests can be initiated by consumers, typically through the company’s website. The sample can be collected at home or in a laboratory, with no or little direct involvement from a health care provider. About a dozen companies have received emergency use authorization (EUA) for diagnostic DTC COVID-19 tests and at least two for serological testing. In our recent article published in the Journal of Law and the Biosciences, we argue that while this type of testing may have a number of benefits, it also raises significant ethical and regulatory concerns, which become particularly urgent due to the scale of the present pandemic.
Over the last decade, there has been considerable focus on programs targeted at reducing the acute health care use of those with the highest health care needs. The logic here is straightforward. If we want to reduce preventable emergency department (ED) visits and hospitalizations, and their associated costs, we should focus on improving care for individuals who use the ED and hospital the most. However, the counter argument is that if we were to direct those resources to lower-risk populations we could see greater health improvements for a larger number of people.
Institutional Review Boards (IRBs) — or “Research Ethics Committees” (RECs) outside the United States—are charged with protecting human research subjects. However, the quality of IRB performance is rarely subject to the same scrutiny that the boards themselves apply to research projects. In AJOB Empirical Bioethics, we conducted the first systematic analysis of 10 IRB quality measurement tools. We found widespread variability in their format, length, and content; a common emphasis on IRB structure and process; a general lack of attention to participant outcomes; and a failure to identify clear priorities for assessment.
Patients with cirrhosis have a high risk of post-operative mortality. As the burden of cirrhosis continues to rise in the United States, it is critical to ensure that we are properly assessing this risk for vulnerable patients prior to surgery. There are concerns in the hepatology and surgical communities that existing prediction tools tend to overestimate the risk, resulting in many patients being denied surgeries that might otherwise be safe to perform.
In a recent study in Hepatology, my colleagues and I developed and tested a novel risk prediction tool—the VOCAL-Penn score—to provide more accurate post-operative mortality predictions for patients with cirrhosis. Using national data of nearly 4,000 veterans with cirrhosis who underwent major surgeries, we compared the VOCAL-Penn Score to three existing tools: the model for end-stage liver disease (MELD), Child-Turcotte-Pugh (CTP), and the Mayo risk score.
The medical community has learned much about the novel coronavirus in the past seven months. We’ve learned about risk factors for severe illness, treatments that could benefit hospitalized patients, and the effectiveness of masks and social distancing to prevent spread of the infection. Yet many questions remain unanswered. One of those questions is why some patients with Covid-19 worsen several days after initially developing symptoms, in a pattern not characteristic of other viral illnesses.
In the Bulletin of the WHO recently, my colleagues Manu Mathur, Harald Schmidt, and I discuss the perception of oral health as a non-essential health care service and its subsequent exclusion from conceptions of Universal Health Coverage (UHC) around the world.
Many hospitals have been slow to improve nurse staffing, even as evidence mounts that nursing resources are associated with better outcomes, including lower rates of patient mortality, avoidable complications, and readmissions. One barrier has been the cost of more and better trained nurses: are the benefits worth it? According to a new study by LDI Senior Fellows, the answer is a resounding yes. The study, led by Karen Lasater, PhD, RN, confirmed that hospitals with better nursing resources achieved better outcomes for Medicare patients at no increased cost, even after accounting for additional nursing expenses.
In a new article in JAMA Network Open, my colleagues and I evaluated two different peer mentor models for patients with diabetes at the VA. In a randomized clinical trial, having a peer mentor marginally helped patients with high starting A1c values improve their glucose control, but these effects did not persist at 12 months. Using past mentees as mentors was not effective, especially if the past mentee had not improved their glucose control when they were a mentee.
The Merit-based Incentive Payment System (MIPS)—Medicare’s largest pay-for-performance program—has stoked controversy since its passage in 2015, with numerous groups calling for its repeal. Because of MIPS’ administrative complexity, the Medicare Payment Advisory Commission (MedPAC) and other stakeholders have speculated that it would not incentivize physicians to improve performance, nor would its scoring distinguish high quality providers or translate to meaningful quality improvement.
New evidence from the first year of the program suggests that these predictions were largely correct. In a recent Health Affairs study, my colleague Jordan Everson and I identify an unexpected issue with the program: providers skipping entire performance categories. Many of these providers nevertheless received positive payment adjustments, while simultaneously forgoing the meaningful quality improvement goals at the heart of MIPS and making its first year metrics unreliable for differentiating provider performance.
While this is certainly not the last word on how Medicare Advantage “special needs plans” (SNPs) affect outcomes for patients with end-stage renal disease (ESRD), it may just be the first. The above chart, from a new study in Health Affairs, compares 3-year unadjusted survival rates of patients with ESRD who switched into a Medicare SNP with similar patients who chose to stay within Medicare fee-for-service coverage. The results, after adjustment for clinical and sociodemographic factors, suggest that SNP enrollees had an average hazard ratio of 0.51, meaning that they were about half as likely as the control group to die at some time within three years.
Suspected opioid overdose deaths are surging during the COVID-19 pandemic, increasing by more than 40 percent in May and continuing to rise. Medications for opioid use disorder (MOUD)—specifically methadone and buprenorphine—cut mortality in half; however, only a minority of the two million people living with opioid use disorder (OUD) in the US receive MOUD. After the Affordable Care Act was implemented, treatment engagement expanded modestly. Yet, racial, income, and geographic inequities persist. Approximately 40 percent of counties do not have a buprenorphine prescriber, and Black patients are significantly less likely to have access to a buprenorphine provider compared to White patients. The economic, social, psychiatric, and emotional havoc of the COVID-19 pandemic has exacerbated an already worsening opioid crisis and highlighted the need for lower threshold access to evidence-based, life-saving OUD treatment. Moreover, the pandemic has disrupted traditional health care delivery methods, further limiting access to buprenorphine through established care settings.
As we approach the sixth month of widespread community transmission of COVID-19 in the United States, our focus must shift beyond acute management of disease to the broader effects of this pandemic on health and wellbeing. In particular, it is important that we understand the consequences of the COVID-19 pandemic on the mental health of children and adolescents. The rate of serious mental health illness in children has been escalating over the past two decades, with teen suicide rates more than doubling over the last ten years. The COVID-19 pandemic has led to significant financial and psychosocial stressors that are likely to increase the burden of mental health needs for youth.