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Tuesday, October 22, 2019

States prepare for the ACA to be invalidated

While a panel of federal judges deliberates on the constitutionality of the ACA, many states are bracing themselves for the fallout if the healthcare law is overturned, The Wall Street Journal reports.
A panel of three judges in the 5th Circuit Court of Appeals heard oral arguments in the case July 9. A decision is expected as soon as this month. If the judges rule the law unconstitutional, the Trump administration has indicated it will seek a stay of enforcement, temporarily delaying potential changes. In this case, the decision will likely be appealed and sent to the Supreme Court, pushing any potential changes into 2020. HHS Secretary Alex Azar confirmed that a ruling would be stayed with The Wall Street Journal. “Our message is to keep calm and carry on,” he said, according to the report.
Nonetheless, due to legislative timelines, many states are already lining up contingency plans, according to the report. At least 11 states, including Louisiana, Indiana and Texas, have already passed laws to improve protections for people with preexisting conditions, The Wall Street Journal reports. This includes mandates for coverage and high-risk pools, which pay insurers subsidies for covering people with costly medical conditions.
Colorado is creating a state-based public option for people who currently buy individual plans on the ACA’s exchanges. And Nevada is planning a patient-protection commission, which would advise the state on how to protect coverage if needed, according to the report.
https://www.beckershospitalreview.com/hospital-management-administration/states-prepare-for-the-aca-to-be-invalidated.html

When a freestanding emergency department comes to town, costs go up

Rather than functioning as substitutes for hospital-based emergency departments, freestanding emergency departments have increased local market spending on emergency care in three of four states’ markets where they have entered, according to a new paper by experts at Rice University.
State policymakers and researchers should carefully track spending and use of emergency care as freestanding emergency departments disseminate, to better understand their potential health benefits and cost implications for patients, the researchers said. The study appears in the journal Academic Emergency Medicine.
Freestanding emergency departments deliver emergency care in a facility that is physically separate from an acute care hospital. They are commonly found in strip malls in urban parts of Texas.
“Proponents of freestanding emergency departments claim that these facilities can relieve the burden of overcrowded waiting rooms in hospital-based emergency departments,” said Vivian Ho, lead author and the James A. Baker III Institute Chair in Health Economics and director of the Center for Health and Biosciences at Rice’s Baker Institute for Public Policy. “We sought to test whether these facilities increase spending, because they might serve as supplements to traditional emergency departments rather than substitutes.”
There have been numerous stories in the media of patients seeking care in these facilities, who were shocked when they later received bills totaling thousands of dollars.
“Consumers mistakenly thought that freestandings would be low-cost because they look so much like a neighborhood clinic, and facility staff often told patients that their care would be covered by their health insurance, when in fact it wasn’t,” said Ho, who is also a professor of economics at Rice and a professor of medicine at Baylor College of Medicine.
The researchers accessed the de-identified claims data for 2013 through 2017 from Arizona, Florida, North Carolina and Texas through Rice’s participation in the Blue Cross Blue Shield Alliance for Health Research, which was established to engage leading U.S. health care researchers in collaborative efforts to explore critical health care issues. The collaboration provides researchers with access to HIPAA-compliant data from Blue Cross Blue Shield Axis, the largest collection of commercial insurance claims, medical professional and cost of care information, through a secure data portal.
They chose to examine claims from these four states, because BCBS has a relatively large market presence in them, and they also experienced significant entry of freestanding emergency departments in the past few years. The researchers aggregated the information on emergency department spending (both at hospitals and freestanding emergency departments) into 495 different local markets (Public Use Microdata Areas, or PUMAs) by quarter and year.
They then merged the spending data with counts of freestanding emergency departments by quarter and year in each local market, as well as demographic characteristics of the population in each PUMA. Finally, the researchers applied regression analysis to track changes in average emergency department spending as freestanding emergency department entry increased over time in each local market, controlling for sociodemographic changes that also occurred during the study period.
The researchers found that entry of an additional freestanding emergency department in a local market was associated with a 3.6 percentage point increase in emergency provider reimbursement per insured beneficiary in Texas, Florida and North Carolina. There was no change in spending associated with a freestanding emergency department’s entry in Arizona. Entry of an additional freestanding emergency department was associated with an increase in emergency department utilization in Texas, Florida and Arizona, but not in North Carolina. The implied increases in utilization varied between roughly 3 and 5%. The estimated out-of-pocket payments for emergency care increased 3.6% with the entry of a freestanding emergency department in Texas, Florida and Arizona, but declined by 15.3 percentage points in North Carolina.
“Health care continues to account for an increasing share of the U.S. economy, and emergency care spending as a share total health care costs is also rising,” Ho said. “Therefore it is troubling that in three of four states, entry of freestanding emergency departments results in higher spending, which may not yield significant health benefits. Given that previous studies suggest that much care provided by freestanding emergency departments could be delivered in lower-cost settings, policy makers should carefully regulate entry of these providers as well as their billing practices.”
“We are pleased to bring transparency and insights to critical health issues, such as the rising cost of emergency care, and to work alongside Rice University and the eight other prestigious institutions participating in the Blue Cross Blue Shield Alliance for Health Research,” said Maureen Sullivan, chief strategy and innovation officer for the Blue Cross Blue Shield Association. “Our priority is to make the data available so we can generate meaningful solutions that improve quality of care and affordability for all Americans.”
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The paper, “Freestanding Emergency Department Entry and Market-Level Spending on Emergency Care,” was co-authored by Rice economics doctoral student Yingying Xu and Dr. Murtaza Akhter, assistant professor of emergency medicine at the University of Arizona College of Medicine-Phoenix.

Solution to Gulf War Illness found in FDA-approved antiviral drugs

A recent study led by scientists at the University of South Carolina’s Arnold School of Public Health has shown that adjusting GI tract viruses by repurposing existing FDA-approved antiviral drugs offers a route for effective treatment for Gulf War Illness and its myriad of symptoms. Their findings were published in the journal, Viruses.
Previously, UofSC researchers have determined that chemical exposure from the Gulf War altered the balance between the viruses and bacteria that naturally occur in the human GI tract, resulting in Gulf War Illness.
Symptoms of Gulf War Illness include gastrointestinal disturbances, , widespread pain, chronic headaches, respiratory/sleep problems and neurological problems in memory and learning. This illness has plagued more than 200,000 Persian Gulf veterans over the past three decades.
“Our own viruses interact with bacteria in the gut to maintain a healthy body and mind,” says Saurabh Chatterjee, associate professor of environmental health sciences and director of the Environmental Health & Disease Laboratory, who led the study. “If we can tweak our own host viruses and their interactions with gut bacteria, then we can treat the disease symptoms of Gulf War Illness. With our most recent research, we have shown that that are already in use can be a great starting point for curing the disease and helping thousands of veterans improve their quality of life.”
Previous research has already established the link between military deployment during the 1990-1991 Persian Gulf War and numerous chronic health symptoms and disorders. Even today, GWI affects 25-33 percent of the 700,000 United States veterans who served in the first Gulf War. Soldiers deployed in subsequent wars have also reported similar immune system or neurological disorders. The chronic persistence and/or worsening of these individuals’ symptoms has proven challenging for both patients and clinicians to fully understand and manage.
By utilizing existing antiviral drugs for treatment, clinicians can begin testing these FDA-approved medications in patient cohorts at an accelerated pace compared to the lengthy timeline associated with traditional pharmaceutical drug trials. This novel approach (i.e., restoring the balance between viruses and bacteria in the GI tract in order to improve symptoms throughout the body) also offers hope to the , who may suffer from GI disturbances, such as irritable bowel syndrome, or neurological problems, such as learning or memory deficits.
https://medicalxpress.com/news/2019-10-scientists-solution-gulf-war-illness.html

Blood factor involved in weight loss and aging

Aging is a process that affects all functions of the human body, particularly brain function. However, aging can be delayed through lifestyle changes (physical exercise, restricting calorie intake, etc.). Researchers at the Institut Pasteur and CNRS have elucidated the properties of a molecule in the blood—GDF11—whose mechanisms were previously unknown. In a mouse model, they showed that this molecule could mimic the benefits of certain calorie restrictions—dietary regimens that have proven their efficacy in reducing cardiovascular disease, preventing cancer and increasing neurogenesis in the brain. The results of this research were published in the journal Aging Cell on October 22, 2019.
Today it is possible to maintain a healthy brain in the long term. For the past 30 years, it has been generally acknowledged that certain diet restrictions such as intermittent fasting can improve cognitive performance and extend life expectancy in several species. It has also been proven that calorie restriction (a reduction in of 20% to 30% while preserving nutritional quality) reduces the risk of and cancer, while increasing production of new neurons in the brain.
In a previous study using mouse models, scientists observed that injecting aged mice with from young mice rejuvenated in the brain, and consequently improved cerebral blood flow, while increasing neurogenesis and cognition . Scientists in the Perception and Memory Unit (Institut Pasteur/CNRS) put forward the theory that, since calorie restriction and supplementation with young blood were effective in rejuvenating organs, they most likely have certain mechanisms in common.
They therefore examined the molecule GDF11, which belongs to the GDF (Growth Differentiation Factor) protein family and is involved in embryonic development. GDF11 was already known to scientists for its ability to rejuvenate the aged brain. “By injecting this molecule into aged mouse models, we noticed an increase in neurogenesis and blood vessel remodeling,” explains Lida Katsimpardi, a scientist in the Perception and Memory Unit and lead author of the study. The scientists also observed that the mice administered with GDF11 had lost weight without changing their appetite. This observation led them to believe that GDF11 could be a link between calorie restriction and the regenerating effects of young blood.
The next step was to confirm this theory by studying adiponectin, a hormone secreted by adipose tissue which induces weight loss without affecting appetite. In animals that have undergone calorie restriction, the blood levels of this hormone are high. “In animals that were administered GDF11, we also observed high levels of adiponectin”, emphasizes Lida Katsimpardi, “and this shows that GDF11 causes metabolic changes similar to those induced by calorie restriction.”
Until recently, there has been controversy over the role of GDF11 in aging, and its mechanisms were largely unknown. The findings of this study show that by inducing phenomena similar to those reported for leading to the stimulation of adiponectin and neurogenesis, GDF11 contributes to the birth of new neurons in the brain. “These findings are encouraging and support therapeutic uses of GDF11 in certain metabolic diseases, such as obesity, and ,” concludes Pierre-Marie Lledo, CNRS researcher, Head of the Institut Pasteur’s Perception and Memory Unit and last author of the study.

Explore further
Researchers make link between genetics, aging

More information: Lida Katsimpardi et al, Systemic GDF11 stimulates the secretion of adiponectin and induces a calorie restriction‐like phenotype in aged mice, Aging Cell (2019). DOI: 10.1111/acel.13038

A ‘shocking’ new way to treat infections

Titanium has many properties that make it a great choice for use in implants. Its low density, high stiffness, high biomechnanical strength-to-weight ratio, and corrosion resistance have led to its use in several types of implants, from dental to joints. However, a persistent problem plagues metal-based implants: the surface is also a perfect home for microbes to accumulate, causing chronic infections and inflammation in the surrounding tissue. Consequently, five to 10 percent of dental implants fail and must be removed within 10-15 years to prevent infection in the blood and other organs.
New research from the University of Pittsburgh’s Swanson School of Engineering introduces a revolutionary treatment for these infections. The group, led by Tagbo Niepa, Ph.D., is utilizing electrochemical therapy (ECT) to enhance the ability of antibiotics to eradicate the microbes.
“We live in a crisis with antibiotics: most of them are failing. Because of the drug- resistance that most microbes develop, antimicrobials stop working, especially with recurring infections,” says Dr. Niepa, author on the paper and assistant professor of chemical and petroleum engineering at the Swanson School, with secondary appointments in civil and environmental engineering and bioengineering. “With this technique, the current doesn’t discriminate as it damages the microbe cell membrane. It’s more likely that antibiotics will be more effective if the cells are simultaneously challenged by the permeabilizing effects of the currents. This would allow even drug-resistant cells to become susceptible to treatment and be eradicated.”
The novel method passes a weak electrical current through the metal-based , damaging the attached microbe’s cell membrane but not harming the surrounding healthy tissue. This damage increases permeability, making the microbe more susceptible to antibiotics. Since most antibiotics specifically work on cells that are going to replicate, they do not work on dormant microbes, which is how infections can recur. The ECT causes electrochemical stress in all the cells to sensitize them, making them more susceptible to antibiotics.
The researchers hope this technology will change how infections are treated. Researchers focused their research on Candida albicans (C. albicans), one of the most common and harmful fungal infections associated with . But while dental implants are one exciting application for this new technology, Niepa says it has other potential applications, such as in wound dressings.
The paper, “Electrochemical Strategy for Eradicating Fluconazole-Tolerant Candida albicans using Implantable Titanium,” was published in the journal ACS Applied Materials & Interfaces.

Explore further
Study: Antibiotics destroy immune cells and worsen oral infection

More information: Eloise Eyo Parry-Nweye et al, Electrochemical Strategy for Eradicating Fluconazole-Tolerant Candida albicans using Implantable Titanium, ACS Applied Materials & Interfaces (2019). DOI: 10.1021/acsami.9b09977

DEA to accept vape products at next Prescription Drug Take Back Day

The U.S. Drug Enforcement Administration announced on Tuesday that it is expanding its successful National Prescription Drug Take Back Day initiative to accept vaping devices and cartridges.
The Take Back program was initiated in 2010 with the intent of removing expired, unused and unwanted prescription drugs from homes where they could be misused, stolen or abused, especially by children and teens.
The DEA said it has collected a total of more than 11 million pounds, almost 6,000 tons, of expired, unused and unwanted prescription medications since the program began. This year’s nationwide event, set for Oct. 26, marks the first time the program has accepted vaping products.
“DEA’s National Prescription Drug Take Back Initiative helps get unused and unwanted prescription medications out of circulation and ensures their safe disposal,” said Acting Administrator Uttam Dhillon. “This year, we are taking a step further by accepting vaping devices and cartridges as we work with our federal partners to combat this emerging public health threat to the nation’s youth.”
Due to safety and environmental concerns, the DEA points out that it cannot accept devices containing lithium ion batteries and encourages individuals to remove the batteries from the devices before turning them in.
https://www.nbcnews.com/politics/politics-news/dea-accept-vaping-products-next-national-prescription-drug-take-back-n1070081

Macrogenics med shows survival benefit in late-stage breast cancer study

A second pre-planned interim overall survival (OS) analysis of a Phase 3 clinical trial, SOPHIA, evaluating MacroGenics’ (NASDAQ:MGNX) margetuximab, an HER2-targeting monoclonal antibody, plus chemo compared to Roche’s Herceptin (trastuzumab) plus chemo in patients with HER2-positive metastatic breast cancer showed a median increase of 1.8 months (21.6 months vs. 19.8 months).
The final pre-specified OS analysis should happen in 2020 after 385 events (deaths) have occurred.
On the safety front, the rate of serious/life-threatening treatment-related adverse events was 55% in the margetuximab arm compared to 53% in the trastuzumab arm.
Detailed results from the second OS analysis will be presented at the San Antonio Breast Cancer Symposium in December.
https://seekingalpha.com/news/3508121-macrogenics-margetuximab-shows-survival-benefit-late-stage-breast-cancer-study