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After three years of research, revision and debates, a town in Northern Westchester voted unanimously to adopt restrictions limiting the generic levitra for sale usage of gas-powered leaf blowers within their community. The new legislation approved in New Castle aims to reduce emissions and noise pollution, and will only prohibit the usage of the equipment between June 1 and Sept. 30, starting generic levitra for sale in 2021. New Castle joins Yonkers, Bedford, Mamaroneck and most recently the village of Larchmont among Westchester communities enacting similar measures.The ban on the usage of gas-powered leaf blowers in the manicuring of Chappaqua Central School District’s &.

Town of New Castle’s recreational fields, tennis courts, country clubs’ tennis courts, homeowner associations’ tennis courts, swim clubs’ tennis courts, golf, courses, and cemeteries. However, according to the wording of the ordinance, this usage will be "minimized to the maximum extent practicable."The town's administrator will also have the ability to allow the usage of gas-powered leaf blowers on a case-by-case generic levitra for sale basis. Officials hope that area residents will switch out their gas-powered blowers for electric ones, listing affordable electric alternatives in a presentation on the new law and suggesting a future partnership with the American Green Zone Alliance or Sustainable Westchester to devise a trade-in program for residents. According to the town board's presentation, area residents who have asked their landscapers to switch to electric leaf blowers "have found no visual difference in their property appearance" and have only experienced a slight increase in their property maintenance costs.

Now, the board aims to post mailers, fliers and generic levitra for sale signs placed throughout town notifying residents about the ordinance. They are also developing an educational seminars to present to property owners and landscapers in the community. Click here to sign up for Daily Voice's free daily emails and news alerts..

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As flu season levitra professional vs levitra creeps up on the Northern Hemisphere, cold and flu relief medications will inevitably fly off store shelves. A natural remedy that shoppers might reach for is elderberry, a small, blackish-purple fruit that companies turn into syrups, lozenges and gummies. Though therapeutic uses of the berry date back centuries, Michael Macknin, a pediatrician at the Cleveland Clinic, hadn’t heard of levitra professional vs levitra using elderberry to treat the flu until a patient’s mother asked him about it. Some industry-sponsored research claims that the herbal remedy could cut the length of the symptoms by up to four days.

For a comparison, Tamiflu, an FDA-approved treatment, only reduces flu duration by about a single day levitra professional vs levitra. €œI said, 'Gee, if that’s really true [about elderberry], it would be a huge benefit,'” Macknin says. But the effectiveness and safety of elderberry is still fairly unclear. Unlike the over-the-counter medicines at your local pharmacy, elderberry hasn't levitra professional vs levitra been through rigorous FDA testing and approval.

However, Macknin and his team recently published a study in the Journal of General Internal Medicine, which found that elderberry treatments did nothing for flu patients. This prompts a need for further studies into the remedy — work levitra professional vs levitra that unfortunately stands a low chance of happening in the future, Macknin says. Looking For ProofElderberries are full of chemicals that could be good for your health. Like similar fruits, the berries contain high levitra professional vs levitra levels of antioxidants, compounds that shut down reactions in our bodies that damage cells.

But whether or not elderberry's properties also help immune systems fend off a virus is murky. There are only a handful of studies that have examined if elderberries reduced the severity or duration of the flu. And though some of the work prior to Macknin’s was well-designed and supported this herbal remedy as a helpful flu aid, at least some — and potentially all — of levitra professional vs levitra those studies were funded by elderberry treatment manufacturers.Macknin says an elderberry supplement company provided his team with their products and a placebo version for free, but that the company wasn’t involved in the research beyond that. Macknin's study is the largest one conducted on elderberry to date, with 87 influenza patients completing the entire treatment course.

Participants in the study were also welcome to take Tamiflu, for ethical reasons, as the team didn’t want to exclude anyone from taking a proven flu levitra professional vs levitra therapy. Additionally, each participant took home either a bottle of elderberry syrup or the placebo with instructions on when and how to take it. The research team called participants every day for a symptom check and to remind them to take their medication.By chance, it turned out that a levitra professional vs levitra higher percentage of the patients given elderberry syrup had gotten their flu shot and also chose to take Tamiflu. Since the vaccination can reduce the severity of infection in recipients who still come down with the flu, the study coincidentally operated in favor of those who took the herbal remedy, Macknin says.

Those patients could have dealt with a shorter, less-intense illness because of the Tamiflu and vaccination. €œEverything was stacked to have it turn out better [for the elderberry group],” Macknin says, “and it levitra professional vs levitra turned out the same.” The researchers found no difference in illness duration or severity between the elderberry and placebo groups. While analyzing the data, the team also found that those on the herbal treatment might have actually fared worse than those on the placebo. The potential for this levitra professional vs levitra intervention to actually harm instead of help influenza patients explains why Macknin thinks the therapy needs further research.But, don't expect that work to happen any time soon.

Researchers are faced with a number of challenges when it comes to studying the efficacy of herbal remedies. For starters, there's little financial incentive levitra professional vs levitra to investigate if they actually work. Plant products are challenging to patent, making them less lucrative prospects for pharmaceutical companies or research organizations to investigate. Additionally, investigations that try and prove a proposed therapy as an effective drug — like the one Macknin and his team accomplished — are expensive, Macknin says.

Those projects need FDA oversight levitra professional vs levitra and additional paperwork, components that drive up study costs. €œIt’s extraordinarily expensive and there’s no money in it for anybody,” Macknin says.Talk To Your DoctorUltimately, research on elderberry therapies for flu patients is a mixed bag, and deserves more attention from scientists. However, if you still want to discuss elderberry treatments for the flu with your doctor, that’s a conversation you should levitra professional vs levitra feel comfortable having, says Erica McIntyre, an expert focused on health and environmental psychology in the School of Public Health at the University of Technology Sydney. Navigating what research says about a particular herbal medicine is challenging for patients and health practitioners alike.

The process is made more complex by the range of similar-sounding products on the market levitra professional vs levitra that lack standardized ingredients, McIntyre says. But when doctors judge or shame patients for asking about non-conventional healthcare interventions, the response can distance people and push them closer to potentially unproven treatments. Even worse, those individuals might start to keep their herbal remedies a secret. €œIt is that fear about being judged for use of that levitra professional vs levitra medication,” McIntyre says, that drives up to 50 percent of people taking herbal treatments to withhold that information from healthcare practitioners.

That’s a dangerous choice, as some herbal and traditional medications can interact and cause health problems.If a physician shames someone for asking about alternative medicines, it’s likely time to find a new doctor, McIntyre says. Look for someone who will listen to your concerns — whether it's that you feel traditional treatments haven’t worked for you, or that levitra professional vs levitra you didn’t like the side effects, the two common reasons people pursue herbal treatments in the first place. €œYou’re not necessarily looking for a doctor that will let you do whatever you want,” McIntyre says, “but that they actually consider you as a patient, your treatment choices and your treatment priorities, and communicate in a way that’s supportive.” And if a doctor suggests that you avoid a treatment you’re interested in, ask why. They generally have a good reason, McIntyre says.For now, know that even if your doctor doesn’t support you taking elderberry, there are other proven preventative measures that are worth your while — like the flu shot.

Anyone six months or older should get it, Macknin says, and stick to the levitra professional vs levitra protocols we’re used to following to prevent COVID-19 infections, like social distancing, mask-wearing and hand-washing. Those measures also help prevent flu transmission, too — something, so far, no elderberry supplement package can claim.The yearly influenza season threatens to make the COVID-19 pandemic doubly deadly, but I believe that this isn’t inevitable.There are two commonly given vaccines – the pneumococcal vaccine and the Hib vaccine – that protect against bacterial pneumonias. These bacteria complicate both influenza and COVID-19, often leading levitra professional vs levitra to death. My examination of disease trends and vaccination rates leads me to believe that broader use of the pneumococcal and Hib vaccines could guard against the worst effects of a COVID-19 illness.I am an immunologist and physiologist interested in the effects of combined infections on immunity.

I have reached my levitra professional vs levitra insight by juxtaposing two seemingly unrelated puzzles. Infants and children get SARS-CoV-2, the virus that causes COVID-19, but very rarely become hospitalized or die. And case numbers and death rates from COVID-19 began varying greatly from nation to nation and city to city even before lockdowns began. I wondered why.One night I woke levitra professional vs levitra up with a possible answer.

Vaccination rates. Most children, beginning at levitra professional vs levitra age two months, are vaccinated against numerous diseases. Adults less so. And, both infant and adult levitra professional vs levitra vaccination rates vary widely across the world.

Could differences in the rates of vaccination against one or more diseases account for differences in COVID-19 risks?. As someone who had previously investigated other pandemics such as the Great Flu Pandemic of 1918-19 and AIDS, and who has worked with vaccines, I had a strong background for tracking down the relevant data to test my hypothesis.Pneumococcal Vaccination Rates Correlate With Lower COVID-19 Cases and DeathsI gathered national and some local data on vaccination rates against influenza, polio, measles-mumps-rubella (MMR), diphtheria-tetanus-pertussis (DTP), tuberculosis (BCG), pneumococci and Haemophilus influenzae type B (Hib). I correlated them with COVID-19 case rates and death rates for 24 levitra professional vs levitra nations that had experienced their COVID-19 outbreaks at about the same time. I controlled for factors such as percentage of the population who were obese, diabetic or elderly.I found that only pneumococcal vaccines afforded statistically significant protection against COVID-19.

Nations such as Spain, Italy, Belgium, Brazil, Peru and Chile that have the highest levitra professional vs levitra COVID-19 rates per million have the poorest pneumococcal vaccination rates among both infants and adults. Nations with the lowest rates of COVID-19 – Japan, Korea, Denmark, Australia and New Zealand – have the highest rates of pneumococcal vaccination among both infants and adults.A recent preprint study (not yet peer-reviewed) from researchers at the Mayo Clinic has also reported very strong associations between pneumococcal vaccination and protection against COVID-19. This is especially true levitra professional vs levitra among minority patients who are bearing the brunt of the coronavirus pandemic. The report also suggests that other vaccines, or combinations of vaccines, such as Hib and MMR may also provide protection.These results are important because in the U.S., childhood vaccination against pneumococci – which protects against Streptococcus pneumoniae bacteria – varies by state from 74% to 92%.

Although the CDC recommends that all adults 18-64 in high risk groups for COVID-19 and all adults over the age of 65 get a pneumococcal vaccination, only 23% of high-risk adults and 64% of those over the age of 65 do so.Similarly, although the CDC recommends at all infants and some high-risk adults be vaccinated against Haemophilus influenzae type B (Hib), only 80.7% of children in the U.S. And a handful of immunologically compromised adults levitra professional vs levitra have been. Pneumococcal and Hib vaccination rates are significantly lower in minority populations in the U.S. And in countries that have been hit harder by COVID-19 than the U.S.Based on these data, I advocate universal pneumococcal and Hib vaccination among children, at-risk adults and all adults over 65 to prevent serious COVID-19 levitra professional vs levitra disease.Left.

Combined rates of childhood and adult (over 65) pneumococcal vaccination (out of a possible 200). Right. Cases (per million) population of COVID-19 at about 90 days into the pandemic for 24 nations. Nations with high pneumococcal vaccination rates have low COVID-19 case rates.

(Credit. CC BY-SA)How Pneumococcal Vaccination Protects Against COVID-19Protection against serious COVID-19 disease by pneumococcal and Hib vaccines makes sense for several reasons. First, recent studies reveal that the majority of hospitalized COVID-19 patients, and in some studies nearly all, are infected with streptococci, which causes pneumococcal pneumonias, Hib or other pneumonia-causing bacteria. Pneumococcal and Hib vaccinations should protect coronavirus patients from these infections and thus significantly cut the risk of serious pneumonia.I also found that pneumococcal, Hib and possibly rubella vaccines may confer specific protection against the SARS-CoV-2 virus that causes COVID-19 by means of “molecular mimicry.”Molecular mimicry occurs when the immune system thinks one microbe looks like another.

In this case, proteins found in pneumococcal vaccines and, to a lesser degree, ones found in Hib and rubella vaccines as well look like several proteins produced by the SARS-CoV-2 virus.Two of these proteins found in pneumococcal vaccines mimic the spike and membrane proteins that permit the virus to infect cells. This suggests pneumococcal vaccination may prevent SARS-CoV-2 infection. Two other mimics are the nucleoprotein and replicase that control virus replication. These proteins are made after viral infection, in which case pneumococcal vaccination may control, but not prevent, SARS-CoV-2 replication.Either way, these vaccines may provide proxy protection against SARS-CoV-2 infection that we can implement right now, even before we have a specific virus vaccine.

Such protection may not be complete. People might still suffer a weakened version of COVID-19 but, like most infants and children, be protected against the worst effects of the infection.Fighting Influenza-related Pneumonias During the COVID-19 PandemicWhile the specific protection these other vaccines confer against COVID-19 has not yet been tested in a clinical trial, I advocate broader implementation of pneumococcal and Hib vaccination for one additional, well-validated reason.Pneumococcal and Hib pneumonias – both caused by bacteria – are the major causes of death following viral influenza. The influenza virus rarely causes death directly. Most often, the virus makes the lungs more susceptible to bacterial pneumonias, which are deadly.

Dozens of studies around the world have demonstrated that increasing rates of pneumococcal and Hib vaccination dramatically lowers influenza-related pneumonias.Similar studies demonstrate that the price of using these vaccines is balanced by savings due to lower rates of influenza-related hospitalizations, intensive care unit admissions and deaths. In the context of COVID-19, lowering rates of influenza-related hospitalizations and ICU admissions would free up resources to fight the coronavirus, independent of any effect these vaccines might have on SARS-CoV-2 itself. In my opinion, that is a winning scenario.In short, we need not wait for a SARS-CoV-2 vaccine to slow down COVID-19.I believe that we can and should act now by fighting the coronavirus with all the tools at our disposal, including influenza, Hib, pneumococcal and perhaps rubella vaccinations.Preventing pneumococcal and Hib complications of influenza and COVID-19, and perhaps proxy-vaccinating against SARS-CoV-2 itself, helps everyone. Administering these already available and well-tested pneumococcal and Hib vaccines to people will save money by freeing up hospital beds and ICUs.

It will also improve public health by reducing the spread of multiple infections and boost the economy by nurturing a healthier population.Robert Root-Bernstein is a Professor of Physiology at Michigan State University. This article was originally published on The Conversation under a Creative Commons liscense Read the original here.This story appeared in the November 2020 issue as "Bacteria and the Brain." Subscribe to Discover magazine for more stories like this.It’s not always easy to convince people that the human gut is a sublime and wondrous place worthy of special attention. Sarkis Mazmanian discovered that soon after arriving at Caltech for his first faculty job 14 years ago, when he explained to a local artist what he had in mind for the walls outside his new office.The resulting mural greets visitors to the Mazmanian Lab today. A vaguely psychedelic, 40-foot-long, tube-shaped colon that’s pink, purple and red snakes down the hallway.

In a panel next to it, fluorescent yellow and green bacteria explode out of a deeply inflamed section of the intestinal tract, like radioactive lava from outer space.The mural is modest compared with what the scientist has been working on since. Over the last decade or so, Mazmanian has been a leading proponent of the idea that the flora of the human digestive tract has a far more powerful effect on the human body and mind than we thought — a scientific effort that earned him a $500,000 MacArthur Fellowship “Genius Grant” in 2012. Since then, Mazmanian and a small but growing cadre of fellow microbiologists have amassed a tantalizing body of evidence on the microbiome’s role in all kinds of brain disorders, including schizophrenia, Alzheimer’s disease, Parkinson’s disease and depression.But the results they’ve seen in autism could, in the end, prove the most transformative. Autism affects about 1 in 59 children in the U.S., and involves profound social withdrawal, communication problems, and sometimes anxiety and aggression.

The causes of the brain disorder have remained speculative. Now, Mazmanian and other researchers are finding that autism may be inextricably linked to — or even caused by — irregularities in the gut microbiome.A Biology StoryAt 47, Mazmanian — with his shaved head, flannel shirt and skinny jeans — resembles a young, urban hipster on his way to write at the local café. Originally, literary life was his plan. Born in Lebanon to two Armenian refugees, neither of whom had more than a first-grade education, Mazmanian landed in the class of an energetic high school English teacher in California’s San Fernando Valley, where his family first settled.

The teacher recognized his gift for language and encouraged him to pursue a career in literature. Mazmanian enrolled at UCLA in 1990, planning to major in English.Everything changed when he took his first biology class. Hunched over his new, thick textbook in the library, reading about basic biological concepts like photosynthesis, Mazmanian felt a vast new world opening up to him.Sarkis Mazmanian, shown in front of a mural that celebrates the human gut, is part of a group of microbiologists researching the effects of the digestive tract on a range of disorders. (Credit.

Caltech)“For the first time in my life, I wanted to turn the page and see where the story was going to go,” he says. €œI think I decided that minute to become a scientist.”Mazmanian was most fascinated by the idea that tiny organisms, invisible to the naked eye, could function as powerful, self-contained machines — powerful enough to take over and destroy the human body. After graduating with a degree in microbiology, Mazmanian joined a UCLA infectious diseases lab and began studying bacteria that cause staph infections.As his dissertation defense approached, Mazmanian read a one-page commentary penned by a prominent microbiologist, highlighting the fact that our intestines are teeming with hundreds, if not thousands, of different species of bacteria. But it was still largely unknown what they are and how they affect the human body.When Mazmanian dug further, he found that no one had yet answered what seemed to him to be the most obvious question.

Why would the human immune system, designed to attack and destroy foreign invaders, allow hundreds of species of bacteria to live and thrive in our guts unmolested?. To him, the bacteria’s survival implied that we had evolved to coexist with them. And if that were so, he reasoned, there must be some benefit to both the microbes and the human body — a symbiotic relationship. But what was it?.

Gut InvadersMazmanian set out to study the link between gut microbes and the immune system. As a postdoctoral researcher, he joined the lab of Harvard University infectious disease specialist Dennis Kasper.To start, Mazmanian examined how the immune systems of germ-free mice — lab mice completely protected, starting at birth, from all microbes — differed from those of mice with either few or normal levels of microbes. He expected this initial census would be just a first step in a long and arduous quest for scientific pay dirt. But when he went to examine a printout of his results in the lab, he realized immediately he might already be onto something big.

The germ-free mice had a 30 to 40 percent reduction in a specific type of immune cell known as helper T-cells.This colorized close-up of a mouse’s gut reveals the tight relationship between the gut microbe Bacteroides fragilis (red) and the epithelial surface of the colon (blue). (Credit. Caltech)Since helper T-cells play a key role in coordinating attacks against invading pathogens, the finding suggested that the immune systems of the germ-free mice were far less robust than those found in peers with normal levels of microbes.“That was exciting, right?. € Mazmanian recalls.

€œObviously I repeated it and tested it in a number of different ways. Then I asked the next question. €˜Can I restore the [immune] function in an adult animal?. €™â€‰â€Mazmanian colonized the guts of the immunocompromised, germ-free mice with microbes from standard lab mice.

After receiving the fecal transplant, their T-cell counts shot up. Within a month, their numbers were identical to mice raised outside the germ-free bubble.Resolving to identify the microorganisms causing this transformation, Mazmanian resorted to trial and error. One by one, he added strains of bacteria found in the guts of mice to the guts of germ-free mice.He got nowhere with the first five or six species he examined. Then, simply because it was convenient, he decided to test one more that was readily available in his lab.

Mazmanian’s adviser, Kasper, had been studying a gut microbe called Bacteroides fragilis. When Mazmanian implanted one of Kasper’s specimens into the gut of his germ-free mice, the results were dramatic. The T-cell numbers spiked to normal. Eventually, Mazmanian demonstrated he could reproduce this effect simply by adding a single molecule that these bacteria produce, called polysaccharide A, to their guts.“There was no logic in the choice whatsoever,” Mazmanian recalls.

€œ[B. Fragilis] was available, it came from the gut.” In other words, he got lucky.Mazmanian dug deeper and discovered that the biggest impact B. Fragilis had was on the population of a subtype of helper T-cells called regulatory, or suppressor, T-cells. These cells play a key role in preventing the immune system from attacking its host body, protecting against autoimmune or inflammatory diseases.

It was the first time any scientist had demonstrated that a single compound from a single microbe could reverse a specific problem with the immune system.To Mazmanian, the finding, published in 2005 in the journal Cell, alluded to new approaches to treating a wide array of autoimmune, inflammatory and allergic disorders. What if it were possible to help a faulty immune system by tweaking a patient’s microbiome?. It was with this exploration in mind that he arrived in Pasadena in 2006 to set up his lab at Caltech.A Convenient CollaborationA few years later, Mazmanian was having lunch on campus with neuroscientist and colleague Paul Patterson. Patterson had been preoccupied with a mystery that had, for years, confounded those studying autism in humans.

When pregnant mothers have a severe infection in the second trimester, their babies are much more likely to develop autism.As Mazmanian tells it, Patterson was a man of few words, and at lunch Mazmanian was “going on and on” about his own work.“You know,” Patterson interjected thoughtfully, “I think kids with autism have GI issues.”Patterson recalled reading that something like 60 percent of children with autism had some form of clinical GI problem, such as bloating, constipation, flatulence or diarrhea. Was it possible, he wondered, that there was a microbiome connection?. As they talked, Mazmanian’s excitement grew.A few years earlier, Patterson had discovered that when he exposed pregnant mice to pathogens like the influenza virus, they gave birth to pups that grew up more likely to be startled by loud noises, to shy away from social contact and to groom themselves repetitively — symptoms that resemble those of autism. Patterson was in the process of comparing the brains of these autism-mimicking mice with their neurotypical cousins to see if he could detect any differences that might explain how the maternal immune system was somehow interfering with the pups’ brain development.Mazmanian had a suggestion.

The next time Patterson sacrificed one of his autistic mice to study their brains, what if he set the intestines aside for his colleague down the hall?. When the guts arrived in Mazmanian’s lab, he found that the intestines of the neurotypical mice looked normal. But the guts of the autism-mimicking offspring were almost uniformly inflamed. Could it be that the microbiome was the cause of this inflammation?.

And could that, in turn, be somehow connected to the behavioral symptoms?. Throughout the winter and spring of 2012, Mazmanian and Patterson continued their conversation. Mazmanian found distinct differences in the microbiomes of the mice. And, they noticed, the mice with the features of autism had leaky gut syndrome, an increased permeability of the gut lining that can allow pathogens and allergens to leach out.

This condition had also been reported in children with autism.So Mazmanian and Patterson turned their attention outside the gut. They took blood samples to see if any gut microbes, or the compounds they produce, were circulating in the rest of the body. They homed in on one molecule in particular, called 4-ethylphenyl sulfate, which was roughly 45 times as abundant in the mice that had symptoms of autism. And it looked familiar.

Structurally, it was almost identical to a molecule recently found to be significantly elevated in human children with autism.It was enough to take the next step. Every day for three weeks, Mazmanian injected the molecule, harvested from the mice with autism-like symptoms, directly into the bloodstream of 5-week-old normal lab mice (the age at which the autistic mice normally developed leaky gut). Then Mazmanian and his team gave them a series of behavioral tests. The mice were far more easily startled and were less comfortable in large empty spaces than their untreated peers, indications of an increase in anxiety-related behaviors commonly seen in the mice with autism-like symptoms.

The researchers published their results in Cell in 2013.Though surprising, the data made sense in some ways. Many drug companies rely on small-molecule drugs that can be taken orally, but still manage to cross the blood-brain barrier and affect behavior. It seemed entirely possible that small molecules, created by bacteria in the gut, could enter the bloodstream and reach the brain. And they don’t even have to leak out of the gut to do so.Of Mice and MenPatterson died in 2014, at age 70, just six months after the publication of the duo’s groundbreaking Cell paper.

Around the same time, a series of parallel experiments in a clinic hundreds of miles away was already paving the way forward. While Patterson and Mazmanian had been working in mice, Rosa Krajmalnik-Brown, a microbiologist at Arizona State University, had teamed up with Jim Adams, who directs the university’s autism and Asperger’s research program, to study humans.The researchers were conducting a detailed analysis of the microbiome of human autism patients and found that the bacteria were far less diverse in the children with autism. Notably, several important species involved in the digestion of carbohydrates were severely depleted.Krajmalnik-Brown and Adams launched a preliminary trial to test the effects of fecal transplants on 18 children between the ages of 7 and 16 with severe autism, who also had severe GI issues. The researchers administered powerful antibiotics to kill off the microbiomes of the children and followed them with a bowel cleanse.

They then replaced the microbes with transplanted flora taken from the guts of healthy neurotypical adult volunteers.The results were better than anyone could have expected. The procedure resulted in a large reduction in GI symptoms and increased the diversity of bacteria in the children’s guts. But more significantly, their neurological symptoms were reduced. At the onset of the study in 2017, an independent evaluator found 83 percent of participants had severe autism.

Two years after the initial trial, only 17 percent were rated as severely autistic. And 44 percent were no longer on the autism scale.“[My child] did a complete 180,” says Dana Woods, whose then-7-year-old son Ethan enrolled in the initial study five years ago. €œHis ability to communicate is so much different now. He’s just so much more present.

He’s so much more aware. He’s no longer in occupational therapy. He’s no longer in speech therapy. After the study, he tested two points away from a neurotypical child.”In their first report on the trial in 2017, the team highlighted a number of distinct changes in the microbiome after the transplants, in particular a surge in the populations of three types of bacteria.

Among them was a four-fold increase in Bifidobacterium, a probiotic organism that seems to play a key role in the maintenance of a healthy gut.But figuring out what was happening on a cellular level — to really look inside some guts — would require another vehicle. The ASU team needed Mazmanian’s mice.“At the end of the day, what we care about is healing people and how the microbiome affects people,” explains Krajmalnik-Brown. €œThat’s why we work with people. But with mice you can do things that are more mechanistic.”The Great Mouse Detective(Credit.

Caltech)Together, Krajmalnik-Brown, Mazmanian and their collaborators would uncover some tantalizing new insights that go a long way to solving the mystery. In May 2019, the team published another high-profile paper in Cell, after they transplanted stool samples from Krajmalnik-Brown’s severely autistic patients into the guts of Mazmanian’s germ-free mice. The offspring of these mice showed the autism-like symptoms, such as repetitive and compulsive behavior.This time, the team dug even deeper into the biochemical processes playing out in the brain, looking not just at behavior but at the chemicals involved in creating it. The mice that developed autism-like behaviors had measurably lower levels of two substances called taurine and 5-aminovaleric acid (5AV).

When they dug into the literature, the team learned that these two substances are known to mimic activity of a key signaling agent in the brain called gamma-aminobutyric acid (GABA) — a neurotransmitter that other studies have found is deficient in the brains of children with autism.What’s more, some have speculated that the tendency of children with autism to experience sensory overstimulation may stem from the inability to tamp down overexcited neurons. A lack of GABA could lead to just that.The scientists next orally administered high levels of taurine and 5AV to pregnant mice with the autistic children’s microbiomes. When their pups were born, the researchers continued to feed the young the substances until they reached adulthood. Compared with untreated animals, the second-generation mice had significantly fewer behavioral symptoms.

Taurine reduced repetitive behavior, as measured by marble burying, increased the level of social interaction, and relieved anxiety. Mice administered 5AV were more active and social.“We healed humans with behavioral problems,” says Krajmalnik-Brown. €œ[And we] transferred some of those deficits and behaviors to mice — basically the opposite. It’s huge.”Mazmanian hopes to take the next step in the months ahead.“I can flip a switch, turn on a light, I know that switch turns on that light.

I don’t know the circuit, I don’t know where the wire is,” Mazmanian says. €œExactly how that’s happening … we just don’t understand that.”This most recent study, by itself, hardly proves that dysregulated microbiomes cause the brain disorder — a point that plenty of other scientists skeptical of Mazmanian’s work are happy to make.“The paper made a big splash, but trying to model psychiatric-related human conditions in mice, in my view, is a little bit of a stretch,” says Sangram Sisodia, a neurobiologist at the University of Chicago who studies the microbiome. €œA mouse with autism?. €Nor was that the only criticism.

Several researchers have suggested that the group didn’t give proper attention to one of their tests ­— one whose results conflicted with their thesis ­— while others found flaws in the statistical methods they used to assess their results. Mazmanian downplays these criticisms, but agrees the work is not yet conclusive.Meanwhile, the ASU trial has also engendered skepticism, mainly due to its tiny sample size, the lack of a control group and the methods by which the children were assessed for autism severity. Krajmalnik-Brown and Adams say they stand by their results, but agree more research is needed. In recent months, they have launched two new studies that will address these issues.Adams insists the work is already changing lives.

€œWe followed up with every one of our 18 participants,” he says, referring to the children who received fecal transplants. €œSure enough, we found that most of the GI benefits had remained. And family after family said their child just slowly, steadily continued making more improvement.” They published the update in Scientific Reports in spring 2019.“I’m not ready to say the case is closed,” says Mazmanian. €œHealthy skepticism is a good thing.

I believe the preclinical data, I believe the mouse data. But there’s a lot of studies that still need to be done.” A Healthy Gut, A New OutlookEthan Woods had GI issues and symptoms of autism until researchers introduced new microbes to his gut. His mother says the treatment changed everything. (Credit.

Dana Woods)Prior to his fecal transplant at age 7, Ethan Woods suffered from chronic and severe diarrhea, constipation and cramping, symptoms so extreme that to his mother, Dana, he sounded like “a bit like a woman in labor when he was trying to have a bowel movement.” “It was just awful watching your child go through this,” she says, explaining that when she enrolled her autistic son in the Arizona State study, her “only goal was to fix his gut.”Remarkably, Ethan’s agony began to disappear just a few weeks into the trial. But that was not the most dramatic difference. Before the transplant, Ethan’s speech was drawn out and slow, his language skills rudimentary. He seemed to live in his own bubble.

He had frequent outbursts. For as long as Dana could remember, her mornings with Ethan had been marked by arguing, fighting, pushing and anger. But then one morning, something shocking happened.“He woke me up one morning with his face right in my face with this big smile and he said, ‘Morning, Mom!. €™â€‰â€ she recalls.

€œAnd he was just excited and happy and ready to go about his day with this big smile. It choked me up to the point where I teared up because I had never experienced a happy kid in the morning.”Later, Ethan carried over an iPad and opened an app with a talking cat that repeats back the words children speak aloud. He played back a video recording of himself from just a few weeks earlier.“[He] looks me in the eye and says, ‘Mom, why did I talk like that?. What is wrong with me?.

€™ And as soon as he did that, I caught my breath. I had to compose myself and say, ‘I don’t know. But do you feel better?. Do you feel different?.

Why do you think?. €™â€‰â€Ethan’s communication skills had already begun to improve. Within a year of the study, his speech therapist graduated him from speech therapy because he had met all his goals.“He went from one end of the rainbow all the way to the other end of the rainbow,” she says. €œPrior to the study, I was very afraid.

My biggest fear was ‘how is he going to navigate the world when I’m not here?. €™ And I think I have a lot of hope now that he is going to be OK now on his own.”There’s something strange about the female orgasm, something that scientists have been unable to explain. Biological functions are normally discussed in terms of evolutionary pressure, or reproductive advantage. If a biological trait improves your chances of having more offspring, then it’s more likely to stick around in your species.

The male orgasm makes perfect sense — ejaculate contains the genetic material that’s necessary for making babies. But the female orgasm has been harder to nail down. Fertilization doesn’t depend on it, and “fun” isn’t exactly in the pantheon of evolutionary explanations.Researchers that study how the female orgasm relates to reproductive success have two main options — either ask people invasive questions about their most personal moments, or to find a way to stick probes in or on them during said moments. Neither of these approaches have resulted in the kind of “wet lab” research that’s the gold standard for biological understanding.What we do know, despite widespread cultural discomfort with talking openly about sex and pleasure, is that there appears to be significant sexual dysfunction in American society.

Back in 2014, researchers from the Kinsey Institute, the preeminent U.S. Academy for the study of sex and relationships, said as much. In a survey of nearly 3,000 people, they found that men, straight or gay, orgasmed 85 percent of the time during consensual sexual encounters. Lesbian women orgasmed less often, 75 percent of the time, while straight women fared worst with just a 60 percent chance of orgasm.

Other studies have shown that something like 10-15 percent of women experience lifelong anorgasmia, meaning they’ve never experienced orgasm. A further 40 percent of women report some kind of inability to reach orgasm in the past year.The orgasm gap is hard to explain. Some think that it comes down to straight men’s finesse, or lack thereof, citing the difference between straight and lesbian satisfaction. Indeed, it makes sense that knowing your way around the territory would help.

But for many couples this isn’t a helpful revelation, since the emotional maturity necessary to teach sexual dexterity is often out of reach. Shortcut to SatisfactionLuckily, we live in an era of Silicon Valley disruption, which has even started lapping at the shores of sex research. Technologist Liz Klinger is at the forefront of this transition. She and her team have built a platform that lets people become citizen scientists of sex —without ever having to get out from between the sheets.About a decade ago, Klinger’s company, Lioness, released what they billed as the first “smart vibrator,” a sex toy that could actually learn about you.

The final product was a far cry from the first prototype, which was much more laboratory object than sex toy.The “test device was this whole mess of wires, with a hard connection. We had to physically send it to our beta testers, who used it and sent it back,” recalls Klinger. The researchers would download the data collected by the toy’s four sensors — temperature, motion, acceleration and pressure — and compile it into a chart that represented arousal and orgasm, as told through the story of pelvic-floor muscle contractions.It was an immediate success for sex partners who needed ways to talk about pleasure in a more objective way. Klinger recalled that when she got the first beta-test couple on the phone, “the wife was like ‘holy crap, we finally were able to talk about these things that I’ve had a lot of trouble talking about.’ It turned out that she wanted more foreplay, and he didn’t know quite that that meant.

He’d spend more time, but it just didn’t match up, you know?. € With the company’s signature offering in hand — a chart of sexual arousal over time — Klinger found that couples could have a conversation “without the subtext of ‘oh, you’re not good enough, or I don’t like you enough,’ on the husband’s part and ‘I’m so tired of talking about this’ on the wife’s part,” she says. The chart “can change people’s perceptions of their own experiences, and how they talk about them with others.”Doing the Deed — For ScienceThis spring, the company has launched a research platform dubbed Lioness 2.0 — a new optional service that, unsurprisingly, their data-obsessed users have greeted with open arms. Now, instead of simply using the toy to understand themselves better, Lioness owners can opt in to the kinds of hands-on studies that are necessary for a deeper understanding of sex and pleasure.

So far, the company is working with Nigeria’s Society for Family Health to study how pleasure changes with menopause across age, race and orientation, as well as with the U.S.’s Center for Genital Health and Education to explore the role of pelvic floor muscles in orgasm.Pani Farvid, a professor of applied psychology at The New School in New York City, has some reservations about the platform. €œI really like what they’re trying to do, but there could be more added to make it a bit more comprehensive. My concern is that there's a misconception that sex is just about the orgasm, that it’s just physiological and that pleasure just has to do with the genitals.” From where she’s sitting, “that’s a very mechanical view of sexuality.” If the Lioness is helping to equalize the orgasm gap, or helping people understand their bodies better, “I think that's great,” says Farvid. €œBut as a critical sexologist, I'm interested in delving deeper into what these practices mean.” If sex is hyper-focused on orgasm, to exclusion of everything else, she cautions that these norms “have real-life negative impacts on people's sex lives and their sense of themselves.”At this point, knee-deep in an era of data collection that was once the sole purview of white-coat-wearing scientists, it’s old news that we need to be careful with what our technology is doing to us.

No tool can serve as a cure-all, even if it comes loaded with a neat app and some space-age sensors. What it can offer, though, is the opportunity to start a conversation, and the chance to take a long, honest look at something about yourself — whether it’s the number of steps you take every day, or the way you want to be touched.Wondering how to keep your glasses from fogging up when your mask is on?. Look no further. If we've learned one thing throughout the COVID-19 pandemic, it's the importance of wearing a mask.

Countless studies have shown over the past eight months that wearing a protective barrier over your nose and mouth — whether it's a standard-issue surgical mask or an N95 respirator — can significantly decrease the odds of catching and transmitting disease. What's more, some research shows that masking up can reduce the severity of an infection if a masked person does contract COVID-19. But while masks are potentially lifesaving, they can be uncomfortable, often changing your breathing patterns and fogging up your glasses when breath escapes through the top of the mask. Among people who choose not to wear a mask to prevent the spread of COVID-19, many cite discomfort as a key reason why.Wesley Wilson, a tumor immunologist in Pennsylvania, knows how annoying it can be when your glasses are fogging up.

He says fogging is “definitely a problem” among his hospital colleagues, who need to wear protective goggles and surgical masks while on the job. Fortunately, they've also picked up a few helpful hacks for keeping their vision clear while wearing a mask with glasses.#1. Use Tape“If you have to keep your mask on for hours, tape works like a charm,” Wilson says. This especially applies to healthcare professionals in his practice who are required to keep their masks on at all times, except during lunch.

€œIf you're putting on your mask and taking it off a lot, tape probably isn't practical — but two small pieces of tape on the cheeks keep the mask fitted closer to your face, and the hot air out of your glasses,” he says.#2. Fit the Mask to Your FaceWhile some air leakage is to be expected, wearing a mask that fits securely to your face will prevent glass fogging and filter the virus more effectively since less air is coming in or out. Find surgical masks or N95s that come with a nose bridge, a small, flexible piece of metal or plastic that allows the mask to more closely fit the contours of your face. Nose bridges can be sewn inside masks or affixed to the front.Read More.

Why It Feels Like You Can't Breathe Inside Your Face Mask#3. Adjust Your MaskAccording to the American Academy of Ophthalmology, a minor adjustment in how you wear your mask could be enough to prevent fog as well. Simply pull the mask over your nose and rest your glasses on top of your face mask. As long as the mask is fitted close to your face, this should prevent hot air from slipping out.#4.

Spray Your GlassesA former ice hockey player, Wilson says the protective visor under his helmet would often fog with hot air while he was on the ice during games. Like an ocean diver, he would use de-misting solution or a defogging spray (such as this one) to keep his visor free of fog. The same concept applies to eyeglass fog caused by masking, he says. €œYou can either buy a spray or you can make your own with either shaving cream or soap and water,” says Wilson.

€œWiping some shaving cream on your glasses and then wiping it off will coat them with a similar surface-tension altering compound that prevents fog.”.

As flu season creeps up on the generic levitra for sale Northern Hemisphere, cold and flu relief medications will inevitably fly off store shelves. A natural remedy that shoppers might reach for is elderberry, a small, blackish-purple fruit that companies turn into syrups, lozenges and gummies. Though therapeutic uses of the berry date back centuries, Michael Macknin, a pediatrician at the Cleveland Clinic, hadn’t heard of using elderberry to treat the generic levitra for sale flu until a patient’s mother asked him about it. Some industry-sponsored research claims that the herbal remedy could cut the length of the symptoms by up to four days.

For a comparison, Tamiflu, generic levitra for sale an FDA-approved treatment, only reduces flu duration by about a single day. €œI said, 'Gee, if that’s really true [about elderberry], it would be a huge benefit,'” Macknin says. But the effectiveness and safety of elderberry is still fairly unclear. Unlike the over-the-counter medicines at your generic levitra for sale local pharmacy, elderberry hasn't been through rigorous FDA testing and approval.

However, Macknin and his team recently published a study in the Journal of General Internal Medicine, which found that elderberry treatments did nothing for flu patients. This prompts a need for further studies into the remedy — work that unfortunately stands a low generic levitra for sale chance of happening in the future, Macknin says. Looking For ProofElderberries are full of chemicals that could be good for your health. Like similar fruits, the berries contain high levels of antioxidants, compounds that shut down reactions in our generic levitra for sale bodies that damage cells.

But whether or not elderberry's properties also help immune systems fend off a virus is murky. There are only a handful of studies that have examined if elderberries reduced the severity or duration of the flu. And though some of the work prior to Macknin’s was well-designed and supported this herbal remedy as a helpful flu aid, at least some — and potentially all — of generic levitra for sale those studies were funded by elderberry treatment manufacturers.Macknin says an elderberry supplement company provided his team with their products and a placebo version for free, but that the company wasn’t involved in the research beyond that. Macknin's study is the largest one conducted on elderberry to date, with 87 influenza patients completing the entire treatment course.

Participants in the study were generic levitra for sale also welcome to take Tamiflu, for ethical reasons, as the team didn’t want to exclude anyone from taking a proven flu therapy. Additionally, each participant took home either a bottle of elderberry syrup or the placebo with instructions on when and how to take it. The research team called generic levitra for sale participants every day for a symptom check and to remind them to take their medication.By chance, it turned out that a higher percentage of the patients given elderberry syrup had gotten their flu shot and also chose to take Tamiflu. Since the vaccination can reduce the severity of infection in recipients who still come down with the flu, the study coincidentally operated in favor of those who took the herbal remedy, Macknin says.

Those patients could have dealt with a shorter, less-intense illness because of the Tamiflu and vaccination. €œEverything was stacked to have it turn out better [for the elderberry group],” Macknin says, “and it turned out the same.” The researchers found no difference in illness duration or severity generic levitra for sale between the elderberry and placebo groups. While analyzing the data, the team also found that those on the herbal treatment might have actually fared worse than those on the placebo. The potential generic levitra for sale for this intervention to actually harm instead of help influenza patients explains why Macknin thinks the therapy needs further research.But, don't expect that work to happen any time soon.

Researchers are faced with a number of challenges when it comes to studying the efficacy of herbal remedies. For starters, there's little financial generic levitra for sale incentive to investigate if they actually work. Plant products are challenging to patent, making them less lucrative prospects for pharmaceutical companies or research organizations to investigate. Additionally, investigations that try and prove a proposed therapy as an effective drug — like the one Macknin and his team accomplished — are expensive, Macknin says.

Those projects generic levitra for sale need FDA oversight and additional paperwork, components that drive up study costs. €œIt’s extraordinarily expensive and there’s no money in it for anybody,” Macknin says.Talk To Your DoctorUltimately, research on elderberry therapies for flu patients is a mixed bag, and deserves more attention from scientists. However, if you still want to discuss elderberry treatments for the flu with your generic levitra for sale doctor, that’s a conversation you should feel comfortable having, says Erica McIntyre, an expert focused on health and environmental psychology in the School of Public Health at the University of Technology Sydney. Navigating what research says about a particular herbal medicine is challenging for patients and health practitioners alike.

The process is made more complex by generic levitra for sale the range of similar-sounding products on the market that lack standardized ingredients, McIntyre says. But when doctors judge or shame patients for asking about non-conventional healthcare interventions, the response can distance people and push them closer to potentially unproven treatments. Even worse, those individuals might start to keep their herbal remedies a secret. €œIt is that fear about being judged for use of that medication,” McIntyre says, that drives up to 50 percent of people taking herbal treatments to withhold generic levitra for sale that information from healthcare practitioners.

That’s a dangerous choice, as some herbal and traditional medications can interact and cause health problems.If a physician shames someone for asking about alternative medicines, it’s likely time to find a new doctor, McIntyre says. Look for someone who will listen to your concerns — whether it's that you feel traditional treatments haven’t worked for you, or that you didn’t like generic levitra for sale the side effects, the two common reasons people pursue herbal treatments in the first place. €œYou’re not necessarily looking for a doctor that will let you do whatever you want,” McIntyre says, “but that they actually consider you as a patient, your treatment choices and your treatment priorities, and communicate in a way that’s supportive.” And if a doctor suggests that you avoid a treatment you’re interested in, ask why. They generally have a good reason, McIntyre says.For now, know that even if your doctor doesn’t support you taking elderberry, there are other proven preventative measures that are worth your while — like the flu shot.

Anyone six months or older should get it, Macknin says, and stick to the protocols we’re generic levitra for sale used to following to prevent COVID-19 infections, like social distancing, mask-wearing and hand-washing. Those measures also help prevent flu transmission, too — something, so far, no elderberry supplement package can claim.The yearly influenza season threatens to make the COVID-19 pandemic doubly deadly, but I believe that this isn’t inevitable.There are two commonly given vaccines – the pneumococcal vaccine and the Hib vaccine – that protect against bacterial pneumonias. These bacteria generic levitra for sale complicate both influenza and COVID-19, often leading to death. My examination of disease trends and vaccination rates leads me to believe that broader use of the pneumococcal and Hib vaccines could guard against the worst effects of a COVID-19 illness.I am an immunologist and physiologist interested in the effects of combined infections on immunity.

I have reached generic levitra for sale my insight by juxtaposing two seemingly unrelated puzzles. Infants and children get SARS-CoV-2, the virus that causes COVID-19, but very rarely become hospitalized or die. And case numbers and death rates from COVID-19 began varying greatly from nation to nation and city to city even before lockdowns began. I wondered why.One night generic levitra for sale I woke up with a possible answer.

Vaccination rates. Most children, beginning at age two months, are vaccinated against numerous generic levitra for sale diseases. Adults less so. And, both infant and adult generic levitra for sale vaccination rates vary widely across the world.

Could differences in the rates of vaccination against one or more diseases account for differences in COVID-19 risks?. As someone who had previously investigated other pandemics such as the Great Flu Pandemic of 1918-19 and AIDS, and who has worked with vaccines, I had a strong background for tracking down the relevant data to test my hypothesis.Pneumococcal Vaccination Rates Correlate With Lower COVID-19 Cases and DeathsI gathered national and some local data on vaccination rates against influenza, polio, measles-mumps-rubella (MMR), diphtheria-tetanus-pertussis (DTP), tuberculosis (BCG), pneumococci and Haemophilus influenzae type B (Hib). I correlated them with COVID-19 case rates and death rates for 24 nations that had experienced their COVID-19 outbreaks generic levitra for sale at about the same time. I controlled for factors such as percentage of the population who were obese, diabetic or elderly.I found that only pneumococcal vaccines afforded statistically significant protection against COVID-19.

Nations such as Spain, Italy, Belgium, Brazil, Peru and Chile that generic levitra for sale have the highest COVID-19 rates per million have the poorest pneumococcal vaccination rates among both infants and adults. Nations with the lowest rates of COVID-19 – Japan, Korea, Denmark, Australia and New Zealand – have the highest rates of pneumococcal vaccination among both infants and adults.A recent preprint study (not yet peer-reviewed) from researchers at the Mayo Clinic has also reported very strong associations between pneumococcal vaccination and protection against COVID-19. This is especially true among minority patients who generic levitra for sale are bearing the brunt of the coronavirus pandemic. The report also suggests that other vaccines, or combinations of vaccines, such as Hib and MMR may also provide protection.These results are important because in the U.S., childhood vaccination against pneumococci – which protects against Streptococcus pneumoniae bacteria – varies by state from 74% to 92%.

Although the CDC recommends that all adults 18-64 in high risk groups for COVID-19 and all adults over the age of 65 get a pneumococcal vaccination, only 23% of high-risk adults and 64% of those over the age of 65 do so.Similarly, although the CDC recommends at all infants and some high-risk adults be vaccinated against Haemophilus influenzae type B (Hib), only 80.7% of children in the U.S. And a handful of immunologically compromised adults have been generic levitra for sale. Pneumococcal and Hib vaccination rates are significantly lower in minority populations in the U.S. And in countries that have been hit harder generic levitra for sale by COVID-19 than the U.S.Based on these data, I advocate universal pneumococcal and Hib vaccination among children, at-risk adults and all adults over 65 to prevent serious COVID-19 disease.Left.

Combined rates of childhood and adult (over 65) pneumococcal vaccination (out of a possible 200). Right. Cases (per million) population of COVID-19 at about 90 days into the pandemic for 24 nations. Nations with high pneumococcal vaccination rates have low COVID-19 case rates.

(Credit. CC BY-SA)How Pneumococcal Vaccination Protects Against COVID-19Protection against serious COVID-19 disease by pneumococcal and Hib vaccines makes sense for several reasons. First, recent studies reveal that the majority of hospitalized COVID-19 patients, and in some studies nearly all, are infected with streptococci, which causes pneumococcal pneumonias, Hib or other pneumonia-causing bacteria. Pneumococcal and Hib vaccinations should protect coronavirus patients from these infections and thus significantly cut the risk of serious pneumonia.I also found that pneumococcal, Hib and possibly rubella vaccines may confer specific protection against the SARS-CoV-2 virus that causes COVID-19 by means of “molecular mimicry.”Molecular mimicry occurs when the immune system thinks one microbe looks like another.

In this case, proteins found in pneumococcal vaccines and, to a lesser degree, ones found in Hib and rubella vaccines as well look like several proteins produced by the SARS-CoV-2 virus.Two of these proteins found in pneumococcal vaccines mimic the spike and membrane proteins that permit the virus to infect cells. This suggests pneumococcal vaccination may prevent SARS-CoV-2 infection. Two other mimics are the nucleoprotein and replicase that control virus replication. These proteins are made after viral infection, in which case pneumococcal vaccination may control, but not prevent, SARS-CoV-2 replication.Either way, these vaccines may provide proxy protection against SARS-CoV-2 infection that we can implement right now, even before we have a specific virus vaccine.

Such protection may not be complete. People might still suffer a weakened version of COVID-19 but, like most infants and children, be protected against the worst effects of the infection.Fighting Influenza-related Pneumonias During the COVID-19 PandemicWhile the specific protection these other vaccines confer against COVID-19 has not yet been tested in a clinical trial, I advocate broader implementation of pneumococcal and Hib vaccination for one additional, well-validated reason.Pneumococcal and Hib pneumonias – both caused by bacteria – are the major causes of death following viral influenza. The influenza virus rarely causes death directly. Most often, the virus makes the lungs more susceptible to bacterial pneumonias, which are deadly.

Dozens of studies around the world have demonstrated that increasing rates of pneumococcal and Hib vaccination dramatically lowers influenza-related pneumonias.Similar studies demonstrate that the price of using these vaccines is balanced by savings due to lower rates of influenza-related hospitalizations, intensive care unit admissions and deaths. In the context of COVID-19, lowering rates of influenza-related hospitalizations and ICU admissions would free up resources to fight the coronavirus, independent of any effect these vaccines might have on SARS-CoV-2 itself. In my opinion, that is a winning scenario.In short, we need not wait for a SARS-CoV-2 vaccine to slow down COVID-19.I believe that we can and should act now by fighting the coronavirus with all the tools at our disposal, including influenza, Hib, pneumococcal and perhaps rubella vaccinations.Preventing pneumococcal and Hib complications of influenza and COVID-19, and perhaps proxy-vaccinating against SARS-CoV-2 itself, helps everyone. Administering these already available and well-tested pneumococcal and Hib vaccines to people will save money by freeing up hospital beds and ICUs.

It will also improve public health by reducing the spread of multiple infections and boost the economy by nurturing a healthier population.Robert Root-Bernstein is a Professor of Physiology at Michigan State University. This article was originally published on The Conversation under a Creative Commons liscense Read the original here.This story appeared in the November 2020 issue as "Bacteria and the Brain." Subscribe to Discover magazine for more stories like this.It’s not always easy to convince people that the human gut is a sublime and wondrous place worthy of special attention. Sarkis Mazmanian discovered that soon after arriving at Caltech for his first faculty job 14 years ago, when he explained to a local artist what he had in mind for the walls outside his new office.The resulting mural greets visitors to the Mazmanian Lab today. A vaguely psychedelic, 40-foot-long, tube-shaped colon that’s pink, purple and red snakes down the hallway.

In a panel next to it, fluorescent yellow and green bacteria explode out of a deeply inflamed section of the intestinal tract, like radioactive lava from outer space.The mural is modest compared with what the scientist has been working on since. Over the last decade or so, Mazmanian has been a leading proponent of the idea that the flora of the human digestive tract has a far more powerful effect on the human body and mind than we thought — a scientific effort that earned him a $500,000 MacArthur Fellowship “Genius Grant” in 2012. Since then, Mazmanian and a small but growing cadre of fellow microbiologists have amassed a tantalizing body of evidence on the microbiome’s role in all kinds of brain disorders, including schizophrenia, Alzheimer’s disease, Parkinson’s disease and depression.But the results they’ve seen in autism could, in the end, prove the most transformative. Autism affects about 1 in 59 children in the U.S., and involves profound social withdrawal, communication problems, and sometimes anxiety and aggression.

The causes of the brain disorder have remained speculative. Now, Mazmanian and other researchers are finding that autism may be inextricably linked to — or even caused by — irregularities in the gut microbiome.A Biology StoryAt 47, Mazmanian — with his shaved head, flannel shirt and skinny jeans — resembles a young, urban hipster on his way to write at the local café. Originally, literary life was his plan. Born in Lebanon to two Armenian refugees, neither of whom had more than a first-grade education, Mazmanian landed in the class of an energetic high school English teacher in California’s San Fernando Valley, where his family first settled.

The teacher recognized his gift for language and encouraged him to pursue a career in literature. Mazmanian enrolled at UCLA in 1990, planning to major in English.Everything changed when he took his first biology class. Hunched over his new, thick textbook in the library, reading about basic biological concepts like photosynthesis, Mazmanian felt a vast new world opening up to him.Sarkis Mazmanian, shown in front of a mural that celebrates the human gut, is part of a group of microbiologists researching the effects of the digestive tract on a range of disorders. (Credit.

Caltech)“For the first time in my life, I wanted to turn the page and see where the story was going to go,” he says. €œI think I decided that minute to become a scientist.”Mazmanian was most fascinated by the idea that tiny organisms, invisible to the naked eye, could function as powerful, self-contained machines — powerful enough to take over and destroy the human body. After graduating with a degree in microbiology, Mazmanian joined a UCLA infectious diseases lab and began studying bacteria that cause staph infections.As his dissertation defense approached, Mazmanian read a one-page commentary penned by a prominent microbiologist, highlighting the fact that our intestines are teeming with hundreds, if not thousands, of different species of bacteria. But it was still largely unknown what they are and how they affect the human body.When Mazmanian dug further, he found that no one had yet answered what seemed to him to be the most obvious question.

Why would the human immune system, designed to attack and destroy foreign invaders, allow hundreds of species of bacteria to live and thrive in our guts unmolested?. To him, the bacteria’s survival implied that we had evolved to coexist with them. And if that were so, he reasoned, there must be some benefit to both the microbes and the human body — a symbiotic relationship. But what was it?.

Gut InvadersMazmanian set out to study the link between gut microbes and the immune system. As a postdoctoral researcher, he joined the lab of Harvard University infectious disease specialist Dennis Kasper.To start, Mazmanian examined how the immune systems of germ-free mice — lab mice completely protected, starting at birth, from all microbes — differed from those of mice with either few or normal levels of microbes. He expected this initial census would be just a first step in a long and arduous quest for scientific pay dirt. But when he went to examine a printout of his results in the lab, he realized immediately he might already be onto something big.

The germ-free mice had a 30 to 40 percent reduction in a specific type of immune cell known as helper T-cells.This colorized close-up of a mouse’s gut reveals the tight relationship between the gut microbe Bacteroides fragilis (red) and the epithelial surface of the colon (blue). (Credit. Caltech)Since helper T-cells play a key role in coordinating attacks against invading pathogens, the finding suggested that the immune systems of the germ-free mice were far less robust than those found in peers with normal levels of microbes.“That was exciting, right?. € Mazmanian recalls.

€œObviously I repeated it and tested it in a number of different ways. Then I asked the next question. €˜Can I restore the [immune] function in an adult animal?. €™â€‰â€Mazmanian colonized the guts of the immunocompromised, germ-free mice with microbes from standard lab mice.

After receiving the fecal transplant, their T-cell counts shot up. Within a month, their numbers were identical to mice raised outside the germ-free bubble.Resolving to identify the microorganisms causing this transformation, Mazmanian resorted to trial and error. One by one, he added strains of bacteria found in the guts of mice to the guts of germ-free mice.He got nowhere with the first five or six species he examined. Then, simply because it was convenient, he decided to test one more that was readily available in his lab.

Mazmanian’s adviser, Kasper, had been studying a gut microbe called Bacteroides fragilis. When Mazmanian implanted one of Kasper’s specimens into the gut of his germ-free mice, the results were dramatic. The T-cell numbers spiked to normal. Eventually, Mazmanian demonstrated he could reproduce this effect simply by adding a single molecule that these bacteria produce, called polysaccharide A, to their guts.“There was no logic in the choice whatsoever,” Mazmanian recalls.

€œ[B. Fragilis] was available, it came from the gut.” In other words, he got lucky.Mazmanian dug deeper and discovered that the biggest impact B. Fragilis had was on the population of a subtype of helper T-cells called regulatory, or suppressor, T-cells. These cells play a key role in preventing the immune system from attacking its host body, protecting against autoimmune or inflammatory diseases.

It was the first time any scientist had demonstrated that a single compound from a single microbe could reverse a specific problem with the immune system.To Mazmanian, the finding, published in 2005 in the journal Cell, alluded to new approaches to treating a wide array of autoimmune, inflammatory and allergic disorders. What if it were possible to help a faulty immune system by tweaking a patient’s microbiome?. It was with this exploration in mind that he arrived in Pasadena in 2006 to set up his lab at Caltech.A Convenient CollaborationA few years later, Mazmanian was having lunch on campus with neuroscientist and colleague Paul Patterson. Patterson had been preoccupied with a mystery that had, for years, confounded those studying autism in humans.

When pregnant mothers have a severe infection in the second trimester, their babies are much more likely to develop autism.As Mazmanian tells it, Patterson was a man of few words, and at lunch Mazmanian was “going on and on” about his own work.“You know,” Patterson interjected thoughtfully, “I think kids with autism have GI issues.”Patterson recalled reading that something like 60 percent of children with autism had some form of clinical GI problem, such as bloating, constipation, flatulence or diarrhea. Was it possible, he wondered, that there was a microbiome connection?. As they talked, Mazmanian’s excitement grew.A few years earlier, Patterson had discovered that when he exposed pregnant mice to pathogens like the influenza virus, they gave birth to pups that grew up more likely to be startled by loud noises, to shy away from social contact and to groom themselves repetitively — symptoms that resemble those of autism. Patterson was in the process of comparing the brains of these autism-mimicking mice with their neurotypical cousins to see if he could detect any differences that might explain how the maternal immune system was somehow interfering with the pups’ brain development.Mazmanian had a suggestion.

The next time Patterson sacrificed one of his autistic mice to study their brains, what if he set the intestines aside for his colleague down the hall?. When the guts arrived in Mazmanian’s lab, he found that the intestines of the neurotypical mice looked normal. But the guts of the autism-mimicking offspring were almost uniformly inflamed. Could it be that the microbiome was the cause of this inflammation?.

And could that, in turn, be somehow connected to the behavioral symptoms?. Throughout the winter and spring of 2012, Mazmanian and Patterson continued their conversation. Mazmanian found distinct differences in the microbiomes of the mice. And, they noticed, the mice with the features of autism had leaky gut syndrome, an increased permeability of the gut lining that can allow pathogens and allergens to leach out.

This condition had also been reported in children with autism.So Mazmanian and Patterson turned their attention outside the gut. They took blood samples to see if any gut microbes, or the compounds they produce, were circulating in the rest of the body. They homed in on one molecule in particular, called 4-ethylphenyl sulfate, which was roughly 45 times as abundant in the mice that had symptoms of autism. And it looked familiar.

Structurally, it was almost identical to a molecule recently found to be significantly elevated in human children with autism.It was enough to take the next step. Every day for three weeks, Mazmanian injected the molecule, harvested from the mice with autism-like symptoms, directly into the bloodstream of 5-week-old normal lab mice (the age at which the autistic mice normally developed leaky gut). Then Mazmanian and his team gave them a series of behavioral tests. The mice were far more easily startled and were less comfortable in large empty spaces than their untreated peers, indications of an increase in anxiety-related behaviors commonly seen in the mice with autism-like symptoms.

The researchers published their results in Cell in 2013.Though surprising, the data made sense in some ways. Many drug companies rely on small-molecule drugs that can be taken orally, but still manage to cross the blood-brain barrier and affect behavior. It seemed entirely possible that small molecules, created by bacteria in the gut, could enter the bloodstream and reach the brain. And they don’t even have to leak out of the gut to do so.Of Mice and MenPatterson died in 2014, at age 70, just six months after the publication of the duo’s groundbreaking Cell paper.

Around the same time, a series of parallel experiments in a clinic hundreds of miles away was already paving the way forward. While Patterson and Mazmanian had been working in mice, Rosa Krajmalnik-Brown, a microbiologist at Arizona State University, had teamed up with Jim Adams, who directs the university’s autism and Asperger’s research program, to study humans.The researchers were conducting a detailed analysis of the microbiome of human autism patients and found that the bacteria were far less diverse in the children with autism. Notably, several important species involved in the digestion of carbohydrates were severely depleted.Krajmalnik-Brown and Adams launched a preliminary trial to test the effects of fecal transplants on 18 children between the ages of 7 and 16 with severe autism, who also had severe GI issues. The researchers administered powerful antibiotics to kill off the microbiomes of the children and followed them with a bowel cleanse.

They then replaced the microbes with transplanted flora taken from the guts of healthy neurotypical adult volunteers.The results were better than anyone could have expected. The procedure resulted in a large reduction in GI symptoms and increased the diversity of bacteria in the children’s guts. But more significantly, their neurological symptoms were reduced. At the onset of the study in 2017, an independent evaluator found 83 percent of participants had severe autism.

Two years after the initial trial, only 17 percent were rated as severely autistic. And 44 percent were no longer on the autism scale.“[My child] did a complete 180,” says Dana Woods, whose then-7-year-old son Ethan enrolled in the initial study five years ago. €œHis ability to communicate is so much different now. He’s just so much more present.

He’s so much more aware. He’s no longer in occupational therapy. He’s no longer in speech therapy. After the study, he tested two points away from a neurotypical child.”In their first report on the trial in 2017, the team highlighted a number of distinct changes in the microbiome after the transplants, in particular a surge in the populations of three types of bacteria.

Among them was a four-fold increase in Bifidobacterium, a probiotic organism that seems to play a key role in the maintenance of a healthy gut.But figuring out what was happening on a cellular level — to really look inside some guts — would require another vehicle. The ASU team needed Mazmanian’s mice.“At the end of the day, what we care about is healing people and how the microbiome affects people,” explains Krajmalnik-Brown. €œThat’s why we work with people. But with mice you can do things that are more mechanistic.”The Great Mouse Detective(Credit.

Caltech)Together, Krajmalnik-Brown, Mazmanian and their collaborators would uncover some tantalizing new insights that go a long way to solving the mystery. In May 2019, the team published another high-profile paper in Cell, after they transplanted stool samples from Krajmalnik-Brown’s severely autistic patients into the guts of Mazmanian’s germ-free mice. The offspring of these mice showed the autism-like symptoms, such as repetitive and compulsive behavior.This time, the team dug even deeper into the biochemical processes playing out in the brain, looking not just at behavior but at the chemicals involved in creating it. The mice that developed autism-like behaviors had measurably lower levels of two substances called taurine and 5-aminovaleric acid (5AV).

When they dug into the literature, the team learned that these two substances are known to mimic activity of a key signaling agent in the brain called gamma-aminobutyric acid (GABA) — a neurotransmitter that other studies have found is deficient in the brains of children with autism.What’s more, some have speculated that the tendency of children with autism to experience sensory overstimulation may stem from the inability to tamp down overexcited neurons. A lack of GABA could lead to just that.The scientists next orally administered high levels of taurine and 5AV to pregnant mice with the autistic children’s microbiomes. When their pups were born, the researchers continued to feed the young the substances until they reached adulthood. Compared with untreated animals, the second-generation mice had significantly fewer behavioral symptoms.

Taurine reduced repetitive behavior, as measured by marble burying, increased the level of social interaction, and relieved anxiety. Mice administered 5AV were more active and social.“We healed humans with behavioral problems,” says Krajmalnik-Brown. €œ[And we] transferred some of those deficits and behaviors to mice — basically the opposite. It’s huge.”Mazmanian hopes to take the next step in the months ahead.“I can flip a switch, turn on a light, I know that switch turns on that light.

I don’t know the circuit, I don’t know where the wire is,” Mazmanian says. €œExactly how that’s happening … we just don’t understand that.”This most recent study, by itself, hardly proves that dysregulated microbiomes cause the brain disorder — a point that plenty of other scientists skeptical of Mazmanian’s work are happy to make.“The paper made a big splash, but trying to model psychiatric-related human conditions in mice, in my view, is a little bit of a stretch,” says Sangram Sisodia, a neurobiologist at the University of Chicago who studies the microbiome. €œA mouse with autism?. €Nor was that the only criticism.

Several researchers have suggested that the group didn’t give proper attention to one of their tests ­— one whose results conflicted with their thesis ­— while others found flaws in the statistical methods they used to assess their results. Mazmanian downplays these criticisms, but agrees the work is not yet conclusive.Meanwhile, the ASU trial has also engendered skepticism, mainly due to its tiny sample size, the lack of a control group and the methods by which the children were assessed for autism severity. Krajmalnik-Brown and Adams say they stand by their results, but agree more research is needed. In recent months, they have launched two new studies that will address these issues.Adams insists the work is already changing lives.

€œWe followed up with every one of our 18 participants,” he says, referring to the children who received fecal transplants. €œSure enough, we found that most of the GI benefits had remained. And family after family said their child just slowly, steadily continued making more improvement.” They published the update in Scientific Reports in spring 2019.“I’m not ready to say the case is closed,” says Mazmanian. €œHealthy skepticism is a good thing.

I believe the preclinical data, I believe the mouse data. But there’s a lot of studies that still need to be done.” A Healthy Gut, A New OutlookEthan Woods had GI issues and symptoms of autism until researchers introduced new microbes to his gut. His mother says the treatment changed everything. (Credit.

Dana Woods)Prior to his fecal transplant at age 7, Ethan Woods suffered from chronic and severe diarrhea, constipation and cramping, symptoms so extreme that to his mother, Dana, he sounded like “a bit like a woman in labor when he was trying to have a bowel movement.” “It was just awful watching your child go through this,” she says, explaining that when she enrolled her autistic son in the Arizona State study, her “only goal was to fix his gut.”Remarkably, Ethan’s agony began to disappear just a few weeks into the trial. But that was not the most dramatic difference. Before the transplant, Ethan’s speech was drawn out and slow, his language skills rudimentary. He seemed to live in his own bubble.

He had frequent outbursts. For as long as Dana could remember, her mornings with Ethan had been marked by arguing, fighting, pushing and anger. But then one morning, something shocking happened.“He woke me up one morning with his face right in my face with this big smile and he said, ‘Morning, Mom!. €™â€‰â€ she recalls.

€œAnd he was just excited and happy and ready to go about his day with this big smile. It choked me up to the point where I teared up because I had never experienced a happy kid in the morning.”Later, Ethan carried over an iPad and opened an app with a talking cat that repeats back the words children speak aloud. He played back a video recording of himself from just a few weeks earlier.“[He] looks me in the eye and says, ‘Mom, why did I talk like that?. What is wrong with me?.

€™ And as soon as he did that, I caught my breath. I had to compose myself and say, ‘I don’t know. But do you feel better?. Do you feel different?.

Why do you think?. €™â€‰â€Ethan’s communication skills had already begun to improve. Within a year of the study, his speech therapist graduated him from speech therapy because he had met all his goals.“He went from one end of the rainbow all the way to the other end of the rainbow,” she says. €œPrior to the study, I was very afraid.

My biggest fear was ‘how is he going to navigate the world when I’m not here?. €™ And I think I have a lot of hope now that he is going to be OK now on his own.”There’s something strange about the female orgasm, something that scientists have been unable to explain. Biological functions are normally discussed in terms of evolutionary pressure, or reproductive advantage. If a biological trait improves your chances of having more offspring, then it’s more likely to stick around in your species.

The male orgasm makes perfect sense — ejaculate contains the genetic material that’s necessary for making babies. But the female orgasm has been harder to nail down. Fertilization doesn’t depend on it, and “fun” isn’t exactly in the pantheon of evolutionary explanations.Researchers that study how the female orgasm relates to reproductive success have two main options — either ask people invasive questions about their most personal moments, or to find a way to stick probes in or on them during said moments. Neither of these approaches have resulted in the kind of “wet lab” research that’s the gold standard for biological understanding.What we do know, despite widespread cultural discomfort with talking openly about sex and pleasure, is that there appears to be significant sexual dysfunction in American society.

Back in 2014, researchers from the Kinsey Institute, the preeminent U.S. Academy for the study of sex and relationships, said as much. In a survey of nearly 3,000 people, they found that men, straight or gay, orgasmed 85 percent of the time during consensual sexual encounters. Lesbian women orgasmed less often, 75 percent of the time, while straight women fared worst with just a 60 percent chance of orgasm.

Other studies have shown that something like 10-15 percent of women experience lifelong anorgasmia, meaning they’ve never experienced orgasm. A further 40 percent of women report some kind of inability to reach orgasm in the past year.The orgasm gap is hard to explain. Some think that it comes down to straight men’s finesse, or lack thereof, citing the difference between straight and lesbian satisfaction. Indeed, it makes sense that knowing your way around the territory would help.

But for many couples this isn’t a helpful revelation, since the emotional maturity necessary to teach sexual dexterity is often out of reach. Shortcut to SatisfactionLuckily, we live in an era of Silicon Valley disruption, which has even started lapping at the shores of sex research. Technologist Liz Klinger is at the forefront of this transition. She and her team have built a platform that lets people become citizen scientists of sex —without ever having to get out from between the sheets.About a decade ago, Klinger’s company, Lioness, released what they billed as the first “smart vibrator,” a sex toy that could actually learn about you.

The final product was a far cry from the first prototype, which was much more laboratory object than sex toy.The “test device was this whole mess of wires, with a hard connection. We had to physically send it to our beta testers, who used it and sent it back,” recalls Klinger. The researchers would download the data collected by the toy’s four sensors — temperature, motion, acceleration and pressure — and compile it into a chart that represented arousal and orgasm, as told through the story of pelvic-floor muscle contractions.It was an immediate success for sex partners who needed ways to talk about pleasure in a more objective way. Klinger recalled that when she got the first beta-test couple on the phone, “the wife was like ‘holy crap, we finally were able to talk about these things that I’ve had a lot of trouble talking about.’ It turned out that she wanted more foreplay, and he didn’t know quite that that meant.

He’d spend more time, but it just didn’t match up, you know?. € With the company’s signature offering in hand — a chart of sexual arousal over time — Klinger found that couples could have a conversation “without the subtext of ‘oh, you’re not good enough, or I don’t like you enough,’ on the husband’s part and ‘I’m so tired of talking about this’ on the wife’s part,” she says. The chart “can change people’s perceptions of their own experiences, and how they talk about them with others.”Doing the Deed — For ScienceThis spring, the company has launched a research platform dubbed Lioness 2.0 — a new optional service that, unsurprisingly, their data-obsessed users have greeted with open arms. Now, instead of simply using the toy to understand themselves better, Lioness owners can opt in to the kinds of hands-on studies that are necessary for a deeper understanding of sex and pleasure.

So far, the company is working with Nigeria’s Society for Family Health to study how pleasure changes with menopause across age, race and orientation, as well as with the U.S.’s Center for Genital Health and Education to explore the role of pelvic floor muscles in orgasm.Pani Farvid, a professor of applied psychology at The New School in New York City, has some reservations about the platform. €œI really like what they’re trying to do, but there could be more added to make it a bit more comprehensive. My concern is that there's a misconception that sex is just about the orgasm, that it’s just physiological and that pleasure just has to do with the genitals.” From where she’s sitting, “that’s a very mechanical view of sexuality.” If the Lioness is helping to equalize the orgasm gap, or helping people understand their bodies better, “I think that's great,” says Farvid. €œBut as a critical sexologist, I'm interested in delving deeper into what these practices mean.” If sex is hyper-focused on orgasm, to exclusion of everything else, she cautions that these norms “have real-life negative impacts on people's sex lives and their sense of themselves.”At this point, knee-deep in an era of data collection that was once the sole purview of white-coat-wearing scientists, it’s old news that we need to be careful with what our technology is doing to us.

No tool can serve as a cure-all, even if it comes loaded with a neat app and some space-age sensors. What it can offer, though, is the opportunity to start a conversation, and the chance to take a long, honest look at something about yourself — whether it’s the number of steps you take every day, or the way you want to be touched.Wondering how to keep your glasses from fogging up when your mask is on?. Look no further. If we've learned one thing throughout the COVID-19 pandemic, it's the importance of wearing a mask.

Countless studies have shown over the past eight months that wearing a protective barrier over your nose and mouth — whether it's a standard-issue surgical mask or an N95 respirator — can significantly decrease the odds of catching and transmitting disease. What's more, some research shows that masking up can reduce the severity of an infection if a masked person does contract COVID-19. But while masks are potentially lifesaving, they can be uncomfortable, often changing your breathing patterns and fogging up your glasses when breath escapes through the top of the mask. Among people who choose not to wear a mask to prevent the spread of COVID-19, many cite discomfort as a key reason why.Wesley Wilson, a tumor immunologist in Pennsylvania, knows how annoying it can be when your glasses are fogging up.

He says fogging is “definitely a problem” among his hospital colleagues, who need to wear protective goggles and surgical masks while on the job. Fortunately, they've also picked up a few helpful hacks for keeping their vision clear while wearing a mask with glasses.#1. Use Tape“If you have to keep your mask on for hours, tape works like a charm,” Wilson says. This especially applies to healthcare professionals in his practice who are required to keep their masks on at all times, except during lunch.

€œIf you're putting on your mask and taking it off a lot, tape probably isn't practical — but two small pieces of tape on the cheeks keep the mask fitted closer to your face, and the hot air out of your glasses,” he says.#2. Fit the Mask to Your FaceWhile some air leakage is to be expected, wearing a mask that fits securely to your face will prevent glass fogging and filter the virus more effectively since less air is coming in or out. Find surgical masks or N95s that come with a nose bridge, a small, flexible piece of metal or plastic that allows the mask to more closely fit the contours of your face. Nose bridges can be sewn inside masks or affixed to the front.Read More.

Why It Feels Like You Can't Breathe Inside Your Face Mask#3. Adjust Your MaskAccording to the American Academy of Ophthalmology, a minor adjustment in how you wear your mask could be enough to prevent fog as well. Simply pull the mask over your nose and rest your glasses on top of your face mask. As long as the mask is fitted close to your face, this should prevent hot air from slipping out.#4.

Spray Your GlassesA former ice hockey player, Wilson says the protective visor under his helmet would often fog with hot air while he was on the ice during games. Like an ocean diver, he would use de-misting solution or a defogging spray (such as this one) to keep his visor free of fog. The same concept applies to eyeglass fog caused by masking, he says. €œYou can either buy a spray or you can make your own with either shaving cream or soap and water,” says Wilson.

€œWiping some shaving cream on your glasses and then wiping it off will coat them with a similar surface-tension altering compound that prevents fog.”.

What should I tell my health care provider before I take Levitra?

They need to know if you have any of these conditions:

  • anatomical deformity of the penis, Peyronie's disease, or ever had an erection that lasted more than 4 hours
  • bleeding disorder
  • cancer
  • diabetes
  • frequent heartburn or gastroesophageal reflux disease (GERD)
  • heart disease, angina, high or low blood pressure, a history of heart attack, or other heart problems
  • high cholesterol
  • HIV infection
  • kidney disease
  • liver disease
  • sickle cell disease
  • stroke
  • stomach or intestinal ulcers
  • eye or vision problems
  • an unusual reaction to vardenafil, medicines, foods, dyes, or preservatives

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At the adderall and levitra start of field work season, ecologist Jory Brinkerhoff usually advises his crew to watch out for summertime fevers. If you develop a fever at that time of year, he tells them, it’s probably not the flu, but a tick-borne illness.But this year, Brinkerhoff, who studies human risk for flea- and tick-transmitted diseases at the University of Richmond, didn’t know exactly what to tell his field crew. A fever in the middle adderall and levitra of summer 2020 could mean a tick-borne illness.

Or, it could mean COVID-19.With the novel SARS-CoV-2 virus still spreading across the country, some experts worry about the overlap between COVID-19 and Lyme disease, which is caused by a bacterium carried by black-legged ticks. While it’s too soon to know exactly how the pandemic will affect Lyme disease rates this year, experts like Brinkerhoff wonder if more people spending time outside beating the quarantine blues could lead to more adderall and levitra people being exposed to disease-carrying ticks. Some overlapping symptoms might also lead to delayed diagnosis and treatment of Lyme, he notes.

At the same time, weather patterns in some parts of the country may actually lead to fewer Lyme disease cases this year. No matter the broader adderall and levitra trends, there are things anyone getting outside can do to protect themselves from ticks. Lyme Disease on the MoveOver the last few decades, Lyme disease has been on the rise in the United States.

There are many overlapping reasons for this, says Brinkerhoff adderall and levitra. Awareness has gone up since the 1970s, when Lyme was first described in the U.S. Landscape changes like cutting forests and building suburbs near wooded areas has put humans in closer contact with ticks and tick-carrying animals.

Deer populations adderall and levitra have exploded in the last 100 years, he notes. And climate change is likely allowing ticks to spread to and thrive in new parts of the continent. This year, people have flocked to the great adderall and levitra outdoors to escape their home quarantines and engage in socially-distant fun.

It’s possible that more people trying to get outside could mean more people exposed to ticks and, therefore, Lyme disease, says Brinkerhoff, who wrote an article in The Conversation on the issue earlier this year. Animals have been behaving differently during the pandemic as well, especially during the early days of lockdown, and it’s unclear if that could also have an effect on Lyme disease rates, he says.In some parts of the country, however, Lyme may be less of a concern this summer than it normally is. Maine is usually a Lyme hotspot in early summer, but unusually hot and adderall and levitra dry weather this year may be keeping ticks close to the ground and away from human contact, says Robert P.

Smith Jr., an infectious disease physician and director of the division of infectious diseases at Maine Medical Center. While it’s too early to tell, Lyme disease rates in Maine could actually go down this summer as a result, he says.Overlapping SymptomsWith everyone rightfully concerned about COVID-19, Lyme disease likely isn’t at the forefront of adderall and levitra someone’s mind if they develop a fever. Plus, about two-thirds of people with Lyme disease don’t remember being bitten by a tick, says Smith.

Many who develop Lyme disease are bitten by poppy seed-sized immature ticks that can stay on the body unnoticed for two or three days before dropping off, he says.There is some overlap between COVID-19 and Lyme disease symptoms that could cause confusion. In both cases, people usually develop a fever and muscle aches, says Smith adderall and levitra. He has heard secondhand about a few cases in Maine in which patients with these symptoms were first tested for COVID-19 and were later found to have Lyme disease.However, there are some crucial differences between the two illnesses, Smith says.

The majority of people with symptomatic COVID-19 will have a cough or shortness adderall and levitra of breath, whereas Lyme disease generally has no respiratory component, says Smith. COVID-19 patients also have a higher risk for gastrointestinal issues, and Lyme patients do not. While not all people with Lyme disease develop a rash, 70 to 80 percent do, Smith notes.

Rashes are adderall and levitra not common symptoms for COVID-19 infections. Receiving an accurate diagnosis and relatively quick treatment can greatly reduce the severity of a Lyme disease infection. €œIt doesn’t adderall and levitra have to be immediate.

If you think you might have Lyme disease, you need to get diagnosed with a week or so,” says Smith. €œThat’s usually very early in the disease and you can expect an excellent response to antibiotic treatment.” Delaying treatment by a couple of weeks can lead to more serious complications, including nerve-related symptoms, Lyme meningitis, facial muscle weakness (Bell’s palsy), Lyme arthritis and other conditions, he says. While antibiotics are still effective at this stage, it tends to take longer to fully recover.Fortunately, for anyone concerned about safe outdoor excursions here and now, there are several practical steps you can take to avoid ticks adderall and levitra.

Use insect repellant and wear protective layers. Stick to the path instead adderall and levitra of straying into dense underbrush, says Smith. When you return from an adventure, put your clothes in the washer and check yourself for ticks.

And if you do start to feel feverish a few days later, call your doctor and be sure to mention you’ve been spending time outside..

At the start of field work season, ecologist Jory Brinkerhoff usually generic levitra for sale advises his crew to watch out for summertime fevers. If you develop a fever at that time of year, he tells them, it’s probably not the flu, but a tick-borne illness.But this year, Brinkerhoff, who studies human risk for flea- and tick-transmitted diseases at the University of Richmond, didn’t know exactly what to tell his field crew. A fever in the middle of summer 2020 could mean a tick-borne illness generic levitra for sale. Or, it could mean COVID-19.With the novel SARS-CoV-2 virus still spreading across the country, some experts worry about the overlap between COVID-19 and Lyme disease, which is caused by a bacterium carried by black-legged ticks.

While it’s too soon to know exactly how the pandemic will affect Lyme disease rates this year, experts like Brinkerhoff wonder if more people spending time outside beating the quarantine blues could lead generic levitra for sale to more people being exposed to disease-carrying ticks. Some overlapping symptoms might also lead to delayed diagnosis and treatment of Lyme, he notes. At the same time, weather patterns in some parts of the country may actually lead to fewer Lyme disease cases this year. No matter the broader trends, there are things anyone getting outside can do to protect themselves generic levitra for sale from ticks.

Lyme Disease on the MoveOver the last few decades, Lyme disease has been on the rise in the United States. There are many overlapping generic levitra for sale reasons for this, says Brinkerhoff. Awareness has gone up since the 1970s, when Lyme was first described in the U.S. Landscape changes like cutting forests and building suburbs near wooded areas has put humans in closer contact with ticks and tick-carrying animals.

Deer populations have exploded in the last 100 years, he notes generic levitra for sale. And climate change is likely allowing ticks to spread to and thrive in new parts of the continent. This year, people have flocked to the great outdoors to escape their home generic levitra for sale quarantines and engage in socially-distant fun. It’s possible that more people trying to get outside could mean more people exposed to ticks and, therefore, Lyme disease, says Brinkerhoff, who wrote an article in The Conversation on the issue earlier this year.

Animals have been behaving differently during the pandemic as well, especially during the early days of lockdown, and it’s unclear if that could also have an effect on Lyme disease rates, he says.In some parts of the country, however, Lyme may be less of a concern this summer than it normally is. Maine is usually a Lyme hotspot in early summer, but unusually generic levitra for sale hot and dry weather this year may be keeping ticks close to the ground and away from human contact, says Robert P. Smith Jr., an infectious disease physician and director of the division of infectious diseases at Maine Medical Center. While it’s too early to tell, Lyme disease rates in Maine could actually go down this summer as a result, he says.Overlapping generic levitra for sale SymptomsWith everyone rightfully concerned about COVID-19, Lyme disease likely isn’t at the forefront of someone’s mind if they develop a fever.

Plus, about two-thirds of people with Lyme disease don’t remember being bitten by a tick, says Smith. Many who develop Lyme disease are bitten by poppy seed-sized immature ticks that can stay on the body unnoticed for two or three days before dropping off, he says.There is some overlap between COVID-19 and Lyme disease symptoms that could cause confusion. In both cases, people usually develop a fever and muscle aches, says generic levitra for sale Smith. He has heard secondhand about a few cases in Maine in which patients with these symptoms were first tested for COVID-19 and were later found to have Lyme disease.However, there are some crucial differences between the two illnesses, Smith says.

The majority of people with symptomatic COVID-19 will have a cough or shortness of breath, generic levitra for sale whereas Lyme disease generally has no respiratory component, says Smith. COVID-19 patients also have a higher risk for gastrointestinal issues, and Lyme patients do not. While not all people with Lyme disease develop a rash, 70 to 80 percent do, Smith notes. Rashes are not common generic levitra for sale symptoms for COVID-19 infections.

Receiving an accurate diagnosis and relatively quick treatment can greatly reduce the severity of a Lyme disease infection. €œIt doesn’t generic levitra for sale have to be immediate. If you think you might have Lyme disease, you need to get diagnosed with a week or so,” says Smith. €œThat’s usually very early in the disease and you can expect an excellent response to antibiotic treatment.” Delaying treatment by a couple of weeks can lead to more serious complications, including nerve-related symptoms, Lyme meningitis, facial muscle weakness (Bell’s palsy), Lyme arthritis and other conditions, he says.

While antibiotics are still effective at this stage, it tends to take longer to fully recover.Fortunately, for anyone concerned about safe outdoor excursions here and now, there are several practical steps you can take generic levitra for sale to avoid ticks. Use insect repellant and wear protective layers. Stick to the path instead of straying into dense underbrush, says Smith generic levitra for sale. When you return from an adventure, put your clothes in the washer and check yourself for ticks.

And if you do start to feel feverish a few days later, call your doctor and be sure to mention you’ve been spending time outside..

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On this page Policy objectiveThis guidance is to provide Canadians with access to information on the safety and efficacy/effectiveness which is safer viagra cialis or levitra of products being used for the COVID-19 pandemic. These products are being imported and sold in Canada under 2 interim orders. All personal and confidential business which is safer viagra cialis or levitra information (CBI) will be protected prior to release. The disclosed information will be made publicly available for non-commercial purposes after Health Canada completes its regulatory review process, while adhering to Canada’s Privacy Act.Providing public access to this information supports Canada’s objective for transparent decision-making. Public access also provides valuable information that may help with the use or development of COVID19 drugs and medical devices.This guidance document outlines the process for publicly disclosing information in a market authorization application under the 2 interim orders.

The process includes which is safer viagra cialis or levitra. procedures when releasing information types of information that fall under the guidelines for CBI and that may be eligible for redaction protection of personal informationScope and application This document applies to information relied upon to issue a market authorization under the. Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (September 16, 2020) and interim order respecting the importation and sale of medical devices for use in relation to COVID-19(March 18, 2020)The public release of safety and efficacy/effectiveness information reviewed under the 2 interim orders is governed by common law. Information requested for release is assessed case by which is safer viagra cialis or levitra case to determine what is CBI. Personal information is removed before the safety and efficacy/effectiveness information is released to the public.Following Health Canada’s review of an application, safety and efficacy information will be released as follows.

Automatically disclosed in applications submitted under the interim order for importing, selling and advertising drugs (proactive release) disclosed on request in applications submitted under the interim order for importing and selling medical devices (released upon request)Information in applications that have been authorized, including those authorized and then revoked, is in scope for public release. This includes which is safer viagra cialis or levitra. Original application documents documents filed after market authorization is issued (filed at Health Canada’s request or to meet a condition of approval)Information in applications that are refused and were never authorized is out of scope for public release. This document does not apply to clinical information submitted to support the market authorization of a medical device under the Medical Device Regulations or of a new drug submission under the Food and Drug Regulations (FDR). The exception are new drug which is safer viagra cialis or levitra submissions for COVID-19 indications submitted under the FDR.

For more information on the public release of this information, see the Public Release of Clinical Information. Guidance document.Also not applicable under this document is the CBI disclosure authority under section 21.1(3)(c) of the Food and Drugs Act. This section permits the Minister of Health to disclose CBI to certain persons for the purpose of protection or promotion of human health which is safer viagra cialis or levitra or the safety of the public. For information on this authority, see the guidance document Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act.Proactive release of drug application informationWe will proactively publish safety and efficacy information used to support interim order drug applications upon authorization. This includes clinical information in applications submitted under sections 3, 6 and 14 of the interim order.How to request clinical information in medical device applicationsWe will publish safety and effectiveness information used to support interim order medical device applications when we receive a request from the public and within the limits of our administrative capacity.

Requests made which is safer viagra cialis or levitra for multiple applications will be processed in sequence and subject to prioritization. Further prioritization may be given to products that have a greater impact on the health system, such as. Products that are used a lot products that have a higher public interestRequests received for information in applications under the interim order will be prioritized over requests for clinical information in non-COVID19-related drugs submissions and device applications.To request clinical information on medical device applications, use our special portal to submit an electronic request form. Be sure which is safer viagra cialis or levitra to identify the product name listed on the following sites. Publication process Publication of safety and efficacy information used to support drug interim order applications The publication of information follows the process described in section 4 and Appendix C of the Public Release of Clinical Information guidance document.In accordance with PRCI timelines, we aim to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from starting the process.

The process starts automatically on the day an authorization is issued.Step 1. Notice to the company and request for proposed CBI redactions and anonymizationFollowing the authorization of a drug under the interim order, Health Canada will give the manufacturer an opportunity to take part in which is safer viagra cialis or levitra a process initiation meeting. The first 60 days of the 120-day publication process is allocated for the company to review the clinical information. The company uses the Proposed Redaction Control Sheet (Appendix E, Public Release of Clinical Information (PRCI) guidance document) to propose any redaction of CBI. Proposed CBI redactions should pertain to information that meets the definition of confidential business which is safer viagra cialis or levitra information.

This is defined in Section 2 of the Food and Drugs Act, which mirrors common law in the context of confidential business information that meets each of the following 3 elements of the definition. That is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitorsFollowing an assessment of the proposals, text within an in-scope document found to meet the above definition will be protected which is safer viagra cialis or levitra. Similar to Public Release of Clinical Information policies, any information that meets the definition of “clinical information” will not be considered confidential business information. Exceptions to the PRCI regulations described in C.08.009.2(2)(a) and (b) of the Food and Drug Regulations or section 43.12(2)(a) and (b) of the Medical Device Regulations will be considered when applying redactions to confidential business information. Further information on the application of these exceptions can be found in the Health Canada PRCI guidance document.All personal information which is safer viagra cialis or levitra should be anonymized in accordance with section 6 of the Public Release of Clinical Information guidance document.

The proposal package from the manufacturer should include. The proposed redaction control sheet the draft anonymization report annotated documentsManufacturers submit for Health Canada assessment using either CanadaPost ePost Connect or a suitable secure file transfer site of the manufacturer’s choosing.Step 2. Health Canada assessment of company representationsWithin 30 days of receiving the proposal package, which is safer viagra cialis or levitra Health Canada will complete and return our assessment of the proposed CBI redactions and anonymization methodology. Proposed redactions that meet the definition of confidential business information will be protected. We will review the anonymization methodology to ensure all personal information is protected while maximizing the disclosure of useful clinical information.

Step 3 which is safer viagra cialis or levitra. Revision of proposed CBI redactions and anonymizationIf proposed CBI redactions are rejected or revision is required to the anonymization methodology, in accordance with the Public Release of Clinical Information. Guidance document, the manufacturer will be given 15 days to make the revisions and resubmit. We will send our final assessment to the manufacturer within 5 days of receiving the which is safer viagra cialis or levitra revised package. Step 4.

Finalization and publicationWithin 5 days of receiving our final assessment, the manufacturer must format and submit the final redacted and anonymization clinical documents within 5 days of receiving our final assessment. The final documents must comply with which is safer viagra cialis or levitra the Guidance Document. Preparation of Regulatory Activities using the Electronic Common Technical Document (eCTD) Format. These documents are to be submitted using the Common Electronic Submission Gateway. We will publish the final redacted documents within 5 days of receiving the final sequence.Publication of safety and effectiveness information used to support medical device interim order applicationsThe which is safer viagra cialis or levitra publication of information within an interim order application will proceed through the abbreviated process described below.

Our goal is to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from initiation of the process.Step 1. Health Canada screening of requestsAfter we receive a request for information, we will retrieve the interim order application from docubridge (or other location). Information related to safety and effectiveness will be considered in-scope of publication which is safer viagra cialis or levitra. Other information will not be released publicly. Only information available at the time the request is made will be considered for disclosure.

Information submitted after the original request for disclosure will be considered which is safer viagra cialis or levitra for public release upon receipt of a subsequent request.Examples of in scope information include. Clinical testing information validation testing that supports the effectiveness of the product, including testing performed in vitro or in silico summaries or overviews on safety or efficacy pre- or post-market, including literature reviewsExamples of out of scope information include. Manufacturing details not related to safety or efficacy engineering and design details general documents, such as user manuals, package inserts and instructions for use individual patient information, such as patient listings and case report forms, that require extensive anonymization interim clinical study data (see the PRCI guidance)Step 2a. Health Canada assessment of confidential business information To reduce which is safer viagra cialis or levitra administrative burden on the manufacturer, we will review in-scope records for confidential business information, as defined in Section 2 of the Food and Drugs Act, which mirrors common law in the context of confidential business information that meets each of the following 3 elements of the definition will be protected. That is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitorsText in an in-scope document found to meet this definition will be redacted using a PDF redaction tool.

Similar to Public Release of Clinical Information policies, any information that meets the definition of “clinical information” will not be considered confidential business information. Exceptions to the which is safer viagra cialis or levitra PRCI regulations are outlined section 43.12(2)(a) and (b) of the Medical Device Regulations. These exceptions will be considered when applying redactions to confidential business information. Further information which is safer viagra cialis or levitra on the application of these exceptions can be found in the PRCI guidance document.Step 2b. Assessing personal informationIn general, in-scope records do not contain a large volume of personal identification information.

Any personal information, as defined in the Privacy Act and in accordance with PRCI guidance, information that could help to identify an individual will be protected. For example, this can include the names of authors and investigators as well as subject identification which is safer viagra cialis or levitra numbers.A large volume of indirectly identifying information is not expected in the medical device records that are in-scope of publication. Consequently, limited protection of personal information is anticipated.Personal information will be redacted using a PDF redaction tool. Step 3. Notice to the company and request for redaction proposalFollowing the review and redaction of in scope documents, we will which is safer viagra cialis or levitra send the manufacturer a written notice indicating our intent to publish the identified documents.

A copy of the release package will be sent for the manufacturer’s review. Any further proposed redactions by the manufacturer must be received within 14 calendar days.Manufacturer are asked to use the Proposed Redaction Control Sheet (see Appendix E of the PRCI guidance document) to suggest further redactions.Step 4. Health Canada assessment of company representationsAny further redactions proposed by the manufacturer will be assessed in accordance with the which is safer viagra cialis or levitra process outlined in step 2, above. Those that meet the definition of personal or confidential business information will be accepted.Step 5. PublicationIn-scope documents will be published within 120 days following receipt of the request.

The redacted information will be uploaded to the Clinical Information Portal, which is safer viagra cialis or levitra indexed by application number. Published documents will carry a watermark and be subject to terms of use, as described in the PRCI guidance.Mailing addressInformation Science and Openness DivisionResource Management and Operations DirectorateHealth Products and Food BranchHealth Canada Graham Spry Building 250 Lanark Ave Ottawa ON K1A 0K9 Telephone. 613-960-4687Email. Hc.clinicaldata-donneescliniques.sc@canada.ca Terminology which is safer viagra cialis or levitra and definitions Anonymization. Means the process through which personal information is modified by.

removing direct identifiers and any related code that would enable linkage with identifying information and ensuring that the remaining indirect identifiers no longer present a serious possibility of re-identifying an individual CBI. Confidential business information, as meant in common law and as defined in Section 2 of the Food and Drugs Act which is safer viagra cialis or levitra. in respect of a person to whose business or affairs the information relates, means (subject to the regulations) business information that. Is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors Clinical information. Means information in respect of a which is safer viagra cialis or levitra clinical trial, clinical studies or investigational testing, such as.

clinical overviews, clinical summaries and clinical study reports for drugs summaries and detailed information of all clinical studies and investigational testing that provided evidence of safety and effectiveness for medical devices Clinical study report. Means an "integrated" full report of an individual study of any therapeutic, prophylactic or diagnostic agent (drug or treatment) conducted in patients, in which. the clinical and statistical description, presentations and analyses are integrated into a single report incorporating tables and figures into the main text of the report or at the end of the text appendices contain which is safer viagra cialis or levitra the protocol, sample case report forms, investigator-related information, information related to the test drugs/investigational products, including active control/comparators, technical statistical documentation, related publications, patient data listings and technical statistical details such as derivations, computations, analyses and computer output FDA. Food and Drugs Act FDR. Food and Drug Regulations IMDRF ToC.

International Medical which is safer viagra cialis or levitra Device Regulators Forum Table of Contents Medical device. Has the same meaning as insee the Medical Devices Regulations. For information on the classification of medical devices, which is safer viagra cialis or levitra please see the guidance documents on the. risk-based classification system for in vitro diagnostic devices (IVDDs) risk-based classification system for non-in vitro diagnostic devices (non-IVDDs) Non-commercial purpose. Means the information will not be used to support a marketing authorization application anywhere in the world or sold or traded to another person Personal information.

Has the same meaning as in Section 3 of the Privacy Act Related linksOn this page About the guidance document This guidance document supports the Interim Order Respecting which is safer viagra cialis or levitra Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. The Minister of Health approved the Interim Order on March 30, 2020, to address the unprecedented demand and urgent need for medical devices to treat, diagnose and protect Canadians against COVID-19. The guidance covers sections 15 to 19 of the Interim Order. It remains which is safer viagra cialis or levitra in effect as long as the Interim Order is in effect. Under the Interim Order, manufacturers and importers must report medical device shortages related to COVID-19 to Health Canada.

The devices to which the shortages apply are on the List of Medical Devices — Notification of Shortages (specified medical devices). A specified medical device is which is safer viagra cialis or levitra a device that is either. set out in the list of medical devices or part of a category of medical devices that is set out in that list The guidance is intended to help manufacturers and importers meet their regulatory obligations. It outlines their responsibilities concerning the mandatory reporting of medical device shortages. About medical which is safer viagra cialis or levitra device shortages and reporting A medical device shortage occurs when a manufacturer is unable to meet Canadian market demand for the device or for its components, accessories, parts or consumable materials.

This does not apply when a substitute device, component, accessory, part or consumable material is available in Canada. There are 2 types of shortages. actual, when the current which is safer viagra cialis or levitra supply can’t meet current demand anticipated, when the future supply can’t meet projected demand Manufacturers and importers must. report a medical device shortage provide a shortage status update if there is a change in the shortage information submitted provide additional information related to a shortage when requested by Health Canada report an end of a medical device shortage This guidance document also provides some guidance on how to voluntarily report a medical device shortage that does not fall under the Interim Order. Everyone has a role to play Manufacturers and importers Manufacturers and importers have a key role to play in preventing and reducing the impact of medical device shortages.

They can control the volume of medical devices in the supply which is safer viagra cialis or levitra chain and can take steps to resolve a medical device shortage when one occurs. They are also in the best position to communicate to customers about the availability of their devices. When a manufacturer experiences a shortage of a critical medical device it sells, we expect that the manufacturer will take all necessary measures to resolve the shortage as quickly as possible. Provincial/territorial governments and health care authorities Provincial and territorial governments and health care authorities also have an important which is safer viagra cialis or levitra role to play in preventing and mitigating critical medical device shortages. They can.

conserve and reallocate stock within regions or provinces to where it is most needed and collaborate to share supply identify and secure additional supplies of medical devices from other vendors or another provincial or territorial government identify and secure other compatible substitute medical devices Government of Canada The federal government administers the Food and Drugs Act, Radiation Emitting Devices Act and Medical Devices Regulations. We do not provide or control the supply of medical devices in Canada or have the authority to which is safer viagra cialis or levitra compel a manufacturer to supply a device. We work with stakeholders across the medical device supply chain to help determine the details and status of a shortage. We also coordinate and facilitate information sharing. When it comes to medical device shortages, Health Canada depends on early reporting of anticipated or actual shortages to help us which is safer viagra cialis or levitra.

prevent or manage impacts related to medical device shortages work with industry to identify mitigation strategies inform the procurement of medical devices for Canada Depending on the situation, our options include. prioritizing the review and approval of regulatory applications received from manufacturers (for example, an application to authorize or import an acceptable compatible device) expediting the process for issuing Medical Device Establishment Licences (MDELs) permitting the importation and sale of medical devices that do not fully meet Canadian regulatory requirements, but are manufactured to comparable standards to help address product shortages due to the COVID-19 pandemic working with international regulators to identify other manufacturers and to share needed safety and manufacturing information helping health care professionals and institutions get access to compatible substitute medical devices on an emergency basis (for example, the Special Access Programme can be used to provide access to unlicensed alternative medical devices) As part of the Government of Canada’s response to COVID-19, the Public Health Agency of Canada is working with other government departments to procure bulk shipments to facilitate access to much-needed medical devices. These include which is safer viagra cialis or levitra ventilators, testing swabs, reagents and test kits as well as personal protective equipment. Related linksOctober 9, 2020Our file number. 20-113699-873 As a standing regulatory member of the International Council for Harmonisation (ICH), which is safer viagra cialis or levitra Health Canada is committed to the adoption and implementation of all ICH guidance.

By way of this Notice, Health Canada is advising of its intent to implement ICH Q12. Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and the ICH Q12 associated annexes. This guidance has been developed by the which is safer viagra cialis or levitra appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH. The target timeframe for Health Canada implementation of ICH Q12 has been set to the third quarter of 2021 in order to allow sufficient time for the preparation of regulators and stakeholders.

Health Canada will be launching a stakeholder consultation in early 2021 to gather feedback on the final elements of the implementation of the Q12 guidance in which is safer viagra cialis or levitra Canada.This new Guideline is proposed to provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Implementation of this new ICH Guideline will promote innovation and continual improvement in the biopharmaceutical sector and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. It will allow regulators (assessors and inspectors) to better understand the firms' Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes.ICH Q12 should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances. This and other ICH which is safer viagra cialis or levitra Guidance documents are available on the ICH Website. Please note that the ICH website is only available in English.

If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox.Contact InformationFor any comments or inquiries related to this notice, please contact:Health Canada – ICH CoordinatorE-mail. Hc.ich.sc@canada.ca Please include "Implementation of ICH Q12" in the subject line.The Register of Innovative Drugs is maintained pursuant to C.08.004.1 of the which is safer viagra cialis or levitra Food and Drug Regulations. The register indicates the drugs that are eligible for data protection. Under C.08.004.1 (3) a subsequent manufacturer that seeks a notice of compliance on the basis of a direct or indirect comparison between the new drug and an innovative drug may not file a submission before the end of a period of six years after the day on which the first notice of compliance was issued for the innovative new drug. In addition, the which is safer viagra cialis or levitra notice of compliance cannot be issued before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator.

The format of the Register of Innovative Drugs is an electronic table, which is updated weekly. The register lists, in alphabetical order, the medicinal ingredients in the innovative drugs which were not previously approved in a drug by the Minister and that are not variations of a previously approved medicinal ingredient. Please note that there may which is safer viagra cialis or levitra be other medicinal ingredients included in the drugs. The register was re-formatted in summer 2016 to increase the clarity of the information provided regarding the medicinal ingredient, brand name and manufacturer of each innovative drug. For information related to treatment options, choices of medications and their uses, illnesses, side effects or drug interactions, please contact your health care professional (for example, doctor, pharmacist, etc.).

We do not provide which is safer viagra cialis or levitra medical advice regarding the use of the products identified in this database. For comments or questions, please contact by hc.opml-bmbl.sc@canada.ca or by telephone at 613-941-7281.Date published. October 7, 2020On this page OverviewAs the global COVID-19 pandemic emerged in December 2019, the need for coherent, pan-Canadian guidance on provincial and territorial testing was quickly recognized. Led by the National Microbiology Laboratory, initial interim which is safer viagra cialis or levitra guidance on laboratory testing was developed in consultation with the Canadian Public Health Lab Network and was finalized and approved by the Special Advisory Committee on April 16, 2020. This guidance was based on scientific evidence and testing resources available at that time.

The recommended testing guidance focused on the molecular polymerase chain reaction (PCR) as the sole laboratory technique to accurately identify SARS-CoV-2 in a patient sample.In May 2020, based on new evidence, the National Laboratory Testing Indication Guidance for COVID-19 was updated to reflect developments in four areas. Expanded laboratory resources viral transmission from asymptomatic individuals or individuals in the pre-symptomatic phase outbreaks in congregate living and work settings new testing modalities (molecular Point of Care and which is safer viagra cialis or levitra serological tests)The COVID-19 landscape has further evolved and it is now necessary to update key aspects of this document to reflect recent scientific and public health data. One key consideration relates to limiting asymptomatic diagnostic PCR testing where public health action could have significant benefits. Several pilot programs were conducted in Canada, confirming very low which is safer viagra cialis or levitra levels of COVID-19 in the general population and supporting an evidence-based approach to the relaunch of economic activity. In addition, it enabled jurisdictions to stress-test testing capacity and prepare jurisdictions for higher testing volumes.

Asymptomatic testing was also found to displace diagnostic capacity for symptomatic individuals, close contacts, high-risk settings and outbreak management. The National Laboratory Testing Indication Guidancefor COVID-19 has been updated to reflect these learnings and advances in science.Recognizing that testing regimes are within provincial and territorial jurisdiction, this document reflects the collaboration among jurisdictions, leveraging learnings from one another through the different adopted which is safer viagra cialis or levitra approaches.Emerging testing and screening technologiesThe Pan-Canadian COVID-19 Testing and Screening Guidance is designed to reflect changing risk management approaches as the pandemic conditions change. Recognizing that one size does not fit all, the Guidance is also designed to respond to a significant increase in the need to access testing and screening technologies. Scaling to meet increased and sustained testing and screening demand will require a paradigm shift, broadening the technologies that are used in a manner that is tailored to the purpose and application of technologies in a variety of settings. Although PCR which is safer viagra cialis or levitra remains the gold standard in diagnostic testing, numerous technologies and testing modalities are emerging that could serve to supplement diagnostic testing.

These recent testing and sampling options could create opportunities to expand the approach to testing by including broad-based approaches to screening through less sensitive and potentially more cost-effective technologies, thereby alleviating strain on the overall public health system.While they can be less sensitive, these technologies could have multiple benefits including ease and reduced cost of production, improved efficiency and reduced reliance on PCR testing supplies. They also have the potential to be less invasive depending on the technology. Antigen and extraction-free which is safer viagra cialis or levitra nucleic acid testing are examples of such technologies that, in addition to being more cost-effective and easier to produce, are also easily adaptable to mobile, rapid applications. However, due to their lower sensitivity than current PCR technology, these emerging technologies may be better used as a part of screening, in conjunction with repeated testing in some settings. Recognizing that these novel technologies have lower sensitivity and specificity than current PCR technology, their use should be targeted to scenarios where both positive and negative are interpreted and acted upon appropriately.Complementing the deployment of these emerging technologies, techniques such as pooled testing are being used to contribute to the preservation of testing resources.

Governments are also tapping which is safer viagra cialis or levitra non-traditional data sources to complement case data. For example, data for wastewater testing could complement COVID-19 surveillance systems by providing readily accessible pooled community samples and data for communities where testing is not available or underutilized.As of September 29, Health Canada has authorized 36 COVID-19 testing devices (PCR and serological). Health Canada is fast-tracking the review of submissions related to antigen and nucleic acid tests. Submissions that are reviewed include which is safer viagra cialis or levitra various sample types, including saliva. Consult the list of authorized medical devices for uses related to COVID-19.In anticipation of regulatory approval for antigen tests, an Interim Guidance on Antigen Testing has been developed to outline potential scenarios such as routine outbreak monitoring, monitoring in different situations including high-risk settings (for example, long-term care facilities) and possible adaptation into mobile, rapid testing in rural and remote communities.Pan-Canadian COVID-19 Testing and Screening GuidanceLike the Laboratory Testing Guidance, the Pan-Canadian COVID-19 Testing and Screening Guidance (“Guidance”) is based on new public health evidence and emerging technologies, while adopting a broadened approach that leverages and tailors technologies to appropriate uses.

The Guidance is designed to protect and expand the resilience of federal, provincial and territorial testing and screening capacity.The Guidance is based on a portfolio approach that uses different types of testing technologies for various purposes (diagnostic, screening, surveillance). The intent which is safer viagra cialis or levitra of the Guidance is to better use testing resources to target the most relevant test in particular situations or use cases to address specific problems or purposes. Figure 1. Technology streams of Pan-Canadian COVID-19 Testing and Screening Guidance Figure 1. Technology streams of Pan-Canadian COVID-19 Testing and Screening Guidance - which is safer viagra cialis or levitra Text equivalent Testing.

Definitive diagnosis of COVID-19 with high sensitivity PCR-based tests, with potential refinements to specimen collecting modalities (for example, saliva) Less amenable to high frequency conduct due to greater resource utilization Screening. Indicative of COVID-19 status, with lower sensitivity Typically newer, rapid technology approaches Amenable to higher frequency repetition and more easily scalable Surveillance. Use of traditional and non-traditional data sources to complement case data Wastewater surveillance complements conventional COVID-19 surveillance systems which is safer viagra cialis or levitra by providing. efficient pooled community sample data for communities where timely clinical testing is underutilized or unavailable data at the local level Five key foundational, interrelated pillars support the advancement of the Guidance. Scientific integrity regulatory excellence proactive procurement robust data and capacity strategic communication and partnershipsUpdates to laboratory testing and antigen testing guidance founded on rigorous scientific integrity enable and inform decision-making on testing allocations within Canada, and support jurisdictions in the timely use of emerging technologies once regulatory approval is received.

Regulatory excellence is equally important as a foundational pillar which is safer viagra cialis or levitra to implementing the Guidance in a manner that allows for rapid approvals while still preserving the scientific integrity of the process.In addition, undertaking a proactive procurement approach ensures steady access to equipment and supplies for testing and screening. Governments continue to take a proactive procurement approach, purchasing whenever possible, contingent on regulatory approvals.Timely and comprehensive data is critical, underpinning decision-making by governments. Governments have established a new data set for COVID-19 cases that provides more targeted information, improving the ability to understand whether infections are acquired via domestic or international travel, or if they are linked to a known outbreak. Race and ethnicity indicators have been which is safer viagra cialis or levitra added as well as greater information on health care workers, allowing a better understanding of the COVID-19 experience among different population groups. In addition to the case data, key data on turnaround times for testing and contact tracing, for example, can also help identify issues related to capacity and timeliness of interventions.Finally, in addition to strong federal, provincial and territorial partnerships, relationships are being further enhanced with key partners in industry and the scientific community.

While ensuring rapid and effective progress is critical, it is also important to communicate what which is safer viagra cialis or levitra we know, what we are doing and what we are going to do. This collaboration and transparency supports critical decisions, including what additional capacity may be required as part of the Guidance, for instance, federal surge capacity to supplement provincial and territorial leadership. Strategic communications and partnerships are critical to maintaining and strengthening the confidence of Canadians in Governments' actions to address COVID-19. Implementation plan which is safer viagra cialis or levitra of the Pan-Canadian COVID-19 Testing and Screening Guidance. Updated Guidance Scientific integrity Regulatory excellence Proactive procurement Robust data and capacity Strategic communications and partnerships Regularly updated public health advice as science evolves Updated national lab testing indication guidance Interim antigen testing guidance Guidance on sample types Prioritized, timely review of emerging and promising technologies Responsive to testing, screening and surveillance developments Founded in and driven by scientific excellence Linking regulatory pipeline with production capacity Prioritizing made in Canada solutions Advance purchasing of promising technologies Surge capacity through full value chain and timely, comprehensive data Improving national performance data (turnaround times) Surge capacity for sample collection, lab testing contact tracing Working closely with key partners FPT.

Enables agile responses to emerging issues Industry. Linking public health and workforce requirements Tapping emerging tech Public education/understanding Looking forwardThe Guidance is expected to which is safer viagra cialis or levitra evolve as the state of knowledge and risk management strategies continue to develop. Guidance on sample types is expected to be finalized during the fall and the balance of testing and screening technologies will be adjusted to respond to the needs of various populations. Researchers and companies continue to innovate and develop new technologies and solutions. Guidance will need to keep pace with, and which is safer viagra cialis or levitra take advantage of, these innovations.

The continuous updating of this Guidance will rely on strong federal, provincial and territorial partnerships and collaboration leveraging key governance bodies, including the Special Advisory Committee. The Guidance will also capitalize on opportunities to leverage input and the capacity to mobilize knowledge in Canada and from around the world.Related linksOn this page Purpose and backgroundThe purpose of this notice is to communicate minimum values of sensitivity for COVID-19 antigen testing devices.Health Canada refers to guidance published by the U.S. Food and Drug Administration which is safer viagra cialis or levitra (FDA) on antigen detecting tests. This guidance outlines the requirements that these products must meet. This document addresses only sensitivity for antigen tests.

It complements the published FDA guidance.Sensitivity is technically a measure of the accuracy of a test against a reference standard which is safer viagra cialis or levitra. No such standard exists at this time, therefore the accuracy of the positive results from a test is currently expressed as the positive percent agreement (PPA). The term sensitivity is used throughout this document in place of PPA for ease of reading. Sensitivity is the proportion of subjects with the target condition which is safer viagra cialis or levitra in whom the test is positiveIt is an important measure to determine whether test information is useful and reliable.Minimum value for sensitivity Health Canada does not usually set minimum standards for sensitivity. Normally we review the submitted data to determine whether a test performs to the standard claimed by the manufacturer.

We then compare that to the standard claimed by similar tests. However, the which is safer viagra cialis or levitra COVID-19 pandemic is a unique public health crisis. For this reason, we are taking a different approach.We have set minimum standards for sensitivity that a COVID-19 antigen test must meet in order for us to consider it for authorization. Tests with sensitivity below this minimum do not meet the criteria of 5(c) and (d) of the interim order on the importation and sale of medical devices for use in relation to COVID-19. For this reason, they will not be authorized.Health Canada considers the following to be unacceptable for authorization which is safer viagra cialis or levitra.

Sensitivity below 80% Sensitivity values below this level will produce too many false negative results. These tests will not be authorized, regardless of other factors.Future considerationsHealth Canada’s target value aligns with the FDA target. However, as more research results become available, we which is safer viagra cialis or levitra may revise this value accordingly.Health Canada welcomes applications for technologies that meet or exceed the minimum limit value. We will continue to monitor emerging science and international experience to determine whether we need to amend this value.Contact usPlease email your questions or comments about this notice to. Hc.meddevices-instrumentsmed.sc@canada.ca.Related Links.

On this page Policy objectiveThis guidance is to provide Canadians with access to information on the safety and efficacy/effectiveness of products being used for the COVID-19 generic levitra for sale pandemic. These products are being imported and sold in Canada under 2 interim orders. All personal and confidential business information (CBI) will be generic levitra for sale protected prior to release.

The disclosed information will be made publicly available for non-commercial purposes after Health Canada completes its regulatory review process, while adhering to Canada’s Privacy Act.Providing public access to this information supports Canada’s objective for transparent decision-making. Public access also provides valuable information that may help with the use or development of COVID19 drugs and medical devices.This guidance document outlines the process for publicly disclosing information in a market authorization application under the 2 interim orders. The process generic levitra for sale includes.

procedures when releasing information types of information that fall under the guidelines for CBI and that may be eligible for redaction protection of personal informationScope and application This document applies to information relied upon to issue a market authorization under the. Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (September 16, 2020) and interim order respecting the importation and sale of medical devices for use in relation to COVID-19(March 18, 2020)The public release of safety and efficacy/effectiveness information reviewed under the 2 interim orders is governed by common law. Information requested for release is assessed case by case to generic levitra for sale determine what is CBI.

Personal information is removed before the safety and efficacy/effectiveness information is released to the public.Following Health Canada’s review of an application, safety and efficacy information will be released as follows. Automatically disclosed in applications submitted under the interim order for importing, selling and advertising drugs (proactive release) disclosed on request in applications submitted under the interim order for importing and selling medical devices (released upon request)Information in applications that have been authorized, including those authorized and then revoked, is in scope for public release. This includes generic levitra for sale.

Original application documents documents filed after market authorization is issued (filed at Health Canada’s request or to meet a condition of approval)Information in applications that are refused and were never authorized is out of scope for public release. This document does not apply to clinical information submitted to support the market authorization of a medical device under the Medical Device Regulations or of a new drug submission under the Food and Drug Regulations (FDR). The exception are new drug submissions for generic levitra for sale COVID-19 indications submitted under the FDR.

For more information on the public release of this information, see the Public Release of Clinical Information. Guidance document.Also not applicable under this document is the CBI disclosure authority under section 21.1(3)(c) of the Food and Drugs Act. This section permits the Minister of Health to disclose CBI to certain persons for the purpose of protection or generic levitra for sale promotion of human health or the safety of the public.

For information on this authority, see the guidance document Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act.Proactive release of drug application informationWe will proactively publish safety and efficacy information used to support interim order drug applications upon authorization. This includes clinical information in applications submitted under sections 3, 6 and 14 of the interim order.How to request clinical information in medical device applicationsWe will publish safety and effectiveness information used to support interim order medical device applications when we receive a request from the public and within the limits of our administrative capacity. Requests made for multiple applications will generic levitra for sale be processed in sequence and subject to prioritization.

Further prioritization may be given to products that have a greater impact on the health system, such as. Products that are used a lot products that have a higher public interestRequests received for information in applications under the interim order will be prioritized over requests for clinical information in non-COVID19-related drugs submissions and device applications.To request clinical information on medical device applications, use our special portal to submit an electronic request form. Be sure to identify the product name listed generic levitra for sale on the following sites.

Publication process Publication of safety and efficacy information used to support drug interim order applications The publication of information follows the process described in section 4 and Appendix C of the Public Release of Clinical Information guidance document.In accordance with PRCI timelines, we aim to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from starting the process. The process starts automatically on the day an authorization is issued.Step 1. Notice to the company and request for proposed CBI redactions and anonymizationFollowing the authorization of a drug under the interim order, Health Canada will generic levitra for sale give the manufacturer an opportunity to take part in a process initiation meeting.

The first 60 days of the 120-day publication process is allocated for the company to review the clinical information. The company uses the Proposed Redaction Control Sheet (Appendix E, Public Release of Clinical Information (PRCI) guidance document) to propose any redaction of CBI. Proposed CBI redactions should pertain to information that meets the definition of confidential business generic levitra for sale information.

This is defined in Section 2 of the Food and Drugs Act, which mirrors common law in the context of confidential business information that meets each of the following 3 elements of the definition. That is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and generic levitra for sale that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitorsFollowing an assessment of the proposals, text within an in-scope document found to meet the above definition will be protected. Similar to Public Release of Clinical Information policies, any information that meets the definition of “clinical information” will not be considered confidential business information.

Exceptions to the PRCI regulations described in C.08.009.2(2)(a) and (b) of the Food and Drug Regulations or section 43.12(2)(a) and (b) of the Medical Device Regulations will be considered when applying redactions to confidential business information. Further information on the application of these exceptions can be found in the Health Canada PRCI guidance document.All personal information should be anonymized in accordance with section 6 of the Public Release of Clinical Information guidance generic levitra for sale document. The proposal package from the manufacturer should include.

The proposed redaction control sheet the draft anonymization report annotated documentsManufacturers submit for Health Canada assessment using either CanadaPost ePost Connect or a suitable secure file transfer site of the manufacturer’s choosing.Step 2. Health Canada assessment generic levitra for sale of company representationsWithin 30 days of receiving the proposal package, Health Canada will complete and return our assessment of the proposed CBI redactions and anonymization methodology. Proposed redactions that meet the definition of confidential business information will be protected.

We will review the anonymization methodology to ensure all personal information is protected while maximizing the disclosure of useful clinical information. Step 3 generic levitra for sale. Revision of proposed CBI redactions and anonymizationIf proposed CBI redactions are rejected or revision is required to the anonymization methodology, in accordance with the Public Release of Clinical Information.

Guidance document, the manufacturer will be given 15 days to make the revisions and resubmit. We will send our final assessment to the manufacturer within 5 days of receiving the revised package generic levitra for sale. Step 4.

Finalization and publicationWithin 5 days of receiving our final assessment, the manufacturer must format and submit the final redacted and anonymization clinical documents within 5 days of receiving our final assessment. The final documents must comply with the Guidance Document generic levitra for sale. Preparation of Regulatory Activities using the Electronic Common Technical Document (eCTD) Format.

These documents are to be submitted using the Common Electronic Submission Gateway. We will generic levitra for sale publish the final redacted documents within 5 days of receiving the final sequence.Publication of safety and effectiveness information used to support medical device interim order applicationsThe publication of information within an interim order application will proceed through the abbreviated process described below. Our goal is to publish a final redacted and anonymized package on our clinical information portal within 120 calendar days from initiation of the process.Step 1.

Health Canada screening of requestsAfter we receive a request for information, we will retrieve the interim order application from docubridge (or other location). Information related to safety and effectiveness will be considered generic levitra for sale in-scope of publication. Other information will not be released publicly.

Only information available at the time the request is made will be considered for disclosure. Information submitted after the original request for disclosure will be considered for public release upon receipt generic levitra for sale of a subsequent request.Examples of in scope information include. Clinical testing information validation testing that supports the effectiveness of the product, including testing performed in vitro or in silico summaries or overviews on safety or efficacy pre- or post-market, including literature reviewsExamples of out of scope information include.

Manufacturing details not related to safety or efficacy engineering and design details general documents, such as user manuals, package inserts and instructions for use individual patient information, such as patient listings and case report forms, that require extensive anonymization interim clinical study data (see the PRCI guidance)Step 2a. Health Canada assessment of confidential business information To reduce administrative burden on the manufacturer, we will review in-scope records for confidential business information, as defined in Section 2 of the Food generic levitra for sale and Drugs Act, which mirrors common law in the context of confidential business information that meets each of the following 3 elements of the definition will be protected. That is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available and that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitorsText in an in-scope document found to meet this definition will be redacted using a PDF redaction tool.

Similar to Public Release of Clinical Information policies, any information that meets the definition of “clinical information” will not be considered confidential business information. Exceptions to generic levitra for sale the PRCI regulations are outlined section 43.12(2)(a) and (b) of the Medical Device Regulations. These exceptions will be considered when applying redactions to confidential business information.

Further information on generic levitra for sale the application of these exceptions can be found in the PRCI guidance document.Step 2b. Assessing personal informationIn general, in-scope records do not contain a large volume of personal identification information. Any personal information, as defined in the Privacy Act and in accordance with PRCI guidance, information that could help to identify an individual will be protected.

For example, this can include the generic levitra for sale names of authors and investigators as well as subject identification numbers.A large volume of indirectly identifying information is not expected in the medical device records that are in-scope of publication. Consequently, limited protection of personal information is anticipated.Personal information will be redacted using a PDF redaction tool. Step 3.

Notice to the company and request for redaction proposalFollowing the review and redaction of in scope documents, generic levitra for sale we will send the manufacturer a written notice indicating our intent to publish the identified documents. A copy of the release package will be sent for the manufacturer’s review. Any further proposed redactions by the manufacturer must be received within 14 calendar days.Manufacturer are asked to use the Proposed Redaction Control Sheet (see Appendix E of the PRCI guidance document) to suggest further redactions.Step 4.

Health Canada assessment of company representationsAny further redactions proposed by the manufacturer will be assessed in accordance with the process outlined in step 2, above generic levitra for sale. Those that meet the definition of personal or confidential business information will be accepted.Step 5. PublicationIn-scope documents will be published within 120 days following receipt of the request.

The redacted information will be uploaded generic levitra for sale to the Clinical Information Portal, indexed by application number. Published documents will carry a watermark and be subject to terms of use, as described in the PRCI guidance.Mailing addressInformation Science and Openness DivisionResource Management and Operations DirectorateHealth Products and Food BranchHealth Canada Graham Spry Building 250 Lanark Ave Ottawa ON K1A 0K9 Telephone. 613-960-4687Email.

Hc.clinicaldata-donneescliniques.sc@canada.ca Terminology generic levitra for sale and definitions Anonymization. Means the process through which personal information is modified by. removing direct identifiers and any related code that would enable linkage with identifying information and ensuring that the remaining indirect identifiers no longer present a serious possibility of re-identifying an individual CBI.

Confidential business information, as meant in common law and as defined generic levitra for sale in Section 2 of the Food and Drugs Act. in respect of a person to whose business or affairs the information relates, means (subject to the regulations) business information that. Is not publicly available in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors Clinical information.

Means information in respect of a clinical trial, clinical generic levitra for sale studies or investigational testing, such as. clinical overviews, clinical summaries and clinical study reports for drugs summaries and detailed information of all clinical studies and investigational testing that provided evidence of safety and effectiveness for medical devices Clinical study report. Means an "integrated" full report of an individual study of any therapeutic, prophylactic or diagnostic agent (drug or treatment) conducted in patients, in which.

the clinical and statistical description, presentations and analyses are integrated into a single report incorporating tables and figures into the main text of the report or at the end of the text appendices contain the protocol, sample case report forms, investigator-related information, information related to the test drugs/investigational products, including active control/comparators, technical statistical generic levitra for sale documentation, related publications, patient data listings and technical statistical details such as derivations, computations, analyses and computer output FDA. Food and Drugs Act FDR. Food and Drug Regulations IMDRF ToC.

International Medical Device Regulators Forum Table of Contents Medical generic levitra for sale device. Has the same meaning as insee the Medical Devices Regulations. For information generic levitra for sale on the classification of medical devices, please see the guidance documents on the.

risk-based classification system for in vitro diagnostic devices (IVDDs) risk-based classification system for non-in vitro diagnostic devices (non-IVDDs) Non-commercial purpose. Means the information will not be used to support a marketing authorization application anywhere in the world or sold or traded to another person Personal information. Has the same meaning as in Section 3 of the Privacy Act Related linksOn this page About the guidance document This guidance document supports the Interim Order Respecting generic levitra for sale Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19.

The Minister of Health approved the Interim Order on March 30, 2020, to address the unprecedented demand and urgent need for medical devices to treat, diagnose and protect Canadians against COVID-19. The guidance covers sections 15 to 19 of the Interim Order. It remains in generic levitra for sale effect as long as the Interim Order is in effect.

Under the Interim Order, manufacturers and importers must report medical device shortages related to COVID-19 to Health Canada. The devices to which the shortages apply are on the List of Medical Devices — Notification of Shortages (specified medical devices). A specified medical generic levitra for sale device is a device that is either.

set out in the list of medical devices or part of a category of medical devices that is set out in that list The guidance is intended to help manufacturers and importers meet their regulatory obligations. It outlines their responsibilities concerning the mandatory reporting of medical device shortages. About medical device shortages and reporting generic levitra for sale A medical device shortage occurs when a manufacturer is unable to meet Canadian market demand for the device or for its components, accessories, parts or consumable materials.

This does not apply when a substitute device, component, accessory, part or consumable material is available in Canada. There are 2 types of shortages. actual, when generic levitra for sale the current supply can’t meet current demand anticipated, when the future supply can’t meet projected demand Manufacturers and importers must.

report a medical device shortage provide a shortage status update if there is a change in the shortage information submitted provide additional information related to a shortage when requested by Health Canada report an end of a medical device shortage This guidance document also provides some guidance on how to voluntarily report a medical device shortage that does not fall under the Interim Order. Everyone has a role to play Manufacturers and importers Manufacturers and importers have a key role to play in preventing and reducing the impact of medical device shortages. They can control the volume of medical devices in generic levitra for sale the supply chain and can take steps to resolve a medical device shortage when one occurs.

They are also in the best position to communicate to customers about the availability of their devices. When a manufacturer experiences a shortage of a critical medical device it sells, we expect that the manufacturer will take all necessary measures to resolve the shortage as quickly as possible. Provincial/territorial governments and health care authorities Provincial and territorial governments and health care generic levitra for sale authorities also have an important role to play in preventing and mitigating critical medical device shortages.

They can. conserve and reallocate stock within regions or provinces to where it is most needed and collaborate to share supply identify and secure additional supplies of medical devices from other vendors or another provincial or territorial government identify and secure other compatible substitute medical devices Government of Canada The federal government administers the Food and Drugs Act, Radiation Emitting Devices Act and Medical Devices Regulations. We do not provide or control the supply of medical devices in Canada or have the authority to compel generic levitra for sale a manufacturer to supply a device.

We work with stakeholders across the medical device supply chain to help determine the details and status of a shortage. We also coordinate and facilitate information sharing. When it comes to medical device shortages, Health Canada generic levitra for sale depends on early reporting of anticipated or actual shortages to help us.

prevent or manage impacts related to medical device shortages work with industry to identify mitigation strategies inform the procurement of medical devices for Canada Depending on the situation, our options include. prioritizing the review and approval of regulatory applications received from manufacturers (for example, an application to authorize or import an acceptable compatible device) expediting the process for issuing Medical Device Establishment Licences (MDELs) permitting the importation and sale of medical devices that do not fully meet Canadian regulatory requirements, but are manufactured to comparable standards to help address product shortages due to the COVID-19 pandemic working with international regulators to identify other manufacturers and to share needed safety and manufacturing information helping health care professionals and institutions get access to compatible substitute medical devices on an emergency basis (for example, the Special Access Programme can be used to provide access to unlicensed alternative medical devices) As part of the Government of Canada’s response to COVID-19, the Public Health Agency of Canada is working with other government departments to procure bulk shipments to facilitate access to much-needed medical devices. These include ventilators, testing swabs, reagents and test kits generic levitra for sale as well as personal protective equipment.

Related linksOctober 9, 2020Our file number. 20-113699-873 As a standing regulatory member of the generic levitra for sale International Council for Harmonisation (ICH), Health Canada is committed to the adoption and implementation of all ICH guidance. By way of this Notice, Health Canada is advising of its intent to implement ICH Q12.

Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and the ICH Q12 associated annexes. This guidance has been developed by the appropriate ICH generic levitra for sale Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH.

The target timeframe for Health Canada implementation of ICH Q12 has been set to the third quarter of 2021 in order to allow sufficient time for the preparation of regulators and stakeholders. Health Canada will be launching a stakeholder consultation in early 2021 to gather feedback on the final elements of the implementation of the Q12 guidance in Canada.This new Guideline is proposed to provide a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable generic levitra for sale and efficient manner across the product lifecycle. Implementation of this new ICH Guideline will promote innovation and continual improvement in the biopharmaceutical sector and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments.

It will allow regulators (assessors and inspectors) to better understand the firms' Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes.ICH Q12 should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances. This and other ICH Guidance documents are available generic levitra for sale on the ICH Website. Please note that the ICH website is only available in English.

If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox.Contact InformationFor any comments or inquiries related to this notice, please contact:Health Canada – ICH CoordinatorE-mail. Hc.ich.sc@canada.ca Please include "Implementation of ICH Q12" in the generic levitra for sale subject line.The Register of Innovative Drugs is maintained pursuant to C.08.004.1 of the Food and Drug Regulations. The register indicates the drugs that are eligible for data protection.

Under C.08.004.1 (3) a subsequent manufacturer that seeks a notice of compliance on the basis of a direct or indirect comparison between the new drug and an innovative drug may not file a submission before the end of a period of six years after the day on which the first notice of compliance was issued for the innovative new drug. In addition, the notice of compliance cannot be issued before the end of a period of eight years after the generic levitra for sale day on which the first notice of compliance was issued to the innovator. The format of the Register of Innovative Drugs is an electronic table, which is updated weekly.

The register lists, in alphabetical order, the medicinal ingredients in the innovative drugs which were not previously approved in a drug by the Minister and that are not variations of a previously approved medicinal ingredient. Please note that generic levitra for sale there may be other medicinal ingredients included in the drugs. The register was re-formatted in summer 2016 to increase the clarity of the information provided regarding the medicinal ingredient, brand name and manufacturer of each innovative drug.

For information related to treatment options, choices of medications and their uses, illnesses, side effects or drug interactions, please contact your health care professional (for example, doctor, pharmacist, etc.). We do not provide medical advice regarding the use of the products identified in generic levitra for sale this database. For comments or questions, please contact by hc.opml-bmbl.sc@canada.ca or by telephone at 613-941-7281.Date published.

October 7, 2020On this page OverviewAs the global COVID-19 pandemic emerged in December 2019, the need for coherent, pan-Canadian guidance on provincial and territorial testing was quickly recognized. Led by the National Microbiology Laboratory, initial interim guidance on laboratory testing was developed in consultation with the Canadian Public Health Lab Network and was finalized and generic levitra for sale approved by the Special Advisory Committee on April 16, 2020. This guidance was based on scientific evidence and testing resources available at that time.

The recommended testing guidance focused on the molecular polymerase chain reaction (PCR) as the sole laboratory technique to accurately identify SARS-CoV-2 in a patient sample.In May 2020, based on new evidence, the National Laboratory Testing Indication Guidance for COVID-19 was updated to reflect developments in four areas. Expanded laboratory resources viral transmission from asymptomatic individuals or individuals in the pre-symptomatic phase outbreaks in congregate living and work generic levitra for sale settings new testing modalities (molecular Point of Care and serological tests)The COVID-19 landscape has further evolved and it is now necessary to update key aspects of this document to reflect recent scientific and public health data. One key consideration relates to limiting asymptomatic diagnostic PCR testing where public health action could have significant benefits.

Several pilot generic levitra for sale programs were conducted in Canada, confirming very low levels of COVID-19 in the general population and supporting an evidence-based approach to the relaunch of economic activity. In addition, it enabled jurisdictions to stress-test testing capacity and prepare jurisdictions for higher testing volumes. Asymptomatic testing was also found to displace diagnostic capacity for symptomatic individuals, close contacts, high-risk settings and outbreak management.

The National Laboratory Testing Indication Guidancefor COVID-19 has been updated to reflect these learnings and generic levitra for sale advances in science.Recognizing that testing regimes are within provincial and territorial jurisdiction, this document reflects the collaboration among jurisdictions, leveraging learnings from one another through the different adopted approaches.Emerging testing and screening technologiesThe Pan-Canadian COVID-19 Testing and Screening Guidance is designed to reflect changing risk management approaches as the pandemic conditions change. Recognizing that one size does not fit all, the Guidance is also designed to respond to a significant increase in the need to access testing and screening technologies. Scaling to meet increased and sustained testing and screening demand will require a paradigm shift, broadening the technologies that are used in a manner that is tailored to the purpose and application of technologies in a variety of settings.

Although PCR remains the gold standard in diagnostic generic levitra for sale testing, numerous technologies and testing modalities are emerging that could serve to supplement diagnostic testing. These recent testing and sampling options could create opportunities to expand the approach to testing by including broad-based approaches to screening through less sensitive and potentially more cost-effective technologies, thereby alleviating strain on the overall public health system.While they can be less sensitive, these technologies could have multiple benefits including ease and reduced cost of production, improved efficiency and reduced reliance on PCR testing supplies. They also have the potential to be less invasive depending on the technology.

Antigen and extraction-free nucleic acid testing are examples of such technologies that, generic levitra for sale in addition to being more cost-effective and easier to produce, are also easily adaptable to mobile, rapid applications. However, due to their lower sensitivity than current PCR technology, these emerging technologies may be better used as a part of screening, in conjunction with repeated testing in some settings. Recognizing that these novel technologies have lower sensitivity and specificity than current PCR technology, their use should be targeted to scenarios where both positive and negative are interpreted and acted upon appropriately.Complementing the deployment of these emerging technologies, techniques such as pooled testing are being used to contribute to the preservation of testing resources.

Governments are also tapping generic levitra for sale non-traditional data sources to complement case data. For example, data for wastewater testing could complement COVID-19 surveillance systems by providing readily accessible pooled community samples and data for communities where testing is not available or underutilized.As of September 29, Health Canada has authorized 36 COVID-19 testing devices (PCR and serological). Health Canada is fast-tracking the review of submissions related to antigen and nucleic acid tests.

Submissions that are reviewed include various sample types, including generic levitra for sale saliva. Consult the list of authorized medical devices for uses related to COVID-19.In anticipation of regulatory approval for antigen tests, an Interim Guidance on Antigen Testing has been developed to outline potential scenarios such as routine outbreak monitoring, monitoring in different situations including high-risk settings (for example, long-term care facilities) and possible adaptation into mobile, rapid testing in rural and remote communities.Pan-Canadian COVID-19 Testing and Screening GuidanceLike the Laboratory Testing Guidance, the Pan-Canadian COVID-19 Testing and Screening Guidance (“Guidance”) is based on new public health evidence and emerging technologies, while adopting a broadened approach that leverages and tailors technologies to appropriate uses. The Guidance is designed to protect and expand the resilience of federal, provincial and territorial testing and screening capacity.The Guidance is based on a portfolio approach that uses different types of testing technologies for various purposes (diagnostic, screening, surveillance).

The intent of the Guidance is to better use testing resources to target the most relevant test in particular situations or use cases to address specific problems or generic levitra for sale purposes. Figure 1. Technology streams of Pan-Canadian COVID-19 Testing and Screening Guidance Figure 1.

Technology streams generic levitra for sale of Pan-Canadian COVID-19 Testing and Screening Guidance - Text equivalent Testing. Definitive diagnosis of COVID-19 with high sensitivity PCR-based tests, with potential refinements to specimen collecting modalities (for example, saliva) Less amenable to high frequency conduct due to greater resource utilization Screening. Indicative of COVID-19 status, with lower sensitivity Typically newer, rapid technology approaches Amenable to higher frequency repetition and more easily scalable Surveillance.

Use of traditional and non-traditional data sources to complement case data Wastewater surveillance complements generic levitra for sale conventional COVID-19 surveillance systems by providing. efficient pooled community sample data for communities where timely clinical testing is underutilized or unavailable data at the local level Five key foundational, interrelated pillars support the advancement of the Guidance. Scientific integrity regulatory excellence proactive procurement robust data and capacity strategic communication and partnershipsUpdates to laboratory testing and antigen testing guidance founded on rigorous scientific integrity enable and inform decision-making on testing allocations within Canada, and support jurisdictions in the timely use of emerging technologies once regulatory approval is received.

Regulatory excellence is equally important as a foundational pillar to implementing the Guidance in a manner that allows for rapid approvals while still preserving the scientific integrity of the process.In addition, undertaking a proactive procurement approach ensures steady access to equipment and supplies for testing and generic levitra for sale screening. Governments continue to take a proactive procurement approach, purchasing whenever possible, contingent on regulatory approvals.Timely and comprehensive data is critical, underpinning decision-making by governments. Governments have established a new data set for COVID-19 cases that provides more targeted information, improving the ability to understand whether infections are acquired via domestic or international travel, or if they are linked to a known outbreak.

Race and ethnicity indicators have been added as well as greater information on health care workers, allowing a better generic levitra for sale understanding of the COVID-19 experience among different population groups. In addition to the case data, key data on turnaround times for testing and contact tracing, for example, can also help identify issues related to capacity and timeliness of interventions.Finally, in addition to strong federal, provincial and territorial partnerships, relationships are being further enhanced with key partners in industry and the scientific community. While ensuring rapid and effective progress is critical, it is also important to communicate what we know, what we are doing and what we are generic levitra for sale going to do.

This collaboration and transparency supports critical decisions, including what additional capacity may be required as part of the Guidance, for instance, federal surge capacity to supplement provincial and territorial leadership. Strategic communications and partnerships are critical to maintaining and strengthening the confidence of Canadians in Governments' actions to address COVID-19. Implementation plan of generic levitra for sale the Pan-Canadian COVID-19 Testing and Screening Guidance.

Updated Guidance Scientific integrity Regulatory excellence Proactive procurement Robust data and capacity Strategic communications and partnerships Regularly updated public health advice as science evolves Updated national lab testing indication guidance Interim antigen testing guidance Guidance on sample types Prioritized, timely review of emerging and promising technologies Responsive to testing, screening and surveillance developments Founded in and driven by scientific excellence Linking regulatory pipeline with production capacity Prioritizing made in Canada solutions Advance purchasing of promising technologies Surge capacity through full value chain and timely, comprehensive data Improving national performance data (turnaround times) Surge capacity for sample collection, lab testing contact tracing Working closely with key partners FPT. Enables agile responses to emerging issues Industry. Linking public health and workforce requirements Tapping emerging tech Public education/understanding Looking forwardThe Guidance is expected to evolve as the state of knowledge and risk management generic levitra for sale strategies continue to develop.

Guidance on sample types is expected to be finalized during the fall and the balance of testing and screening technologies will be adjusted to respond to the needs of various populations. Researchers and companies continue to innovate and develop new technologies and solutions. Guidance will generic levitra for sale need to keep pace with, and take advantage of, these innovations.

The continuous updating of this Guidance will rely on strong federal, provincial and territorial partnerships and collaboration leveraging key governance bodies, including the Special Advisory Committee. The Guidance will also capitalize on opportunities to leverage input and the capacity to mobilize knowledge in Canada and from around the world.Related linksOn this page Purpose and backgroundThe purpose of this notice is to communicate minimum values of sensitivity for COVID-19 antigen testing devices.Health Canada refers to guidance published by the U.S. Food and Drug Administration (FDA) generic levitra for sale on antigen detecting tests.

This guidance outlines the requirements that these products must meet. This document addresses only sensitivity for antigen tests. It complements the published FDA guidance.Sensitivity is generic levitra for sale technically a measure of the accuracy of a test against a reference standard.

No such standard exists at this time, therefore the accuracy of the positive results from a test is currently expressed as the positive percent agreement (PPA). The term sensitivity is used throughout this document in place of PPA for ease of reading. Sensitivity is generic levitra for sale the proportion of subjects with the target condition in whom the test is positiveIt is an important measure to determine whether test information is useful and reliable.Minimum value for sensitivity Health Canada does not usually set minimum standards for sensitivity.

Normally we review the submitted data to determine whether a test performs to the standard claimed by the manufacturer. We then compare that to the standard claimed by similar tests. However, the COVID-19 generic levitra for sale pandemic is a unique public health crisis.

For this reason, we are taking a different approach.We have set minimum standards for sensitivity that a COVID-19 antigen test must meet in order for us to consider it for authorization. Tests with sensitivity below this minimum do not meet the criteria of 5(c) and (d) of the interim order on the importation and sale of medical devices for use in relation to COVID-19. For this reason, they will not be authorized.Health Canada considers the following to generic levitra for sale be unacceptable for authorization.

Sensitivity below 80% Sensitivity values below this level will produce too many false negative results. These tests will not be authorized, regardless of other factors.Future considerationsHealth Canada’s target value aligns with the FDA target. However, as more research results become available, we may revise this value accordingly.Health Canada welcomes applications for technologies that meet or exceed the minimum limit value.

We will continue to monitor emerging science and international experience to determine whether we need to amend this value.Contact usPlease email your questions or comments about this notice to. Hc.meddevices-instrumentsmed.sc@canada.ca.Related Links.

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All of the attachments with the various levels are where to buy levitra in singapore posted here. NEED TO KNOW PAST MEDICAID INCOME AND RESOURCE LEVELS?. Which household size applies?. The where to buy levitra in singapore rules are complicated.

See rules here. On the HRA Medicaid Levels chart - Boxes 1 and 2 are NON-MAGI Income and Resource levels -- Age 65+, Blind or Disabled and other adults who need to use "spend-down" because they are over the MAGI income levels. Box where to buy levitra in singapore 10 on page 3 are the MAGI income levels -- The Affordable Care Act changed the rules for Medicaid income eligibility for many BUT NOT ALL New Yorkers. People in the "MAGI" category - those NOT on Medicare -- have expanded eligibility up to 138% of the Federal Poverty Line, so may now qualify for Medicaid even if they were not eligible before, or may now be eligible for Medicaid without a "spend-down." They have NO resource limit.

Box 3 on page 1 is Spousal Impoverishment levels for Managed Long Term Care &. Nursing Homes and Box 8 has the Transfer Penalty rates for nursing home eligibility Box 4 has Medicaid Buy-In for Working People with Disabilities Under Age 65 (still 2017 levels til April 2018) Box 6 are Medicare Savings Program levels (will be updated in April 2018) MAGI INCOME LEVEL of 138% FPL applies to most adults who are not disabled and who do not have Medicare, AND can also apply to adults with Medicare if they have a where to buy levitra in singapore dependent child/relative under age 18 or under 19 if in school. 42 C.F.R. § 435.4.

Certain populations have an even higher income limit - 224% FPL for pregnant women and babies < where to buy levitra in singapore. Age 1, 154% FPL for children age 1 - 19. CAUTION. What is counted as income may not be where to buy levitra in singapore what you think.

For the NON-MAGI Disabled/Aged 65+/Blind, income will still be determined by the same rules as before, explained in this outline and these charts on income disregards. However, for the MAGI population - which is virtually everyone under age 65 who is not on Medicare - their income will now be determined under new rules, based on federal income tax concepts - called "Modifed Adjusted Gross Income" (MAGI). There are good changes and where to buy levitra in singapore bad changes. GOOD.

Veteran's benefits, Workers compensation, and gifts from family or others no longer count as income. BAD where to buy levitra in singapore. There is no more "spousal" or parental refusal for this population (but there still is for the Disabled/Aged/Blind.) and some other rules. For all of the rules see.

ALSO SEE 2018 Manual on Lump Sums and Impact on Public Benefits - where to buy levitra in singapore with resource rules The income limits increase with the "household size." In other words, the income limit for a family of 5 may be higher than the income limit for a single person. HOWEVER, Medicaid rules about how to calculate the household size are not intuitive or even logical. There are different rules depending on the "category" of the person seeking Medicaid. Here are the where to buy levitra in singapore 2 basic categories and the rules for calculating their household size.

People who are Disabled, Aged 65+ or Blind - "DAB" or "SSI-Related" Category -- NON-MAGI - See this chart for their household size. These same rules apply to the Medicare Savings Program, with some exceptions explained in this article. Everyone else -- MAGI - All children and adults under age 65, including people with disabilities who are not yet on Medicare -- this is the new "MAGI" where to buy levitra in singapore population. Their household size will be determined using federal income tax rules, which are very complicated.

New rule is explained in State's directive 13 ADM-03 - Medicaid Eligibility Changes under the Affordable Care Act (ACA) of 2010 (PDF) pp. 8-10 of the PDF, This PowerPoint by NYLAG on MAGI Budgeting attempts to explain the new MAGI budgeting, including how where to buy levitra in singapore to determine the Household Size. See slides 28-49. Also seeLegal Aid Society and Empire Justice Center materials OLD RULE used until end of 2013 -- Count the person(s) applying for Medicaid who live together, plus any of their legally responsible relatives who do not receive SNA, ADC, or SSI and reside with an applicant/recipient.

Spouses or legally responsible for one another, and parents are legally responsible for their children under age 21 (though if the child is disabled, use the rule in the 1st "DAB" category where to buy levitra in singapore. Under this rule, a child may be excluded from the household if that child's income causes other family members to lose Medicaid eligibility. See 18 NYCRR 360-4.2, MRG p. 573, NYS GIS 2000 MA-007 where to buy levitra in singapore CAUTION.

Different people in the same household may be in different "categories" and hence have different household sizes AND Medicaid income and resource limits. If a man is age 67 and has Medicare and his wife is age 62 and not disabled or blind, the husband's household size for Medicaid is determined under Category 1/ Non-MAGI above and his wife's is under Category 2/MAGI. The following programs were available prior to where to buy levitra in singapore 2014, but are now discontinued because they are folded into MAGI Medicaid. Prenatal Care Assistance Program (PCAP) was Medicaid for pregnant women and children under age 19, with higher income limits for pregnant woman and infants under one year (200% FPL for pregnant women receiving perinatal coverage only not full Medicaid) than for children ages 1-18 (133% FPL).

Medicaid for adults between ages 21-65 who are not disabled and without children under 21 in the household. It was where to buy levitra in singapore sometimes known as "S/CC" category for Singles and Childless Couples. This category had lower income limits than DAB/ADC-related, but had no asset limits. It did not allow "spend down" of excess income.

This category has now been subsumed under the new MAGI adult group whose limit is now raised where to buy levitra in singapore to 138% FPL. Family Health Plus - this was an expansion of Medicaid to families with income up to 150% FPL and for childless adults up to 100% FPL. This has now been folded into the new MAGI adult group whose limit is 138% FPL. For applicants between 138%-150% FPL, they will be eligible for a new program where Medicaid will subsidize their purchase where to buy levitra in singapore of Qualified Health Plans on the Exchange.

PAST INCOME &. RESOURCE LEVELS -- Past Medicaid income and resource levels in NYS are shown on these oldNYC HRA charts for 2001 through 2019, in chronological order. These include where to buy levitra in singapore Medicaid levels for MAGI and non-MAGI populations, Child Health Plus, MBI-WPD, Medicare Savings Programs and other public health programs in NYS. This article was authored by the Evelyn Frank Legal Resources Program of New York Legal Assistance Group.A huge barrier to people returning to the community from nursing homes is the high cost of housing.

One way New York State is trying to address that barrier is with the Special Housing Disregard that allows certain members of Managed Long Term Care or FIDA plans to keep more of their income to pay for rent or other shelter costs, rather than having to "spend down" their "excess income" or spend-down on the cost of Medicaid home care. The special income standard for housing expenses helps pay for housing expenses to help certain nursing where to buy levitra in singapore home or adult home residents to safely transition back to the community with MLTC. Originally it was just for former nursing home residents but in 2014 it was expanded to include people who lived in adult homes. GIS 14/MA-017 Since you are allowed to keep more of your income, you may no longer need to use a pooled trust.

KNOW YOUR where to buy levitra in singapore RIGHTS - FACT SHEET on THREE ways to Reduce Spend-down, including this Special Income Standard. September 2018 NEWS -- Those already enrolled in MLTC plans before they are admitted to a nursing home or adult home may obtain this budgeting upon discharge, if they meet the other criteria below. "How nursing home administrators, adult home operators and MLTC plans should identify individuals who are eligible for the special income standard" and explains their duties to identify eligible individuals, and the MLTC plan must notify the local DSS that the individual may qualify. "Nursing home administrators, nursing home discharge planning staff, adult home operators and MLTC health plans where to buy levitra in singapore are encouraged to identify individuals who may qualify for the special income standard, if they can be safely discharged back to the community from a nursing home and enroll in, or remain enrolled in, an MLTC plan.

Once an individual has been accepted into an MLTC plan, the MLTC plan must notify the individual's local district of social services that the transition has occurred and that the individual may qualify for the special income standard. The special income standard will be effective upon enrollment into the MLTC plan, or, for nursing home residents already enrolled in an MLTC plan, the month of discharge to the community. Questions regarding the special income standard may be directed to DOH at where to buy levitra in singapore 518-474-8887. Who is eligible for this special income standard?.

must be age 18+, must have been in a nursing home or an adult home for 30 days or more, must have had Medicaid pay toward the nursing home care, and must enroll in or REMAIN ENROLLED IN a Managed Long Term Care (MLTC) plan or FIDA plan upon leaving the nursing home or adult home must have a housing expense if married, spouse may not receive a "spousal impoverishment" allowance once the individual is enrolled in MLTC. How much where to buy levitra in singapore is the allowance?. The rates vary by region and change yearly. Region Counties Deduction (2020) Central Broome, Cayuga, Chenango, Cortland, Herkimer, Jefferson, Lewis, Madison, Oneida, Onondaga, Oswego, St.

Lawrence, Tioga, Tompkins $436 Long Island Nassau, Suffolk $1,361 NYC Bronx, Kings, Manhattan, Queens, Richmond $1,451 (up from 1,300 in 2019) Northeastern Albany, Clinton, Columbia, Delaware, Essex, Franklin, Fulton, Greene, Hamilton, Montgomery, Otsego, Rensselaer, Saratoga, Schenectady, Schoharie, Warren, Washington $483 North Metropolitan Dutchess, Orange, Putnam, Rockland, Sullivan, Ulster, Westchester $930 Rochester Chemung, Livingston, Monroe, where to buy levitra in singapore Ontario, Schuyler, Seneca, Steuben, Wayne, Yates $444 Western Allegany, Cattaraugus, Chautauqua, Erie, Genesee, Niagara, Orleans, Wyoming $386 Past rates published as follows, available on DOH website 2020 rates published in Attachment I to GIS 19 MA/12 – 2020 Medicaid Levels and Other Updates 2019 rates published in Attachment 1 to GIS 18/MA015 - 2019 Medicaid Levels and Other Updates 2018 rates published in GIS 17 MA/020 - 2018 Medicaid Levels and Other Updates. The guidance on how the standardized amount of the disregard is calculated is found in NYS DOH 12- ADM-05. 2017 rate -- GIS 16 MA/018 - 2016 Medicaid Only Income and Resource Levels and Spousal Impoverishment Standards Attachment 12016 rate -- GIS 15-MA/0212015 rate -- Were not posted by DOH but were updated in WMS. 2015 Central $382 Long Island $1,147 NYC $1,001 Northeastern $440 N.

Metropolitan $791 Rochester $388 Western $336 2014 rate -- GIS-14-MA/017 HOW DOES IT WORK?. Here is a sample budget for a single person in NYC with Social Security income of $2,386/month paying a Medigap premium of $261/mo. Gross monthly income $2,575.50 DEDUCT Health insurance premiums (Medicare Part B) - 135.50 (Medigap) - 261.00 DEDUCT Unearned income disregard - 20 DEDUCT Shelter deduction (NYC—2019) - 1,300 DEDUCT Income limit for single (2019) - 859 Excess income or Spend-down $0 WITH NO SPEND-DOWN, May NOT NEED POOLED TRUST!. HOW TO OBTAIN THE HOUSING DISREGARD.

When you are ready to leave the nursing home or adult home, or soon after you leave, you or your MLTC plan must request that your local Medicaid program change your Medicaid budget to give you the Housing Disregard. See September 2018 NYS DOH Medicaid Update that requires MLTC plan to help you ask for it. The procedures in NYC are explained in this Troubleshooting guide. NYC Medicaid program prefers that your MLTC plan file the request, using Form MAP-3057E - Special income housing Expenses NH-MLTC.pdf and Form MAP-3047B - MLTC/NHED Cover Sheet Form MAP-259f (revised 7-31-18)(page 7 of PDF)(DIscharge Notice) - NH must file with HRA upon discharge, certifying resident was informed of availability of this disregard.

GOVERNMENT DIRECTIVES (beginning with oldest). NYS DOH 12- ADM-05 - Special Income Standard for Housing Expenses for Individuals Discharged from a Nursing Facility who Enroll into the Managed Long Term Care (MLTC) Program Attachment II - OHIP-0057 - Notice of Intent to Change Medicaid Coverage, (Recipient Discharged from a Skilled Nursing Facility and Enrolled in a Managed Long Term Care Plan) Attachment III - Attachment III – OHIP-0058 - Notice of Intent to Change Medicaid Coverage, (Recipient Disenrolled from a Managed Long Term Care Plan, No Special Income Standard) MLTC Policy 13.02. MLTC Housing Disregard NYC HRA Medicaid Alert Special Income Standard for housing expenses NH-MLTC 2-9-2013.pdf 2018-07-28 HRA MICSA ALERT Special Income Standard for Housing Expenses for Individuals Discharged from a Nursing Facility and who Enroll into the MLTC Program - update on previous policy. References Form MAP-259f (revised 7-31-18)(page 7 of PDF)(Discharge Notice) - NH must file with HRA upon discharge, certifying resident was informed of availability of this disregard.

GIS 18 MA/012 - Special Income Standard for Housing Expenses for Certain Managed Long-Term Care Enrollees Who are Discharged from a Nursing Home issued Sept. 28, 2018 - this finally implements the most recent Special Terms &. Conditions of the CMS 1115 Waiver that governs the MLTC program, dated Jan. 19, 2017.

The section on this income standard is at pages 26-27. In these revised ST&C, this special income standard applies to people who were in a NH or adult home paid by Medicaid and "who enroll into or remain enrolled in the MLTC program in order to receive community based long term services and supports" and to those in a NH who were required to enroll into MLTC because of "...the mandatory Nursing Facility transition, and subsequently able to be discharged to the community from the nursing facility, with the services of MLTC program in place." September 2018 DOH Medicaid Update - explains this benefit to medical providers (nursing homes, MLTC plans, home care agencies, adult home operators, and requires them to identify potential individuals who could benefit and help them apply - described here..

18 or < generic levitra for sale. 19 in school) 138% FPL*** Children <. 5 and pregnant women have HIGHER LIMITS than shown ESSENTIAL PLAN For MAGI-eligible people over MAGI income limit up to 200% FPL No long term care. See info here 1 2 1 2 3 1 2 Income $875 (up from $859 in 201) $1284 (up from $1,267 in 2019) $1,468 $1,983 $2,498 $2,127 $2,873 Resources $15,750 (up from $15,450 in 2019) $23,100 (up from $22,800 in 2019) NO LIMIT** generic levitra for sale NO LIMIT SOURCE for 2019 figures is GIS 18 MA/015 - 2019 Medicaid Levels and Other Updates (PDF). All of the attachments with the various levels are posted here.

NEED TO KNOW PAST MEDICAID INCOME AND RESOURCE LEVELS?. Which household generic levitra for sale size applies?. The rules are complicated. See rules here. On the HRA Medicaid Levels chart - Boxes 1 and 2 are NON-MAGI Income and Resource levels -- Age 65+, Blind or Disabled and other adults who need to generic levitra for sale use "spend-down" because they are over the MAGI income levels.

Box 10 on page 3 are the MAGI income levels -- The Affordable Care Act changed the rules for Medicaid income eligibility for many BUT NOT ALL New Yorkers. People in the "MAGI" category - those NOT on Medicare -- have expanded eligibility up to 138% of the Federal Poverty Line, so may now qualify for Medicaid even if they were not eligible before, or may now be eligible for Medicaid without a "spend-down." They have NO resource limit. Box 3 on page 1 is Spousal Impoverishment levels for Managed Long Term generic levitra for sale Care &. Nursing Homes and Box 8 has the Transfer Penalty rates for nursing home eligibility Box 4 has Medicaid Buy-In for Working People with Disabilities Under Age 65 (still 2017 levels til April 2018) Box 6 are Medicare Savings Program levels (will be updated in April 2018) MAGI INCOME LEVEL of 138% FPL applies to most adults who are not disabled and who do not have Medicare, AND can also apply to adults with Medicare if they have a dependent child/relative under age 18 or under 19 if in school. 42 C.F.R.

§ 435.4 generic levitra for sale. Certain populations have an even higher income limit - 224% FPL for pregnant women and babies <. Age 1, 154% FPL for children age 1 - 19. CAUTION generic levitra for sale. What is counted as income may not be what you think.

For the NON-MAGI Disabled/Aged 65+/Blind, income will still be determined by the same rules as before, explained in this outline and these charts on income disregards. However, for the MAGI population - which is virtually everyone under age 65 who is not on Medicare - their income will now be determined under new rules, based on generic levitra for sale federal income tax concepts - called "Modifed Adjusted Gross Income" (MAGI). There are good changes and bad changes. GOOD. Veteran's benefits, Workers compensation, and gifts from family or others no longer generic levitra for sale count as income.

BAD. There is no more "spousal" or parental refusal for this population (but there still is for the Disabled/Aged/Blind.) and some other rules. For all generic levitra for sale of the rules see. ALSO SEE 2018 Manual on Lump Sums and Impact on Public Benefits - with resource rules The income limits increase with the "household size." In other words, the income limit for a family of 5 may be higher than the income limit for a single person. HOWEVER, Medicaid rules about how to calculate the household size are not intuitive or even logical.

There are different rules depending on the "category" of generic levitra for sale the person seeking Medicaid. Here are the 2 basic categories and the rules for calculating their household size. People who are Disabled, Aged 65+ or Blind - "DAB" or "SSI-Related" Category -- NON-MAGI - See this chart for their household size. These same rules apply to the Medicare Savings Program, with some exceptions explained in this generic levitra for sale article. Everyone else -- MAGI - All children and adults under age 65, including people with disabilities who are not yet on Medicare -- this is the new "MAGI" population.

Their household size will be determined using federal income tax rules, which are very complicated. New generic levitra for sale rule is explained in State's directive 13 ADM-03 - Medicaid Eligibility Changes under the Affordable Care Act (ACA) of 2010 (PDF) pp. 8-10 of the PDF, This PowerPoint by NYLAG on MAGI Budgeting attempts to explain the new MAGI budgeting, including how to determine the Household Size. See slides 28-49. Also seeLegal Aid Society and Empire Justice generic levitra for sale Center materials OLD RULE used until end of 2013 -- Count the person(s) applying for Medicaid who live together, plus any of their legally responsible relatives who do not receive SNA, ADC, or SSI and reside with an applicant/recipient.

Spouses or legally responsible for one another, and parents are legally responsible for their children under age 21 (though if the child is disabled, use the rule in the 1st "DAB" category. Under this rule, a child may be excluded from the household if that child's income causes other family members to lose Medicaid eligibility. See generic levitra for sale 18 NYCRR 360-4.2, MRG p. 573, NYS GIS 2000 MA-007 CAUTION. Different people in the same household may be in different "categories" and hence have different household sizes AND Medicaid income and resource limits.

If a man is age 67 and has Medicare and his wife generic levitra for sale is age 62 and not disabled or blind, the husband's household size for Medicaid is determined under Category 1/ Non-MAGI above and his wife's is under Category 2/MAGI. The following programs were available prior to 2014, but are now discontinued because they are folded into MAGI Medicaid. Prenatal Care Assistance Program (PCAP) was Medicaid for pregnant women and children under age 19, with higher income limits for pregnant woman and infants under one year (200% FPL for pregnant women receiving perinatal coverage only not full Medicaid) than for children ages 1-18 (133% FPL). Medicaid for adults generic levitra for sale between ages 21-65 who are not disabled and without children under 21 in the household. It was sometimes known as "S/CC" category for Singles and Childless Couples.

This category had lower income limits than DAB/ADC-related, but had no asset limits. It did not generic levitra for sale allow "spend down" of excess income. This category has now been subsumed under the new MAGI adult group whose limit is now raised to 138% FPL. Family Health Plus - this was an expansion of Medicaid to families with income up to 150% FPL and for childless adults up to 100% FPL. This has now been folded generic levitra for sale into the new MAGI adult group whose limit is 138% FPL.

For applicants between 138%-150% FPL, they will be eligible for a new program where Medicaid will subsidize their purchase of Qualified Health Plans on the Exchange. PAST INCOME &. RESOURCE LEVELS -- Past Medicaid income and resource levels in NYS are shown generic levitra for sale on these oldNYC HRA charts for 2001 through 2019, in chronological order. These include Medicaid levels for MAGI and non-MAGI populations, Child Health Plus, MBI-WPD, Medicare Savings Programs and other public health programs in NYS. This article was authored by the Evelyn Frank Legal Resources Program of New York Legal Assistance Group.A huge barrier to people returning to the community from nursing homes is the high cost of housing.

One way New York State is trying generic levitra for sale to address that barrier is with the Special Housing Disregard that allows certain members of Managed Long Term Care or FIDA plans to keep more of their income to pay for rent or other shelter costs, rather than having to "spend down" their "excess income" or spend-down on the cost of Medicaid home care. The special income standard for housing expenses helps pay for housing expenses to help certain nursing home or adult home residents to safely transition back to the community with MLTC. Originally it was just for former nursing home residents but in 2014 it was expanded to include people who lived in adult homes. GIS generic levitra for sale 14/MA-017 Since you are allowed to keep more of your income, you may no longer need to use a pooled trust. KNOW YOUR RIGHTS - FACT SHEET on THREE ways to Reduce Spend-down, including this Special Income Standard.

September 2018 NEWS -- Those already enrolled in MLTC plans before they are admitted to a nursing home or adult home may obtain this budgeting upon discharge, if they meet the other criteria below. "How nursing home administrators, generic levitra for sale adult home operators and MLTC plans should identify individuals who are eligible for the special income standard" and explains their duties to identify eligible individuals, and the MLTC plan must notify the local DSS that the individual may qualify. "Nursing home administrators, nursing home discharge planning staff, adult home operators and MLTC health plans are encouraged to identify individuals who may qualify for the special income standard, if they can be safely discharged back to the community from a nursing home and enroll in, or remain enrolled in, an MLTC plan. Once an individual has been accepted into an MLTC plan, the MLTC plan must notify the individual's local district of social services that the transition has occurred and that the individual may qualify for the special income standard. The special income standard will be effective upon enrollment into the MLTC plan, or, for nursing home residents already enrolled in an MLTC plan, the month of discharge to generic levitra for sale the community.

Questions regarding the special income standard may be directed to DOH at 518-474-8887. Who is eligible for this special income standard?. must be age 18+, must have been in a nursing home or an adult home for 30 days or more, must have had Medicaid pay toward the nursing home care, and must enroll in or REMAIN ENROLLED IN a Managed Long Term Care (MLTC) plan or FIDA generic levitra for sale plan upon leaving the nursing home or adult home must have a housing expense if married, spouse may not receive a "spousal impoverishment" allowance once the individual is enrolled in MLTC. How much is the allowance?. The rates vary by region and change yearly.

Region Counties Deduction (2020) Central Broome, Cayuga, Chenango, Cortland, Herkimer, generic levitra for sale Jefferson, Lewis, Madison, Oneida, Onondaga, Oswego, St. Lawrence, Tioga, Tompkins $436 Long Island Nassau, Suffolk $1,361 NYC Bronx, Kings, Manhattan, Queens, Richmond $1,451 (up from 1,300 in 2019) Northeastern Albany, Clinton, Columbia, Delaware, Essex, Franklin, Fulton, Greene, Hamilton, Montgomery, Otsego, Rensselaer, Saratoga, Schenectady, Schoharie, Warren, Washington $483 North Metropolitan Dutchess, Orange, Putnam, Rockland, Sullivan, Ulster, Westchester $930 Rochester Chemung, Livingston, Monroe, Ontario, Schuyler, Seneca, Steuben, Wayne, Yates $444 Western Allegany, Cattaraugus, Chautauqua, Erie, Genesee, Niagara, Orleans, Wyoming $386 Past rates published as follows, available on DOH website 2020 rates published in Attachment I to GIS 19 MA/12 – 2020 Medicaid Levels and Other Updates 2019 rates published in Attachment 1 to GIS 18/MA015 - 2019 Medicaid Levels and Other Updates 2018 rates published in GIS 17 MA/020 - 2018 Medicaid Levels and Other Updates. The guidance on how the standardized amount of the disregard is calculated is found in NYS DOH 12- ADM-05. 2017 rate -- GIS 16 MA/018 - 2016 Medicaid Only Income and Resource Levels generic levitra for sale and Spousal Impoverishment Standards Attachment 12016 rate -- GIS 15-MA/0212015 rate -- Were not posted by DOH but were updated in WMS. 2015 Central $382 Long Island $1,147 NYC $1,001 Northeastern $440 N.

Metropolitan $791 Rochester $388 Western $336 2014 rate -- GIS-14-MA/017 HOW DOES IT WORK?. Here is a sample budget for a single person in NYC with Social Security income of $2,386/month paying a Medigap premium of $261/mo. Gross monthly income $2,575.50 DEDUCT Health insurance premiums (Medicare Part B) - 135.50 (Medigap) - 261.00 DEDUCT Unearned income disregard - 20 DEDUCT Shelter deduction (NYC—2019) - 1,300 DEDUCT Income limit for single (2019) - 859 Excess income or Spend-down $0 WITH NO SPEND-DOWN, May NOT NEED POOLED TRUST!. HOW TO OBTAIN THE HOUSING DISREGARD. When you are ready to leave the nursing home or adult home, or soon after you leave, you or your MLTC plan must request that your local Medicaid program change your Medicaid budget to give you the Housing Disregard.

See September 2018 NYS DOH Medicaid Update that requires MLTC plan to help you ask for it. The procedures in NYC are explained in this Troubleshooting guide. NYC Medicaid program prefers that your MLTC plan file the request, using Form MAP-3057E - Special income housing Expenses NH-MLTC.pdf and Form MAP-3047B - MLTC/NHED Cover Sheet Form MAP-259f (revised 7-31-18)(page 7 of PDF)(DIscharge Notice) - NH must file with HRA upon discharge, certifying resident was informed of availability of this disregard. GOVERNMENT DIRECTIVES (beginning with oldest). NYS DOH 12- ADM-05 - Special Income Standard for Housing Expenses for Individuals Discharged from a Nursing Facility who Enroll into the Managed Long Term Care (MLTC) Program Attachment II - OHIP-0057 - Notice of Intent to Change Medicaid Coverage, (Recipient Discharged from a Skilled Nursing Facility and Enrolled in a Managed Long Term Care Plan) Attachment III - Attachment III – OHIP-0058 - Notice of Intent to Change Medicaid Coverage, (Recipient Disenrolled from a Managed Long Term Care Plan, No Special Income Standard) MLTC Policy 13.02.

MLTC Housing Disregard NYC HRA Medicaid Alert Special Income Standard for housing expenses NH-MLTC 2-9-2013.pdf 2018-07-28 HRA MICSA ALERT Special Income Standard for Housing Expenses for Individuals Discharged from a Nursing Facility and who Enroll into the MLTC Program - update on previous policy. References Form MAP-259f (revised 7-31-18)(page 7 of PDF)(Discharge Notice) - NH must file with HRA upon discharge, certifying resident was informed of availability of this disregard. GIS 18 MA/012 - Special Income Standard for Housing Expenses for Certain Managed Long-Term Care Enrollees Who are Discharged from a Nursing Home issued Sept. 28, 2018 - this finally implements the most recent Special Terms &.

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A key consideration in timing of aortic valve replacement (AVR) for patients with aortic stenosis (AS) is whether there is an increased risk of sudden cardiac death (SCD) what i should buy with levitra that might be reduced by relief of outflow obstruction. Minners and colleagues1 addressed this issue in a retrospective analysis of outcomes in 1840 patients with mild what i should buy with levitra to moderate AS (aortic maximum velocity 2.5–4.0 m/s) in the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. Overall the annualised rate of SCD was 0.39% per year with 27 events in asymptomatic patients. The most recent echocardiogram prior to SCD showed mild–moderate AS in most what i should buy with levitra (80%) of these patients with no difference in SCD event rates in those who progressed to severe AS compared to those who did not develop severe valve obstruction. On Cox what i should buy with levitra regression analysis, the only independent risk factors for SCD were age (HR 1.06, 95% CI 1.01 to 1.11 per year, p=0.02), increased left ventricular mass index (HR 1.20, 95% CI 1.10 to 1.32 per 10 g/m2, p<0.001) and lower body mass index (HR 0.87, 95% CI 0.79 to 0.97 per kg/m2, p=0.01) but not the severity of valve obstruction (figure 1).Univariate (top) and multivariate (bottom) Cox regression analyses for SCD during 46.1±14.6 months of follow-up in the Simvastatin and Ezetimibe in Aortic Stenosis study.

The number of events for each variable is reflected by the dark, horizontal bars with separation at the median for continuous variables. A forest plot visualisation of HRs for SCD is provided on the right what i should buy with levitra. LVED, left ventricular enddiastolic diameter. LVES, left what i should buy with levitra ventricular endsystolic diameter. LVM, left what i should buy with levitra ventricular mass.

SCD, sudden cardiac death." data-icon-position data-hide-link-title="0">Figure 1 Univariate (top) and multivariate (bottom) Cox regression analyses for SCD during 46.1±14.6 months of follow-up in the Simvastatin and Ezetimibe in Aortic Stenosis study. The number of events for each variable is reflected by what i should buy with levitra the dark, horizontal bars with separation at the median for continuous variables. A forest plot visualisation of HRs for SCD is provided on the right. LVED, left ventricular enddiastolic diameter what i should buy with levitra. LVES, left ventricular what i should buy with levitra endsystolic diameter.

LVM, left ventricular mass. SCD, sudden cardiac death.The lack of association between AS severity and the risk of SCD in the SEAS study is thought-provoking and challenges the conventional wisdom that early AVR would prevent SCD in asymptomatic patients with AS.2 In the past, syncope and SCD in patients with AS were thought to be due to mechanisms such as left ventricle (LV) baroreceptor malfunction, hypotension secondary to peripheral vasodilation in the face of fixed valve obstruction, or a shortened diastolic filling interval at high heart rates what i should buy with levitra leading to a reduced stroke volume. However, it is doubtful that any of these mechanisms would account for SCD when what i should buy with levitra AS is only mild to moderate in severity. €˜It is increasingly recognised that that AS is not simply a mechanical problem of the valve leaflets not opening fully. Instead, AS compromises a complex what i should buy with levitra interplay between the valve, ventricle and vasculature with abnormal function of all three components of the disease process.’ As I conclude in an editorial, ‘It is unlikely that early AVR will reduce the risk of sudden death when severe valve obstruction is not present.

Perhaps it is time to turn our attention to mitigating the non-valvular disease processes in adults with calcific valve disease.’In another interesting paper in this issue of Heart, Williams and Brown3 hypothesised that the apparent benefit of fractional flow reserve (FFR) guidance of percutaneous coronary intervention (PCI) in patients with chronic coronary syndromes (CCS) might simply be due to utilisation of fewer stents rather than to knowledge about the physiological severity of the coronary lesions. In a Monte Carlo simulation what i should buy with levitra using data from the PCI strata of the Bypass Angioplasty Revascularization Investigation 2 Diabetes study, random deferral of PCI progressively reduced the risk of death and myocardial infarction at 1 year, suggesting that FFR-guided deferral of PCI improves outcomes simply because fewer stents are placed.In an editorial, Weintraub and Boden4 put this data into the context of 30 years of clinical trials comparing PCI with optimal medical therapy from CCS and conclude ‘In contrast to patients with acute coronary syndrome, there remains no convincing evidence that PCI will prevent events in patients with stable angina and chronic ischaemic heart disease. We know that, what i should buy with levitra if needed, PCI will ameliorate severe angina, but we also know that this may not be a durable effect. By contrast, for the great majority of patients who are not disabled by angina, PCI can be safely deferred in both diabetic and non-diabetic patients, with revascularisation reserved only for those with unacceptable angina or who develop an acute coronary syndrome during follow-up. The role of FFR remains uncertain at best and need not be performed routinely in all patients with CCS, though it may be useful where the visual estimation of angiographical severity is what i should buy with levitra uncertain.’Cardiac involvement in patients with sepsis contributes to adverse outcomes with most previous studies focusing on left ventricular dysfunction.

In order to assess the impact of right ventricular involvement on outcomes in sepsis Kim and colleagues5 performed a retrospective cohort study of 778 patients with septic shock with echocardiographic imaging. Sepsis-induced cardiac dysfunction was present in 34.7% of the entire cohort, affecting the what i should buy with levitra LV in 67.3% and the right ventricle (RV) in 40.7% of these patients. Any type of sepsis-induced cardiac dysfunction was associated with a significantly higher 28-day mortality (35.9 what i should buy with levitra vs 26.8%. P<0.01), longer intensive care unit length of stay and longer duration of mechanical ventilator, compared with those without cardiac dysfunction. Isolated RV dysfunction was rare (24/270, 8.9%) but was associated with a higher risk of 28-day mortality (adjusted OR 2.77, 95% CI 1.20 to 6.40, p=0.02) (figure 2).Comparisons of survival curves between each what i should buy with levitra type of dysfunction.

LV, left ventricle. RV, right ventricle." data-icon-position data-hide-link-title="0">Figure 2 Comparisons of survival what i should buy with levitra curves between each type of dysfunction. LV, left what i should buy with levitra ventricle. RV, right ventricle.The mechanisms of cardiac dysfunction in patients with sepsis are summarised in an editorial by Dugar and Vallabhajosyula6 (figure 3). They also point out the challenges in what i should buy with levitra understanding cardiac involvement in patients with sepsis including the effect of timing of imaging on detection, difficulties in measuring RV systolic performance, and differing definitions of RV dysfunction.

They conclude what i should buy with levitra. €˜there is a crucial need to understand the how to identify RV dysfunction in sepsis and the causative mechanisms associated with higher mortality in this population, which will significantly influence how we prevent and manage this disease process.’Mechanism of RV dysfunction associated organ failure and mortality in sepsis. RV, right ventricular." data-icon-position data-hide-link-title="0">Figure 3 Mechanism what i should buy with levitra of RV dysfunction associated organ failure and mortality in sepsis. RV, right ventricular.The Education-in-Heart article in this issue by Steiner and Kirkpatrick7 focuses on palliative care in management of pateints with cardiovascular disease. Palliative care now what i should buy with levitra encompasses much more than end-of-life comfort measures.

Instead, ‘Palliative what i should buy with levitra care is a specialised type of medical care that focuses on improving communication about goals of care, maximising quality of life and reducing symptoms’ and thus applies to many of our patients at many time points in their disease course. Each of you will want to read the entire article yourself which includes several useful tools, such as the one shown in figure 4, to improve conversations with patients about treatment options, goals of care and planning for adverse outcomes.Ask-Tell-Ask tool to guide difficult conversations." data-icon-position data-hide-link-title="0">Figure 4 Ask-Tell-Ask tool to guide difficult conversations.Be sure to try the two Image Challenge questions in this issue.8 9 Over 150 board-review format multiple choice questions based on all types of cardiac images can be found in our online archive on the Heart homepage (https://heart.bmj.com/pages/collections/image_challenges/).In symptomatic patients with severe aortic stenosis (AS), there is no question that aortic valve replacement (AVR) relieves symptoms and prolongs life. In asymptomatic patients, clinical decision making is less clear because of the need to balance the risks of intervention what i should buy with levitra and a prosthetic valve against the risks of continued watchful waiting. On the other hand, symptom onset is inevitable in patients with severe AS—the decision is not whether but rather when to replace the valve.The primary rationale for deferring AVR until a later date is the lack of evidence that AVR before symptom onset would improve longevity. In addition, the risks, what i should buy with levitra discomfort and disability associated with a surgical or transcatheter procedure are postponed until a later date.

Furthermore, if a mechanical AVR is chosen, delaying intervention reduces the length of time the patient is exposed to the risks and what i should buy with levitra inconvenience of warfarin anticoagulation. If a bioprosthetic AVR is chosen, implantation later in life increases the likelihood that the valve will not deteriorate to the point of reintervention during the patient’s lifetime. Unfortunately, patients with AS do not have the option of a what i should buy with levitra normal aortic valve. Instead the diseased native valve is replaced with an imperfect prosthetic valve.On the other hand, accumulating evidence from advanced imaging studies shows that aortic valve obstruction is associated with adverse changes in left ventricular (LV) structure and function, even in the absence of symptoms, which may not resolve after AVR.1 In addition, observational studies suggest that there may be an increased risk of sudden cardiac death in apparently asymptomatic patients with severe AS, although the magnitude and predictors of risk remain unclear.In order to provide clarity about the risk of sudden death in asymptomatic adults with AS, Minners and colleagues examined the data from the Simvastatin and Ezetimibe in Aortic ….

A key consideration generic levitra for sale in timing of aortic valve replacement (AVR) for patients with aortic stenosis (AS) is whether there is an increased risk of sudden cardiac death (SCD) that might be reduced by relief of outflow obstruction. Minners and colleagues1 addressed this issue generic levitra for sale in a retrospective analysis of outcomes in 1840 patients with mild to moderate AS (aortic maximum velocity 2.5–4.0 m/s) in the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. Overall the annualised rate of SCD was 0.39% per year with 27 events in asymptomatic patients. The most recent echocardiogram prior to SCD showed mild–moderate AS in most (80%) of these patients with no difference in SCD event rates in those who progressed to severe AS compared to generic levitra for sale those who did not develop severe valve obstruction.

On Cox regression analysis, the only independent risk factors for SCD were age (HR 1.06, 95% CI 1.01 to 1.11 per year, p=0.02), increased left ventricular mass index (HR 1.20, 95% CI 1.10 to 1.32 per 10 g/m2, p<0.001) and lower body mass index (HR 0.87, 95% CI 0.79 to 0.97 per kg/m2, p=0.01) but not the severity of generic levitra for sale valve obstruction (figure 1).Univariate (top) and multivariate (bottom) Cox regression analyses for SCD during 46.1±14.6 months of follow-up in the Simvastatin and Ezetimibe in Aortic Stenosis study. The number of events for each variable is reflected by the dark, horizontal bars with separation at the median for continuous variables. A forest plot visualisation of HRs for SCD is provided on generic levitra for sale the right. LVED, left ventricular enddiastolic diameter.

LVES, left generic levitra for sale ventricular endsystolic diameter. LVM, left generic levitra for sale ventricular mass. SCD, sudden cardiac death." data-icon-position data-hide-link-title="0">Figure 1 Univariate (top) and multivariate (bottom) Cox regression analyses for SCD during 46.1±14.6 months of follow-up in the Simvastatin and Ezetimibe in Aortic Stenosis study. The number generic levitra for sale of events for each variable is reflected by the dark, horizontal bars with separation at the median for continuous variables.

A forest plot visualisation of HRs for SCD is provided on the right. LVED, left generic levitra for sale ventricular enddiastolic diameter. LVES, left ventricular endsystolic diameter generic levitra for sale. LVM, left ventricular mass.

SCD, sudden cardiac death.The lack of association between AS severity and the risk of SCD in the SEAS study is thought-provoking generic levitra for sale and challenges the conventional wisdom that early AVR would prevent SCD in asymptomatic patients with AS.2 In the past, syncope and SCD in patients with AS were thought to be due to mechanisms such as left ventricle (LV) baroreceptor malfunction, hypotension secondary to peripheral vasodilation in the face of fixed valve obstruction, or a shortened diastolic filling interval at high heart rates leading to a reduced stroke volume. However, it generic levitra for sale is doubtful that any of these mechanisms would account for SCD when AS is only mild to moderate in severity. €˜It is increasingly recognised that that AS is not simply a mechanical problem of the valve leaflets not opening fully. Instead, AS compromises a complex interplay between the valve, ventricle and vasculature with abnormal function of all three components of the disease process.’ As I conclude in an editorial, ‘It is unlikely that early AVR will reduce generic levitra for sale the risk of sudden death when severe valve obstruction is not present.

Perhaps it is time to turn our attention to mitigating the non-valvular disease processes in adults with calcific valve disease.’In another interesting paper in this issue of Heart, Williams and Brown3 hypothesised that the apparent benefit of fractional flow reserve (FFR) guidance of percutaneous coronary intervention (PCI) in patients with chronic coronary syndromes (CCS) might simply be due to utilisation of fewer stents rather than to knowledge about the physiological severity of the coronary lesions. In a Monte Carlo simulation using data from the PCI strata of the Bypass Angioplasty Revascularization Investigation 2 Diabetes study, random deferral of PCI progressively reduced the risk of death and myocardial infarction at 1 year, suggesting that FFR-guided deferral of PCI improves outcomes simply because fewer stents are placed.In an editorial, Weintraub and generic levitra for sale Boden4 put this data into the context of 30 years of clinical trials comparing PCI with optimal medical therapy from CCS and conclude ‘In contrast to patients with acute coronary syndrome, there remains no convincing evidence that PCI will prevent events in patients with stable angina and chronic ischaemic heart disease. We know that, if needed, PCI will ameliorate severe angina, but generic levitra for sale we also know that this may not be a durable effect. By contrast, for the great majority of patients who are not disabled by angina, PCI can be safely deferred in both diabetic and non-diabetic patients, with revascularisation reserved only for those with unacceptable angina or who develop an acute coronary syndrome during follow-up.

The role of FFR generic levitra for sale remains uncertain at best and need not be performed routinely in all patients with CCS, though it may be useful where the visual estimation of angiographical severity is uncertain.’Cardiac involvement in patients with sepsis contributes to adverse outcomes with most previous studies focusing on left ventricular dysfunction. In order to assess the impact of right ventricular involvement on outcomes in sepsis Kim and colleagues5 performed a retrospective cohort study of 778 patients with septic shock with echocardiographic imaging. Sepsis-induced cardiac dysfunction was present in 34.7% generic levitra for sale of the entire cohort, affecting the LV in 67.3% and the right ventricle (RV) in 40.7% of these patients. Any type of sepsis-induced cardiac dysfunction was associated with a significantly higher 28-day mortality (35.9 vs generic levitra for sale 26.8%.

P<0.01), longer intensive care unit length of stay and longer duration of mechanical ventilator, compared with those without cardiac dysfunction. Isolated RV dysfunction was rare (24/270, 8.9%) but generic levitra for sale was associated with a higher risk of 28-day mortality (adjusted OR 2.77, 95% CI 1.20 to 6.40, p=0.02) (figure 2).Comparisons of survival curves between each type of dysfunction. LV, left ventricle. RV, right ventricle." data-icon-position data-hide-link-title="0">Figure 2 Comparisons generic levitra for sale of survival curves between each type of dysfunction.

LV, left generic levitra for sale ventricle. RV, right ventricle.The mechanisms of cardiac dysfunction in patients with sepsis are summarised in an editorial by Dugar and Vallabhajosyula6 (figure 3). They also point out the challenges in understanding cardiac involvement in patients with sepsis including the effect of timing of imaging on detection, difficulties in measuring RV systolic performance, and differing definitions of RV dysfunction generic levitra for sale. They conclude generic levitra for sale.

€˜there is a crucial need to understand the how to identify RV dysfunction in sepsis and the causative mechanisms associated with higher mortality in this population, which will significantly influence how we prevent and manage this disease process.’Mechanism of RV dysfunction associated organ failure and mortality in sepsis. RV, right ventricular." data-icon-position data-hide-link-title="0">Figure 3 Mechanism of RV dysfunction generic levitra for sale associated organ failure and mortality in sepsis. RV, right ventricular.The Education-in-Heart article in this issue by Steiner and Kirkpatrick7 focuses on palliative care in management of pateints with cardiovascular disease. Palliative care now encompasses much more than generic levitra for sale end-of-life comfort measures.

Instead, ‘Palliative care is a specialised type of medical care that focuses on improving generic levitra for sale communication about goals of care, maximising quality of life and reducing symptoms’ and thus applies to many of our patients at many time points in their disease course. Each of you will want to read the entire article yourself which includes several useful tools, such as the one shown in figure 4, to improve conversations with patients about treatment options, goals of care and planning for adverse outcomes.Ask-Tell-Ask tool to guide difficult conversations." data-icon-position data-hide-link-title="0">Figure 4 Ask-Tell-Ask tool to guide difficult conversations.Be sure to try the two Image Challenge questions in this issue.8 9 Over 150 board-review format multiple choice questions based on all types of cardiac images can be found in our online archive on the Heart homepage (https://heart.bmj.com/pages/collections/image_challenges/).In symptomatic patients with severe aortic stenosis (AS), there is no question that aortic valve replacement (AVR) relieves symptoms and prolongs life. In asymptomatic patients, clinical decision making is less clear because of the need to balance the risks of intervention and a prosthetic valve generic levitra for sale against the risks of continued watchful waiting. On the other hand, symptom onset is inevitable in patients with severe AS—the decision is not whether but rather when to replace the valve.The primary rationale for deferring AVR until a later date is the lack of evidence that AVR before symptom onset would improve longevity.

In addition, the risks, discomfort and disability associated with generic levitra for sale a surgical or transcatheter procedure are postponed until a later date. Furthermore, if a mechanical AVR generic levitra for sale is chosen, delaying intervention reduces the length of time the patient is exposed to the risks and inconvenience of warfarin anticoagulation. If a bioprosthetic AVR is chosen, implantation later in life increases the likelihood that the valve will not deteriorate to the point of reintervention during the patient’s lifetime. Unfortunately, patients with AS do not have the generic levitra for sale option of a normal aortic valve.

Instead the diseased native valve is replaced with an imperfect prosthetic valve.On the other hand, accumulating evidence from advanced imaging studies shows that aortic valve obstruction is associated with adverse changes in left ventricular (LV) structure and function, even in the absence of symptoms, which may not resolve after AVR.1 In addition, observational studies suggest that there may be an increased risk of sudden cardiac death in apparently asymptomatic patients with severe AS, although the magnitude and predictors of risk remain unclear.In order to provide clarity about the risk of sudden death in asymptomatic adults with AS, Minners and colleagues examined the data from the Simvastatin and Ezetimibe in Aortic ….

Levitra best dosage

The odds are it’s not available to levitra best dosage you, and there is a reason for that. You may be hearing about how virtual care, often described as telehealth or telemedicine, is beneficial during COVID-19 and how health systems are offering virtual access like never before. There’s a reason for that, too. For the past few weeks I’ve seen Facebook posts daily from former nursing colleagues in metro levitra best dosage Detroit, one of the hardest hit areas in the country, as they provide front-line care to patients with COVID-19.

It makes me very proud to call these nurses my friends. As a former emergency department nurse, I recall the feeling of satisfaction knowing that I’ve helped someone on the worst day of their life. One of the best parts of being a nurse levitra best dosage is knowing you matter to the only person in health care that truly matters. The patient.

Several years ago I made the difficult decision to no longer perform bedside nursing and become a nurse administrator. The biggest loss from my levitra best dosage transition is the feeling that what I do matters to the patient. COVID-19 has forced a lot of us to rethink the role we play in health care and what the real priority should be. Things that were top priorities three months ago have been rightfully cast aside to either care for patients in a pandemic or prepare for the unknown future of, “When is our turn?.

€ For me, COVID-19 has reignited the feeling that what I do matters levitra best dosage as virtual care has become a powerful tool on the forefront of care during this crisis. It has also shown that many of the powerful rules and regulations that limit virtual care are not needed and should be discarded permanently. When I became the director of virtual care at our organization in 2015 I knew nothing about telehealth. Sure, I had seen a stroke robot in levitra best dosage some Emergency Departments, and I had some friends that told me their insurance company lets them FaceTime a doctor for free (spoiler alert.

It’s not FaceTime). I was tech-savvy from a consumer perspective and a tech novice from an IT perspective. Nevertheless, my team and I spent the next few years learning as we built one of levitra best dosage the higher volume virtual care networks in the state of Michigan. We discovered a lot of barriers that keep virtual care from actually making the lives of patients and providers better and we also became experts in working around those barriers.

But, there were two obstacles that we could not overcome. Government regulation levitra best dosage and insurance provider willingness to cover virtual visits. These two barriers effectively cripple most legitimate attempts to provide value-added direct-to-consumer virtual care, which I define as using virtual care technologies to provide care outside of our brick-and-mortar facilities, most commonly in the patient home. The need to social distance, cancel appointments, close provider offices, keep from overloading emergency departments and urgent cares and shelter in place created instant demand for direct-to-consumer virtual care.

In all honesty, I’ve always considered direct-to-consumer virtual care to be the flashy, must-have holiday gift levitra best dosage of the year that organizations are convinced will be the way of the future. If a health system wants to provide on-demand access to patients for low-complexity acute conditions, they will easily find plenty of vendors that will sell them their app and their doctors and put the health system’s logo on it. What a health system will struggle with is to find is enough patient demand to cover the high cost. Remember my levitra best dosage friends from earlier that told me about the app their insurance gave them?.

Nearly all of them followed that up by telling me they’ve never actually used it. I am fortunate that I work for an organization that understands this and instead focuses on how can we provide care that our patients actually want and need from the doctors they want to see. Ironically, this fiscal year we had a corporate top priority around direct-to-consumer virtual care levitra best dosage. We wanted to expand what we thought were some successful pilots and perform 500 direct-to-consumer visits.

This year has been one of the hardest of my leadership career because, frankly, up until a month ago I was about to fail on this top priority. With only four months left, we were only about halfway there levitra best dosage. The biggest problem we ran into was that every great idea a physician brought to me was instantly dead in the water because practically no insurance company would pay for it. There are (prior to COVID-19) a plethora of rules around virtual care billing but the simplest way to summarize it is that most virtual care will only be paid if it happens in a rural location and inside of a health care facility.

It is extremely limited what will be paid for in the patient home and most of it is so specific that the average levitra best dosage patient isn’t eligible to get any in-home virtual care. Therefore, most good medical uses for direct-to-consumer care would be asking the patient to pay cash or the physician to forgo reimbursement for a visit that would be covered if it happened in office. Add to that the massive capital and operating expenses it takes to build a virtual care network and you can see why these programs don’t exist. A month ago I was skeptical we’d have a robust direct-to-consumer program any time soon and then levitra best dosage COVID-19 hit.

When COVID-19 started to spread rapidly in the United States, regulations and reimbursement rules were being stripped daily. The first change that had major impact is when the Centers for Medicare and Medicaid Services (CMS) announced that they would temporarily begin reimbursing for virtual visits conducted in the patient’s home for COVID-19 and non-COVID related visits. We were already frantically designing a virtual program levitra best dosage to handle the wave of COVID-19 screening visits that were overloading our emergency departments and urgent cares. We were having plenty of discussions around reimbursement for this clinic.

Do we attempt to bill insurances knowing they will likely deny, do we do a cash clinic model or do we do this as a community benefit and eat the cost?. The CMS waiver gave us hope that we would be compensated for diverting patients away from reimbursed visits to a virtual visit that is more convenient for the patient and aligns with the concept of social levitra best dosage distancing. Realistically we don’t know if we will be paid for any of this. We are holding all of the bills for at least 90 days while the industry sorts out the rules.

I was excited by the reimbursement announcement because I knew we had eliminated one of the biggest direct-to-consumer virtual care levitra best dosage barriers. However, I was quickly brought back to reality when I was reminded that HIPAA (Health Insurance Portability and Accountability Act) still existed. I had this crazy idea that during a pandemic we should make it as easy as possible for people to receive virtual care and that the best way to do that was to meet the patient on the device they are most comfortable with and the application (FaceTime, Facebook, Skype, etc.) that they use every day. The problem is nearly every app the consumer uses on a daily basis is banned by HIPAA because “it’s not secure.” I’m not quite sure what a hacker stands to gain by listening into to my doctor and me talk about how my kids yet again gave me strep throat but levitra best dosage apparently the concern is great enough to stifle the entire industry.

Sure, not every health care discussion is as low-key as strep throat and a patient may want to protect certain topics from being discussed over a “non-secure” app but why not let the patient decide through informed consent?. Regulators could also abandon this all-or-nothing approach and lighten regulations surrounding specific health conditions. The idea that regulations change based levitra best dosage on medical situation is not new. For example, in my home state of Michigan, adolescents are essentially considered emancipated if it involves sexual health, mental health or substance abuse.

Never mind that this same information is freely given over the phone by every office around the country daily without issue, but I digress. While my levitra best dosage job is to innovate new pathways for care, our lawyer’s job is to protect the organization and he, along with IT security, rightfully shot down my consumer applications idea. A few days later I legitimately screamed out loud in joy when the Department of Health and Human Services announced that it would use discretion on enforcing HIPAA compliance rules and specifically allowed for use of consumer applications. The elimination of billing restrictions and HIPAA regulations changed what is possible for health care organizations to offer virtually.

Unfortunately both changes are listed as temporary levitra best dosage and will likely be removed when the pandemic ends. Six days after the HIPAA changes were announced, we launched a centralized virtual clinic for any patient that wanted a direct-to-consumer video visit to be screened by a provider for COVID-19. It allows patients to call in without a referral and most patients are on-screen within five minutes of clicking the link we text them. They don’t have to download an app, create an account or even be an established patient of our health system levitra best dosage.

It saw over 900 patients in the first 12 days it was open. That is 900 real patients that received care from a physician or advanced practice provider without risking personal exposure and without going to an already overwhelmed ED or urgent care. To date, 70 percent of the patients seen by levitra best dosage the virtual clinic did not meet CDC testing criteria for COVID-19. I don’t believe we could have reached even half of these patients had the consumer application restrictions been kept.

A program like this almost certainly wouldn’t exist if not for the regulations being lifted and even if it did, it would have taken six to 12 months to navigate barriers and implement in normal times. Sure, the urgency of a pandemic helps but the impact of provider, patients, regulators and payors being on the same page levitra best dosage is what fueled this fire. During the virtual clinic’s first two weeks, my team turned its attention to getting over 300 providers across 60+ offices virtual so they could see their patients at home. Imagine being an immunocompromised cancer patient right now and being asked to leave your home and be exposed to other people in order to see your oncologist.

Direct-to-consumer virtual care is the best way to safely care for these patients and without these temporary waivers it wouldn’t be covered by insurance even if you did navigate levitra best dosage the clunky apps that are HIPAA compliant. Do we really think the immunocompromised cancer patient feels any more comfortable every normal flu season?. Is it any more appropriate to ask them to risk exposure to the flu than it is to COVID-19?. And yet we deny them this access in normal times and it quite possibly will be stripped away from them when this levitra best dosage crisis is over.

Now 300 to 400 patients per day in our health system are seen virtually by their own primary care doctor or specialist for non-COVID related visits. Not a single one of these would have been reimbursed one month ago and I am highly skeptical I would have gotten approval to use the software that connects us to the patient. Lastly, recall that levitra best dosage prior to COVID-19, our system had only found 250 total patients that direct-to-consumer care was value-added and wasn’t restricted by regulation or reimbursement. COVID-19 has been a wake-up call to the whole country and health care is no exception.

It has put priorities in perspective and shined a light on what is truly value-added. For direct-to-consumer virtual care it has shown us what is possible when we get out of our levitra best dosage own way. If a regulation has to be removed to allow for care during a crisis then we must question why it exists in the first place. HIPAA regulation cannot go back to its antiquated practices if we are truly going to shift the focus to patient wellness.

CMS and private payors must embrace value-added direct-to-consumer virtual care and allow patients the access they deserve levitra best dosage. COVID-19 has forced this industry forward, we cannot allow it to regress and be forgotten when this is over. Tom Wood is the director of trauma and virtual care for MidMichigan Health, a non-profit health system headquartered in Midland, Michigan, affiliated with Michigan Medicine, the health care division of the University of Michigan. The views and opinions expressed in this commentary are his own.When dealing with all of the aspects levitra best dosage of diabetes, it’s easy to let your feel fall to the bottom of the list.

But daily care and evaluation is one of the best ways to prevent foot complications. It’s important to identify your risk factors and take the proper steps in limiting your complications. Two of levitra best dosage the biggest complications with diabetes are peripheral neuropathy and ulcer/amputation. Symptoms of peripheral neuropathy include numbness, tingling and/or burning in your feet and legs.

You can slow the progression of developing neuropathy by making it a point to manage your blood sugars and keep them in the normal range. If you are experiencing these symptoms, it is important to establish and maintain a relationship with a levitra best dosage podiatrist. Your podiatrist can make sure things are looking healthy and bring things to your attention to monitor and keep a close eye on. Open wounds or ulcers can develop secondary to trauma, pressure, diabetes, neuropathy or poor circulation.

If ulcerations levitra best dosage do develop, it’s extremely important to identify the cause and address it. Ulcers can get worse quickly, so it’s necessary to seek immediate medical treatment if you find yourself or a loved one dealing with this complication. Untreated ulcerations often lead to amputation and can be avoided if proper medical attention is sought right away. There are important things to remember when dealing with levitra best dosage diabetic foot care.

It’s very important to inspect your feet daily, especially if you have peripheral neuropathy. You may have a cut or a sore on your feet that you can’t feel, so your body doesn’t alarm you to check your feet. Be gentle when bathing levitra best dosage your feet. Moisturize your feet, but not between your toes.

Do not treat calluses or corns on your own. Wear clean, dry socks.

The odds are it’s not available to you, and there is a reason for generic levitra for sale that. You may be hearing about how virtual care, often described as telehealth or telemedicine, is beneficial during COVID-19 and how health systems are offering virtual access like never before. There’s a reason for that, too. For the past few weeks I’ve seen Facebook posts daily from former nursing colleagues generic levitra for sale in metro Detroit, one of the hardest hit areas in the country, as they provide front-line care to patients with COVID-19. It makes me very proud to call these nurses my friends.

As a former emergency department nurse, I recall the feeling of satisfaction knowing that I’ve helped someone on the worst day of their life. One of the generic levitra for sale best parts of being a nurse is knowing you matter to the only person in health care that truly matters. The patient. Several years ago I made the difficult decision to no longer perform bedside nursing and become a nurse administrator. The biggest loss from my transition is the feeling that what generic levitra for sale I do matters to the patient.

COVID-19 has forced a lot of us to rethink the role we play in health care and what the real priority should be. Things that were top priorities three months ago have been rightfully cast aside to either care for patients in a pandemic or prepare for the unknown future of, “When is our turn?. € For me, COVID-19 has reignited the feeling that what I do matters as generic levitra for sale virtual care has become a powerful tool on the forefront of care during this crisis. It has also shown that many of the powerful rules and regulations that limit virtual care are not needed and should be discarded permanently. When I became the director of virtual care at our organization in 2015 I knew nothing about telehealth.

Sure, I had seen a stroke robot in some Emergency Departments, and I had generic levitra for sale some friends that told me their insurance company lets them FaceTime a doctor for free (spoiler alert. It’s not FaceTime). I was tech-savvy from a consumer perspective and a tech novice from an IT perspective. Nevertheless, my team and I spent the next few years generic levitra for sale learning as we built one of the higher volume virtual care networks in the state of Michigan. We discovered a lot of barriers that keep virtual care from actually making the lives of patients and providers better and we also became experts in working around those barriers.

But, there were two obstacles that we could not overcome. Government regulation and generic levitra for sale insurance provider willingness to cover virtual visits. These two barriers effectively cripple most legitimate attempts to provide value-added direct-to-consumer virtual care, which I define as using virtual care technologies to provide care outside of our brick-and-mortar facilities, most commonly in the patient home. The need to social distance, cancel appointments, close provider offices, keep from overloading emergency departments and urgent cares and shelter in place created instant demand for direct-to-consumer virtual care. In all honesty, I’ve always considered direct-to-consumer virtual care to be the flashy, must-have holiday gift of the year that organizations are convinced will be the way of the future generic levitra for sale.

If a health system wants to provide on-demand access to patients for low-complexity acute conditions, they will easily find plenty of vendors that will sell them their app and their doctors and put the health system’s logo on it. What a health system will struggle with is to find is enough patient demand to cover the high cost. Remember my friends from earlier that told me generic levitra for sale about the app their insurance gave them?. Nearly all of them followed that up by telling me they’ve never actually used it. I am fortunate that I work for an organization that understands this and instead focuses on how can we provide care that our patients actually want and need from the doctors they want to see.

Ironically, this generic levitra for sale fiscal year we had a corporate top priority around direct-to-consumer virtual care. We wanted to expand what we thought were some successful pilots and perform 500 direct-to-consumer visits. This year has been one of the hardest of my leadership career because, frankly, up until a month ago I was about to fail on this top priority. With only four months generic levitra for sale left, we were only about halfway there. The biggest problem we ran into was that every great idea a physician brought to me was instantly dead in the water because practically no insurance company would pay for it.

There are (prior to COVID-19) a plethora of rules around virtual care billing but the simplest way to summarize it is that most virtual care will only be paid if it happens in a rural location and inside of a health care facility. It is extremely limited what will be paid for in the patient home and most of it is so specific that the generic levitra for sale average patient isn’t eligible to get any in-home virtual care. Therefore, most good medical uses for direct-to-consumer care would be asking the patient to pay cash or the physician to forgo reimbursement for a visit that would be covered if it happened in office. Add to that the massive capital and operating expenses it takes to build a virtual care network and you can see why these programs don’t exist. A month ago I was skeptical generic levitra for sale we’d have a robust direct-to-consumer program any time soon and then COVID-19 hit.

When COVID-19 started to spread rapidly in the United States, regulations and reimbursement rules were being stripped daily. The first change that had major impact is when the Centers for Medicare and Medicaid Services (CMS) announced that they would temporarily begin reimbursing for virtual visits conducted in the patient’s home for COVID-19 and non-COVID related visits. We were already frantically designing a virtual program to handle the wave of COVID-19 screening generic levitra for sale visits that were overloading our emergency departments and urgent cares. We were having plenty of discussions around reimbursement for this clinic. Do we attempt to bill insurances knowing they will likely deny, do we do a cash clinic model or do we do this as a community benefit and eat the cost?.

The CMS waiver gave us hope that we would be compensated for diverting patients away from reimbursed visits to a virtual visit that is more convenient for the patient and aligns with generic levitra for sale the concept of social distancing. Realistically we don’t know if we will be paid for any of this. We are holding all of the bills for at least 90 days while the industry sorts out the rules. I was excited by generic levitra for sale the reimbursement announcement because I knew we had eliminated one of the biggest direct-to-consumer virtual care barriers. However, I was quickly brought back to reality when I was reminded that HIPAA (Health Insurance Portability and Accountability Act) still existed.

I had this crazy idea that during a pandemic we should make it as easy as possible for people to receive virtual care and that the best way to do that was to meet the patient on the device they are most comfortable with and the application (FaceTime, Facebook, Skype, etc.) that they use every day. The problem is nearly every app the consumer uses on a daily basis is banned by HIPAA because “it’s not secure.” I’m not quite sure what a hacker stands to gain by listening into to my doctor and me talk about how my kids yet generic levitra for sale again gave me strep throat but apparently the concern is great enough to stifle the entire industry. Sure, not every health care discussion is as low-key as strep throat and a patient may want to protect certain topics from being discussed over a “non-secure” app but why not let the patient decide through informed consent?. Regulators could also abandon this all-or-nothing approach and lighten regulations surrounding specific health conditions. The idea that regulations generic levitra for sale change based on medical situation is not new.

For example, in my home state of Michigan, adolescents are essentially considered emancipated if it involves sexual health, mental health or substance abuse. Never mind that this same information is freely given over the phone by every office around the country daily without issue, but I digress. While my job is generic levitra for sale to innovate new pathways for care, our lawyer’s job is to protect the organization and he, along with IT security, rightfully shot down my consumer applications idea. A few days later I legitimately screamed out loud in joy when the Department of Health and Human Services announced that it would use discretion on enforcing HIPAA compliance rules and specifically allowed for use of consumer applications. The elimination of billing restrictions and HIPAA regulations changed what is possible for health care organizations to offer virtually.

Unfortunately both changes are listed as temporary and will likely be removed when generic levitra for sale the pandemic ends. Six days after the HIPAA changes were announced, we launched a centralized virtual clinic for any patient that wanted a direct-to-consumer video visit to be screened by a provider for COVID-19. It allows patients to call in without a referral and most patients are on-screen within five minutes of clicking the link we text them. They don’t have to download an app, create an account or even be generic levitra for sale an established patient of our health system. It saw over 900 patients in the first 12 days it was open.

That is 900 real patients that received care from a physician or advanced practice provider without risking personal exposure and without going to an already overwhelmed ED or urgent care. To date, 70 percent of the patients seen by generic levitra for sale the virtual clinic did not meet CDC testing criteria for COVID-19. I don’t believe we could have reached even half of these patients had the consumer application restrictions been kept. A program like this almost certainly wouldn’t exist if not for the regulations being lifted and even if it did, it would have taken six to 12 months to navigate barriers and implement in normal times. Sure, the urgency of a pandemic helps but the impact of provider, patients, regulators and payors being on the same page is what fueled generic levitra for sale this fire.

During the virtual clinic’s first two weeks, my team turned its attention to getting over 300 providers across 60+ offices virtual so they could see their patients at home. Imagine being an immunocompromised cancer patient right now and being asked to leave your home and be exposed to other people in order to see your oncologist. Direct-to-consumer virtual care is the best way to safely care for these patients generic levitra for sale and without these temporary waivers it wouldn’t be covered by insurance even if you did navigate the clunky apps that are HIPAA compliant. Do we really think the immunocompromised cancer patient feels any more comfortable every normal flu season?. Is it any more appropriate to ask them to risk exposure to the flu than it is to COVID-19?.

And yet we deny them this access in normal times and it quite possibly will be stripped away from them when generic levitra for sale this crisis is over. Now 300 to 400 patients per day in our health system are seen virtually by their own primary care doctor or specialist for non-COVID related visits. Not a single one of these would have been reimbursed one month ago and I am highly skeptical I would have gotten approval to use the software that connects us to the patient. Lastly, recall that prior to COVID-19, our system had only found 250 total patients generic levitra for sale that direct-to-consumer care was value-added and wasn’t restricted by regulation or reimbursement. COVID-19 has been a wake-up call to the whole country and health care is no exception.

It has put priorities in perspective and shined a light on what is truly value-added. For direct-to-consumer virtual care it has shown us what is possible when we get out of our generic levitra for sale own way. If a regulation has to be removed to allow for care during a crisis then we must question why it exists in the first place. HIPAA regulation cannot go back to its antiquated practices if we are truly going to shift the focus to patient wellness. CMS and private payors must embrace value-added direct-to-consumer virtual care and allow patients the access they deserve generic levitra for sale.

COVID-19 has forced this industry forward, we cannot allow it to regress and be forgotten when this is over. Tom Wood is the director of trauma and virtual care for MidMichigan Health, a non-profit health system headquartered in Midland, Michigan, affiliated with Michigan Medicine, the health care division of the University of Michigan. The views and opinions expressed in this commentary are his own.When dealing with all of the aspects of diabetes, it’s easy to let your feel fall to the bottom of the list generic levitra for sale. But daily care and evaluation is one of the best ways to prevent foot complications. It’s important to identify your risk factors and take the proper steps in limiting your complications.

Two of the biggest complications with generic levitra for sale diabetes are peripheral neuropathy and ulcer/amputation. Symptoms of peripheral neuropathy include numbness, tingling and/or burning in your feet and legs. You can slow the progression of developing neuropathy by making it a point to manage your blood sugars and keep them in the normal range. If you are experiencing these symptoms, it is important to establish and maintain a relationship with a podiatrist generic levitra for sale. Your podiatrist can make sure things are looking healthy and bring things to your attention to monitor and keep a close eye on.

Open wounds or ulcers can develop secondary to trauma, pressure, diabetes, neuropathy or poor circulation. If ulcerations do develop, it’s extremely generic levitra for sale important to identify the cause and address it. Ulcers can get worse quickly, so it’s necessary to seek immediate medical treatment if you find yourself or a loved one dealing with this complication. Untreated ulcerations often lead to amputation and can be avoided if proper medical attention is sought right away. There are important things to remember when dealing generic levitra for sale with diabetic foot care.

It’s very important to inspect your feet daily, especially if you have peripheral neuropathy. You may have a cut or a sore on your feet that you can’t feel, so your body doesn’t alarm you to check your feet. Be gentle generic levitra for sale when bathing your feet. Moisturize your feet, but not between your toes. Do not treat calluses or corns on your own.

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Q. How could Covid-19 financial relief affect my income taxes for 2020?. A. The COVID pandemic has caused widespread economic distress across the United States, with the stress of job loss compounded in many cases by the loss of employer-sponsored health coverage.Fortunately, the CARES Act and subsequent government regulations have provided many Americans with additional unemployment benefits that would not normally have been available. And the Affordable Care Act ensured that Americans losing their health coverage would be able to transition to an individual-market health plan, regardless of their medical history.

It also made Medicaid available – in most states – to people whose monthly income fell to no more than 138 percent of the federal poverty level. (For a single person, that’s about $1,467 in monthly income.)But there are still 13 states where there’s a coverage gap for people who earn less than the poverty level, due to those states’ refusal to accept federal funding to expand Medicaid. And there are pitfalls that go along with premium subsidies for individual-market health coverage – some of which people might not fully understand until they file their 2020 taxes next spring, and some of which are related to the benefits provided by the CARES Act.The basics of Covid-19 financial reliefFirst, the basics of the financial assistance and how it’s counted in terms of your income. Covid-19 financial relief and your income taxes for 2020So what does all of that mean in terms of the 2020 tax return that you’ll be filing next spring?. It will depend on your specific income, but some people who received advance premium tax credits (APTC) to offset the cost of health coverage in 2020 might end up having to repay some or all of that money to the IRS when they file their 2020 taxes.Dave Keller, President of My1HR, is appealing to Congress to change the rules so that the additional COVID-related federal unemployment benefits would not be counted as part of a person’s ACA-specific MAGI.

Keller notes that “while the APTC has enabled many people to enroll in an ACA plan at little or no cost to them, they may be staring at a large tax consequence when they file their 2020 taxes next year, at a time that they can least afford it.”If Congress moved to exempt that federal relief, it would remove a potential tax burden for Americans already facing financial strain during this pandemic. Will the COVID-related financial assistance affect my 2020 health insurance subsidy?. Absent additional Congressional action, most of this is water under the bridge at this point. But here’s what you need to know in order to avoid surprises on your tax return:If you were eligible for Medicaid at some point this year based on your monthly income, that will not have any effect on your 2020 tax return. Medicaid does not get reconciled with the IRS.If you are in one of the 13 states where there’s still a coverage gap (plus Nebraska prior to October 2020, when there was still a coverage gap there), the additional federal unemployment benefits might have been enough to push your total projected income above the poverty level, making you eligible for premium subsidies in the exchange.

Even if your income ultimately ends up below the poverty level when all is said and done, you won’t have to repay the APTC that was paid on your behalf when you file your taxes.But on the higher end of the scale, if the additional federal benefits push your total ACA-specific MAGI higher than you originally projected but not above 400 percent of the poverty level, you’ll have to pay back some or all of the APTC, although there are caps that apply to the repayment amounts in that case.And unfortunately, if the additional federal benefits push your MAGI for 2020 above 400 percent of the poverty level, you will have to repay all of the APTC that was paid on your behalf this year.This last point is the most pressing concern, as it can amount to thousands of dollars being owed to the IRS, depending on where you live, how old you are, and how many months APTC was paid on your behalf for a plan purchased in the exchange (APTC is larger in areas where coverage is more expensive, and it’s larger for older people since their pre-subsidy premiums are higher).People are often caught off guard by the fact that the APTC reconciliation process uses the entire year’s income — not just income during the time you were enrolled in a plan through the exchange. So it’s not just the enhanced federal unemployment benefits and Lost Wage Assistance benefits that could cause a snag here. It’s also income that a person earns later in the year, after having a plan through the exchange for only part of the year.This could present a problem for people who enrolled in an exchange plan with APTC in the spring of 2020 (after losing an employer’s plan due to the pandemic), and then transition back to full-time work later in the year. If their total income for the year — including money they earned prior to their transition to an individual market health plan as well as unemployment benefits and any money they earn later in the year — goes above 400 percent of the poverty level, they’ll have to repay all of the APTC that was paid on their behalf during the months they had self-purchased health coverage.What can I do to avoid a surprise at tax time?. If you’re facing the possibility of having to repay some or all of your APTC, there are a few things to keep in mind:Contributions to pre-tax retirement accounts and health savings accounts will reduce your ACA-specific MAGI.In order to contribute to a health savings account (HSA), you need to have an HSA-qualified high-deductible health plan (HDHP).You can make the full year’s contribution to an HSA even if you only have HSA-qualified coverage in place during the last month of the year, as long as you then continue to maintain HSA-qualified coverage for all of the following year.If you’re returning to full-time work and are eligible to participate in your employer’s health plan, you might want to check to see whether they offer an HDHP and whether it would be worth your while to enroll in it and contribute to the HSA.

(Definitely check with a financial advisor to see if this is the best overall strategy, as it’s a decision that should only be made with your full financial situation in mind.)If you’re still enrolled in a plan through the exchange and are realizing that you’re going to have to repay your APTC because your total MAGI is going to be higher than you had projected, you can contact the exchange and have them adjust your APTC so that it’s no longer paid for the final months of the year. This will reduce the amount you’ll have to repay to the IRS, but that also means you’ll have to pay full price for your health coverage for the final months of the year, which may or may not be possible depending on your circumstances.Talk with a financial advisor to see if they have any suggestions that might ease your tax burden next spring.If you feel strongly about this, you can follow Keller’s lead and reach out to your members of Congress, asking them to take action to address this situation with a one-time COVID-specific adjustment to the way that APTC is reconciled on tax returns. Louise Norris is an individual health insurance broker who has been writing about health insurance and health reform since 2006. She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org. Her state health exchange updates are regularly cited by media who cover health reform and by other health insurance experts..

Q. How could Covid-19 financial relief affect my income taxes for 2020?. A. The COVID pandemic has caused widespread economic distress across the United States, with the stress of job loss compounded in many cases by the loss of employer-sponsored health coverage.Fortunately, the CARES Act and subsequent government regulations have provided many Americans with additional unemployment benefits that would not normally have been available.

And the Affordable Care Act ensured that Americans losing their health coverage would be able to transition to an individual-market health plan, regardless of their medical history. It also made Medicaid available – in most states – to people whose monthly income fell to no more than 138 percent of the federal poverty level. (For a single person, that’s about $1,467 in monthly income.)But there are still 13 states where there’s a coverage gap for people who earn less than the poverty level, due to those states’ refusal to accept federal funding to expand Medicaid. And there are pitfalls that go along with premium subsidies for individual-market health coverage – some of which people might not fully understand until they file their 2020 taxes next spring, and some of which are related to the benefits provided by the CARES Act.The basics of Covid-19 financial reliefFirst, the basics of the financial assistance and how it’s counted in terms of your income.

Covid-19 financial relief and your income taxes for 2020So what does all of that mean in terms of the 2020 tax return that you’ll be filing next spring?. It will depend on your specific income, but some people who received advance premium tax credits (APTC) to offset the cost of health coverage in 2020 might end up having to repay some or all of that money to the IRS when they file their 2020 taxes.Dave Keller, President of My1HR, is appealing to Congress to change the rules so that the additional COVID-related federal unemployment benefits would not be counted as part of a person’s ACA-specific MAGI. Keller notes that “while the APTC has enabled many people to enroll in an ACA plan at little or no cost to them, they may be staring at a large tax consequence when they file their 2020 taxes next year, at a time that they can least afford it.”If Congress moved to exempt that federal relief, it would remove a potential tax burden for Americans already facing financial strain during this pandemic. Will the COVID-related financial assistance affect my 2020 health insurance subsidy?.

Absent additional Congressional action, most of this is water under the bridge at this point. But here’s what you need to know in order to avoid surprises on your tax return:If you were eligible for Medicaid at some point this year based on your monthly income, that will not have any effect on your 2020 tax return. Medicaid does not get reconciled with the IRS.If you are in one of the 13 states where there’s still a coverage gap (plus Nebraska prior to October 2020, when there was still a coverage gap there), the additional federal unemployment benefits might have been enough to push your total projected income above the poverty level, making you eligible for premium subsidies in the exchange. Even if your income ultimately ends up below the poverty level when all is said and done, you won’t have to repay the APTC that was paid on your behalf when you file your taxes.But on the higher end of the scale, if the additional federal benefits push your total ACA-specific MAGI higher than you originally projected but not above 400 percent of the poverty level, you’ll have to pay back some or all of the APTC, although there are caps that apply to the repayment amounts in that case.And unfortunately, if the additional federal benefits push your MAGI for 2020 above 400 percent of the poverty level, you will have to repay all of the APTC that was paid on your behalf this year.This last point is the most pressing concern, as it can amount to thousands of dollars being owed to the IRS, depending on where you live, how old you are, and how many months APTC was paid on your behalf for a plan purchased in the exchange (APTC is larger in areas where coverage is more expensive, and it’s larger for older people since their pre-subsidy premiums are higher).People are often caught off guard by the fact that the APTC reconciliation process uses the entire year’s income — not just income during the time you were enrolled in a plan through the exchange.

So it’s not just the enhanced federal unemployment benefits and Lost Wage Assistance benefits that could cause a snag here. It’s also income that a person earns later in the year, after having a plan through the exchange for only part of the year.This could present a problem for people who enrolled in an exchange plan with APTC in the spring of 2020 (after losing an employer’s plan due to the pandemic), and then transition back to full-time work later in the year. If their total income for the year — including money they earned prior to their transition to an individual market health plan as well as unemployment benefits and any money they earn later in the year — goes above 400 percent of the poverty level, they’ll have to repay all of the APTC that was paid on their behalf during the months they had self-purchased health coverage.What can I do to avoid a surprise at tax time?. If you’re facing the possibility of having to repay some or all of your APTC, there are a few things to keep in mind:Contributions to pre-tax retirement accounts and health savings accounts will reduce your ACA-specific MAGI.In order to contribute to a health savings account (HSA), you need to have an HSA-qualified high-deductible health plan (HDHP).You can make the full year’s contribution to an HSA even if you only have HSA-qualified coverage in place during the last month of the year, as long as you then continue to maintain HSA-qualified coverage for all of the following year.If you’re returning to full-time work and are eligible to participate in your employer’s health plan, you might want to check to see whether they offer an HDHP and whether it would be worth your while to enroll in it and contribute to the HSA.

(Definitely check with a financial advisor to see if this is the best overall strategy, as it’s a decision that should only be made with your full financial situation in mind.)If you’re still enrolled in a plan through the exchange and are realizing that you’re going to have to repay your APTC because your total MAGI is going to be higher than you had projected, you can contact the exchange and have them adjust your APTC so that it’s no longer paid for the final months of the year. This will reduce the amount you’ll have to repay to the IRS, but that also means you’ll have to pay full price for your health coverage for the final months of the year, which may or may not be possible depending on your circumstances.Talk with a financial advisor to see if they have any suggestions that might ease your tax burden next spring.If you feel strongly about this, you can follow Keller’s lead and reach out to your members of Congress, asking them to take action to address this situation with a one-time COVID-specific adjustment to the way that APTC is reconciled on tax returns. Louise Norris is an individual health insurance broker who has been writing about health insurance and health reform since 2006. She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org.

Her state health exchange updates are regularly cited by media who cover health reform and by other health insurance experts..