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Sign up get lasix prescription for lasix 40mg cost our newsletter Full-page version of the map. hypertension medications continued its record-breaking spread in rural counties last week, climbing by more than lasix 40mg cost 16% over the previous week and placing six out of every 10 rural counties on the red-zone list. Just over 71,000 rural Americans tested positive for the novel hypertension last week, October 4-10, according to a Daily Yonder analysis based on data from USA Facts. The previous week’s revised total was lasix 40mg cost 60,883 new cases. An additional lasix 40mg cost 140 rural counties were placed on the red-zone list last week.

The red zone is a term used by the White House hypertension Task Force to identify counties where the lasix is out of control and where local governments should consider additional measures to contain the spread of the lasix. Red-zone localities have an rate of 100 or more new cases per 100,000 population (1 or more cases lasix 40mg cost per 1,000 residents). Sixty-one percent of the lasix 40mg cost nation’s rural counties are on the red-zone list (1,198 of 1,976 counties). In metropolitan America, about 47% of counties are on the red-zone list (538 of 1,115). Midwest The Upper Midwest continued to be the hardest hit region in lasix 40mg cost the nation, with states such as North and South Dakota, Iowa, Minnesota, Wisconsin, and Iowa having all but a few of counties (both urban and rural) on the red-zone list.

(See the chart below for a list of states ranked by the percentage of their rural counties that are in the red zone.)Kansas, Nebraska, Oklahoma, and Arkansas also had high numbers of rural red-zone counties.Missouri added 12 counties to the red-zone list last week, putting 74 of 81 of its rural counties (88%) on the red-zone list.Illinois added four rural red-zone counties last week and had over 80% of its 62 rural counties on the list.Indiana added nine rural counties to the red-zone list last week, bringing its total to 30 of 48 (63%).Ohio added six rural red-zone counties, and Michigan added nine. But red-zone counties remained lasix 40mg cost a small percentage of all rural counties in those states compared to other parts of the U.S. South Although the South is doing better than it did this summer, trouble spots remain.Tennessee had 94% of its rural counties (50 of 53) on lasix 40mg cost the red-zone list. Statewide, 90 of 95 counties (both metro and nonmetro) were on the list.North Carolina has seen a resurgence of red-zone counties. The state added five rural counties to the red zone last week, after adding 31 in the preceding two weeks, bringing its total to 40 out of 54 rural counties.Mississippi gained seven lasix 40mg cost rural red-zone counties last week after dropping one the week before.

Nearly three quarters of the state’s 65 rural counties are on the red-zone list.Kentucky lasix 40mg cost added 10 rural counties to the red zone, after adding 12 the week before, bringing its total red-zone list to 53 of its 81 rural counties.Florida had 16 of 23 rural counties on the red-zone list, an increase of five counties from the previous week.For the first time in months, Georgia had less than half of its 85 rural counties on the red-zone list. A net of seven counties dropped off the list last week.Texas added the most rural counties to the red zone list last week – 15. But only about a third of the state’s 172 rural counties lasix 40mg cost were on the list.Louisiana dropped 10 counties from its rural red-zone list, the largest decrease of any state last week. Northeast The Northeast continued to have fewer rural red-zone counties than any other region.Pennsylvania added five rural counties to the red-zone list, but less than a quarter lasix 40mg cost of the state’s 26 rural counties were on the list.Connecticut, Maine, Maryland, Massachusetts, New Hampshire, and Vermont had no rural red-zone counties.New York had two of 24 rural counties on the red-zone list. West The northern Rockies and Intermountain region were the hardest hit in the West.After adding 20 rural red-zone counties two weeks ago, Montana added eight more last week, putting 42 of its 51 rural counties (82%) on the listIdaho had three-fourths of its 32 rural counties in the red zone.Wyoming had two-thirds of its 21 rural counties in the red-zone.Utah had 10 of 19 rural counties in the red zone.New Mexico added five rural red-zone counties last week to bring its total to 10 out of 26 rural counties.Arizona’s rural red-zone total remained steady at three of seven counties.California, Oregon, and Washington clustered near the bottom of the list in the percentage of their rural counties that were on the red-zone list.

National Numbers Fifty-eight rural counties had no new cases of hypertension last week.Just under 600 rural counties had fewer cases last week than the week before.And 1,036 or about half of all rural counties saw increased rates of s last week.The remaining 290 rural counties had about the same number of cases for lasix 40mg cost the past two weeks. Deaths The number of hypertension medications-related deaths in rural America last week rose only marginally, from 1,127 two weeks ago to 1,133 last week.About two thirds of the nation’s rural counties did not have a hypertension medications-related death last week.The largest number of deaths in a rural county last week was 11 in Bath County, New York. Maverick County, Texas, and Lawrence County, Missouri, each had 10 deaths.McHenry County, North Dakota, had the highest rate of death (104 per lasix 40mg cost 100,000) among rural counties. McHenry has 5,745 residents and lasix 40mg cost is located in north central North Dakota. Eight people died there from hypertension medications-related causes last week, according to US Facts data.

The Dickinson Press of Dickinson, North Dakota, says the state is on track for its deadliest month of lasix 40mg cost the lasix. CORRECTION lasix 40mg cost. An earlier version of this article mistakenly said McHenry County, North Dakota, was in South Dakota. We’re sorry for the error. You Might Also Like.

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Latest Healthy Kids News By Alan Mozes how long before lasix works HealthDay http://cassiausa.com/how-can-i-buy-lasix ReporterTUESDAY, Nov. 24, 2020 (HealthDay News)Small, powerful magnets in toys like Buckyballs building sets and jewelry kits are causing an alarming number of serious pediatric injuries in the United States, new research warns.Analyzing national data, researchers found an 80% rise in these injuries to children from 2016 to 2019, following the repeal of a sales ban on the magnets by a federal court.When these small rare earth magnets are swallowed, the potential for serious gastrointestinal injury is high, noted how long before lasix works study lead author Dr. Michael Flaherty.Cases are popping up all over the United States, according to a recent report from NBC News. In Indiana, a 4-year-old boy was rushed to surgery after swallowing how long before lasix works 27 magnetized balls.

One 2-year-old girl in Illinois needed her appendix removed in December how long before lasix works after swallowing five of the balls. And in 2018, a Wisconsin 4-year-old needed part of his colon, intestine and appendix removed after swallowing 13 magnetic balls, the network reported.More recently, 6-year-old Cameron Moreau, of New Jersey, landed in the hospital with eight perforations to his colon after swallowing magnets from a toy he got for his birthday. Two of the holes were so close together surgeons had to remove a portion of the colon, NBC News said.The magnets are made of neodymium, said Flaherty, a pediatric critical care physician at MassGeneral Hospital for Children in Boston.The magnets come in circular, rectangular, cylindrical or cubed form, and range from BB-pellet size to roughly 0.10 to 0.25 inches (3 to 6 mm).They're also "five to 10 times more powerful than traditional ferrite magnets," said Flaherty, "and were initially intended for commercial applications."But over time they've come to be included in a wide variety of "entertainment products," Flaherty how long before lasix works noted. "Many products now carry warnings to keep away from children, but the small size of the magnets and their inclusion in sets composed of many small magnets make them easily accessible to young children, even if purchased by an adult."The harm can be considerable when a child ingests how long before lasix works two of these magnets, or a magnet with another metal object, Flaherty explained.

"This can lead to bowel walls becoming attached and kinked, leading to catastrophic bowel injury and/or death," he said.In 2012, the U.S. Consumer Product Safety Commission (CPSC) took steps to limit their how long before lasix works sale with voluntary recalls and safety standards. That effort culminated with a how long before lasix works prohibition in 2014. But in 2016 a federal court determined that the commission had overstepped its bounds, and the ban was overturned.For this study, Flaherty and his colleagues reviewed almost 37,000 emergency department visits that took place between 2009 and 2019 by kids under 18 years of age who had swallowed an object.

Data was compiled how long before lasix works from the U.S. National Electronic Injury Surveillance System.Just over 1,400 of the visits involved magnet ingestion or inhalation, with about 850 occurring in children younger than 6 years of age. (All magnet how long before lasix works ingestions were included. Rare earth magnets could not be separated out.)The investigators found that between 2012 and 2016 -- when protection efforts were underway -- pediatric emergency department visits stemming from magnet ingestions dropped significantly (from 3.58 per 100,000 persons how long before lasix works to 2.83 per 100,000).

But from 2016 to 2019 -- after the protections were thrown out of court -- magnet ingestions jumped to 5.16 per 100,000, an increase of more than 80%."Products with [small rare earth magnets] really should not be in any home with children under 14," Flaherty said. "The significant reduction in how long before lasix works ER visits associated with the CPSC's initial ban indicate that further federal action is necessary, and that industry standards should be revisited."His advice. "As the holiday season approaches, product-related hazards such as these magnets become even more of how long before lasix works an important issue. Parents should always read labels carefully before buying any toys or sets for their children or home, to ensure they are age appropriate.

And consult the CPSC website to check on recent toy recalls."Parents must be vigilant, another expert agreed."The problem is that a small child is a natural detective, how long before lasix works always discovering and looking at things," said Anthony Green, chief advocacy and network officer for Safe Kids Worldwide in Washington, D.C."And the tools of investigation for a child are their fingers and their mouth," Green said. "It can be button batteries, liquid laundry packets, medications that look like candy, or how long before lasix works rare earth magnets. And that issue has been aggravated by hypertension medications, where everyone's at home and parents are trying to juggle both caregiving and work."In the absence of a ban, Safe Kids is trying to promote awareness of the issue, he said. Meanwhile, Green added, "what a parent can and should do is really survey their house, and identify where children how long before lasix works go in the house, to look for dangers that could expose a child to these magnets and serious injury."The study was published in the Nov.

24 issue of the Journal of the American Medical Association.More informationThere's more on magnet safety at the U.S. Consumer Product Safety Commission.SOURCES how long before lasix works. Michael R how long before lasix works. Flaherty, DO, pediatric critical care physician, division of pediatric critical care medicine, MassGeneral Hospital for Children, Boston.

Anthony Green, chief advocacy how long before lasix works and network officer, Safe Kids Worldwide, Washington, D.C.. NBC News how long before lasix works. Journal of the American Medical Association, Nov. 24, 2020Copyright © 2020 how long before lasix works HealthDay.

All rights how long before lasix works reserved. SLIDESHOW 8 First Aid Kit Essentials for Scrapes, Cuts, Bug Bites, and More in Pictures See SlideshowLatest Cancer News WEDNESDAY, Nov. 25, 2020 (HealthDay News)Colon cancer treatment for low-income Americans has improved with Medicaid expansion under the Affordable Care Act, a new study says.That includes earlier diagnosis, increased access to treatment how long before lasix works and better surgical care, according to the researchers.They compared data for more than 4,400 patients in 19 states that expanded Medicaid in January 2014 and more than 6,000 patients in 19 states that didn't expand Medicaid.A comparison of data for 2011-2012 and 2015-2016 found no significant differences in outcomes after colon cancer surgery between expansion and non-expansion states. Those measures included length of hospital stay, readmission rates and deaths.However, there were differences in how soon patients with stage 1 to 3 colon cancer received treatment.In non-expansion states, time until treatment (primarily with surgery) increased, and the percentage of patients treated in less than 30 days dropped.

This didn't occur in expansion states.Researchers also how long before lasix works found that a larger number of patients in expansion states were treated at integrated network cancer programs accredited by the Commission on Cancer of the American College of Surgeons. Research on other cancer types suggests that patients in these programs have better survival rates.Patients in expansion states traveled farther for care, suggesting that coverage allowed those who lived greater distances from hospitals to get care, researchers said.Patients in expansion states who had end-stage colon cancer were more likely to receive palliative care services that can improve quality of life, the study found.Among patients who had surgery for their colon cancer, those in expansion states were more likely to have minimally invasive and non-urgent operations, how long before lasix works possibly due to earlier diagnosis, according to study lead author Dr. Richard Hoehn, a surgical oncology fellow at the University of Pittsburgh Medical Center (UPMC).The study was published Nov. 23 online in the Journal of the American College of Surgeons."Studies like ours how long before lasix works are building an increasing body of work that suggests the Affordable Care Act and Medicaid expansion are improving health care access and treatment for cancer patients," Hoehn said in a journal news release.The findings indicate that Medicaid expansion has made it possible for more previously uninsured people to see a primary care physician and get screened for colon cancer, according to study senior investigator Dr.

Samer Tohme, a surgical oncologist at UPMC."Studies show that patients who are diagnosed with cancer at an earlier stage are more likely to have better treatment options, improved quality of care, and longer survival," Tohme said in the release.More informationFor more on colon cancer, see the how long before lasix works U.S. National Cancer Institute.SOURCE. Journal of the American how long before lasix works College of Surgeons, news release, Nov. 23, 2020Robert how long before lasix works PreidtCopyright © 2020 HealthDay.

All rights reserved. IMAGES Colon Cancer Illustration Browse through our medical how long before lasix works image collection to see illustrations of human anatomy and physiology See ImagesLatest hypertension News By Ernie Mundell HealthDay ReporterWEDNESDAY, Nov 25, 2020The turnaround time -- from the emergence of the new hypertension to the advent of multiple treatments to prevent it -- has been nothing short of "breathtaking," said Dr. Anthony Fauci, the nation's leading expert on infectious disease.Still, many Americans are still uncertain about getting a hypertension medications shot.[embedded content]Speaking on Thursday with HD Live!. , Fauci said "it's understandable that people might be concerned when there's something new that's put in front of them." Especially when initial projections had the approval of the first hypertension medications treatment taking at least 18 months.But that was then, he said."People need to understand that the speed how long before lasix works of [treatment development] is a reflection of the extraordinarily exquisite — breathtaking in some respects — advances in science which are allowing us to do things in weeks to months that formerly took years," Fauci explained.

"Without compromising safety and without compromising scientific integrity."Currently, pharmaceutical companies how long before lasix works Pfizer, Moderna and AstraZeneca have all presented trial data on their respective treatment candidates that shows each to be highly effective and safe.In trials involving tens of thousands of volunteers, treatments from the first two companies have demonstrated about 95% effectiveness in preventing — a rate that exceeded most experts' expectations. The AstraZeneca treatment has shown an effectiveness of between 70% to 90%, depending on the regimen used.'Umbrella of protection'Despite this good news, poll after poll shows many Americans still distrustful of any treatment developed in so short a time.One CNN poll, taken early last month, found just 51% of Americans saying they'd get a hypertension medications treatment should one arrive.That's disheartening, since it would take "somewhere between 75% and 80% of the people to get vaccinated in order to get a real umbrella of protection over the community — the 'community' being the United States of America," Fauci said. "When you get that much protection, the lasix how long before lasix works really has no place to go."Fauci, who directs the U.S. National Institute of Allergy and Infectious Diseases, believes many Americans may simply be unaware of the rigorous science involved in how long before lasix works vetting a treatment."Perhaps because of the divisiveness in our society, and mixed signals that we might get from Washington," many people still worry about oversight, he said.Those worries are unfounded, Fauci stressed.

That's because the process of treatment approval has always been kept separate from either the pressures of politicians or the financial incentives of industry."There are so many levels of independence and transparency there that people should feel confident — I do — that the treatment is determined to be safe and effective," he said.'Crushing the outbreak'First and foremost, he said, Americans need to know that the results of clinical trials into a candidate treatment are scrutinized by career scientists placed on longstanding committees at both the U.S. Centers for Disease how long before lasix works Control and Prevention and the U.S. Food and Drug Administration.At that point, the treatment maker "is not involved in this — you separate them so that the Data and Safety Monitoring how long before lasix works Board does [its review] independently," Fauci said.Only after committees from both the FDA and CDC confer and agree on the data would FDA officials decide that "'we're going to do an EUA' — we are going to have an Emergency Use Authorization," Fauci explained.As soon as that EUA is issued, another independent expert committee — this time at the CDC — "makes a determination of how you are going to distribute the treatment," he added.The final and perhaps most crucial step. Convincing hundreds of millions of Americans, and billions elsewhere around the world, to get immunized against hypertension medications.How soon might that process begin?.

"We know that we are going to start getting doses of treatment towards the middle and end how long before lasix works of December to the higher-risk groups," Fauci said. "As we get into the first quarter of 2021, January, February, March, more and more people will get vaccinated.""Hopefully that can get done worldwide so that we globally crush this outbreak," Fauci said. SLIDESHOW Whooping Cough (Pertussis) Symptoms, treatment Facts See Slideshow He said that when his turn comes, how long before lasix works "I will take the treatment. And I certainly will advise my family and friends when their turn comes, to take the treatment."More informationFind out more how long before lasix works about the search for a hypertension treatment at the CDC.SOURCE.

HD Live!. interview with Anthony how long before lasix works Fauci, MD, Nov. 24, 2020Copyright © 2020 how long before lasix works HealthDay. All rights reserved.

From Parenting Resources Featured Centers Health Solutions From Our SponsorsLatest Asthma News By Amy Norton how long before lasix works HealthDay ReporterTUESDAY, Nov. 24, 2020 (HealthDay News)Women with asthma may suffer fewer severe symptom attacks if they are on birth control pills, a large new study suggests.The study of more than 83,000 women with asthma how long before lasix works found that those who used birth control pills for at least three years tended to have fewer severe flare-ups.The difference between pill users and non-users was small, and the findings do not prove a cause-and-effect relationship, the researchers stressed.However, there's reason to believe birth control pills could affect asthma symptoms, according to study author Bright Nwaru.For one, it's known that some women with asthma see their symptoms flare at certain points in the menstrual cycle. Fluctuating hormone levels are suspected to be the reason, explained Nwaru, of the University of Gothenburg in Sweden."Anecdotal evidence suggests that some women with menstrual-related asthma appear to get relief by taking hormonal contraceptives," he said.But, Nwaru added, studies on the question have come to conflicting results.This latest study, published online Nov. 23 in how long before lasix works the journal Thorax, is the "most robust" to date, according to Nwaru.

It followed a large group of women over 17 years and found what could be a "small" protective effect of birth control pills, he said.No one, however, is suggesting women try the pill to manage asthma."This is just a link -- so it's not enough [evidence] to use the pill as a treatment," said Dr. Purvi Parikh, a national spokeswoman for the Allergy and Asthma Network.According to Parikh, there are various lines of evidence that the body's how long before lasix works sex hormones (like estrogen) affect asthma. Before puberty, boys are more likely to develop asthma than girls are, how long before lasix works but after puberty, the reverse is true. Boys also outgrow asthma more often, which all results in asthma being more common in women than men.Pregnancy plays a role, too.

One-third of pregnant women with asthma see their symptoms improve, while just as many have a worsening, said Parikh, who is also a clinical assistant professor at NYU Grossman School of Medicine in New York City.Why how long before lasix works would hormones matter?. Parikh said hormonal fluctuations can affect immune system cells called mast cells, which are involved in allergic reactions and asthma.To Parikh, it's how long before lasix works important for doctors and patients to be aware that hormones can affect asthma control. But the evidence does not support using hormones as treatment, she said.The current study included 83,084 women aged 16 to 45 who had asthma. At the outset, one-third were using oral how long before lasix works contraceptives.

Nwaru's team used hospital and how long before lasix works prescription records to track how the women fared over 17 years.In general, the investigators found, women on combined birth control pills (containing estrogen/progestin) were slightly less likely to have severe asthma attacks. "Severe" meant symptoms bad enough to require an ER visit or hospital admission, or treatment with oral corticosteroids.Longer-term pill use seemed more protective. Women who'd used birth control pills for at least three years were 6% to 9% less likely to have how long before lasix works a severe asthma attack, compared to non-users.It's only a small effect, Nwaru said, and more studies are needed to confirm the link.Like Parikh, he did not see the study as support for using the pill as an asthma treatment.Instead, Nwaru said, researchers should try to better understand the "biological processes" through which hormonal contraceptives affect asthma. QUESTION Asthma is a chronic respiratory disease.

See Answer For now, how long before lasix works Parikh encouraged women to talk to their doctor if their asthma symptoms are not well-controlled."Often women are caregivers and put their own health on the back burner to take care of others," she said. "So if you're waking up at night with asthma symptoms, easily winded from doing household chores or playing with kids, or using how long before lasix works your albuterol more than two times per week -- these are signs your asthma is not controlled and you should see a specialist."More informationThe U.S. Office on Women's Health has more on asthma in women.SOURCES. Bright Nwaru, PhD, associate senior lecturer, molecular how long before lasix works medicine, Krefting Research Center, University of Gothenburg, Sweden.

Purvi Parikh, how long before lasix works MD, national spokeswoman, Allergy and Asthma Network, Vienna, Va., and clinical assistant professor, medicine and pediatrics, NYU Grossman School of Medicine, New York City. Thorax, Nov. 23, 2020, onlineCopyright © how long before lasix works 2020 HealthDay. All rights how long before lasix works reserved.

From Asthma and Allergy Resources Featured Centers Health Solutions From Our SponsorsLatest hypertension News WEDNESDAY, Nov. 18, 2020 (HealthDay News) -- A mutation that developed in the new hypertension early in the lasix may have made it more infectious, a number of new findings suggest.First detected in eastern China in January, the mutation, called 614G, took over much of the world within months, displacing other variants, The New York Times reported.There's been ongoing debate about whether the mutation made the hypertension more infectious.But a growing body of research suggests that this variant does infect people more easily than the original variant that emerged in Wuhan, China, the Times reported.Copyright © 2020 HealthDay. All rights reserved..

Latest Healthy Kids News By Alan Mozes HealthDay ReporterTUESDAY, lasix 40mg cost Nov. 24, 2020 (HealthDay News)Small, powerful magnets in toys like Buckyballs building sets and jewelry kits are causing an alarming number of serious pediatric injuries in the United States, new research warns.Analyzing national data, researchers found an 80% rise in these injuries to children from 2016 to 2019, following the repeal of a sales ban on the magnets by a federal court.When these small rare earth magnets are swallowed, the potential for lasix 40mg cost serious gastrointestinal injury is high, noted study lead author Dr. Michael Flaherty.Cases are popping up all over the United States, according to a recent report from NBC News. In Indiana, a 4-year-old lasix 40mg cost boy was rushed to surgery after swallowing 27 magnetized balls. One 2-year-old lasix 40mg cost girl in Illinois needed her appendix removed in December after swallowing five of the balls.

And in 2018, a Wisconsin 4-year-old needed part of his colon, intestine and appendix removed after swallowing 13 magnetic balls, the network reported.More recently, 6-year-old Cameron Moreau, of New Jersey, landed in the hospital with eight perforations to his colon after swallowing magnets from a toy he got for his birthday. Two of the holes were so close together surgeons had to remove a portion of the colon, NBC News said.The magnets are made of neodymium, said Flaherty, a pediatric critical care physician at MassGeneral Hospital for Children in Boston.The magnets come in circular, rectangular, cylindrical or cubed form, and range from BB-pellet size to roughly 0.10 to 0.25 inches (3 to 6 mm).They're also "five to 10 times more powerful than traditional ferrite magnets," lasix 40mg cost said Flaherty, "and were initially intended for commercial applications."But over time they've come to be included in a wide variety of "entertainment products," Flaherty noted. "Many products now carry warnings to keep away from children, but the small size of the magnets and their inclusion in sets composed of many small magnets make them easily accessible to young children, even if purchased by lasix 40mg cost an adult."The harm can be considerable when a child ingests two of these magnets, or a magnet with another metal object, Flaherty explained. "This can lead to bowel walls becoming attached and kinked, leading to catastrophic bowel injury and/or death," he said.In 2012, the U.S. Consumer Product Safety Commission (CPSC) took steps to limit their sale with voluntary lasix 40mg cost recalls and safety standards.

That effort culminated with lasix 40mg cost a prohibition in 2014. But in 2016 a federal court determined that the commission had overstepped its bounds, and the ban was overturned.For this study, Flaherty and his colleagues reviewed almost 37,000 emergency department visits that took place between 2009 and 2019 by kids under 18 years of age who had swallowed an object. Data was lasix 40mg cost compiled from the U.S. National Electronic Injury Surveillance System.Just over 1,400 of the visits involved magnet ingestion or inhalation, with about 850 occurring in children younger than 6 years of age. (All magnet ingestions were lasix 40mg cost included.

Rare earth magnets could not be separated out.)The investigators found lasix 40mg cost that between 2012 and 2016 -- when protection efforts were underway -- pediatric emergency department visits stemming from magnet ingestions dropped significantly (from 3.58 per 100,000 persons to 2.83 per 100,000). But from 2016 to 2019 -- after the protections were thrown out of court -- magnet ingestions jumped to 5.16 per 100,000, an increase of more than 80%."Products with [small rare earth magnets] really should not be in any home with children under 14," Flaherty said. "The significant lasix 40mg cost reduction in ER visits associated with the CPSC's initial ban indicate that further federal action is necessary, and that industry standards should be revisited."His advice. "As the holiday season approaches, product-related lasix 40mg cost hazards such as these magnets become even more of an important issue. Parents should always read labels carefully before buying any toys or sets for their children or home, to ensure they are age appropriate.

And consult the CPSC website to check on recent toy recalls."Parents must be lasix 40mg cost vigilant, another expert agreed."The problem is that a small child is a natural detective, always discovering and looking at things," said Anthony Green, chief advocacy and network officer for Safe Kids Worldwide in Washington, D.C."And the tools of investigation for a child are their fingers and their mouth," Green said. "It can be button batteries, liquid laundry lasix 40mg cost packets, medications that look like candy, or rare earth magnets. And that issue has been aggravated by hypertension medications, where everyone's at home and parents are trying to juggle both caregiving and work."In the absence of a ban, Safe Kids is trying to promote awareness of the issue, he said. Meanwhile, Green added, "what a parent can and should do is really lasix 40mg cost survey their house, and identify where children go in the house, to look for dangers that could expose a child to these magnets and serious injury."The study was published in the Nov. 24 issue of the Journal of the American Medical Association.More informationThere's more on magnet safety at the U.S.

Consumer Product lasix 40mg cost Safety Commission.SOURCES. Michael R lasix 40mg cost. Flaherty, DO, pediatric critical care physician, division of pediatric critical care medicine, MassGeneral Hospital for Children, Boston. Anthony Green, chief advocacy and network lasix 40mg cost officer, Safe Kids Worldwide, Washington, D.C.. NBC News lasix 40mg cost.

Journal of the American Medical Association, Nov. 24, 2020Copyright © 2020 HealthDay lasix 40mg cost. All rights lasix 40mg cost reserved. SLIDESHOW 8 First Aid Kit Essentials for Scrapes, Cuts, Bug Bites, and More in Pictures See SlideshowLatest Cancer News WEDNESDAY, Nov. 25, 2020 (HealthDay News)Colon cancer treatment lasix 40mg cost for low-income Americans has improved with Medicaid expansion under the Affordable Care Act, a new study says.That includes earlier diagnosis, increased access to treatment and better surgical care, according to the researchers.They compared data for more than 4,400 patients in 19 states that expanded Medicaid in January 2014 and more than 6,000 patients in 19 states that didn't expand Medicaid.A comparison of data for 2011-2012 and 2015-2016 found no significant differences in outcomes after colon cancer surgery between expansion and non-expansion states.

Those measures included length of hospital stay, readmission rates and deaths.However, there were differences in how soon patients with stage 1 to 3 colon cancer received treatment.In non-expansion states, time until treatment (primarily with surgery) increased, and the percentage of patients treated in less than 30 days dropped. This didn't occur in expansion states.Researchers also found that a larger number of patients in expansion states were treated lasix 40mg cost at integrated network cancer programs accredited by the Commission on Cancer of the American College of Surgeons. Research on other cancer types suggests that patients in these programs have better survival rates.Patients in expansion states traveled farther for care, suggesting that coverage allowed those who lived greater distances from hospitals to get care, researchers said.Patients in expansion states who had end-stage colon cancer were more likely to receive palliative care services that can improve quality of life, the study found.Among patients who had surgery for their colon cancer, those in expansion states were more lasix 40mg cost likely to have minimally invasive and non-urgent operations, possibly due to earlier diagnosis, according to study lead author Dr. Richard Hoehn, a surgical oncology fellow at the University of Pittsburgh Medical Center (UPMC).The study was published Nov. 23 online in the Journal of the American lasix 40mg cost College of Surgeons."Studies like ours are building an increasing body of work that suggests the Affordable Care Act and Medicaid expansion are improving health care access and treatment for cancer patients," Hoehn said in a journal news release.The findings indicate that Medicaid expansion has made it possible for more previously uninsured people to see a primary care physician and get screened for colon cancer, according to study senior investigator Dr.

Samer Tohme, a surgical oncologist at UPMC."Studies show that patients who are diagnosed with cancer at an earlier stage lasix 40mg cost are more likely to have better treatment options, improved quality of care, and longer survival," Tohme said in the release.More informationFor more on colon cancer, see the U.S. National Cancer Institute.SOURCE. Journal of the American College of lasix 40mg cost Surgeons, news release, Nov. 23, 2020Robert PreidtCopyright © lasix 40mg cost 2020 HealthDay. All rights reserved.

IMAGES Colon Cancer Illustration Browse through our medical image collection to see illustrations of human anatomy and physiology See ImagesLatest hypertension News By Ernie Mundell HealthDay ReporterWEDNESDAY, Nov 25, 2020The turnaround time -- from the emergence of the new lasix 40mg cost hypertension to the advent of multiple treatments to prevent it -- has been nothing short of "breathtaking," said Dr. Anthony Fauci, the nation's leading expert on infectious disease.Still, many Americans are still uncertain about getting a hypertension medications shot.[embedded content]Speaking on Thursday with HD Live!. , Fauci said "it's understandable that people might be concerned when there's something new that's put in front of them." Especially when initial projections had the approval of lasix 40mg cost the first hypertension medications treatment taking at least 18 months.But that was then, he said."People need to understand that the speed of [treatment development] is a reflection of the extraordinarily exquisite — breathtaking in some respects — advances in science which are allowing us to do things in weeks to months that formerly took years," Fauci explained. "Without compromising safety and without compromising scientific integrity."Currently, pharmaceutical companies Pfizer, Moderna and AstraZeneca have all presented trial data on their respective treatment candidates that shows each to be highly effective and safe.In trials involving tens of thousands of volunteers, treatments lasix 40mg cost from the first two companies have demonstrated about 95% effectiveness in preventing — a rate that exceeded most experts' expectations. The AstraZeneca treatment has shown an effectiveness of between 70% to 90%, depending on the regimen used.'Umbrella of protection'Despite this good news, poll after poll shows many Americans still distrustful of any treatment developed in so short a time.One CNN poll, taken early last month, found just 51% of Americans saying they'd get a hypertension medications treatment should one arrive.That's disheartening, since it would take "somewhere between 75% and 80% of the people to get vaccinated in order to get a real umbrella of protection over the community — the 'community' being the United States of America," Fauci said.

"When you get that much protection, the lasix 40mg cost lasix really has no place to go."Fauci, who directs the U.S. National Institute of Allergy and Infectious Diseases, believes many Americans may simply be unaware of the rigorous science involved in vetting a treatment."Perhaps lasix 40mg cost because of the divisiveness in our society, and mixed signals that we might get from Washington," many people still worry about oversight, he said.Those worries are unfounded, Fauci stressed. That's because the process of treatment approval has always been kept separate from either the pressures of politicians or the financial incentives of industry."There are so many levels of independence and transparency there that people should feel confident — I do — that the treatment is determined to be safe and effective," he said.'Crushing the outbreak'First and foremost, he said, Americans need to know that the results of clinical trials into a candidate treatment are scrutinized by career scientists placed on longstanding committees at both the U.S. Centers for Disease Control and Prevention lasix 40mg cost and the U.S. Food and Drug Administration.At that point, the treatment maker "is not involved in this — you separate them so that the Data and Safety Monitoring Board does [its review] independently," Fauci said.Only after committees from both the FDA and CDC confer and agree on the data would FDA officials decide that "'we're going to do an EUA' — we are going to lasix 40mg cost have an Emergency Use Authorization," Fauci explained.As soon as that EUA is issued, another independent expert committee — this time at the CDC — "makes a determination of how you are going to distribute the treatment," he added.The final and perhaps most crucial step.

Convincing hundreds of millions of Americans, and billions elsewhere around the world, to get immunized against hypertension medications.How soon might that process begin?. "We know that we are going to start getting doses of treatment lasix 40mg cost towards the middle and end of December to the higher-risk groups," Fauci said. "As we get into the first quarter of 2021, January, February, March, more and more people will get vaccinated.""Hopefully that can get done worldwide so that we globally crush this outbreak," Fauci said. SLIDESHOW Whooping Cough (Pertussis) Symptoms, treatment Facts See Slideshow He said lasix 40mg cost that when his turn comes, "I will take the treatment. And I certainly will advise my family and friends when their turn comes, to take the treatment."More informationFind out more about the search for lasix 40mg cost a hypertension treatment at the CDC.SOURCE.

HD Live!. interview with Anthony Fauci, MD, lasix 40mg cost Nov. 24, 2020Copyright © 2020 HealthDay lasix 40mg cost. All rights reserved. From Parenting lasix 40mg cost Resources Featured Centers Health Solutions From Our SponsorsLatest Asthma News By Amy Norton HealthDay ReporterTUESDAY, Nov.

24, 2020 (HealthDay News)Women with asthma may suffer fewer severe symptom attacks if they are on birth control pills, a large new study suggests.The study of more than 83,000 women with asthma found that those who used birth control pills for at least three years tended to have fewer severe flare-ups.The difference between pill users and non-users was small, and the findings do not prove a cause-and-effect relationship, the researchers stressed.However, there's reason to believe birth control pills could affect asthma symptoms, according to study author Bright Nwaru.For one, it's known that some women with asthma see their symptoms lasix 40mg cost flare at certain points in the menstrual cycle. Fluctuating hormone levels are suspected to be the reason, explained Nwaru, of the University of Gothenburg in Sweden."Anecdotal evidence suggests that some women with menstrual-related asthma appear to get relief by taking hormonal contraceptives," he said.But, Nwaru added, studies on the question have come to conflicting results.This latest study, published online Nov. 23 in the journal lasix 40mg cost Thorax, is the "most robust" to date, according to Nwaru. It followed a large group of women over 17 years and found what could be a "small" protective effect of birth control pills, he said.No one, however, is suggesting women try the pill to manage asthma."This is just a link -- so it's not enough [evidence] to use the pill as a treatment," said Dr. Purvi Parikh, a national spokeswoman for the Allergy and Asthma Network.According to Parikh, there lasix 40mg cost are various lines of evidence that the body's sex hormones (like estrogen) affect asthma.

Before puberty, boys are more likely to develop asthma than lasix 40mg cost girls are, but after puberty, the reverse is true. Boys also outgrow asthma more often, which all results in asthma being more common in women than men.Pregnancy plays a role, too. One-third of pregnant women with asthma see their symptoms improve, while just as many have a worsening, said Parikh, who is also lasix 40mg cost a clinical assistant professor at NYU Grossman School of Medicine in New York City.Why would hormones matter?. Parikh said hormonal fluctuations can affect immune system cells called mast cells, which are involved in allergic reactions and asthma.To Parikh, it's important for lasix 40mg cost doctors and patients to be aware that hormones can affect asthma control. But the evidence does not support using hormones as treatment, she said.The current study included 83,084 women aged 16 to 45 who had asthma.

At the outset, lasix 40mg cost one-third were using oral contraceptives. Nwaru's team used hospital and prescription records to track how the women fared over 17 years.In general, the investigators found, women on combined birth control pills (containing estrogen/progestin) were slightly less likely to have severe asthma attacks lasix 40mg cost. "Severe" meant symptoms bad enough to require an ER visit or hospital admission, or treatment with oral corticosteroids.Longer-term pill use seemed more protective. Women who'd used birth control pills for at least three years were 6% to 9% less likely to have a severe asthma attack, compared to non-users.It's only a small effect, Nwaru said, and more studies are needed to confirm the link.Like Parikh, he did not see the study as support for using the pill as an asthma treatment.Instead, Nwaru said, researchers lasix 40mg cost should try to better understand the "biological processes" through which hormonal contraceptives affect asthma. QUESTION Asthma is a chronic respiratory disease.

See Answer For now, Parikh encouraged women to talk lasix 40mg cost to their doctor if their asthma symptoms are not well-controlled."Often women are caregivers and put their own health on the back burner to take care of others," she said. "So if you're waking up at night with lasix 40mg cost asthma symptoms, easily winded from doing household chores or playing with kids, or using your albuterol more than two times per week -- these are signs your asthma is not controlled and you should see a specialist."More informationThe U.S. Office on Women's Health has more on asthma in women.SOURCES. Bright Nwaru, PhD, associate senior lecturer, molecular medicine, Krefting Research Center, University of Gothenburg, lasix 40mg cost Sweden. Purvi Parikh, MD, national spokeswoman, Allergy and Asthma Network, Vienna, Va., and clinical assistant professor, medicine and pediatrics, NYU Grossman School lasix 40mg cost of Medicine, New York City.

Thorax, Nov. 23, 2020, onlineCopyright © 2020 HealthDay lasix 40mg cost. All rights reserved lasix 40mg cost. From Asthma and Allergy Resources Featured Centers Health Solutions From Our SponsorsLatest hypertension News WEDNESDAY, Nov. 18, 2020 (HealthDay News) -- A mutation that developed in the new hypertension early in the lasix lasix 40mg cost may have made it more infectious, a number of new findings suggest.First detected in eastern China in January, the mutation, called 614G, took over much of the world within months, displacing other variants, The New York Times reported.There's been ongoing debate about whether the mutation made the hypertension more infectious.But a growing body of research suggests that this variant does infect people more easily than the original variant that emerged in Wuhan, China, the Times reported.Copyright © 2020 HealthDay.

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Back Door to Extra Help with lasix 20mg tablet Part D MSPs Automatically Waive Late Enrollment Penalties for Part B - and allow enrollment in Part B year-round outside of the short Annual Enrollment Period No Medicaid Lien on Estate to Recover Payment of Expenses Paid by MSP you could look here Food Stamps/SNAP not reduced by Decreased Medical Expenses when Enroll in MSP - at least temporarily 5. Enrolling in an MSP - Automatic Enrollment &. Applications for People who Have Medicare What is Application Process?. 6 lasix 20mg tablet.

Enrolling in an MSP for People age 65+ who Do Not Qualify for Free Medicare Part A - the "Part A Buy-In Program" 7. What Happens After MSP Approved - How Part B Premium is Paid 8 Special Rules for QMBs - How Medicare Cost-Sharing Works 1. NO ASSET LIMIT! lasix 20mg tablet. Since April 1, 2008, none of the three MSP programs have resource limits in New York -- which means many Medicare beneficiaries who might not qualify for Medicaid because of excess resources can qualify for an MSP.

1.A. SUMMARY CHART OF MSP lasix 20mg tablet BENEFITS QMB SLIMB QI-1 Eligibility ASSET LIMIT NO LIMIT IN NEW YORK STATE INCOME LIMIT (2020) Single Couple Single Couple Single Couple $1,064 $1,437 $1,276 $1,724 $1,436 $1,940 Federal Poverty Level 100% FPL 100 – 120% FPL 120 – 135% FPL Benefits Pays Monthly Part B premium?. YES, and also Part A premium if did not have enough work quarters and meets citizenship requirement. See “Part A Buy-In” YES YES Pays Part A &.

B deductibles lasix 20mg tablet &. Co-insurance YES - with limitations NO NO Retroactive to Filing of Application?. Yes - Benefits begin the month after the month of the MSP application. 18 NYCRR §360-7.8(b)(5) Yes – Retroactive to 3rd lasix 20mg tablet month before month of application, if eligible in prior months Yes – may be retroactive to 3rd month before month of applica-tion, but only within the current calendar year.

(No retro for January application). See GIS 07 MA 027. Can Enroll in MSP and lasix 20mg tablet Medicaid at Same Time?. YES YES NO!.

Must choose between QI-1 and Medicaid. Cannot have both, not even lasix 20mg tablet Medicaid with a spend-down. 2. INCOME LIMITS and RULES Each of the three MSP programs has different income eligibility requirements and provides different benefits.

The lasix 20mg tablet income limits are tied to the Federal Poverty Level (FPL). 2019 FPL levels were released by NYS DOH in GIS 20 MA/02 - 2020 Federal Poverty Levels -- Attachment II and have been posted by Medicaid.gov and the National Council on Aging and are in the chart below. NOTE. There is usually a lag in time of several weeks, or even months, from January 1st of each year until the new FPLs are release, lasix 20mg tablet and then before the new MSP income limits are officially implemented.

During this lag period, local Medicaid offices should continue to use the previous year's FPLs AND count the person's Social Security benefit amount from the previous year - do NOT factor in the Social Security COLA (cost of living adjustment). Once the updated guidelines are released, districts will use the new FPLs and go ahead and factor in any COLA. See 2019 Fact Sheet on MSP in NYS by Medicare lasix 20mg tablet Rights Center ENGLISH SPANISH Income is determined by the same methodology as is used for determining in eligibility for SSI The rules for counting income for SSI-related (Aged 65+, Blind, or Disabled) Medicaid recipients, borrowed from the SSI program, apply to the MSP program, except for the new rules about counting household size for married couples. N.Y.

Soc. Serv. L. 367-a(3)(c)(2), NYS DOH 2000-ADM-7, 89-ADM-7 p.7.

Gross income is counted, although there are certain types of income that are disregarded. The most common income disregards, also known as deductions, include. (a) The first $20 of your &. Your spouse's monthly income, earned or unearned ($20 per couple max).

(b) SSI EARNED INCOME DISREGARDS. * The first $65 of monthly wages of you and your spouse, * One-half of the remaining monthly wages (after the $65 is deducted). * Other work incentives including PASS plans, impairment related work expenses (IRWEs), blind work expenses, etc. For information on these deductions, see The Medicaid Buy-In for Working People with Disabilities (MBI-WPD) and other guides in this article -- though written for the MBI-WPD, the work incentives apply to all Medicaid programs, including MSP, for people age 65+, disabled or blind.

(c) monthly cost of any health insurance premiums but NOT the Part B premium, since Medicaid will now pay this premium (may deduct Medigap supplemental policies, vision, dental, or long term care insurance premiums, and the Part D premium but only to the extent the premium exceeds the Extra Help benchmark amount) (d) Food stamps not counted. You can get a more comprehensive listing of the SSI-related income disregards on the Medicaid income disregards chart. As for all benefit programs based on financial need, it is usually advantageous to be considered a larger household, because the income limit is higher. The above chart shows that Households of TWO have a higher income limit than households of ONE.

The MSP programs use the same rules as Medicaid does for the Disabled, Aged and Blind (DAB) which are borrowed from the SSI program for Medicaid recipients in the “SSI-related category.” Under these rules, a household can be only ONE or TWO. 18 NYCRR 360-4.2. See DAB Household Size Chart. Married persons can sometimes be ONE or TWO depending on arcane rules, which can force a Medicare beneficiary to be limited to the income limit for ONE person even though his spouse who is under 65 and not disabled has no income, and is supported by the client applying for an MSP.

EXAMPLE. Bob's Social Security is $1300/month. He is age 67 and has Medicare. His wife, Nancy, is age 62 and is not disabled and does not work.

Under the old rule, Bob was not eligible for an MSP because his income was above the Income limit for One, even though it was well under the Couple limit. In 2010, NYS DOH modified its rules so that all married individuals will be considered a household size of TWO. DOH GIS 10 MA 10 Medicare Savings Program Household Size, June 4, 2010. This rule for household size is an exception to the rule applying SSI budgeting rules to the MSP program.

Under these rules, Bob is now eligible for an MSP. When is One Better than Two?. Of course, there may be couples where the non-applying spouse's income is too high, and disqualifies the applying spouse from an MSP. In such cases, "spousal refusal" may be used SSL 366.3(a).

(Link is to NYC HRA form, can be adapted for other counties). 3. The Three Medicare Savings Programs - what are they and how are they different?. 1.

Qualified Medicare Beneficiary (QMB). The QMB program provides the most comprehensive benefits. Available to those with incomes at or below 100% of the Federal Poverty Level (FPL), the QMB program covers virtually all Medicare cost-sharing obligations. Part B premiums, Part A premiums, if there are any, and any and all deductibles and co-insurance.

QMB coverage is not retroactive. The program’s benefits will begin the month after the month in which your client is found eligible. ** See special rules about cost-sharing for QMBs below - updated with new CMS directive issued January 2012 ** See NYC HRA QMB Recertification form ** Even if you do not have Part A automatically, because you did not have enough wages, you may be able to enroll in the Part A Buy-In Program, in which people eligible for QMB who do not otherwise have Medicare Part A may enroll, with Medicaid paying the Part A premium (Materials by the Medicare Rights Center). 2.

Specifiedl Low-Income Medicare Beneficiary (SLMB). For those with incomes between 100% and 120% FPL, the SLMB program will cover Part B premiums only. SLMB is retroactive, however, providing coverage for three months prior to the month of application, as long as your client was eligible during those months. 3.

Qualified Individual (QI-1). For those with incomes between 120% and 135% FPL, and not receiving Medicaid, the QI-1 program will cover Medicare Part B premiums only. QI-1 is also retroactive, providing coverage for three months prior to the month of application, as long as your client was eligible during those months. However, QI-1 retroactive coverage can only be provided within the current calendar year.

(GIS 07 MA 027) So if you apply in January, you get no retroactive coverage. Q-I-1 recipients would be eligible for Medicaid with a spend-down, but if they want the Part B premium paid, they must choose between enrolling in QI-1 or Medicaid. They cannot be in both. It is their choice.

DOH MRG p. 19. In contrast, one may receive Medicaid and either QMB or SLIMB. 4.

Four Special Benefits of MSPs (in addition to NO ASSET TEST). Benefit 1. Back Door to Medicare Part D "Extra Help" or Low Income Subsidy -- All MSP recipients are automatically enrolled in Extra Help, the subsidy that makes Part D affordable. They have no Part D deductible or doughnut hole, the premium is subsidized, and they pay very low copayments.

Once they are enrolled in Extra Help by virtue of enrollment in an MSP, they retain Extra Help for the entire calendar year, even if they lose MSP eligibility during that year. The "Full" Extra Help subsidy has the same income limit as QI-1 - 135% FPL. However, many people may be eligible for QI-1 but not Extra Help because QI-1 and the other MSPs have no asset limit. People applying to the Social Security Administration for Extra Help might be rejected for this reason.

Recent (2009-10) changes to federal law called "MIPPA" requires the Social Security Administration (SSA) to share eligibility data with NYSDOH on all persons who apply for Extra Help/ the Low Income Subsidy. Data sent to NYSDOH from SSA will enable NYSDOH to open MSP cases on many clients. The effective date of the MSP application must be the same date as the Extra Help application. Signatures will not be required from clients.

In cases where the SSA data is incomplete, NYSDOH will forward what is collected to the local district for completion of an MSP application. The State implementing procedures are in DOH 2010 ADM-03. Also see CMS "Dear State Medicaid Director" letter dated Feb. 18, 2010 Benefit 2.

MSPs Automatically Waive Late Enrollment Penalties for Part B Generally one must enroll in Part B within the strict enrollment periods after turning age 65 or after 24 months of Social Security Disability. An exception is if you or your spouse are still working and insured under an employer sponsored group health plan, or if you have End Stage Renal Disease, and other factors, see this from Medicare Rights Center. If you fail to enroll within those short periods, you might have to pay higher Part B premiums for life as a Late Enrollment Penalty (LEP). Also, you may only enroll in Part B during the Annual Enrollment Period from January 1 - March 31st each year, with Part B not effective until the following July.

Enrollment in an MSP automatically eliminates such penalties... For life.. Even if one later ceases to be eligible for the MSP. AND enrolling in an MSP will automatically result in becoming enrolled in Part B if you didn't already have it and only had Part A.

See Medicare Rights Center flyer. Benefit 3. No Medicaid Lien on Estate to Recover MSP Benefits Paid Generally speaking, states may place liens on the Estates of deceased Medicaid recipients to recover the cost of Medicaid services that were provided after the recipient reached the age of 55. Since 2002, states have not been allowed to recover the cost of Medicare premiums paid under MSPs.

In 2010, Congress expanded protection for MSP benefits. Beginning on January 1, 2010, states may not place liens on the Estates of Medicaid recipients who died after January 1, 2010 to recover costs for co-insurance paid under the QMB MSP program for services rendered after January 1, 2010. The federal government made this change in order to eliminate barriers to enrollment in MSPs. See NYS DOH GIS 10-MA-008 - Medicare Savings Program Changes in Estate Recovery The GIS clarifies that a client who receives both QMB and full Medicaid is exempt from estate recovery for these Medicare cost-sharing expenses.

Benefit 4. SNAP (Food Stamp) benefits not reduced despite increased income from MSP - at least temporarily Many people receive both SNAP (Food Stamp) benefits and MSP. Income for purposes of SNAP/Food Stamps is reduced by a deduction for medical expenses, which includes payment of the Part B premium. Since approval for an MSP means that the client no longer pays for the Part B premium, his/her SNAP/Food Stamps income goes up, so their SNAP/Food Stamps go down.

Here are some protections. Do these individuals have to report to their SNAP worker that their out of pocket medical costs have decreased?. And will the household see a reduction in their SNAP benefits, since the decrease in medical expenses will increase their countable income?. The good news is that MSP households do NOT have to report the decrease in their medical expenses to the SNAP/Food Stamp office until their next SNAP/Food Stamp recertification.

Even if they do report the change, or the local district finds out because the same worker is handling both the MSP and SNAP case, there should be no reduction in the household’s benefit until the next recertification. New York’s SNAP policy per administrative directive 02 ADM-07 is to “freeze” the deduction for medical expenses between certification periods. Increases in medical expenses can be budgeted at the household’s request, but NYS never decreases a household’s medical expense deduction until the next recertification. Most elderly and disabled households have 24-month SNAP certification periods.

Eventually, though, the decrease in medical expenses will need to be reported when the household recertifies for SNAP, and the household should expect to see a decrease in their monthly SNAP benefit. It is really important to stress that the loss in SNAP benefits is NOT dollar for dollar. A $100 decrease in out of pocket medical expenses would translate roughly into a $30 drop in SNAP benefits. See more info on SNAP/Food Stamp benefits by the Empire Justice Center, and on the State OTDA website.

Some clients will be automatically enrolled in an MSP by the New York State Department of Health (NYSDOH) shortly after attaining eligibility for Medicare. Others need to apply. The 2010 "MIPPA" law introduced some improvements to increase MSP enrollment. See 3rd bullet below.

Also, some people who had Medicaid through the Affordable Care Act before they became eligible for Medicare have special procedures to have their Part B premium paid before they enroll in an MSP. See below. WHO IS AUTOMATICALLY ENROLLED IN AN MSP. Clients receiving even $1.00 of Supplemental Security Income should be automatically enrolled into a Medicare Savings Program (most often QMB) under New York State’s Medicare Savings Program Buy-in Agreement with the federal government once they become eligible for Medicare.

They should receive Medicare Parts A and B. Clients who are already eligible for Medicare when they apply for Medicaid should be automatically assessed for MSP eligibility when they apply for Medicaid. (NYS DOH 2000-ADM-7 and GIS 05 MA 033). Clients who apply to the Social Security Administration for Extra Help, but are rejected, should be contacted &.

Enrolled into an MSP by the Medicaid program directly under new MIPPA procedures that require data sharing. Strategy TIP. Since the Extra Help filing date will be assigned to the MSP application, it may help the client to apply online for Extra Help with the SSA, even knowing that this application will be rejected because of excess assets or other reason. SSA processes these requests quickly, and it will be routed to the State for MSP processing.

Since MSP applications take a while, at least the filing date will be retroactive. Note. The above strategy does not work as well for QMB, because the effective date of QMB is the month after the month of application. As a result, the retroactive effective date of Extra Help will be the month after the failed Extra Help application for those with QMB rather than SLMB/QI-1.

Applying for MSP Directly with Local Medicaid Program. Those who do not have Medicaid already must apply for an MSP through their local social services district. (See more in Section D. Below re those who already have Medicaid through the Affordable Care Act before they became eligible for Medicare.

If you are applying for MSP only (not also Medicaid), you can use the simplified MSP application form (theDOH-4328(Rev. 8/2017-- English) (2017 Spanish version not yet available). Either application form can be mailed in -- there is no interview requirement anymore for MSP or Medicaid. See 10 ADM-04.

Applicants will need to submit proof of income, a copy of their Medicare card (front &. Back), and proof of residency/address. See the application form for other instructions. One who is only eligible for QI-1 because of higher income may ONLY apply for an MSP, not for Medicaid too.

One may not receive Medicaid and QI-1 at the same time. If someone only eligible for QI-1 wants Medicaid, s/he may enroll in and deposit excess income into a pooled Supplemental Needs Trust, to bring her countable income down to the Medicaid level, which also qualifies him or her for SLIMB or QMB instead of QI-1. Advocates in NYC can sign up for a half-day "Deputization Training" conducted by the Medicare Rights Center, at which you'll be trained and authorized to complete an MSP application and to submit it via the Medicare Rights Center, which submits it to HRA without the client having to apply in person. Enrolling in an MSP if you already have Medicaid, but just become eligible for Medicare Those who, prior to becoming enrolled in Medicare, had Medicaid through Affordable Care Act are eligible to have their Part B premiums paid by Medicaid (or the cost reimbursed) during the time it takes for them to transition to a Medicare Savings Program.

In 2018, DOH clarified that reimbursement of the Part B premium will be made regardless of whether the individual is still in a Medicaid managed care (MMC) plan. GIS 18 MA/001 Medicaid Managed Care Transition for Enrollees Gaining Medicare ( PDF) provides, "Due to efforts to transition individuals who gain Medicare eligibility and who require LTSS, individuals may not be disenrolled from MMC upon receipt of Medicare. To facilitate the transition and not disadvantage the recipient, the Medicaid program is approving reimbursement of Part B premiums for enrollees in MMC." The procedure for getting the Part B premium paid is different for those whose Medicaid was administered by the NYS of Health Exchange (Marketplace), as opposed to their local social services district. The procedure is also different for those who obtain Medicare because they turn 65, as opposed to obtaining Medicare based on disability.

Either way, Medicaid recipients who transition onto Medicare should be automatically evaluated for MSP eligibility at their next Medicaid recertification. NYS DOH 2000-ADM-7 Individuals can also affirmatively ask to be enrolled in MSP in between recertification periods. IF CLIENT HAD MEDICAID ON THE MARKETPLACE (NYS of Health Exchange) before obtaining Medicare. IF they obtain Medicare because they turn age 65, they will receive a letter from their local district asking them to "renew" Medicaid through their local district.

See 2014 LCM-02. Now, their Medicaid income limit will be lower than the MAGI limits ($842/ mo reduced from $1387/month) and they now will have an asset test. For this reason, some individuals may lose full Medicaid eligibility when they begin receiving Medicare. People over age 65 who obtain Medicare do NOT keep "Marketplace Medicaid" for 12 months (continuous eligibility) See GIS 15 MA/022 - Continuous Coverage for MAGI Individuals.

Since MSP has NO ASSET limit. Some individuals may be enrolled in the MSP even if they lose Medicaid, or if they now have a Medicaid spend-down. If a Medicare/Medicaid recipient reports income that exceeds the Medicaid level, districts must evaluate the person’s eligibility for MSP. 08 OHIP/ADM-4 ​If you became eligible for Medicare based on disability and you are UNDER AGE 65, you are entitled to keep MAGI Medicaid for 12 months from the month it was last authorized, even if you now have income normally above the MAGI limit, and even though you now have Medicare.

This is called Continuous Eligibility. EXAMPLE. Sam, age 60, was last authorized for Medicaid on the Marketplace in June 2016. He became enrolled in Medicare based on disability in August 2016, and started receiving Social Security in the same month (he won a hearing approving Social Security disability benefits retroactively, after first being denied disability).

Even though his Social Security is too high, he can keep Medicaid for 12 months beginning June 2016. Sam has to pay for his Part B premium - it is deducted from his Social Security check. He may call the Marketplace and request a refund. This will continue until the end of his 12 months of continues MAGI Medicaid eligibility.

He will be reimbursed regardless of whether he is in a Medicaid managed care plan. See GIS 18 MA/001 Medicaid Managed Care Transition for Enrollees Gaining Medicare (PDF) When that ends, he will renew Medicaid and apply for MSP with his local district. Individuals who are eligible for Medicaid with a spenddown can opt whether or not to receive MSP. (Medicaid Reference Guide (MRG) p.

19). Obtaining MSP may increase their spenddown. MIPPA - Outreach by Social Security Administration -- Under MIPPA, the SSA sends a form letter to people who may be eligible for a Medicare Savings Program or Extra Help (Low Income Subsidy - LIS) that they may apply. The letters are.

· Beneficiary has Extra Help (LIS), but not MSP · Beneficiary has no Extra Help (LIS) or MSP 6. Enrolling in MSP for People Age 65+ who do Not have Free Medicare Part A - the "Part A Buy-In Program" Seniors WITHOUT MEDICARE PART A or B -- They may be able to enroll in the Part A Buy-In program, in which people eligible for QMB who are age 65+ who do not otherwise have Medicare Part A may enroll in Part A, with Medicaid paying the Part A premium. See Step-by-Step Guide by the Medicare Rights Center). This guide explains the various steps in "conditionally enrolling" in Part A at the SSA office, which must be done before applying for QMB at the Medicaid office, which will then pay the Part A premium.

See also GIS 04 MA/013. In June, 2018, the SSA revised the POMS manual procedures for the Part A Buy-In to to address inconsistencies and confusion in SSA field offices and help smooth the path for QMB enrollment. The procedures are in the POMS Section HI 00801.140 "Premium-Free Part A Enrollments for Qualified Medicare BenefiIaries." It includes important clarifications, such as. SSA Field Offices should explain the QMB program and conditional enrollment process if an individual lacks premium-free Part A and appears to meet QMB requirements.

SSA field offices can add notes to the “Remarks” section of the application and provide a screen shot to the individual so the individual can provide proof of conditional Part A enrollment when applying for QMB through the state Medicaid program. Beneficiaries are allowed to complete the conditional application even if they owe Medicare premiums. In Part A Buy-in states like NYS, SSA should process conditional applications on a rolling basis (without regard to enrollment periods), even if the application coincides with the General Enrollment Period. (The General Enrollment Period is from Jan 1 to March 31st every year, in which anyone eligible may enroll in Medicare Part A or Part B to be effective on July 1st).

7. What happens after the MSP approval - How is Part B premium paid For all three MSP programs, the Medicaid program is now responsible for paying the Part B premiums, even though the MSP enrollee is not necessarily a recipient of Medicaid. The local Medicaid office (DSS/HRA) transmits the MSP approval to the NYS Department of Health – that information gets shared w/ SSA and CMS SSA stops deducting the Part B premiums out of the beneficiary’s Social Security check. SSA also refunds any amounts owed to the recipient.

) CMS “deems” the MSP recipient eligible for Part D Extra Help/ Low Income Subsidy (LIS). ​Can the MSP be retroactive like Medicaid, back to 3 months before the application?. ​The answer is different for the 3 MSP programs. QMB -No Retroactive Eligibility – Benefits begin the month after the month of the MSP application.

18 NYCRR § 360-7.8(b)(5) SLIMB - YES - Retroactive Eligibility up to 3 months before the application, if was eligible This means applicant may be reimbursed for the 3 months of Part B benefits prior to the month of application. QI-1 - YES up to 3 months but only in the same calendar year. No retroactive eligibility to the previous year. 7.

QMBs -Special Rules on Cost-Sharing. QMB is the only MSP program which pays not only the Part B premium, but also the Medicare co-insurance. However, there are limitations. First, co-insurance will only be paid if the provide accepts Medicaid.

Not all Medicare provides accept Medicaid. Second, under recent changes in New York law, Medicaid will not always pay the Medicare co-insurance, even to a Medicaid provider. But even if the provider does not accept Medicaid, or if Medicaid does not pay the full co-insurance, the provider is banned from "balance billing" the QMB beneficiary for the co-insurance. Click here for an article that explains all of these rules.

This article was authored by the Empire Justice Center.THE PROBLEM. Meet Joe, whose Doctor has Billed him for the Medicare Coinsurance Joe Client is disabled and has SSD, Medicaid and Qualified Medicare Beneficiary (QMB). His health care is covered by Medicare, and Medicaid and the QMB program pick up his Medicare cost-sharing obligations. Under Medicare Part B, his co-insurance is 20% of the Medicare-approved charge for most outpatient services.

He went to the doctor recently and, as with any other Medicare beneficiary, the doctor handed him a bill for his co-pay. Now Joe has a bill that he can’t pay. Read below to find out -- SHORT ANSWER. QMB or Medicaid will pay the Medicare coinsurance only in limited situations.

First, the provider must be a Medicaid provider. Second, even if the provider accepts Medicaid, under recent legislation in New York enacted in 2015 and 2016, QMB or Medicaid may pay only part of the coinsurance, or none at all. This depends in part on whether the beneficiary has Original Medicare or is in a Medicare Advantage plan, and in part on the type of service. However, the bottom line is that the provider is barred from "balance billing" a QMB beneficiary for the Medicare coinsurance.

Unfortunately, this creates tension between an individual and her doctors, pharmacies dispensing Part B medications, and other providers. Providers may not know they are not allowed to bill a QMB beneficiary for Medicare coinsurance, since they bill other Medicare beneficiaries. Even those who know may pressure their patients to pay, or simply decline to serve them. These rights and the ramifications of these QMB rules are explained in this article.

CMS is doing more education about QMB Rights. The Medicare Handbook, since 2017, gives information about QMB Protections. Download the 2020 Medicare Handbook here. See pp.

53, 86. 1. To Which Providers will QMB or Medicaid Pay the Medicare Co-Insurance?. "Providers must enroll as Medicaid providers in order to bill Medicaid for the Medicare coinsurance." CMS Informational Bulletin issued January 6, 2012, titled "Billing for Services Provided to Qualified Medicare Beneficiaries (QMBs).

The CMS bulletin states, "If the provider wants Medicaid to pay the coinsurance, then the provider must register as a Medicaid provider under the state rules." If the provider chooses not to enroll as a Medicaid provider, they still may not "balance bill" the QMB recipient for the coinsurance. 2. How Does a Provider that DOES accept Medicaid Bill for a QMB Beneficiary?. If beneficiary has Original Medicare -- The provider bills Medicaid - even if the QMB Beneficiary does not also have Medicaid.

Medicaid is required to pay the provider for all Medicare Part A and B cost-sharing charges, even if the service is normally not covered by Medicaid (ie, chiropractic, podiatry and clinical social work care). Whatever reimbursement Medicaid pays the provider constitutes by law payment in full, and the provider cannot bill the beneficiary for any difference remaining. 42 U.S.C. § 1396a(n)(3)(A), NYS DOH 2000-ADM-7 If the QMB beneficiary is in a Medicare Advantage plan - The provider bills the Medicare Advantage plan, then bills Medicaid for the balance using a “16” code to get paid.

The provider must include the amount it received from Medicare Advantage plan. 3. For a Provider who accepts Medicaid, How Much of the Medicare Coinsurance will be Paid for a QMB or Medicaid Beneficiary in NYS?. The answer to this question has changed by laws enacted in 2015 and 2016.

In the proposed 2019 State Budget, Gov. Cuomo has proposed to reduce how much Medicaid pays for the Medicare costs even further. The amount Medicaid pays is different depending on whether the individual has Original Medicare or is a Medicare Advantage plan, with better payment for those in Medicare Advantage plans. The answer also differs based on the type of service.

Part A Deductibles and Coinsurance - Medicaid pays the full Part A hospital deductible ($1,408 in 2020) and Skilled Nursing Facility coinsurance ($176/day) for days 20 - 100 of a rehab stay. Full payment is made for QMB beneficiaries and Medicaid recipients who have no spend-down. Payments are reduced if the beneficiary has a Medicaid spend-down. For in-patient hospital deductible, Medicaid will pay only if six times the monthly spend-down has been met.

For example, if Mary has a $200/month spend down which has not been met otherwise, Medicaid will pay only $164 of the hospital deductible (the amount exceeding 6 x $200). See more on spend-down here. Medicare Part B - Deductible - Currently, Medicaid pays the full Medicare approved charges until the beneficiary has met the annual deductible, which is $198 in 2020. For example, Dr.

John charges $500 for a visit, for which the Medicare approved charge is $198. Medicaid pays the entire $198, meeting the deductible. If the beneficiary has a spend-down, then the Medicaid payment would be subject to the spend-down. In the 2019 proposed state budget, Gov.

Cuomo proposed to reduce the amount Medicaid pays toward the deductible to the same amount paid for coinsurance during the year, described below. This proposal was REJECTED by the state legislature. Co-Insurance - The amount medicaid pays in NYS is different for Original Medicare and Medicare Advantage. If individual has Original Medicare, QMB/Medicaid will pay the 20% Part B coinsurance only to the extent the total combined payment the provider receives from Medicare and Medicaid is the lesser of the Medicaid or Medicare rate for the service.

For example, if the Medicare rate for a service is $100, the coinsurance is $20. If the Medicaid rate for the same service is only $80 or less, Medicaid would pay nothing, as it would consider the doctor fully paid = the provider has received the full Medicaid rate, which is lesser than the Medicare rate. Exceptions - Medicaid/QMB wil pay the full coinsurance for the following services, regardless of the Medicaid rate. ambulance and psychologists - The Gov's 2019 proposal to eliminate these exceptions was rejected.

hospital outpatient clinic, certain facilities operating under certificates issued under the Mental Hygiene Law for people with developmental disabilities, psychiatric disability, and chemical dependence (Mental Hygiene Law Articles 16, 31 or 32). SSL 367-a, subd. 1(d)(iii)-(v) , as amended 2015 If individual is in a Medicare Advantage plan, 85% of the copayment will be paid to the provider (must be a Medicaid provider), regardless of how low the Medicaid rate is. This limit was enacted in the 2016 State Budget, and is better than what the Governor proposed - which was the same rule used in Original Medicare -- NONE of the copayment or coinsurance would be paid if the Medicaid rate was lower than the Medicare rate for the service, which is usually the case.

This would have deterred doctors and other providers from being willing to treat them. SSL 367-a, subd. 1(d)(iv), added 2016. EXCEPTIONS.

The Medicare Advantage plan must pay the full coinsurance for the following services, regardless of the Medicaid rate. ambulance ) psychologist ) The Gov's proposal in the 2019 budget to eliminate these exceptions was rejected by the legislature Example to illustrate the current rules. The Medicare rate for Mary's specialist visit is $185. The Medicaid rate for the same service is $120.

Current rules (since 2016). Medicare Advantage -- Medicare Advantage plan pays $135 and Mary is charged a copayment of $50 (amount varies by plan). Medicaid pays the specialist 85% of the $50 copayment, which is $42.50. The doctor is prohibited by federal law from "balance billing" QMB beneficiaries for the balance of that copayment.

Since provider is getting $177.50 of the $185 approved rate, provider will hopefully not be deterred from serving Mary or other QMBs/Medicaid recipients. Original Medicare - The 20% coinsurance is $37. Medicaid pays none of the coinsurance because the Medicaid rate ($120) is lower than the amount the provider already received from Medicare ($148). For both Medicare Advantage and Original Medicare, if the bill was for a ambulance or psychologist, Medicaid would pay the full 20% coinsurance regardless of the Medicaid rate.

The proposal to eliminate this exception was rejected by the legislature in 2019 budget. . 4. May the Provider 'Balance Bill" a QMB Benficiary for the Coinsurance if Provider Does Not Accept Medicaid, or if Neither the Patient or Medicaid/QMB pays any coinsurance?.

No. Balance billing is banned by the Balanced Budget Act of 1997. 42 U.S.C. § 1396a(n)(3)(A).

In an Informational Bulletin issued January 6, 2012, titled "Billing for Services Provided to Qualified Medicare Beneficiaries (QMBs)," the federal Medicare agency - CMS - clarified that providers MAY NOT BILL QMB recipients for the Medicare coinsurance. This is true whether or not the provider is registered as a Medicaid provider. If the provider wants Medicaid to pay the coinsurance, then the provider must register as a Medicaid provider under the state rules. This is a change in policy in implementing Section 1902(n)(3)(B) of the Social Security Act (the Act), as modified by section 4714 of the Balanced Budget Act of 1997, which prohibits Medicare providers from balance-billing QMBs for Medicare cost-sharing.

The CMS letter states, "All Medicare physicians, providers, and suppliers who offer services and supplies to QMBs are prohibited from billing QMBs for Medicare cost-sharing, including deductible, coinsurance, and copayments. This section of the Act is available at. CMCS Informational Bulletin http://www.ssa.gov/OP_Home/ssact/title19/1902.htm. QMBs have no legal obligation to make further payment to a provider or Medicare managed care plan for Part A or Part B cost sharing.

Providers who inappropriately bill QMBs for Medicare cost-sharing are subject to sanctions. Please note that the statute referenced above supersedes CMS State Medicaid Manual, Chapter 3, Eligibility, 3490.14 (b), which is no longer in effect, but may be causing confusion about QMB billing." The same information was sent to providers in this Medicare Learning Network bulletin, last revised in June 26, 2018. CMS reminded Medicare Advantage plans of the rule against Balance Billing in the 2017 Call Letter for plan renewals. See this excerpt of the 2017 call letter by Justice in Aging - Prohibition on Billing Medicare-Medicaid Enrollees for Medicare Cost Sharing 5.

How do QMB Beneficiaries Show a Provider that they have QMB and cannot be Billed for the Coinsurance?. It can be difficult to show a provider that one is a QMB. It is especially difficult for providers who are not Medicaid providers to identify QMB's, since they do not have access to online Medicaid eligibility systems Consumers can now call 1-800-MEDICARE to verify their QMB Status and report a billing issue. If a consumer reports a balance billng problem to this number, the Customer Service Rep can escalate the complaint to the Medicare Administrative Contractor (MAC), which will send a compliance letter to the provider with a copy to the consumer.

See CMS Medicare Learning Network Bulletin effective Dec. 16, 2016. Medicare Summary Notices (MSNs) that Medicare beneficiaries receive every three months state that QMBs have no financial liability for co-insurance for each Medicare-covered service listed on the MSN. The Remittance Advice (RA) that Medicare sends to providers shows the same information.

By spelling out billing protections on a service-by-service basis, the MSNs provide clarity for both the QMB beneficiary and the provider. Justice in Aging has posted samples of what the new MSNs look like here. They have also updated Justice in Aging’s Improper Billing Toolkit to incorporate references to the MSNs in its model letters that you can use to advocate for clients who have been improperly billed for Medicare-covered services. CMS is implementing systems changes that will notify providers when they process a Medicare claim that the patient is QMB and has no cost-sharing liability.

The Medicare Summary Notice sent to the beneficiary will also state that the beneficiary has QMB and no liability. These changes were scheduled to go into effect in October 2017, but have been delayed. Read more about them in this Justice in Aging Issue Brief on New Strategies in Fighting Improper Billing for QMBs (Feb. 2017).

QMBs are issued a Medicaid benefit card (by mail), even if they do not also receive Medicaid. The card is the mechanism for health care providers to bill the QMB program for the Medicare deductibles and co-pays. Unfortunately, the Medicaid card dos not indicate QMB eligibility. Not all people who have Medicaid also have QMB (they may have higher incomes and "spend down" to the Medicaid limits.

Advocates have asked for a special QMB card, or a notation on the Medicaid card to show that the individual has QMB. See this Report - a National Survey on QMB Identification Practices published by Justice in Aging, authored by Peter Travitsky, NYLAG EFLRP staff attorney. The Report, published in March 2017, documents how QMB beneficiaries could be better identified in order to ensure providers do not bill them improperly. 6.

If you are Billed -​ Strategies Consumers can now call 1-800-MEDICARE to report a billing issue. If a consumer reports a balance billng problem to this number, the Customer Service Rep can escalate the complaint to the Medicare Administrative Contractor (MAC), which will send a compliance letter to the provider with a copy to the consumer. See CMS Medicare Learning Network Bulletin effective Dec. 16, 2016.

Send a letter to the provider, using the Justice In Aging Model model letters to providers to explain QMB rights.​​​ both for Original Medicare (Letters 1-2) and Medicare Advantage (Letters 3-5) - see Overview of model letters. Include a link to the CMS Medicare Learning Network Notice. Prohibition on Balance Billing Dually Eligible Individuals Enrolled in the Qualified Medicare Beneficiary (QMB) Program (revised June 26. 2018) In January 2017, the Consumer Finance Protection Bureau issued this guide to QMB billing.

A consumer who has a problem with debt collection, may also submit a complaint online or call the CFPB at 1-855-411-2372. TTY/TDD users can call 1-855-729-2372. Medicare Advantage members should complain to their Medicare Advantage plan. In its 2017 Call Letter, CMS stressed to Medicare Advantage contractors that federal regulations at 42 C.F.R.

§ 422.504 (g)(1)(iii), require that provider contracts must prohibit collection of deductibles and co-payments from dual eligibles and QMBs. Toolkit to Help Protect QMB Rights ​​In July 2015, CMS issued a report, "Access to Care Issues Among Qualified Medicare Beneficiaries (QMB's)" documenting how pervasive illegal attempts to bill QMBs for the Medicare coinsurance, including those who are members of managed care plans. Justice in Aging, a national advocacy organization, has a project to educate beneficiaries about balance billing and to advocate for stronger protections for QMBs. Links to their webinars and other resources is at this link.

Enrolling in an MSP for People age 65+ who Do Not Qualify http://charltonsingleton.com/where-to-buy-levitra-pills// for Free lasix 40mg cost Medicare Part A - the "Part A Buy-In Program" 7. What Happens After MSP Approved - How Part B Premium is Paid 8 Special Rules for QMBs - How Medicare Cost-Sharing Works 1. NO ASSET LIMIT!.

Since April 1, 2008, none of the three MSP programs have resource limits in New lasix 40mg cost York -- which means many Medicare beneficiaries who might not qualify for Medicaid because of excess resources can qualify for an MSP. 1.A. SUMMARY CHART OF MSP BENEFITS QMB SLIMB QI-1 Eligibility ASSET LIMIT NO LIMIT IN NEW YORK STATE INCOME LIMIT (2020) Single Couple Single Couple Single Couple $1,064 $1,437 $1,276 $1,724 $1,436 $1,940 Federal Poverty Level 100% FPL 100 – 120% FPL 120 – 135% FPL Benefits Pays Monthly Part B premium?.

YES, and also lasix 40mg cost Part A premium if did not have enough work quarters and meets citizenship requirement. See “Part A Buy-In” YES YES Pays Part A &. B deductibles &.

Co-insurance YES - with limitations NO NO lasix 40mg cost Retroactive to Filing of Application?. Yes - Benefits begin the month after the month of the MSP application. 18 NYCRR §360-7.8(b)(5) Yes – Retroactive to 3rd month before month of application, if eligible in prior months Yes – may be retroactive to 3rd month before month of applica-tion, but only within the current calendar year.

(No retro for lasix 40mg cost January application). See GIS 07 MA 027. Can Enroll in MSP and Medicaid at Same Time?.

YES lasix 40mg cost YES NO!. Must choose between QI-1 and Medicaid. Cannot have both, not even Medicaid with a spend-down.

2 lasix 40mg cost. INCOME LIMITS and RULES Each of the three MSP programs has different income eligibility requirements and provides different benefits. The income limits are tied to the Federal Poverty Level (FPL).

2019 FPL levels were released by NYS DOH in GIS 20 MA/02 - 2020 Federal Poverty lasix 40mg cost Levels -- Attachment II and have been posted by Medicaid.gov and the National Council on Aging and are in the chart below. NOTE. There is usually a lag in time of several weeks, or even months, from January 1st of each year until the new FPLs are release, and then before the new MSP income limits are officially implemented.

During this lag period, local Medicaid offices should continue to use the previous year's FPLs AND count the person's Social Security benefit amount from the previous year - do NOT factor in the Social Security lasix 40mg cost COLA (cost of living adjustment). Once the updated guidelines are released, districts will use the new FPLs and go ahead and factor in any COLA. See 2019 Fact Sheet on MSP in NYS by Medicare Rights Center ENGLISH SPANISH Income is determined by the same methodology as is used for determining in eligibility for SSI The rules for counting income for SSI-related (Aged 65+, Blind, or Disabled) Medicaid recipients, borrowed from the SSI program, apply to the MSP program, except for the new rules about counting household size for married couples.

N.Y lasix 40mg cost. Soc. Serv.

L. 367-a(3)(c)(2), NYS DOH 2000-ADM-7, 89-ADM-7 p.7. Gross income is counted, although there are certain types of income that are disregarded.

The most common income disregards, also known as deductions, include. (a) The first $20 of your &. Your spouse's monthly income, earned or unearned ($20 per couple max).

(b) SSI EARNED INCOME DISREGARDS. * The first $65 of monthly wages of you and your spouse, * One-half of the remaining monthly wages (after the $65 is deducted). * Other work incentives including PASS plans, impairment related work expenses (IRWEs), blind work expenses, etc.

For information on these deductions, see The Medicaid Buy-In for Working People with Disabilities (MBI-WPD) and other guides in this article -- though written for the MBI-WPD, the work incentives apply to all Medicaid programs, including MSP, for people age 65+, disabled or blind. (c) monthly cost of any health insurance premiums but NOT the Part B premium, since Medicaid will now pay this premium (may deduct Medigap supplemental policies, vision, dental, or long term care insurance premiums, and the Part D premium but only to the extent the premium exceeds the Extra Help benchmark amount) (d) Food stamps not counted. You can get a more comprehensive listing of the SSI-related income disregards on the Medicaid income disregards chart.

As for all benefit programs based on financial need, it is usually advantageous to be considered a larger household, because the income limit is higher. The above chart shows that Households of TWO have a higher income limit than households of ONE. The MSP programs use the same rules as Medicaid does for the Disabled, Aged and Blind (DAB) which are borrowed from the SSI program for Medicaid recipients in the “SSI-related category.” Under these rules, a household can be only ONE or TWO.

18 NYCRR 360-4.2. See DAB Household Size Chart. Married persons can sometimes be ONE or TWO depending on arcane rules, which can force a Medicare beneficiary to be limited to the income limit for ONE person even though his spouse who is under 65 and not disabled has no income, and is supported by the client applying for an MSP.

EXAMPLE. Bob's Social Security is $1300/month. He is age 67 and has Medicare.

His wife, Nancy, is age 62 and is not disabled and does not work. Under the old rule, Bob was not eligible for an MSP because his income was above the Income limit for One, even though it was well under the Couple limit. In 2010, NYS DOH modified its rules so that all married individuals will be considered a household size of TWO.

DOH GIS 10 MA 10 Medicare Savings Program Household Size, June 4, 2010. This rule for household size is an exception to the rule applying SSI budgeting rules to the MSP program. Under these rules, Bob is now eligible for an MSP.

When is One Better than Two?. Of course, there may be couples where the non-applying spouse's income is too high, and disqualifies the applying spouse from an MSP. In such cases, "spousal refusal" may be used SSL 366.3(a).

(Link is to NYC HRA form, can be adapted for other counties). 3. The Three Medicare Savings Programs - what are they and how are they different?.

1. Qualified Medicare Beneficiary (QMB). The QMB program provides the most comprehensive benefits.

Available to those with incomes at or below 100% of the Federal Poverty Level (FPL), the QMB program covers virtually all Medicare cost-sharing obligations. Part B premiums, Part A premiums, if there are any, and any and all deductibles and co-insurance. QMB coverage is not retroactive.

The program’s benefits will begin the month after the month in which your client is found eligible. ** See special rules about cost-sharing for QMBs below - updated with new CMS directive issued January 2012 ** See NYC HRA QMB Recertification form ** Even if you do not have Part A automatically, because you did not have enough wages, you may be able to enroll in the Part A Buy-In Program, in which people eligible for QMB who do not otherwise have Medicare Part A may enroll, with Medicaid paying the Part A premium (Materials by the Medicare Rights Center). 2.

Specifiedl Low-Income Medicare Beneficiary (SLMB). For those with incomes between 100% and 120% FPL, the SLMB program will cover Part B premiums only. SLMB is retroactive, however, providing coverage for three months prior to the month of application, as long as your client was eligible during those months.

3. Qualified Individual (QI-1). For those with incomes between 120% and 135% FPL, and not receiving Medicaid, the QI-1 program will cover Medicare Part B premiums only.

QI-1 is also retroactive, providing coverage for three months prior to the month of application, as long as your client was eligible during those months. However, QI-1 retroactive coverage can only be provided within the current calendar year. (GIS 07 MA 027) So if you apply in January, you get no retroactive coverage.

Q-I-1 recipients would be eligible for Medicaid with a spend-down, but if they want the Part B premium paid, they must choose between enrolling in QI-1 or Medicaid. They cannot be in both. It is their choice.

DOH MRG p. 19. In contrast, one may receive Medicaid and either QMB or SLIMB.

4. Four Special Benefits of MSPs (in addition to NO ASSET TEST). Benefit 1.

Back Door to Medicare Part D "Extra Help" or Low Income Subsidy -- All MSP recipients are automatically enrolled in Extra Help, the subsidy that makes Part D affordable. They have no Part D deductible or doughnut hole, the premium is subsidized, and they pay very low copayments. Once they are enrolled in Extra Help by virtue of enrollment in an MSP, they retain Extra Help for the entire calendar year, even if they lose MSP eligibility during that year.

The "Full" Extra Help subsidy has the same income limit as QI-1 - 135% FPL. However, many people may be eligible for QI-1 but not Extra Help because QI-1 and the other MSPs have no asset limit. People applying to the Social Security Administration for Extra Help might be rejected for this reason.

Recent (2009-10) changes to federal law called "MIPPA" requires the Social Security Administration (SSA) to share eligibility data with NYSDOH on all persons who apply for Extra Help/ the Low Income Subsidy. Data sent to NYSDOH from SSA will enable NYSDOH to open MSP cases on many clients. The effective date of the MSP application must be the same date as the Extra Help application.

Signatures will not be required from clients. In cases where the SSA data is incomplete, NYSDOH will forward what is collected to the local district for completion of an MSP application. The State implementing procedures are in DOH 2010 ADM-03.

Also see CMS "Dear State Medicaid Director" letter dated Feb. 18, 2010 Benefit 2. MSPs Automatically Waive Late Enrollment Penalties for Part B Generally one must enroll in Part B within the strict enrollment periods after turning age 65 or after 24 months of Social Security Disability.

An exception is if you or your spouse are still working and insured under an employer sponsored group health plan, or if you have End Stage Renal Disease, and other factors, see this from Medicare Rights Center. If you fail to enroll within those short periods, you might have to pay higher Part B premiums for life as a Late Enrollment Penalty (LEP). Also, you may only enroll in Part B during the Annual Enrollment Period from January 1 - March 31st each year, with Part B not effective until the following July.

Enrollment in an MSP automatically eliminates such penalties... For life.. Even if one later ceases to be eligible for the MSP.

AND enrolling in an MSP will automatically result in becoming enrolled in Part B if you didn't already have it and only had Part A. See Medicare Rights Center flyer. Benefit 3.

No Medicaid Lien on Estate to Recover MSP Benefits Paid Generally speaking, states may place liens on the Estates of deceased Medicaid recipients to recover the cost of Medicaid services that were provided after the recipient reached the age of 55. Since 2002, states have not been allowed to recover the cost of Medicare premiums paid under MSPs. In 2010, Congress expanded protection for MSP benefits.

Beginning on January 1, 2010, states may not place liens on the Estates of Medicaid recipients who died after January 1, 2010 to recover costs for co-insurance paid under the QMB MSP program for services rendered after January 1, 2010. The federal government made this change in order to eliminate barriers to enrollment in MSPs. See NYS DOH GIS 10-MA-008 - Medicare Savings Program Changes in Estate Recovery The GIS clarifies that a client who receives both QMB and full Medicaid is exempt from estate recovery for these Medicare cost-sharing expenses.

Benefit 4. SNAP (Food Stamp) benefits not reduced despite increased income from MSP - at least temporarily Many people receive both SNAP (Food Stamp) benefits and MSP. Income for purposes of SNAP/Food Stamps is reduced by a deduction for medical expenses, which includes payment of the Part B premium.

Since approval for an MSP means that the client no longer pays for the Part B premium, his/her SNAP/Food Stamps income goes up, so their SNAP/Food Stamps go down. Here are some protections. Do these individuals have to report to their SNAP worker that their out of pocket medical costs have decreased?.

And will the household see a reduction in their SNAP benefits, since the decrease in medical expenses will increase their countable income?. The good news is that MSP households do NOT have to report the decrease in their medical expenses to the SNAP/Food Stamp office until their next SNAP/Food Stamp recertification. Even if they do report the change, or the local district finds out because the same worker is handling both the MSP and SNAP case, there should be no reduction in the household’s benefit until the next recertification.

New York’s SNAP policy per administrative directive 02 ADM-07 is to “freeze” the deduction for medical expenses between certification periods. Increases in medical expenses can be budgeted at the household’s request, but NYS never decreases a household’s medical expense deduction until the next recertification. Most elderly and disabled households have 24-month SNAP certification periods.

Eventually, though, the decrease in medical expenses will need to be reported when the household recertifies for SNAP, and the household should expect to see a decrease in their monthly SNAP benefit. It is really important to stress that the loss in SNAP benefits is NOT dollar for dollar. A $100 decrease in out of pocket medical expenses would translate roughly into a $30 drop in SNAP benefits.

See more info on SNAP/Food Stamp benefits by the Empire Justice Center, and on the State OTDA website. Some clients will be automatically enrolled in an MSP by the New York State Department of Health (NYSDOH) shortly after attaining eligibility for Medicare. Others need to apply.

The 2010 "MIPPA" law introduced some improvements to increase MSP enrollment. See 3rd bullet below. Also, some people who had Medicaid through the Affordable Care Act before they became eligible for Medicare have special procedures to have their Part B premium paid before they enroll in an MSP.

See below. WHO IS AUTOMATICALLY ENROLLED IN AN MSP. Clients receiving even $1.00 of Supplemental Security Income should be automatically enrolled into a Medicare Savings Program (most often QMB) under New York State’s Medicare Savings Program Buy-in Agreement with the federal government once they become eligible for Medicare.

They should receive Medicare Parts A and B. Clients who are already eligible for Medicare when they apply for Medicaid should be automatically assessed for MSP eligibility when they apply for Medicaid. (NYS DOH 2000-ADM-7 and GIS 05 MA 033).

Clients who apply to the Social Security Administration for Extra Help, but are rejected, should be contacted &. Enrolled into an MSP by the Medicaid program directly under new MIPPA procedures that require data sharing. Strategy TIP.

Since the Extra Help filing date will be assigned to the MSP application, it may help the client to apply online for Extra Help with the SSA, even knowing that this application will be rejected because of excess assets or other reason. SSA processes these requests quickly, and it will be routed to the State for MSP processing. Since MSP applications take a while, at least the filing date will be retroactive.

Note. The above strategy does not work as well for QMB, because the effective date of QMB is the month after the month of application. As a result, the retroactive effective date of Extra Help will be the month after the failed Extra Help application for those with QMB rather than SLMB/QI-1.

Applying for MSP Directly with Local Medicaid Program. Those who do not have Medicaid already must apply for an MSP through their local social services district. (See more in Section D.

Below re those who already have Medicaid through the Affordable Care Act before they became eligible for Medicare. If you are applying for MSP only (not also Medicaid), you can use the simplified MSP application form (theDOH-4328(Rev. 8/2017-- English) (2017 Spanish version not yet available).

Either application form can be mailed in -- there is no interview requirement anymore for MSP or Medicaid. See 10 ADM-04. Applicants will need to submit proof of income, a copy of their Medicare card (front &.

Back), and proof of residency/address. See the application form for other instructions. One who is only eligible for QI-1 because of higher income may ONLY apply for an MSP, not for Medicaid too.

One may not receive Medicaid and QI-1 at the same time. If someone only eligible for QI-1 wants Medicaid, s/he may enroll in and deposit excess income into a pooled Supplemental Needs Trust, to bring her countable income down to the Medicaid level, which also qualifies him or her for SLIMB or QMB instead of QI-1. Advocates in NYC can sign up for a half-day "Deputization Training" conducted by the Medicare Rights Center, at which you'll be trained and authorized to complete an MSP application and to submit it via the Medicare Rights Center, which submits it to HRA without the client having to apply in person.

Enrolling in an MSP if you already have Medicaid, but just become eligible for Medicare Those who, prior to becoming enrolled in Medicare, had Medicaid through Affordable Care Act are eligible to have their Part B premiums paid by Medicaid (or the cost reimbursed) during the time it takes for them to transition to a Medicare Savings Program. In 2018, DOH clarified that reimbursement of the Part B premium will be made regardless of whether the individual is still in a Medicaid managed care (MMC) plan. GIS 18 MA/001 Medicaid Managed Care Transition for Enrollees Gaining Medicare ( PDF) provides, "Due to efforts to transition individuals who gain Medicare eligibility and who require LTSS, individuals may not be disenrolled from MMC upon receipt of Medicare.

To facilitate the transition and not disadvantage the recipient, the Medicaid program is approving reimbursement of Part B premiums for enrollees in MMC." The procedure for getting the Part B premium paid is different for those whose Medicaid was administered by the NYS of Health Exchange (Marketplace), as opposed to their local social services district. The procedure is also different for those who obtain Medicare because they turn 65, as opposed to obtaining Medicare based on disability. Either way, Medicaid recipients who transition onto Medicare should be automatically evaluated for MSP eligibility at their next Medicaid recertification.

NYS DOH 2000-ADM-7 Individuals can also affirmatively ask to be enrolled in MSP in between recertification periods. IF CLIENT HAD MEDICAID ON THE MARKETPLACE (NYS of Health Exchange) before obtaining Medicare. IF they obtain Medicare because they turn age 65, they will receive a letter from their local district asking them to "renew" Medicaid through their local district.

See 2014 LCM-02. Now, their Medicaid income limit will be lower than the MAGI limits ($842/ mo reduced from $1387/month) and they now will have an asset test. For this reason, some individuals may lose full Medicaid eligibility when they begin receiving Medicare.

People over age 65 who obtain Medicare do NOT keep "Marketplace Medicaid" for 12 months (continuous eligibility) See GIS 15 MA/022 - Continuous Coverage for MAGI Individuals. Since MSP has NO ASSET limit. Some individuals may be enrolled in the MSP even if they lose Medicaid, or if they now have a Medicaid spend-down.

If a Medicare/Medicaid recipient reports income that exceeds the Medicaid level, districts must evaluate the person’s eligibility for MSP. 08 OHIP/ADM-4 ​If you became eligible for Medicare based on disability and you are UNDER AGE 65, you are entitled to keep MAGI Medicaid for 12 months from the month it was last authorized, even if you now have income normally above the MAGI limit, and even though you now have Medicare. This is called Continuous Eligibility.

EXAMPLE. Sam, age 60, was last authorized for Medicaid on the Marketplace in June 2016. He became enrolled in Medicare based on disability in August 2016, and started receiving Social Security in the same month (he won a hearing approving Social Security disability benefits retroactively, after first being denied disability).

Even though his Social Security is too high, he can keep Medicaid for 12 months beginning June 2016. Sam has to pay for his Part B premium - it is deducted from his Social Security check. He may call the Marketplace and request a refund.

This will continue until the end of his 12 months of continues MAGI Medicaid eligibility. He will be reimbursed regardless of whether he is in a Medicaid managed care plan. See GIS 18 MA/001 Medicaid Managed Care Transition for Enrollees Gaining Medicare (PDF) When that ends, he will renew Medicaid and apply for MSP with his local district.

Individuals who are eligible for Medicaid with a spenddown can opt whether or not to receive MSP. (Medicaid Reference Guide (MRG) p. 19).

Obtaining MSP may increase their spenddown. MIPPA - Outreach by Social Security Administration -- Under MIPPA, the SSA sends a form letter to people who may be eligible for a Medicare Savings Program or Extra Help (Low Income Subsidy - LIS) that they may apply. The letters are.

· Beneficiary has Extra Help (LIS), but not MSP · Beneficiary has no Extra Help (LIS) or MSP 6. Enrolling in MSP for People Age 65+ who do Not have Free Medicare Part A - the "Part A Buy-In Program" Seniors WITHOUT MEDICARE PART A or B -- They may be able to enroll in the Part A Buy-In program, in which people eligible for QMB who are age 65+ who do not otherwise have Medicare Part A may enroll in Part A, with Medicaid paying the Part A premium. See Step-by-Step Guide by the Medicare Rights Center).

This guide explains the various steps in "conditionally enrolling" in Part A at the SSA office, which must be done before applying for QMB at the Medicaid office, which will then pay the Part A premium. See also GIS 04 MA/013. In June, 2018, the SSA revised the POMS manual procedures for the Part A Buy-In to to address inconsistencies and confusion in SSA field offices and help smooth the path for QMB enrollment.

The procedures are in the POMS Section HI 00801.140 "Premium-Free Part A Enrollments for Qualified Medicare BenefiIaries." It includes important clarifications, such as. SSA Field Offices should explain the QMB program and conditional enrollment process if an individual lacks premium-free Part A and appears to meet QMB requirements. SSA field offices can add notes to the “Remarks” section of the application and provide a screen shot to the individual so the individual can provide proof of conditional Part A enrollment when applying for QMB through the state Medicaid program.

Beneficiaries are allowed to complete the conditional application even if they owe Medicare premiums. In Part A Buy-in states like NYS, SSA should process conditional applications on a rolling basis (without regard to enrollment periods), even if the application coincides with the General Enrollment Period. (The General Enrollment Period is from Jan 1 to March 31st every year, in which anyone eligible may enroll in Medicare Part A or Part B to be effective on July 1st).

7. What happens after the MSP approval - How is Part B premium paid For all three MSP programs, the Medicaid program is now responsible for paying the Part B premiums, even though the MSP enrollee is not necessarily a recipient of Medicaid. The local Medicaid office (DSS/HRA) transmits the MSP approval to the NYS Department of Health – that information gets shared w/ SSA and CMS SSA stops deducting the Part B premiums out of the beneficiary’s Social Security check.

SSA also refunds any amounts owed to the recipient. (Note. This process can take awhile!.

!. !. ) CMS “deems” the MSP recipient eligible for Part D Extra Help/ Low Income Subsidy (LIS).

​Can the MSP be retroactive like Medicaid, back to 3 months before the application?. ​The answer is different for the 3 MSP programs. QMB -No Retroactive Eligibility – Benefits begin the month after the month of the MSP application.

18 NYCRR § 360-7.8(b)(5) SLIMB - YES - Retroactive Eligibility up to 3 months before the application, if was eligible This means applicant may be reimbursed for the 3 months of Part B benefits prior to the month of application. QI-1 - YES up to 3 months but only in the same calendar year. No retroactive eligibility to the previous year.

7. QMBs -Special Rules on Cost-Sharing. QMB is the only MSP program which pays not only the Part B premium, but also the Medicare co-insurance.

However, there are limitations. First, co-insurance will only be paid if the provide accepts Medicaid. Not all Medicare provides accept Medicaid.

Second, under recent changes in New York law, Medicaid will not always pay the Medicare co-insurance, even to a Medicaid provider. But even if the provider does not accept Medicaid, or if Medicaid does not pay the full co-insurance, the provider is banned from "balance billing" the QMB beneficiary for the co-insurance. Click here for an article that explains all of these rules.

This article was authored by the Empire Justice Center.THE PROBLEM. Meet Joe, whose Doctor has Billed him for the Medicare Coinsurance Joe Client is disabled and has SSD, Medicaid and Qualified Medicare Beneficiary (QMB). His health care is covered by Medicare, and Medicaid and the QMB program pick up his Medicare cost-sharing obligations.

Under Medicare Part B, his co-insurance is 20% of the Medicare-approved charge for most outpatient services. He went to the doctor recently and, as with any other Medicare beneficiary, the doctor handed him a bill for his co-pay. Now Joe has a bill that he can’t pay.

Read below to find out -- SHORT ANSWER. QMB or Medicaid will pay the Medicare coinsurance only in limited situations. First, the provider must be a Medicaid provider.

Second, even if the provider accepts Medicaid, under recent legislation in New York enacted in 2015 and 2016, QMB or Medicaid may pay only part of the coinsurance, or none at all. This depends in part on whether the beneficiary has Original Medicare or is in a Medicare Advantage plan, and in part on the type of service. However, the bottom line is that the provider is barred from "balance billing" a QMB beneficiary for the Medicare coinsurance.

Unfortunately, this creates tension between an individual and her doctors, pharmacies dispensing Part B medications, and other providers. Providers may not know they are not allowed to bill a QMB beneficiary for Medicare coinsurance, since they bill other Medicare beneficiaries. Even those who know may pressure their patients to pay, or simply decline to serve them.

These rights and the ramifications of these QMB rules are explained in this article. CMS is doing more education about QMB Rights. The Medicare Handbook, since 2017, gives information about QMB Protections.

Download the 2020 Medicare Handbook here. See pp. 53, 86.

1. To Which Providers will QMB or Medicaid Pay the Medicare Co-Insurance?. "Providers must enroll as Medicaid providers in order to bill Medicaid for the Medicare coinsurance." CMS Informational Bulletin issued January 6, 2012, titled "Billing for Services Provided to Qualified Medicare Beneficiaries (QMBs).

The CMS bulletin states, "If the provider wants Medicaid to pay the coinsurance, then the provider must register as a Medicaid provider under the state rules." If the provider chooses not to enroll as a Medicaid provider, they still may not "balance bill" the QMB recipient for the coinsurance. 2. How Does a Provider that DOES accept Medicaid Bill for a QMB Beneficiary?.

If beneficiary has Original Medicare -- The provider bills Medicaid - even if the QMB Beneficiary does not also have Medicaid. Medicaid is required to pay the provider for all Medicare Part A and B cost-sharing charges, even if the service is normally not covered by Medicaid (ie, chiropractic, podiatry and clinical social work care). Whatever reimbursement Medicaid pays the provider constitutes by law payment in full, and the provider cannot bill the beneficiary for any difference remaining.

42 U.S.C. § 1396a(n)(3)(A), NYS DOH 2000-ADM-7 If the QMB beneficiary is in a Medicare Advantage plan - The provider bills the Medicare Advantage plan, then bills Medicaid for the balance using a “16” code to get paid. The provider must include the amount it received from Medicare Advantage plan.

3. For a Provider who accepts Medicaid, How Much of the Medicare Coinsurance will be Paid for a QMB or Medicaid Beneficiary in NYS?. The answer to this question has changed by laws enacted in 2015 and 2016.

In the proposed 2019 State Budget, Gov. Cuomo has proposed to reduce how much Medicaid pays for the Medicare costs even further. The amount Medicaid pays is different depending on whether the individual has Original Medicare or is a Medicare Advantage plan, with better payment for those in Medicare Advantage plans.

The answer also differs based on the type of service. Part A Deductibles and Coinsurance - Medicaid pays the full Part A hospital deductible ($1,408 in 2020) and Skilled Nursing Facility coinsurance ($176/day) for days 20 - 100 of a rehab stay. Full payment is made for QMB beneficiaries and Medicaid recipients who have no spend-down.

Payments are reduced if the beneficiary has a Medicaid spend-down. For in-patient hospital deductible, Medicaid will pay only if six times the monthly spend-down has been met. For example, if Mary has a $200/month spend down which has not been met otherwise, Medicaid will pay only $164 of the hospital deductible (the amount exceeding 6 x $200).

See more on spend-down here. Medicare Part B - Deductible - Currently, Medicaid pays the full Medicare approved charges until the beneficiary has met the annual deductible, which is $198 in 2020. For example, Dr.

John charges $500 for a visit, for which the Medicare approved charge is $198. Medicaid pays the entire $198, meeting the deductible. If the beneficiary has a spend-down, then the Medicaid payment would be subject to the spend-down.

In the 2019 proposed state budget, Gov. Cuomo proposed to reduce the amount Medicaid pays toward the deductible to the same amount paid for coinsurance during the year, described below. This proposal was REJECTED by the state legislature.

Co-Insurance - The amount medicaid pays in NYS is different for Original Medicare and Medicare Advantage. If individual has Original Medicare, QMB/Medicaid will pay the 20% Part B coinsurance only to the extent the total combined payment the provider receives from Medicare and Medicaid is the lesser of the Medicaid or Medicare rate for the service. For example, if the Medicare rate for a service is $100, the coinsurance is $20.

If the Medicaid rate for the same service is only $80 or less, Medicaid would pay nothing, as it would consider the doctor fully paid = the provider has received the full Medicaid rate, which is lesser than the Medicare rate. Exceptions - Medicaid/QMB wil pay the full coinsurance for the following services, regardless of the Medicaid rate. ambulance and psychologists - The Gov's 2019 proposal to eliminate these exceptions was rejected.

hospital outpatient clinic, certain facilities operating under certificates issued under the Mental Hygiene Law for people with developmental disabilities, psychiatric disability, and chemical dependence (Mental Hygiene Law Articles 16, 31 or 32). SSL 367-a, subd. 1(d)(iii)-(v) , as amended 2015 If individual is in a Medicare Advantage plan, 85% of the copayment will be paid to the provider (must be a Medicaid provider), regardless of how low the Medicaid rate is.

This limit was enacted in the 2016 State Budget, and is better than what the Governor proposed - which was the same rule used in Original Medicare -- NONE of the copayment or coinsurance would be paid if the Medicaid rate was lower than the Medicare rate for the service, which is usually the case. This would have deterred doctors and other providers from being willing to treat them. SSL 367-a, subd.

1(d)(iv), added 2016. EXCEPTIONS. The Medicare Advantage plan must pay the full coinsurance for the following services, regardless of the Medicaid rate.

ambulance ) psychologist ) The Gov's proposal in the 2019 budget to eliminate these exceptions was rejected by the legislature Example to illustrate the current rules. The Medicare rate for Mary's specialist visit is $185. The Medicaid rate for the same service is $120.

Current rules (since 2016). Medicare Advantage -- Medicare Advantage plan pays $135 and Mary is charged a copayment of $50 (amount varies by plan). Medicaid pays the specialist 85% of the $50 copayment, which is $42.50.

The doctor is prohibited by federal law from "balance billing" QMB beneficiaries for the balance of that copayment. Since provider is getting $177.50 of the $185 approved rate, provider will hopefully not be deterred from serving Mary or other QMBs/Medicaid recipients. Original Medicare - The 20% coinsurance is $37.

Medicaid pays none of the coinsurance because the Medicaid rate ($120) is lower than the amount the provider already received from Medicare ($148). For both Medicare Advantage and Original Medicare, if the bill was for a ambulance or psychologist, Medicaid would pay the full 20% coinsurance regardless of the Medicaid rate. The proposal to eliminate this exception was rejected by the legislature in 2019 budget.

. 4. May the Provider 'Balance Bill" a QMB Benficiary for the Coinsurance if Provider Does Not Accept Medicaid, or if Neither the Patient or Medicaid/QMB pays any coinsurance?.

No. Balance billing is banned by the Balanced Budget Act of 1997. 42 U.S.C.

§ 1396a(n)(3)(A). In an Informational Bulletin issued January 6, 2012, titled "Billing for Services Provided to Qualified Medicare Beneficiaries (QMBs)," the federal Medicare agency - CMS - clarified that providers MAY NOT BILL QMB recipients for the Medicare coinsurance. This is true whether or not the provider is registered as a Medicaid provider.

If the provider wants Medicaid to pay the coinsurance, then the provider must register as a Medicaid provider under the state rules. This is a change in policy in implementing Section 1902(n)(3)(B) of the Social Security Act (the Act), as modified by section 4714 of the Balanced Budget Act of 1997, which prohibits Medicare providers from balance-billing QMBs for Medicare cost-sharing. The CMS letter states, "All Medicare physicians, providers, and suppliers who offer services and supplies to QMBs are prohibited from billing QMBs for Medicare cost-sharing, including deductible, coinsurance, and copayments.

This section of the Act is available at. CMCS Informational Bulletin http://www.ssa.gov/OP_Home/ssact/title19/1902.htm. QMBs have no legal obligation to make further payment to a provider or Medicare managed care plan for Part A or Part B cost sharing.

Providers who inappropriately bill QMBs for Medicare cost-sharing are subject to sanctions. Please note that the statute referenced above supersedes CMS State Medicaid Manual, Chapter 3, Eligibility, 3490.14 (b), which is no longer in effect, but may be causing confusion about QMB billing." The same information was sent to providers in this Medicare Learning Network bulletin, last revised in June 26, 2018. CMS reminded Medicare Advantage plans of the rule against Balance Billing in the 2017 Call Letter for plan renewals.

See this excerpt of the 2017 call letter by Justice in Aging - Prohibition on Billing Medicare-Medicaid Enrollees for Medicare Cost Sharing 5. How do QMB Beneficiaries Show a Provider that they have QMB and cannot be Billed for the Coinsurance?. It can be difficult to show a provider that one is a QMB.

It is especially difficult for providers who are not Medicaid providers to identify QMB's, since they do not have access to online Medicaid eligibility systems Consumers can now call 1-800-MEDICARE to verify their QMB Status and report a billing issue. If a consumer reports a balance billng problem to this number, the Customer Service Rep can escalate the complaint to the Medicare Administrative Contractor (MAC), which will send a compliance letter to the provider with a copy to the consumer. See CMS Medicare Learning Network Bulletin effective Dec.

16, 2016. Medicare Summary Notices (MSNs) that Medicare beneficiaries receive every three months state that QMBs have no financial liability for co-insurance for each Medicare-covered service listed on the MSN. The Remittance Advice (RA) that Medicare sends to providers shows the same information.

By spelling out billing protections on a service-by-service basis, the MSNs provide clarity for both the QMB beneficiary and the provider. Justice in Aging has posted samples of what the new MSNs look like here. They have also updated Justice in Aging’s Improper Billing Toolkit to incorporate references to the MSNs in its model letters that you can use to advocate for clients who have been improperly billed for Medicare-covered services.

CMS is implementing systems changes that will notify providers when they process a Medicare claim that the patient is QMB and has no cost-sharing liability. The Medicare Summary Notice sent to the beneficiary will also state that the beneficiary has QMB and no liability. These changes were scheduled to go into effect in October 2017, but have been delayed.

Read more about them in this Justice in Aging Issue Brief on New Strategies in Fighting Improper Billing for QMBs (Feb. 2017). QMBs are issued a Medicaid benefit card (by mail), even if they do not also receive Medicaid.

The card is the mechanism for health care providers to bill the QMB program for the Medicare deductibles and co-pays. Unfortunately, the Medicaid card dos not indicate QMB eligibility. Not all people who have Medicaid also have QMB (they may have higher incomes and "spend down" to the Medicaid limits.

Advocates have asked for a special QMB card, or a notation on the Medicaid card to show that the individual has QMB. See this Report - a National Survey on QMB Identification Practices published by Justice in Aging, authored by Peter Travitsky, NYLAG EFLRP staff attorney. The Report, published in March 2017, documents how QMB beneficiaries could be better identified in order to ensure providers do not bill them improperly.

6. If you are Billed -​ Strategies Consumers can now call 1-800-MEDICARE to report a billing issue. If a consumer reports a balance billng problem to this number, the Customer Service Rep can escalate the complaint to the Medicare Administrative Contractor (MAC), which will send a compliance letter to the provider with a copy to the consumer.

See CMS Medicare Learning Network Bulletin effective Dec. 16, 2016. Send a letter to the provider, using the Justice In Aging Model model letters to providers to explain QMB rights.​​​ both for Original Medicare (Letters 1-2) and Medicare Advantage (Letters 3-5) - see Overview of model letters.

Include a link to the CMS Medicare Learning Network Notice. Prohibition on Balance Billing Dually Eligible Individuals Enrolled in the Qualified Medicare Beneficiary (QMB) Program (revised June 26. 2018) In January 2017, the Consumer Finance Protection Bureau issued this guide to QMB billing.

A consumer who has a problem with debt collection, may also submit a complaint online or call the CFPB at 1-855-411-2372. TTY/TDD users can call 1-855-729-2372. Medicare Advantage members should complain to their Medicare Advantage plan.

In its 2017 Call Letter, CMS stressed to Medicare Advantage contractors that federal regulations at 42 C.F.R. § 422.504 (g)(1)(iii), require that provider contracts must prohibit collection of deductibles and co-payments from dual eligibles and QMBs. Toolkit to Help Protect QMB Rights ​​In July 2015, CMS issued a report, "Access to Care Issues Among Qualified Medicare Beneficiaries (QMB's)" documenting how pervasive illegal attempts to bill QMBs for the Medicare coinsurance, including those who are members of managed care plans.

Justice in Aging, a national advocacy organization, has a project to educate beneficiaries about balance billing and to advocate for stronger protections for QMBs. Links to their webinars and other resources is at this link. Their information includes.

September 4, 2009, updated 6/20/20 by Valerie Bogart, NYLAG Author. Cathy Roberts. Author.

Geoffrey Hale This article was authored by the Empire Justice Center..

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Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization. 541 were assigned to the best natural lasix remdesivir group and 522 to the placebo group (Figure 1). Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned.

Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse best natural lasix event or a serious adverse event other than death (36 patients) or because the patient withdrew consent (13). Of those assigned to receive placebo, 518 patients (99.2%) received placebo as assigned. Fifty-three patients discontinued placebo before day 10 because of an adverse event or a best natural lasix serious adverse event other than death (36 patients), because the patient withdrew consent (15), or because the patient was found to be ineligible for trial enrollment (2).

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The analysis population included 1059 patients for whom we have at least some postbaseline data available (538 in the remdesivir best natural lasix group and 521 in the placebo group). Four of the 1063 patients were not included in the primary analysis because no postbaseline data were available at the time of the database freeze. Table 1 best natural lasix.

Table 1. Demographic and Clinical Characteristics best natural lasix at Baseline. The mean age of patients was 58.9 years, and 64.3% were male (Table 1).

On the basis of the evolving epidemiology best natural lasix of hypertension medications during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia (Table S1). Overall, 53.2% of the patients were white, 20.6% were black, 12.6% were Asian, and 13.6% were designated as other or not reported. 249 (23.4%) were Hispanic or best natural lasix Latino.

Most patients had either one (27.0%) or two or more (52.1%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (49.6%), obesity (37.0%), and type 2 diabetes mellitus (29.7%). The median number of days between symptom onset best natural lasix and randomization was 9 (interquartile range, 6 to 12). Nine hundred forty-three (88.7%) patients had severe disease at enrollment as defined in the Supplementary Appendix.

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Primary Outcome Figure 2. Figure 2 best natural lasix. Kaplan–Meier Estimates of Cumulative Recoveries.

Cumulative recovery estimates are shown in best natural lasix the overall population (Panel A), in patients with a baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 (receiving oxygen. Panel C), in those with a baseline score of 6 (receiving high-flow oxygen best natural lasix or noninvasive mechanical ventilation.

Panel D), and in those with a baseline score of 7 (receiving mechanical ventilation or ECMO. Panel E) best natural lasix. Table 2.

Table 2 best natural lasix. Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population. Figure 3 best natural lasix.

Figure 3. Time to Recovery best natural lasix According to Subgroup. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects.

Race and ethnic group were reported by the patients. Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 11 days, as best natural lasix compared with 15 days. Rate ratio for recovery, 1.32.

95% confidence best natural lasix interval [CI], 1.12 to 1.55. P<0.001. 1059 patients (Figure 2 and best natural lasix Table 2).

Among patients with a baseline ordinal score of 5 (421 patients), the rate ratio for recovery was 1.47 (95% CI, 1.17 to 1.84). Among patients with a baseline score of 4 (127 patients) and those with a baseline score of 6 (197 patients), the rate ratio estimates for recovery best natural lasix were 1.38 (95% CI, 0.94 to 2.03) and 1.20 (95% CI, 0.79 to 1.81), respectively. For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal scores of 7.

272 patients), the rate ratio for recovery was 0.95 (95% CI, best natural lasix 0.64 to 1.42). A test of interaction of treatment with baseline score on the ordinal scale was not significant. An analysis adjusting for baseline ordinal score as a stratification variable was conducted to evaluate the overall effect (of the percentage of patients in each best natural lasix ordinal score category at baseline) on the primary outcome.

This adjusted analysis produced a similar treatment-effect estimate (rate ratio for recovery, 1.31. 95% CI, best natural lasix 1.12 to 1.54. 1017 patients).

Table S2 in the Supplementary Appendix shows results according to the best natural lasix baseline severity stratum of mild-to-moderate as compared with severe. Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.28 (95% CI, 1.05 to 1.57. 664 patients), whereas patients who underwent randomization more than 10 days after the onset of symptoms best natural lasix had a rate ratio for recovery of 1.38 (95% CI, 1.05 to 1.81.

380 patients) (Figure 3). Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 best natural lasix visit, than in the placebo group (odds ratio for improvement, 1.50. 95% CI, 1.18 to 1.91.

P=0.001. 844 patients) (Table 2 and Fig. S5).

Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70. 95% CI, 0.47 to 1.04. 1059 patients).

The Kaplan–Meier estimates of mortality by 14 days were 7.1% and 11.9% in the remdesivir and placebo groups, respectively (Table 2). The Kaplan–Meier estimates of mortality by 28 days are not reported in this preliminary analysis, given the large number of patients that had yet to complete day 29 visits. An analysis with adjustment for baseline ordinal score as a stratification variable showed a hazard ratio for death of 0.74 (95% CI, 0.50 to 1.10).

Safety Outcomes Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group (Table S3). 4 events (2 in each group) were judged by site investigators to be related to remdesivir or placebo. There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients).

Acute respiratory failure, hypotension, viral pneumonia, and acute kidney injury were slightly more common among patients in the placebo group. No deaths were considered to be related to treatment assignment, as judged by the site investigators. Grade 3 or 4 adverse events occurred in 156 patients (28.8%) in the remdesivir group and in 172 in the placebo group (33.0%) (Table S4).

The most common adverse events in the remdesivir group were anemia or decreased hemoglobin (43 events [7.9%], as compared with 47 [9.0%] in the placebo group). Acute kidney injury, decreased estimated glomerular filtration rate or creatinine clearance, or increased blood creatinine (40 events [7.4%], as compared with 38 [7.3%]). Pyrexia (27 events [5.0%], as compared with 17 [3.3%]).

Hyperglycemia or increased blood glucose level (22 events [4.1%], as compared with 17 [3.3%]). And increased aminotransferase levels including alanine aminotransferase, aspartate aminotransferase, or both (22 events [4.1%], as compared with 31 [5.9%]). Otherwise, the incidence of adverse events was not found to be significantly different between the remdesivir group and the placebo group.Trial Design and Oversight The RECOVERY trial was designed to evaluate the effects of potential treatments in patients hospitalized with hypertension medications at 176 National Health Service organizations in the United Kingdom and was supported by the National Institute for Health Research Clinical Research Network.

(Details regarding this trial are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The trial is being coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although the randomization of patients to receive dexamethasone, hydroxychloroquine, or lopinavir–ritonavir has now been stopped, the trial continues randomization to groups receiving azithromycin, tocilizumab, or convalescent plasma. Hospitalized patients were eligible for the trial if they had clinically suspected or laboratory-confirmed hypertension and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial.

Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020. Pregnant or breast-feeding women were eligible. Written informed consent was obtained from all the patients or from a legal representative if they were unable to provide consent.

The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the Cambridge East Research Ethics Committee. The protocol with its statistical analysis plan is available at NEJM.org and on the trial website at www.recoverytrial.net.

The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee. The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan.

Randomization We collected baseline data using a Web-based case-report form that included demographic data, the level of respiratory support, major coexisting illnesses, suitability of the trial treatment for a particular patient, and treatment availability at the trial site. Randomization was performed with the use of a Web-based system with concealment of the trial-group assignment. Eligible and consenting patients were assigned in a 2:1 ratio to receive either the usual standard of care alone or the usual standard of care plus oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days (or until hospital discharge if sooner) or to receive one of the other suitable and available treatments that were being evaluated in the trial.

For some patients, dexamethasone was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated. These patients were excluded from entry in the randomized comparison between dexamethasone and usual care and hence were not included in this report. The randomly assigned treatment was prescribed by the treating clinician.

Patients and local members of the trial staff were aware of the assigned treatments. Procedures A single online follow-up form was to be completed when the patients were discharged or had died or at 28 days after randomization, whichever occurred first. Information was recorded regarding the patients’ adherence to the assigned treatment, receipt of other trial treatments, duration of admission, receipt of respiratory support (with duration and type), receipt of renal support, and vital status (including the cause of death).

In addition, we obtained routine health care and registry data, including information on vital status (with date and cause of death), discharge from the hospital, and respiratory and renal support therapy. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization. Further analyses were specified at 6 months.

Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death. Other prespecified clinical outcomes included cause-specific mortality, receipt of renal hemodialysis or hemofiltration, major cardiac arrhythmia (recorded in a subgroup), and receipt and duration of ventilation. Statistical Analysis As stated in the protocol, appropriate sample sizes could not be estimated when the trial was being planned at the start of the hypertension medications lasix.

As the trial progressed, the trial steering committee, whose members were unaware of the results of the trial comparisons, determined that if 28-day mortality was 20%, then the enrollment of at least 2000 patients in the dexamethasone group and 4000 in the usual care group would provide a power of at least 90% at a two-sided P value of 0.01 to detect a clinically relevant proportional reduction of 20% (an absolute difference of 4 percentage points) between the two groups. Consequently, on June 8, 2020, the steering committee closed recruitment to the dexamethasone group, since enrollment had exceeded 2000 patients. For the primary outcome of 28-day mortality, the hazard ratio from Cox regression was used to estimate the mortality rate ratio.

Among the few patients (0.1%) who had not been followed for 28 days by the time of the data cutoff on July 6, 2020, data were censored either on that date or on day 29 if the patient had already been discharged. That is, in the absence of any information to the contrary, these patients were assumed to have survived for 28 days. Kaplan–Meier survival curves were constructed to show cumulative mortality over the 28-day period.

Cox regression was used to analyze the secondary outcome of hospital discharge within 28 days, with censoring of data on day 29 for patients who had died during hospitalization. For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who were not receiving invasive mechanical ventilation at randomization), the precise date of invasive mechanical ventilation was not available, so a log-binomial regression model was used to estimate the risk ratio. Table 1.

Table 1. Characteristics of the Patients at Baseline, According to Treatment Assignment and Level of Respiratory Support. Through the play of chance in the unstratified randomization, the mean age was 1.1 years older among patients in the dexamethasone group than among those in the usual care group (Table 1).

To account for this imbalance in an important prognostic factor, estimates of rate ratios were adjusted for the baseline age in three categories (<70 years, 70 to 79 years, and ≥80 years). This adjustment was not specified in the first version of the statistical analysis plan but was added once the imbalance in age became apparent. Results without age adjustment (corresponding to the first version of the analysis plan) are provided in the Supplementary Appendix.

Prespecified analyses of the primary outcome were performed in five subgroups, as defined by characteristics at randomization. Age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk. (One further prespecified subgroup analysis regarding race will be conducted once the data collection has been completed.) In prespecified subgroups, we estimated rate ratios (or risk ratios in some analyses) and their confidence intervals using regression models that included an interaction term between the treatment assignment and the subgroup of interest.

Chi-square tests for linear trend across the subgroup-specific log estimates were then performed in accordance with the prespecified plan. All P values are two-sided and are shown without adjustment for multiple testing. All analyses were performed according to the intention-to-treat principle.

The full database is held by the trial team, which collected the data from trial sites and performed the analyses at the Nuffield Department of Population Health, University of Oxford.To the Editor The positive antibody response to the messenger RNA (mRNA) treatment described by Jackson et al. (published online on July 14 at NEJM.org)1 is a hopeful step toward controlling the hypertension medications lasix. However, this treatment and other DNA and RNA treatments against hypertension continuously stimulate cellular production of the target antigen.

A mechanism is required to be able to stop the antigen production after a period of time to avoid the possibility of eventual desensitization, as is seen with allergen immunotherapy.2-5 Without such a mechanism, a sustained lack of response may make hypertension a lot worse in the long run. It will be important to evaluate this potential before declaring that any DNA or RNA treatment is safe and efficacious. Ronald A.

Schachar, M.D., Ph.D.University of Texas at Arlington, Arlington, TX [email protected]Ira H. Schachar, M.D.Stanford University, Stanford, CA Dr. R.A.

Schachar reports being employed by Pfizer. No other potential conflict of interest relevant to this letter was reported. This letter was published on August 19, 2020, at NEJM.org.5 References1.

Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA treatment against hypertension — preliminary report. N Engl J Med.

DOI. 10.1056/NEJMoa2022483.Free Full TextGoogle Scholar2. Su Y, Romeu-Bonilla E, Anagnostou A, Fitz-Patrick D, Hearl W, Heiland T.

Safety and long-term immunological effects of CryJ2-LAMP plasmid treatment in Japanese red cedar atopic subjects. A phase I study. Hum Vaccin Immunother 2017;13:2804-2813.3.

Niezold T, Storcksdieck Genannt Bonsmann M, Maaske A, et al. DNA treatments encoding DEC205-targeted antigens. Immunity or tolerance?.

Immunology 2015;145:519-533.4. Scheiblhofer S, Thalhamer J, Weiss R. DNA and mRNA vaccination against allergies.

Pediatr Allergy Immunol 2018;29:679-688.5. Barouch DH, Kunstman J, Glowczwskie J, et al. Viral escape from dominant simian immunodeficiency lasix epitope-specific cytotoxic T lymphocytes in DNA-vaccinated rhesus monkeys.

J Virol 2003;77:7367-7375.To the Editor Jackson et al. Report the successful results of a trial of the mRNA-1273 treatment, which induced an impressive IgG antibody response. However, Jackson and colleagues, as well as Heaton,1 in her editorial corresponding to the article, did not comment on IgA.

IgA is a crucial first-line defense in mucosal tissues, and we wonder whether there was any increase in hypertension–specific IgA. The role of treatment-induced IgA is under discussion for parenteral vaccination against rotalasix.2 Since hypertension primarily infiltrates mucosal tissue, hypertension–specific IgA may be necessary for full protection. Moreover, the lack of IgA may cause unprotected spread of hypertension from nasal mucosal tissue.

Chumakov and colleagues discussed the use of oral polio treatment to ameliorate or prevent hypertension medications.3 In both nasal and intestinal cells, Sungnak et al. Detected angiotensin-converting enzyme 2 (ACE2), which is crucial for binding of hypertension, and transmembrane serine protease 2 (TMPRSS2), which is crucial for uptake of the lasix.4 Thus, the intestinal and nasal mucosa are ideal targets for hypertension and for vaccination to trigger IgA responses. Studies of an oral treatment containing attenuated hypertension to stimulate an early protective systemic immune response by the highly effective gut-associated immune system are warranted.

Juergen R. Schaefer, M.D.Yulia Sharkova, M.D.Tanja Nickolaus, M.D.University Clinic Marburg, Marburg, Germany [email protected] No potential conflict of interest relevant to this letter was reported. This letter was published on August 19, 2020, at NEJM.org.4 References1.

Heaton PM. The hypertension medications treatment-development multiverse. N Engl J Med.

DOI. 10.1056/NEJMe2025111.Free Full TextGoogle Scholar2. Bines JE, Kotloff KL.

Next-generation rotalasix treatments. Important progress but work still to be done. Lancet Infect Dis 2020;20:762-764.3.

Chumakov K, Benn CS, Aaby P, Kottilil S, Gallo R. Can existing live treatments prevent hypertension medications?. Science 2020;368:1187-1188.4.

Sungnak W, Huang N, Bécavin C, et al. hypertension entry factors are highly expressed in nasal epithelial cells together with innate immune genes. Nat Med 2020;26:681-687.Response The authors reply.

We agree with Schachar and Schachar that the interim findings of the phase 1 trial of the mRNA-1273 treatment against hypertension are promising. These findings provided support for the initiation of the phase 2 and 3 trials that are under way. This treatment is a lipid nanoparticle–encapsidated, nonreplicating, nucleoside-modified mRNA–based treatment that, after entering the cell cytoplasm, results in rapid, transient expression of the treatment antigen.1 The question regarding the duration of immunity is important, and the phase 1 and 2 trials are designed to follow participants for 1 year after the second vaccination and to obtain samples to characterize humoral and cellular immunologic responses.

The phase 3 trial is designed to follow participants for 2 years in order to allow assessment of the durability of protective immunity during that interval. In reply to Schaefer and colleagues. IgA and IgM responses are exploratory immunologic end points in the phase 1 trial, and reporting of these findings is planned as part of the reporting of the final results.

The role of monomeric IgA induced by parenteral treatments is unknown, and monomeric IgA is unlikely to reach the mucosal compartment in substantial quantities. Mucosal delivery of treatment would be needed to reliably induce secretory IgA localized in mucosal tissues. In a study of hypertension and the use of mRNA-1273 in nonhuman primates, intramuscular administration of the treatment protected the animals against upper- and lower-airway challenge with hypertension, and S-specific IgG and IgA were detected in bronchoalveolar-lavage fluid after the challenge.2 Although these findings may suggest that antibody responses correlate with protection, as noted by Corbett et al.,2 further evaluations, including passive-transfer studies and challenge studies of lower, subprotective treatment doses in nonhuman primates, are warranted to further elucidate antibody specificities or functions that correlate with protection.

Lisa A. Jackson, M.D., M.P.H.Kaiser Permanente Washington Health Research Institute, Seattle, WA [email protected]Paul C. Roberts, Ph.D.Barney S.

Graham, M.D., Ph.D.National Institute of Allergy and Infectious Diseases, Bethesda, MD Since publication of their article, the authors report no further potential conflict of interest. This letter was published on August 19, 2020, at NEJM.org.2 References1. Bahl K, Senn JJ, Yuzhakov O, et al.

Preclinical and clinical demonstration of immunogenicity by mRNA treatments against H10N8 and H7N9 influenza lasixes. Mol Ther 2017;25:1316-1327.2. Corbett KS, Flynn B, Foulds KE, et al.

Evaluation of the mRNA-1273 treatment against hypertension in nonhuman primates. N Engl J Med. DOI.

10.1056/NEJMoa2024671.Free Full TextGoogle Scholar.

Patients Figure 1 lasix 40mg cost. Figure 1. Enrollment and lasix 40mg cost Randomization. Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization.

541 were assigned to lasix 40mg cost the remdesivir group and 522 to the placebo group (Figure 1). Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned. Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death (36 patients) or because lasix 40mg cost the patient withdrew consent (13). Of those assigned to receive placebo, 518 patients (99.2%) received placebo as assigned.

Fifty-three patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death (36 patients), because the patient withdrew consent (15), or because the patient was found to be ineligible for lasix 40mg cost trial enrollment (2). As of April 28, 2020, a total of 391 patients in the remdesivir group and 340 in the placebo group had completed the trial through day 29, recovered, or died. Eight patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day lasix 40mg cost 29. There were 132 patients in the remdesivir group and 169 in the placebo group who had not recovered and had not completed the day 29 follow-up visit.

The analysis population included 1059 patients for whom we have at least some postbaseline lasix 40mg cost data available (538 in the remdesivir group and 521 in the placebo group). Four of the 1063 patients were not included in the primary analysis because no postbaseline data were available at the time of the database freeze. Table 1 lasix 40mg cost. Table 1.

Demographic and Clinical lasix 40mg cost Characteristics at Baseline. The mean age of patients was 58.9 years, and 64.3% were male (Table 1). On the basis of the evolving epidemiology of hypertension medications during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% lasix 40mg cost in Asia (Table S1). Overall, 53.2% of the patients were white, 20.6% were black, 12.6% were Asian, and 13.6% were designated as other or not reported.

249 (23.4%) lasix 40mg cost were Hispanic or Latino. Most patients had either one (27.0%) or two or more (52.1%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (49.6%), obesity (37.0%), and type 2 diabetes mellitus (29.7%). The median number of days between symptom onset lasix 40mg cost and randomization was 9 (interquartile range, 6 to 12). Nine hundred forty-three (88.7%) patients had severe disease at enrollment as defined in the Supplementary Appendix.

272 (25.6%) patients met category 7 criteria on the ordinal scale, 197 (18.5%) category 6, 421 (39.6%) category 5, and 127 (11.9%) category 4 lasix 40mg cost. There were 46 (4.3%) patients who had missing ordinal scale data at enrollment. No substantial imbalances in baseline characteristics were observed between the remdesivir group and lasix 40mg cost the placebo group. Primary Outcome Figure 2.

Figure 2 lasix 40mg cost. Kaplan–Meier Estimates of Cumulative Recoveries. Cumulative recovery estimates are shown in the lasix 40mg cost overall population (Panel A), in patients with a baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 (receiving oxygen.

Panel C), lasix 40mg cost in those with a baseline score of 6 (receiving high-flow oxygen or noninvasive mechanical ventilation. Panel D), and in those with a baseline score of 7 (receiving mechanical ventilation or ECMO. Panel E) lasix 40mg cost. Table 2.

Table 2 lasix 40mg cost. Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population. Figure 3 lasix 40mg cost. Figure 3.

Time to Recovery According to Subgroup lasix 40mg cost. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects. Race and ethnic group were reported by the patients. Patients in the remdesivir group lasix 40mg cost had a shorter time to recovery than patients in the placebo group (median, 11 days, as compared with 15 days.

Rate ratio for recovery, 1.32. 95% confidence lasix 40mg cost interval [CI], 1.12 to 1.55. P<0.001. 1059 patients (Figure lasix 40mg cost 2 and Table 2).

Among patients with a baseline ordinal score of 5 (421 patients), the rate ratio for recovery was 1.47 (95% CI, 1.17 to 1.84). Among patients with a baseline score of 4 (127 patients) and those with a baseline score of 6 (197 patients), lasix 40mg cost the rate ratio estimates for recovery were 1.38 (95% CI, 0.94 to 2.03) and 1.20 (95% CI, 0.79 to 1.81), respectively. For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal scores of 7. 272 patients), the lasix 40mg cost rate ratio for recovery was 0.95 (95% CI, 0.64 to 1.42).

A test of interaction of treatment with baseline score on the ordinal scale was not significant. An analysis adjusting for baseline ordinal score as a stratification variable was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome lasix 40mg cost. This adjusted analysis produced a similar treatment-effect estimate (rate ratio for recovery, 1.31. 95% CI, 1.12 to 1.54 lasix 40mg cost.

1017 patients). Table S2 lasix 40mg cost in the Supplementary Appendix shows results according to the baseline severity stratum of mild-to-moderate as compared with severe. Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.28 (95% CI, 1.05 to 1.57. 664 patients), whereas patients who underwent lasix 40mg cost randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.38 (95% CI, 1.05 to 1.81.

380 patients) (Figure 3). Key Secondary Outcome The odds of improvement lasix 40mg cost in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.50. 95% CI, 1.18 to 1.91. P=0.001.

844 patients) (Table 2 and Fig. S5). Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70. 95% CI, 0.47 to 1.04.

1059 patients). The Kaplan–Meier estimates of mortality by 14 days were 7.1% and 11.9% in the remdesivir and placebo groups, respectively (Table 2). The Kaplan–Meier estimates of mortality by 28 days are not reported in this preliminary analysis, given the large number of patients that had yet to complete day 29 visits. An analysis with adjustment for baseline ordinal score as a stratification variable showed a hazard ratio for death of 0.74 (95% CI, 0.50 to 1.10).

Safety Outcomes Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group (Table S3). 4 events (2 in each group) were judged by site investigators to be related to remdesivir or placebo. There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients). Acute respiratory failure, hypotension, viral pneumonia, and acute kidney injury were slightly more common among patients in the placebo group.

No deaths were considered to be related to treatment assignment, as judged by the site investigators. Grade 3 or 4 adverse events occurred in 156 patients (28.8%) in the remdesivir group and in 172 in the placebo group (33.0%) (Table S4). The most common adverse events in the remdesivir group were anemia or decreased hemoglobin (43 events [7.9%], as compared with 47 [9.0%] in the placebo group). Acute kidney injury, decreased estimated glomerular filtration rate or creatinine clearance, or increased blood creatinine (40 events [7.4%], as compared with 38 [7.3%]).

Pyrexia (27 events [5.0%], as compared with 17 [3.3%]). Hyperglycemia or increased blood glucose level (22 events [4.1%], as compared with 17 [3.3%]). And increased aminotransferase levels including alanine aminotransferase, aspartate aminotransferase, or both (22 events [4.1%], as compared with 31 [5.9%]). Otherwise, the incidence of adverse events was not found to be significantly different between the remdesivir group and the placebo group.Trial Design and Oversight The RECOVERY trial was designed to evaluate the effects of potential treatments in patients hospitalized with hypertension medications at 176 National Health Service organizations in the United Kingdom and was supported by the National Institute for Health Research Clinical Research Network.

(Details regarding this trial are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The trial is being coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although the randomization of patients to receive dexamethasone, hydroxychloroquine, or lopinavir–ritonavir has now been stopped, the trial continues randomization to groups receiving azithromycin, tocilizumab, or convalescent plasma. Hospitalized patients were eligible for the trial if they had clinically suspected or laboratory-confirmed hypertension and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial. Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020.

Pregnant or breast-feeding women were eligible. Written informed consent was obtained from all the patients or from a legal representative if they were unable to provide consent. The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the Cambridge East Research Ethics Committee.

The protocol with its statistical analysis plan is available at NEJM.org and on the trial website at www.recoverytrial.net. The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee. The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan.

Randomization We collected baseline data using a Web-based case-report form that included demographic data, the level of respiratory support, major coexisting illnesses, suitability of the trial treatment for a particular patient, and treatment availability at the trial site. Randomization was performed with the use of a Web-based system with concealment of the trial-group assignment. Eligible and consenting patients were assigned in a 2:1 ratio to receive either the usual standard of care alone or the usual standard of care plus oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days (or until hospital discharge if sooner) or to receive one of the other suitable and available treatments that were being evaluated in the trial. For some patients, dexamethasone was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated.

These patients were excluded from entry in the randomized comparison between dexamethasone and usual care and hence were not included in this report. The randomly assigned treatment was prescribed by the treating clinician. Patients and local members of the trial staff were aware of the assigned treatments. Procedures A single online follow-up form was to be completed when the patients were discharged or had died or at 28 days after randomization, whichever occurred first.

Information was recorded regarding the patients’ adherence to the assigned treatment, receipt of other trial treatments, duration of admission, receipt of respiratory support (with duration and type), receipt of renal support, and vital status (including the cause of death). In addition, we obtained routine health care and registry data, including information on vital status (with date and cause of death), discharge from the hospital, and respiratory and renal support therapy. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization. Further analyses were specified at 6 months.

Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death. Other prespecified clinical outcomes included cause-specific mortality, receipt of renal hemodialysis or hemofiltration, major cardiac arrhythmia (recorded in a subgroup), and receipt and duration of ventilation. Statistical Analysis As stated in the protocol, appropriate sample sizes could not be estimated when the trial was being planned at the start of the hypertension medications lasix. As the trial progressed, the trial steering committee, whose members were unaware of the results of the trial comparisons, determined that if 28-day mortality was 20%, then the enrollment of at least 2000 patients in the dexamethasone group and 4000 in the usual care group would provide a power of at least 90% at a two-sided P value of 0.01 to detect a clinically relevant proportional reduction of 20% (an absolute difference of 4 percentage points) between the two groups.

Consequently, on June 8, 2020, the steering committee closed recruitment to the dexamethasone group, since enrollment had exceeded 2000 patients. For the primary outcome of 28-day mortality, the hazard ratio from Cox regression was used to estimate the mortality rate ratio. Among the few patients (0.1%) who had not been followed for 28 days by the time of the data cutoff on July 6, 2020, data were censored either on that date or on day 29 if the patient had already been discharged. That is, in the absence of any information to the contrary, these patients were assumed to have survived for 28 days.

Kaplan–Meier survival curves were constructed to show cumulative mortality over the 28-day period. Cox regression was used to analyze the secondary outcome of hospital discharge within 28 days, with censoring of data on day 29 for patients who had died during hospitalization. For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who were not receiving invasive mechanical ventilation at randomization), the precise date of invasive mechanical ventilation was not available, so a log-binomial regression model was used to estimate the risk ratio. Table 1.

Table 1. Characteristics of the Patients at Baseline, According to Treatment Assignment and Level of Respiratory Support. Through the play of chance in the unstratified randomization, the mean age was 1.1 years older among patients in the dexamethasone group than among those in the usual care group (Table 1). To account for this imbalance in an important prognostic factor, estimates of rate ratios were adjusted for the baseline age in three categories (<70 years, 70 to 79 years, and ≥80 years).

This adjustment was not specified in the first version of the statistical analysis plan but was added once the imbalance in age became apparent. Results without age adjustment (corresponding to the first version of the analysis plan) are provided in the Supplementary Appendix. Prespecified analyses of the primary outcome were performed in five subgroups, as defined by characteristics at randomization. Age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk.

(One further prespecified subgroup analysis regarding race will be conducted once the data collection has been completed.) In prespecified subgroups, we estimated rate ratios (or risk ratios in some analyses) and their confidence intervals using regression models that included an interaction term between the treatment assignment and the subgroup of interest. Chi-square tests for linear trend across the subgroup-specific log estimates were then performed in accordance with the prespecified plan. All P values are two-sided and are shown without adjustment for multiple testing. All analyses were performed according to the intention-to-treat principle.

The full database is held by the trial team, which collected the data from trial sites and performed the analyses at the Nuffield Department of Population Health, University of Oxford.To the Editor The positive antibody response to the messenger RNA (mRNA) treatment described by Jackson et al. (published online on July 14 at NEJM.org)1 is a hopeful step toward controlling the hypertension medications lasix. However, this treatment and other DNA and RNA treatments against hypertension continuously stimulate cellular production of the target antigen. A mechanism is required to be able to stop the antigen production after a period of time to avoid the possibility of eventual desensitization, as is seen with allergen immunotherapy.2-5 Without such a mechanism, a sustained lack of response may make hypertension a lot worse in the long run.

It will be important to evaluate this potential before declaring that any DNA or RNA treatment is safe and efficacious. Ronald A. Schachar, M.D., Ph.D.University of Texas at Arlington, Arlington, TX [email protected]Ira H. Schachar, M.D.Stanford University, Stanford, CA Dr.

R.A. Schachar reports being employed by Pfizer. No other potential conflict of interest relevant to this letter was reported. This letter was published on August 19, 2020, at NEJM.org.5 References1.

Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA treatment against hypertension — preliminary report. N Engl J Med. DOI.

10.1056/NEJMoa2022483.Free Full TextGoogle Scholar2. Su Y, Romeu-Bonilla E, Anagnostou A, Fitz-Patrick D, Hearl W, Heiland T. Safety and long-term immunological effects of CryJ2-LAMP plasmid treatment in Japanese red cedar atopic subjects. A phase I study.

Hum Vaccin Immunother 2017;13:2804-2813.3. Niezold T, Storcksdieck Genannt Bonsmann M, Maaske A, et al. DNA treatments encoding DEC205-targeted antigens. Immunity or tolerance?.

Immunology 2015;145:519-533.4. Scheiblhofer S, Thalhamer J, Weiss R. DNA and mRNA vaccination against allergies. Pediatr Allergy Immunol 2018;29:679-688.5.

Barouch DH, Kunstman J, Glowczwskie J, et al. Viral escape from dominant simian immunodeficiency lasix epitope-specific cytotoxic T lymphocytes in DNA-vaccinated rhesus monkeys. J Virol 2003;77:7367-7375.To the Editor Jackson et al. Report the successful results of a trial of the mRNA-1273 treatment, which induced an impressive IgG antibody response.

However, Jackson and colleagues, as well as Heaton,1 in her editorial corresponding to the article, did not comment on IgA. IgA is a crucial first-line defense in mucosal tissues, and we wonder whether there was any increase in hypertension–specific IgA. The role of treatment-induced IgA is under discussion for parenteral vaccination against rotalasix.2 Since hypertension primarily infiltrates mucosal tissue, hypertension–specific IgA may be necessary for full protection. Moreover, the lack of IgA may cause unprotected spread of hypertension from nasal mucosal tissue.

Chumakov and colleagues discussed the use of oral polio treatment to ameliorate or prevent hypertension medications.3 In both nasal and intestinal cells, Sungnak et al. Detected angiotensin-converting enzyme 2 (ACE2), which is crucial for binding of hypertension, and transmembrane serine protease 2 (TMPRSS2), which is crucial for uptake of the lasix.4 Thus, the intestinal and nasal mucosa are ideal targets for hypertension and for vaccination to trigger IgA responses. Studies of an oral treatment containing attenuated hypertension to stimulate an early protective systemic immune response by the highly effective gut-associated immune system are warranted. Juergen R.

Schaefer, M.D.Yulia Sharkova, M.D.Tanja Nickolaus, M.D.University Clinic Marburg, Marburg, Germany [email protected] No potential conflict of interest relevant to this letter was reported. This letter was published on August 19, 2020, at NEJM.org.4 References1. Heaton PM. The hypertension medications treatment-development multiverse.

N Engl J Med. DOI. 10.1056/NEJMe2025111.Free Full TextGoogle Scholar2. Bines JE, Kotloff KL.

Next-generation rotalasix treatments. Important progress but work still to be done. Lancet Infect Dis 2020;20:762-764.3. Chumakov K, Benn CS, Aaby P, Kottilil S, Gallo R.

Can existing live treatments prevent hypertension medications?. Science 2020;368:1187-1188.4. Sungnak W, Huang N, Bécavin C, et al. hypertension entry factors are highly expressed in nasal epithelial cells together with innate immune genes.

Nat Med 2020;26:681-687.Response The authors reply. We agree with Schachar and Schachar that the interim findings of the phase 1 trial of the mRNA-1273 treatment against hypertension are promising. These findings provided support for the initiation of the phase 2 and 3 trials that are under way. This treatment is a lipid nanoparticle–encapsidated, nonreplicating, nucleoside-modified mRNA–based treatment that, after entering the cell cytoplasm, results in rapid, transient expression of the treatment antigen.1 The question regarding the duration of immunity is important, and the phase 1 and 2 trials are designed to follow participants for 1 year after the second vaccination and to obtain samples to characterize humoral and cellular immunologic responses.

The phase 3 trial is designed to follow participants for 2 years in order to allow assessment of the durability of protective immunity during that interval. In reply to Schaefer and colleagues. IgA and IgM responses are exploratory immunologic end points in the phase 1 trial, and reporting of these findings is planned as part of the reporting of the final results. The role of monomeric IgA induced by parenteral treatments is unknown, and monomeric IgA is unlikely to reach the mucosal compartment in substantial quantities.

Mucosal delivery of treatment would be needed to reliably induce secretory IgA localized in mucosal tissues. In a study of hypertension and the use of mRNA-1273 in nonhuman primates, intramuscular administration of the treatment protected the animals against upper- and lower-airway challenge with hypertension, and S-specific IgG and IgA were detected in bronchoalveolar-lavage fluid after the challenge.2 Although these findings may suggest that antibody responses correlate with protection, as noted by Corbett et al.,2 further evaluations, including passive-transfer studies and challenge studies of lower, subprotective treatment doses in nonhuman primates, are warranted to further elucidate antibody specificities or functions that correlate with protection. Lisa A. Jackson, M.D., M.P.H.Kaiser Permanente Washington Health Research Institute, Seattle, WA [email protected]Paul C.

Roberts, Ph.D.Barney S. Graham, M.D., Ph.D.National Institute of Allergy and Infectious Diseases, Bethesda, MD Since publication of their article, the authors report no further potential conflict of interest. This letter was published on August 19, 2020, at NEJM.org.2 References1. Bahl K, Senn JJ, Yuzhakov O, et al.

Preclinical and clinical demonstration of immunogenicity by mRNA treatments against H10N8 and H7N9 influenza lasixes. Mol Ther 2017;25:1316-1327.2. Corbett KS, Flynn B, Foulds KE, et al. Evaluation of the mRNA-1273 treatment against hypertension in nonhuman primates.

N Engl J Med. DOI. 10.1056/NEJMoa2024671.Free Full TextGoogle Scholar.

Can dogs take lasix for humans

Participants Figure can dogs take lasix for humans 1 her explanation. Figure 1. Enrollment and can dogs take lasix for humans Randomization. The diagram represents all enrolled participants through November 14, 2020. The safety subset (those with a median of 2 months of follow-up, in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date.

The further procedures that one participant in the placebo can dogs take lasix for humans group declined after dose 2 (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.Table 1. Table 1. Demographic Characteristics of the Participants in the Main Safety Population. Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons can dogs take lasix for humans 16 years of age or older underwent randomization at 152 sites worldwide (United States, 130 sites. Argentina, 1.

Brazil, 2. South Africa, can dogs take lasix for humans 4. Germany, 6. And Turkey, 9) in the phase 2/3 portion of the trial. A total of can dogs take lasix for humans 43,448 participants received injections.

21,720 received BNT162b2 and 21,728 received placebo (Figure 1). At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months can dogs take lasix for humans of safety data available after the second dose and contributed to the main safety data set. Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of participants were older than 55 years of age (Table 1 and Table S2). Safety Local can dogs take lasix for humans Reactogenicity Figure 2.

Figure 2. Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions can dogs take lasix for humans and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after each vaccination. Solicited injection-site (local) reactions are shown in Panel A. Pain at the injection site was assessed according to the following scale.

Mild, does can dogs take lasix for humans not interfere with activity. Moderate, interferes with activity. Severe, prevents daily activity. And grade 4, emergency department visit or can dogs take lasix for humans hospitalization. Redness and swelling were measured according to the following scale.

Mild, 2.0 to 5.0 cm in diameter. Moderate, >5.0 to 10.0 cm can dogs take lasix for humans in diameter. Severe, >10.0 cm in diameter. And grade 4, necrosis can dogs take lasix for humans or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown in Panel B.

Fever categories are designated in the key. Medication use was can dogs take lasix for humans not graded. Additional scales were as follows. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild. Does not interfere with can dogs take lasix for humans activity.

Moderate. Some interference with activity. Or severe can dogs take lasix for humans. Prevents daily activity), vomiting (mild. 1 to 2 times in 24 hours.

Moderate. >2 times in 24 hours. Or severe. Requires intravenous hydration), and diarrhea (mild. 2 to 3 loose stools in 24 hours.

Moderate. 4 to 5 loose stools in 24 hours. Or severe. 6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization.

Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants. Overall, BNT162b2 recipients reported more local reactions than placebo recipients. Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose. 66% after the second dose) than among younger participants (83% after the first dose.

78% after the second dose). A noticeably lower percentage of participants reported injection-site redness or swelling. The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B).

The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients). The frequency of any severe systemic event after the first dose was 0.9% or less. Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose.

Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients. Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the treatment and placebo groups reported temperatures above 40.0°C. Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1. 45% after dose 2) than older treatment recipients (20% after dose 1.

38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter. Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3).

More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy. Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia).

Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the treatment or placebo. No hypertension medications–associated deaths were observed. No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of treatment.

Efficacy Table 2. Table 2. treatment Efficacy against hypertension medications at Least 7 days after the Second Dose. Table 3. Table 3.

treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2. Figure 3. Figure 3. Efficacy of BNT162b2 against hypertension medications after the First Dose. Shown is the cumulative incidence of hypertension medications after the first dose (modified intention-to-treat population).

Each symbol represents hypertension medications cases starting on a given day. Filled symbols represent severe hypertension medications cases. Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point.

The time period for hypertension medications case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior hypertension , 8 cases of hypertension medications with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients. This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6. Table 2). Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of hypertension medications at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3).

Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4). treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%. 95% CI, 68.7 to 99.9. Case split. BNT162b2, 2 cases.

Placebo, 44 cases). Figure 3 shows cases of hypertension medications or severe hypertension medications with onset at any time after the first dose (mITT population) (additional data on severe hypertension medications are available in Table S5). Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a treatment efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the treatment, starting as soon as 12 days after the first dose.Trial Oversight This phase 3 randomized, stratified, observer-blinded, placebo-controlled trial enrolled adults in medically stable condition at 99 U.S. Sites. Participants received the first trial injection between July 27 and October 23, 2020.

The trial is being conducted in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practice guidelines, and applicable government regulations. The central institutional review board approved the protocol and the consent forms. All participants provided written informed consent before enrollment. Safety is reviewed by a protocol safety review team weekly and by an independent data and safety monitoring board on a continual basis. The trial Investigational New Drug sponsor, Moderna, was responsible for the overall trial design (with input from the Biomedical Advanced Research and Development Authority, the NIAID, the hypertension medications Prevention Network, and the trial cochairs), site selection and monitoring, and data analysis.

Investigators are responsible for data collection. A medical writer funded by Moderna assisted in drafting the manuscript for submission. The authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol. The trial is ongoing, and the investigators remain unaware of participant-level data. Designated team members within Moderna have unblinded access to the data, to facilitate interface with the regulatory agencies and the data and safety monitoring board.

All other trial staff and participants remain unaware of the treatment assignments. Participants, Randomization, and Data Blinding Eligible participants were persons 18 years of age or older with no known history of hypertension and with locations or circumstances that put them at an appreciable risk of hypertension , a high risk of severe hypertension medications, or both. Inclusion and exclusion criteria are provided in the protocol (available with the full text of this article at NEJM.org). To enhance the diversity of the trial population in accordance with Food and Drug Administration Draft Guidance, site-selection and enrollment processes were adjusted to increase the number of persons from racial and ethnic minorities in the trial, in addition More Help to the persons at risk for hypertension in the local population. The upper limit for stratification of enrolled participants considered to be “at risk for severe illness” at screening was increased from 40% to 50%.17 Participants were randomly assigned in a 1:1 ratio, through the use of a centralized interactive response technology system, to receive treatment or placebo.

Assignment was stratified, on the basis of age and hypertension medications complications risk criteria, into the following risk groups. Persons 65 years of age or older, persons younger than 65 years of age who were at heightened risk (at risk) for severe hypertension medications, and persons younger than 65 years of age without heightened risk (not at risk). Participants younger than 65 years of age were categorized as having risk for severe hypertension medications if they had at least one of the following risk factors, based on the Centers for Disease Control and Prevention (CDC) criteria available at the time of trial design. Chronic lung disease (e.g., emphysema, chronic bronchitis, idiopathic pulmonary fibrosis, cystic fibrosis, or moderate-to-severe asthma). Cardiac disease (e.g., heart failure, congenital coronary artery disease, cardiomyopathies, or pulmonary hypertension).

Severe obesity (body mass index [the weight in kilograms divided by the square of the height in meters] ≥40). Diabetes (type 1, type 2, or gestational). Liver disease. Or with the human immunodeficiency lasix.18 treatment dose preparation and administration were performed by pharmacists and treatment administrators who were aware of treatment assignments but had no other role in the conduct of the trial. Once the injection was completed, only trial staff who were unaware of treatment assignments performed assessments and interacted with the participants.

Access to the randomization code was strictly controlled at the pharmacy. The data and safety monitoring board reviewed efficacy data at the group level and unblinded safety data at the participant level. Trial treatment The mRNA-1273 treatment, provided as a sterile liquid at a concentration of 0.2 mg per milliliter, was administered by injection into the deltoid muscle according to a two-dose regimen. Injections were given 28 days apart, in the same arm, in a volume of 0.5 ml containing 100 μg of mRNA-1273 or saline placebo.1 treatment mRNA-1273 was stored at 2° to 8°C (35.6° to 46.4°F) at clinical sites before preparation and vaccination. No dilution was required.

Doses could be held in syringes for up to 8 hours at room temperature before administration. Safety Assessments Safety assessments included monitoring of solicited local and systemic adverse events for 7 days after each injection. Unsolicited adverse reactions for 28 days after each injection. Adverse events leading to discontinuation from a dose, from participation in the trial, or both. And medically attended adverse events and serious adverse events from day 1 through day 759.

Adverse event grading criteria and toxicity tables are described in the protocol. Cases of hypertension medications and severe hypertension medications were continuously monitored by the data and safety monitoring board from randomization onward. Efficacy Assessments The primary end point was the efficacy of the mRNA-1273 treatment in preventing a first occurrence of symptomatic hypertension medications with onset at least 14 days after the second injection in the per-protocol population, among participants who were seronegative at baseline. End points were judged by an independent adjudication committee that was unaware of group assignment. hypertension medications cases were defined as occurring in participants who had at least two of the following symptoms.

Fever (temperature ≥38°C), chills, myalgia, headache, sore throat, or new olfactory or taste disorder, or as occurring in those who had at least one respiratory sign or symptom (including cough, shortness of breath, or clinical or radiographic evidence of pneumonia) and at least one nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if the participant was hospitalized) that was positive for hypertension by reverse-transcriptase–polymerase-chain-reaction (RT-PCR) test. Participants were assessed for the presence of hypertension–binding antibodies specific to the hypertension nucleocapsid protein (Roche Elecsys, Roche Diagnostics International) and had a nasopharyngeal swab for hypertension RT-PCR testing (Viracor, Eurofins Clinical Diagnostics) before each injection. hypertension–infected volunteers were followed daily, to assess symptom severity, for 14 days or until symptoms resolved, whichever was longer. A nasopharyngeal swab for RT-PCR testing and a blood sample for identifying serologic evidence of hypertension were collected from participants with symptoms of hypertension medications. The consistency of treatment efficacy at the primary end point was evaluated across various subgroups, including age groups (18 to <65 years of age and ≥65 years), age and health risk for severe disease (18 to <65 years and not at risk.

18 to <65 years and at risk. And ≥65 years), sex (female or male), race and ethnic group, and risk for severe hypertension medications illness. If the number of participants in a subgroup was too small, it was combined with other subgroups for the subgroup analyses. A secondary end point was the efficacy of mRNA-1273 in the prevention of severe hypertension medications as defined by one of the following criteria. Respiratory rate of 30 or more breaths per minute.

Heart rate at or exceeding 125 beats per minute. Oxygen saturation at 93% or less while the participant was breathing ambient air at sea level or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen below 300 mm Hg. Respiratory failure. Acute respiratory distress syndrome. Evidence of shock (systolic blood pressure <90 mm Hg, diastolic blood pressure <60 mm Hg, or a need for vasopressors).

Clinically significant acute renal, hepatic, or neurologic dysfunction. Admission to an intensive care unit. Or death. Additional secondary end points included the efficacy of the treatment at preventing hypertension medications after a single dose or at preventing hypertension medications according to a secondary (CDC), less restrictive case definition. Having any symptom of hypertension medications and a positive hypertension test by RT-PCR (see Table S1 in the Supplementary Appendix, available at NEJM.org).

Statistical Analysis For analysis of the primary end point, the trial was designed for the null hypothesis that the efficacy of the mRNA-1273 treatment is 30% or less. A total of 151 cases of hypertension medications would provide 90% power to detect a 60% reduction in the hazard rate (i.e., 60% treatment efficacy), with two planned interim analyses at approximately 35% and 70% of the target total number of cases (151) and with a one-sided O’Brien–Fleming boundary for efficacy and an overall one-sided error rate of 0.025. The efficacy of the mRNA-1273 treatment could be demonstrated at either the interim or the primary analysis, performed when the target total number of cases had been observed. The Lan–DeMets alpha-spending function was used for calculating efficacy boundaries at each analysis. At the first interim analysis on November 15, 2020, treatment efficacy had been demonstrated in accordance with the prespecified statistical criteria.

The treatment efficacy estimate, based on a total of 95 adjudicated cases (63% of the target total), was 94.5%, with a one-sided P value of less than 0.001 to reject the null hypothesis that treatment efficacy would be 30% or less. The data and safety monitoring board recommendation to the oversight group and the trial sponsor was that the efficacy findings should be shared with the participants and the community (full details are available in the protocol and statistical analysis plan). treatment efficacy was assessed in the full analysis population (randomized participants who received at least one dose of mRNA-1273 or placebo), the modified intention-to-treat population (participants in the full analysis population who had no immunologic or virologic evidence of hypertension medications on day 1, before the first dose), and the per-protocol population (participants in the modified intention-to-treat population who received two doses, with no major protocol deviations). The primary efficacy end point in the interim and primary analyses was assessed in the per-protocol population. Participants were evaluated in the treatment groups to which they were assigned.

treatment efficacy was defined as the percentage reduction in the hazard ratio for the primary end point (mRNA-1273 vs. Placebo). A stratified Cox proportional hazards model was used to assess the treatment efficacy of mRNA-1273 as compared with placebo in terms of the percentage hazard reduction. (Details regarding the analysis of treatment efficacy are provided in the Methods section of the Supplementary Appendix.) Safety was assessed in all participants in the solicited safety population (i.e., those who received at least one injection and reported a solicited adverse event). Descriptive summary data (numbers and percentages) for participants with any solicited adverse events, unsolicited adverse events, unsolicited severe adverse events, serious adverse events, medically attended adverse events, and adverse events leading to discontinuation of the injections or withdrawal from the trial are provided by group.

Two-sided 95% exact confidence intervals (Clopper–Pearson method) are provided for the percentages of participants with solicited adverse events. Unsolicited adverse events are presented according to the Medical Dictionary for Regulatory Activities (MedDRA), version 23.0, preferred terms and system organ class categories. To meet the regulatory agencies’ requirement of a median follow-up duration of at least 2 months after completion of the two-dose regimen, a second analysis was performed, with an efficacy data cutoff date of November 21, 2020. This second analysis is considered the primary analysis of efficacy, with a total of 196 adjudicated hypertension medications cases in the per-protocol population, which exceeds the target total number of cases (151) specified in the protocol. This was an increase from the 95 cases observed at the first interim analysis data cutoff on November 11, 2020.

Results from the primary analysis are presented in this report. Subsequent analyses are considered supplementary.Baseline Anti-Spike IgG Assays and PCR Testing Rates Table 1. Table 1. Demographic Characteristics and hypertension PCR Testing for 12,541 Health Care Workers According to hypertension Anti-Spike IgG Status. A total of 12,541 health care workers underwent measurement of baseline anti-spike antibodies.

11,364 (90.6%) were seronegative and 1177 (9.4%) seropositive at their first anti-spike IgG assay, and seroconversion occurred in 88 workers during the study (Table 1, and Fig. S1A in the Supplementary Appendix). Of 1265 seropositive health care workers, 864 (68%) recalled having had symptoms consistent with those of hypertension disease 2019 (hypertension medications), including symptoms that preceded the widespread availability of PCR testing for hypertension. 466 (37%) had had a previous PCR-confirmed hypertension , of which 262 were symptomatic. Fewer seronegative health care workers (2860 [25% of the 11,364 who were seronegative]) reported prebaseline symptoms, and 24 (all symptomatic, 0.2%) were previously PCR-positive.

The median age of seronegative and seropositive health care workers was 38 years (interquartile range, 29 to 49). Health care workers were followed for a median of 200 days (interquartile range, 180 to 207) after a negative antibody test and for 139 days at risk (interquartile range, 117 to 147) after a positive antibody test. Rates of symptomatic PCR testing were similar in seronegative and seropositive health care workers. 8.7 and 8.0 tests per 10,000 days at risk, respectively (rate ratio, 0.92. 95% confidence interval [CI], 0.77 to 1.10).

A total of 8850 health care workers had at least one postbaseline asymptomatic screening test. Seronegative health care workers attended asymptomatic screening more frequently than seropositive health care workers (141 vs. 108 per 10,000 days at risk, respectively. Rate ratio, 0.76. 95% CI, 0.73 to 0.80).

Incidence of PCR-Positive Results According to Baseline Anti-Spike IgG Status Positive baseline anti-spike antibody assays were associated with lower rates of PCR-positive tests. Of 11,364 health care workers with a negative anti-spike IgG assay, 223 had a positive PCR test (1.09 per 10,000 days at risk), 100 during asymptomatic screening and 123 while symptomatic. Of 1265 health care workers with a positive anti-spike IgG assay, 2 had a positive PCR test (0.13 per 10,000 days at risk), and both workers were asymptomatic when tested. The incidence rate ratio for positive PCR tests in seropositive workers was 0.12 (95% CI, 0.03 to 0.47. P=0.002).

The incidence of PCR-confirmed symptomatic in seronegative health care workers was 0.60 per 10,000 days at risk, whereas there were no confirmed symptomatic s in seropositive health care workers. No PCR-positive results occurred in 24 seronegative, previously PCR-positive health care workers. Seroconversion occurred in 5 of these workers during follow-up. Figure 1. Figure 1.

Observed Incidence of hypertension–Positive PCR Results According to Baseline Anti-Spike IgG Antibody Status. The incidence of polymerase-chain-reaction (PCR) tests that were positive for hypertension during the period from April through November 2020 is shown per 10,000 days at risk among health care workers according to their antibody status at baseline. In seronegative health care workers, 1775 PCR tests (8.7 per 10,000 days at risk) were undertaken in symptomatic persons and 28,878 (141 per 10,000 days at risk) in asymptomatic persons. In seropositive health care workers, 126 (8.0 per 10,000 days at risk) were undertaken in symptomatic persons and 1704 (108 per 10,000 days at risk) in asymptomatic persons. RR denotes rate ratio.Incidence varied by calendar time (Figure 1), reflecting the first (March through April) and second (October and November) waves of the lasix in the United Kingdom, and was consistently higher in seronegative health care workers.

After adjustment for age, gender, and month of testing (Table S1) or calendar time as a continuous variable (Fig. S2), the incidence rate ratio in seropositive workers was 0.11 (95% CI, 0.03 to 0.44. P=0.002). Results were similar in analyses in which follow-up of both seronegative and seropositive workers began 60 days after baseline serologic assay. With a 90-day window after positive serologic assay or PCR testing.

And after random removal of PCR results for seronegative health care workers to match asymptomatic testing rates in seropositive health care workers (Tables S2 through S4). The incidence of positive PCR tests was inversely associated with anti-spike antibody titers, including titers below the positive threshold (P<0.001 for trend) (Fig. S3A). Anti-Nucleocapsid IgG Status With anti-nucleocapsid IgG used as a marker for prior in 12,666 health care workers (Fig. S1B and Table S5), 226 of 11,543 (1.10 per 10,000 days at risk) seronegative health care workers tested PCR-positive, as compared with 2 of 1172 (0.13 per 10,000 days at risk) antibody-positive health care workers (incidence rate ratio adjusted for calendar time, age, and gender, 0.11.

95% CI, 0.03 to 0.45. P=0.002) (Table S6). The incidence of PCR-positive results fell with increasing anti-nucleocapsid antibody titers (P<0.001 for trend) (Fig. S3B). A total of 12,479 health care workers had both anti-spike and anti-nucleocapsid baseline results (Fig.

S1C and Tables S7 and S8). 218 of 11,182 workers (1.08 per 10,000 days at risk) with both immunoassays negative had subsequent PCR-positive tests, as compared with 1 of 1021 workers (0.07 per 10,000 days at risk) with both baseline assays positive (incidence rate ratio, 0.06. 95% CI, 0.01 to 0.46) and 2 of 344 workers (0.49 per 10,000 days at risk) with mixed antibody assay results (incidence rate ratio, 0.42. 95% CI, 0.10 to 1.69). Seropositive Health Care Workers with PCR-Positive Results Table 2.

Table 2. Demographic, Clinical, and Laboratory Characteristics of Health Care Workers with Possible hypertension Re. Three seropositive health care workers subsequently had PCR-positive tests for hypertension (one with anti-spike IgG only, one with anti-nucleocapsid IgG only, and one with both antibodies). The time between initial symptoms or seropositivity and subsequent positive PCR testing ranged from 160 to 199 days. Information on the workers’ clinical histories and on PCR and serologic testing results is shown in Table 2 and Figure S4.

Only the health care worker with both antibodies had a history of PCR-confirmed symptomatic that preceded serologic testing. After five negative PCR tests, this worker had one positive PCR test (low viral load. Cycle number, 21 [approximate equivalent cycle threshold, 31]) at day 190 after while the worker was asymptomatic, with subsequent negative PCR tests 2 and 4 days later and no subsequent rise in antibody titers. If this worker’s single PCR-positive result was a false positive, the incidence rate ratio for PCR positivity if anti-spike IgG–seropositive would fall to 0.05 (95% CI, 0.01 to 0.39) and if anti-nucleocapsid IgG–seropositive would fall to 0.06 (95% CI, 0.01 to 0.40). A fourth dual-seropositive health care worker had a PCR-positive test 231 days after the worker’s index symptomatic , but retesting of the worker’s sample was negative twice, which suggests a laboratory error in the original PCR result.

Subsequent serologic assays showed waning anti-nucleocapsid and stable anti-spike antibodies..

Participants Figure lasix 40mg cost i loved this 1. Figure 1. Enrollment and Randomization lasix 40mg cost. The diagram represents all enrolled participants through November 14, 2020.

The safety subset (those with a median of 2 months of follow-up, in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date. The further procedures that one participant lasix 40mg cost in the placebo group declined after dose 2 (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.Table 1. Table 1. Demographic Characteristics of the Participants in the Main Safety Population.

Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or lasix 40mg cost older underwent randomization at 152 sites worldwide (United States, 130 sites. Argentina, 1. Brazil, 2. South Africa, lasix 40mg cost 4.

Germany, 6. And Turkey, 9) in the phase 2/3 portion of the trial. A total of 43,448 participants received injections lasix 40mg cost. 21,720 received BNT162b2 and 21,728 received placebo (Figure 1).

At the data cut-off date of October 9, a total of 37,706 participants had a median of at lasix 40mg cost least 2 months of safety data available after the second dose and contributed to the main safety data set. Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of participants were older than 55 years of age (Table 1 and Table S2). Safety Local lasix 40mg cost Reactogenicity Figure 2.

Figure 2. Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 lasix 40mg cost participants) for 7 days after each vaccination. Solicited injection-site (local) reactions are shown in Panel A.

Pain at the injection site was assessed according to the following scale. Mild, does not interfere with lasix 40mg cost activity. Moderate, interferes with activity. Severe, prevents daily activity.

And grade 4, emergency department lasix 40mg cost visit or hospitalization. Redness and swelling were measured according to the following scale. Mild, 2.0 to 5.0 cm in diameter. Moderate, >5.0 to 10.0 lasix 40mg cost cm in diameter.

Severe, >10.0 cm in diameter. And grade lasix 40mg cost 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown in Panel B. Fever categories are designated in the key.

Medication use lasix 40mg cost was not graded. Additional scales were as follows. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild. Does not lasix 40mg cost interfere with activity.

Moderate. Some interference with activity. Or severe lasix 40mg cost. Prevents daily activity), vomiting (mild.

1 to 2 times in 24 hours. Moderate. >2 times in 24 hours. Or severe.

Requires intravenous hydration), and diarrhea (mild. 2 to 3 loose stools in 24 hours. Moderate. 4 to 5 loose stools in 24 hours.

Or severe. 6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization. Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants.

Overall, BNT162b2 recipients reported more local reactions than placebo recipients. Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose. 66% after the second dose) than among younger participants (83% after the first dose.

78% after the second dose). A noticeably lower percentage of participants reported injection-site redness or swelling. The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days.

Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B). The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients).

The frequency of any severe systemic event after the first dose was 0.9% or less. Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose. Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients. Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose.

Two participants each in the treatment and placebo groups reported temperatures above 40.0°C. Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1. 45% after dose 2) than older treatment recipients (20% after dose 1. 38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose.

Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter. Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3).

More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy. Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial.

Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia). Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the treatment or placebo. No hypertension medications–associated deaths were observed.

No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of treatment. Efficacy Table 2. Table 2.

treatment Efficacy against hypertension medications at Least 7 days after the Second Dose. Table 3. Table 3. treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2.

Figure 3. Figure 3. Efficacy of BNT162b2 against hypertension medications after the First Dose. Shown is the cumulative incidence of hypertension medications after the first dose (modified intention-to-treat population).

Each symbol represents hypertension medications cases starting on a given day. Filled symbols represent severe hypertension medications cases. Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days.

Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point. The time period for hypertension medications case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior hypertension , 8 cases of hypertension medications with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients. This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6.

Table 2). Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of hypertension medications at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3). Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4). treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%.

95% CI, 68.7 to 99.9. Case split. BNT162b2, 2 cases. Placebo, 44 cases).

Figure 3 shows cases of hypertension medications or severe hypertension medications with onset at any time after the first dose (mITT population) (additional data on severe hypertension medications are available in Table S5). Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a treatment efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the treatment, starting as soon as 12 days after the first dose.Trial Oversight This phase 3 randomized, stratified, observer-blinded, placebo-controlled trial enrolled adults in medically stable condition at 99 U.S. Sites. Participants received the first trial injection between July 27 and October 23, 2020.

The trial is being conducted in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practice guidelines, and applicable government regulations. The central institutional review board approved the protocol and the consent forms. All participants provided written informed consent before enrollment. Safety is reviewed by a protocol safety review team weekly and by an independent data and safety monitoring board on a continual basis.

The trial Investigational New Drug sponsor, Moderna, was responsible for the overall trial design (with input from the Biomedical Advanced Research and Development Authority, the NIAID, the hypertension medications Prevention Network, and the trial cochairs), site selection and monitoring, and data analysis. Investigators are responsible for data collection. A medical writer funded by Moderna assisted in drafting the manuscript for submission. The authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol.

The trial is ongoing, and the investigators remain unaware of participant-level data. Designated team members within Moderna have unblinded access to the data, to facilitate interface with the regulatory agencies and the data and safety monitoring board. All other trial staff and participants remain unaware of the treatment assignments. Participants, Randomization, and Data Blinding Eligible participants were persons 18 years of age or older with no known history of hypertension and with locations or circumstances that put them at an appreciable risk of hypertension , a high risk of severe hypertension medications, or both.

Inclusion and exclusion criteria are provided in the protocol (available with the full text of this article at NEJM.org). To enhance the diversity of the trial population in accordance with Food and Drug Administration Draft Guidance, site-selection and enrollment processes were adjusted to increase the number of persons from racial and ethnic minorities in the trial, in addition to the persons at risk for hypertension in the local population. The upper limit for stratification of enrolled participants considered to be “at risk for severe illness” at screening was increased from 40% to 50%.17 Participants were randomly assigned in a 1:1 ratio, through the use of a centralized interactive response technology system, to receive treatment or placebo. Assignment was stratified, on the basis of age and hypertension medications complications risk criteria, into the following risk groups.

Persons 65 years of age or older, persons younger than 65 years of age who were at heightened risk (at risk) for severe hypertension medications, and persons younger than 65 years of age without heightened risk (not at risk). Participants younger than 65 years of age were categorized as having risk for severe hypertension medications if they had at least one of the following risk factors, based on the Centers for Disease Control and Prevention (CDC) criteria available at the time of trial design. Chronic lung disease (e.g., emphysema, chronic bronchitis, idiopathic pulmonary fibrosis, cystic fibrosis, or moderate-to-severe asthma). Cardiac disease (e.g., heart failure, congenital coronary artery disease, cardiomyopathies, or pulmonary hypertension).

Severe obesity (body mass index [the weight in kilograms divided by the square of the height in meters] ≥40). Diabetes (type 1, type 2, or gestational). Liver disease. Or with the human immunodeficiency lasix.18 treatment dose preparation and administration were performed by pharmacists and treatment administrators who were aware of treatment assignments but had no other role in the conduct of the trial.

Once the injection was completed, only trial staff who were unaware of treatment assignments performed assessments and interacted with the participants. Access to the randomization code was strictly controlled at the pharmacy. The data and safety monitoring board reviewed efficacy data at the group level and unblinded safety data at the participant level. Trial treatment The mRNA-1273 treatment, provided as a sterile liquid at a concentration of 0.2 mg per milliliter, was administered by injection into the deltoid muscle according to a two-dose regimen.

Injections were given 28 days apart, in the same arm, in a volume of 0.5 ml containing 100 μg of mRNA-1273 or saline placebo.1 treatment mRNA-1273 was stored at 2° to 8°C (35.6° to 46.4°F) at clinical sites before preparation and vaccination. No dilution was required. Doses could be held in syringes for up to 8 hours at room temperature before administration. Safety Assessments Safety assessments included monitoring of solicited local and systemic adverse events for 7 days after each injection.

Unsolicited adverse reactions for 28 days after each injection. Adverse events leading to discontinuation from a dose, from participation in the trial, or both. And medically attended adverse events and serious adverse events from day 1 through day 759. Adverse event grading criteria and toxicity tables are described in the protocol.

Cases of hypertension medications and severe hypertension medications were continuously monitored by the data and safety monitoring board from randomization onward. Efficacy Assessments The primary end point was the efficacy of the mRNA-1273 treatment in preventing a first occurrence of symptomatic hypertension medications with onset at least 14 days after the second injection in the per-protocol population, among participants who were seronegative at baseline. End points were judged by an independent adjudication committee that was unaware of group assignment. hypertension medications cases were defined as occurring in participants who had at least two of the following symptoms.

Fever (temperature ≥38°C), chills, myalgia, headache, sore throat, or new olfactory or taste disorder, or as occurring in those who had at least one respiratory sign or symptom (including cough, shortness of breath, or clinical or radiographic evidence of pneumonia) and at least one nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if the participant was hospitalized) that was positive for hypertension by reverse-transcriptase–polymerase-chain-reaction (RT-PCR) test. Participants were assessed for the presence of hypertension–binding antibodies specific to the hypertension nucleocapsid protein (Roche Elecsys, Roche Diagnostics International) and had a nasopharyngeal swab for hypertension RT-PCR testing (Viracor, Eurofins Clinical Diagnostics) before each injection. hypertension–infected volunteers were followed daily, to assess symptom severity, for 14 days or until symptoms resolved, whichever was longer. A nasopharyngeal swab for RT-PCR testing and a blood sample for identifying serologic evidence of hypertension were collected from participants with symptoms of hypertension medications.

The consistency of treatment efficacy at the primary end point was evaluated across various subgroups, including age groups (18 to <65 years of age and ≥65 years), age and health risk for severe disease (18 to <65 years and not at risk. 18 to <65 years and at risk. And ≥65 years), sex (female or male), race and ethnic group, and risk for severe hypertension medications illness. If the number of participants in a subgroup was too small, it was combined with other subgroups for the subgroup analyses.

A secondary end point was the efficacy of mRNA-1273 in the prevention of severe hypertension medications as defined by one of the following criteria. Respiratory rate of 30 or more breaths per minute. Heart rate at or exceeding 125 beats per minute. Oxygen saturation at 93% or less while the participant was breathing ambient air at sea level or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen below 300 mm Hg.

Respiratory failure. Acute respiratory distress syndrome. Evidence of shock (systolic blood pressure <90 mm Hg, diastolic blood pressure <60 mm Hg, or a need for vasopressors). Clinically significant acute renal, hepatic, or neurologic dysfunction.

Admission to an intensive care unit. Or death. Additional secondary end points included the efficacy of the treatment at preventing hypertension medications after a single dose or at preventing hypertension medications according to a secondary (CDC), less restrictive case definition. Having any symptom of hypertension medications and a positive hypertension test by RT-PCR (see Table S1 in the Supplementary Appendix, available at NEJM.org).

Statistical Analysis For analysis of the primary end point, the trial was designed for the null hypothesis that the efficacy of the mRNA-1273 treatment is 30% or less. A total of 151 cases of hypertension medications would provide 90% power to detect a 60% reduction in the hazard rate (i.e., 60% treatment efficacy), with two planned interim analyses at approximately 35% and 70% of the target total number of cases (151) and with a one-sided O’Brien–Fleming boundary for efficacy and an overall one-sided error rate of 0.025. The efficacy of the mRNA-1273 treatment could be demonstrated at either the interim or the primary analysis, performed when the target total number of cases had been observed. The Lan–DeMets alpha-spending function was used for calculating efficacy boundaries at each analysis.

At the first interim analysis on November 15, 2020, treatment efficacy had been demonstrated in accordance with the prespecified statistical criteria. The treatment efficacy estimate, based on a total of 95 adjudicated cases (63% of the target total), was 94.5%, with a one-sided P value of less than 0.001 to reject the null hypothesis that treatment efficacy would be 30% or less. The data and safety monitoring board recommendation to the oversight group and the trial sponsor was that the efficacy findings should be shared with the participants and the community (full details are available in the protocol and statistical analysis plan). treatment efficacy was assessed in the full analysis population (randomized participants who received at least one dose of mRNA-1273 or placebo), the modified intention-to-treat population (participants in the full analysis population who had no immunologic or virologic evidence of hypertension medications on day 1, before the first dose), and the per-protocol population (participants in the modified intention-to-treat population who received two doses, with no major protocol deviations).

The primary efficacy end point in the interim and primary analyses was assessed in the per-protocol population. Participants were evaluated in the treatment groups to which they were assigned. treatment efficacy was defined as the percentage reduction in the hazard ratio for the primary end point (mRNA-1273 vs. Placebo).

A stratified Cox proportional hazards model was used to assess the treatment efficacy of mRNA-1273 as compared with placebo in terms of the percentage hazard reduction. (Details regarding the analysis of treatment efficacy are provided in the Methods section of the Supplementary Appendix.) Safety was assessed in all participants in the solicited safety population (i.e., those who received at least one injection and reported a solicited adverse event). Descriptive summary data (numbers and percentages) for participants with any solicited adverse events, unsolicited adverse events, unsolicited severe adverse events, serious adverse events, medically attended adverse events, and adverse events leading to discontinuation of the injections or withdrawal from the trial are provided by group. Two-sided 95% exact confidence intervals (Clopper–Pearson method) are provided for the percentages of participants with solicited adverse events.

Unsolicited adverse events are presented according to the Medical Dictionary for Regulatory Activities (MedDRA), version 23.0, preferred terms and system organ class categories. To meet the regulatory agencies’ requirement of a median follow-up duration of at least 2 months after completion of the two-dose regimen, a second analysis was performed, with an efficacy data cutoff date of November 21, 2020. This second analysis is considered the primary analysis of efficacy, with a total of 196 adjudicated hypertension medications cases in the per-protocol population, which exceeds the target total number of cases (151) specified in the protocol. This was an increase from the 95 cases observed at the first interim analysis data cutoff on November 11, 2020.

Results from the primary analysis are presented in this report. Subsequent analyses are considered supplementary.Baseline Anti-Spike IgG Assays and PCR Testing Rates Table 1. Table 1. Demographic Characteristics and hypertension PCR Testing for 12,541 Health Care Workers According to hypertension Anti-Spike IgG Status.

A total of 12,541 health care workers underwent measurement of baseline anti-spike antibodies. 11,364 (90.6%) were seronegative and 1177 (9.4%) seropositive at their first anti-spike IgG assay, and seroconversion occurred in 88 workers during the study (Table 1, and Fig. S1A in the Supplementary Appendix). Of 1265 seropositive health care workers, 864 (68%) recalled having had symptoms consistent with those of hypertension disease 2019 (hypertension medications), including symptoms that preceded the widespread availability of PCR testing for hypertension.

466 (37%) had had a previous PCR-confirmed hypertension , of which 262 were symptomatic. Fewer seronegative health care workers (2860 [25% of the 11,364 who were seronegative]) reported prebaseline symptoms, and 24 (all symptomatic, 0.2%) were previously PCR-positive. The median age of seronegative and seropositive health care workers was 38 years (interquartile range, 29 to 49). Health care workers were followed for a median of 200 days (interquartile range, 180 to 207) after a negative antibody test and for 139 days at risk (interquartile range, 117 to 147) after a positive antibody test.

Rates of symptomatic PCR testing were similar in seronegative and seropositive health care workers. 8.7 and 8.0 tests per 10,000 days at risk, respectively (rate ratio, 0.92. 95% confidence interval [CI], 0.77 to 1.10). A total of 8850 health care workers had at least one postbaseline asymptomatic screening test.

Seronegative health care workers attended asymptomatic screening more frequently than seropositive health care workers (141 vs. 108 per 10,000 days at risk, respectively. Rate ratio, 0.76. 95% CI, 0.73 to 0.80).

Incidence of PCR-Positive Results According to Baseline Anti-Spike IgG Status Positive baseline anti-spike antibody assays were associated with lower rates of PCR-positive tests. Of 11,364 health care workers with a negative anti-spike IgG assay, 223 had a positive PCR test (1.09 per 10,000 days at risk), 100 during asymptomatic screening and 123 while symptomatic. Of 1265 health care workers with a positive anti-spike IgG assay, 2 had a positive PCR test (0.13 per 10,000 days at risk), and both workers were asymptomatic when tested. The incidence rate ratio for positive PCR tests in seropositive workers was 0.12 (95% CI, 0.03 to 0.47.

P=0.002). The incidence of PCR-confirmed symptomatic in seronegative health care workers was 0.60 per 10,000 days at risk, whereas there were no confirmed symptomatic s in seropositive health care workers. No PCR-positive results occurred in 24 seronegative, previously PCR-positive health care workers. Seroconversion occurred in 5 of these workers during follow-up.

Figure 1. Figure 1. Observed Incidence of hypertension–Positive PCR Results According to Baseline Anti-Spike IgG Antibody Status. The incidence of polymerase-chain-reaction (PCR) tests that were positive for hypertension during the period from April through November 2020 is shown per 10,000 days at risk among health care workers according to their antibody status at baseline.

In seronegative health care workers, 1775 PCR tests (8.7 per 10,000 days at risk) were undertaken in symptomatic persons and 28,878 (141 per 10,000 days at risk) in asymptomatic persons. In seropositive health care workers, 126 (8.0 per 10,000 days at risk) were undertaken in symptomatic persons and 1704 (108 per 10,000 days at risk) in asymptomatic persons. RR denotes rate ratio.Incidence varied by calendar time (Figure 1), reflecting the first (March through April) and second (October and November) waves of the lasix in the United Kingdom, and was consistently higher in seronegative health care workers. After adjustment for age, gender, and month of testing (Table S1) or calendar time as a continuous variable (Fig.

S2), the incidence rate ratio in seropositive workers was 0.11 (95% CI, 0.03 to 0.44. P=0.002). Results were similar in analyses in which follow-up of both seronegative and seropositive workers began 60 days after baseline serologic assay. With a 90-day window after positive serologic assay or PCR testing.

And after random removal of PCR results for seronegative health care workers to match asymptomatic testing rates in seropositive health care workers (Tables S2 through S4). The incidence of positive PCR tests was inversely associated with anti-spike antibody titers, including titers below the positive threshold (P<0.001 for trend) (Fig. S3A). Anti-Nucleocapsid IgG Status With anti-nucleocapsid IgG used as a marker for prior in 12,666 health care workers (Fig.

S1B and Table S5), 226 of 11,543 (1.10 per 10,000 days at risk) seronegative health care workers tested PCR-positive, as compared with 2 of 1172 (0.13 per 10,000 days at risk) antibody-positive health care workers (incidence rate ratio adjusted for calendar time, age, and gender, 0.11. 95% CI, 0.03 to 0.45. P=0.002) (Table S6). The incidence of PCR-positive results fell with increasing anti-nucleocapsid antibody titers (P<0.001 for trend) (Fig.

S3B). A total of 12,479 health care workers had both anti-spike and anti-nucleocapsid baseline results (Fig. S1C and Tables S7 and S8). 218 of 11,182 workers (1.08 per 10,000 days at risk) with both immunoassays negative had subsequent PCR-positive tests, as compared with 1 of 1021 workers (0.07 per 10,000 days at risk) with both baseline assays positive (incidence rate ratio, 0.06.

95% CI, 0.01 to 0.46) and 2 of 344 workers (0.49 per 10,000 days at risk) with mixed antibody assay results (incidence rate ratio, 0.42. 95% CI, 0.10 to 1.69). Seropositive Health Care Workers with PCR-Positive Results Table 2. Table 2.

Demographic, Clinical, and Laboratory Characteristics of Health Care Workers with Possible hypertension Re. Three seropositive health care workers subsequently had PCR-positive tests for hypertension (one with anti-spike IgG only, one with anti-nucleocapsid IgG only, and one with both antibodies). The time between initial symptoms or seropositivity and subsequent positive PCR testing ranged from 160 to 199 days. Information on the workers’ clinical histories and on PCR and serologic testing results is shown in Table 2 and Figure S4.

Only the health care worker with both antibodies had a history of PCR-confirmed symptomatic that preceded serologic testing. After five negative PCR tests, this worker had one positive PCR test (low viral load. Cycle number, 21 [approximate equivalent cycle threshold, 31]) at day 190 after while the worker was asymptomatic, with subsequent negative PCR tests 2 and 4 days later and no subsequent rise in antibody titers. If this worker’s single PCR-positive result was a false positive, the incidence rate ratio for PCR positivity if anti-spike IgG–seropositive would fall to 0.05 (95% CI, 0.01 to 0.39) and if anti-nucleocapsid IgG–seropositive would fall to 0.06 (95% CI, 0.01 to 0.40).

A fourth dual-seropositive health care worker had a PCR-positive test 231 days after the worker’s index symptomatic , but retesting of the worker’s sample was negative twice, which suggests a laboratory error in the original PCR result. Subsequent serologic assays showed waning anti-nucleocapsid and stable anti-spike antibodies..

Lasix 20mg tablets side effects

And, in lasix 20mg tablets side effects states go to this web-site that do not permit any rating variation based on age or tobacco use, uniform family tier structures and corresponding multipliers. In addition, states that elect to merge their individual and small group market risk pools into a combined pool will notify CMS of such election. This information will allow CMS to determine whether state-specific rules apply or Federal default rules apply.

It will lasix 20mg tablets side effects also support the accuracy of the federal risk adjustment methodology. Form Number. CMS-10454 (OMB control number 0938-1258).

State, Local, or Tribal Governments. Number of Respondents. 3.

Total Annual Responses. 3. Total Annual Hours.

17. (For policy questions regarding this collection contact Russell Tipps at 301-869-3502.) 3. Type of Information Collection Request.

Extension of a currently approved collection. Title of Information Collection. Quality Improvement Organization (QIO) Assumption of Responsibilities and Supporting Regulations.

Use. The Peer Review Improvement Act of 1982 amended Title XI of the Social Security Act to create the Utilization and Quality Control Peer Review Organization (PRO) program which replaces the Professional Standards Review Organization (PSRO) program and streamlines peer review activities. The term PRO has been renamed Quality Improvement Organization (QIO).

This information collection describes the review functions to be performed by the QIO. It outlines relationships among QIOs, providers, practitioners, beneficiaries, intermediaries, and carriers. Form Number.

CMS-R-71 (OMB control number. 0938-0445). Frequency.

Yearly. Affected Public. Business or other for-profit and Not-for-profit institutions.

Number of Respondents. 6,939. Total Annual Responses.

(For policy questions regarding this collection contact Kimberly Harris at 401-837-1118.) 4. Type of Information Collection Request. Extension of a currently approved collection.

Titles of Information Collection. ASC Forms for Medicare Program Certification. Use.

The form CMS-370 titled “Health Insurance Benefits Agreement” is used for the purpose of establishing an ASC's eligibility for payment under Title XVIII of the Social Security Act (the “Act”). This agreement, upon acceptance by the Secretary of Health &. Human Services, shall be binding on the ASC and the Secretary.

The agreement may be Start Printed Page 73722terminated by either party in accordance with regulations. In the event of termination of this agreement, payment will not be available for the ASC's services furnished to Medicare beneficiaries on or after the effective date of termination. The CMS-377 form is used by ASCs to initiate both the initial and renewal survey by the State Survey Agency, which provides the certification required for an ASC to participate in the Medicare program.

An ASC must complete the CMS-377 form and send it to the appropriate State Survey Agency prior to their scheduled accreditation renewal date. The CMS-377 form provides the State Survey Agency with information about the ASC facility's characteristics, such as, determining the size and the composition of the survey team on the basis of the number of ORs/procedure rooms and the types of surgical procedures performed in the ASC. Form Numbers.

CMS-370 and CMS-377 (OMB control number. 0938-0266). Frequency.

Occasionally. Affected Public. Private Sector—Business or other for-profit and Not-for-profit institutions.

Number of Respondents. 1,567. Total Annual Responses.

(For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.) 5. Type of Information Collection Request. Revision of a currently approved collection.

Title of Information Collection. Home Health Agency Survey and Deficiencies Report. Use.

In order to participate in the Medicare Program as a Home Health Agency (HHA) provider, the HHA must meet federal standards. This form is used to record information and patients' health and provider compliance with requirements and to report the information to the federal government. Form Number.

CMS-1572 (OMB control number. 0938-0355). Frequency.

Yearly. Affected Public. State, Local or Tribal Government.

Number of Respondents. 3,833. Total Annual Responses.

(For policy questions regarding this collection contact Tara Lemons at 410-786-3030.) 6. Type of Information Collection Request. Extension of a currently approved collection.

Title of Information Collection. Disclosure Requirement for the In-Office Ancillary Services Exception. Use.

Section 6003 of the Affordable Care Act (ACA) established a new disclosure requirement that a physician must perform for certain imaging services to meet the in-office ancillary services exception to the prohibition of the physician self-referral law. This section of the ACA amended section 1877(b)(2) of the Act by adding a requirement that the referring physician informs the patient, at the time of the referral and in writing, that the patient may receive the imaging service from another supplier. Physicians who provide certain imaging services (MRI, CT, and PET) under the in-office ancillary services exception to the physician self-referral prohibition are required to provide the disclosure notice as well as the list of other imaging suppliers to the patient.

The patient will then be able to use the disclosure notice and list of suppliers in making an informed decision about his or her course of care for the imaging service. CMS would use the collected information for enforcement purposes. Specifically, if we were investigating the referrals of a physician providing advanced imaging services under the in- office ancillary services exception, we would review the written disclosure in order to determine if it satisfied the requirement.

Form Number. CMS-10332 (OMB control number. 0938-1133).

Private Sector, Business or other for-profits, Not-for-profits institutions. Number of Respondents. 2,239.

Total Annual Responses. 989,971. Total Annual Hours.

18,694. (For questions regarding this collection contact Laura Dash at 410-786-8623.) Start Signature Dated. November 16, 2020.

William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. End Signature End Supplemental Information [FR Doc.

2020-25598 Filed 11-18-20. 8:45 am]BILLING CODE 4120-01-PStart Preamble Centers for Medicare &. Medicaid Services (CMS), Department of Health and Human Services (HHS).

Notice of new matching program. In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare &. Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Social Security Administration (SSA), “Determining Enrollment or Eligibility for Insurance Affordability Programs Under the Patient Protection and Affordable Care Act.” The deadline for comments on this notice is December 21, 2020.

The re-established matching program will commence not sooner than 30 days after publication of this notice, provided no comments are received that warrant a change to this notice. The matching program will be conducted for an initial term of 18 months (from approximately March 9, 2021 to September 8, 2022) and within three months of expiration may be renewed for one additional year if the parties make no change to the matching program and certify that the program has been conducted in compliance with the matching agreement. Interested parties may submit comments on the new matching program to the CMS Privacy Officer by mail at.

Division of Security, Privacy Policy &. Governance, Information Security &. Privacy Group, Office of Information Technology, Centers for Medicare &.

Medicaid Services, Location. N1-14-56, 7500 Security Blvd., Baltimore, MD 21244-1850, or walter.stone@cms.hhs.gov. Start Further Info If you have questions about the matching program, you may contact Anne Pesto, Senior Advisor, Marketplace Eligibility and Enrollment Group, Center for Consumer Information and Insurance Oversight, Centers for Medicare &.

Medicaid Services, at 410-786-3492, by email at anne.pesto@cms.hhs.gov, or by mail at 7500 Security Blvd., Baltimore, MD 21244. End Further Info End Preamble Start Supplemental Information The Privacy Act of 1974, as amended (5 U.S.C. 552a) provides certain protections for individuals applying for and receiving federal benefits.

The law governs the use of computer matching by federal agencies when records in a system of records (meaning, federal agency records about individuals retrieved by name or other personal identifier) are matched with records of other federal or non-federal agencies. The Privacy Act requires agencies involved in a matching program to. 1.

Enter into a written agreement, which must be prepared in accordance with the Privacy Act, approved by the Data Integrity Board of each source and recipient federal agency, provided to Congress and the Office of Management and Budget (OMB), and made available to the public, as required by 5 U.S.C. 552a(o), (u)(3)(A), and (u)(4). 2.

Notify the individuals whose information will be used in the matching program that the information they provide is subject to verification through matching, as required by 5 U.S.C. 552a(o)(1)(D). 3.

Verify match findings before suspending, terminating, reducing, or making a final denial of an individual's benefits or payments or taking other adverse action against the individual, as required by 5 U.S.C. 552a(p). 4.

Report the matching program to Congress and the OMB, in advance and Start Printed Page 73720annually, as required by 5 U.S.C. 552a(o) (2)(A)(i), (r), and (u)(3)(D). 5.

Publish advance notice of the matching program in the Federal Register as required by 5 U.S.C. 552a(e)(12). This matching program meets these requirements.

Start Signature Barbara Demopulos, Privacy Advisor, Division of Security, Privacy Policy and Governance, Office of Information Technology, Centers for Medicare &. Medicaid Services. End Signature PARTICIPATING AGENCIES.

The Department of Health and Human Services (HHS), Centers for Medicare &. Medicaid Services (CMS) is the recipient agency, and the Social Security Administration (SSA) is the source agency. AUTHORITY FOR CONDUCTING THE MATCHING PROGRAM.

The statutory authority for the matching program is 42 U.S.C. Secs. 18081 and 18083.

PURPOSE(S). The purpose of the matching program is to provide CMS with SSA information which CMS and state-based administering entities will use to determine individuals' eligibility for initial enrollment in a Qualified Health Plan through an Exchange established under the Patient Protection and Affordable Care Act, for Insurance Affordability Programs (IAPs), and certificates of exemption from the shared responsibility payment. And to make eligibility redeterminations and renewal decisions, including appeal determinations.

IAPs include. 1. Advance payments of the premium tax credit (APTC) and cost sharing reductions (CSRs), 2.

Medicaid, 3. Children's Health Insurance Program (CHIP), and 4. Basic Health Program (BHP).

CATEGORIES OF INDIVIDUALS. The individuals whose information will be used in the matching program are consumers (applicants and enrollees) who receive the eligibility determinations and redeterminations described in the preceding Purpose(s) section. CATEGORIES OF RECORDS.

The categories of records used in the matching program are identity information, citizenship, death/disability indicators, incarceration information, and income.

Type of Information Collection lasix 40mg cost Request useful link. Extension of a currently approved collection. Title of Information Collection.

Quality Improvement Organization (QIO) lasix 40mg cost Assumption of Responsibilities and Supporting Regulations. Use. The Peer Review Improvement Act of 1982 amended Title XI of the Social Security Act to create the Utilization and Quality Control Peer Review Organization (PRO) program which replaces the Professional Standards Review Organization (PSRO) program and streamlines peer review activities.

The term PRO has been renamed Quality Improvement Organization (QIO) lasix 40mg cost. This information collection describes the review functions to be performed by the QIO. It outlines relationships among QIOs, providers, practitioners, beneficiaries, intermediaries, and carriers.

Form Number lasix 40mg cost. CMS-R-71 (OMB control number. 0938-0445).

Business or other for-profit and Not-for-profit institutions. Number of Respondents. 6,939.

Total Annual Responses. 972,478. Total Annual Hours.

1,034,655. (For policy questions regarding this collection contact Kimberly Harris at 401-837-1118.) 4. Type of Information Collection Request.

Extension of a currently approved collection. Titles of Information Collection. ASC Forms for Medicare Program Certification.

Use. The form CMS-370 titled “Health Insurance Benefits Agreement” is used for the purpose of establishing an ASC's eligibility for payment under Title XVIII of the Social Security Act (the “Act”). This agreement, upon acceptance by the Secretary of Health &.

Human Services, shall be binding on the ASC and the Secretary. The agreement may be Start Printed Page 73722terminated by either party in accordance with regulations. In the event of termination of this agreement, payment will not be available for the ASC's services furnished to Medicare beneficiaries on or after the effective date of termination.

The CMS-377 form is used by ASCs to initiate both the initial and renewal survey by the State Survey Agency, which provides the certification required for an ASC to participate in the Medicare program. An ASC must complete the CMS-377 form and send it to the appropriate State Survey Agency prior to their scheduled accreditation renewal date. The CMS-377 form provides the State Survey Agency with information about the ASC facility's characteristics, such as, determining the size and the composition of the survey team on the basis of the number of ORs/procedure rooms and the types of surgical procedures performed in the ASC.

Form Numbers. CMS-370 and CMS-377 (OMB control number. 0938-0266).

Private Sector—Business or other for-profit and Not-for-profit institutions. Number of Respondents. 1,567.

Total Annual Responses. 1,567. Total Annual Hours.

1,012. (For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.) 5. Type of Information Collection Request.

Revision of a currently approved collection. Title of Information Collection. Home Health Agency Survey and Deficiencies Report.

Use. In order to participate in the Medicare Program as a Home Health Agency (HHA) provider, the HHA must meet federal standards. This form is used to record information and patients' health and provider compliance with requirements and to report the information to the federal government.

Form Number. CMS-1572 (OMB control number. 0938-0355).

State, Local or Tribal Government. Number of Respondents. 3,833.

Total Annual Responses. 3,833. Total Annual Hours.

1,917. (For policy questions regarding this collection contact Tara Lemons at 410-786-3030.) 6. Type of Information Collection Request.

Extension of a currently approved collection. Title of Information Collection. Disclosure Requirement for the In-Office Ancillary Services Exception.

Use. Section 6003 of the Affordable Care Act (ACA) established a new disclosure requirement that a physician must perform for certain imaging services to meet the in-office ancillary services exception to the prohibition of the physician self-referral law. This section of the ACA amended section 1877(b)(2) of the Act by adding a requirement that the referring physician informs the patient, at the time of the referral and in writing, that the patient may receive the imaging service from another supplier.

Physicians who provide certain imaging services (MRI, CT, and PET) under the in-office ancillary services exception to the physician self-referral prohibition are required to provide the disclosure notice as well as the list of other imaging suppliers to the patient. The patient will then be able to use the disclosure notice and list of suppliers in making an informed decision about his or her course of care for the imaging service. CMS would use the collected information for enforcement purposes.

Specifically, if we were investigating the referrals of a physician providing advanced imaging services under the in- office ancillary services exception, we would review the written disclosure in order to determine if it satisfied the requirement. Form Number. CMS-10332 (OMB control number.

Affected Public. Private Sector, Business or other for-profits, Not-for-profits institutions. Number of Respondents.

Total Annual Hours. 18,694. (For questions regarding this collection contact Laura Dash at 410-786-8623.) Start Signature Dated.

November 16, 2020. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.

End Signature End Supplemental Information [FR Doc. 2020-25598 Filed 11-18-20. 8:45 am]BILLING CODE 4120-01-PStart Preamble Centers for Medicare &.

Medicaid Services (CMS), Department of Health and Human Services (HHS). Notice of new matching program. In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare &.

Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Social Security Administration (SSA), “Determining Enrollment or Eligibility for Insurance Affordability Programs Under the Patient Protection and Affordable Care Act.” The deadline for comments on this notice is December 21, 2020. The re-established matching program will commence not sooner than 30 days after publication of this notice, provided no comments are received that warrant a change to this notice. The matching program will be conducted for an initial term of 18 months (from approximately March 9, 2021 to September 8, 2022) and within three months of expiration may be renewed for one additional year if the parties make no change to the matching program and certify that the program has been conducted in compliance with the matching agreement.

Interested parties may submit comments on the new matching program to the CMS Privacy Officer by mail at. Division of Security, Privacy Policy &. Governance, Information Security &.

Privacy Group, Office of Information Technology, Centers for Medicare &. Medicaid Services, Location. N1-14-56, 7500 Security Blvd., Baltimore, MD 21244-1850, or walter.stone@cms.hhs.gov.

Start Further Info If you have questions about the matching program, you may contact Anne Pesto, Senior Advisor, Marketplace Eligibility and Enrollment Group, Center for Consumer Information and Insurance Oversight, Centers for Medicare &. Medicaid Services, at 410-786-3492, by email at anne.pesto@cms.hhs.gov, or by mail at 7500 Security Blvd., Baltimore, MD 21244. End Further Info End Preamble Start Supplemental Information The Privacy Act of 1974, as amended (5 U.S.C.

552a) provides certain protections for individuals applying for and receiving federal benefits. The law governs the use of computer matching by federal agencies when records in a system of records (meaning, federal agency records about individuals retrieved by name or other personal identifier) are matched with records of other federal or non-federal agencies. The Privacy Act requires agencies involved in a matching program to.

1. Enter into a written agreement, which must be prepared in accordance with the Privacy Act, approved by the Data Integrity Board of each source and recipient federal agency, provided to Congress and the Office of Management and Budget (OMB), and made available to the public, as required by 5 U.S.C. 552a(o), (u)(3)(A), and (u)(4).

2. Notify the individuals whose information will be used in the matching program that the information they provide is subject to verification through matching, as required by 5 U.S.C. 552a(o)(1)(D).

3. Verify match findings before suspending, terminating, reducing, or making a final denial of an individual's benefits or payments or taking other adverse action against the individual, as required by 5 U.S.C. 552a(p).

4. Report the matching program to Congress and the OMB, in advance and Start Printed Page 73720annually, as required by 5 U.S.C. 552a(o) (2)(A)(i), (r), and (u)(3)(D).

5. Publish advance notice of the matching program in the Federal Register as required by 5 U.S.C. 552a(e)(12).

This matching program meets these requirements. Start Signature Barbara Demopulos, Privacy Advisor, Division of Security, Privacy Policy and Governance, Office of Information Technology, Centers for Medicare &. Medicaid Services.

End Signature PARTICIPATING AGENCIES. The Department of Health and Human Services (HHS), Centers for Medicare &. Medicaid Services (CMS) is the recipient agency, and the Social Security Administration (SSA) is the source agency.

AUTHORITY FOR CONDUCTING THE MATCHING PROGRAM. The statutory authority for the matching program is 42 U.S.C. Secs.

18081 and 18083. PURPOSE(S). The purpose of the matching program is to provide CMS with SSA information which CMS and state-based administering entities will use to determine individuals' eligibility for initial enrollment in a Qualified Health Plan through an Exchange established under the Patient Protection and Affordable Care Act, for Insurance Affordability Programs (IAPs), and certificates of exemption from the shared responsibility payment.

And to make eligibility redeterminations and renewal decisions, including appeal determinations. IAPs include. 1.

Advance payments of the premium tax credit (APTC) and cost sharing reductions (CSRs), 2. Medicaid, 3. Children's Health Insurance Program (CHIP), and 4.

Basic Health Program (BHP). CATEGORIES OF INDIVIDUALS. The individuals whose information will be used in the matching program are consumers (applicants and enrollees) who receive the eligibility determinations and redeterminations described in the preceding Purpose(s) section.

CATEGORIES OF RECORDS. The categories of records used in the matching program are identity information, citizenship, death/disability indicators, incarceration information, and income. To request information from SSA, CMS will submit a submission file to SSA that contains the following mandatory specified data elements.

Last name, first name, date of birth, Social Security Number (SSN), and citizenship indicator. When SSA is able to match the SSN and name provided by CMS and information is available, SSA will provide CMS with the following about each individual, as relevant. Last name, first name, date of birth, death indicator, disability indicator, incarceration information, Title II (annual and monthly) income information, and confirmation of attestations of citizenship status and SSN.

SSA may also provide Quarters of Coverage data when CMS requests it. System of Records Maintained by CMS CMS Health Insurance Exchanges System (HIX), CMS System No. 09-70-0560, last published in full at 78 FR 63211 (Oct.

23, 2013), and amended at 83 FR 6591 (Feb. 14, 2018). Routine use 3 authorizes CMS' disclosures of identifying information about applicants to SSA for use in this matching program.

B. Systems of Records Maintained by SSA The SSA SORNs and routine uses that support this matching program are identified below. (1) Master Files of SSN Holders and SSN Applications, 60-0058, last fully published at 75 FR 82121 (Dec.

29, 2010) and amended at 78 FR 40542 (July 5, 2013), 79 FR 8780 (Feb. 13, 2014), 83 FR 31250 (July 3, 2018), and 83 FR 54969 (Nov. 1, 2018).

(2) Prisoner Update Processing System (PUPS), 60-0269, last fully published at 64 FR 11076 (Mar.