(FORT MYERS, Fla.) — Florida is seeing an increase in confirmed cases of flesh-eating bacteria this year due to the impact of Hurricane Ian, health officials said.
The Florida Health Department has reported 65 confirmed cases of Vibrio vulnificus, a flesh-eating bacteria, and 11 deaths so far this year as of Friday.
That compares to 34 cases and 10 deaths reported in 2021, and 36 cases and seven deaths in 2020, according to state data. This year has seen the highest number of reported cases in Florida since 2008, state data shows.
The increase is driven by a surge in cases in coastal Lee County, which was devastated by Hurricane Ian after the Category 4 storm made landfall on Florida’s southwestern coast on Sept. 28.
Lee County has reported 29 confirmed cases and four deaths so far this year — after reporting five cases and one death last year and no cases in 2020 — state data shows.
The “abnormal increase” in cases of the rare infection in the county is “due to the impact of Hurricane Ian,” the state health department noted.
Nearby Collier County has also seen an atypical increase in cases due to Ian, the department said, with three cases reported so far this year compared to zero last year and one in 2021.
Health officials in Lee County warned residents earlier this month about the risk of infection in the wake of Hurricane Ian.
“Flood waters and standing waters following a hurricane pose many risks, including [organisms that cause] infectious diseases such as Vibrio vulnificus,” the Lee County health department said in an Oct. 3 notice. “For that reason, the Florida Department of Health in Lee County is urging the public to take precautions against infection and illness caused by Vibrio vulnificus.”
Lee County Public Safety said last week that the state health department is seeing an uptick in Vibrio cases “as people clear homes and yards.”
“Stay out of flood and standing water,” the agency said in a Facebook post on Oct. 10. “Cover wounds with a waterproof bandage. Always wash wounds and cuts thoroughly if they touch the water.”
Vibrio bacteria live in warm, brackish seawater — such as where rivers meet the sea — and typically grow faster during warmer months. People can become infected if they have cuts or scrapes and then walk on the beach or enter the water. The skin infection — known as necrotizing fasciitis — can be especially dangerous for people who are immune compromised.
It is also possible to develop vibriosis by eating contaminated raw oysters. When ingested, the bacteria usually causes stomach cramping, diarrhea, or nausea and vomiting
The Centers for Disease Control and Prevention estimates that 80,000 people get sick each year in the U.S. due to the bacteria. Among those, the majority are the result of eating contaminated food.
Experts warn that climate change may contribute to waterborne pathogens such as Vibrio vulnificus to thrive and multiply faster in increasingly warming waters. As climate change brings more strong hurricanes that forces more salt water to mix with fresh, it’s creating large brackish areas and the conditions where the Vibrio can flourish, experts told ABC News last year.
ABC News’ Sony Salzman and Julia Jacobo contributed to this report.
(NEW YORK) — Women who use chemical hair-straightening products may be at a higher risk for uterine cancer, and Black women may be more affected due to their higher rate of use, according to a new study.
The study, funded by the National Institutes of Health, found an association that women who self-reported frequent use of hair straightening products were more than twice as likely to later develop uterine cancer than women who did not use the products, but there was not enough evidence to prove the hair straightener caused the cancer.
Uterine cancer, a type of cancer that starts in the uterus, is a risk factor for all women with a uterus, but the risk increases with age, especially during and after menopause, according to the Centers for Disease Control and Prevention.
It is still a relatively rare cancer overall, representing around 3% of all cancer cases, but is the most common gynecologic cancer in the U.S., according to the CDC.
“We estimated that 1.64% of women who never used hair straighteners would go on to develop uterine cancer by the age of 70; but for frequent users, that risk goes up to 4.05%,” Dr. Alexandra White, the study’s lead author, said in a summary of the study released Monday by the National Institutes of Health.
Frequent use of the products is defined as more than four times in the previous year, according to the study, which included more than 33,000 women between the ages of 35 to 74.
Black women may be more at risk for uterine cancer due to hair-straightening products not because of their race but because of their higher rate of use of those products, according to the study.
Around 60% of women in the study who reported using chemical straightening products were self-identified Black women.
“Because Black women use hair straightening or relaxer products more frequently and tend to initiate use at earlier ages than other races and ethnicities, these findings may be even more relevant for them,” said Dr. Che-Jung Chang, an author of the study, alongside White.
Dr. Madeliene Gainers, a board-certified dermatologist, called the study’s findings a “huge concern for Black women,” who have long used hair straightening and relaxing products in part because of the hair bias they face in society, including in workplaces and schools.
Several cities and states have taken action to combat the issue through the CROWN Act (Create a Respectful and Open Workplace for Natural Hair), legislation that bans discrimination against race-based ethnic hairstyles. There are currently no federal laws that address hair discrimination, but the NAACP Legal Defense and Educational Fund is advocating for making the CROWN Act law in all 50 states.
Gainers said she advises patients to transition to natural hair and to avoid relaxers as well as perms.
“Hair relaxers are problematic. They’re not strictly regulated and they’re not even required to list all the ingredients,” said Gainers, who was not involved in the NIH-funded study. “With hair relaxers, it’s such a harsh chemical it can cause lesions and burns on the scalp, so it makes penetration of these chemicals that much greater and the scalp absorbs better, so it’s a huge problem.”
Gainers said chemicals from hair products can be absorbed into the body, where they may disrupt the body’s hormonal balance, resulting in cancers and other medical issues.
“It can affect your body in a similar manner as ingesting the chemicals,” she said. “Just because it’s being put on the skin, it doesn’t stop it from being harmful, unfortunately.”
More research needs to be done
The authors of the new study point out that “more research is needed” to determine exactly what type of hair-straightening chemicals could be linked to an increased risk for uterine cancer.
The study did include some significant limitations. More than 80% of the women in the study were Non-Hispanic white women and only 7% were Black, meaning the statistics may be different with an equal distribution of races.
All of the women were first-degree relatives of a woman who had been diagnosed with breast cancer, which puts them at a higher risk of getting cancers themselves.
Uterine cancer rates have also been rising in Black women in general, so there could be an association that is not directly caused by using chemical hair-straightening products.
“More research is needed to confirm these findings in different populations, to determine if hair products contribute to health disparities in uterine cancer and to identify the specific chemicals that may be increasing the risk of cancers in women,” White wrote in the study’s summary.
Researchers in this study also couldn’t identify the specific chemical that could be causing uterine cancer. They only noted that the chemicals were historically found in straighteners, where parabens, bisphenol A, metals and formaldehyde, could be contributing to the increased risk.
The study, which collected data over 11 years, did not include information on brands or ingredients in the hair products that participants used, according to the NIH.
In 2019, researchers used data from the same study to report an association between the use of hair dye and relaxers and breast cancer rates in women who were already at an increased risk level of getting breast cancer.
Other studies have also shown no increased risk of breast cancer due to the use of hair dye.
The Food and Drug Administration, the agency that regulates cosmetics, including hair smoothing products and hair dyes, says on its website it does not “have reliable evidence showing a link between cancer and coal-tar hair dyes on the market today.” Coal-tar hair dyes, according to the agency, includes permanent, semi-permanent, and temporary hair dyes.
The agency issued a warning earlier this year that hair smoothing products often contain formaldehyde, described as a “colorless, strong-smelling gas that presents a health hazard when breathed into the lungs, or when it gets into the eyes or onto the skin.” In hair smoothing products, the formaldehyde is released into the air as a gas when the products are heated.
The FDA warned that the use of hair smoothing products in an area that is not properly ventilated could lead to a risk of a person inhaling formaldehyde.
Gainers said that as research continues, she would like to see the hair products industry more closely regulated, including requiring ingredients to be clearly listed.
“I think we’re still at the beginning stage and I do think more research needs to be done,” she said. “I also think that the cosmetic industry needs to be regulated, and I do think that it should be mandatory for all chemicals that are being used in a product to be on the label.”
(NEW YORK) — Even as COVID-19 cases and hospitalizations driven by the omicron subvariant BA.5 continue to fall in the United States, the proportion of infections attributed to other omicron offshoots is rising.
According to data from the Centers for Disease Control and Prevention, BA.5 currently makes up 67.9% of new virus cases as of last Friday.
The remaining cases are made up of BA.4.6 — which has been circulating in the U.S. for weeks — as well as newly identified subvariants like BQ.1, B.Q.1.1 and BF.7, which have been spreading mainly in Europe.
The subvariants have been attributed to an increase in infections in Europe. According to the latest weekly report from the World Health Organization, published Oct. 12, there were more than 1.66 million COVID-19 cases recorded across the continent, up from more than 1.53 million cases recorded in the previous report published on Oct. 5
Throughout the course of the pandemic, Europe has been considered a bellwether of what’s to come in the U.S.
Should we be concerned about the new subvariants? Experts told ABC News that the U.S. may see a new wave as we enter the colder weather months and move indoors and it’s important to remain vigilant.
“In the next few months, I think there’s reasonable expectation that we’ll probably see a fall wave,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital and an ABC News contributor. “But the magnitude of that wave, I think, is still very much in question.”
What are the new subvariants?
The subvariant that makes up the most cases after BA.5 is BA.4.6. An offshoot of the omicron subvariant BA.4, it’s estimated to account for 12% of new cases, according to the CDC.
Then there are newer subvariants, which have recently begun steadily spreading in the U.S: BQ.1 and BQ.1.1, Both are offshoots of BA.5 and make up 12% of new cases together. This is a rapid rate of increase considering they made up just 3% of new cases for the week ending Oct. 1.
“It seems to have come out of nowhere,” Dr. Peter Chin-Hong, an infectious diseases specialist at the University of California, San Francisco, told ABC News. “But it didn’t really come of nowhere. It was first seen in Nigeria in summer and then spread to other countries in Europe and Asia, and now in the United States.”
Another offshoot of BA.5 that is picking up speed is BF.7. It makes up 5.3% of new cases in the U.S., up from 3.2% just two weeks prior.
Meanwhile, there have been reports of another subvariant called XBB, which combines multiple strains of the omicron variant and other COVID-19 variants and has been detected mostly in Asia. So far, it has not been detected in the U.S.
Not much is known about any of these newer subvariants. Preliminary data suggests they have mutations that are better at evading immunity, whether from vaccination or prior infection, and may be more transmissible.
Another reason these offshoots could be spreading more rapidly is because human behavior has changed. Travel is reaching pre-pandemic levels, children are back in school and most restrictions — including masking, social distancing and vaccinations requirements — have ended.
There is some good news. Since September, bivalent boosters that target BA.4 and BA.5 have been approved in the U.S. for those aged 12 and older and for those aged 5 and older since last week. Early data suggests the booster increases antibody response.
Because these subvariants are related to BA.4 and BA.5, it’s likely that the booster will provide at least some protection against them as well.
“I think there’s a very reasonable expectation that the vaccines, especially with the new boosters, will provide good protection,” said Brownstein. “But we’re still missing a lot of real-world data, especially given that these new sort of omicron variants of BA.5 and BA.4 are starting to take hold in various parts of the world.”
“We’ll hopefully have reasonable insight from other countries that will help inform some of the forecast for the coming months, but that data is still being compiled,” he continued.
Chin-Hong said it’s also reasonable to expect, as with previous variants, that those most at risk are Americans with the least amount of protection.
“For people who are unvaccinated, those over age 65 who’ve never gotten a booster, or people who are immunocompromised, they may become more seriously ill and die if they don’t protect themselves,” Chin-Hong said.
Should we be concerned?
Brownstein said he thinks public health officials should remain vigilant and keep tracking the spread of these subvariants but the public should not yet worry.
“I think it’s too early to tell the level of concern,” Brownstein said. “Of course, everyone should be concerned about how new variants emerge, especially when there’s uneven vaccination across the U.S and then across the globe.”
He added, “The brunt of that concern should be on public health and scientists right now, as we try to work out [what’s happening].”
Brownstein said Americans should be willing to modify their behavior — like masking indoors again — if cases spike or a new variant emerges.
According to CDC data, the daily average of COVID-19 cases sits at 35,000 as of Oct.16 and the average estimate of new hospital admissions is 2,990 as of Oct. 15.
Brownstein said if the health care system becomes overwhelmed by a surge, city- or state-level officials might consider masking to reduce the number of patients entering hospitals.
“I think that clearly targeted masking, especially in high-risk places like health care settings and long-term care facilities, will be critical, because those places are charged with protecting the most vulnerable,” Brownstein said. “Beyond that, I think it’s going to be really driven by local level cases.”
(NEW YORK) — Nearly 30% of Americans living with diabetes who are uninsured may ration their insulin to save money, according to a new study.
Researchers at Harvard Medical School, the City University of New York’s Hunter College and consumer advocacy organization Public Citizen determined the prevalence of insulin rationing by analyzing the Centers for Disease Control and Prevention’s 2021 National Health Interview Survey in the study, published in the Annals of Internal Medicine on Monday.
Overall, researchers found that 16.5% of adults with diabetes who use insulin — some 1.3 million Americans — rationed insulin by either skipping doses, taking less or delaying buying it to save money in the past year.
Rates of insulin rationing were highest among those with no insurance, at 29.2%, the study found. Among those with private insurance, it was nearly 19%.
Rationing was lower among those with public coverage, such as Medicare (13.5%), and those ages 65 and older (11.2%), who would be largely eligible for Medicare.
Insulin rationing was also found to be more common among Black Americans (23.2%) than white and Hispanic (16%), as well as among middle-income insulin users (19.8%) than higher-income (10.8%) and low-income (14.6%), researchers found.
There was no data provided on the health consequences of insulin rationing, though prior research has shown cost-associated non-adherence to insulin can have serious negative consequences.
The study “provides the first national estimate of how many Americans with diabetes are rationing their insulin now due to cost,” Public Citizen said in a news release, noting that soaring insulin costs can average at least $1,000 each month.
Rationing insulin can put people at risk for serious and even deadly complications, experts say.
“In the ICU, I have cared for patients who have life-threatening complications of diabetes because they couldn’t afford this life-saving drug,” Dr. Adam Gaffney, a pulmonary and critical care physician at Harvard Medical School and the Cambridge Health Alliance and the lead author of the study, said in a statement. “Universal access to insulin, without cost barriers, is urgently needed.”
The findings of the study come amid policy debates around the price of insulin.
The Biden administration’s Inflation Reduction Act, which goes into effect next year, includes a provision to cap the monthly cost of insulin for people on Medicare at $35, though the bill excludes those on private insurance or the uninsured.
The initial draft of the bill would have also capped insulin costs for those with private insurance, though Republicans stripped that provision from the bill due to a technicality in the reconciliation process.
More than 37 million Americans have diabetes, according to the American Diabetes Association. Among them, 8.4 million use insulin, which costs 10 times more in the U.S. than anywhere else in the world, according to the association.
(NEW YORK) — Racial and ethnic minorities are more likely to be hospitalized with the flu in the United States, new federal data shows.
A new report published by the Centers for Disease Control and Prevention Tuesday looked at data from the 2009-10 through the 2021-22 flu seasons — excluding the 2020-21 season — and flu vaccination coverage from the 2010-11 season through the 2021-22 season.
They found that compared to white adults, influenza-related hospitalizations were 80% higher among Black adults.
Although there was some variation by season, during most seasons, hospitalization rates for Black adults were between 1.5 and 2.4 times the rates among white adults.
Additionally, American Indian and Alaska Natives (Ai/AN) flu-related hospitalizations were 30% higher and hospitalizations among Hispanics were 20% higher.
For AI/AN adults, rates were highest during the 2011-12 season and the 2021-22 seasons with rates 2.7 times those of white adults.
Meanwhile for Hispanics, the highest rates were seen during the 2009-10 and 2021-22 seasons and were 2.1 times those of their white counterparts.
The report also found that Asian/Pacific Islander adults had the lowest rates of hospitalization of all the racial and ethnic groups, ranging from 60% to 90% of hospitalization rates of white adults.
Although experts say flu vaccination is the best protection against the flu, rates are lower among racial and ethnic minorities.
“Every year, the flu continues to cause severe illness hospitalization and death,” said CDC Acting Principal Deputy Director Dr. Debra Houry in a press briefing to reporters Tuesday.
“Unfortunately, flu vaccination rates have been consistently lower among black, Hispanic, and American Indian, Alaska Native adults in the United States since 2010,” Houry said.
During the 2021-22 season, 49.4% of white adults were vaccinated against flu. By comparison, just 42% of Black adults, 37.9% of Hispanic minorities and 40.9% of AI/AN adults were vaccinated.
Asian and Pacific Islander adults had the highest rate of vaccination at 54.2%.
According to the CDC, there are several reasons for racial and ethnic disparities, including lack of access to health care and insurance, which in turn leads to less vaccine access.
Another reason for the disparities is missed opportunities to vaccinate.
“For adults who reported a recent medical checkup, vaccination coverage was still lower for Black, Hispanic, American Indian and Alaska Native and adults of other races than for white adults,” Dr. Carla Black, an epidemiologist from the CDC’s Immunization Services Division, said during the press conference. “This suggests that health care providers are missing opportunities during routine medical appointments to vaccinate people from certain groups.”
She added there may be misinformation about how serious flu is and vaccine safety as well as distrust due to past racist health policies that have negatively affected America’s communities of color.
CDC officials recommend that doctors encourage their patients, including those of color, to get the flu shot and that public health officials host outreach events including town halls and pop-up clinics to increase access to flu vaccines.
Black also encouraged flu vaccination due to the risk of a potentially severe flu season this year after the U.S. had two years of little to no flu activity:
“Well, what we can so far is that we’ve had mild flu season, and this means we might be ripe for a severe season, because people are not, you know taking all the measures they took for COVID which also had an impact on flu like masking and social distancing,” she said. “People haven’t had natural disease in two years. So, you know, there’s less natural immunity out there. People are going back to work. People are traveling again; all of these factors could contribute to us having a more severe flu season.”
(NEW YORK) — A United Nations report published Tuesday showed women’s and children’s health have backslid due to the impacts of the COVID-19 pandemic, conflict and climate change.
The report, titled Every Woman Every Child Progress Report, found that since 2020, rates of anxiety and depression, food insecurity and intimate partner violence have risen while rates of vaccination have declined.
“The impacts of COVID-19, conflicts and climate crises have raised the stakes for vulnerable communities, revealing the weaknesses and inequities in health care systems and reversing hard-won progress for women, children and adolescents — but we are not powerless to change this,” UNICEF Executive Catherine Russell said in a statement.
“By investing in resilient, inclusive primary health care systems, jumpstarting routine immunization programs and strengthening the health workforce, we can make sure that every woman and every child can access the care they need to survive and thrive,” Russell said.
The report found that at least 25 million children were either unvaccinated or under-vaccinated in 2021 — at least six million more than in 2019.
This includes routine childhood vaccinations like the diphtheria, tetanus and pertussis (DTaP) vaccine and the human papillomavirus (HPV) vaccine, which prevents against certain strains of the virus that can lead to cervical cancer.
The pandemic also forced millions of children to miss school, and the report estimates that 80% of children in 104 countries and territories “experienced learning loss because of school closures.”
Additionally, the report found that more than 45 million children are suffering from acute malnutrition, which occurs when children don’t have adequate nutrient intake. According to the report, this leaves children vulnerable to developmental delays, disease and death.
What’s more, world hunger had risen since the beginning of the pandemic, with 768 million people experiencing hunger.
The report attributes the rise in global hunger to pandemic-related economic disruption and climate change events such as drought and conflicts, including the Russia-Ukraine war.
In addition, estimates showed an increase in mental health conditions compared to years prior, including an increase in major depressive disorders of 27.6% and a 25.6% increase in anxiety disorders since the pandemic began.
The report also examined how records from helplines, police departments and other organizations showed an increase in violence against women and, specifically, intimate partner violence.
The authors said the rise could be attributed to several factors, including lockdowns forcing women to spend more time in close proximity to abusive partners, stress from the pandemic leading to violence and less access to social services.
“Almost three years on from the onset of COVID-19, the pandemic’s long-term impact on the health and well-being of women, children and adolescents is becoming evident: Their chances for healthy and productive lives have declined sharply,” Dr. Tedros Adhanom Ghebreyesus, director-general for the World Health Organization, said in a statement.
The statement added, “As the world emerges from the pandemic, protecting and promoting the health of women, children and young people is essential for supporting and sustaining the global recovery.”
(LONDON) — The world could be only a few years away from a cancer vaccine, according to the couple behind the Pfizer/BioNtech COVID-19 vaccine.
“We feel that a cure for cancer or to changing cancer patients’ lives is in our grasp,” professor Ozlem Tureci told BBC News in an interview over the weekend.
Her husband, professor Ugur Sahin, with whom she cofounded the German pharmaceutical company BioNTech, said he thought cancer vaccines could be widely available “before 2030.”
The husband-and-wife duo founded BioNTech in 2008 originally to develop and produce treatments for individualized cancer immunotherapy, using mRNA technology. But when the pandemic hit, they adapted this technology to create one of the first and most effective COVID-19 vaccines.
Scientists have been working on a cancer vaccine for decades. One approach is to teach the immune system to recognize and destroy cancer cells — ideally preventing cancer from growing in the first place. Further along are other types of vaccines designed to treat people who already have cancer, including one Food and Drug Administration-approved cancer vaccine for people with advanced prostate cancer.
“From the very beginning, our focus has always been on exploiting the full potential of the body’s immune system to successfully help address cancer and infectious diseases,” the company’s website says.
In this recent interview, the two professors explained that their experience of developing the COVID vaccine could help accelerate their work on a cancer vaccine as it launched the mRNA technology into the mainstream.
“What we have developed over decades for cancer vaccine development has been the tailwind for developing the COVID-19 vaccine, and now the Covid-19 vaccine and our experience in developing it gives back to our cancer work,” Tureci said, explaining that “mRNA acts as a blueprint and allows you to tell the body to produce the drug or the vaccine … and when you use mRNA as a vaccine, the mRNA is a blueprint for the ‘wanted poster’ of the enemy — in this case, cancer antigens which distinguish cancer cells from normal cells.”
“The development of several COVID vaccines in record time showed the possibilities of mRNA vaccine technology, which could one day become an effective treatment to help beat cancer,” Dr. Sam Godfrey, research information lead at Cancer Research U.K., said.
“Just as science was our route out of the pandemic, science is our route to beating cancer. We’re optimistic that, in the future, we will see mRNA technology and other exciting vaccine approaches giving doctors more treatment options to help beat cancer,” Godfrey added.
Many other pharmaceutical companies, including vaccine maker Moderna, are also working on mRNA vaccines to target specific cancers.
“Using vaccines to treat cancer is an exciting emerging field,” Godfrey said. “We’ve already partnered with Vaccitech to trial one of the world’s first therapeutic vaccines for lung cancer, and we are funding cutting-edge research learning how virus and vaccine technology might activate the immune system against cancer.”
This approach is not without roadblocks. For example, the BioNTech vaccine needs to be custom-designed for each person. However, a preliminary study in pancreatic cancer suggested the vaccine might help delay cancer reoccurrence, though more research is needed.
“Every step, every patient we treat in our cancer trials helps us to find out more about what we are against and how to address that,” Tureci said, before adding a note of caution: “We are always hesitant to say we will have a cure for cancer. We have a number of breakthroughs and we will continue to work on them.”
(NEW YORK) — Monkeypox cases are continuing to decline in the United States as the outbreak keeps showing signs of receding.
As of Oct. 12, the U.S. recorded a seven-day average of 60 cases, according to the Centers for Disease Control and Prevention.
This is the lowest average recorded since June 29, which is right around the time that infections began climbing. It’s also down from the seven-day average of 443 cases recorded in early August, Centers for Disease Control and Prevention data shows.
Trends seen in cities across the country mirror those nationwide.
In New York City — the epicenter of the outbreak — the seven-day average has fallen to 2 as of Oct. 11, according to the city’s Department of Health & Mental Hygiene. This is a sharp decline from the peak of 73 recorded in late July and early August.
Similarly, in Los Angeles, the seven-day average sits at 5 as of most recent data from Oct. 3, according to the Los Angeles County Department of Public Health, which is the lowest since early July. It’s also a marked drop from the peak of 41 in late August.
Dr. Shira Doron, an infectious disease physician and hospital epidemiologist at Tufts Medical Center in Boston, told ABC News the outbreak has fallen for a few reasons, one being behavioral changes.
The outbreak has primarily been concentrated in men who have sex with men, a group that includes people who identify as gay, bisexual, transgender and nonbinary, although health officials have said anyone — regardless of sexual orientation — is at risk if they have direct contact with an infected person.
Surveys have shown that high-risk groups listened to public health advice and made changes such as reducing the number of sexual partners and anonymous sexual encounters.
“There were really substantial changes among men who have sex men,” Doron said. “High proportions said that they had made significant changes in their behavior.”
Another reason, she said, is vaccines. As of Oct. 11, more than 906,000 doses of the JYNNEOS vaccine — the only vaccine approved by the Food and Drug Administration to prevent smallpox and monkeypox disease — have been administered across the U.S., according to the CDC.
To increase the number of JYNNEOS doses available, the FDA authorized a new strategy in August to inject the vaccine intradermally, just below the first layer of skin, rather than subcutaneously, or under all the layers of skin, allowing one vial of vaccine to be given out as five separate doses rather than a single dose.
Doron, however, said it’s too soon to claim victory over the outbreak and added that it’s important for those who are at high-risk to keep taking precautions.
“As we have learned and seen with COVID, case numbers have a certain shape and what goes down can come up again,” she said. “So, we can’t rest on our laurels and think that’s it over.”
“The public can relax to a much greater extent than public health officials and hospital officials,” she added.
(NEW YORK) — Health care giant Cigna improperly obtained tens of millions of dollars in Medicare funding by making certain Medicare Part C recipients seem sicker than they actually were, the federal government alleged in a civil lawsuit filed Monday.
Cigna submitted false and invalid diagnoses to artificially inflate the payments it would receive for providing insurance coverage to its Medicare Advantage plan members, the suit said.
The lawsuit resulted from a whistleblower complaint and seeks damages and penalties.
“CIGNA knew that, under the Medicare Advantage reimbursement system, it would be paid more if its plan members appeared to be sicker,” Damian Williams, the U.S. attorney for the Southern District of New York, said in a statement. “This Office is dedicated to holding insurers accountable if they seek to manipulate the system and boost their profits by submitting false information to the Government.”
Cigna relied on diagnoses based solely on forms completed by vendors retained and paid by the company to conduct in-home assessments of plan members, according to the lawsuit.
The nurse practitioners who typically conducted these home visits did not perform or order the testing or imaging that would have been necessary to reliably diagnose the serious, complex conditions reported, the lawsuit claims.
The nurse practitioners spent limited time with the patients and did not conduct a comprehensive physical examination. Instead, they relied largely on the patient’s own self-assessment and their responses to various basic screening questions, the government said.
There was allegedly no access to the patient’s full medical history and they typically did not obtain or review relevant medical records in advance of the visit.
Still, Cigna submitted these diagnoses to Medicare to claim increased payments and falsely certified on an annual basis that its diagnosis data submissions were “accurate, complete, and truthful,” the lawsuit said.
In response to the lawsuit, Cigna said in a statement: “We are proud of the high-quality, affordable Medicare Advantage benefits we are privileged to provide to beneficiaries nationwide in compliance with government rules. We reject these allegations and will vigorously defend our Medicare Advantage business against them. Our focus remains on serving our Medicare customers and advancing our mission of making health care more affordable, predictable, and simple for all.”
Medicare Advantage, also known as Medicare Part C, provides health insurance for tens of millions of Americans who opt out of traditional Medicare through private insurers like Cigna. They receive payments from the Centers for Medicare and Medicaid Services based on demographic information and the diagnoses of each beneficiary.
CMS then uses the diagnosis data, in conjunction with demographic factors, to calculate a “risk score” for each beneficiary and, in turn, the amount of the monthly payment the private insurer will receive for covering that beneficiary. The model is intended to pay more to provide health care for sicker enrollees.
According to the government’s lawsuit, Cigna structured home visits for the primary purpose of capturing and recording lucrative diagnosis codes that would significantly increase the monthly capitated payments it received from CMS.
When identifying plan members to receive home visits, the lawsuit said Cigna targeted individuals who were likely to yield the greatest risk score increases and thus the greatest increased payment.
(NEW YORK) — For the first time, hearing aids are available for purchase over the counter at retailers across the United States.
Starting Monday, under a historic ruling issued by the U.S. Food and Drug Administration, adults with mild-to-moderate hearing loss can buy hearing aids at a store or online without a prescription, medical exam or audiologist fitting — and for thousands of dollars less than they previously cost, according to the White House.
The FDA estimates the new rule could lower average costs for hearing aids by as much as $3,000 per pair, the White House said. Consumers are expected to save about $1,400 per individual hearing aid, or over $2,800 per pair.
“A person’s ‘whole health’ is a combination of many factors, including hearing, that influence physical and mental well-being,” Walmart’s chief medical officer, Dr. John Wigneswaran, said in a statement Monday. “Offering easy access to OTC hearing aids — something that seems quite small — is a solution that can improve our customer’s health outcomes and their ability to live better and healthier.”
Walgreens is now selling hearing aids at stores nationwide and online for $799 per pair. Walmart is also offering an assortment of over-the-counter hearing aids — ranging in price from $199 to $999 per pair — on Walmart.com, SamsClub.com and in over 1,000 Vision Centers in Walmart stores across Colorado, Michigan, Missouri, Ohio, Pennsylvania, Tennessee and Texas, as well as 474 Sam’s Club Hearing Aid Center locations. CVS is now selling over-the-counter hearing aids online, with varying options on model and price point. The company will also offer hearing aids in select CVS Pharmacy locations beginning in November, according to the White House.
Best Buy will offer nearly 20 different hearing devices online starting this week. By the end of the month, the company will offer hearing aids in nearly 300 stores across the country. Devices will range in price between $200 and $3,000.
Hy-Vee will sell over-the-counter hearing aids online and in 34 locations across Iowa, Kansas, Minnesota, Missouri, Nebraska and Wisconsin starting this week. The company plans to offer hearing aids in 100 locations by the end of the year. There will be four different models ranging in price from $499.99 to $999.99, according to the White House.
The FDA announced the move back in August, issuing a final ruling that established a new category of over-the-counter hearing aids to improve access and, in turn, lower costs for millions of Americans. The ruling followed an executive order from President Joe Biden in 2021 that called for the FDA to take steps to allow hearing aids to be sold over the counter.
“The new over-the-counter category applies to certain air conduction hearing aids, intended for adults aged 18 and older who have perceived mild-to-moderate hearing loss,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said at a briefing on Aug. 16. “Hearing aids for severe hearing loss or for users younger than age 18 will be prescription devices, to assure patient safety as well as effectiveness.”
Air conduction hearing aids are worn inside the ear or on the ear, with an inside-the-ear component and amplified sound into the ear canal. In an effort to prevent further hearing loss, these devices will have sound limits, the FDA said.
Nearly 30 million Americans suffer from some degree of hearing loss, including nearly 10 million adults under the age of 60, according to the White House.
