In a disturbing sign of the times, Medicare this week implemented a change to its claims-processing system that adds two extra digits to money amounts, expanding the fields from eight digits to 10. The change now allows for billing and payment totals of up to $99,999,999.99, or a penny shy of $100 million.
In a notice released last month, the Centers for Medicare & Medicaid Services (CMS) explained the change, writing, “With the increase of Part B procedures/treatments exceeding the $999,999.99 limitation, CMS is implementing the expansion of display screens for monetary amount fields related to billing and payment within [the Fiscal Intermediary Shared System (FISS)] to accept and process up to 10 digits ($99,999,999.99).”
The FISS is the processing system used by hospitals and doctors’ offices to process Medicare claims.
Stat news, which first reported the update, noted that it’s not the first time CMS has struggled to make room for ever-increasing drug and treatment prices in its claims processing systems. In 2022, the agency had to give technical advice to doctors submitting claims for chimeric antigen receptor (CAR) T-cell therapy, which is used to treat blood cancers. CAR T-cell therapies run around half a million dollars, or eight digits. But in a different claims processing system, called the Multi-Carrier System (MCS), the money amount fields only included seven digits. In that case, rather than expanding the field, the CMS requested that doctors divide the bill by either five or 10, depending on the size, and then bill Medicare five or 10 separate times for a single claim.
CAR T-cell therapies aren’t the only treatments with eye-popping price points these days. Just last month, the drug Lenmeldy, a lifesaving gene therapy for a tragic childhood condition, set the current record for the highest drug price in the world at $4.25 million. Before Lenmeldy arrived, the hemophilia B drug Hemgenix held that record, with its price set at $3.5 million.
While these advanced therapies come with mind-boggling prices, prescription drug costs in the US are a problem across the board. In a KFF poll published in August, 28 percent of US adults reported difficulty affording their prescription medication, while 31 percent reported not taking their medicine as prescribed in the past year due to the cost. A federal report from 2022 found that Americans pay nearly three times more for prescription drugs than people in 33 other wealthy countries.
Enlarge/ A billboard from the AIDS Healthcare Foundation is seen on Sunset Boulevard in Hollywood, California, on May 29, 2018, warning of a drug-resistant gonorrhea.
Health officials have long warned that gonorrhea is becoming more and more resistant to all the antibiotic drugs we have to fight it. Last year, the US reached a grim landmark: For the first time, two unrelated people in Massachusetts were found to have gonorrhea infections with complete or reduced susceptibility to every drug in our arsenal, including the frontline drug ceftriaxone. Luckily, they were still able to be cured with high-dose injections of ceftriaxone. But, as the US Centers for Disease Control and Prevention bluntly notes: “Little now stands between us and untreatable gonorrhea.”
If public health alarm bells could somehow hit a higher pitch, a study published Thursday from researchers in China would certainly accomplish it. The study surveyed gonorrhea bacterial isolates—Neisseria gonorrhoeae—from around the country and found that the prevalence of ceftriaxone-resistant isolates nearly tripled between 2017 and 2021. Ceftriaxone-resistant strains made up roughly 8 percent of the nearly 3,000 bacterial isolates collected from gonorrhea infections in 2022. That’s up from just under 3 percent in 2017. The study appears in the CDC’s Morbidity and Mortality Weekly Report.
While those single-digit percentages may seem low, compared to other countries they’re extremely high. In the US, for instance, the prevalence of ceftriaxone-resistant strains never went above 0.2 percent between 2017 and 2021, according to the CDC. In Canada, ceftriaxone-resistance was stable at 0.6 percent between 2017 and 2021. The United Kingdom had a prevalence of 0.21 percent in 2022.
Ceftriaxone is currently the first-line treatment for gonorrhea because Neisseria gonorrhoeae has spent the past several decades building up resistance to pretty much everything else. As the CDC notes, in the 1980s, the drugs of choice for gonorrhea infections were penicillin and tetracycline. But the bacteria developed resistance. By the 1990s, the CDC was forced to switch to a class of antibiotics called fluoroquinolones, including ciprofloxacin (Cipro). But fluoroquinolone-resistance developed, too, and resistance to Cipro is now widespread. In the early 2000s, the CDC began having to tweak the recommendations as resistance spread to new places and populations.
Resistance rising
By 2007, the agency switched to cephalosporins, including cefixime. In 2010, the CDC updated the treatment again, recommending that doctors combine cephalosporins with one of two other types of antibiotics—azithromycin or doxycycline—to try to thwart the development of resistance. But, it also was no use. Two years later, in 2012, the CDC updated recommendations when cefixime resistance developed. In 2020, azithromycin was also abandoned. The cephalosporin ceftriaxone is the last drug standing in the US to treat gonorrhea infections.
Enlarge/ Resistance of gonococcal isolates to ciprofloxacin, penicillin, tetracycline, azithromycin, cefixime, ceftriaxone, and spectinomycin—13 Gonococcal Resistance Surveillance Program sentinel sites, China, 2022.
In China, the swift spread of ceftriaxone-resistance isolates is alarming. The data stems from 2,804 isolates, representing 2.9 percent of all cases reported in China during 2022. Those figures come from 13 of the country’s 19 provinces. While the overall prevalence of ceftriaxone-resistance isolates was 8.1 percent among the 2,804 isolates, five of those 13 provinces had prevalence rates above 10 percent. Three provinces had prevalence rates above 25 percent. In all, 18 isolates were resistant to all the antibiotics tested except for a bygone antibiotic called spectinomycin, which is discontinued in the US and elsewhere.
The study has limitations. For one, the reported number of gonorrhea cases are very likely an undercount of actual cases. Beyond gaps in reporting, many people with gonorrhea have no symptoms and, as such, don’t seek treatment. Additionally, the isolates the researchers did have represented less than 3 percent of reported cases, so it’s possible the prevalence rates don’t represent the isolates of the entire country. Also, the researchers didn’t have detailed case data that might help identify specific risk factors for resistance development, such as the antibiotic treatments patients had. The authors did note that antibiotics are only given by prescription in China.
“These findings underscore the urgent need for a comprehensive approach to address antibiotic-resistant N. gonorrhoeae in China, including identifying factors contributing to this high resistance rate, especially in provinces where the percentage of gonococcal isolates resistant to ceftriaxone is >10 percent,” the authors write.
But they also note that this is not just an alarming finding for China but also a “pressing public health concern” for the entire world. “These resistant clones have spread internationally, and collaborative cross-border efforts will be essential to monitoring and mitigating its further spread,” they write.
Female Aedes aegypti mosquito as she was in the process of obtaining a “blood meal.”
Puerto Rico has declared a public health emergency amid an ongoing outbreak of dengue infections, a mosquito-spread viral infection that can cause fever, aches, rash, vomiting, and, in about 5 percent of cases, a severe disease marked by internal bleeding and shock.
The US territory has tallied 549 cases since the start of the year, representing a 140 percent increase compared with cases tallied at this point last year, according to the territory’s health department. The Associated Press reported that more than 340 of the 549 cases have been hospitalized.
In 2023, the island nation of more than 3.2 million people had over 1,000 cases of dengue throughout the year.
But this year’s cases are rising rapidly, leading health officials to warn residents to be vigilant and take prevention measures. That includes wearing insect repellent and draining or treating any standing water where mosquitoes can breed. The mosquitoes that transmit dengue—Aedes aegypti—seem to prefer breeding in artificial containers, such as flower pots, buckets, water drums, vases, plastic containers of any kind, the inner rings of discarded automobile tires, and trash in general. They can breed in tiny amounts of water, such as in bottle caps.
Puerto Rico’s outbreak of dengue is part of a larger regional trend, the island’s health department noted. Last year, the Americas saw the highest number of dengue cases ever recorded, totaling 4,565,911, according to the Pan American Health Organization (PAHO), a division of the World Health Organization. So far this year, the region has reported 3,578,414 cases, including 1,039 deaths. The bulk of the cases are in Brazil, which has reported over 2.9 million cases so far. Paraguay has reported over 191,000 cases, and Argentina has reported over 134,000 cases.
In a December 2023 risk assessment, the PAHO deemed the risk to human health from dengue to be “high” in the region. The report noted that the effects of climate change are driving higher rainfall, higher temperatures, and more humidity, allowing A. aegypti to expand into new areas and increase breeding. A. aegypti are already found in much of South America, Central America, and the southeastern US.
This post was updated to include additional case tallies.
Wild migratory birds likely spread a deadly strain of bird flu to dairy cows in Texas and Kansas, state and federal officials announced this week.
It is believed to be the first time the virus, a highly pathogenic avian influenza (HPAI), has been found in cows in the US. Last week, officials in Minnesota confirmed finding an HPAI case in a young goat, marking the first time the virus has been found in a domestic ruminant in the US.
According to the Associated Press, officials with the Texas Animal Health Commission confirmed the flu virus is the Type A H5N1 strain, which has been ravaging bird populations around the globe for several years. The explosive, ongoing spread of the virus has led to many spillover events into mammals, making epidemiologists anxious that the virus could adapt to spread widely in humans.
For now, the risk to the public is low. According to a release from the US Department of Agriculture (USDA), genetic testing by the National Veterinary Services Laboratories indicated that H5N1 strain that spread to the cows doesn’t appear to contain any mutations that would make it more transmissible to humans. Though the flu strain was found in some milk samples from the infected cows, the USDA emphasized that all the milk from affected animals is being diverted and destroyed. Dairy farms are required to send only milk from healthy animals to be processed for human consumption. Still, even if some flu-contaminated milk was processed for human consumption, the standard pasteurization process inactivates viruses, including influenza, as well as bacteria.
So far, officials believe the virus is primarily affecting older cows. The virus was detected in milk from sick cows on two farms in Kansas and one in Texas, as well as in a throat swab from a cow on a second Texas farm. The USDA noted that farmers have found dead birds on their properties, indicating exposure to infected birds. Sick cows have also been reported in New Mexico. Symptoms of the bird flu in cows appear to include decreased milk production and low appetite.
But so far, the USDA believes the spread of H5N1 will not significantly affect milk production or the herds. Milk loss has been limited; only about 10 percent of affected herds have shown signs of the infection, and there has been “little to no associated mortality.” The USDA suggested it will remain vigilant, calling the infections a “rapidly evolving situation.”
While federal and state officials continue to track the virus, Texas officials aim to assure consumers. “There is no threat to the public and there will be no supply shortages,” Texas Agriculture Commissioner Sid Miller said in a statement. “No contaminated milk is known to have entered the food chain; it has all been dumped. In the rare event that some affected milk enters the food chain, the pasteurization process will kill the virus.”
American workers who have more flexibility and security in their jobs also have better mental health, according to a study of 2021 survey data from over 18,000 nationally representative working Americans.
The study, published Monday in JAMA Network Open, may not be surprising to those who have faced return-to-office mandates and rounds of layoffs amid the pandemic. But, it offers clear data on just how important job flexibility and security are to the health and well-being of workers.
For the study, job flexibility was assessed in terms of ease of adjusting work schedules, advance notice of scheduling changes, and whether schedules were changed by employers often. People who reported greater flexibility in their job had 26 percent lower odds of serious psychological distress, which was measured on a validated, widely used questionnaire that assesses depression, nervousness, hopelessness, and worthlessness, among other forms of distress. Greater job flexibility was also linked to 13 percent lower odds of experiencing daily anxiety, 11 percent lower odds of experiencing weekly anxiety, and 9 percent lower odds of experiencing anxiety a few times a year.
Job security also appeared to be a boon for mental health. Workers were asked how likely they thought that they may lose their job or get laid off in the next 12 months. Those who reported feeling more secure in their positions had 25 percent lower odds of serious psychological distress. Job security was also associated with 27 percent lower odds of experiencing daily anxiety and 21 percent lower odds of experiencing weekly anxiety.
The study, led by Monica Wang of Boston University’s School of Public Health, also looked at how job flexibility and security affected job absenteeism, finding mixed results. Both job flexibility and security were linked to fewer days where workers reported working while they were sick—suggesting that flexibility and security enabled workers to make use of sick leave when they needed it. In line with that finding, more job flexibility led to more days where workers reported being absent due to illness in the three months prior to the survey. Greater job security, on the other hand, led to fewer absences over the previous three and 12 months.
It’s unclear why that would be the case, but the researchers speculated that “Job security may lead to lower work absenteeism due to higher work satisfaction, decreased job-related stress, and financial security,” they wrote.
Overall, the study’s findings indicate “the substantive impact that flexible and secure jobs can have on mental health in the short-term and long-term,” the researchers conclude.
They do note limitations of the study, the main one being that the study identifies associations and can’t determine that job flexibility and security directly caused mental health outcomes and the work absence findings. Still, they suggest that workplace policies could improve the mental health of employees. This includes flexible scheduling, leave policies, and working arrangements, including remote and hybrid options, which can all allow workers to accommodate personal and family needs. For improving job security, the researchers recommend longer-term contracts and long-term strategies to invest in employees, such as “uptraining,” skill development, and advancement opportunities.
Enlarge/ A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004.
In a medical triumph, US Food and Drug Administration on Monday approved a gene therapy that appears to trounce a rare, tragic disease that progressively steals children’s ability to talk, move, and think, leading to a vegetative state and death. For those who begin to slip away in infancy, many die by age 5. But, with the new therapy, 37 children in an initial trial were all still alive at age 6. Most could still talk, walk on their own, and perform normally on IQ tests, which was unseen in untreated children. Some of the earliest children treated have now been followed for up to 12 years—and they continue to do well.
But, the triumph turned bittersweet today, Wednesday, as the company behind the therapy, Lenmeldy, set the price for the US market at $4.25 million, making it the most expensive drug in the world. The price is $310,000 higher than what experts calculated to be the maximum fair price for the lifesaving drug; the nonprofit Institute for Clinical and Economic Review, or ICER, gave a range last October of between $2.29 million to $3.94 million.
The price raises questions about whether state, federal, and private health insurance plans will be able to shoulder the costs. “Unless states have allocated appropriately for it, and looked at the drug pipeline, they may not be prepared for what could be significant cost spikes,” Edwin Park, a research professor at the McCourt School of Public Health at Georgetown University, told CNN.
It’s also unclear whether the drug can reach the children who need it in time. Lenmeldy must be given before symptoms develop or early on in symptom development in children. However, diagnosis of the rare genetic condition can be slow, and many children treated so far were identified because older siblings, now too old for treatment, developed the condition first.
Devastating disease
Stat, for instance, spoke with the mother of an 8-year-old with the condition, who can no longer talk or move, has frequent seizures, and requires a feeding tube and 28 different medications. Meanwhile, her 3-year-old brother, who has the same genetic mutation, is a typical toddler—he was able to get the new treatment when he was six months old. To get it, the family flew him to Milan, Italy, where Lenmeldy was first developed. It was approved for use in Europe in 2021.
The condition Lenmeldy treats is called metachromatic leukodystrophy (MLD), which occurs in about 40 children in the US each year. MLD is caused by a mutation in the gene that codes for the enzyme arylsulfatase A (ARSA). Without this enzyme, the body can’t break down sulfatides, a fatty substance that then builds up to toxic levels in the brain and peripheral nervous system. Sulfatides are essential components of myelin, the fatty insulation on nerve cells critical for quick transmission of electrical impulses. But, too much sulfatides leads to a loss of myelin, which gradually destroys myelin producing cells and leads to nervous system damage.
Lenmeldy prevents that damage by giving the body a working copy of the ARSA gene. In a one-time infusion, patients are given a dose of their own blood stem cells that have been genetically engineered to contain a functional ARSA gene. Patients undergo chemotherapy to clear out their own stem cells from bone marrow so the genetically modified cells can replace them. The engineered stem cells then produce myeloid cells that travel around the body in the blood, producing ARSA enzyme that can halt progression of MLD.
It’s unknown how long the therapy lasts, but it’s clearly buying children time and giving them hope for a full, normal life.
“MLD is a devastating disease that profoundly affects the quality of life of patients and their families,” Nicole Verdun, director of the FDA’s Office of Therapeutic Products, said in a statement. “Advancements in treatment options offer hope for improved outcomes and the potential to positively influence the trajectory of disease progression.”
It “has the potential to stop or slow the progression of this devastating childhood disease with a single treatment, particularly when administered prior to the onset of symptoms,” Bobby Gaspar, CEO of Lenmeldy’s maker, Orchard Therapeutics, said in a statement Wednesday. “We are committed to enabling broad, expedient, and sustainable access to this important therapy for eligible patients with early-onset MLD in the US.”
The company is working on expanding newborn screening to include tests for MLD, to try to find children early, Orchard reported. Still, with such a rare condition, it’s unclear if the pricey drug will be a moneymaker for the company. Stat notes that Orchard has previously abandoned four therapies for other rare genetic conditions because of the difficulty in meeting regulatory standards for essentially custom therapies and questions about whether health plans will pay the steep, multimillion-dollar prices. In April of last year, Belgium, Ireland, and the Netherlands walked away from price negotiations with the company, saying they couldn’t come to an agreement on this “extremely expensive therapy.”
Enlarge/ A view from a hospital as children receiving medical treatment, in capital Kabul, Afghanistan on April 18, 2022. More than 130 children have died from the measles in Afghanistan since the beginning of this year.
The Centers for Disease Control and Prevention and the American Medical Association sent out separate but similar pleas on Monday for unvaccinated Americans to get vaccinated against the extremely contagious measles virus as vaccination rates have slipped, cases are rising globally and nationally, and the spring-break travel period is beginning.
In the first 12 weeks of 2024, US measles cases have already matched and likely exceeded the case total for all of 2023. According to the CDC, there were 58 measles cases reported from 17 states as of March 14. But media tallies indicate there have been more cases since then, with at least 60 cases now in total, according to CBS News. In 2023, there were 58 cases in 20 states.
“As evident from the confirmed measles cases reported in 17 states so far this year, when individuals are not immunized as a matter of personal preference or misinformation, they put themselves and others at risk of disease—including children too young to be vaccinated, cancer patients, and other immunocompromised people,” AMA President Jesse Ehrenfeld said in a statement urging vaccination Monday.
The latest data indicates that vaccination rates among US kindergarteners have slipped to 93 percent nationally, below the 95 percent target to prevent the spread of the disease. And vaccine exemptions for non-medical reasons have reached an all-time high.
The CDC released a health advisory on Monday also urging measles vaccination. The CDC drove home the point that unvaccinated Americans are largely responsible for importing the virus, and pockets of unvaccinated children in local communities spread it once it’s here. The 58 measles infections that have been reported to the agency so far include cases from seven outbreaks in seven states. Most of the cases are in vaccine-eligible children aged 12 months and older who are unvaccinated. Of the 58 cases, 54 (93 percent) are linked to international travel, and most measles importations are by unvaccinated US residents who travel abroad and bring measles home with them, the CDC flagged.
The situation is likely to worsen as Americans begin spring travel, the CDC suggested. “Many countries, including travel destinations such as Austria, the Philippines, Romania, and the United Kingdom, are experiencing measles outbreaks,” the CDC said. “To prevent measles infection and reduce the risk of community transmission from importation, all US residents traveling internationally, regardless of destination, should be current on their [measles-mumps-rubella (MMR)] vaccinations.” The agency added in a recommendation to parents that “even if not traveling, ensure that children receive all recommended doses of MMR vaccine. Two doses of MMR vaccine provide better protection (97 percent) against measles than one dose (93 percent). Getting MMR vaccine is much safer than getting measles, mumps, or rubella.”
For Americans who are already vaccinated and communities with high vaccination coverage, the risk is low, the CDC noted. “However, pockets of low coverage leave some communities at higher risk for outbreaks.” This, in turn, threatens wider, continuous spread that could overturn the country’s status of having eliminated measles, which was declared in 2000. The US was close to losing its elimination status in 2019 when outbreaks among unvaccinated children drove 1,247 cases across 31 states. Vaccination rates have only fallen since then.
“The reduction in measles vaccination threatens to erase many years of progress as this previously eliminated vaccine-preventable disease returns,” the AMA’s Ehrenfeld warned.
As Ars has reported previously, measles is among the most contagious viruses known and can linger in airspace for up to two hours. Up to 90 percent of unvaccinated people exposed will contract it. Symptoms can include high fever, runny nose, red and watery eyes, and a cough, as well as the hallmark rash. About 1 in 5 unvaccinated people with measles are hospitalized, while 1 in 20 infected children develop pneumonia, and up to 3 in 1,000 children die of the infection. Brain swelling (encephalitis) can occur in 1 in 1,000 children, which can lead to hearing loss and intellectual disabilities. The virus can also destroy immune responses to previous infections—a phenomenon known as “immune amnesia”—which can leave children vulnerable to various other infections for years afterward.
Enlarge/ Mature morel mushrooms in a greenhouse at an agriculture garden in Zhenbeibu Town of Xixia District of Yinchuan, northwest China’s Ningxia Hui Autonomous Region.
True morel mushrooms are widely considered a prized delicacy, often pricey and surely safe to eat. But these spongey, earthy forest gems have a mysterious dark side—one that, on occasion, can turn deadly, highlighting just how little we know about morels and fungi generally.
On Thursday, Montana health officials published an outbreak analysis of poisonings linked to the honeycombed fungi in March and April of last year. The outbreak sickened 51 people who ate at the same restaurant, sending four to the emergency department. Three were hospitalized and two died. Though the health officials didn’t name the restaurant in their report, state and local health departments at the time identified it as Dave’s Sushi in Bozeman. The report is published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.
The outbreak coincided with the sushi restaurant introducing a new item: a “special sushi roll” that contained salmon and morel mushrooms. The morels were a new menu ingredient for Dave’s. They were served two ways: On April 8, the morels were served partially cooked, with a hot, boiled sauce poured over the raw mushrooms and left to marinate for 75 minutes; and on April 17, they were served uncooked and cold-marinated.
The mystery poison worked fast. Symptoms began, on average, about an hour after eating at the restaurant. And it was brutal. “Vomiting and diarrhea were reportedly profuse,” the health officials wrote, “and hospitalized patients had clinical evidence of dehydration. The two patients who died had chronic underlying medical conditions that might have affected their ability to tolerate massive fluid loss.”
Of the 51 sickened, 46 were restaurant patrons and five were employees. Among them, 45 (88 percent) recalled eating morels. While that’s a high percentage for such an outbreak investigation, certainly enough to make the morels the prime suspect, the health officials went further. With support from the CDC, they set up a matched case-control study, having people complete a detailed questionnaire with demographic information, food items they ate at the restaurant, and symptoms.
Mysterious poison
Forty-one of the poisoned people filled out the questionnaire, as did 22 control patrons who ate at the restaurant but did not report subsequent illness. The analysis indicated that the odds of recalling eating the special sushi roll were nearly 16 times higher among the poisoned patrons than among the controls. The odds of reporting any morel consumption were nearly 11 times higher than controls.
The detailed consumption data also allowed the health officials to model a dose response, which suggested that with each additional piece of the special roll a person recalled eating, their odds of sickness increased nearly threefold compared with people who reported eating none. Those who ate four or more pieces of the roll had odds nearly 22.5 times higher. A small analysis focusing on the five employees sickened, which was not included in the published study but was noted by the Food and Drug Administration, echoed the dose-response finding, indicating that sickness was linked with larger amounts of morel consumption.
When the officials broke down the analysis by people who ate at the restaurant on April 17, when the morels were served uncooked, and those who ate at the restaurant on April 8, when the mushrooms were slightly cooked, the cooking method seemed to matter. People who ate the uncooked rather than the slightly cooked mushrooms had much higher odds of sickness.
This all strongly points to the morels being responsible. At the time, the state and local health officials engaged the FDA, as well as the CDC, to help tackle the outbreak investigation. But the FDA reported that “samples of morel mushrooms collected from the restaurant were screened for pesticides, heavy metals, toxins, and pathogens. No significant findings were identified.” In addition, the state and local health officials noted that DNA sequencing identified the morels used by the restaurant as Morchella sextelata, a species of true morel. This rules out the possibility that the mushrooms were look-alike morels, called “false morels,” which are known to contain a toxin called gyromitrin.
The health officials and the FDA tracked down the distributor of the mushrooms, finding they were cultivated and imported fresh from China. Records indicated that 12 other locations in California also received batches of the mushrooms. Six of those facilities responded to inquiries from the California health department and the FDA, and all six reported no illnesses. They also all reported cooking the morels or at least thoroughly heating them.
As health systems around the US are still grappling with an unprecedented ransomware attack on the country’s largest health care payment processor, the US Department of Health and Human Services is opening an investigation into whether that processor and its parent company, UnitedHealthcare Group, complied with federal rules to protect private patient data.
As Ars reported previously, the attack was disclosed on February 21 by UHG’s subsidiary, Optum, which now runs Change Healthcare. On February 29, UHG accused the notorious Russian-speaking ransomware gang known both as AlphV and BlackCat of being responsible. According to The Washington Post, the attack involved stealing patient data, encrypting company files, and demanding money to unlock them. The result is a paralysis of claims processing and payments, causing hospitals to run out of cash for payroll and services and preventing patients from getting care and prescriptions. Additionally, the attack is believed to have exposed the health data of millions of US patients.
Earlier this month, Rick Pollack, the president and CEO of the American Hospital Association, called the ransomware attack on Change Healthcare “the most significant and consequential incident of its kind against the US health care system in history.”
Now, three weeks into the attack, many health systems are still struggling. On Tuesday, members of the Biden administration met with UHG CEO Andrew Witty and other health industry leaders at the White House to demand they do more to stabilize the situation for health care providers and services and provide financial assistance. Some improvements may be in sight; on Wednesday, UHG posted an update saying that “all major pharmacy and payment systems are up and more than 99 percent of pre-incident claim volume is flowing.”
HIPAA compliance
Still, the data breach leaves big questions about the extent of the damage to patient privacy, and the adequacy of protections moving forward. In an additional development Wednesday, the health department’s Office for Civil Rights (OCR) announced that it is opening an investigation into UHG and Change Healthcare over the incident. It noted that such an investigation was warranted “given the unprecedented magnitude of this cyberattack, and in the best interest of patients and health care providers.”
In a “Dear Colleague” letter dated Wednesday, the OCR explained that the investigation “will focus on whether a breach of protected health information occurred and Change Healthcare’s and UHG’s compliance with the HIPAA Rules.” HIPAA is the Health Insurance Portability and Accountability Act, which establishes privacy and security requirements for protected health information, as well as breach notification requirements.
In a statement to the press, UHG said it would cooperate with the investigation. “Our immediate focus is to restore our systems, protect data and support those whose data may have been impacted,” the statement read. “We are working with law enforcement to investigate the extent of impacted data.”
The Post notes that the federal government does have a history of investigating and penalizing health care organizations for failing to implement adequate safeguards to prevent data breaches. For instance, health insurance provider Anthem paid a $16 million settlement in 2020 over a 2015 data breach that exposed the private data of almost 79 million people. The exposed data included names, Social Security numbers, medical identification numbers, addresses, dates of birth, email addresses, and employment information. The OCR investigation into the breach discovered that the attack began with spear phishing emails that at least one employee of an Anthem subsidiary fell for, opening the door to further intrusions that went undetected between December 2, 2014, and January 27, 2015.
“Unfortunately, Anthem failed to implement appropriate measures for detecting hackers who had gained access to their system to harvest passwords and steal people’s private information,” OCR Director Roger Severino said at the time. “We know that large health care entities are attractive targets for hackers, which is why they are expected to have strong password policies and to monitor and respond to security incidents in a timely fashion or risk enforcement by OCR.”
Enlarge/ A view of the Centers for Disease Control and Prevention headquarters in Atlanta.
COVID-19 is becoming more like the flu and, as such, no longer requires its own virus-specific health rules, the Centers for Disease Control and Prevention said Friday alongside the release of a unified “respiratory virus guide.”
In a lengthy background document, the agency laid out its rationale for consolidating COVID-19 guidance into general guidance for respiratory viruses—including influenza, RSV, adenoviruses, rhinoviruses, enteroviruses, and others, though specifically not measles. The agency also noted the guidance does not apply to health care settings and outbreak scenarios.
“COVID-19 remains an important public health threat, but it is no longer the emergency that it once was, and its health impacts increasingly resemble those of other respiratory viral illnesses, including influenza and RSV,” the agency wrote.
The most notable change in the new guidance is the previously reported decision to no longer recommend a minimum five-day isolation period for those infected with the pandemic coronavirus, SARS-CoV-2. Instead, the new isolation guidance is based on symptoms, which matches long-standing isolation guidance for other respiratory viruses, including influenza.
“The updated Respiratory Virus Guidance recommends people with respiratory virus symptoms that are not better explained by another cause stay home and away from others until at least 24 hours after both resolution of fever AND overall symptom are getting better,” the document states. “This recommendation addresses the period of greatest infectiousness and highest viral load for most people, which is typically in the first few days of illness and when symptoms, including fever, are worst.”
“Residual risk”
The CDC acknowledged that the eased isolation guidance will create “residual risk of SARS-CoV-2 transmission,” and that most people are no longer infectious only after 8 to 10 days. As such, the agency urged people to follow additional interventions—including masking, testing, distancing, hygiene, and improving air quality—for five additional days after their isolation period.
“Today’s announcement reflects the progress we have made in protecting against severe illness from COVID-19,” CDC Director Dr. Mandy Cohen said in a statement. “However, we still must use the commonsense solutions we know work to protect ourselves and others from serious illness from respiratory viruses—this includes vaccination, treatment, and staying home when we get sick.”
Overall, the agency argued that a shorter isolation period would be inconsequential. Other countries and states that have similarly abandoned fixed isolation times did not see jumps in COVID-19 emergency department visits or hospitalizations, the CDC pointed out. And most people who have COVID-19 don’t know they have it anyway, making COVID-19-specific guidance moot, the agency argued. In a recent CDC survey, less than half of people said they would test for SARS-CoV-2 if they had a cough or cold symptoms, and less than 10 percent said they would go to a pharmacy or health care provider to get tested. Meanwhile, “The overall sensitivity of COVID-19 antigen tests is relatively low and even lower in individuals with only mild symptoms,” the agency said.
The CDC also raised practical concerns for isolation, including a lack of paid sick leave for many, social isolation, and “societal costs.”
The points are likely to land poorly with critics.
“The CDC is again prioritizing short-term business interests over our health by caving to employer pressure on COVID guidelines. This is a pattern we’ve seen throughout the pandemic,” Lara Jirmanus, Clinical Instructor of Medicine at Harvard Medical School, said in a press release last month after the news first broke of the CDC’s planned isolation update. Jirmanus is a member of the People’s CDC, a group that advocates for more aggressive COVID-19 policies, which put out the press release.
Another member of the group, Sam Friedman, a professor of population health at NYU Grossman School of Medicine, also blasted the CDC’s stance last month. The guidance will “make workplaces and public spaces even more unsafe for everyone, particularly for people who are high-risk for COVID complications,” he said.
COVID and flu
But, the CDC argues that the threat of COVID-19 is fading. Hospitalizations, deaths, prevalence of long COVID, and COVID-19 complications in children (MIS-C) are all down. COVID-19 vaccines are safe and effective at preventing severe disease, death, and to some extent, long COVID—we just need more people to get them. Over 95 percent of adults hospitalized with COVID-19 in the 2023–2024 respiratory season had no record of receiving the seasonal booster dose, the agency noted. Only 22 percent of adults got the latest shot, including only 42 percent of people ages 65 and older. In contrast, 48 percent of adults got the latest flu shot, including 73 percent of people ages 65 and older.
But even with the crummy vaccination rates for COVID-19, a mix of past infection and shots have led to a substantial protection in the overall population. The CDC even went as far as arguing that COVID-19 deaths have fallen to a level that is similar to what’s seen with flu.
“Reported deaths involving COVID-19 are several-fold greater than those reported to involve influenza and RSV. However, influenza and likely RSV are often underreported as causes of death,” the CDC said. In the 2022–2023 respiratory virus season, there were nearly 90,000 reported COVID-19 deaths. For flu, there were 9,559 reported deaths, but the CDC estimates the true number to be between 18,000 and 97,000. In the current season, there have been 32,949 reported COVID-19 deaths to date and 5,854 reported flu deaths, but the agency estimates the real flu deaths are between 17,000 and 50,000.
“Total COVID-19 deaths, accounting for underreporting, are likely to be higher than, but of the same order of magnitude as, total influenza deaths,” the agency concluded.
In all, the CDC was ready to fold SARS-CoV-2 into the gang of common seasonal respiratory viruses, with most cases mild and undiagnosed. “Viruses cause most acute respiratory illnesses, but it is rarely possible to determine the type of virus without testing, and oftentimes testing does not change clinical management,” the agency wrote.
Officials in Alabama have shut down an elementary school for the rest of the week and are conducting a deep clean after 773 of the school’s 974 students were absent Wednesday amid an explosive outbreak of gastrointestinal illness.
Local media reported that only 29 students were absent from Fairhope West Elementary School on Tuesday. However, the situation escalated quickly on Wednesday as word spread of a stomach bug going around the Gulf Coast school. A spokesperson for the county school district told AL.com that 773 students and 50 staff were absent Wednesday. It’s unclear how many of the absences were due to sickness or precaution.
Health officials are now investigating the cause of the gastrointestinal outbreak, collecting specimens for testing. So far, officials are working under the assumption that it is norovirus, a highly infectious gastrointestinal bug that can survive hand sanitizer and transmit easily from surfaces, food, and water. The symptoms of the unidentified illness align with norovirus: vomiting, diarrhea, abdominal cramps, and nausea.
On Wednesday, Baldwin County Schools Superintendent Eddie Tyler sent a message to parents saying that the county had decided to shut the school down for the rest of the week. “Due to the amount of staff and students who are absent, the number who are experiencing symptoms, and in an effort to help contain the contagion, we unfortunately need to shut the building down,” Tyler wrote. “While out, we will be conducting a deep cleaning of the school so when students return next week, it will be sanitized to the fullest extent.”
But local outlet WKRG reported Thursday that the outbreak has already spread beyond Fairhope West. On Thursday, 1,231 students from four other area schools were also absent, including 721 students at Fairhope East Elementary School, 136 at a third elementary school, 170 at a middle school, and 204 at a high school. These are in addition to the 974 students at Fairhope West who are out of school while it is shut down.
Norovirus activity is high across the country, with the northeastern region seeing the largest surge, according to surveillance by the Centers for Disease Control and Prevention. The agency notes that outbreaks are commonly linked to health care settings, restaurants or catered events, cruise ships, as well as schools and childcare centers. “Close quarters, shared spaces, and high-touch surfaces make it easy for norovirus to spread in schools,” the CDC points out.
In 2022, the COVID-19 pandemic flipped the script on standard norovirus outbreaks. People who were hoping to avoid close contact and share indoor air with strangers headed to the great outdoors, which led to a large outbreak of norovirus in the Grand Canyon.
Enlarge/ A cannabis flower is seen at East End Flower Farm, in Mattituck, New York, on November 16, 2023.
Survey data collected from more than 430,000 US adults over multiple years suggests a strong, statistically significant link between the use of cannabis and an increased risk of cardiovascular disease, specifically heart attack and stroke.
The open-access study, published this week in Journal of the American Heart Association, found that people who used cannabis every day had 25 percent higher odds of having a heart attack and 42 percent higher odds of having a stroke compared with those who did not use cannabis at all.
But, the national survey data—collected between 2016 and 2020—also contained data on people who used cannabis less frequently than daily. Survey respondents were asked how many days in the past 30 days they used cannabis, which allowed researchers to estimate the odds of cardiovascular disease along the whole spectrum of cannabis use. And they found near-linear dose-responses, with more days of use per month associated with higher risk.
This isn’t the first time that researchers have found an association between cannabis use and cardiovascular disease, but the study is among the largest to date—with a sample size between three and 17 times larger than previous studies. Its size not only added weight to the link but also allowed the researchers to drill down into other risk factors for cardiovascular disease.
Clear link
One common complicating factor is that people who use cannabis also often use tobacco products, which carry their own increased risk for cardiovascular disease. In the new study, led by Abra Jeffers of Massachusetts General Hospital, researchers were able to do two additional analyses: one that looked at cardiovascular disease risk in people who use cannabis but had never used tobacco products and a second one that looked at people who used cannabis but had never used tobacco products or e-cigarettes. Without tobacco use, the higher odds of heart attack and stroke persisted for people who used cannabis. For those without tobacco or e-cigarette use, only the higher odds of stroke remained.
The researchers also looked at age, another complicating factor. Heart disease can take years or decades to develop, but people who use cannabis tend to skew younger. The 434,104 people who took the survey ranged from age 18 to 74, and the analyses adjusted for other health factors, including alcohol use, diabetes, body mass index, and physical activity. When the researchers looked at just the adults who would be considered on the young side for developing cardiovascular disease (less than 55 for men and less than 65 for women), they found that cannabis use also increased the odds of premature cardiovascular disease—and again the link was independent of tobacco and e-cigarette use.
In all, the researchers concluded that “these data suggest that cannabis use may be a risk factor for cardiovascular disease and may be a risk factor for premature cardiovascular disease,” they wrote. This is particularly concerning, they add, because of the growing acceptance and use of cannabis in the US and a decline in perceived health risks.
Limitations
But, the study has limitations that preclude a firm conclusion that cannabis is causing cardiovascular disease. The study relies on self-reported data on both cardiovascular health and cannabis use—both of which can be unreliable. It also relied on data collected at a specific point in time. It’s possible that some people turned to cannabis use after developing cardiovascular disease rather than before, for instance. The survey data can’t make that distinction; it’s only making an association. The authors note that cardiovascular disease, heart attack, and stroke have not previously been identified as major reasons that people use cannabis. This lessens the reverse concern that cardiovascular disease is increasing the odds of cannabis use. But, the researchers do note that many studies have linked the use of cannabis to chronic pain, insomnia, and anxiety—all of which have also been associated with cardiovascular disease. Last, the survey data does not include data on people’s actual cardiovascular health, such as blood pressure and lipid profiles.
Another wrinkle to the study is the route of cannabis use and how it may play a role in the link to cardiovascular disease. About 74 percent of cannabis users in the study reported smoking cannabis, which could potentially increase the risk of cardiovascular disease much the same way tobacco cigarettes do—a result of inhaling particulate matter into the lungs. It’s unclear if edible cannabis products would weaken the association seen in the study.
But, the authors note that there is a biologically plausible link between cannabis and cardiovascular disease. Cell signaling receptors that detect components of cannabis (endocannabinoid receptors) are ubiquitous throughout the cardiovascular system, the researchers note. And the key psychoactive substance in cannabis, Tetrahydrocannabinol (THC), can increase blood pressure and heart rate during use.
