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Sunday, May 5, 2024

Measles, which can lead to complications and even death, threatens to make a comeback; vaccine is 97% protective against it

Photo by Pro-Stock Studio, iStock/Getty Images
By Nicholas Van Sickels
University of Kentucky

Over two decades ago, measles – a highly contagious and potentially deadly childhood disease – was declared eliminated in the United States. As of April 18, at least 125 measles cases have been recorded nationwide this year – more than double the amount of cases observed in all of 2023.

Measles most commonly affects unvaccinated children, and 20 to 40% of infected children require hospitalization. Ear infections, pneumonia, long-term neurologic issues and even death can occur. In general, most will recover, but some will have complications from the infection.

The sharp increase in cases is due to:
  • A national and international decline in measles vaccination rates.
  • International travel to areas with active outbreaks.
  • The extreme contagiousness of the measles virus. On average, one infected person can infect nine to 10 other people, if unvaccinated.
Experts still consider measles to be eliminated in the U.S. but that could change if we don’t continue to take proper preventative measures. In response to the increase in cases, the Centers for Disease Control and Prevention has issued warnings to health professionals and the general public throughout the spring.

How do I protect myself from measles?

Fortunately, the best tool for preventing a measles infection is still highly effective. Measles is almost entirely preventable through vaccination. One dose of measles, mumps, and rubella (MMR) vaccine is 93% protective. Two doses – the recommended number – are 97% protective against the disease.

Because of the inherent contagiousness of measles, 95% or more of a population needs to be vaccinated for the entire population to be protected from an outbreak. Currently the U.S. has 93.1% vaccination coverage.
 
Kentucky has 91.6% coverage (of greater than one dose of MMR vaccine).

This last week of April is World Immunization Week – a good opportunity to discuss the importance of measles vaccination with family and friends, especially those who are planning to travel internationally or to parts of the U.S. where a measles outbreak is active. The latest tracking of measles cases and more information about the disease can be found on the CDC’s measles webpage.

What are the symptoms of measles?
  • Measles symptoms typically include: Fevers (can be very high)
  • Cough
  • Runny nose
  • Red eyes
After the above symptoms, the characteristic red rash appears, starting from the head and spreading downward.

People with measles are thought to be contagious from about four days prior to developing the rash to four days after the onset of the rash (with the onset being day zero).

What to do if you think you’ve been exposed: If you’re concerned you or your child have been exposed to measles, contact your health care provider immediately.

Many of us, fortunately, have never seen a case of measles in our lifetime. With a renewed focus on prevention, hopefully, we never will.

Nicholas Van Sickels, M.D., is infectious-disease specialist and director of infection prevention and control at UK HealthCare.

Friday, May 3, 2024

UK colleges launch program to train more public-health nurses by getting nursing and public-health degrees in four and a half years

A University of Kentucky nursing class (UK photo)
By Jonathan Greene
University of Kentucky

One of the greatest challenges facing the state and the nation is the current and growing shortage of health professionals, particularly nurses.

A combined program from the University of Kentucky College of Public Health and the UK College of Nursing offers students a new pathway to make a difference in communities.

Through the Public Health Nursing Scholars program, students will earn two degrees – Bachelor of Public Health (BPH) and Bachelor of Science in Nursing (BSN) – in just four and a half years.

“Having these two programs together shows how important it is to try to fix health issues on the front side as much as possible before people end up in the hospital. We need to intervene much sooner and try to make our communities healthier,” said Andrea Flinchum, manager of the Healthcare-Associated Infection/Antibiotic Resistance Prevention Program at the state Department for Public Health. “I love that I can impact a large group or a population with my knowledge and skills. This program is taking nursing to a larger scale, rather than one or two patients. Nurses play a key role in public health.”

Public-health nurses play key roles in preventing disease while promoting public safety and well-being. Public-health nurses promote better health and safety in communities and help prepare them for and recover from public health incidents, such as natural disasters and disease outbreaks.

“Public health is faced with existing and emerging complex health challenges: chronic conditions, infectious diseases and pandemics, traumatic injuries, and environmental hazards," said Heather Bush, dean of the College of Public Health.

“Effective solutions require bringing people, skills and expertise together. The Public Health Nursing Scholars Program is such a partnership,” Bush said. “Training at the intersection of our two colleges equips graduates to tackle emerging health needs on two fronts: delivering high-quality care to individuals while addressing upstream factors impacting health outcomes to ultimately build a more resilient health-care system.”

Rosalie Mainous, dean of the College of Nursing, said “Public health is the cornerstone of the work of the baccalaureate-prepared registered nurse. A partnership with the College of Public Health will now prepare practitioners that are uniquely qualified to blend the practice degree with one that is steeped in the evidence in genetics, the environment, and health policy to support healthy outcomes.”

A variety of agencies and industries are looking to hire people with a public-health nursing background.

Government and other public agencies hire public-health nurses, and job opportunities are available with agencies and organizations that serve the health needs of a community. Public-health nurses might work for a school system to educate students and their parents about hygiene and nutrition or work for a community clinic caring for individuals and promoting disease prevention.

Public-health nurses also work with nonprofit organizations like the Red Cross or smaller grassroots groups concerned about health, social justice, and education.

The Kentucky Nurses Association predicted a potential need for 20,000 nurses in the state by 2025. Across the country, the need for nurses is only continuing to grow with more than 300,000 additional nursing jobs expected by 2032. The median salary for nurses is $37.28 per hour or $77,500 per year.

Bird flu is bad for livestock; it's not a dire threat to most of us - yet

Getty Images
By Amy Maxmen
KFF Health News

Headlines are flying after the Department of Agriculture confirmed that the H5N1 bird flu virus has infected dairy cows around the country. Tests have detected the virus among cattle in nine states, mainly in Texas and New Mexico, and most recently in Colorado, said Nirav Shah, principal deputy director at the Centers for Disease Control and Prevention, at a May 1 event held by the Council on Foreign Relations.

A menagerie of other animals have been infected by H5N1, and at least one person in Texas. But what scientists fear most is if the virus were to spread efficiently from person to person. That hasn’t happened and might not. Shah said the CDC considers the H5N1 outbreak “a low risk to the general public at this time.”

Viruses evolve and outbreaks can shift quickly. “As with any major outbreak, this is moving at the speed of a bullet train,” Shah said. “What we’ll be talking about is a snapshot of that fast-moving train.” What he means is that what’s known about the H5N1 bird flu today will undoubtedly change.

With that in mind, KFF Health News explains what you need to know now.

Who gets the bird flu? Mainly birds. Over the past few years, however, the H5N1 bird flu virus has increasingly jumped from birds into mammals around the world. The growing list of more than 50 species includes seals, goats, skunks, cats, and wild bush dogs at a zoo in the United Kingdom. At least 24,000 sea lions died in outbreaks of H5N1 bird flu in South America last year.

What makes the current outbreak in cattle unusual is that it’s spreading rapidly from cow to cow, whereas the other cases — except for the sea-lion infections — appear limited. Researchers know this because genetic sequences of the H5N1 viruses drawn from cattle this year were nearly identical to one another.

The cattle outbreak is also concerning because the country has been caught off guard. Researchers examining the virus’s genomes suggest it originally spilled over from birds into cows late last year in Texas, and has since spread among many more cows than have been tested. “Our analyses show this has been circulating in cows for four months or so, under our noses,” said Michael Worobey, an evolutionary biologist at the University of Arizona in Tucson.

Is this the start of the next pandemic? Not yet. But it’s a thought worth considering because a bird flu pandemic would be a nightmare. More than half of people infected by older strains of H5N1 bird flu viruses from 2003 to 2016 died. Even if death rates turn out to be less severe for the H5N1 strain currently circulating in cattle, repercussions could involve loads of sick people and hospitals too overwhelmed to handle other medical emergencies.

Although at least one person has been infected with H5N1 this year, the virus can’t lead to a pandemic in its current state. To achieve that horrible status, a pathogen needs to sicken many people on multiple continents. And to do that, the H5N1 virus would need to infect a ton of people. That won’t happen through occasional spillovers of the virus from farm animals into people. Rather, the virus must acquire mutations for it to spread from person to person, like the seasonal flu, as a respiratory infection transmitted largely through the air as people cough, sneeze, and breathe. As we learned in the depths of covid-19, airborne viruses are hard to stop.

That hasn’t happened yet. However, H5N1 viruses now have plenty of chances to evolve as they replicate within thousands of cows. Like all viruses, they mutate as they replicate, and mutations that improve the virus’s survival are passed to the next generation. And because cows are mammals, the viruses could be getting better at thriving within cells that are closer to ours than birds’.

The evolution of a pandemic-ready bird flu virus could be aided by a sort of superpower possessed by many viruses. Namely, they sometimes swap their genes with other strains in a process called reassortment. In a study published in 2009, Worobey and other researchers traced the origin of the H1N1 “swine flu” pandemic to events in which different viruses causing the swine flu, bird flu, and human flu mixed and matched their genes within pigs that they were simultaneously infecting. Pigs need not be involved this time around, Worobey warned.

Will a pandemic start if a person drinks virus-contaminated milk? Not yet. Cow’s milk, as well as powdered milk and infant formula, sold in stores is considered safe because the law requires all milk sold commercially to be pasteurized. That process of heating milk at high temperatures kills bacteria, viruses, and other teeny organisms. Tests have identified fragments of H5N1 viruses in milk from grocery stores but confirm that the virus bits are dead and, therefore, harmless.

Unpasteurized “raw” milk, however, has been shown to contain living H5N1 viruses, which is why the FDA and other health authorities strongly advise people not to drink it. Doing so could cause a person to become seriously ill or worse. But even then, a pandemic is unlikely to be sparked because the virus — in its current form — does not spread efficiently from person to person, as the seasonal flu does.

What should be done? A lot! Because of a lack of surveillance, the U.S. Department of Agriculture and other agencies have allowed the H5N1 bird flu to spread under the radar in cattle. To get a handle on the situation, the USDA recently ordered all lactating dairy cattle to be tested before farmers move them to other states, and the outcomes of the tests to be reported.

But just as restricting covid tests to international travelers in early 2020 allowed the coronavirus to spread undetected, testing only cows that move across state lines would miss plenty of cases.

Such limited testing won’t reveal how the virus is spreading among cattle — information desperately needed so farmers can stop it. A leading hypothesis is that viruses are being transferred from one cow to the next through the machines used to milk them.

To boost testing, Fred Gingrich, executive director of a nonprofit organization for farm veterinarians, the American Association of Bovine Practitioners, said the government should offer funds to cattle farmers who report cases so that they have an incentive to test. Barring that, he said, reporting just adds reputational damage atop financial loss.

“These outbreaks have a significant economic impact,” Gingrich said. “Farmers lose about 20% of their milk production in an outbreak because animals quit eating, produce less milk, and some of that milk is abnormal and then can’t be sold.”

The government has made the H5N1 tests free for farmers, Gingrich added, but they haven’t budgeted money for veterinarians who must sample the cows, transport samples, and file paperwork. “Tests are the least expensive part,” he said.

If testing on farms remains elusive, evolutionary virologists can still learn a lot by analyzing genomic sequences from H5N1 viruses sampled from cattle. The differences between sequences tell a story about where and when the current outbreak began, the path it travels, and whether the viruses are acquiring mutations that pose a threat to people. Yet this vital research has been hampered by the USDA’s slow and incomplete posting of genetic data, Worobey said.

The government should also help poultry farmers prevent H5N1 outbreaks since those kill many birds and pose a constant threat of spillover, said Maurice Pitesky, an avian disease specialist at the University of California-Davis.

Waterfowl like ducks and geese are the usual sources of outbreaks on poultry farms, and researchers can detect their proximity using remote sensing and other technologies. By zeroing in on zones of potential spillover, farmers can target their attention. That can mean routine surveillance to detect early signs of infections in poultry, using water cannons to shoo away migrating flocks, relocating farm animals, or temporarily ushering them into barns. “We should be spending on prevention,” Pitesky said.

OK, it’s not a pandemic, but what could happen to people who get this year’s H5N1 bird flu? No one really knows. Only one person in Texas has been diagnosed with the disease this year, in April. This person worked closely with dairy cows, and had a mild case with an eye infection. The CDC found out about them because of its surveillance process.

Clinics are supposed to alert state health departments when they diagnose farmworkers with the flu, using tests that detect influenza viruses, broadly. State health departments then confirm the test, and if it’s positive, they send a person’s sample to a CDC laboratory, where it is checked for the H5N1 virus, specifically. “Thus far we have received 23,” Shah said. “All but one of those was negative.”

State health departments are also monitoring around 150 people, he said, who have spent time around cattle. They’re checking in with these farmworkers via phone calls, text messages, or in-person visits to see if they develop symptoms. And if that happens, they’ll be tested.

Another way to assess farmworkers would be to check their blood for antibodies against the H5N1 bird flu virus; a positive result would indicate they might have been unknowingly infected. But Shah said health officials are not yet doing this work.

“The fact that we’re four months in and haven’t done this isn’t a good sign,” Worobey said. “I’m not super worried about a pandemic at the moment, but we should start acting like we don’t want it to happen.”

New official recommendation: Women should start every-other-year mammograms at age 40; some groups favor annual scans

Photo illustration from Medical News Today
By Carla K. Johnson
Associated Press

Regular mammograms to screen for breast cancer should start younger, at age 40, according to an influential U.S. task force. Women ages 40 to 74 should get screened every other year, the group said.

Previously, the task force had said women could choose to start breast cancer screening as young as 40, with a stronger recommendation that they get the exams every two years from age 50 through 74.

Tuesday's announcement by the U.S. Preventive Services Task Force makes official a draft recommendation announced last year. It was published in the Journal of the American Medical Association.

“It’s a win that they are now recognizing the benefits of screening women in their 40s,” said Dr. Therese Bevers of MD Anderson Cancer Center in Houston. She was not involved in the guidance.

Other medical groups, including the American College of Radiology and the American Cancer Society, suggest mammograms every year — instead of every other year — starting at age 40 or 45, which may cause confusion, Bevers said, but “now the starting age will align with what many other organizations are saying.”

Breast-cancer death rates have fallen as treatment continues to improve. But breast cancer is still the second most common cause of cancer death for U.S. women. About 240,000 cases are diagnosed annually and nearly 43,000 women die from breast cancer.

The nudge toward earlier screening is meant to address two vexing issues: the increasing incidence of breast cancer among women in their 40s — it’s risen 2% annually since 2015 — and the higher breast cancer death rate among Black women compared to white women, said task force vice chair Dr. John Wong of Tufts Medical Center in Boston.

“Sadly, we know all too well that Black women are 40% more likely to die from breast cancer than white women,” Wong said. Modeling studies predict that earlier screening may help all women, and have “even more benefit for women who are Black,” he said.

Here are more details on what’s changed, why it’s important and who should pay attention.

When should I get my first mammogram? Age 40 is when mammograms should start for women, transgender men and nonbinary people at average risk. They should have the X-ray exam every other year, according to the new guidance. Other groups recommend annual mammograms, starting at 40 or 45.

The advice does not apply to women who’ve had breast cancer or those at very high risk of breast cancer because of genetic markers. It also does not apply to women who had high-dose radiation therapy to the chest when they were young, or to women who’ve had a lesion on previous biopsies.

What about women 75 and older? It’s not clear whether older women should continue getting regular mammograms. Studies rarely include women 75 and older, so the task force is calling for more research.

Bevers suggests that older women talk with their doctors about the benefits of screening, as well as harms like false alarms and unnecessary biopsies.

What about women with dense breasts? Mammograms don’t work as well for women with dense breasts, but they should still get the exams.

The task force would like to see more evidence about additional tests such as ultrasounds or MRIs for women with dense breasts. It’s not yet clear whether those types of tests would help detect cancer at an earlier, more treatable stage, Wong said.

Does this affect insurance coverage? Congress already passed legislation requiring insurers to pay for mammograms for women 40 and older without copays or deductibles. In addition, the Affordable Care Act requires insurers to cover task-force recommendations with an “A” or “B” letter grade. The mammography recommendation has a “B” grade, meaning it has moderate net benefit.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

Fact Check: Contrary to social-media posts, there is still no evidence that Covid-19 vaccines increase your risk of cancer

By Catalina Jaramillo
FactCheck.org

It has not been shown that Covid-19 vaccines cause or accelerate cancer. Yet opponents of the vaccines say a new review article “has found that Covid-19 mRNA vaccines could aid cancer development.” That statement is based mainly on misinterpretation of a study on mRNA cancer vaccines in mice.

Clinical trials, involving thousands of people, and multiple studies have shown that the mRNA Covid-19 vaccines from Pfizer/BioNTech and Moderna are safe. Hundreds of millions of doses have been administered under close monitoring systems that have found serious side effects are rare. Studies have also shown that the vaccines work very well in preventing severe Covid-19 disease and death, saving millions of lives across the globe.
 
There is no evidence to support a link between Covid-19 vaccines and cancer, as we’ve reported. Both the National Cancer Institute and the American Cancer Society have stated there’s no information that suggests COVID-19 vaccines cause cancer, make it more aggressive or lead to recurrence of cancer.

Yet, vaccine opponents falsely claim a review article published in April proves the contrary.

“A review in the International Journal of Biological Macromolecules has found that Covid-19 mRNA vaccines could aid cancer development,” reads an April 16 Facebook post by America’s Frontline Doctors, a group that has repeatedly spread misinformation about the pandemic -- and whose founder was sentenced to 60 days in prison for entering the U.S. Capitol during the Jan. 6 riot. Other posts made similar, baseless claims.

Messenger RNA, or mRNA, vaccines work by instructing a small number of a person’s cells to make specific proteins, which then prompt the body to mount an immune response. They use N1-methylpseudouridine, a modification naturally found in some RNA molecules, to allow the mRNA to deliver its message to the cell without being destroyed by an innate immune response.

The review paper being cited is based on other published articles and does not contain original research. Experts told us that it misleads by misinterpreting several studies and the role of N1-methylpseudouridine in vaccines. The authors also refer to an unreliable review article, written by authors known for spreading misinformation, that falsely claimed the mRNA Covid-19 vaccines impair the immune system and increase the risk of cancer, as we have explained.

One of the most important misrepresentations, and one that the authors heavily rely on, is based on the findings of a study on mRNA cancer vaccines in mice. The study looked at the efficacy of mRNA cancer vaccines with different degrees of N1-methylpseudouridine modification in a mouse melanoma model. According to the review, the study found that “adding 100% of N1-methyl-pseudouridine (m1Ψ) to the mRNA vaccine in a melanoma model stimulated cancer growth and metastasis, while non-modified mRNA vaccines induced opposite results, thus suggesting that Covic-19 mRNA vaccines could aid cancer development.”

But that’s not what the study found.

“Our results did not show, suggest or indicate that modified mRNA promotes tumor growth/metastasis,” Tanapat Palaga, professor of microbiology at the Chulalongkorn University in Thailand and the corresponding author of that study, told us in an email.

What the study actually showed is that both unmodified mRNA and modified mRNA induced immune responses against the tumor antigens, but only the unmodified mRNA reduced cancer growth and metastasis, while the modified mRNA didn’t. The study was published in 2022 and co-authored by Drew Weissman, who won the 2023 Nobel Prize with Katalin Karikó for discovering this mRNA modification that eventually led to the mRNA Covid-19 vaccines.

Dr. James A. Hoxie, an emeritus professor of medicine at the University of Pennsylvania and co-director of the Penn Institute of RNA Innovation (directed by Weissman), told us those findings are relevant for scientists who are studying ways in which mRNA cancer vaccines can elicit immune responses needed to prevent or delay cancer progression. (See “Social Media Posts Misinterpret Biden on mRNA Cancer Vaccines” for more information about mRNA cancer vaccines.)

“But that is a far cry from saying that the vaccine that was used to prevent Covid-19 disease causes cancer,” he said. Implying that by regulating the innate immune system, which is something scientists working in immunotherapies are trying to understand, “you’re leaving yourself open for cancer risk — that is ludicrous.”

Palaga told us, “I believe that the authors of this review article intentionally or [unintentionally] misinterpret our results and tried to twist the conclusion to support their agenda.”

There are no studies supporting a link between N1-methylpseudouridine and cancer in animals or mice, experts told us.

There is also no evidence mRNA Covid-19 vaccines impair, much less suppress, the immune system, as we’ve reported. In fact, the vaccines enhance immunity by teaching the immune system how to identify and fight the coronavirus.

N1-methylpseudouridine and its role in mRNA vaccines

To understand the role of N1-methylpseudouridine we have to look back at the history of mRNA vaccines.

Normally, when a cell encounters a foreign RNA, a molecule present in most living organisms and viruses, it activates a strong innate immune response against the molecule.

This was a problem for scientists trying to use mRNA as a therapeutic, since the goal was for the cell to receive the instructions carried by the mRNA and produce certain proteins. Until the mid-2000s, Karikó, Weissman and others observed that if they attached certain chemical modifications found in some kinds of natural RNA molecules, such as pseudouridine, into one of the four bases of mRNA, they could blunt that innate immune response and, at the same time, increase the mRNA’s capacity to translate its code for the cell to make the desired proteins.

Later, scientists found N1-methylpseudouridine, another modification naturally found in some kinds of RNA molecules, worked better than pseudouridine.

The modification is not “suppressing” the immune system, Hoxie told us — it just allows for certain parts of the immune system not to activate temporarily “in order to get the desired effect.”

Jordan L. Meier, senior investigator at the National Cancer Institute who has studied the role of N1-methylpseudouridine in Covid-19 vaccines, told us the authors of the review paper misrepresent what N1-methylpseudouridine, which is abbreviated as m1Ψ, does.

The review “incorrectly” confuses “m1Ψ’s ability to hide from the immune system with an ability to weaken or disable it,” he told us in an email.

To explain it, Meier compared the mRNA modification to a spy using a disguise in order to pass security guards.

“The authors are essentially suggesting that the disguise somehow makes the guards less able to do their jobs going forward,” he wrote. “In reality, once the disguised person is through, the guards remain just as vigilant and capable as before.”

The review, he added, doesn’t provide evidence that N1-methylpseudouridine “leaves the immune system any worse off for future threats.”
 
Misrepresented studies in the review paper

Similarly, the review misleads by cherry-picking or misrepresenting figures and tables of this and other papers.

For example, in the study by Palaga, Weissman and others using a mouse melanoma model (in which malignant cells from a tumor are given to a mouse), scientists found that relative to mice that received no vaccine (and instead received a saline solution) no increase in tumor growth or decrease in survival occurred when animals were vaccinated with a modified mRNA vaccine.

However, when animals received a vaccine containing unmodified mRNA, the study showed a decrease in tumor growth and an increase in survival compared with the control group that received the saline solution. In other words, the study found that the unmodified mRNA generated immune responses that decreased tumor growth and improved survival, while, similar to the control group, the modified mRNA had no effect on the tumor.

Table 1 of the review, however, incorrectly says the study found that the modified mRNA vaccine “increases tumor growth” and “decreases survival.”

Hoxie said, “This is simply not true and is a gross misrepresentation of the data that paper actually shows. The modified RNA had no effect on the tumor, and results using that vaccine were the same as using a saline solution.”

The tumor growth in mice receiving the modified mRNA was “increased relative to the unmodified vaccine, but it was identical to when there was no intervention,” Hoxie said. “Animals that received the modified mRNA vaccine died at the same rate and with the same amount of tumor as did animals that received the saline solution. The fact tumor progression in this model was reduced with the unmodified mRNA vaccine is the key point of this paper and indicated that in this model immune responses to unmodified mRNA may have anti-tumor activity, an important finding for the cancer immunotherapy field.”

The review also refers to a study that has been extensively misinterpreted to falsely claim that the Pfizer/BioNTech mRNA Covid-19 vaccine causes what vaccine opponents called “turbo cancer.” The study describes one mouse that died from a lymphoma after 14 mice were given a high dose of the vaccine. The review paper reproduces images from the study that show dissected mice and compares the organs of the mouse that died with one with a normal anatomy.

As we explained, and as the authors of that paper noted in an addendum, there is no such thing as “turbo cancer,” and, more importantly, the case report does not demonstrate a causal relationship between the lymphoma and the vaccine.

Meier told us the review also wrongly refers to a study published in 2016 to support its thesis that modified mRNA vaccines turn off an immune sensor known as RIG-I.

“In reality, this study only showed m1Y mRNAs are unable to activate RIG-I and did not test inhibition. In other words, what was shown was that m1Y is a strong camouflage, not that it is an immune suppressor,” he wrote.

FactCheck.org is a nonpartisan, nonprofit organization at the University of Pennsylvania that monitors the factual accuracy of public statements.

Thursday, May 2, 2024

Industry says Biden administration's rule mandating staffing levels for nursing homes is 'impossible' for them to meet

Centers for Disease Control and Prevention photo
By Melissa Patrick
Kentucky Health News

A new law that sets minimum staffing requirements for federally funded long-term care facilities will require many of them to hire more nurses and nurse aides. It has been met with pushback from the nursing-home industry. 

Morgan Jemtrud, director of communications for the Kentucky Association of Health Care Facilities and the Kentucky Center for Assisted Living, told Kentucky Health News in an email that the staffing mandate is not attainable for several reasons, including the health-care workforce shortage. 

"The staffing mandate is impossible. CMS estimates it will cost around $300,000 per building (AHCA estimates more), but there is no funding to support the implementation of the rule," said Jemtrud. "Also, the required staff are simply not available. RNs are in demand across all health -care sectors, and no pipeline is being built to produce the number of RNs this rule requires." 

Jemtrud was referring to an analysis from the American Health Care Association, a nursing-home lobby, that says meeting the mandate would require nursing homes to hire more than 100,000 more nurses and nurse aides at an annual cost of $6.8 billion. The analysis also says 94% of nursing homes were not meeting at least one of the proposed staffing requirements.

New staffing requirements

The "Nursing Home Minimum Staffing Rule" requires all nursing homes that receive Medicare or Medicaid payments to provide 3.48 hours of direct nursing care per resident per day, including a defined number for registered nurses (0.55 per resident per day) and nurse aides (2.45 hours per resident per day). 

"This means a facility with 100 residents would need at least two or three RNs and at least 10 or 11 nurse aides as well as two additional nurse staff (which could be registered nurses, licensed professional nurses, or nurse aides) per shift to meet the minimum staffing standards," says a White House fact sheet about the rule.

It will also require facilities to have an RN onsite 24 hours a day, seven days a week, to provide skilled nursing care. 

The new staffing requirements will be phased in over three years, except at rural facilities, which will get up to five years. The law allows for some "limited, temporary exemptions" for facilities in areas with workforce shortages that demonstrate a good faith effort to hire the required staff. 

Within two years, most homes must provide an average of at least 3.48 hours of daily care per resident. About 6 in 10 nursing homes are already operating at that level, according to a Kaiser Family Foundation analysis. But the analysis says only 19% meet the defined number of hours required for RNs (.55)  and nurse aides (2.45) that is required under the full implementation of the law.  

“When facilities are understaffed, residents may go without basic necessities like baths, trips to the bathroom, and meals – and it is less safe when residents have a medical emergency,” said the fact sheet,  noting that it will also “ensure that workers aren’t stretched too thin by having inadequate staff on site.”

Brice Mitchell, spokesperson for the state Cabinet for Health and Family Services, told Kentucky Health News in an email that the administration is reviewing the federal rule and its impact. 

"Medicaid funds 70% of all long-term care in the state and there is ongoing work to expand a nurse career ladder to help increase recruitment," Mitchell said. "At this time, we are unable to determine the number of Kentucky nursing homes that don’t meet the new federal rules." 

Pushback on the new mandate

Denise Wells, executive director of the Nursing Home Ombudsman Agency of the Bluegrass, said her group was "very pleased" with the 24-hour RN requirement, but didn't think the minimum hours per resident per day went far enough.

She said  the 24/7 RN requirement is important because the acuity level of patients has increased over the years, meaning patients need more assistance with their activities of daily living than ever before. And, she said, "Medical emergencies don't just happen for eight hours of the day; they can happen 24 hours a day." 

Wells said they were disappointed in the hours per resident per day only being 3.48 because research shows that the minimum care that an average resident needs is 4.1 hours per day.

"And that is simply to avoid negative health outcomes," she said. "It's not to live their best lives, it's not to have the greatest quality of life, it's just to have that minimum care provided." 

Wells called the new staffing rules a "good first step." 

"We are trying to make sure that the message is that this is not the ceiling; that it's a floor," said Wells. "It's the absolute minimum, but facilities should be staffing higher than this. . . . Nursing homes are required to staff to sufficient levels to meet resident needs, and so if they have residents that their care plan indicates that they need more than the 3.48 hours per day, then the facility needs to staff to meet that need." 

Jemtrud with KAHCF and KCAL was asked about the financial impact of the rule. She said Kentucky nursing homes are already financially strained and there are no funds to help meet the new requirements. 

"Before this rule, 79.9% of Kentucky facilities are in distress or at risk of financial distress using the Altman Z-score," Jentrud said, citing a formula used to determine a company's risk of bankruptcy.

"CMS estimates the total cost of the final rule at about $4.3 billion per year, but AHCA continues to estimate the cost above $6 billion per year," she said. "There are no funds from Medicare, Medicaid, or other payers to increase payment rates to providers for any of the rule requirements." 

Wells, asked how facilities can address the health-care workforce shortage, said her group prefers to call it a "job quality crisis" caused by low pay, poor conditions and little support.  She pointed to reports from the National Consumer Voice for Quality Long-Term Care that have showed how nursing homes hide profits, and saif there is not enough transparency in how Medicaid and Medicare dollars are used these facilities. 

KFF Health News also points to researchers who are "skeptical that all nursing homes are as broke as the industry claims or as their books show. A study published in March by the National Bureau of Economic Research estimated that 63% of profits were secretly siphoned to owners through inflated rents and other fees paid to other companies owned by the nursing homes’ investors."

In a lengthy statement from the American Hospital Association, Stacey Hughes, AHA executive vice president, said, in part, "CMS’ one-size-fits-all minimum staffing rule for nursing homes creates more problems than it solves and could jeopardize access to all types of care across the continuum, especially in rural and underserved communities that may not have the workforce levels to support these requirements."

The American Health Care Association issued a statement in opposition of the mandate and said the industry will keep pressing Congress to overturn the regulation. 

“While it may be well intentioned, the federal staffing mandate is an unreasonable standard that only threatens to shut down more nursing homes, displace hundreds of thousands of residents, and restrict seniors’ access to care,” Mark Parkinson, CEO of the AHCA, said in a statement. “Issuing a final rule that demands hundreds of thousands of additional caregivers when there’s a nationwide shortfall of nurses just creates an impossible task for providers. This unfunded mandate doesn’t magically solve the nursing crisis.”

The mandate also implements stronger transparency measures to ensure nursing home residents and their families know when a nursing home is using an exemption, according to the fact sheet.  

Guthrie expresses comcern

Jemtrud said industry associations will "continue to reach out to Congress where there’s been bipartisan support for helpful legislation." 

"Providers have been hosting legislators for visits within their facilities to share firsthand the challenges they’re facing," she wrote. "Also, the AHCA/NCAL Congressional Briefing scheduled June 3-4 will allow members to discuss their concerns directly with members of Congress on Capitol Hill." 

On Tuesday, U.S. House Republicans at a House Energy and Commerce health subcommittee voiced their concerns about the new staffing mandate. 

The subcmmittee chair, Republican Rep. Brett Guthrie of Kentucky's Second District, said he was "extremely concerned" about the mandate along with the 80/20 rule which requires agencies that provide home- and community-based services to spend 80% of their Medicaid payments on compensation for workers who directly provide care. 

Guthrie said both rules "threaten access to long term care services for Medicaid beneficiaries by setting arbitrary staffing and pay standards. . . . This approach simply won't work." He added later, "These rules come at a time where we have seen more than 500 nursing home facilities close since the start of the pandemic and where we have 150,000 fewer long-term care workers than we did before 2020."

Wednesday, May 1, 2024

Does Ky. law protect in vitro fertilization? Depends on who's asked

State Rep. Lindsey Burke, D-Lexington, whose son was born through in
vitro fertilization, said state law doesn't protect the procedure. (LRC photo) 
By Sarah Ladd
Kentucky Lantern

None of the bills to explicitly protect in vitro fertilization in Kentucky got a hearing this legislative session, making them effectively dead on arrival.

With roughly eight months until the next session, some lawmakers and attorneys disagree on what protections exist for IVF under current Kentucky law.

Republican Sen. Whitney Westerfield — who has children thanks to IVF — believes there is an appetite in the General Assembly to pass specific IVF protections. The failure to do so, he said, was probably “a function of time.”

Westerfield filed a bill to protect the process on the filing deadline for Senate bills. His House and Senate colleagues who filed similar bills also did so right before or on the filing deadlines.

The issue, he noted, wasn’t on “anybody’s radar” until an Alabama Supreme Court decision — which came down right before the deadline to file Kentucky bills — seemingly complicated the treatment.

Westerfield, of Fruit Hill in Christian County, announced before the legislative session began that he would not seek re-electin this year.
 
‘They should always be preserved’

Westerfield and his wife, Amanda, are expecting triplets this summer. The three, as well as their 6-year-old son, were adopted as embryos — the result of someone going through IVF and donating eggs. The Westerfields also have a daughter who joined their family as a “traditional domestic adoption.” They have another embryo they are paying around $500 annually to preserve.

“I think they should always be preserved,” Westerfield said. “But I also understand not everybody holds that view. My son is one of those that was preserved, thankfully. These boys that are on the way were preserved.”

The Westerfields chose to have children this way because, had they gone through IVF themselves, “We were worried that we might have more than we could try to transfer on our own,” Westerfield said.

“We didn’t want to have so many left over that we couldn’t … bring to full-term birth ourselves and give a home to. And then you worry about making sure they end up in a home somewhere because we don’t want them destroyed. Not everybody wants to adopt an embryo and be pregnant. Some people do, thankfully.”

Even though the legislature didn’t pass the IVF-specific bills this year, it did pass House Bill 159, which Gov. Andy Beshear then signed into law. It gives health-care providers immunity from criminal charges for medical mistakes.

On the day HB 159 passed the Senate, Westerfield said he believed it would protect IVF by default because it broadly protects “providers.”

The law states: “A health-care provider providing health services shall be immune from criminal liability for any harm or damages alleged to arise from an act or omission relating to the provision of health services.”

Westerfield, who is also a lawyer, said this is “more comprehensive” than what he proposed to specifically protect IVF. “It covered everything mine covered and then some,” he said.

Ben Potash, a lawyer representing three Jewish women who are suing over Kentucky’s abortion law, believes HB 159 does not protect IVF since discarding extra eggs in the IVF process is a willful act.

HB 159 says “Nothing … limits any liability for gross negligence or wanton, willful, malicious, or intentional misconduct.”
 
‘No one really knows what the law is’

Potash believes the two topics — abortion and IVF — are too closely related to be separated. Going through IVF in Kentucky right now is “precarious,” he said. “No one really knows what the law is.”

Kentucky Attorney General Russell Coleman has called IVF “an incredible blessing for so many seeking to become parents,” and said “The plain language of Kentucky’s laws makes it clear that neither IVF nor the disposal of embryos created through IVF and not yet implanted are prohibited.”

But Potash says, “Making it civil, secular law that life begins at conception introduces all kinds of complications to IVF, to motherhood in general, to parenthood in general.”

Kentucky’s “Human Life Protection Act” — the trigger law that went into effect after the U.S. Supreme Court overturned Roe v. Wade in 2022 — states that an embryo is an “unborn human being” from egg fertilization to birth.

The 1973 Roe v. Wade decision established abortion as a constitutional right. Once that federal protection was gone, Kentucky’s law updated to all but ban abortion entirely, except in rare and life-threatening situations

Judith Daar, dean of Northern Kentucky University’s Chase College of Law and a legal expert on reproductive assistance, said that while “Many states have language in their statutes regarding abortion that declare life begins at conception or fertilization,” those laws also link abortion to pregnancy, which “is defined as an attachment of the embryo inside the mom.”

That is the case in Kentucky. The law states that “‘pregnant’ means the human female reproductive condition of having a living unborn human being within her body throughout the entire embryonic and fetal stages.”

“To the extent that all the abortion laws tether and condition the conduct on the existence of a pregnancy, then IVF really does escape application of the abortion laws, at least in the preimplantation stage when the embryos are still in the laboratory,” Daar explained. “That is not, per se, a pregnancy because it doesn’t meet the definition of the attachment of the embryo into the uterus.”

Because of this, Daar said, Kentucky doesn’t necessarily need to pass an explicit bill on IVF at this time: “There’s nothing that I’m aware of … that suggests that any aspect of IVF practice is illegal under Kentucky law.”
 
The IVF process

Dr. Sigal Klipstein, chair of the Ethics Committee of the American Society for Reproductive Medicine, said people need IVF for many reasons. Some seek it because of infertility — a man has little to no sperm or a woman does not ovulate, for example. Same-sex couples may undergo IVF as a way to have biological children, she said, or uncoupled people may seek that service for themselves.

“In a typical IVF cycle, a woman might take about 10 days of injections,” Klipstein explained. These are “little, under the skin injections, kind of like insulin needles.”

“They sort of bypass the system,” she said. “So instead of having enough hormone to release one egg, you might release five or 10 or 20 eggs.”

A final shot at the end of those 10 days triggers ovulation, Klipstein said. The patient then undergoes anesthesia and eggs are removed with a needle that enters through the vagina under ultrasound guidance.

Eggs are then mixed with sperm in a lab and grown for five to six days. The best one is then implanted into the uterus.

Usually, there are extra eggs leftover, Klipstein said. They can be donated, stored, discarded, or be placed in the uterus during a time that won’t result in pregnancy. This is called “compassionate transfer,” Klipstein explained. In this process, “you’re sort of more physiologically, more naturally, allowing the embryos to reabsorb into the body.”

Potash said the “routine” extra eggs make the process complicated if they are considered human beings by law. The Alabama Supreme Court set the precedent for that complication when it ruled in mid February that frozen embryos are children.

“It’s unrealistic and cost prohibitive, as well as I think a little cruel,” Potash said, “to make those mothers keep those fertilized ova on ice, essentially, forever.”

Klipstein agreed, and asked: What happens if someone stops paying or a storage facility closes? “Do you require them to have more babies than they want? I mean, I don’t think you can compel someone to get pregnant against their will to prevent them from discarding those embryos.”

“It would be nice if we had one embryo for one baby, and we could do it as a one to one ratio,” she added. “But, you know, medicine doesn’t work that way. And IVF doesn’t work that way.”

Westerfield has a different perspective. “It’s hard for me to imagine someone going into that process without an awareness of the cost,” he said.

IVF can cost between $15,000 and $30,000 per cycle, according to a 2023 article in Forbes. Storage can cost from $350 to $600 per year as well, the magazine reported.

“I don’t think anybody goes into that without knowing whether or not they either can afford it, or have insurance to cover it, or what have you,” Westerfield said.

He and his wife wouldn’t have adopted as many embryos as they did, he said, “if we thought we couldn’t afford to keep this one on ice, frozen.”

“We wouldn’t have done more than what we could transfer at a time,” he said. “We wouldn’t have adopted three; we would have adopted one or maybe two.”

Providers, parents in ‘limbo’

Sen. Cassie Chambers Armstrong, D-Louisville, filed one of several unsuccessful bills to protect IVF this session. She said she is “disappointed” that no specific protections passed.

It might be plausible, she said, that HB 159 “does provide protection to IVF.” But, she said: “I don’t think that it’s decisive.”

The new law deals with criminal and not civil prosecution. That makes it unlikely to be applied to IVF, NKU’s Daar said.

“Instances of physicians acting in a criminal manner in the IVF setting is virtually non-existent,” Daar said. “I’m not saying it never happens, but it’s very, very rare. So a bill that generalizes criminal immunity … would not have a tremendous impact, if any impact, on IVF because that conduct just doesn’t occur.”

For now, Chambers Armstrong is particularly worried about how providers view the law. She wants to spend the interim talking to those people ahead of the next session.

“If IVF providers feel as though they have protection and this bill gives that to them, they will continue to offer services,” she said. “If they are concerned that they’re going to be subject to criminal liability for just doing their jobs, I’m worried that we’re going to see a chilling of making those services available.”

Meanwhile, she does think the state should “repeal … language that people believe could give embryos rights,” she said. But: “I don’t believe this General Assembly is going to do that anytime soon. I hope that people are correct when they say that we can provide some level of protection to IVF with those statutes on the books.”

Rep. Daniel Grossberg, D-Louisville, said the legislature has left “women and medical professionals” in “limbo”. He filed one of the unsuccessful bills to protect the process, and the only one in the House.

“The message that (this) sends,” he said, “is that women in Kentucky don’t have control over their reproductive choices.”
 
‘Let’s be proactive’

Rep. Lindsey Burke, D-Lexington, has openly discussed her journey with assault, infertility, IVF, miscarriage and abortion. She told the Lantern she doesn’t believe IVF is truly protected under current law.

“As long as fetal personhood is enshrined in Kentucky law, IVF is at risk,” said Burke, who is an attorney and mother of a son whom she had after undergoing IVF.

She is also paying $100 per month to store an embryo, as she hopes for another child someday.

Burke would like to file legislation to get “better insurance coverage for reproductive care” next year. She went into debt around $60,000 to have her son, she said. And: “I don’t think that anybody should have to do that.”

Chambers Armstrong, who is also a lawyer, said “I’m not sure that we’re going to get an answer as to whether this bill provides the type of protection for IVF that we’re hoping (for) unless and until it is challenged in court and we get a decision from the court.” But she doesn’t want to wait on litigation.

“Let’s be proactive. Let’s go ahead and pass a law that is very clear that it’s protecting IVF services and make sure that folks know that they can continue to receive the care that they have been seeking,” Chambers Armstrong said.

That must wait until at least 2025.