Public Health

The Hard Realities of a ‘No Jab, No Job’ Mandate for Health Care Workers

Christopher Richmond keeps a running tab on how many workers at the ManorCare skilled nursing facility he manages in western Pennsylvania have rolled up their sleeves for a covid-19 vaccine.

Although residents were eager for the shots this year, he’s counted only about 3 in 4 workers vaccinated at any one time. The excuses, among its staff of roughly 100, had a familiar ring: Because covid vaccines were authorized only for emergency use, some staffers worried about safety. Convenience mattered. In winter, shots were administered at work through a federal rollout. By spring, though, workers had to sign up online through a state program — a time-sucking task.

ManorCare urges every worker to be immunized against covid but turnover has vexed that effort. Managers at ProMedica, a nonprofit health system that operates ManorCare and senior care facilities in 26 states, faced a workforce conundrum familiar to all manner of providers during the pandemic: how to persuade essential workers to get vaccinated — and in a way that didn’t drive them away. Raises and bonuses, costing millions of dollars, did not move the needle to 100%.

Animus toward the vaccine created turmoil for some providers. Dr. Eric Berger, a pediatrician in Philadelphia who opened his practice more than a dozen years ago, enforced mandatory shots in May and saw six of his 47 staff members walk out. Berger said he worked for months to educate resistant workers. In April, he learned that several, women in their 20s and 30s, had attended a private karaoke party. Within days, four staffers were infected with covid.

Berger, who had seen in-office costs for protective equipment soar, then set a deadline for shots. He looks back with steely resolve over the last-minute “I quit” texts he received — and the hassle of finding a new receptionist and billing and medical assistants.

“Fortunately, we had some wonderful people who put in extra time,” he said. “It’s been stressful, but I think we did the right thing.”

Brittany Kissling, 33 and a mother of four, was one of the hesitant workers at Berger’s practice who decided — largely for financial reasons — to get vaccinated. The clinic manager couldn’t afford to lose her job. But she said she was nervous and that most of the workers who left recoiled at being told vaccinations were not negotiable. “I was a no-show my first time,” Kissling said about her first vaccine appointment. “I was scared. There were a lot of unknowns.”

But Kissling said Berger’s practice has spent “thousands and thousands and thousands of dollars” on masks and even paid workers for five days a week when they worked only two during the pandemic’s worst months. She said she understood how and why the karaoke episode prompted a mandate. “I get it from the business side,” said Kissling, about the requirement. “I do think it’s fair. I do think it is tough.”

Berger saw no other choice. “Vaccines are fundamental to our practices. That’s what we do,” he said. “Some got it in their heads that it could cause infertility; some had other reasons. It’s frustrating … [and] I don’t think it was political. If anything, most of these people are apolitical.”

At ManorCare, managers decided money could make a difference. Bonuses — up to $200 per employee — were added as an incentive, which in Pennsylvania alone cost ProMedica $3 million, said Luke Pile, vice president and general manager for ProMedica Senior Care skilled nursing centers.

Richmond, at ManorCare, said the resident council has been pivotal in keeping the focus on the risks of covid to the elderly — and no one there needs a reminder about the stress of the past year. According to Medicare records, the facility had 107 cases of covid among staffers and residents — and 14 deaths among residents beginning in March 2020.

“I constantly wear a mask. Not out of fear, but I don’t want to spread it by being asymptomatic,” Richmond said. “I tell people here: Whatever is happening in the community, that is what is happening in the community. But we are a health care institution and caring for the elderly. We need to be constantly vigilant.”

Richmond and other administrators admit it can be a struggle to understand why some health workers are unmoved by the science.

“Everything has been so polarized this past year. I don’t know that there is a single reason that individuals don’t get the vaccine,” Pile said. “In trying to educate people, personally and professionally, we talk about the history and science. Unfortunately, individual opinions don’t always align with that.”

Medical workers and pedestrians cross an intersection outside the Houston Methodist Hospital on June 9 in Houston. A judge dismissed a lawsuit this month from more than 100 hospital system staffers who objected to its compulsory vaccination.(Brandon Bell / Getty Images)

Mandating vaccines is a step that ProMedica has yet to take, even as more businesses, universities and health care providers do so. A few long-term care operators, such as Atria Senior Living, operating in the United and Canada, and Juniper Communities, announced mandates. Some have been met with lawsuits from workers aligned with conservative groups. In May, more than 100 staffers at Houston Methodist Hospital filed suit to dispute and derail the hospital system’s compulsory vaccination. A judge dismissed the challenge this month on the grounds that the hospital’s requirement did not violate state or federal law or public policy.

Last week, the U.S. Labor Department issued a temporary emergency standard for health care workers, saying they face “grave danger” in the workplace when “less than 100 percent of the workforce is fully vaccinated.”

In Pennsylvania, whose population ranks among the oldest according to 2019 census data, statistical snapshots published in April underscored the need for vigilance. Two state agencies overseeing skilled nursing care and personal care homes reported that only half of their workers were vaccinated. Covid was notably devastating to long-term care facilities nationwide in 2020; some of Pennsylvania’s deadliest outbreaks were reported by local media in places shown later to have low staff vaccination rates.

A survey by the Delphi Group, begun in March 2020 with over 700,000 Facebook respondents ages 18 to 64, recently was analyzed by researchers from Carnegie Mellon and the University of Pittsburgh, who found that health care workers were largely leading the vaccine uptake. But there were notable differences over the winter among people working, side by side, in health care settings.

Pharmacists, physicians and registered nurses were the least hesitant to get vaccinated. Home health care aides, EMTs and nursing assistants showed the highest hesitancy among front-line health workers. Overall hesitancy across professions decreased from January to March 2021, as much as 5 percentage points, as vaccinations expanded, according to the analysis by the university researchers.

University of Pittsburgh researcher Wendy King said people indicated they were receptive to the vaccine if they were familiar with its science. Educators, overall, displayed the least hesitancy; workers in construction, mining and oil/gas extraction showed the greatest. Half of those who were hesitant cited possible side effects — a fear that could be eased by education, King said. A third among the hesitant gave other reasons: They didn’t believe they needed the vaccine. They didn’t trust the government. Or they didn’t trust the covid-19 vaccines.

“We expected hesitancy to vary by group, but how much they varied was surprising,” King said. “These were not people who were anti-vaccine, but they were worried about the effect of the vaccine.”

Still, King said the percentage who didn’t trust the government was alarming. “If somebody doesn’t understand the vaccine, that’s one thing. If you don’t trust that government, that is a much more difficult issue to address.”

That may change as two prominent vaccine makers approach full approval by the Food and Drug Administration. Pfizer and BioNTech applied for approval in May; Moderna applied in early June. A recent KFF poll found nearly a third of unvaccinated adults said they would be more likely to get a vaccine once it was fully approved by the FDA.

At ProMedica, Pile described a multipronged approach in such states as Florida and Pennsylvania, home to large elderly populations. On-site counseling in groups, with familiar doctors and staff, helped persuade some who were reluctant, he said. Short videos on why and how the vaccine worked were readied. ProMedica senior medical staff flew to Florida to advise as the National Guard arrived at its facility in Pinellas County, the health system’s first to receive the vaccine.

Falon Blessing, a nurse, manages other practitioners at ManorCare Health Services Center throughout the Tampa region. She recounted how employees had wondered aloud how such newly created vaccines could be safe.

“I think people at first just wanted to know: I’m not going to grow a tail in five years,” she said. “But then there was a momentum. It wasn’t so much ‘Are you going to get vaccinated?’ but rather ‘Of course, I’m going to get vaccinated.’”

During three vaccinations sessions ended in January, though, the facility reached about the same rate as Pennsylvania overall — about 76% of its workers were vaccinated. That rate has fallen to 62% this month because of attrition. An education effort continues, a ProMedica spokesperson said.

“My takeaway was it mattered to have one-on-one discussions,” Pile said. “If you talk to 10 people, why they wouldn’t get the vaccine, you’d get 10 different reasons.”

“And there were political opinions — what they heard on Facebook — and then they’d say: I want to see how it goes,” he said.

The questions and qualms about vaccines came at the end of a deeply distressing pandemic year for health care workers, and facilities are now finding fewer applicants for essential care.

By spring, ProMedica had 1,500 job postings in Pennsylvania alone, compared with a typical 400 openings. Pile said ProMedica raised wages in dozens of locations, though he declined to provide wage ranges or rates. It spent $4.5 million in Pennsylvania from March through last week — and still supplemented its workforce across the U.S. by hiring through staffing agencies.

“In 2020, we spent over $32 million on staffing agencies,” he said. Through this spring, ProMedica was on course to spend $66 million on staffing agencies for 2021, said Pile, who has worked in the care sector for 18 years.

“I have less employees than ever before,” he said. “I have never seen anything like it.”

The Pennsylvania Health Care Association, an advocacy group, surveyed members in April to better understand vaccine reluctance. Zachary Shamberg, the group’s president, said it found that defining “hesitancy is not that simple.”

Shamberg said PHCA focused on why people had yet to be immunized and the characteristics of the workforce were telling: About 92% of all its workers are women; 65% are between ages 16 and 44. Among them, some worried early on about possible infertility from the new vaccine, he said, and some wanted to wait for the single-shot Johnson & Johnson vaccine. Others were sick with covid and were advised, once recovered, not to get a vaccine for 90 days.

Shamberg was also critical of the state data. Those surveys, taken in March and released in April, reflected a time when the vaccine was new to many people.

Pennsylvania, a battleground state in recent presidential elections, remains politically charged, and Shamberg noted that politics likely plays a role among holdouts. In recent months, PHCA enlisted churches and doctors’ consortiums to change minds. Keeping residents and workers safe should be a priority in a state that, in a few years, will face a “silver tsunami” of residents in their 80s, Shamberg said.

In recent weeks, there has been clear momentum among the general population for shots in Pennsylvania. The state now ranks among the top 10 states in the nation to administer first doses of vaccines, according to data from the Centers for Disease Control and Prevention.

“Pennsylvania is a big and diverse state,” Shamberg said. “And it’s interesting why some of our staff in western Pennsylvania were hesitant versus workers in the city of Philadelphia.”

“The vast majority of workers in Philadelphia are female and, among them, minority populations that have some inherent distrust based on historical experience. Then you go out west and you have a more conservative viewpoint — and a distrust of government today and a distrust of government vaccine.”

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Why We May Never Know Whether the $56,000-a-Year Alzheimer’s Drug Actually Works

The Food and Drug Administration’s approval in June of a drug purporting to slow the progression of Alzheimer’s disease was widely celebrated, but it also touched off alarms. There were worries in the scientific community about the drug’s mixed results in studies — the FDA’s own expert advisory panel was nearly unanimous in opposing its approval. And the annual $56,000 price tag of the infusion drug, Aduhelm, was decried for potentially adding costs in the tens of billions of dollars to Medicare and Medicaid.

But lost in this discussion is the underlying problem with using the FDA’s “accelerated” pathway to approve drugs for conditions such as Alzheimer’s, a slow, degenerative disease. Though patients will start taking it, if the past is any guide, the world may have to wait many years to find out whether Aduhelm is actually effective — and may never know for sure.

The accelerated approval process, begun in 1992, is an outgrowth of the HIV/AIDS crisis. The process was designed to approve for sale — temporarily — drugs that studies had shown might be promising but that had not yet met the agency’s gold standard of “safe and effective,” in situations where the drug offered potential benefit and where there was no other option.

Unfortunately, the process has too often amounted to a commercial end run around the agency.

The FDA explained its controversial decision to greenlight the Biogen pharmaceutical company’s latest product: Families are desperate, and there is no other Alzheimer’s treatment. Also, importantly, when drugs receive this type of fast-track approval, manufacturers are required to do further controlled studies “to verify the drug’s clinical benefit.” If those studies fail “to verify clinical benefit, the FDA may” — may — withdraw them.

But those subsequent studies have often taken years to complete, if they are finished at all. That’s in part because of the FDA’s notoriously lax follow-up and in part because drugmakers tend to drag their feet. When the drug is in use and profits are good, why would a manufacturer want to find out that a lucrative blockbuster is a failure?

Historically, so far, most of the new drugs that have received accelerated approval treat serious malignancies.

And follow-up studies are far easier to complete when the disease is cancer, not a neurodegenerative disease such as Alzheimer’s. In cancer, “no benefit” means tumor progression and death. The mental decline of Alzheimer’s often takes years and is much harder to measure. So years, possibly decades, later, Aduhelm studies might not yield a clear answer, even if Biogen manages to enroll a significant number of patients in follow-up trials.

Now that Aduhelm is shipping into the marketplace, enrollment in the required follow-up trials is likely to be difficult, if not impossible. If your loved one has Alzheimer’s, with its relentless diminution of mental function, you would want the drug treatment to start right now. How likely would you be to enroll and risk placement in a placebo group?

The FDA gave Biogen nine years for follow-up studies but acknowledged that the timeline was “conservative.”

Even when the required additional studies are performed, the FDA historically has been slow to respond to disappointing results.

In a 2015 study of 36 cancer drugs approved by the FDA, only five ultimately showed evidence of extending life. But making that determination took more than four years, and over that time the drugs had been sold, at a handsome profit, to treat countless patients. Few drugs are removed.

It took 17 years after initial approval via the accelerated process for Mylotarg, a drug to treat a form of leukemia, to be removed from the market after subsequent trials failed to show clinical benefit and suggested possible harm. (The FDA permitted the drug to be sold at a lower dose, with less toxicity.)

Avastin received fast-track approval as a breast cancer treatment in 2008, but three years later the FDA revoked the approval after studies showed the drug did more harm than good in that use. (It is still approved for other, generally less common cancers.)

In April, the FDA said it would be a better policeman of cancer drugs that had come to markets via accelerated approval. But time — as in delays — means money to drug manufacturers.

A few years ago, when I was writing a book about the business of U.S. medicine, a consultant who had worked with pharmaceutical companies on marketing drug treatments for hemophilia told me the industry referred to that serious bleeding disorder as a “high-value disease state,” since the medicines to treat it can top $1 million a year for a single patient.

Aduhelm, at $56,000 a year, is a relative bargain — but hemophilia is a rare disease, and Alzheimer’s is terrifyingly common. Drugs to combat it will be sold and taken. The crucial studies that will define their true benefit will take many years or may never be successfully completed. And from a business perspective, that doesn’t really matter.

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Texas Winter Storm Exposes Gaps in Senior Living Oversight

HOUSTON — When the big, red and extremely loud fire alarm went off in Maria Skladzien’s apartment, the 74-year-old ventured into the hallway with fellow residents of her Houston-area senior living community. The brutal winter storm that swept through Texas had knocked out power, which, in turn, disrupted water to the four-story building. The blaring alarms raised fears of fire.

The building’s elevators were unusable without power. Dependent on her wheelchair, Skladzien went back inside her second-floor apartment. She watched as residents gathered in the subfreezing temperatures outside, wondering if she would have to “throw herself out the window” to survive.

“It’s a very uneasy feeling,” she said, sitting in the living room of her small apartment a week later, packages of water brought by friends and volunteers tucked against walls and sitting on tables. No fire had occurred, but her fears continued because the elevators were still not functioning. “So many crazy things race through your mind in a situation like this.”

Winter storm Uri brought power failure and burst water pipes to millions of homes and businesses throughout Texas. But the impact, as is often the case in emergencies, was most profound on the state’s most vulnerable — including residents of senior living facilities.

Of the state’s 1,200 nursing facilities, about 50% lost power or had burst pipes or water issues, and 23 had to be evacuated, said Patty Ducayet, long-term care ombudsman for Texas. Of 2,000 assisted living facilities, about 25% had storm-related issues and 47 were evacuated. Some facilities reported building temperatures in the 50s.

The federal government requires nursing homes to maintain safe ambient temperatures but does not stipulate how and does not require generators or other alternative energy sources to run heating and air conditioning systems. States can implement more stringent guidelines, but, to date, Texas has not. Several bills were introduced in the Texas legislature after Uri to do just that, said Ducayet.

Uri was the latest disaster to highlight an ongoing problem. Evacuations and nursing home deaths in Hurricane Katrina in 2005 led to calls for similar protections. In 2009, Hurricane Sandy forced the evacuation of more than 4,000 nursing home residents in New York when backup power systems failed and emergency plans buckled. And calls for stricter rules were renewed when Hurricane Irma tore into Florida in 2017 and left a dozen residents dead in a nursing home that lost air conditioning. Multiple blackouts and wildfires in California also have exposed lax adherence to federal requirements for backup power at skilled nursing facilities, as well as weak state enforcement of those rules, according to a 2019 report from the U.S. Department of Health and Human Services.

“Every time we come back around with a new disaster, you see that these facilities still aren’t as prepared as, maybe, they can or should be,” said Lori Smetanka, executive director of the National Consumer Voice for Quality Long-Term Care, an advocacy organization based in Washington, D.C. “And many of them still aren’t following the requirements that are in place. So it’s like: What’s it going to take to actually get the plans in place and to get enforcement of those plans?”

In November 2016, the Centers for Medicare & Medicaid Services implemented a slate of new regulations, including rules on disaster planning and emergency backup power in the nation’s nursing homes.

A month later, Mark Parkinson, president and CEO of the long-term care industry’s trade group, the American Health Care Association and National Center for Assisted Living, sent a letter to then-President-elect Donald Trump requesting new rules because the regulations were burdensome and financially onerous, according to reporting by ProPublica.

In 2019, CMS published final rules with revised emergency preparedness guidance, agency spokesperson William Polglase said, after feedback from the public that those requirements were “overly burdensome and duplicative.” But, he added, the rules require such facilities to have emergency and standby power systems and emergency plans. “We did not remove or modify any requirements that would endanger patient health or safety,” he said.

Advocates for older adults, however, decried the changes as watering down the protections.

“The facilities push back because of the expense, but what I think recent years have shown us is that we’re not talking about once-in-a-century type of disasters,” said Eric Carlson, directing attorney with Justice in Aging, a national legal advocacy nonprofit.

But it’s not just nursing homes at risk.

Cristina Crawford, an AHCA spokesperson, said prioritizing long-term care facilities at all levels is important in emergencies. “Nursing homes and assisted living facilities should be prioritized for power restoration and supplies for resource delivery in emergency situations,” she said. “Long-term care facilities should also be included in community-based exercises to help ensure successful coordination in actual emergencies.”

Although nursing homes face federal oversight, the licensing and regulatory authority for assisted and senior independent living facilities lies with the states, meaning a patchwork of definitions and guidelines for the facilities. Given that assisted and independent living communities have been the fastest-growing sector in senior living for many years, the disparate definitions and rules often leave residents and their families without a clear understanding of a facility’s offerings and safety guardrails.

“There’s no transparency from a consumer perspective about what are these different options, what am I getting in each of them,” said David Grabowski, professor of health care policy at Harvard Medical School.

Years ago, Grabowski and others said, independent and assisted living facilities were filled with a generally healthier population who didn’t need much medical assistance and who could afford to pay out-of-pocket for enhanced lifestyle amenities such as restaurants or outings.

But as the population ages, residents are often less healthy and may not have the financial resources to afford the higher level of care they need. And unlike nursing homes, assisted and independent living facilities do not necessarily operate under regulations that require building codes to address the needs of elderly or disabled residents, or requirements for backup power or emergency systems. It depends on where they are.

In Texas, assisted living facilities are required to have emergency plans but not generators. The legislation introduced in the wake of winter storm Uri seeks to change that. Independent living facilities like the one Skladzien lives in might not be covered, though; they already have even fewer state guidelines to follow.

“We still don’t have good emergency management planning and preparation ingrained within the regulations to make sure our loved ones are safe within these facilities, because it just comes down to the money,” said Brian Lee, executive director of Families for Better Care, a nonprofit in Austin, Texas, focused on the nation’s long-term care facilities.

The debate is analogous to previous efforts to require sprinkler systems in nursing homes, he said. “How many more people have to be injured, maybe even have to have suffered death, because of power failure negligence?”

Lee and others said there is a distinction to be made between staff members — some of whom stayed in their facilities throughout the winter storm to keep residents safe — and industry forces resisting regulatory efforts to beef up backup safety systems.

“We can’t, and shouldn’t, let the industry decide how this is going to work,” said Ducayet. “There needs to be involvement and organization at government levels, so that there is clarity and information about how these different settings work.”

With elevators still not working at Skladzien’s independent living building a week after the storm, she was trying to figure out how she would get to her weekly post-cancer medical treatment.

Skladzien, who owned her own cleaning business for 25 years and drove a school bus for 15 years, moved into senior housing in 2019 when she could no longer handle the upkeep on her home. When she was looking for a place to live, though, it never occurred to her that apartments marketed toward older adults would not have a generator or plans to help residents in an emergency. And she never thought to ask.

“I had no experience,” she said.

It may not have mattered: Medical bills had depleted her savings, leaving her only the choice of what was available in low-income housing. In her building, she was told, wheelchair-accessible apartments on the first floor were beyond her financial reach.

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