Kaiser Health News
Amgen Plows Ahead With Costly, Highly Toxic Cancer Dosing Despite FDA Challenge
Arthur Allen
Tue, 07 May 2024 09:00:00 +0000
When doctors began using the drug sotorasib in 2021 with high expectations for its innovative approach to attacking lung cancer, retired medical technician Don Crosslin was an early beneficiary. Crosslin started the drug that July. His tumors shrank, then stabilized.
But while the drug has helped keep him alive, its side effects have gradually narrowed the confines of his life, said Crosslin, 76, who lives in Ocala, Florida: “My appetite has been minimal. I’m very weak. I walk my dogs and get around a bit, but I haven’t been able to golf since last July.”
He wonders whether he’d do better on a lower dose, “but I do what my oncologist tells me to do,” Crosslin said. Every day, he takes eight of the 120-milligram pills, sold under Amgen’s brand name Lumakras.
Crosslin’s concern lies at the heart of an FDA effort to make cancer drugs less toxic and more effective. Cancer drug trials are structured to promote high doses, which then become routine patient care. In the face of evidence that thousands of patients become so ill that they skip doses or stop taking the drugs — thereby risking resurgence of their cancers — the FDA has begun requiring companies to pinpoint the right dosage before they reach patients.
The initiative, Project Optimus, launched in 2021 just as Amgen was seeking to market sotorasib. At the time, the FDA’s leading cancer drug regulator, Richard Pazdur, co-authored an editorial in the New England Journal of Medicine that said Amgen’s trials of the $20,000-a-month drug were “hampered by a lack of robust dose exploration.”
The FDA conditionally approved sotorasib but required Amgen to conduct a study comparing the labeled dosage of 960 mg with a dosage of 240 mg. The trial, published in November, showed that the 960-mg dose may have given patients a month more of life, on average, but caused more severe side effects than the lower dose.
Amgen is keeping the 960-mg dosage as it conducts further tests to get final approval for the drug, spokesperson Elissa Snook said, adding that the dose showed superiority in one study. Whether medically justified or not, the heavier dosage allows the company to protect 75% of its revenue from the drug, which brought in nearly $200 million in the United States last year.
And there appears to be nothing the FDA can do about it.
“There’s a gap in FDA’s authority that results in patients getting excess doses of a drug at excess costs,” said Mark Ratain, a University of Chicago oncologist who has pushed for more accurate cancer drug dosing. “We should do something about this.”
Deciding on Dosage
It may be too late for the FDA to change the sotorasib dosage, although in principle it could demand a new regimen before granting final approval, perhaps in 2028. Under Project Optimus, however, the agency is doing something about dosage guidelines for future drugs. It is stressing dose optimization in its meetings with companies, particularly as they prepare to test drugs on patients for the first time, spokesperson Lauren-Jei McCarthy said.
“When you go in front of FDA with a plan to approve your drug now, they are going to address dosing studies,” said Julie Gralow, chief medical officer of the American Society of Clinical Oncology. “A lot of companies are struggling with this.”
That’s largely because the new requirements add six months to a year and millions in drug development costs, said Julie Bullock, a former FDA drug reviewer who advocated for more extensive dosing studies and is now senior vice president at Certara, a drug development consultancy.
In part, Project Optimus represents an effort to manage the faults of the FDA’s accelerated approval process, begun in 1992. While the process gets innovative drugs to patients more quickly, some medicines have proved lackluster or had unacceptable side effects.
That’s especially true of the newer pills to treat cancer, said Donald Harvey, an Emory University pharmacology professor, who has led or contributed to more than 100 early-phase cancer trials.
A study released last month in the Journal of the American Medical Association showed that 41% of the cancer drugs granted accelerated approval from 2013 to 2017 did not improve overall survival or quality of life after five years.
Many of these drugs flop because they must be given at toxic dosages to have any effect, Harvey said, adding that sotorasib might work better if the company had found an appropriate dosage earlier on.
“Sotorasib is a poster child for incredibly bad development,” Harvey said. The drug was the first to target the KRAS G12C mutation, which drives about 15% of lung cancers and was considered “undruggable” until University of California-San Francisco chemist Kevan Shokat figured out how to attack it in 2012.
Given the specificity of sotorasib’s target, Harvey said, Amgen could have found a lower dosage. “Instead, they followed the old model and said, ‘We’re going to push the dose up until we see a major side effect.’ They didn’t need to do that. They just needed more experience with a lower dose.”
The 960-mg dose “is really tough on patients,” said Yale University oncologist and assistant professor Michael Grant. “They get a lot of nausea and other GI side effects that are not pleasant. It hurts their quality of life.”
The FDA noted in its review of sotorasib that in phase 1 studies tumors shrank when exposed to as little as a fifth of the 960-mg daily dose Amgen selected. At all doses tested in that early trial, the drug reached roughly the same concentrations in the blood, which suggested that at higher doses the drug was mostly just intensifying side effects like diarrhea, vomiting, and mouth sores.
For most classes of drugs, companies spend considerable time in phases 1 and 2 of development, homing in on the right dosage. “No one would think of dosing a statin or antibiotic at the highest tolerable dose,” Ratain said.
Things are different in cancer drug creation, whose approach originated with chemotherapy, which damages as many cancer cells as possible, wrecking plenty of healthy tissue in the bargain. Typically, a company’s first series of cancer drug trials involve escalating doses in small groups of patients until something like a quarter of them get seriously ill. That “maximum tolerated dose” is then employed in more advanced clinical trials, and goes on the drug’s label. Once a drug is approved, a doctor can “go off-label” and alter the dosage, but most are leery of doing so.
Patients can find the experience rougher than advertised. During clinical trials, the side effects of the cancer drug osimertinib (Tagrisso) were listed as tolerable and manageable, said Jill Feldman, a lung cancer patient and advocate. “That killed me. After two months on that drug, I had lost 15 pounds, had sores in my mouth and down my throat, stomach stuff. It was horrible.”
Some practitioners, at least, have responded to the FDA’s cues on sotorasib. In the Kaiser Permanente health system, lung cancer specialists start with a lower dose of the drug, spokesperson Stephen Shivinsky said.
Smaller Doses — And Revenue
Amgen was clearly aware of the advantages of the 240-mg dosage before it sought FDA approval: It filed a provisional patent application on that dosage before the agency gave breakthrough approval for the drug at 960 mg. The company doesn’t appear to have disclosed the patent filing to investors or the FDA. McCarthy said the FDA was prohibited by law from discussing the particulars of its sotorasib regulation plans.
Switching to a 240-mg dosage could register a huge hit to Amgen’s revenue. The company markets the drug at more than $20,000 for a month of 960-mg daily doses. Each patient who could get by with a quarter of that would trim the company’s revenue by roughly $180,000 a year.
Amgen declined to comment on the patent issue or to make an official available to discuss the dosage and pricing issues.
Crosslin, who depends on Social Security for his income, couldn’t afford the $3,000 a month that Medicare required him to pay for sotorasib, but he has received assistance from Amgen and a charity that covers costs for patients below a certain income.
While the drug has worked well for Crosslin and other patients, its overall modest impact on lung cancer suggests that $5,000, rather than $20,000, might be a more appropriate price, Ratain said.
In the company’s phase 3 clinical trial for advanced lung cancer patients, sotorasib kept patients alive for about a month longer than docetaxel, the current, highly toxic standard of care. Docetaxel is a generic drug for which Medicare pays about $1 per injection. The trial was so unconvincing that the FDA sent Amgen back to do another.
Ratain, a staunch critic of Amgen’s handling of sotorasib, told Centers for Medicare & Medicaid Services officials at a recent meeting that they should pay for sotorasib on a basis of 240 mg per day. But CMS would do that only “if there is a change in the drug’s FDA-approved dosage,” spokesperson Aaron Smith said.
Drug companies generally don’t want to spend money on trials like the one the FDA ordered on sotorasib. In 2018, Ratain and other researchers used their institutions’ funding to conduct a dosing trial on the prostate cancer drug abiraterone, marketed under the brand name Zytiga by Johnson & Johnson. They found that taking one 250-mg pill with food was just as effective as taking four on an empty stomach, as the label called for.
Although J&J hasn’t changed the Zytiga label, the evidence generated in that trial was strong enough for the standards-setting National Comprehensive Cancer Network to change its recommendations.
Post-marketing studies like that one are hard to conduct, Emory’s Harvey said. Patients are reluctant to join a trial in which they may have to take a lower dosage, since most people tend to believe “the more the better,” he said.
“It’s better for everyone to find the right dose before a drug is out on the market,” Harvey said. “Better for the patient, and better for the company, which can sell more of a good drug if the patients aren’t getting sick and no longer taking it.”
——————————
By: Arthur Allen
Title: Amgen Plows Ahead With Costly, Highly Toxic Cancer Dosing Despite FDA Challenge
Sourced From: kffhealthnews.org/news/article/amgen-cancer-drug-sotorasib-lumakras-high-dosage-fda-dosing-trials/
Published Date: Tue, 07 May 2024 09:00:00 +0000
Kaiser Health News
How To Find the Right Medical Rehab Services
Rehabilitation therapy can be a godsend after hospitalization for a stroke, a fall, an accident, a joint replacement, a severe burn, or a spinal cord injury, among other conditions. Physical, occupational, and speech therapy are offered in a variety of settings, including at hospitals, nursing homes, clinics, and at home. It’s crucial to identify a high-quality, safe option with professionals experienced in treating your condition.
What kinds of rehab therapy might I need?
Physical therapy helps patients improve their strength, stability, and movement and reduce pain, usually through targeted exercises. Some physical therapists specialize in neurological, cardiovascular, or orthopedic issues. There are also geriatric and pediatric specialists. Occupational therapy focuses on specific activities (referred to as “occupations”), often ones that require fine motor skills, like brushing teeth, cutting food with a knife, and getting dressed. Speech and language therapy help people communicate. Some patients may need respiratory therapy if they have trouble breathing or need to be weaned from a ventilator.
Will insurance cover rehab?
Medicare, health insurers, workers’ compensation, and Medicaid plans in some states cover rehab therapy, but plans may refuse to pay for certain settings and may limit the amount of therapy you receive. Some insurers may require preauthorization, and some may terminate coverage if you’re not improving. Private insurers often place annual limits on outpatient therapy. Traditional Medicare is generally the least restrictive, while private Medicare Advantage plans may monitor progress closely and limit where patients can obtain therapy.
Should I seek inpatient rehabilitation?
Patients who still need nursing or a doctor’s care but can tolerate three hours of therapy five days a week may qualify for admission to a specialized rehab hospital or to a unit within a general hospital. Patients usually need at least two of the main types of rehab therapy: physical, occupational, or speech. Stays average around 12 days.
How do I choose?
Look for a place that is skilled in treating people with your diagnosis; many inpatient hospitals list specialties on their websites. People with complex or severe medical conditions may want a rehab hospital connected to an academic medical center at the vanguard of new treatments, even if it’s a plane ride away.
“You’ll see youngish patients with these life-changing, fairly catastrophic injuries,” like spinal cord damage, travel to another state for treatment, said Cheri Blauwet, chief medical officer of Spaulding Rehabilitation in Boston, one of 15 hospitals the federal government has praised for cutting-edge work.
But there are advantages in selecting a hospital close to family and friends who can help after you are discharged. Therapists can help train at-home caregivers.
How do I find rehab hospitals?
The discharge planner or caseworker at the acute care hospital should provide options. You can search for inpatient rehabilitation facilities by location or name through Medicare’s Care Compare website. There you can see how many patients the rehab hospital has treated with your condition — the more the better. You can search by specialty through the American Medical Rehabilitation Providers Association, a trade group that lists its members.
Find out what specialized technologies a hospital has, like driving simulators — a car or truck that enable a patient to practice getting in and out of a vehicle — or a kitchen table with utensils to practice making a meal.
How can I be confident a rehab hospital is reliable?
It’s not easy: Medicare doesn’t analyze staffing levels or post on its website results of safety inspections as it does for nursing homes. You can ask your state public health agency or the hospital to provide inspection reports for the last three years. Such reports can be technical, but you should get the gist. If the report says an “immediate jeopardy” was called, that means inspectors identified safety problems that put patients in danger.
The rate of patients readmitted to a general hospital for a potentially preventable reason is a key safety measure. Overall, for-profit rehabs have higher readmission rates than nonprofits do, but there are some with lower readmission rates and some with higher ones. You may not have a nearby choice: There are fewer than 400 rehab hospitals, and most general hospitals don’t have a rehab unit.
You can find a hospital’s readmission rates under Care Compare’s quality section. Rates lower than the national average are better.
Another measure of quality is how often patients are functional enough to go home after finishing rehab rather than to a nursing home, hospital, or health care institution. That measure is called “discharge to community” and is listed under Care Compare’s quality section. Rates higher than the national average are better.
Look for reviews of the hospital on Yelp and other sites. Ask if the patient will see the same therapist most days or a rotating cast of characters. Ask if the therapists have board certifications earned after intensive training to treat a patient’s particular condition.
Visit if possible, and don’t look only at the rooms in the hospital where therapy exercises take place. Injuries often occur in the 21 hours when a patient is not in therapy, but in his or her room or another part of the building. Infections, falls, bedsores, and medication errors are risks. If possible, observe whether nurses promptly respond to call lights, seem overloaded with too many patients, or are apathetically playing on their phones. Ask current patients and their family members if they are satisfied with the care.
What if I can’t handle three hours of therapy a day?
A nursing home that provides rehab might be appropriate for patients who don’t need the supervision of a doctor but aren’t ready to go home. The facilities generally provide round-the-clock nursing care. The amount of rehab varies based on the patient. There are more than 14,500 skilled nursing facilities in the United States, 12 times as many as hospitals offering rehab, so a nursing home may be the only option near you.
You can look for them through Medicare’s Care Compare website. (Read our previous guide to finding a good, well-staffed home to know how to assess the overall staffing.)
What if patients are too frail even for a nursing home?
They might need a long-term care hospital. Those specialize in patients who are in comas, on ventilators, and have acute medical conditions that require the presence of a physician. Patients stay at least four weeks, and some are there for months. Care Compare helps you search. There are fewer than 350 such hospitals.
I’m strong enough to go home. How do I receive therapy?
Many rehab hospitals offer outpatient therapy. You also can go to a clinic, or a therapist can come to you. You can hire a home health agency or find a therapist who takes your insurance and makes house calls. Your doctor or hospital may give you referrals. On Care Compare, home health agencies list whether they offer physical, occupational, or speech therapy. You can search for board-certified therapists on the American Physical Therapy Association’s website.
While undergoing rehab, patients sometimes move from hospital to nursing facility to home, often at the insistence of their insurers. Alice Bell, a senior specialist at the APTA, said patients should try to limit the number of transitions, for their own safety.
“Every time a patient moves from one setting to another,” she said, “they’re in a higher risk zone.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
USE OUR CONTENT
This story can be republished for free (details).
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Subscribe to KFF Health News’ free Morning Briefing.
This article first appeared on KFF Health News and is republished here under a Creative Commons license.
The post How To Find the Right Medical Rehab Services appeared first on kffhealthnews.org
Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.
Political Bias Rating: Centrist
This article from KFF Health News provides a comprehensive, fact-based guide to rehabilitation therapy options and how to navigate insurance, care settings, and provider quality. It avoids ideological framing and presents information in a neutral, practical tone aimed at helping consumers make informed medical decisions. While it touches on Medicare and private insurance policies, it does so without political commentary or value judgments, and no partisan viewpoints or advocacy positions are evident. The focus remains on patient care, safety, and informed choice, supporting a nonpartisan, service-oriented approach to health reporting.
Kaiser Health News
States Brace for Reversal of Obamacare Coverage Gains Under Trump’s Budget Bill
Shorter enrollment periods. More paperwork. Higher premiums. The sweeping tax and spending bill pushed by President Donald Trump includes provisions that would not only reshape people’s experience with the Affordable Care Act but, according to some policy analysts, also sharply undermine the gains in health insurance coverage associated with it.
The moves affect consumers and have particular resonance for the 19 states (plus Washington, D.C.) that run their own ACA exchanges.
Many of those states fear that the additional red tape — especially requirements that would end automatic reenrollment — would have an outsize impact on their policyholders. That’s because a greater percentage of people in those states use those rollovers versus shopping around each year, which is more commonly done by people in states that use the federal healthcare.gov marketplace.
“The federal marketplace always had a message of, ‘Come back in and shop,’ while the state-based markets, on average, have a message of, ‘Hey, here’s what you’re going to have next year, here’s what it will cost; if you like it, you don’t have to do anything,’” said Ellen Montz, who oversaw the federal ACA marketplace under the Biden administration as deputy administrator and director at the Center for Consumer Information and Insurance Oversight. She is now a managing director with the Manatt Health consulting group.
Millions — perhaps up to half of enrollees in some states — may lose or drop coverage as a result of that and other changes in the legislation combined with a new rule from the Trump administration and the likely expiration at year’s end of enhanced premium subsidies put in place during the covid-19 pandemic. Without an extension of those subsidies, which have been an important driver of Obamacare enrollment in recent years, premiums are expected to rise 75% on average next year. That’s starting to happen already, based on some early state rate requests for next year, which are hitting double digits.
“We estimate a minimum 30% enrollment loss, and, in the worst-case scenario, a 50% loss,” said Devon Trolley, executive director of Pennie, the ACA marketplace in Pennsylvania, which had 496,661 enrollees this year, a record.
Drops of that magnitude nationally, coupled with the expected loss of Medicaid coverage for millions more people under the legislation Trump calls the “One Big Beautiful Bill,” could undo inroads made in the nation’s uninsured rate, which dropped by about half from the time most of the ACA’s provisions went into effect in 2014, when it hovered around 14% to 15% of the population, to just over 8%, according to the most recent data.
Premiums would rise along with the uninsured rate, because older or sicker policyholders are more likely to try to jump enrollment hurdles, while those who rarely use coverage — and are thus less expensive — would not.
After a dramatic all-night session, House Republicans passed the bill, meeting the president’s July 4 deadline. Trump is expected to sign the measure on Independence Day. It would increase the federal deficit by trillions of dollars and cut spending on a variety of programs, including Medicaid and nutrition assistance, to partly offset the cost of extending tax cuts put in place during the first Trump administration.
The administration and its supporters say the GOP-backed changes to the ACA are needed to combat fraud. Democrats and ACA supporters see this effort as the latest in a long history of Republican efforts to weaken or repeal Obamacare. Among other things, the legislation would end several changes put in place by the Biden administration that were credited with making it easier to sign up, such as lengthening the annual open enrollment period and launching a special program for very low-income people that essentially allows them to sign up year-round.
In addition, automatic reenrollment, used by more than 10 million people for 2025 ACA coverage, would end in the 2028 sign-up season. Instead, consumers would have to update their information, starting in August each year, before the close of open enrollment, which would end Dec. 15, a month earlier than currently.
That’s a key change to combat rising enrollment fraud, said Brian Blase, president of the conservative Paragon Health Institute, because it gets at what he calls the Biden era’s “lax verification requirements.”
He blames automatic reenrollment, coupled with the availability of zero-premium plans for people with lower incomes that qualify them for large subsidies, for a sharp uptick in complaints from insurers, consumers, and brokers about fraudulent enrollments in 2023 and 2024. Those complaints centered on consumers’ being enrolled in an ACA plan, or switched from one to another, without authorization, often by commission-seeking brokers.
In testimony to Congress on June 25, Blase wrote that “this simple step will close a massive loophole and significantly reduce improper enrollment and spending.”
States that run their own marketplaces, however, saw few, if any, such problems, which were confined mainly to the 31 states using the federal healthcare.gov.
The state-run marketplaces credit their additional security measures and tighter control over broker access than healthcare.gov for the relative lack of problems.
“If you look at California and the other states that have expanded their Medicaid programs, you don’t see that kind of fraud problem,” said Jessica Altman, executive director of Covered California, the state’s Obamacare marketplace. “I don’t have a single case of a consumer calling Covered California saying, ‘I was enrolled without consent.’”
Such rollovers are common with other forms of health insurance, such as job-based coverage.
“By requiring everyone to come back in and provide additional information, and the fact that they can’t get a tax credit until they take this step, it is essentially making marketplace coverage the most difficult coverage to enroll in,” said Trolley at Pennie, 65% of whose policyholders were automatically reenrolled this year, according to KFF data. KFF is a health information nonprofit that includes KFF Health News.
Federal data shows about 22% of federal sign-ups in 2024 were automatic-reenrollments, versus 58% in state-based plans. Besides Pennsylvania, the states that saw such sign-ups for more than 60% of enrollees include California, New York, Georgia, New Jersey, and Virginia, according to KFF.
States do check income and other eligibility information for all enrollees — including those being automatically renewed, those signing up for the first time, and those enrolling outside the normal open enrollment period because they’ve experienced a loss of coverage or other life event or meet the rules for the low-income enrollment period.
“We have access to many data sources on the back end that we ping, to make sure nothing has changed. Most people sail through and are able to stay covered without taking any proactive step,” Altman said.
If flagged for mismatched data, applicants are asked for additional information. Under current law, “we have 90 days for them to have a tax credit while they submit paperwork,” Altman said.
That would change under the tax and spending plan before Congress, ending presumptive eligibility while a person submits the information.
A white paper written for Capital Policy Analytics, a Washington-based consultancy that specializes in economic analysis, concluded there appears to be little upside to the changes.
While “tighter verification can curb improper enrollments,” the additional paperwork, along with the expiration of higher premiums from the enhanced tax subsidies, “would push four to six million eligible people out of Marketplace plans, trading limited fraud savings for a surge in uninsurance,” wrote free market economists Ike Brannon and Anthony LoSasso.
“Insurers would be left with a smaller, sicker risk pool and heightened pricing uncertainty, making further premium increases and selective market exits [by insurers] likely,” they wrote.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
USE OUR CONTENT
This story can be republished for free (details).
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Subscribe to KFF Health News’ free Morning Briefing.
This article first appeared on KFF Health News and is republished here under a Creative Commons license.
The post States Brace for Reversal of Obamacare Coverage Gains Under Trump’s Budget Bill appeared first on kffhealthnews.org
Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.
Political Bias Rating: Center-Left
This content presents a critique of Republican-led changes to the Affordable Care Act, emphasizing potential negative impacts such as increased premiums, reduced enrollment, and the erosion of coverage gains made under the ACA. It highlights the perspective of policy analysts and state officials who express concern over these measures, while also presenting conservative viewpoints, particularly those focusing on fraud reduction. Overall, the tone and framing lean toward protecting the ACA and its expansions, which traditionally aligns with Center-Left media analysis.
Kaiser Health News
Dual Threats From Trump and GOP Imperil Nursing Homes and Their Foreign-Born Workers
In a top-rated nursing home in Alexandria, Virginia, the Rev. Donald Goodness is cared for by nurses and aides from various parts of Africa. One of them, Jackline Conteh, a naturalized citizen and nurse assistant from Sierra Leone, bathes and helps dress him most days and vigilantly intercepts any meal headed his way that contains gluten, as Goodness has celiac disease.
“We are full of people who come from other countries,” Goodness, 92, said about Goodwin House Alexandria’s staff. Without them, the retired Episcopal priest said, “I would be, and my building would be, desolate.”
The long-term health care industry is facing a double whammy from President Donald Trump’s crackdown on immigrants and the GOP’s proposals to reduce Medicaid spending. The industry is highly dependent on foreign workers: More than 800,000 immigrants and naturalized citizens comprise 28% of direct care employees at home care agencies, nursing homes, assisted living facilities, and other long-term care companies.
But in January, the Trump administration rescinded former President Joe Biden’s 2021 policy that protected health care facilities from Immigration and Customs Enforcement raids. The administration’s broad immigration crackdown threatens to drastically reduce the number of current and future workers for the industry. “People may be here on a green card, and they are afraid ICE is going to show up,” said Katie Smith Sloan, president of LeadingAge, an association of nonprofits that care for older adults.
Existing staffing shortages and quality-of-care problems would be compounded by other policies pushed by Trump and the Republican-led Congress, according to nursing home officials, resident advocates, and academic experts. Federal spending cuts under negotiation may strip nursing homes of some of their largest revenue sources by limiting ways states leverage Medicaid money and making it harder for new nursing home residents to retroactively qualify for Medicaid. Care for 6 in 10 residents is paid for by Medicaid, the state-federal health program for poor or disabled Americans.
“We are facing the collision of two policies here that could further erode staffing in nursing homes and present health outcome challenges,” said Eric Roberts, an associate professor of internal medicine at the University of Pennsylvania.
The industry hasn’t recovered from covid-19, which killed more than 200,000 long-term care facility residents and workers and led to massive staff attrition and turnover. Nursing homes have struggled to replace licensed nurses, who can find better-paying jobs at hospitals and doctors’ offices, as well as nursing assistants, who can earn more working at big-box stores or fast-food joints. Quality issues that preceded the pandemic have expanded: The percentage of nursing homes that federal health inspectors cited for putting residents in jeopardy of immediate harm or death has risen alarmingly from 17% in 2015 to 28% in 2024.
In addition to seeking to reduce Medicaid spending, congressional Republicans have proposed shelving the biggest nursing home reform in decades: a Biden-era rule mandating minimum staffing levels that would require most of the nation’s nearly 15,000 nursing homes to hire more workers.
The long-term care industry expects demand for direct care workers to burgeon with an influx of aging baby boomers needing professional care. The Census Bureau has projected the number of people 65 and older would grow from 63 million this year to 82 million in 2050.
In an email, Vianca Rodriguez Feliciano, a spokesperson for the Department of Health and Human Services, said the agency “is committed to supporting a strong, stable long-term care workforce” and “continues to work with states and providers to ensure quality care for older adults and individuals with disabilities.” In a separate email, Tricia McLaughlin, a Department of Homeland Security spokesperson, said foreigners wanting to work as caregivers “need to do that by coming here the legal way” but did not address the effect on the long-term care workforce of deportations of classes of authorized immigrants.
Goodwin Living, a faith-based nonprofit, runs three retirement communities in northern Virginia for people who live independently, need a little assistance each day, have memory issues, or require the availability of around-the-clock nurses. It also operates a retirement community in Washington, D.C. Medicare rates Goodwin House Alexandria as one of the best-staffed nursing homes in the country. Forty percent of the organization’s 1,450 employees are foreign-born and are either seeking citizenship or are already naturalized, according to Lindsay Hutter, a Goodwin spokesperson.
“As an employer, we see they stay on with us, they have longer tenure, they are more committed to the organization,” said Rob Liebreich, Goodwin’s president and CEO.
Jackline Conteh spent much of her youth shuttling between Sierra Leone, Liberia, and Ghana to avoid wars and tribal conflicts. Her mother was killed by a stray bullet in her home country of Liberia, Conteh said. “She was sitting outside,” Conteh, 56, recalled in an interview.
Conteh was working as a nurse in a hospital in Sierra Leone in 2009 when she learned of a lottery for visas to come to the United States. She won, though she couldn’t afford to bring her husband and two children along at the time. After she got a nursing assistant certification, Goodwin hired her in 2012.
Conteh said taking care of elders is embedded in the culture of African families. When she was 9, she helped feed and dress her grandmother, a job that rotated among her and her sisters. She washed her father when he was dying of prostate cancer. Her husband joined her in the United States in 2017; she cares for him because he has heart failure.
“Nearly every one of us from Africa, we know how to care for older adults,” she said.
Her daughter is now in the United States, while her son is still in Africa. Conteh said she sends money to him, her mother-in-law, and one of her sisters.
In the nursing home where Goodness and 89 other residents live, Conteh helps with daily tasks like dressing and eating, checks residents’ skin for signs of swelling or sores, and tries to help them avoid falling or getting disoriented. Of 102 employees in the building, broken up into eight residential wings called “small houses” and a wing for memory care, at least 72 were born abroad, Hutter said.
Donald Goodness grew up in Rochester, New York, and spent 25 years as rector of The Church of the Ascension in New York City, retiring in 1997. He and his late wife moved to Alexandria to be closer to their daughter, and in 2011 they moved into independent living at the Goodwin House. In 2023 he moved into one of the skilled nursing small houses, where Conteh started caring for him.
“I have a bad leg and I can’t stand on it very much, or I’d fall over,” he said. “She’s in there at 7:30 in the morning, and she helps me bathe.” Goodness said Conteh is exacting about cleanliness and will tell the housekeepers if his room is not kept properly.
Conteh said Goodness was withdrawn when he first arrived. “He don’t want to come out, he want to eat in his room,” she said. “He don’t want to be with the other people in the dining room, so I start making friends with him.”
She showed him a photo of Sierra Leone on her phone and told him of the weather there. He told her about his work at the church and how his wife did laundry for the choir. The breakthrough, she said, came one day when he agreed to lunch with her in the dining room. Long out of his shell, Goodness now sits on the community’s resident council and enjoys distributing the mail to other residents on his floor.
“The people that work in my building become so important to us,” Goodness said.
While Trump’s 2024 election campaign focused on foreigners here without authorization, his administration has broadened to target those legally here, including refugees who fled countries beset by wars or natural disasters. This month, the Department of Homeland Security revoked the work permits for migrants and refugees from Cuba, Haiti, Nicaragua, and Venezuela who arrived under a Biden-era program.
“I’ve just spent my morning firing good, honest people because the federal government told us that we had to,” Rachel Blumberg, president of the Toby & Leon Cooperman Sinai Residences of Boca Raton, a Florida retirement community, said in a video posted on LinkedIn. “I am so sick of people saying that we are deporting people because they are criminals. Let me tell you, they are not all criminals.”
At Goodwin House, Conteh is fearful for her fellow immigrants. Foreign workers at Goodwin rarely talk about their backgrounds. “They’re scared,” she said. “Nobody trusts anybody.” Her neighbors in her apartment complex fled the U.S. in December and returned to Sierra Leone after Trump won the election, leaving their children with relatives.
“If all these people leave the United States, they go back to Africa or to their various countries, what will become of our residents?” Conteh asked. “What will become of our old people that we’re taking care of?”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Subscribe to KFF Health News’ free Morning Briefing.
This article first appeared on KFF Health News and is republished here under a Creative Commons license.
The post Dual Threats From Trump and GOP Imperil Nursing Homes and Their Foreign-Born Workers appeared first on kffhealthnews.org
Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.
Political Bias Rating: Center-Left
This content primarily highlights concerns about the impact of restrictive immigration policies and Medicaid spending cuts proposed by the Trump administration and Republican lawmakers on the long-term care industry. It emphasizes the importance of immigrant workers in healthcare, the challenges that staffing shortages pose to patient care, and the potential negative effects of GOP policy proposals. The tone is critical of these policies while sympathetic toward immigrant workers and advocates for maintaining or increasing government support for healthcare funding. The framing aligns with a center-left perspective, focusing on social welfare, immigrant rights, and concern about the consequences of conservative economic and immigration policies without descending into partisan rhetoric.
-
News from the South - Texas News Feed7 days ago
Rural Texas uses THC for health and economy
-
Mississippi Today3 days ago
After 30 years in prison, Mississippi woman dies from cancer she says was preventable
-
News from the South - Georgia News Feed5 days ago
Woman charged after boy in state’s custody dies in hot car
-
Our Mississippi Home6 days ago
Porch Lights and Lightning Bugs: An August Evening in Mississippi
-
Mississippi News Video7 days ago
Safe Haven Baby Box opens in Gluckstadt
-
News from the South - Georgia News Feed7 days ago
Trump's new tariffs give some countries a break, shares and US dollar sink
-
News from the South - Oklahoma News Feed7 days ago
Woman honored for 50 years of giving back
-
News from the South - Kentucky News Feed6 days ago
Bowling Green man faces drug charges following traffic stop