Hunt died five days later. Her death certificate said the foot injury was a “significant” factor. Genesis denied wrongdoing but agreed to pay $3.5 million in a settlement Hunt’s son signed in August 2024.

Yet Genesis hasn’t paid most of that debt, court records show. It may never have to.

Once the nation’s largest nursing home chain, it was spending $8 million a month defending and settling lawsuits over resident injuries and deaths in recent years. But the company is now poised to wipe the liability slate clean by seeking refuge in the most protective corner of the legal system for the nursing home industry: bankruptcy court.

The Genesis case, one of 11 large senior care bankruptcies this year, illustrates how health care companies can dodge public and financial accountability for alleged negligence through delays, confidentiality clauses, and bankruptcy maneuvers, a Ñî¹óåú´«Ã½Ò•îl Health News investigation found.

When it filed for bankruptcy in Dallas in July, Genesis estimated its total liability for nearly a thousand settled and pending lawsuits at $259 million. A Ñî¹óåú´«Ã½Ò•îl Health News review of the terms of 155 settlement agreements and shows Genesis officials knew insolvency was possible yet included provisions in its settlement agreements allowing it to defer payment, often for a year or more.

As a result, Genesis paid nothing in 85 cases and only a portion in the other 70, according to civil court records and bankruptcy claims made available through people with access to them. It still owes $41 million of the $58 million it had agreed to pay in those cases, the records show.

“It just feels like they killed my mom and got away with it,” said Vanessa Betancourt, whose mother, Nellie Betancourt, a retired nurse, fractured her hip at a Genesis home in Albuquerque, New Mexico — an injury the medical examiner’s report said led to her death. Genesis agreed to a $650,000 settlement with Betancourt’s family in April under the condition it would not need to pay the first of seven installments for another year, according to the settlement document.

Genesis denied wrongdoing in all lawsuits and settlements. In a written statement, the company did not answer questions about individual personal injury cases. The statement said Genesis remained “focused on delivering high-quality, compassionate care to our patients and residents without disruption” during bankruptcy.

One lawsuit Genesis settled for nearly $1 million alleged nursing home managers ignored repeated warnings about a male resident’s behavior before he sexually assaulted a female Alzheimer’s patient, according to court records. In a case the company resolved for $500,000, a Genesis nursing home was accused of delaying the hospitalization of a resident who had vomited brown mucus. He died of a bowel obstruction. Genesis has paid nothing for either settlement, according to bankruptcy claims.

Creditors, including families of the deceased, are expected to salvage a fraction of what they were promised, if anything. On Dec. 10, the company’s owners were scheduled to seek approval by the U.S. Bankruptcy Court for the Northern District of Texas to sell its nursing homes and other assets to its largest investor, a private equity firm. In court papers, lawyers for residents and other creditors say the complex plan will from pursuing Genesis’ new ownership and other companies the company’s collapse.

John Anthony, a bankruptcy attorney representing 340 personal injury claims against Genesis, said, “They never had any intention to honor these deals.”

Low Ratings and Fines

During years of financial turmoil, Genesis has frequently struggled to provide top-notch care, federal records show. Using its five-star system, the Centers for Medicare & Medicaid Services affiliated with Genesis as below average or much below average. CMS Genesis homes $10 million for violating federal health standards over the past three years.

In 2022, a Genesis home after two deaths and multiple violations. The company this year after residents twice were evacuated over safety concerns.

In its filing, Genesis said it cared for about 15,000 residents in 165 nursing homes and 10 assisted living facilities in 18 states. They are centered in Pennsylvania, West Virginia, New Mexico, New Hampshire, New Jersey, Maine, Alabama, Maryland, and North Carolina, according to the bankruptcy filing.

The company said it owed $709 million in secured debt to lenders and the IRS. Under bankruptcy rules, those debts, backed by Genesis collateral, take precedence over the $1.6 billion in unsecured debt Genesis said it owes. Unsecured creditors include a pension fund; contractors that provided health services and equipment; Pennsylvania, New Mexico, and West Virginia for unpaid provider taxes; and former residents and their families who sued.

Dangers in Memory Care

Sandia Ridge Center, a Genesis home in Albuquerque, was repeatedly faulted by health regulators for not preventing sexual misbehavior in its memory care unit. In November 2021, CMS for lacking enough nurses to prevent sexual abuse among residents. An inspection report the following August inappropriate sexual contact. Police were called to investigate sexual assault allegations in and of 2023, police reports show; neither resulted in criminal charges.

Then in April 2023, a 61-year-old male resident with alcohol-related dementia sexually assaulted a female resident with Alzheimer’s in the dining room, according to a and an . When the resident screamed for him to stop and that he was hurting her, he responded “shut up bitch I know you like this,” according to a lawsuit brought on behalf of the woman, identified in court papers as R.S.

Sandia Ridge management had been aware of the male resident’s behavioral issues for months, according to employee depositions in the case. Police had investigated a against him the previous year without bringing charges. In one deposition, a former activities assistant testified he hit her and twice pushed her into a bathroom while announcing, “I want to have sex with you.” When she reported him to a senior Genesis manager, she said in the deposition, the manager put his finger over his lips and said, “Shhh.”

The activities worker testified that R.S. used to happily sing along with Elvis Presley songs. After the assault, the worker said, R.S. “don’t sing anymore.”

Inspectors cited the home for failing to protect R.S. The same report said the home didn’t provide a therapist for another female resident who was being sexually harassed. Medicare fined Sandia Ridge Center $91,247. Genesis denied liability but settled R.S.’ lawsuit for $925,000 in May, according to the bankruptcy claim.

“We just felt we have to hold them accountable,” R.S.’ daughter said in an interview, speaking on the condition that she and her mother not be identified, because of the nature of the assault. “Maybe I’m wrong, maybe I’m naive, but the only way to do that is to sue someone, right?”

Genesis has not paid any of the settlement, according to the family’s claim filing.

Growth and Debt

Genesis’ downfall can be , when affiliates of two private equity firms acquired the company in a $1.5 billion leveraged buyout, taking on substantial debt, according to its bankruptcy filing. Private equity also has been involved in other health care bankruptcies, including those of the nursing home chain, the prison health care contractor , and two for-profit hospital systems, and .

In 2011, Genesis raised $2.4 billion by transferring substantially all its nursing home buildings and other real estate to Welltower, a publicly traded real estate investment trust, according to Genesis’ bankruptcy filing. Genesis then rented the buildings back from Welltower, which made leasing costs a significant expense.

Genesis went on a nationwide buying spree. At its peak in 2016, it had grown to more than 500 nursing homes. In a court declaration, Louis Robichaux IV, a consultant overseeing Genesis’ bankruptcy restructuring, wrote that as the company expanded, it became harder to manage and “mired in corporate inefficiencies.” Robichaux wrote that Genesis’ financial woes were exacerbated by rapidly increasing labor costs and lawsuits, including some predating the covid pandemic.

Starting in 2021, Genesis avoided bankruptcy after from a founded by Joel Landau, the owner of a , according to Robichaux’s filing.

But Genesis continued to teeter on the edge of insolvency. In for 2022 and 2023 submitted to a California oversight agency, management and auditors said rent and debt obligations raised “substantial doubt about the company’s ability to continue as a going concern.”

In a court filing, a committee appointed by the U.S. Trustee’s Office to represent the unsecured creditors in the bankruptcy accused Landau and Welltower of that allowed Welltower to keep getting its rents while Landau could run the company and “siphon value to himself.” The committee alleged their efforts forced the company into insolvency while “staffing levels and patient care declined precipitously.” Landau and Welltower did not respond to requests for comment.

Drawn-Out Lawsuits

Erin Pearson sued Genesis over the death of her father, James Sanderson, a retired mining company executive who died in 2018 after spending less than a month at Bear Canyon Rehabilitation Center in Albuquerque. In the memory care unit, Sanderson fell repeatedly, suffered medication errors made by nursing home staff, and developed a bowel obstruction and sepsis, according to the lawsuit, filed in 2019. Pearson’s lawyers said he was not hospitalized until eight days after nurses noticed he was vomiting brown mucus.

After the judge rejected Genesis’ request to force Pearson into arbitration, Genesis appealed. It took 2½ years before an appeals court affirmed the original decision to let the case go forward in court, records show.

This past May, more than five years after suing, Pearson reached a $500,000 settlement, with the first payment required by November, according to a copy of the agreement. Nothing was paid, according to the bankruptcy claim.

“It was so drawn out and for so long,” Pearson said in an interview, calling Genesis’ bankruptcy “despicable.”

Payouts Postponed

Jennifer Foote, an Albuquerque attorney who represents clients in multiple lawsuits against Genesis, including Pearson’s, said the company frequently filed appeals. “They did not usually win them on these issues,” she said, “and our sense was that they were doing it as a delay tactic.”

Genesis started using installment payments around 2018, said Dusti Harvey, Foote’s law partner. “The payments wouldn’t start for several months out,” Harvey said. Foote said Genesis’ lawyers often wanted to time the payments to start the month the trial in the case was scheduled to occur.

Families had to wait even when comparatively small amounts of money were involved, settlement agreements show. Genesis’ settlement agreements also included a confidentiality clause prohibiting discussion of the incidents.

Genesis agreed to pay $42,000 in a November 2024 settlement, but the first payment was not due until nine months later. It was not paid, according to the bankruptcy claim.

A $250,000 settlement signed in October 2023 did not start paying out until the following September. When Genesis declared bankruptcy — 21 months after the case was resolved — it still owed $100,000, according to the family’s claim.

‘We Never Found Out the Truth’

Settling cases allowed Genesis to avoid the expense and publicity of a trial, at which details of how its nursing homes functioned might have been revealed. In October 2020, Margarett Johnson, a retired school bus driver, fell out of her wheelchair at a Genesis nursing home in Waldorf, Maryland, fracturing her jawbone, nose, and neck, according to a lawsuit brought by her family. Johnson was sent to a trauma center and placed on a ventilator. She died three months later, at age 76, from ventilator-associated pneumonia, the lawsuit said.

“It looked like she was hit by a truck,” Angelina Harley, one of her daughters, said in an interview. “I knew my mom was not going to come home. I knew the Lord was not going to punish her more.”

The company denied negligence and blamed the accident on Johnson’s jacket getting tangled in the wheel of her wheelchair, according to the lawsuit. Harley and her sister Angela Swann were dubious.

“We never found out the truth,” Harley said. “They wanted to settle out of court.”

The company denied liability but agreed to a $950,000 settlement in October 2024. It never paid the final $112,500 installment, according to a letter Johnson’s five children sent to the bankruptcy judge.

“If you settle out of court, you know doggone well you did something wrong,” Harley said.

Maddening Judges

By summer 2025, judges in some civil cases had run out of patience.

Alma Brown, a retired day care manager and accordion teacher living in a Genesis nursing home in Clovis, New Mexico, suffered falls, infections, bedsores, and other neglect that hastened her death in 2023, according to her estate’s lawsuit. In Santa Fe District Court, Judge Kathleen McGarry Ellenwood castigated Genesis after it failed to pay $2 million of the $3 million settlement to Brown’s estate or explain the delay.

Genesis “obviously benefited by not having to go to trial,” McGarry Ellenwood said in one hearing, according to a court transcript. “They assure me that they’re not trying to renege on their contract, but it certainly seems like they haven’t lived up to what the bargain was.”

Genesis declared bankruptcy the day McGarry Ellenwood announced she would impose more than $100,000 in fines, plus $10,000 more each day until the settlement was paid.

In Pennsylvania, Greg Hunt petitioned a judge to punish Genesis after it stopped payments of the $3.5 million settlement after the death of his mother, Nancy, the resident with the gangrenous foot. She had spent eight months in 2019 at Brandywine Hall, a Genesis facility in West Chester that was later sold and renamed.

In a filing with the Common Pleas Court of Montgomery County, Genesis admitted it was in arrears but asked the judge for more time, citing “unforeseen and exigent financial challenges.” Genesis said care for patients at its nursing homes would suffer if it had to pay immediately.

Unswayed, Judge Richard Haaz in June ordered Genesis to pay up, along with punitive interest. But the bankruptcy court stayed that order. Genesis still owes $1.4 million of the $2 million it was supposed to pay, according to Hunt’s claim. (The rest of the $3.5 million settlement is supposed to be paid by an insurer in January 2026.) Ian Norris, Hunt’s lawyer, declined to comment, citing confidentiality provisions in the settlement.

Court records indicate Genesis lawyers never disclosed in either case that it was preparing to declare bankruptcy.

‘Bankruptcy as a Tool’

In the first nine months of 2025, 10 other senior living companies with liabilities over $10 million entered Chapter 11 bankruptcy, according to , a consulting firm.

Hamid Rafatjoo, a bankruptcy lawyer representing nursing homes who is not involved in the Genesis bankruptcy case, said filings may increase as the industry has become costlier to run and class action lawsuits have become a fixture.

“Nursing homes get sued all the time for everything,” Rafatjoo said. “A lot of operators wait too long to use bankruptcy as a tool.”

On Dec. 1, Genesis announced the , saying it had elected to to a private equity firm controlled by Landau. In a court filing, Anthony, the attorney for the personal injury claimants, in Landau’s favor despite an “objectively better and higher competing bid” from another private equity investor that would have provided more money to creditors. Genesis said in its statement that Landau’s group had increased its bid during the auction.

Sen. Elizabeth Warren (D-Mass.) and two other senators last month to intervene in the case, out of concern that “individuals who already own or control Genesis are trying to sell it to themselves, wiping away legal and other creditor debts in the process.” Lawyers representing those in charge of the auction did not respond to a request for comment.

Families of former Genesis residents said they fear the capacity to purge lawsuits through bankruptcy emboldens nursing home owners who provide deficient care.

“They can file bankruptcy again,” said Gabe Betancourt, whose wife, Nellie, died after her stay at Uptown Rehabilitation Center in Albuquerque. “And we’re the ones that will pay for it, with our memories, our lives.”

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Both patients, a man and a woman, had agreed to donate their brains after they died for further research. “An amazing gift,” said Edward Lee, the neuropathologist who directs the at the university’s Perelman School of Medicine. “They were both very dedicated to helping us understand Alzheimer’s disease.”

The man, who died at 83 with dementia, had lived in the Center City neighborhood of Philadelphia with hired caregivers. The autopsy showed large amounts of amyloid plaques and tau tangles, the proteins associated with Alzheimer’s disease, spreading through his brain.

Researchers also found infarcts, small spots of damaged tissue, indicating that he had suffered several strokes.

By contrast, the woman, who was 84 when she died of brain cancer, “had barely any Alzheimer’s pathology,” Lee said. “We had tested her year after year, and she had no cognitive issues at all.”

The man had lived a few blocks from Interstate 676, which slices through downtown Philadelphia. The woman had lived a few miles away in the suburb of Gladwyne, Pennsylvania, surrounded by woods and a country club.

The amount of air pollution she was exposed to — specifically, the level of fine particulate matter called PM2.5 — was less than half that of his exposure. Was it a coincidence that he had developed severe Alzheimer’s while she had remained cognitively normal?

With increasing evidence that chronic exposure to PM2.5, a neurotoxin, not only damages lungs and hearts but is also associated with dementia, probably not.

“The quality of the air you live in affects your cognition,” said Lee, the senior author of a recent , one of several large studies in the past few months to demonstrate an association between PM2.5 and dementia.

Scientists have been tracking the connection for at least a decade. In 2020, the influential Lancet Commission to its list of modifiable risk factors for dementia, along with common problems like hearing loss, diabetes, smoking, and high blood pressure.

Yet such findings are emerging when the federal government is dismantling efforts by previous administrations to continue reducing air pollution by shifting from fossil fuels to renewable energy sources.

“‘Drill, baby, drill’ is totally the wrong approach,” said John Balmes, a spokesperson for the American Lung Association who researches the effects of air pollution on health at the University of California-San Francisco.

“All these actions are going to decrease air quality and lead to increasing mortality and illness, dementia being one of those outcomes,” Balmes said, referring to recent environmental moves by the White House.

Many factors contribute to dementia, of course. But the role of particulates — microscopic solids or droplets in the air — is drawing closer scrutiny.

Particulates arise from many sources: emissions from power plants and home heating, factory fumes, motor vehicle exhaust, and, increasingly, wildfire smoke.

Of the several particulate sizes, PM2.5 “seems to be the most damaging to human health,” Lee said, because it is among the smallest. Easily inhaled, the particles enter the bloodstream and circulate through the body; they can also travel directly from the nose to the brain.

The research at the University of Pennsylvania, the largest autopsy study to date of people with dementia, included more than 600 brains donated over two decades.

Previous research on pollution and dementia mostly relied on epidemiological studies to establish an association. Now, “we’re linking what we actually see in the brain with exposure to pollutants,” Lee said, adding, “We’re able to do a deeper dive.”

The study participants had undergone years of cognitive testing at Penn Memory. With an environmental database, the researchers were able to calculate their PM2.5 exposure based on their home addresses.

The scientists also devised a matrix to measure how severely Alzheimer’s and other dementias had damaged donors’ brains.

Lee’s team concluded that “the higher the exposure to PM2.5, the greater the extent of Alzheimer’s disease,” he said. The odds of more severe Alzheimer’s pathology at autopsy were almost 20% greater among donors who had lived where PM2.5 levels were high.

Another research team recently between PM2.5 exposure and Lewy body dementia, which includes dementia related to Parkinson’s disease. Generally considered the second most common type after Alzheimer’s, Lewy body accounts for an estimated 5% to 15% of dementia cases.

In what the researchers believe is the largest epidemiological study to date of pollution and dementia, they analyzed records from more than 56 million beneficiaries with traditional Medicare from 2000 to 2014, comparing their initial hospitalizations for neurodegenerative diseases with their exposure to PM2.5 by ZIP codes.

“Chronic PM2.5 exposure was linked to hospitalization for Lewy body dementia,” said Xiao Wu, an author of the study and a biostatistician at the Mailman School of Public Health at Columbia University.

After controlling for socioeconomic and other differences, the researchers found that the rate of Lewy body hospitalizations was 12% higher in U.S. counties with the worst concentrations of PM2.5 than in those with the lowest.

To help verify their findings, the researchers nasally administered PM2.5 to laboratory mice, which after 10 months showed “clear dementia-like deficits,” senior author Xiaobo Mao, a neuroscientist at the Johns Hopkins School of Medicine, wrote in an email.

The mice got lost in mazes that they had previously dashed through. They had earlier built nests quickly and compactly; now their efforts were sloppy, disorganized. At autopsy, Mao said, their brains had atrophied and contained accumulations of the protein associated with Lewy bodies in human brains, called alpha-synuclein.

A , published this summer in The Lancet, included 32 studies conducted in Europe, North America, Asia, and Australia. It also found “a dementia diagnosis to be significantly associated with long-term exposure to PM2.5” and to certain other pollutants.

Whether so-called ambient air pollution — the outdoor kind — increases dementia because of inflammation or other physiological causes awaits the next round of research.

Although air pollution has declined in the United States over two decades, scientists are calling for still stronger policies to promote cleaner air. “People argue that air quality is expensive,” Lee said. “So is dementia care.”

President Donald Trump, however, reentered office vowing to increase and to block the transition to renewable energy. His administration for solar installations and electric vehicles, Balmes noted, adding, “They’re encouraging continuing to burn coal for power generation.”

The administration has , announced in the Arctic National Wildlife Refuge in Alaska, and moved to stop to transition to electric cars by 2035. (The state has challenged that action in court.)

“If policy goes in the opposite direction, with more air pollution, that’s a big health risk for older adults,” Wu said.

Last year, under the Biden administration, the Environmental Protection Agency for PM2.5, noting that “the available scientific evidence and technical information indicate that the current standards may not be adequate to protect public health and welfare, as required by the Clean Air Act.”

In March, the EPA’s that the agency would be “revisiting” those stricter standards.

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El documento indicará que se alejará del volante cuando sus hijos se lo pidan.

“Es posible que, llegado el momento, no sea capaz de tomar la mejor decisión sobre conducir, y quiero dejar claro que confío en mis hijos para asumir esa responsabilidad”, dijo Morgenstern, profesor de neurología, neurocirugía y medicina de emergencia en la Universidad de Michigan.

Su esposa, de 59, tiene la intención de firmar un documento similar a los 65.

Morgenstern ha reflexionado mucho sobre el tema controversial de cuándo dejar de conducir. Fue coautor de reciente publicado en el Journal of the American Geriatrics Society que reveló que el 61% de los adultos mayores con deterioro cognitivo seguían manejando a pesar de que el 36% de sus cuidadores estaban preocupados por su capacidad para hacerlo.

Muchos de estos adultos mayores probablemente se hayan adaptado siendo precavidos y recurriendo a una amplia experiencia detrás del volante, dijo Morgenstern. Pero remarcó que “indudablemente hay un grupo de personas que están conduciendo y no deberían hacerlo porque representan un riesgo para sí mismos y para los demás”.

Pocos estudios han examinado cuántos adultos mayores con deterioro cognitivo leve o demencia continúan conduciendo, y no hay estándares nacionales sobre cuándo las personas deberían “colgar las llaves”. Pero es una preocupación creciente a medida que aumenta la población de adultos mayores de 70, 80 y 90 años, el grupo de edad más propenso a tener deterioro cognitivo.

Casi 50 millones de personas de 65 años o más tenían licencias de conducir en 2021, un aumento del 38% desde 2012, según datos de la American Automobile Association (AAA). Casi 19 millones tenían 75 años o más, un aumento del 31%. Durante este período, las muertes por accidentes de vehículos entre personas de 65 años o más aumentaron un 34%: fueron 7,489 en 2021. El número de personas mayores lesionadas en accidentes de tráfico ese año superó las 266,000.

En su mayoría, los seniors conducen de manera segura. Usan el cinturón de seguridad con más frecuencia, beben menos, y son menos propensos a conducir a alta velocidad que los más jóvenes.

En comparación con los adultos más jóvenes y de mediana edad, están involucrados en menos accidentes automovilísticos fatales cada año. Y son más propensos a restringir dónde y cuándo conducen, siguiendo rutas familiares, evitando calles con mucho tráfico y no manejando de noche.

Sin embargo, los riesgos para los conductores mayores aumentan con la edad y el desarrollo de afecciones como la artritis, el glaucoma y el Parkinson. Y cuando ocurren accidentes, los adultos mayores son más propensos a sufrir heridas graves o morir porque son físicamente más vulnerables.

El deterioro cognitivo y la demencia plantean desafíos especialmente preocupantes porque la toma de decisiones, la atención, el juicio y la evaluación del riesgo se ven comprometidos en las personas con estas afecciones.

En este contexto, “conducir es un gran desafío, porque las personas no reaccionan adecuadamente y no pueden controlarse a sí mismas”, dijo Emmy Betz, profesora de medicina de emergencia en la Escuela de Medicina de la Universidad de Colorado, que ha estudiado las directivas anticipadas sobre el manejo.

Este fue el caso del suegro de Morgenstern, quien desarrolló Alzheimer moderado en sus 70s pero seguía convencido de que podía conducir. Después de perderse un día, su esposa le sacó las llaves del auto, y “él no entendía por qué. Estaba muy infeliz”, contó Morgenstern.

El interés de Morgenstern en las directivas anticipadas de manejo, una opción que recomienda en su artículo, surgió de esta experiencia.

Existen varios tipos de directivas. Una pide a una persona que nombre a un familiar o amigo que, en el futuro, hablará con ellos sobre si es seguro seguir conduciendo. La AAA y la American Occupational Therapy Association han respaldado , que no es legalmente vinculante (básicamente es poner por escrito un acuerdo de palabra).

También los familiares deben comprometerse a ayudar a la persona a explorar si es posible seguir conduciendo, o a intentar el transporte público o programas de conductores voluntarios. Uber y Lyft, que han creado programas para personas mayores, son nuevas opciones que se utilizan con frecuencia.

Otra , respaldada por la Asociación de Alzheimer, reconoce que las personas con demencia no podrán conducir a medida que avanza su enfermedad. También nombra a personas que deberían expresar preocupación sobre el manejo cuando sea relevante. Pero va más allá declarando: “Comprendo que puedo olvidar que ya no puedo conducir y puedo intentar seguir conduciendo. Si esto sucede, apoyo todas las acciones tomadas, incluido el retiro o desactivación de mi automóvil, para ayudar a garantizar mi seguridad y la de los demás”.

En la Universidad de South Florida Health, Lori Dee Grismore, terapeuta ocupacional y especialista certificada en rehabilitación del manejo, dijo que hasta el 75% de los adultos mayores que evalúa tienen algún tipo de deterioro cognitivo.

Esto es evidente durante la primera parte de su evaluación integral: una entrevista sobre los hábitos de manejo de la persona y problemas recientes; una revisión de su historial médico; un examen de la vista; una evaluación física; y una batería de seis pruebas cognitivas. “Si alguien no tiene perspicacia, que es común, no entienden por qué estas pruebas tienen algo que ver con conducir”, dijo.

Si lo considera seguro, Grismore lleva a los adultos mayores a la calle, verificando su capacidad para seguir direcciones, girar, mantenerse en sus carriles y conducir a velocidades apropiadas e interpretar señales, entre otras medidas de desempeño.

Si bien la mayoría con deterioro cognitivo leve aprueban estos tests, Grismore generalmente recomienda volver a evaluar a intervalos regulares e imponer restricciones como conducir solo cerca de casa y evitar autopistas. Pero reconoció que no hay garantía de que los adultos mayores recuerden estas restricciones.

La evaluación de tres horas de Grismore cuesta $420. Medicare no la paga, una barrera para los adultos mayores con ingresos bajos. Los adultos mayores y las familias interesadas en encontrar un proveedor de rehabilitación de manejo pueden consultar un directorio de la American Occupational Therapy Association en .

Elin Schold Davis, quien coordina la Older Driver Initiative en la asociación de terapia ocupacional, recomienda tener una evaluación de este tipo cuando hay un diagnóstico de deterioro cognitivo o cuando los familiares comienzan a notar problemas.

“Todos deberíamos estar planificando nuestras cambiantes necesidades de transporte en nuestros 70, 80 y 90 años”, dijo. “La parte difícil es que conducir está asociado con la independencia, y este es un problema muy emocional. Por eso, cuanto más se planee, más opciones y control se podrá tener”.

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The directive will say that when his children want him to stop getting behind the wheel, Morgenstern will follow their advice.

“I recognize that I might not be able to make the best decision about driving at a certain point, and I want to make it clear I trust my children to take over that responsibility,” said Morgenstern, a professor of neurology, neurosurgery, and emergency medicine at the University of Michigan.

His wife, 59, intends to sign a similar document at 65.

Morgenstern has given a lot of thought to the often-divisive issue of when to stop driving. He co-authored a in the Journal of the American Geriatrics Society that found 61% of older adults with cognitive impairment continued to drive even though 36% of their caregivers were concerned about their performance.

Many of these seniors probably adapted by exercising caution and drawing on extensive experience behind the wheel, Morgenstern said. But, he noted, “there is undoubtedly a group of people who are driving and shouldn’t be because they’re a risk to themselves and to others.”

Relatively few studies have looked at how many older adults with mild cognitive impairment or dementia continue to drive, and there aren’t any national standards on when people should hand over the car keys. But the issue is a growing concern as the ranks of seniors in their 70s, 80s, and 90s — the age group most likely to have cognitive impairment — expand.

Nearly 50 million people 65 and older held driver’s licenses in 2021, a 38% increase from 2012, according to data compiled by the American Automobile Association. Almost 19 million were 75 or older, a rise of 31%. During this period, motor vehicle deaths for people 65 and older increased 34%, reaching 7,489 in 2021. The number of seniors injured in vehicle crashes that year exceeded 266,000.

For the most part, older adults drive safely. They use seat belts more often, are intoxicated less often, and are less likely to speed than younger adults. Compared with younger and middle-aged adults, they’re involved in fewer fatal car crashes each year. And they’re more likely to restrict where and when they drive — following familiar routes, avoiding heavily trafficked streets, and not driving at night.

Still, risks for older drivers rise with advancing age and the onset of medical conditions such as arthritis, glaucoma, and Parkinson’s disease. And when crashes occur, seniors are more likely to be severely injured or die because they’re more vulnerable physically.

Cognitive impairment and dementia pose especially worrisome challenges because decision-making, attention, judgment, and risk assessment are compromised in people with these conditions. 

“This is a big challenge when it comes to driving, because people don’t react appropriately and self-regulate,” said Emmy Betz, a professor of emergency medicine at the University of Colorado School of Medicine who has studied advance driving directives.

This was the case for Morgenstern’s beloved father-in-law, who developed moderate Alzheimer’s disease in his 70s but remained convinced he was fit to drive. After he got badly lost one day, Morgenstern’s mother-in-law took away the car keys, and “he didn’t understand why. He was very unhappy,” Morgenstern said.

Morgenstern’s interest in advance directives for driving, an option he recommends in his paper, springs from this experience.

Several types of directives exist. One asks a person to name a family member or friend who will talk to them about whether it’s safe to continue driving. AAA and the American Occupational Therapy Association have of this kind, which is not legally binding.

Obligations also run in the other direction, with family members agreeing to help the person explore ways to keep driving, if possible. If not, family members agree to help the person find other ways to get out and about by offering rides and helping them use public transportation, carpooling services, or volunteer-driver programs. Uber and Lyft, which have created programs for seniors, are newer options frequently used.

, endorsed by the Alzheimer’s Association, recognizes that people with dementia will not be able to drive as their illness progresses. It, too, names people who should raise concerns about driving when it becomes important. But it goes further by stating: “I understand that I may forget that I cannot drive anymore and may try to continue driving. If this happens, please know that I support all actions taken, including removing or disabling my car, to help ensure my safety and the safety of others.”

At the University of South Florida Health, Lori Dee Grismore, an occupational therapist and certified driving rehabilitation specialist, said up to 75% of the seniors she evaluates have some type of cognitive impairment.

This becomes evident during the first part of Grismore’s comprehensive evaluation: an interview about the person’s driving habits and recent problems; a review of their medical history; a vision exam; a physical assessment; and a battery of six cognitive tests. “If someone doesn’t have insight, which is common, they don’t understand why these tests have anything to do with driving,” she told me.

If she thinks it’s safe, Grismore then takes older adults out on the road, checking their ability to follow directions, make turns, stay in their lanes, maintain appropriate speeds, and interpret signs, among other performance measures.

While most older adults with mild cognitive impairment pass these tests, Grismore usually recommends retesting at regular intervals and imposing restrictions such as driving only close to home and staying off highways. But she acknowledged there’s no guarantee seniors will remember these restrictions.

Grismore’s three-hour assessment costs $420. Medicare doesn’t pay — a barrier to seniors with low or fixed incomes. Older adults and families interested in finding a driving rehab provider can consult an American Occupational Therapy Association directory at .

Elin Schold Davis, who coordinates the Older Driver Initiative at the occupational therapy association, recommends getting an evaluation of this kind when someone is diagnosed with cognitive impairment or when family members begin to notice problems.

“We should all be planning for our changing transportation needs in our 70s, 80s, and 90s,” she said. “The hard part is that driving is associated with independence, and this is such an emotional issue. But the more people look ahead, the more choice and control they can have.”

Steering Older Drivers to Resources

Many people with cognitive impairment continue to drive and don’t want to stop. There are no standards for when they should give up their car keys, but planning ahead is recommended. Here are some resources that offer guidance.

For basic information:Alzheimer’s Association: “”National Highway Traffic Safety Administration: “”

Hitting the milestone:Healthwise: “Is It Time to Stop Driving?”

A conversation guide:The Hartford Center for Mature Market Excellence: “.”

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What’s the difference between long-term care insurance and medical insurance?

Long-term care insurance is for people who may develop permanent cognitive problems like Alzheimer’s disease or who will need help with basic daily tasks like bathing or dressing. It can help pay for personal aides, adult day care, or institutional housing in an assisted living facility or a nursing home. Medicare does not cover such costs for the chronically ill.

How does it work?

Policies generally pay a set rate per day, week, or month — say, up to $1,400 a week for home care aides. Before buying a policy, ask which services it covers and how much it pays out for each kind of care, such as a nursing home, an assisted living facility, a home personal care service, or adult day care. Some policies will pay family members who are providing the care; ask who qualifies as a family member and whether the policy pays for their training.

You should check to see if benefits are increased to take inflation into account, and by how much. Ask about the maximum amount the policy will pay out and if the benefits can be shared by a domestic partner or spouse.

How much does it cost?

In 2023, a 60-year-old man buying a $165,000 policy would typically pay about $2,585 annually for a policy that grew at 3% a year to take inflation into account, according to a survey by the American Association for Long-Term Care Insurance, a . A woman of the same age would pay $4,450 for the same policy because women tend to live longer and are more likely to use it. The higher the inflation adjustment, the more the policy will cost.

If a company has been paying out more than it anticipated, it’s more likely to raise rates. Companies need the approval of your state’s regulators, so you should find out if the insurer is asking the state insurance department to increase rates for the next few years — and, if so, by how much — since companies can’t raise premiums without permission. You can find contacts for your state’s insurance department through the .

Should I buy it?

It’s probably not worth the cost if you don’t own your home or have a significant amount of money saved and won’t have a sizable pension beyond Social Security. If that describes you, you’ll probably qualify for Medicaid once you spend what you have. But insurance may be worth it if the value of all your savings and possessions, excluding your primary home, is at least $75,000, according to a from the insurance commissioners’ association.

Even if you have savings and valuable things that you can sell, you should think about whether you can afford the premiums. While insurers can’t cancel a policy once they’ve sold it to you, they can — and often do — raise the premium rate each year. The insurance commissioners’ group says you probably should consider coverage only if it’s less than 7% of your current income and if you can still pay it without pain if the premium were raised by 25%.

Many insurers are selling hybrid policies that combine life insurance and long-term care insurance. Those are popular because if you don’t use the long-term care benefit, the policy pays out to a beneficiary after you die. But compared with long-term care policies, hybrid policies “are even more expensive, and the coverage is not great,” said Howard Bedlin, government relations and advocacy principal at the National Council on Aging.

When should I buy a policy?

Wait too long and you may have developed medical conditions that make you too risky for any insurer. Buy too early and you may be diverting money that would be better invested in your retirement account, your children’s tuition, or other financial priorities. Jesse Slome, executive director of the American Association for Long-Term Care Insurance, says the “sweet spot” is when you’re between ages 55 and 65. People younger than that often have other financial priorities, he said, that make the premiums more painful.

When can I tap the benefits?

Make sure you know which circumstances allow you to draw benefits. That’s known as the “trigger.” Policies often require proof that you need help with at least two of the six “activities of daily living,” which are: bathing, dressing, eating, being able to get out of bed and move, continence, and being able to get to and use the toilet. You can also tap your policy if you have a diagnosis of dementia or some other kind of cognitive impairment. Insurance companies will generally send a representative to do an evaluation, or require a doctor’s assessment.

Many policies won’t start paying until after you’ve paid out of your own pocket for a set period, such as 20 days or 100 days. This is known as the “elimination period.”

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This might seem appealing on the surface, but the development has Alzheimer’s researchers and clinicians up in arms.

The Quest Diagnostics blood test, AD-Detect, measures elevated levels of amyloid-beta proteins, a signature characteristic of Alzheimer’s. Introduced in late July, the test is targeted primarily at people 50 and older who suspect their memory and thinking might be impaired and people with a family history of Alzheimer’s or genetic risks for the condition.

Given Alzheimer’s is among the most feared of all medical conditions, along with cancer, this could be a sizable market, indeed. Nearly 7 million older adults in the U.S. have Alzheimer’s, and that number is expected to double by 2060 if medical breakthroughs don’t occur.

But Alzheimer’s researchers and clinicians aren’t convinced the Quest test is backed by sound scientific research. The possibility of false-positive results is high, as is the likelihood that older adults won’t understand the significance of their results, they say. The test should be taken only under a physician’s supervision, if at all, they advise. And, priced originally at $399 (recently discounted to $299) and not covered by insurance, it isn’t cheap.

Though blood tests for Alzheimer’s are likely to become common in the years ahead, the Alzheimer’s Association said it’s premature to offer a test of this kind directly to consumers.

For its part, Quest, which also sells direct-to-consumer tests for sexually transmitted diseases and various other conditions, suggests older adults can be trusted to respond responsibly to AD-Detect results. The test is not meant to diagnose Alzheimer’s, the company stressed; instead, it’s meant to help assess an individual’s risk of developing the condition. But under a new, proposed biological definition of Alzheimer’s, excess amyloid could automatically trigger a diagnosis of “preclinical” Alzheimer’s.

Michael Racke, Quest’s medical director of neurology, said individuals who test positive might be inspired to talk to their physicians about cognitive symptoms and seek comprehensive evaluations from dementia specialists. Others may just want to adopt behaviors associated with brain health, such as exercising more and maintaining healthy blood pressure, blood sugar, and cholesterol levels.

“People who do consumer-initiated testing are often very motivated to figure out what they can do to help reduce the risk of disease,” he said.

To get the test, a person first needs to go to the and report that they’re experiencing mild cognitive decline and have at least one other risk factor. (Self-reported complaints of this kind are often unreliable, experts note.) The order then goes automatically to a doctor paid by Quest, who will order a blood test to be drawn at a Quest laboratory.

Results classifying a person as low, medium, or high risk will be provided on a secure patient portal. Post-test counseling isn’t mandatory, but individuals can speak to a physician paid by Quest, if they like. (There is a separate $13 “physician service fee.”)

A confirms that older adults will take results seriously: Ninety-seven percent of seniors said they would take steps to improve brain health upon receiving a positive result from a blood test, while 77% said they would consider changes to financial or end-of-life plans.

But research scientists and clinicians worry that Quest hasn’t published any peer-reviewed studies documenting the test’s validity. The company’s preliminary data released at the 2022 Alzheimer’s Association International Conference in San Diego suggests there’s a relatively high chance of false-positive results, said Suzanne Schindler, an associate professor of neurology at Washington University School of Medicine in St. Louis.

That’s a significant problem because telling someone they have biological changes associated with Alzheimer’s disease is a “big deal and you want to be as accurate as possible,” Schindler noted.

Racke said at least three scientific studies giving more details about the AD-Detect test have been submitted to medical journals and might be published by the end of this year.

Experts also question the usefulness of the test since a positive result (indicating abnormal levels of amyloid in the blood) doesn’t mean an individual will definitely develop Alzheimer’s disease. Amyloid in the brain accumulates slowly over the course of decades, typically beginning in middle age, and becomes more common as people age.

“This test gives you a fuzzy answer. We don’t know whether you’re going to get dementia, or when symptoms might begin, or, really, how high the risk is for any individual,” said Meera Sheffrin, medical director of the Senior Care clinic at Stanford Healthcare.

Also, cognitive symptoms that prompt someone to take the test might be due to a wide variety of other causes, including mini-strokes, sleep apnea, thyroid problems, vitamin B12 deficiency, or medication interactions. If an older adult becomes anxious, depressed, or hopeless upon learning they’re at risk for Alzheimer’s — another source of concern — “they may not go for further evaluation and seek appropriate care,” said Rebecca Edelmayer, senior director of scientific engagement at the Alzheimer’s Association.

The University of Michigan poll confirms the potential for misunderstanding. Upon receiving a positive result from a blood test, 74% of seniors said they would believe they were likely to develop Alzheimer’s and 64% said they would be likely to experience significant distress.

Because the science behind blood tests for Alzheimer’s is still developing and because “patients may not really understand the uncertainty of test results,” Edelmayer said, the Alzheimer’s Association “does not endorse the use of the AD-Detect test by consumers.”

Quest’s blood test is one of several developments altering the landscape of Alzheimer’s care in the United States. In early July, the FDA granted full approval to Leqembi, an anti-amyloid therapy that slightly slows cognitive decline in people with mild cognitive impairment and early-stage Alzheimer’s. Early detection of cognitive symptoms and diagnosis of cognitive dysfunction have assumed greater importance now that this disease-modifying drug is available.

Also in July, a work group convened by the National Institute on Aging and the Alzheimer’s Association of Alzheimer’s disease to be used in clinical practice.

Previously, Alzheimer’s could be diagnosed only when there was evidence of underlying brain pathology (amyloid plaques and tau tangles) as well as cognitive symptoms (memory loss, poor judgment, disorientation, among others) and accompanying impairments (difficulty with managing finances, wandering, problems with self-care, and more). Under the new definition, Alzheimer’s would be defined purely on a biological basis, as a “continuum that is first evident with the appearance of brain pathologic changes” including amyloid accumulation, according to a draft of the work group’s report.

That would mean “you can get a positive result from the Quest test and be diagnosed with Alzheimer’s disease if these guidelines are adopted, even if you’re cognitively normal,” cautioned Eric Widera, a professor of medicine at the University of California-San Francisco.

Demand for follow-up evaluations by dementia specialists is likely to be high and contribute to already-long waits for care, he suggested.

Additional concerns about the test relate to safeguarding privacy and the potential for discrimination. No federal laws protect people who receive Alzheimer’s biomarker results from discriminatory practices, such as employment discrimination or the denial of life, disability, or long-term care insurance. (The Genetic Information Nondiscrimination Act applies only to genetic tests.) And “laws that normally protect the privacy of health information do not apply in this space,” said Emily Largent, an assistant professor of medical ethics and health policy at the University of Pennsylvania’s Perelman School of Medicine.

Notably, HIPAA, the Health Insurance Portability and Accountability Act, doesn’t extend to laboratory tests marketed directly to consumers.

The bottom line: Before taking a test, “older adults need to ask themselves, ‘Why do I want to know this? What will I do with the information? How will I react? What would I change in the future?’” said C. Munro Cullum, a neuropsychologist and distinguished professor of clinical psychology at the University of Texas Southwestern Medical Center. “This test needs to be used very cautiously and with great forethought.”

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care, and advice you need in dealing with the health care system. Visit  to submit your requests or tips.

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It’s a fraught moment, with hope running high for families and other promising therapies such as donanemab on the horizon. Still, medical providers are cautious. “This is an important first step in developing treatments for complex neurodegenerative diseases, but it’s just a first step,” said Ronald Petersen, director of the Mayo Clinic’s Alzheimer’s Disease Research Center in Rochester, Minnesota.

Unanswered questions abound as this new era of treatment begins for mild cognitive impairment and early-stage Alzheimer’s. Will Leqembi’s primary benefit — a slight slowing of decline in cognition and functioning — make a significant difference to patients and family members or will it be difficult to discern? Will its effects accelerate, decelerate, or flatten out over time?

Will demand for Leqembi (the brand name for lecanemab), a monoclonal antibody that requires infusions every two weeks, be robust or restrained? How many older adults in their 70s and 80s will be able and willing to travel to medical centers for infusions twice a month and have regular MRI scans and physician visits to monitor for potential side effects such as brain bleeds or swelling?

Even with Medicare coverage, how many people will be able to afford the suite of medical services required, including cognitive tests, infusions, doctors’ appointments, MRI scans, genetic tests, and spinal taps or PET scans to verify the presence of amyloid plaques, a hallmark of Alzheimer’s and a precondition for receiving this therapy?

Will primary care physicians start routinely screening older adults for mild cognitive impairment, something that doesn’t happen currently?

These questions aren’t surprising, given that these dementia treatments are opening uncharted territory. Here’s some of what people should know:

Leqembi basics. Leqembi is very effective at removing amyloid plaques (a protein that clumps between neurons) from people’s brains. But it doesn’t reverse cognitive decline or prevent future deterioration.

In a , Eisai, the company that makes Leqembi, said clinical trials showed a 27% slower rate of decline for people taking the drug. But when raw scores on the cognitive scale used to measure results are considered (4.41 for the Leqembi group at the end of 18 months versus 4.86 for the placebo group), the rate of improvement was 9%, according to Lon Schneider, a professor of psychiatry, neurology, and gerontology at the University of Southern California’s Keck School of Medicine.

Benefits may be hard to detect. Research suggests that patients notice a “clinically meaningful” change in cognitive performance — a noticeable alteration in their ability to think, remember, and perform daily tasks — when scores rise at least 1 point on an 18-point scale used to measure Leqembi’s impact. But the change detected after 18 months for patients taking this medication was only 0.45.

“That’s a minimal difference, and people are unlikely to perceive any real alteration in cognitive functioning,” said Alberto Espay, a professor of neurology at the University of Cincinnati College of Medicine.

Petersen has a different perspective since many patients have told him they’d be happy to put off getting worse. “If we can keep these patients stable for a somewhat longer period of time, that’s meaningful,” he told me.

Side effects are common. The drugmaker reported 17% of patients taking Leqembi experienced swelling in the brain and 13% had brain bleeds. Most of these side effects occurred during the first three months of treatment and resolved without serious consequences four months later.

In slightly more than 1 in 4 cases, there were also infusion-related side effects — chills, aches, nausea, vomiting, a spike or drop in blood pressure, and more.

A little-discussed side effect is a reduction in brain volume associated with Leqembi and other anti-amyloid therapies. “We don’t know what this will mean to patients long term, and that’s concerning,” Espay said.

Because people with the APOE4 gene variant, which raises the risk of Alzheimer’s, are also at higher risk of Leqembi side effects, physicians at major medical centers will recommend genetic testing as they evaluate potential patients.

Not all patients will qualify. “I’m very carefully selecting the patients I think will be appropriate, focusing on people with mild cognitive symptoms who are otherwise healthy,” said Erik Musiek, an associate professor of neurology at the Washington University School of Medicine in St. Louis.

He has about 20 patients ready to start treatment once Washington University starts offering Leqembi, perhaps by early autumn. Delivering this therapy “is going to be challenging, and I think we need to err on the side of caution,” he said.

In Los Angeles, UCLA Health has set up a multidisciplinary group of specialists, similar to a cancer tumor board, to undertake comprehensive reviews of patients who want to take Leqembi, said Keith Vossel, director of UCLA’s Mary S. Easton Center for Alzheimer’s Research and Care. They will disqualify people with evidence of more than four microbleeds on brain MRIs, those taking blood thinners, and those with a history of seizures.

At the Mayo Clinic in Minnesota, a new Alzheimer’s therapeutics clinic will carefully assess potential patients over three to four days and treat only people who live within a 100-mile radius. “We’ll start with patients who are fairly healthy and follow them very closely,” Petersen said.

At Mount Sinai School of Medicine in New York City, Mary Sano, director of Alzheimer’s Disease Research, is concerned about older patients with mild cognitive impairment who want to take Leqembi but don’t have evidence of amyloid plaque accumulation in their brains. “We’ll only treat people who are amyloid-positive, and I’m afraid this could lead to people feeling like we’re not taking care of them,” she said. About 40% to 60% of patients 58 and older with mild cognitive impairment are amyloid-positive, research indicates.

Also of concern are patients who have moderate Alzheimer’s or early-stage cognitive impairment due to vascular dementia or various metabolic causes. They, too, would not be able to take Leqembi and may well be disappointed, Sano noted.

Costs could be considerable. Costs for Leqembi are difficult to calculate since Medicare officials haven’t announced what the government will pay for services. But the University of Southern California estimates that a year’s worth of care, including the $26,500 cost of the medication, could total about $90,000, according to Schneider.

by the Institute for Clinical and Economic Review suggests that all the medical services necessary to administer the drug, monitor patients, and undertake needed testing could total an average of $82,500 yearly on top of Leqembi’s direct cost.

Assuming a patient copayment of 20%, that would mean at least $18,000 in out-of-pocket spending. While many older adults have supplemental insurance (a Medigap plan or employer-sponsored retiree coverage) to cover these costs, nearly 1 in 10 Medicare beneficiaries lack this type of protection. And it remains to be seen what policies private Medicare Advantage plans will put in place for this medication.

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care, and advice you need in dealing with the health care system. Visit  to submit your requests or tips.

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Medicare and Medicaid patients will make up 92% of the market for lecanemab, according to Eisai Co., which sells the drug under the brand name Leqembi. In addition to the company’s $26,500 annual price tag for the drug, treatment could cost U.S. taxpayers $82,500 per patient per year, on average, for genetic tests and frequent brain scans, safety monitoring, and other care, according to estimates from the Institute for Clinical and Economic Review, or ICER. The FDA gave the drug full approval July 6. About 1 million Alzheimer’s patients in the U.S. could qualify to use it.

Patients with early Alzheimer’s disease who took lecanemab declined an average of five months slower than other subjects over an 18-month period, but many suffered brain swelling and bleeding. Although those side effects usually resolved without obvious harm, they apparently caused three deaths. The great expense of the drug and its treatment raises questions about how it will be paid for, and who will benefit.

“In the history of science, it’s a significant achievement to slightly slow down progression of dementia,” said John Mafi, a researcher and associate professor of medicine at the David Geffen School of Medicine at UCLA. “But the actual practical benefits to patients are very marginal, and there is a real risk and a real cost.”

To qualify for Leqembi, patients must undergo a PET scan that looks for amyloid plaques, the protein clumps that clog the brains of many Alzheimer’s patients. About 1 in 5 patients who took Leqembi in the major clinical test of the drug developed brain hemorrhaging or swelling, a risk that requires those taking the drug to undergo frequent medical checkups and brain scans called MRIs.

In anticipation of additional costs from the Leqembi drug class, the Centers for Medicare & Medicaid Services in 2021 increased monthly premiums for Medicare patients by 15%, and in 2024 after this year.

Such increases can be a significant burden for many of the 62 million Medicare subscribers who live on fixed incomes. “Real people will be affected,” Mafi said. that estimated lecanemab and related care would cost Medicare $2 billion to $5 billion a year, making it one of the most expensive taxpayer-funded treatments.

In its analysis, ICER suggested that Leqembi could be cost-effective at an annual price of $8,900 to $21,500. In an interview, David Rind, ICER’s chief medical officer, said $10,000 to $15,000 a year would be reasonable. “Above that range doesn’t seem like a good place,” he said.

Whatever its price, patients may be delayed getting access to Leqembi because of the relative shortage of specialists capable of managing the drug, which will require genetic and neuropsychological testing as well as the PET scan to confirm a patient’s eligibility. A similar drug, Eli Lilly’s donanemab, is likely to win FDA approval this year.

Already there are long waits for the testing needed to assess dementia, Mafi said, noting that one of his patients with mild cognitive impairment had to wait eight months for an evaluation.

Such testing is not readily at hand because of the paucity of effective treatment for Alzheimer’s, which has helped to make geriatrics a . The United States has about a third as many dementia specialists per capita as Germany, and about half as many as Italy.

“Time is of the essence” for the neuropsychological testing, Mafi said, because once a patient’s cognitive ability declines below a certain threshold, they become ineligible for treatment with the drug, which was tested only in patients in the earliest stages of the disease.

Mafi’s study estimates that patients without supplemental Medicare coverage will have to pay about $6,600 out-of-pocket for each year of treatment. That could put it out of reach for many of the Medicare beneficiaries whose income is low enough to simultaneously qualify them for state Medicaid programs. Those programs are responsible for about 20% of physician bills for drug infusions, but they don’t always cover the full amount.

Some practitioners, such as cancer centers, cover their Medicaid losses by receiving higher rates for privately insured patients. But since almost all lecanemab patients are likely to be on government insurance, that “cross-subsidization” is less of an option, said Soeren Mattke, director of the Center for Improving Chronic Illness Care at the University of Southern California.

This poses a serious health equity issue because “dual eligibles are low-income patients with limited opportunities and education, and at higher risk of chronic illnesses including dementia,” Mattke said in an interview. Yet many doctors may not be willing to treat them, he said. “The idea of denying access to this group is just appalling.”

Eisai spokesperson Libby Holman said the company was reaching out to specialists and primary care physicians to make them aware of the drug, and that reimbursement options were improving. Eisai will provide the drug at no cost to patients in financial need, she said, and its “patient navigators” can help lock down insurance coverage.

“A lot of clinicians are excited about the drug, and patients are hearing about it,” said David Moss, chief financial officer of INmune Bio, a company that has another Alzheimer’s drug in development. “It’s a money center for infusion centers and MRI operators. It provides reasons for patients to come into the office, which is a billing thing.”

Outstanding s have given urgency to efforts to monitor patient experiences. patients to be entered into a registry that tracks their outcomes. The agency has established a registry, but the Alzheimer’s Association, the leading advocacy group for dementia patients, to track those being treated, offering physician practices $2,500 to join it and up to $300 per patient visit.

In a letter to CMS on July 27, a group of policy experts said CMS should ensure that any and all Leqembi registries create and share data detailed enough for researchers and FDA safety teams to obtain a clear picture of the drug’s real-world profile.

The anti-amyloid drugs like lecanemab have created a polarized environment in medicine between those who think the drugs are a dangerous waste of money and those who believe they are a brilliant first step to a cure, said ICER’s Rind, who thinks lecanemab has modest benefits.

“People are as dug in on this as almost anything I’ve ever seen in medicine,” he said. “I don’t think it’s healthy.”

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But while patient advocates are celebrating, critics see it as the unfortunate triumph of a flawed theory of the disease’s cause and predict the rollout of the drug will aggravate racial disparities in elder care.

An FDA advisory panel last month voted 6-0 to support FDA approval of lecanemab, from the Japanese pharmaceutical company Eisai. In a clinical trial involving nearly 1,800 early-stage Alzheimer’s patients, the drug slowed progression of the disease somewhat in those who got biweekly infusions, compared with those given a placebo.

But the drug didn’t reverse Alzheimer’s symptoms, and it will require careful monitoring of patients for months or years, including many brain scans. Those receiving lecanemab, which carries the brand name Leqembi, were twice as likely as placebo recipients in the major trial to suffer hemorrhaging or swelling in the brain. These incidents, related to the drug’s stripping away of amyloid proteins, were generally minor, but three deaths appear to have been caused by the drug.

With the FDA’s approval of lecanemab, Eisai is set to to the primary care physicians who treat most dementia patients and critics are speaking out. Some say the drug, which Eisai plans to market for $26,500 a year, offers false hope. Others say any positive impact it has won’t benefit lower-income patients, who tend to be diagnosed too late for the drug to be effective, and usually receive care in settings ill-equipped to handle the drug’s stringent requirements.

“The most likely consequence of this medication is to take resources and attention away from addressing basic supports for older adults with cognitive impairment,” said Maria Glymour, chair of the Department of Epidemiology at the Boston University School of Public Health. The money spent on expensive drugs like lecanemab would be better invested in fighting diseases like high blood pressure and diabetes, which hasten dementia, and on community-based services for older adults, she said.

The critique of lecanemab builds on another complexity of the drug’s approval: Few African Americans were involved in testing it.

Of the 859 people infused with lecanemab during the trial, . Minorities are often underrepresented in research, but this study had an additional barrier, said Carey Gleason, a clinical neuropsychologist at the University of Wisconsin School of Medicine and Public Health. Many Black volunteers in the trial “screened out,” she said, because PET scans showed relatively low levels of amyloid in their brains. Lecanemab works by removing amyloid, so the trial organizers excluded patients — regardless of their Alzheimer’s symptoms — if their PET scans were negative.

Eisai spokesperson Libby Holman said the company worked to enroll a diverse population but that amyloid levels “differed among racial and ethnic groups.” She added, “If individuals do not have elevated amyloid, they do not have Alzheimer’s disease.”

Indeed, lecanemab’s approval marks the culmination of the idea, , that Alzheimer’s disease can be understood as cognitive decline , the “trigger,” in combination with the “bullet,” a protein called tau.

For example, Blacks are up to twice as likely as whites to have Alzheimer’s, yet they show equivalent levels of amyloid in most major studies. No one is sure why, but the hypothesis is that having multiple simultaneous health conditions and being exposed to environmental stressors put Blacks as a group at higher risk.

Furthermore, Blacks and other minorities tend to be diagnosed at later stages, which automatically excludes them from use of lecanemab, which was designed and approved to treat early-stage Alzheimer’s.

“The drug has to be used in the very early window of the disease,” Gleason said. “It’s well documented that marginalized communities and people don’t get access to diagnostic services as do more privileged populations, because our medical care is two-tiered.”

“Lecanemab should still come to market,” she said. “But we need to be investing in other pathways.”

In its review of the costs and benefits of lecanemab, a 15-member panel appointed by the Institute for Clinical and Economic Review gave the drug low marks. Its rollout would aggravate elder care disparities, the panel said, by favoring wealthier patients who have more resources, better insurance, and an easier time getting to multiple appointments.

Advocates for minority health care are well aware of these risks. But many feel the only response is to push harder for access to the drug. There is no research to suggest the drug would not work in Black people, said Carl Hill, chief diversity, equity and inclusion officer for the Alzheimer’s Association, which is raising awareness of the drug through churches and grassroots groups.

Manly is not so sure. “There are reasons to question whether it would be safe in Black people,” she said, noting that older Black people diagnosed with dementia have higher rates of vascular conditions like hardening of the arteries compared with white patients. That could pose potentially higher risks of brain hemorrhaging if they took the drug. In general, the trial’s lack of representativeness across racial and ethnic groups means the drug may not perform as well against Alzheimer’s disease across these groups, Manly said.

“In terms of equity I feel conflicted,” she said. “I’d love for all families like mine to have equitable access to an Alzheimer’s drug, but only if it’s safe and effective.”

Even the most optimistic Alzheimer’s experts believe the drug’s risks of patients by highly trained clinicians with sufficient resources to detect and monitor any problems.

Jason Karlawish, a neurologist at the Perelman School of Medicine at the University of Pennsylvania, said the FDA should set up a Risk Evaluation and Mitigation Strategy, or REMS, which would require doctors administering the drug to follow a series of steps to reduce and monitor its dangers. A REMS, currently in place on , generally limits access to a drug. While FDA’s approval of lecanemab warned of risks, especially for people who are on blood thinners, it did not require a REMS.

The conflict between safety and access is only one paradox of lecanemab’s arrival.

The FDA anti-amyloid treatment, Aduhelm, in 2021. but most doctors rejected it as ineffective and unsafe. Some Alzheimer’s scientists who that amyloid isn’t the whole answer feel that lecanemab’s middling performance only confirms their thesis.

One skeptic is George Perry, a neurobiology professor at the University of Texas at San Antonio. He has hypothesized that amyloid and tau buildup are a reaction to the aging process that play a role in preserving, rather than wrecking, the brain. The accumulation of amyloid in older people’s brains, in Perry’s view, reflects the body’s effort to fight aging disease.

Dementia clearly has many causes, said S. Ahmad Sajjadi, a clinician and neuroscientist at the University of California-Irvine. Ideally, patients will someday receive treatments as specific and targeted as those increasingly available to treat cancers, he said.

For now, for a select group of patients, lecanemab offers a whisper of hope that some will want to pursue, despite the risks, Karlawish said — perhaps a 10% chance of freezing the progression of the disease for months or even longer.

Patient groups such as the Alzheimer’s Association, which funds much of the research in the field, are demanding broad access to lecanemab and oppose the Biden administration’s plan to have Medicare initially pay for the drug only if patients are enrolled in a registry, a kind of post-marketing clinical trial.

At a public hearing during the FDA advisory panel meeting on the drug, Alzheimer’s Association CEO Joanne Pike noted that patients on lecanemab declined five months more slowly in their first 18 months on the drug, on average. That “deserves celebration,” she said.

Perry, who has received research funding from the Alzheimer’s Association, questions its strong support for the drug but isn’t surprised, given the group’s promise to its members and supporters to help find a cure for the disease.

“They’ve pushed amyloid so hard for 30 years,” he said, “and they can’t turn back.”

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Unlike support groups, these programs teach caregivers concrete skills such as how to cope with stress, make home environments safe, communicate effectively with someone who’s confused, or solve problems that arise as this devastating illness progresses.

Some of these programs, known as “comprehensive dementia care,” also employ coaches or navigators who help assess patients’ and caregivers’ needs, develop individualized care plans, connect families to community resources, coordinate medical and social services, and offer ongoing practical and emotional support.

Unfortunately, despite a significant body of research documenting their effectiveness, these programs aren’t broadly available or widely known. Only a small fraction of families coping with dementia participate, even in the face of . And funding is scant, compared with the amount of money that has flooded into the decades-long, headline-grabbing quest for pharmaceutical therapies.

“It’s distressing that the public conversation about dementia is dominated by drug development, as if all that’s needed were a magic pill,” said Laura Gitlin, a prominent dementia researcher and dean of the College of Nursing and Health Professions at Drexel University in Philadelphia.

“We need a much more comprehensive approach that recognizes the prolonged, degenerative nature of this illness and the fact that dementia is a family affair,” she said.

In the U.S., more than 11 million unpaid and largely untrained family members and friends provide more than 80% of care to people with dementia, supplying assistance worth $272 billion in 2021, . (This excludes patients living in nursing homes and other institutions.) these “informal” caretakers devote longer hours to tending to those with dementia and have a higher burden of psychological and physical distress than other caregivers.

Despite those contributions, Medicare expected to spend $146 billion in 2022, while Medicaid, which pays for nursing home care for people with low incomes or disabilities, expected to spend about $61 billion.

One might think such enormous spending ensures high-quality medical care and adequate support services. But quite the opposite is true. Medical care for people with Alzheimer’s and other types of dementia in the U.S. — , most of them seniors — is widely acknowledged to be . And support services are few and far between.

“What we offer people, for the most part, is entirely inadequate,” said Carolyn Clevenger, associate dean for transformative clinical practice at Emory University’s Nell Hodgson Woodruff School of Nursing.

Clevenger helped create the Integrated Memory Care program at Emory, a primary care practice run by nurse practitioners with expertise in dementia. Like other comprehensive care programs, they pay considerable attention to caregivers’ as well as patients’ needs. “We spent a great deal of time answering all kinds of questions and coaching,” she told me. This year, Clevenger said, she hopes three additional sites will open across the country.

Expansion is a goal shared by other comprehensive care programs at UCLA (, now available at 18 sites), in Indianapolis, the University of California-San Francisco (, 26 sites), Johns Hopkins University (), and the Benjamin Rose Institute on Aging in Cleveland (, 35 sites).

Over the past decade, has shown these programs improve the quality of life for people with dementia; alleviate troublesome symptoms; help avoid unnecessary emergency room visits or hospitalizations; and delay nursing home placement, while also reducing depression symptoms, physical and emotional strain, and overall stress for caregivers.

In an important development in 2021, an expert panel organized by the National Academies of Sciences, Engineering, and Medicine to recommend that comprehensive dementia care programs be broadly implemented.

Now, leaders of these programs and dementia advocates are lobbying Medicare to launch a pilot project to test a new model to pay for comprehensive dementia care. They have been meeting with staff at the Center for Medicare and Medicaid Innovation and “CMMI has expressed a considerable amount of interest in this,” according to Dr. David Reuben, chief of geriatric medicine at UCLA and a leader of its dementia care program.

“I’m very optimistic that something will happen” later this year, said Dr. Malaz Boustani, a professor at Indiana University who helped develop Eskenazi Health’s Aging Brain Care program and who has been part of the discussions with the Centers for Medicare & Medicaid Services.

The Alzheimer’s Association also advocates for a pilot project of this kind, which could be adopted “Medicare-wide” if it’s shown to beneficial and cost-effective, said Matthew Baumgart, the association’s vice president of health policy. Under a model proposed by the association, comprehensive dementia care programs would receive between $175 and $225 per month for each patient in addition to what Medicare pays for other types of care.

estimates that implementing a comprehensive care dementia model could save Medicare and Medicaid $21 billion over 10 years, largely by reducing patients’ use of intensive health care services.

Several challenges await, even if Medicare experiments with ways to support comprehensive dementia care. There aren’t enough health care professionals trained in dementia care, especially in rural areas and low-income urban areas. Moving programs into clinical settings, including primary care practices and medical clinics, may be challenging given the extent of dementia patients’ needs. And training needs for program staff members are significant.

Even if families receive some assistance, they may not be able to afford necessary help in the home or other services such as adult day care. And many families coping with dementia may remain at a loss to find help.

To address that, later this year plans to publish an online consumer directory of evidence-based programs for dementia caregivers. For the first time, people will be able to search, by ZIP code, for assistance available near them. “We want to get the word out to caregivers that help is available,” said David Bass, a senior vice president at the Benjamin Rose Institute who’s leading that effort.

Generally, are financed by grants or government funding and free to families. Often, they’re available through Area Agencies on Aging — organizations that families should consult if they’re looking for help. Some examples:

• , delivered over six weeks to small groups in person or over Zoom. Each week, a group leader (often a social worker) gives a mini-lecture, discusses useful strategies, and guides group members through exercises designed to help them manage issues associated with dementia. Now offered in 20 states, Savvy Caregiver recently introduced an online, seven-session version of the program that caregivers can follow on their schedule.
• , a streamlined version of a program recommended in the 2021 National Academy of Sciences report. In four hour-long sessions in person or over the phone, a coach teaches caregivers about dementia, problem-solving strategies, and managing symptoms, moods, stress, and safety. A similar program, , is available across the country through the Department of Veterans Affairs.
• . In up to eight in-home sessions over four months, an occupational therapist assesses the interests, functional abilities, and home environment of a person living with dementia. Activities that can keep the individual meaningfully engaged are suggested, along with advice on how to carry them out and tips for simplifying the activities as dementia progresses. The program is being rolled out across health care settings in Australia and is being reviewed as a possible component of geriatric home-based care by the VA, Gitlin said.

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Ñî¹óåú´«Ã½Ò•îl 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 .

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This story can be republished for free (details).