California Healthline Wed, 20 Dec 2023 19:41:23 +0000 en-US hourly 1 161476318 ‘I Am Just Waiting to Die’: Social Security Clawbacks Drive Some Into Homelessness Wed, 20 Dec 2023 10:00:00 +0000 More than a year after the federal government first cut off her disability benefits, Denise Woods drives nightly to strip malls, truck stops, and parking lots around Savannah, Georgia, looking for a safe place to sleep in her Chevy.

Woods, 51, said she had rented a three-bedroom house she shared with her adult son and grandson until March 2022, when the government terminated her disability payments without notice.

According to letters sent by the Social Security Administration, the agency determined it had been overpaying Woods and demanded she send back nearly $58,000.

Woods couldn’t come up with the money. So, until February 2026, the agency is withholding the $2,048 in disability she would have received each month.

“I still don’t know how it happened,” said Woods, who has requested a waiver and is seeking a hearing. “No one will give me answers. It takes weeks or months to get a caseworker on the phone. They have made my life unbearable.”

Kilolo Kijakazi, acting commissioner of the Social Security Administration, told a congressional subcommittee in October that her agency notifies recipients when they have received overpayments and works to “help those who want to establish repayment plans or who seek waiver of the debt.”

But relief from overpayments goes to only a relatively small number of people. And many others face dire consequences: Some become homeless, are evicted from rental housing, or see their mortgages fall into foreclosure.

The SSA has a painful legacy of excluding Black people from benefits. Today the agency’s own published research shows its overpayments most often hit Black and Hispanic people, the poorest of the poor, those with the least education, and those whose medical conditions are unlikely to improve.

Woods is one of millions who have been targeted in the Social Security Administration’s attempt to claw back billions of dollars it says was wrongly sent to beneficiaries. Years can pass before the agency catches a mistake, and even the little bit extra it might send each month can add up.

In reclaiming it, the government is imposing debts that can reach tens of thousands of dollars against those least able to pay.

(WHIO, Dayton)

‘Wreaking Havoc in People’s Lives’

KFF Health News and Cox Media Group reporters interviewed people who have received overpayment notices and nonprofit attorneys who advocate for them and reviewed SSA publications, policy papers, and congressional testimony.

A 64-year-old Florida man said he could no longer afford rent after his Social Security retirement payments were garnished last year because he allegedly had been overpaid $35,176 in disability benefits. He said he now lives in a tent in the woods. A 24-year-old Pennsylvania woman living with her mother and younger siblings in public housing lost the chance to buy her own home because of an alleged $6,063 overpayment that accrued when she was a child.

“Social Security overpayments are wreaking havoc in people’s lives,” said Jen Burdick, an attorney with Community Legal Services of Philadelphia, which represents clients who have received overpayment notices. “They are asking the poorest among us to account for every dollar they get. Under their rules, some people can save up money for a funeral burial but not enough to get housing.”

Woods has lupus and congestive heart failure and struggles to walk, but she started working part-time after her benefits were rescinded. She said she makes $14 an hour transporting railroad crew members in her 2015 Chevy Equinox between Savannah and Jacksonville, Florida, when she can get assignments and her health allows it.

The SUV costs $386 a month — a large portion of her income — but without it, Woods said, she would not have a job or a place to sleep.

“My life is just survival now,” Woods said. “Sometimes I feel like I am just waiting to die.”

The Social Security Administration has said it is required by law to attempt to recover overpayments. Notices ask beneficiaries to repay the money directly. Authorities can also recoup money by reducing or halting monthly benefits and garnishing wages and federal tax refunds.

Agency officials describe an orderly process in which they explain to beneficiaries the reason for the overpayment and offer the chance to appeal the decision and have the charges waived if they cannot afford it. One way to qualify for a waiver is if “paying us back would mean you could not pay your bills for food, clothing, housing, medical care or other necessary expenses,” according to a letter sent to one recipient.

Those most impacted by Social Security’s decisions, including people with disabilities and widows receiving survivors’ benefits, paint a different picture. They talk about having their benefits terminated without explanation or warning, an appeals process that can drag on for years, and an inability to get answers from the SSA to even basic questions.

Nancy Altman, president of Social Security Works, a group that pushes for the protection and expansion of the program, recalled how stressful it was when a colleague’s mother received an overpayment notice.

“After weeks of nonstop phone calls, he was able to get the matter resolved, but not before it put his mother in the hospital,” Altman said. “One can just imagine how much worse it would be for someone for whom English is not their native language, who lacks a high school education, and who is unassisted by such a knowledgeable and caring advocate.”

Problems surrounding the Social Security Administration are aggravated by congressional actions, including funding shortages that brought agency staffing to a 25-year low by the end of fiscal year 2022. Even so, advocates for people with disabilities say the agency does far less than it could to help people who have been overpaid, often through no fault of their own.

They said challenges faced by beneficiaries underscore how overpayments disproportionately impact Black people and other minority groups even as President Joe Biden and Social Security leaders promise to fix racial inequity in government programs.

Most overpayments are linked to the Supplemental Security Income program, which gives money to people with little or no income who are disabled, blind, or at least 65. The majority of SSI recipients are Black, Hispanic, or Asian people.

“Congress has turned a blind eye to this,” said David Weaver, a former associate commissioner for research, demonstration, and employment support at the SSA. Politicians “just want to save money. It is misplaced priorities. It is completely inexcusable.”

The Social Security Administration did not make its leaders available for an interview. Spokesperson Nicole Tiggemann declined to answer questions about the cases of Woods and other beneficiaries, citing privacy laws.

In a written statement, Tiggemann acknowledged that receiving an overpayment notice can be “unsettling,” but said the agency helps beneficiaries navigate the process and informs them of their rights if they believe they were not at fault or cannot repay the debt.

“Even if they do not want to appeal or request a waiver, the notice says to contact us if the planned withholding would cause hardship,” Tiggemann said. “We have flexible repayment options — including repayment of as low as $10 per month. Each person’s situation is unique, and we handle overpayments on a case-by-case basis.”

Critics say fighting an overpayment notice is not that simple.

Beneficiaries — many challenged by physical, mental, or intellectual disabilities — often are overwhelmed by complex paperwork or unable to find financial documents that may be years old.

The Social Security Administration has the authority to waive overpayments if officials determine recovering them would violate “equity and good conscience,” or the disputed amount falls below certain thresholds. The agency’s guidance also says collecting an overpayment “defeats the purpose” when the “individual needs substantially all of their current income to meet their current ordinary and necessary living expenses.”

Advocates for people with disabilities contend most overpayments arise from delays in processing paperwork and errors by the Social Security Administration or recipients making innocent mistakes. The agency can waive overpayments when the beneficiary is found not at fault.

But in fiscal year 2023, the Social Security Administration collected about $4.9 billion in overpayments with an additional $23 billion yet uncollected, according to an agency report. Just $267 million was waived, the report said.

David Camp, the interim chief executive officer of the National Organization of Social Security Claimants’ Representatives, which advocates for improvements in federal disability programs, said the Social Security Administration is a “broken structure.”

The agency sometimes tries to claw back overpayments from people falsely accused of failing to provide required documents, Camp said.

“Dropping off forms at their field offices is not a guarantee” paperwork will be processed, he said. “Mail is slow, or it doesn’t get opened. We see it so many times you are left with the idea that has to do with the structure.”

(WFXT, Boston)

Left Destitute

Advocacy groups and others said they don’t know how many people become homeless after their benefits are terminated, but they say anecdotal accounts are common.

A study found that more than 800,000 disability applicants from 2007 to 2017 experienced homelessness. Advocates say it only makes sense that overpayments could lead more people to become homeless, since nearly 40% of people receiving disability benefits experience food insecurity and cannot keep up with their rent and utility bills, according to research.

Ronald Harrell sleeps in the woods near Wildwood, Florida, about 50 miles northwest of Orlando. He said he shelters in a tent, cooks his meals on a small grill, and showers at a friend’s house.

Harrell, 64, said he rented a room in a house for $125 a week until last year, when the Social Security Administration cut off his retirement benefits.

A letter the SSA sent him, dated Feb. 6, 2023, says his benefits are being withheld because of overpayment of $35,176 that accrued when Harrell received disability payments. The letter acknowledges he has asked the agency to lower his payments.

“I don’t know how they are doing this to me,” Harrell said. “I did everything by the law.”

Harrell said he once worked as an HVAC technician, but nerve damage left him unable to work sometime around 2002.

He said he collected disability benefits until about 2009, when rehabilitation allowed him to return to the workforce, and he said he reported the information to the federal government. Harrell said he applied for early Social Security retirement benefits last year when his health again declined.

“I started working when I was 16,” Harrell said. “I never thought my life would be like this.”

Kijakazi, the acting Social Security commissioner, and others have said overpayments stem at least partly from low staffing and budget cuts.

From 2010 to 2023, the agency’s customer service budget dropped by 17%, after inflation, according to a report by the Center on Budget and Policy Priorities, a think tank that conducts research on government programs.

At the same time, the report says, the number of Social Security beneficiaries grew by nearly 12 million people, or 22%.

Jonathan Stein, a former attorney with Community Legal Services of Philadelphia who has participated in workgroups and meetings with federal officials about access to Social Security payments for vulnerable populations, said budget cuts cannot fully account for the agency’s penchant for denying applications and terminating benefits.

Officials suspended Supplemental Security Income benefits for about 136,540 people in 2019 for “failure to furnish report,” which means they did not meet deadlines or paperwork requirements, Stein said, despite knowing many of those people were unable to contact the agency because they are homeless or have been evicted and lost access to phones and computers.

That’s more than double the number in 2010, he said.

“They have an implicit bias for denying benefits,” Stein said. “It is a very skewed view of integrity. It reinforces a culture of suspicion and prosecution of applicants.”

The 24-year-old Pennsylvania woman who received Supplemental Security Income as a child because of a learning disability described her ordeal on the condition that her name not be published. A letter from the Social Security Administration says she received an overpayment notice for more than $6,000.

“It was frustrating,” the woman said. “You are dealing with nasty people on the phone. I couldn’t get any answers.”

In November 2022, she contacted a nonprofit law firm, which helped her file an appeal. One year later, she received another letter from Social Security saying the overpayment had been waived because it was not her fault. The letter also said officials would not seek repayment because she could not afford basic needs such as food and housing without the monthly benefits.

The woman had already paid a price.

She lived in public housing and the Philadelphia Housing Authority had offered her a chance to fulfill a long-held goal of owning a house. But when the overpayment appeared on her credit report, she said, she could not obtain a mortgage.

“I was excited about getting my own home,” she said. “That’s what everybody wants. Losing it is not a good feeling.”

David Hilzenrath of KFF Health News, Jodie Fleischer of Cox Media Group, and Ben Becker of ActionNewsJax in Jacksonville, Florida, contributed to this report.

Do you have an experience with Social Security overpayments you’d like to share? Click here to contact our reporting team.

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

A New Test Could Save Arthritis Patients Time, Money, and Pain. But Will It Be Used? Wed, 20 Dec 2023 10:00:00 +0000 SAN DIEGO — Erinn Maury knew Remicade wasn’t the right drug for Patti Schulte, a rheumatoid arthritis patient the physician saw at her Millersville, Maryland, practice. Schulte’s swollen, painful joints hadn’t responded to Enbrel or Humira, two drugs in the same class.

But the insurer insisted, so Schulte went on Remicade. It didn’t work either.

What’s more, Schulte suffered a severe allergic reaction to the infusion therapy, requiring a heavy dose of prednisone, a steroid with grave side effects if used at high doses for too long.

After 18 months, her insurer finally approved Maury’s drug of choice, Orencia. By then, Schulte’s vertebrae, weakened by prednisone, had started cracking. She was only 60.

Schulte’s story of pain, drug-hopping, and insurance meddling is all too common among patients with rheumatoid arthritis, who often cycle agonizingly through half a dozen drugs in search of one that provides a measure of relief. It’s also a story of how doctors are steered by pharmacy benefit managers — the middlemen of the drug market — as well as by insurers.

Once people with inflammatory conditions such as rheumatoid arthritis reach a certain stage, the first prescription offered is typically Humira, the best-selling drug in history, and part of a class known as tumor necrosis factor inhibitors, or TNFis, which fail to significantly help about half of the patients who take it.

“We practice rheumatology without any help,” said Vibeke Strand, a rheumatologist and adjunct clinical professor at Stanford. She bemoaned the lack of tools available to choose the right drug while bristling at corporate intervention in the decision. “We are told by the insurer what to prescribe to the patient. After they fail methotrexate, it’s a TNF inhibitor, almost always Humira. And that’s not OK.”

If there’s a shred of hope in this story, it’s that a blood test, PrismRA, may herald an era of improved care for patients with rheumatoid arthritis and other autoimmune conditions. But first, it must be embraced by insurers.

PrismRA employs a predictive model that combines clinical factors, blood tests, and 19 gene patterns to identify the roughly 60% of patients who are very unlikely to respond to a TNFi drug.

Over the past 25 years, drug companies have introduced five new classes of autoimmune drugs. TNFis were the first to market, starting in the late 1990s.

Some 1.3 million Americans have rheumatoid arthritis, a disease in which a person’s immune system attacks their joints, causing crippling pain and, if improperly treated, disfigurement. The newer drugs, mostly so-called biologics, are also used by some of the 25 million or more Americans with other autoimmune diseases, such as lupus, Crohn’s disease, and psoriasis. Typically costing tens of thousands of dollars annually, the drugs are prescribed after a patient fails to respond to older, cheaper drugs like methotrexate.

Until recently, rheumatologists have had few ways to predict which of the new drugs would work best on which patients. Often, “it’s a coin flip whether I prescribe drug A or B,” said Jeffrey Curtis, a rheumatology professor at the University of Alabama-Birmingham.

Yet about 90% of the patients who are given one of these advanced drugs start on a TNFi, although there’s often no reason to think a TNFi will work better than another type.

Under these puzzling circumstances, it’s often the insurer rather than the doctor who chooses the patient’s drug. Insurers lean toward TNFis such as adalimumab, commonly sold as brand-name Humira, in part because they get large rebates from manufacturers for using them. Although the size of such payments is a trade secret, AbbVie is said to be offering rebates to insurers of up to 60% of Humira’s price. That has enabled it to control 98.5% of the U.S. adalimumab market, even though it has eight biosimilar competitors.

PrismRA’s developer, Scipher Medicine, has provided more than 26,000 test results, rarely covered by insurance. But on Oct. 15, the Centers for Medicare & Medicaid began reimbursing for the test, and its use is expected to rise. At least two other companies are developing drug-matching tests for rheumatoid arthritis patients.

Although critics say PrismRA is not always useful, it is likely to be the first in a series of diagnostics anticipated over the next decade that could reduce the time that autoimmune disease patients suffer on the wrong drug.

Academics, small biotechs, and large pharmaceutical companies are investing in methods to distinguish the biological pathways involved in these diseases, and the best way to treat each one. This approach, called precision medicine, has existed for years in cancer medicine, in which it’s routine to test the genetics of patients’ tumors to determine the appropriate drug treatment.

“You wouldn’t give Herceptin to a breast cancer patient without knowing whether her tumor was HER2-positive,” said Costantino Pitzalis, a rheumatology professor at the William Harvey Research Institute in London. He was speaking before a well-attended session at an American College of Rheumatology conference in San Diego in November. “Why do we not use biopsies or seek molecular markers in rheumatoid arthritis?”

It’s not only patients and doctors who have a stake in which drugs work best for a given person.

When Remicade failed and Schulte waited for the insurer to approve Orencia, she insisted on keeping her job as an accountant. But as her prednisone-related spinal problems worsened, Schulte was forced to retire, go on Medicaid, and seek disability, something she had always sworn to avoid.

Now taxpayers, rather than the insurer, are covering Schulte’s medical bills, Maury noted.

Precision medicine hasn’t seemed like a priority for large makers of autoimmune drugs, which presumably have some knowledge of which patients are most likely to benefit from their drugs, since they have tested and sold millions of doses over the years. By offering rebate incentives to insurers, companies like AbbVie, which makes Humira, can guarantee theirs are the drugs of choice with insurers.

“If you were AbbVie,” Curtis said, “why would you ever want to publish data showing who’s not going to do well on your drug, if, in the absence of the test, everyone will start with your drug first?”

What Testing Could Do

Medicare and commercial insurers haven’t yet set a price for PrismRA, but it could save insurers thousands of dollars a year for each patient it helps, according to Krishna Patel, Scipher’s associate director of medical affairs.

“If the test cost $750, I still only need it once, and it costs less than a month of whatever drug is not going to work very well for you,” said Curtis, a co-author of some studies of the test. “The economics of a biomarker that’s anything but worthless is pretty favorable because our biologics and targeted drugs are so expensive.”

Patients are enthusiastic about the test because so many have had to take TNFis that didn’t work. Many insurers require patients to try a second TNFi, and sometimes a third.

Jen Weaver, a patient advocate and mother of three, got little benefit from hydroxychloroquine, sulfasalazine, methotrexate, and Orencia, a non-TNFi biologic therapy, before finding some relief in another, Actemra. But she was taken off that drug when her white blood cells plunged, and the next three drugs she tried — all TNFis — caused allergic reactions, culminating with an outbreak of pus-filled sores. Another drug, Otezla, eventually seemed to help heal the sores, and she’s been stable on it since in combination with methotrexate, Weaver said.

“What is needed is to substantially shorten this trial-and-error period for patients,” said Shilpa Venkatachalam, herself a patient and the director of research operations at the Global Healthy Living Foundation. “There’s a lot of anxiety and frustration, weeks in pain wondering whether a drug is going to work for you and what to do if it doesn’t.” A survey by her group found that 91% of patients worried their medications would stop working. And there is evidence that the longer it takes to resolve arthritis symptoms, the less chance they will ever stop.

How insurers will respond to the availability of tests isn’t clear, partly because the arrival of new biosimilar drugs — essentially generic versions — are making TNFis cheaper for insurance plans. While Humira still dominates, AbbVie has increased rebates to insurers, in effect lowering its cost. Lower prices make the PrismRA test less appealing to insurers, since widespread use of the test could cut TNFi prescriptions by up to a third.

However, rheumatologist John Boone in Louisville, Kentucky, found to his surprise that insurers mostly accepted alternative prescriptions for 41 patients whom the test showed unlikely to respond to TNFis as part of a clinical trial. Boone receives consulting fees from Scipher.

Although the test didn’t guarantee good outcomes, he said, the few patients given TNFis despite the test results almost all did poorly on that regimen.

Scientists from AbbVie, which makes several rheumatology drugs in addition to Humira, presented a study at the San Diego conference examining biomarkers that might show which patients would respond to Rinvoq, a new immune-suppressing drug in a class known as the JAK inhibitors. When asked about its use of precision medicine, AbbVie declined to comment.

Over two decades, Humira has been a blockbuster drug for AbbVie. The company sold more than $3.5 billion worth of Humira in the third quarter of 2023, 36% less than a year ago. Sales of Rinvoq, which AbbVie is marketing as a treatment for patients failed by Humira and its class, jumped 60% to $1.1 billion.

What Patients Want

Shannan O’Hara-Levi, a 38-year-old in Monroe, New York, has been on scores of drugs and supplements since being diagnosed with juvenile arthritis at age 3. She’s been nauseated, fatigued, and short of breath and has suffered allergic reactions, but she says the worst part of it was finding a drug that worked and then losing access because of insurance. This happened shortly after she gave birth to a daughter in 2022, and then endured intense joint pain.

“If I could take a blood test that tells me not to waste months or years of my life — absolutely,” she said. “If I could have started my current drug last fall and saved many months of not being able to engage with my baby on the floor — absolutely.”

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

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.


This story can be republished for free (details).

Listen to the Latest ‘KFF Health News Minute’ Tue, 19 Dec 2023 16:00:00 +0000 Dec. 14

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This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

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.


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Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk? Tue, 19 Dec 2023 10:00:00 +0000 Too old and too sick for a heart transplant, Arvid Herrman was given a choice: Have a mechanical pump implanted in his heart, potentially keeping him alive for several years, or do nothing and almost certainly die within a year.

The 68-year-old Wisconsin farmer chose the pump, called a HeartMate 3 — currently the only FDA-approved device of its kind in use. Instead of extending his life, though, the device led to his death, according to a lawsuit filed in December 2020 by his daughter Jamie Edwards.

The lawsuit alleged that Herrman died because a defect in the locking mechanism of the HeartMate 3 prevented the device from sealing, causing multiple strokes and leading to a severe brain injury and multiorgan failure. Herrman “could not have anticipated the danger this defect … created for him,” the lawsuit said.

Herrman’s death was reported to a Food and Drug Administration database where the public can learn about device-related deaths, serious injuries, and malfunctions. The event was also described in the peer-reviewed Journal of Heart and Lung Transplantation.

In September 2021, Ramon Flores Sr. had the same device implanted at Methodist Hospital of San Antonio. A lawsuit his family filed in August alleges that the locking mechanism defect led to air embolism strokes. Flores died eight days after surgery, at age 76.

“How many other people is this going to happen to?” said his daughter, Alanna Flores Blanco, 52. “We never, ever were explained that the device could malfunction and this could happen.”

After the deaths of Herrman and Flores, Thoratec Corp., the device’s manufacturer, evaluated the pumps involved. In both cases, Thoratec, a subsidiary of Abbott Laboratories, confirmed a bent locking arm. But “a direct correlation” between the HeartMate 3 and the deaths “could not conclusively be established,” the manufacturer reported to the FDA.

Abbott did not respond to questions about the deaths or the alleged defects. The manufacturer denied liability in both cases. It settled Herrman’s lawsuit this fall, and the Flores case is ongoing.

The men’s deaths are among more than 4,500 reports since August 2017 in which the HeartMate 3 may have caused or contributed to a patient’s death, according to a California Healthline analysis of the FDA’s database of medical device incidents, known as the Manufacturer and User Facility Device Experience, or MAUDE. Hospitals, doctors, and others report device-related deaths, serious injuries, and malfunctions to manufacturers, who are required to investigate and report cases to the FDA.

In nearly 90% of those 4,500-plus reports, Thoratec said it found no problem with the device or how it was used, according to a California Healthline review of the FDA database.

In cases where Abbott finds the HeartMate 3 did not cause or contribute to a death or serious injury, the company files “corrective reports,” said Justin Paquette, an Abbott public affairs director.

He added, “The complexity of the device – combined with patients battling late stage heart failure and associated comorbidities – creates very dynamic clinical care situations.”

Abbott said the HeartMate 3 is the safest iteration yet of any left ventricular assist device, or LVAD, a type of mechanical heart pump introduced in the 1960s and refined over the last six decades.

The HeartMate 3 was first approved by the FDA, for use in patients awaiting a heart transplant, in August 2017, and one year later it was approved as a long-term therapy. The device is often considered only for patients with end-stage heart failure, and even then it is a last resort.

HeartMate 3 has “dramatically improved the safety of LVADs by reducing rates of complications that had historically challenged heart pump technology, including clotting, stroke and bleeding,” Paquette said.

As recently as August, the FDA also expressed support for the device. “The FDA believes the benefits of HeartMate 3 continue to outweigh the risks for this vulnerable patient population with few available alternatives,” said Jeremy Kahn, an agency spokesperson.

Others aren’t so sure. Former FDA medical device official Madris Kinard sees the high number of death reports as a warning.

“To me this is a safety signal and it’s hard to know if the FDA is working on something to address it,” said Kinard, founder of Device Events, a company that makes FDA device data more user-friendly for hospitals, law firms, investors, and others. “You have to wonder why [death reports are] still happening, and at the same rate.”

Larry Kessler, a former director in the FDA’s medical device office, agrees the death reports for HeartMate 3 need more study. “The FDA may be missing some signals,” he said. Perhaps “there’s a little more here than meets the eye.”

Not all device problems are reported to MAUDE, and submitting a report is not necessarily an admission that a device caused a death or a serious injury. Device problem reports can be inaccurate or incomplete, or lack verification, and a single incident may be reported more than once — or not at all.

Those limitations ultimately can leave patients and their caregivers uninformed about risks associated with a device such as the HeartMate 3, said Sanket Dhruva, a cardiologist and expert in medical device safety and regulation at the University of California-San Francisco.

“They’re making perhaps the biggest decision of their lives: Do I proceed with an LVAD or not? And even if I proceed, what are the risks I’m facing?” he said. “And they are left with incomplete data and uncertainty about how to make that determination.”

Even doctors cannot use the FDA database as a tool to effectively counsel patients, Dhruva added.

“lf you don’t know what is a real safety signal and what’s not,” he said, “then how can that information help us to calibrate our benefits-and-risks discussion with patients?”

Tracking Incident Reports

The HeartMate 3 is not the only device whose safety profile is hard to ascertain in MAUDE, Dhruva said. The information in the FDA database is insufficient to give patients an adequate understanding of any medical device’s safety risks and reflects “the overall weakness of postmarket surveillance” after a device has been approved for sale, he said.

Under federal regulations, device manufacturers typically must report adverse events to the FDA within 30 days of learning about them, and that data is often used by researchers and regulators to identify potential safety concerns. Reports also can be submitted voluntarily by doctors, patients, or others. The FDA says that reports don’t need to be filed if the manufacturer determines that a device did not cause or contribute to an adverse event.

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But with millions of reports for thousands of devices, it can be difficult to detect and prevent problems that put patients at risk.

Hospitals and surgeons also might self-censor what they report to manufacturers due to concerns about being sued, said Kessler, now a professor at the University of Washington.

“Health care facilities, and risk managers in particular, they aren’t always forthcoming with detailed data about events,” he said.

Reports in MAUDE show that patients with a HeartMate 3 have experienced adverse events, such as bleeding, infection, and respiratory failure, that the manufacturer warned were possible in its instructions for use.

About 400 reports cited infusion or flow problems with the HeartMate 3. In thousands of other cases, the manufacturer said it did not observe any problems with the device, making it even more difficult for a doctor or a patient’s family to understand the safety history of the product.

Reports in MAUDE also describe fatal incidents due to complications not mentioned in the manufacturer’s instructions, such as the locking mechanism malfunction. In one report, a patient died of smoke inhalation after an external battery charger caught fire.

Each report in MAUDE has dozens of data points and summaries describing what happened. What’s lacking in the database: context and details that would be useful for patients and doctors, such as the total number of devices in use and the name of the hospital where the event occurred.

Flores Blanco had never heard of MAUDE before her father’s surgery. Even if she had, it’s unlikely she would have found a locking mechanism issue amid the morass of records, much less anticipated what might happen.

Missed Signals?

A routine FDA inspection of Abbott’s manufacturing plant in 2017 showed that Thoratec had fallen behind schedule reporting adverse events, according to agency records obtained by California Healthline under a Freedom of Information Act request.

The company updated training and hired additional staff to handle complaints submitted by hospitals, doctors, patients, and others, according to an inspection report. It provided the FDA inspector with “quantitative evidence” that late reporting to the FDA had decreased.

By October 2020, during a follow-up inspection, Thoratec was using a database to enter and process complaints and submit device reports electronically, according to an inspection report.

FDA inspectors did not cite any deficiencies with how Thoratec handled complaints after the visit. Inspectors noted the company had received 8,115 complaints related to the HeartMate 3 during the 12 months prior to the inspection in October 2020, the records show.

It’s not clear what the complaints concerned. Abbott did not respond when asked how many of the complaints led to an adverse event report to the FDA.

In Kinard’s view, device-makers in general often take longer than 30 days to investigate the root cause of an incident and frequently conclude that an adverse event was due to user error.

“They are using this regularly to downplay the problems with the device,” she said.

In Herrman’s case, a Thoratec representative was in the operating room and witnessed the incident, according to a deposition in the lawsuit. The company submitted a report to the FDA about Herrman’s injury within 30 days of the June 2019 incident.

Herrman’s surgeon, John Stulak, was experienced at implanting the device, according to the lawsuit, and he was also a principal investigator on the clinical trial that brought the HeartMate 3 to market. Stulak did not respond to interview requests. But, in 2020, he and two Mayo Clinic colleagues described Herrman’s case in The Journal of Heart and Lung Transplantation, where they noted the locking mechanism malfunction. “The lack of a tight seal from this defect resulted in the multiple subsequent air embolism events and irrecoverable neurological damage,” they wrote.

The article describes how Stulak replaced the device with a new one, but it was too late to prevent the injuries to Herrman. Thoratec submitted at least three follow-up reports to the FDA about the incident and said its investigation could not determine whether the HeartMate 3 caused Herrman’s death.

Herrman’s death certificate cites complications of ischemic heart disease. Flores’ death certificate says he died of cardiac arrest and hypoxic ischemic encephalopathy, or brain damage.

The FDA has had its own problems keeping the MAUDE database up to date.

The agency is years behind schedule on anonymizing and releasing adverse event reports for all medical devices.

Kinard said the FDA has yet to publicly release “millions” of follow-up reports that manufacturers have filed after their initial adverse event report for a medical device.

The FDA acknowledged that the agency is not up to date on public reporting but could not say how many reports are pending — for the HeartMate 3 or any device.

“We are currently working on redaction for public posting in MAUDE, of all supplemental reports dated 2021-2023,” said Kahn, the FDA spokesperson. “It is difficult to determine how many of those – pending redaction of supplemental reports – pertain to the subject device.”

FDA press officer Lauren-Jei McCarthy noted that, besides adverse event reports, the agency also monitors published literature, patients, patient advocacy groups, professional societies, individual health care providers, and other sources to determine whether further action is warranted.

“We review and take seriously all reports of adverse events associated with medical devices,” McCarthy said. She said patients and providers who use the HeartMate 3 “remain a high priority” and that the agency cannot comment on investigations.

A Last-Resort Treatment

Before he got a HeartMate 3 implanted in January 2022, Sid Covington, of Austin, Texas, said he had researched the device during years of medication therapy and cardiac rehabilitation to treat his congestive heart failure.

“I looked at case studies. I looked at a number of the different heart studies,” Covington said. “I looked at their marketing brochures and all that stuff, just whatever I could find.”

Covington, 76, said he was familiar with MAUDE and Intermacs, a private registry that tracks LVAD patients, but didn’t consult them. When he had to decide whether to get the device, he was in the hospital with chest pain, shortness of breath, and fatigue from advanced heart failure. Covington said his only option was the HeartMate 3.

“When it comes down to the moment, you really don’t have much choice,” he said. “It’s any port in the storm at that point.”

The HeartMate 3 requires constant attention and care from patients, who must keep the external parts of the device dry at all times and avoid jumping and contact sports. Patients must also ensure that it always has an external source of power, which is supplied through a cord attached to the pump that exits the body through a surgical opening.

Patients who get the device are often out of options to treat their end-stage heart failure, said Larry Allen, a cardiologist with the University of Colorado and member of a multidisciplinary medical team that cares for heart failure patients.

“We wouldn’t proceed with an LVAD unless we think the risk of death is really high and we’ve tried everything else,” he said.

That informs the regulatory view, too, Kessler said.

“When you’re talking about people who are seriously ill, then the FDA will accept a potentially higher risk,” he said, “but not an irresponsible one, and certainly not one that couldn’t be communicated to clinicians and the public.”

Allen, who helped develop a decision aid for patients considering an LVAD, said reliable data on safety and risks to patients is key.

“It’s about as high-risk, high-reward a choice as there can be,” Allen said. “It’s a really complicated decision to make and I think standard informed consent approaches are really inadequate for fully understanding that.”

Data Exists but Is Confidential

Long-term data for the HeartMate 3 — including performance metrics for the more than 180 U.S. hospitals certified to implant the device — are kept in Intermacs, managed by The Society of Thoracic Surgeons, which has promised to provide transparency but has yet to deliver.

The registry tracks mortality and injury rates for patients with an LVAD and logs the number of devices implanted each year.

But Intermacs is proprietary, and access at hospitals requires a principal investigator and at least one trained staff member, who can use the data to evaluate their facility’s performance against an aggregate from their peers across the nation.

Francis Pagani, a heart transplant and LVAD surgeon at University of Michigan Health, leads a medical society task force that oversees Intermacs. He said 12,000 to 14,000 HeartMate 3 implants have been recorded in Intermacs since 2017. The HeartMate 3 has “the best outcomes of any other LVAD, ever,” he said.

Over the years, federal regulators have made it easier for patients to access LVADs, reducing surgery volume requirements for implant centers and no longer requiring patients to be on a transplant waiting list to receive one of the pumps.

Though the HeartMate 3 is presently the only LVAD being implanted in the United States, it once had a competitor, Medtronic’s HeartWare, which the manufacturer removed from the market in June 2021, citing a high risk of stroke and pumps failing to restart if stopped.

While the FDA provides consumers with concise information about key clinical trials supporting the approval of new drugs, the agency provides no comparable data for medical devices. And though Medicare reimburses hospitals nearly $200,000 for most HeartMate 3 implants, federal administrators do not track patient outcomes or enforce performance standards for the heart pumps.

James Kirklin, a cardiac surgeon and researcher, was the principal investigator for Intermacs when the FDA, Centers for Medicare & Medicaid Services, and National Heart, Lung, and Blood Institute awarded a contract to the University of Alabama at Birmingham to establish the registry in 2005.

Federal agencies paid about $15 million over 10 years for Intermacs, Kirklin said, because they wanted to better understand the risk factors for death and other adverse events with so-called mechanical circulatory support devices, including LVADs, as well as the factors that indicated a higher likelihood of patients doing well on the pumps.

The FDA monitors annual reports of Intermacs data, including adverse events, and allows companies to use the registry’s data to analyze their devices’ performance and to fulfill reporting requirements after a device enters the market.

LVAD implant centers are required to report their data to Intermacs in order to be certified by the accrediting nonprofit The Joint Commission. And while CMS requires that centers implant at least 10 devices every three years to continue receiving Medicare reimbursement, there are no requirements for outcomes or other quality metrics. CMS does not track LVAD patient outcomes at individual facilities, said Sara Lonardo, CMS press secretary at the time.

Kirklin said he is working with The Society of Thoracic Surgeons to create a risk model that would allow the public to see quality scores for individual hospitals that implant LVADs, a need the group has recognized since at least 2018. But it will be a year before the tool is ready.

Kirklin and Pagani said the number of death reports for the HeartMate 3 in the FDA’s MAUDE database can be misleading without the outcome and longitudinal perspective that Intermacs provides.

“When you see a lot of deaths it means, ‘Let’s investigate.’ I couldn’t agree more,” Kirklin said. “But it’s rather limited. It’s not time-related and you don’t know the denominator. If you look up Intermacs, it’s all there.”

The families of Herrman and Flores filed lawsuits, in part, to find out what went wrong. Herrman’s family settled the lawsuit and agreed to confidentiality. Thoratec has filed a motion to dismiss the ongoing Flores case based on the FDA’s approval of the device.

Alanna Flores Blanco said she and her father were aware of the HeartMate 3’s positive outcomes, including published research that shows those who receive the device have a better than 50% chance of living five years or more.

“That’s why he took the chance to do it,” she said.

Flores Blanco said her father was a model patient, meeting regularly with cardiologists and other specialists, attending classes to learn how to live with the device, and receiving approval for surgery from the medical review board at Methodist Hospital in San Antonio.

The family felt informed and her father was prepared, she said.

“He did everything he was supposed to do,” she said. “What failed him ultimately was that device.”

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

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.


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When a Quick Telehealth Visit Yields Multiple Surprises Beyond a Big Bill Tue, 19 Dec 2023 10:00:00 +0000 In September 2022, Elyse Greenblatt of Queens returned home from a trip to Rwanda with a rather unwelcome-back gift: persistent congestion.

She felt a pain in her sinuses and sought a quick resolution.

Covid-19 couldn’t be ruled out, so rather than risk passing on an unknown infection to others in a waiting room, the New Yorker booked a telehealth visit through her usual health system, Mount Sinai — a perennial on best-hospitals lists.

That proved an expensive decision. She remembers the visit as taking barely any time. The doctor decided it was likely a sinus infection, not covid, and prescribed her fluticasone, a nasal spray that relieves congestion, and an antibiotic, Keflex. (The Centers for Disease Control and Prevention says antibiotics “are not needed for many sinus infections, but your doctor can decide if you need” one.)

Then the bill came.

The Patient: Elyse Greenblatt, now 38, had insurance coverage through Empire BlueCross BlueShield, a New York-based insurer.

Medical Services: A telehealth urgent care visit through Mount Sinai’s personal record app. Greenblatt was connected with an urgent care doctor through the luck of the draw. She was diagnosed with sinusitis, prescribed an antibiotic and Flonase, and told to come back if there was no improvement.

All this meant a big bill. The insurer said the telehealth visit was deemed an out-of-network service — a charge Greenblatt said the digital service didn’t do a great job of warning her about. It came as a surprise. “In my mind, if all my doctors are ‘in-insurance,’ why would they pair me with someone who was ‘out-of-insurance’?” she asked. And the hospital system tried its best to make contesting the charge difficult, she said.

Service Provider: The doctor was affiliated with Mount Sinai’s health system, though where the bill came from was unclear: Was it from one of the system’s hospitals or another unit?

Total Bill: $660 for what was billed as a 45- to 59-minute visit. The insurer paid nothing, ruling it out of network.

What Gives: The bill was puzzling on multiple levels. Most notably: How could this be an out-of-network service? Generally, urgent care visits delivered via video are a competitive part of the health care economy, and they’re not typically terribly expensive.

Mount Sinai’s telehealth booking process is at pains to assure bookers they’re getting a low price. After receiving the bill, Greenblatt went back to the app to recreate her steps — and she took a screenshot of one particular part of the app: the details. She got an estimated wait time of 10 minutes, for a cost of $60. “Cost may be less based on insurance,” the app said; this information, Mount Sinai spokesperson Lucia Lee said, is “for the patient’s benefit,” and the “cost may differ depending on the patient’s insurance.”

A $60 fee would be in line with, if not a bit cheaper than, many other telehealth services. Doctor on Demand, for example, offers visits from a clinician for $79 for a 15-minute visit, assuming the customer’s insurance doesn’t cover it. Amazon’s new clinic service, offering telehealth care for a wide range of conditions, advertises that charges start at $30 for a sinus infection.

The Health Care Cost Institute, an organization that analyzes health care claims data, told KFF Health News its data shows an urgent care telehealth visit runs, on average, $120 in total costs — but only $14 in out-of-pocket charges.

So how did this visit end up costing astronomically so much more than the average? After all, one of the selling points of telemedicine is not only convenience but cost savings.

First, there was the length of the visit. The doctor’s bill described it as moderately lengthy. But Greenblatt recalled the visit as simple and straightforward; she described her symptoms and got an antibiotic prescription — not a moderately complex visit requiring the better part of an hour to resolve.

The choice of description is a somewhat wonky part of health care billing that plays a big part in how expensive care can get. The more complex the case, and the longer it takes to diagnose and treat, the more providers can charge patients and insurers.

Greenblatt’s doctor billed her at a moderate level of care — curious, given her memory of the visit as quick, almost perfunctory. “I think it was five minutes,” she recalled. “I said it was a sinus infection; she told me I was right. ‘Take some meds, you’ll be fine.’”

Ishani Ganguli, a doctor at Brigham and Women’s Hospital in Boston who studies telehealth, said she didn’t know the exact circumstances of care but was “a bit surprised that it was not billed at a lower level” if it was indeed a quick visit.

That leaves the out-of-network aspect of the bill, allowing the insurer to pay nothing for the care. (Stephanie DuBois, a spokesperson for Empire BlueCross BlueShield, Greenblatt’s insurer, said the payer covers virtual visits through two services, or through in-network doctors. The Mount Sinai doctor fit neither criteria.) Still, why did Mount Sinai, Greenblatt’s usual health care system, assign her an out-of-network doctor?

“If one gets their care from the Mount Sinai system and the care is within network, I don’t think it is reasonable for the patients to expect or understand that one of the Mount Sinai clinicians is suddenly going to be out of network,” said Ateev Mehrotra, a hospitalist and telehealth researcher at Beth Israel Deaconess Medical Center.

It struck the doctors specializing in telehealth research whom KFF Health News consulted as an unusual situation, especially since the doctor who provided the care was employed by the prestigious health system.

The doctor in question may have been in network for no insurers whatsoever: A review of the doctor’s Mount Sinai profile page — archived in November 2022 — does not list any accepted insurance. (That’s in contrast to other doctors in the system.)

Lee, Mount Sinai’s spokesperson, said the doctor did take at least some insurance. When asked about the doctor’s webpage not showing any accepted plans, she responded the site “instructs patients to contact her office for the most up-to-date information.”

Attempting to solve this billing puzzle turned into a major league headache for Greenblatt. Deepening the mystery: After calling Mount Sinai’s billing department, she was told the case had been routed to disputes and marked as “urgent.”

But the doctor’s office would seemingly not respond. “In most other professions, you can’t just ignore a message for a year,” she observed.

The bill would disappear on her patient portal, then come back again. Another call revealed a new twist: She was told by a staffer that she’d signed a form consenting to the out-of-network charge. But “when I asked to get a copy of the form I signed, she asked if she could fax it,” Greenblatt said. Greenblatt said no. The billing department then asked whether they could put the form in her patient portal, for which Greenblatt gave permission. No form materialized.

When KFF Health News asked Mount Sinai about the case in mid-October of this year, Lee, the system’s spokesperson, forwarded a copy of the three-page form — which Greenblatt didn’t remember signing. Lee said the forms are presented as part of the flow of the check-in process and “intended to be obvious to the patient as required by law.” Lee said on average, a patient signs two to four forms before checking into the visit.

But, according to the time stamp on the forms, Greenblatt’s visit concluded before she signed. Lee said it is “not standard” to sign forms after the visit has concluded, and said that once informed, patients “may contact the office and reschedule with an ‘in-network provider.’”

“If it was provided after the service was rendered, that is an exception and situational,” she concluded.

The business with the forms — their timing and their obviousness — is potentially a vital distinction. In December 2020, Congress enacted the No Surprises Act, designed to crack down on so-called surprise medical bills that arise when patients think their care is covered by insurance but actually isn’t. Allie Shalom, a lawyer with Foley & Lardner, said the law requires notice to be given to patients, and consent obtained in advance.

But the legislation provides an exception. It applies only to hospitals, hospital outpatient facilities, critical access hospitals, and ambulatory surgery centers. Greenblatt’s medical bill variously presents her visit as “Office/Outpatient” or “Episodic Telehealth,” making it hard to “tell the exact entity that provided the services,” Shalom said.

That, in turn, makes its status under the No Surprises Act unclear. The rules apply when an out-of-network provider charges a patient for care received at an in-network facility. But Shalom couldn’t be sure what entity charged Greenblatt, and, therefore, whether that entity was in network.

As for Mount Sinai, Lee said asking for consent post-visit does not comply with the No Surprises Act, though she said the system needed more time to research whether Greenblatt was billed by the hospital or another entity.

The Resolution: Greenblatt’s bill is unpaid and unresolved.

The Takeaway: Unfortunately, patients need to be on guard to protect their wallets.

If you want to be a smart shopper, consider timing the length of your visit. The “Bill of the Month” team regularly receives submissions from patients who were billed for a visit significantly longer than what took place. You shouldn’t, for example, be charged for time sitting in a virtual waiting room.

Most important, even when you seek care at an in-network hospital, whose doctors are typically in network, always ask if a particular physician you’ve not seen before is in your network. Many practices and hospitals offer providers in both categories (even if that logically feels unfair to patients). Providers are supposed to inform you that the care being rendered is out of network. But that “informed consent” is often buried in a pile of consent forms that you auto-sign, in rapid fire. And the language is often a blanket statement, such as “I understand that some of my care may be provided by caregivers not in my insurance network” or “I agree to pay for services not covered by my insurance.”

To a patient trying to quickly book care, that may not feel like “informed consent” at all.

“It’s problematic to expect patients to read the fine print, especially when they feel unwell,” Ganguli said.

Emily Siner reported the audio story.

Bill of the Month is a crowdsourced investigation by KFF Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

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.


This story can be republished for free (details).

Social Security Chief Apologizes to Congress for Misleading Testimony on Overpayments Mon, 18 Dec 2023 22:00:00 +0000 The head of the Social Security Administration has sent a letter of apology to members of Congress about testimony in which she understated the extent of the agency’s overpayments to beneficiaries.

“I want to apologize for any confusion or misunderstanding during the October hearing,” acting Commissioner Kilolo Kijakazi wrote in a letter dated Dec. 11.

Kijakazi sent the letter days after KFF Health News and Cox Media Group reported that the agency has been demanding money back from more than 2 million people a year — more than twice as many as Kijakazi disclosed to a House panel at an Oct. 18 hearing.

The report was based on a Social Security document the news organizations obtained through a records request under the Freedom of Information Act.

“In my effort to be responsive to Committee questions on overpayment numbers, I provided a preliminary, unvetted and partial answer,” Kijakazi said in her apology letter.

“My goal — and SSA’s goal — is always to provide Congress with the most complete, accurate, and responsive information possible,” Kijakazi said. “We did not do that in this case and will use this experience to improve our communications with Congress going forward.”

In an interview before she sent the apology, Rep. Greg Steube (R-Fla.) said Kijakazi “wasn’t being completely upfront” at the hearing, and he wondered whether the agency had “intentionally deflated the numbers.”

Meanwhile, in a Dec. 12 interview, the chairman of the Senate Finance Committee, Ron Wyden (D-Ore.), said the agency had damaged its credibility by “not telling the truth.”

(WFXT-TV, Boston)

(WSB-TV, Atlanta)

The hearing of the House Ways and Means Committee’s Subcommittee on Social Security focused on the agency’s record of sending out billions of dollars of benefit payments that it later concludes it never should have paid — and then, sometimes years later, demanding the recipients pay the money back.

The unexpected bills, which can total tens of thousands of dollars or more, can be devastating for the recipients. Many are disabled and struggling to get by on minimal incomes.

Until the hearing, the agency had not disclosed the number of people affected, making it harder for policymakers to assess the seriousness of the problem and what to do about it.

At the hearing, Rep. Mike Carey (R-Ohio) asked how many people a year are receiving overpayment notices.

Reading from a piece of paper, Kijakazi gave two precise numbers: 1,028,389 for the 2022 fiscal year and 986,912 for the 2023 fiscal year.

Under further questioning, she repeated the numbers.

She also said they were “under Social Security” and “for Social Security.”

After the hearing, KFF Health News and Cox Media Group sent the Social Security press office several emails over a period of weeks asking for clarification: Did the numbers Kijakazi gave at the hearing represent all programs administered by the Social Security Administration, or just a subset?

SSA spokesperson Nicole Tiggemann did not give a direct answer.

The news organizations filed the FOIA request for a copy of the document from which Kijakazi read the numbers at the hearing.

The document showed that Kijakazi did not tell House members the whole story.

She read numbers that included two benefit programs, but she repeatedly omitted numbers for a third program her agency administers under the Social Security Act. The numbers she omitted were bigger than the numbers she disclosed, and, on the piece of paper, they appeared directly below the numbers she disclosed.

She left out more than a million people a year.

More than seven weeks passed before she sent Congress the apology.

(WSOC-TV, Charlotte)

(WFTV-TV, Orlando)

“We should have followed up with additional context following the hearing,” she said in her letter. “I take seriously the commitment that all Federal officials make to provide the Congress with accurate information and I very much regret not contacting you with more information right away.”

KFF Health News and Cox Media Group obtained a copy of the letter addressed to Rep. Drew Ferguson (R-Ga.), chair of the Ways and Means’ Subcommittee on Social Security, and a copy sent to a Democratic member of the committee.

Asked which members of Congress were sent the letter, Tiggemann said in an email, “The correspondence was between Acting Commissioner Kijakazi and members of the committee.”

Tiggemann did not respond to a request for an interview with Kijakazi.

In her letter, Kijakazi essentially disavowed the numbers she gave the committee. She said the agency is trying to make sure it has “the right data to make meaningful improvements.”

“We are committed to sharing this data with the Committee and the public,” she wrote, “as soon as it is fully vetted.”

Addressing overpayment problems — and communicating with Congress about them — will soon be someone else’s responsibility.

The evening of Dec. 18, the Senate voted 50 to 11 to confirm former Maryland Gov. Martin O’Malley (D) as commissioner of Social Security.

At his confirmation hearing in November, O’Malley said he would “absolutely prioritize” reducing overpayments and overhauling the appeals process for people asked to repay money.

“It’s been heartbreaking reading some of these stories” of people who face government collection efforts “through no fault of their own” and “without regard” for their circumstances, O’Malley said.

“We have to do a better job of recognizing the justice at stake in each of these individual cases,” O’Malley, a former presidential candidate, said at the hearing.

O’Malley said he would emphasize improving customer service, measuring results, and disclosing data.

Instead of hoarding information, he said, “you need to share information openly and transparently.”

Do you have an experience with Social Security overpayments you’d like to share? Click here to contact our reporting team.

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

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.


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Mysterious Morel Mushrooms at Center of Food Poisoning Outbreak Mon, 18 Dec 2023 10:00:00 +0000 A food poisoning outbreak that killed two people and sickened 51, stemming from a Montana restaurant, has highlighted just how little is known about morel mushrooms and the risks in preparing the popular and expensive delicacy.

The FDA conducted an investigation into morel mushrooms after the severe illness outbreak linked to Dave’s Sushi in Bozeman in late March and April. The investigation found that undercooked or raw morels were the likely culprit, and it led the agency to issue its first guidelines on preparing morels.

“The toxins in morel mushrooms that may cause illness are not fully understood; however, using proper preparation procedures, such as cooking, can help to reduce toxin levels,” according to the FDA guidance.

Even then, a risk remains, according to the FDA: “Properly preparing and cooking morel mushrooms can reduce risk of illness, however there is no guarantee of safety even if cooking steps are taken prior to consumption.”

Jon Ebelt, spokesperson for Montana’s health department, said there is limited public health information or medical literature on morels. And samples of the morels taken from Dave’s Sushi detected no specific toxin, pathogen, pesticide, or volatile or nonvolatile organic compound in the mushrooms.

Aaron Parker, the owner of Dave’s Sushi, said morels are a “boutique item.” In season, generally during the spring and fall, morels can cost him $40 per pound, while morels purchased out of season are close to $80 per pound, he said.

Many highly regarded recipe books describe sauteing morels to preserve the sought-after, earthy flavor. At Dave’s, a marinade, sometimes boiling, was poured over the raw mushrooms before they were served, Parker said. After his own investigation, Parker said he found boiling them between 10 and 30 minutes is the safest way to prepare morel mushrooms.

Parker said he reached out to chefs across the country and found that many, like him, were surprised to learn about the toxicity of morels.

“They had no idea that morel mushrooms had this sort of inherent risk factor regardless of preparation,” Parker said.

According to the FDA’s Food Code, the vast majority of the more than 5,000 fleshy mushroom species that grow naturally in North America have not been tested for toxicity. Of those that have, 15 species are deadly, 60 are toxic whether raw or cooked — including “false” morels, which look like spongy edible morels — and at least 40 are poisonous if eaten raw, but safer when cooked.

The North American Mycological Association, a national nonprofit whose members are mushroom experts, recorded 1,641 cases of mushroom poisonings and 17 deaths from 1985 to 2006. One hundred and twenty-nine of those poisonings were attributed to morels, but no deaths were reported.

Marian Maxwell, the outreach chairperson for the Puget Sound Mycological Society, based in Seattle, said cooking breaks down the chitin in mushrooms, the same compound found in the exoskeletons of shellfish, and helps destroy toxins. Maxwell said morels may naturally contain a type of hydrazine — a chemical often used in pesticides or rocket fuel that can cause cancer — which can affect people differently. Cooking does boil off the hydrazine, she said, “but some people still have reactions even though it’s cooked and most of that hydrazine is gone.”

Heather Hallen-Adams, chair of the toxicology committee of the North American Mycological Association, said hydrazine has been shown to exist in false morels, but it’s not as “clear-cut” in true morels, which were the mushrooms used at Dave’s Sushi.

Mushroom-caused food poisonings in restaurant settings are rare — the Montana outbreak is believed to be one of the first in the U.S. related to morels — but they have happened infrequently abroad. In 2019, a morel food poisoning outbreak at a Michelin-star-rated restaurant in Spain sickened about 30 customers. One woman who ate the morels died, but her death was determined to be from natural causes. Raw morels were served on a pasta salad in Vancouver, British Columbia, in 2019 and poisoned 77 consumers, though none died.

Before the new guidelines were issued, the FDA’s Food Code guidance to states was only that serving wild mushrooms must be approved by a “regulatory authority.”

The FDA’s Food Code bans the sale of wild-picked mushrooms in a restaurant or other food establishment unless it’s been approved to do so, though cultivated wild mushrooms can be sold if the cultivation operations are overseen by a regulatory agency, as was the case with the morels at Dave’s Sushi. States’ regulations vary, according to a 2021 study by the Georgia Department of Public Health and included in the Association of Food and Drug Officials’ regulatory guidelines. For example, Montana and a half-dozen other states allow restaurants to sell wild mushrooms if they come from a licensed seller, according to the study. Seventeen other states allow the sale of wild mushrooms that have been identified by a state-credentialed expert.

The study found that the varied resources states use to identify safe wild mushrooms — including mycological associations, academics, and the food service industry — may suggest a need for better communication.

The study recognized a “guidance document” as the “single most important step forward” given the variety in regulations and the demand for wild mushrooms.

Hallen-Adams said raw morels are known to be poisonous by “mushroom people,” but that’s not common knowledge among chefs.

In the Dave’s Sushi case, Hallen-Adams said, it was obvious that safety information didn’t get to the people who needed it. “And this could be something that could be addressed by labeling,” she said.

There hasn’t been much emphasis placed on making sure consumers know how to properly prepare the mushrooms, Hallen-Adams said, “and that’s something we need to start doing.”

Hallen-Adams, who trains people in Nebraska on mushroom identification, said the North American Mycological Association planned to update its website and include more prominent information about the need to cook mushrooms, with a specific mention of morels.

Montana’s health department intends to publish guidelines on morel safety in the spring, when morel season is approaching.

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

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.


This story can be republished for free (details).

‘They See a Cash Cow’: Corporations Could Consume $50 Billion of Opioid Settlements Mon, 18 Dec 2023 10:00:00 +0000 The marketing pitches are bold and arriving fast: Invest opioid settlement dollars in a lasso-like device to help police detain people without Tasers or pepper spray. Pour money into psychedelics, electrical stimulation devices, and other experimental treatments for addiction. Fund research into new, supposedly abuse-deterrent opioids and splurge on expensive, brand-name naloxone.

These pitches land daily in the inboxes of state and local officials in charge of distributing more than $50 billion from settlements in opioid lawsuits.

The money is coming from an array of companies that made, sold, or distributed prescription painkillers, including Johnson & Johnson, AmerisourceBergen, and Walgreens. Thousands of state and local governments sued the companies for aggressively promoting and distributing opioid medications, fueling an epidemic that progressed to heroin and fentanyl and has killed more than half a million Americans. The settlement money, arriving over nearly two decades, is meant to remediate the effects of that corporate behavior.

But as the dollars land in government coffers — more than $4.3 billion as of early November — a swarm of private, public, nonprofit, and for-profit entities are eyeing the gold rush. Some people fear that corporations, in particular — with their flashy products, robust marketing budgets, and hunger for profits — will now gobble up the windfall meant to rectify it.

“They see a cash cow,” said JK Costello, director of behavioral health consulting for the Steadman Group, a firm that is being paid to help local governments administer the settlements in Colorado, Kansas, Oregon, and Virginia. “Everyone is interested.”

Costello receives multiple emails a week from businesses and nonprofits seeking guidance on how to apply for the funds. To keep up with the influx, he has developed a standard response: Thanks, but we can’t respond to individual requests, so here’s a link to your locality’s website, public meeting schedule, or application portal.

California Healthline obtained email records in eight states that show health departments, sheriffs’ offices, and councils overseeing settlement funds are receiving a similar deluge of messages. In the emails, marketing specialists offer phone calls, informational presentations, and meetings with their companies.

Alabama Attorney General Steve Marshall recently sent a letter reminding local officials to vet organizations that reach out. “I am sure that many of you have already been approached by a variety of vendors seeking funding for opioid initiatives,” he wrote. “Please proceed with caution.”

Of course, not all marketing efforts should prompt concern. Emails and calls are one way people in power learn about innovative products and services. The country’s addiction crisis is too large for the public sector to tame alone, and many stakeholders agree that partnering with industry is crucial. After all, pharmaceutical companies manufacture medications to treat opioid addiction. Corporations run treatment facilities and telehealth services.

“It’s unrealistic and even harmful to say we don’t want any money going to any private companies,” said Kristen Pendergrass, vice president of state policy at Shatterproof, a national nonprofit focused on addiction.

The key, agree public health and policy experts, is to critically evaluate products or services to see if they are necessary, evidence-based, and sustainable — instead of flocking to companies with the best marketing.

Otherwise, “you end up with lots of shiny objects,” Costello said.

And, ultimately, failure to do due diligence could leave some jurisdictions holding an empty bag.

Take North Carolina. In 2022, state lawmakers allotted $1.85 million of settlement funds for a pilot project using the first FDA-approved app for opioid use disorder, developed by Pear Therapeutics. There were high hopes the app would help people stay in treatment longer.

But less than a year later, Pear Therapeutics filed for bankruptcy.

The state hadn’t paid the company yet, so the money isn’t lost, according to the North Carolina Department of Health and Human Services. But the department and lawmakers have not decided what to do with those dollars next.

$1 Million for Drug Disposal Pouches

Jason Sundby, CEO of Verde Environmental Technologies, said the Deterra pouches his company sells are a low-cost way to prevent expensive addictions.

Customers place their unused medications in a Deterra pouch and add water, deactivating the drugs before tossing them, ensuring they cannot be used even if fished out of the trash. A medium Deterra pouch costs $3.89 and holds 45 pills.

The goal is to “get these drugs out of people’s homes before they can be misused, diverted, and people start down the path of needing treatment or naloxone or emergency room visits,” Sundby said.

Sundby’s company ran an ad about spending settlement dollars on its product in a National Association of Counties newsletter and featured similar information online.

It may be paying off, as Deterra is set to receive $1 million in settlement funds from the health department in Delaware County, Pennsylvania, and $12,000 from the sheriff’s office in Henry County, Iowa. The company also has partnerships with St. Croix and Milwaukee counties in Wisconsin, and is working on a deal in Connecticut.

Several other companies with similar products have also used their product sites to urge jurisdictions to consider the settlements as a funding stream — and they’re seeing early success.

DisposeRx makes a drug deactivation product — its version costs about a dollar each — and received $144,000 in South Carolina for mailing 134,000 disposal packets to a program that educated high school football players, coaches, and parents about addiction.

SafeRx makes $3 pill bottles with a locking code to store medications and was awarded $189,000 by South Carolina’s opioid settlement council to work with the Greenville County Sheriff’s Office and local prevention groups. It also won smaller awards from Weld and Custer counties in Colorado.

None of the companies said they are dependent on opioid settlements to sustain their business long-term. But the funds provide a temporary boost. In a 2022 presentation to prospective investors, SafeRx called the opioid settlements a “growth catalyst.”

Critics of such investments say the products are not worthwhile. Today’s crisis of fatal overdoses is largely driven by illicit fentanyl. Even if studies suggest the companies’ products make people more likely to safely store and dispose of medications, that’s unlikely to stem the record levels of deaths seen in recent years.

“The plausible mechanism by which they would even be able to reduce overdose is a mystery because prescription medications are not driving overdose,” said Tricia Christensen, policy director with the nonprofit Community Education Group, which is tracking settlement spending across Appalachia.

Safe storage and disposal can be accomplished with a locking cabinet and toilet, she said. The FDA lists opioids on its flush list for disposal and says there is no evidence that low levels of the medicines that end up in rivers harm human health.

But Milton Cohen, CEO of SafeRx’s parent company, Caring Closures International, said keeping prescription medicines secure addresses the root of the epidemic. Fentanyl kills, but often where people start, “where water is coming into the boat still, is the medicine cabinet,” he said. “We can bail all we want, but the right thing to do is to plug the hole first.”

Products to secure and dispose of drugs also provide an opportunity for education and destigmatization, said Melissa Lyon, director of the Delaware County Health Department in Pennsylvania. The county will be mailing Deterra pouches and postcards about preventing addiction to three-quarters of its residents.

“The Deterra pouch is to me a direct correlation” to the overprescribing that came from pharmaceutical companies’ aggressive marketing, she added. Since the settlement money is to compensate for that, “this is a good use of the funds.”

Tools for Law Enforcement That Superheroes Would Envy

Other businesses making pitches for settlement funds have a less clear relationship to opioids.

Wrap Technologies creates tools for law enforcement to reduce lethal uses of force. Its chief product, the BolaWrap, shoots a 7½-foot Kevlar tether more than a dozen feet through the air until it wraps around a person’s limbs or torso — almost like Wonder Woman’s Lasso of Truth.

Terry Nichols, director of business development for the company, said the BolaWrap can be used as an alternative to Tasers or pepper spray when officers need to detain someone experiencing a mental health crisis or committing crimes related to their addiction, like burglary.

“If you want to be more humane in the way you treat people in substance use disorder and crisis, this is an option,” he said.

The company posts body camera footage of officers using BolaWrap on YouTube and says that out of 192 field reports of its use, about 75% of situations were resolved without additional use of force.

When officers de-escalate situations, people are less likely to end up in jail, Nichols said. And diverting people from the criminal justice system is among the suggested investments in opioid settlement agreements.

That argument convinced the city of Brownwood, Texas, where Nichols was police chief until 2019. It has spent about $15,000 of opioid settlement funds to buy nine BolaWrap devices.

“Our goal is to avoid using force when a citizen is in need,” said James Fuller, assistant police chief in Brownwood. “If we’re going to take someone to get help, the last thing we want to do is poke holes in them with a Taser.”

After Brownwood’s purchase, Wrap Technologies issued a press release in which CEO Kevin Mullins encouraged more law enforcement agencies to “take the opportunity afforded by the opioid settlement funds to empower their officers.” The company has also sent a two-page document to police departments explaining how settlement funds can be used to buy BolaWraps.

Language from that document appeared nearly word-for-word in a briefing sheet given to Brownwood City Council before the BolaWrap purchase. The council voted unanimously in favor.

But the process hasn’t been as smooth elsewhere. In Hawthorne, California, the police department planned to buy 80 BolaWrap devices using opioid settlement funds. It paid its first installment of about $25,000 in June. However, it was later informed by the state Department of Health Care Services that the BolaWrap is not an allowable use of these dollars.

“Bola Wraps will not be purchased with the Settlement Funds in the future,” Hawthorne City Clerk Dayna Williams-Hunter wrote in an email.

Carolyn Williams, a member of the advocacy group Vocal-TX, said she doesn’t see how the devices will address the overdose crisis in Texas or elsewhere.

Her son Haison Akiem Williams dealt with mental health and addiction issues for years. Without insurance, he couldn’t afford rehab. When he sought case management services, there was a three-month wait, she said. Police charged him with misdemeanors but never connected him to care, she said.

In February, he died of an overdose at age 47. His mother misses how he used to make her laugh by calling her “Ms. Carol.”

She wants settlement funds to support services she thinks could have kept him alive: mental health treatment, case management, and housing. BolaWrap doesn’t make that list.

“It’s heartbreaking to see what the government is doing with this money,” she said. “Putting it in places they really don’t need it.”

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

New Doula Benefit ‘Life-Changing’ for California Mom Mon, 18 Dec 2023 10:00:00 +0000 VICTORVILLE — When Mia Bloomer found out she was pregnant with her fourth child, she wanted a different birth experience. She wanted to feel empowered, informed, and heard — elements she found lacking during her earlier births.

Somewhat by accident, Bloomer, 26, found Priya Kalyan-Masih six months into her pregnancy. Kalyan-Masih is a doula, a professional childbirth companion who provides emotional support, physical comfort, and education to women before, during, and after pregnancy. Bloomer hadn’t realized Medi-Cal would cover the service until she visited an informational fair near her home in the High Desert region of Southern California.

Medi-Cal, California’s Medicaid program for low-income residents, started offering the benefit in January — but doulas have wrestled with the program’s bureaucratic requirements and what they say is insufficient pay.

“Priya really listened to me. Out of all my births, this was the most peaceful and stress-free,” said Bloomer, who is a student working part-time as an in-home caregiver and at a detox center. “The fact that I didn’t have to pay anything out-of-pocket was life-changing.”

Having Kalyan-Masih at her side was critical for Bloomer because her partner — now fiancé — was imprisoned a few weeks after she found out she was pregnant, which would have meant she’d have to navigate her pregnancy and delivery without him.

Across the country, doulas are being enlisted to combat rising maternal mortality rates. In 2021, the most recent year for which data is available, about 1,200 women in the U.S. died from pregnancy complications either during pregnancy or within six weeks afterward, about 60% more deaths than were reported two years earlier, according to the Centers for Disease Control and Prevention.

The numbers are starkest for Black women and their children. In 2021, Black women died at more than 2½ times the rate of white women.

Doulas are distinct from the medical team and act as advocates for birthing parents. A National Institutes of Health study published this year found that doula care was associated with reductions in cesarean sections, epidural use, length of labor, premature deliveries, and maternal stress.

During Bloomer’s pregnancy, Kalyan-Masih assisted with strategies such as mapping a birth plan and coaching Bloomer on breathing techniques to ease her anxiety.

Less than a year after Bloomer moved from Texas to be with her fiancé, Tim Smith, he was arrested for firearm possession while on probation for drug-related charges. That left Bloomer in Victorville, on the edge of the Mojave Desert, far from friends and family.

In Smith’s absence, Bloomer was grateful for Kalyan-Masih’s companionship and reminders to take care of herself, she said.

But what meant the most was Kalyan-Masih’s willingness to weave Smith into the birth without judgment, she said. Kalyan-Masih acted as his eyes and ears at the hospital in June, running around with Bloomer’s phone so Smith could meet his newborn daughter, Tiara, via FaceTime.

“It meant everything. I mean, I’m locked up and I saw the baby before Mia did,” Smith recalled, laughing. “Priya made everything possible. She held the phone. She was running around when the baby came out. She made it feel like I was there.”

Smith met Tiara in person when he was released a month later.

Kalyan-Masih’s presence also led to a noticeable difference in how medical staff treated her, Bloomer said.

During her previous deliveries, she felt the medical professionals had been pushy and dismissive. For example, when her son Thaddeus was born last year, she said, doctors pressured her to get an epidural against her wishes after Smith left the room to grab her lunch.

“When I had Priya in the room, they were more attentive to my needs and didn’t treat me like my opinion didn’t matter,” Bloomer said. “It wasn’t an argument or debate. It was just like, ‘OK, that’s what we’re doing.’”

Medi-Cal covers up to 11 doula visits before and after pregnancy, and support during labor and delivery — and patients can petition for extra postpartum visits. Doulas can also be paid by Medi-Cal for providing support during and after miscarriages or abortions.

“I always explain it as obstetricians and midwives are the ones catching babies, and doulas catch Mom,” said Kalyan-Masih, who is a medical doctor by training and a doula since January.

Kalyan-Masih is pleased with California’s investment in doula services but said it has been a challenge to maneuver Medi-Cal’s administrative requirements, like acquiring business licenses.

Samsarah Morgan, a doula and founder of the Oakland Better Birth Foundation, said the business license fees, in addition to Medi-Cal’s reimbursement rates, prevent some doulas from participating in the program.

The state pays doulas fixed rates per visit, adding up to $1,154 if patients schedule the standard number of nine visits before and after birth, in addition to labor and delivery. Doulas can make up to $2,078 through Medi-Cal if patients schedule additional postpartum visits. The $1,154 rate is more than twice what the state initially proposed in 2022, and Morgan said that she’s grateful for the increase — but that it’s still not enough.

In her own practice, most clients pay $2,500 to $3,500, typically out-of-pocket since, in her experience, many private insurance plans don’t cover doula services, she said.

“I want to work with clients who are on Medi-Cal, but I also need to pay my bills,” Morgan said.

Griselda Melgoza, a spokesperson for the Department of Health Care Services, which administers Medi-Cal, said the department pays doulas the same as other providers — including doctors, nurses, and physician assistants — for the same services. The department has proposed rate increases for doula services next year, which would vary by type of delivery. A doula who provides the standard nine visits and attends a vaginal delivery, for example, would be paid $2,180, 89% more than the current rate.

Preliminary data shows that 50 doula claims were processed statewide as of July 31 and that claims from that time frame are still coming in, Melgoza said. She added that the department is working to make the benefit more accessible. In November, for instance, it eliminated most referral requirements, removing a hurdle for patients.

Bloomer said she wishes she had been able to work with a doula during previous pregnancies, especially when she was carrying Lucas, her first child, at age 19.

At the time, she didn’t know what questions to ask or what to expect, including how to cope with postpartum depression.

“With a doula, I would have been more informed,” Bloomer said as 6-month-old Tiara babbled on her lap. “I would have felt more empowered. I would have had the kind of support that would have made me a better mom.”

This article is part of “Faces of Medi-Cal,” a California Healthline series exploring the impact of the state’s safety-net health program on enrollees.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

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.


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‘Financial Ruin Is Baked Into the System’: Readers on the Costs of Long-Term Care Fri, 15 Dec 2023 15:00:00 +0000 Thousands of readers reacted to the articles in the “Dying Broke” series about the financial burden of long-term care in the United States. They offered their assessments for the government and market failures that have drained the lifetime savings of so many American families. And some offered possible solutions.

In more than 4,200 comments, readers shared their struggles in caring for spouses, older parents, and grandparents. They expressed anxieties about getting older themselves and needing help to stay at home or in institutions like nursing homes or assisted living facilities.

Many suggested changes to U.S. policy, like expanding the government’s payments for care and allowing more immigrants to stay in the country to help meet the demand for workers. Some even said they would rather end their lives than become a financial burden to their children.

Many readers blamed the predominantly for-profit nature of American medicine and the long-term care industry for depleting the financial resources of older people, leaving the federal-state Medicaid programs to take care of them once they were destitute.

“It is incorrect to say the money isn’t there to pay for elder care,” Jim Castrone, 72, a retired financial controller in Placitas, New Mexico, commented. “It’s there, in the form of profits that accrue to the owners of these facilities.”

“It is a system of wealth transference from the middle class and the poor to the owners of for-profit medical care, including hospitals and the long-term care facilities outlined in this article, underwritten by the government,” he added.

Other readers pointed to insurance policies that, despite limitations, had helped them pay for services. And some relayed their concerns that Americans were not saving enough and were unprepared to take care of themselves as they aged.

What Other Nations Provide

Other countries’ treatment of their older citizens was repeatedly mentioned. Readers contrasted the care they observed older people receiving in foreign countries with the treatment in the United States, which spends less on long-term care as a portion of its gross domestic product than do most wealthy nations.

Marsha Moyer, 75, a retired teaching assistant in Memphis, Tennessee, said she spent 12 years as a caregiver for her parents in San Diego County and an additional six for her husband. While they had advantages many don’t, Moyer said, “it was a long, lonely job, a sad job, an uphill climb.”

By contrast, her sister-in-law’s mother lived to 103 in a “fully funded, lovely elder care home” in Denmark during her last five years. “My sister-in-law didn’t have to choose between her own life, her career, and helping her healthy but very old mother,” Moyer said. “She could have both. I had to choose.”

Birgit Rosenberg, 58, a software developer in Southampton, Pennsylvania, said her mother had end-stage dementia and had been in a nursing home in Germany for more than two years. “The cost for her absolutely excellent care in a cheerful, clean facility is her pittance of Social Security, about $180 a month,” she said. “A friend recently had to put her mother into a nursing home here in the U.S. Twice, when visiting, she has found her mother on the floor in her room, where she had been for who knows how long.”

Brad and Carol Burns moved from Fort Worth, Texas, in 2019 to Chapala, Jalisco, in Mexico, dumping their $650-a-month long-term care policy because care is so much more affordable south of the border. Brad, 63, a retired pharmaceutical researcher, said his mother lived just a few miles away in a memory care facility that costs $2,050 a month, which she can afford with her Social Security payments and an annuity. She is receiving “amazing” care, he said.

“As a reminder, most people in Mexico cannot afford the care we find affordable and that makes me sad,” he said. “But their care for us is amazing, all health care, here, actually. At her home, they address her as Mom or Barbarita, little Barbara.”

Insurance Policies Debated

Many, many readers said they could relate to problems with long-term care insurance policies, and their soaring costs. Some who hold such policies said they provided comfort for a possible worst-case scenario while others castigated insurers for making it difficult to access benefits.

“They really make you work for the money, and you’d better have someone available who can call them and work on the endless and ever-changing paperwork,” said Janet Blanding, 62, a technical writer in Fancy Gap, Virginia.

Derek Sippel, 47, a registered nurse in Naples, Florida, cited the $11,000 monthly cost of his mother’s nursing home care for dementia as the reason he bought a policy. He pays about $195 a month with a lifetime benefit of $350,000. “I may never need to use the benefit[s], but it makes me feel better knowing that I have it if I need it,” he said in his comment. He said he could not make that kind of money by investing on his own.

“It’s the risk you take with any kind of insurance,” he said. “I don’t want to be a burden on anyone.”

Pleas for More Immigrant Workers

One solution that readers proposed was to increase the number of immigrants allowed into the country to help address the chronic shortage of long-term care workers. Larry Cretan, 73, a retired bank executive in Woodside, California, said that over time, his parents had six caretakers who were immigrants. “There is no magic bullet,” he said, “but one obvious step — hello, people — we need more immigrants! Who do you think does most of this work?”

Victoria Raab, 67, a retired copy editor in New York, said that many older Americans must use paid help because their grown children live far away. Her parents and some of their peers rely on immigrants from the Philippines and Eritrea, she said, “working loosely within the margins of labor regulations.”

“These exemplary populations should be able to fill caretaker roles transparently in exchange for citizenship because they are an obvious and invaluable asset to a difficult profession that lacks American workers of their skill and positive cultural attitudes toward the elderly,” Raab said.

Federal Fixes Sought

Other readers called for the federal government to create a comprehensive, national long-term care system, as some other countries have. In the United States, federal and state programs that finance long-term care are mainly available only to the very poor. For middle-class families, sustained subsidies for home care, for example, are fairly nonexistent.

“I am a geriatric nurse practitioner in New York and have seen this story time and time again,” Sarah Romanelli, 31, said. “My patients are shocked when we review the options and its costs. Medicaid can’t be the only option to pay for long-term care. Congress needs to act to establish a better system for middle-class Americans to finance long-term care.”

John Reeder, 76, a retired federal economist in Arlington, Virginia, called for a federal single-payer system “from birth to senior care in which we all pay and profit-making [is] removed.”

Other readers, however, argued that people needed to take more responsibility by preparing for the expense of old age.

Mark Dennen, 69, in West Harwich, Massachusetts, said people should save more rather than expect taxpayers to bail them out. “For too many, the answer is, ‘How can we hide assets and make the government pay?’ That is just another way of saying, ‘How can I make somebody else pay my bills?’” he said, adding, “We don’t need the latest phone/car/clothes, but we will need long-term care. Choices.”

Questioning the Value of Life-Prolonging Procedures

A number of readers condemned the country’s medical culture for pushing expensive surgeries and other procedures that do little to improve the quality of people’s few remaining years.

Thomas Thuene, 60, a consultant in Boston’s Roslindale neighborhood, described how a friend’s mother who had heart failure was repeatedly sent from the elder care facility where she lived to the hospital and back, via ambulance. “There was no arguing with the care facility,” he said. “However, the moment all her money was gone, the facility gently nudged my friend to think of end-of-life care for his mother. It seems the financial ruin is baked into the system.”

Joan Chambers, 69, an architectural draftsperson in Southold, New York, said that during a hospitalization on a cardiac unit she observed many fellow patients “bedridden with empty eyes,” awaiting implants of stents and pacemakers.

“I realized then and there that we are not patients, we are commodities,” she said. “Most of us will die from heart failure. It will take courage for a family member to refuse a ‘simple’ procedure that will keep a loved one’s heart beating for a few more years, but we have to stop this cruelty.

“We have to remember that even though we are grateful to our health care professionals, they are not our friends. They are our employees and we can say no.”

One physician, James Sullivan, 64, in Cataumet, a neighborhood of Bourne, Massachusetts, said he planned to refuse hospitalization and other extraordinary measures if he suffered from dementia. “We spend billions of dollars, and a lot of heartache, treating demented people for pneumonia, urinary tract infections, cancers, things that are going to kill them sooner or later, for no meaningful benefit,” Sullivan said. “I would not want my son to spend his good years, and money, helping to maintain me alive if I don’t even know what’s going on,” he said.

Considering ‘Assisted Dying’

Others went further, declaring they would rather arrange for their own deaths than suffer in greatly diminished capacity. “My long-term care plan is simple,” said Karen Clodfelter, 65, a library assistant in St. Louis. “When the money runs out, I will take myself out of the picture.” Clodfelter said she helped care for her mother until her death at 101. “I’ve seen extreme old age,” she said, “and I’m not interested in going there.”

Some suggested that medically assisted death should be a more widely available option in a country that takes such poor care of its elderly. Meridee Wendell, 76, of Sunnyvale, California, said: “If we can’t manage to provide assisted living to our fellow Americans, could we at least offer assisted dying? At least some of us would see it as a desirable solution.”

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

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.


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