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.

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This story can be republished for free (details).

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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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.

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“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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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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The Social Security Administration assured lawmakers in the past that it had been addressed, but “what you all found in your reporting is that the problem hadn’t been fixed,” Finance Committee Chair Ron Wyden (D-Ore.) said in an interview.

Wyden was referring to an ongoing investigation by KFF Health News and Cox Media Group television stations reporting how the agency has been issuing billions of dollars in overpayments — benefits it claims people never should have received — and then, sometimes years later, demanding they pay the money back.

“Millions of these individuals are walking an economic tightrope, balancing their food bill against the fuel bill, the fuel bill against the rent bill,” Wyden said. “And they have one of these overpayments and it just hits them like a wrecking ball.”

Meanwhile, congressional legislation that would raise asset limits for millions of Social Security recipients for the first time in decades has been gaining support.

The amounts the agency alleges people owe the government often total tens of thousands of dollars. The recipients include many of the nation’s most vulnerable — people who are disabled and have minimal savings and incomes. Often the overpayments result from errors or lapses on the part of the Social Security Administration.

The agency has been sending overpayment notices to more than 2 million people a year, according to a government document KFF Health News and CMG obtained through a request under the Freedom of Information Act. The notices typically ask recipients to repay the government within 30 days. They also explain how to appeal or request that the government waive the debt.

The Finance Committee oversees Social Security. Wyden spoke with KFF Health News and CMG on Dec. 12 in his first interview with the news organizations since they began reporting on Social Security overpayments and clawbacks months ago. He was elaborating on a statement the committee posted last week.

“As the point person for getting this fixed, I’m committing to getting this turned around,” Wyden said.

“Your reporting has just been invaluable in terms of kind of opening up a lot of visibility and awareness to something that needs to be fixed.”

Wyden is co-sponsor of a Senate bill that would address one of the root causes of overpayments.

(WSB-TV, Atlanta)

In the Supplemental Security Income program, which provides monthly checks to people who have little or no income or assets and are over 65 or disabled, asset limits for beneficiaries haven’t been adjusted since the 1980s. Those limits stand at $2,000 for individuals and $3,000 for couples.

The bill, spearheaded by Sens. Sherrod Brown (D-Ohio) and Bill Cassidy (R-La.), would raise the asset limits to $10,000 and $20,000, respectively, and adjust them for inflation in the future.

The bill has seven other co-sponsors in the Senate, including recent additions Lisa Murkowski (R-Alaska) and Sen. Patty Murray (D-Wash.), chair of the Appropriations Committee.

Chief executives of several major Wall Street firms, including Bank of America, Citigroup, Goldman Sachs, and Morgan Stanley, expressed support for the bill at a recent hearing, CNBC reported.

At a September news conference on Capitol Hill, a representative of JPMorgan Chase, which also backs the proposal, said the asset limits often prevent employees from participating in a 401(k) retirement plan to which the firm makes matching contributions.

A parallel bill in the House of Representatives has 10 lawmakers behind it.

“With growing bipartisan support in Congress and among the business and faith communities, we have a good chance to finally get this done,” Brown said in a statement for this article.

Legislation to raise the asset limits could be included in a government funding bill early next year, Brown spokesperson Kevin Donohoe said.

Wyden said he hopes the legislation becomes a campaign issue in the election year and that candidates are asked whether they support it.

The monthly meetings with the Social Security Administration will begin when a new commissioner is in place, Wyden said. President Joe Biden’s nominee to head the agency, former Maryland Gov. Martin O’Malley (D), cleared the Finance Committee and is awaiting a confirmation vote by the full Senate.

In a recent hearing, O’Malley said accounts of people facing clawbacks were “heartbreaking” and promised to make the issue a priority.

Wyden said he expects the oversight meetings will include the top Republican on the Finance Committee, Sen. Mike Crapo of Idaho.

A spokesperson for Crapo, Mandi Critchfield, said he “is committed to addressing the overpayments issue, and looks forward to working with Senator Wyden to conduct proper oversight.”

One of the goals for those meetings, Wyden said, is to find out whether the agency can do more about overpayments using the legal powers it already has, including the authority to waive debts.

Wyden said he has discussed Social Security overpayments and clawbacks with officials at the White House.

In the interview, Wyden also addressed a recent report by KFF Health News and CMG that, according to the results of a public records request, the SSA has been sending overpayment notices to over a million more people a year than the agency’s acting commissioner, Kilolo Kijakazi, disclosed at an October House hearing.

“When you have Social Security officials not telling the truth — and that’s how I would characterize that report on the number of people for whom there was actually a problem — it really damages this incredibly important program’s credibility,” Wyden said.

The news organizations obtained a copy of a piece of paper from which Kijakazi read aloud some numbers but not others at the October hearing.

SSA spokesperson Nicole Tiggemann said last week the agency could not confirm the accuracy of the counts — those Kijakazi presented at the hearing and those she left out.

Meanwhile, senior Democrats on the House Ways and Means Committee issued a statement this week calling for action on overpayments and clawbacks.

“Recent news reports have highlighted that the harm and unfairness Social Security beneficiaries experience after unknowingly being overpaid is more widespread than previously thought,” Reps. John B. Larson of Connecticut and Danny K. Davis of Illinois said.

Larson is the ranking Democrat on the Ways and Means Subcommittee on Social Security, and Davis is the ranking Democrat on the Subcommittee on Work and Welfare.

“The need for action is clear,” they said. “There must be a fundamental overhaul of Social Security’s overpayment process – one that puts seniors and Americans with severe disabilities first.”

While the government is at fault for some overpayments, others result from beneficiaries failing to comply with requirements, intentionally or otherwise. That can include failing to keep the SSA updated about items such as earnings, assets, and in-kind support — for example, whether family members are giving the beneficiary food or a place to stay.

Systemic problems also contribute.

The SSA has relied on manual systems, and those are subject to human error.

Rules are complex and difficult for SSA staff and beneficiaries alike to follow.

People who receive federal disability benefits yet try to work can easily run afoul of restrictions not only on how much they are allowed to save but also on how much they are allowed to earn. For individuals who aren’t blind, the monthly limit is $1,470.

The SSA relies heavily on beneficiaries to report changes in income, assets, and the like. For instance, the agency has been slow to implement systems that would automatically tap payroll data from outside sources.

Beneficiaries and advocates for Social Security recipients say the agency frequently loses information they submit. Getting through to humans at the agency can be extremely difficult, they say. Wait times are long, and calls get dropped.

O’Malley, the nominee for commissioner, recently told the Senate Finance Committee that the agency has a “customer service crisis.”

“The current wait times, backlogs, and delays are simply unacceptable,” O’Malley wrote.

The agency has cited staffing and funding. In the 2023 fiscal year, “we began to rebuild our workforce after ending FY 2022 with the lowest staffing level in 25 years,” the acting commissioner said in an October statement to a congressional subcommittee.

The agency closed field offices during the pandemic. That made it more difficult for beneficiaries to communicate with the SSA, and it caused problems to pile up.

The agency checks benefits retrospectively, which leaves it playing catch-up, researchers at the Urban Institute have said.

Regardless of who was originally at fault, by the time the SSA issues an overpayment notice, years can pass and the alleged overpayment total can balloon.

Under federal law, the agency must try to recover overpaid amounts, Kijakazi said in her October statement, and there is no statute of limitations. To collect debts, the SSA can reach back decades and across generations.

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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The pandemic illustrated how a rift between the CDC and workplace safety officials can have serious repercussions. Most recently, the giant hospital system Sutter Health in California appealed a citation from the state’s Division of Occupational Safety and Health, known as Cal/OSHA, by pointing to the CDC’s shifting advice on when and whether N95 masks were needed at the start of the pandemic. By contrast, Cal/OSHA requires employers in high-risk settings like hospitals to improve ventilation, use air filtration, and provide N95s to all staff exposed to diseases that are — or may be — airborne.

The agencies are once again at odds. The CDC’s advisory committee prescribes varying degrees of protection based on ill-defined categories, such as whether a virus or bacteria is considered common or how far it seems to travel in the air. As a result, occupational safety experts warn that choices on how to categorize covid, influenza, and other airborne diseases — and the corresponding levels of protection — may once again be left to administrators at hospitals, nursing homes, and jails or prisons.

Eric Berg, deputy chief of health at Cal/OSHA, warned the CDC in November that, if it accepted its committee’s recommendations, the guidelines would “create confusion and result in workers being not adequately protected.”

Also called respirators, N95 masks filter out far more particles than looser-fitting surgical masks but cost roughly 10 times as much, and were in short supply in 2020. Black, Hispanic, and Asian health workers more often went without N95 masks than white staffers, which helped explain why members of racial and ethnic minorities tested positive for covid nearly five times as often as the general population in the early months of the pandemic. (Hispanic people can be of any race or combination of races.)

Cal/OSHA issued dozens of citations to health care facilities that failed to provide N95 masks and take other measures to protect workers in 2020 and 2021. Many appealed, and some cases are ongoing. In October, the agency declined Sutter’s appeal against a $6,750 citation for not giving its medical assistants N95 masks in 2020 when they accompanied patients who appeared to have covid through clinics. Sutter pointed to the CDC’s advice early in the pandemic, according to court testimony. It noted that the CDC called surgical masks an “acceptable alternative” in March 2020, “seemed to recommend droplet precautions rather than airborne precautions,” and suggested that individuals were unlikely to be infected if they were farther than 6 feet away from a person with covid.

This is a loose interpretation of the CDC’s 2020 advice, which was partly made for reasons of practicality. Respirators were in short supply, for example, and physical distancing beyond 6 feet is complicated in places where people must congregate. Scientifically, there were clear indications that the coronavirus SARS-CoV-2 spread through the air, leading Cal/OSHA to enact its straightforward rules created after the 2009 swine flu pandemic. Workers need stiffer protection than the general population, said Jordan Barab, a former official at the federal Occupational Safety and Health Administration: “Health workers are exposed for eight, 10, 12 hours a day.”

The CDC’s advisory committee offers a weaker approach in certain cases, suggesting that health workers wear surgical masks for “common, often endemic respiratory pathogens” that “spread predominantly over short distances.” The draft guidance pays little attention to ventilation and air filtration, and advises N95 masks only for “new or emerging” diseases and those that spread “efficiently over long distances.” Viruses, bacteria, and other pathogens that spread through the air don’t neatly fit into such categories.

“Guidelines that are incomplete, weak, and without scientific basis will greatly undermine CDC’s credibility,” said a former OSHA director, David Michaels, in minutes from an October meeting where he and others urged CDC Director Mandy Cohen to reconsider advice from the committee before it issues final guidance next year.

Although occupational safety agencies — not the CDC — have the power to make rules, enforcement often occurs long after the damage is done, if ever. Cal/OSHA began to investigate Sutter only after a nurse at its main Oakland hospital died from covid and health workers complained they weren’t allowed to wear N95 masks in hallways shared with covid patients. And more than a dozen citations from Cal/OSHA against Kaiser Permanente, Sharp HealthCare, and other health systems lagged months and years behind health worker complaints and protests.

Outside California, OSHA faces higher enforcement obstacles. A dwindling budget left the agency with fewer workplace inspectors than it had in 45 years, at the peak of the pandemic. Plus, the Trump and Biden administrations stalled the agency’s ongoing efforts to pass regulations specific to airborne infections. As a result, the agency followed up on only about 1 in 5 covid-related complaints that employees and labor representatives officially filed with the group from January 2020 to February 2022 — and just 4% of those made informally through media reports, phone calls, and emails. Many deaths among health care workers weren’t reported to the agency in the first place.

Michaels, who is now on the faculty at the George Washington University School of Public Health, said the CDC would further curtail OSHA’s authority to punish employers who expose staff members to airborne diseases, if its final guidelines follow the committee’s recommendations. Such advice would leave many hospitals, correctional facilities, and nursing homes as unprepared as they were before the pandemic, said Deborah Gold, a former deputy chief of health at Cal/OSHA. Strict standards prompt employers to stockpile N95 masks and improve air filtration and ventilation to avoid citations. But if the CDC’s guidance leaves room for interpretation, she said, they can justify cutting corners on costly preparation.

Although the CDC committee and OSHA both claim to follow the science, researchers arrived at contradictory conclusions because the committee relied on explicitly flawed trials comparing health workers who wore surgical masks with those using N95s. Cal/OSHA based its standards on a variety of studies, including reviews of hospital infections and engineering research on how airborne particles spread.

In decades past, the CDC’s process for developing guidelines included labor representatives and experts focused on hazards at work. Barab was a health researcher at a trade union for public sector employees when he helped the CDC develop HIV-related recommendations in the 1980s.

“I remember asking about how to protect health care workers and correction officers who get urine or feces thrown at them,” Barab said. Infectious disease researchers on the CDC’s committee initially scoffed at the idea, he recalled, but still considered his input as someone who understood the conditions employees faced. “A lot of these folks hadn’t been on hospital floors in years, if not decades.”

The largest organization for nurses in the United States, National Nurses United, made the same observation. It’s now collecting signatures for an online petition urging the CDC to scrap the committee’s guidelines and develop new recommendations that include insights from health care workers, many of whom risked their lives in the pandemic.

Barab attributed the lack of labor representation in the CDC’s current process to the growing corporate influence of large health systems. Hospital administrators prefer not to be told what to do, particularly when it requires spending money, he said.

In an email, CDC communications officer Dave Daigle stressed that before the guidelines are finalized, the CDC will “review the makeup of the workgroups and solicit participation to ensure that the appropriate expertise is included.”

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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The award-winning project has exposed the enormous scale of this problem, finding, among other things, that 100 million people in the U.S. are saddled with some kind of health care debt.

KFF Health News senior correspondent Noam N. Levey joined NPR’s “The Sunday Story” to talk about the project, its findings, and the impact the reporting has had on policymakers and patients across the country. Listen to the program here.

About This Project

“Diagnosis: Debt” is a reporting partnership between KFF Health News and NPR exploring the scale, impact, and causes of medical debt in America.

The series draws on original polling by KFF, court records, federal data on hospital finances, contracts obtained through public records requests, data on international health systems, and a yearlong investigation into the financial assistance and collection policies of more than 500 hospitals across the country. 

Additional research was conducted by the Urban Institute, which analyzed credit bureau and other demographic data on poverty, race, and health status for KFF Health News to explore where medical debt is concentrated in the U.S. and what factors are associated with high debt levels.

The JPMorgan Chase Institute analyzed records from a sampling of Chase credit card holders to look at how customers’ balances may be affected by major medical expenses. And the CED Project, a Denver nonprofit, worked with KFF Health News on a survey of its clients to explore links between medical debt and housing instability. 

KFF Health News journalists worked with KFF public opinion researchers to design and analyze the “KFF Health Care Debt Survey.” The survey was conducted Feb. 25 through March 20, 2022, online and via telephone, in English and Spanish, among a nationally representative sample of 2,375 U.S. adults, including 1,292 adults with current health care debt and 382 adults who had health care debt in the past five years. The margin of sampling error is plus or minus 3 percentage points for the full sample and 3 percentage points for those with current debt. For results based on subgroups, the margin of sampling error may be higher.

Reporters from KFF Health News and NPR also conducted hundreds of interviews with patients across the country; spoke with physicians, health industry leaders, consumer advocates, debt lawyers, and researchers; and reviewed scores of studies and surveys about medical debt.

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.

USE OUR CONTENT

This story can be republished for free (details).

But in her mid-40s, Woodward retired after being diagnosed with a debilitating form of arthritis. Her condition required expensive drugs and regular medical care, which left her with more than $20,000 in medical debts.

She had no option but to move out of her home and restart her life in a small town in Virginia’s Shenandoah Valley. At times, she has relied on food banks to get enough to eat.

Woodward is one of 100 million people in the U.S. with health care debt. Watch her story here.

About This Project

“Diagnosis: Debt” is a reporting partnership between KFF Health News and NPR exploring the scale, impact, and causes of medical debt in America.

The series draws on original polling by KFF, court records, federal data on hospital finances, contracts obtained through public records requests, data on international health systems, and a yearlong investigation into the financial assistance and collection policies of more than 500 hospitals across the country. 

Additional research was conducted by the Urban Institute, which analyzed credit bureau and other demographic data on poverty, race, and health status for KFF Health News to explore where medical debt is concentrated in the U.S. and what factors are associated with high debt levels.

The JPMorgan Chase Institute analyzed records from a sampling of Chase credit card holders to look at how customers’ balances may be affected by major medical expenses. And the CED Project, a Denver nonprofit, worked with KFF Health News on a survey of its clients to explore links between medical debt and housing instability. 

KFF Health News journalists worked with KFF public opinion researchers to design and analyze the “KFF Health Care Debt Survey.” The survey was conducted Feb. 25 through March 20, 2022, online and via telephone, in English and Spanish, among a nationally representative sample of 2,375 U.S. adults, including 1,292 adults with current health care debt and 382 adults who had health care debt in the past five years. The margin of sampling error is plus or minus 3 percentage points for the full sample and 3 percentage points for those with current debt. For results based on subgroups, the margin of sampling error may be higher.

Reporters from KFF Health News and NPR also conducted hundreds of interviews with patients across the country; spoke with physicians, health industry leaders, consumer advocates, debt lawyers, and researchers; and reviewed scores of studies and surveys about medical debt.

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.

USE OUR CONTENT

This story can be republished for free (details).

Davis had planned to give birth at a small community hospital about 20 minutes from her home in North Charleston, South Carolina. But that changed when her medical team started repeatedly calling her cellphone and pressuring her to come to the hospital and deliver the baby.

Davis said she’d told her doctor on more than one occasion that she was opposed to inducing labor early. Eventually, she reached her wits’ end.

“It was ridiculous,” said Davis, 33. “I don’t feel heard most of the time. I feel like it’s their way or no way, you know? Like you don’t have a choice.”

Davis had given birth twice before and knew from experience that Black women, like herself, and their infants face higher health risks during pregnancy and childbirth. In 2021, Davis lost a baby in the womb after a dangerous pregnancy complication in her first trimester.

“I was very fearful that the same thing would happen,” Davis said when she found out in late 2022 that she was pregnant again.

Her fears weren’t unfounded. Across South Carolina, Black infant and maternal deaths are troubling. About an hour and a half northwest of Charleston in Orangeburg County, the infant death rate was the highest in the state in 2021. Higher, in fact, than it was 50 years earlier in 1971, according to data California Healthline obtained via a Freedom of Information Act request from the state health department. All but one of the 17 infants who died in 2021 in Orangeburg was Black.

Statistics like this scared Davis. But it was a horror story out of Georgia that really caught her attention: In July, a Black infant was decapitated during delivery by an obstetrician who allegedly used excessive force. Davis was eight months pregnant when the news broke.

“Something’s terribly wrong,” she recalled thinking.

‘Moving in the Wrong Direction’

Being Black has always been dangerous for pregnant women and infants in the South. The origin story of modern reproductive medicine can be traced to experiments conducted on Black enslaved women in Alabama during the 1840s by physician J. Marion Sims, the so-called Father of Gynecology, who subjected his patients to painful pelvic surgeries without anesthesia and drugged them with opium.

Sims, a native South Carolinian who is memorialized on the Statehouse grounds in Columbia, is credited with inventing an early version of the vaginal speculum, which he designed after probing an enslaved woman named Betsey with the bent handle of a spoon.

Fast-forward nearly 200 years, following a legacy of systemic discrimination that has prevented some Black families from getting health care: Poor outcomes for Black women and babies across the United States are alarmingly high compared with white patients.

These problems aren’t unique to the South. In places such as Kansas, Arizona, and Wisconsin, for example, Black infants die at more than double the rate of white babies. In Flint, Michigan, where more than half of residents are Black, the infant mortality rate for all babies in 2021 exceeded the rate in any Southern state.

But in Deep South states like South Carolina, Louisiana, and Mississippi, infant mortality rates in rural counties, especially for Black babies, often resemble those in much poorer parts of the world.

Things are poised to get worse. More than one year after the U.S. Supreme Court issued its decision in Dobbs v. Jackson Women’s Health Organization, allowing state legislatures to outlaw abortion, most states in the South have passed either full or partial bans. Both research and preliminary data suggest this will further jeopardize Black women and babies.

In 2021, 42% of all reported abortions in the United States were obtained by Black women, accounting for a larger share than any other race, according to KFF data. And more than half of all Black Americans live in the South, where many of the country’s strictest abortion policies were enacted this year and last.

Already, birth rates in states that banned or restricted access to abortion have increased since the Dobbs ruling. State-level abortion bans will undoubtedly prove fatal for some people, particularly Black women and children, who are more likely to die before, during, and after childbirth than white women and children.

“There is so much anger,” said Kelli Parker, director of communications and marketing for the nonprofit Women’s Rights and Empowerment Network. “This type of legislation uniquely impacts women of color and other historically marginalized groups.”

In Texas, for example, infant mortality data from the Department of State Health Services shows the number of babies who died during their first year of life significantly increased after lawmakers passed a six-week abortion ban in 2021, according to data obtained by CNN through a public records request. In Texas, Black babies die before their 1st birthday at a rate more than twice that of white infants. That’s because the health of the mother often translates to the health of the infant, and Black women face much higher pregnancy risks, such as high blood pressure, stroke, and hemorrhage.

In South Carolina, where the state Supreme Court upheld a ban that outlaws abortion if fetal cardiac activity can be detected, non-Hispanic Black infants are also more than twice as likely to die during their first year than non-Hispanic white infants. And the state’s Black infant mortality rate increased by nearly 40% from 2017 to 2021.

Meanwhile, non-Hispanic Black women in South Carolina experienced a 67% higher pregnancy-related mortality ratio compared with their white counterparts in 2018 and 2019, according to the latest data from the state’s Maternal Morbidity and Mortality Review Committee.

“We have a lot of work to do,” said Sarah Knox, senior director of policy and advocacy at the nonprofit Children’s Trust of South Carolina. “Unfortunately, our latest data shows we are moving in the wrong direction.”

Most states haven’t released infant and maternal death data that reflects the impact of the Dobbs decision. But maternal health experts aren’t optimistic.

A KFF survey conducted this year of 569 OB-GYNs found that most doctors reported the Dobbs decision has worsened pregnancy-related mortality and exacerbated racial and ethnic inequities in maternal health.

But Dobbs isn’t the only factor. Across the South, public health experts point to a confluence of things: the closure of rural hospitals, the scarcity of doctors and midwives, the pervasiveness of obesity and chronic disease, and many states’ refusal to expand Medicaid under the Affordable Care Act.

In many cases, though, the intersection of poverty and structural racism in medicine is to blame for the deaths of Black women and their infants.

A KFF survey released this week found Black patients regularly said their health care provider assumed something about them without asking; suggested they were personally at fault for a health problem; ignored a direct request or question; or refused to prescribe them pain medication they thought they needed. More than half of all Black respondents also said they prepare to visit their health care provider by expecting insults or by being very careful about their appearance — or both.

“People are tired of being bullied by their providers,” said Tiffany Townsend, a midwife and the owner of De la Flor Midwifery in Columbia, South Carolina.

In the KFF survey, Black women reported the highest rates of unfair treatment, with 1 in 5 saying a health care provider treated them differently because of their racial or ethnic background. And about twice as many Black adults who were pregnant or gave birth in the past decade said they were refused pain medicine they thought they needed compared with white adults.

The nation’s Black maternal mortality rate is almost three times as high as the rate for white women. Townsend, one of the few Black midwives practicing in South Carolina, said that’s because doctors often ignore their patients’ complaints until it’s too late.

“They don’t listen,” she said.

‘Using Their Voice’

In March 2012, Kim Smith was about 22 weeks pregnant when she felt an “unbelievable pain” in the upper-right side of her abdomen. She was immediately admitted to a hospital in Lexington, South Carolina, where she was diagnosed with HELLP syndrome, a severe case of a pregnancy condition called preeclampsia, which is marked by high blood pressure. She’d been tested for preeclampsia a few weeks earlier and the results were negative.

While the preeclampsia rate is much higher among Black women than white women, the diagnosis still came as a shock to Smith, who liked to run, taught aerobics classes in college, and thought of herself as a healthy person. She hadn’t considered the possibility of a high-risk pregnancy.

“I was placed in a wheelchair and rushed to get an ultrasound,” she remembered after arriving at the emergency room. The first ultrasound showed a faint heartbeat, but within a few minutes, it had stopped. Smith was prepped for labor and delivery, but it was too late. The baby she had named Lauren Kelly didn’t survive.

More than half of all 516 fetal deaths reported that year in South Carolina were linked to Black mothers.

The loss of her daughter devastated Smith. She has since given birth to three boys and channeled the pain of her first pregnancy into the development of a patient navigation app called “Lauren,” funded by the South Carolina Research Authority, which she hopes will be used to spare other women from a similar loss.

The app is designed to allow pregnant and postpartum women to track their stress levels and vital signs, including their blood pressure, and to automatically relay those readings to their physicians. While not a diagnostic tool, Smith intends for the app to empower patients with real-time information so they can identify potential problems early and use it to advocate for themselves.

“You have to use your voice. You have to speak up,” said Smith, who wants the Lauren app to be made available free to pregnant women enrolled in Medicaid. “I’m still finding that people are not using their voice when they go into the doctor’s.”

New Research

Across the South, researchers are trying to identify solutions to improve health outcomes for mothers and babies. “Nothing seems to be moving the needle,” said Joseph Biggio, a maternal-fetal specialist at Ochsner Health in New Orleans.

The National Institutes of Health recently awarded Ochsner Health and its partners a $16.5 million grant to establish the Southern Center for Maternal Health Equity to address Louisiana’s high maternal mortality rate. Part of that research will involve finding ways to deliver care in rural parts of the state where hospitals have closed, high-risk specialists don’t exist, and pregnant women are disproportionately Black.

Biggio said the new research center will also compare birth outcomes in Louisiana to those in neighboring Mississippi, where infant and maternal mortality rates are the highest in the country, according to the Centers for Disease Control and Prevention.

A key difference between these two Deep South states: Lawmakers in Louisiana have expanded access to the Medicaid program under the Affordable Care Act, while lawmakers in Mississippi haven’t.

Women in most states who qualify for Medicaid during pregnancy are also covered for 12 months after they give birth. But every year, many childless women in Southern states are not eligible for the low-income health insurance program until they become pregnant. Medicaid expansion, as it was designed under the Affordable Care Act, would fill this gap by loosening eligibility restrictions, but most states in the South haven’t adopted the expansion.

Some health care policy experts believe that covering women before they become pregnant and between pregnancies would reduce the burden of obesity, diabetes, and hypertension, and the risks those conditions pose to women and infants.

Tracking long-term improvement is crucial because success won’t be achieved overnight, said John Simpkins, president of the North Carolina-based MDC, a nonprofit focused on improving racial equity and economic mobility in the South.

“If we’re talking about population health improvements, then really the intervention should be beginning with kids who are being born right now, and following them through adulthood, and then probably their kids,” Simpkins said. Medicaid expansion, for example, could raise families out of poverty, but those benefits might not be realized for another generation, he said.

“I’ve found that the things that work the most are sustained investment over time,” he said.

But this work isn’t relegated to the South. In the majority-Black city of Flint, Michigan, for example, researchers are poised to launch in 2024 a multiyear project called Rx Kids to determine if direct, unrestricted cash payments to pregnant women and new moms improve birth outcomes.

“This is standard in other countries. This is common, basic sense,” said Mona Hanna-Attisha, a pediatrician and the associate dean of public health at the Michigan State University College of Human Medicine, who is leading the Flint research.

Poverty tends to peak just before a woman gives birth, she said, and the project in Flint will attempt to offset that hardship by offering every woman in the city who becomes pregnant, regardless of race, a payment of $1,500 at the halfway point of her pregnancy and then an additional $500 a month during the first year of her infant’s life, for a total of $7,500.

“This is designed to address this critical window, both economically and neurodevelopmentally,” Hanna-Attisha said. “It’s fundamentally how we are supposed to take care of each other. And it is not revolutionary.”

‘Extra Bad for Black Women’

Back in Charleston, the first seeds of concern had been planted during the first half of O’laysha Davis’ pregnancy when, she said, an OB-GYN prescribed a drug to control high blood pressure. She’d declined to take it — against her doctor’s guidance — because her blood pressure is normally “up and down,” she said. It wasn’t unusual for her reading to be high at the doctor’s office and normal at home, a common phenomenon known as “white coat hypertension.”

But high blood pressure during pregnancy, if left untreated, can be fatal for moms and babies. Along with medication, Davis’ doctor recommended delivering the infant a few weeks before her due date to avoid complications.

It wasn’t necessarily bad medical advice, but Davis feared the risks associated with inducing labor early, knowing that babies born after 39 weeks of gestation are generally healthier.

“I’m not getting an induction. Don’t schedule me,” she told the doctor.

Her OB-GYN scheduled one anyway. But on the morning of the scheduled induction, Davis received mixed messages from the hospital. First, there wasn’t a hospital bed available, so they told her not to come in. Later that day, though, in phone calls to Davis and her emergency contact, they advised that she come in immediately.

Finally, Davis said, she lost trust in her medical team. Compelled to find someone who would listen, she Googled the names of midwives in Charleston.

Davis reached midwife Nicole Lavallee by phone.

“I have the same conversation multiple times a week,” Lavallee said, with women who feel their medical team has stopped listening to them. “It’s extra bad for Black women.”

Lavallee connected Davis with a doula, then helped her make an appointment at another birthing hospital in Charleston.

Davis avoided an induction. She felt the first pains of labor at home and then delivered her baby — a girl named Journee Divine — on Aug. 31, a few days shy of her due date, at the Medical University of South Carolina.

“I labored at home, which is what I wanted to do to begin with,” she said. “I’m going to do it my way.”

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.