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‘It Was a Bloodbath’: Rare Dialysis Complication Can Kill, and More Could Be Done To Stop It

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by Brett Kelman
Fri, 07 Jul 2023 09:00:00 +0000

Nieltje Gedney was half-asleep in her Virginia home, watching murder mysteries over the hum of a bedside hemodialysis machine, when she felt something warm and wet in her armpit.

A needle inserted into her arm had fallen loose, breaking a circuit that the machine used to clean her blood. It was still pumping, drawing and filtering blood as designed, but the blood was now spilling into her bed instead of returning to her body.

Gedney, a leader of the Home Dialyzors United support group, knew what to do. Armed with a decade of experience with hemodialysis, she calmly applied pressure to her arm and pressed a red button that turned off the pump. Her blood loss stopped. In the seconds her needle was loose, Gedney's blood had soaked through her pajamas, bedsheets, and quilt.

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“I sat up and looked down, and I was literally covered in blood,” said Gedney, 71. “It was a bloodbath.”

On that frightful night last year, Gedney survived a rare and very dangerous complication of hemodialysis — a venous needle dislodgment, or VND. About 500,000 Americans with kidney failure rely on hemodialysis to mimic the function of healthy kidneys by pumping their blood through an external cleaning machine. If the venous needle dislodges, the machine continues to pump and clean blood, but the blood escapes. The patient is methodically drained and, unless someone intervenes, can die in minutes.

By some estimates, at least one American is killed this way every week.

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A relatively simple solution is available in Europe: An alarm detects blood loss with a disposable sensor patch, then automatically shuts off the dialysis pump. Dialysis companies in the United States have not embraced this fail-safe technology, so it is largely unavailable to Americans. The alarm costs $649 and each patch about $2.25. Neither is covered by Medicare, which insures most dialysis .

“That's the ugly side of dialysis,” said Debbie Brouwer-Maier, a 40-year dialysis nurse and member of the American Nephrology Nurses Association's VND task force. She said the dialysis industry resists “any item that's going to improve care if there is added cost.”

“The patch is the problem,” Brouwer-Maier said. “It's a disposable you have to buy without being reimbursed for every single treatment the patient does.”

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Currently, most American dialysis treatment occurs in a nationwide network of clinics where patients sit in rows of chairs for hours at a time about three times a week. Only about 2% of patients undergo hemodialysis at home, sometimes with the aid of family or a caregiver.

But hemodialysis is changing: The Trump and Biden administrations promoted home dialysis with increased Medicare payments. A new generation of portable machines offer better results, more independence, and a lower overall cost to the and insurers. Home patients can be treated more often or for longer periods, putting less stress on their bodies, and may find it easier to travel or keep a day job.

Dialysis experts and patient advocates interviewed for this article agreed that many hemodialysis patients, if carefully selected and thoroughly trained, would benefit greatly from the momentum toward home care. Some also worry that no amount of training could erase the increased threat of needle dislodgment for those who dialyze at home while alone or asleep.

“It is the widowmaker heart attack of dialysis,” said Ankur Shah, a Brown University nephrologist. “If you have a VND at home, and you go one or two minutes before you recognize it, you are now trying to intervene while you are physically going into shock.”

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Shah's concerns are shared by others. In 2020, the nurse association task force found that patients who do hemodialysis at home or while asleep “may be at higher risk.” ECRI, a nonprofit focused on safety, named needle dislodgments a top health hazard for 2023 with a “particular concern” for patients at home. Both said dialysis machines don't reliably detect dislodgments, so blood pumps cannot be counted on to turn themselves off.

Ismael Cordero, an ECRI engineer who evaluates medical devices, said the absence of an automatic shut-off may also endanger patients in dialysis clinics, where a patient's blanket could obscure a loose needle or staff members may not react in time.

Decades ago, Cordero witnessed a few dislodgments while working his way through college at a clinic in Pennsylvania. It was his job to mop up the blood.

“If that needle slips out, and no alarm goes off, and nobody notices, then within 10 minutes that patient would lose all of their blood,” he said.

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Two companies make hemodialysis machines that the FDA has approved for home use.

Outset Medical, whose Tablo machines resemble a mini-fridge and were approved for home use in 2020, said in response to emailed questions that it has received no reports of VNDs among Tablo patients at home. The company said it believes VNDs may be more common or dangerous in a clinical setting than at home because staffers monitor multiple patients who are “frequently sleeping under blankets” and “completely disengaged from their treatment.”

“At home, a patient has been trained to manage themselves, including this rare ,” the company said in an email. “And despite the potential severity of the event, the treatment is simple and a procedure the patient performs every time they dialyze. Stop the blood pump.”

Fresenius, one of the world's largest dialysis companies, which has sold NxStage hemodialysis machines for home use in the U.S. since 2005, declined to comment.

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Despite the lethality of venous needle dislodgments, there is no accounting of how often they occur. The National Institutes of Health maintains voluminous data on kidney failure and dialysis patients but does not track VND in clinics or at home. The Centers of Medicare & Medicaid Services requires dialysis companies to log them internally but not to report them to the government or the public.

But research shows they do happen. A 2017 study by researchers in Portugal reported 88 venous needle dislodgments among about 733,000 dialysis sessions in one year. A 2012 survey of more than 1,100 dialysis nurses reported that 76% witnessed a dislodgment in the prior five years, and 8% said they had seen five or more. A 2008 study of dialysis clinics run by the Health Administration found 47 needle dislodgments or similar disconnects among 2.5 million sessions over a six-year span, including many that required hospitalization and some that were fatal.

Redsense Medical, a Swedish company that makes dialysis safety products, estimates that needle dislodgment kills three Americans and 21 people globally each week. But these estimates are extrapolated from a mid-2000s study from a single Pittsburgh hospital — one of the few efforts in the U.S. to count them.

Redsense's signature product is a stand-alone alarm system, used by some clinics and home patients in the U.S., Canada, Europe, and Australia. The system detects a needle dislodgment with a blood sensor patch, then sounds an alarm and flashes red lights to alert someone to turn off the pump.

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But these alarms could be doing more. Since 2017, some Redsense alarms have also been able to send a signal that will automatically turn off a blood pump without human intervention. This fail-safe was requested by dialysis clinics in Europe, said Redsense Pontus Nobréus, but it has never been submitted to the FDA for approval because no companies showed interest in using it in the United States.

Currently, no hemodialysis machine used in the U.S. is programmed to respond to the shut-off signal, Nobréus said.

“It hasn't been used to its full potential, which is a pity,” Nobréus said. “We can send a signal to the machine, but the manufacturer has to have the software integrated to actually tell the machine to stop.”

Although Redsense alarms are not covered by Medicare, new legislation could change that. In May, Rep. Adrian Smith (R-Neb.) and Rep. Melanie Stansbury (D-N.M.) introduced the “Home Dialysis Risk Prevention Act,” which would extend Medicare coverage to VND alarms and related supplies for home patients only.

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The bill was motivated in part by rural constituents who hours to dialysis clinics, Smith said, and he believes Medicare coverage lags far behind the latest dialysis technology.

“We want our public policy to be parallel with what technology can deliver,” Smith said, “and more than that, encourage innovation and more technology that will ultimately help patients.”

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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By: Brett Kelman
Title: ‘It Was a Bloodbath': Rare Dialysis Complication Can Kill, and More Could Be Done To Stop It
Sourced From: kffhealthnews.org/news/article/dialysis-hemodialysis-complication-vnd-needles/
Published Date: Fri, 07 Jul 2023 09:00:00 +0000

Did you miss our previous article…
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Kaiser Health News

Democrats Seek To Make GOP Pay for Threats to Reproductive Rights

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Samantha Liss
Fri, 10 May 2024 09:00:00 +0000

ST. CHARLES, Mo. — Democrat Lucas Kunce is to pin reproductive care restrictions on Sen. Josh Hawley (R-Mo.), betting it will boost his chances of unseating the incumbent in November.

In a recent ad campaign, Kunce accuses Hawley of jeopardizing reproductive care, in vitro fertilization. Staring straight into the camera, with tears in her eyes, a Missouri mom identified only as Jessica recounts how she struggled for years to conceive.

“Now there are efforts to ban IVF, and Josh Hawley got them started,” Jessica says. “I want Josh Hawley to look me in the eye and tell me that I can't have the child that I deserve.”

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Never mind that IVF is legal in Missouri, or that Hawley has said he supports limited access to abortion as a “pro-life” Republican. In key races across the country, Democrats are branding their Republican rivals as threats to women's after a broad erosion of reproductive rights since the Supreme Court struck down , including near-total state abortion bans, efforts to restrict medication abortion, and a court ruling that limited IVF in Alabama.

On top of the messaging campaigns, Democrats hope ballot measures to guarantee abortion rights in as many as 13 states — including Missouri, Arizona, and Florida — will boost turnout in their favor.

The issue puts the GOP on the defensive, said J. Miles Coleman, an election analyst at the of Virginia.

“I don't really think have found a great way to respond to it yet,” he said.

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Abortion is such a salient issue in Arizona, for example, that election analysts say a U.S. House seat occupied by Republican Juan Ciscomani is now a toss-up.

Hawley appears in less peril, for now. He a wide lead in polls, though Kunce outraised him in the most recent quarter, raking in $2.25 million in donations compared with the incumbent's $846,000, according to campaign finance reports. Still, Hawley's war chest is more than twice the size of Kunce's.

Kunce, a Marine veteran and antitrust advocate, said he likes his odds.

“I just don't think we're gonna lose,” he told KFF Health . “Missourians want freedom and the ability to control their own lives.”

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Hawley's campaign declined to comment. He has backed a federal ban on abortion after 15 weeks and has said he supports exceptions for rape and incest and to protect the lives of pregnant women. Missouri's state ban is near total, with no exceptions for rape or incest.

“This is Josh Hawley's life's mission. It's his family's business,” Kunce said, a nod to Erin Morrow Hawley, the senator's wife, a lawyer who argued before the Supreme Court in March on behalf of activists who sought to limit access to the abortion pill mifepristone.

State abortion rights have won out everywhere they've been on the ballot since the end of Roe in 2022, including in Republican-led Kentucky and Ohio.

An abortion rights ballot initiative is also expected in Montana, where a Republican to Democrat Jon Tester could decide control of the Senate.

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On a late-April Saturday along historic Main Street in St. Charles, Missouri, people holding makeshift clipboards fashioned from yard signs from past elections invited locals strolling brick sidewalks to sign a petition to get the initiative on Missouri ballots. Nearby, diners enjoyed lunch on a patio tucked under a canopy of trees in this affluent St. Louis suburb.

Missouri was the first state to ban abortion after Roe fell; it is outlawed except in “cases of medical emergency.” The measure would add the right to abortion to the state constitution.

Larry Bax, 65, of St. Charles County, said he votes Republican most of the time but signed the ballot measure petition along with his wife, Debbie Bax, 66.

“We were never single-issue voters. Never in our life,” he said. “This has made us single-issue because this is so wrong.”

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They won't vote for Hawley this fall, they said, but are unsure if they'll support the Democratic nominee.

Jim Seidel, 64, who lives in Wright City, 50 miles west of St. Louis, also signed the petition. He said he believes Missourians deserve the opportunity to vote on the issue.

“I've been a Republican all my life until just recently,” Seidel said. “It's just gone really wacky.”

He plans to vote for Kunce in November if he wins the Democratic primary in August, as seems likely. Seidel previously voted for a few Democrats, including Bill Clinton and Claire McCaskill, whom Hawley unseated as senator six years ago.

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“Most of the time,” he added, Hawley is “strongly in the wrong camp.”

Over about two hours in conservative St. Charles, KFF Health News observed only one person actively declining to sign the petition. The woman told the volunteers she and her family opposed abortion rights and quickly walked away. The Catholic Church has discouraged voters from signing. At St. Joseph Parish in a nearby suburb, for example, a sign flashed: “Decline to Sign Reproductive Health Petition!”

The ballot measure organizers turned in more than twice the required number of signatures May 3, though, and now await certification from the secretary of state's office.

Larry Bax's concern goes beyond abortion and the ballot measure in Missouri. He worries about more governmental limits on reproductive care, such as on IVF or birth control. “How much further can that reach extend?” he said. Kunce is banking on enough voters feeling like Bax and Seidel to get an upset similar to the one that occurred in 2012 for the same seat — also over abortion. McCaskill defeated Republican Todd Akin that year, largely because of his infamous response when asked about abortion: “If it's a legitimate rape, the female body has ways to try to shut that whole thing down.”

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——————————
By: Samantha Liss
Title: Democrats Seek To Make GOP Pay for Threats to Reproductive Rights
Sourced From: kffhealthnews.org/news/article/democrats-campaign-reproductive-rights-abortion/
Published Date: Fri, 10 May 2024 09:00:00 +0000

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Their First Baby Came With Medical Debt. These Illinois Parents Won’t Have Another.

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Noam N. Levey
Fri, 10 May 2024 09:00:00 +0000

JACKSONVILLE, Ill. — Heather Crivilare was a month from her due date when she was rushed to an operating room for an emergency cesarean section.

The first-time mother, a high school teacher in rural Illinois, had developed high blood pressure, a sometimes life-threatening condition in pregnancy that prompted to hospitalize her. Then Crivilare's blood pressure spiked, and the baby's heart rate dropped. “It was terrifying,” Crivilare said.

She gave birth to a healthy daughter. What followed, though, was another ordeal: thousands of dollars in medical debt that sent Crivilare and her husband scrambling for nearly a year to keep collectors at bay.

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The Crivilares would eventually get on nine payment plans as they juggled close to $5,000 in bills.

“It really felt like a full-time job some days,” Crivilare recalled. “Getting the baby down to sleep and then getting on the phone. I'd set up one payment plan, and then a new bill would come that afternoon. And I'd have to set up another one.”

Crivilare's pregnancy may have been more dramatic than most. But for millions of new , medical debt is now as much a hallmark of as long nights and dirty diapers.

About 12% of the 100 million U.S. adults with health care debt attribute at least some of it to pregnancy or childbirth, according to a KFF poll.

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These people are more likely to report they've had to take on extra work, change their living situation, or make other sacrifices.

Overall, women between 18 and 35 who have had a baby in the past year and a half are twice as likely to have medical debt as women of the same age who haven't given birth recently, other KFF research conducted for this project found.

“You feel bad for the patient because you know that they want the best for their pregnancy,” said Eilean Attwood, a Rhode Island OB-GYN who said she routinely sees pregnant women anxious about going into debt.

“So often, they may be coming to the office or the hospital with preexisting debt from school, from other financial pressures of starting adult life,” Attwood said. “They are having to make real choices, and what those real choices may entail can include the choice to not get certain services or medications or what may be needed for the care of themselves or their fetus.”

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Best-Laid Plans

Crivilare and her husband, Andrew, also a teacher, anticipated some of the costs.

The young couple settled in Jacksonville, in part because the farming community less than two hours north of St. Louis was the kind of place two public school teachers could afford a house. They saved aggressively. They bought life insurance.

And before Crivilare got pregnant in 2021, they enrolled in the most robust health insurance plan they could, paying higher premiums to minimize their deductible and out-of-pocket costs.

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Then, two months before their baby was due, Crivilare learned she had developed preeclampsia. Her pregnancy would no longer be routine. Crivilare was put on blood pressure medication, and doctors at the local hospital recommended bed rest at a larger medical center in Springfield, about 35 miles away.

“I remember thinking when they insisted that I ride an ambulance from Jacksonville to Springfield … ‘I'm never going to financially recover from this,'” she said. “‘But I want my baby to be OK.'”

For weeks, Crivilare remained in the hospital alone as covid protocols limited visitors. Meanwhile, doctors steadily upped her medications while monitoring the fetus. It was, she said, “the scariest month of my life.”

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Fear turned to relief after her daughter, Rita, was born. The baby was small and had to spend nearly two weeks in the neonatal intensive care unit. But there were no complications. “We were incredibly lucky,” Crivilare said.

When she and Rita finally came home, a stack of medical bills awaited. One was already past due.

Crivilare rushed to set up payment plans with the hospitals in Jacksonville and Springfield, as well as the anesthesiologist, the surgeon, and the labs. Some providers demanded hundreds of dollars a month. Some settled for monthly payments of $20 or $25. Some pushed Crivilare to apply for new credit cards to pay the bills.

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“It was a blur of just being on the phone constantly with all the different people collecting money,” she recalled. “That was a nightmare.”

Big Bills, Big Consequences

The Crivilares' bills weren't unusual. Parents with private health coverage now face on average more than $3,000 in medical bills related to a pregnancy and childbirth that aren't covered by insurance, researchers at the University of Michigan found.

Out-of-pocket costs are even higher for families with a newborn who needs to stay in a neonatal ICU, averaging $5,000. And for 1 in 11 of these families, medical bills related to pregnancy and childbirth exceed $10,000, the researchers found.

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“This forces very difficult trade-offs for families,” said Michelle Moniz, a University of Michigan OB-GYN who worked on the study. “Even though they have insurance, they still have these very high bills.”

Nationwide polls suggest millions of these families end up in debt, with sometimes devastating consequences.

About three-quarters of U.S. adults with debt related to pregnancy or childbirth have cut spending on food, clothing, or other essentials, KFF polling found.

About half have put off buying a home or delayed their own or their children's education.

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These burdens have spurred calls to limit what families must pay out-of-pocket for medical care related to pregnancy and childbirth.

In , state Sen. Cindy Friedman has proposed legislation to exempt all these bills from copays, deductibles, and other cost sharing. This would parallel federal rules that require health plans to cover recommended preventive services like annual physicals without cost sharing for . “We want … healthy children, and that starts with healthy mothers,” Friedman said. Massachusetts health insurers have warned the proposal will raise costs, but an independent state analysis estimated the bill would add only $1.24 to monthly insurance premiums.

Tough Lessons

For her part, Crivilare said she wishes new parents could catch their breath before paying down medical debt.

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“No one is in the right frame of mind to deal with that when they have a new baby,” she said, noting that college graduates get such a break. “When I graduated with my college degree, it was like: ‘Hey, new adult, it's going to take you six months to kind of figure out your life, so we'll give you this six-month grace period before your student loans kick in and you can get a job.'”

Rita is now 2. The scraped by on their payment plans, retiring the medical debt within a year, with help from Crivilare's side job selling resources for teachers online.

But they are now back in debt, after Rita's recurrent ear infections required surgery last year, leaving the family with thousands of dollars in new medical bills.

Crivilare said the stress has made her think twice about seeing a doctor, even for Rita. And, she added, she and her husband have decided their family is complete.

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“It's not for us to have another child,” she said. “I just hope that we can put some of these big bills behind us and give [Rita] the life that we want to give her.”

About This Project

“Diagnosis: Debt” is a 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 , 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.

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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 , consumer advocates, debt lawyers, and researchers; and reviewed scores of studies and surveys about medical debt.

——————————
By: Noam N. Levey
Title: Their First Baby Came With Medical Debt. These Illinois Parents Won't Have Another.
Sourced From: kffhealthnews.org/news/article/babies-come-with-medical-debt/
Published Date: Fri, 10 May 2024 09:00:00 +0000

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KFF Health News’ ‘What the Health?’: Newly Minted Doctors Are Avoiding Abortion Ban States

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Thu, 09 May 2024 19:30:00 +0000

The Host

Julie Rovner
KFF Health


@jrovner


Read Julie's stories.

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Julie Rovner is chief Washington correspondent and host of KFF Health News' weekly health policy news , “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care and Policy A to Z,” now in its third edition.

A new analysis finds that graduating medical students were less likely to apply this year for residency in states that ban or restrict . That was true not only for aspiring OB-GYNs and others who regularly treat pregnant patients, but for all specialties.

Meanwhile, another study has found that more than 4 million children have been terminated from Medicaid or the Children's Health Insurance Program since the federal ended a covid-related provision barring such disenrollments. The study estimates about three-quarters of those children were still eligible and were kicked off for procedural reasons.

This week's panelists are Julie Rovner of KFF Health News, Lauren Weber of The Washington Post, Joanne Kenen of the Johns Hopkins University schools of nursing and public health and Politico Magazine, and Anna Edney of Bloomberg News.

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Panelists

Anna Edney
Bloomberg


@annaedney


Read Anna's stories.

Joanne Kenen
Johns Hopkins University and Politico

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@JoanneKenen


Read Joanne's articles.

Lauren Weber
The Washington Post


@LaurenWeberHP

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Read Lauren's stories.

Among the takeaways from this week's episode:

  • More medical students are avoiding applying to residency programs in states with abortion restrictions. That could worsen access problems in that already don't have enough doctors and other health providers in their communities.
  • New threats to abortion care in the United States include not only state laws penalizing abortion pill possession and abortion travel, but also online misinformation campaigns — which are trying to discourage people from supporting abortion ballot measures by telling them lies about how their information might be used.
  • The latest news is out on the fate of Medicare, and a pretty robust appears to have bought the program's trust fund another five years. Still, its overall health depends on a long-term solution — and a long-term solution depends on Congress.
  • In Medicaid expansion news, Mississippi lawmakers' latest attempt to expand the program was unsuccessful, and a report shows two other nonexpansion states — and Florida — account for about 40% of the 4 million kids who were dropped from Medicaid and CHIP last year. By not expanding Medicaid, holdout states say no to billions of federal dollars that could be used to health care for low-income residents.
  • Finally, the bankruptcy of the hospital chain Steward Health Care tells a striking story of what happens when private equity invests in health care.

Also this week, Rovner interviews KFF Health News' Katheryn Houghton, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” feature, about a patient who went outside his insurance network for a surgery and thought he had covered all his bases. It turned out he hadn't. If you have an outrageous or incomprehensible medical bill you'd like to share with us, you can do that here.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: The Nation's “The Abortion Pill Underground,” by Amy Littlefield.

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Joanne Kenen: The New York Times' “In Medicine, the Morally Unthinkable Too Easily Comes to Seem Normal,” by Carl Elliott.

Anna Edney: ProPublica's “Facing Unchecked Syphilis Outbreak, Great Plains Tribes Sought Federal Help. Months Later, No One Has Responded,” by Anna Maria Barry-Jester.

Lauren Weber: Stat's “NYU Professors Who Defended Vaping Didn't Disclose Ties to Juul, Documents Show,” by Nicholas Florko.

Also mentioned on this week's podcast:

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Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News' “What the Health?” on SpotifyApple PodcastsPocket Casts, or wherever you listen to podcasts.

——————————
Title: KFF Health News' ‘What the Health?': Newly Minted Doctors Are Avoiding Abortion Ban States
Sourced From: kffhealthnews.org/news/podcast/what-the-health-346-abortion-ban-residency-decline-may-9-2024/
Published Date: Thu, 09 May 2024 19:30:00 +0000

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