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Thousands of Children Got Tested for Lead With Faulty Devices: What Parents Should Know

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Julie Appleby, KFF Health
Fri, 07 Jun 2024 09:00:00 +0000

A company that makes tests for lead poisoning has agreed to resolve criminal charges that it concealed for years a malfunction that resulted in inaccurately low results.

It's the latest in a long-running saga involving Massachusetts-based Magellan Diagnostics, which will pay $42 million in penalties, according to the Department of Justice.

While many of the fault-prone devices were used from 2013 to 2017, some were being recalled as late as 2021. The Justice Department said the malfunction produced inaccurate results for “potentially tens of thousands” of children and other patients.

Doctors don't consider any level of lead in the blood to be safe, especially for children. Several U.S. cities, including Washington, D.C., and Flint, Michigan, have struggled with widespread lead contamination of their water supplies in the last two decades, making accurate tests critical for public .

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It's possible faulty Magellan kits were used to test children for lead exposure into the early 2020s, based on the recall in 2021. Here's what parents should know.

What tests were affected?

The inaccurate results came from three Magellan devices: LeadCare Ultra, LeadCare II, and LeadCare Plus. One, the LeadCare II, uses finger-stick samples primarily and accounted for more than half of all blood lead tests conducted in the U.S. from 2013 to 2017, according to the Justice Department. It was often used in physician offices to check children's lead levels.

The other two could also be used with blood drawn from a vein and may have been more common in labs than doctor's offices. The company “first learned that a malfunction in its LeadCare Ultra device could cause inaccurate lead test results – specifically, lead test results that were falsely low” in June 2013 while seeking regulatory clearance to sell the product, the DOJ said. But it did not disclose that information and went on to market the tests, according to the settlement.

The agency said 2013 testing indicated the same flaw affected the LeadCare II device. A 2021 recall included most of all three types of test kits distributed since October 27, 2020.

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The company said in a press release announcing the resolution that “the underlying issues that affected the results of some of Magellan's products from 2013 to 2018 have been fully and effectively remediated,” and that the tests it currently sells are safe.

What does a falsely low result mean?

Children are often tested during pediatrician visits at age 1 and again at age 2. Elevated lead levels can put kids at risk of developmental delay, lower IQ, and other problems. And symptoms, such as stomachache, poor appetite, or irritability, may not appear until high levels are reached.

Falsely low test results could mean parents and physicians were unaware of the problem.

That's a concern because treatment for lead poisoning is, initially, mainly preventive. Results showing elevated levels should prompt parents and health officials to determine the sources of lead and take steps to prevent continued lead intake, said Janine Kerr, health educator with the Virginia Department of Health's Childhood Lead Poisoning Prevention Program.

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Children can be exposed to lead in a variety of ways, including by drinking water contaminated with lead from old pipes, such as in Flint and Washington; ingesting lead-based paint flakes often found in older homes; or, as reported recently, eating some brands of cinnamon-flavored applesauce.

What should parents do now?

“Parents can contact their child's pediatrician to determine if their child had a blood lead test with a LeadCare device” and discuss whether a repeat blood lead test is needed, said Maida Galvez, a pediatrician and professor at the Icahn School of Medicine at Mount Sinai in New York.

During an earlier recall of some Magellan devices, in 2017, the Centers for Disease Control and Prevention recommended that patients be retested if they were pregnant, nursing, or children younger than 6 and had a blood lead level of less than 10 micrograms per deciliter as determined by a Magellan device from a venous blood draw.

The 2021 recall of Magellan devices recommended retesting children whose results were less than the current CDC reference level of 3.5 micrograms per deciliter. Many of those tests were of the finger-stick variety.

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Kerr, at the Virginia health department, said her agency has not had many calls about that recall.

The finger-stick tests “are not that widely used in Virginia,” said Kerr, adding that “we did get a lot of questions about the applesauce recall.”

In any case, she said, the “best course of action for parents is to talk with a health care provider.”

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By: Julie Appleby, KFF
Title: Thousands of Children Got Tested for Lead With Faulty Devices: What Parents Should Know
Sourced From: kffhealthnews.org/news/article/children-lead-testing-doj-settlement-faulty-devices/
Published Date: Fri, 07 Jun 2024 09:00:00 +0000

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Kaiser Health News

KFF Health News’ ‘What the Health?’: Live From Aspen: Health and the 2024 Elections

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Fri, 21 Jun 2024 16:20:00 +0000

The Host

Julie Rovner
KFF


@jrovner


Read Julie's stories.

Julie Rovner is chief Washington correspondent and host of KFF ' 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 Politics and Policy A to Z,” now in its third edition.

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The presidential election is less than five months away, and while abortion is the only health policy issue expected to play a leading role, others are likely to be raised in the presidential and down-ballot races. This election could be critical in determining the future of key health care programs, such as Medicaid and the Affordable Care Act.

In this special episode of KFF Health News' “What the Health?” taped at the Aspen Ideas: Health festival in Aspen, Colorado, Margot Sanger-Katz of The New York Times and Sandhya Raman of CQ Roll Call join Julie Rovner, KFF Health News' chief Washington correspondent, to discuss what the election season portends for top health issues.

Panelists

Margot Sanger-Katz
The New York Times


@sangerkatz


Read Margot's stories.

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Sandhya Raman
CQ Roll Call


@SandhyaWrites


Read Sandhya's stories.

Among the takeaways from this week's episode:

  • Policies surrounding abortion — and reproductive health issues, in general — likely will dominate in many races, as Democrats try to exploit an issue that is motivating their voters and dividing Republican voters. The topics of contraception and in vitro fertilization are playing a more prominent role in 2024 than they have in past elections.
  • High prescription drug prices — which, for frustrated Americans, are a longtime symbol, and symptom, of the nation's dysfunctional health care system — have been a priority for the Biden administration and, previously, the Trump administration. But the issue is so confusing and progress so incremental that it is hard to say whether either party has an advantage.
  • The fate of many major health programs will be determined by who wins the presidency and who controls Congress after this fall's elections. For example, the temporary subsidies that have made Affordable Care Act health plans more affordable will expire at the end of 2025. If the subsidies are not renewed, millions of Americans will likely be priced out of coverage again.
  • Previously hot-button issues like gun violence, opioid addiction, and mental health are not playing a high-profile role in the 2024 races. But that could change case by case.
  • Finally, huge health issues that could use public airing and debate — like what to do about the nation's crumbling long-term care system and the growing shortage of vital health professionals — are not likely to become campaign issues.

Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

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To hear all our click here.

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

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Title: KFF Health News' ‘What the Health?': Live From Aspen: Health and the 2024 Elections
Sourced From: kffhealthnews.org/news/podcast/what-the-health-352-health-policy-elections-aspen-festival-june-21-2024/
Published Date: Fri, 21 Jun 2024 16:20:00 +0000

Did you miss our previous article…
https://www.galvestontrendingnews.com/kaiser-health-news/super-bowl-parade-shooting-survivors-await-promised-donations-while-bills-pile-up/

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Super Bowl Parade Shooting Survivors Await Promised Donations While Bills Pile Up

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Peggy Lowe, KCUR and Bram Sable-Smith
Fri, 21 Jun 2024 09:00:00 +0000

Abigail Arellano keeps her son Samuel's medical bills in a blue folder in a cabinet above the microwave. Even now, four months after the 11-year-old was shot at the Kansas City Chiefs Super Bowl parade, the bills keep coming.

There's one for $1,040 for the ambulance ride to the hospital that February afternoon. Another for $2,841.17 from an emergency room visit they made three days after the shooting because his bullet wound looked infected. More follow-ups and counseling in March added another $1,500.

“I think I'm missing some,” Arellano said as she leafed through the pages.

The Arellanos are uninsured and counting on assistance from the fund that raised nearly $2 million in the aftermath of the shooting that left one dead and at least 24 other people with bullet wounds. She keeps that application in the blue folder as well.

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The medical costs incurred by the survivors of the shooting are hitting hard, and they won't end soon. The average medical spending for someone who is shot increases by nearly $30,000 in the first year, according to a Harvard Medical School study. Another study found that number goes up to $35,000 for children. Ten kids were shot at the parade.

Then there are life's ordinary bills — rent, utilities, car repairs — that don't stop just because someone survived a mass shooting, even if their injuries prevent them from working or sending kids to school.

The financial burden that comes with surviving is so common it has a name, according to Aswad Thomas of the nonprofit Alliance for Safety and Justice: victimization debt. Some pay it out-of-pocket. Some open a new credit card. Some find help from generous strangers. Others can't make ends meet.

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“We're really broke right now,” said Jacob Gooch Sr., another survivor, who was shot through the foot and has not yet been able to return to work.

“We're, like, exhausting our third credit card.”

As is common after mass shootings, a mosaic of new and established resources emerged in this Missouri city promising help. Those include the #KCStrong fund established by the United Way of Greater Kansas City, which is expected to begin paying victims at the end of June.

Survivors must navigate each opportunity to request help as best they can — and hope money comes through.

GoFundMes, Generous Strangers, and a New Line of Credit

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Mostly, it's the moms who keep the bills organized. Tucked above the microwave. Zipped inside a purse. Screenshots stored on a phone. And then there's a maze of paperwork: The Missouri state victims' compensation form is five pages, including instructions. It's another six pages for help from the United Way.

Emily Tavis keeps stacks of paperwork with color-coded binder clips in her basement: Black for her partner, Gooch Sr.; blue for her stepson, Jacob Gooch Jr.; pink for herself. All three were shot at the parade.

Tavis was able to walk after a bullet ripped through her leg, and she considered declining the ambulance ride because she was worried about the cost — she lacked insurance at the time.

Gooch Sr. was unable to walk because he'd been shot in the foot. So they shared an ambulance to the hospital with two of their kids.

Tavis and Gooch Sr. received separate $1,145 bills for the ambulance. Gooch Jr. did not, possibly because he has coverage through Medicaid, Tavis said.

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She sends the medical bills to victims' compensation, a program to help with the economic losses from a crime, such as medical expenses and lost wages. Even though Tavis and Gooch live in Leavenworth, Kansas, their compensation comes from the program in Missouri, where the shooting occurred.

The program pays only for economic losses not covered by other sources like health insurance, donations, and crowdsourced fundraisers. Gooch Sr. and Jr. both had health insurance at the time of the parade, so the family has been sending only the uncovered portion to victims' compensation.

The family initially received a lot of support. Friends and relatives made sure they had food to eat. The founder of an online group of Kansas City Chiefs fans sent $1,000 and gifts for the family. A GoFundMe page raised $9,500. And their tax refund helped.

They knew money might get tight with Gooch Sr. unable to work, so they paid three months' rent in advance. They also paid to have his Ford Escape fixed so he could eventually return to work and bought Tavis a used Honda Accord so she could drive to the job she started 12 days after the parade.

And because the donations were intended for the whole family, they decided to buy summer passes to the Worlds of Fun amusement park for the kids.

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But recently, they've felt stretched. Gooch Sr.'s short-term disability payments abruptly stopped in May when his health insurance prompted him to see an in-network doctor. He said the short-term disability plan initially didn't approve the paperwork from his new doctor and started an investigation. The issue was resolved in June and he was expecting back pay soon. In the interim, though, the couple opened a new credit card to cover their bills.

In the interim, the couple opened a new credit card to cover their bills.

“We've definitely been robbing Peter to pay Paul,” Tavis said.

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Ideally, the money that eventually comes from the United Way, victims' compensation, and, they hope, back pay from short-term disability will be enough to pay off their debts.

But, Tavis said, “You gotta do what you gotta do. We're not going to go without lights.”

United Way Payout Expected at End of June

With every mass shooting, donations for survivors inevitably flow in, “just like peanut butter goes with jelly, because people want to help,” said Jeff Dion, executive director of the Mass Violence Survivors Fund, a nonprofit that has helped many communities manage such funds.

Typically, he said, it takes about five months to disburse the money from these large community funds. Victims can potentially get money sooner if their community has a plan in place for these types of funds before a mass shooting. Funds may also advance money to people with urgent financial needs who are certain to qualify.

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The United Way hung banners in the Chiefs colors on Kansas City's Union Station with its #KCStrong campaign within days of the shootings. Driven by large donations from the team, the NFL, quarterback Patrick Mahomes, other individuals, and local companies, it ultimately raised more than $1.8 million.

The promise of a large payout has kept the injured hopeful, even as many felt confused by the process. Some people interviewed for this story did not wish to say anything negative, fearing it would hurt their allocation.

United Way officials announced in April that donations would be closed at the end of that month. On May 1, the organization posted a notice saying it would issue “claimant forms” and that the Jackson County Prosecutor's Office was helping verify shooting victims. The United Way affiliate's board of trustees plans to meet June 26 to determine allocations, with payments arriving as early as June 27.

Kera Mashek, a spokesperson for United Way of Greater Kansas City, said payouts will be made to 20 of the 24 shooting survivors. The other four either couldn't be verified as victims or turned down the funds, she said. Claimants do not include the 67 people prosecutors say were trampled in the melee, she said.

Pending board approval, money will also be disbursed to 14 community groups that support nonviolence initiatives, mental health concerns, and first responders, Mashek said.

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To criticism that the United Way didn't communicate well with the victims, Mashek said it tried to respond in a timely manner.

“We've tried to keep that line of communication open as fast as possible and most people have been very patient,” she said. “I think that they will be very grateful and very, I believe, pleasantly surprised with the amount of funding that they receive.”

Other Resources Available

Abigail Arellano hadn't heard of victims' compensation, which is common. A 2022 survey from the Alliance for Safety and Justice found that 96% of victims did not receive that support and many didn't know it existed.

Arellano and her husband, Antonio, didn't attend the parade but they've had medical expenses as well. Antonio has been going to therapy at a local health center to help with the stressful task of guiding his son through the trauma. It's been helpful. But he's been paying around $125 out-of-pocket for each session, he said, and the bills are mounting.

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One of Samuel's sisters set up a GoFundMe that raised $12,500, and Abigail said it helped that the family shared their story publicly and that Abigail reached out to help others in the Latino community affected by the shooting.

It was Abigail, for instance, who connected 71-year-old Sarai Holguin with the Mexican Consulate in Kansas City. The consulate, in turn, helped Holguin register as an official victim of the shooting, which will enable her to receive assistance from the United Way. Holguin's bills now include a fourth surgery, to remove the bullet lodged near her knee that she had previously made peace with living with forever — until it began protruding through her skin.

‘Generous and Quick' Relief to Victims

Several survivors were relieved and grateful to receive funds from a less high-profile, nondenominational group called “The Church Loves Kansas City.

The day after the shooting, Gary Kendall, who ran a Christian nonprofit called “Love KC,” started a text chain at 6 a.m. with city leaders and faith-based groups, and eventually received pledges of $184,500. (Love KC has now merged with another nonprofit, “Unite KC,” which is disbursing its funds.)

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The first payout went to the family of Lisa Lopez-Galvan, the 43-year-old mother of two and popular DJ who was the sole fatality during the parade shootings. Unite KC spent $15,000 on her burial expenses.

Unite KC spent $2,800 so James and Brandie Lemons could get their health insurance restored because James couldn't work. Unite KC also paid $2,200 for the out-of-pocket surgical costs when James decided to get the bullet removed from his leg.

“I appreciate it,” an emotional James Lemons said. “They don't have to do that, to open their hearts for no reason.”

Erika Nelson was struggling to pay for household expenses and had to take time off from her home health care job to take her injured daughter, 15-year-old Mireya, to doctor appointments. Mireya was shot in the chin and shoulder and is recovering.

A GoFundMe page set up by Nelson's best friend raised about $11,000, but it was frozen after Nelson tried to get into the account and GoFundMe thought it was being hacked. She feared the lights would be shut off in their apartment, because of unpaid electric bills, and was feeling desperate.

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“I'm struggling with, like, you know, groceries,” Nelson said. “People were like, ‘Oh, go to food pantries.' Well, the food pantries are not open the times I can get off. I can't just take off work to go to a food pantry.”

After meeting with Gary Kendall, Nelson received three months of rent and utility payments, about $3,500.

“A weight off my shoulder. I mean, yeah. In a big way,” she whispered. “'Cause you never know. You never know what can happen in two days, five days, two weeks, two months.”

Samuel Arellano's family recently connected with Unite KC, which will pay for his ambulance bill, one of the hospital bills, and some therapy, worth about $6,000. The bill for the initial emergency room trip was about $20,000, his parents said, but the hospital had been reluctant to send it and ultimately covered the cost.

And Unite KC also intends to pay off a $1,300 credit card bill for Emily Tavis and Jacob Gooch Sr.

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Unite KC has disbursed $40,000 so far and hopes to connect with more of the injured families, hoping to be as “generous and quick as we can,” Kendall said. United Way will be like a “lightning bolt” for victims' relief, Kendall said, but his group is aiming for something different, more like a campfire that burns for the next year.

“We agree this is a horrific thing that happened. It's a sad state of humanity but it's a real part,” he said. “So we want to remind them that God has not forgotten you. And that although he allowed this, he has not abandoned them. We believe we can be like an extension of his love to these people.”

——————————
By: Peggy Lowe, KCUR and Bram Sable-Smith
Title: Super Bowl Parade Shooting Survivors Await Promised Donations While Bills Pile Up
Sourced From: kffhealthnews.org//article/super-bowl-parade-shooting-survivors-donations-bills-wait-kansas-city/
Published Date: Fri, 21 Jun 2024 09:00:00 +0000

Did you miss our previous article…
https://www.galvestontrendingnews.com/kaiser-health-news/california-leaders-tussle-with-health-industry-over-billions-of-new-dollars-for-medi-cal/

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California Leaders Tussle With Health Industry Over Billions of New Dollars for Medi-Cal

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Bernard J. Wolfson
Thu, 20 Jun 2024 19:13:00 +0000

Gov. Gavin Newsom, state lawmakers, and industry leaders have a small window to reach an agreement on billions of new dollars for Medi-Cal before it's put to voters in November.

An initiative, supported by virtually every sector of the state's health care industry as well as the local Republican and Democratic parties, would lock in the money for Medi-Cal, California's version of the Medicaid health insurance program for low-income residents. The funds would be used primarily to increase payment rates for health care professionals who serve Medi-Cal patients.

Newsom, a Democrat, initially supported using the money for that purpose. But after California's fiscal situation darkened, he reversed course in May, proposing to divert most of it to reduce the state's $45 billion budget deficit.

The money is from a tax on managed-care health plans that's been around for two decades but has historically been used to offset existing state spending rather than support new investments in Medi-Cal.

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“The importance of this ballot initiative is finally being serious about investing in the viability of the Medi-Cal system,” said Adam Dougherty, chief of emergency medicine at Sutter Medical Center in Sacramento. “The MCO tax literally touches every aspect of the Medi-Cal system, and it can't be at the mercy of year-to-year budget crises.”

Michael Genest, a former finance director under Republican Gov. Arnold Schwarzenegger, noted that several ballot initiatives approved by voters in the past continue to narrow the state's fiscal choices, including one that limits property tax increases and another that guarantees a large share of the state budget to schools.

“We do ballot-box budgeting in the state of California. We've done it forever. And everything we've done in that regard has turned out to be very hard on fiscal stability,” Genest said.

It's possible that the Coalition to Protect Access to Care, made up of doctors, hospitals, health plans, and other medical providers, could settle their differences with state leaders before a June 27 deadline to withdraw the initiative.

Newsom's desire to claw back most of the promised money puts him at odds with proponents of the initiative, many of whom have long counted themselves among his allies. Elana Ross, a spokesperson for Newsom, declined to comment on the status of the initiative.

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In May, Newsom proposed using about $6.7 billion previously earmarked for Medi-Cal pay hikes and some other health care priorities, mostly in 2025 and 2026, to offset existing state spending. His proposal would retain Medi-Cal payment increases totaling around $300 million a year for some primary care, mental health, and maternity services.

The legislature passed a new budget on June 13 largely following the governor's wishes by canceling the planned Medi-Cal increases in 2025. But Newsom hasn't signed off.

“What was approved represents a two-house agreement between the Senate and the Assembly — not an agreement with the governor,” said H.D. Palmer, spokesperson for the state's Department of Finance. “We'll respectfully decline to speculate on what the contours of a final agreement would look like.”

Revenue from the managed-care tax allows the state to draw matching federal dollars, more than doubling the amount available. Federal and state money would also be used to reimburse the health plans for nearly all the taxes they paid, theoretically having no effect on insurance premiums.

California is among 19 states that have such an “MCO tax” in place to help fund their Medicaid programs. Using the tax revenue to pay Medi-Cal providers more is “a generational opportunity to fundamentally fix access to care for Medi-Cal recipients,” said Dustin Corcoran, CEO of the California Medical Association and a spokesperson for the ballot initiative.

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Corcoran said internal polling shows the initiative has public support by “very healthy margins,” though he declined to share specific numbers.

If the initiative does end up on the November ballot and is approved, it would override any compromise Newsom strikes with lawmakers. It would restore the previously planned Medi-Cal investments for 2025 and 2026. And it would make the increased funding, and more of it, permanent starting in 2027, though that would require federal approval.

Proponents of the initiative say it is fundamentally a question of health equity. Medi-Cal covers medical and mental health services for nearly 15 million Californians, well over a third of the state, many of them among the poorest and most vulnerable residents. The program has a budget of about $157 billion, including recent expansions to cover all immigrants regardless of legal status and a $12 billion experiment to offer socioeconomic supports not traditionally covered by health insurance.

But access to care is notoriously spotty for many Medi-Cal patients, in part because low payment rates discourage providers from seeing them. The shortage is particularly acute in specialty care.

“Our patients wait months for access to specialists or travel great distances to see them,” said Joel Ramirez, chief medical officer of Camarena Health, a chain of over 20 community clinics based in Madera. “Higher rates would allow for more providers.”

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Ramirez said 60% to 70% of Camarena's patients are on Medi-Cal, many of them farmworkers. “It's a tall ask for them to find time off work and get the transportation to travel an hour for an appointment,” he said. “Whatever condition that patient has that needs the attention of a specialist is being either untreated or incompletely treated.”

Dougherty, Sutter Medical Center's ER chief, said that over half of his patients are on Medi-Cal and the ER is always at full capacity, with the waiting rooms jammed and an insufficient number of beds. The initiative, he said, “allows us to hire more staff, add more beds, create more infrastructure for the volume we're seeing.”

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

——————————
By: Bernard J. Wolfson
Title: California Leaders Tussle With Health Industry Over Billions of New Dollars for Medi-Cal
Sourced From: kffhealthnews.org//article/california-lmedi-cal-managed-care-organization-tax-budget-ballot-initiative/
Published Date: Thu, 20 Jun 2024 19:13:00 +0000

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