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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
Fri, 07 Jun 2024 09:00:00 +0000

A company that makes tests for 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 -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 and other .

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Doctors don't consider any level of lead in the blood to be safe, especially for children. Several U.S. cities, 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 health.

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 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.

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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.

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?

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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 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.

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.

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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 with a health care provider.”

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By: Julie Appleby, KFF Health News
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

Indiana Weighs Hospital Monopoly as Officials Elsewhere Scrutinize Similar Deals

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Samantha Liss
Fri, 14 Jun 2024 09:00:00 +0000

TERRE HAUTE, Ind. — Locals in this city of 58,000 are used to having to wait at railroad crossings for one of the dozens of cargo trains to pass through.

But a proposed merger between the two hospitals on either side of the city could exacerbate the problem in emergencies if the hospitals shut down some services, such as trauma care, at one site, which the proposal cites as a possibility. Tom High, fire chief of a nearby township, said some first responders would be forced to transport critical farther, risking longer delays, if they become what locals call “railroaded” by a passing train.

That's just one of the fears in this community as Indiana review whether to allow Union Hospital, licensed as a 341-bed facility, to purchase the county's only other acute care hospital, the 278-bed Terre Haute Regional Hospital. The proposed deal also raises concerns about reduced tax revenue, worsening care, and higher prices.

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Within the next few months, the Indiana Department of Health must find “clear evidence” that the proposed merger would improve health outcomes, access, and the quality of care. Those benefits must “outweigh any potential disadvantages.”

As the nation's health care industry has become more concentrated amid a steady clip of mergers in recent decades, it's common for one large system to dominate a market. In this case, the deal would be Indiana's first merger under the COPA law, short for Certificate of Public Advantage, that the enacted in 2021. Such laws allow deals that the Federal Trade Commission otherwise considers illegal because they reduce competition and often create monopolies. To mitigate the negative effects of a monopoly, the merged hospitals typically agree to conditions imposed by state regulators.

Union Hospital said it's time to move “beyond competition” for the sake of the region, which has struggled to keep jobs and raise expectancy rates. Hospital spokesperson Neil Garrison said the merger would ultimately improve care, increase access, and cut costs. Leaders of Regional Hospital, which is owned by for-profit chain HCA Healthcare, did not respond to questions about the proposal.

One unusual implication arises, though: If the merger is approved, the surrounding county would lose tax revenue from one of its larger businesses. Union Hospital, which as a nonprofit is exempt from paying taxes, would be acquiring tax-paying Terre Haute Regional, which paid roughly $508,000 in county taxes for 2023, said Vigo County Auditor Jim Bramble. That's the equivalent of the starting salaries of about nine sheriff's deputies, per the county's $83 million 2024 budget.

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Garrison said the hospital system is aware of the tax implications for the county and is “exploring opportunities” to address it.

Meanwhile, Roland Kohr, formerly a pathologist at Regional and a county coroner, frets about erasing competition that forced the hospitals to add services or match the other. “The push to introduce new technologies, to recruit more physicians, that may not happen,” he said.

The FTC has urged states to avoid COPAs, pointing to research that found they “have resulted in significant price increases and contributed to declines in quality of care.” The fallout of similar mergers has triggered federal sanctions in North Carolina and pushback from locals and legislators in Tennessee.

“A merged hospital system that faces little remaining competition after the merger usually has little incentive to follow through with its promises because patients have no other choice,” wrote Chris Garmon, a University of Missouri-Kansas City economist who has studied COPA mergers, in a warning to Indiana health officials about the proposed merger.

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Indiana already has among the highest hospital prices in the country, according to a study by the Rand Corp. research organization. The Indiana spent the past year trying to rein in prices. Gloria Sachdev, of Indianapolis-based Employers' Forum of Indiana, which pushed for those pricing limits on behalf of frustrated business leaders, is worried a Union-Regional merger would undo those gains and raise prices further.

Indiana's COPA restricts how much the hospital could increase charges, Garrison said.

Elsewhere, the largest COPA-created hospital system in the country, Ballad Health, has reported that the time patients spend in its ERs in Virginia and Tennessee before being hospitalized has more than tripled, reaching nearly 11 hours, in the six years since that monopoly of 20 hospitals formed. Still, Tennessee has awarded Ballad top marks even when certain quality metrics, including its ER speed, fall below established benchmarks.

Ballad Health spokesperson Molly Luton said the system's performance has improved since those statistics were gathered.

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Last fall, some Tennesseans unsuccessfully urged a county board to call on the state to better regulate the hospital system. This spring, state lawmakers refused to hear testimony from residents who drove five hours to Nashville to testify for a bill that sought to limit future COPA mergers in the state — which ultimately didn't make it to a full vote.

Problems have also occurred when a COPA — and its oversight — are , leaving the merged hospital system as an “unregulated monopoly.” After North Carolina repealed its COPA in 2015, a subsidiary of HCA Healthcare bought Mission Health, a COPA-created monopoly in Asheville, for $1.5 billion in 2019. The monopoly in Asheville remained but none of the COPA's conditions applied to the new owner.

Last year, government inspectors found “deficiencies” at Mission Health that contributed to four patient deaths and posed an “immediate jeopardy” to patients' health and safety, according to the 384-page federal inspection . North Carolina Attorney General Joshua Stein sued HCA's subsidiary last year, alleging the ER was “significantly degraded,” and that the company failed to maintain certain critical services, including oncology care, a violation of a purchase agreement Stein's office negotiated with it because the company acquired a nonprofit.

HCA said it promptly addressed the issues and denied Stein's allegations in its legal response to the ongoing lawsuit, arguing it has expanded services since its purchase. HCA also argued that the agreement is silent about maintaining the quality of care.

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Back in Indiana, Union Hospital laid the groundwork for its merger more than three years ago when its leaders provided the language for COPA legislation to then-state Sen. Jon Ford, a Republican in Terre Haute, believing he would be “the best champion for this proposal,” according to legislative testimony from Taylor Hollenbeck, an RJL Solutions consultant on the merger. Ford, listed on the legislature's site as the bill's co-author, did not respond to requests for comment.

Union CEO Steve Holman testified in the bill's hearings that the county's public health rankings — with an average life expectancy ranking 68th out of 92 counties in the state — should be a “call to action” to do something “big and bold.”

Terre Haute Mayor Brandon Sakbun agrees the merger could help what he called the county's “abysmal” public health statistics. Last year, he was elected the city's youngest mayor at age 27 on a promise to “turn Terre Haute around.” The region's workforce has steadily declined and local leaders have pinned their hopes on a new casino and a manufacturer of battery parts for electric vehicles to reverse this trend.

Sakbun's father is an OB-GYN at Union, but the mayor said that doesn't color his opinion and that he supports the hospital merger despite the loss of the tax base. He believes it will help recruit medical and other professionals to an area that has struggled to attract top talent.

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“Do I believe that this is the one that bucks the research?” Sakbun said. “I truthfully do.”

KFF Health News correspondent Brett Kelman contributed to this article.

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By: Samantha Liss
Title: Indiana Weighs Hospital Monopoly as Officials Elsewhere Scrutinize Similar Deals
Sourced From: kffhealthnews.org/news/article/indiana-copa-hospital-monopoly-scrutiny/
Published Date: Fri, 14 Jun 2024 09:00:00 +0000

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California Lawmakers Preserve Aid to Older, Disabled Immigrants

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Vanessa G. Sánchez
Fri, 14 Jun 2024 09:00:00 +0000

California lawmakers on Thursday passed a 2024-25 budget that rejected Gov. Gavin Newsom's proposal to cut in-home supportive services for low-income older, blind, and disabled immigrants lacking legal residency. However, the Democratic governor has not said whether he'll use his line-item veto authority to close the 's $45 billion deficit.

The , controlled by Democrats, passed a $211 general fund spending plan for the fiscal year starting July 1 by drawing more from the state's rainy-day fund and reducing corporate tax deductions to prevent cuts to health and social services.

“Our legislative budget plan achieves those goals with targeted, carefully calibrated investments in safety-net programs that protect our most vulnerable,” said Assembly member Jesse Gabriel, chair of the Assembly's budget committee, following voting in Sacramento.

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Newsom and lawmakers are expected to continue talks.

“What was approved represents a two-house agreement between the Senate and the Assembly – not an agreement with the governor,” said state Department of Finance spokesperson H.D. Palmer. “We've made good progress, but there's still more work to do.”

Newsom had proposed eliminating the new in-home benefit for qualified immigrants to save nearly $95 million in the next fiscal year, with no plans to bring it back. Lawmakers not only rejected Newsom's cut to the in-home services program; they also refused the governor's proposal to slash $300 million a year from public health agencies. However, they accepted delaying food assistance to low-income older immigrants without legal residency.

The In-Home Supportive Services program helps low-income older, blind, and disabled individuals care in their homes, which helps keep them out of more costly nursing and residential facilities. The program works by paying $16 to $21 an hour to caregivers, many of them family members.

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Advocates applauded lawmakers for rejecting the cut. They had urged the governor to adopt the legislature's budget, arguing the state could end up paying more in the long run as Medi-Cal recipients tap nursing services. The state has estimated the annual per-person cost of nursing homes is $124,189, compared with the roughly $28,000 average cost for people without legal residency in the in-home services program.

“These individuals would need to essentially go into costly hospital or nursing care,” said Ronald Coleman Baeza, managing policy director at the California Pan-Ethnic Health Network. “It's not only cruel for undocumented immigrants, but it doesn't make sense as a fiscal either.”

The governor has said he's trying to maintain fiscal discipline while preserving Medi-Cal benefits for immigrants. California was the first state to expand Medicaid eligibility to all qualified immigrants regardless of legal status, phasing it in over several years: in 2016, adults ages 19-26 in 2020, people 50 and older in 2022, and all remaining adults this year.

“It's a core of I think who we are as a state, and we should be as a nation,” Newsom said in May.

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As part of the Medi-Cal expansion, the state authorized nearly 3,000 older, blind, and disabled immigrants without legal residency to access paramedical services and daily care, meal preparation, bathing, feeding, and transportation to medical appointments. Advocates estimate 17,000 immigrants qualify.

“Fixing California's deficit means making tough choices, so the Assembly came to these negotiations focused on preserving programs that matter most to Californians,” said Assembly Speaker Robert Rivas, a Central Coast Democrat, in an earlier statement.

Lawmakers did agree to Newsom's proposal to delay around $165 a month in food assistance to low-income immigrants without legal residency ages 55 and older. Lawmakers had approved the benefit two years ago, but the governor proposed delaying it by two fiscal years to 2027.

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

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By: Vanessa G. Sánchez
Title: California Lawmakers Preserve Aid to Older, Disabled Immigrants
Sourced From: kffhealthnews.org//article/california-lawmakers-aid-immigrants-in-home-services-budget-newsom/
Published Date: Fri, 14 Jun 2024 09:00:00 +0000

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KFF Health News’ ‘What the Health?’: SCOTUS Rejects Abortion Pill Challenge — For Now 

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Thu, 13 Jun 2024 18:50:00 +0000

The Host

Julie Rovner
KFF


@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 “ Politics and Policy A to Z,” now in its third edition.

A unanimous Supreme Court turned back a to the FDA's approval and rules for the abortion pill mifepristone, finding that the anti-abortion doctor group that sued lacked standing to do so. But abortion foes have other ways they intend to curtail availability of the pill, which is commonly used in medication abortions, which now make up nearly two-thirds of abortions in the U.S.

Meanwhile, the Biden administration is proposing regulations that would bar credit agencies from including medical debt on individual credit reports. And former President Donald Trump, signaling that drug prices remain a potent campaign issue, attempts to take credit for the $35-a-month cap on insulin for Medicare beneficiaries — which was backed and signed into by Biden.

This 's panelists are Julie Rovner of KFF Health News, Anna Edney of Bloomberg News, Rachana Pradhan of KFF Health News, and Emmarie Huetteman of KFF Health News.

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Panelists

Anna Edney
Bloomberg


@annaedney


Read Anna's stories.

Emmarie Huetteman
KFF Health News

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@emmarieDC


Read Emmarie's stories.

Rachana Pradhan
KFF Health News


@rachanadpradhan

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Read Rachana's stories.

Among the takeaways from this week's episode:

  • All nine Supreme Court justices on June 13 rejected a challenge to the abortion pill mifepristone, ruling the plaintiffs did not have standing to sue. But that may not be the last word: The leaves open the possibility that different plaintiffs — including three states already part of the case — could raise a similar challenge in the future, and that the court could then vote to block access to the pill.
  • As the presidential race heats up, and former President Donald Trump are angling for health care voters. The Biden administration this week proposed eliminating all medical debt from Americans' credit scores, which would expand on the previous, voluntary move by the major credit agencies to erase from credit reports medical bills under $500. Meanwhile, Trump continues to court vaccine skeptics and wrongly claimed credit for Medicare's $35 monthly cap on insulin — enacted under a law backed and signed by Biden.
  • Problems are compounding at the pharmacy counter. Pharmacists and drugmakers are reporting the highest numbers of drug shortages in more than 20 years. And independent pharmacists in particular say they are struggling to keep drugs on the shelves, pointing to a recent Biden administration policy change that reduces costs for seniors — but also cash flow for pharmacies.
  • And the Southern Baptist Convention, the nation's largest branch of Protestantism, voted this week to restrict the use of in vitro fertilization. As evidenced by recent flip-flopping stances on abortion, Republican candidates are feeling pressed to satisfy a wide range of perspectives within even their own party.

Also this week, Rovner interviews KFF president and CEO Drew Altman about KFF's new “Health Policy 101” primer. You can learn more about it here.

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

Julie Rovner: HuffPost's “How America's Mental Health Crisis Became This Family's Worst Nightmare,” by Jonathan Cohn.

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Anna Edney: Stat News' “Four Tops Singer's Lawsuit Says He Visited ER for Chest Pain, Ended Up in Straitjacket,” by Tara Bannow.

Rachana Pradhan: The New York Times' “Abortion Groups Say Tech Companies Suppress Posts and Accounts,” by Emily Schmall and Sapna Maheshwari.

Emmarie Huetteman: CBS News' “As FDA Urges Crackdown on Bird Flu in Raw Milk, Some States Say Their Hands Are Tied,” by Alexander Tin.

Also mentioned on this week's podcast:

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Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

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?': SCOTUS Rejects Abortion Pill Challenge — For Now 
Sourced From: kffhealthnews.org/news/podcast/what-the-health-351-supreme-court-abortion-pill-mifepristone-june-13-2024/
Published Date: Thu, 13 Jun 2024 18:50:00 +0000

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