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Bird Flu Tests Are Hard To Get. So How Will We Know When To Sound the Pandemic Alarm?

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Amy Maxmen and Arthur Allen
Tue, 11 Jun 2024 09:00:00 +0000

Stanford University infectious disease doctor Abraar Karan has seen a lot of with runny noses, fevers, and irritated eyes lately. Such symptoms could signal allergies, covid, or a cold. This year, there's another , bird flu — but there's no way for most doctors to know.

If the government doesn't prepare to ramp up H5N1 bird flu testing, he and other researchers warn, the United States could be caught off guard again by a pandemic.

“We're making the same mistakes today that we made with covid,” Deborah Birx, who served as former President Donald Trump's coronavirus response coordinator, said June 4 on CNN.

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To become a pandemic, the H5N1 bird flu virus would need to spread from person to person. The best way to keep tabs on that possibility is by testing people.

Scientifically speaking, many diagnostic laboratories could detect the virus. However, red tape, billing issues, and minimal investment are barriers to quickly ramping up widespread availability of testing. At the moment, the Food and Drug Administration has authorized only the Centers for Disease Control and Prevention's bird flu test, which is used only for people who work closely with livestock.

and federal authorities have detected bird flu in dairy cattle in 12 states. Three people who work on separate dairy farms tested positive, and it is presumed they caught the virus from cows. Yet researchers agree that number is an undercount given the CDC has tested only about 40 people for the disease.

“It's important to know if this is contained on farms, but we have no information because we aren't looking,” said Helen Chu, an infectious disease specialist at the University of Washington in Seattle who alerted the country to covid's spread in 2020 by testing people more broadly.

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Reports of untested sick farmworkers — as well as a maternity worker who had flu symptoms — in the with H5N1 outbreaks among cattle in suggest the numbers are higher. And the mild symptoms of those who tested positive — a cough and eye inflammation, without a fever — are such that infected people might not bother seeking medical care and, therefore, wouldn't be tested.

The CDC has asked farmworkers with flu symptoms to get tested, but researchers are concerned about a lack of outreach and incentives to encourage testing among people with limited job security and access to health care. Further, by testing only on dairy farms, the agency likely would miss evidence of wider spread.

“It's hard to not compare this to covid, where early on we only tested people who had traveled,” said Benjamin Pinsky, medical director of the clinical virology laboratory at Stanford University. “That left us open to not immediately recognizing that it was transmitting among the community.”

In the early months of covid, the rollout of testing in the United States was catastrophically slow. Although the World Health Organization had validated a test and other groups had developed their own using basic molecular biology techniques, the CDC at first insisted on creating and relying on its own test. Adding to delays, the first version it shipped to state health labs didn't work.

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The FDA lagged, too. It didn't authorize tests from diagnostic laboratories outside of the CDC until late February 2020.

On Feb. 27, 2020, Chu's research lab detected covid in a teenager who didn't meet the CDC's narrow testing criteria. This case sounded an alarm that covid had spread below the radar. Scaling up to meet demand took time: Months passed before anyone who needed a covid test could get one.

Chu notes this isn't 2020 — not by a long shot. Hospitals aren't overflowing with bird flu patients. Also, the country has the tools to do much better this time around, she said, if there's political will.

For starters, tests that detect the broad category of influenzas that H5N1 belongs to, called influenza A, are FDA-approved and ubiquitous. These are routinely run in the “flu season,” from November to February. An unusual number of positives from these garden-variety flu tests this spring and summer could alert researchers that something is awry.

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Doctors, however, are unlikely to request influenza A tests for patients with respiratory symptoms outside of flu season, in part because health insurers may not them except in limited circumstances, said Alex Greninger, assistant director of the clinical virology laboratory at the University of Washington.

That's a solvable problem, he added. At the peak of the covid pandemic, the government overcame billing issues by mandating that insurance companies cover tests, and set a lucrative price to make it worthwhile for manufacturers. “You ran into a testing booth on every other block in Manhattan because companies got $100 every time they stuck a swab in someone's nose,” Greninger said.

Another obstacle is that the FDA has yet to allow companies to run their influenza A tests using eye swabs, although the CDC and public health labs are permitted to do so. Notably, the bird flu virus was detected only in an eye swab from one farmworker infected this year — and not in samples drawn from the nose or throat.

Overcoming such barriers is essential, Chu said, to ramp up influenza A testing in regions with livestock. “The biggest bang for the buck is making sure that these tests are routine at clinics that serve farmworker communities,” she said, and suggested pop-up testing at state fairs, too.

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In the meantime, novel tests that detect the H5N1 virus, specifically, could be brought up to speed. The CDC's current test isn't very sensitive or simple to use, researchers said.

Stanford, the University of Washington, the Mayo Clinic, and other diagnostic laboratories that serve hospital systems have developed alternatives to detecting the virus circulating now. However, their reach is limited, and researchers stress a need to jump-start additional capacity for testing before a crisis is underway.

“How can we make sure that if this becomes a public health emergency we aren't stuck in the early days of covid, where things couldn't move quickly?” Pinsky said.

A recent rule that gives the FDA more oversight of lab-developed tests may bog down authorization. In a statement to KFF Health News, the FDA said that, for now, it may allow tests to proceed without a full approval process. The CDC did not respond to requests for comment.

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But the American Clinical Laboratory Association has asked the FDA and the CDC for clarity on the new rule. “It's slowing things down because it's adding to the confusion about what is allowable,” said Susan Van Meter, president of the diagnostic laboratory trade group.

Labcorp, Quest Diagnostics, and other major testing companies are in the best position to manage a surge in testing demand because they can process hundreds per day, rather than dozens. But that would require adapting testing processes for their specialized equipment, a process that consumes time and money, said Matthew Binnicker, director of clinical virology at the Mayo Clinic.

“There's only been a handful of H5N1 cases in humans the last few years,” he said, “so it's hard for them to invest millions when we don't know the future.”

The government could provide to underwrite its research, or commit to buying tests in bulk, much as Operation Warp Speed did to advance covid vaccine .

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“If we need to move to scale this, there would need to be an infusion of money,” said Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories. Like an insurance policy, the upfront expense would be slight with the economic blow of another pandemic.

Other means of tracking the H5N1 virus are critical, too. Detecting antibodies against the bird flu in farmworkers would reveal whether more people have been infected and recovered. And analyzing wastewater for the virus could indicate an uptick in infections in people, birds, or cattle.

As with all pandemic preparedness efforts, the difficulty lies in stressing the need to act before a crisis strikes, Greninger said.

“We should absolutely get prepared,” he said, “but until the government insures some of the risk here, it's hard to make a move in that direction.”

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By: Amy Maxmen and Arthur Allen
Title: Bird Flu Tests Are Hard To Get. So How Will We Know When To Sound the Pandemic Alarm?
Sourced From: kffhealthnews.org/news/article/bird-flu-tests-pandemic-possibility-preparedness/
Published Date: Tue, 11 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 officials 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 must find “clear evidence” that the proposed merger would improve health outcomes, access, and the quality of care. Those 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 state 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 leaders said it's time to move “beyond competition” for the sake of the region, which has struggled to keep and raise life 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 to rein in prices. Gloria Sachdev, CEO 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, 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 removed, 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 report. 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 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 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.

——————————
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 help close the state'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 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, 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 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 decision either.”

The governor has said he's trying to maintain fiscal discipline while preserving Medi-Cal for immigrants. California was the first state to expand eligibility to all qualified immigrants regardless of legal status, phasing it in over several years: children 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/news/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 News


@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 podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “ and Policy A to Z,” now in its third edition.

A unanimous Supreme Court turned back a challenge to the FDA's approval and rules for the 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 the highest numbers of drug shortages in more than 20 years. And independent pharmacists in particular say they are struggling to keep 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 podcasts, 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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