Midwest Bureau Archives - ĢӰԺ Health News /topics/states/midwest-bureau/ Fri, 14 Jun 2024 11:05:59 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.4 /wp-content/uploads/sites/2/2023/04/kffhealthnews-icon.png?w=32 Midwest Bureau Archives - ĢӰԺ Health News /topics/states/midwest-bureau/ 32 32 161476233 Indiana Weighs Hospital Monopoly as Officials Elsewhere Scrutinize Similar Deals /news/article/indiana-copa-hospital-monopoly-scrutiny/ Fri, 14 Jun 2024 09:00:00 +0000 /?post_type=article&p=1864842 TERRE HAUTE, Ind. — Locals in this city of 58,000 are used to for one of the dozens of daily cargo trains to pass through.

But a proposed merger between the two hospitals on either side of the city could in emergencies if the hospitals shut down some services, such as trauma care, at one site, which cites as a possibility. Tom High, fire chief of a nearby township, said some first responders would be forced to transport critical patients 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.

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 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 jobs 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 2024 budget.

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, 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 , a University of Missouri-Kansas City economist who has studied COPA mergers, in a warning to Indiana health officials about the proposed merger.

Indiana already has among the , according to a study by the Rand Corp. research organization. The Indiana Legislature spent the past year trying to . Gloria Sachdev, CEO of Indianapolis-based , 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.

Last fall, some Tennesseans unsuccessfully 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 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 “.” 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 report. North Carolina Attorney General Joshua Stein 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.

Back in Indiana, Union Hospital laid the groundwork for its merger more than three years ago when its leaders provided the language for to then-state Sen. , 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 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 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.

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

ĢӰԺ Health News correspondent Brett Kelman contributed to this article.

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Wins at the Ballot Box for Abortion Rights Still Mean Court Battles for Access /news/article/abortion-ballot-initiatives-states-laws-courts-access/ Thu, 06 Jun 2024 09:00:00 +0000 /?post_type=article&p=1861686 Before Ohio voters last year to protect abortion rights, the state’s attorney general, an anti-abortion Republican, said that doing so at least 10 state laws limiting abortions.

But those laws remain a hurdle and straightforward access to abortions has yet to resume, said Bethany Lewis, executive director of the in Cleveland. “Legally, what actually happened in practice was not much,” she said.

Today, most of those laws limiting abortions — including a 24-hour waiting period and a 20-week abortion ban — continue to govern Ohio health providers, despite the constitutional amendment’s passage with nearly . For abortion rights advocates, it’s going to take time and money to challenge the laws in the courts.

Voters in as many as could also weigh in this year on abortion ballot initiatives. But the seven states that have voted on abortion-related ballot measures since the Supreme Court two years ago in Dobbs v. Jackson Women’s Health Organization show that an election can be just the beginning.

The state-by-state patchwork of constitutional amendments, laws, and regulations that determine where and how abortions are available across the country could take years to crystallize as old rules are reconciled with new ones in legislatures and courtrooms. And even though a ballot measure result may seem clear-cut, the residual web of older laws often still needs to be untangled. Left untouched, the statutes could pop up decades later, like did this year.

Michigan was one of the where voters weighed in on abortion rights following the Dobbs decision in June 2022. In November of that year, Michigan voters approved by an amendment to add abortion rights to the state constitution. It would be an additional 15 months, however, before the first the state’s existing abortion restrictions, sometimes called “targeted regulation of abortion providers,” or TRAP, laws. Michigan’s include a 24-hour waiting period.

The delay had a purpose, according to , state policy and advocacy director at the Center for Reproductive Rights, which filed the lawsuit: It’s preferable to change laws through the legislature than through litigation because the courts can only strike down a law, not replace one.

“It felt really important to allow the legislative process to go forward, and then to consider litigation if there were still statutes that were on the books the legislature hadn’t repealed,” Smith said.

Michigan’s Democratic-led legislature did pass an last year that was signed into law by the state’s Democratic governor in December. But the package left some regulations intact, including the mandatory waiting period, mandatory counseling, and a ban on abortions by non-doctor clinicians, such as nurse practitioners and midwives.

Smith’s group filed the lawsuit in February on behalf of and . Smith said it’s unclear how long the litigation will take, but she hopes for a decision this year.

Abortion opponents such as , state policy director for Susan B. Anthony Pro-Life America, are critical of the lawsuit and such policy unwinding efforts. She said abortion rights advocates used “deceptive campaigns” that claimed they wanted to restore the status quo in place before the Dobbs decision left abortion regulation up to the states.

“The litigation proves these amendments go farther than they will ever admit in a 30-second commercial,” Daniel said. “Removing the waiting period, counseling, and the requirement that abortions be done by doctors endangers women and limits their ability to know about resources and support available to them.”

A most of the abortion restrictions in Ohio came from Preterm and other abortion providers four months after that state’s ballot measure passed. A legislative fix was unlikely because Republicans control the legislature and governor’s office. Preterm’s Lewis said she anticipated the litigation would take “quite some time.”

Dave Yost, the Ohio attorney general, is one of the defendants named in the suit. In a the case, Yost argued that the abortion providers — which include several clinics as well as a physician, Catherine Romanos — lacked standing to sue.

He argued that Romanos failed to show she was harmed by the laws, explaining that “under any standard, Dr. Romanos, having always complied with these laws as a licensed physician in Ohio, is not harmed by them.”

, an attorney representing Romanos and three of the clinics in the case, called the argument “just very wrong.” If Romanos can’t challenge the constitutionality of the old laws because she is complying with them, Hill said, then she would have to violate those laws and risk felonies to honor the new amendment.

“So, then she’s got to go get arrested and show up in court and then defend herself based on this new constitutional amendment?” Hill said. “For obvious reasons, that is not a system that we want to have.”

This year, Missouri is among the states poised to vote on a to write protections for abortion into the state constitution. Abortions in Missouri have been banned in nearly every circumstance since 2022, but they were largely halted years earlier by a series of laws seeking to make abortions scarce.

Over the course of more than three decades, Missouri lawmakers instituted a , imposed for procedure rooms and hallways in abortion clinics, and mandated that abortion providers have at nearby hospitals, .

Emily Wales, president and chief executive of , said trying to comply with those laws visibly changed her organization’s facility in Columbia, Missouri: widened doorways, additional staff lockers, and even the distance between recovery chairs and door frames.

Even so, by 2018 the organization had to halt abortion services at that Columbia location, she said, with recovery chairs left in position for a final inspection that never happened. That left just operating in the state, a separate Planned Parenthood affiliate in St. Louis. In 2019, that organization opened a about 20 miles away in Illinois, where lawmakers were rather than restricting it.

By 2021, the last full year before the Dobbs decision opened the door for Missouri’s ban, the number of recorded abortions in the state had , down from .

“At that point, Missourians were generally better served by leaving the state,” Wales said.

Both of Missouri’s Planned Parenthood affiliates have vowed to restore abortion services in the state as swiftly as possible if voters approve the proposed ballot measure. But the laws that diminished abortion access in the state would still be on the books and likely wouldn’t be overturned legislatively under a Republican-controlled legislature and governor’s office. The laws would surely face challenges in court, yet that could take a while.

“They will be unconstitutional under the language that’s in the amendment,” Wales said. “But it’s a process.”

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Health Worker for a Nonprofit? The New Ban on Noncompete Contracts May Not Help You /news/article/ftc-noncompete-rule-nonprofit-health-workers/ Wed, 05 Jun 2024 09:00:00 +0000 /?post_type=article&p=1856349 Many physicians and nurses are happy about the Federal Trade Commission’s banning the use of noncompete agreements in employment contracts. But they are disappointed that it may not protect those who work for nonprofit hospitals and health care facilities, which provide most of the nation’s care and employ the largest number of medical professionals.

In April, in a 3-2 vote, the FTC prohibiting contracts that prevent an employee from taking a job with a competitor. Calling the noncompete agreements “a widespread and often exploitative practice,” an agency announcement described them as an unfair method of competition that depresses wages and hinders new business formation.

The rule bars employers in most industries, including health care, from using contract clauses that block employees from leaving for other jobs or starting a competing business in the same geographic area for a fixed period of time.

But that doesn’t help many health professionals, because the FTC Act gives the agency authority over companies organized to operate for profit but not over nonprofit, charitable organizations, which are also tax-exempt.

Still, the agency noted some nonprofits could be bound by the rule if they do not operate as true charities. The rule establishes a two-part test to determine if the FTC has jurisdiction over a nonprofit — whether the organization is carrying on business for only charitable purposes, and whether its income goes to public rather than private interests.

“Our rulemaking record includes powerful stories from health care workers who are employed by nonprofits about how noncompetes hurt patients and providers,” said FTC Commissioner Rebecca Kelly Slaughter, one of three Democratic commissioners, before the April 23 vote. “I do not think there is a good justification for them to be excluded from this rule.”

Noncompete contract terms for physicians, nurse practitioners, and other medical professionals in hospitals and various health care facilities. Some providers say these agreements have forced them to leave their communities and patients behind if they wanted to exit unethical or unsafe workplace conditions.

of U.S. community hospitals are nonprofits or government-owned, and they employ many of the nation’s medical professionals. As of 2022, nearly three-quarters of U.S. physicians were employed by , both nonprofit and for-profit.

Based on their designation as charities that don’t have to pay income or property taxes, U.S. nonprofit hospitals received a total estimated tax exemption of , according to ĢӰԺ, a nonpartisan research organization.

That exceeded the estimated $16 billion they spent on charity care for patients unable to afford their medical bills, ĢӰԺ said.

Physician and nursing groups say it makes no sense to treat nonprofit hospitals differently because they are just as money-driven as for-profit hospitals. Patients, they say, will benefit if providers are free to call out unsafe conditions and change jobs. “Giving physicians freedom of movement will force hospitals to compete to improve working conditions,” said Jonathan Jones, immediate past president of the American Academy of Emergency Medicine.

Chad Golder, general counsel and secretary of the American Hospital Association, which represents mostly nonprofit hospitals, said the rule would increase health care costs and reduce patient access by triggering hospital bidding wars for physicians. He predicted the FTC would try to apply the rule to both nonprofit and for-profit hospitals.

“They aren’t saying exactly what they’ll do, but it’s a pretty significant move for them to say we’ll apply our own test to determine if we can regulate a nonprofit,” Golder said. “Nonprofit entities now will need to be extra careful.”

In addition, some nonprofit hospitals have joint ventures with for-profit hospitals and medical groups. That could create complicated questions about whether their employee contracts come under the rule, said Chip Kahn, president and CEO of the Federation of American Hospitals, which represents for-profits.

The new rule arose from President Joe Biden’s 2021 executive order to curb the unfair use of noncompete agreements, part of his broader mandate to boost U.S. economic competition and worker mobility.

The FTC argued that banning noncompetes, which it said cover 1 in 5 American workers, would lower health care costs by up to $194 billion over the next decade. It will ensure Americans “freedom to pursue a new job, start a new business, or bring a new idea to market,” FTC Chair Lina Khan said.

The rule also prohibits contract terms that function like noncompetes to stop employees from leaving to work for competing companies or start their own businesses. These might include overbroad nondisclosure agreements, training repayment provisions, and nonsolicitation clauses.

“No one should be trapped in an unsafe job by onerous contracts that prevent them from taking another job,” said Brynne O’Neal, a regulatory policy specialist at National Nurses United, the profession’s largest dedicated labor union in the U.S. Hospitals, she said, use that require nurses to pay as much as $30,000 in training costs if they leave, essentially locking them in their jobs.

California, Minnesota, North Dakota, and Oklahoma already ban enforcement of noncompete clauses for all employees of both nonprofits and for-profits, while prohibit noncompetes for physicians. Even in states without bans, when they have found them to be overbroad or unreasonable.

Hospital executives argue that the noncompete rule will force them to compete against each other to hire physicians and other providers and ultimately cost them more, and that it advantages nonprofits over for-profits. “All it would do is increase the price of labor in a field that already has labor shortages and thin margins,” Golder said.

“The nonprofit hospital across the street could pursue our employees, while their employees would be protected, and that’s a basic fairness issue,” Kahn said.

But Clifford Atlas, an employment attorney with Jackson Lewis in New York, said that argument against the noncompete rule “won’t fly” in court because preventing competition for the services of physicians or other workers is not a business interest that’s protected by law or public policy.

The rule is set to take effect in September, though business groups against it in Texas and . Many legal experts predict that conservative judges will strike down the rule on the grounds that it .

Physician and nurses’ groups hope the FTC rule, whatever its fate in the courts, helps persuade hospitals and other health care employers to stop using noncompetes and to prohibit them.

“We’re telling our members it could be struck down, but we’re asking them to renegotiate their contracts,” said Jones of the American Academy of Emergency Medicine. “They should be asking their employers, ‘Wouldn’t you like to be on the right side and not to be seen as fighting against physicians and patients?’”

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An Obscure Drug Discount Program Stifles Use of Federal Lifeline by Rural Hospitals /news/article/rural-emergency-hospitals-340b-drug-discount-program/ Thu, 30 May 2024 09:00:00 +0000 /?post_type=article&p=1855575 Facing ongoing concerns about rural hospital closures, Capitol Hill lawmakers have introduced a spate of proposals to fix a federal program created to keep lifesaving services in small towns nationwide.

In Anamosa, Iowa — a town of fewer than 6,000 residents located more than 900 miles from the nation’s capital — rural hospital leader Eric Briesemeister is watching for Congress’ next move. The 22-bed hospital Briesemeister runs averages about seven inpatients each night, and its most recent federal filings show it earned just $95,445 in annual net income from serving patients.

Yet Briesemeister isn’t interested in converting the facility into a rural emergency hospital, which would mean getting millions of extra dollars each year from federal payments. In exchange for that financial support, hospitals that join the program keep their emergency departments open and give up inpatient beds.

“It wasn’t for us,” said Briesemeister, chief executive of UnityPoint Health-Jones Regional Medical Center. “I think that program is a little bit more designed for hospitals that might not be around without it.”

Nationwide, only of the more than 1,500 eligible hospitals have become rural emergency hospitals since the program launched last year. At the same time, rural hospitals continue to close — 10 since the fix became available.

Federal lawmakers have introduced a handful of legislative solutions since March. In , senators from Kansas and Minnesota list a myriad of tactics, including allowing older closed facilities to reopen.

Another in the House by two Michigan lawmakers is the Rural 340B Access Act. It would allow rural emergency hospitals to use the 340B federal drug discount program, which Congress created in 1992.

The 340B program, named after its federal statute, lets eligible hospitals and clinics buy drugs at a discount and then bill insurance companies, Medicare, or Medicaid at market rates. Hospitals get to keep the money they make from the difference.

Congress approved 340B as an indirect aid package to help struggling hospitals stay afloat. Many larger hospitals say the cash is used for community benefits and charity care, while many small hospitals depend on the drug discounts to help cover staffing and operational shortfalls.

Currently, emergency hospitals are not eligible for 340B discounts. According from U.S. Rep. Jack Bergman (R-Mich.), the House proposal would “correct this oversight.” Backers of the House bill include the American Hospital Association and the National Rural Health Association.

In Iowa, Briesemeister said the 340B federal drug discount program “can be used for tremendous good.” The small-town hospital uses money it makes from 340B to subsidize emergency services and uninsured and underinsured patients who frequent the emergency department, he said.

Chuck Grassley, Iowa’s longtime Republican senator, shepherded the Rural Emergency Hospital program into law. His spokesperson, Gillie Maddox, did not respond directly to questions about why the federal law creating rural emergency hospitals omitted the 340B program. Instead, Maddox said the designation was a “product of bipartisan negotiations.”

A survey conducted by the health analytics and consulting firm Chartis, along with the National Rural Health Association, found that nearly 80% of rural hospitals had participated in 340B and nearly 40% said they reaped $750,000 or more annually from the program.

Sanford Health, a largely rural health system headquartered in Sioux Falls, South Dakota, considered converting a handful of smaller critical access hospitals into rural emergency hospitals.

Martha Leclerc, vice president of corporate contracting for Sanford, said the system analyzed how much revenue would be lost by closing inpatient beds, which is also a requirement of the emergency hospital program, and by being unable to file for drug discounts.

In the end, she said, switching did not “make a lot of sense.”

While many rural hospitals are clamoring for the 340B provision to be added to the rural emergency hospital program, opponents have said 340B can be a cash cow for hospitals that don’t serve enough vulnerable patients.

Nicole Longo is deputy vice president of public affairs for the Pharmaceutical Research and Manufacturers of America, the nation’s largest, most influential pharmaceutical lobbying group. She wrote in a recent blog post that hospital systems and chain pharmacies are “exploiting the program” and said patients have not benefited from the growth in the program.

In an interview, Longo said PhRMA supports rural emergency hospitals being able to access 340B because they are treating “vulnerable patients in underserved communities” and are “true safety net providers.”

PhRMA, she said, wants to encourage a thoughtful conversation about “which types of hospitals should be in the program.” Last year, PhRMA formed an unlikely pact with community health centers to create the Alliance to Save America’s 340B Program, or ASAP 340B.

Vacheria Keys, associate vice president of policy and regulatory affairs at the National Association of Community Health Centers, said, “There is a new day of openness, from all parties.”

Use of the drug discount program skyrocketed after provisions in the Patient Protection and Affordable Care Act, , increased the number of hospitals and clinics allowed to contract with an unlimited number of retail pharmacies, such as Walgreens and CVS, which are paid a fee to dispense the discounted drugs.

Adam J. Fein, president of the industry research organization Drug Channels Institute, reports that the 340B program is the second-largest federal drug program, trailing Medicare Part D. The flow of drugs purchased under the 340B program , about $9.8 billion more .

In response to the exploding use of contract pharmacies, pharmaceutical manufacturers have restricted the drugs they offer at a discount through the pharmacies. That throttling is affecting rural hospitals like Labette Health, a Kansas hospital whose president asked President Joe Biden for help in dealing with the pharmaceutical companies.

Rena Conti, an associate professor of markets, public policy, and law at Boston University’s Questrom School of Business, has studied the drug discounts for years and said she has “significant worries about expanding” the 340B program.

“There is a lot of money being generated in this program that we really can’t understand exactly how much that really is and exactly who it is benefiting,” Conti said.

At the same time, said Conti, a health care economist, giving rural hospitals access to the federal drug discounts “makes sense because they are hospitals that are serving particularly vulnerable patient populations.”

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Farmworkers Face High-Risk Exposures to Bird Flu, but Testing Isn’t Reaching Them /news/article/farmworkers-bird-flu-risk-limited-testing-incentives-h5n1/ Wed, 29 May 2024 09:00:00 +0000 /?post_type=article&p=1857194 Farmworkers face some of the most intense exposures to the bird flu virus, but advocates say many of them would lack resources to fall back on if they became ill.

As of May 30, only three people in the United States had tested positive after being exposed to a wave of bird flu spreading among cows. Those people, dairy farm workers in Texas and Michigan, experienced eye irritation. One of them also had a cough and sore throat.

Scientists warn the virus could mutate to spread from person to person like the seasonal flu, which could spark a pandemic. By keeping tabs on farmworkers, researchers could track infections, learn how dangerous they are, and be alerted if the virus becomes more infectious.

But people generally get tested when they seek treatment for illnesses. Farmworkers rarely do that, because many lack health insurance and paid sick leave, said Elizabeth Strater, director of strategic campaigns for the national group United Farm Workers. They are unlikely to go to a doctor unless they become very ill.

Strater said about 150,000 people work in U.S. dairies. She said many worker advocates believe the virus has spread to more people than tests are showing. “The method being used to surveil at-risk workers has been very passive,” she said.

Federal officials told reporters May 22 that just 40 people connected to U.S. dairy farms had been tested for the virus, although others are being “actively monitored” for symptoms.

Federal authorities they would pay farmworkers $75 each to be tested for the virus, as part of a new program that also offers incentives for farm owners to allow testing of their dairy herds.

Officials of the federal Centers for Disease Control and Prevention said they recognize the importance of gaining cooperation and trust from front-line dairy employees.

CDC spokesperson Rosa Norman said in an email that the incentive payment compensates workers for their time contributing to the monitoring of how many people are infected, how sick they become, and whether humans are spreading the virus to each other.

She noted the CDC believes the virus currently poses a .

But Strater is skeptical of the incentive for farmworkers to be checked for the virus. If a worker tests positive, they’d likely be instructed to go to a clinic then stay home from work. She said they couldn’t afford to do either.

“That starts to sound like a really bad deal for 75 bucks, because at the end of the week, they’re supposed to feed their families,” she said.

Katherine Wells, director of public health in Lubbock, Texas, said that in her state, health officials would provide short-term medical care, such as giving farmworkers the flu treatment Tamiflu. Those arrangements wouldn’t necessarily cover hospitalization if it were needed, she said.

She said the workers’ bigger concern appears to be that they would have to stay home from work or might even lose their jobs if they tested positive.

Many farmworkers , and they often labor in grueling conditions for little pay.

They may fear attention to cases among them will inflame anti-immigrant fervor, said Monica Schoch-Spana, a medical anthropologist at the Johns Hopkins Center for Health Security.

Societies have a long marginalized communities for the spread of contagious diseases. Latino immigrants were verbally attacked during the H1N1 “swine flu” pandemic in 2009, for example, and some media personalities used the outbreak to push for a crackdown on immigration.

Bethany Boggess Alcauter, director of research and public health programs at the National Center for Farmworker Health, said many workers on dairy farms have been told very little about this new disease spreading in the cows they handle. “Education needs to be a part of testing efforts, with time for workers to ask questions,” she said.

These conversations should be conducted in the farmworkers’ language, with people they are likely to trust, she said.

Georges Benjamin, executive director of the American Public Health Association, said public health officials must make clear that workers’ immigration status will not be reported as part of the investigation into the new flu virus. “We’re not going to be the police,” he said.

Dawn O’Connell, an administrator at the Department of Health and Human Services, said in a press conference May 22 that nearly 5 million doses of a vaccine against H5N1, the bird flu virus circulating in cattle, are being prepared, but that officials have not decided whether the shots will be offered to farmworkers when they’re ready later this year.

The CDC asked states in early May to share personal protective equipment with farm owners, to help them shield workers from the bird flu virus. State health departments in California, Texas, and Wisconsin, which have large dairy industries, all said they have offered to distribute such equipment.

Chris Van Deusen, a Texas health department spokesperson, said four dairy farms had requested protective equipment from the state stockpile. He said other farms may already have had what they needed. Spokespeople for the California and Wisconsin health departments said they did not immediately receive requests from farm owners for the extra equipment.

Strater, the United Farm Workers official, said protective equipment offerings need to be practical.

Most dairy workers already wear waterproof aprons, boots, and gloves, she said. It wouldn’t be realistic to expect them to also wear N95 face masks in the wet, hot conditions of a milking operation, she said. Plastic face shields seem like a better option for that environment, especially to prevent milk from spraying into workers’ eyes, where it could cause infection, she said.

Other types of agricultural workers, including those who work with chickens, also face potential infection. But scientists say the version of the virus spreading in cows could be particularly dangerous, because it has adapted to live in mammals.

Strater said she’s most worried about dairy workers, who spend 10 to 12 hours a day in enclosed spaces with cows.

“Their faces are approximately 5 inches away from the milk and the udders all day long,” she said. “The intimacy of it, where their face is so very close to the infectious material, is different.”

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FDA Urged To Relax Decades-Old Tissue Donation Restrictions for Gay and Bisexual Men /news/article/tissue-donation-rules-fda-gay-bisexual-men-cornea-transplant/ Fri, 24 May 2024 09:00:00 +0000 /?post_type=article&p=1853221 The federal government in 2020 and 2023 changed who it said could safely donate organs and blood, reducing the restrictions on men who have had sex with another man.

But the FDA’s restrictions on donated tissue, a catchall term encompassing everything from a person’s eyes to their skin and ligaments, remain in place. Advocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular, said they are frustrated the FDA hasn’t heeded their calls. They want to align the guidelines for tissue donated by gay and bisexual men with those that apply to the rest of the human body.

Such groups have been asking the FDA for years to reduce the deferral period from five years to 90 days, meaning a man who has had sex with another man would be able to donate tissue as long as such sex didn’t occur within three months of his death.

One of the loudest voices on lightening the restrictions is Sheryl J. Moore, who has been an advocate since her 16-year-old son’s death in 2013. Alexander “AJ” Betts Jr.’s internal organs were successfully donated to seven people, but his eyes were rejected because of a single question asked by the donor network: “Is AJ gay?”

Moore and a Colorado doctor named Michael Puente Jr. started a “Legalize Gay Eyes” and together got the attention of national eye groups and lawmakers.

Puente, a pediatric ophthalmologist with the University of Colorado School of Medicine and Children’s Hospital Colorado, said the current patchwork of donor guidelines is nonsensical considering advancements in the ability to test potential donors for HIV.

“A gay man can donate their entire heart for transplant, but they cannot donate just the heart valve,” said Puente, who is gay. “It’s essentially a categorical ban.”

The justification for these policies, as a means of preventing HIV transmission, has been undercut by the knowledge gained through scientific progress. Now, they are unnecessary and discriminatory in that they focus on specific groups of people rather than on specific behaviors known to heighten HIV risk, according to those who advocate for changing them.

Since 2022, the FDA’s Center for Biologics Evaluation and Research has put changes to the tissue guidance on but has yet to act on them.

“It is simply unacceptable,” Rep. Joe Neguse (D-Colo.) said in a statement. He was one of dozens of Congress members who that said the current deferral policies perpetuate stigma against gay men and should be based on individualized risk assessments instead.

“FDA policy should be derived from the best available science, not historic bias and prejudice,” the letter read.

The FDA said in a statement to ĢӰԺ Health News that, “while the absolute risk transmission of HIV due to ophthalmic surgical procedures appears to be remote, there are still relative risks.”

The agency routinely reviews donor screening and testing “to determine what changes, if any, are appropriate based on technological and evolving scientific knowledge,” the statement said. The FDA provided to Neguse in 2022.

In 2015, the FDA dubbed the “blood ban,” which barred gay and bisexual men from donating blood, before in 2023 with a policy that treats all prospective donors the same. Anyone who, in the past three months, has had anal sex and a new sexual partner or more than one sexual partner is not allowed to donate. An FDA study found that, while men who have sex with men make up most of the nation’s new HIV diagnoses, a questionnaire was enough to low-risk versus high-risk donors.

The U.S. Public Health Service adjusted the guidelines for organ donation . Nothing prevents sexually active gay men from donating their organs, though if they’ve had sex with another man in the past 30 days — down from — the patient set to receive the organ can decide whether or not to accept it.

But Puente said gay men like him cannot donate their corneas unless they were celibate for five years prior to their death.

He found that, in one year alone, at least 360 people because they were men who had had sex with another man in the past five years, or in the past year in the case of Canadian donors.

Corneas are the clear domes that protect the eyes from the outside world. They have the look and consistency of a transparent jellyfish, and transplanting one can restore a person’s sight. They contain no blood, nor any other bodily fluid . Scientists there are no known cases of a patient contracting HIV from a cornea transplant, even when those corneas came from donors of organs that did infect recipients.

Currently, all donors, whether of blood, organs, or tissue, are tested for HIV and two types of hepatitis. Such tests aren’t perfect: There is still what scientists call a “window period” following infection during which the donor’s body has not yet produced a detectable amount of virus.

But such windows are now quite narrow. Researchers with the Centers for Disease Control and Prevention , which are commonly used to screen donors, are unlikely to miss someone having HIV unless they acquired it in the two weeks preceding donation. Another study even if someone had sex with an HIV-positive person a couple of weeks to a month before donating, the odds are less than 1 in a million that a nucleic acid test would miss that infection.

“Very low, but not zero,” said Sridhar Basavaraju, who was one of the researchers on that study and directs the CDC’s Office of Blood, Organ, and Other Tissue Safety. He said the risk of undetected hepatitis B is slightly higher “but still low.”

At least one senior FDA official has indirectly agreed. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, that said “three months amply covers” the window period in which someone might have the virus but at levels too low for tests to pick up. Scott Haber, director of public health advocacy at the American Academy of Ophthalmology, said his is that the tissue donation guideline “should be at least roughly in alignment” with that for blood donations.

Kevin Corcoran, who leads the Eye Bank Association of America, said the five-year abstinence required of corneal donors who are gay or bisexual isn’t just “badly out of date” but also impractical, requiring grieving relatives to recall five years of their loved one’s sexual history.

That’s the situation Moore found herself in on a July day in 2013.

Her son loved anime, show tunes, and drinking pop out of the side of his mouth. He was bad at telling jokes but good at helping people: Betts once replaced his little sister’s lost birthday money with his own savings, she said, and enthusiastically chose to be an organ donor when he got his driver’s license. Moore remembered telling her son to ignore the harassment by antigay bigots at school.

“The kids in show choir had told him he’s going to hell for being gay, and he might as well just kill himself to save himself the time,” she recalled.

That summer, he did. At the hospital, as medical staff searched for signs of brain activity in the boy before he died, Moore found herself answering a list of questions from Iowa Donor Network, including, she recalled: “Is AJ gay?”

“I remember very vividly saying to them, ‘Well, what do you mean by, “Was he gay?” I mean, he’s never had penetrative sex,’” she said. “But they said, ‘We just need to know if he was gay.’ And I said, ‘Yes, he identified as gay.’”

The Iowa Donor Network said in a statement that the organization can’t comment on Moore’s case, but said, “We sincerely hope for a shift in FDA policy to align with the more inclusive approach seen in blood donation guidelines, enabling us to honor the decision of all individuals who want to save lives through organ and tissue donation.”

Moore said her son’s organs helped save or prolong the lives of seven other people, including a boy who received his heart and a middle-aged woman who received his liver. Moore sometimes exchanges messages with her on Facebook.

She found out a year later that her son’s corneas were rejected as donor tissue because of that conversation with Iowa Donor Network about her son’s sexuality.

“I felt like they wasted my son’s body parts,” Moore said. “I very much felt like AJ was continuing to be bullied beyond the grave.”

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He Fell Ill on a Cruise. Before He Boarded the Rescue Boat, They Handed Him the Bill. /news/article/surprise-bill-cruise-ship-seizures-travel-insurance/ Wed, 22 May 2024 09:00:00 +0000 /?post_type=article&p=1853917 Vincent Wasney and his fiancée, Sarah Eberlein, had never visited the ocean. They’d never even been on a plane. But when they bought their first home in Saginaw, Michigan, in 2018, their real estate agent gifted them tickets for a Royal Caribbean cruise.

After two years of delays due to the coronavirus pandemic, they set sail in December 2022.

The couple chose a cruise destined for the Bahamas in part because it included a trip to CocoCay, a private island accessible to Royal Caribbean passengers that featured a water park, balloon rides, and an excursion swimming with pigs.

It was on that day on CocoCay when Wasney, 31, started feeling off, he said.

The next morning, as the couple made plans in their cabin for the last full day of the trip, Wasney made a pained noise. Eberlein saw him having a seizure in bed, with blood coming out of his mouth from biting his tongue. She opened their door to find help and happened upon another guest, who roused his wife, an emergency room physician.

Wasney was able to climb into a wheelchair brought by the ship’s medical crew to take him down to the medical facility, where he was given anticonvulsants and fluids and monitored before being released.

Wasney had had seizures in the past, starting about 10 years ago, but it had been a while since his last one. Imaging back then showed no tumors, and doctors concluded he was likely epileptic, he said. He took medicine initially, but after two years without another seizure, he said, his doctors took him off the medicine to avoid liver damage.

Wasney had a second seizure on the ship a few hours later, back in his cabin. This time he stopped breathing, and Eberlein remembered his lips being so purple, they almost looked black. Again, she ran to find help but, in her haste, locked herself out. By the time the ship’s medical team got into the cabin, Wasney was breathing again but had broken blood vessels along his chest and neck that he later said resembled tiger stripes.

Wasney was in the ship’s medical center when he had a third seizure — a grand mal, which typically causes a loss of consciousness and violent muscle contractions. By then, the ship was close enough to port that Wasney could be evacuated by rescue boat. He was put on a stretcher to be lowered by ropes off the side of the ship, with Eberlein climbing down a rope ladder to join him.

But before they disembarked, the bill came.

The Patient: Vincent Wasney, 31, who was uninsured at the time.

Medical Services: General and enhanced observation, a blood test, anticonvulsant medicine, and a fee for services performed outside the medical facility.

Service Provider: Independence of the Seas Medical Center, the on-ship medical facility on the .

Total Bill: $2,500.22.

What Gives: As , cruise passengers “agree to pay in full” all expenses incurred on board by the end of the cruise, including those related to medical care. In addition, Royal Caribbean “land-based” health insurance plans.

Wasney said he was surprised to learn that, along with other charges like wireless internet, Royal Caribbean required he pay his medical bills before exiting the ship — even though he was being evacuated urgently.

“Are we being held hostage at this point?” Eberlein remembered asking. “Because, obviously, if he’s had three seizures in 10 hours, it’s an issue.”

Wasney said he has little memory of being on the ship after his first seizure — seizures often leave victims groggy and disoriented for a few hours afterward.

But he certainly remembers being shown a bill, the bulk of which was the $2,500.22 in medical charges, while waiting for the rescue boat.

Still groggy, Wasney recalled saying he couldn’t afford that and a cruise employee responding: “How much can you pay?”

They drained their bank accounts, including money saved for their next house payment, and maxed out Wasney’s credit card but were still about $1,000 short, he said.

Ultimately, they were allowed to leave the ship. He later learned his card was overdrafted to cover the shortfall, he said.

Royal Caribbean International did not respond to multiple inquiries from ĢӰԺ Health News.

Once on land, in Florida, Wasney was taken by ambulance to the emergency room at Broward Health Medical Center in Fort Lauderdale, where he incurred thousands of dollars more in medical expenses.

He still isn’t entirely sure what caused the seizures.

On the ship he was told it could have been extreme dehydration — and he said he does remember being extra thirsty on CocoCay. He also has mused whether trying escargot for the first time the night before could have played a role. Eberlein’s mother is convinced the episode was connected to swimming with pigs, he said. And not to be discounted, Eberlein accidentally broke a pocket mirror three days before their trip.

Wasney, who works in a stone shop, was uninsured when they set sail. He said that one month before they embarked on their voyage, he finally felt he could afford the health plan offered through his employer and signed up, but the plan didn’t start until January 2023, after their return.

They also lacked travel insurance. As inexperienced travelers, Wasney said, they thought it was for lost luggage and canceled trips, not unexpected medical expenses. And because the cruise was a gift, they were never prompted to buy coverage, which often happens when tickets are purchased.

The Resolution: Wasney said the couple returned to Saginaw with essentially no money in their bank account, several thousand dollars of medical debt, and no idea how they would cover their mortgage payment. Because he was uninsured at the time of the cruise, Wasney did not try to collect reimbursement for the cruise bill from his new health plan when his coverage began weeks later.

The couple set up payment plans to cover the medical bills for Wasney’s care after leaving the ship: one each with two doctors he saw at Broward Health, who billed separately from the hospital, and one with the ambulance company. He also made payments on a bill with Broward Health itself. Those plans do not charge interest.

But Broward Health said Wasney missed two payments to the hospital, and that bill was ultimately sent to collections.

In a statement, Broward Health spokesperson Nina Levine said Wasney’s bill was reduced by 73% because he was uninsured.

“We do everything in our power to provide the best care with the least financial impact, but also cannot stress enough the importance of taking advantage of private and Affordable Care Act health insurance plans, as well as travel insurance, to lower risks associated with unplanned medical issues,” she said.

The couple was able to make their house payment with $2,690 they raised through a that Wasney set up. Wasney said a lot of that help came from family as well as friends he met playing disc golf, a sport he picked up during the pandemic.

“A bunch of people came through for us,” Wasney said, still moved to tears by the generosity. “But there’s still the hospital bill.”

The Takeaway: Billing practices differ by cruise line, but , chair of the cruise ship medicine section of the American College of Emergency Physicians, said medical charges are typically added to a cruise passenger’s onboard account, which must be paid before leaving the ship. Individuals can then submit receipts to their insurers for possible reimbursement.

More from Bill of the Month

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He recommended that those planning to take a cruise purchase travel insurance that specifically covers their trips. “This will facilitate reimbursement if they do incur charges and potentially cover a costly medical evacuation if needed,” Scott said.

Royal Caribbean passengers who receive onboard care submit their paid bills to their health insurer for possible reimbursement. Many health plans received on cruise ships, however. medically necessary health care services on cruise ships, but not if the ship is more than six hours away from a U.S. port.

Travel insurance can be designed to address , like lost baggage or even transportation and lodging for a loved one to visit if a traveler is hospitalized.

Travel medical insurance, as well as plans that offer “emergency evacuation and repatriation,” are two types that can specifically assist with medical emergencies. Such plans can be purchased individually. Credit cards may offer travel medical insurance among their benefits, as well.

But travel insurance plans come with limitations. For instance, they may not cover care associated with preexisting conditions or what the plans consider “risky” activities, such as rock climbing. Some plans also require that travelers file first with their primary health insurance before seeking reimbursement from travel insurance.

As with other insurance, be sure to read the fine print and understand how reimbursement works.

Wasney said that’s what they plan to do before their next Royal Caribbean cruise. They’d like to go back to the Bahamas on basically the same trip, he said — there’s a lot about CocoCay they didn’t get to explore.

Bill of the Month is a crowdsourced investigation by ĢӰԺ Health News and that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? !

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The Lure of Specialty Medicine Pulls Nurse Practitioners From Primary Care /news/article/nurse-practitioners-trend-primary-care-specialties/ Fri, 17 May 2024 09:00:00 +0000 /?post_type=article&p=1851622 For many patients, seeing a nurse practitioner has become a routine part of primary care, in which these “NPs” often perform the same tasks that patients have relied on doctors for.

But NPs in specialty care? That’s not routine, at least not yet. Increasingly, though, nurse practitioners and physician assistants are joining cardiology, dermatology, and other specialty practices, broadening their skills and increasing their income.

This development worries some people who track the health workforce, because current trends suggest primary care, which has counted on nurse practitioners to backstop physician shortages, soon might not be able to rely on them to the same extent.

“They’re succumbing to the same challenges that we have with physicians,” said Atul Grover, executive director of the Research and Action Institute at the Association of American Medical Colleges. The rates NPs can command in a specialty practice “are quite a bit higher” than practice salaries in primary care, he said.

When nurse practitioner programs began to proliferate in the 1970s, “at first it looked great, producing all these nurse practitioners that go to work with primary care physicians,” said Yalda Jabbarpour, director of the American Academy of Family Physicians’ Robert Graham Center for Policy Studies. “But now only 30% are going into primary care.”

Jabbarpour was referring to the 2024 primary care scorecard by the Milbank Memorial Fund, which found that from 2016 to 2021 the proportion of nurse practitioners who worked in primary care practices hovered between 32% and 34%, even though their numbers . The proportion of physician assistants, also known as physician associates, in primary care ranged from 27% to 30%, the study found.

Both nurse practitioners and physician assistants are advanced practice clinicians who, in addition to graduate degrees, must complete distinct education, training, and certification steps. NPs can practice without a doctor’s supervision in more than two dozen states, while PAs have similar independence in only a handful of states.

About 88% of nurse practitioners are certified in an area of primary care, according to the . But it is difficult to track exactly how many work in primary care or in specialty practices. Unlike physicians, they’re generally not required to be endorsed by a national standard-setting body to practice in specialties like oncology or cardiology, for example. The AANP declined to answer questions about its annual workforce survey or the extent to which primary care NPs are moving toward specialties.

Though data tracking the change is sparse, specialty practices are adding these advanced practice clinicians at almost the same rate as primary care practices, according to frequently cited research .

The clearest evidence of the shift: From 2008 to 2016, there was a 22% increase in the number of specialty practices that employed nurse practitioners and physician assistants, according to that study. The increase in the number of primary care practices that employed these professionals was 24%.

Once more, the by the Association of American Medical Colleges predict a dearth of at least 20,200 primary care physicians by 2036. There will also be a shortfall of non-primary care specialists, including a deficiency of at least 10,100 surgical physicians and up to 25,000 physicians in other specialties.

When it comes to the actual work performed, the lines between primary and specialty care are often blurred, said Candice Chen, associate professor of health policy and management at George Washington University.

“You might be a nurse practitioner working in a gastroenterology clinic or cardiology clinic, but the scope of what you do is starting to overlap with primary care,” she said.

Nurse practitioners’ salaries vary widely by location, type of facility, and experience. Still, according to data from health care recruiter , formerly known as Merritt Hawkins, the total annual average starting compensation, including signing bonus, for nurse practitioners and physician assistants in specialty practice was $172,544 in the year that ended March 31, slightly higher than the $166,544 for those in primary care.

According to forecasts from the federal , nurse practitioner jobs will increase faster than jobs in almost any other occupation in the decade leading up to 2032, growing by 123,600 jobs or 45%. (Wind turbine service technician is the only other occupation projected to grow as fast.) The growth rate for physician assistants is also much faster than average, at 27%. There are more than twice as many nurse practitioners as physician assistants, however: 323,900 versus 148,000, in 2022.

To Grover, of the AAMC, numbers like this signal that there will probably be enough NPs, PAs, and physicians to meet primary care needs. At the same time, “expect more NPs and PAs to also flow out into other specialties,” he said.

When Pamela Ograbisz started working as a registered nurse 27 years ago, she worked in a cardiothoracic intensive care unit. After she became a family nurse practitioner a few years later, she found a job with a similar specialty practice, which trained her to take on a bigger role, first running their outpatient clinic, then working on the floor, and later in the intensive care unit.

If nurse practitioners want to specialize, often “the doctors mentor them just like they would with a physician residency,” said Ograbisz, now vice president of clinical operations at temporary placement recruiter LocumTenens.com.

If physician assistants want to specialize, they also can do so through mentoring, or they can receive “certificates of added qualifications” in 10 specialties to demonstrate their expertise. Most employers don’t “encourage or require” these certificates, however, said Jennifer Orozco, chief medical officer at the American Academy of Physician Associates.

There are a number of training programs for family nurse practitioners who want to develop skills in other areas.

Raina Hoebelheinrich, 40, a family nurse practitioner at a regional medical center in Yankton, South Dakota, recently enrolled in a three-semester post-master’s endocrinology training program at . She lives on a farm in nearby northeastern Nebraska with her husband and five sons.

Hoebelheinrich’s new skills could be helpful in her current hospital job, in which she sees a lot of patients with acute diabetes, or in a clinic setting like the one in Sioux Falls, South Dakota, where she is doing her clinical endocrinology training.

Lack of access to endocrinology care in rural areas is a real problem, and many people may travel hundreds of miles to see a specialist.

“There aren’t a lot of options,” she said.

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Federal Panel Prescribes New Mental Health Strategy To Curb Maternal Deaths /news/article/postpartum-mental-health-federal-strategy-maternal-deaths/ Thu, 16 May 2024 09:00:00 +0000 /?post_type=article&p=1852717 For help, call or text the at 1-833-TLC-MAMA (1-833-852-6262) or contact the by dialing or texting “988.” are also available.

BRIDGEPORT, Conn. — Milagros Aquino was trying to find a new place to live and had been struggling to get used to new foods after she moved to Bridgeport from Peru with her husband and young son in 2023.

When Aquino, now 31, got pregnant in May 2023, “instantly everything got so much worse than before,” she said. “I was so sad and lying in bed all day. I was really lost and just surviving.”

Aquino has lots of company.

Perinatal depression affects as many as 20% of women in the United States during pregnancy, the postpartum period, or both, . In some states, anxiety or depression afflicts nearly a quarter of new mothers or pregnant women.

Many women in the U.S. go untreated because there is no widely deployed system to screen for mental illness in mothers, despite widespread recommendations to do so. Experts say the lack of screening has driven higher rates of mental illness, suicide, and drug overdoses that are now the leading causes of death in the first year after a woman gives birth.

“This is a systemic issue, a medical issue, and a human rights issue,” said Lindsay R. Standeven, a perinatal psychiatrist and the clinical and education director of the Johns Hopkins Reproductive Mental Health Center.

Standeven said the root causes of the problem include racial and socioeconomic disparities in maternal care and a lack of support systems for new mothers. She also pointed a finger at a shortage of mental health professionals, insufficient maternal mental health training for providers, and insufficient reimbursement for mental health services. Finally, Standeven said, the problem is exacerbated by the absence of national maternity leave policies, and the access to weapons.

Those factors helped drive a in postpartum depression from 2010 to 2021, according to the American Journal of Obstetrics & Gynecology.

For Aquino, it wasn’t until the last weeks of her pregnancy, when she signed up for acupuncture to relieve her stress, that a social worker helped her get care through the Emme Coalition, which connects girls and women with financial help, mental health counseling services, and other resources.

Mothers diagnosed with perinatal depression or anxiety during or after pregnancy are at about three times the risk of suicidal behavior and six times the risk of suicide compared with mothers without a mood disorder, according to recent U.S. and international studies in and .

The toll of the maternal mental health crisis is particularly acute in rural communities that have become maternity care deserts, as small hospitals close their labor and delivery units because of plummeting birth rates, or because of financial or staffing issues.

This week, the Maternal Mental Health Task Force — co-led by the Office on Women’s Health and the Substance Abuse and Mental Health Services Administration and formed in September to respond to the problem — that could serve as hubs of integrated care and birthing facilities by building upon the services and personnel already in communities.

The task force will soon determine what portions of the plan will require congressional action and funding to implement and what will be “low-hanging fruit,” said Joy Burkhard, a member of the task force and the executive director of the nonprofit Policy Center for Maternal Mental Health.

Burkhard said equitable access to care is essential. The task force recommended that federal officials identify areas where maternity centers should be placed based on data identifying the underserved. “Rural America,” she said, “is first and foremost.”

There are shortages of care in “unlikely areas,” including Los Angeles County, where some maternity wards have recently closed, said Burkhard. Urban areas that are underserved would also be eligible to get the new centers.

“All that mothers are asking for is maternity care that makes sense. Right now, none of that exists,” she said.

Several pilot programs are designed to help struggling mothers by training and equipping midwives and doulas, people who provide guidance and support to the mothers of newborns.

In Montana, rates of maternal depression before, during, and after pregnancy are higher than the national average. From 2017 to 2020, approximately 15% of mothers experienced postpartum depression and 27% experienced perinatal depression, according to the The state had the sixth-highest maternal mortality rate in the country in 2019, when it received a federal grant to begin training doulas.

To date, the program has trained 108 doulas, many of whom are Native American. Native Americans make up 6.6% of Montana’s population. Indigenous people, particularly those in rural areas, have of severe maternal morbidity and mortality compared with white women, according to a study in Obstetrics and Gynecology.

Stephanie Fitch, grant manager at Montana Obstetrics & Maternal Support at Billings Clinic, said training doulas “has the potential to counter systemic barriers that disproportionately impact our tribal communities and improve overall community health.”

and Washington, D.C., have Medicaid coverage for doula care, according to the National Health Law Program. They are California, Florida, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, Oklahoma, Oregon, Rhode Island, and Virginia. Medicaid pays for about in the U.S., according to the Centers for Disease Control and Prevention.

Jacqueline Carrizo, a doula assigned to Aquino through the Emme Coalition, played an important role in Aquino’s recovery. Aquino said she couldn’t have imagined going through such a “dark time alone.” With Carrizo’s support, “I could make it,” she said.

Genetic and environmental factors, or a past mental health disorder, can increase the risk of depression or anxiety during pregnancy. But mood disorders can happen to anyone.

Teresa Martinez, 30, of Price, Utah, had struggled with anxiety and infertility for years before she conceived her first child. The joy and relief of giving birth to her son in 2012 were short-lived.

Without warning, “a dark cloud came over me,” she said.

Martinez was afraid to tell her husband. “As a woman, you feel so much pressure and you don’t want that stigma of not being a good mom,” she said.

In recent years, programs around the country have started to help doctors recognize mothers’ mood disorders and learn how to help them before any harm is done.

One of the most successful is the Massachusetts Child Psychiatry Access Program for Moms, which began a decade ago and has since spread to 29 states. The program, supported by federal and state funding, provides tools and training for physicians and other providers to screen and identify disorders, triage patients, and offer treatment options.

But the expansion of maternal mental health programs is taking place amid sparse resources in much of rural America. Many programs across the country have run out of money.

The federal task force proposed that Congress fund and create consultation programs similar to the one in Massachusetts, but not to replace the ones already in place, said Burkhard.

In April, Missouri became the latest state to adopt the Massachusetts model. Women on Medicaid in Missouri are 10 times as likely to die within one year of pregnancy as those with private insurance. From 2018 through 2020, an average of 70 Missouri women died each year while pregnant or within one year of giving birth, according to state .

Wendy Ell, executive director of the Maternal Health Access Project in Missouri, called her service a “lifesaving resource” that is free and easy to access for any health care provider in the state who sees patients in the perinatal period.

About 50 health care providers have signed up for Ell’s program since it began. Within 30 minutes of a request, the providers can consult over the phone with one of three perinatal psychiatrists. But while the doctors can get help from the psychiatrists, mental health resources for patients are not as readily available.

The task force called for federal funding to train more mental health providers and place them in high-need areas like Missouri. The task force also recommended training and certifying a more diverse workforce of community mental health workers, patient navigators, doulas, and peer support specialists in areas where they are most needed.

A new in reproductive psychiatry is designed to help psychiatry residents, fellows, and mental health practitioners who may have little or no training or education about the management of psychiatric illness in the perinatal period. A small that the curriculum significantly improved psychiatrists’ ability to treat perinatal women with mental illness, said Standeven, who contributed to the training program and is one of the study’s authors.

Nancy Byatt, a perinatal psychiatrist at the University of Massachusetts Chan School of Medicine who led the launch of the Massachusetts Child Psychiatry Access Program for Moms in 2014, said there is still a lot of work to do.

“I think that the most important thing is that we have made a lot of progress and, in that sense, I am kind of hopeful,” Byatt said.

Cheryl Platzman Weinstock’s reporting is supported by a grant from the National Institute for Health Care Management Foundation.

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FDA Said It Never Inspected Dental Lab That Made Controversial AGGA Device /news/article/fda-inspection-johns-dental-agga-device/ Mon, 13 May 2024 11:30:00 +0000 /?post_type=article&p=1838624 The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or “AGGA,” a dental device that has allegedly harmed patients and is now the subject of a criminal investigation.

According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by ĢӰԺ Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later.

That inspection found that the Indiana dental device manufacturer didn’t require all customer complaints to be investigated and the company did not investigate some complaints about people being hurt by products, including the AGGA, the FDA documents state. The FDA requires device companies to to the agency. Johns Dental had “never” alerted the FDA to any such complaints, according to the documents.

The AGGA, which its inventor testified has been used on more than 10,000 patients, was promoted by dentists nationwide, some of whom said it could “grow” or “expand” an adult’s jaw without surgery and treat common ailments like sleep apnea. But these claims were not backed by peer-reviewed research, and Johns Dental has settled lawsuits from 20 patients who alleged the AGGA caused them grievous harm. The company has not admitted liability.

Two former FDA officials said the AGGA was likely able to stay on the market — and off the FDA’s radar — for so long because of the lack of inspections and investigations at Johns Dental. Madris Kinard, a former FDA manager who founded , which analyzes FDA data, said it defies belief that Johns Dental never received a complaint worthy of relaying to the FDA.

“That’s a red flag for me. If I don’t see a single report to the FDA, I typically think there is something going on,” Kinard said. “When they don’t report, what you have is devices that stay on the market much longer than they should. And patients get harmed.”

Johns Dental Laboratories declined to comment when reached by phone and its lawyers did not respond to requests for an interview. The family-owned company, which has operated since 1939 in the western Indiana city of Terre Haute, to dentists and makes hundreds of retainers and sleep apnea appliances each month, according to its website.

Twelve of Johns Dental’s products are registered with the FDA as medical devices, meaning they carry at least a moderate risk, and some have been featured on the company website for at least two decades, according to preserved by the Internet Archive.

The AGGA, which was invented by Tennessee dentist Steve Galella in the 1990s, was not registered with the FDA like Johns Dental’s other devices. Company owner Jerry Neuenschwander has said in sworn court depositions that Johns Dental started making the AGGA in 2012 and became Galella’s exclusive manufacturer in 2015 and that at one point the AGGA was responsible for about one-sixth of Johns Dental’s total sales revenue.

In another deposition, Johns Dental CEO Lisa Bendixen said the company made about 3,000 to 4,000 AGGAs a year and paid Galella’s company a “royalty” of $50 to $65 for every sale.

“We are not dentists. We do not know how these appliances work. All we do is manufacture to Dr. Galella’s specifications,” she said, according to a deposition transcript.

The FDA’s lack of knowledge about the AGGA likely contributed to its loose oversight of Johns Dental. When asked to explain the lack of inspection, the FDA said that, based on what it knew at the time, it was not required to inspect Johns Dental until 2018 when the company registered as a “contract manufacturer” of other medical devices. Prior to 2018, the FDA was only aware of Johns Dental operating as a “dental laboratory,” which normally do not manufacture their own products and only modify devices made by other companies to fit dentists’ specifications. The FDA does not regularly inspect dental labs, although it can if it has concerns or gets complaints, the agency said.

Kinard said that based on her experience at the FDA she believes the agency prioritizes medical devices over dental devices, which may have contributed to the lack of inspections at Johns Dental.

“There hasn’t been much attention to dental devices in the past,” Kinard said. “Hopefully that’s going to change because of dental implant failures, as well as this device, which has quite obviously had serious issues.”

The AGGA resembles a retainer and uses springs to apply pressure to the front teeth and upper palate, according to a patent application. Last year, the ĢӰԺ Health News-CBS News investigation revealed the AGGA was not backed by any peer-reviewed research and had never been submitted to the FDA for review. At the time, at least 20 patients had alleged in lawsuits that the AGGA had caused grievous harm to their teeth, gums, and bone — and some said they’d lost teeth. Multiple dental specialists said in interviews that they had examined AGGA patients whose teeth had been shoved out of position by the device, sometimes causing tens of thousands of dollars in damage.

“The entire concept of this device, of this treatment, makes zero sense,” said Kasey Li, a maxillofacial surgeon who that appeared on a National Institutes of Health website. “It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.

Johns Dental and Galella have negotiated out-of-court settlements with the original 20 AGGA plaintiffs without publicly admitting fault. At least 13 more AGGA patients have filed similar lawsuits since the ĢӰԺ Health News-CBS News investigation. Johns Dental and Galella denied wrongdoing or have not yet responded to the allegations in the newer lawsuits.

Galella declined to be interviewed in 2023 and neither he nor his attorneys responded to recent requests for comment. One of his attorneys, Alan Fumuso, said in a 2023 statement that the AGGA “is safe and can achieve beneficial results” when used properly.

In the wake of the ĢӰԺ Health News-CBS News report, Johns Dental abruptly stopped making the AGGA, according to the newly released FDA documents. The Department of Justice soon after opened a criminal investigation into the AGGA that was ongoing as of December, according to court filings. No charges have been filed. A DOJ spokesperson declined comment.

Spurred by the March 2023 news report, the FDA inspected Johns Dental in July. The FDA’s website shows that Johns Dental was , but the substance of the agency’s findings was not known until the inspection report was obtained this year.

FDA investigator David Gasparovich wrote in that report that he arrived unannounced at Johns Dental last July and was met by five attorneys who instructed employees not to answer any questions about the AGGA or the company’s complaint policies. Neuenschwander was told by his attorney not to talk to the inspector, the report states.

“He asked if he could photograph my credentials,” Gasparovich wrote in his report. “This was the last conversation I would have with Mr. Neuenschwander at the request of his attorney.”

The FDA requires device companies to investigate product complaints and submit a “medical device report” to the agency within 30 days if the products may have contributed to serious injury or death. Gasparovich’s inspection report states that Johns Dental had “not adequately investigated customer complaints,” and its complaint policies were “not adequately established,” allowing employees to not investigate if the product was not first returned to the company.

Johns Dental received four complaints about the AGGA after the ĢӰԺ Health News-CBS News report, including one that came after the about the device, according to the inspection report.

“Zero (0) out of the four (4) complaints were investigated,” Gasparovich wrote in the report. “Each complaint was closed on the same day it was received.”

In the months after Gasparovich’s inspection, Johns Dental sent letters to the FDA saying it revised its complaint policies to require more investigations and hired a consultant and an auditor to address other FDA concerns, according to the documents obtained through FOIA.

Former FDA analyst M. Jason Brooke, now an attorney who advises medical device companies, said the FDA uses an internal risk-based algorithm to determine when to inspect manufacturers and he advises his clients to expect inspections every three to five years.

Brooke said the AGGA is an example of how the FDA’s oversight can be hamstrung by its reliance on device manufacturers to be transparent. If device companies don’t report to the agency, it can be left unaware of patient complaints, malfunctions, or even entire products, he said.

When a company “doesn’t follow the law,” Brooke said, “the FDA is in the dark.”

“If there aren’t complaints coming from patients, doctors, competitors, or the company itself, then in a lot of ways, there’s just a dearth of information for the FDA to consume to trigger an inspection,” Brooke said.

CBS News producer Nicole Keller contributed to this article.

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