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Sign Here? Financial Agreements May Leave Doctors in the Driver’s Seat

Katheryn Houghton — Tue, 30 Apr 2024 09:00:00 +0000

Cass Smith-Collins jumped through hoops to get the surgery that would match his chest to his gender.

Living in Las Vegas and then 50, he finally felt safe enough to come out as a transgender man. He had his wife’s support and a doctor’s letter showing he had a long history of gender dysphoria, the psychological distress felt when one’s sex assigned at birth and gender identity don’t match.

Although in-network providers were available, Smith-Collins selected Florida-based surgeon Charles Garramone, who markets himself as and says that he . Smith-Collins said he was willing to pay more to go out-of-network.

“I had one shot to get the chest that I should have been born with, and I wasn’t going to chance it to someone who was not an expert at his craft,” he said.

Smith-Collins arranged to spend a week in Florida and contacted friends there who could help him recover from the outpatient procedure, he said.

Garramone’s practice required that the patient agree to its financial policies, according to documents shared by Smith-Collins. One document stated that “full payment” of Garramone’s surgical fees is required four weeks in advance of surgery and that all payments to the practice are “non-refundable.”

Smith-Collins said he and his wife dipped into their retirement savings to cover the approximately $14,000 upfront. With prior authorization from his insurer in hand saying the procedure would be “covered,” he thought his insurance would reimburse anything he paid beyond his out-of-pocket maximum for out-of-network care: $6,900.

The day before surgery, Smith-Collins signed another agreement from the surgeon’s practice, outlining how it would file an out-of-network claim with his insurance. Any insurance payment would be received by the doctor, it said.

The procedure went well. Smith-Collins went home happy and relieved.

Then the bill came. Or in this case: The reimbursement didn’t.

The Patient: Cass Smith-Collins, now 52, who has employer-based coverage through UnitedHealthcare.

Medical Services: Double-incision top surgery with nipple grafts, plus lab work.

Service Provider: Aesthetic Plastic Surgery Institute, doing business as The Garramone Center, which is owned by Garramone, according to Florida public records.

Total Bill: The surgeon’s practice billed the patient and insurance a total of $120,987 for his work. It charged the patient about $14,000 upfront — which included $300 for lab work and a $1,000 reservation fee — and then billed the patient’s insurer an additional $106,687.

The surgeon later wrote the patient that the upfront fee was for the “cosmetic” portion of the surgery, while the insurance charge was for the “reconstructive” part. Initially, the insurer paid $2,193.54 toward the surgeon’s claim, and the patient received no reimbursement.

After Ģ��ӰԺ Health News began reporting this story, the insurer reprocessed the surgeon’s claim and increased its payment to the practice to $97,738.46. Smith-Collins then received a reimbursement from Garramone of $7,245.

What Gives: Many patients write to Bill of the Month each year with their own tangled billing question. In many cases — including this one — the short answer is that the patient misunderstood their insurance coverage.

Smith-Collins was in a confusing situation. UnitedHealthcare said his out-of-network surgery would be “covered,” then it later told Smith-Collins it didn’t owe the reimbursement he had counted on. Then, after Ģ��ӰԺ Health News began reporting, he received a reimbursement.

Adding to the confusion were the practice’s financial polices, which set a pre-surgery payment deadline, gave the doctor control of any insurance payment, and left the patient vulnerable to more bills (though, fortunately, he received none).

Agreeing to an out-of-network provider’s own financial policy — which generally protects its ability to get paid and may be littered with confusing insurance and legal jargon — can create a binding contract that leaves a patient owing. In short, it can put the doctor in the driver’s seat, steering the money.

The agreement Smith-Collins signed the day before surgery says that the patient understands he is receiving out-of-network care and “may be responsible for additional costs for all services provided” by the out-of-network practice.

Federal billing protections shield patients from big, out-of-network bills — but not in cases in which the patient knowingly chose out-of-network care. Smith-Collins could have been on the hook for the difference between what his out-of-network doctor and insurer said the procedure should cost: nearly $102,000.

Emails show Smith-Collins had a couple of weeks to review a version of the practice’s out-of-network agreement before he signed it. But he said he likely hadn’t read the entire document because he was focused on his surgery and willing to agree to just about anything to get it.

“Surgery is an emotional experience for anyone, and that’s not an ideal time for anyone to sign a complex legal agreement,” said Marianne Udow-Phillips, a health policy instructor at the University of Michigan School of Public Health.

Udow-Phillips, who reviewed the agreement, said it includes complicated terms that could confuse consumers.

Another provision in the agreement says the surgeon’s upfront charges are “a separate fee that is not related to charges made to your insurance.”

Months after his procedure, having received no reimbursement, Smith-Collins contacted his surgeon, he said. Garramone replied to him in an email, explaining that UnitedHealthcare had paid for the “reconstructive aspect of the surgery” — while the thousands of dollars Smith-Collins paid upfront was for the “cosmetic portion.”

Filing an insurance claim had initially led to a payment for Garramone, but no refund for Smith-Collins.

Garramone did not respond to questions from Ģ��ӰԺ Health News for this article or to repeated requests for an interview.

Smith-Collins had miscalculated how much his insurance would pay for an out-of-network surgeon.

Documents show that before the procedure Smith-Collins received a receipt from Garramone’s practice marked “final payment” with a zero balance due, as well as prior authorization from UnitedHealthcare stating that the surgery performed by Garramone would be “covered.”

More from Bill of the Month

But out-of-network providers aren’t limited in what they can charge, and insurers don’t have a minimum they must pay.

An explanation of benefits, or EOB, statement shows Garramone submitted a claim to UnitedHealthcare for more than $106,000. Of that, UnitedHealthcare determined the maximum it would pay — known as the “allowed amount” — was about $4,400. A UnitedHealthcare representative later told Smith-Collins in an email that the total was based on what Medicare would have paid for the procedure.

Smith-Collins’ upfront charges of roughly $14,000 went well beyond the price the insurer deemed fair, and UnitedHealthcare wasn’t going to pay the difference. By UnitedHealthcare’s math, Smith-Collins’ share of its allowed amount was about $2,200, which is what counted toward his out-of-pocket costs. That meant, in the insurer’s eyes, Smith-Collins still hadn’t reached his $6,900 maximum for the year, so no refund.

Neither UnitedHealthcare nor the surgeon provided Ģ��ӰԺ Health News with billing codes, making it difficult to compare the surgeon’s charges to cost estimates for the procedure.

his fee varies depending on the size and difficulty of the procedure. The site says his prices reflect his experience and adds that “cheaper” may lead to “very poor results.”

Though he spent more than he expected, Smith-Collins said he’ll never regret the procedure. He said he had lived with thoughts of suicide since youth, having realized at a young age that his body didn’t match his identity and feared others would target him for being trans.

“It was a lifesaving thing,” he said. “I jumped through whatever hoops they wanted me to go through so I could get that surgery, so that I could finally be who I was.”

The Resolution: Smith-Collins submitted two appeals with his insurer, asking UnitedHealthcare to reimburse him for what he spent beyond his out-of-pocket maximum. The insurer denied both appeals, finding its payments were correct based on the terms of his plan, and said his case was not eligible for a third, outside review.

But after being contacted by Ģ��ӰԺ Health News, UnitedHealthcare reprocessed Garramone’s roughly $106,000 claim and increased its payment to the practice to $97,738.46.

Maria Gordon Shydlo, a UnitedHealthcare spokesperson, told Ģ��ӰԺ Health News the company’s initial determination was correct, but that it had reprocessed the claim so that Smith-Collins is “only” responsible for his patient share: $6,755.

“We are disappointed that this non-contracted provider elected to charge the member so much,” she said.

After that new payment, Garramone gave Smith-Collins a $7,245 refund in mid-April.

The Takeaway: Udow-Phillips, who worked in health insurance for decades and led provider services for Blue Cross Blue Shield of Michigan, said she had never seen a provider agreement like the one Smith-Collins signed.

Patients should consult a lawyer before signing any out-of-network agreements, she said, and they should make sure they understand prior authorization letters from insurers.

The prior authorization Smith-Collins received “doesn’t say covered in full, and it doesn’t say covered at what rate,” Udow-Phillips said, adding later, “I am sure [Smith-Collins] thought the prior authorization was for the cost of the procedure.”

Patients can seek in-network care to feel more secure about what insurance will cover and what their doctors might charge.

But for those who have a specific out-of-network doctor in mind, there are ways to try to avoid sticker shock, said Sabrina Corlette, a research professor and co-director of the Center on Health Insurance Reforms at Georgetown University:

Patients should always ask insurers to define what “covered” means, specifically whether that means payment in full and for what expenses. And before making an upfront payment, patients should ask their insurer how much of that total it would reimburse.
Patients also can ask their provider to agree in advance to accept any insurance reimbursement as payment in full, though there’s no requirement that they do so.
And patients can try asking their insurer to provide an exact dollar estimate for their out-of-pocket costs and ask if they are refundable should insurance pick up the tab.

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

Ģ��ӰԺ Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at Ģ��ӰԺ—an independent source of health policy research, polling, and journalism. Learn more about .

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Ten Doctors on FDA Panel Reviewing Abbott Heart Device Had Financial Ties With Company

David Hilzenrath and Holly K. Hacker — Mon, 08 Apr 2024 09:00:00 +0000

When the FDA recently convened a committee of advisers to assess a cardiac device made by Abbott, the agency didn’t disclose that most of them had received payments from the company or conducted research it had funded — information readily available in a federal database.

One member of the FDA advisory committee was linked to hundreds of payments from Abbott totaling almost $200,000, according to a database maintained by the Department of Health and Human Services. Another was connected to 100 payments totaling about $100,000 and conducted research supported by about $50,000 from Abbott. A third member of the committee worked on research supported by more than $180,000 from the company.

The government database, called “,” records financial relationships between doctors and certain other health care providers and the makers of drugs and medical devices. Ģ��ӰԺ Health News found records of Abbott payments associated with 10 of the 14 voting members of the FDA advisory panel, which was weighing clinical evidence for a heart device called TriClip G4 System. The money, paid from 2016 through 2022 — the most recent year for which the database shows payments — adds up to about $650,000.

The panel voted almost unanimously that the benefits of the device outweigh its risks. Abbott announced on April 2 that the FDA had approved TriClip, which is designed to treat leakage from the heart’s tricuspid valve.

The Abbott payments illustrate the reach of medical industry money and the limits of transparency at the FDA. They also shed light on how the agency weighs relationships between people who serve on its advisory panels and the makers of drugs and medical devices that those committees review as part of the regulatory approval process.

The payments do not reflect wrongdoing on the part of the agency, its outside experts, or the device manufacturer. The database does not show that any of the payments were related directly to the TriClip device.

But some familiar with the process, including people who have served on FDA advisory committees, said the payments should have been disclosed at the Feb. 13 meeting — if not as a regulatory requirement, then in the interest of transparency, because the money might call into question committee members’ objectivity.

“This is a problem,” Joel Perlmutter, a former FDA advisory committee member and a professor of neurology at Washington University School of Medicine in St. Louis, said by email. “They should or must disclose this due to bias.”

The records several kinds of payments from drug and device makers. One category, called “associated research funding,” supports research in which a physician is named a principal investigator in the database. Another category, called “general payments,” includes consulting fees, travel expenses and meals connected to physicians in the database. The money can flow from manufacturers to third parties, such as hospitals, universities, or other corporate entities, but the database explicitly connects doctors by name to the payments.

At the to consider the TriClip device, an FDA official announced that committee members had been screened for potential financial conflicts of interest and found in compliance with government requirements.

FDA spokesperson Audra Harrison said by email that the agency doesn’t comment on matters related to individual advisory committee members.

“The FDA followed all appropriate procedures and regulations in vetting these panel members and stands firmly by the integrity of the disclosure and vetting processes in place,” she said. “This includes ensuring advisory committee members do not have, or have the appearance of, a conflict of interest.”

Abbott “has no influence over who is selected to participate in FDA advisory committees,” a spokesperson for the company, Brent Tippen, said in a statement.

Diana Zuckerman, president of the National Center for Health Research, a think tank, said the FDA shouldn’t have allowed recipients of funding from Abbott in recent years to sit in judgment of the Abbott product. The agency takes too narrow a view of what should be disqualifying, she said.

One committee member was Craig Selzman, chief of the Division of Cardiothoracic Surgery at the University of Utah. The Open Payments database connects to Selzman about $181,000 in associated research funding from Abbott to the University of Utah Hospitals & Clinics.

Asked in an interview if a reasonable person could question the impartiality of committee members based on the Abbott payments, Selzman said: “People from the outside looking in would probably say yes.”

He noted that Abbott’s money went to the university, not to him personally. Participating in industry-funded clinical trials benefits doctors professionally, he said. He added: “There’s probably a better way to provide transparency.”

The FDA has a history of appointing people to advisory committees who had relationships with manufacturers of the products under review. For example, in 2020, the doctor who chaired an FDA advisory committee had been a Pfizer consultant.

Appearance Issues

FDA advisory committee candidates, selected to provide expert advice on often complicated drug and device applications, must complete a confidential disclosure report that asks about current and past financial interests as well as “anything that would give an ‘appearance’ of a conflict.”

The FDA has discretion to decide whether someone with an “appearance issue” can serve on a panel, according to a guidance document posted on the agency’s website. Relationships more than a year in the past generally don’t give rise to appearance problems, according to the document, unless they suggest close ties to a company or involvement with the product under review. The main question is whether financial interests would cause a reasonable person to question the member’s impartiality, the document says.

The FDA draws a distinction between appearance issues and financial conflicts of interest. Conflicts of interest occur when someone chosen to serve on an advisory committee has financial interests that “may be impacted” by their work on the committee, says.

If the FDA finds a conflict of interest but still wants the applicant on a panel, it can issue a public waiver. None of the panelists voting on TriClip received a waiver.

The FDA’s approach to disclosure contrasts with at which doctors earn credit for continuing medical education. For example, for a recent conference in Boston on technology for treatment of heart failure, including TriClip, the group holding the meeting directed speakers to include in their slide presentations disclosures .

Those disclosures — naming companies from which speakers had received consulting fees, grant support, travel expenses, and the like — also appeared on the conference website.

‘Unbridled Enthusiasm’

The FDA has designated TriClip a “breakthrough” device with “the potential to provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease” compared with current treatments, an agency official, Megan Naber, .

Naber said that for breakthrough devices, the “totality of data must still provide a reasonable assurance of safety and effectiveness” but the FDA “may be willing to accept greater uncertainty” about the balance of risks and benefits.

In a for the advisory committee, FDA staff pointed out findings from a clinical trial that didn’t reflect well on TriClip. For example, patients treated with TriClip had “numerically higher” mortality and heart failure hospitalization rates during the 12 months after the procedure compared with a control group, according to the report. Tippen, the Abbott spokesperson, didn’t respond to a request for comment on those findings.

The committee voted 14-0 that TriClip was safe for its intended use. The panel voted 12-2 that the device was effective, and it voted 13-1 that the benefits of TriClip outweighed the risks.

The committee member to whom the database attributes the most money from Abbott, Paul Hauptman, cast one of the votes against the device on effectiveness and the sole vote against the device on the bottom-line question of its risks versus benefits.

Hauptman said during the meeting that the question of safety was “very, very clear” but added: “I just felt the need to pull back a little bit on unbridled enthusiasm.” Who will benefit from the device, he said, “needs better definition.”

Hauptman, dean of the University of Nevada-Reno School of Medicine, is connected to 268 general payments from Abbott in the Open Payments database. Some payments are listed as going to an entity called Keswick Cardiovascular.

Hauptman said in an email that he followed FDA guidance and added, “My impartiality speaks for itself based on my vote and critical comments.”

Some committee members voted in favor of the device despite concerns.

Marc Katz, chief of the Division of Cardiothoracic Surgery at the Medical University of South Carolina, is linked to 77 general about $53,000 from Abbott and worked on research supported by about $10,000 from the company, according to Open Payments.

“I voted yes for safety, no for effectiveness, but then caved and voted yes for the benefits outweighing the risks,” he said in the meeting.

In an email, he said of his Abbott payments: “All was disclosed and reviewed by the FDA.” He said that he “can be impartial” and that he “openly expressed … concerns about the treatment.”

Mitchell Krucoff, a professor at Duke University School of Medicine, is connected to 100 general about $105,000. Some went to a third party, HPIC Consulting. He also worked on research supported by about $51,000 from Abbott, according to Open Payments.

He said during the meeting that he voted in favor of the device on all three questions and added that doctors have “a lot to learn” once it’s on the market. For instance: By using the device to treat patients now, “do we set people up for catastrophes later?”

In an email, Krucoff said he completed a “very thorough conflict of interest screening by FDA for this panel,” which focused not only on Abbott but also on “any work done/payments received from any other manufacturer with devices in this space.”

John Hirshfeld Jr., an emeritus professor of medicine at the University of Pennsylvania, is linked by the database to six general payments from Abbott . Two of the payments linked to him went to a nonprofit, the Cardiovascular Research Foundation, according to the database. He voted yes on all three questions about TriClip but said at the meeting that he “would have liked to have seen more rigorous data to support efficacy.”

In an email, Hirshfeld said he disclosed the payments to the FDA. The agency did not deem him to have a conflict because he had no stake in Abbott’s success and his involvement with the company had ended, he said. Through the conflict-of-interest screening process, he said, he had been excluded from prior advisory panels.

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How National Political Ambition Could Fuel, or Fail, Initiatives to Protect Abortion Rights in States

Bram Sable-Smith and Rachana Pradhan — Tue, 19 Mar 2024 09:00:00 +0000

ST. LOUIS — In early February, abortion rights supporters gathered to change Missouri history at the Pageant — a storied club where rock ’n’ roll revolutionary Chuck Berry often had played: They launched a signature-gathering campaign to put a constitutional amendment to voters this year to legalize abortion in the state.

“We have fought long for this moment,” the , the emcee, told the crowd. “Just two years after Missouri made abortion illegal in virtually all circumstances, the people of our state are going to forever protect abortion access in Missouri’s constitution.”

The — which would allow abortions until fetal viability — outlasted 16 other related proposals and of with Republican state officials. Next, its supporters must gather more than 171,000 valid signatures by May 5.

Missouri is one of weighing abortion-related ballot measures, most of which would protect abortion rights. Abortion rights supporters hope to build on prior ballot wins in seven politically diverse states — California, Kansas, Kentucky, Michigan, Montana, Ohio, and Vermont — since the Supreme Court in 2022 overturned federal abortion protections, handing authority back to states.

In a presidential election year, national strategy also steers the money. The success of initiatives could hinge on a state’s relevance to broader party ambitions. Democrats are focused on where anger over the abortion rollback could propel voter turnout and spur party victories up and down the ballot, including in key races for the Senate and White House. Those wins would help guard against what Democrats see as a bigger threat: a national abortion ban.

Republicans are quieter about their national strategy around abortion. But at the state level, the are putting foot soldiers on the streets ballot petitions.

Abortion rights supporters have raised millions more for ballot campaigns than have opponents, according to a Ģ��ӰԺ Health News review of campaign finance records in multiple states.

Still, they “don’t have unlimited resources,” said , an associate professor of political science at Hofstra University and expert on ballot initiatives. They must consider, “Where am I going to get the best bang for my buck here?”

Think Big America, a nonprofit founded by J.B. Pritzker, the billionaire Democratic governor of Illinois, is giving money to abortion rights initiatives in Arizona and Nevada and plans to do so in Montana, senior adviser Mike Ollen said. All are states where abortion remains legal to varying points in pregnancy, but each could have an outsize impact on the national political balance.

Arizona and Nevada are presidential swing states viewed as crucial for President Joe Biden to win reelection. They and Montana all have races that could flip control of the U.S. Senate from Democrats to Republicans in 2025.

Ollen said electoral consequences are “part of the calculus” for Think Big America. “We want to make sure that we protect abortion in the states that we’re going into,” Ollen said. “But we’re also not naive to the threat of a national abortion ban.”

About a fifth of key voter groups — Democratic women, women who live in states where abortion is banned, women who plan to vote for Biden, and women of reproductive age — identify as abortion voters, according to .

Anti-abortion groups have pressured Republican candidates to support a national ban. Presumptive GOP presidential nominee Donald Trump quietly supports a 16-week ban with some exceptions, .

Susan B. Anthony Pro-Life America, one of the nation’s largest anti-abortion groups, to spend “$92 million and reach 10 million voters” to back candidates in the political battleground states of Arizona, Georgia, Michigan, Montana, North Carolina, Ohio, Pennsylvania, and Wisconsin who would “protect life across America.” It will focus on “low turnout and persuadable voters to win the presidency and a majority in Congress.”

Ballot initiatives are one way for voters to assert their power over the political whims of state legislatures or courts. They are often viewed as more stable and harder to undo.

Abortion rights supporters must fend off statehouse maneuvers by Republicans to thwart ballot initiatives, such as proposals or to buttress rules on collecting signatures. Politicians are appealing to the courts to beat back abortion rights.

In Montana, abortion is legally protected as a fundamental privacy right by a . Still, supporters are seeking to enshrine abortion access in the state constitution with a ballot measure.

Republican Attorney General Austin Knudsen, who has unsuccessfully asked the courts to overturn the 1999 precedent, rejected the draft initiative because it places “multiple distinct political choices into a single initiative.” The initiative’s backers, led by Planned Parenthood of Montana’s chief medical officer, Samuel Dickman, have to overturn Knudsen’s ruling and allow them to start gathering signatures.

Democrats hope the ballot question will drive voter turnout and boost reelection chances for incumbent U.S. Sen. Jon Tester against the likely Republican candidate, Tim Sheehy.

Tides Foundation, a social-justice-focused charity based in California, is monitoring ballot campaigns in Montana, Arizona, and Missouri, said Beth Huang, its program officer for civic engagement and democracy. It has granted funds in Florida and is in the process of approving funds for Colorado and Nevada, she said.

As a public charity, the group “legally cannot consider the partisan implications on any set of candidate elections” in funding decisions, she said. It will fund only ballot measures that would allow abortions at least until fetal viability — generally about 24 weeks — the standard under Roe v. Wade. A proposed initiative in Arkansas is off the table because access would go to 20 weeks.

“We are not interested in policies that do less than reestablish Roe,” Huang said.

In South Dakota, Dakotans for Health wants to reinstate abortion rights in the state. But an says out-of-state money pays for signature drives that pressure people to sign the petitions without providing sufficient information on the measure. The Republican-dominated legislature to let people remove their signatures from such ballot petitions. An emergency clause would put the bill into effect immediately if the governor signs it — ahead of the deadline to place the abortion question on the November ballot.

Critics of other states’ measures see other avenues for defeat.

, a St. Louis-based Republican political strategist, said Missouri’s proposed amendment goes further than the measure passed last year in Ohio. For example, abortions could be allowed after fetal viability to protect the mental health of a pregnant person.

If opponents can get out the word that this goes further than what was done in Ohio and other states, “we have a chance of actually beating this thing,” Keller said. “If they are able to raise money. That’s a big if.”

Ballot supporters here raised $4.2 million as of March 12, . Money has come from national groups including the American Civil Liberties Union and the , which has supported ballot efforts on various progressive causes. Kansas City-based Health Forward Foundation has also donated.

So far opponents of the Missouri measure have raised $55,000, nearly half of which comes from the Catholic Church, .

“We went into this knowing that we were going to be outspent,” said Missouri Catholic Conference Executive Director Jamie Morris, who said he didn’t know whether the church would spend more. “We’re still going to be out trying to educate the faithful as best as we can, with the resources we have.”

Abortion Action Missouri Executive Director said the the state’s abortion measure is confident it will hit the signature goal by the May deadline.

If that happens, it will be up to outgoing Republican Gov. Mike Parson, who near-total abortion ban, to decide whether to put the measure before voters in the state’s August primary or the November general election.

Keller, the GOP strategist, said the governor will face tremendous pressure to put it on the August ballot. Five of six statewide offices are on the November ballot, as is Republican Josh Hawley’s U.S. Senate seat. An abortion ballot measure could overshadow those campaigns — just based on the war chests in play: Hawley’s 2018 campaign , for example, while the three political action committees backing Ohio’s abortion amendment last year

“I am telling anyone who is running as a Republican this year that if you want to be able to make your case about how and why you deserve to be elected, and you want to be able to get your story out,” Keller said, “then clearly you would not want to have a $50 million ballot initiative on in November.”

Ģ��ӰԺ Health News rural health care correspondent Arielle Zionts and Mountain States editor Matt Volz contributed to this report.

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Hoping to Clear the Air in Casinos, Workers Seek to Ban Tobacco Smoke

Sandy West — Thu, 11 Jan 2024 10:00:00 +0000

The instant Tammy Brady felt the lump in her breast in February 2022, she knew it was cancer. With no known genetic predisposition for breast cancer, she suspects 38 years of working in smoky Atlantic City casinos played a role.

“I was just trying to make a living,” said Brady, 56, a dealer and supervisor at Borgata in that New Jersey resort city. “You don’t think, you know, that you’re going to get sick at your job.”

Some casinos continue to allow indoor smoking even as the share of Americans who smoke fell from about and smoking is banned in at least some public spaces , the District of Columbia, and U.S. territories. Still, 13 of the that allow casino gambling permit smoking in at least part of their facilities.

Brady is among the casino employees, anti-smoking advocates, and public health experts who argue it is long past time to snuff out casino exemptions from smoking bans, given the dangers of secondhand smoke. But they’ve faced stiff pushback from some gambling industry leaders, including in Missouri, Louisiana, Kentucky, and New Jersey, who argue that smoking bans drive gamblers away — especially in places where patrons can go instead to a casino in a nearby jurisdiction that allows them to light up.

The covid-19 pandemic renewed this fight and sharpened the arguments on both sides — on the dangers of particulate matter for the anti-smoking side and the vulnerability of revenues for the casino industry, even as the American Gaming Association reported in 2022 for in-person casino gambling beyond the growth of sports betting and online gambling.

Casinos were for several months in spring 2020 as part of the nationwide effort to mitigate the spread of the coronavirus. Rules governing reopening, including masking and physical distancing requirements and bans on smoking, varied by state and, in some cases, by casino operator and community.

After suffering , some casino executives, and representing workers, leaned into commissioned by the Casino Association of New Jersey to combat efforts to ban or restrict smoking at their properties. Using data from 2019, the report suggests that as many as 2,500 Atlantic City casino workers could lose their jobs and tax revenue could fall by as much as $44 million in the first year if smoking is banned in New Jersey but not in neighboring Pennsylvania. Both states considered prohibitions on casino smoking in 2023; New Jersey lawmakers and Pennsylvania’s .

, a social media influencer specializing in casinos and gambling, said he has heard the arguments about lost business before — and is unconvinced. “People are not driving or flying to a casino to have a cigarette,” he said.

Still, officials in some places are persuaded by arguments about depressed tax revenue. Last spring, Shreveport, Louisiana, officials on smoking in casinos. Those pushing said local gambling taxes fell when gamblers left for nearby casinos where they could smoke. The new ordinance of the casino floor.

And announced in June it was planned for empty mall space in Owensboro, Kentucky, to a location outside the city limits. Though the company declined to comment for this article, the city’s mayor told the newspaper that a primary reason for the move was the city’s long-standing voter-approved smoking restrictions, which do not exempt casinos.

, director of the St. Louis County Department of Public Health in Missouri, was part of an effort last year to end a casino loophole in her county’s 2011 indoor smoking ban. But after pushback from the gambling company , a allowing smoking on 50% of a casino’s floor.

“It’s a balance and one that we feel the marketplace should determine, particularly in such a competitive environment with other gaming facilities nearby and in neighboring states,” said Jeff Morris, Penn Entertainment’s vice president of public affairs and government relations.

Penn Entertainment employs “state of the art ventilation systems, extremely high ceilings,” and “adequate separation of smoking and non-smoking areas,” he wrote in an email to Ģ��ӰԺ Health News.

The problem, Cunningham said, is that secondhand smoke cannot be contained to a single location in a big room.

“There’s no safe amount, and trying to restrict it to a certain area isn’t going to work,” she said.

Filtration systems can remove much of the visible smoke, as well as the odor, from indoor spaces even when lots of people are smoking, creating the impression of clean air. But existing technology does not eliminate the dangerous particulates in cigarette smoke, according to a from the American Society of Heating, Refrigerating and Air-Conditioning Engineers, or ASHRAE.

A for the National Institutes of Health evaluated particulate matter at eight Las Vegas casinos that allowed smoking and one that did not. In casinos where smoking is allowed, particulate levels were significantly higher — even in areas designated as nonsmoking — than at the nonsmoking casino.

And in ventilated casinos where indoor smoking is allowed, , workers can have nicotine levels as much as 600% higher than employees exposed to smoking in other workplaces.

can cause coronary heart disease, stroke, lung cancer, and other diseases. Some studies have shown a link to breast cancer, although more research is needed, .

The pandemic raised awareness of the dangers of airborne particulates, giving smoking bans fresh momentum, said , co-founder of the independent industry consulting group C3 Gaming, which produced a largely refuting the economic risk of casinos going smoke-free.

Indeed, more than 1,000 U.S. casinos and other gambling properties , including more than 140 tribal casinos, according to Americans Nonsmokers’ Rights Foundation.

New Mexico’s tribal leaders collectively agreed to maintain smoking bans when pandemic restrictions were lifted, said , chief executive of Acoma Business Enterprises and in North Acomita Village. Employee health has improved, he said, qualifying the casino for rebates on its insurance premium. Cleaning and replacement costs for carpets and equipment fell, he said, and the tribes “haven’t missed a beat” on revenues.

Some guests have grumbled about having to go outside to smoke, Floge said, but that’s about it. “We don’t have anybody who jumps up and down, or throws a fit and says, ‘I’m leaving and never coming back!’” he said.

Casino executives who oppose smoking restrictions overlook people who want to enjoy the “great food and the great entertainment, but won’t step foot in a casino because they get hit by a blast of smoke as soon as they step in,” said Pete Naccarelli, a Borgata dealer and one of three co-founders of the advocacy organization

He said they founded the group, which has chapters in New Jersey, Kansas, Pennsylvania, Rhode Island, and Virginia, after his casino put out ashtrays at 12:01 a.m. the day the pandemic-related smoking ban officially ended. Borgata did not answer requests for comment.

The industry-commissioned report on New Jersey suggests that while more nonsmokers might frequent casinos once smoking is banned, they probably would not make up for the revenue lost if smokers choose other venues or when smokers take breaks from gambling to light up.

But Brady, now cancer-free after chemotherapy and a full mastectomy, believes that if policymakers spent some time breathing the same air she and her co-workers do they’d act more quickly to ban smoking in casinos, rather than prioritize tax revenues. “Our lives are more important,” she said.

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Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records

Fred Schulte, Ģ��ӰԺ Health News and Holly K. Hacker — Thu, 21 Dec 2023 10:00:00 +0000

Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.

The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.

The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin.

“There’s a big hole left where he was,” said Gautney’s daughter, Carla Wiggins, who is suing the manufacturer. “A big part of me is missing.”

The wrongful-death lawsuit alleges the pump was “defective and unreasonably dangerous.” Medtronic has denied the pump caused Gautney’s death and filed a court motion for summary judgment, which is pending.

The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could “lead to an over or under delivery of insulin,” which could “be life threatening or may result in death.”

As the recall played out, federal regulators discovered that Medtronic had delayed acting — and warning patients of possible hazards with the pumps — despite amassing tens of thousands of complaints about the rings, government records show.

Over the past year, Ģ��ӰԺ Health News has investigated medical device malfunctions including:

Artificial knees manufactured by a Gainesville, Florida, company that remained on the market for more than 15 years despite packaging issues could have caused more than 140,000 of the implants to wear out prematurely.
Metal inside patients who said in lawsuits that they required urgent surgery.
Last-resort that FDA records state may have caused or contributed to thousands of patient deaths.
And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones. CBS News co-reported and aired TV stories about the and devices.

The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have “substantial equivalence” to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks.

“Patients believe they are getting an implant that’s been proven safe,” said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. “No, it hasn’t,” Sharlin said.

And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries — while injured patients face legal barriers trying to hold manufacturers accountable for product defects.

In a statement to Ģ��ӰԺ Health News, the FDA said it “has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.”

‘Too Little, Too Late’

The FDA approved the MiniMed 670G insulin pump on Sept. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval.

In a that day, Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health, lauded the device as a “first-of-its-kind technology” that would give patients “greater freedom to live their lives” and to monitor and dispense insulin as needed. The pump was tested on 123 patients in a clinical trial over several months with “no serious adverse events,” the release said. Shuren declined to be interviewed.

The FDA’s enthusiasm didn’t last. In November 2019, Medtronic, citing the ring problem, launched an “” of the pumps, which it expanded in late 2021.

During an inspection at Medtronic’s plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall. More than 800 complaints weren’t investigated at all, according to the FDA, which sharply criticized the company in a December 2021 .

Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.

Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.

In one pending case, a Las Vegas man using the pump allegedly fell into an “insulin-induced coma” that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.

The recall notice Medtronic sent to a 43-year-old Missouri man’s home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. “Simply too little, too late,” the suit reads. The case is pending, and Medtronic has yet to file an answer in court.

Medtronic declined to answer written questions from Ģ��ӰԺ Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones “redesigned to reduce the risk of damage” and “fulfilled all pump replacement requests at no cost to customers.”

In April, that the FDA had lifted the warning letter a few days after it of the MiniMed pump system.

Shortcut to Market

The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier — and less costly — pathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has “substantial equivalence” to one already on the market, even if the prior product has been recalled.

Critics have worried for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.

In July 2011, an concluded that 510(k) was “not intended to evaluate the safety and effectiveness of medical devices” and said “a move away from the 510(k) clearance process should occur as soon as reasonably possible.”

More than a decade later, that hasn’t happened, even amid over the clearance of hundreds of devices that employ artificial intelligence.

The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000. That compares with about 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device, according to FDA data. Diana Zuckerman, president of the National Center for Health Research, said even many doctors don’t realize devices cleared for sale typically have not undergone clinical trials to establish their safety.

“Doctors are shocked to learn this,” she said. “Patients aren’t going to know it when their doctors don’t.”

3,000

Approximate number of low- to moderate-risk devices cleared every year through 510(k).

30

Approximate number of devices receiving original approval from the FDA each year through stricter premarketing requirements.

In response to written questions from Ģ��ӰԺ Health News, the FDA said it “continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices.” The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence — what the agency refers to as “predicate” devices.

“We can’t get detailed data,” said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. “It’s very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems.”

Rothenberg cited the history of “” artificial hip implants, which under 510(k) spawned many new brands — along with a of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation. Just four of these hip devices have been the target of more than 25,000 lawsuits seeking damages, court records show. In early 2016, the FDA requiring safety testing before approving new metal-on-metal hip devices.

Alarm Bells

Two former Medtronic sales executives in California argue in a whistleblower lawsuit that the 510(k) process can be abused.

According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.

Medtronic’s subsidiary company Covidien made its claim even though the device has completely different “guts” and operates using software and other “substantially different” mechanisms, according to the whistleblowers’ suit.

In response, Medtronic said it “believes the allegations are without merit and has moved to dismiss the case.” The case is pending.

The whistleblowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021.

One ventilator billowed smoke in an intensive care unit while the whistleblowers were told by one hospital that “the wheels for the ventilator cart may actually fall off the ventilator during transport,” according to the suit.

Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.

The of the PB 980 cited a “manufacturing assembly error” that the company said may cause the ventilator to become “inoperable.”

Medtronic said in an email that the ventilator “has helped thousands of patients around the world,” including playing a “critical role in the global response to the COVID-19 pandemic.”

Late Warnings

The FDA operates a massive , to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. These reports must be submitted within 30 days unless a special exemption is granted.

But FDA officials acknowledge that many serious adverse events go unreported — just how many is anybody’s guess.

Since 2010, the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time. For instance, the FDA cited an Ohio company that made electric beds and other devices more than 15 times for failing to properly scrutinize complaints or report adverse events, including the death of a patient who allegedly became trapped between a bedrail and mattress, agency records show.

In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a Ģ��ӰԺ Health News analysis found. That works out to nearly 60,000 delayed reports a year.

Experts and lawmakers say the FDA needs to find a way to detect safety problems quicker.

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to Ģ��ӰԺ Health News, Grassley called that a “commonsense step we can take up front to mitigate risk, improve certainty and save money later.”

10%

Approximate number of reports in which more than a year or two elapsed from when a death or serious injury occurred to when the FDA received the reports

The FDA said it is working to “strike the right balance between assuring safety and fostering device innovation and patient access.” Yet it noted: “Additional resources are required to establish a fully functioning active surveillance system for medical devices.” For now, injured patients suing device companies often cite the volume of adverse event reports to MAUDE, or FDA citations for failing to report them, to bolster claims that the company knew about product malfunctions but failed to correct them.

In one case, a New York man is suing manufacturer Boston Scientific, claiming injuries from a device called the AMS 800 that is used to treat stress urinary incontinence.

Though Boston Scientific says on its website that 200,000 men have been treated successfully, the lawsuit argues complaints piled up in MAUDE year after year and no action was taken — by the company or by regulators.

The number of complaints filed soared from six in 2016 to 2,753 in 2019, according to the suit. By far, the largest category involved incontinence, the condition the device was supposed to fix, according to the suit. Boston Scientific did not respond to a request for comment. The company has filed a motion to dismiss the case, which is pending.

By the FDA’s own count, more than 57,000 of some 74,000 complaints Medtronic received about the MiniMed insulin pump’s retainer rings were reported to the agency. The FDA said the complaints “were part of the information that led to the compliance actions.” The agency said it “ to the retainer ring to correct this issue” and “has reviewed information confirming the effectiveness of the modification.”

“What is the threshold for the FDA to step in and do something?” said Mara Schwartz, who is a nurse, diabetes educator, and pump user. “How many deaths or adverse events does there have to be?”

In 2020, she sued Medtronic, alleging she suffered seizures when the pump mistakenly delivered an overdose of insulin. Medtronic denied her claims, and the case has since been settled under confidential terms.

Private Eyes

Some countries don’t trust the device industry to play such a key role in oversight.

Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.

That’s not likely to happen in the United States, where no device or drug manufacturer must demonstrate its new product is better than what’s already for sale.

Product liability lawsuits in the U.S. often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants manufactured by Florida device company Exactech years before a major recall. Exactech has declined comment.

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Tiny, Rural Hospitals Feel the Pinch as Medicare Advantage Plans Grow

Sarah Jane Tribble, Ģ��ӰԺ Health News — Mon, 23 Oct 2023 09:00:00 +0000

Jason Bleak runs Battle Mountain General Hospital, a small facility in a remote Nevada gold mining town that he described as “out here in the middle of nowhere.”

When several representatives from private health insurance companies called on him a few years ago to offer Medicare Advantage plan contracts so their enrollees could use his hospital, Bleak sent them away.

“Come back to the table with a better offer,” the chief executive recalled telling them. The representatives haven’t returned.

Battle Mountain is in north-central Nevada about a three-hour drive from Reno, and four hours from Salt Lake City. Bleak suspects insurance companies simply haven’t enrolled enough of the area’s seniors to need his hospital in their network.

Medicare Advantage insurers are private companies that contract with the federal government to provide Medicare benefits to seniors in place of traditional Medicare. The plans have become dubious payers for and small hospitals, which report the insurers are often slow to pay or don’t pay.

Private plans now cover more than half of all those eligible for Medicare. And while enrollment is highest in metropolitan areas, it has increased . Meanwhile, more than since 2010, according to the Cecil G. Sheps Center for Health Services Research at the University of North Carolina. Largely rural states such as Texas, Tennessee, and Georgia have had the most closures.

Medicare Advantage growth has had an outsize impact on the finances of small, rural hospitals that Medicare has designated as “.” Under the designation, government-administered Medicare pays extra to those hospitals to compensate for low patient volumes. Medicare Advantage plans, on the other hand, offer negotiated rates that hospital operators say often don’t match those of traditional Medicare.

“It’s happening across the country,” said Carrie Cochran-McClain, chief policy officer of the National Rural Health Association, whose members include small-town hospitals.

“Depending on the level of Medicare Advantage penetration in individual communities, some facilities are seeing a significant portion of their traditional Medicare patient or beneficiary move into Medicare Advantage,” Cochran-McClain said.

Kelly Adams is the CEO of Mesa View Regional Hospital, another rural hospital in Nevada. He said he applauds Battle Mountain’s Bleak for keeping Medicare Advantage plans out of his hospital “as long as he has.”

Mesa View, which is a little more than an hour’s drive east of Las Vegas, has a high percentage of patients enrolled in Medicare Advantage plans.

“Am I going to say I’m not going to take care of 40% of our patients at the hospital or the clinic?” Adams said, adding that it would be a “tough deal” to be forced to reject patients because they didn’t have traditional Medicare.

Mesa View has 21 Medicare Advantage contracts with multiple insurance companies. Adams said he has trouble getting the plans to pay for care the hospital has provided. They are either “slow pay or no pay,” he said.

In all, the plans owe Mesa View more than $800,000 for care already provided. Mesa View lost about $1.3 million taking care of patients, according to its most recent annual cost report.

NRHA’s Cochran-McClain said the growth in the plans also narrows options for patients because “the contracting that is happening under Medicare Advantage frequently has an influence on steering patients to specific types of providers.” If a hospital or provider does not contract with a Medicare Advantage plan, then a patient may have to pay for out-of-network care. That generally wouldn’t happen with traditional Medicare, which is widely accepted.

At Mesa View, patients must drive to Utah to find nursing homes and rehabilitation facilities covered by their Medicare Advantage plans.

“Our local nursing homes are not taking Medicare Advantage patients because they don’t get paid. But if you’re straight Medicare, they’d be happy to take that patient,” Adams said.

David Allen, a spokesperson for AHIP, an industry trade group formerly known as America’s Health Insurance Plans, declined to respond to Bleak’s and Adams’ specific concerns. Instead, he said enrollees are signing on because the plans “are more efficient, more cost-effective, and deliver better value than original Medicare.”

Centers for Medicare & Medicaid Services press secretary Sara Lonardo said CMS has acted to ensure “that private insurance companies are held accountable for providing quality coverage and care.”

The reach of private Medicare Advantage plans varies widely in rural areas, said Keith Mueller, director of the Rural Policy Research Institute at the University of Iowa College of Public Health. If recent trends continue, enrollment could tip to 50% of all rural Medicare beneficiaries in about three years — with some regions like the Upper Midwest already higher than 50% and others lower, such as Nevada and the Mountain States, but trending upward.

In June, a bipartisan group of Congress members, led by Sen. Sherrod Brown (D-Ohio), urging federal agencies to do more to force Medicare Advantage insurers to pay health systems what they owe for patient care.

In an August response, CMS Administrator Chiquita Brooks-LaSure wrote that a final rule issued in April made “impactful changes” to speed up care and address concerns about prior authorization — when a hospital and patient must get advance permission for care to ensure it will be covered by an insurer. Brooks-LaSure noted another proposed rule that, once finalized, could mandate that insurers provide specific reasons for denying care within seven days.

Hospital operators Adams and Bleak also want more federal action, and fast.

Bleak at Battle Mountain said he knows Medicare Advantage plans will eventually move into his area and he will have to contract with them.

“The question is,” Bleak said, “how can we match the reimbursement so that we can sustain and keep our hospitals in these rural areas viable and strong?”

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Feds Try to Head Off Growing Problem of Overdoses Among Expectant Mothers

Jazmin Orozco Rodriguez and Katheryn Houghton — Thu, 19 Oct 2023 09:00:00 +0000

LAS VEGAS — When Andria Peterson began working as a clinical pharmacist in the pediatric and neonatal intensive care units at St. Rose Dominican Hospital in Henderson, Nevada, in 2009, she witnessed the devastating effects the opioid crisis had on the hospital’s youngest patients.

She recalled vividly one baby who stayed in the NICU for 90 days with neonatal abstinence syndrome, a form of withdrawal, because his mother had used substances while pregnant.

The mother came in every day, Peterson said. She took three buses to get to the hospital to see her baby. Peterson watched her sing to him some days and read to him on others.

“I saw in the NICU the love that she had for that baby,” Peterson said. “When it came down to it, she lost custody.”

At the time, Peterson said, she felt more could be done to help people like that mother. That’s why, in 2018, she founded Empowered, a program that provides services for pregnant and postpartum women who have a history of opioid or stimulant use or are currently using drugs.

The program helps about 100 women at any given time, Peterson said. Pregnancy often motivates people to seek treatment for substance use, she said. Yet significant barriers stand in the way of those who want care, even as national rates of fatal drug overdoses during and shortly after pregnancy continue to rise. In addition to the risk of overdose, substance use during pregnancy premature birth, low birth weight, and sudden infant death syndrome.

A federal initiative seeking to combat those overdoses is distributing millions of dollars to states to help fund and expand programs like Empowered. Six states from the Substance Abuse and Mental Health Services Administration to increase access to treatment during and after pregnancy. The Nevada Health and Human Services Department is distributing the state’s portion of that funding, about $900,000 annually for up to three years, to help the Empowered program expand into northern Nevada, including by establishing an office in Reno and sending mobile staff into nearby rural communities.

Other states are trying to spread the federal funds to maximize reach. State officials in Montana have awarded their state’s latest $900,000 grant to a handful of organizations since first receiving a pool of funding in 2020. Connecticut, Iowa, Maryland, and South Carolina will also receive $900,000 each.

Officials hope the financial boosts will help tamp down the rise in overdoses.

Deaths from drug overdoses hit , according to the Centers for Disease Control and Prevention. More recent preliminary data shows that the rates of fatal drug overdoses .

Deaths in pregnant and postpartum people have also increased. Homicides, suicides, and drug overdoses are the .

Fatal overdoses among pregnant and postpartum people from 2017 to 2020, according to a 2022 study. Of 7,642 reported deaths related to pregnancy during those years, 1,249 were overdoses. Rates of pregnancy-related opioid overdose deaths had already from 2007 to 2016.

Meanwhile, mothers and mothers-to-be in rural parts of the country, by the opioid crisis, face greater barriers to care because of fewer treatment facilities specializing in pregnant and postpartum people in their communities and who can prescribe buprenorphine, a medication used to treat opioid addiction.

Data distinguishing the rates of overdose mortality among pregnant and postpartum people in urban and rural areas is hard to come by, but higher rates of neonatal opioid withdrawal syndrome in rural parts of the country. Women in rural areas also from drug overdoses in 2020 compared with women in urban areas, while the overall rate and the rate among men were greater in urban areas.

In Nevada, a 2022 maternal mortality and found that most of the state’s pregnancy-related deaths, 78%, happened in Clark County, home to Las Vegas and two-thirds of the state’s population. However, the state’s rural counties had the highest pregnancy-related death rate — 179.5 per 100,000 live births — while Clark County’s was 123 per 100,000 live births.

During a hosted by Empowered, four mothers recounted their struggles with addiction while pregnant. “It was never my intention to actually have a drug addiction,” said a mother named Amani. “I’ve always wanted to get out of the cycle of relapsing and drug usage.”

Amani, who asked to be identified only by her first name for fear of stigma associated with using drugs while pregnant or after giving birth, said she found the support she needed to treat her addiction in 2021. That’s when she began seeking help at Empowered.

Substance use while pregnant or postpartum is “incredibly stigmatizing,” said Emilie Bruzelius, a postdoctoral fellow in the Department of Epidemiology at Columbia University’s Mailman School of Public Health and author of a mortality during and after pregnancy. The stigma and fear of interacting with child welfare or law enforcement agencies prevents people from seeking help, she said.

A found that states with punitive policies toward mothers with substance use disorders have more cases of neonatal abstinence syndrome. Nevada was among them.

Researchers have found that, in addition to facing fear of punishment, many women don’t have access to treatment during and after pregnancy because in treating mothers.

Both Nevada and Montana had fewer than one treatment facility with specialized programs for pregnant and postpartum women per 1,000 reproductive-age women with substance use disorders, with Montana ranking in the lowest quintile.

One Health, a community health center covering Montana’s sprawling southeastern plains, is using the newly awarded federal money to train peer support specialists as doulas, professionals specialized in childbirth who can provide support throughout pregnancy and after.

Megkian Doyle, who directs the center’s community-based work, said in one case a survivor of sex trafficking who was drugged by her abusers worked with a recovery doula to prepare for the potential triggers of being exposed to medical workers or needing an IV. In another, a mom in stable recovery from addiction was able to keep her baby when hospital staffers called child protective services because she already had a safety plan with her doula and the agency.

After birth, recovery doulas visit families daily for two weeks, “the window when overdose, relapse, and suicide is happening,” Doyle said. The workers, in their peer support role, can continue helping clients for years.

While doula care, rarely covered by insurance, is unaffordable for many, Medicaid typically covers peer support care. As of late September, 37 states and Washington, D.C., had to cover care for 12 months postpartum. Montana and Nevada have approved plans to do so. Health centers in similarly rural states have taken note. The program’s latest cohort of recovery doulas includes five peer support specialists from Utah.

With its trauma-informed approach, the Nevada-based Empowered program takes a different tack.

The program focuses on meeting its participants’ most pressing need, which varies depending on the person. Some people need help getting government-issued identification so they can access other social services, including aid from food pantries, said Peterson, the founder and executive director. Others may need safe housing above all.

Empowered is not abstinence-based, meaning its participants do not lose access to services if they relapse or use substances while seeking help. Because some participants may be actively using drugs, the Empowered office is also a distribution site for the overdose reversal medication naloxone and test strips that detect fentanyl, a powerful synthetic opioid that has contributed to jumps in fatal overdose rates in recent years. The program’s staff also provide education about the effects drugs have on an unborn baby during pregnancy.

Being able to be honest with Empowered staff made a difference for Amani.

“I can’t tell you how many times I’ve tripped and fallen but tried to get back up and fallen again,” she said.

The goal is not only to stabilize participants’ lives but to make them resilient — whatever that may look like for each individual. For many, that includes having stable housing, food security, job security, and custody of their children.

To her, Amani said, the Empowered program means love, support, and not being alone.

“I wouldn’t be here, literally, without them,” she said.

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Con cambios en Medicaid, residentes de zonas rurales se sienten abandonados a su suerte

Jazmin Orozco Rodriguez — Wed, 20 Sep 2023 19:19:23 +0000

Cada día en su trabajo, Abby Madore cubre muchas cosas.

Madore trabaja en un centro de salud comunitario de Carson City, Nevada, donde pasa el día ayudando a residentes de bajos ingresos a entender sus opciones de seguro médico, incluyendo Medicaid. Cuenta que su teléfono no para de sonar y que atiende llamadas de clientes de zonas remotas del estado en busca de ayuda.

Es una gran responsabilidad, sobre todo este año, ya que los estados están revisando sus listas de inscripción de Medicaid desde que terminaron las protecciones por la pandemia que prohibían remover a los afiliados.

Varias docenas de especialistas trabajan para siete organizaciones encargadas de ayudar a los residentes de Nevada a inscribirse o mantener su cobertura. Madore dijo que trabaja principalmente con personas que viven en zonas rurales del estado, una enorme extensión de tierra de más de 90,000 millas cuadradas.

Katie Charleson, encargada de comunicación del mercado de seguros de salud de Nevada, dijo que es un desafío llegar a las personas de zonas rurales. Los expertos dicen que no es un caso aislado y que temen que la falta de recursos ponga en riesgo a residentes rurales de otros estados a medida que continúe el desmantelamiento de Medicaid.

Datos recientes presentados a los Centros de Servicios de Medicare y Medicaid (CMS) que perdieron la cobertura de Medicaid desde que los estados comenzaron el proceso de desmantelamiento este año fueron dados de baja por razones de procedimiento, y no porque no reunieran los requisitos para el programa federal-estatal de seguro de salud.

Los expertos afirman que estas pérdidas de beneficios por cancelaciones de Medicaid podrían afectar de forma desproporcionada a la población rural.

Un por investigadores del Center for Children and Families de la Universidad de Georgetown señala que los beneficiarios de Medicaid que viven en zonas rurales enfrentan ciertos obstáculos, como distancias más largas a las oficinas de elegibilidad y menos acceso a Internet, que hacen más difícil renovar su cobertura.

En todo el país, Medicaid y el Programa de Seguro Médico Infantil (CHIP) cubrían al 47% de los niños y al 18% de los adultos, respectivamente, en las ciudades pequeñas y las zonas rurales, en comparación con el 40% de los niños y el 15% de los adultos en los condados metropolitanos.

“Como muestra claramente nuestra investigación, las comunidades rurales dependen en gran medida de Medicaid para formar su sistema de atención de salud para niños y familias”, dijo Joan Alker, una de las coautoras del informe, directora ejecutiva del Center for Children and Families y profesora de investigación en la McCourt School of Public Policy de Georgetown. “Si los estados no gestionan bien el proceso de desmantelamiento de Medicaid, esto va a impactar a las comunidades rurales, que ya de por sí están luchando por mantener suficientes proveedores y conservar sus hospitales”.

En las zonas rurales, la falta de acceso a navegadores, las personas que ayudan a los beneficiarios de Medicaid a mantener su cobertura o encontrar otro seguro si ya no reúnen los requisitos, podría agravar estas dificultades.

Los a determinar si son elegibles para Medicaid o CHIP, la cobertura para niños cuyas familias ganan demasiado para calificar para Medicaid, y los ayudan a inscribirse. Si las personas no son elegibles para estos programas, los navegadores pueden inscribirlos en otros planes del mercado de seguros de salud.

Los navegadores operan separados de los más de 200 empleados del centro de llamadas de Nevada que ayudan a los residentes a gestionar beneficios de servicios sociales.

Están obligados por el gobierno federal a prestar sus servicios sin costo para los consumidores y a proveer información imparcial. Esto los distingue de los agentes de seguros, quienes ganan comisiones al vender ciertos planes de seguro de salud. Sin los navegadores, no existiría un servicio gratuito para guiar a los consumidores a la hora de buscar un seguro médico y determinar si sus planes de salud cubren servicios claves, como los exámenes preventivos.

Entre 30 y 40 consejeros de inscripción certificados como Madore trabajan para organizaciones de navegadores ayudando a consumidores a inscribirse en planes a través de Nevada Health Link, el mercado de seguros de salud del estado que vende planes de la Ley del Cuidado de Salud a Bajo Precio (ACA), dijo Charleson. Uno de estos grupos tiene su sede en la pequeña ciudad de Carson City, la capital de Nevada ubicada a 30 millas al sur de Reno, donde viven menos de 60,000 personas. El resto residen en los centros urbanos de Reno y Las Vegas.

La disponibilidad de navegadores y sus tácticas para llegar a las comunidades varían de un estado a otro.

En Montana, un estado que es más grande que Nevada pero que tiene un tercio de su población, seis personas trabajan como navegadores. Cubren todo el estado, llegando a los beneficiarios de Medicaid y a las personas que buscan ayuda con su cobertura por teléfono o en persona y viajando a comunidades remotas.

Por ejemplo, un navegador de Billings, en el centro sur de Montana, ha trabajado con las tribus indígenas Crow y Cheyenne del Norte, cuyas reservas se encuentran relativamente cerca, explica Olivia Riutta, directora de salud poblacional de la Montana Primary Care Association. Pero a los funcionarios les cuesta llegar al noreste de Montana, donde está la reserva de Fort Peck.

Contar con navegadores en las comunidades rurales del país que puedan ayudar a la gente en persona es un desafío permanente, dijo Alker. Pero las circunstancias actuales hacen que el papel de los navegadores, que pueden guiar a las personas a través de estos complejos procesos de seguros, sea especialmente importante, agregó.

Esto quedó claro tras una sobre la experiencia de los consumidores cuando intentan comprar un seguro de salud de forma independiente usando Google. “Los resultados son realmente preocupantes”, afirmó JoAnn Volk, coautora de la encuesta, profesora de investigación y fundadora y co-directora del Center on Health Insurance Reforms de la Universidad de Georgetown.

Los investigadores descubrieron que las personas anteriormente afiliadas a Medicaid que buscan planes de salud en el mercado privado se enfrentan a estrategias de publicidad agresivas y engañosas. Estas suelen promover productos con beneficios limitados que no cubren servicios importantes y no protegen a los consumidores de los altos costos de la atención de salud.

Los investigadores buscaron cobertura utilizando dos perfiles de consumidores que estaban perdiendo la cobertura de Medicaid y que eran elegibles para un plan sin primas ni deducibles en el mercado de ACA.

Sin embargo, según el equipo, ninguno de los 20 representantes de ventas que respondieron a sus consultas mencionó este tipo de plan. De hecho, más de la mitad de ellos promovieron productos con beneficios limitados. Los representantes también hicieron declaraciones falsas y engañosas sobre los planes que ofrecían y tergiversaron la disponibilidad o asequibilidad de los planes del mercado.

Según Volk, los representantes de ventas y los agentes ofrecieron planes limitados que costaban entre $200 y $300 al mes, un costo que podría resultar inasequible para consumidores que tienen bajos ingresos a pesar de no ser elegibles para Medicaid.

“Si no pueden llegar a un navegador, no creo que puedan conseguir la mejor opción de cobertura en los mercados de seguros, ni que puedan siquiera llegar a estos mercados, francamente”, dijo Volk.

Complicando más el asunto, el gobierno federal no exige a los estados que desglosen los datos de desafiliación de Medicaid por condado, lo cual hace más difícil para los investigadores y expertos hacer seguimiento y diferenciar los problemas rurales de los urbanos. El Center for Children and Families lo hace con datos de la Oficina del Censo, que no estarán disponibles hasta el próximo otoño, señaló Alker.

Un dato que será importante observar a medida que los estados continúen con este proceso, dijo Alker, son las estadísticas de los centros de llamadas. Los habitantes de las zonas rurales recurren más a este método que a cualquier otro para renovar su cobertura.

La “tasa de abandono de llamadas” es una de esas estadísticas. Los CMS la definen como el porcentaje de personas que abandonan la fila de llamadas, clasificadas en dos categorías: las llamadas abandonadas en los primeros 60 segundos y las abandonadas después de 60 segundos.

En agosto, la agencia al Departamento de Salud y Servicios Humanos de Nevada sobre su tasa: en mayo, el primer mes tras el inicio del desmantelamiento de Medicaid en el estado, un promedio de 56% de las llamadas fueron abandonadas.

Anne Marie Costello, subdirectora de los CMS, dijo en una carta que a la agencia “le preocupa que el tiempo de espera y la tasa de abandono de llamadas estén impidiendo el acceso equitativo a la asistencia y la capacidad de renovar la cobertura de Medicaid y CHIP por teléfono, y que pueden indicar el incumplimiento de los requisitos federales”.

Costello también citó la cifra del 45% de los inscritos en Medicaid cuya cobertura se dio de baja en mayo por cuestiones de procedimiento.

Los sobre los datos, pero sólo Idaho, Carolina del Sur, Texas y Utah tuvieron tasas de cancelación de afiliación más altas que Nevada, y ningún estado tuvo una tasa más alta de abandono de llamadas.

Funcionarios de la División de Bienestar y Servicios de Apoyo Social de Nevada dijeron que su centro de llamadas, atendido por 277 especialistas en servicios familiares, recibe más de 200,000 llamadas al mes.

Un vocero dijo que el sistema telefónico ofrece opciones de autoservicio mediante el cual los clientes pueden obtener información sobre su fecha de renovación de Medicaid y beneficios. Como a esas llamadas no las atiende un gestor de casos, se consideran “abandonadas”, lo que eleva la tasa aunque las preguntas de las personas se hayan respondido.

Las personas que buscan cobertura tras perder su seguro de Medicaid o CHIP a veces entran en pánico, explica Madore, y la mejor parte de su trabajo es poder ayudarlos a entender sus opciones.

Cuando se enteran de la amplia gama de servicios gratuitos que ofrecen los navegadores como Madore, se sorprenden, dijo.

“No están informados sobre todo el apoyo que podemos ofrecerles”, afirma Madore. “Me han llamado personas y me han dicho: ‘Es la primera vez que uso el seguro. ¿Dónde encuentro un centro de atención de urgencias?”.

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How Will Rural Americans Fare During Medicaid Unwinding? Experts Fear They’re on Their Own

Jazmin Orozco Rodriguez — Wed, 20 Sep 2023 09:00:00 +0000

Abby Madore covers a lot of ground each day at work.

A staffer at a community health center in Carson City, Nevada, Madore spends her days helping low-income residents understand their health insurance options, including Medicaid. Her phone is always ringing, she said, as she fields calls from clients who dial in from the state’s remote reaches seeking help.

It’s a big job, especially this year as states work to sort through their Medicaid rolls after the end of a pandemic-era freeze that prohibited disenrollment.

A few dozen specialists work for seven navigator organizations tasked with helping Nevadans enroll in or keep their coverage. Madore said she mostly works with people who live in rural Nevada, a sprawling landmass of more than 90,000 square miles.

Katie Charleson, communications officer for Nevada’s state health marketplace, said it’s always a challenge to reach people in rural areas. Experts say this problem isn’t unique to the state and is causing concern that limited resources will throw rural Americans into jeopardy as the Medicaid unwinding continues.

Ģ��ӰԺ’s Medicaid Enrollment and Unwinding Tracker shows that who have lost Medicaid coverage since states began the unwinding process this year were disenrolled for procedural reasons, not because officials determined they are no longer eligible for the joint state-federal health insurance program.

By late August, directed state Medicaid overseers to pause some procedural disenrollments and reinstate some recipients whose coverage was dropped.

Experts say those procedural disenrollments could disproportionately affect rural people.

A by researchers at the Georgetown University Center for Children and Families noted that rural Medicaid recipients face additional barriers to renewing coverage, including longer distances to eligibility offices and less access to the internet.

Nationwide, Medicaid and CHIP, the Children’s Health Insurance Program, covered 47% of children and 18% of adults, respectively, in small towns and rural areas, compared with 40% of children and 15% of adults in metropolitan counties.

“As is clear from our research, rural communities rely on Medicaid to form the backbone of their health care system for children and families,” said Joan Alker, who is one of the brief’s co-authors, the executive director of the Center for Children and Families, and a research professor at Georgetown’s McCourt School of Public Policy. “So if states bungle unwinding, this is going to impact rural communities, which are already struggling to keep enough providers around and keep their hospitals.”

A lack of access to navigators in rural locales to help Medicaid enrollees keep their coverage or find other insurance if they’re no longer eligible could exacerbate the difficulties rural residents face. whether they’re eligible for Medicaid or CHIP, coverage for children whose families earn too much to qualify for Medicaid, and help them enroll. If their clients are not eligible for these programs, navigators help them enroll in marketplace plans.

Navigators operate separately from Nevada’s more than 200 call center staffers who help residents manage social service benefits.

Navigators are required by the federal government to provide their services at no cost to consumers and give unbiased guidance, setting them apart from insurance broker agents, who earn commissions on certain health plans. Without them, there would be no free service guiding consumers through shopping for health insurance and understanding whether their health plans cover key services, like preventive care.

Roughly 30 to 40 certified enrollment counselors like Madore work at navigator organizations helping consumers enroll in plans through Nevada Health Link, the state health marketplace, which sells Affordable Care Act plans, said Charleson. One of these groups is based in the small capital city of Carson City, 30 miles south of Reno, where fewer than 60,000 people live. The rest are in the urban centers of Reno and Las Vegas.

Availability of navigators and their outreach tactics vary from state to state.

In Montana, which is larger than Nevada but has one-third the population, six people work as navigators. They cover the entire state, reaching Medicaid beneficiaries and people seeking help with coverage by phone or in person by traveling to far-flung communities. For example, a navigator in Billings, in south-central Montana, has worked with the Crow and Northern Cheyenne Tribes, whose reservations lie relatively nearby, said Olivia Riutta, director of population health for the Montana Primary Care Association. But officials struggle to reach northeastern Montana, with its Fort Peck Reservation.

Having navigators in rural communities to help people in person is an ongoing challenge the country faces, said Alker. But the unwinding circumstances make it an especially important moment for the role navigators play in guiding people through complex insurance processes, she said.

This became clear following a regarding what consumers encounter when independently searching for health coverage on Google. “The results are really concerning,” said survey co-author JoAnn Volk, a research professor and the founder and co-director of the Georgetown University Center on Health Insurance Reforms.

The researchers found that former Medicaid enrollees looking for health plans on the private market face aggressive, misleading marketing of limited-benefit products that don’t cover important services and fail to protect consumers from high health costs.

Researchers shopped for coverage using two profiles of consumers who were losing Medicaid coverage and were eligible for a plan with no premiums or deductibles on the ACA marketplace.

The team reported, though, that none of 20 sales representatives who responded to their queries mentioned that plan, and more than half pushed the limited-benefit products. The representatives also made false and misleading statements about the plans they were touting and misrepresented the availability or affordability of the marketplace plans.

The sales reps and brokers quoted limited plans that cost $200 to $300 a month, Volk said. Such an expense could prove unaffordable for consumers who may still be low-income despite being ineligible for Medicaid.

“If they can’t get to a navigator, I would not trust that they would get to their best coverage option in the marketplace, or to the marketplace at all, frankly,” Volk said.

Making a difficult problem more challenging, the federal government does not require states to break down Medicaid disenrollment data by county, making it harder for experts and researchers to track and differentiate rural and urban concerns. The Center for Children and Families does so with data from the Census Bureau, which Alker pointed out won’t be available until next fall.

A data point that will be important to watch as states continue the redetermination process, Alker said, is call center statistics. People in rural areas rely more heavily on that method of renewing coverage.

“Call abandonment rate” is one such statistic. CMS defines it as the percentage of calls that drop from the queue in two separate measures — calls dropped up to and including 60 seconds, and calls dropped after 60 seconds. In August, the agency to the Nevada Department of Health and Human Services about its rate: An average of 56% of calls dropped in May, the first month after Nevada’s unwinding began.

The agency “has concerns that your average call center wait time and abandonment rate are impeding equitable access to assistance and the ability for people to apply for or renew Medicaid and CHIP coverage by phone and may indicate non-compliance with federal requirements,” said Anne Marie Costello, deputy director of CMS.

In the letter, Costello also cited the 45% of Medicaid enrollees whose coverage was terminated for procedural reasons in May.

All about early data, but only Idaho, South Carolina, Texas, and Utah had higher disenrollment rates than Nevada, and no state had a higher rate of call abandonment.

Officials at Nevada’s Division of Welfare and Supportive Services said its call center, staffed by 277 family service specialists, receives more than 200,000 calls a month. A spokesperson said the phone system offers self-service options whereby customers can obtain information about their Medicaid renewal date and benefit amounts by following prompts. Because those calls aren’t handled by a case manager, they are considered “abandoned,” the spokesperson said, raising the rate even though callers’ questions may have been fully addressed.

People shopping around for coverage after a lapse might go into a panic, Madore said, and the best part of her job is providing relief by helping them understand their options after disenrollment from Medicaid or CHIP.

When people find out the wide range of free services navigators like Madore offer, they’re shocked, she said.

“They’re unaware of how much support we can provide,” Madore said. “I’ve had people call me back and they say, ‘It’s my first time using insurance. Where do I go to urgent care?’”

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Trabajadores sufren mientras el Congreso y empresarios debaten la necesidad de normas contra el calor

Amy Maxmen — Tue, 05 Sep 2023 15:07:00 +0000

A veces el calor te hace vomitar, contó Carmen García, trabajadora agrícola en el Valle de San Joaquín, en California. Ella y su marido pasaron el mes de julio en los campos de ajo, arrodillados sobre la tierra ardiente mientras las temperaturas superaban los 105 grados.

El cansancio y las náuseas de su marido fueron tan intensas que no fue a trabajar por tres días. Pero bebió agua con lima en lugar de ir al médico porque no tienen seguro médico. “A mucha gente le pasa esto”, agregó.

No existen normas federales para proteger a los trabajadores como los García cuando los días son excesivamente calurosos. Y sin el apoyo bipartidista del Congreso, incluso con la atención urgente de la administración Biden, es posible que el alivio no llegue en años.

El presidente Joe Biden a la Administración de Seguridad y Salud Ocupacional (OSHA) la elaboración de normas para prevenir los accidentes y las enfermedades causados por el calor.

Pero ese proceso de 46 pasos puede llevar más de una década y podría estancarse si un republicano es elegido presidente en 2024, porque el Partido Republicano se ha opuesto generalmente a las regulaciones de salud laboral en los últimos 20 años.

Estas normas podrían obligar a los empleadores a proporcionar abundante agua potable, descansos y un espacio para refrescarse a la sombra o con aire acondicionado cuando las temperaturas superen un determinado umbral.

El 7 de septiembre, OSHA comenzó reuniones con propietarios de pequeñas empresas para discutir sus propuestas, incluidas las medidas que deberían adoptar las empresas cuando las temperaturas llegan a los 90 grados.

Como este verano se han batido récords de calor, la congresista Judy Chu (demócrata de California) y otros miembros del Congreso han impulsado una legislación que aceleraría el proceso de elaboración de normas de OSHA.

El proyecto de ley lleva el nombre de Asunción Valdivia, una trabajadora agrícola que se desmayó mientras recogía uvas en California en un día de 105 grados en 2004. Su hijo la recogió del campo y Valdivia murió de un golpe de calor en el trayecto a su casa.

“Ya sea en una granja, conduciendo un camión o trabajando en un almacén, los trabajadores como Asunción mantienen nuestro país en funcionamiento mientras soportan algunas de las condiciones más difíciles”, dijo Chu en en la que instaba al Congreso a aprobar el proyecto de ley.

Las organizaciones profesionales que representan a los empresarios se han opuesto a las normas, calificándolas de “exageradas”. También afirman que faltan datos que justifiquen regulaciones generales, dada la diversidad de trabajadores y lugares de trabajo, desde restaurantes de comida rápida hasta granjas.

La Cámara de Comercio de Estados Unidos, uno de los grupos de presión más poderosos de Washington, que tales medidas carecen de sentido “porque cada empleado experimenta el calor de forma diferente”. Además, según la Cámara, normas como los ciclos de trabajo-descanso “amenazan con perjudicar directa y sustancialmente… la productividad de los empleados y, por lo tanto, la viabilidad económica de su empleador”.

“Muchos de los problemas relacionados con el calor no son consecuencia del trabajo agrícola ni de la mala gestión del empresario, sino del moderno estilo de vida de los empleados”, escribió el Consejo Nacional del Algodón en su respuesta a la legislación propuesta.

Por ejemplo, el aire acondicionado hace más difícil que las personas se adapten a un ambiente caluroso después de haber estado en una vivienda o un vehículo fríos, y señaló que “los trabajadores más jóvenes, más acostumbrados a un estilo de vida más sedentario, no pueden aguantar un día trabajando al aire libre”.

La Asociación de Recursos Forestales, que representa a los propietarios de terrenos forestales, la industria maderera y los aserraderos, agregó que “las enfermedades y muertes relacionadas con el calor no figuran entre los riesgos laborales más graves a los que se enfrentan los trabajadores”. Citaron : la agencia documentó 789 hospitalizaciones y 54 muertes relacionadas con el calor a través de investigaciones e infracciones de 2018 a 2021.

OSHA admite que sus datos son cuestionables. Ha dicho que sus cifras “sobre enfermedades, accidentes y muertes relacionadas con el calor en el trabajo son probablemente grandes subestimaciones”.

Los accidentes y enfermedades no siempre se registran, las muertes provocadas por las altas temperaturas no siempre se atribuyen al calor, y los daños relacionados con el calor pueden ser acumulativos, provocando infartos, insuficiencia renal y otras dolencias después de que la persona haya abandonado su lugar de trabajo.

El efecto de la temperatura

Para establecer normas, OSHA debe conocer los efectos del calor en los que trabajan en interiores y al aire libre. La justificación es una parte necesaria del proceso, porque las normativas aumentarán los costos para los empresarios que necesiten instalar sistemas de aire acondicionado y ventilación en el interior, y para aquellos cuya productividad pueda bajar si se permite a los que trabajan a la intemperie tomar descansos o reducir las jornadas cuando suban las temperaturas.

Lo ideal sería que los empresarios tomaran medidas para proteger a los trabajadores del calor independientemente de las normas, afirmó Georges Benjamin, director ejecutivo de la Asociación Americana de Salud Pública. “Tenemos que hacer un mejor trabajo para convencer a los empresarios de que hay una compensación entre la eficiencia y los trabajadores enfermos”, dijo.

García y su marido sufrieron los síntomas del golpe de calor: vómitos, náuseas y fatiga. Pero sus casos forman parte de los miles que no se contabilizan cuando la gente no va al hospital ni presenta denuncias por miedo a perder su empleo o estatus migratorio.

Los trabajadores agrícolas están notoriamente subrepresentados en las estadísticas oficiales sobre accidentes y enfermedades laborales, según David Michaels, epidemiólogo de la Universidad George Washington y ex administrador de OSHA.

Investigadores que encuestaron a trabajadores agrícolas de y encontraron que más de un tercio presentaba síntomas de enfermedad por calor durante los veranos analizados, una cifra muy superior a la registrada por OSHA. En particular, el estudio de Georgia reveló que el 34% de los trabajadores agrícolas no tenía descansos regulares, y una cuarta parte no tenía acceso a espacios con sombra.

Incluso los casos en los que los trabajadores son hospitalizados pueden no atribuirse al calor si los médicos no documentan la conexión. Muchos estudios relacionan los accidentes laborales con el estrés térmico, que puede causar fatiga, deshidratación y vértigo.

En un estudio realizado en el estado de Washington, se observó que los trabajadores agrícolas se con más frecuencia en junio y julio, unos de los meses más calurosos y húmedos. Y en un informe de 2021, investigadores calcularon que las temperaturas más cálidas causaron aproximadamente en California entre 2001 y 2018, según los reclamos de compensación de los trabajadores.

Las lesiones renales por calor también aparecen en la base de de trabajadores lesionados gravemente en el trabajo, como el caso de un empleado de una planta de procesamiento de carne hospitalizado por deshidratación y lesión renal aguda en un caluroso día de junio en Arkansas.

Sin embargo, la investigación revela que el daño renal provocado por el calor también. Un estudio de trabajadores de la construcción que estuvieron durante un verano en Arabia Saudita reveló que el signos de lesión renal, lo que los ponía en riesgo de insuficiencia renal futura.

Además de cuantificar las lesiones y muertes causadas por el calor, OSHA trata de atribuirles un costo para poder calcular el ahorro potencial derivado de la prevención. “Hay que medir las cosas, como ¿cuánto vale una vida?”, afirmó Michaels.

Para los trabajadores y sus familias, el sufrimiento tiene consecuencias de largo alcance que son difíciles de enumerar. Los gastos médicos son más obvios. Por ejemplo, OSHA calcula que el costo directo de la postración por calor (sobrecalentamiento debido a insolación o hipertermia), es de casi $80,000 en costos directos e indirectos por caso.

Si esto parece elevado, hay que pensar en un trabajador de la construcción de Nueva York que perdió el conocimiento en un día caluroso y se cayó de una plataforma, y sufrió una laceración renal, fracturas faciales y varias costillas rotas.

El precio de los golpes de calor

Investigadores también han intentado determinar el costo que supone para los empresarios la pérdida de productividad. El trabajo es menos eficiente cuando suben las temperaturas, y si los trabajadores se ausentan por enfermedad y tienen que ser reemplazados, la producción disminuye mientras se entrena a nuevos trabajadores.

Cullen Page, cocinero de Austin, Texas, y miembro del sindicato Restaurant Workers United, trabaja durante horas frente a un horno de pizza, donde, según dijo, las temperaturas oscilaron entre los 90 y los 100 grados cuando las olas de calor golpeaban la ciudad en agosto.

“Es brutal. Afecta tu forma de pensar. Estás confundido”, dijo. “Me dio un sarpullido por calor que no se me quitaba”. Como hace tanto calor, agregó, el restaurante tiene un alto índice de rotación de empleados. Una campana extractora adecuada sobre los hornos y un mejor aire acondicionado ayudarían, pero los propietarios aún no han hecho las mejoras, dijo.

Via 313, la cadena de pizzerías en la que trabaja Page, no respondió al pedido de comentario.

Page no es el único. Una organización que representa a los empleados de restaurantes, Restaurant Opportunities Centers United, encuestó a miles de trabajadores, muchos de los cuales informaron de : el 24% de los trabajadores de Houston, por ejemplo, y el 37% de los de Philadelphia.

“Los trabajadores estuvieron expuestos a temperaturas de hasta 100 grados después de que se rompieron los aparatos de aire acondicionado y los ventiladores de las cocinas, lo que les dificultaba respirar”, escribió el Sindicato Internacional de Empleados de Servicios, que incluye a trabajadores del sector de comida rápida, en una nota a OSHA. “No hay razón para retrasar más la creación de una norma cuando conocemos la magnitud del problema y sabemos cómo proteger a los trabajadores”, dijeron.

Investigadores del Atlantic Council calculan que Estados Unidos de $100,000 millones anuales por la baja de la productividad laboral inducida por el calor a medida que el clima se vuelve más cálido. “A los empresarios les cuesta mucho dinero no proteger a sus trabajadores”, afirmó Juley Fulcher, defensora de salud y seguridad de los trabajadores de Public Citizen, organización de Washington D.C. que aboga por que el proyecto de ley Asunción Valdivia permita a OSHA promulgar normas el año que viene.

Como modelo, Fulcher sugirió fijarse en California, Maryland, Nevada, Oregon y Washington, los únicos estados con normas que obligan a que todos los trabajadores al aire libre tengan acceso a agua, descanso y sombra.

Aunque las normas no siempre se hacen cumplir, parece que surten efecto. Después de que California instaurara la suya en 2005, se registraron menos accidentes en los reclamos de indemnización de los trabajadores cuando las temperaturas superaban los 85 grados.

Michaels afirmó que OSHA ha demostrado que puede actuar con más rapidez de lo habitual cuando el Congreso se lo permite.

En los primeros días de la epidemia de VIH/SIDA, la agencia aprobó rápidamente normas para evitar que médicos, enfermeras y dentistas se infectaran accidentalmente con agujas. Ahora existe una urgencia similar, dijo. “Dada la crisis climática y la prolongación de los períodos de calor extremo”, señaló, “es imperativo que el Congreso apruebe una legislación que permita a OSHA promulgar rápidamente una norma que salve vidas”.

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