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From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA

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David Hilzenrath and Holly K. Hacker
Tue, 09 Jul 2024 09:00:00 +0000

In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.”

In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has it to “landing a man on the moon.”

MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ill with a condition called mitral regurgitation and too frail to undergo surgery.

“It changed the face of cardiac medicine,” Oz said in a video.

But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show. Products in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. The case is pending, and Abbott has denied illegally marketing the device.

The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices.

Manufacturer-sponsored research on the device has long been questioned. In 2013, an outside adviser to the FDA compared some of the data marshaled in support of its approval to “poop.”

The FDA expanded its approval of MitraClip to a wider set of patients in 2019, based on a clinical trial in which Abbott was deeply involved and despite conflicting findings from another study.

In the three recalls, the first of which warned of potentially deadly consequences, neither the manufacturer nor the FDA withdrew inventory from the market. The company told doctors it was OK for them to continue using the recalled products.

In response to questions for this article, both Abbott and the FDA described MitraClip as safe and effective.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” Abbott spokesperson Brent Tippen said. “Patients suffering from mitral regurgitation have severely limited quality of . MitraClip can significantly improve survival, for hospitalization and quality of life via a minimally invasive, now common procedure.”

An FDA spokesperson, Audra Harrison, said patient safety “is the FDA’s highest priority and at the forefront of our work in medical device regulation.”

She said reports to the FDA about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results the FDA reviewed for its 2013 and 2019 approvals.

In other words: They were expected.

Inspiration in Italy

When a person has mitral regurgitation, blood flows backward through the mitral valve. Severe cases can to heart failure.

With MitraClip, flaps of the valve — known as “leaflets” — are clipped together at one or more points to achieve a tighter seal when they close. The clips are deployed via a catheter threaded through a major vein, typically from an incision in the groin. The procedure offers an alternative to connecting the patient to a heart-lung machine and repairing or replacing the mitral valve in open-heart surgery.

Oz has said in online videos that he got the idea after hearing a doctor describe a surgical technique for the mitral valve at a conference in Italy. “And on the way home that night, on a plane heading back to Columbia , where I was on the faculty, I wrote the patent,” he told KFF Health News.

A patent obtained by Columbia in 2001, one of several associated with MitraClip, lists Oz first among the inventors.

But a Silicon Valley-based startup, Evalve, would develop the device. Evalve was later acquired by Abbott for about $400 million.

“I think the engineers and people at Evalve always cringe a little bit when they see Mehmet taking a lot of, you know, basically claiming responsibility for what was a really extraordinary team effort, and he was a small to almost no player in that team,” one of the company’s founders, cardiologist Fred St. Goar, told KFF Health News.

As of 2019, the MitraClip device cost $30,000 per procedure, according to an article in a medical journal. According to the Abbott website, more than 200,000 people around the world have been treated with MitraClip.

Oz filed a financial disclosure during his unsuccessful run for the U.S. Senate in 2022 that showed him receiving hundreds of thousands of dollars in annual MitraClip royalties.

Abbott recently received FDA approval for TriClip, a variation of the MitraClip system for the heart’s tricuspid valve.

Endorsed ‘With Trepidation’

Before the FDA said yes to MitraClip in 2013, agency staffers pushed back.

Abbott had originally wanted the device approved for “patients with significant mitral regurgitation,” a relatively broad term. After the FDA objected, the company narrowed its proposal to patients at too-high risk for open-heart surgery.

Even then, in an analysis, the FDA identified “fundamental” flaws in Abbott’s data.

One example: The data compared MitraClip patients with patients who underwent open-heart surgery for valve repair — but the comparison might have been biased by differences in the expertise of doctors treating the two groups, the FDA analysis said. While MitraClip was implanted by a highly select, experienced group of interventional cardiologists, many of the doctors doing the open-heart surgeries had performed only a “very low volume” of such operations.

FDA “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered,” the FDA said in a review prepared for a March 2013 meeting of a committee of outside advisers to the agency.

Some committee members expressed misgivings. “If your right shoe goes into horse poop and your left shoe goes into dog poop, it’s still poop,” cardiothoracic surgeon Craig Selzman said, according to a transcript.

The committee voted 5-4 against MitraClip on the question of whether it proved effective. But members voted 8-0 that they considered the device safe and 5-3 that the benefits of the device outweighed its risks.

Selzman voted yes on the last question “with trepidation,” he said at the time.

In October 2013, the FDA approved the MitraClip Clip Delivery System for a narrower group of patients: those with a particular type of mitral regurgitation who were considered a surgery risk.

“The reality is, there is no perfect procedure,” said Jason Rogers, an interventional cardiologist and University of California-Davis professor who is an Abbott consultant. The company referred KFF Health News to Rogers as an authority on MitraClip. He called MitraClip “extremely safe” and said some patients treated with it are “on death’s door to begin with.”

“At least you’re trying to do something for them,” he said.

Conflicting Studies

In 2019, the FDA expanded its approval of MitraClip to a wider set of patients.

The agency based that decision on a clinical trial in the United States and Canada that Abbott not only sponsored but also helped design and manage. It participated in site selection and data analysis, according to a September 2018 New England Journal of Medicine paper reporting the trial results. Some of the authors received consulting fees from Abbott, the paper disclosed.

A separate study in France reached a different conclusion. It found that, for some patients who fit the expanded profile, the device did not significantly reduce deaths or hospitalizations for heart failure over a year.

The French study, which appeared in the New England Journal of Medicine in August 2018, was funded by the government of France and Abbott. As with the North American study, some of the researchers disclosed they had received money from Abbott. However, the write-up in the journal said Abbott played no role in the design of the French trial, the selection of sites, or in data analysis.

Gregg Stone, one of the leaders of the North American study, said there were differences between patients enrolled in the two studies and how they were medicated. In addition, outcomes were better in the North American study in part because doctors in the U.S. and Canada had more MitraClip experience than their counterparts in France, Stone said.

Stone, a clinical trial specialist with a background in interventional cardiology, acknowledged skepticism toward studies sponsored by manufacturers.

“There are some people who say, ‘Oh, well, you know, these results may have been manipulated,’” he said. “But I can guarantee you that’s not the truth.”

‘Nationwide Scheme’

A former Abbott employee alleges in a lawsuit that after MitraClip won approval, the company promoted the device to doctors and hospitals using inducements such as marketing support, the chance to participate in Abbott clinical trials, and payments for participating in “sham speaker programs.”

The former employee alleges that she was instructed to tell referring physicians that if they observed mitral regurgitation in their patients to “just send it” for a MitraClip procedure because “everything can be clipped.” She also alleges that, using a script, she was told to promote the device to hospital administrators based on financial advantages such as “growth opportunities through profitable procedures, ancillary tests, and referral streams.”

The inducements were part of a “nationwide scheme” of illegal kickbacks that defrauded government health insurance programs including Medicare and Medicaid, the lawsuit claims.

The company denied doing anything illegal and said in a court filing that “to its groundbreaking therapy reach patients, Abbott needed to educate cardiologists and other providers.”

Those efforts are “not only routine, they are laudable — as physicians cannot use, or refer a patient to another doctor who can use, a device that they do not understand or in some cases even know about,” the company said in the filing.

Under federal law, the person who filed the suit can a share of any money the government recoups from Abbott. The suit was filed by a company associated with a former employee in Abbott’s Structural Heart Division, Lisa Knott. An attorney for the company declined to comment and said Knott had no comment.

Reports to the FDA

As doctors started using MitraClip, the FDA began receiving reports about malfunctions and cases in which the product might have caused or contributed to a or an injury.

According to some reports, clips detached from valve flaps. Flaps became damaged. Procedures were aborted. Mitral leakage worsened. Doctors struggled to control the device. Clips became “entangled in chordae” — cord-like structures also known as heartstrings that connect the valve flaps to the heart muscle. Patients treated with MitraClip underwent corrective operations.

As of March 2024, the FDA had received more than 17,000 reports documenting more than 22,000 “events” involving mitral valve repair devices, FDA data shows. All but about 200 of those reports mention one iteration of MitraClip or another, a KFF Health News review of FDA data found.

Almost all the reports came from Abbott. The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.

The reports are not proof that devices caused problems, and the same event might be reported multiple times. Other events may go unreported.

Despite the reports’ limitations, the FDA provides an analysis of them for the public on its website.

MitraClip’s risks weren’t a surprise.

Like the rapid-fire fine print in television ads for prescription drugs, the original product label for the device listed more than 60 types of potential complications.

Indeed, during clinical research on the device, about 6% of patients implanted with MitraClip died within 30 days, according to the label. Almost 1 in 4 — 23.6% – were dead within a year.

The FDA spokesperson, Harrison, pointed to a study originally published in 2021 in The Annals of Thoracic Surgery, based on a central registry of mitral valve procedures, that found lower rates of death after MitraClip went on the market.

“These data confirmed that the MitraClip device remains safe and effective in the real-world setting,” Harrison said.

But the study’s authors, several of whom disclosed financial or other connections to Abbott, said data was missing for more than a quarter of patients one year after the procedure.

A major measure of success would be the proportion of MitraClip patients who are alive “with an acceptable quality of life” a year after undergoing the procedure, the study said. Because such information was available for fewer than half of the living patients, “we have omitted those outcomes from this report,” the authors wrote.

If you’ve had an experience with MitraClip or another medical device and would like to tell KFF Health News about it, click here to share your story with us.

KFF Health News audience engagement producer Tarena Lofton contributed to this report.

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

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By: David Hilzenrath and Holly K. Hacker
Title: From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA
Sourced From: kffhealthnews.org/news/article/mitraclip-heart-valve-device-dr-oz-fda/
Published Date: Tue, 09 Jul 2024 09:00:00 +0000

Kaiser Health News

Harris’ California Health Care Battles Signal Fights Ahead for Hospitals if She Wins

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Bernard J. Wolfson and Phil Galewitz, KFF Health News
Mon, 05 Aug 2024 09:00:00 +0000

When Kamala Harris was California’s top prosecutor, she was concerned that mergers among hospitals, physician groups, and health insurers could thwart competition and to higher prices for patients. If she wins the presidency in November, she’ll have a wide range of options to blunt monopolistic behavior nationwide.

The Democratic vice president could influence the Federal Trade Commission and instruct the departments of Justice and Health and Human Services to prioritize enforcement of antitrust laws and channel resources accordingly. Already, the Biden administration has taken an aggressive stance against mergers and acquisitions. In his first year in office, issued an executive order intended to intensify antitrust enforcement across multiple industries, .

Under Biden, the FTC and DOJ have fought more mergers than they have in decades, often targeting health care deals.

“What Harris could do is set the tone that she is going to continue this laser focus on competition and health care prices,” said Katie Gudiksen, a senior health policy researcher at University of California College of the Law, San Francisco.

The Harris campaign didn’t respond to a request for comment.

For decades, the health industry has undergone consolidation despite government efforts to maintain competition. When health systems expand, adding hospitals and doctor practices to their portfolios, they often gain a large enough share of regional health care resources to command higher prices from insurers. That results in higher premiums and other health care costs for consumers and employers, according to numerous studies.

Health insurers have also consolidated in recent decades, leaving only a handful controlling most markets.

Health care analysts say it’s possible for Harris to slow the momentum of consolidation by blocking future mergers that could lead to higher prices and lower-quality care. But many of them agree the consolidation that has already taken place is an inescapable feature of the U.S. health care landscape.

“It’s hard to unscramble the eggs,” said Bob Town, an economics professor at the University of .

There were nearly 1,600 hospital mergers in the U.S. from 1998 to 2017 and 428 hospital and health system mergers from 2018 to 2023, according to a KFF study. The percentage of community hospitals that belong to a larger health system rose from 53 in 2005 to 68 in 2022. And in another sign of market concentration, as of January, well over three-quarters of the nation’s physicians were employed by hospitals or corporations, according to a produced by Avalere Health.

Despite former President Donald Trump’s hostility to regulation as a candidate, his administration was active on antitrust efforts — though it did allow one of the largest health care mergers in U.S. history, between drugstore chain CVS Health and the insurer Aetna. Overall, Trump’s Justice Department was more aggressive on mergers than past Republican administrations.

Harris, as California’s attorney general from 2011 to 2017, jump-started health care investigations and enforcement.

“She pushed back against anticompetitive pricing,” said Rob Bonta, California’s current attorney general, who is a Democrat.

One of Harris’ most impactful decisions was a 2012 investigation into whether consolidation among hospitals and physician practices gave health systems the clout to demand higher prices. That probe bore fruit six years later after Harris’ successor, Xavier Becerra, filed a landmark lawsuit against Sutter Health, the giant Northern California hospital operator, for anticompetitive behavior. Sutter settled with the state for $575 million.

In 2014, Harris was among 16 state attorneys general who joined the FTC in a lawsuit to dismantle a merger between one of Idaho’s largest hospital chains and its biggest physician group. In 2016, Harris joined the U.S. Department of Justice and 11 other states in a successful lawsuit to block a proposed $48.3 billion merger between two of the nation’s largest health insurers, Cigna and Anthem.

Attempts to give the state attorney general the power to nix or impose conditions on a wide range of health care mergers have been fiercely, and successfully, opposed by California’s hospital industry. Most recently, the hospital industry persuaded state lawmakers to exempt for-profit hospitals from pending legislation that would subject private equity-backed health care transactions to by the attorney general.

A spokesperson for the California Hospital Association declined to comment.

As attorney general of California, Harris’ work was eased by the state’s deep blue political hue. Were she to be elected president, she could face a less hospitable political environment, especially if Republicans control one or both houses of . In addition, she could face opposition from powerful health care lobbyists.

Though it often gets a bad rap, consolidation in health care also confers . Many doctors choose to join large organizations because it relieves them of the administrative headaches and financial burdens of running their own practices. And being absorbed into a large health system can be a lifeline for financially troubled hospitals.

Still, a major reason health systems choose to expand through acquisition is to accumulate market clout so they can match consolidation among insurers and bargain with them for higher payments. It’s an understandable reaction to the financial pressures hospitals are under, said James Robinson, a professor of health economics at the University of California-Berkeley.

Robinson noted that hospitals are required to treat anyone who shows up at the emergency room, including uninsured people. Many hospitals have a large number of patients on , which pays poorly. And in California, they face a series of regulatory requirements, including seismic retrofitting and nurse staffing minimums, that are expensive. “How are they going to pay for that?” Robinson said.

At the federal level, any effort to blunt anticompetitive mergers would depend in part on how aggressive the FTC is in pursuing the most egregious cases. FTC Chair Lina Khan has made the FTC more proactive in this regard.

Last year, the FTC and DOJ jointly issued new merger guidelines, which suggested the federal government would scrutinize deals more closely and take a broader view of which ones violate antitrust laws. In September, the FTC filed a lawsuit against an anesthesiology group and its private equity backer, alleging they had engaged in anticompetitive practices in Texas to drive up prices.

In January, the agency sued to stop a $320 million hospital acquisition in North Carolina.

Still, many transactions don’t come to the attention of the FTC because their value is below its $119.5 million reporting threshold. And even if it heard about more deals, “it is very underresourced and needing to be very selective in which mergers they challenge,” said Paul Ginsburg, a professor of the practice of health policy at the University of Southern California’s Sol Price School of Public Policy.

Khan’s term ends in September 2024, and Harris, if elected, could try to reappoint her, though her ability to do so may depend on which party controls the Senate.

Harris could also promote regulations that discourage monopolistic behaviors such as all-or-nothing contracting, in which large health systems refuse to do business with insurance companies unless they agree to include all their facilities in their networks, whether needed or not. That behavior was one of the core allegations in the Sutter case.

She could also seek policies at the Department of Health and Human Services, which runs Medicare and Medicaid, that encourage competition.

Bonta, California’s current attorney general, said that, while there are bad mergers, there are also good ones. “We approve them all the time,” he said. “And we approve them with conditions that address cost and that address access and that address quality.”

He expects Harris to bring similar concerns to the presidency if she wins.

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

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By: Bernard J. Wolfson and Phil Galewitz, KFF Health News
Title: Harris’ California Health Care Battles Signal Fights Ahead for Hospitals if She Wins
Sourced From: kffhealthnews.org/news/article/kamala-harris-california-hospitals-health-care-antitrust-ftc/
Published Date: Mon, 05 Aug 2024 09:00:00 +0000

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Urgent Care or ER? With ‘One-Stop Shop,’ Hospitals Offer Both Under Same Roof

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Phil Galewitz, KFF Health
Fri, 02 Aug 2024 09:00:00 +0000

JACKSONVILLE, . — Facing an ultracompetitive market in one of the nation’s fastest-growing cities, UF Health is a new way to attract patients: a combination emergency room and urgent care center.

In the past year and a half, UF Health and a private equity-backed company, Intuitive Health, have opened three centers that offer both types of care 24/7 so patients don’t have to decide which facility they need.

Instead, doctors there decide whether it’s urgent or emergency care —the health system bills accordingly — and inform the patient of their decision at the time of the service.

“Most of the time you do not realize where you should go — to an urgent care or an ER — and that triage decision you make can have dramatic economic repercussions,” said Steven Wylie, associate vice president for planning and business development at UF Health Jacksonville. About 70% of patients at its facilities are billed at urgent care rates, Wylie said.

Emergency care is almost always more expensive than urgent care. For patients who might otherwise show up at the ER with an urgent care-level problem — a small cut that requires stitches or an infection treatable with antibiotics — the savings could be hundreds or thousands of dollars.

While no research has been conducted on this new hybrid model, consumer advocates worry hospitals are more likely to route patients to costlier ER-level care whenever possible.

For instance, some services that trigger higher-priced, ER-level care at UF Health’s facilities — such as blood work and ultrasounds — can be obtained at some urgent care centers.

“That sounds crazy, that a blood test can trigger an ER fee, which can cost thousands of dollars,” said Cynthia Fisher, founder and chair of PatientRightsAdvocate.org, a patient advocacy organization.

For UF Health, the hybrid centers can increase profits because they help attract patients. Those patient visits can lead to more revenue through diagnostic testing and referrals for specialists or inpatient care.

Offering less expensive urgent care around-the-clock, the hybrid facilities stand out in an industry known for its aggressive billing practices.

On a recent visit to one of UF Health’s facilities about 15 miles southeast of downtown, several patients said in interviews that they sought a short wait for care. None had sat in the waiting room more than five minutes.

“Sometimes urgent care sends you to the ER, so here you can get everything,” said Andrea Cruz, 24, who was pregnant and came in for shortness of breath. Cruz said she was being treated as an ER patient because she needed blood tests and monitoring.

“It’s good to have a place like this that can treat you no matter what,” said Penny Wilding, 91, who said she has no regular physician and was being evaluated for a likely urinary tract infection.

UF Health is one of about a dozen health systems in 10 states partnering with Intuitive Health to set up and run hybrid ER-urgent care facilities. More are in the works; VHC Health, a large hospital in Arlington, Virginia, plans to start building one this year.

Intuitive Health was established in 2008 by three emergency physicians. For several years the company ran independent combination ER-urgent care centers in .

Then Altamont Capital Partners, a multibillion-dollar private equity firm based in Palo Alto, California, bought a majority stake in Intuitive in 2014.

Soon after, the company began partnering with hospitals to open facilities in states including Arizona, Indiana, Kentucky, and Delaware. Under their agreements, the hospitals handle medical staff and billing while Intuitive manages administrative functions — including initial efforts to collect payment, including checking insurance and taking copays — and nonclinical staff, said Thom Herrmann, CEO of Intuitive Health.

Herrmann said hospitals have become more interested in the concept as Medicare and other insurers pay for value instead of just a fee for each service. That means hospitals have an incentive to find ways to treat patients for less.

And Intuitive has a strong incentive to partner with hospitals, said Christine Monahan, an assistant research professor at the Center on Health Insurance Reforms at Georgetown : Facilities licensed as freestanding emergency rooms — as Intuitive’s are — must be affiliated with hospitals to be covered by Medicare.

At the combo facilities, emergency room specialists determine whether to bill for higher-priced ER or lower-priced urgent care after patients undergo a medical screening. They compare the care needed against a list of criteria that trigger emergency-level care and bills, such as the patient requiring IV fluids or cardiac monitoring.

Inside its combo facilities, UF posts a sign listing some of the urgent care services it offers, including treatment for ear infections, sprains, and minor wounds. When its doctors determine ER-level care is necessary, UF requires patients to sign a form acknowledging they will be billed for an ER visit.

Patients who opt out of ER care at that time are charged a triage fee. UF would not disclose the amount of the fee, saying it varies.

UF officials say patients pay only for the level of care they need. Its centers accept most insurance plans, including Medicare, which covers people older than 65 and those with disabilities, and , the program for low-income people.

But there are important caveats, said Fisher, the patient advocate.

Patients who pay cash for urgent care at UF’s hybrid centers are charged an “all-inclusive” $250 fee, whether they need an X-ray or a rapid strep test, to name two such services, or both.

But if they use insurance, patients may have higher cost sharing if their health plan is charged more than it would pay for stand-alone urgent care, she said.

Also, federal surprise billing protections that shield patients in an ER don’t extend to urgent care centers, Fisher said.

Herrmann said Intuitive’s facilities charge commercial insurers for urgent care the same as if they provided only urgent care. But Medicare may pay more.

While urgent care has long been intended for minor injuries and illnesses and ERs are supposed to be for life- or health-threatening conditions, the two models have melded in recent years. Urgent care clinics have increased the scope of injuries and conditions they can treat, while hospitals have taken to advertising ER wait times on highway billboards to attract patients.

Intuitive is credited with pioneering hybrid ER-urgent care, though its facilities are not the only ones with both “emergency” and “urgent care” on their signs. Such branding can sometimes confuse patients.

While Intuitive’s hybrid facilities offer some price transparency, providers have the upper hand on cost, said Vivian Ho, a health economist at Rice University in Texas. “Patients are at the mercy of what the hospital tells them,” she said.

But Daniel Marthey, an assistant professor of health policy and management at Texas A&M University, said the facilities can help patients find a lower-cost option for care by avoiding steep ER bills when they need only urgent-level care. “This is a potentially good thing for patients,” he said.

Marthey said hospitals may be investing in hybrid facilities to make up for lost revenue after federal surprise medical billing protections took effect in 2022 and restricted what hospitals could charge patients treated by out-of-network providers, particularly in emergencies.

“Basically, they are just competing for market share,” Marthey said.

UF Health has placed its new facilities in suburban near freestanding ERs owned by competitors HCA Healthcare and Ascension rather than near its downtown hospital in Jacksonville. It is also building a fourth facility, near The Villages, a large retirement community more than 100 miles south.

“This has been more of an offensive move to expand our market reach and go into suburban markets,” Wylie said.

Though the three centers are not -approved to care for trauma patients, doctors there said they can handle almost any emergency, including heart attacks and strokes. Patients needing hospitalization are taken by ambulance to the UF hospital about 20 minutes away. If they need to follow up with a specialist, they’re referred to a UF physician.

“If you fall and sprain your leg and need an X-ray and crutches, you can here and get charged urgent care,” said Justin Nippert, medical director of two of UF’s combo centers. “But if you break your ankle and need it put back in place it can get treated here, too. It’s a one-stop .”

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By: Phil Galewitz, KFF Health News
Title: Urgent Care or ER? With ‘One-Stop Shop,’ Hospitals Offer Both Under Same Roof
Sourced From: kffhealthnews.org/news/article/urgent-emergency-care-combo-centers-intuitive-health-jacksonville-florida/
Published Date: Fri, 02 Aug 2024 09:00:00 +0000

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https://www.biloxinewsevents.com/since-fall-of-roe-self-managed-abortions-have-increased/

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Since Fall of ‘Roe,’ Self-Managed Abortions Have Increased

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Sarah Varney, KFF
Fri, 02 Aug 2024 09:00:00 +0000

The percentage of people who say they’ve tried to end a pregnancy without medical assistance increased after the Supreme Court overturned . That’s according to a study published Tuesday in the online journal JAMA Network Open.

Tia Freeman, a reproductive health organizer, workshops for Tennesseans on how to safely take medication abortion pills outside of medical settings.

Abortion is almost entirely illegal in Tennessee. Freeman, who lives near Nashville, said people planning to stop pregnancies have all sorts of reasons for wanting to do so without help from the formal system — including the cost of traveling to another state, challenge of finding child care, and fear of lost wages.

“Some people, it’s that they don’t have the support networks in their families where they would need to have someone them to a clinic and then sit with them,” said Freeman, who works for Self-Managed Abortion; Safe and Supported, a U.S.-based project of Women Help Women, an international nonprofit that advocates for abortion access.

“Maybe their is superconservative and they would rather get the pills in their home and do it by themselves,” she said.

The new study is from Advancing New Standards in Reproductive Health, a research group based at the of California-San Francisco. The researchers surveyed more than 7,000 people ages 15 to 49 from December 2021 to January 2022 and another 7,000-plus from June 2023 to July 2023.

Of the respondents who had attempted self-managed abortions, they found the percentage who used the abortion pill mifepristone was 11 in 2023 — up from 6.6 before the Supreme Court ended federal abortion rights in 2022.

One of the most common reasons for seeking a self-administered abortion was privacy concerns, said a study co-author, epidemiologist Lauren Ralph.

“So not wanting others to know that they were seeking or in need of an abortion or wanted to maintain autonomy in the ,” Ralph said. “They liked it was something under their control that they could do on their own.”

Kristi Hamrick, vice president of and policy at Students for Life Action, a national anti-abortion group, said she doesn’t believe the study findings, which she said benefit people who provide abortion pills.

“It should surprise no one that the abortion lobby reports their business is doing well, without problems,” Hamrick said in an emailed statement.

Ralph said in addition to privacy concerns, state laws criminalizing abortion also weighed heavily on women’s minds.

“We found 6% of people said the reason they self-managed was because abortion was illegal where they lived,” Ralph said.

In the JAMA study, women who self-managed abortion attempts reported using a range of methods, including using drugs or alcohol, lifting heavy objects, and taking a hot bath. In addition, about 22% reported hitting themselves in the stomach. Nearly 4% reported inserting an object in their body.

The term “self-managed abortion” may conjure images of back-alley procedures from the 1950s and ’60s. But OB-GYN Laura Laursen, a family planning physician in Chicago, said self-managed abortions using medication abortion — the drugs mifepristone and misoprostol — are far safer, whether done inside or outside the health care system.

“They’re equally safe no matter which way you do it,” Laursen said. “It involves passing a pregnancy and bleeding, which is what happens when you have a miscarriage. If your body doesn’t have a miscarriage on its own, these are actually the medications we give women to pass the miscarriage.”

Since Roe‘s end, more than 20 states have banned or further restricted abortion.

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By: Sarah Varney, KFF Health News
Title: Since Fall of ‘Roe,’ Self-Managed Abortions Have Increased
Sourced From: kffhealthnews.org/news/article/self-managed-abortions-increase-post-roe-dobbs-privacy-concerns/
Published Date: Fri, 02 Aug 2024 09:00:00 +0000

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