Kaiser Health News

Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?

Published

9 months ago

December 19, 2023

Daniel Chang and Holly K. Hacker
Tue, 19 Dec 2023 10:00:00 +0000

Too old and too sick for a heart transplant, Arvid Herrman was given a choice: Have a mechanical pump implanted in his heart, potentially keeping him alive for several years, or do nothing and almost certainly die within a year.

The 68-year-old Wisconsin farmer chose the pump, called a HeartMate 3 — currently the only FDA-approved device of its kind in use. Instead of extending his life, though, the device led to his death, according to a lawsuit filed in December 2020 by his daughter Jamie Edwards.

The lawsuit alleged that Herrman died because a defect in the locking mechanism of the HeartMate 3 prevented the device from sealing, causing multiple strokes and leading to a severe brain injury and multiorgan failure. Herrman “could not have anticipated the danger this defect … created for him,” the lawsuit said.

Herrman’s death was reported to a Food and Drug Administration database where the public can learn about device-related deaths, serious injuries, and malfunctions. The event was also described in the peer-reviewed Journal of Heart and Lung Transplantation.

In September 2021, Ramon Flores Sr. had the same device implanted at Methodist Hospital of San Antonio. A lawsuit his family filed in August alleges that the locking mechanism defect led to air embolism strokes. Flores died eight days after surgery, at age 76.

“How many other people is this going to happen to?” said his daughter, Alanna Flores Blanco, 52. “We never, ever were explained that the device could malfunction and this could happen.”

After the deaths of Herrman and Flores, Thoratec Corp., the device’s manufacturer, evaluated the pumps involved. In both cases, Thoratec, a subsidiary of Abbott Laboratories, confirmed a bent locking arm. But “a direct correlation” between the HeartMate 3 and the deaths “could not conclusively be established,” the manufacturer reported to the FDA.

Abbott did not respond to questions about the deaths or the alleged defects. The manufacturer denied liability in both cases. It settled Herrman’s lawsuit this fall, and the Flores case is ongoing.

The men’s deaths are among more than 4,500 reports since August 2017 in which the HeartMate 3 may have caused or contributed to a patient’s death, according to a KFF Health News analysis of the FDA’s database of medical device incidents, known as the Manufacturer and User Facility Device Experience, or MAUDE. Hospitals, doctors, and others report device-related deaths, serious injuries, and malfunctions to manufacturers, who are required to investigate and report cases to the FDA.

In nearly 90% of those 4,500-plus reports, Thoratec said it found no problem with the device or how it was used, according to a KFF Health News review of the FDA database.

In cases where Abbott finds the HeartMate 3 did not cause or contribute to a death or serious injury, the company files “corrective reports,” said Justin Paquette, an Abbott public affairs director.

He added, “The complexity of the device – combined with patients battling late stage heart failure and associated comorbidities – creates very dynamic clinical care situations.”

Abbott said the HeartMate 3 is the safest iteration yet of any left ventricular assist device, or LVAD, a type of mechanical heart pump introduced in the 1960s and refined over the last six decades.

The HeartMate 3 was first approved by the FDA, for use in patients awaiting a heart transplant, in August 2017, and one year later it was approved as a long-term therapy. The device is often considered only for patients with end-stage heart failure, and even then it is a last resort.

HeartMate 3 has “dramatically improved the safety of LVADs by reducing rates of complications that had historically challenged heart pump technology, including clotting, stroke and bleeding,” Paquette said.

As recently as August, the FDA also expressed support for the device. “The FDA believes the benefits of HeartMate 3 continue to outweigh the risks for this vulnerable patient population with few available alternatives,” said Jeremy Kahn, an agency spokesperson.

Others aren’t so sure. Former FDA medical device official Madris Kinard sees the high number of death reports as a warning.

“To me this is a safety signal and it’s hard to know if the FDA is working on something to address it,” said Kinard, founder of Device Events, a company that makes FDA device data more user-friendly for hospitals, law firms, investors, and others. “You have to wonder why [death reports are] still happening, and at the same rate.”

Larry Kessler, a former director in the FDA’s medical device office, agrees the death reports for HeartMate 3 need more study. “The FDA may be missing some signals,” he said. Perhaps “there’s a little more here than meets the eye.”

Not all device problems are reported to MAUDE, and submitting a report is not necessarily an admission that a device caused a death or a serious injury. Device problem reports can be inaccurate or incomplete, or lack verification, and a single incident may be reported more than once — or not at all.

Those limitations ultimately can leave patients and their caregivers uninformed about risks associated with a device such as the HeartMate 3, said Sanket Dhruva, a cardiologist and expert in medical device safety and regulation at the University of California-San Francisco.

“They’re making perhaps the biggest decision of their lives: Do I proceed with an LVAD or not? And even if I proceed, what are the risks I’m facing?” he said. “And they are left with incomplete data and uncertainty about how to make that determination.”

Even doctors cannot use the FDA database as a tool to effectively counsel patients, Dhruva added.

“lf you don’t know what is a real safety signal and what’s not,” he said, “then how can that information help us to calibrate our benefits-and-risks discussion with patients?”

Tracking Incident Reports

The HeartMate 3 is not the only device whose safety profile is hard to ascertain in MAUDE, Dhruva said. The information in the FDA database is insufficient to give patients an adequate understanding of any medical device’s safety risks and reflects “the overall weakness of postmarket surveillance” after a device has been approved for sale, he said.

Under federal regulations, device manufacturers typically must report adverse events to the FDA within 30 days of learning about them, and that data is often used by researchers and regulators to identify potential safety concerns. Reports also can be submitted voluntarily by doctors, patients, or others. The FDA says that reports don’t need to be filed if the manufacturer determines that a device did not cause or contribute to an adverse event.

More from the series

But with millions of reports for thousands of devices, it can be difficult to detect and prevent problems that put patients at risk.

Hospitals and surgeons also might self-censor what they report to manufacturers due to concerns about being sued, said Kessler, now a professor at the University of Washington.

“Health care facilities, and risk managers in particular, they aren’t always forthcoming with detailed data about events,” he said.

Reports in MAUDE show that patients with a HeartMate 3 have experienced adverse events, such as bleeding, infection, and respiratory failure, that the manufacturer warned were possible in its instructions for use.

About 400 reports cited infusion or flow problems with the HeartMate 3. In thousands of other cases, the manufacturer said it did not observe any problems with the device, making it even more difficult for a doctor or a patient’s family to understand the safety history of the product.

Reports in MAUDE also describe fatal incidents due to complications not mentioned in the manufacturer’s instructions, such as the locking mechanism malfunction. In one report, a patient died of smoke inhalation after an external battery charger caught fire.

Each report in MAUDE has dozens of data points and summaries describing what happened. What’s lacking in the database: context and details that would be useful for patients and doctors, such as the total number of devices in use and the name of the hospital where the event occurred.

Flores Blanco had never heard of MAUDE before her father’s surgery. Even if she had, it’s unlikely she would have found a locking mechanism issue amid the morass of records, much less anticipated what might happen.

Missed Signals?

A routine FDA inspection of Abbott’s manufacturing plant in 2017 showed that Thoratec had fallen behind schedule reporting adverse events, according to agency records obtained by KFF Health News under a Freedom of Information Act request.

The company updated training and hired additional staff to handle complaints submitted by hospitals, doctors, patients, and others, according to an inspection report. It provided the FDA inspector with “quantitative evidence” that late reporting to the FDA had decreased.

By October 2020, during a follow-up inspection, Thoratec was using a database to enter and process complaints and submit device reports electronically, according to an inspection report.

FDA inspectors did not cite any deficiencies with how Thoratec handled complaints after the visit. Inspectors noted the company had received 8,115 complaints related to the HeartMate 3 during the 12 months prior to the inspection in October 2020, the records show.

It’s not clear what the complaints concerned. Abbott did not respond when asked how many of the complaints led to an adverse event report to the FDA.

In Kinard’s view, device-makers in general often take longer than 30 days to investigate the root cause of an incident and frequently conclude that an adverse event was due to user error.

“They are using this regularly to downplay the problems with the device,” she said.

In Herrman’s case, a Thoratec representative was in the operating room and witnessed the incident, according to a deposition in the lawsuit. The company submitted a report to the FDA about Herrman’s injury within 30 days of the June 2019 incident.

Herrman’s surgeon, John Stulak, was experienced at implanting the device, according to the lawsuit, and he was also a principal investigator on the clinical trial that brought the HeartMate 3 to market. Stulak did not respond to interview requests. But, in 2020, he and two Mayo Clinic colleagues described Herrman’s case in The Journal of Heart and Lung Transplantation, where they noted the locking mechanism malfunction. “The lack of a tight seal from this defect resulted in the multiple subsequent air embolism events and irrecoverable neurological damage,” they wrote.

The article describes how Stulak replaced the device with a new one, but it was too late to prevent the injuries to Herrman. Thoratec submitted at least three follow-up reports to the FDA about the incident and said its investigation could not determine whether the HeartMate 3 caused Herrman’s death.

Herrman’s death certificate cites complications of ischemic heart disease. Flores’ death certificate says he died of cardiac arrest and hypoxic ischemic encephalopathy, or brain damage.

The FDA has had its own problems keeping the MAUDE database up to date.

The agency is years behind schedule on anonymizing and releasing adverse event reports for all medical devices.

Kinard said the FDA has yet to publicly release “millions” of follow-up reports that manufacturers have filed after their initial adverse event report for a medical device.

The FDA acknowledged that the agency is not up to date on public reporting but could not say how many reports are pending — for the HeartMate 3 or any device.

“We are currently working on redaction for public posting in MAUDE, of all supplemental reports dated 2021-2023,” said Kahn, the FDA spokesperson. “It is difficult to determine how many of those – pending redaction of supplemental reports – pertain to the subject device.”

FDA press officer Lauren-Jei McCarthy noted that, besides adverse event reports, the agency also monitors published literature, patients, patient advocacy groups, professional societies, individual health care providers, and other sources to determine whether further action is warranted.

“We review and take seriously all reports of adverse events associated with medical devices,” McCarthy said. She said patients and providers who use the HeartMate 3 “remain a high priority” and that the agency cannot comment on investigations.

A Last-Resort Treatment

Before he got a HeartMate 3 implanted in January 2022, Sid Covington, of Austin, Texas, said he had researched the device during years of medication therapy and cardiac rehabilitation to treat his congestive heart failure.

“I looked at case studies. I looked at a number of the different heart studies,” Covington said. “I looked at their marketing brochures and all that stuff, just whatever I could find.”

Covington, 76, said he was familiar with MAUDE and Intermacs, a private registry that tracks LVAD patients, but didn’t consult them. When he had to decide whether to get the device, he was in the hospital with chest pain, shortness of breath, and fatigue from advanced heart failure. Covington said his only option was the HeartMate 3.

“When it comes down to the moment, you really don’t have much choice,” he said. “It’s any port in the storm at that point.”

The HeartMate 3 requires constant attention and care from patients, who must keep the external parts of the device dry at all times and avoid jumping and contact sports. Patients must also ensure that it always has an external source of power, which is supplied through a cord attached to the pump that exits the body through a surgical opening.

Patients who get the device are often out of options to treat their end-stage heart failure, said Larry Allen, a cardiologist with the University of Colorado and member of a multidisciplinary medical team that cares for heart failure patients.

“We wouldn’t proceed with an LVAD unless we think the risk of death is really high and we’ve tried everything else,” he said.

That informs the regulatory view, too, Kessler said.

“When you’re talking about people who are seriously ill, then the FDA will accept a potentially higher risk,” he said, “but not an irresponsible one, and certainly not one that couldn’t be communicated to clinicians and the public.”

Allen, who helped develop a decision aid for patients considering an LVAD, said reliable data on safety and risks to patients is key.

“It’s about as high-risk, high-reward a choice as there can be,” Allen said. “It’s a really complicated decision to make and I think standard informed consent approaches are really inadequate for fully understanding that.”

Data Exists but Is Confidential

Long-term data for the HeartMate 3 — including performance metrics for the more than 180 U.S. hospitals certified to implant the device — are kept in Intermacs, managed by The Society of Thoracic Surgeons, which has promised to provide transparency but has yet to deliver.

The registry tracks mortality and injury rates for patients with an LVAD and logs the number of devices implanted each year.

But Intermacs is proprietary, and access at hospitals requires a principal investigator and at least one trained staff member, who can use the data to evaluate their facility’s performance against an aggregate from their peers across the nation.

Francis Pagani, a heart transplant and LVAD surgeon at University of Michigan Health, leads a medical society task force that oversees Intermacs. He said 12,000 to 14,000 HeartMate 3 implants have been recorded in Intermacs since 2017. The HeartMate 3 has “the best outcomes of any other LVAD, ever,” he said.

Over the years, federal regulators have made it easier for patients to access LVADs, reducing surgery volume requirements for implant centers and no longer requiring patients to be on a transplant waiting list to receive one of the pumps.

Though the HeartMate 3 is presently the only LVAD being implanted in the United States, it once had a competitor, Medtronic’s HeartWare, which the manufacturer removed from the market in June 2021, citing a high risk of stroke and pumps failing to restart if stopped.

While the FDA provides consumers with concise information about key clinical trials supporting the approval of new drugs, the agency provides no comparable data for medical devices. And though Medicare reimburses hospitals nearly $200,000 for most HeartMate 3 implants, federal administrators do not track patient outcomes or enforce performance standards for the heart pumps.

James Kirklin, a cardiac surgeon and researcher, was the principal investigator for Intermacs when the FDA, Centers for Medicare & Medicaid Services, and National Heart, Lung, and Blood Institute awarded a contract to the University of Alabama at Birmingham to establish the registry in 2005.

Federal agencies paid about $15 million over 10 years for Intermacs, Kirklin said, because they wanted to better understand the risk factors for death and other adverse events with so-called mechanical circulatory support devices, including LVADs, as well as the factors that indicated a higher likelihood of patients doing well on the pumps.

The FDA monitors annual reports of Intermacs data, including adverse events, and allows companies to use the registry’s data to analyze their devices’ performance and to fulfill reporting requirements after a device enters the market.

LVAD implant centers are required to report their data to Intermacs in order to be certified by the accrediting nonprofit The Joint Commission. And while CMS requires that centers implant at least 10 devices every three years to continue receiving Medicare reimbursement, there are no requirements for outcomes or other quality metrics. CMS does not track LVAD patient outcomes at individual facilities, said Sara Lonardo, CMS press secretary at the time.

Kirklin said he is working with The Society of Thoracic Surgeons to create a risk model that would allow the public to see quality scores for individual hospitals that implant LVADs, a need the group has recognized since at least 2018. But it will be a year before the tool is ready.

Kirklin and Pagani said the number of death reports for the HeartMate 3 in the FDA’s MAUDE database can be misleading without the outcome and longitudinal perspective that Intermacs provides.

“When you see a lot of deaths it means, ‘Let’s investigate.’ I couldn’t agree more,” Kirklin said. “But it’s rather limited. It’s not time-related and you don’t know the denominator. If you look up Intermacs, it’s all there.”

The families of Herrman and Flores filed lawsuits, in part, to find out what went wrong. Herrman’s family settled the lawsuit and agreed to confidentiality. Thoratec has filed a motion to dismiss the ongoing Flores case based on the FDA’s approval of the device.

Alanna Flores Blanco said she and her father were aware of the HeartMate 3’s positive outcomes, including published research that shows those who receive the device have a better than 50% chance of living five years or more.

“That’s why he took the chance to do it,” she said.

Flores Blanco said her father was a model patient, meeting regularly with cardiologists and other specialists, attending classes to learn how to live with the device, and receiving approval for surgery from the medical review board at Methodist Hospital in San Antonio.

The family felt informed and her father was prepared, she said.

“He did everything he was supposed to do,” she said. “What failed him ultimately was that device.”

——————————
By: Daniel Chang and Holly K. Hacker
Title: Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?
Sourced From: kffhealthnews.org/news/article/medical-device-heart-lvad-fda-database-abbott-thoratec/
Published Date: Tue, 19 Dec 2023 10:00:00 +0000

Post Views: 332

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

Published

2 months ago

August 5, 2024

Staff Editor

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 lead 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, President Joe Biden issued an executive order intended to intensify antitrust enforcement across multiple industries, including health care.

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 Texas.

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 report 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 review 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 Congress. In addition, she could face opposition from powerful health care lobbyists.

Though it often gets a bad rap, consolidation in health care also confers benefits. 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 Medicaid, 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.

——————————
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

Post Views: 217

Kaiser Health News

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

Published

2 months ago

August 2, 2024

Staff Editor

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

JACKSONVILLE, Fla. — Facing an ultracompetitive market in one of the nation’s fastest-growing cities, UF Health is trying 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 Texas.

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 University: 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 Medicaid, 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 areas 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 state-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 come 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 shop.”

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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

Did you miss our previous article…
https://www.biloxinewsevents.com/since-fall-of-roe-self-managed-abortions-have-increased/

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Kaiser Health News

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

Published

2 months ago

August 2, 2024

Staff Editor

Sarah Varney, KFF Health News
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 Roe v. Wade. That’s according to a study published Tuesday in the online journal JAMA Network Open.

Tia Freeman, a reproductive health organizer, leads 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 health care 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 drive 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 family 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 University 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 decision,” Ralph said. “They liked it was something under their control that they could do on their own.”

Kristi Hamrick, vice president of media 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

Post Views: 238