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

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Fred Schulte, KFF 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, KFF 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 that the company said could have caused more than 140,000 of the implants to wear out prematurely.
  • Metal hip implants that snapped in two inside patients who said in lawsuits that they required urgent surgery.
  • Last-resort heart pumps 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 hip and dental 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 KFF 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 news release 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 “urgent medical device recall” 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 warning letter.

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 KFF 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, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version 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 Institute of Medicine report 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 mounting controversy 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 KFF 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 “metal-on-metal” artificial hip implants, which under 510(k) spawned many new brands — along with a disastrous toll 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 issued an order 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 December 2021 recall 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 database, called MAUDE, 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 KFF 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.) have tried for years 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 KFF 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 “approved design and manufacturing changes 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.

Related Links

The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country’s health authority to suspend its use for six months until Medtronic completed training for health care workers and took other steps to improve it, court records show. Medtronic told KFF Health News that it had “worked closely” with the Australian group to resolve the problems. “We take patient safety very seriously and have processes to identify quality issues and determine appropriate actions,” Medtronic said.

Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.

One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it’s not available to them.

‘Exciting Features’

While the FDA clears thousands of devices for use based on the “substantial equivalence” premise, manufacturers often tout “new and exciting features” in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.

These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.

Marketing campaigns directed at prospective patients may receive little scrutiny. The FDA has “limited resources to actively monitor the volume of direct-to-consumer advertising,” according to a Government Accountability Office report issued in September. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, according to the GAO report.

Legal Barriers

While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.

Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.

Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn’t have agreed to the procedure.

He lost when the judge cited a legal doctrine called “learned intermediary.” The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device’s risks and relay them to patients.

The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.

Greisberg, 81, felt sucker-punched. “They never gave me any warning about what could happen down the road,” he said in an interview. “I never had a chance to have my day in court.”

The family of PeeWee Gautney also faces challenges pursuing the insulin pump lawsuit.

Gautney died in a motel room in Destin, Florida, a day after riding his Harley-Davidson to the Panhandle beach town on a weekend jaunt. The MiniMed pump was still strapped to his body, according to a police report.

Medtronic had sent Gautney a form letter in late March 2020, less than two months before he died, advising him to make sure the ring was locking in place correctly. A week later, he wrote back, telling the company: “It’s fine right now,” court records show.

Wiggins, 33, his daughter, who is also a neonatal respiratory therapist, said she believes a crack in the retainer ring caused it to release too much insulin, which her dad may not have recognized.

“It should never be put on the patient to determine if there is a problem,” Wiggins said.

Medtronic has denied the pump failed and caused Gautney’s death. The FDA approved the device knowing patients faced the risk of it administering wrong doses, but believed the benefits outweighed these risks, Medtronic argued in a motion for summary judgment in September. The motion is pending.

Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.

Wiggins hopes to beat those odds, arguing that the December 2021 FDA warning letter reveals that Medtronic violated safety and manufacturing standards.

Her lawyer, Scott Murphy, said that insulin pumps are “really wonderful” devices for people with diabetes when they work right. He argues that the FDA records confirm that Medtronic significantly downplayed its pump’s hazards.

“The risks get minimized and the benefits exaggerated,” he said.

——————————
By: Fred Schulte, KFF Health News and Holly K. Hacker
Title: Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records
Sourced From: kffhealthnews.org/news/article/medical-device-malfunction-fda-oversight-patient-harm/
Published Date: Thu, 21 Dec 2023 10:00:00 +0000

Kaiser Health News

Trump Team’s Reworking Delays Billions in Broadband Build-Out

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kffhealthnews.org – Sarah Jane Tribble, KFF Health News – 2025-06-20 04:00:00


Millions of Americans in rural areas face delays in receiving high-speed internet after the Trump administration disrupted the $42 billion Broadband Equity, Access, and Deployment (BEAD) program. New Commerce Department rules require states to solicit new bids, causing confusion and timeline setbacks for many states ready to start construction. Critics warn that shifting focus from fiber-optic cables to satellite providers like Starlink may deliver inadequate speeds, leaving rural residents without reliable internet critical for telehealth, education, and economic growth. Areas lacking broadband also suffer higher health risks and limited access to care, exacerbating rural disparities.



Millions of Americans who have waited decades for fast internet connections will keep waiting after the Trump administration threw a $42 billion high-speed internet program into disarray.

The Commerce Department, which runs the massive Broadband Equity, Access, and Deployment Program, announced new rules in early June requiring states — some of which were ready to begin construction later this year — to solicit new bids from internet service providers.

The delay leaves millions of rural Americans stranded in places where health care is hard to access and telehealth is out of reach.

“This does monumental harm to rural America,” said Christopher Ali, a professor of telecommunications at Penn State.

The Biden-era program, known as BEAD, was hailed when created in 2021 as a national plan to bring fast internet to all, including millions in remote rural areas.

A yearlong KFF Health News investigation, with partner Gray Media’s InvestigateTV, found nearly 3 million people live in mostly rural counties that lack broadband as well as primary care and behavioral health care providers. In those same places, the analysis found, people live sicker and die earlier on average.

The program adopts a technology-neutral approach to “guarantee that American taxpayers obtain the greatest return on their broadband investment,” according to the June policy notice. The program previously prioritized the use of fiber-optic cable lines, but broadband experts like Ali said the new focus will make it easier for satellite-internet providers such as Elon Musk’s Starlink and Amazon’s Kuiper to win federal funds.

“We are going to connect rural America with technologies that cannot possibly meet the needs of the next generation of digital users,” Ali said. “They’re going to be missing out.”

Republicans have criticized BEAD for taking too long, and Commerce Secretary Howard Lutnick vowed in March to get rid of its “woke mandates.” The revamped “Benefit of the Bargain BEAD Program,” which was released with a fact sheet titled “Ending Biden’s Broadband Burdens,” includes eliminating some labor and employment requirements and obligations to perform climate analyses on projects.

The requirement for states to do a new round of bidding with internet service providers makes it unclear whether states will be able to connect high-speed internet to all homes, said Drew Garner, director of policy engagement at the Benton Institute for Broadband & Society.

Garner said the changes have caused “pure chaos” in state broadband offices. More than half the states have been knocked off their original timeline to deliver broadband to homes, he said.

The change also makes the program more competitive for satellite companies and wireless providers such as Verizon and T-Mobile, Garner said.

Garner analyzed in March what the possible increase in low-Earth-orbit satellites would mean for rural America. He found that fiber networks are generally more expensive to build but that satellites are more costly to maintain and “much more expensive” to consumers.

Commerce Secretary Lutnick said in a June release that the new direction of the program would be efficient and deliver high-speed internet “at the right price.” The National Telecommunications and Information Administration, the Commerce Department agency overseeing BEAD, declined to release a specific amount it hopes to save with the restructuring.

The NTIA also declined to respond on the record to questions about program revisions and delays.

More than 40 states had already begun selecting companies to provide high-speed internet and fill in gaps in underserved areas, according to an agency dashboard created to track state progress.

In late May, the website was altered and columns showing the states that had completed their work with federal regulators disappeared. Three states — Delaware, Louisiana, and Nevada — had reached the finish line and were waiting for the federal government to distribute funding.

The tracker, which KFF Health News saved in March, details the steps each state made in their years-long efforts to create location-based maps and bring high-speed internet to those missing service. West Virginia had completed selection of internet service providers and a leaked draft of its proposed plan shows the state was set to provide fiber connections to all homes and businesses.

Sen. Shelley Moore Capito (R-W.Va.) praised removal of some of the hurdles that delayed implementation and said she thought her state would not have to make very many changes to existing plans during a call with West Virginia reporters.

West Virginia’s broadband council has worked aggressively to expand in a state where 25% of counties lack high-speed internet and health providers, according to KFF Health News’ analysis.

In Lincoln County, West Virginia, Gary Vance owns 21 acres atop a steep ridge that has no internet connection. Vance, who sat in his yard enjoying the sun on a recent day, said he doesn’t want to wait any longer.

Vance said he has various medical conditions: high blood sugar, deteriorating bones, lung problems — “all kinds of crap.” He’s worried about his family’s inability to make a phone call or connect to the internet.

“You can’t call nobody to get out if something happens,” said Vance, who also lacks running water.

KFF Health News, using data from federal and academic sources, found more than 200 counties — with large swaths in the South, Appalachia, and the remote West — lack high-speed internet, behavioral health providers, and primary care doctors who serve low-income patients on Medicaid. On average, residents in those counties experienced higher rates of diabetes, obesity, chronically high blood pressure, and cardiovascular disease.

The gaps in telephone and internet services didn’t cause the higher rates of illness, but Ali said it does not help either.

Ali, who traveled rural America for his book “Farm Fresh Broadband: The Politics of Rural Connectivity,” said telehealth, education, banking, and the use of artificial intelligence all require fast download and upload speeds that cannot always be guaranteed with satellite or wireless technology.

It’s “the politics of good enough,” Ali said. “And that is always how we’ve treated rural America.”

Fiber-optic cables, installed underground or on poles, consistently provide broadband speeds that meet the Federal Communications Commission’s requirements for broadband download speed of 100 megabits per second and 20 Mbps upload speed. By contrast, a national speed analysis, performed by Ookla, a private research and analytics company, found that only 17.4% of Starlink satellite internet users nationwide consistently get those minimum speeds. The report also noted Starlink’s speeds were rising nationwide in the first three months of 2025.

In March, West Virginia’s Republican governor, Patrick Morrisey, announced plans to collaborate with the Trump administration on the new requirements.

Republican state Del. Dan Linville, who has been working with Morrisey’s office, said his goal is to eventually get fiber everywhere but said other opportunities could be available to get internet faster.

In May, the West Virginia Broadband Enhancement Council signaled it preferred fiber-optic cables to satellite for its residents and signed a unanimous resolution that noted “fiber connections offer the benefits of faster internet speeds, enhanced data security, and the increased reliability that is necessary to promote economic development and support emerging technologies.”

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.

Subscribe to KFF Health News’ free Morning Briefing.

This article first appeared on KFF Health News and is republished here under a Creative Commons license.

The post Trump Team’s Reworking Delays Billions in Broadband Build-Out appeared first on kffhealthnews.org



Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.

Political Bias Rating: Center-Left

This article adopts a generally critical stance toward the Trump administration’s handling of the broadband program, emphasizing delays and negative consequences for rural communities. It highlights concerns from experts and advocates for fiber-optic technology, portraying the Biden-era BEAD program positively while critiquing the Trump-era restructuring as harmful to rural Americans. The tone and framing focus on social equity and government responsibility to underserved areas, which align with Center-Left perspectives prioritizing infrastructure investment and rural access. However, the article also presents viewpoints from Republican officials and notes bipartisan concerns, maintaining a level of balance overall.

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Kaiser Health News

Have Job-Based Health Coverage at 65? You May Still Want To Sign Up for Medicare

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kffhealthnews.org – Michelle Andrews – 2025-06-18 04:00:00


When Alyne Diamond, 67, broke her back in 2023, her employer-based UnitedHealthcare plan covered the care. But later injuries revealed a costly oversight: since turning 65, Medicare should have been her primary insurer due to her small firm’s size. UnitedHealthcare denied newer claims and began reclaiming over \$50,000 previously paid, leaving Diamond to cover much of the cost. Experts say this scenario is common among people unaware of Medicare coordination rules. Without proper notification from insurers or employers, late Medicare enrollment can result in denied claims and steep medical debt, with little recourse outside litigation or special enrollment appeals.


When Alyne Diamond fell off a horse in August 2023 and broke her back, her employer-based health plan through UnitedHealthcare covered her emergency care in Aspen, Colorado. It also covered related pain management and physical therapy after she returned home to New York City. The bills totaled more than $100,000.

The real estate lawyer, now 67, was eligible for Medicare at the time but hadn’t enrolled. Since she was still working, she thought her employer health insurance plan would cover her.

That misunderstanding has had financial repercussions that she continues to deal with today.

More than a year after her riding accident, Diamond was back at the emergency room after she tripped on a step while entering a New York restaurant. Her face covered in blood, Diamond was examined by staff, who did multiple CT scans. The bill for that care: $12,000.

This time, though, the insurance coverage wasn’t routine. Nearly all her claims were denied.

Diamond was caught in a fairly common coverage snag: People who have group health insurance when they become eligible for Medicare sometimes find themselves on the hook for their medical bills because their group plan stops paying.

Diamond contacted several people at UnitedHealthcare before she found out why the insurer refused to pay her claims.

When Diamond turned 65 in 2022, Medicare — unbeknownst to her — became the “primary payer” for her claims, meaning the federal health program for older or disabled people was supposed to take the lead in covering her medical bills, before other insurers paid anything. (As secondary payer, Diamond’s employer policy picked up 20% of what Medicare would have paid.)

Had she signed up for the government insurance plan when she turned 65, Diamond could have avoided a financially perilous situation that left her unexpectedly responsible for the medical costs she incurred during that time.

She began to understand what had happened as she made inquiries about the denied claims.

Diamond said she was told that UnitedHealthcare audited her claims last year and determined it had been improperly paying for her care, perhaps because her pricey medical claims after her fall from the horse raised a red flag.

The insurer not only stopped paying current claims but also moved to claw back tens of thousands of dollars it had paid to providers in the two years since she turned 65. Some of those providers are now seeking payment from her.

“It’s horrifying,” she said. “For about two months I was devastated. I thought, ‘Where am I going to get the money to pay all these people? There goes my retirement.’”

The mistake has already cost her $25,000 and may cost her much more if providers continue to bill her for amounts that UnitedHealthcare has clawed back for care she received before signing up for Medicare in February.

A UnitedHealthcare spokesperson declined to provide an on-the-record statement, citing safety concerns.

Patient advocates say they frequently hear from people who, like Diamond, thought they didn’t need to sign up for Medicare upon turning 65 because they had group health coverage.

That assumption is generally correct if they or their spouse is working at a company with at least 20 employees. In that case, employer coverage is considered primary and they can delay signing up for Medicare as long as they or their spouse continues to be employed there.

But if someone has employer coverage through a company with fewer than 20 workers, Medicare generally becomes the primary payer when they turn 65. The real estate law firm at which Diamond is a partner has a handful of employees.

Similarly, if someone is older than 65 and has retiree health coverage or has left their job and opted to continue their employer coverage under the Consolidated Omnibus Budget Reconciliation Act, also known as COBRA, Medicare pays first. The issue can also arise for people who are younger than 65 if they are eligible for Medicare because of a disability. In those instances, Medicare pays first if they or their family member works at a company with fewer than 100 employees.

If people in these groups don’t sign up for Medicare when they become eligible, they can find themselves responsible for all their medical bills for years. (They may also owe a penalty for late enrollment in the Medicare program.)

“It’s very alarming and there’s no current fix to the situation,” said Fred Riccardi, president of the New York-based Medicare Rights Center, a national patient advocacy organization.

The Centers for Medicare & Medicaid Services did not respond to a request for comment.

Mark Scherzer, a lawyer in Germantown, New York, who helps people with insurance problems, and who advised Diamond, said he gets calls a couple of times a month from people who face this issue.

“What I see constantly now is that insurers go back and they claw back the money from the doctor and the doctor then claws the money back from the patient,” he said.

Costly claims may trigger an insurer to examine someone’s coverage.

Those big claims “seem to get on the insurer’s radar,” said Casey Schwarz, senior counsel for education and federal policy at the Medicare Rights Center.

UnitedHealthcare has recouped over $50,000 in medical bills from some of the providers who treated Diamond in New York after her riding accident. She’s paid them about $25,000 so far. Some have agreed to let her pay the amount Medicare would have paid.

But there may be more bills to come. Under New York law, health plans have two years after claims are paid to claw back payments from providers, and providers have three years to sue patients for medical debt. So, while there is still time for Diamond to be billed, the clock will eventually run out.

Diamond plans to sue the broker who manages her company’s health plan and other benefits for negligence.

“The Medicare secondary payment rules basically say that if you didn’t sign up because you didn’t know Medicare was supposed to be primary, that’s on you,” said Melanie Lambert, senior Medicare advocate at the Center for Medicare Advocacy in Connecticut.

Lambert said she has seen the issue “many, many times.” In some instances, if a beneficiary can demonstrate they were misled by an employer or a federal employee, they may qualify for relief or a special enrollment period, she said.

In a 2023 letter to the acting secretary of the Department of Labor, the National Association of Insurance Commissioners advocated applying a “commonsense rule to COBRA plans, individual health insurance, and other coverage sources: those entitled to Medicare Part B but not enrolled in it should not lose benefits they pay for from a non-Medicare coverage source.”

The Department of Labor didn’t respond to a request for comment.

In earlier times, people started collecting Social Security benefits then automatically got Medicare when they turned 65.

Now, enrolling in Medicare is more complicated for many people, said Tricia Neuman, a senior vice president and the executive director of the Program on Medicare Policy at KFF, a health information nonprofit that includes KFF Health News.

“As more people are delaying going on Social Security and delaying going on Medicare, there’s more opportunities for people to make mistakes, and those mistakes are costly,” Neuman said.

Coverage experts say there are no clear requirements for insurers, employers, or the federal government to notify people about how the payment rules governing coordination of benefits between health plans may change when they become eligible for Medicare.

The information appears in a chart in the government’s “Medicare & You” handbook, if someone knows to look for it. But it is not easy to find.

A straightforward fix could solve many of the problems people face in this area, Scherzer said. Since every health plan knows its enrollees’ ages, why not require them to notify people approaching 65 of possible benefit coordination issues with Medicare? “It’s so simple and such a no-brainer.”

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.

Subscribe to KFF Health News’ free Morning Briefing.

This article first appeared on KFF Health News and is republished here under a Creative Commons license.

The post Have Job-Based Health Coverage at 65? You May Still Want To Sign Up for Medicare appeared first on kffhealthnews.org



Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.

Political Bias Rating: Centrist

This content provides a detailed and fact-based account of the complexities and pitfalls associated with Medicare enrollment and coordination of benefits with employer health plans. The tone is neutral, focusing on patient experiences, insurance practices, and systemic challenges without advocating for specific partisan policies. It presents information from multiple stakeholders, including patient advocates, insurers, and government entities, aiming to inform readers rather than promote a political agenda. Such balanced reporting aligns with a centrist perspective that highlights practical issues in healthcare administration without ideological bias.

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Kaiser Health News

The Price You Pay for an Obamacare Plan Could Surge Next Year

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kffhealthnews.org – Daniel Chang – 2025-06-17 04:00:00


Josefina Muralles, a part-time night receptionist in North Miami Beach, struggles to care for her family while relying on subsidized Obamacare coverage. Her household income is too high for Medicaid but qualifies for Affordable Care Act subsidies, which are set to expire at the end of 2025. Without them, premiums could rise by 75% or more, threatening access to critical care. Over 24 million Americans, especially in Florida and Texas, face similar risks. If the subsidies lapse, the uninsured rate could jump by millions. Advocates warn that without swift congressional action, low- and middle-income families will face devastating coverage losses.


MIAMI — Josefina Muralles works a part-time overnight shift as a receptionist at a Miami Beach condominium so that during the day she can care for her three kids, her aging mother, and her brother, who is paralyzed.

She helps her mother feed, bathe, and give medicine to her adult brother, Rodrigo Muralles, who has epilepsy and became disabled after contracting covid-19 in 2020.

“He lives because we feed him and take care of his personal needs,” said Josefina Muralles, 41. “He doesn’t say, ‘I need this or that.’ He has forgotten everything.”

Though her husband works full time, the arrangement means their household income is just above the federal poverty line — too high to qualify for Florida’s Medicaid program but low enough to make Muralles and her husband eligible for subsidized health insurance through the Affordable Care Act marketplace, also known as Obamacare.

Next year, Muralles said, she and her husband may not be able to afford that health insurance coverage, which has paid for her prescription blood thinners, cholesterol medication, and two surgeries, including one to treat a genetic disorder.

Extra subsidies put in place during the pandemic — which reduced the premiums Muralles and her husband paid by more than half, to $30 a month — are in place only through Dec. 31. Without enhanced subsidies, Affordable Care Act insurance premiums would rise by more than 75% on average, with bills for people in some states more than doubling, according to estimates from KFF, a health information nonprofit that includes KFF Health News.

Florida and Texas would be hit especially hard, as they have more people enrolled in the marketplace than other states. Some of their congressional districts alone, especially in South Florida, have more people signed up for Obamacare than entire states.

Like many of the more than 24 million Americans enrolled in the insurance marketplace this year, Muralles was unaware that the enhanced subsidies are slated to expire. She said she cannot afford a premium hike because inflation has already eaten into her household’s budget.

“The rent is going up,” she said. “The water bill is going up.”

Low-income enrollees like the Muralles couple would see the biggest percentage increases in premiums if enhanced subsidies expire.

Middle-income enrollees who earn more than four times the federal poverty line would no longer be eligible for subsidies at all. Those middle-income enrollees (who earn at least $62,600 for a single person in 2025) are disproportionately older, self-employed, and living in rural areas.

Julio Fuentes, president of the Florida State Hispanic Chamber of Commerce, said many of his organization’s members are small business owners who rely on Obamacare for health coverage.

“It’s either this or nothing,” he said.

The Congressional Budget Office estimated that letting the enhanced subsidies expire would, by 2034, increase the number of people without health insurance by 4.2 million. In tandem with changes to Medicaid in the House of Representatives’ reconciliation bill and the Trump administration’s proposed rules for the marketplace, including toughening income verification and shortening enrollment periods, it would increase the number of uninsured people by 16 million over that time period.

A study by the Urban Institute, a nonprofit think tank, found that Hispanic and Black people would see greater coverage losses than other groups if the extra subsidies lapse.

Fuentes noted that about 5 million Hispanics are enrolled in the ACA marketplace, and that Donald Trump won the Hispanic vote in Florida in 2024. He hopes the president and congressional Republicans see extending the enhanced subsidies as a way to hold on to those voters.

“This is probably a good way, or a good start, to possibly grow that base even more,” he said.

Enrollment in the marketplace has grown faster since 2020 in the states won by Trump in 2024. A recent KFF survey found that 45% of Americans who buy their own health insurance identify as or lean Republican, including 3 in 10 who identify as Make America Great Again supporters. Smaller shares identify as Democrats or Democratic-leaning independents (35%) or do not lean toward either party (20%).

Kush Desai, a White House spokesperson, said the rules proposed by the Trump administration, combined with the provisions in the House-passed budget bill, would “strengthen the ACA marketplace.” He noted that the CBO projects the legislation would reduce premiums for some plans about 12% on average by 2034 — but out-of-pocket costs would rise or remain the same for most subsidized ACA consumers.

“Democrats know Americans broadly support ending waste, fraud, and abuse, as The One, Big, Beautiful Bill does, which is why they are desperately trying to change the conversation,” Desai said.

But Lauren Aronson, executive director of Keep Americans Covered, a group in Washington, D.C., representing health insurers, hospitals, physicians, and patient advocates, said it is critical to raise awareness about the likely impact of losing the enhanced subsidies, which are also known as advanced premium tax credits. She is encouraged that Democrats have proposed legislation to extend the enhanced tax credits, and that some Republican senators have voiced support.

What worries Aronson most is that the Republican-controlled Congress is more focused on extending tax cuts than enhanced subsidies, she said. The current bill extending the 2017 tax cuts would increase the federal deficit by about $2.4 trillion over the next decade, according to the CBO, while making the enhanced subsidies permanent would increase the deficit by $358 billion over roughly the same period.

“Congress is moving forward on a tax reconciliation package that purports to benefit working families,” Aronson said. “But if you don’t take care of the tax credits, working families will be left holding the bag.”

Brian Blase, president of Paragon Health Institute, a conservative health policy think tank, said the enhanced subsidies were supposed to be a temporary measure during the covid-19 pandemic to help people at risk of losing coverage.

Instead, he said, the enhanced subsidies facilitated fraud because enrollees did not need to verify their income eligibility to receive zero-premium plans if they reported incomes at or near the federal poverty level.

The enhanced subsidies also worsen health inflation, discourage employers from offering health insurance benefits, and crowd out alternative models, such as short-term insurance and Farm Bureau plans, Blase said.

“Permitting these subsidies to expire would just be going back to Obamacare as it was written,” Blase said. “That is a more efficient program than the program that we have now.”

New rules for the marketplace proposed by the Trump administration in March are already designed to address fraud, said Anna Howard, a policy expert with the American Cancer Society Cancer Action Network, which advocates for increased health insurance coverage. Howard said extending the enhanced tax credits would help ensure that people who are legitimately eligible for coverage can get it.

“We don’t want to see over 5 million people be kicked off their health insurance coverage out of fears of fraud when the policies being proposed don’t necessarily address fraud,” she said.

Without affordable premiums, many consumers will turn to short-term health plans, health care cost-sharing ministries, and other forms of coverage that do not have the benefits or protections of the health law, she said.

“These are plans that don’t provide coverage for prescription drugs, or they have lifetime and annual limits,” she said. “For a cancer patient, those plans don’t work.”

Though the enhanced subsidies do not expire until the end of the year, the Blue Cross Blue Shield Association would prefer Congress to act by fall to avoid confusion during open enrollment, said David Merritt, a senior vice president. Insurers are preparing rates to meet state deadlines. By October, consumers will receive 60-day plan renewal notices with their 2026 premiums.

Without enhanced subsidies, Merritt said, competition in the marketplace will wither, leading to fewer coverage options and higher prices, especially in states that have not expanded Medicaid eligibility and where Obamacare enrollment spiked during the past four years, like Florida and Texas. “Voters and patients are really going to see the impact,” he said.

Republican and Democratic representatives for some of the Florida congressional districts with the highest numbers of people in the marketplace did not respond to repeated interview requests.

Muralles, of North Miami, Florida, said she wants her representatives to work in the interest of constituents like herself, who need health insurance coverage to care for their families.

“Now is the time to prove to us that they are with us,” Muralles said. “When everybody’s healthy, everybody goes to work, everybody can pay taxes, everybody can have a better life.”

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.

Subscribe to KFF Health News’ free Morning Briefing.

This article first appeared on KFF Health News and is republished here under a Creative Commons license.

The post The Price You Pay for an Obamacare Plan Could Surge Next Year appeared first on kffhealthnews.org



Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.

Political Bias Rating: Center-Left

The content primarily advocates for the continuation of enhanced subsidies under the Affordable Care Act, highlighting the potential negative impacts on low- and middle-income Americans if these subsidies expire. It includes voices concerned about healthcare affordability and coverage losses, emphasizing the human and economic consequences. While it does present perspectives from conservative sources criticizing the subsidies and noting fraud concerns, the overall tone and framing favor sustaining or expanding government healthcare support, which aligns with center-left policy priorities. The article avoids overt partisan rhetoric, aiming for a balanced but slightly progressive leaning on health policy matters.

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