Lester credits the chats for keeping her out of the hospital and reducing the need for clinic visits to manage chronic conditions including depression, fibromyalgia, and hypertension.

“Just knowing someone is going to check on me is comforting,” said Lester, 73, who lives with her dogs, Sophie and Dolly, in Independence, Kansas.

have two or more chronic health conditions, . That makes them eligible for a federal program that, since 2015, has rewarded doctors for doing more to manage their health outside office visits.

But while the service, called Chronic Care Management, reduced emergency room and in-patient hospital visits and lowered total health spending, uptake has been sluggish.

shows just 4% of potentially eligible enrollees participated in the program, a figure that appears to have held steady through 2023, according to a Mathematica analysis. About 12,000 physicians billed Medicare under the CCM mantle in 2021, according to the latest Medicare data analyzed by Ä¢¹½Ó°Ôº Health News. (The Medicare data includes doctors who have annually billed CCM at least a dozen times.)

By comparison, federal data shows about 1 million providers participate in Medicare.

Even as the strategy has largely failed to live up to its potential, thousands of physicians have boosted their annual pay by participating, and auxiliary for-profit businesses have sprung up to help doctors take advantage of the program. The federal data showed about 4,500 physicians received at least $100,000 each in CCM pay in 2021.

Through the CCM program, Medicare pays to develop a patient care plan, coordinate treatment with specialists, and regularly check in with beneficiaries. Medicare pays doctors a monthly average of , for 20 minutes of work with each, according to companies in the business.

Without the program, providers often have little incentive to spend time coordinating care because they can’t bill Medicare for such services.

Health policy experts say a host of factors limit participation in the program. Chief among them is that it requires both doctors and patients to opt in. Doctors may not have the capacity to regularly monitor patients outside office visits. Some also worry about meeting the strict Medicare documentation requirements for reimbursement and are reluctant to ask patients to join a program that may require a monthly copayment if they don’t have a supplemental policy.

“This program had potential to have a big impact,” said , an Emory University health policy expert on chronic diseases. “But I knew it was never going to work from the start because it was put together wrong.”

He said most doctors’ offices are not set up for monitoring patients at home. “This is very time-intensive and not something physicians are used to doing or have time to do,” Thorpe said.

For patients, the CCM program is intended to expand the type of care offered in traditional, fee-for-service Medicare to match benefits that — at least in theory — they may get through Medicare Advantage, which is administered by private insurers.

But the CCM program is open to both Medicare and Medicare Advantage beneficiaries.

The program was also intended to boost pay to primary care doctors and other physicians who are paid significantly less by Medicare than specialists, said Mark Miller, a former executive director of the Medicare Payment Advisory Commission, which advises Congress. He’s currently an executive vice president of Arnold Ventures, a philanthropic organization focused on health policy. (The organization has also provided funding for Ä¢¹½Ó°Ôº Health News.)

Despite the allure of extra money, some physicians have been put off by the program’s upfront costs.

“It may seem like easy money for a physician practice, but it is not,” said Namirah Jamshed, a physician at UT Southwestern Medical Center in Dallas.

Jamshed said the CCM program was cumbersome to implement because her practice was not used to documenting time spent with patients outside the office, a challenge that included finding a way to integrate the data into electronic health records. Another challenge was hiring staff to handle patient calls before her practice started getting reimbursed by the program.

Only about 10% of the practice’s Medicare patients are enrolled in CCM, she said.

Jamshed said her practice has been approached by private companies looking to do the work, but the practice demurred out of concerns about sharing patients’ health information and the cost of retaining the companies. Those companies can take more than half of what Medicare pays doctors for their CCM work.

Physician Jennifer Bacani McKenney, who runs a family medicine practice in Fredonia, Kansas, with her father — where Carrie Lester is a patient — said the CCM program has worked well.

She said having a system to keep in touch with patients at least once a month has reduced their use of emergency rooms — including for some who were prone to visits for nonemergency reasons, such as running out of medication or even feeling lonely. The CCM funding enables the practice’s medical assistant to call patients regularly to check in, something it could not afford before.

For a small practice, having a staffer who can generate extra revenue makes a big difference, McKenney said.

While she estimates about 90% of their patients would qualify for the program, only about 20% are enrolled. One reason is that not everyone needs or wants the calls, she said.

While the program has captured interest among internists and family medicine doctors, it has also paid out hundreds of thousands of dollars to specialists, such as those in cardiology, urology, and gastroenterology, the Ä¢¹½Ó°Ôº Health News analysis found. Primary care doctors are often seen as the ones who coordinate patient care, making the payments to specialists notable.

A federally funded found the CCM program saves Medicare $74 per patient per month, or $888 per patient per year — due mostly to a decreased need for hospital care.

The study quoted providers who were unhappy with attempts to outsource CCM work. “Third-party companies out there turn this into a racket,” the study cited one physician as saying, noting companies employ nurses who don’t know patients.

Nancy McCall, a Mathematica researcher who co-authored the 2017 study, said doctors are not the only resistance point. “Patients may not want to be bothered or asked if they are exercising or losing weight or watching their salt intake,” she said.

Still, some physician groups say it’s convenient to outsource the program.

UnityPoint Health, a large integrated health system based in Iowa, tried doing chronic care management on its own, but found it administratively burdensome, said Dawn Welling, the UnityPoint Clinic’s chief nursing officer.

For the past year, it has contracted with a Miami-based company, HealthSnap, to enroll patients, have its nurses make check-in calls each month, and help with billing. HealthSnap helps manage care for over 16,000 of UnityHealth’s Medicare patients — a small fraction of its Medicare patients, which includes those enrolled in Medicare Advantage.

Some doctors were anxious about sharing patient records and viewed the program as a sign they weren’t doing enough for patients, Welling said. But she said the program has been helpful, particularly to many enrollees who are isolated and need help changing their diet and other behaviors to improve health.

“These are patients who call the clinic regularly and have needs, but not always clinical needs,” Welling said.

Samson Magid, CEO of HealthSnap, said more doctors have started participating in the CCM program since Medicare increased pay in 2022 for 20 minutes of work, to $62 from $41, and added billing codes for additional time.

To help ensure patients pick up the phone, caller ID shows HealthSnap calls as coming from their doctor’s office, not from wherever the company’s nurse might be located. The company also hires nurses from different regions so they may speak with dialects similar to those of the patients they work with, Magid said.

He said some enrollees have been in the program for three years and many could stay enrolled for life — which means they can bill patients and Medicare long-term.

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

The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death.

The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the market. In an emailed response, Abbott said it had communicated the risk to customers this year.

The delayed action raises questions for some safety advocates about how and when issues with approved medical devices should be reported. The heart devices in question have been associated with thousands of reports of patients’ injuries and deaths, as described in a Ä¢¹½Ó°Ôº Health News investigation late last year.

“Why doesn’t the public know?” said , a cardiologist and an expert in medical device safety and regulation at the University of California-San Francisco. Though some surgeons may have been aware of issues, others, particularly those who do not implant the device frequently, may have been in the dark. “And their patients are suffering adverse events,” he said.

The recall involves a pair of mechanical pumps that help the heart pump blood when it can’t do so on its own. The devices, small enough to fit in the palm of a hand, are implanted in patients with end-stage heart failure who are waiting for a transplant or as a permanent solution when a transplant is not an option. The recall affects nearly 14,000 devices.

Amanda Hils, an FDA press officer, said the agency is working with Abbott to investigate the reported injuries and deaths and determine if further action is needed.

“To date, the number of deaths reported appears consistent with the ,” Hils said in an email.

According to the FDA’s recall notice, the devices can cause buildup of “biological material” that reduces their ability to help the heart circulate blood and keep patients alive. The buildup accumulates gradually and can appear two years or more after a device is implanted in a patient’s chest.

Doctors were advised to watch out for “low-flow alarms” on the devices and, if they do diagnose the obstruction, to either monitor the patient or perform surgery to implant a stent, release the blockage, or replace the pump. “Rates of outflow obstruction are low,” Abbott spokesperson Justin Paquette said in an email, adding that patients whose devices are functioning normally “have no reason for concern.”

A review of the FDA device database shows at least 130 reports related to HeartMate II or 3 that mention the complication reported by regulators. The earliest such report filed with the FDA dates to at least 2020, according to a Ä¢¹½Ó°Ôº Health News review of the database.

Monday’s alert is the second Class 1 recall of a HeartMate device this year.

In January, Abbott issued an urgent “” to hospitals about in which the HeartMate 3 unintentionally starts and stops due to the pump’s communication system, which cardiologists use to assess patients’ status. The FDA in March.

In February, Abbott issued to hospitals about the blockage problem, asking them to inform physicians, complete and return an acknowledgment form, and pay attention to low-flow alarms on the device’s monitor that may indicate an obstruction. The company said in the letter that it is working on “a design solution” to prevent the blockages.

A in the Journal of Thoracic and Cardiovascular Surgery reported the obstruction in about 3% of cases, though the incidence rate was higher the longer a patient had the device.

The only other Class 1 was in May 2018, when the company issued corrective action notices to hospitals and physicians warning that the graft line that carries blood from the pump to the aorta could twist and stop blood flow.

The FDA recall notice issued Monday includes to diagnose the blockage using an algorithm to detect obstructions and, if needed, a CT angiogram to verify the cause.

At present, the HeartMate 3, which was first approved by the FDA in 2017, is the only medical option for many patients with end-stage heart failure and who do not qualify for a transplant. The HeartMate 3 has supplanted the HeartMate II, which received FDA approval in 2008.

If the new recall leads to the device being removed from the market, end-stage heart failure patients could have no options, said , a cardiothoracic surgeon at the University of Michigan who also oversees a proprietary database of HeartMate II and HeartMate 3 implants.

If that happens, “we are in trouble,” Pagani said. “It would be devastating to the patients to not have this option. It’s not a perfect option — no pump ever is — but this is as good as it’s ever been.”

It’s not known precisely how many patients have received a HeartMate II or HeartMate 3 implant. That information is proprietary. The FDA recall notices show worldwide distribution of more than and more than .

The blockage complication may have gone unreported to the public for so long partly because physicians are not required to report adverse events to federal regulators, said Madris Kinard, a former FDA medical device official and founder of , a company that makes FDA device data more user-friendly for hospitals, law firms, and investors.

Only device manufacturers, device importers, and hospitals are to report device-related injuries, deaths, and significant malfunctions to the FDA.

“If this is something physicians were aware of, but they weren’t mandated to report to the FDA,” Kinard said, “at what point does that communication between those two groups need to happen?”

Dhruva, the cardiologist, said he is looking for transparency from Abbott about what the company is doing to address the problem so he can have more thorough conversations with patients considering a HeartMate device.

“We’re going to expect to have some data saying, ‘Hey we created this fix, and this fix works, and it doesn’t cause a new problem.’ That’s what I want to know,” he said. “There’s just a ton more that I feel in the dark about, to be honest, and I’m sure that patients and their families do as well.”

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

The government database, called “,” records financial relationships between doctors and certain other health care providers and the makers of drugs and medical devices. Ä¢¹½Ó°Ôº Health News found records of Abbott payments associated with 10 of the 14 voting members of the FDA advisory panel, which was weighing clinical evidence for a heart device called TriClip G4 System. The money, paid from 2016 through 2022 — the most recent year for which the database shows payments — adds up to about $650,000.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Appearance Issues

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

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

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

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

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

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

‘Unbridled Enthusiasm’

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Ä¢¹½Ó°Ôº Health News has been tracking how that money is used — or misused — nationwide.

But determining how much of that windfall arrived in a specific county or city — and how much will follow in the future — can be challenging. Most localities are not required to make the information public.

, the court-appointed firm administering the settlements, tracks much of this data but kept it private until Ä¢¹½Ó°Ôº Health News negotiated to obtain it last year. Ä¢¹½Ó°Ôº Health News made that information public for the first time last June.

Five months later, BrownGreer began quietly posting updated versions of the information .

, a partner at BrownGreer, told Ä¢¹½Ó°Ôº Health News that the change was made to assist state and local governments in accessing the information easily and “to promote transparency into the administration” of the settlements. She said the data is updated “regularly when new payments are issued,” which can be as frequent as twice a month.

Ä¢¹½Ó°Ôº Health News downloaded the data on March 4 and transformed it from state-by-state spreadsheets with separate entries for each settling company to a searchable database. Users can determine the total dollar amount their city, county, or state has received or expects to receive each year.

Determining how much money has arrived is the first step in assessing whether the settlements will make a dent in the nation’s addiction crisis.

Although this is the most comprehensive data available at a national scale, it provides just a snapshot of all opioid settlement payouts.

The information currently reflects only the largest settlement to date: $26 billion to be paid by pharmaceutical distributors AmerisourceBergen (now called Cencora), Cardinal Health, and McKesson, as well as opioid manufacturer Janssen (now known as Johnson & Johnson Innovative Medicine).

Most states have also settled with drug manufacturers Teva and Allergan, as well as Walmart, Walgreens, and CVS. Petkauskas said BrownGreer began distributing payments from these five companies in 2024 and plans to update its data to reflect such payments in July.

Other settlements, including with OxyContin manufacturer Purdue, are still pending.

This data does not reflect additional settlements that some state and local governments have entered into beyond the national deals, such as the agreement between Illinois, Indiana, Kentucky, Michigan, and Ohio and regional supermarket chain Meijer.

As such, this database undercounts the amount of opioid settlement money most places have received and will receive.

Payment details for some states are not available because those states were not , had unique settlement terms, or opted not to have their payments distributed via BrownGreer. A few examples include:

• Alabama and West Virginia declined to join several national settlements and instead reached individual settlements with many of these companies.
• Texas and Nevada were paid in full by Janssen outside of the national settlement, so their payout data reflects payments only from AmerisourceBergen, Cardinal Health, and McKesson.
• Florida, Louisiana, and Pennsylvania, among others, opted to receive a lump-sum payment via BrownGreer then distribute the money to localities themselves.

Ä¢¹½Ó°Ôº Health News’ Colleen DeGuzman contributed to this report. Jai Aslam also contributed.

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The devices send those measurements electronically to his doctor in Gulf Shores, Alabama, and a health technology company based in New York, to help him control his high blood pressure.

Nurses with the company, Cadence, remotely monitor his readings along with the vital signs of about 17,000 other patients around the nation. They call patients regularly and follow up if anything appears awry. If needed, they can change a patient’s medication or dosage without first alerting their doctor.

Abbott, 85, said he likes that someone is watching out for him outside his regular doctor appointments. “More doctors should recommend this to their patients,” he said.

Increasingly, they are.

Dozens of tech companies have streamed in, pushing their remote monitoring service to primary care doctors as a way to keep tabs on patients with chronic illnesses and free up appointment time, and as a new source of Medicare revenue.

But some experts say remote monitoring’s huge growth — spurred on during the covid-19 pandemic, when patients were hesitant to sit in crowded doctors’ waiting rooms — has outpaced oversight and evidence of how the technology is best used.

“It is the wild West where any patient can get it if a doctor decides it is reasonable and necessary,” said Caroline Reignley, a partner with the law firm McDermott Will & Emery who advises health providers.

In 2019, Medicare made it easier for doctors to bill for monitoring routine vital signs such as blood pressure, weight, and blood sugar. Previously, Medicare coverage for remote monitoring was limited to certain patients, such as those with a pacemaker.

Medicare also began allowing physicians to get paid for the service even when the monitoring is done by clinical staff who work in different places than the physician — an adjustment advocated by telemedicine companies.

In just the first two full years, remote monitoring services billed to Medicare grew from fewer than 134,000 to 2.4 million in 2021, according to federal records analyzed by Ä¢¹½Ó°Ôº Health News.

Total Medicare payments for the four most common billing codes for remote monitoring rose from $5.5 million in 2019 to $101.4 million in 2021, the latest year for which data is available.

Part of the allure is that Medicare will pay for remote monitoring indefinitely regardless of patients’ health conditions as long as their doctors believe it will help.

For doctors with 2,000 to 3,000 patients, the money can add up quickly, with Medicare paying an average of about $100 a month per patient for the monitoring, plus more for setting up the device, several companies confirmed.

Medicare enrollees may face 20% in cost sharing for the devices and monthly monitoring, though certain private plans through Medicare Advantage and Medicare supplement policies may cover those costs. The government allowed insurers to waive the patient cost sharing during the pandemic.

About 400 doctors and other providers repeatedly billed Medicare for remote patient monitoring in 2019. Two years later, that had mushroomed to about 3,700 providers, according to Medicare data analyzed by Ä¢¹½Ó°Ôº Health News. (The data tracks providers who billed more than 10 patients for at least one type of remote monitoring.)

Federal law enforcement officials say they are conducting investigations after a surge in complaints about some remote patient monitoring companies but would not provide details.

The Department of Health and Human Services’ Office of Inspector General in November issued a consumer alert about companies signing up Medicare enrollees without their doctors’ knowledge: “Unscrupulous companies are signing up Medicare enrollees for this service, regardless of medical necessity,” and bill Medicare even when no monitoring occurs.

In a statement to Ä¢¹½Ó°Ôº Health News, Meena Seshamani, director of the federal Center for Medicare, part of the Centers for Medicare & Medicaid Services, did not say how CMS is ensuring only patients who can benefit from remote monitoring receive it. She said the agency balances the need to give patients access to emerging technology that can improve health outcomes with the need to combat fraud and make proper payments to providers.

While some small studies show remote monitoring can improve patient outcomes, researchers say it is unclear which patients are helped most and how long they need to be monitored.

“The research evidence is not as robust as we would like to show that it is beneficial,” said Ateev Mehrotra, a Harvard Medical School researcher.

by the Bipartisan Policy Center, a Washington, D.C.-based think tank, warned about “a lack of robust evidence on the optimal use of remote monitoring” and said some policy and medical experts “question whether we are effectively ‘rightsizing’ the use of these services, ensuring access for patients who need it most, and spending health care dollars in effective ways.”

Denton Shanks, a medical director at the American Academy of Family Physicians, said remote monitoring helps patients manage their diseases and helps physician practices be more efficient. He has used it for the past two years as a doctor at the University of Kansas Health System.

It has worked well, he said, though sometimes it can be challenging to persuade patients to sign up if they have to pay for it.

“For the vast majority of patients, once they are enrolled, they see a benefit, and we see a benefit as their vital signs come in the normal range,” Shanks said.

The size of the market is tantalizing.

About two-thirds of the more than 66 million Medicare beneficiaries , the most common metric monitored remotely, according to physicians and the monitoring companies.

“The patient need is so enormous,” Cadence CEO Chris Altchek said. The company has about 40 nurses, medical assistants, and other providers monitoring patients in 17 states. He said patients enrolled in remote monitoring experience a 40% reduction in emergency room visits. Cadence says 82% of its patients use the devices at least once every two days.

Timothy Mott, a family physician in Foley, Alabama, said valuable appointment times in his office open up as patients who previously needed vital signs to be checked there turn to remote monitoring.

Cadence nurses regularly contact Mott’s patients and monitor their readings and make changes as needed.

“I was concerned early on whether they were going to make the right decisions with our patients,” Mott said. “But over time the dosage changes or changes in medication they are making are following the best guidelines on effectiveness.”

At the six-month mark, about 75% of patients have stayed with the monitoring, Mott said.

The advantages are apparent even to some providers who do not get paid by Medicare to offer the service. Frederick Health, a Maryland health system, provides remote monitoring to 364 high-risk patients and estimates the program saves the nonprofit system $10 million a year by reducing hospital admissions and ER visits. That estimate is based on comparisons of patients’ Medicare claims before they started the program and after, said Lisa Hogan, who runs the program.

The hospital pays for the program and does not bill Medicare, she said.

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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, Ä¢¹½Ó°Ôº Health News has investigated medical device malfunctions including:

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

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

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

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

In a statement to Ä¢¹½Ó°Ôº Health News, the FDA said it “has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.”

‘Too Little, Too Late’

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

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

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

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

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

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

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

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

Medtronic declined to answer written questions from Ä¢¹½Ó°Ôº Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones “redesigned to reduce the risk of damage” and “fulfilled all pump replacement requests at no cost to customers.”

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

Shortcut to Market

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

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

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

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

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

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

3,000

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

30

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

In response to written questions from Ä¢¹½Ó°Ôº Health News, the FDA said it “continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices.” The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence — what the agency refers to as “predicate” devices.

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

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

Alarm Bells

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

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

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

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

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

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

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

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

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

Late Warnings

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

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

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

In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a Ä¢¹½Ó°Ôº Health News analysis found. That works out to nearly 60,000 delayed reports a year.

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

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to Ä¢¹½Ó°Ôº Health News, Grassley called that a “commonsense step we can take up front to mitigate risk, improve certainty and save money later.”

10%

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

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

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

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

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

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

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

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

Private Eyes

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

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

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

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

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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 Ä¢¹½Ó°Ôº 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, , 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 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.

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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 to a Food and Drug Administration database where the public can learn about device-related deaths, serious injuries, and malfunctions. The in the peer-reviewed Journal of Heart and Lung Transplantation.

In September 2021, Ramon Flores Sr. had 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 , 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 Ä¢¹½Ó°Ôº Health News analysis of the FDA’s database of medical device incidents, known as the , or MAUDE. Hospitals, doctors, and others report device-related deaths, serious injuries, and malfunctions to manufacturers, who are 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 Ä¢¹½Ó°Ôº 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 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 , 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.”

, 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 , 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 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 by doctors, patients, or others. The FDA says that reports if the manufacturer determines that a device did not cause or contribute to an adverse event.

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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 .

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 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 Ä¢¹½Ó°Ôº 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, , 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 , 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 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 certified to implant the device — are kept in Intermacs, managed by , 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.

, 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, for implant centers and 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 in June 2021, citing a high risk of stroke and pumps failing to restart if stopped.

While the FDA provides consumers with 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.

, 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 .

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 . 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 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.”

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Testing at the time “was outside of communities of color,” said the Rev. Jordan Boyd, pastor of Rockwell AME Zion Church in Charlotte. For Boyd, pandemic losses were personal: Covid-related complications killed a brother-in-law who worked as a truck driver. “We saw what was happening with our folks.”

Mandy Cohen, who led the state’s pandemic response as secretary of North Carolina’s health department, had said widespread testing was one of “our best tools to keep our community safe and to protect our frontline workers.” But the state was failing to get tests to its most vulnerable people, with grim consequences: Black people in North Carolina from covid-related causes at far higher rates than white people, data show.

Ä¢¹½Ó°Ôº Health News analyzed and confirmed , including the location of testing sites that Cohen’s office directed the public to in mid-May 2020 in Mecklenburg County, home to Charlotte, the state’s largest city. Just 1 in 4 fixed sites stood in more disadvantaged areas with significant Black populations, including what is known as the Crescent, neighborhoods reaching west, north, and east of downtown that for generations have had elevated rates of diabetes, high blood pressure, lung disease, and other conditions that can cause life-threatening complications from covid. Far more testing was available in south Charlotte and suburban areas — the whiter, wealthier neighborhoods.

Life in the Crescent is marked by higher rates of poverty, crowded housing, and less access to health care, transportation, and internet service — factors that fueled transmission of the virus and created barriers to testing.

“There were a lot of hurdles that you had to go through,” said Boyd, who helped spearhead the effort to bring testing to Black churches.

President Joe Biden and others in political and health policy circles have praised Cohen’s pandemic leadership in North Carolina. Biden in June cited her “proven track-record protecting Americans’ health and safety” when elevating Cohen to run the Centers for Disease Control and Prevention, the nation’s top public health agency.

Those on the ground in North Carolina’s most vulnerable communities, including Cohen’s admirers, tell another story — about living with the downsides of the state’s emergency response. These include advocates for groups that were disproportionately harmed during the public health crisis, including minority and immigrant communities, people with disabilities, and families of nursing home residents.

Corine Mack, president of the Charlotte-Mecklenburg NAACP, recalled that in late 2020 she and others complained to Cohen about public money going to white-led organizations instead of Black-led ones working in minority neighborhoods.

“I said we had to send resources tomorrow, not next month,” Mack said. “She started crying. I was so passionate about our people dying. Once she understood the severity of the situation, she did what she had to do.”

The challenges Cohen faced in North Carolina were exacerbated by structural inequities in and outside the health care system, problems that are too large for any one person to fix. Still, Cohen now faces the same challenges on a national scale, as she’s charged with fixing the CDC after its pandemic missteps.

Cohen, through her spokesperson at the CDC, declined multiple requests for an interview.

A called “Building the CDC the Country Needs,” which was signed by dozens of health policy experts, urged an agency overhaul. Among the priorities cited: more quickly collecting data on racial, ethnic, economic, and geographic factors that is “foundational to improving equity of access to services.”

For most of the pandemic, Black, Hispanic, and Native Americans across the country.

In North Carolina, critics and allies alike say Cohen heeded concerns. She relied heavily on data and followed federal guidance closely, they said. And Cohen showed vigilance when she interpreted rules, like those on nursing home visitation and mask mandates, even in the face of criticism.

She also repeatedly urged personal responsibility to contain the spread of the virus, underscoring how public health messaging often focuses on choice rather than societal constraints, said Anne Sosin, a researcher at Dartmouth College who focuses on health equity.

“Many of the people and communities hardest-hit by the pandemic had little choice in their exposure” because they got covid where they lived or worked, Sosin said. “Limiting our focus on the choices that people make — rather than on the broader structural and social forces that shape risk — really will set us up for the same failures in the future.”

With more than 1 million residents, Mecklenburg County has become a symbol both of North Carolina’s economic rise and of its struggles to overcome a long history of racial discrimination and disparities. A short drive from the headquarters of Fortune 500 companies, such as Bank of America and Honeywell, sit minority neighborhoods plagued by poverty. A national study on social mobility found that, among the 50 largest cities, Charlotte was the for a child to move from poverty to the upper class.

Researchers from North Carolina’s health agency and the University of North Carolina found that access to tests during the first three months of the pandemic — between March and June 2020 — across racial and ethnic groups, with inadequate access for Black and Latino residents.

On May 14, 2020 — two months after the national emergency was declared — to prioritize testing for people from “racial and ethnic minority groups disproportionately affected by adverse COVID-19 outcomes,” and using mobile testing for “vulnerable populations,” documents show.

The disparities persisted. In Charlotte, the difference in testing sites underscored the inequity people of color often face in health care, as they were left to depend on a few mobile units whose routes and hours varied by the day. Meanwhile, wealthier areas had an abundance of well-resourced, fixed sites with regular hours.

Critics say the state was slow to address glaring and predictable problems. Mecklenburg County Commissioner Pat Cotham, a Democrat, said it took authorities precious time to shift testing to the hardest-hit neighborhoods. Cotham said officials should have more quickly enlisted Black ministers and others who had established trust with residents. Instead, she said, even elected representatives of those areas were often locked out. “I remember getting information from press releases or TV,” she said.

North Carolina initially failed to prioritize testing for people who were exposed to covid because of where they live or work, said Jeanne Milliken Bonds, a professor of social impact investing at the University of North Carolina. She co-authored a white paper that , saying, “We are ignoring the critical impact of systemic racism in vulnerabilities to the deadly virus.”

Black people, immigrants, and ethnic minorities disproportionately hold jobs that governments deemed essential — in food processing plants, retail stores, and nursing homes — and they were unable to isolate and work from home, Milliken Bonds said.

Charlotte had one of the biggest disparities in access to testing in the nation, according to a by researchers at Drexel and Temple universities. Only Austin and Houston in Texas fared worse.

In 2020, Black people in North Carolina died from covid at a higher rate than white people, although the disparity was slightly less pronounced than in the U.S. overall. A Ä¢¹½Ó°Ôº Health News analysis of that 112 of every 100,000 non-Hispanic Black residents in the state died, compared with 89 per 100,000 non-Hispanic white residents. North Carolina’s death rates for all racial and ethnic groups that year were lower than those nationally.

“The driving factor for testing and vaccination was, ‘Let’s get older people and let’s protect our health care workers,’” Milliken Bonds said. “You end up losing the health equity lens. There was a course correction later in 2020. They looked at the data and said, ‘Oh my God!’ They were missing people of color.”

Tensions Rose

In April 2020, when covid tests were scarce nationally and states had little federal support, Cohen’s Department of Health and Human Services to increase testing. The initiative began as Democratic Gov. Roy Cooper indicated he would ease the restrictions he’d put in place in March to limit covid’s spread.

The group included state employees, consultants, local officials, and representatives from major hospital systems, community health centers, and commercial labs, North Carolina HHS news releases and state documents show. Officials set priority groups for testing, including hospitalized patients, health care workers and first responders, and people in long-term care or correctional facilities, according to . The last item: “additional emphasis on equity and ensuring communities of color have access to testing.”

The state also received guidance .

“We know that there’s more covid-19 out in our communities than gets captured by what’s in our lab data,” Cohen said April 30, during one of Cooper’s pandemic briefings.

Of the covid test results reported to North Carolina’s health department at that time, a smaller share were coming back positive relative to prior weeks, and covid hospitalizations were level — developments Cohen hailed as progress. But tensions were brewing.

By May 5, Disability Rights North Carolina with the U.S. Department of Health and Human Services about a proposed state emergency plan. The advocacy group said the plan — which determined who would get lifesaving treatments in hospitals if supplies were scarce — would put people with disabilities in the “back of the line” and lead to a disproportionate death toll among people of color or with low incomes.

As the state began reopening businesses in early May, officials knew testing levels were not adequate, according to a review of public documents, interviews, and Cohen’s public remarks. Hundreds of sites were up and running, “but there’s more to do,” Cohen said May 20.

In a , North Carolina HHS employees and a consultant with Accenture said “testing was difficult to access outside of a hospital” that month. “Of the tests being performed early in the pandemic, the majority were in White populations even though we could already see differences in poor outcomes in Black/African American, American Indian/Alaskan Native, and Latinx populations infected with the virus around the country,” they wrote.

Kody Kinsley, who worked for Cohen and succeeded her as health secretary, said the state’s response was stymied by factors beyond its control, including supply chain shortages. “We were essentially riding the backbone of the existing health care network with inadequate supplies,” Kinsley said. The department tried to contract with outside firms to boost testing access in historically marginalized communities, but “resources weren’t available.”

Boyd, the pastor, said it was “difficult times.” To reach hard-hit communities across the state, “you have to be able to do that through connections on the ground,” he said. “Otherwise it’s not going to happen. But that takes time.”

In Charlotte, he said, fixed testing sites at hospitals and elsewhere, which required appointments, weren’t as accessible for those in the city’s poorest neighborhoods. “You had to go online and sign up,” he said.

Black residents were desperate for testing: When a mobile van run by Atrium Health, the dominant hospital system in Charlotte, arrived at Boyd’s church in early May, “Cars were lined up around the block at 4 or 5 o’clock in the morning,” he said.

Atrium’s mobile testing started in April, circulating in minority communities where data showed emerging hot spots. While people could walk up to get a test, locations shifted daily, according to internet archives, social media posts, and other announcements. Between mid-April and early July, the units stopped at many Black churches only once.

“We were last on the list. We lost a lot of people,” said Vilma Leake, a Democratic member of the Mecklenburg Board of County Commissioners. Leake said she never received a satisfactory answer when she asked why people of color were not prioritized for testing given the South’s long history of racial exclusion and wide disparities in health, education, and income. “History is repeating itself. It is always a fight for some people,” she added.

Kinsley said the state’s response “was intentionally designed to be conscious of class and race and ethnicity,” which he said informed its guidance for essential workers and efforts to push businesses to provide paid leave and on-the-job covid tests.

By late spring, the state’s testing data, which captured only a fraction of infections, painted a troubling picture. As of May 26, Black residents made up despite being 22% of the state’s population. Latinos made up 9.6% of the state’s population and 35% of covid cases.

That same day, Cohen stood at Cooper’s pandemic briefing. While she described the state’s efforts to improve safety for workers at meat processing plants, she again called for personal responsibility.

“Our ability to continue to ease restrictions and get back to work as safely as possible hinges on all of us working together to protect each other,” Cohen said, adding, “We want to save lives. And we can do that with simple individual actions.” By that time, North Carolina had allowed restaurants, pools, and personal care businesses such as barbers to open at 50% capacity.

The state’s response “was not adequate for protecting essential workers,” said the Rev. Rodney Sadler, the director of the Center for Social Justice and Reconciliation at Union Presbyterian Seminary.

“It was targeted toward those who had resources, who had a knowledge base, who had greater freedoms, who had the ability to work from home,” he said, adding that it’s important to “think about how this hits differently for poor Black and brown people in inner-city communities than it does for wealthier, white communities in the suburbs.”

The Rev. Greg Jarrell helps lead QC Family Tree, a social justice organization in Enderly Park, a Black neighborhood near downtown Charlotte that is gentrifying. He said people often waited hours for testing at a site near his neighborhood, even with appointments.

“We saw the severe limitations of the whole system,” he said. “Who has got time to sit in line for three hours? Not an hourly employee.”

If you don’t set up “race-conscious and class-conscious policy,” Jarrell said, “the system is always going to serve people who have more resources.”

Throughout June, as North Carolina’s covid infections and hospitalizations climbed, the state focused more intensely on Black, Latino, and Native American residents. It took until July 7 for officials to announce they would deploy 300 free temporary testing sites in underserved communities across the state.

The state’s covid death toll had , and 989 more were hospitalized. The trajectory, Cohen said, was “moving in the wrong direction.”

A Bigger Challenge at the CDC

Political leaders, public health experts, and advocacy groups say Cohen is well suited to run the CDC.

She has navigated vast government agencies — experience her predecessor, Rochelle Walensky, lacked. Cohen has political acumen, having worked effectively in a politically divided state “with a range of views about public health,” said Tom Inglesby, director of the Johns Hopkins Center for Health Security and a former senior White House adviser on covid response. “She is super bright and a very clear communicator about the issues on the table.”

During the Obama administration, Cohen, a physician, climbed the ranks to become chief operating officer and chief of staff at the Centers for Medicare & Medicaid Services, which has more than 6,000 employees and oversees government programs like Medicare and Medicaid that insure millions of Americans. In 2017 Cooper appointed her North Carolina health secretary. She stepped down at the end of 2021.

Cohen’s time “in North Carolina will inform the practical, on-the-ground work that will make a big difference at the CDC,” Kinsley said, citing efforts to minimize racial and ethnic disparities in covid vaccination.

According to CDC data comparing covid mortality rates by state, North Carolina had the 12th lowest age-adjusted death rate in 2020. But the state’s fortunes changed in 2021, when it dropped to 30th place. North Carolinians said Cohen listened to their perspectives, but their calls for help were punctuated by a drumbeat of deaths.

Mecklenburg County Commissioner Mark Jerrell, a Democrat, said the pandemic exposed how North Carolina is still reeling from centuries of racial discrimination. Even as Cohen “became a trusted community voice,” he said, “there was a disconnect between the discussion of equity and the application of equity.”

He worries that painful lessons of those early pandemic months seem forgotten, saying, “We don’t even hear this conversation now.”

Data reporter Hannah Recht contributed to this story.

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Medicare had paid the Blue Cross plan more than $20,000 to cover the care of 11 patients seen by Aggeus Healthcare, a chain of podiatry clinics, in 2011.

Blue Cross said it couldn’t locate any records to justify the payments because Aggeus shut down in the wake of the indictment, which included charges of falsifying patient medical files. So Blue Cross asked the Centers for Medicare & Medicaid Services for a “hardship” exemption to a strict requirement that health plans retain these files in the event of an audit.

CMS granted the request and auditors removed the 11 patients from a random sample of 201 Blue Cross plan members whose records were reviewed.

A review of 90 government audits, released exclusively to KHN in response to a Freedom of Information Act lawsuit, reveals that health insurers that issue Medicare Advantage plans have repeatedly tried to sidestep regulations requiring them to document medical conditions the government paid them to treat.

The audits, the most recent ones the agency has completed, sought to validate payments to Medicare Advantage health plans for 2011 through 2013.

As , auditors uncovered millions of dollars in improper payments — citing overcharges of more than $1,000 per patient a year on average — by nearly two dozen health plans.

The hardship requests, together with other documents obtained by KHN through the lawsuit, shed light on the secretive audit process that Medicare relies on to hold accountable the increasingly popular — which are an alternative to original Medicare and primarily run by major insurance companies.

Reacting to the audit findings, Sen. Chuck Grassley (R-Iowa) called for “aggressive oversight” to recoup overcharges.

“CMS must aggressively use every tool at its disposal to ensure that it’s efficiently identifying Medicare Advantage fraud and working with the Justice Department to prosecute and recover improper payments,” Grassley said in a written statement to KHN.

Medicare reimburses Medicare Advantage plans using a complex formula called a risk score that computes higher rates for sicker patients and lower ones for healthier people.

But federal officials rarely demand documentation to verify that patients have these conditions, or that they are as serious as claimed. Only about 5% of Medicare Advantage plans are audited yearly.

When auditors came calling, the previously hidden CMS records show, they often found little or no support for diagnoses submitted by the Advantage plans, such as chronic obstructive pulmonary disease, diabetes, or vascular disease. Though auditors look at the records of a relatively small sample of patients, they can extrapolate the error rate to the broad population of patients in the Medicare Advantage health plan and calculate millions of dollars in overpayments.

Overall, CMS auditors flagged diagnostic billing codes — which show what patients were treated for — as invalid more than 8,600 times. The audits covered records for 18,090 patients over the three-year period.

In many cases, auditors found that the medical credentials of the health care provider who made the diagnosis were unclear, the records provided were unacceptable, or the record lacked a signature as required. Other files bore the wrong patient’s name or were missing altogether.

The rates of billing codes rejected by auditors varied widely across the 90 audits. The rate of invalid codes topped 80% at Touchstone Health, a defunct New York HMO, according to CMS records. The company also was shown to have the highest average annual overcharges — $5,888 per patient billed to the government.

By contrast, seven health plans had fewer than 10% of their codes flagged.

Registering Excuses

One Medicare Advantage health plan submitted 57 hardship requests, more than any other insurer, though CMS approved only six. In three cases, the health plans said the records were destroyed in floods. Another cited a warehouse fire, and two said the records couldn’t be turned over because a doctor had been convicted for his role in illegally distributing millions of oxycodone pills through his network of pain clinics.

Other Medicare Advantage health plans argued they had no luck retrieving medical records from doctors who had moved, retired, died — and in some cases been arrested or lost their licenses for misconduct.

CMS found most excuses wanting, telling health plans they granted exceptions only in “truly extraordinary circumstances.” CMS said it receives about 100 of these requests for each year it audits and approves about 20% of them.

The Medicare Advantage plan issued by Minnesota Blue Cross won its appeal after it relied on Aggeus Healthcare for diagnoses of vascular disease for 11 of its patients who got podiatry care.

Dr. Yev Gray, a Chicago podiatrist who owned the Aggeus chain that operated in more than a dozen states, was indicted on federal fraud charges in Missouri in October 2015.

The indictment accused him of creating an electronic medical record that fraudulently added billing codes for treatment of medical conditions patients didn’t necessarily have, including vascular disease.

Gray pleaded guilty in May 2017 to charges of conspiracy to defraud the United States and making false statements related to health care matters. He was sentenced to 90 months in prison.

Blue Cross said it “terminated” its network agreements with Aggeus about two weeks after learning of the indictment. Jim McManus, director of public relations for Blue Cross and Blue Shield of Minnesota, had no comment on the case but said the insurer “is committed to investigating credible cases of fraud, waste, and abuse.”

Dara Corrigan, a CMS deputy administrator, said that as a “general matter,” its Medicare Advantage audits “are not designed to detect fraud, nor are they intended to identify all improper diagnosis submissions.”

Protecting Taxpayers

The costs to taxpayers from improper payments have mushroomed over the past decade as plans. CMS has estimated the total overpayments to health plans for the 2011-2013 audits at $650 million, yet how much it will eventually claw back remains unclear.

Payment errors continue to be a drain on the government program. CMS has estimated to Medicare Advantage plans triggered by unconfirmed medical diagnoses at $11.4 billion for 2022.

“This isn’t a partisan issue,” said Sen. Sherrod Brown (D-Ohio). “I’ve requested a plan from CMS as to how they plan to recoup these taxpayer-funded overpayments and prevent future overbilling.”

Leslie Gordon, an acting director of health care for the Government Accountability Office, said CMS needs to speed up the audit and appeals process to get quicker results.

“That is money that should be recovered,” Gordon told KHN.

As Medicare Advantage faces mounting criticism from government watchdogs and in Congress, the industry has tried to rally seniors to its side while disputing audit findings and research that asserts the program .

AHIP, an insurance industry trade group, on the newly released audits as “misleading,” while the pro-industry group said the audits were “in some cases, more than a decade old.”

Jeff De Los Reyes, a senior vice president at GHG Advisors health care consulting group, said he believes the health plans have improved their documentation in recent years. But, he said, “coding is never 100% perfect and there will be errors despite the best of intentions.”

Rep. Katie Porter, a Democrat from Southern California and a critic of Medicare Advantage, countered: “When big insurance bills taxpayers for care it never intends to deliver, it is stealing our tax dollars.”

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Summaries of the 90 audits, which examined billings from 2011 through 2013 and are the most recent reviews completed, were obtained exclusively by KHN through a three-year Freedom of Information Act lawsuit, which was settled in late September.

The government’s audits uncovered about $12 million in net overpayments for the care of 18,090 patients sampled, though the actual losses to taxpayers are likely much higher. Medicare Advantage, a fast-growing alternative to original Medicare, is run primarily by major insurance companies.

Officials at the Centers for Medicare & Medicaid Services have said they intend to extrapolate the payment error rates from those samples across the total membership of each plan — and recoup an estimated $650 million as a result.

But after nearly a decade, that has yet to happen. CMS was set to unveil a final extrapolation rule Nov. 1 but until February.

Ted Doolittle, a former deputy director of CMS’ Center for Program Integrity, which oversees Medicare’s efforts to fight fraud and billing abuse, said the agency has failed to hold Medicare Advantage plans accountable. “I think CMS fell down on the job on this,” said Doolittle, now the health care advocate for the state of Connecticut.

Doolittle said CMS appears to be “carrying water” for the insurance industry, which is “making money hand over fist” off Medicare Advantage. “From the outside, it seems pretty smelly,” he said.

In an email response to written questions posed by KHN, Dara Corrigan, a CMS deputy administrator, said the agency hasn’t told health plans how much they owe because the calculations “have not been finalized.”

Corrigan declined to say when the agency would finish its work. “We have a fiduciary and statutory duty to address improper payments in all of our programs,” she said.

The 90 audits are the only ones CMS has completed over the past decade, a time when Medicare Advantage has grown explosively. Enrollment in the plans during that period, passing 28 million in 2022, at a cost to the government of $427 billion.

Seventy-one of the 90 audits uncovered net overpayments, which topped $1,000 per patient on average in 23 audits, according to the government’s records. Humana, one of the largest Medicare Advantage sponsors, had overpayments exceeding that $1,000 average in 10 of 11 audits, according to the records.

CMS paid the remaining plans too little on average, anywhere from $8 to $773 per patient.

Auditors flag overpayments when a patient’s records fail to document that the person had the medical condition the government paid the health plan to treat, or if medical reviewers judge the illness is less severe than claimed.

That happened on average for just over 20% of medical conditions examined over the three-year period; rates of unconfirmed diseases were higher in some plans.

As Medicare Advantage’s popularity among seniors has grown, CMS has fought to keep its audit procedures, and the mounting losses to the government, largely under wraps.

That approach has frustrated both the industry, which has blasted the audit process as “fatally flawed” and , and Medicare advocates, who worry some insurers are getting away with ripping off the government.

“At the end of the day, it’s taxpayer dollars that were spent,” said David Lipschutz, a senior policy attorney with the Center for Medicare Advocacy. “The public deserves more information about that.”

At least three parties, including KHN, have sued CMS under the Freedom of Information Act to shake loose details about the overpayment audits, which CMS calls Risk Adjustment Data Validation, or RADV.

In one case, CMS charged a law firm an advance search fee of $120,000 and then provided next to nothing in return, according to court filings. The law firm filed suit last year, and the case is pending in federal court in Washington, D.C.

KHN sued CMS in September 2019 after the agency failed to respond to a FOIA request for the audits. Under the settlement, CMS agreed to hand over the audit summaries and other documents and pay $63,000 in legal fees to Davis Wright Tremaine, the law firm that represented KHN. CMS did not admit to wrongfully withholding the records.

High Coders

Most of the audited plans fell into what CMS calls a “high coding intensity group.” That means they were among the most aggressive in seeking extra payments for patients they claimed were sicker than average. The government pays the health plans using a formula called a “risk score” that is supposed to render higher rates for sicker patients and lower ones for healthier ones.

But often medical records supplied by the health plans failed to support those claims. Unsupported conditions ranged from diabetes to congestive heart failure.

Overall, average overpayments to health plans ranged from a low of $10 to a high of $5,888 per patient collected by Touchstone Health HMO, a New York health plan whose contract was terminated “by mutual consent” in 2015, according to CMS records.

Most of the audited health plans had 10,000 members or more, which sharply boosts the overpayment amount when the rates are extrapolated.

In all, the plans received $22.5 million in overpayments, though these were offset by underpayments of $10.5 million.

Auditors scrutinize 30 contracts a year, a small sample of about 1,000 Medicare Advantage contracts nationwide.

UnitedHealthcare and Humana, the two biggest Medicare Advantage insurers, accounted for 26 of the 90 contract audits over the three years.

Eight audits of UnitedHealthcare plans found overpayments, while seven others found the government had underpaid.

UnitedHealthcare spokesperson Heather Soule said the company welcomes “the program oversight that RADV audits provide.” But she said the audit process needs to compare Medicare Advantage to original Medicare to provide a “complete picture” of overpayments. “Three years ago we made a recommendation to CMS suggesting that they conduct RADV audits on every plan, every year,” Soule said.

Humana’s 11 audits with overpayments included plans in Florida and Puerto Rico that CMS had audited twice in three years.

The Florida Humana plan also was the target of an unrelated audit in April 2021 by the Health and Human Services inspector general. That audit, which covered billings in 2015, concluded Humana improperly collected nearly $200 million that year by overstating how sick some patients were. Officials have yet to recoup any of that money, either.

In an email, Humana spokesperson Jahna Lindsay-Jones called the CMS audit findings “preliminary” and noted they were based on a sampling of years-old claims.

“While we continue to have substantive concerns with how CMS audits are conducted, Humana remains committed to working closely with regulators to improve the Medicare Advantage program in ways that increase seniors’ access to high-quality, lower cost care,” she wrote.

Billing Showdown

Results of the 90 audits, though years old, mirror more recent findings of a slew of other and whistleblower lawsuits alleging that Medicare Advantage plans routinely have inflated patient risk scores to overcharge the government by billions of dollars.

Brian Murphy, an expert in medical record documentation, said collectively the reviews show that the problem is “absolutely endemic” in the industry.

Auditors are finding the same inflated charges “over and over again,” he said, adding: “I don’t think there is enough oversight.”

When it comes to getting money back from the health plans, extrapolation is the big sticking point.

Although extrapolation is routinely used as a tool in most Medicare audits, CMS officials have never applied it to Medicare Advantage audits because of fierce opposition from the insurance industry.

“While this data is more than a decade old, more recent research demonstrates Medicare Advantage’s affordability and responsible stewardship of Medicare dollars,” said Mary Beth Donahue, president of the Better Medicare Alliance, a group that advocates for Medicare Advantage. She said the industry “delivers better care and better outcomes” for patients.

But critics argue that CMS audits only a tiny percentage of Medicare Advantage contracts nationwide and should do more to protect tax dollars.

Doolittle, the former CMS official, said the agency needs to “start keeping up with the times and doing these audits on an annual basis and extrapolating the results.”

But Kathy Poppitt, a Texas health care attorney, questioned the fairness of demanding huge refunds from insurers so many years later. “The health plans are going to fight tooth and nail and not make this easy for CMS,” she said.

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