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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Tracking Incident Reports

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

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

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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 instructions for use.

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

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

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

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

Missed Signals?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A Last-Resort Treatment

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

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

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

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

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

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

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

That informs the regulatory view, too, Kessler said.

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

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

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

Data Exists but Is Confidential

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

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

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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 were getting sick and dying from covid-related causes at far higher rates than white people, data show.

California Healthline analyzed and confirmed publicly available data, 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 report in January 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 fared worse than whites 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 hardest place 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 — was not evenly distributed 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 — Cohen’s agency directed clinicians to prioritize testing for people from “racial and ethnic minority groups disproportionately affected by adverse COVID-19 outcomes,” and officials recommended 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 criticized the national pandemic response, 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 study of 30 large cities 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 California Healthline analysis of CDC data shows 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 convened a work group 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 meeting minutes from April 24. The last item: “additional emphasis on equity and ensuring communities of color have access to testing.”

The state also received guidance from experts focused on equity.

“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 filed a civil rights complaint 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 letter in the North Carolina Medical Journal, 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 31% of cases and 35% of deaths 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 reached 1,420 people, 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.

This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism. 

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 KHN reported late last month, 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 Medicare Advantage health plans — 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 more seniors pick Medicare Advantage 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 net overpayments 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 costs taxpayers more than it should.

AHIP, an insurance industry trade group, criticized KHN’s reporting on the newly released audits as “misleading,” while the pro-industry group Better Medicare Alliance 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.”

This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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 put that decision off 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 more than doubled 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 hopes to torpedo it, 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 government reports 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.

This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.