KEOKUK, Iowa — Folks in this Mississippi River town hope a new federal program can revive the optimism engraved long ago in a plaque on the side of their hospital.
"Dedicated to the Future of Health Care in the Tri-State Area," the sign declares. "May 11, 1981."
More recent placards posted at the facility's entryways are ominous, however. "Closed," they say. "No Trespassing."
The Keokuk hospital, which served rural areas of Iowa, Illinois, and Missouri, closed in October 2022. But new owners plan to reopen the hospital with the help of a new federal payment system. The Rural Emergency Hospital program guarantees hospitals extra cash if they provide emergency and outpatient services but end inpatient care.
"We've been without a hospital for over a year — and I don't think anybody in Keokuk or the surrounding areas will be picky in any way, shape, or form," said Kathie Mahoney, mayor of the town of about 9,800 people. She said residents would prefer to have a full-service hospital with inpatient beds, even though those types of beds had been used sparingly in recent years.
The revival of the Keokuk hospital would mark a small victory in the nationwide struggle to save rural hospitals, which continue to close due to staffing shortages, low reimbursement rates, and declining patient numbers. The new federal program, which went into effect in January 2023, is meant to stem the closures. But there have been growing pains, said George Pink, deputy director of the North Carolina Rural Health Research Program, which tracks hospital closures and conversions.
Just 18 of the more than 1,700 eligible rural hospitals nationwide have applied for and won the new designation. Many hospitals are reluctant to give up inpatient services entirely, and some are concerned about how other payment streams could be affected, rural health leaders say. The new designation's unclear definition of "rural" has also caused confusion.
"We are still in an era of rural hospital closures," Pink said. Nine hospitals closed in 2023, and that number could rise in 2024, he said. An influx of federal relief funds during the pandemic kept struggling hospitals afloat, but now that money is largely gone.
The Rural Emergency Hospital program is the first new federal payment model for hospitals since 1997. Dora Hughes, acting chief medical officer of the Centers for Medicare & Medicaid Services, said the new model's criteria are outlined by statute and "hospitals should consider specific circumstances before making the decision to apply."
The federal agency is providing outreach to rural communities and welcomes feedback, Hughes wrote in an email to KFF Health News.
Now, rural health leaders and federal lawmakers are working quickly to tweak the new program to attract more applicants, said Carrie Cochran-McClain, chief policy officer of the National Rural Health Association.
Currently, facilities that convert to rural emergency hospitals receive a 5% increase in Medicare payments, plus an average annual payment of about $3.2 million, in exchange for giving up their expensive inpatient beds and focusing solely on emergency and outpatient care. Rural hospitals with no more than 50 beds, like Keokuk's, that closed after the law was signed on Dec. 27, 2020, are eligible to apply for the program and reopen with emergency and outpatient services.
More than 100 rural hospitals nationwide have inquired about converting, said Janice Walters, interim executive director for the Rural Health Redesign Center, which has a federal grant to provide technical assistance to hospitals that want to apply.
But only about a quarter of those inquiries are likely to become a rural emergency hospital, and persuading more troubled hospitals to make the leap would require regulators to make changes, Walters said.
Her advice? "Give them 10 beds to just take care of their community."
In a journal article published last year, general surgeon Sara Schaefer worried about the unintended consequences of getting rid of rural inpatient beds. Schaefer, who spent six months of medical school at a small rural Idaho hospital, said she saw firsthand how difficult it was for the hospital to transfer patients to bigger facilities, which were often too full to take them.
"There has to be a better way," said Schaefer, who is also a research fellow at the Center for Healthcare Outcomes & Policy at the University of Michigan.
The rural health association's Cochran-McClain said lawmakers are considering changes that could allow the hospitals to:
Keep overnight beds for patients who need moderate levels of care, such as those with pneumonia or in need of physical therapy after surgery.
Allow participation in a federal drug discount program called 340B, which provides hospitals with extra revenue.
Keep inpatient psychiatric or rehabilitation units open.
Clarify eligibility, including which facilities qualify under the definition of "rural" and whether the hospitals that closed before the 2020 date in the law can apply.
Updates to the law could affect communities nationwide. In Fort Scott, Kansas, where the hospital closed in late 2018, Mayor Matthew Wells said the community wants the eligibility date pushed back. U.S. Sen. Jerry Moran (R-Kan.) introduced a bill in December that, if passed, would push eligibility back to 2015.
"This is a matter of life and death to my community," Wells said. "I see a clear path, but the federal regulations in particular make that path nearly impossible."
In Holly Springs, Mississippi, hospital chief executive Kenneth Williams said he doesn't understand the federal definition of "rural." His hospital, Alliance Healthcare Hospital, was one of the first to win the new Rural Emergency Hospital designation in early 2023. He laid off staff and shut down his inpatient beds. Then, CMS officials called to tell him they had made a mistake.
"And I said, 'Wait a minute,'" Williams said. The hospital, which is about an hour south of Memphis, Tennessee, doesn't meet the current criteria of rural, they told him. Williams, an internal medicine doctor, bought the hospital in 1999 and has been trying to keep it running since.
Federal regulators are now asking Williams to convert the facility into another type of Medicare payment model, such as the sole community hospital with inpatient beds that it was before. Williams said that would be difficult: "What kind of transition can I make, especially with reduced services?"
In Keokuk, the hospital fits the current requirements. Insight Health Group, the Michigan company that bought the shuttered facility last March, plans to apply for the new federal designation as soon as it obtains state permits under new Iowa regulations tailored to rural emergency hospitals. It would be the first such hospital in the state.
Like many other rural hospitals struggling to survive, Keokuk's shuttered several key departments years ago, including its birthing and inpatient psychiatric units. In 2021, the last full year it was open, the hospital averaged fewer than three inpatients per night, according to data posted by the Iowa Hospital Association.
More than half of the three-story building would remain mothballed if the facility reopened under the new designation, but the emergency department could serve patients again as soon as late summer, said Atif Bawahab, Insight"s chief strategy officer.
Bruce Mackie has worked 32 years at the hospital, including 10 years as director of plant operations. The new owners kept him on to watch over the building. Beds, high-tech scanners, and lab equipment remain, but most of the clocks have stopped. "It's spooky," he said.
Even if the services are more limited than before, Mackie said, "everybody wants the hospital to reopen. This city needs an ER."
Former HHS Secretary Alex Azar is chairman of LifeScience Logistics, a company Florida is paying $39 million to manage its Canadian drug importation program.
This article was published on Monday, January 15, 2024 in KFF Health News.
The Food and Drug Administration's unprecedented approval of Florida's plan to import drugs from Canada was made possible only after Alex Azar, as the Trump administration's Health and Human Services secretary, certified that bringing medicines over the border could be done safely.
Azar made the historic declaration in September 2020, just two months before his boss, former President Donald Trump, lost reelection.
Now, Azar's involved in the business of making importation happen. He is chairman of the board of LifeScience Logistics, a Dallas-based company that Florida is paying as much as $39 million to help manage its Canadian drug importation program, not including the cost of drugs.
LifeScience officials confirmed Azar's position but didn't respond to questions about how much he is paid or whether he's involved in the Florida work. Azar didn't return messages left with his employers or sent to a personal email address.
The revolving door between government and private sector jobs is well documented. It's common for top U.S. officials in both parties to leave government service for what are often far better-paid jobs or board seats at companies in the industries they formerly regulated.
About 57% of presidential Cabinet-level officials later served on corporate boards of directors, according to a 2019 study by researchers at Boston and Harvard universities in The Journal of Politics, which examined 84 Cabinet members who served from 1992 to 2014.
"In general, we favor Cabinet secretaries not going into industries which they once regulated, because the possibility of conflicts of interest are unavoidable," said Robert Weissman, president of Public Citizen, a government watchdog group.
He called Azar's case atypical because his approval of drug importation was opposed by the pharmaceutical industry, in which Azar was formerly employed. Drugmakers argue the policy puts patients at risk of consuming counterfeit medicines. Azar joined the LifeScience board in January 2022, one year after the end of Trump's term and about a year after Florida contracted with LifeScience in late 2020.
Katie Hernandez, a spokesperson for LifeScience Logistics, said in a statement that the company, which manages nearly 6 million square feet of warehouse storage across 11 states, signed its deal with Florida before Azar joined the board.
Ivana Katic, assistant professor of organizational behavior at the Yale School of Management, said that Azar's position at LifeScience "can appear as a conflict of interest" because his policy decision as HHS secretary later benefited him professionally.
Azar was a deputy secretary at HHS during the George W. Bush administration before joining pharmaceutical giant Eli Lilly and Co. as a top executive in 2007, remaining there until months before joining the Trump administration.
Weissman, who supports drug importation, said he doubts Azar had any personal benefit in mind before his decision. Florida Gov. Ron DeSantis had pushed Trump to authorize importation from Canada, and the former president had said he supported importation before Azar certified it was safe.
Canadian drug importation has been the subject of decades of debate. While the U.S. does not regulate most drug costs, Canada does, generally resulting in lower prices than across the border.
In 2018, Azar called importation a "gimmick" because Canada's pharmaceutical market isn't large enough to meet U.S. demand. Indeed, the Canadian government has repeatedly warned the U.S. against importation, promising to block any plan that poses a risk of causing shortages in Canada.
The country has implemented regulations "to prohibit certain drugs intended for the Canadian market from being sold for consumption outside of Canada if that sale could cause, or worsen, a drug shortage in Canada," Health Canada, which regulates drug safety, said in a Jan. 8 statement after the FDA's approval of Florida's plan. "This includes all drugs that are eligible for bulk importation to the U.S., including those identified in Florida's bulk importation plan, or any other US state's future importation programs."
Under its contract with Florida, LifeScience Logistics must buy drugs from Canadian suppliers, contract with a lab to verify their authenticity, store the medicines, and ship them to state agencies for distribution. LifeScience built a 100,000-square-foot facility in Lakeland, Florida, to warehouse drugs imported from Canada.
President Joe Biden supported drug importation during his 2020 campaign, but after the election his administration moved slowly to advance the process. Colorado has an importation application pending with the FDA, while several other states have passed laws allowing for importation. DeSantis has accused the Biden administration of slow-walking a decision, and his administration filed a lawsuit over the FDA's delay.
Florida's importation plan will save the state up to $180 million in the first year of the program, the state said. The importation program wouldn't aid consumers directly. It's instead aimed at helping state agencies, including its prisons, health department, and Medicaid program, obtain lower-cost drugs for HIV and AIDS, diabetes, and other conditions.
Florida's plan still faces many hurdles. On top of Canada's reluctance to participate in U.S. importation programs, some drug manufacturers have deals with Canadian wholesalers preventing them from exporting medicines, and the FDA decision is likely to face a legal challenge by drugmakers.
The drug industry's major lobbying group, the Pharmaceutical Research and Manufacturers of America, or PhRMA, previously sued to stop Azar's importation decision. It's expected to file suit to block Florida's program as well.
A PhRMA spokesperson declined to comment on Azar's role.
Kevin Stansbury, the CEO of Lincoln Community Hospital in the 800-person town of Hugo, Colorado, is facing a classic Catch-22: He could boost his rural hospital's revenues by offering hip replacements and shoulder surgeries, but the 64-year-old hospital needs more money to be able to expand its operating room to do those procedures.
"I've got a surgeon that's willing to do it. My facility isn't big enough," Stansbury said. "And urgent services like obstetrics I can't do in my hospital, because my facility won't meet code."
Besides securing additional revenue for the hospital, such an expansion could keep locals from having to drive the 100 miles to Denver for orthopedic surgeries or to deliver babies.
Rural hospitals throughout the nation are facing a similar conundrum. An increase in costs amid lower payments from insurance plans makes it harder for small hospitals to fund large capital improvement projects. And high inflation and rising interest rates coming out of the pandemic are making it tougher for aging facilities to qualify for loans or other types of financing to upgrade their facilities to meet the ever-changing standards of medical care.
"Most of us are operating at very low margins, if any margin at all," Stansbury said. "So, we're struggling to find the money."
Aging hospital infrastructure, particularly in rural areas, is a growing concern. Data on the age of hospitals is hard to come by, because hospitals expand, upgrade, and refurbish different parts of their facilities over time. A 2017 analysis by the American Society for Health Care Engineering, a part of the American Hospital Association, found that the average age of hospitals in the U.S. increased from 8.6 years in 1994 to 11.5 years in 2015. That number has likely grown, industry insiders say, as many hospitals delayed capital improvement projects, particularly during the pandemic.
Research published in 2021 by the capital planning firm Facility Health Inc., now called Brightly, found that U.S. health care facilities had deferred about 41% of their maintenance and would need $243 billion to complete the backlog.
Rural hospitals don't have the resources of larger hospitals, particularly those in hospital chains, to fund billion-dollar expansions.
Most of today's rural hospitals were opened with funding from the Hill-Burton Act, passed by Congress in 1946. That program was rolled into the Public Health Service Act in the 1970s and, by 1997, had funded the construction of nearly 7,000 hospitals and clinics. Now, many of those buildings, particularly those in rural areas, are in dire need of improvements.
Stansbury, who is also board chair of the Colorado Hospital Association, said at least a half-dozen rural hospitals in the state need significant capital investment.
Harold Miller, president and CEO of the Center for Healthcare Quality and Payment Reform, a think tank in Pittsburgh, said the major problem for small rural hospitals is that private insurance is no longer covering the full cost of providing care. Medicare Advantage, a program under which Medicare pays private plans to provide coverage for seniors and people with disabilities, is a major contributor to the problem, he said.
"You're basically taking patients away from what may be the best payer that the small hospital has, and pushing those patients onto a private insurance plan, which doesn't pay the same way that traditional Medicare pays and ends up also using a variety of techniques to deny claims," Miller said.
Rural hospitals also must staff their emergency rooms with physicians round-the-clock, but the hospitals get paid only if someone comes in.
Meanwhile, labor costs coming out of the pandemic have increased, and inflation has driven up the cost of supplies. Those financial headwinds will likely push more rural hospitals out of business. Hospital closures dropped during the pandemic, from a record 18 closures in 2020 to a combined eight closures in 2021 and 2022, according to the Cecil G. Sheps Center for Health Services Research at the University of North Carolina-Chapel Hill, as emergency relief funds kept them open. But that life support has ended, and at least nine more closed in 2023. Miller said closures are reverting to pre-pandemic rates.
That raises concerns that some hospitals might invest in new facilities and end up shutting down anyway. Miller said only a small portion of rural hospitals might be able to make a meaningful difference to their bottom lines by adding new services.
Lawmakers have tried to help. California, for example, has loan programs charging low to no interest that rural hospitals can participate in, and hospital representatives are urging Colorado legislators to approve similar support.
At the federal level, Rep. Yadira Caraveo, a Colorado Democrat, has introduced the bipartisan Rural Health Care Facilities Revitalization Act, which would help rural hospitals get more funding for capital projects through the U.S. Department of Agriculture. The USDA has been one of the largest funders of rural development through its Community Facilities Programs, providing over $3 billion in loans a year. In 2019, half of the more than $10 billion in outstanding loans through the program helped health care facilities.
"Otherwise, facilities would have to go to private lenders," said Carrie Cochran-McClain, chief policy officer for the National Rural Health Association.
Rural hospitals might not be very attractive to private lenders because of their financial constraints, and thus may have to pay higher interest rates or meet additional requirements to get those loans, she said.
Caraveo's bill would also allow hospitals that already have loans to refinance at lower interest rates, and would cover more categories of medical equipment, such as devices and technology used for telehealth.
"We need to keep these places open, even not just for emergencies, but to deliver babies, to have your cardiology appointment," said Caraveo, who is also a pediatrician. "You shouldn't have to drive two, three hours to get it."
"They're trying to do this while they're doing their regular jobs running a hospital," Juliar said. "A lot of times when there are funding opportunities, for example, the timing may be just too tight for them to put together a project."
Some funding is contingent on the hospital raising matching funds, which may be difficult in distressed rural communities. And most projects require hospitals to cobble together funding from multiple sources, adding complexity. And since these projects often take a long time to put together, rural hospital CEOs or board members sometimes leave before they come to fruition.
"You get going at something and then key people disappear, and then you feel like you're starting all over again," she said.
Expansion of Lincoln Community Hospital could keep locals from having to drive the 100 miles to Denver for orthopedic surgeries or to deliver babies.(Lincoln Health)
The hospital in Hugo opened in 1959 after soldiers coming back from World War II decided that Lincoln County on the eastern Colorado plains needed a hospital. They donated money, materials, land, and labor to build it. The hospital has added four family practice clinics, an attached skilled nursing facility, and an off-site assisted living center. It brings in specialists from Denver and Colorado Springs.
Stansbury would like to build a new hospital roughly double the size of the current 45,000-square-foot facility. With inflation easing and interest rates likely to go down this year, Stansbury hopes to get financing lined up in 2024 and to break ground in 2025.
"The problem is, every day I wake up, it gets more expensive," Stansbury said.
When hospital officials first contemplated building a new hospital three years ago, they estimated a total project cost of about $65 million. But inflation skyrocketed and now interest rates have gone up, pushing the total cost to $75 million.
"If we have to wait another couple of years, we may be pushing up closer to $80 million," Stansbury said. "But we've got to do it. I can't wait five years and think the costs of construction are going to go down."
SACRAMENTO, Calif. — Gov. Gavin Newsom is revisiting California's phase-in of a nation-leading $25 minimum wage for health workers in the face of a projected $38 billion deficit, less than three months after he approved the measure. But renegotiating wages could threaten a delicate compromise between unions and the health industry.
Newsom, whose administration initially opposed the wage deal as too costly, signed the bill, SB 525, into law without knowing the final price tag. His Democratic administration now projects the first-year cost to be $4 billion, though that number has been questioned by labor leaders.
Citing data from the U.S. Bureau of Labor Statistics, finance officials said the law would boost wages for at least 500,000 workers who directly provide health care, not including related employees like janitors, groundskeepers, and security staff who also are covered under the law. According to the Department of Finance, it would also increase wages for state employees and boost the cost of health services by increasing Medi-Cal managed care payments. About half that cost is expected to be paid by California taxpayers and the rest covered by federal payments to Medi-Cal providers.
The governor's latest budget asks the state legislature to add an annual trigger making the minimum wage increases contingent on state revenues and to clarify which state employees are included, citing "the significant fiscal impact" of the law. Newsom acknowledged that negotiations are ongoing, a month after his office said talks would begin.
"We continue to work to land that," he said, adding he hoped for legislation in a matter of weeks.
The governor insisted he had reservations all along and pledged to work with fellow Democrats, who control the legislature, to make the law more affordable. But the bill he signed did not include built-in triggers, such as those used by his predecessor, Democratic Gov. Jerry Brown, that could have delayed the increase in the face of a budgetary downturn. Newsom did, however, reject a number of spending bills last year.
"We had a commitment on the trigger," even though it wasn't in the bill, Newsom said in response to reporters' questioning on Jan. 10. "We're confident all parties that committed to that agreement are going to meet it and do so very shortly."
David Huerta, president of Service Employees International Union California and SEIU United Service Workers West, said in a statement Jan. 10 that the union looks forward to working with the administration and the legislature "to ensure that these critically needed workforce investments are implemented while maximizing federal funds and holding the healthcare industry accountable for investing their resources in their workers and in patient care."
Yet last month, SEIU-United Healthcare Workers West President Dave Regan asserted the state must "hold fast to its commitment." SEIU-UHW is a local affiliate of SEIU California.
Assembly Speaker Robert Rivas, who helped negotiate the earlier deal, wouldn't comment on reopening the negotiations, and State Sen. María Elena Durazo, the Los Angeles Democrat who introduced the bill, also declined comment.
The law currently phases in the wage boosts, with large health facilities and dialysis clinics reaching the $25 hourly minimum in 2026; community clinics in 2027; and other health facilities in 2028. The $25 minimum would not take effect until 2033 for hospitals with a high percentage of patients covered by Medicare or Medicaid, rural independent hospitals, and small county facilities.
The phase-ins are set to start in June, giving state officials time to roll them back before the new fiscal year.
"I just don't understand how the governor signed the bill to begin with. I don't know why anyone thought it was going to be relatively cheap for the government," said Michael Genest, now a private consultant after serving as former Republican Gov. Arnold Schwarzenegger's finance director. "Does he think the unions care so much about him that they will go back to the table on something they've already won? That would be incredibly naive."
Proponents of the law say it covers about 3,000 employees in the state departments of Corrections and Rehabilitation, Veterans Affairs, and Developmental Services because they operate facilities licensed as hospitals, clinics, or nursing homes.
But undoing one portion of the law threatens to unravel the entire intricate compromise between labor and the health industry.
For instance, as part of the deal United Healthcare Workers West agreed in a separate memorandum of understanding to halt for four years its repeated attempts to impose regulations on dialysis clinics.
The union also previously advocated for health worker minimum wage increases in several California cities. The compromise banned such local boosts for 10 years, a big relief to the California Hospital Association.
Regan, of SEIU-UHW, said the administration's cost estimate "has been severely overstated."
Nearly half of health workers who would see wage increases, or a family member, currently rely on safety-net programs such as Medi-Cal, CalFresh, and CalWORKs, said Laurel Lucia, director of the Health Care Program at the University of California-Berkeley Labor Center. So increasing their income would reduce their reliance on those tax-funded programs.
"We're estimating that the health care minimum wage impact on the state budget could be up to $300 million in the first year, but it's possible that it could be substantially less than that" depending on how and when the state adjusts Medi-Cal payments to hospitals and clinics, Lucia said.
Genest put the cost to the state's general fund at about $1.2 billion in an August calculation for the health industry when it opposed the bill before the last-minute compromise.
Finance Department spokesperson H.D. Palmer acknowledged the administration's calculation did not include offsets such as a reduction in the number of lower-income workers relying on Medi-Cal.
Lucia estimated the $25 minimum wage law would raise wages for about 450,000 health workers, both those providing direct care and those in related occupations — at least 50,000 fewer than the administration's estimate.
As I checked in at a Manhattan radiology clinic for my annual mammogram in November, the front desk staffer reviewing my paperwork asked an unexpected question: Would I like to spend $40 for an artificial intelligence analysis of my mammogram? It's not covered by insurance, she added.
I had no idea how to evaluate that offer. Feeling upsold, I said no. But it got me thinking: Is this something I should add to my regular screening routine? Is my regular mammogram not accurate enough? If this AI analysis is so great, why doesn't insurance cover it?
I'm not the only person posing such questions. The mother of a colleague had a similar experience when she went for a mammogram recently at a suburban Baltimore clinic. She was given a pink pamphlet that said: "You Deserve More. More Accuracy. More Confidence. More power with artificial intelligence behind your mammogram." The price tag was the same: $40. She also declined.
In recent years, AI software that helps radiologists detect problems or diagnose cancer using mammography has been moving into clinical use. The software can store and evaluate large datasets of images and identify patterns and abnormalities that human radiologists might miss. It typically highlights potential problem areas in an image and assesses any likely malignancies. This extra review has enormous potential to improve the detection of suspicious breast masses and lead to earlier diagnoses of breast cancer.
While studies showing better detection rates are extremely encouraging, some radiologists say, more research and evaluation are needed before drawing conclusions about the value of the routine use of these tools in regular clinical practice.
"I see the promise and I hope it will help us," said Etta Pisano, a radiologist who is chief research officer at the American College of Radiology, a professional group for radiologists. However, "it really is ambiguous at this point whether it will benefit an individual woman," she said. "We do need more information."
The radiology clinics that my colleague's mother and I visited are both part of RadNet, a company with a network of more than 350 imaging centers around the country. RadNet introduced its AI product for mammography in New York and New Jersey last February and has since rolled it out in several other states, according to Gregory Sorensen, the company's chief science officer.
Sorensen pointed to research the company conducted with 18 radiologists, some of whom were specialists in breast mammography and some of whom were generalists who spent less than 75% of their time reading mammograms. The doctors were asked to find the cancers in 240 images, with and without AI. Every doctor's performance improved using AI, Sorensen said.
Among all radiologists, "not every doctor is equally good," Sorensen said. With RadNet's AI tool, "it's as if all patients get the benefit of our very top performer."
But is the tech analysis worth the extra cost to patients? There's no easy answer.
"Some people are always going to be more anxious about their mammograms, and using AI may give them more reassurance," said Laura Heacock, a breast imaging specialist at NYU Langone Health's Perlmutter Cancer Center in New York. The health system has developed AI models and is testing the technology with mammograms but doesn't yet offer it to patients, she said.
Still, Heacock said, women shouldn't worry that they need to get an additional AI analysis if it's offered.
"At the end of the day, you still have an expert breast imager interpreting your mammogram, and that is the standard of care," she said.
About 1 in 8 women will be diagnosed with breast cancer during their lifetime, and regular screening mammograms are recommended to help identify cancerous tumors early. But mammograms are hardly foolproof: They miss about 20% of breast cancers, according to the National Cancer Institute.
The FDA has authorized roughly two dozen AI products to help detect and diagnose cancer from mammograms. However, there are currently no billing codes radiologists can use to charge health plans for the use of AI to interpret mammograms. Typically, the federal Centers for Medicare & Medicaid Services would introduce new billing codes and private health plans would follow their lead for payment. But that hasn't happened in this field yet and it's unclear when or if it will.
CMS didn't respond to requests for comment.
Thirty-five percent of women who visit a RadNet facility for mammograms pay for the additional AI review, Sorensen said.
Radiology practices don't handle payment for AI mammography all in the same way.
The practices affiliated with Boston-based Massachusetts General Hospital don't charge patients for the AI analysis, said Constance Lehman, a professor of radiology at Harvard Medical School who is co-director of the Breast Imaging Research Center at Mass General.
Asking patients to pay "isn't a model that will support equity," Lehman said, since only patients who can afford the extra charge will get the enhanced analysis. She said she believes many radiologists would never agree to post a sign listing a charge for AI analysis because it would be off-putting to low-income patients.
Sorensen said RadNet's goal is to stop charging patients once health plans realize the value of the screening and start paying for it.
Some large trials are underway in the United States, though much of the published research on AI and mammography to date has been done in Europe. There, the standard practice is for two radiologists to read a mammogram, whereas in the States only one radiologist typically evaluates a screening test.
Interim results from the highly regarded MASAI randomized controlled trial of 80,000 women in Sweden found that cancer detection rates were 20% higher in women whose mammograms were read by a radiologist using AI compared with women whose mammograms were read by two radiologists without any AI intervention, which is the standard of care there.
"The MASAI trial was great, but will that generalize to the U.S.? We can't say," Lehman said.
In addition, there is a need for "more diverse training and testing sets for AI algorithm development and refinement" across different races and ethnicities, said Christoph Lee, director of the Northwest Screening and Cancer Outcomes Research Enterprise at the University of Washington School of Medicine.
The long shadow of an earlier and largely unsuccessful type of computer-assisted mammography hangs over the adoption of newer AI tools. In the late 1980s and early 1990s, "computer-assisted detection" software promised to improve breast cancer detection. Then the studies started coming in, and the results were often far from encouraging. Using CAD at best provided no benefit, and at worst reduced the accuracy of radiologists' interpretations, resulting in higher rates of recalls and biopsies.
"CAD was not that sophisticated," said Robert Smith, senior vice president of early cancer detection science at the American Cancer Society. Artificial intelligence tools today are a whole different ballgame, he said. "You can train the algorithm to pick up things, or it learns on its own."
Smith said he found it "troubling" that radiologists would charge for the AI analysis.
"There are too many women who can't afford any out-of-pocket cost" for a mammogram, Smith said. "If we're not going to increase the number of radiologists we use for mammograms, then these new AI tools are going to be very useful, and I don't think we can defend charging women extra for them."
After Iowa lawmakers passed a ban on gender-affirming care for minors in March, managers of an LGBTQ+ health clinic located just across the state line in Moline, Illinois, decided to start offering that care.
The added services would provide care to patients who live in largely rural eastern Iowa, including some of the hundreds previously treated at a University of Iowa clinic, saving them half-day drives to clinics in larger cities like Chicago and Minneapolis.
By June, The Project of the Quad Cities, as the Illinois clinic is called, had hired a provider who specializes in transgender health care. So, Andy Rowe, The Project's health care operations director, called the clinic's insurance broker to see about getting the new provider added to the nonprofit's malpractice policy.
"I didn't anticipate that it was going to be a big deal," Rowe said. Then the insurance carriers' quotes came. The first one specifically excluded gender-affirming care for minors. The next response was the same. And the one after that. By early November, more than a dozen malpractice insurers had declined to offer the clinic a policy.
Rowe didn't know it at the time, but he wasn't alone in his frustrating quest.
Nearly half the states have banned medication or surgical treatment for transgender youth. Independent clinics and medical practices located in states where such care is either allowed or protected have moved to fill that void for patients commuting or relocating across state lines. But as the risk of litigation rises for clinics, obtaining malpractice insurance on the commercial marketplace has become a quiet barrier to offering care, even in states with legal protections for health care for trans people. In extreme cases, lawmakers have deployed malpractice insurance regulations against gender-affirming care in states where courts have slowed or blocked anti-trans legislation.
Five months after starting his search for malpractice insurance, Rowe said, he received a quote for a policy that would allow The Project to treat trans youth. That's when he realized finding a policy was only the first hurdle. He expected the coverage to cost $8,000 to $10,000 a year, but he was quoted $50,000.
Rowe said he hadn't experienced anything like it in his 20 years working in health care administration.
Insurance industry advocates argue that higher premiums are justified because the rise in legislation surrounding gender-affirming care for minors means clinics are at increased risk of being sued.
"If state laws increase the risk of civil liability for health professionals, premiums will be adjusted accordingly and appropriately to reflect the level of financial risk incurred by the insured," Mike Stinson, vice president of public policy and legal affairs at the Medical Professional Liability Association, an insurance trade association, said in an emailed statement. If state laws make an activity illegal, then insurance will not cover it at all, he said.
Only a few states have passed laws preventing malpractice insurers from treating gender-affirming care differently than other care. Massachusetts was the first, when lawmakers there passed legislation that says insurers could not increase rates for health care providers for offering services that are illegal in other states.
Since then, five other states have passed laws requiring malpractice insurers to treat gender-affirming health care as they do any other legally protected health activity: Colorado, Vermont, New York, Oregon, and California (similar legislation is pending in Hawaii).
"This was a preventative measure, and it was met with full acceptance by both the insured and the insurers," said Vermont state Sen. Virginia "Ginny" Lyons, a Democrat who co-sponsored the state's law. She said lawmakers consulted with both physicians and malpractice insurance companies to make sure the language was accurate. Insurers just wanted to be able to clearly assess the risk, she said.
Lyons said she hadn't heard of any providers in Vermont who had trouble with their malpractice insurance before the law was enacted, but she was concerned politics might get in the way of doctors' ability to offer care. In March 2022, The Texas Tribune reported that one Texas doctor had stopped offering care because his malpractice provider had stopped covering hormone therapy for minors.
Lawmakers in some states have gone further and revised malpractice provisions to restrict access to gender-affirming care, often while bans on offering that care to trans youth are stalled in court. In 2021, Arkansas became the first state to ban gender-affirming care for trans children. When that ban was held up in court last year, the governor signed a new law allowing anyone who received gender-affirming care as a minor to file a malpractice lawsuit up to 15 years after they turn 18.
Similar laws followed in Tennessee, Florida, and Missouri, all extending the statute of limitations on filing a malpractice claim anywhere from 15 to 30 years. (Another was introduced but not passed in Texas that would have stretched the statute of limitations to the length of the patient's life.) Typically, malpractice suits must be filed within one to three years of injury.
The civil liability that those laws created has forced at least one clinic to stop offering some treatments. The Washington University Transgender Center in Missouri said the law subjected the clinic to "unacceptable level of liability."
Alejandra Caraballo, a civil rights attorney and clinical instructor at the Harvard Law School Cyberlaw Clinic, said there has been "a concerted effort on the part of anti-trans activists to utilize malpractice insurance as a means of eliminating care."
She likens the strategy to laws that have long targeted abortion providers by increasing "legal liability to chill a certain type of conduct."
Anti-trans activists have drawn attention to a small number of "detransitioners," who have filed lawsuits against the doctors who provided them with gender-affirming care, she said. She believes those lawsuits, filed in such states as California, Nebraska, and North Carolina, will be used to lobby for longer statutes of limitations and to create the perception that liability for providers is increasing.
For independent clinics, like The Project in the Quad Cities, and small medical practices that purchase their malpractice insurance on the commercial marketplace, those tactics are restricting their ability to offer care. Many providers of gender-affirming care are protected from rising premiums such as health centers that receive federal funding, which are covered under the Federal Tort Claims Act, or academic medical centers and Planned Parenthood clinics, which are self-insured. But a small number of independent clinics have been priced out.
In Albuquerque, New Mexico, a state that, like Illinois, has protected access to gender-affirming care, family medicine physician Anjali Taneja said the clinic where she works is running into the same trouble getting coverage.
Casa de Salud, where Taneja is the executive director, has provided gender-affirming care to adults for years, but when the clinic decided to start offering that care to younger patients, insurers wouldn't issue a malpractice policy. The clinic was quoted "double what we paid a few years ago," just to cover the gender-affirming care it offers to adults, Taneja said.
The red tape both Casa de Salud and The Project are encountering has prevented treatment for patients. When Iowa's ban on gender-affirming care took effect Sept. 1, officials at The Project had hoped to offer services to the transgender youth who previously sought care an hour west at the University of Iowa's LGBTQ Clinic. Instead, Rowe said, patients are making the difficult decision between going without treatment or commuting four hours to Chicago or Minneapolis.
After months of fundraising, The Project has almost enough money to pay for the $50,000 malpractice policy. But, Rowe said, "it's a tough swallow."
In 2016, Richard Timmins went to a free informational seminar to learn more about Medicare coverage.
"I listened to the insurance agent and, basically, he really promoted Medicare Advantage," Timmins said. The agent described less expensive and broader coverage offered by the plans, which are funded largely by the government but administered by private insurance companies.
For Timmins, who is now 76, it made economic sense then to sign up. And his decision was great, for a while.
Then, three years ago, he noticed a lesion on his right earlobe.
"I have a family history of melanoma. And so, I was kind of tuned in to that and thinking about that," Timmins said of the growth, which doctors later diagnosed as malignant melanoma. "It started to grow and started to become rather painful."
Timmins, though, discovered that his enrollment in a Premera Blue Cross Medicare Advantage plan would mean a limited network of doctors and the potential need for preapproval, or prior authorization, from the insurer before getting care. The experience, he said, made getting care more difficult, and now he wants to switch back to traditional, government-administered Medicare.
But he can't. And he's not alone.
"I have very little control over my actual medical care," he said, adding that he now advises friends not to sign up for the private plans. "I think that people are not understanding what Medicare Advantage is all about."
Enrollment in Medicare Advantage plans has grown substantially in the past few decades, enticing more than half of all eligible people, primarily those 65 or older, with low premium costs and perks like dental and vision insurance. And as the private plans' share of the Medicare patient pie has ballooned to 30.8 million people, so too have concerns about the insurers' aggressive sales tactics and misleading coverage claims.
Enrollees, like Timmins, who sign on when they are healthy can find themselves trapped as they grow older and sicker.
"It's one of those things that people might like them on the front end because of their low to zero premiums and if they are getting a couple of these extra benefits — the vision, dental, that kind of thing," said Christine Huberty, a lead benefit specialist supervising attorney for the Greater Wisconsin Agency on Aging Resources.
"But it's when they actually need to use it for these bigger issues," Huberty said, "that's when people realize, ‘Oh no, this isn't going to help me at all.'"
Medicare pays private insurers a fixed amount per Medicare Advantage enrollee and in many cases also pays out bonuses, which the insurers can use to provide supplemental benefits. Huberty said those extra benefits work as an incentive to "get people to join the plan" but that the plans then "restrict the access to so many services and coverage for the bigger stuff."
David Meyers, assistant professor of health services, policy, and practice at the Brown University School of Public Health, analyzed a decade of Medicare Advantage enrollment and found that about 50% of beneficiaries — rural and urban — left their contract by the end of five years. Most of those enrollees switched to another Medicare Advantage plan rather than traditional Medicare.
In the study, Meyers and his co-authors muse that switching plans could be a positive sign of a free marketplace but that it could also signal "unmeasured discontent" with Medicare Advantage.
"The problem is that once you get into Medicare Advantage, if you have a couple of chronic conditions and you want to leave Medicare Advantage, even if Medicare Advantage isn't meeting your needs, you might not have any ability to switch back to traditional Medicare," Meyers said.
Traditional Medicare can be too expensive for beneficiaries switching back from Medicare Advantage, he said. In traditional Medicare, enrollees pay a monthly premium and, after reaching a deductible, in most cases are expected to pay 20% of the cost of each nonhospital service or item they use. And there is no limit on how much an enrollee may have to pay as part of that 20% coinsurance if they end up using a lot of care, Meyers said.
To limit what they spend out-of-pocket, traditional Medicare enrollees typically sign up for supplemental insurance, such as employer coverage or a private Medigap policy. If they are low-income, Medicaid may provide that supplemental coverage.
But, Meyers said, there's a catch: While beneficiaries who enrolled first in traditional Medicare are guaranteed to qualify for a Medigap policy without pricing based on their medical history, Medigap insurers can deny coverage to beneficiaries transferring from Medicare Advantage plans or base their prices on medical underwriting.
Only four states — Connecticut, Maine, Massachusetts, and New York — prohibit insurers from denying a Medigap policy if the enrollee has preexisting conditions such as diabetes or heart disease.
Paul Ginsburg is a former commissioner on the Medicare Payment Advisory Commission, also known as MedPAC. It's a legislative branch agency that advises Congress on the Medicare program. He said the inability of enrollees to easily switch between Medicare Advantage and traditional Medicare during open enrollment periods is "a real concern in our system; it shouldn't be that way."
The federal government offers specific enrollment periods every year for switching plans. During Medicare's open enrollment period, from Oct. 15 to Dec. 7, enrollees can switch out of their private plans to traditional, government-administered Medicare.
Medicare Advantage enrollees can also switch plans or transfer to traditional Medicare during another open enrollment period, from Jan. 1 to March 31.
"There are a lot of people that say, 'Hey, I'd love to come back, but I can't get Medigap anymore, or I'll have to just pay a lot more,'" said Ginsburg, who is now a professor of health policy at the University of Southern California.
Timmins is one of those people. The retired veterinarian lives in a rural community on Whidbey Island just north of Seattle. It's a rugged, idyllic landscape and a popular place for second homes, hiking, and the arts. But it's also a bit remote.
While it's typically harder to find doctors in rural areas, Timmins said he believes his Premera Blue Cross plan made it more challenging to get care for a variety of reasons, including the difficulty of finding and getting in to see specialists.
Nearly half of Medicare Advantage plan directories contained inaccurate information on what providers were available, according to the most recent federal review. Beginning in 2024, new or expanding Medicare Advantage plans must demonstrate compliance with federal network expectations or their applications could be denied.
Amanda Lansford, a Premera Blue Cross spokesperson, declined to comment on Timmins' case. She said the plan meets federal network adequacy requirements as well as travel time and distance standards "to ensure members are not experiencing undue burdens when seeking care."
Traditional Medicare allows beneficiaries to go to nearly any doctor or hospital in the U.S., and in most cases enrollees do not need approval to get services.
Timmins, who recently finished immunotherapy, said he doesn't think he would be approved for a Medigap policy, "because of my health issue." And if he were to get into one, Timmins said, it would likely be too expensive.
For now, Timmins said, he is staying with his Medicare Advantage plan.
"I'm getting older. More stuff is going to happen."
There is also a chance, Timmins said, that his cancer could resurface: "I'm very aware of my mortality."
CAIRO, Ga. — Zita Magloire carefully adjusted a soft measuring tape across Kenadie Evans' pregnant belly.
Determining a baby's size during a 28-week obstetrical visit is routine. But Magloire, a family physician trained in obstetrics, knows that finding the mother's uterus and, thus, checking the baby, can be tricky for inexperienced doctors.
"Sometimes it's, like, off to the side," Magloire said, showing a visiting medical student how to press down firmly and complete the hands-on exam. She moved her finger slightly to calculate the fetus's height: "There she is, right here."
Evans smiled and later said Magloire made her "comfortable."
The 21-year-old had recently relocated from Louisiana to southeastern Georgia, two states where both maternal and infant mortality are persistently high. She moved in with her mother and grandfather near Cairo, an agricultural community where the hospital has a busy labor and delivery unit. Magloire and other doctors at the local clinic where she works deliver hundreds of babies there each year.
Scenes like the one between Evans and Magloire regularly play out in this rural corner of Georgia despite grim realities mothers and babies face nationwide. Maternal deaths keep rising, with Black and Indigenous mothers most at risk; the number of babies who died before their 1st birthday climbed last year; and more than half of all rural counties in the United States have no hospital services for delivering babies, increasing travel time for parents-to-be and causing declines in prenatal care.
There are many reasons labor and delivery units close, including high operating costs, declining populations, low Medicaid reimbursement rates, and staffing shortages. Family medicine physicians still provide the majority of labor and delivery care in rural America, but few new doctors recruited to less populated areas offer obstetrics care, partly because they don't want to be on call 24/7. Now, with rural America hemorrhaging health care providers, the federal government is investing dollars and attention to increase the ranks.
"Obviously the crisis is here," said Hana Hinkle, executive director of the Rural Training Track Collaborative, which works with more than 70 rural residency training programs. Federal grants have boosted training programs in recent years, Hinkle said.
In July, the Department of Health and Human Services announced a nearly $11 million investment in new rural programs, including family medicine residencies that focus on obstetrical training.
Nationwide, a declining number of primary care doctors — internal and family medicine — has made it difficult for patients to book appointments and, in some cases, find a doctor at all. In rural America, training family medicine doctors in obstetrics can be more daunting because of low government reimbursement and increasing medical liability costs, said Hinkle, who is also assistant dean of Rural Health Professions at the University of Illinois College of Medicine in Rockford.
In the 1980s, about 43% of general family physicians who completed their residencies were trained in obstetrics. In 2021, the American Academy of Family Physicians' annual practice profile survey found that 15% of respondents had practiced obstetrics.
Yet family doctors, who also provide the full spectrum of primary care services, are "the backbone of rural deliveries," said Julie Wood, a doctor and senior vice president of research, science, and health of the public at the AAFP.
In a survey of 216 rural hospitals in 10 states, family practice doctors delivered babies in 67% of the hospitals, and at 27% of the hospitals they were the only ones who delivered babies. The data counted babies delivered from 2013 to 2017. And, the authors found, if those family physicians hadn't been there, many patients would have driven an average of 86 miles round-trip for care.
Mark Deutchman, the report's lead author, said he was "on call for 12 years" when he worked in a town of 2,000 residents in rural Washington. Clarifying that he was exaggerating, Deutchman explained that he was one of just two local doctors who performed cesarean sections. He said the best way to ensure family physicians can bolster obstetric units is to make sure they work as part of a team to prevent burnout, rather than as solo do-it-all doctors of old.
There needs to be a core group of physicians, nurses, and a supportive hospital administration to share the workload "so that somebody isn't on call 365 days a year," said Deutchman, who is also associate dean for rural health at the University of Colorado Anschutz Medical Campus School of Medicine. The school's College of Nursing received a $2 million federal grant this fall to train midwives to work in rural areas of Colorado.
Nationwide, teams of providers are ensuring rural obstetric units stay busy. In Lakin, Kansas, Drew Miller works with five other family physicians and a physician assistant who has done an obstetrical fellowship. Together, they deliver about 340 babies a year, up from just over 100 annually when Miller first moved there in 2010. Word-of-mouth and two nearby obstetric unit closures have increased their deliveries. Miller said he has seen friends and partners "from surrounding communities stop delivering just from sheer burnout."
In Galesburg, Illinois, Annevay Conlee has watched four nearby obstetric units close since 2012, forcing some pregnant people to drive up to an hour and a half for care. Conlee is a practicing family medicine doctor and medical director overseeing four rural areas with a team of OB-GYNs, family physicians, and a nurse-midwife. "There's no longer the ability to be on 24/7 call for your women to deliver," Conlee said. "There needs to be a little more harmony when recruiting in to really support a team of physicians and midwives."
In Cairo, Magloire said practicing obstetrics is "just essential care." In fact, pregnancy care represents just a slice of her patient visits in this Georgia town of about 10,000 people. On a recent morning, Magloire's patients included two pregnant people as well as a teen concerned about hip pain and an ecstatic 47-year-old who celebrated losing weight.
Cairo Medical Care, an independent clinic situated across the street from the 60-bed Archbold Grady hospital, is in a community best known for its peanut crops and as the birthplace of baseball legend Jackie Robinson. The historical downtown has brick-accented streets and the oldest movie theater in Georgia, and a corner of the library is dedicated to local history.
The clinic's six doctors, who are a mix of family medicine practitioners, like Magloire, and obstetrician-gynecologists, pull in patients from the surrounding counties and together deliver nearly 300 babies at the hospital each year.
Deanna Buckins, a 36-year-old mother of four boys, said she was relieved when she found "Dr. Z" because she "completely changed our lives."
"She actually listens to me and accepts my decisions instead of pushing things upon me," said Buckins, as she held her 3-week-old son, whom Magloire had delivered. Years earlier, Magloire helped diagnose one of Buckins' older children with autism and built trust with the family.
"Say I go in with one kid; before we leave, we've talked about every single kid on how they're doing and, you know, getting caught up with life," Buckins said.
Magloire grew up in Tallahassee, Florida, and did her residency in rural Kansas. The smallness of Cairo, she said, allows her to see patients as they grow — chatting up the kids when the mothers or siblings come for appointments.
"She's very friendly," Evans said of Magloire. Evans, whose first child was delivered by an OB-GYN, said she was nervous about finding the right doctor. The kind of specialist her doctor was didn't matter as much as being with "someone who cares," she said.
As a primary care doctor, Magloire can care for Evans and her children for years to come.
Dan Weissmann goes toe-to-toe with Scott Purcell, CEO of ACA International, a trade association for the collection industry.
This podcast was launched on Thursday, December 28, 2023 by KFF Health News.
Some hospitals sue patients who can’t afford to pay their medical bills. Such lawsuits don’t tend to bring in much money for the hospital but can really harm patients already experiencing financial hardships.
In this episode of "An Arm and a Leg," Dan Weissmann goes toe-to-toe with Scott Purcell, CEO of ACA International, a trade association for the collection industry, on the effects these lawsuits have on patients.
With help from The Baltimore Banner and Scripps News, Weissmann pulls back the curtain on hospital bill lawsuits in three states — Maryland, Wisconsin, and New York — and discovers some good news for a change.
Dan Weissmann
@danweissmann
Host and producer of "An Arm and a Leg." Previously, Dan was a staff reporter for Marketplace and Chicago's WBEZ. His work also appears on All Things Considered, Marketplace, the BBC, 99 Percent Invisible, and Reveal, from the Center for Investigative Reporting.
Too old and too sick for a heart transplant, Arvid Herrman was given a choice: Have a mechanical pump implanted in his heart, potentially keeping him alive for several years, or do nothing and almost certainly die within a year.
The 68-year-old Wisconsin farmer chose the pump, called a HeartMate 3 — currently the only FDA-approved device of its kind in use. Instead of extending his life, though, the device led to his death, according to a lawsuit filed in December 2020 by his daughter Jamie Edwards.
The lawsuit alleged that Herrman died because a defect in the locking mechanism of the HeartMate 3 prevented the device from sealing, causing multiple strokes and leading to a severe brain injury and multiorgan failure. Herrman "could not have anticipated the danger this defect … created for him," the lawsuit said.
Herrman's death was reported to a Food and Drug Administration database where the public can learn about device-related deaths, serious injuries, and malfunctions. The event was also described in the peer-reviewed Journal of Heart and Lung Transplantation.
In September 2021, Ramon Flores Sr. had the same device implanted at Methodist Hospital of San Antonio. A lawsuit his family filed in August alleges that the locking mechanism defect led to air embolism strokes. Flores died eight days after surgery, at age 76.
"How many other people is this going to happen to?" said his daughter, Alanna Flores Blanco, 52. "We never, ever were explained that the device could malfunction and this could happen."
After the deaths of Herrman and Flores, Thoratec Corp., the device's manufacturer, evaluated the pumps involved. In bothcases, Thoratec, a subsidiary of Abbott Laboratories, confirmed a bent locking arm. But "a direct correlation" between the HeartMate 3 and the deaths "could not conclusively be established," the manufacturer reported to the FDA.
Abbott did not respond to questions about the deaths or the alleged defects. The manufacturer denied liability in both cases. It settled Herrman's lawsuit this fall, and the Flores case is ongoing.
The men's deaths are among more than 4,500 reports since August 2017 in which the HeartMate 3 may have caused or contributed to a patient's death, according to a KFF Health News analysis of the FDA's database of medical device incidents, known as the Manufacturer and User Facility Device Experience, or MAUDE. Hospitals, doctors, and others report device-related deaths, serious injuries, and malfunctions to manufacturers, who are required to investigate and report cases to the FDA.
In nearly 90% of those 4,500-plus reports, Thoratec said it found no problem with the device or how it was used, according to a KFF Health News review of the FDA database.
In cases where Abbott finds the HeartMate 3 did not cause or contribute to a death or serious injury, the company files "corrective reports," said Justin Paquette, an Abbott public affairs director.
He added, "The complexity of the device – combined with patients battling late stage heart failure and associated comorbidities – creates very dynamic clinical care situations."
Abbott said the HeartMate 3 is the safest iteration yet of any left ventricular assist device, or LVAD, a type of mechanical heart pump introduced in the 1960s and refined over the last six decades.
The HeartMate 3 was first approved by the FDA, for use in patients awaiting a heart transplant, in August 2017, and one year later it was approved as a long-term therapy. The device is often considered only for patients with end-stage heart failure, and even then it is a last resort.
HeartMate 3 has "dramatically improved the safety of LVADs by reducing rates of complications that had historically challenged heart pump technology, including clotting, stroke and bleeding," Paquette said.
As recently as August, the FDA also expressed support for the device. "The FDA believes the benefits of HeartMate 3 continue to outweigh the risks for this vulnerable patient population with few available alternatives," said Jeremy Kahn, an agency spokesperson.
Others aren't so sure. Former FDA medical device official Madris Kinard sees the high number of death reports as a warning.
"To me this is a safety signal and it's hard to know if the FDA is working on something to address it," said Kinard, founder of Device Events, a company that makes FDA device data more user-friendly for hospitals, law firms, investors, and others. "You have to wonder why [death reports are] still happening, and at the same rate."
Larry Kessler, a former director in the FDA's medical device office, agrees the death reports for HeartMate 3 need more study. "The FDA may be missing some signals," he said. Perhaps "there's a little more here than meets the eye."
Not all device problems are reported to MAUDE, and submitting a report is not necessarily an admission that a device caused a death or a serious injury. Device problem reports can be inaccurate or incomplete, or lack verification, and a single incident may be reported more than once — or not at all.
Those limitations ultimately can leave patients and their caregivers uninformed about risks associated with a device such as the HeartMate 3, said Sanket Dhruva, a cardiologist and expert in medical device safety and regulation at the University of California-San Francisco.
"They're making perhaps the biggest decision of their lives: Do I proceed with an LVAD or not? And even if I proceed, what are the risks I'm facing?" he said. "And they are left with incomplete data and uncertainty about how to make that determination."
Even doctors cannot use the FDA database as a tool to effectively counsel patients, Dhruva added.
"lf you don't know what is a real safety signal and what's not," he said, "then how can that information help us to calibrate our benefits-and-risks discussion with patients?"
Tracking Incident Reports
The HeartMate 3 is not the only device whose safety profile is hard to ascertain in MAUDE, Dhruva said. The information in the FDA database is insufficient to give patients an adequate understanding of any medical device's safety risks and reflects "the overall weakness of postmarket surveillance" after a device has been approved for sale, he said.
Under federal regulations, device manufacturers typically must report adverse events to the FDA within 30 days of learning about them, and that data is often used by researchers and regulators to identify potential safety concerns. Reports also can be submitted voluntarily by doctors, patients, or others. The FDA says that reports don't need to be filed if the manufacturer determines that a device did not cause or contribute to an adverse event.
But with millions of reports for thousands of devices, it can be difficult to detect and prevent problems that put patients at risk.
Hospitals and surgeons also might self-censor what they report to manufacturers due to concerns about being sued, said Kessler, now a professor at the University of Washington.
"Health care facilities, and risk managers in particular, they aren't always forthcoming with detailed data about events," he said.
Reports in MAUDE show that patients with a HeartMate 3 have experienced adverse events, such as bleeding, infection, and respiratory failure, that the manufacturer warned were possible in its instructions for use.
About 400 reports cited infusion or flow problems with the HeartMate 3. In thousands of other cases, the manufacturer said it did not observe any problems with the device, making it even more difficult for a doctor or a patient's family to understand the safety history of the product.
Reports in MAUDE also describe fatal incidents due to complications not mentioned in the manufacturer's instructions, such as the locking mechanism malfunction. In one report, a patient died of smoke inhalation after an external battery charger caught fire.
Each report in MAUDE has dozens of data points and summaries describing what happened. What's lacking in the database: context and details that would be useful for patients and doctors, such as the total number of devices in use and the name of the hospital where the event occurred.
Flores Blanco had never heard of MAUDE before her father's surgery. Even if she had, it's unlikely she would have found a locking mechanism issue amid the morass of records, much less anticipated what might happen.
Missed Signals?
A routine FDA inspection of Abbott's manufacturing plant in 2017 showed that Thoratec had fallen behind schedule reporting adverse events, according to agency records obtained by KFF Health News under a Freedom of Information Act request.
The company updated training and hired additional staff to handle complaints submitted by hospitals, doctors, patients, and others, according to an inspection report. It provided the FDA inspector with "quantitative evidence" that late reporting to the FDA had decreased.
By October 2020, during a follow-up inspection, Thoratec was using a database to enter and process complaints and submit device reports electronically, according to an inspection report.
FDA inspectors did not cite any deficiencies with how Thoratec handled complaints after the visit. Inspectors noted the company had received 8,115 complaints related to the HeartMate 3 during the 12 months prior to the inspection in October 2020, the records show.
It's not clear what the complaints concerned. Abbott did not respond when asked how many of the complaints led to an adverse event report to the FDA.
In Kinard's view, device-makers in general often take longer than 30 days to investigate the root cause of an incident and frequently conclude that an adverse event was due to user error.
"They are using this regularly to downplay the problems with the device," she said.
In Herrman's case, a Thoratec representative was in the operating room and witnessed the incident, according to a deposition in the lawsuit. The company submitted a report to the FDA about Herrman's injury within 30 days of the June 2019 incident.
Herrman's surgeon, John Stulak, was experienced at implanting the device, according to the lawsuit, and he was also a principal investigator on the clinical trial that brought the HeartMate 3 to market. Stulak did not respond to interview requests. But, in 2020, he and two Mayo Clinic colleagues described Herrman's case in The Journal of Heart and Lung Transplantation, where they noted the locking mechanism malfunction. "The lack of a tight seal from this defect resulted in the multiple subsequent air embolism events and irrecoverable neurological damage," they wrote.
The article describes how Stulak replaced the device with a new one, but it was too late to prevent the injuries to Herrman. Thoratec submitted at least three follow-up reports to the FDA about the incident and said its investigation could not determine whether the HeartMate 3 caused Herrman's death.
Herrman's death certificate cites complications of ischemic heart disease. Flores' death certificate says he died of cardiac arrest and hypoxic ischemic encephalopathy, or brain damage.
The FDA has had its own problems keeping the MAUDE database up to date.
The agency is years behind schedule on anonymizing and releasing adverse event reports for all medical devices.
Kinard said the FDA has yet to publicly release "millions" of follow-up reports that manufacturers have filed after their initial adverse event report for a medical device.
The FDA acknowledged that the agency is not up to date on public reporting but could not say how many reports are pending — for the HeartMate 3 or any device.
"We are currently working on redaction for public posting in MAUDE, of all supplemental reports dated 2021-2023," said Kahn, the FDA spokesperson. "It is difficult to determine how many of those – pending redaction of supplemental reports – pertain to the subject device."
FDA press officer Lauren-Jei McCarthy noted that, besides adverse event reports, the agency also monitors published literature, patients, patient advocacy groups, professional societies, individual health care providers, and other sources to determine whether further action is warranted.
"We review and take seriously all reports of adverse events associated with medical devices," McCarthy said. She said patients and providers who use the HeartMate 3 "remain a high priority" and that the agency cannot comment on investigations.
A Last-Resort Treatment
Before he got a HeartMate 3 implanted in January 2022, Sid Covington, of Austin, Texas, said he had researched the device during years of medication therapy and cardiac rehabilitation to treat his congestive heart failure.
"I looked at case studies. I looked at a number of the different heart studies," Covington said. "I looked at their marketing brochures and all that stuff, just whatever I could find."
Covington, 76, said he was familiar with MAUDE and Intermacs, a private registry that tracks LVAD patients, but didn't consult them. When he had to decide whether to get the device, he was in the hospital with chest pain, shortness of breath, and fatigue from advanced heart failure. Covington said his only option was the HeartMate 3.
"When it comes down to the moment, you really don't have much choice," he said. "It's any port in the storm at that point."
The HeartMate 3 requires constant attention and care from patients, who must keep the external parts of the device dry at all times and avoid jumping and contact sports. Patients must also ensure that it always has an external source of power, which is supplied through a cord attached to the pump that exits the body through a surgical opening.
Patients who get the device are often out of options to treat their end-stage heart failure, said Larry Allen, a cardiologist with the University of Colorado and member of a multidisciplinary medical team that cares for heart failure patients.
"We wouldn't proceed with an LVAD unless we think the risk of death is really high and we've tried everything else," he said.
That informs the regulatory view, too, Kessler said.
"When you're talking about people who are seriously ill, then the FDA will accept a potentially higher risk," he said, "but not an irresponsible one, and certainly not one that couldn't be communicated to clinicians and the public."
Allen, who helped develop a decision aid for patients considering an LVAD, said reliable data on safety and risks to patients is key.
"It's about as high-risk, high-reward a choice as there can be," Allen said. "It's a really complicated decision to make and I think standard informed consent approaches are really inadequate for fully understanding that."
Data Exists but Is Confidential
Long-term data for the HeartMate 3 — including performance metrics for the more than 180 U.S. hospitals certified to implant the device — are kept in Intermacs, managed by The Society of Thoracic Surgeons, which has promised to provide transparency but has yet to deliver.
The registry tracks mortality and injury rates for patients with an LVAD and logs the number of devices implanted each year.
But Intermacs is proprietary, and access at hospitals requires a principal investigator and at least one trained staff member, who can use the data to evaluate their facility's performance against an aggregate from their peers across the nation.
Francis Pagani, a heart transplant and LVAD surgeon at University of Michigan Health, leads a medical society task force that oversees Intermacs. He said 12,000 to 14,000 HeartMate 3 implants have been recorded in Intermacs since 2017. The HeartMate 3 has "the best outcomes of any other LVAD, ever," he said.
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."