A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA's most serious recall, the agency announced Monday.
The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the market. In an emailed response, Abbott said it had communicated the risk to customers this year.
The delayed action raises questions for some safety advocates about how and when issues with approved medical devices should be reported. The heart devices in question have been associated with thousands of reports of patients' injuries and deaths, as described in a KFF Health News investigation late last year.
"Why doesn't the public know?" said Sanket Dhruva, a cardiologist and an expert in medical device safety and regulation at the University of California-San Francisco. Though some surgeons may have been aware of issues, others, particularly those who do not implant the device frequently, may have been in the dark. "And their patients are suffering adverse events," he said.
The recall involves a pair of mechanical pumps that help the heart pump blood when it can't do so on its own. The devices, small enough to fit in the palm of a hand, are implanted in patients with end-stage heart failure who are waiting for a transplant or as a permanent solution when a transplant is not an option. The recall affects nearly 14,000 devices.
The HeartMate 3 is a mechanical pump designed for patients with end-stage heart failure and manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. Known as a left ventricular assist device, the HeartMate 3 helps the main pumping chamber of the heart pump blood to the rest of the body. The device can be used by patients awaiting a heart transplant or for long-term therapy. The device is powered by a cable that is attached to the pump and exits the body through a surgical opening and connects to a controller and batteries or other power source, according to the manufacturer's instruction manual.
Amanda Hils, an FDA press officer, said the agency is working with Abbott to investigate the reported injuries and deaths and determine if further action is needed.
According to the FDA's recall notice, the devices can cause buildup of "biological material" that reduces their ability to help the heart circulate blood and keep patients alive. The buildup accumulates gradually and can appear two years or more after a device is implanted in a patient's chest.
Doctors were advised to watch out for "low-flow alarms" on the devices and, if they do diagnose the obstruction, to either monitor the patient or perform surgery to implant a stent, release the blockage, or replace the pump. "Rates of outflow obstruction are low," Abbott spokesperson Justin Paquette said in an email, adding that patients whose devices are functioning normally "have no reason for concern."
A review of the FDA device database shows at least 130 reports related to HeartMate II or 3 that mention the complication reported by regulators. The earliest such report filed with the FDA dates to at least 2020, according to a KFF Health News review of the database.
Monday's alert is the second Class 1 recall of a HeartMate device this year.
In January, Abbott issued an urgent "correction letter" to hospitals about a separate issue in which the HeartMate 3 unintentionally starts and stops due to the pump's communication system, which cardiologists use to assess patients' status. The FDA alerted the public in March.
In February, Abbott issued another urgent letter to hospitals about the blockage problem, asking them to inform physicians, complete and return an acknowledgment form, and pay attention to low-flow alarms on the device's monitor that may indicate an obstruction. The company said in the letter that it is working on "a design solution" to prevent the blockages.
A study published in 2022 in the Journal of Thoracic and Cardiovascular Surgery reported the obstruction in about 3% of cases, though the incidence rate was higher the longer a patient had the device.
The only other Class 1 recall issued for the HeartMate 3 was in May 2018, when the company issued corrective action notices to hospitals and physicians warning that the graft line that carries blood from the pump to the aorta could twist and stop blood flow.
The FDA recall notice issued Monday includes additional guidance for physicians to diagnose the blockage using an algorithm to detect obstructions and, if needed, a CT angiogram to verify the cause.
At present, the HeartMate 3, which was first approved by the FDA in 2017, is the only medical option for many patients with end-stage heart failure and who do not qualify for a transplant. The HeartMate 3 has supplanted the HeartMate II, which received FDA approval in 2008.
If the new recall leads to the device being removed from the market, end-stage heart failure patients could have no options, said Francis Pagani, a cardiothoracic surgeon at the University of Michigan who also oversees a proprietary database of HeartMate II and HeartMate 3 implants.
If that happens, "we are in trouble," Pagani said. "It would be devastating to the patients to not have this option. It's not a perfect option — no pump ever is — but this is as good as it's ever been."
It's not known precisely how many patients have received a HeartMate II or HeartMate 3 implant. That information is proprietary. The FDA recall notices show worldwide distribution of more than 22,000 HeartMate 3 devices and more than 2,200 of the HeartMate II.
The blockage complication may have gone unreported to the public for so long partly because physicians are not required to report adverse events to federal regulators, said Madris Kinard, a former FDA medical device official and founder of Device Events, a company that makes FDA device data more user-friendly for hospitals, law firms, and investors.
Only device manufacturers, device importers, and hospitals are required by law to report device-related injuries, deaths, and significant malfunctions to the FDA.
"If this is something physicians were aware of, but they weren't mandated to report to the FDA," Kinard said, "at what point does that communication between those two groups need to happen?"
Dhruva, the cardiologist, said he is looking for transparency from Abbott about what the company is doing to address the problem so he can have more thorough conversations with patients considering a HeartMate device.
"We're going to expect to have some data saying, ‘Hey we created this fix, and this fix works, and it doesn't cause a new problem.' That's what I want to know," he said. "There's just a ton more that I feel in the dark about, to be honest, and I'm sure that patients and their families do as well."
[Update: This article was updated at 5:20 p.m. ET on April 16, 2024, with a response from Abbott Laboratories, which it provided after publication.]
Nearly half of people who lost their government coverage signed back up weeks or months later — suggesting they should never have been dropped in the first place.
This article was published on Friday, April 12, in KFF Health News.
Nearly a quarter of adults disenrolled from Medicaid in the past year say they are now uninsured, according to a survey released Friday that details how tens of millions of Americans struggled to retain coverage in the government insurance program for low-income people after pandemic-era protections began expiring last spring.
The first national survey of adults whose Medicaid eligibility was reviewed during the unwinding found nearly half of people who lost their government coverage signed back up weeks or months later — suggesting they should never have been dropped in the first place.
While 23% reported being uninsured, an additional 28% found other coverage — through an employer, Medicare, the Affordable Care Act's insurance marketplace, or health care for members of the military, the survey by KFF found.
"Twenty-three percent is a striking number especially when you think about the number of people who lost Medicaid coverage," said Chima Ndumele, an associate professor of health policy at the Yale University School of Public Health.
Going without insurance even for a short period of time can lead people to delay seeking care and leave them at financial risk when they do.
Seven in 10 adults who were disenrolled during the unwinding process say they became uninsured at least temporarily when they lost their Medicaid coverage.
Adrienne Hamar, 49, of Plymouth Meeting, Pennsylvania, said she struggled to enroll in an Affordable Care Act marketplace plan this winter after the state informed her that she and her two children no longer qualified for Medicaid. They had been enrolled since 2020. She said phone lines were busy at the state's marketplace and she couldn't complete the process online.
Hamar, who works as a home health aide, and her children were uninsured in March. But since April 1, they've been enrolled in a marketplace plan that, with the help of government subsidies, costs $50 a month for the family.
"I was very relieved," she said. Unsure of their insurance status, Hamar said, her 23-year-old daughter delayed getting a dental checkup.
Hamar's struggles were common, the survey found.
Of adults enrolled in Medicaid before the unwinding, about 35% who tried to renew their coverage described the process as difficult, and about 48% said it was at least somewhat stressful.
About 56% of those disenrolled say they skipped or delayed care or prescriptions while attempting to renew their Medicaid coverage.
"People's current insurance status is likely to be very much in flux, and we would expect at least some of the people who say they are currently uninsured to reenroll in Medicaid — many say they are still trying — or enroll in other coverage within a short period of time," said Jennifer Tolbert, a co-author of the KFF report and the director of KFF's State Health Reform and Data Program.
The survey didn't include children, and the KFF researchers said their findings therefore couldn't be extrapolated to determine how the Medicaid unwinding has affected the overall U.S. uninsured rate, which hit a record low of 7.7% in early 2023. Nearly half of enrollees in Medicaid and the related Children's Health Insurance Program are children.
The unwinding, in which states are reassessing eligibility for Medicaid among millions of Americans who enrolled before or during the pandemic and dropping those who no longer qualify or did not complete the renewal process, won't be completed until later this year. Enrollment in Medicaid and CHIP grew to a record of nearly 94.5 million in April of last year, three years after the federal government prohibited states from cutting people from their rolls during the covid-19 public health emergency.
Nationally, states have disenrolled about 20 million people from Medicaid in the past year, most of them for procedural reasons such as failure to submit required paperwork. That number is expected to grow, as states have a few more months to redetermine enrollees' eligibility.
Among adults who had Medicaid prior to the start of the unwinding, 83% retained their coverage or reenrolled, while 8% found other insurance and 8% were uninsured. The share left uninsured was larger in states that have not expanded Medicaid under the ACA (17%) than in states that have (6%). Forty states have expanded Medicaid to cover everyone with an income under 138% of the federal poverty rate, or $31,200 for a family of four this year.
The KFF survey found that nearly 1 in 3 disenrolled adults discovered only when they sought health care — such as going to a doctor or a pharmacy — that they had been dropped from Medicaid.
Indira Navas of Miami found out that her 6-year-old son, Andres, had been disenrolled from Florida's Medicaid program when she took him to a doctor appointment in March. She had scheduled Andres' appointment months in advance and is frustrated that he remains uninsured and his therapy for anxiety and hyperactivity has been disrupted.
Navas said the state could not explain why her 12-year-old daughter, Camila, remained covered by Medicaid even though the children live in the same household with their parents.
"It doesn't make sense that they would cover one of my children and not the other," she said.
Kate McEvoy, executive director of the National Association of Medicaid Directors, said the sheer volume of millions of people being redetermined for eligibility has overwhelmed some state call centers trying to support enrollees.
She said states have tried many ways to communicate with enrollees, including through public outreach campaigns, text, email, and apps. "Until the moment your coverage is at stake, it's hard to penetrate people's busy lives," she said.
The KFF survey, of 1,227 adults who had Medicaid coverage in early 2023 prior to the start of the unwinding on April 1, 2023, was conducted between Feb. 15, 2024, and March 11, 2024. The margin of sampling error was plus or minus 4 percentage points.
KFF Health News correspondent Daniel Chang contributed to this article.
A wide-ranging lawsuit filed Friday outlines a moneymaking scheme by which large insurance sales agency call centers enrolled people into Affordable Care Act plans or switched their coverage, all without their permission.
According to the lawsuit, filed in U.S. District Court for the Southern District of Florida, two such call centers paid tens of thousands of dollars a day to buy names of people who responded to misleading advertisements touting free government "subsidies" and other rewards. In turn, sales agents used the information to either enroll them in ACA plans or switch their existing policies without their consent.
As a result, the lawsuit alleges, consumers lost access to their doctors or medications and faced financial costs, such as owing money toward medical care or having to repay tax credits that were paid toward the unauthorized coverage.
Some consumers were switched multiple times or had duplicative policies.
"We allege there was a plan that targeted the poorest of Americans into enrolling in health insurance through deceptive ads and unauthorized switching," to gain compensation for the sign-ups or capture the commissions that would have been paid to legitimate insurance agents, said Jason Doss, one of two lawyers who filed the case following a four-month investigation.
Doss and Jason Kellogg, the other lawyer on the case, which was filed on behalf of several affected policyholders and agents, are seeking class action status.
Named as defendants are TrueCoverage and Enhance Health, which operate insurance call centers in Florida and other states; Speridian Technologies, a New Mexico-based limited liability company that owns and controls TrueCoverage; and Number One Prospecting, doing business as Minerva Marketing, which is also a lead-generating company. The lawsuit also names two people: Brandon Bowsky, founder and CEO of Minerva; and Matthew Herman, CEO of Enhance Health. Attempts to reach the companies for comment were unsuccessful.
According to the lawsuit, the call centers had access to policyholder accounts through "enhanced direct enrollment" platforms, including one called Benefitalign, owned by Speridian.
Such private sector platforms, which must be approved by the Centers for Medicare & Medicaid Services, streamline enrollment by integrating with the federal ACA marketplace, called healthcare.gov. The ones included in this case were not open to the public, but only to those call center agencies granted permission by the platforms.
One of the plaintiffs, Texas resident Conswallo Turner, signed up for ACA coverage in December through an agent she knew, and expected it to go into effect on Jan. 1, according to the lawsuit. Not long after, Turner saw an ad on Facebook promising a monthly cash card to help with household expenses.
She called the number on the ad and provided her name, date of birth, and state, the lawsuit says. Armed with that information, sales agents then changed her ACA coverage and the agent listed on it five times in just a few weeks, dropping coverage of her son along with way, all without her consent.
She ended up with a higher-deductible plan along with medical bills for her now-uninsured son, the lawsuit alleges. Her actual agent also lost the commission.
The lawsuit contains similar stories from other plaintiffs.
The routine worked, it alleges, by collecting names of people responding to online and social media ads claiming to offer monthly subsidies to help with rent or groceries. Those calls were recorded, the suit alleges, and the callers' information obtained by TrueCoverage and Enhance Health.
The companies knew people were calling on the promise "of cash benefits that do not exist," the lawsuit said. Instead, call center agents were encouraged to be "vague" about the money mentioned in the ads, which was actually the subsidies paid by the government to insurers toward the ACA plans.
The effort targeted people with low enough incomes to qualify for large subsidies that fully offset the monthly cost of their premium, the lawsuit alleges. The push began after March 2022, when a special enrollment period for low-income people became available, opening up a year-round opportunity to enroll in an ACA plan.
The suit asserts that those involved did not meet the privacy and security rules required for participation in the ACA marketplace. The lawsuit also alleges violations of the federal Racketeer Influenced and Corrupt Organizations Act, known as RICO.
"Health insurance is important for people to have, but it's also important to be sold properly," said Doss, who said both consumers and legitimate agents can suffer when it's not.
"It's not a victimless crime to get zero-dollar health insurance if you don't qualify for it and it ends up causing you tax or other problems down the road," he said. "Unfortunately, there's so much fraud that legitimate agents who are really trying to help people are also being pushed out."
Tax season is never fun. But some tax filers this year face an added complication: Their returns are being rejected because they failed to provide information about Affordable Care Act coverage they didn't even know they had.
While the concern about unscrupulous brokers enrolling unsuspecting people in ACA coverage has simmered for years, complaints have risen in recent months as consumers discover their health insurance coverage isn't what they thought it was.
Now such unauthorized enrollments are also causing tax headaches. Returns are getting rejected by the IRS and some people will have to pay more in taxes.
"It's definitely gotten worse over the past year. We've helped three to four dozen people this year already," said Erin Kinard, director of systems and intake for the Health and Economic Opportunity Program at Pisgah Legal Services in North Carolina, which helps low-income families enroll in ACA plans and get tax help.
Neither the IRS nor the Centers for Medicare & Medicaid Services, which oversees the federal Obamacare marketplace, responded to questions about the problem.
The IRS did, however, issue an FAQ in February instructing consumers on what to do if their electronically filed returns are rejected because of ACA issues.
Unauthorized sign-ups can happen in several ways, Kinard and others said. Some rogue agents troll online enrollment portals that are accessible only to brokers but are integrated with the healthcare.gov website. When those agents open a new policy or switch an already enrolled policyholder to a different plan, they garner the associated monthly commissions. Other consumers unwittingly sign up when they respond to advertisements touting gift cards or government subsidies then are transferred to agents who enroll them in health coverage. It's happening even after new rules were put in place requiring agents to get written or recorded consent from clients before making changes.
CMS has not released details on how many consumers have been affected or how many agents have been sanctioned for participating in such schemes.
There's also no public tally of how many taxpayers are facing problems as a result. And the tax consequences can come as a surprise.
"Many people are finding out when they go to e-file their taxes and it bounces back and the IRS says it can't accept your return," said Christine Speidel, an associate professor and the director of the Federal Tax Clinic at Villanova University's Charles Widger School of Law.
Returns are rejected if the IRS has information indicating the taxpayer has ACA coverage but the returns don't include forms that help determine whether premium tax credits paid on the policyholder's behalf to insurers were correct. If their income was misstated by the rogue broker who enrolled them, for example, they might not have qualified for the full amount paid. Or, if they had affordable employer coverage, they would not have been eligible for ACA subsidies at all.
Ashley Zukoski, an ultrasound technologist in Charlotte, North Carolina, had employer coverage but now faces a tax bill for an ACA plan she said she never signed up for. She reached out to KFF Health News after it reported on such unauthorized plan enrollments.
Unbeknownst to her, she said, a broker in Florida enrolled her family in an ACA plan in late February 2023, even though Zukoski had coverage starting that January through her job. The broker listed an income that qualified the household for a full subsidy, so Zukoski never received a premium bill.
Her first inkling that something was amiss came early in 2024 when she received a special form, called a 1095-A, which showed she had an ACA plan. After reporting the problem to the federal marketplace, she sought to get the 1095-A voided so she would not be liable for the plan's premium subsidies paid by the government to the insurer.
But, because Zukoski's pharmacy had billed the ACA plan instead of her job-based coverage, her request was denied. She plans to appeal.
In the meantime, the family has filed an extension on their taxes.
"Instead of getting a $4,100 refund, we now owe almost $700 in taxes based on the 1095-A and premium tax credit applied," Zukoski said.
With the April 15 federal tax filing deadline upon us, there are some important steps for affected consumers to take, tax and insurance experts said.
First, because it could take weeks to get corrected forms, experts recommend filing for an extension to buy more time. When consumers file for that extension, they should also pay any taxes owed to avoid penalties and interest.
In general, consumers who at any point in the year think they are victims of an unauthorized enrollment or plan switch should report it immediately to the relevant federal or state ACA marketplace and request a corrected Form 1095-A. But move fast. Appeals to cancel coverage retroactively must be made within 60 days of discovering the fraudulent enrollment, Speidel said.
Consumers can ask for help filing a complaint with federal or state regulators by contacting their own insurance agents or seeking help from assisters or "navigator" programs, which are government-funded nonprofit groups that help people enroll or deal with insurance problems.
Navigators and assisters are fielding many such cases this year and can submit what are called "complex case forms," which help federal officials investigate such complaints, said Lynn Cowles, program manager for Prosper Health Coverage, a navigator program in Texas.
MODESTO, Calif. — When American Advanced Management made a bid for the bankrupt Madera Community Hospital last year, many local officials and others involved in trying to reopen the facility didn't take the company seriously.
The 11-year-old firm, based in Modesto, was already running a handful of small, rural hospitals, but Madera had far larger and more prestigious suitors, including Trinity Health and then Adventist Health.
After those two entities had backed out, the bankruptcy judge tentatively greenlighted the AAM proposal. But a nonprofit community group later objected in a court filing, citing concerns about AAM's commitment to fully reopen the hospital and airing allegations of "dishonesty, fraud, perjury, and maladministration."
The Madera Coalition for Community Justice and other critics of the AAM deal hoped that Adventist and the University of California-San Francisco, which made a last-minute joint proposal in February to take over the hospital, might get another look.
But Gov. Gavin Newsom all but ended the drama on April 8 by announcing the state had approved the AAM plan and would provide a $57 million loan from a fund for distressed hospitals to help reopen and operate the Madera facility.
The closure of the hospital in January 2023 left Madera County, home to 160,000 people, largely Hispanic agricultural workers, without a general acute care facility. Like many rural hospitals in California and around the country, the Madera hospital had suffered financial and demographic challenges, including a large proportion of patients on low-paying government insurance programs, low patient volumes, and difficulty attracting talent, in addition to pandemic-related pressures.
AAM has committed to pay up to $30 million to creditors and reopen the hospital as soon as late summer. The company has a portfolio of nine hospitals, many of them in underserved regions of California.
"American Advanced Management has a proven track record of reopening closed hospitals in California and saving others from the brink of closure," said Matthew Beehler, the company's chief strategy officer.
It remains uncertain whether AAM can make the Madera hospital financially viable. Reopening alone will cost millions, and many of the same constraints that led to the bankruptcy remain. In its final two years of operations, the Madera hospital lost $14 million.
Beehler said AAM would aim for "operational efficiency" through centralized administration and "elevate the quality of care" to attract more patients. "These strategic investments and improvements are designed to stabilize the hospital's financial footing and ensure its sustainability in the long term," he said.
According to a recent study by the Pittsburgh-based Center for Healthcare Quality and Payment Reform, 30% of California's 56 rural hospitals and the same percentage of rural hospitals nationwide are at risk of closing.
"The economics of small hospitals is such that it is unlikely they are going to be highly profitable," said Harold Miller, the center's CEO.
The group objecting to AAM, along with many members of the community, are particularly worried that the company won't reopen the Madera hospital's labor and delivery department, where over 700 babies were born in 2022.
Labor and delivery at many rural hospitals are among the first services new owners cut because they tend to lose money, said Ge Bai, professor of health policy and management at Johns Hopkins University's Bloomberg School of Public Health.
Beehler said a reopened Madera would provide "many of the ancillary services" related to pregnancy and that AAM would "regularly evaluate" whether it makes financial and clinical sense to have a labor and delivery unit at the hospital.
'Someone Has to Take a Stand'
AAM is the brainchild of Gurpreet Singh Randhawa, who says he is its sole owner.
Singh, a gastroenterologist-turned-entrepreneur, has amassed hospitals and other health care-related companies, as well as numerous real estate holdings. Public records show dozens of businesses that are or have been associated with Singh.
After graduating from medical school in India in 2000, Singh completed further training in New York and New Jersey before moving to California in 2008. In an interview, Singh said he was inspired to open his first hospital after seeing a friend drive three hours round trip to the Sacramento area every day to visit his father in a long-term acute care hospital because Modesto didn't have one of its own.
Singh said he thought "‘someone has to take a stand,' so I took that stand." He said he spent $36 million to open Central Valley Specialty Hospital at the site of a shuttered facility in Modesto. It opened in mid-2013, marking the beginning of AAM.
Since then, AAM has acquired numerous hospitals and clinics in Northern California and the Central Valley, including Colusa Medical Center and Glenn Medical Center in 2017, Sonoma Specialty Hospital in 2019, and Coalinga Regional Medical Center in 2020.
In 2023, the firm took over management of the troubled Orchard Hospital in Gridley, California. Last September, AAM announced it had taken over operations of Kentfield Specialty Hospital, with locations in San Francisco and Marin County. It also owns a rehabilitation hospital in Amarillo, Texas.
AAM lost a combined $22.3 million in 2021 and 2022, state data shows. But Beehler said the company returned to profitability in 2023 and expects profit margins in the high single digits this year. He estimated that AAM's total operating revenue will jump to approximately $400 million in 2024 from $290 million in 2023, mainly due to the addition of three hospitals.
The source of the funds to finance the company's growth is not entirely clear. Singh cited family wealth and real estate, but he declined to discuss his family's money. The firm's agreement with the Madera hospital says AAM will have "immediately available funds in cash" to meet its obligations. The $57 million approved by the state this week will be a key source of funding.
Beehler said another source of cash to finance growth is AAM's earnings on longer-term care. Central Valley Specialty Hospital has been profitable since its first full year of operations in 2014, posting cumulative earnings of over $66 million through 2022, according to data from the state's Department of Health Care Access and Information. Coalinga Regional Medical Center has a 99-bed skilled nursing facility in addition to its acute care beds, and Sonoma Specialty Hospital recently added 21 beds, according to Beehler.
Acute vs. Long-Term Care
Critics fear AAM might take the Madera hospital in the direction of long-term care, depriving the community of a viable acute care facility. Cece Gallegos, who recently lost her bid for a seat on the Madera County Board of Supervisors, said in a campaign mailer that the firm would turn Madera into "a glorified nursing home."
Beehler rebuffed that notion, saying the company couldn't do that even if it wanted to. He said the conditions imposed by the state attorney general "require an acute care hospital with fully functional ER and ancillary services." The attorney general's conditions, however, require AAM only to make "commercially reasonable efforts" to provide those services.
Singh and his health care businesses have hit plenty of bumps as they've grown.
In 2018, AAM took over management of Sonoma West Medical Center, a publicly owned hospital in the city of Sebastopol that had declared bankruptcy. In 2019, AAM acquired it outright and changed its name to Sonoma Specialty Hospital. Later that year, a bankruptcy trustee sued Singh, AAM, and the hospital for allegedly taking money that belonged to its predecessor, and the parties settled for $1.15 million. Beehler said AAM did not retain any of the money but used it for hospital operations and became "an unintended victim." The company chose to settle, he said, "to bring finality to this complex issue."
In 2021, the state fined AAM's Pacific Gardens Medical Center $276,000 for four situations that put patients in "immediate jeopardy," including one in which inadequate training caused an intravenous dose of fentanyl to drip into a patient nearly seven times as rapidly as the doctor had ordered.
AAM had reopened the hospital in January 2021, about three years after buying it out of bankruptcy. Its license was suspended less than five months later, according to the California Department of Public Health. Beehler said the hospital had reopened as a pandemic surge hospital with support, including the provision of nurses and physicians, from the state's Emergency Medical Services Authority. "By its nature, a surge facility opening is temporary," he said.
The accelerated timeline for getting it open contributed to the patient-jeopardy situations, he said.
In 2022, the California Department of Health Care Services sued Sonoma Specialty Hospital, Singh, and AAM, accusing them of illegitimately seeking, and accepting, $270,000 from a program that provides federal financing for certain public hospitals.
DHCS said it had told AAM that it wasn't eligible for the money, because it was now a for-profit facility, but that the company refused to pay it back. In February, a Sonoma County judge sided with DHCS. DHCS spokesperson Leah Myers said in an emailed statement that the state does not typically have to sue to recover money. Beehler said AAM "disputes that there is any liability" and is appealing the decision.
Another Singh venture was Advanced College, a private vocational school for health care professionals with three locations in central and Southern California. After receiving numerous complaints, state regulators ordered the school to cease operations in December 2022, alleging it had falsified records and test results, and "failed to provide documentation of sufficient financial resources."
Joshua Maruca, the school's custodian of records, said Advanced College disagreed with the state's allegations but had already been planning to shut down for other reasons, so it did not contest them.
Bank of the West also sued Singh and several of his businesses for repeated defaults on over $4.7 million in loans, mostly related to the college. The lawsuit was settled, but one of the bank's lawyers, Wayne Terry, said he could not discuss the settlement. Beehler said the loans were not part of AAM's financials. The bank was "paid fully," he said.
The company's critics say the state didn't sufficiently scrutinize AAM before approving the loan and the operating plan this week.
"The state agencies and the Attorney General, all tasked here with protecting the public interest, have utterly failed to do the basic due diligence that would ensure Madera Community Hospital is resurrected as a viable going concern, under the stewardship of a reliable, trustworthy, and capable operator," the MCCJ said in the court filing opposing the challenge to its objection.
AAM said in a statement that it was "grateful" to Newsom and the state for approving the deal, and "honored to serve the Madera community." The bankruptcy court is likely to give its final blessing next week.
Safety-nets are integrating oral health into medical checkups for children, pregnant women, and others who cannot afford or do not have easy access to dentists.
This article was published on Wednesday, April 10, 2024 in KFF Health News.
DENVER — Pediatrician Patricia Braun and her team saw roughly 100 children at a community health clinic on a recent Monday. They gave flu shots and treatments for illnesses like ear infections. But Braun also did something most primary care doctors don't. She peered inside mouths searching for cavities or she brushed fluoride varnish on their teeth.
"We're seeing more oral disease than the general population. There is a bigger need," Braun said of the patients she treats at Bernard F. Gipson Eastside Family Health Center, which is part of Denver Health, the largest safety-net hospital in Colorado, serving low-income, uninsured, and underinsured residents.
Braun is part of a trend across the United States to integrate oral health into medical checkups for children, pregnant women, and others who cannot afford or do not have easy access to dentists. With federal and private funding, these programs have expanded in the past 10 years, but they face socioeconomic barriers, workforce shortages, and the challenge of dealing with the needs of new immigrants.
With a five-year, $6 million federal grant, Braun and her colleagues have helped train 250 primary care providers in oral health in Colorado, Montana, Wyoming, and Arizona. Similar projects are wrapping up in Illinois, Michigan, Virginia, and New York, funded by the federal Health Resources and Services Administration's Maternal and Child Health Bureau. Beyond assessment, education, and preventive care, primary care providers refer patients to on- or off-site dentists, or work with embedded dental hygienists as part of their practice.
"Federally qualified health centers have a long history of co-locating dental services within their systems," Braun said. "We're taking that next step where care is not just co-located, meaning, say, we're upstairs and dental is downstairs, but we're integrated so that it becomes part of the same visit for the patient."
Having doctors, nurses, and physician assistants who assess oral health, make referrals, and apply fluoride at community health centers is critical for the many children who lack access to dental care, said Tara Callaghan, director of operations for the Montana Primary Care Association, which represents 14 federally qualified health centers and five Urban Indian organizations.
"Providing these services during medical visits increases the frequency of fluoride application," Callaghan said, and "improves parents' knowledge of caring for their child's teeth." But obstacles remain.
Because of Montana's large geographic area and small population, recruiting dental professionals is difficult, Callaghan said. Fifty of the state's 56 counties are designated dental shortage areas and some counties don't have a single dentist who takes Medicaid, she added. Montana ranks near the bottom for residents having access to fluoridated water, which can prevent cavities and strengthen teeth.
Pediatric dental specialists, in particular, are scarce in rural areas, with families sometimes driving hours to neighboring counties for care, she said.
Embedding dental hygienists with medical doctors is one way to reach patients in a single medical visit.
Valerie Cuzella, a registered dental hygienist, works closely with Braun and others at Denver Health, which serves nearly half of the city's children and has embedded hygienists in five of its clinics that see children.
State regulations vary on which services hygienists can provide without supervision from a dentist. In Colorado, Cuzella can, among other things, independently perform X-rays and apply silver diamine fluoride, a tool to harden teeth and slow decay. She does all this in a cozy corner office.
Braun and Cuzella work so closely that they often finish each other's sentences. Throughout the day they text each other, taking advantage of brief lulls when Cuzella can pop into an exam room to check for gum disease or demonstrate good brushing habits. Braun herself takes similar opportunities to assess oral health during her exams, and both focus on educating parents.
Medical and dental care have traditionally been siloed. "Schools are getting better at interprofessional collaboration and education, but by and large we train separately, we practice separately," said Katy Battani, a registered dental hygienist and assistant professor at Georgetown University.
Battani is trying to bridge the divide by helping community health centers in nine states — including California, Texas, and Maryland — integrate dental care into prenatal visits for pregnant women. Pregnancy creates opportunities to improve oral health because some women gain dental coverage with Medicaid and see providers at least once a month, Battani said.
In Denver, housing instability, language barriers, lack of transportation, and the "astronomical cost" of dentistry without insurance make dental care inaccessible for many children, the migrant community, and seniors, said Sung Cho, a dentist who oversees the dental program at STRIDE Community Health Center, serving the Denver metro area.
STRIDE tries to overcome these barriers by offering interpretation services and a sliding pay scale for those without insurance. That includes people like Celinda Ochoa, 35, of Wheat Ridge, who waited at STRIDE Community Health Center while her 15-year-old son, Alexander, had his teeth cleaned. He was flagged for dental care during a past medical checkup and now he and his three siblings regularly see a dentist and hygienist at STRIDE.
One of Ochoa's children has Medicaid dental coverage, but her three others are uninsured, and they couldn't otherwise afford dental care, said Ochoa. STRIDE offers an exam, X-rays, and cleaning for $60 for the uninsured.
In the past year, Cho has seen an influx of migrants and refugees who have never seen a dentist before and need extensive care. Medical exams for refugees at STRIDE increased to 1,700 in 2023 from 1,300 in 2022, said Ryn Moravec, STRIDE's director of development. She estimates the program has seen 800 to 1,000 new immigrants in 2024.
Even with growing needs, Cho said the Medicaid "unwinding" — the process underway to reexamine post-pandemic eligibility for the government program that provides health coverage for people with low incomes and disabilities — has created financial uncertainty. He said he worries about meeting the upfront costs of new staff and of replacing aging dental equipment.
At STRIDE's Wheat Ridge clinic, two hygienists float between dental and pediatrics as part of the medical-dental integration. Yet Cho said he needs more hygienists at other locations to keep up with demand. The pandemic created bottlenecks of need that are only now being slowly cleared, particularly because few dentists take Medicaid. If they do accept it, they often limit the number of Medicaid patients they'll take, said Moravec. Ideally, STRIDE could hire two hygienists and three dental assistants, Moravec said.
In 2022, Colorado enacted a law to alleviate workforce shortages by allowing dental therapists — midlevel providers who do preventive and restorative care — to practice. But Colorado does not have any schools to train or accredit them.
Before age 3, children are scheduled to see a pediatrician for 12 well visits, a metric that medical and dental integration capitalizes on, particularly for at-risk children. As part of Braun's program in the Rocky Mountain region, providers have applied more than 17,000 fluoride varnishes and increased the percentage of children 3 and younger who received preventive oral health care to 78% from 33% in its first 2½ years.
Callaghan, at the Montana Primary Care Association, witnesses that on the ground at community health centers in Montana. "It's about leveraging the fact that kids see their medical provider for a well-child visit much more often and before they see their dental provider — if they have one."
Nearly two hours into a Capitol Hill hearing focused on rural health, Rep. Brad Wenstrup emphatically told the committee's five witnesses: "Hang with us."
Federal lawmakers face a year-end deadline to solidify or scuttle an array of COVID-era payment changes for telehealth services that include allowing people to stay in their homes to see a doctor or therapist.
During the hearing in early March, Wenstrup and other House members offered personal anecdotes on how telehealth, home visits, and remote monitoring helped their patients, relatives, and constituents. Wenstrup, a Republican from Ohio who is also a podiatric surgeon and a retired Army reservist, told the audience: "Patients are less anxious and heal better when they can be at home."
Most of the proposals focus on how Medicare covers telehealth services. But the rules affect patients on all types of insurance plans because typically private insurers and some government programs follow Medicare's example. Without congressional action, virtual health care services like audio-only calls or meeting online with specialty doctors — such as an occupational therapist — could end. The bills would also continue to allow rural health clinics and other health centers to offer telehealth services while waiving a requirement for in-person mental health visits.
Telehealth use ballooned in the early months of the COVID-19 pandemic and grew into a household term. The practice has become a popular issue for lawmakers on both sides of the aisle.
In one U.S. Census Bureau survey conducted from April 2021 to August 2022, Medicare and Medicaid enrollees reported using telehealth visits the most — 26.8% and 28.3%, respectively. The survey of nearly 1.2 million adults also found that Black patients and those earning less than $25,000 reported high rates of telehealth use. Notably, people of color were more likely to use audio-only visits.
Ensuring access to telehealth services "is the best public policy," said Debbie Curtis, a vice president of McDermott+Consulting, a Washington, D.C.-based health care lobbying firm. "It's the best business outcome. It's the best patient care outcome."
But it's a presidential election year and Congress is a "deadline-driven organization," Curtis said. She expects that Congress will be "kicking the can" past the November election.
Kyle Zebley, senior vice president of public policy at the American Telemedicine Association who also lobbies on Capitol Hill, said Congress "might well be in that lame-duck period." "This is no way to run a healthcare system on a popular bipartisan issue," he said.
In January, lawmakers — including senators from Mississippi and South Dakota — sent a letter to the Biden administration urging the White House to work quickly with Congress to ensure payments continue for Medicare patients who use telehealth, "especially for rural and underserved communities."
Maya Sandalow, a senior policy analyst for the Bipartisan Policy Center, a Washington, D.C.-based think tank, said lawmakers and policymakers are likely to consider a temporary extension of the payments rather than permanent changes.
"Research is still coming out that covers more recent years than the acute effects of the pandemic," Sandalow said. The center expects to release policy recommendations in the coming months.
Questions being considered include which kind of health care services are best for audio-only and video visits. Sandalow said researchers are also weighing how telehealth can "expand access to affordable, high-quality care while ensuring in-person options remain for patients."
In North Dakota, Sanford Health's David Newman said virtual care is often the only way some of his patients in the western part of the state can get sub-specialty care, such as with behavioral health.
Newman, an endocrinologist and Sanford's medical officer of virtual care, said 10% to 20% of his patients are seen virtually during the summer, as compared with about 40% in the winter months because "the weather can be so bad" that roads are impassable.
In winters past, Newman would sit around "doing nothing for a day" because patients couldn't visit him. Now, he has a full clinic using telehealth technology.
"I tell my patients that if you can make a restaurant reservation or if you can order a pizza online, you can do a virtual visit," Newman said.
Until last week, the system that is used to enroll people in federal Affordable Care Act insurance plans inadvertently allowed access by insurance brokers to consumers' full Social Security numbers, information brokers don't need.
That raised concerns about the potential for misuse.
The access to policyholders' personal information was one of the problems cited in a KFF Health News article describing growing complaints about rogue agents enrolling people in ACA coverage, also known as Obamacare, or switching consumers' plans without their permission in order to garner the commissions. The consumers are often unaware of the changes until they go to use their plan and find their doctors are not in the new plan's network or their drugs are not covered.
Agent Joshua Brooker told KFF Health News it was relatively easy for agents to access full Social Security numbers through the federal insurance marketplace's enrollment platforms, warning that "bad eggs now have access to all this private information about an individual."
On April 1, the morning the article was posted on NPR's website, Brooker said, he got a call from the Centers for Medicare & Medicaid Services questioning the accuracy of his comments.
A CMS representative told him he was wrong and that the numbers were hidden, Brooker said April 7. "I illustrated that they were not," he said.
After he showed how the information could be accessed, "the immediate response was a scramble to patch what was acknowledged as 'problematic,'" Brooker posted to social media late last week.
After some phone calls with CMS and other technical experts, Brooker said, the federal site and direct enrollment partner platforms now mask the first six digits of the SSNs.
"It was fixed Wednesday evening," Brooker told KFF Health News. "This is great news for consumers."
An April 8 written statement from CMS said the agency places the highest priority on protecting consumer privacy.
"Upon learning of this system vulnerability, CMS took immediate action to reach out to the direct enrollment platform where vulnerability was identified to make sure it was addressed," wrote Jeff Wu, acting director of the Center for Consumer Information & Insurance Oversight at CMS.
He added that the Social Security numbers were not accessible through routine use of the platform but were in a portion of the site called developer tools. "This issue does not impact healthcare.gov," Wu wrote.
Brooker's concern about Social Security numbers centered on access by licensed agents to existing policyholder information though the federal marketplace, not including the parts of healthcare.gov used by consumers, who cannot access anything but their own accounts.
While consumers can enroll on their own, many turn to agents for assistance. There are about 70,000 licensed agents nationwide certified to use the healthcare.gov site or its partner enrollment platforms. They must meet certain training and licensing requirements to do so. Brooker has been quick to say it is a minority of agents who are causing the problem.
But agents increasingly are frustrated by what they describe as a sharp increase during the second half of 2023 and into 2024 of unscrupulous rivals switching people from one plan to another, or at least switching the "agent of record" on the accounts, which directs the commission to the new agent. Wu's statements have so far not included requested information on the number of complaints about unauthorized switching, or the number of agents who have been sanctioned as a result.
The changes shielding the Social Security numbers are helpful, Brooker said, but won't necessarily slow unauthorized switching of plans. Rogue agents can still switch an enrollee's plan with simply their name, date of birth, and state of residence, despite rules that require agents to collect written or recorded consent from consumers before making any changes.
In Matthew Roach's two years as vital statistics manager for the Arizona Department of Health Services, and 10 years previously in its epidemiology program, he has witnessed a trend in mortality rates that has rural health experts worried.
As Roach tracked the health of Arizona residents, the gap between mortality rates of people living in rural areas and those of their urban peers was widening.
The health disparities between rural and urban Americans have long been documented, but a recent report from the Department of Agriculture's Economic Research Service found the chasm has grown in recent decades. In their examination, USDA researchers found rural Americans from the ages of 25 to 54 die from natural causes, like chronic diseases and cancer, at wildly higher rates than the same age group living in urban areas. The analysis did not include external causes of death, such as suicide or accidental overdose.
The research analyzed Centers for Disease Control and Prevention death data from two three-year periods — 1999 through 2001 and 2017 through 2019. In 1999, the natural-cause mortality rate for people ages 25 to 54 in rural areas was only 6% higher than for city dwellers in the same age bracket. By 2019, the gap widened to 43%.
The researchers found the expanding gap was driven by rapid growth in the number of women living in rural places who succumb young to treatable or preventable diseases. In the most rural places, counties without an urban core population of 10,000 or more, women in this age group saw an 18% increase in natural-cause mortality rates during the study period, while their male peers experienced a 3% increase.
Within the prime working-age group, cancer and heart disease were the leading natural causes of death for both men and women in both rural and urban areas. Among women, the incidence of lung disease in remote parts of the nation grew the most when compared with rates in urban areas, followed by hepatitis. Pregnancy-related deaths also played a role, accounting for the highest rate of natural-cause mortality growth for women ages 25 to 54 in rural areas.
The negative trends for rural non-Hispanic American Indian and Alaska Native people were especially pronounced. The analysis shows Native Americans 25 to 54 years old had a 46% natural-cause mortality rate increase over those two decades. Native women had an even greater mortality rate jump, 55%, between the two studied time periods, while the rate for non-Hispanic White women went up 23%.
The rural-urban gap grew in all regions across the nation but was widest in the South.
The increased mortality rates are an indicator of worsening population health, the study authors noted, which can harm local economies and employment.
As access to and quality of health services in rural areas continue to erode, rural health experts said, the USDA findings should spur stronger policies focused on rural health.
Alan Morgan, CEO of the National Rural Health Association, said he found the report "shocking," though, "unfortunately, not surprising."
The disparity warrants greater attention from state and national leaders, Morgan said.
The study does not address causes for the increase in mortality rates, but the authors note that differences in healthcare resources could compromise the accessibility, quality, and affordability of care in rural areas. Hospitals in small and remote communities have long struggled, and continued closures or conversions limit healthcare services in many places. The authors note that persistently higher rates of poverty, disability, and chronic disease in rural areas, compounded by fewer physicians per capita and the closure of hospitals, affect community health.
Roach said his past job as an epidemiologist included working with social vulnerability indexes, which factor in income, race, education, and access to resources like housing to get a sense of a community's resilience against adverse health outcomes. A map of Arizona shows that rural counties and reservations have some of the highest vulnerability rankings.
Janice C. Probst, a retired professor at the University of South Carolina whose work focused on rural health, said many current rural health efforts are focused on sustaining hospitals, which she noted are essential sources of healthcare. But she said that may not be the best way to address the inequities.
"We may have to take a community approach," said Probst, who reviewed the report before its release. "Not how do we keep the hospital in the community, but how do we keep the community alive at all?"
The disparities among demographics stood out to Probst, along with something else. She said the states with the highest rates of natural-cause mortality in rural areas included South Carolina, Mississippi, Georgia, Alabama, and others that have not expanded Medicaid, the joint federal and state health insurance program for low-income people, though there are efforts to expand it in some states, particularly Mississippi.
It's an observation the USDA researchers make as well.
"Regionally, differences in State implementation of Medicaid expansion under the 2010 Affordable Care Act could have increased implications for uninsured rural residents in States without expansions by potentially influencing the frequency of medical care for those at risk," they wrote.
Wesley James, founding executive director of the Center for Community Research and Evaluation, at the University of Memphis, said state lawmakers could address part of the problem by advocating for Medicaid expansion in their states, which would increase access to healthcare in rural areas. A large group of people want it, but politicians aren't listening to their needs, he said. James also reviewed the report before it was published.
According to KFF polling, two-thirds of people living in nonexpansion states want their state to expand the health insurance program.
Morgan added the study focused on deaths that occurred prior to the COVID-19 pandemic, which had a devastating effect in rural areas.
"COVID really changed the nature of public health in rural America," he said. "I hope that this prompts Congress to direct the CDC to look at rural-urban life expectancies during COVID and since COVID to get a handle on what we're actually seeing nationwide."
In Arizona, the leading cause of death for people 45 to 64 in 2021 in both rural and urban areas was COVID, according to Roach.
When the FDA recently convened a committee of advisers to assess a cardiac device made by Abbott, the agency didn't disclose that most of them had received payments from the company or conducted research it had funded — information readily available in a federal database.
One member of the FDA advisory committee was linked to hundreds of payments from Abbott totaling almost $200,000, according to a database maintained by the Department of Health and Human Services. Another was connected to 100 payments totaling about $100,000 and conducted research supported by about $50,000 from Abbott. A third member of the committee worked on research supported by more than $180,000 from the company.
The government database, called "Open Payments," records financial relationships between doctors and certain other health care providers and the makers of drugs and medical devices. KFF Health News found records of Abbott payments associated with 10 of the 14 voting members of the FDA advisory panel, which was weighing clinical evidence for a heart device called TriClip G4 System. The money, paid from 2016 through 2022 — the most recent year for which the database shows payments — adds up to about $650,000.
The panel voted almost unanimously that the benefits of the device outweigh its risks. Abbott announced on April 2 that the FDA had approved TriClip, which is designed to treat leakage from the heart's tricuspid valve.
The Abbott payments illustrate the reach of medical industry money and the limits of transparency at the FDA. They also shed light on how the agency weighs relationships between people who serve on its advisory panels and the makers of drugs and medical devices that those committees review as part of the regulatory approval process.
The payments do not reflect wrongdoing on the part of the agency, its outside experts, or the device manufacturer. The database does not show that any of the payments were related directly to the TriClip device.
But some familiar with the process, including people who have served on FDA advisory committees, said the payments should have been disclosed at the Feb. 13 meeting — if not as a regulatory requirement, then in the interest of transparency, because the money might call into question committee members' objectivity.
"This is a problem," Joel Perlmutter, a former FDA advisory committee member and a professor of neurology at Washington University School of Medicine in St. Louis, said by email. "They should or must disclose this due to bias."
The Open Payments database records several kinds of payments from drug and device makers. One category, called "associated research funding," supports research in which a physician is named a principal investigator in the database. Another category, called "general payments," includes consulting fees, travel expenses and meals connected to physicians in the database. The money can flow from manufacturers to third parties, such as hospitals, universities, or other corporate entities, but the database explicitly connects doctors by name to the payments.
At the public meeting to consider the TriClip device, an FDA official announced that committee members had been screened for potential financial conflicts of interest and found in compliance with government requirements.
FDA spokesperson Audra Harrison said by email that the agency doesn't comment on matters related to individual advisory committee members.
"The FDA followed all appropriate procedures and regulations in vetting these panel members and stands firmly by the integrity of the disclosure and vetting processes in place," she said. "This includes ensuring advisory committee members do not have, or have the appearance of, a conflict of interest."
Abbott "has no influence over who is selected to participate in FDA advisory committees," a spokesperson for the company, Brent Tippen, said in a statement.
Diana Zuckerman, president of the National Center for Health Research, a think tank, said the FDA shouldn't have allowed recipients of funding from Abbott in recent years to sit in judgment of the Abbott product. The agency takes too narrow a view of what should be disqualifying, she said.
One committee member was Craig Selzman, chief of the Division of Cardiothoracic Surgery at the University of Utah. The Open Payments database connects to Selzman about $181,000 in associated research funding from Abbott to the University of Utah Hospitals & Clinics.
Asked in an interview if a reasonable person could question the impartiality of committee members based on the Abbott payments, Selzman said: "People from the outside looking in would probably say yes."
He noted that Abbott's money went to the university, not to him personally. Participating in industry-funded clinical trials benefits doctors professionally, he said. He added: "There's probably a better way to provide transparency."
The FDA has a history of appointing people to advisory committees who had relationships with manufacturers of the products under review. For example, in 2020, the doctor who chaired an FDA advisory committee reviewing Pfizer's covid-19 vaccine had been a Pfizer consultant.
Appearance Issues
FDA advisory committee candidates, selected to provide expert advice on often complicated drug and device applications, must complete a confidential disclosure report that asks about current and past financial interests as well as "anything that would give an ‘appearance' of a conflict."
The FDA has discretion to decide whether someone with an "appearance issue" can serve on a panel, according to a guidance document posted on the agency's website. Relationships more than a year in the past generally don't give rise to appearance problems, according to the document, unless they suggest close ties to a company or involvement with the product under review. The main question is whether financial interests would cause a reasonable person to question the member's impartiality, the document says.
The FDA draws a distinction between appearance issues and financial conflicts of interest. Conflicts of interest occur when someone chosen to serve on an advisory committee has financial interests that "may be impacted" by their work on the committee, an FDA explainer says.
If the FDA finds a conflict of interest but still wants the applicant on a panel, it can issue a public waiver. None of the panelists voting on TriClip received a waiver.
The FDA's approach to disclosure contrasts with rules for conferences at which doctors earn credit for continuing medical education. For example, for a recent conference in Boston on technology for treatment of heart failure, including TriClip, the group holding the meeting directed speakers to include in their slide presentations disclosures going back 24 months.
Those disclosures — naming companies from which speakers had received consulting fees, grant support, travel expenses, and the like — also appeared on the conference website.
'Unbridled Enthusiasm'
The FDA has designated TriClip a "breakthrough" device with "the potential to provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease" compared with current treatments, an agency official, Megan Naber, told the advisory committee.
Naber said that for breakthrough devices, the "totality of data must still provide a reasonable assurance of safety and effectiveness" but the FDA "may be willing to accept greater uncertainty" about the balance of risks and benefits.
In a briefing paper for the advisory committee, FDA staff pointed out findings from a clinical trial that didn't reflect well on TriClip. For example, patients treated with TriClip had "numerically higher" mortality and heart failure hospitalization rates during the 12 months after the procedure compared with a control group, according to the report. Tippen, the Abbott spokesperson, didn't respond to a request for comment on those findings.
The committee voted 14-0 that TriClip was safe for its intended use. The panel voted 12-2 that the device was effective, and it voted 13-1 that the benefits of TriClip outweighed the risks.
The committee member to whom the database attributes the most money from Abbott, Paul Hauptman, cast one of the votes against the device on effectiveness and the sole vote against the device on the bottom-line question of its risks versus benefits.
Hauptman said during the meeting that the question of safety was "very, very clear" but added: "I just felt the need to pull back a little bit on unbridled enthusiasm." Who will benefit from the device, he said, "needs better definition."
Hauptman, dean of the University of Nevada-Reno School of Medicine, is connected to 268 general payments from Abbott totaling about $197,000 in the Open Payments database. Some payments are listed as going to an entity called Keswick Cardiovascular.
Hauptman said in an email that he followed FDA guidance and added, "My impartiality speaks for itself based on my vote and critical comments."
Some committee members voted in favor of the device despite concerns.
Marc Katz, chief of the Division of Cardiothoracic Surgery at the Medical University of South Carolina, is linked to 77 general payments totaling about $53,000 from Abbott and worked on research supported by about $10,000 from the company, according to Open Payments.
"I voted yes for safety, no for effectiveness, but then caved and voted yes for the benefits outweighing the risks," he said in the meeting.
In an email, he said of his Abbott payments: "All was disclosed and reviewed by the FDA." He said that he "can be impartial" and that he "openly expressed … concerns about the treatment."
Mitchell Krucoff, a professor at Duke University School of Medicine, is connected to 100 general payments totaling about $105,000. Some went to a third party, HPIC Consulting. He also worked on research supported by about $51,000 from Abbott, according to Open Payments.
He said during the meeting that he voted in favor of the device on all three questions and added that doctors have "a lot to learn" once it's on the market. For instance: By using the device to treat patients now, "do we set people up for catastrophes later?"
In an email, Krucoff said he completed a "very thorough conflict of interest screening by FDA for this panel," which focused not only on Abbott but also on "any work done/payments received from any other manufacturer with devices in this space."
John Hirshfeld Jr., an emeritus professor of medicine at the University of Pennsylvania, is linked by the database to six general payments from Abbott totaling $6,000. Two of the payments linked to him went to a nonprofit, the Cardiovascular Research Foundation, according to the database. He voted yes on all three questions about TriClip but said at the meeting that he "would have liked to have seen more rigorous data to support efficacy."
In an email, Hirshfeld said he disclosed the payments to the FDA. The agency did not deem him to have a conflict because he had no stake in Abbott's success and his involvement with the company had ended, he said. Through the conflict-of-interest screening process, he said, he had been excluded from prior advisory panels.